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RNS Number : 0908W  AstraZeneca PLC  06 February 2025

AstraZeneca

6 February 2025

Full Year and Q4 2024 results

 

Strong momentum in FY 2024 with Total Revenue and Core EPS up 21% and 19%
respectively

 

Revenue and EPS summary

 

                              FY 2024   % Change                      Q4 2024   % Change
                              $m        Actual    CER 1  (#_ftn1)     $m        Actual    CER
 - Product Sales              50,938    16        19                  13,362    18        19
 - Alliance Revenue           2,212     55        55                  714       68        69
 - Collaboration Revenue      923       56        54                  815       >2x       >2x
 Total Revenue                54,073    18        21                  14,891    24        25
 Reported EPS                 $4.54     18        29                  $0.97     56        71
 Core 2  (#_ftn2) EPS         $8.21     13        19                  $2.09     44        49

 

Financial performance for FY 2024 (Growth numbers at constant exchange rates)

 

‒    Total Revenue up 21% to $54,073m, driven by a 19% increase in
Product Sales, continued growth of partnered medicines (Alliance Revenue) and
the achievement of sales-based milestones (Collaboration Revenue)

 

‒    Total Revenue growth from Oncology was 24%, CVRM 20%, R&I 25%,
V&I 8% and Rare Disease 16%

 

‒    Core EPS increased 19% to $8.21

 

‒    Second interim dividend declared of $2.10 per share, making a total
annual dividend declared for FY 2024 of $3.10 per share, an increase of 7%.
Dividend to be further increased in FY 2025

 

‒    Guidance for FY 2025: Total Revenue is expected to increase by a
high single-digit percentage and Core EPS is expected to increase by a low
double-digit percentage, both at CER

 

Pascal Soriot, Chief Executive Officer, AstraZeneca, said:

 

"Our company delivered a very strong performance in 2024 with Total Revenue
and Core EPS up 21% and 19% respectively. We also delivered nine positive high
value Phase III studies in the year, which coupled with increasing demand for
our medicines in all key regions, will help sustain our growth momentum into
2025.

 

This year marks the beginning of an unprecedented, catalyst-rich period for
our company, an important step on our Ambition 2030 journey to deliver $80
billion Total Revenue by the end of the decade. In 2025 alone, we anticipate
the first Phase III data for seven new medicines, along with several important
new indication opportunities for our existing medicines.

 

We are also investing in and making significant progress with transformative
technologies that have the potential to drive our growth well beyond 2030,
many of which have now entered pivotal trials."

 

Key milestones achieved since the prior results announcement

 

‒    Positive read-outs for Truqap in combination with abiraterone and
androgen deprivation therapy in PTEN-deficient de novo metastatic
hormone-sensitive prostate cancer (CAPItello-281) and Tagrisso with or without
chemotherapy in resectable early-stage EGFRm NSCLC (NeoADAURA)

 

‒    US approvals for Imfinzi in limited-stage small cell lung cancer
(ADRIATIC), Calquence in combination with bendamustine and rituximab in mantle
cell lymphoma (ECHO), Datroway (datopotamab deruxtecan) in HR+ HER2-
metastatic breast cancer (TROPION-Breast01) and Enhertu in
chemotherapy-na•ve HER2-low and -ultralow metastatic breast cancer
(DESTINY-Breast06). EU approvals for Tagrisso in unresectable EGFRm NSCLC
(LAURA) and Kavigale for prevention of COVID-19 (SUPERNOVA). Japan approvals
for Imfinzi in endometrial cancer (DUO-E), Lynparza plus Imfinzi in pMMR
endometrial cancer (DUO-E), Calquence tablet formulation in chronic / small
lymphocytic leukaemia, Datroway in HR+ HER2- metastatic breast cancer, Fasenra
in EGPA (MANDARA) and Kavigale for prevention of COVID-19. China approvals for
Lynparza in gBRCAm HER2- early breast cancer (OlympiA), Orpathys in locally
advanced or metastatic MET Exon 14 NSCLC (NCT04923945)

 

Guidance

 

The Company issues its Total Revenue and Core EPS guidance for FY 2025 at CER,
based on the average foreign exchange rates through 2024.

 

 Total Revenue is expected to increase by a high single-digit percentage

Core EPS is expected to increase by a low double-digit percentage

 

‒    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 2025 to December 2025 were to remain at
the average rates seen in January 2025, it is anticipated that Total Revenue
in FY 2025 would incur a low single-digit percentage adverse impact compared
to the performance at CER, and Core EPS would incur a mid-single-digit
percentage adverse impact. The Company's foreign exchange rate sensitivity
analysis is provided in Table 17.

 

Capital allocation

 

In FY 2025, the Company intends to increase the annual dividend declared to
$3.20 per share. The Company also expects to increase capital expenditure 3 
(#_ftn3) by approximately 50%, driven by manufacturing expansion projects and
investment in IT systems, to support portfolio growth and build capacity for
transformative technologies.

 

China

 

In relation to the illegal drug importation allegations, in January 2025,
AstraZeneca received a Notice of Transfer to the Prosecutor and an Appraisal
Opinion from the Shenzhen City Customs Office regarding suspected unpaid
importation taxes amounting to $0.9 million. To the best of AstraZeneca's
knowledge, the importation taxes referred to in the Appraisal Opinion relate
to Imfinzi and Imjudo. A fine of between one and five times the amount of
unpaid importation taxes may also be levied if AstraZeneca is found liable.
AstraZeneca continues to fully cooperate with the Chinese authorities.

 

In December 2024 AstraZeneca announced the appointment of Iskra Reic as
Executive Vice President, International, which encompasses China, Asian and
Eurasian markets, Middle East & Africa, Latin America, Australia & New
Zealand. Iskra succeeds Leon Wang who is on extended leave from the Company
while under investigation in China.

 

Table 1: Key elements of Total Revenue performance in Q4 2024

 

     % Change

 

 Revenue type                       $m        Actual %    CER %
 Product Sales                      13,362    18          19
 Alliance Revenue                   714       68          69            *   $392m Enhertu (Q4 2023: $281m)

                                                                        *   $133m Tezspire (Q4 2023: $80m)

                                                                        *   $161m Beyfortus (Q4 2023: $41m)
 Collaboration Revenue              815       >2x         >2x           *   $600m Lynparza (Q4 2023: $245m)

                                                                        *   $111m Beyfortus (Q4 2023: $27m)

                                                                        *   $100m Koselugo (Q4 2023: nil)
 Total Revenue                      14,891    24          25
 Therapy areas                      $m        Actual %    CER %
 Oncology                           6,344     27          29            *   Tagrisso up 20% (21% at CER), Calquence up 20%, Enhertu up 48% (54% at
                                                                        CER)
 CVRM( )                            3,138     16          17            *   Farxiga up 21% (22% at CER), Lokelma up 35%
 R&I                                2,127     27          28            *   Breztri up 29%. Saphnelo up 65%, Tezspire up 86% (85% at CER), Symbicort
                                                                        up 31% (33% CER)
 V&I                                651       58          55            *   Beyfortus Total Revenue up >3x
 Rare Disease( )                    2,377     21          22            *   Ultomiris up 32% (33% at CER), partially offset by decline in Soliris of
                                                                        24% (22% at CER), Strensiq up 38% (37% at CER) and Koselugo up >3x
 Other Medicines                    254       (7)         (6)
 Total Revenue                      14,891    24          25
 Regions                            $m        Actual %    CER %
 US                                 6,532     28          28            *   Product Sales up 25%
 Emerging Markets                   3,134     13          19
 - China                            1,364     (1)         (3)           *   Decline primarily due to low rates of seasonal respiratory viral
                                                                        infections, and impact from year-end hospital budget dynamics
 - Ex-China Emerging Markets        1,770     26          42
 Europe                             3,948     37          35            *   Product Sales up 20% (18% at CER)
 Established RoW                    1,277     1           2
 Total Revenue                      14,891    24          25

 

Key alliance medicines

 

‒    Combined sales of Enhertu, recorded by Daiichi Sankyo Company
Limited (Daiichi Sankyo) and AstraZeneca, amounted to $3,754m in FY 2024 (FY
2023: $2,566m)

 

‒    Combined sales of Tezspire, recorded by Amgen and AstraZeneca,
amounted to $1,219m in FY 2024 (FY 2023: $653m)

 

Table 2: Key elements of financial performance in Q4 2024

 

 Metric                                          Reported  Reported change                   Core      Core                                Comments 4  (#_ftn4)

change
 Total Revenue                                   $14,891m  24% Actual      25% CER           $14,891m  24% Actual      25% CER             *   See Table 1 and the Total Revenue section of this document for further
                                                                                                                                           details
 Product Sales Gross Margin                      80%       Stable Actual      +1pp CER       79%       -1pp Actual      Stable CER         *   Variations in Product Sales Gross Margin can be expected between
                                                                                                                                           periods, due to product seasonality, foreign exchange fluctuations and other
                                                                                                                                           effects
 R&D                                             $4,677m   52% Actual      52% CER           $3,573m   23% Actual      22% CER             + Increased investment in the pipeline

 expense                                                                                                                                   *   Core R&D-to-Total Revenue ratio of 24%

(Q4 2023: 24%)

                                                                                                                                           *   Reported R&D includes $753m impairment recorded against the
                                                                                                                                           vemircopan (ALXN2050) intangible asset
 SG&A expense                                    $5,410m   1% Actual      1% CER             $4,275m   6% Actual      7% CER               + Market development for recent launches and pre-launch activities

                                                                                                                                           *   Core SG&A-to-Total Revenue ratio of 29%

(Q4 2023: 34%)
 Other operating income and expense 5  (#_ftn5)  $100m     -7% Actual      -6% CER           $101m     -7% Actual      -6% CER
 Operating Margin                                14%       +3pp Actual      +4pp CER         28%       +5pp Actual      +6pp CER           *   See commentary above on Gross Margin, R&D, SG&A and Other
                                                                                                                                           operating income and expense
 Net finance expense                             $365m     9% Actual      8% CER             $310m     20% Actual      20% CER             + Recent debt issued at higher interest rates

                                                                                                                                           + Decrease in interest income

                                                                                                                                           + Higher level of Net debt
 Tax rate                                        10%       +17pp Actual      +15pp CER       16%       +7pp Actual      +7pp CER           *   Variations in the tax rate can be expected between periods
 EPS                                             $0.97     56% Actual      71% CER           $2.09     44% Actual      49% CER             *   Further details of differences between Reported and Core are shown in
                                                                                                                                           Table 12

 

Table 3: Pipeline highlights since prior results announcement

 

 Event                                                            Medicine            Indication / Trial                                                   Event
 Regulatory approvals and other regulatory actions                Tagrisso            EGFRm NSCLC (Stage III                                               Regulatory approval (EU, CN)

                                                                                      unresectable) (LAURA)
                                                                  Imfinzi             Limited-stage SCLC (ADRIATIC)                                        Regulatory approval (EU)
                                                                  Imfinzi             Advanced endometrial cancer                                          Regulatory approval (JP)
                                                                  Calquence           Tablets for chronic lymphocytic leukaemia                            Regulatory approval (JP)
                                                                  Calquence           Mantle cell lymphoma (1st-line) (ECHO)                               Regulatory approval (US)
                                                                  Lynparza + Imfinzi  Advanced endometrial cancer with mismatch repair proficiency         Regulatory approval (JP)

                                                                                      (DUO-E)
                                                                  Lynparza            gBRCAm HER2- eBC (OlympiA)                                           Regulatory approval (CN)
                                                                  Enhertu             HR+ HER2-low and -ultralow mBC                                       Regulatory approval (US)

                                                                                      (DESTINY-Breast06)
                                                                  Datroway            HR+ HER2- mBC (TROPION-Breast01)                                     Regulatory approval (JP, US)
                                                                  Orpathys            MET exon 14 skipping altered NSCLC (NCT04923945)                     Regulatory approval (CN)
                                                                  Fasenra             EGPA (MANDARA)                                                       Regulatory approval (JP)
                                                                  Kavigale            Prevention of COVID-19 (SUPERNOVA)                                   Regulatory approval (EU, JP)

 Regulatory submissions                                           Imfinzi             Muscle-invasive bladder                                              Regulatory submission (US, JP)

or acceptances*

                                                                                      cancer (NIAGARA)
                                                                  Imfinzi + Imjudo    NSCLC (1st-line) (POSEIDON)                                          Regulatory submission (CN)
                                                                  Calquence           Chronic lymphocytic leukaemia (1st-line) (AMPLIFY)                   Regulatory submission (EU)
                                                                  Datroway            EGFRm NSCLC (later line) (TROPION-Lung05)                            Regulatory submission (US)
                                                                  Tezspire            Severe uncontrolled asthma (NAVIGATOR/                               Regulatory submission (CN)

                                                                                      DIRECTION)
                                                                  Koselugo            Neurofibromatosis type 1 adult (KOMET)                               Regulatory submission (EU, JP)

 Phase III / registrational data readouts and other developments  Tagrisso            Resectable early-stage EGFRm NSCLC (NeoADAURA)                       Primary endpoint met
                                                                  Truqap              PTEN-deficient de novo metastatic hormone-sensitive prostate cancer  Primary endpoint met
                                                                                      (CAPItello-281)

 

*US, EU and China regulatory submission denotes filing acceptance

 

Other pipeline updates

 

In January 2025, the vemircopan (ALXN2050) Phase II development programme was
terminated. The decision was based on safety and efficacy data from Phase II
trials.

 

Upcoming pipeline catalysts

 

For recent trial starts and anticipated timings of key trial readouts, please
refer to the Clinical Trials Appendix, available on
www.astrazeneca.com/investor-relations.html
(https://www.astrazeneca.com/investor-relations.html) .

 

Sustainability highlights

 

The Company convened an event on health equity for investors and analysts in
November that detailed AstraZeneca's health equity strategy, which is embedded
from the Company's science through to healthcare delivery and community
engagement.

 

At the end of 2024, the Company's cumulative reduction in Scope 1 and 2
greenhouse gas (GHG) emissions was 77.5% from the 2015 baseline.

 

Conference call

 

A conference call and webcast for investors and analysts will begin today, 6
February 2025, at 11:00 UK time. Details can be accessed via astrazeneca.com
(https://www.astrazeneca.com/) .

 

Reporting calendar

 

The Company intends to publish its Q1 2025 results on 29 April 2025.

 

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. The performance shown in this announcement covers the twelve-month
period to 31 December 2024 ('the year' or 'FY 2024') compared to the
twelve-month period to 31 December 2023 (FY 2023), or the three-month period
to 31 December 2024 ('the quarter' or 'Q4 2024') compared to the three-month
period to 31 December 2023 ('Q4 2023'), unless stated otherwise.

 

Core financial measures, EBITDA, Net debt, Product Sales 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:

 

‒    Charges and provisions related to our global restructuring
programmes, which includes charges that relate to the impact of restructuring
programmes on our capitalised manufacturing assets and IT assets

 

‒    Amortisation and impairment of intangible assets, including
impairment reversals but excluding any charges relating to IT assets

 

‒    Other specified items, principally comprising acquisition-related
costs and credits, which include 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, remeasurement adjustments
relating to certain Other payables and debt items assumed from the Alexion
acquisition and legal settlements

 

‒    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 61 of
the Annual Report and Form 20-F Information 2023.
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2023/pdf/AstraZeneca_AR_2023.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 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 4: Total Revenue by therapy area and medicine 6  (#_ftn6)

 

         FY 2024    Q4 2024

 

                 % Change            % Change

 

                                    $m        % Total    Actual     CER                    $m        % Total    Actual     CER
 Oncology                           22,353    41         21         24                     6,344     43         27         29
 - Tagrisso                         6,580     12         13         16                     1,703     11         20         21
 - Imfinzi                          4,717     9          17         21                     1,254     8          16         18
 - Calquence                        3,129     6          24         25                     808       5          20         20
 - Lynparza                         3,672     7          20         22                     1,444     10         46         47
 - Enhertu                          1,982     4          54         58                     540       4          48         54
 - Zoladex                          1,097     2          11         17                     252       2          (4)        (1)
 - Imjudo                           281       1          29         31                     73        -          27         28
 - Truqap                           430       1          >10x       >10x                   163       1          >10x       >10x
 - Orpathys                         46        -          -          2                      10        -          (15)       (16)
 - Other Oncology                   419       1          (19)       (14)                   97        1          (25)       (22)
 BioPharmaceuticals: CVRM           12,517    23         18         20                     3,138     21         16         17
 - Farxiga                          7,717     14         29         31                     1,938     13         21         22
 - Brilinta                         1,333     2          1          2                      341       2          4          4
 - Crestor                          1,155     2          4          8                      261       2          5          6
 - Lokelma                          542       1          32         34                     150       1          35         35
 - Seloken/Toprol-XL                606       1          (5)        -                      140       1          (3)        1
 - roxadustat                       336       1          22         23                     75        1          17         14
 - Andexxa                          219       -          20         22                     59        -          11         11
 - Wainua                           85        -          n/m        n/m                    42        -          n/m        n/m
 - Other CVRM                       524       1          (24)       (22)                   132       1          (9)        (7)
 BioPharmaceuticals: R&I            7,876     15         23                  25            2,127     14         27         28
 - Symbicort                        2,879     5          22         25                     684       5          31         33
 - Fasenra                          1,689     3          9          9                      471       3          12         12
 - Breztri                          978       2          44         46                     257       2          29         29
 - Pulmicort                        682       1          (4)        (1)                    164       1          (25)       (23)
 - Tezspire                         684       1          98         99                     213       1          86         85
 - Saphnelo                         474       1          69         70                     147       1          65         65
 - Airsupra                         66        -          >10x       >10x                   25        -          >10x       >10x
 - Other R&I                        424       1          (10)       (9)                    166       1          50         50
 BioPharmaceuticals: V&I            1,462     3          8          8                      651       4          58         55
 - Beyfortus                        722       1          >2x        >2x                    403       3          >3x        >3x
 - Synagis                          447       1          (18)       (14)                   101       1          (38)       (36)
 - COVID-19 mAbs                    31        -          (90)       (90)                   -         -          (96)       (93)
 - FluMist                          258       -          14         10                     149       1          7          3
 - Other V&I                        4         -          (68)       (68)                   (2)       -          (86)       (88)
 Rare Disease                       8,768     16         13         16                     2,377     16         21         22
 - Ultomiris                        3,924     7          32         34                     1,089     7          32         33
 - Soliris                          2,588     5          (18)       (14)                   543       4          (24)       (22)
 - Strensiq                         1,416     3          23         24                     420       3          38         37
 - Koselugo                         631       1          91         96                     265       2          >3x        >3x
 - Kanuma                           209       -          22         24                     60        -          47         48
 Other Medicines                    1,097     2          (9)        (5)                    254       2          (7)        (6)
 - Nexium                           886       2          (8)        (2)                    201       1          (6)        (4)
 - Others                           211       -          (16)       (14)                   53        -          (13)       (13)
 Total                              54,073    100        18         21                     14,891    100        24         25

 

Table 5: Alliance Revenue

 

         FY 2024                Q4 2024
               % Change               % Change
         $m    Actual    CER    $m    Actual    CER

 

 Enhertu                     1,437    41      41      392    40      41
 Tezspire                    436      69      69      133    67      67
 Beyfortus                   237      >4x     >4x     161    >3x     >3x
 Other royalty income        91       13      13      24     14      13
 Other Alliance Revenue      11       12      11      4      57      52
 Total                       2,212    55      55      714    68      69

 

Table 6: Collaboration Revenue

             FY 2024                            Q4 2024
                            % Change                           % Change
         $m          Actual        CER    $m            Actual        CER

 

 Lynparza: sales milestones       600    >2x       >2x       600    >2x       >2x
 Beyfortus: sales milestones      167    70        64        111    >4x       >3x
 Koselugo: sales milestones       100    n/m       n/m       100    n/m       n/m
 Farxiga: sales milestones        56     95        95        4      >5x       >5x
 Others                           -      n/m       n/m       -      n/m       n/m
 Total                            923    56        54        815    >2x       >2x

 

Table 7: Total Revenue by therapy area

 

     FY 2024    Q4 2024

 

         % Change        % Change

 

                         $m        % Total     Actual     CER    $m        % Total     Actual     CER
 Oncology                22,353    41         21          24     6,344     43         27          29
 Biopharmaceuticals      21,855    40         19          21     5,916     40         23          24
 CVRM                    12,517    23         18          20     3,138     21         16          17
 R&I                     7,876     15         23          25     2,127     14         27          28
 V&I                     1,462     3          8           8      651       4          58          55
 Rare Disease            8,768     16         13          16     2,377     16         21          22
 Other Medicines         1,097     2          (9)         (5)    254       2          (7)         (6)
 Total                   54,073    100        18          21     14,891    100        24          25

 

Table 8: Total Revenue by region

 

     FY 2024    Q4 2024

 

         % Change        % Change

 

                                 $m        % Total     Actual     CER    $m        % Total     Actual     CER
 US                              23,235    43         22          22     6,532     44         28          28
 Emerging Markets                13,675    25         14          22     3,134     21         13          19
 China                           6,413     12         9           11     1,364     9          (1)         (3)
 Emerging Markets ex. China      7,262     13         18          32     1,770     12         26          42
 Europe                          12,188    23         27          26     3,948     27         37          35
 Established ROW                 4,975     9          (2)         3      1,277     9          1           2
 Total                           54,073    100        18          21     14,891    100        24          25

 

Oncology

 

Oncology Total Revenue of $22,353m in FY 2024 increased by 21% (24% at CER),
representing 41% of overall Total Revenue (FY 2023: 40%). Collaboration
Revenue was $600m in FY 2024 (FY 2023: $245m), from a sales-related milestone
for Lynparza.

 

Tagrisso

 

 FY 2024, $m      Worldwide    US     Emerging Markets  Europe  Established RoW
 Total Revenue    6,580        2,763  1,755             1,301   761
 Actual change    13%          21%    8%                16%     (3%)
 CER change       16%          21%    16%               15%     4%

 

 Region               Drivers and commentary
 Worldwide           *   Strong global demand for Tagrisso in adjuvant (ADAURA) and 1st-line
                     settings (FLAURA, FLAURA-2)
 US                  *   Continued demand growth in both the adjuvant and 1st-line settings and,
                     early launch momentum in Stage III unresectable disease (LAURA), with
                     additional favourability coming from improved affordability
 Emerging Markets    *   Encouraging demand growth, partially offset by year-end hospital budget
                     dynamics in China in the fourth quarter
 Europe              *   Continued demand growth across adjuvant and 1st-line settings
 Established RoW     *   Strong demand growth in 1st-line settings with year-over-year comparison
                     reflecting price reduction in Japan in June 2023

 

Imfinzi

 

 FY 2024, $m      Worldwide    US     Emerging Markets  Europe  Established RoW
 Total Revenue    4,717        2,603  479               948     687
 Actual change    17%          20%    35%               28%     (8%)
 CER change       21%          20%    59%               27%     (2%)

 

 Region               Drivers and commentary
 Worldwide           *   Strong demand growth driven by HCC (HIMALAYA), BTC (TOPAZ-1), increased
                     patient share in Stage IV NSCLC (POSEIDON), and extensive-stage SCLC (CASPIAN)
 US                  *   Continued demand growth driven primarily by HCC and extensive-stage SCLC

                     *   Early growth signals from launches in early NSCLC (AEGEAN) and
                     limited-stage SCLC (ADRIATIC)
 Emerging Markets    *   Strong demand growth driven across all approved indications, in
                     particular BTC
 Europe              *   Growth driven by share gains in extensive-stage SCLC as well as new
                     launches in HCC, BTC and NSCLC
 Established RoW     *   Increased demand in GI indications, offset by 25% and 11% mandatory
                     price reductions in Japan effective from 1 February 2024 and 1 August 2024
                     respectively

 

Calquence

 

 FY 2024, $m      Worldwide    US     Emerging Markets  Europe  Established RoW
 Total Revenue    3,129        2,190  153               656     130
 Actual change    24%          21%    56%               33%     20%
 CER change       25%          21%    79%               32%     22%

 

 Region        Drivers and commentary
 Worldwide    *   Sustained BTKi leadership in front-line CLL (ELEVATE-TN)
 US           *   Growth driven by leading share of new patient starts in front-line CLL
              despite increased competitive pressure, with additional favourability coming
              from improved affordability
 Europe       *   Strong growth in front-line CLL, maintaining share of 1L new patient
              starts in competitive environment

 

Lynparza

 

 FY 2024, $m      Worldwide    US     Emerging Markets  Europe  Established RoW
 Total Revenue    3,672        1,332  655               1,432   253
 Actual change    20%          6%     21%               46%     (10%)
 CER change       22%          6%     30%               46%     (5%)

 

 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

                     *   Collaboration Revenue $600m (FY 2023: $245m)
 US                  *   Continued leadership within competitive PARP inhibitor class, with
                     demand growth across all indications), and additional favourability coming
                     from improved affordability
 Emerging Markets    *   Volume growth in China from increased share following inclusion of
                     HRD-positive ovarian cancer (PAOLA-1) on NRDL with no price reduction
                     effective 1 January 2024
 Europe              *   Growth driven by increased market share and additional launches in early
                     breast cancer (OlympiA) and metastatic prostate cancer (PROpel)

                     *   Recognised a $600m sales-related milestone payment, recorded as
                     Collaboration Revenue in Q4 2024
 Established RoW     *   PARP class leadership maintained with year-over-year comparison
                     reflecting 7.7% price reduction in Japan in November 2023

 

 

Enhertu

 

 FY 2024, $m      Worldwide    US   Emerging Markets  Europe  Established RoW
 Total Revenue    1,982        893  478               542     69
 Actual change    54%          27%  88%               83%     >2x
 CER change       58%          27%  >2x               82%     >2x

 

 Region               Drivers and commentary
 Worldwide           *   Established standard of care in HER2-positive (DESTINY-Breast03) and
                     HER2-low (DESTINY-Breast04) metastatic breast cancer

                     *   Encouraging early uptake, particularly in gynaecological indications
                     following tumour-agnostic approval in April 2024 (DESTINY-PanTumor02,
                     DESTINY-Lung01, DESTINY‑CRC02)

                     *   Combined sales of Enhertu, recorded by Daiichi Sankyo and AstraZeneca,
                     amounted to $3,754m in FY 2024 (FY 2023: $2,566m)
 US                  *   US in-market sales, recorded by Daiichi Sankyo, amounted to $1,864m in
                     FY 2024 (FY 2023: $1,472m)

                     *   Some spontaneous use in chemotherapy-na•ve and HER2-ultralow
                     populations following data presentation and New England Journal of Medicine
                     publication (DESTINY-Breast06)
 Emerging Markets    *   Increased demand growth following Q1 2024 launch in HER2-positive and
                     HER2-low metastatic breast cancer in China with some stock compensation 7 
                     (#_ftn7) in Q4 2024 due to NRDL enlistment
 Europe              *   AstraZeneca's European revenue includes a mid single-digit percentage
                     royalty on Daiichi Sankyo's sales in Japan, recorded as Alliance Revenue

 

Other Oncology medicines

 

   FY 2024  Change

 

 Total Revenue     $m     Actual   CER      Drivers and commentary
 Zoladex           1,097  11%      17%      *   Strong underlying growth in China and Emerging Markets and moderate
                                            growth in Europe with reduced uptake in Japan
 Imjudo            281    29%      31%      *   Continued growth across markets
 Truqap            430    >10x     >10x     *   Strong demand growth with uptake in biomarker altered subgroup of HR+
                                            HER2- metastatic breast cancer (CAPItello-291), some benefit in the US in Q4
                                            2024 due to one-off launch stocking of blister pack
 Orpathys          46     -        2%       *   Demand in China for the treatment of patients with NSCLC with MET exon
                                            14 skipping alterations
 Other Oncology    419    (19%)    (14%)    *   Decline in Faslodex Total Revenue due to VBP implementation in China in
                                            March 2024 and generic erosion in Europe

 

 

BioPharmaceuticals

 

BioPharmaceuticals Total Revenue increased by 19% (21% at CER) in FY 2024 to
$21,855m, representing 40% of overall Total Revenue (FY 2023: 40%).

 

BioPharmaceuticals - CVRM

 

CVRM Total Revenue increased by 18% (20% at CER) to $12,517m in FY 2024 and
represented 23% of overall Total Revenue (FY 2023: 23%).

 

Farxiga

 

 FY 2024, $m      Worldwide    US     Emerging Markets  Europe  Established RoW
 Total Revenue    7,717        1,752  2,853             2,634   478
 Actual change    29%          21%    29%               40%     6%
 CER change       31%          21%    35%               39%     12%

 

 Region               Drivers and commentary
 Worldwide           *   Continued volume growth in all major regions, driven by continued demand
                     in heart failure and CKD

                     *   SGLT2 class growth underpinned by updated cardiorenal guidelines
 US                  *   Growth driven by underlying demand in HFrEF and CKD and launch of an
                     authorised generic in the first quarter of 2024
 Emerging Markets    *   Increased reimbursement in ex-China Emerging Markets supporting growth

                   despite entry of generic competition in some markets

                     *   Q4 2024 sales in China impacted by year-end hospital budget dynamics
 Europe              *   Continued strong class growth and market share gains
 Established RoW     *   Continued demand growth partially offset by generic competition in
                     Canada

                     *   In Japan, AstraZeneca sells to collaborator Ono Pharmaceutical Co., Ltd,
                     which records in-market sales

 

Other CVRM medicines

 

   FY 2024  Change

 

 Total Revenue    $m     Actual  CER    Drivers and commentary
 Brilinta         1,333  1%      2%     *   Continued sales growth in Emerging Markets, offset partly by decline in
                                        Established RoW driven by generic competition in Canada
 Crestor          1,155  4%      8%     *   Continued sales growth in Emerging Markets, decline in other regions
 Seloken          606    (5%)    -      *   Growth in ex-China Emerging Markets offsetting declines in most other
                                        major regions
 Lokelma          542    32%     34%    *   Strong growth in all major regions, particularly in Europe and Emerging

      Markets

      *   Continued patient and volume growth
 Roxadustat       336    22%     23%
 Andexxa          219    20%     22%    *   Growth in year
 Wainua           85     n/m     n/m    *   Continued strong US launch momentum
 Other CVRM       524    (24%)   (22%)

 

BioPharmaceuticals - R&I

 

Total Revenue of $7,876m from R&I medicines increased 23% (25% at CER) and
represented 15% of overall Total Revenue (FY 2023: 14%).

 

Fasenra

 

 FY 2024, $m      Worldwide    US     Emerging Markets  Europe  Established RoW
 Total Revenue    1,689        1,049  92                404     144
 Actual change    9%           6%     44%               14%     1%
 CER change       9%           6%     55%               13%     6%

 

 Region               Drivers and commentary
 Worldwide           *   Expanded severe asthma market share leadership in IL-5 class across
                     major markets
 US                  *   Sustained double-digit volume growth, partially offset by channel mix
 Emerging Markets    *   Continued strong demand growth driven by launch acceleration across key
                     markets 
 Europe              *   Sustained leadership in severe eosinophilic asthma
 Established RoW     *   In Japan, maintained class leadership in a broadly stable market

 

Breztri

 

 FY 2024, $m      Worldwide    US   Emerging Markets  Europe  Established RoW
 Total Revenue    978          516  245               143     74
 Actual change    44%          35%  52%               78%     41%
 CER change       46%          35%  57%               77%     47%

 

 Region               Drivers and commentary
 Worldwide           *   Fastest growing triple medicine within the expanding FDC triple class
 US                  *   Consistent share growth within the expanding FDC triple class
 Emerging Markets    *   Maintained market share leadership in China with strong FDC triple class
                     penetration

                     *   Demand in fourth quarter in China impacted by low rates of respiratory
                     viral infections

                     *   Further expansion with launches in additional geographies
 Europe              *   Sustained growth across markets driven by new launches
 Established RoW     *   Increased market share in Japan

 

Tezspire

 

 FY 2024, $m      Worldwide      US   Emerging Markets  Europe  Established RoW
 Total Revenue    684            436  11                156     81
 Actual change    98%            67%  >8x               >3x     >2x
 CER change       99%            67%  >8x               >3x     >2x

 

 Region              Drivers and commentary
 Worldwide          *   Combined sales of Tezspire, recorded by Amgen and AstraZeneca, amounted
                    to $1,219m in FY 2024 (FY 2023: $653m)
 US                 *   Continued strong volume growth YoY, with majority of patients
                    new-to-biologics
 Europe             *   Achieved and maintained new-to-brand leadership across multiple markets,
                    new launches continue to progress
 Established RoW    *   Sustained market share growth in Japan and other major geographies, with
                    continued launches

 

Symbicort

 

 FY 2024, $m      Worldwide    US     Emerging Markets  Europe  Established RoW
 Total Revenue    2,879        1,187  805               559     328
 Actual change    22%          63%    7%                2%      (2%)
 CER change       25%          63%    16%               1%      -

 

 Region               Drivers and commentary
 Worldwide           *   Symbicort remained the global market leader within a stable ICS/LABA
                     class
 US                  *   Continued strong demand for the authorised generic and favourable
                     channel mix
 Emerging Markets    *   Sustained demand growth across markets in Ex-China regions

                     *   Demand in fourth quarter in China impacted by low rates of respiratory
                     viral infections
 Europe              *   Continued growth within mild asthma in some markets partially offset
                     generic erosion and a slowing overall market
 Established RoW     *   Continued generic erosion in Japan

 

Other R&I medicines

 

   FY 2024     Change

 

 Total Revenue      $m   Actual   CER      Drivers and commentary
 Pulmicort          682  (4%)     (1%)     *   Emerging Markets are >80% of Pulmicort revenues

                                           *   Emerging Markets declined 23% (21% at CER) in the fourth quarter due to
                                           low rates of seasonal respiratory viral infections in China
 Saphnelo           474  69%      70%      *   Demand acceleration in the US, and additional growth driven by ongoing
                                           launches in Europe and Established RoW
 Airsupra           66   >10x     >10x     *   Strong US launch momentum and volume uptake. Revenue in the period
                                           continues to reflect patient introductory discounts as access continues to
                                           build
 Other R&I          424  (10%)    (9%)     *   Continued generic competition

 

BioPharmaceuticals - V&I

 

Total Revenue from V&I medicines increased by 8% to $1,462m (FY 2023:
$1,357m) and represented 3% of overall Total Revenue (FY 2023: 3%).

 

V&I medicines

 

   FY 2024  Change

 

 Total Revenue      $m   Actual  CER     Drivers and commentary
 Beyfortus          722  >2x     >2x     *   Growth driven by increased demand and expanded production capacity

                                         *   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, and 25% of brand revenues
                                         in rest of world markets

                                         *   AstraZeneca has no participation in US profits or losses
 Synagis            447  (18%)   (14%)   *   Synagis demand decreased following rapid adoption of Beyfortus
 COVID-19 mAbs      31   (90%)   (90%)   *   Decline in Evusheld sales and Collaboration Revenue (Total Revenue FY
                                         2023: $312m)
 FluMist            258  14%     10%     *   Demand growth across key markets, in particular Europe, and benefit from
                                         earlier start in flu season compared to prior year
 Other V&I          4    (68%)   (68%)   *   Decline in Vaxzevria sales (FY 2023: $11m)

 

Rare Disease

 

Total Revenue from Rare Disease medicines increased by 13% (16% at CER) in FY
2024 to $8,768m, representing 16% of overall Total Revenue (FY 2023: 17%).
 Koselugo Collaboration Revenue was $100m in FY 2024 (FY 2023: $0m)
reflecting achievement of sales milestone. Product Sales increased by 12%
(14% at CER) in FY 2024 to $8,668m.

 

Ultomiris

 

 FY 2024, $m      Worldwide    US     Emerging Markets  Europe  Established RoW
 Total Revenue    3,924        2,261  141               884     638
 Actual change    32%          29%    100%              32%     34%
 CER change       34%          29%    >2x               31%     43%

 

 Region               Drivers and commentary
 Worldwide           *   Growth due to increased use in neurology, geographic expansion, further
                     patient demand and conversion from Soliris

                     *   Ultomiris Total Revenue includes sales of Voydeya, which is approved as
                     an add‑on treatment to Ultomiris and Soliris for the 10-20% of PNH patients
                     who experience clinically significant EVH
 US                  *   Strong growth in patient demand in gMG (CHAMPION-MG) and NMOSD
                     (CHAMPION-NMOSD), both new-to-branded medicines, as well as continued
                     conversion from Soliris
 Emerging Markets    *   Expansion into new markets and growth in patient demand
 Europe              *   Strong demand growth following recent launches, particularly from
                     neurology indications, conversion from Soliris
 Established RoW     *   Continued conversion from Soliris and strong demand following new
                     launches

 

 

Soliris

 

 FY 2024, $m      Worldwide    US     Emerging Markets  Europe  Established RoW
 Total Revenue    2,588        1,523  443               416     206
 Actual change    (18%)        (12%)  4%                (38%)   (35%)
 CER change       (14%)        (12%)  34%               (38%)   (32%)

 

 Region               Drivers and commentary
 Worldwide           *   Decline driven by successful conversion of patients from Soliris to
                     Ultomiris
 Emerging Markets    *   Growth driven by patient demand
 Europe              *   Decline driven by successful conversion from Soliris to Ultomiris and
                     biosimilar erosion in PNH and aHUS

 

Strensiq

 

 FY 2024, $m      Worldwide    US     Emerging Markets  Europe  Established RoW
 Total Revenue    1,416        1,167  54                99      96
 Actual change    23%          25%    33%               11%     12%
 CER change       24%          25%    43%               10%     18%

 

 Region               Drivers and commentary
 Worldwide           *   Growth driven by strong patient demand and geographic expansion
 Emerging Markets    *   Q4 2024 benefitted from favourable timing of tender orders

 

Koselugo

 

 FY 2024, $m      Worldwide    US   Emerging Markets  Europe  Established RoW
 Total Revenue    631          212  177               203     39
 Actual change    91%          9%   >3x               >3x     62%
 CER change       96%          9%   >3x               >3x     73%

 

 Region               Drivers and commentary
 Worldwide           *   Growth driven by strong patient demand and geographic expansion
 Europe              *   Total Revenue includes $100m Collaboration Revenue booked in Q4 2024
                     from achievement of sales-based milestone
 Emerging Markets    *   Growing demand following new approvals and reimbursements, Q4 2024
                     benefitted from favourable timing of tender orders

 

Other Rare Disease medicines

 

   FY 2024  Change

 

 Total Revenue    $m   Actual  CER  Drivers and commentary
 Kanuma           209  22%     24%  *   Continued global demand

 

Other medicines (outside the main therapy areas)

 

   FY 2024  Change

 

 Total Revenue      $m   Actual  CER    Drivers and commentary
 Nexium             886  (8%)    (2%)   *   Growth in Emerging Markets, which now accounts for two-thirds of Nexium
                                        revenue, offset by generic erosion in other markets
 Others             211  (16%)   (14%)  *   Continued impact of generic competition

 

Financial performance

 

Table 9: Reported Profit and Loss

 

     FY 2024  FY 2023  % Change    Q4 2024  Q4 2023  % Change

 

                                           $m        $m        Actual    CER     $m        $m        Actual    CER
 Total Revenue                             54,073    45,811    18        21      14,891    12,024    24        25
 - Product Sales                           50,938    43,789    16        19      13,362    11,323    18        19
 - Alliance Revenue                        2,212     1,428     55        55      714       424       68        69
 - Collaboration Revenue                   923       594       56        54      815       277       >2x       >2x
 Cost of sales                             (10,207)  (8,268)   23        25      (2,725)   (2,308)   18        16
 Gross profit                              43,866    37,543    17        20      12,166    9,716     25        27
 Distribution expense                      (555)     (539)     3         5       (143)     (145)     (1)       1
 R&D expense                               (13,583)  (10,935)  24        25      (4,677)   (3,073)   52        52
 SG&A expense                              (19,977)  (19,216)  4         5       (5,410)   (5,371)   1         1
 Other operating income & expense          252       1,340     (81)      (81)    100       107       (7)       (6)
 Operating profit                          10,003    8,193     22        32      2,036     1,234     65        79
 Net finance expense                       (1,284)   (1,282)   -         (3)     (365)     (337)     9         8
 Joint ventures and associates             (28)      (12)      >2x       >2x     (5)       -         n/m       n/m
 Profit before tax                         8,691     6,899     26        38      1,666     897       86        >2x
 Taxation                                  (1,650)   (938)     76        92      (166)     62        >4x       >4x
 Tax rate                                  19%       14%                         10%       -7%
 Profit after tax                          7,041     5,961     18        29      1,500     959       56        71
 Earnings per share                        $4.54     $3.84     18        29      $0.97     $0.62     56        71

 

Table 10: Reconciliation of Reported Profit before tax to EBITDA

 

     FY 2024  FY 2023  % Change  Q4 2024  Q4 2023  % Change

 

                                                $m        $m        Actual    CER     $m       $m       Actual    CER
 Reported Profit before tax                     8,691     6,899     26        38      1,666    897      86        >2x
 Net finance expense                            1,284     1,282     -         (3)     365      337      9         8
 Joint ventures and associates                  28        12        >2x       >2x     5        -        n/m       n/m
 Depreciation, amortisation and impairment      6,688     5,387     24        24      2,337    1,327    76        76
 EBITDA                                         16,691    13,580    23        29      4,373    2,561    71        77

 

Table 11: Reconciliation of Reported to Core financial measures: FY 2024 8 
(#_ftn8)

 

 FY 2024    Reported  Restructuring  Intangible Asset Amortisation & Impairments      Other  Core  Core

                                                                                                   % Change

 

                                           $m        $m       $m       $m       $m        Actual    CER
 Gross profit                              43,866    569      32       5        44,472    18        20
 Product Sales Gross Margin                80%                                  81%       -1pp      -
 Distribution expense                      (555)     -        -        -        (555)     3         5
 R&D expense                               (13,583)  275      1,090    7        (12,211)  19        19
 % of Total Revenue                        25%                                  23%       -         -
 SG&A expense                              (19,977)  312      4,286    351      (15,028)  9         11
 % of Total Revenue                        37%                                  28%       +2pp      +2pp
 Total operating expense                   (34,115)  587      5,376    358      (27,794)  13        14
 Other operating income & expense          252       (2)      -        -        250       (81)      (81)
 Operating profit                          10,003    1,154    5,408    363      16,928    16        22
 Operating Margin                          18%                                  31%       -         -
 Net finance expense                       (1,284)   -        -        115      (1,169)   19        15
 Taxation                                  (1,650)   (219)    (1,044)  (88)     (3,001)   31        38
 EPS                                       $4.54     $0.60    $2.82    $0.25    $8.21     13        19

 

Table 12: Reconciliation of Reported to Core financial measures: Q4 20248

 

 Q4 2024                                   Reported  Restructuring          Intangible Asset Amortisation & Impairments         Other  Core      Core

                                                                                                                                                 % Change
                                           $m               $m       $m                               $m                               $m        Actual    CER
 Gross profit                              12,166           (86)     8                                1                                12,089    24        26
 Product Sales Gross Margin                80%                                                                                         79%       -1pp      -
 Distribution expense                      (143)            -        -                                -                                (143)     (1)       1
 R&D expense                               (4,677)          54       1,052                            (2)                              (3,573)   23        22
 % of Total Revenue                        31%                                                                                         24%       -         +1pp
 SG&A expense                              (5,410)          132      943                              60                               (4,275)   6         7
 % of Total Revenue                        36%                                                                                         29%       +5pp      +5pp
 Total operating expense                   (10,230)         186      1,995                            58                               (7,991)   13        13
 Other operating income & expense          100              -        -                                1                                101       (7)       (6)
 Operating profit                          2,036            100      2,003                            60                               4,199     53        58
 Operating Margin                          14%                                                                                         28%       +5pp      +6pp
 Net finance expense                       (365)            -        -                                55                               (310)     20        20
 Taxation                                  (166)            (30)     (423)                            (21)                             (640)     >2x       >2x
 EPS                                       $0.97            $0.05    $1.02                            $0.05                            $2.09     44        49

 

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
2024 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

 

‒      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 Sales 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 records
its sales of manufactured product to its distribution partner Sanofi as
Product Sales; those have a lower Product Sales Gross Margin than the Company
average

 

‒      Dilutive effects from geographic mix. In Emerging Markets, the
Product Sales Gross Margin tends to be below the Company
average

 

‒      The reported Product Sales Gross Margin included inventory and
related contract provisions of $529m related to Andexxa, which was part of the
PAAGR restructuring program (see Note 2 in the Notes to the Condensed
consolidated financial statements section)

 

‒    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:

 

‒      Positive data read-outs for high value pipeline opportunities
that have ungated late-stage trials

 

‒      Investment in platforms, new technology and capabilities to
enhance R&D capabilities

 

‒      Addition of R&D projects following completion of previously
announced business development activity including Icosavax, Gracell, Fusion
and Amolyt

 

‒    The change in Reported R&D expense was also impacted by
intangible asset impairments in the year, including $753m recorded against the
vemircopan (ALXN2050) intangible asset

 

SG&A expense

 

‒    The change in SG&A expense (Reported and Core) in the period was
driven primarily by market development activities for launches and to support
continued growth in existing brands

 

‒    The Reported SG&A expense included impairment charges of $504m
recorded against the Andexxa intangible asset

 

Other operating income and expense

 

‒    In the prior year period, Other operating income and expense
included a $241m gain on disposal of the US rights to Pulmicort Flexhaler and
a $712m gain relating to updated contractual arrangements for Beyfortus

 

Net finance expense

 

‒    Core Net finance expense increased 19% (15% increase at CER) due to
the increased level of debt and new debt issued at higher interest rates

 

Taxation

 

‒    The effective Reported and Core Tax rate for the twelve months to 31
December 2024 was 19% (FY 2023: 14% and 17% respectively)

 

‒    The cash tax paid for the twelve months to 31 December 2024 was
$2,750m (2023: $2,366m), representing 32% of Reported Profit before tax (2023:
34%)

 

Dividends

 

‒    A second interim dividend of $2.10 per share (168.0 pence, 22.96
SEK) has been declared, resulting in a full-year dividend per share of $3.10
(245.6 pence, 33.75 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 2024 second interim dividend: ex-dividend
20 February 2025, record date 21 February 2025, payable on 24 March 2025.

 

Table 13: Cash Flow summary

 

                                                                  FY 2024    FY 2023    Change
                                                                  $m         $m         $m
 Reported Operating profit                                        10,003     8,193      1,810
 Depreciation, amortisation and impairment                        6,688      5,387      1,301
 Movement in working capital and short-term provisions            (893)      300        (1,193)
 Gains on disposal of intangible assets                           (64)       (251)      187
 Fair value movements on contingent consideration arising from    311        549        (238)

 business combinations
 Non-cash and other movements                                     (121)      (386)      265
 Interest paid                                                    (1,313)    (1,081)    (232)
 Taxation paid                                                    (2,750)    (2,366)    (384)
 Net cash inflow from operating activities                        11,861     10,345     1,516
 Net cash inflow before financing activities                      3,881      6,281      (2,400)
 Net cash outflow from financing activities                       (3,996)    (6,567)    2,571

 

The change in Net cash inflow before financing activities of $2,400m is
primarily driven by Acquisitions of subsidiaries, net of cash acquired of
$2,771m, and relates to the acquisition of Gracell Biotechnologies, Inc. for
$774m and acquisition of Fusion Pharmaceuticals Inc., for $1,997m as compared
to the acquisition of Neogene Therapeutics, Inc. for $189m in FY 2023.

 

The decrease in Net cash outflow from financing activities of $2,571m is
primarily driven by increased issuance of long-term loans of $6,492m in the
period compared to $3,816m issued in the comparative period.

 

Capital expenditure

 

Capital expenditure on tangible assets and Software-related intangible assets
amounted to $2,218m in FY 2024 (FY 2023: $1,516m). The increase of capital
expenditure in 2024 was driven by investment in several major manufacturing
projects and continued investment in technology upgrades.

 

Table 14: Net debt summary

 

                                                         At 31        At 31

                                                          Dec 2024    Dec 2023
                                                         $m           $m
 Cash and cash equivalents                               5,488        5,840
 Other investments                                       166          122
 Cash and investments                                    5,654        5,962
 Overdrafts and short-term borrowings                    (330)        (515)
 Lease liabilities                                       (1,452)      (1,128)
 Current instalments of loans                            (2,007)      (4,614)
 Non-current instalments of loans                        (26,506)     (22,365)
 Interest-bearing loans and borrowings (Gross debt)      (30,295)     (28,622)
 Net derivatives                                         71           150
 Net debt                                                (24,570)     (22,510)

 

 

Net debt increased by $2,060m in the twelve months to 31 December 2024 to
$24,570m. 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.

 

Summarised financial information for guarantee of securities of subsidiaries

 

AstraZeneca Finance LLC ("AstraZeneca Finance") is the issuer of 1.2% Notes
due 2026, 4.8% Notes due 2027, 4.875% Notes due 2028, 1.75% Notes due 2028,
4.85% Notes due 2029, 4.9% Notes due 2030, 4.9% Notes due 2031, 2.25% Notes
due 2031, 4.875% Notes due 2033 and 5% Notes due 2034 (the "AstraZeneca
Finance USD Notes"). Each series of AstraZeneca Finance USD 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 USD 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 USD 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 USD Notes are
structurally subordinated to indebtedness and other liabilities of the
subsidiaries of AstraZeneca PLC, none of which guarantee the AstraZeneca
Finance USD 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 as filed with the SEC and information
contained herein for further financial information regarding AstraZeneca PLC
and its consolidated subsidiaries. For further details, terms and conditions
of the AstraZeneca Finance USD Notes please refer to AstraZeneca PLC's reports
on Form 6-K furnished to the SEC on 22 February 2024, 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.

 

Capital allocation

 

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. In FY 2025, the Company intends to
increase the annual dividend per share declared to $3.20 per share.

 

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.

 

In FY 2024, capital expenditure on tangible assets and Software-related
intangible assets amounted to $2,218m. In FY 2025 the Company expects to
increase expenditure on tangible assets and Software-related intangible assets
by approximately 50%, driven by manufacturing expansion projects and
investments in systems and technology.

 

Table 15: Obligor group summarised Statement of comprehensive income

 

                                                                        FY 2024  FY 2023
                                                                        $m       $m
 Total Revenue                                                          -        -
 Gross profit                                                           -        -
 Operating loss                                                         (34)     (34)
 Loss for the period                                                    (1,182)  (976)
 Transactions with subsidiaries that are not issuers or guarantors      1,661    15,660

 

Table 16: Obligor group summarised Statement of financial position

 

                                                                       At 31 Dec 2024     At 31 Dec 2023
                                                                       $m                 $m
 Current assets                                                        54                 5
 Non-current assets                                                    -                  -
 Current liabilities                                                   (2,347)            (4,856)
 Non-current liabilities                                               (26,603)           (22,239)
 Amounts due from subsidiaries that are not issuers or guarantors      18,272             18,421
 Amounts due to subsidiaries that are not issuers or guarantors        -                  -

 

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 17: Currency sensitivities

 

The Company provides the following information on currency sensitivity:

 

                                                  Average                                                                              Annual impact ($m) of 5% weakening vs USD (FY 2025 average rate vs. FY 2024

                                                                                    average) (( 9  (#_ftn9) ))
                                                  rates vs. USD
 Currency                  Primary Relevance      FY                   YTD                  Change  Jan 31                 Change      Total Revenue                            Core Operating Profit

2024 10  (#_ftn10)
2025 11  (#_ftn11)
        2025 12  (#_ftn12)

                                                                                             (%)                            (%)
 EUR                       Total Revenue          0.92                 0.97                 (4)     0.96                   (4)         (461)                                    (232)
 CNY                       Total Revenue          7.21                 7.32                 (2)     7.30                   (1)         (313)                                    (171)
 JPY                       Total Revenue          151.46               156.52               (3)     154.70                 (2)         (179)                                    (121)
 Other(( 13  (#_ftn13) ))                                                                                                              (557)                                    (289)
 GBP                       Operating expense      0.78                 0.81                 (3)     0.80                   (3)         (68)                                     124
 SEK                       Operating expense      10.57                11.09                (5)     11.02                  (4)         (9)                                      69

 

Sustainability

 

AstraZeneca was recognised by TIME as one of the World's Best Companies in
Sustainable Growth 2025, for its strong financial and environmental
performance.

 

Access to healthcare

 

‒    AstraZeneca ranked fifth overall in the Access to Medicine Index
(ATMI) 2024, an independent ranking of 20 of the world's largest
pharmaceutical companies evaluating efforts to improve access to medicines in
low and middle-income countries. AstraZeneca was ranked fourth in both
Governance of Access and Product Delivery, with ATMI recognising the Company's
best practice in reporting outcomes for its access strategies across different
countries' income classifications. The Company also performed well in Research
and Development, having the largest pipeline for non-communicable diseases of
all companies in scope

‒    By end of December 2024, the Company's flagship Healthy Heart Africa
programme had conducted more than 67.4 million blood pressure screenings,
identifying more than 12.9 million people with elevated blood pressure, and
diagnosing more than 5.3 million with high blood pressure, since launch in
2014

‒    The Company convened an event on health equity for investors and
analysts in November that detailed AstraZeneca's health equity strategy, which
is embedded from the Company's science through to healthcare delivery and
community engagement

‒    AstraZeneca also convened the second meeting of its Global Health
Equity Advisory Board, a group of 15 external stakeholders with representation
from 11 countries, to advise on the Company's approach to help improve
equitable health outcomes globally

‒    In November, the Company held its first lung health expert summit in
Philadelphia, US, bringing together medical experts and non-governmental
organisations (NGOs) to build alignment and consensus on more integrated and
equitable service models for patients with lung diseases

‒    During the fourth quarter of 2024, the Partnership for Health System
Sustainability and Resilience (PHSSR) launched three new country reports at
engagements with ministerial representation in Egypt, Malaysia and India. The
first PHSSR EU Expert Advisory Group workshop on sustainable healthcare
financing also took place, focusing on how to prioritise funding for
healthcare to improve patient access and outcomes, and enhance innovation

‒    The Young Health Programme (YHP) won Community Partnership of the
Year at the SCRIP Awards, in partnership with UNICEF. Now active in 41
countries, in 2024 the YHP directly reached 4.5 million young people, trained
more than 140,000 people and engaged more than 3,500 employee volunteers

 

Environmental protection

 

‒    At the end of 2024, the Company's cumulative reduction in Scope 1
and 2 greenhouse gas (GHG) emissions was 77.5% from the 2015 baseline

‒    Insights from CEO Pascal Soriot on climate risks and opportunities
were featured in a report from the World Economic Forum Alliance of CEO
Climate Leaders on The Cost of Inaction: A CEO Guide to Navigating Climate
Risk

‒    EVP Global Operations & IT and Chief Sustainability Officer Pam
Cheng was recognised on the TIME100 Climate 2024 list as a global climate
leader

‒    Reducing the carbon impact of pressurised metered dose inhalers is a
key product-related element of AstraZeneca's Ambition Zero Carbon strategy.
Regulatory filings for Breztri/Trixeo Aerosphere with an innovative,
next-generation propellant, with 99.9% lower Global Warming Potential than
propellants used in currently available inhaled medicines, were submitted to
the European Medicines Agency, in China, the UK and other countries

‒    Continued transition to electronic product information (ePI),
including in Brazil, where AstraZeneca helped launch the consultation for a
paperless pilot in partnership with the national regulator. In the EU, the
Company supported a workshop at the EU Patient Safety Conference 2024,
building on the upcoming introduction of ePI proposed in the revised EU
General Pharmaceutical Legislation

‒    In December, AstraZeneca became the first organisation to achieve
the new My Green Lab 2.0 Certification. The Company has over 129 lab spaces
certified in 15 countries, and 91 achieved the highest level of certification
- Green. My Green Lab is a key measure of progress recognised by the United
Nations Race to Zero campaign

 

Ethics and transparency

 

‒    In October 2024, AstraZeneca launched its annual mandatory Code of
Ethics awareness training, reminding employees of the Company's commitment to
high ethical standards across the enterprise. The training uses real-world
scenarios and provides a new Ethical Decision Making Model tool to help
employees think through ethical dilemmas

‒    The Company highlighted its Values on Global Ethics Day in October
through a range of global and local engagements. Employees were also invited
to complete the 2024 Global Ethics Survey to share their perspectives on how
the Company's Values are embedded

‒    The Company's annual 'Pulse' employee survey results published in
December 2024, showing that 87% of employees worldwide understand how they can
contribute to AstraZeneca's sustainability priorities

 

Research and development

 

This section covers R&D events and milestones that have occurred since the
prior results announcement on 12 November 2024, up to and including events on
5 February 2025.

 

A comprehensive view of AstraZeneca's pipeline of medicines in human trials
can be found in the latest Clinical Trials Appendix, available on
www.astrazeneca.com/investor-relations
(https://www.astrazeneca.com/investor-relations.html) . The Clinical Trials
Appendix includes tables with details of the ongoing clinical trials for
AstraZeneca medicines and new molecular entities in the pipeline.

 

Oncology

 

AstraZeneca presented new data across its diverse portfolio of cancer
medicines at two major medical congresses since the prior results
announcement: the American Society of Hematology 66th Annual Meeting and
Exposition and the San Antonio Breast Cancer Symposium 2024. Across the two
meetings, more than 100 abstracts were presented featuring 18 approved and
potential new medicines including 11 oral presentations.

 

Tagrisso

 

 Event                                 Commentary
 Approval                 Europe       For the treatment of adult patients with locally advanced, unresectable NSCLC
                                       whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution
                                       mutations and whose disease has not progressed during or following
                                       platinum-based chemoradiation therapy. (LAURA, December 2024)
 Approval                 China        For locally advanced, unresectable (stage III) NSCLC whose tumours have EGFR
                                       exon 19 deletion or exon 21 (L858R) substitution mutation and whose disease
                                       has not progressed during or following platinum‑based chemoradiation
                                       therapy. (New disclosure, LAURA, January 2025)
 Phase III trial readout  NeoADAURA    Tagrisso with or without chemotherapy demonstrated a statistically significant
                                       and  clinically meaningful improvement in the primary endpoint of major
                                       pathologic response compared to neoadjuvant chemotherapy alone for patients
                                       with resectable, early-stage (II, IIIA and IIIB) EGFRm NSCLC. There was also
                                       an improvement in pathologic complete response and an early trend to event
                                       free survival improvement vs neoadjuvant chemotherapy alone. The safety and
                                       tolerability profiles for Tagrisso monotherapy and in combination with
                                       chemotherapy, were consistent with the established profiles of each product.
                                       The data will be presented at a forthcoming medical meeting. (New disclosure,
                                       Q4 2024)

 

Imfinzi and Imjudo

 

 Event                       Commentary
 Approval         Japan      For advanced or recurrent endometrial cancer. (New disclosure, DUO-E, November
                             2024)
 Approval         US         For limited-stage small cell lung cancer whose disease has not progressed
                             following concurrent platinum-based chemotherapy and radiation therapy.
                             (ADRIATIC, December 2024)
 Priority Review  US         For the treatment of patients with muscle-invasive bladder cancer. (NIAGARA,
                             December 2024)
 CHMP Opinion     EU         Recommended for approval for limited-stage small cell lung cancer whose
                             disease has not progressed following platinum-based chemoradiation therapy.
                             (ADRIATIC, January 2025)

 

k

 

Lynparza

 

 Event                                     Commentary
 Approval                       Japan      For maintenance treatment after treatment with platinum-based chemotherapy in
                                           combination with Imfinzi (genetical recombination) in advanced or recurrent
                                           endometrial cancer with pMMR. (New disclosure, DUO-E, November 2024)
 Phase III presentation: SABCS  OlympiA    At a median follow-up of 6.1 years in eligible patients, who had completed
                                           local treatment and standard neoadjuvant or adjuvant chemotherapy, results
                                           showed Lynparza reduced the risk of death by 28% (HR 0.72; 95% CI 0.56-0.93)
                                           versus placebo. In addition, 87.5% of patients treated with Lynparza remained
                                           alive versus 83.2% of those on placebo. (December 2024)
 Approval                       China      For the adjuvant treatment of deleterious or suspected deleterious gBRCAm,
                                           HER2-negative high risk early breast cancer who have been treated with
                                           neoadjuvant or adjuvant chemotherapy. (New disclosure, OlympiA, December 2024)

 

Enhertu

 

 Event             Commentary
 Approval  US      For unresectable or metastatic HR-positive, HER2-low (IHC 1+ or IHC 2+/ISH-)
                   or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined
                   by a FDA-approved test, that has progressed on one or more endocrine therapies
                   in the metastatic setting. (DESTINY-Breast06, January 2026)

 

Calquence

 

 Event                                     Commentary
 Phase III presentation: ASH  AMPLIFY      Calquence plus venetoclax reduced the risk of disease progression or death by

            35% compared to standard-of-care chemoimmunotherapy (HR 0.65; 95% CI
                                           0.49-0.87; p=0.0038). Calquence plus venetoclax with obinutuzumab demonstrated
                                           a 58% reduction in the risk of disease progression or death compared to
                                           standard-of-care chemoimmunotherapy (HR 0.42; 95% CI 0.30-0.59; p<0.0001).
                                           Median PFS was not reached for either experimental arm versus median PFS of
                                           47.6 months for chemoimmunotherapy. (December 2024)
 Approval                     Japan        Calquence tablets 100 mg for chronic lymphocytic leukaemia (including small
                                           lymphocytic lymphoma) (New disclosure, December 2024)
 Approval                     US           Calquence in combination with bendamustine and rituximab for patients with
                                           previously untreated mantle cell lymphoma who are ineligible for autologous
                                           hematopoietic stem cell transplantation. (ECHO, January 2024)

 

Truqap

 

 Event                                       Commentary
 Phase III trial readout  CAPItello-281      Truqap in combination with abiraterone and androgen deprivation therapy

                  demonstrated a statistically significant and clinically meaningful improvement
                                             in the primary endpoint of radiographic PFS versus abiraterone and ADT with
                                             placebo in patients with PTEN-deficient de novo metastatic hormone-sensitive
                                             prostate cancer. (November 2024)

 

Datroway (datopotamab deruxtecan)

 

 Event                          Commentary
 Regulatory update  Europe      Voluntary withdrawal of marketing authorisation application for the treatment

           of adult patients with locally advanced or metastatic non-squamous NSCLC.
                                (TROPION-Lung01, December 2024)
 Approval           Japan       For unresectable or metastatic HR-positive, HER2-negative breast cancer who
                                have received prior endocrine-based therapy and chemotherapy for unresectable
                                or metastatic disease. (New disclosure, TROPION-Breast01, December 2025)
 Priority Review    US          For locally advanced or metastatic EGFRm NSCLC who have received prior

           systemic therapies, including an EGFR-directed therapy. (TROPION-Lung05,
                                TROPION-Lung01, TROPION-PanTumor01, January 2025)
 Approval           US          For unresectable or metastatic HR-positive, HER2-negative breast cancer who
                                have received prior endocrine-based therapy and chemotherapy for unresectable
                                or metastatic disease. (TROPION-Breast01, January 2025)
 CHMP opinion       EU          Recommended for approval for unresectable or metastatic HR-positive,
                                HER2-negative breast cancer who have received endocrine therapy and at least
                                an additional line of chemotherapy in the advanced setting. (New disclosure,
                                TROPION-Breast01, January 2025)

 

Orpathys

 

 Event                Commentary
 Approval  China      For locally advanced or metastatic non-small cell lung cancer with MET exon 14
                      skipping alteration. (New disclosure, NCT04923945, January 2025)

 

BioPharmaceuticals - CVRM

 

Andexxa

 

 Event                    Commentary
 Regulatory update  US    The US FDA issued a CRL regarding the supplemental Biologics License
                          Application to convert Andexxa to traditional approval. (November 2024)

 

BioPharmaceuticals - R&I

 

Breztri

 

 Event                         Commentary
 Regulatory submission  NGP    Regulatory submissions for Breztri with the next-generation propellant have

      been accepted in the UK and China. (New disclosure, November 2024, December
                               2024)

 

Fasenra

 

 Event                        Commentary
 Approval    Japan            For the treatment of adult patients with eosinophilic granulomatosis with
                              polyangiitis. (New disclosure, MANDARA, December 2024)
 Approval    Europe           As an add-on treatment for adult patients with relapsing or refractory
                              eosinophilic granulomatosis with polyangiitis. (New disclosure, MANDARA,
                              October 2024)

 

BioPharmaceuticals - V&I

 

Kavigale

 

 Event               Commentary
 Approval  Japan     For the pre-exposure prophylaxis (prevention) of COVID-19 in
                     immune-compromised individuals aged 12 years or older. (New disclosure,
                     SUPERNOVA, December 2024)
 Approval  Europe    For the pre-exposure prophylaxis (prevention) of COVID-19 in
                     immune-compromised individuals aged 12 years or older. (New disclosure,
                     SUPERNOVA, January 2025)

 

Condensed consolidated financial statements

 

Table 18: Condensed consolidated statement of comprehensive income: FY 2024

 

 For the twelve months ended 31 December                                          2024      2023
                                                                                  $m        $m
 Total Revenue                                                                    54,073    45,811
 Product Sales                                                                    50,938    43,789
 Alliance Revenue                                                                 2,212     1,428
 Collaboration Revenue                                                            923       594
 Cost of sales                                                                    (10,207)  (8,268)
 Gross profit                                                                     43,866    37,543
 Distribution expense                                                             (555)     (539)
 Research and development expense                                                 (13,583)  (10,935)
 Selling, general and administrative expense                                      (19,977)  (19,216)
 Other operating income and expense                                               252       1,340
 Operating profit                                                                 10,003    8,193
 Finance income                                                                   458       344
 Finance expense                                                                  (1,742)   (1,626)
 Share of after tax losses in associates and joint ventures                       (28)      (12)
 Profit before tax                                                                8,691     6,899
 Taxation                                                                         (1,650)   (938)
 Profit for the period                                                            7,041     5,961
 Other comprehensive income:
 Items that will not be reclassified to profit or loss:
 Remeasurement of the defined benefit pension liability                           80        (406)
 Net gains on equity investments measured at fair value through other             139       278
 comprehensive income
 Fair value movements related to own credit risk on bonds designated as fair      12        (6)
 value through profit or loss
 Tax on items that will not be reclassified to profit or loss                     (43)      101
                                                                                  188       (33)
 Items that may be reclassified subsequently to profit or loss:
 Foreign exchange arising on consolidation                                        (957)     608
 Foreign exchange arising on designated liabilities in net investment hedges      (122)     24
 Fair value movements on cash flow hedges                                         (129)     266
 Fair value movements on cash flow hedges transferred to profit and loss          177       (145)
 Fair value movements on derivatives designated in net investment hedges          39        44
 Costs of hedging                                                                 (21)      (19)
 Tax on items that may be reclassified subsequently to profit or loss             25        (12)
                                                                                  (988)     766
 Other comprehensive (expense)/income, net of tax                                 (800)     733
 Total comprehensive income for the period                                        6,241     6,694
 Profit attributable to:
 Owners of the Parent                                                             7,035     5,955
 Non-controlling interests                                                        6         6
                                                                                  7,041     5,961
 Total comprehensive income attributable to:
 Owners of the Parent                                                             6,236     6,688
 Non-controlling interests                                                        5         6
                                                                                  6,241     6,694
 Basic earnings per $0.25 Ordinary Share                                          $4.54     $3.84
 Diluted earnings per $0.25 Ordinary Share                                        $4.50     $3.81
 Weighted average number of Ordinary Shares in issue (millions)                   1,550     1,549
 Diluted weighted average number of Ordinary Shares in issue (millions)           1,563     1,562

 

Table 19: Condensed consolidated statement of comprehensive income: Q4 2024

 

 For the quarter ended 31 December
                                                                                    2024      2023
                                                                                    $m        $m
 Total Revenue                                                                      14,891    12,024
 Product Sales                                                                      13,362    11,323
 Alliance Revenue                                                                   714       424
 Collaboration Revenue                                                              815       277
 Cost of sales                                                                      (2,725)   (2,308)
 Gross profit                                                                       12,166    9,716
 Distribution expense                                                               (143)     (145)
 Research and development expense                                                   (4,677)   (3,073)
 Selling, general and administrative expense                                        (5,410)   (5,371)
 Other operating income and expense                                                 100       107
 Operating profit                                                                   2,036     1,234
 Finance income                                                                     64        108
 Finance expense                                                                    (429)     (445)
 Share of after tax losses in associates and joint ventures                         (5)       -
 Profit before tax                                                                  1,666     897
 Taxation                                                                           (166)     62
 Profit for the period                                                              1,500     959
 Other comprehensive income:
 Items that will not be reclassified to profit or loss:
 Remeasurement of the defined benefit pension liability                             (56)      (405)
 Net (losses)/gains on equity investments measured at fair value through other      (125)     233
 comprehensive income
 Fair value movements related to own credit risk on bonds designated as fair        -         (11)
 value through profit or loss
 Tax on items that will not be reclassified to profit or loss                       7         101
                                                                                    (174)     (82)
 Items that may be reclassified subsequently to profit or loss:
 Foreign exchange arising on consolidation                                          (1,500)   809
 Foreign exchange arising on designated liabilities in net investment hedges        (38)      87
 Fair value movements on cash flow hedges                                           (87)      204
 Fair value movements on cash flow hedges transferred to profit and loss            176       (173)
 Fair value movements on derivatives designated in net investment hedges            26        (3)
 Costs of hedging                                                                   (23)      (16)
 Tax on items that may be reclassified subsequently to profit or loss               9         (5)
                                                                                    (1,437)   903
 Other comprehensive (expense)/income, net of tax                                   (1,611)   821
 Total comprehensive (expense)/income for the period                                (111)     1,780
 Profit attributable to:
 Owners of the Parent                                                               1,500     960
 Non-controlling interests                                                          -         (1)
                                                                                    1,500     959
 Total comprehensive income attributable to:
 Owners of the Parent                                                               (110)     1,781
 Non-controlling interests                                                          (1)       (1)
                                                                                    (111)     1,780
 Basic earnings per $0.25 Ordinary Share                                            $0.97     $0.62
 Diluted earnings per $0.25 Ordinary Share                                          $0.96     $0.62
 Weighted average number of Ordinary Shares in issue (millions)                     1,550     1,549
 Diluted weighted average number of Ordinary Shares in issue (millions)             1,562     1,561

 

Table 20: Condensed consolidated statement of financial position

 

                                                   At 31 Dec  At 31 Dec

                                                   2024       2023
                                                   $m         $m
 Assets

 Non-current assets
 Property, plant and equipment                     10,252     9,402
 Right-of-use assets                               1,395      1,100
 Goodwill                                          21,025     20,048
 Intangible assets                                 37,177     38,089
 Investments in associates and joint ventures      268        147
 Other investments                                 1,632      1,530
 Derivative financial instruments                  182        228
 Other receivables                                 930        803
 Deferred tax assets                               5,347      4,718
                                                   78,208     76,065
 Current assets
 Inventories                                       5,288      5,424
 Trade and other receivables                       12,972     12,126
 Other investments                                 166        122
 Derivative financial instruments                  54         116
 Income tax receivable                             1,859      1,426
 Cash and cash equivalents                         5,488      5,840
                                                   25,827     25,054
 Total assets                                      104,035    101,119
 Liabilities

 Current liabilities
 Interest-bearing loans and borrowings             (2,337)    (5,129)
 Lease liabilities                                 (339)      (271)
 Trade and other payables                          (22,465)   (22,374)
 Derivative financial instruments                  (50)       (156)
 Provisions                                        (1,269)    (1,028)
 Income tax payable                                (1,406)    (1,584)
                                                   (27,866)   (30,542)
 Non-current liabilities
 Interest-bearing loans and borrowings             (26,506)   (22,365)
 Lease liabilities                                 (1,113)    (857)
 Derivative financial instruments                  (115)      (38)
 Deferred tax liabilities                          (3,305)    (2,844)
 Retirement benefit obligations                    (1,330)    (1,520)
 Provisions                                        (921)      (1,127)
 Income tax payable                                (238)      -
 Other payables                                    (1,770)    (2,660)
                                                   (35,298)   (31,411)
 Total liabilities                                 (63,164)   (61,953)
 Net assets                                        40,871     39,166

 Share capital                                     388        388
 Share premium account                             35,226     35,188
 Other reserves                                    2,012      2,065
 Retained earnings                                 3,160      1,502
                                                   40,786     39,143
 Non-controlling interests                         85         23
 Total equity                                      40,871     39,166

 

Table 21: Condensed consolidated statement of changes in equity

 

                                                         Share capital  Share premium account  Other reserves  Retained earnings  Total attributable to owners of the parent  Non-controlling interests  Total equity
                                                         $m             $m                     $m              $m                 $m                                          $m                         $m
 At 1 Jan 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

 At 1 Jan 2024                                           388            35,188                 2,065           1,502              39,143                                      23                         39,166
 Profit for the period                                   -              -                      -               7,035              7,035                                       6                          7,041
 Other comprehensive expense                             -              -                      -               (799)              (799)                                       (1)                        (800)
 Transfer to other reserves                              -              -                      15              (15)               -                                           -                          -
 Transactions with owners
 Dividends                                               -              -                      -               (4,602)            (4,602)                                     -                          (4,602)
 Dividends paid to non-controlling interests             -              -                      -               -                  -                                           (4)                        (4)
 Issue of Ordinary Shares                                -              38                     -               -                  38                                          -                          38
 Changes in non-controlling interests                    -              -                      -               -                  -                                           61                         61
 Movement in shares held by Employee Benefit Trusts      -              -                      (68)            -                  (68)                                        -                          (68)
 Share-based payments charge for the period              -              -                      -               660                660                                         -                          660
 Settlement of share plan awards                         -              -                      -               (621)              (621)                                       -                          (621)
 Net movement                                            -              38                     (53)            1,658              1,643                                       62                         1,705
 At 31 Dec 2024                                          388            35,226                 2,012           3,160              40,786                                      85                         40,871

 

Table 22: Condensed consolidated statement of cash flows:

 

 For the twelve months ended 31 December    2024    2023
                                            $m      $m

 

 Cash flows from operating activities
 Profit before tax                                                            8,691     6,899
 Finance income and expense                                                   1,284     1,282
 Share of after tax losses of associates and joint ventures                   28        12
 Depreciation, amortisation and impairment                                    6,688     5,387
 Movement in working capital and short-term provisions                        (893)     300
 Gains on disposal of intangible assets                                       (64)      (251)
 Fair value movements on contingent consideration arising from business       311       549
 combinations
 Non-cash and other movements                                                 (121)     (386)
 Cash generated from operations                                               15,924    13,792
 Interest paid                                                                (1,313)   (1,081)
 Tax paid                                                                     (2,750)   (2,366)
 Net cash inflow from operating activities                                    11,861    10,345

 Cash flows from investing activities
 Acquisition of subsidiaries, net of cash acquired                            (2,771)   (189)
 Payments upon vesting of employee share awards attributable to business      (3)       (84)
 combinations
 Payment of contingent consideration from business combinations               (1,008)   (826)
 Purchase of property, plant and equipment                                    (1,924)   (1,361)
 Disposal of property, plant and equipment                                    55        132
 Purchase of intangible assets                                                (2,662)   (2,417)
 Disposal of intangible assets                                                123       291
 Movement in profit-participation liability                                   -         190
 Purchase of non-current asset investments                                    (96)      (136)
 Disposal of non-current asset investments                                    78        32
 Movement in short-term investments, fixed deposits and other investing       30        97
 instruments
 Payments to associates and joint ventures                                    (158)     (80)
 Disposal of investments in associates and joint ventures                     13        -
 Interest received                                                            343       287
 Net cash outflow from investing activities                                   (7,980)   (4,064)
 Net cash inflow before financing activities                                  3,881     6,281

 Cash flows from financing activities
 Proceeds from issue of share capital                                         38        33
 Own shares purchased by Employee Benefit Trusts                              (81)      -
 Issue of loans and borrowings                                                6,492     3,816
 Repayment of loans and borrowings                                            (4,652)   (4,942)
 Dividends paid                                                               (4,629)   (4,481)
 Hedge contracts relating to dividend payments                                16        (19)
 Repayment of obligations under leases                                        (316)     (268)
 Movement in short-term borrowings                                            (31)      161
 Payment of Acerta Pharma share purchase liability                            (833)     (867)
 Net cash outflow from financing activities                                   (3,996)   (6,567)
 Net decrease in Cash and cash equivalents in the period                      (115)     (286)
 Cash and cash equivalents at the beginning of the period                     5,637     5,983
 Exchange rate effects                                                        (93)      (60)
 Cash and cash equivalents at the end of the period                           5,429     5,637
 Cash and cash equivalents consist of:
 Cash and cash equivalents                                                    5,488     5,840
 Overdrafts                                                                   (59)      (203)
                                                                              5,429     5,637

 

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 2024 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 2024 and 2023 together
with the Statement of financial position as at 31 December 2024 and 2023. The
results for the year to 31 December 2024 have been extracted from the 31
December 2024 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 18 February 2025
within the Annual Report and Form 20-F Information 2024.

 

The financial information set out above does not constitute the Group's
statutory accounts for the years to 31 December 2024 or 2023 but is derived
from these 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 2024 or for 31 December 2023. Statutory accounts for the year to 31
December 2024 were approved by the Board of Directors for release on 6
February 2025.

 

Amendments to accounting standards issued by the IASB and adopted in the year
ended 31 December 2024 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 2023.

The comparative figures for the financial year ended 31 December 2023 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.

 

Going concern

The Group has considerable financial resources available. As at 31 December
2024, the Group has $10.4bn in financial resources (cash and cash equivalent
balances of $5.5bn and undrawn committed bank facilities of $4.9bn that were
available until April 2029), with $2.7bn of borrowings due within one year.
These facilities contain no financial covenants, and in January 2025 their
maturity was extended to April 2030.

 

The Group has assessed the prospects of the Group over a period longer than
the required 12 months from the date of Board approval of these consolidated
financial statements, with no deterioration noted requiring a further
extension of this review. 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 2023.
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2023/pdf/AstraZeneca_AR_2023.pdf)

 

Employee Benefit Trusts

Following an amendment to the Employee Benefit Trust (EBT) Deed on 10 June
2024, AstraZeneca obtained control and commenced consolidation of the EBT from
June 2024. From that date, cash paid on purchases of AstraZeneca Ordinary
shares or American Depositary Receipts is presented within Financing
activities in the Condensed consolidated statement of cash flows.

 

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. In 2024, the Group recorded impairment charges of $504m in
respect of launched products. Following a strategic review of our portfolio
priorities, the business decision was made to cease promotional activity for
Andexxa resulting in impairment charges of $504m recorded against the Andexxa
intangible asset under a value-in-use model applying a discount rate of 7.5%
(revised carrying amount: $nil).

 

Impairment charges recorded against products in development totalled $1,073m.
This included vemircopan (ALXN2050) (acquired as part of the Alexion business
combination in 2021 - $753m) which was terminated, the decision was based on
safety and efficacy data from Phase II trials across multiple indications. In
December 2024, the intangible asset relating to the product in development,
FPI-2059, was fully impaired by $165m due to portfolio prioritisation
decisions. Development of FPI-2265 and AZD2068 are still ongoing and continue
to be a priority. The remaining impairments of $155m relate to impairments of
various products in development, due to either management's decision to
discontinue development as part of Group-wide portfolio prioritisation
decisions, or due to the outcome of research activities.

 

Icosavax

The acquisition of Icosavax, Inc. completed on 19 February 2024. The
transaction is recorded as an asset acquisition based on the concentration
test permitted under IFRS 3 'Business Combinations', with consideration of
$841m principally relating to $639m of intangible assets, $141m of cash and
cash equivalents and $51m of marketable securities. Contingent consideration
of up to $300m could be paid on achievement of regulatory and sales
milestones; these potential liabilities would be recorded when the relevant
recognition event for a regulatory or sales milestone is achieved.

 

Amolyt

The acquisition of Amolyt Pharma completed on 15 July 2024. The transaction is
recorded as an asset acquisition based on the concentration test permitted
under IFRS 3 'Business Combinations', with consideration of $857m principally
relating to $800m of intangible assets and $98m of cash and cash equivalents.
Contingent consideration of up to $250m could be paid on achievement of a
regulatory milestone; this potential liability would be recorded when the
relevant recognition event for a regulatory milestone is achieved.

 

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 2023
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2023/pdf/AstraZeneca_AR_2023.pdf)
. Net debt is a non-GAAP financial measure.

 

Table 23: Net debt

 

                                                         At 1 Jan 2024  Cash flow  Acquisitions  Non-cash      Exchange movements  At 31 Dec 2024
                                                                                                 & other
                                                         $m             $m         $m            $m            $m                  $m
 Non-current instalments of loans                        (22,365)       (6,498)    (3)           2,081         279                 (26,506)
 Non-current instalments of leases                       (857)          -          (12)          (275)         31                  (1,113)
 Total long-term debt                                    (23,222)       (6,498)    (15)          1,806         310                 (27,619)
 Current instalments of loans                            (4,614)        4,590      (9)           (2,001)       27                  (2,007)
 Current instalments of leases                           (271)          374        (6)           (450)         14                  (339)
 Collateral received from derivative counterparties      (215)          34         -             -             -                   (181)
 Other short-term borrowings excluding overdrafts        (97)           (3)        -             -             10                  (90)
 Overdrafts                                              (203)          144        -             -             -                   (59)
 Total current debt                                      (5,400)        5,139      (15)          (2,451)       51                  (2,676)
 Gross borrowings                                        (28,622)       (1,359)    (30)          (645)         361                 (30,295)
 Net derivative financial instruments                    150            41         -             (120)         -                   71
 Net borrowings                                          (28,472)       (1,318)    (30)          (765)         361                 (30,224)
 Cash and cash equivalents                               5,840          (501)      242           -             (93)                5,488
 Other investments - current                             122            (30)       87            -             (13)                166
 Cash and investments                                    5,962          (531)      329           -             (106)               5,654
 Net debt                                                (22,510)       (1,849)    299           (765)         255                 (24,570)

 

Net debt increased by $2,060m in the twelve months to 31 December 2024 to
$24,570m. Details of the committed undrawn bank facilities are disclosed
within the going concern section of Note 1. Non-cash movements in the period
include fair value adjustments under IFRS 9 'Financial Instruments'.

 

In February 2024, AstraZeneca issued the following:

 

‒      $1,250m of fixed-rate notes with a coupon of 4.8% maturing in
February 2027

‒      $1,250m of fixed-rate notes with a coupon of 4.85% maturing in
February 2029

‒      $1,000m of fixed-rate notes with a coupon of 4.9% maturing in
February 2031

‒      $1,500m of fixed-rate notes with a coupon of 5% maturing in
February 2034

 

In August 2024, AstraZeneca issued the following:

 

‒      Û650m of fixed-rate notes with a coupon of 3.121% maturing in
August 2030

‒      Û750m of fixed-rate notes with a coupon of 3.278% maturing in
August 2033

 

Each of the above notes were issued by AstraZeneca Finance LLC and are fully
and unconditionally guaranteed by AstraZeneca PLC.

 

AstraZeneca repaid two bonds with a total carrying value of $2,569m and
floating rate bank loans of $2,000m during the twelve months which is included
in the cash outflow from Repayment of loans and borrowings of $4,652m.

 

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 2024 was $181m (31 December 2023: $215m) and the
carrying value of such cash collateral posted by the Group at 31 December 2024
was $129m (31 December 2023: $102m).

 

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 $nil (31 December 2023: $833m).

 

During the quarter ended 31 December 2024, there have been no changes to the
Company's solicited long term credit ratings. Moody's credit rating were long
term: A2; short term: P-1. Standard and Poor's credit ratings were 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 $353m (31 December 2023: $313m) and
for which a fair value loss of $9m has been recognised in the twelve months
ended 31 December 2024 (FY 2023: gains of $17m). In the absence of specific
market data, these unlisted investments are held at fair value based on the
cost of investment and adjusted 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 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 2024, are Level 1 fair value measurements, valued based on
quoted prices in active markets.

 

Financial instruments measured at fair value include $1,669m of other
investments, $4,177m held in money-market funds and $71m of derivatives as at
31 December 2024. With the exception of derivatives being Level 2 fair valued,
and certain equity instruments of $353m categorised as Level 3, the
aforementioned balances are Level 1 fair valued. Financial instruments
measured at amortised cost include $129m of cash collateral pledged to
counterparties. The total fair value of Interest-bearing loans and borrowings
as at 31 December 2024, which have a carrying value of $30,295m in the
Condensed consolidated statement of financial position, was $29,179m.

 

Table 24: Financial instruments - contingent consideration

 

       2024      2023

 

                                              Diabetes alliance  Other  Total    Total
                                              $m                 $m     $m       $m
 At 1 January                                 1,945              192    2,137    2,222
 Additions through business combinations      -                  198    198      60
 Settlements                                  (998)              (10)   (1,008)  (826)
 Revaluations                                 260                51     311      549
 Discount unwind                              102                11     113      132
 On 31 December                               1,309              442    1,751    2,137

 

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 $1,309m (31 December 2023: $1,945m) would
increase/decrease by $131m with an increase/decrease in sales of 10%, as
compared with the current estimates.

 

Note 5: Business combinations

 

Gracell

On 22 February 2024, AstraZeneca completed the acquisition of Gracell
Biotechnologies Inc. (Gracell), a global clinical-stage biopharmaceutical
company developing innovative cell therapies for the treatment of cancer and
autoimmune diseases.

 

The purchase price allocation review has been completed with no changes to the
amounts reported in the H1 and Q2 2024 results announcement. The transaction
is recorded as a business combination using the acquisition method of
accounting in accordance with IFRS 3 'Business Combinations'.

 

The total consideration fair value of $1,037m includes cash consideration of
$983m and future regulatory milestone-based consideration of $54m. Intangible
assets recognised relate to products in development, principally AZD0120.
Goodwill of $136m has been recognised. Gracell's results have been
consolidated into the Group's results from 22 February 2024.

 

Fusion

On 4 June 2024, AstraZeneca completed the acquisition of Fusion
Pharmaceuticals Inc., (Fusion) a clinical-stage biopharmaceutical company
developing next-generation radioconjugates.

 

The purchase price allocation review has been completed with no changes to the
amounts reported in the H1 and Q2 2024 results announcement. The transaction
is recorded as a business combination using the acquisition method of
accounting in accordance with IFRS 3 'Business Combinations'.

 

The total consideration fair value of $2,195m includes cash consideration of
$2,051m and future regulatory milestone-based consideration of $144m.
Intangible assets relating to products in development comprise the FPI-2265
($848m), FPI-2059 ($165m) and AZD2068 ($313m) programmes. Goodwill of $947m
has been recognised. Fusion's results have been consolidated into the Group's
results from 4 June 2024.

 

In December 2024, the intangible asset relating to the product in development,
FPI-2059, was fully impaired by $165m due to portfolio prioritisation
decisions. Development of FPI-2265 and AZD2068 are still ongoing and continue
to be a priority.

 

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 2023, the H1 2024 and the Q3 2024 results
announcements (the Disclosures). Information about the nature and facts of the
cases is disclosed in accordance with IAS 37.

 

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.

 

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 2024 and to 6 February
2025

 

Table 25: Patent litigation

 

 

 Legal proceedings brought against AstraZeneca

 

 Soliris patent proceedings, Turkey          *   In November 2024, Salute HC İlalarõ Sanayi ve Ticaret A.Ş (Salute)

                                           served an action in the Industrial and Intellectual Property Rights Court in
                                             Istanbul, Turkey seeking to invalidate and enjoin enforcement of Alexion's

                                           patent relating to eculizumab.
 Considered to be a contingent liability

 

 Legal proceedings brought by AstraZeneca

 

 Calquence patent proceedings, US          *   In February 2022, in response to Paragraph IV notices from multiple ANDA

                                         filers, AstraZeneca filed patent infringement lawsuits in the US District
                                           Court for the District of Delaware (District Court). In its complaints,

                                         AstraZeneca alleged that a generic version of Calquence capsules, if approved
 Considered to be a contingent asset       and marketed, would infringe patents that are owned or licensed by

                                         AstraZeneca.

                                           *   In 2024, AstraZeneca entered into settlement agreements with all five
                                           generic manufacturers, resolving the Calquence capsule ANDA litigation
                                           proceedings.

                                           *   AstraZeneca received Paragraph IV notices relating to patents listed in
                                           the FDA Orange Book with reference to Calquence tablets from Cipla USA, Inc.
                                           and Cipla Limited (collectively, Cipla) in April 2024 and from MSN
                                           Pharmaceuticals Inc. and MSN Laboratories Pvt. Ltd. (collectively, MSN) in
                                           November 2024.

                                           *   In response to these Paragraph IV notices, AstraZeneca filed patent
                                           infringement lawsuits against Cipla in May 2024 and against MSN in January
                                           2025 in the District Court. In the complaints, AstraZeneca alleges that a
                                           generic version of Calquence tablets, if approved and marketed, would infringe
                                           patents that are owned or licensed by AstraZeneca. No trial date has been
                                           scheduled.
 Lynparza patent proceedings, US           *   AstraZeneca received a Paragraph IV notice relating to Lynparza patents

                                         from Natco Pharma Limited (Natco) in December 2022, Sandoz Inc. (Sandoz) in
                                           December 2023, Cipla USA, Inc. and Cipla Limited (collectively, Cipla) in May

                                         2024, and Zydus Pharmaceuticals (USA) Inc. (Zydus) in November 2024. In
 Considered to be a contingent asset       response to these Paragraph IV notices, AstraZeneca, MSD International

                                         Business GmbH, and the University of Sheffield initiated ANDA litigations
                                           against Natco, Sandoz, Cipla, and Zydus in the US District Court for the
                                           District of New Jersey. In the complaints, AstraZeneca alleged that the
                                           defendants' generic versions of Lynparza, if approved and marketed, would
                                           infringe AstraZeneca's patents.

                                           *   No trial date has been scheduled.
 Soliris patent proceedings, Europe        *   In March 2024, Alexion filed motions for provisional measures against

                                         Amgen Pharmaceuticals Inc (Amgen) and Samsung Bioepis Co. Ltd. (Samsung) and
                                           their respective affiliates at the Hamburg Local Division of the Unified

                                         Patent Court (UPC) on the basis that Amgen's and Samsung's biosimilar
 Considered to be a contingent asset       eculizumab products infringe an Alexion patent. Alexion appealed and in

                                         December 2024 the UPC appellate division denied Alexion's appeal requesting
                                           provisional measures.

                                           *   In parallel, Samsung and Amgen have filed oppositions to the patent at
                                           the European Patent Office.

                                           *   In November 2024, Amgen filed a revocation action for the patent at the
                                           UPC Central Division in Milan.
 Tagrisso patent proceedings, Russia       *   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 (Axelpharm) related to Axelpharm's

                                         improper use of AstraZeneca's information to obtain authorisation to market a
 Considered to be a contingent asset       generic version of Tagrisso. In December 2023, the Court dismissed the lawsuit

                                         against the Ministry of Health of the Russian Federation. The appellate court
                                           affirmed the dismissal in March 2024. AstraZeneca filed a further appeal,
                                           which was dismissed in July 2024. The lawsuit against Axelpharm was dismissed
                                           in September 2024, and AstraZeneca appealed.

                                           *   In November 2023, Axelpharm filed a compulsory licensing action against
                                           AstraZeneca in the Court related to a patent that covers Tagrisso. The
                                           compulsory licensing action remains pending. AstraZeneca has also challenged
                                           before the Russian Patent and Trademark Office (PTO) the validity of the
                                           Axelpharm patent on which the compulsory licensing action is predicated. In
                                           August 2024, the PTO determined that Axelpharm's patent is invalid and, in
                                           November 2024, Axelpharm filed an appeal.

                                           *   In July 2024, AstraZeneca filed a patent infringement lawsuit, which
                                           remains pending, and an unfair competition claim with the Federal
                                           Anti-Monopoly Service of Russia (FAS) against AxelPharm and others related to
                                           the securing of state contracts in Russia for its generic version of
                                           Osimertinib.

                                           *   In August 2024, the FAS initiated an unfair competition case against
                                           Axelpharm and OncoTarget based on AstraZeneca's unfair competition claim.

                                           *   In November 2024, the FAS determined that Axelpharm had committed unfair
                                           competition and that OncoTarget had not; the FAS ordered Axelpharm to cease
                                           sales of its generic osimertinib and pay the Russian government the income it
                                           received from its sales of its generic Osimertinib. In December 2024,
                                           Axelpharm appealed.

 

Table 26: Product liability litigation

 

 Legal proceedings brought against AstraZeneca

 

 Nexium and Prilosec, US          *   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.
 A provision has been taken

                                  *   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
                                  (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.

                                  *   In December 2024, AstraZeneca resolved the sole remaining case, which
                                  had been pending in the District Court.

 

Table 27: Commercial litigation

 

 Legal proceedings brought against AstraZeneca

 

 Securities Litigation, US                             *   In December 2024, a putative securities class action lawsuit was filed

                                                     in the US District Court for the Central District of California against
                                                       AstraZeneca PLC and certain officers, on behalf of purchasers of AstraZeneca

                                                     publicly traded securities between February 2022 and December 2024. The
 Considered to be a contingent liability               complaint alleges that defendants made materially false and misleading
                                                       statements in connection with the Company's business in China.

 

Table 28: Government investigations and proceedings

 

 Legal proceedings brought against AstraZeneca

 

 Shenzhen City Customs Office                *   In relation to the illegal drug importation allegations, in January

                                           2025, AstraZeneca received a Notice of Transfer to the Prosecutor and an
                                             Appraisal Opinion from the Shenzhen City Customs Office regarding suspected

                                           unpaid importation taxes amounting to $0.9m.
 Considered to be a contingent liability

                                             *   To the best of AstraZeneca's knowledge, the importation taxes referred
                                             to in the Appraisal Opinion relate to Imfinzi and Imjudo.

                                             *   A fine of between one and five times the amount of unpaid importation
                                             taxes may also be levied if AstraZeneca is found liable.

 

 Legal proceedings brought by AstraZeneca

 

 340B State Litigation, US                 *   AstraZeneca has filed lawsuits against Arkansas, Kansas, Louisiana,

                                         Maryland, Minnesota, Mississippi, Missouri, and West Virginia challenging the
                                           constitutionality of each state's 340B statute.

 Considered to be a contingent asset       *   In the Arkansas matter, trial is scheduled for April 2025. In the
                                           Arkansas administrative proceeding, the state has moved for a preliminary
                                           injunction to enjoin AstraZeneca's 340B policy in Arkansas.

                                           *   In the Kansas matter, after obtaining a stipulation from the state that
                                           AstraZeneca's policy does not violate the Kansas 340B statute, AstraZeneca
                                           agreed to dismiss its complaint.

                                           *   In the Louisiana matter, the Court granted the state's motion for
                                           summary judgment.  AstraZeneca has filed an appeal.

                                           *   In the Maryland, Minnesota, and Missouri matters, the state has moved to
                                           dismiss AstraZeneca's complaint.

                                           *   In the Maryland and Mississippi matters, the Court has rejected
                                           AstraZeneca's preliminary injunction motion.

                                           *   The West Virginia matter remains in its preliminary stages.

 

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.

 

Note 8

 

Table 29: FY 2024 - Product Sales year-on-year analysis
 14  (#_ftn14)

 

CER information in respect of FY 2024 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                     20,275    18         21         9,510     23     4,502     18         28         4,082     23         22         2,181    (4)        2
 Tagrisso                     6,580     13         16         2,763     21     1,755     8          16         1,301     16         15         761      (3)        4
 Imfinzi                      4,717     17         21         2,603     20     479       35         59         948       28         27         687      (8)        (2)
 Calquence                    3,129     24         25         2,190     21     153       56         79         656       33         32         130      20         22
 Lynparza                     3,072     9          11         1,332     6      655       21         30         832       13         12         253      (10)       (5)
 Enhertu                      545       n/m        n/m        -         -      350       n/m        n/m        126       n/m        n/m        69       n/m        n/m
 Zoladex                      1,058     11         17         16        14     795       16         23         148       12         10         99       (16)       (12)
 Imjudo                       281       29         31         180       23     16        n/m        n/m        36        n/m        n/m        49       (5)        2
 Truqap                       430       n/m        n/m        408       n/m    2         n/m        n/m        12        n/m        n/m        8        n/m        n/m
 Orpathys                     44        (1)        1          -         -      44        (1)        1          -         -          -          -        -          -
 Others                       419       (19)       (14)       18        (51)   253       (18)       (12)       23        (30)       (30)       125      (13)       (6)
 BioPharmaceuticals: CVRM     12,448    18         20         3,075     12     5,339     16         22         3,270     31         30         764      3          9
 Farxiga                      7,656     28         31         1,750     21     2,853     29         35         2,634     40         39         419      -          6
 Brilinta                     1,333     1          2          751       1      294       3          10         268       (1)        (2)        20       (17)       (16)
 Crestor                      1,153     4          8          46        (16)   934       8          12         37        (29)       (30)       136      (2)        5
 Seloken/Toprol-XL            605       (5)        -          -         (42)   589       (5)        -          13        13         12         3        (53)       (44)
 Lokelma                      542       32         34         256       20     86        73         79         92        59         58         108      20         29
 Roxadustat                   331       22         24         -         -      331       22         24         -         -          -          -        -          -
 Andexxa                      219       20         22         81        7      3         n/m        n/m        80        30         28         55       22         31
 Wainua                       85        n/m        n/m        85        n/m    -         -          -          -         -          -          -        -          -
 Others                       524       (24)       (22)       106       (50)   249       (13)       (9)        146       (13)       (12)       23       18         20
 BioPharmaceuticals: R&I      7,416     21         23         3,416     34     1,897     7          13         1,416     22         21         687      10         14
 Symbicort                    2,879     22         25         1,187     63     805       7          16         559       2          1          328      (2)        -
 Fasenra                      1,689     9          9          1,049     6      92        44         55         404       14         13         144      1          6
 Pulmicort                    682       (4)        (1)        6         (77)   568       (1)        3          71        5          3          37       (12)       (10)
 Breztri                      978       44         46         516       35     245       52         57         143       78         77         74       41         47
 Tezspire                     248       n/m        n/m        -         -      11        n/m        n/m        156       n/m        n/m        81       n/m        n/m
 Saphnelo                     474       69         70         425       63     7         n/m        n/m        26        n/m        n/m        16       69         80
 Airsupra                     66        n/m        n/m        66        n/m    -         -          -          -         -          -          -        -          -
 Others                       400       (8)        (7)        167       7      169       (21)       (20)       57        5          4          7        (8)        (4)
 BioPharmaceuticals: V&I      1,058     5          6          280       n/m    213       1          9          409       3          1          156      (47)       (44)
 Synagis                      447       (18)       (14)       (8)       n/m    210       8          17         116       (34)       (35)       129      (27)       (22)
 Beyfortus                    318       n/m        n/m        232       n/m    -         n/m        n/m        84        n/m        n/m        2        n/m        n/m
 FluMist                      258       19         15         28        19     1         28         30         204       8          4          25       n/m        n/m
 COVID-19 mAbs                31        (76)       (76)       28        n/m    -         n/m        n/m        3         (74)       (75)       -        n/m        n/m
 Others                       4         (68)       (68)       -         -      2         (82)       (82)       2         10         14         -        n/m        n/m
 Rare Disease                 8,668     12         14         5,263     12     849       36         63         1,568     3          2          988      8          15
 Ultomiris                    3,924     32         34         2,261     29     141       n/m        n/m        884       32         31         638      34         43
 Soliris                      2,588     (18)       (14)       1,523     (12)   443       4          34         416       (38)       (38)       206      (35)       (32)
 Strensiq                     1,416     23         24         1,167     25     54        33         43         99        11         10         96       12         18
 Koselugo                     531       60         66         212       9      177       n/m        n/m        103       93         92         39       62         73
 Kanuma                       209       22         24         100       17     34        19         28         66        35         35         9        11         15
 Other medicines              1,073     (9)        (4)        111       (17)   735       1          8          103       (2)        (3)        124      (40)       (36)
 Nexium                       867       (8)        (2)        96        (16)   591       2          11         60        13         11         120      (40)       (36)
 Others                       206       (11)       (9)        15        (20)   144       (6)        (4)        43        (17)       (17)       4        (44)       (41)
 Total Product Sales          50,938    16         19         21,655    21     13,535    15         23         10,848    20         19         4,900    (3)        3

 

 
Table 30: Q4 2024 - Product Sales year-on-year analysis
 15  (#_ftn15)

 

The Q4 2024 information in respect of the three months ended 31 December 2024
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                     5,341     20         22         2,640    28     1,057    17         27         1,082    20         18         562      (3)        (3)
 Tagrisso                     1,703     20         21         767      28     391      9          14         344      15         14         201      23         24
 Imfinzi                      1,254     16         18         721      26     113      30         53         253      22         21         167      (22)       (21)
 Calquence                    808       20         20         573      20     37       27         54         167      20         18         31       9          8
 Lynparza                     844       14         15         378      8      180      35         45         220      15         13         66       1          2
 Enhertu                      148       78         98         -        -      91       89         n/m        35       73         72         22       48         46
 Zoladex                      242       (5)        (2)        5        n/m    174      4          10         37       6          3          26       (47)       (48)
 Imjudo                       73        27         28         45       18     5        83         n/m        10       n/m        n/m        13       7          8
 Truqap                       163       n/m        n/m        148      n/m    1        n/m        n/m        10       n/m        n/m        4        n/m        n/m
 Orpathys                     9         (16)       (17)       -        -      9        (16)       (17)       -        -          -          -        -          -
 Others                       97        (25)       (22)       3        (86)   56       (15)       (10)       6        (17)       (15)       32       (4)        (4)
 BioPharmaceuticals: CVRM     3,132     16         17         853      9      1,193    11         14         886      31         28         200      24         24
 Farxiga                      1,933     20         21         472      5      628      12         17         731      39         37         102      43         43
 Brilinta                     341       4          4          208      7      62       2          6          65       (4)        (5)        6        (4)        (12)
 Crestor                      261       5          6          13       (11)   208      13         14         5        (56)       (58)       35       (6)        (6)
 Seloken/Toprol-XL            140       (3)        1          -        n/m    137      (1)        2          3        (20)       (24)       -        n/m        n/m
 Lokelma                      150       35         35         75       30     18       44         50         26       53         51         31       28         28
 Roxadustat                   74        18         16         -        -      74       17         15         -        -          -          -        -          -
 Andexxa                      59        11         11         19       6      -        n/m        n/m        20       9          7          20       17         18
 Wainua                       42        n/m        n/m        42       n/m    -        -          -          -        -          -          -        -          -
 Others                       132       (9)        (7)        24       (44)   66       10         12         36       (3)        (1)        6        40         54
 BioPharmaceuticals: R&I      1,985     25         26         996      54     408      (11)       (7)        391      23         21         190      12         12
 Symbicort                    684       31         33         299      n/m    153      -          5          144      1          (1)        88       (1)        -
 Fasenra                      471       12         12         299      9      23       46         64         110      18         17         39       7          6
 Pulmicort                    164       (25)       (23)       (7)      n/m    141      (23)       (21)       20       8          6          10       (12)       (12)
 Breztri                      257       29         29         149      24     45       19         21         42       60         59         21       37         38
 Tezspire                     80        n/m        n/m        -        n/m    4        n/m        n/m        51       n/m        n/m        25       85         87
 Saphnelo                     147       65         65         131      60     2        n/m        n/m        9        n/m        n/m        5        75         76
 Airsupra                     25        n/m        n/m        25       n/m    -        -          -          -        -          -          -        -          -
 Others                       157       49         49         100      n/m    40       (37)       (38)       15       7          5          2        14         28
 BioPharmaceuticals: V&I      378       10         8          80       35     45       46         58         219      12         9          34       (43)       (44)
 Synagis                      101       (38)       (36)       (6)      n/m    42       13         21         35       (47)       (47)       30       (50)       (50)
 Beyfortus                    130       n/m        n/m        84       61     -        -          -          45       n/m        n/m        1        n/m        n/m
 FluMist                      149       7          3          2        (73)   1        (10)       21         143      10         5          3        n/m        n/m
 COVID-19 mAbs                -         n/m        n/m        -        n/m    -        n/m        n/m        -        n/m        n/m        -        n/m        n/m
 Others                       (2)       n/m        n/m        -        -      2        n/m        n/m        (4)      n/m        n/m        -        -          -
 Rare Disease                 2,277     16         17         1,421    15     221      63         84         379      4          2          256      7          8
 Ultomiris                    1,089     32         33         632      29     49       n/m        n/m        235      36         33         173      25         26
 Soliris                      543       (24)       (22)       353      (16)   77       (10)       11         70       (50)       (50)       43       (38)       (37)
 Strensiq                     420       38         37         352      43     15       31         30         26       2          1          27       24         20
 Koselugo                     165       94         97         56       9      69       n/m        n/m        29       91         90         11       27         28
 Kanuma                       60        47         48         28       22     11       n/m        n/m        19       71         69         2        20         14
 Other medicines              249       (6)        (4)        24       (18)   171      14         17         28       (27)       (28)       26       (46)       (45)
 Nexium                       197       (6)        (4)        19       (26)   133      11         16         20       16         13         25       (47)       (46)
 Others                       52        (8)        (8)        5        60     38       23         22         8        (61)       (61)       1        (7)        (8)
 Total Product Sales          13,362    18         19         6,014    25     3,095    12         19         2,985    20         18         1,268    1          1

 

 

Table 31: Alliance Revenue

 

                           FY 2024    FY 2023
                           $m         $m
 Enhertu                   1,437      1,022
 Tezspire                  436        259
 Beyfortus                 237        57
 Other royalty income      91         81
 Other Alliance Revenue    11         9
 Total                     2,212      1,428

 

Table 32: Collaboration Revenue

 

                                     FY 2024    FY 2023
                                     $m         $m
 Lynparza: sales milestones          600        -
 Beyfortus: sales milestones         167        27
 Koselugo: sales milestones          100        -
 Farxiga: sales milestones           56         29
 Lynparza: regulatory milestones     -          245
 COVID-19 mAbs licence fees          -          180
 Beyfortus: regulatory milestones    -          71
 tralokinumb: sales milestones       -          20
 Other Collaboration Revenue         -          22
 Total                               923        594

 

Table 33: Other operating income and expense

 

                                                                       FY 2024    FY 2023
                                                                       $m         $m
 brazikumab licence termination funding                                -          75
 Divestment of US rights to Pulmicort Flexhaler                        -          241
 Update to the contractual relationships for Beyfortus (nirsevimab)    -          712
 Other                                                                 252        312
 Total                                                                 252        1,340

 

Other shareholder information

 

Financial calendar

 

Announcement of Q1 2025 results:                    29 April
2025

Announcement of H1 and Q2 2025 results:        29 July 2025

 

Proposed dividend payment dates

 

Dividends are normally paid as follows:

 

First interim:      Announced with the half year results and paid in
September

Second interim: Announced with the full year results and paid in March

 

 Dividend                               Announced        Ex-dividend date 16  (#_ftn16)      Record date  Payment date
 FY 2024 Second interim                 6 Feb 2025       20 Feb 2025       21 Feb 2025                    24 Mar 2025
 FY 2025 First interim 17  (#_ftn17)    29 Jul 2025      7 Aug 2025        8 Aug 2025                     8 Sep 2025

 

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         Swedish Central Securities Depository  US depositary

transfer office

 1 Francis Crick Avenue        Equiniti Limited      Euroclear Sweden AB                    J.P. Morgan Chase Bank N.A.

EQ Shareowner Services
 Cambridge Biomedical Campus   Aspect House          PO Box 191

                                      P.O. Box 64504
 Cambridge                     Spencer Road          SE-101 23 Stockholm

                                                            St. Paul
 CB2 0AA                       Lancing

                                                            MN 55164-0504
                               West Sussex

                               BN99 6DA

 United Kingdom                United Kingdom        Sweden                                 US
 +44 (0) 20 3749 5000          0800 389 1580         +46 (0) 8 402 9000                     +1 (888) 697 8018 (US only)
                               +44 (0) 121 415 7033                                         +1 (651) 453 2128

 

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:
Beyfortus, a trademark of Sanofi Pasteur Inc.; Enhertu and Datroway,
trademarks 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 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 and AI 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 our sustainability targets, regulatory
requirements and stakeholder expectations with respect to the environment;

‒    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 risks related to the Group's products;

‒    the risk of failure to achieve strategic plans or meet targets or
expectations;

‒    the risk of geopolitical and/or macroeconomic volatility disrupting
the operation of our global business;

‒    the risk of failure in internal control, financial reporting or the
occurrence of fraud;

‒    the risk of unexpected deterioration in the Group's financial
position;

‒    the risk of foreign exchange rate movements impacting our financial
condition or results of operations; and

‒    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.

 

Glossary

1L, 2L, etc                   First line, second line, etc

ADC                             Antibody drug
conjugate

aHUS                           Atypical haemolytic
uraemic syndrome

ADT                              Androgen
deprivation therapy

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

cCRT                            Concurrent
chemoradiotherapy

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 gene / mutation

EGPA                           Eosinophilic
granulomatosis with polyangiitis

EPS                              Earnings per
share

ER                                Estrogen
receptor

ERBB2                        v-erb-b2 avian
erythroblastic leukaemia viral oncogene homologue 2 gene

EVH                             Extravascular
haemolysis

FDA                              Food and Drug
Agency (US)

FDC                             Fixed dose
combination

FISH                             Fluorescence in
situ hybridization, as in FISH10+

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 / gene mutant

HF/ pEF / rEF              Heart failure / with preserved ejection
fraction / with reduced ejection fraction

hMPV                           Human metapneumovirus

HR                                Hazard ratio

HR / + / -                      Hormone receptor /
positive / negative

HRD                             Homologous
recombination deficiency

HRR / m                       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, as in IHC90+, etc

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

LS-SCLC                    Limited stage small cell lung
cancer

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

n/m                               Not meaningful

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

PAAGR                        Post Alexion Acquisition
Group Review

PARP / i / -1sel           Poly ADP ribose polymerase / inhibitor
/-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 gene

pMMR                          proficient mismatch
repair

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 gene

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

sNDA                           Supplemental new drug
application

SPA                              Share Purchase
Agreement

T2D                              Type-2 diabetes

TACE                           Transarterial
chemoembolization

THP                              A treatment
regimen: docetaxel, trastuzumab and pertuzumab

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 2024
vs. 2023. 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) Core financial measures are adjusted to exclude certain items.
The differences between Reported and Core measures are primarily due to costs
relating to the amortisation of intangibles, impairments, legal settlements
and restructuring charges. A full reconciliation between Reported EPS and Core
EPS is provided in Table 11 and Table 12 in the Financial performance section
of this document.

 3  (#_ftnref3)   In FY 2024, capital expenditure on tangible assets and
Software-related intangibles amounted to $2,218m

 4  (#_ftnref4) In Table 2, the plus and minus symbols denote the directional
impact of the item being discussed, e.g. a Ô+Õ symbol next to a comment
related to the R&D expense indicates that the item resulted in an increase
in the R&D spend relative to the prior year.

 5  (#_ftnref5) 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 GroupÕs financial
statements.

 6  (#_ftnref6) The presentation of Table 4 has been updated to show Total
Revenue by medicine, by including Alliance Revenue and Collaboration Revenue
within each revenue figure. Previously, this table showed Product Sales for
each medicine and therapy area, and the CompanyÕs total Alliance Revenue and
Collaboration Revenue were shown as separate lines at the bottom of the table.

 7  (#_ftnref7) ÔStock compensationÕ encourages distributors to maintain
steady inventory levels ahead of the date of a price reduction. After the
price reduction takes effect, the supplier compensates the distributor for the
reduction in the resale value of their inventory

 8  (#_ftnref8) The presentation of this table has been updated by removing
the "Acquisition of Alexion" column due to immateriality of items in this
category

 9  (#_ftnref9) Based on best prevailing assumptions around currency profiles.

 10  (#_ftnref10) Based on average daily spot rates 1 Jan 2024 to 31 Dec 2024.

 11  (#_ftnref11) Based on average daily spot rates 1 Jan 2025 to 31 Jan 2025.

 12  (#_ftnref12) Based on average daily spot rates on Jan 31 2025.

 13  (#_ftnref13) Other currencies include AUD, BRL, CAD, KRW and RUB.

 14  (#_ftnref14) 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.

 15  (#_ftnref15) 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.

 16  (#_ftnref16) The ex-dividend dates shown in the table are for ordinary
shares listed on the London Stock Exchange; the ex-dividend dates are one day
sooner for ordinary shares listed on the Stockholm Stock Exchange and for
American Depository Receipts listed on NASDAQ.

 17  (#_ftnref17) Provisional dates, subject to Board approval.

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