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FORM 6-K

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Report of Foreign Issuer

Pursuant to Rule 13a-16 or 15d-16 of

the Securities Exchange Act of 1934

For the month of July 2024

Commission File Number: 001-11960

AstraZeneca PLC

1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, CB2 0AA England

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F 

Form 40-F 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): 

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes 

No 

If “Yes” is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b): 82-

Graphic

AstraZeneca

25 July 2024

H1 and Q2 2024 results

Strong underlying growth supports FY 2024 guidance upgrade, with both Total Revenue and Core EPS now expected to increase by a mid teens percentage at CER1

Revenue and EPS summary

H1 2024

% Change

Q2 2024

% Change

    

$m

    

Actual

    

CER

  

  

$m

    

Actual

    

CER

- Product Sales

 

24,629

 

15

 

18

 

12,452

 

14

 

18

- Alliance Revenue

 

939

 

50

 

50

 

482

 

42

 

42

- Collaboration Revenue

 

49

 

(78)

 

(78)

 

4

 

(98)

 

(98)

Total Revenue

 

25,617

 

15

 

18

 

12,938

 

13

 

17

Reported EPS

$

2.65

 

13

 

23

$

1.24

 

6

 

15

Core2 EPS

$

4.03

 

(1)

 

5

$

1.98

 

(8)

 

(3)

Financial performance for H1 2024 (Growth numbers at constant exchange rates)

Total Revenue up 18% to $25,617m, driven by an 18% increase in Product Sales and continued growth in Alliance Revenue from partnered medicines

Total Revenue growth from Oncology was 22%, CVRM 22%, R&I 22%, and Rare Disease 15%

Core Product Sales Gross Margin3 of 82%

Core Operating Margin of 33%

Core Tax Rate of 20%

Core EPS increased 5% to $4.03. The increase in Core EPS was lower than Total Revenue growth principally due to gains recognised in the prior year, specifically a $241m gain on the disposal of Pulmicort Flexhaler US rights (Q1 2023), and a $712m gain relating to updates to contractual arrangements for Beyfortus (Q2 2023)

Interim dividend increased 7c to $1.00 (77.6 pence, 10.79 SEK) has been declared

Guidance for FY 2024 increased, with Total Revenue and Core EPS anticipated to grow by a
mid teens percentage at CER (previously a low double-digit to low teens percentage). An increase in Collaboration Revenue is not assumed in the upgraded guidance

Pascal Soriot, Chief Executive Officer, AstraZeneca, said:

“Building on our strong growth in the first half of the year and continued underlying demand for our medicines we are upgrading our FY 2024 guidance for both Total Revenue and Core EPS.

At our Investor Day in May we set out a new revenue ambition to deliver $80 billion of Total Revenue by 2030. This is a clear reflection of the substantial growth potential we see from both our approved medicines and those in our late-stage pipeline. Already this year we have announced five positive, potentially practice-changing Phase III studies that are anticipated to meaningfully contribute to our growth.

In the year to date we have continued to make encouraging progress with several disruptive technologies, including antibody drug conjugates, bispecifics, cell and gene therapies, radioconjugates, and weight management medicines, all of which have the potential to drive our growth beyond 2030.”

2

Graphic

Key milestones achieved since the prior results announcement

Positive read-outs for Imfinzi in combination with chemotherapy in muscle-invasive bladder cancer (NIAGARA), Calquence in untreated mantle cell lymphoma (ECHO), Enhertu in HR-positive, HER2-low metastatic breast cancer (DESTINY-Breast06)

US approvals for Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy for primary advanced or recurrent endometrial cancer that is mismatch repair deficient (DUO-E). EU approvals for Truqap in combination with Faslodex for biomarker-positive estrogen receptor-positive, HER2negative advanced breast cancer (CAPItello-291), Tagrisso with the addition of chemotherapy for 1st-line EGFRm NSCLC (FLAURA2). Japan and China approvals for Tagrisso with the addition of chemotherapy for the 1st-line EGFRm NSCLC (FLAURA2)

Guidance

Due to strong underlying growth in Product Sales and Alliance Revenue, the Company raises its Total Revenue and Core EPS guidance for FY 2024 at CER, based on the average foreign exchange rates through 2023.

Total Revenue is expected to increase by a mid teens percentage

(previously a low double-digit to low teens percentage)

Core EPS is expected to increase by a mid teens percentage

(previously a low double-digit to low teens percentage)

An increase in Collaboration Revenue is not assumed in the upgraded guidance (previously assumed a substantial increase)

Other operating income is expected to decrease substantially (FY 2023 included a $241m gain on the disposal of Pulmicort Flexhaler US rights, and a $712m one-time gain relating to updates to contractual arrangements for Beyfortus)

The Core Tax rate is expected to be between 18-22%

The Company is unable to provide guidance on a Reported basis because it cannot reliably forecast material elements of the Reported results, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement.

Currency impact

If foreign exchange rates for July 2024 to December 2024 were to remain at the average rates seen in June 2024, it is anticipated that FY 2024 Total Revenue 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.

3

Graphic

Table 1: Key elements of Total Revenue performance in Q2 2024

% Change

Revenue type

    

$m

    

Actual %

    

CER %

    

    

Product Sales

12,452

14

18

Alliance Revenue

482

42

42

$344m Enhertu (Q2 2023: $255m)
$104m Tezspire (Q2 2023: $62m)

Collaboration Revenue

4

(98)

(98)

Q2 2023 included $180m for COVID-19 mAbs

Total Revenue

12,938

13

17

Therapy areas

$m

Actual %

CER %

Oncology

5,331

15

19

Tagrisso up 8% (12% at CER) due to strong global demand, Calquence up 21% (22% at CER) with sustained leadership in 1L CLL. Enhertu Total Revenue up 46% (49% at CER)

CVRM

3,160

18

22

Farxiga up 29% (32% at CER), Lokelma up 36% (41% at CER)

R&I

1,905

23

26

Breztri up 44% (47% at CER). Saphnelo up 65%, Tezspire up 97% (>2x at CER), Symbicort up 20% (25% CER)

V&I

119

(57)

(53)

The drop in V&I revenue was primarily driven by lower Collaboration Revenue from COVID-19 mAbs
Beyfortus revenue was $35m (Q2 2023: $2m), which more than offset a $6m decline in Synagis

Rare Disease

2,147

10

14

Ultomiris up 33% (36% at CER), partially offset by decline in Soliris of 14% (8% at CER)
Strensiq up 13% (14% at CER) and Koselugo up 43% (45% at CER)

Other Medicines

276

(11)

(5)

Total Revenue

12,938

13

17

Regions

$m

Actual %

CER %

US

5,571

17

17

Emerging Markets

3,386

9

18

- China

1,630

13

18

- Ex-China Emerging Markets

1,756

5

18

Europe

2,732

24

24

Established RoW

1,249

(5)

6

Total Revenue

12,938

13

17

Key partnered medicines

Combined sales of Enhertu, recorded by Daiichi Sankyo Company Limited (Daiichi Sankyo) and AstraZeneca, amounted $1,772m in H1 2024 (H1 2023: $1,169m).

Combined sales of Tezspire, recorded by Amgen and AstraZeneca, amounted to $507m in H1 2024 (H1 2023: $257m).

4

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Table 2: Key elements of financial performance in Q2 2024

Metric

    

Reported

    

Reported 
change

    

Core

    

Core 
change

    

Comments4

Total Revenue

$12,938m

13% Actual
17% CER

$12,938m

13% Actual
17% CER

See Table 1 and the Total Revenue section of this document for further details

Product Sales Gross Margin

82%

Stable Actual
Stable CER

83%

Stable Actual
Stable CER

Variations in Product Sales Gross Margin can be expected between periods due to product seasonality (e.g. FluMist and Beyfortus in H2), foreign exchange fluctuations and other effects

R&D expense

$3,008m

13% Actual
13% CER

$2,872m

12% Actual
13% CER

+

Increased investment in the pipeline

Core R&D-to-Total Revenue ratio of 22%
(Q2 2023: 22%)

SG&A expense

$4,929m

-1% Actual
1% CER

$3,735m

13% Actual
16% CER

+

Market development for recent launches and pre-launch activities

Core SG&A-to-Total Revenue ratio of 29%
(Q2 2023: 29%)

Other operating income and expense5

$60m

-92% Actual
-92% CER

$60m

-92% Actual
-92% CER

The prior year quarter included a $712m gain relating to updates to contractual arrangements for Beyfortus

Operating Margin

21%

Stable Actual
+1pp CER

32%

-6pp Actual
-5pp CER

See commentary above on Gross Margin, R&D, SG&A and Other operating income and expense

Net finance expense

$343m

-7% Actual
-7% CER

$285m

10% Actual
10% CER

+

Higher level of Net debt

Tax rate

20%

+7pp Actual
+7pp CER

19%

+2pp Actual
+2pp CER

Variations in the tax rate can be expected between periods

EPS

$1.24

6% Actual
15% CER

$1.98

-8% Actual
-3% CER

Further details of differences between Reported and Core are shown in Table 12

5

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Table 3: Pipeline highlights since prior results announcement

Event

    

Medicine

    

Indication / Trial

    

Event

Regulatory approvals and other regulatory actions

Imfinzi

Primary advanced or recurrent endometrial cancer with mismatch repair deficiency (DUO-E)

Regulatory approval (US), CHMP positive opinion (EU)

Imfinzi + Lynparza

Primary advanced or recurrent endometrial cancer with mismatch repair proficiency (DUO-E)

CHMP positive opinion (EU)

Tagrisso

EGFRm NSCLC (1st-line) (FLAURA2)

Regulatory approval (EU, JP, CN)

Truqap

Biomarker-positive ER-positive HER2-negative locally advanced or metastatic breast cancer (CAPItello-291)

Regulatory approval (EU)

Regulatory submissions
or acceptances*

Tagrisso

EGFRm NSCLC (Stage III unresectable) (LAURA)

sNDA acceptance and Priority Review (US)

Dato-DXd

Non-squamous NSCLC (2nd- and 3rd-line) (TROPION-Lung01)

Regulatory submission (EU)

sipavibart

Prevention of COVID-19 (SUPERNOVA)

Regulatory submission (EU)

Major Phase III data readouts and other developments

Calquence

Mantle cell lymphoma (1st-line) (ECHO)

Primary endpoint met

Dato-DXd

Locally advanced or metastatic NSCLC (TROPION-Lung01)

Dual primary endpoint OS not met in the intention to treat population

Enhertu

HER2-low breast cancer (2nd-line) (DESTINY-Breast-06)

Primary endpoint met

Imfinzi

Muscle-invasive bladder cancer (NIAGARA)

Primary endpoint met

Imfinzi

Adjuvant use in early-stage PD-L1 ≥25% NSCLC (Adjuvant BR.31)

Primary endpoint not met

Truqap

Locally advanced or metastatic TNBC (CAPItello-290)

Primary endpoint not met

sipavibart

Prevention of COVID-19 (SUPERNOVA)

Primary endpoint met

*US, EU and China regulatory submission denotes filing acceptance

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.

6

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Corporate and business development

In May 2024, AstraZeneca announced its intention to build a $1.5 billion manufacturing facility in Singapore for antibody drug conjugates (ADCs), enhancing global supply of its ADC portfolio. ADCs are next-generation treatments that deliver highly potent cancer-killing agents directly to cancer cells through a targeted antibody. The planned greenfield facility, supported by the Singapore Economic Development Board, will be AstraZeneca’s first end-to-end ADC production site, fully incorporating all steps of the manufacturing process at a commercial scale. Manufacturing of ADCs is a multi-step process that comprises antibody production, synthesis of chemotherapy drug and linker, conjugation of drug-linker to the antibody, and filling of the completed ADC substance.

In May 2024, AstraZeneca completed an additional $140m equity investment in Cellectis, a clinical-stage biotechnology company. The equity investment and a research collaboration agreement, announced in November 2023, will leverage the Cellectis proprietary gene editing technologies and manufacturing capabilities, to design up to 10 novel cell and gene therapy products for areas of high unmet need, including oncology, immunology and rare diseases. In Q4 2023, Cellectis received an initial payment of $105m from AstraZeneca, which comprised a $25m upfront cash payment under the terms of a research collaboration agreement and an $80m equity investment. Now that the additional $140m equity investment has closed, AstraZeneca holds a total equity stake of c.44% in Cellectis and AstraZeneca continues to treat its investment in Cellectis as an associate.

In June 2024, AstraZeneca completed the acquisition of Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing next-generation radioconjugates. The acquisition marks a major step forward in AstraZeneca delivering on its ambition to transform cancer treatment and outcomes for patients by replacing traditional regimens like chemotherapy and radiotherapy with more targeted treatments. The acquisition complements AstraZeneca’s leading oncology portfolio with the addition of the Fusion pipeline of radioconjugates, including FPI-2265, a potential new treatment for patients with mCRPC, and brings new expertise and pioneering R&D, manufacturing and supply chain capabilities in actinium-based radioconjugates to AstraZeneca. See Note 5 for further information.

In July 2024, AstraZeneca completed the acquisition of Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases. The acquisition bolsters the Alexion, AstraZeneca Rare Disease late-stage pipeline and expands on its bone metabolism franchise with the notable addition of eneboparatide (AZP-3601), a Phase III investigational therapeutic peptide with a novel mechanism of action designed to meet key therapeutic goals for hypoparathyroidism. In patients with hypoparathyroidism, a deficiency in parathyroid hormone production results in significant dysregulation of calcium and phosphate, which can lead to life-altering symptoms and complications, including chronic kidney disease. See Note 7 for further information.

Sustainability highlights

At the 77th World Health Assembly in Geneva, Switzerland in May, AstraZeneca convened Ministers of Health, industry, civil society and patient groups. Areas of focus for engagement, led by Ruud Dobber, EVP BioPharmaceuticals, included the need to increase early action to prevent, diagnose and treat disease and to accelerate collaboration to build resilient, equitable and net zero health systems.

Conference call

A conference call and webcast for investors and analysts will begin today, 25 July 2024, at 11:45 UK time. Details can be accessed via astrazeneca.com.

Reporting calendar

The Company intends to publish its 9M and Q3 2024 results on 12 November 2024.

Conclusion of audit tender

Following a rigorous process, the audit tender for the Group’s external audit provider has now concluded. The Audit Committee has recommended, and the Board has endorsed, the appointment of KPMG as the Group’s external auditor for the financial year ending 31 December 2026. A resolution will be put to shareholders at the 2026 Annual General Meeting (AGM) to approve this appointment. It is intended that PwC, who have been the Group’s auditor since the year ended 31 December 2017, will continue as the Group’s auditors for the years ended 31 December 2024 and 2025 and will cease to hold office at the conclusion of the Company’s 2026 AGM.

7

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Notes

A glossary of acronyms can be found at the end of this document.

1.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.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.The calculations for Reported and Core Product Sales Gross Margin exclude the impact of Alliance Revenue and Collaboration Revenue.
4.In Table 2, the plus and minus symbols denote the directional impact of the item being discussed, e.g. a ‘+’ 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.Income from disposals of assets and businesses, where the Group does not retain a significant ongoing economic interest, continue to be recorded in Other operating income and expense in the Company’s financial statements.

8

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Contents

Operating and financial review

10

Financial performance

19

Sustainability

26

Research and development

28

Interim financial statements

32

Responsibility statement of the directors in respect of the half-yearly financial report

37

Independent review report to AstraZeneca PLC

38

Notes to the Interim financial statements

40

Other shareholder information

54

Glossary

56

List of tables

Table 1: Key elements of Total Revenue performance in Q2 2024

4

Table 2: Key elements of financial performance in Q2 2024

5

Table 3: Pipeline highlights since prior results announcement

6

Table 4: Total Revenue by therapy area and medicine

11

Table 5: Alliance Revenue

12

Table 6: Collaboration Revenue

12

Table 7: Total Revenue by therapy area

12

Table 8: Total Revenue by region

12

Table 9: Reported Profit and Loss

19

Table 10: Reconciliation of Reported Profit before tax to EBITDA

19

Table 11: Reconciliation of Reported to Core financial measures: H1 2024

20

Table 12: Reconciliation of Reported to Core financial measures: Q2 2024

20

Table 13: Cash Flow summary

22

Table 14: Net debt summary

22

Table 15: Obligor group summarised Statement of comprehensive income

23

Table 16: Obligor group summarised Statement of financial position

24

Table 17: Currency sensitivities

24

Table 18: Condensed consolidated statement of comprehensive income: H1 2024

32

Table 19: Condensed consolidated statement of comprehensive income: Q2 2024

33

Table 20: Condensed consolidated statement of financial position

34

Table 21: Condensed consolidated statement of changes in equity

35

Table 22: Condensed consolidated statement of cash flows: H1 2024

36

Table 23: Net debt

41

Table 24: Financial instruments - contingent consideration

42

Table 25: H1 2024 - Product Sales year-on-year analysis

51

Table 26: Q2 2024 - Product Sales year-on-year analysis (Unreviewed)

52

Table 27: Alliance Revenue

53

Table 28: Collaboration Revenue

53

Table 29: Other operating income and expense

53

9

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Operating and financial review

All narrative on growth and results in this section is based on actual exchange rates, and financial figures are in US$ millions ($m), unless stated otherwise. Unless stated otherwise, the performance shown in this announcement covers the six month period to 30 June 2024 (‘the half year’ or ‘H1 2024’) compared to the six month period to 30 June 2023 (‘H1 2023’).

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 restructuring programmes, which includes charges that relate to the impact of restructuring programmes on capitalised IT assets

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

Other specified items, principally the imputed finance charges and fair value movements relating to contingent consideration on business combinations, imputed finance charges and remeasurement adjustments on certain Other payables arising from intangible asset acquisitions, legal settlements and remeasurement adjustments relating to Other payables assumed from the Alexion acquisition

The tax effects of the adjustments above are excluded from the Core Tax charge

Details on the nature of Core financial measures are provided on page 61 of the Annual Report and Form 20-F Information 2023.

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 Interim 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.

10

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Total Revenue

Table 4: Total Revenue by therapy area and medicine6

H1 2024

  

  

Q2 2024

% Change

% Change

Total Revenue

$m

% Total

Actual

CER

$m

% Total

Actual

CER

Oncology

    

10,440

    

41

    

19

    

22

    

5,331

    

41

    

15

    

19

- Tagrisso

 

3,203

 

13

 

10

 

13

 

1,608

 

12

 

8

 

12

- Imfinzi

 

2,259

 

9

 

20

 

25

 

1,147

 

9

 

13

 

18

- Calquence

 

1,508

 

6

 

27

 

28

 

790

 

6

 

21

 

22

- Lynparza

 

1,450

 

6

 

6

 

9

 

744

 

6

 

4

 

7

- Enhertu

 

932

 

4

 

61

 

62

 

472

 

4

 

46

 

49

- Zoladex

 

567

 

2

 

19

 

26

 

282

 

2

 

17

 

25

- Imjudo

 

136

 

1

 

35

 

38

 

74

 

1

 

17

 

19

- Truqap

 

142

 

1

 

n/m

 

n/m

 

92

 

1

 

n/m

 

n/m

- Orpathys

 

25

 

 

14

 

18

 

13

 

 

(5)

 

(1)

- Other Oncology

 

216

 

1

 

(21)

 

(15)

 

109

 

1

 

(17)

 

(11)

BioPharmaceuticals: CVRM

 

6,220

 

24

 

19

 

22

 

3,160

 

24

 

18

 

22

- Farxiga

 

3,836

 

15

 

35

 

38

 

1,945

 

15

 

29

 

32

- Brilinta

 

665

 

3

 

 

2

 

342

 

3

 

3

 

5

- Crestor

 

590

 

2

 

1

 

6

 

293

 

2

 

4

 

11

- Lokelma

 

249

 

1

 

26

 

30

 

136

 

1

 

36

 

41

- Seloken/Toprol-XL

 

315

 

1

 

(8)

 

(1)

 

150

 

1

 

(8)

 

- roxadustat

 

167

 

1

 

22

 

27

 

90

 

1

 

20

 

25

- Andexxa

 

105

 

 

18

 

21

 

59

 

 

29

 

35

- Wainua

 

21

 

 

n/m

 

n/m

 

16

 

 

n/m

 

n/m

- Other CVRM

 

272

 

1

 

(30)

 

(28)

 

130

 

1

 

(26)

 

(24)

BioPharmaceuticals: R&I

 

3,791

 

15

 

19

 

22

 

1,905

 

15

 

23

 

26

- Symbicort

 

1,491

 

6

 

16

 

19

 

722

 

6

 

20

 

25

- Fasenra

 

781

 

3

 

5

 

6

 

423

 

3

 

4

 

5

- Breztri

 

454

 

2

 

48

 

51

 

235

 

2

 

44

 

47

- Pulmicort

 

379

 

1

 

10

 

14

 

155

 

1

 

25

 

30

- Tezspire

 

280

 

1

 

>2x

 

>2x

 

160

 

1

 

97

 

>2x

- Saphnelo

 

203

 

1

 

77

 

77

 

112

 

1

 

65

 

65

- Airsupra

 

21

 

 

n/m

 

n/m

 

14

 

 

n/m

 

n/m

- Other R&I

 

181

 

1

 

(26)

 

(25)

 

83

 

1

 

(21)

 

(19)

BioPharmaceuticals: V&I

 

350

 

1

 

(45)

 

(42)

 

119

 

1

 

(57)

 

(53)

- Beyfortus

 

80

 

 

>10x

 

>10x

 

35

 

 

>10x

 

>10x

- Synagis

 

253

 

1

 

(11)

 

(6)

 

81

 

1

 

(6)

 

8

- COVID-19 mAbs

 

3

 

 

(99)

 

(99)

 

1

 

 

(99)

 

(99)

- FluMist

 

8

 

 

(34)

 

(36)

 

2

 

 

(84)

 

(84)

- Other V&I

 

6

 

 

(79)

 

(80)

 

 

 

n/m

 

n/m

Rare Disease

 

4,243

 

17

 

11

 

15

 

2,147

 

17

 

10

 

14

- Ultomiris

 

1,804

 

7

 

32

 

35

 

946

 

7

 

33

 

36

- Soliris

 

1,439

 

6

 

(13)

 

(8)

 

700

 

5

 

(14)

 

(8)

- Strensiq

 

653

 

3

 

16

 

18

 

340

 

3

 

13

 

14

- Koselugo

 

247

 

1

 

55

 

64

 

114

 

1

 

43

 

45

- Kanuma

 

100

 

 

17

 

20

 

47

 

 

3

 

8

Other Medicines

 

573

 

2

 

(9)

 

(2)

 

276

 

2

 

(11)

 

(5)

- Nexium

 

469

 

2

 

(6)

 

2

 

227

 

2

 

(10)

 

(3)

- Others

 

104

 

 

(21)

 

(18)

 

49

 

 

(16)

 

(12)

Total

 

25,617

 

100

 

15

 

18

 

12,938

 

100

 

13

 

17

6

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 Company’s total Alliance Revenue and Collaboration Revenue were shown as separate lines at the bottom of the table.

11

Graphic

Table 5: Alliance Revenue

H1 2024

  

  

Q2 2024

% Change

% Change

    

$m

    

% Total

    

Actual

    

CER

  

$m

    

% Total

    

Actual

    

CER

Enhertu

 

683

 

73

 

44

 

44

344

 

71

 

35

 

36

Tezspire

 

180

 

19

 

72

 

72

104

 

22

 

67

 

67

Beyfortus

 

26

 

3

 

n/m

 

n/m

7

 

1

 

n/m

 

n/m

Other Alliance Revenue

 

50

 

5

 

4

 

4

27

 

6

 

17

 

17

Total

 

939

 

100

 

50

 

50

482

 

100

 

42

 

42

Table 6: Collaboration Revenue

H1 2024

  

  

Q2 2024

% Change

% Change

    

$m

    

% Total

    

Actual

    

CER

  

$m

    

% Total

    

Actual

    

CER

Farxiga: sales milestones

 

49

 

100

 

96

 

96

4

 

100

 

>5x

 

>5x

COVID-19 mAbs: licence fees

 

 

 

n/m

 

n/m

 

 

n/m

 

n/m

Other Collaboration Revenue

 

 

 

(98)

 

(98)

 

 

n/m

 

n/m

Total

 

49

 

100

 

(78)

 

(78)

4

 

100

 

(98)

 

(98)

Table 7: Total Revenue by therapy area

    

H1 2024

  

  

Q2 2024

% Change

% Change

$m

    

% Total

    

Actual

   

CER

$m

   

% Total

   

Actual

   

CER

Oncology

10,440

 

41

 

19

 

22

5,331

 

41

 

15

 

19

Biopharmaceuticals

10,362

 

40

 

14

 

17

5,184

 

40

 

15

 

19

CVRM

6,220

 

24

 

19

 

22

3,160

 

24

 

18

 

22

R&I

3,791

 

15

 

19

 

22

1,905

 

15

 

23

 

26

V&I

350

 

1

 

(45)

 

(42)

119

 

1

 

(57)

 

(53)

Rare Disease

4,243

 

17

 

11

 

15

2,147

 

17

 

10

 

14

Other Medicines

573

 

2

 

(9)

 

(2)

276

 

2

 

(11)

 

(5)

Total

25,617

 

100

 

15

 

18

12,938

 

100

 

13

 

17

Table 8: Total Revenue by region

    

H1 2024

  

  

Q2 2024

 

% Change

 

% Change

$m

   

% Total

   

Actual

   

CER

$m

   

% Total

   

Actual

   

CER

US

10,695

 

42

 

18

 

18

5,571

 

43

 

17

 

17

Emerging Markets

7,119

 

28

 

13

 

22

3,386

 

26

 

9

 

18

China

3,378

 

13

 

11

 

15

1,630

 

13

 

13

 

18

Emerging Markets ex. China

3,740

 

15

 

16

 

29

1,756

 

14

 

5

 

18

Europe

5,365

 

21

 

23

 

22

2,732

 

21

 

24

 

24

Established ROW

2,438

 

10

 

(5)

 

4

1,249

 

10

 

(5)

 

6

Total

25,617

 

100

 

15

 

18

12,938

 

100

 

13

 

17

12

Graphic

Oncology

Oncology Total Revenue of $10,440m in H1 2024 increased by 19% (22% at CER), representing 41% of overall Total Revenue (H1 2023: 39%).

Tagrisso

H1 2024, $m

    

Worldwide

    

US

    

Emerging Markets

    

Europe

    

Established RoW

Total Revenue

 

3,203

 

1,282

 

919

 

628

 

374

Actual change

 

10%

16%

8%

16%

(11%)

CER change

 

13%

16%

16%

15%

(2%)

Region

    

Drivers and commentary

Worldwide

·

Strong global demand for Tagrisso in adjuvant (ADAURA) and 1st -line settings (FLAURA, FLAURA2)

US

·

Continued adjuvant and 1st-line demand growth

Emerging Markets

·

Encouraging demand growth across markets despite local competition in China

Europe

·

Continued demand growth in 1st-line and adjuvant settings

Established RoW

·

Continued growth across indications, impacted by 10.5% mandatory price reduction in Japan effective from June 2023

Imfinzi

H1 2024, $m

    

Worldwide

    

US

    

Emerging Markets

    

Europe

    

Established RoW

 

Total Revenue

 

2,259

 

1,202

 

245

 

459

 

353

Actual change

 

20%

17%

35%

38%

7%

CER change

 

25%

17%

58%

36%

19%

Region

    

Drivers and commentary

Worldwide

·

Continued growth driven by BTC (TOPAZ-1), HCC (HIMALAYA), and 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, having achieved peak market share and stabilisation in BTC

Emerging Markets

·

New patient share growth across all indications

·

China growth driven largely by increasing demand in BTC

Europe

·

Growth driven by share gains in extensive-stage SCLC and new launches in HCC, BTC and NSCLC

Established RoW

·

Increased demand in GI indications, offset by a 25% mandatory price reduction in Japan effective from 1 February 2024

Calquence

H1 2024, $m

    

Worldwide

    

US

    

Emerging Markets

    

Europe

    

Established RoW

 

Total Revenue

 

1,508

 

1,048

 

75

 

320

 

65

Actual change

 

27%

21%

82%

42%

30%

CER change

 

28%

21%

>2x

 

41%

34%

Region

    

Drivers and commentary

Worldwide

·

Sustained leadership in front-line CLL (ELEVATE-TN) and increased global penetration

US

·

Growth driven by leading share of new patient starts in front-line CLL, and improved affordability

Europe

·

Continued strong growth in front-line

Lynparza

H1 2024, $m

    

Worldwide

    

US

    

Emerging Markets

    

Europe

    

Established RoW

Total Revenue

 

1,450

 

607

 

320

 

398

 

125

Actual change

 

6%

5%

15%

9%

(14%)

CER change

 

9%

5%

26%

8%

(6%)

13

Graphic

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

·

No Collaboration Revenue for Lynparza was recognised in either H1 2024 or H1 2023, hence the Product Sales numbers are identical to the Total Revenue numbers shown above

US

·

Continued leadership within PARP inhibitor class despite competition, offset by negative class pressure and maturity

Emerging Markets

·

Volume growth in China from increased share in newly diagnosed BRCA-mutated ovarian cancer (SOLO-1) and inclusion of HRD-positive ovarian cancer (PAOLA-1) on NRDL with no price reduction

Europe

·

Demand growth driven by recent launches in mCRPC (PROpel) and early breast cancer (OlympiA)

Established RoW

·

Demand growth from 1st-line ovarian cancer, offset by price reduction in Japan effective from November 2023

Enhertu

H1 2024, $m

    

Worldwide

    

US

    

Emerging Markets

    

Europe

    

Established RoW

Total Revenue

 

932

 

414

 

224

 

263

 

31

Actual change

 

61%

22%

>2x

 

>2x

 

>3x

CER change

 

62%

22%

>2x

 

>2x

 

>3x

Region

    

Drivers and commentary

Worldwide

·

Combined sales of Enhertu, recorded by Daiichi Sankyo and AstraZeneca, amounted to $1,772m in H1 2024 (H1 2023: $1,169m)

US

·

US in-market sales, recorded by Daiichi Sankyo, amounted to $865m in H1 2024 (H1 2023: $712m)

·

Continued demand across all indications with encouraging early launch following tumour-agnostic approval in April 2024 (DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02)

Emerging Markets

·

Sustained demand growth, with quarterly phasing impacted by launch-related inventory build in China in Q1 2024 and subsequent destocking

Europe

·

Continued demand growth due to increasing adoption in HER2-positive (DESTINY-Breast03) and HER2-low (DESTINY-Breast04) metastatic breast cancer

Established RoW

·

AstraZeneca’s Alliance Revenue includes a mid single-digit percentage royalty on Daiichi Sankyo’s sales in Japan

Other Oncology medicines

H1 2024

Change

Total Revenue

    

$m

    

Actual

    

CER

    

Drivers and commentary

Zoladex

567

19%

26%

·

Strong underlying growth in China and Emerging Markets and moderate growth in Europe offset by drop in Japan

Imjudo

136

35%

38%

·

Continued growth across markets slightly offset by US inventory destocking in H1 2024

Truqap

142

n/m

n/m

·

Strong demand growth with strong uptake in biomarker altered subgroup of HR-positive HER2-negative metastatic breast cancer (CAPItello-291)

Orpathys

25

14%

18%

·

Demand in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations

Other Oncology

216

(21%)

(15%)

·

Decline in Faslodex Total Revenue due to VBP implementation in China in March 2024 in addition to ongoing generic erosion in Europe

BioPharmaceuticals

BioPharmaceuticals Total Revenue increased by 14% (17% at CER) in H1 2024 to $10,362m, representing 40% of overall Total Revenue (H1 2023: 41%).

14

Graphic

BioPharmaceuticals – CVRM

CVRM Total Revenue increased by 19% (22% at CER) to $6,220m in H1 2024 and represented 24% of overall Total Revenue (H1 2023: 24%).

Farxiga

H1 2024, $m

    

Worldwide

    

US

    

Emerging Markets

    

Europe

    

Established RoW

Total Revenue

 

3,836

 

869

 

1,474

 

1,233

 

260

Actual change

 

35%

37%

37%

45%

(5%)

CER change

 

38%

37%

44%

44%

3%

Region

    

Drivers and commentary

Worldwide

Farxiga volume is growing faster than the overall SGLT2 market 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
Launch of an authorised generic in the first quarter of 2024

Emerging Markets

Increased reimbursement supporting solid growth despite entry of generic competition in some markets
Strong momentum in Latin America

Europe

Continued strong class growth and market share gains fuelled by HFpEF approval in 2023 and guidelines updates

Established RoW

Performance impacted by generic competition in Canada
In Japan, AstraZeneca sells to collaborator Ono Pharmaceutical Co., Ltd, which records in-market sales

Other CVRM medicines

H1 2024

Change

Total Revenue

    

$m

    

Actual

    

CER

    

Drivers and commentary

Brilinta

665

2%

·

Continued sales growth in Emerging Markets, decline in Est. RoW driven by generic competition in Canada

Crestor

590

1%

6%

·

Continued sales growth in Emerging Markets

Seloken

315

(8%)

(1%)

·

Stable following VBP implementation in China in 2022

Lokelma

249

26%

30%

·

Strong growth in all major regions. Continued launches in new markets

roxadustat

167

22%

27%

·

Increased demand in both the dialysis and non-dialysis-dependent populations. NRDL listing renewed

Andexxa

105

18%

21%

·

Growth in all major regions

Wainua

21

n/m

n/m

·

Encouraging launch uptake following ATTRv-PN approval in the US in December 2023

Other CVRM

272

(30%)

(28%)

BioPharmaceuticals – R&I

Total Revenue of $3,791m from R&I medicines increased 19% (22% at CER) and represented 15% of overall Total Revenue (H1 2023: 14%). This reflected growth in Fasenra, Tezspire, Breztri, Saphnelo and Airsupra, following its recent launch.

Fasenra

H1 2024, $m

    

Worldwide

    

US

    

Emerging Markets

    

Europe

    

Established RoW

Total Revenue

 

781

 

478

 

41

 

192

 

70

Actual change

 

5%

2%

45%

9%

(2%)

CER change

 

6%

2%

53%

8%

6%

15

Graphic

Region

    

Drivers and commentary

Worldwide

·

Continued asthma market share leadership in IL-5 class across major markets

US

·

Maintained share of a growing severe asthma biologics market

Emerging Markets

·

Continued strong demand growth driven by launch acceleration across key markets 

Europe

·

Expanded leadership in severe eosinophilic asthma

Established RoW

·

In Japan, maintained class leadership in a broadly stable market

Breztri

H1 2024, $m

    

Worldwide

    

US

    

Emerging Markets

    

Europe

    

Established RoW

 

Total Revenue

 

454

 

225

 

131

 

65

 

33

Actual change

 

48%

37%

61%

80%

33%

CER change

 

51%

37%

69%

79%

44%

Region

    

Drivers and commentary

Worldwide

Fastest growing medicine within the expanding FDC triple class, across major markets

US

Consistent share growth within the expanding FDC triple class

Emerging Markets

Maintained market share leadership in China with strong triple FDC class penetration
Further expansion with launches in additional geographies

Europe

Sustained growth across markets driven by new launches

Established RoW

Increased market share in Japan

Tezspire

H1 2024, $m

    

Worldwide

    

US

    

Emerging Markets

    

Europe

    

Established RoW

Total Revenue

 

280

 

180

 

5

 

61

 

34

Actual change

 

>2x

 

72%

>10x

 

>3x

 

>2x

CER change

 

>2x

 

72%

>10x

 

>3x

 

>2x

Region

    

Drivers and commentary

Worldwide

Combined sales of Tezspire, recorded by Amgen and AstraZeneca, amounted to $507m in H1 2024 (H1 2023: $257m)

US

Continued growth in total prescriptions, and maintained new-to-brand market share with majority of patients new-to-biologics

Europe

Achieved new-to-brand leadership across multiple markets, new launches continue to progress

Established RoW

Japan maintained new-to-brand leadership

Symbicort

H1 2024, $m

    

Worldwide

    

US

    

Emerging Markets

    

Europe

    

Established RoW

Total Revenue

 

1,491

 

598

 

450

 

286

 

157

Actual change

 

16%

38%

11%

 

(4%)

CER change

 

19%

38%

21%

(1%)

 

(2%)

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

Strong demand growth

Europe

Continued price and volume erosion from generics and a slowing overall market partially offset by growth in some markets within mild asthma

Established RoW

Continued generic erosion in Japan

16

Graphic

Other R&I medicines

H1 2024

Change

Total Revenue

    

$m

    

Actual

    

CER

    

Drivers and commentary

Pulmicort

379

10%

14%

>80% of revenues from Emerging Markets

Saphnelo

203

77%

77%

Demand acceleration in the US, and additional growth driven by ongoing launches in Europe and Established RoW

Airsupra

21

n/m

n/m

Strong US launch momentum and volume uptake. Revenue in the period reflects introductory discounts as early access continues to build

Other R&I

181

(26%)

(25%)

Generic competition

BioPharmaceuticals – V&I

Total Revenue from V&I medicines reduced by 45% (42% at CER) to $350m (H1 2023: $632m) and represented 1% of overall Total Revenue (H1 2023: 3%). Collaboration Revenue was $nil in the period (H1 2023: $190m).

V&I medicines

H1 2024

Change

Total Revenue

    

$m

    

Actual

    

CER

    

Drivers and commentary

Beyfortus

80

>10x

>10x

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

253

(11%)

(6%)

Decline has been more than offset by Beyfortus growth

COVID-19 mAbs

3

(99%)

(99%)

Decline in Evusheld sales and Collaboration Revenue (Total Revenue H1 2023: $306m)

FluMist

8

(34%)

(36%)

Other V&I

6

(79%)

(80%)

Decline in Vaxzevria sales (H1 2023: $28m)

Rare Disease

Total Revenue from Rare Disease medicines increased by 11% (15% at CER) in H1 2024 to $4,243m, representing 17% of overall Total Revenue (H1 2023: 17%).

Ultomiris

H1 2024, $m

    

Worldwide

    

US

    

Emerging Markets

    

Europe

    

Established RoW

 

Total Revenue

 

1,804

 

1,032

 

66

 

411

 

295

Actual change

 

32%

27%

>2x

 

32%

42%

CER change

 

35%

27%

>2x

 

31%

58%

17

Graphic

Region

    

Drivers and commentary

Worldwide

Growth due to increased use in neurology, geographic expansion, further patient demand and conversion from Soliris
The reported revenues for Ultomiris include 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.
Voydeya is a strategic launch in this small subset of PNH patients. Voydeya ensures these patients can remain on the standard of care, Ultomiris

US

Patient growth in gMG and newly launched NMOSD, continued conversion from Soliris

Emerging Markets

Continued growth following launches in new markets

Europe

Strong demand growth following recent launches, particularly from neurology indications, accelerated conversion from Soliris in key markets, partially offset by price reductions to secure reimbursement for new indications

Established RoW

Continued conversion from Soliris and strong demand following new launches

Soliris

H1 2024, $m

    

Worldwide

    

US

    

Emerging Markets

    

Europe

Established RoW

Total Revenue

1,439

808

255

260

116

Actual change

 

(13%)

 

(9%)

 

19%

(29%)

(33%)

CER change

 

(8%)

 

(9%)

 

54%

(30%)

(30%)

Region

    

Drivers and commentary

US

Decline driven by successful conversion of Soliris patients to Ultomiris

Emerging Markets

Growth driven by patient demand following launches in new markets

Europe

Decline driven by biosimilar erosion in PNH and aHUS and successful conversion from Soliris to Ultomiris

Established RoW

Decline driven by successful conversion from Soliris to Ultomiris

Strensiq

H1 2024, $m

    

Worldwide

    

US

    

Emerging Markets

    

Europe

Established RoW

Total Revenue

653

529

31

48

45

Actual change

 

16%

 

17%

 

30%

14%

4%

CER change

 

18%

 

17%

 

47%

12%

15%

Region

    

Drivers and commentary

Worldwide

Growth driven by strong patient demand

Other Rare Disease medicines

H1 2024

Change

Total Revenue

    

$m

    

Actual

    

CER

    

Drivers and commentary

Koselugo

247

55%

  

64%

Driven by patient demand and expansion in new markets

Kanuma

100

17%

  

20%

Continued global demand

Other medicines (outside the main therapy areas)

H1 2024

Change

Total Revenue

    

$m

    

Actual

    

CER

    

Drivers and commentary

Nexium

469

(6%)

  

2%

Growth in Emerging Markets offset declines elsewhere

Others

104

(21%)

  

(18)%

Continued impact of generic competition

18

Graphic

Financial performance

Table 9: Reported Profit and Loss

H1 2024

    

H1 2023

    

% Change

  

  

Q2 2024

    

Q2 2023

    

% Change

    

$m 

    

$m 

    

Actual  

    

CER  

  

  

$m

    

$m

    

Actual  

    

CER  

Total Revenue

    

25,617

    

22,295

    

15

    

18

  

12,938

    

11,416

    

13

    

17

- Product Sales

 

24,629

 

21,448

 

15

 

18

 

12,452

 

10,882

 

14

 

18

- Alliance Revenue

 

939

 

627

 

50

 

50

 

482

 

341

 

42

 

42

- Collaboration Revenue

 

49

 

220

 

(78)

 

(78)

 

4

 

193

 

(98)

 

(98)

Cost of sales

 

(4,401)

 

(3,865)

 

14

 

17

 

(2,183)

 

(1,960)

 

11

 

17

Gross profit

 

21,216

 

18,430

 

15

 

18

 

10,755

 

9,456

 

14

 

17

Distribution expense

 

(267)

 

(265)

 

1

 

3

 

(132)

 

(131)

 

1

 

4

R&D expense

 

(5,791)

 

(5,278)

 

10

 

10

 

(3,008)

 

(2,667)

 

13

 

13

SG&A expense

 

(9,424)

 

(9,045)

 

4

 

6

 

(4,929)

 

(4,986)

 

(1)

 

1

Other operating income & expense

 

127

 

1,163

 

(89)

 

(89)

 

60

 

784

 

(92)

 

(92)

Operating profit

 

5,861

 

5,005

 

17

 

25

 

2,746

 

2,456

 

12

 

20

Net finance expense

 

(645)

 

(654)

 

(1)

 

(4)

 

(343)

 

(367)

 

(7)

 

(7)

Joint ventures and associates

 

(19)

 

(1)

 

n/m

 

n/m

 

(6)

 

(1)

 

n/m

 

n/m

Profit before tax

 

5,197

 

4,350

 

19

 

29

 

2,397

 

2,088

 

15

 

24

Taxation

 

(1,089)

 

(726)

 

50

 

62

 

(469)

 

(268)

 

75

 

90

Tax rate

 

21%

17%

  

 

  

 

20%

13%

  

 

  

Profit after tax

 

4,108

 

3,624

 

13

 

23

 

1,928

 

1,820

 

6

 

15

Earnings per share

$

2.65

$

2.34

 

13

 

23

$

1.24

$

1.17

 

6

 

15

Table 10: Reconciliation of Reported Profit before tax to EBITDA

H1 2024

H1 2023

% Change

  

  

Q2 2024

Q2 2023

% Change

    

$m 

    

$m 

   

Actual  

    

CER  

  

  

$m

    

$m

    

Actual  

    

CER  

Reported Profit before tax

 

5,197

4,350

   

19

    

29

2,397

    

2,088

15

24

Net finance expense

 

645

654

 

(1)

 

(4)

343

 

367

(7)

(7)

Joint ventures and associates

 

19

1

 

n/m

 

n/m

6

 

1

n/m

n/m

Depreciation, amortisation and impairment

 

2,534

2,778

 

(9)

 

(9)

1,279

 

1,276

1

EBITDA

 

8,395

7,783

 

8

 

13

4,025

 

3,732

8

14

19

Graphic

Table 11: Reconciliation of Reported to Core financial measures: H1 20247

    

    

    

Intangible 

    

    

    

    

Asset 

Amortisation & 

Core

Reported

Restructuring

Impairments

Other

Core

% Change

H1 2024

$m

$m

$m

$m

$m

Actual

CER

Gross profit

    

21,216

 

36

 

19

 

 

21,271

 

14

 

17

Product Sales Gross Margin

 

82%

 

82%

 

-1pp

 

-1pp

Distribution expense

 

(267)

 

 

 

 

(267)

 

1

 

3

R&D expense

 

(5,791)

 

177

 

39

 

5

 

(5,570)

 

14

 

15

% of Total Revenue

 

23%

 

22%

 

 

+1pp

SG&A expense

    

(9,424)

    

138

    

1,884

    

254

    

(7,148)

    

13

    

15

% of Total Revenue

 

37%

 

28%

 

+1pp

 

+1pp

Total operating expense

 

(15,482)

 

315

 

1,923

 

259

 

(12,985)

 

13

 

15

Other operating income & expense

 

127

 

(2)

 

 

 

125

 

(89)

 

(89)

Operating profit

 

5,861

 

349

 

1,942

 

259

 

8,411

 

2

 

7

Operating Margin

 

23%

 

33%

 

-4pp

 

-3pp

Net finance expense

 

(645)

 

 

 

115

 

(530)

 

6

 

3

Taxation

 

(1,089)

 

(80)

 

(368)

 

(71)

 

(1,608)

 

13

 

19

EPS

 

$

2.65

$

0.17

$

1.01

$

0.20

$

4.03

 

(1)

 

5

Table 12: Reconciliation of Reported to Core financial measures: Q2 20247

    

    

    

Intangible 

    

    

    

Asset 

Amortisation & 

Core 

Reported

Restructuring

Impairments

Other

Core

% Change

Q2 2024

$m

$m

$m

$m

$m

Actual

CER

Gross profit

 

10,755

 

16

 

9

 

 

10,780

 

13

 

17

Product Sales Gross Margin

 

82%

 

83%

 

 

Distribution expense

 

(132)

 

 

(132)

 

1

 

4

R&D expense

 

(3,008)

97

35

 

4

 

(2,872)

 

12

 

13

% of Total Revenue

 

23%

 

 

22%

 

 

+1pp

SG&A expense

 

(4,929)

41

943

 

210

 

(3,735)

 

13

 

16

% of Total Revenue

 

38%

 

 

29%

 

 

Total operating expense

 

(8,069)

138

978

 

214

 

(6,739)

 

12

 

14

Other operating income & expense

 

60

 

 

60

 

(92)

 

(92)

Operating profit

 

2,746

154

987

 

214

 

4,101

 

(4)

 

1

Operating Margin

 

21%

 

 

32%

 

-6pp

 

-5pp

Net finance expense

 

(343)

 

58

 

(285)

 

10

 

10

Taxation

 

(469)

(35)

 

(185)

 

(52)

 

(741)

 

7

 

13

EPS

$

1.24

$

0.08

$

0.51

$

0.15

$

1.98

 

(8)

 

(3)

7

The presentation of this table has been updated by removing the “Acquisition of Alexion” column due to immateriality of items in this category

20

Graphic

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 H1 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 is responsible for manufacturing, and Sanofi is responsible for distribution. AstraZeneca records its sales to Sanofi as Product Sales, and those sales generate 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

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 several high priority medicines 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 and Fusion

The change in Reported R&D expense was also impacted by intangible asset impairments in the prior period

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

Other operating income and expense

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

Net finance expense

Core Net finance expense increased 6% (3% increase at CER) principally due to the higher level of gross debt partially offset by the higher level of cash and short-term investments.

Taxation

The effective Reported Tax rate for the six months to 30 June 2024 was 21% (H1 2023: 17%) and the effective Core Tax rate was 20% (H1 2023: 18%)

The cash tax paid for the six months to 30 June 2024 was $1,337m (H1 2023: $1,061m), representing 26% of Reported Profit before tax (H1 2023: 24%)

Dividend

An Interim dividend of $1 per share (77.6 pence, 10.79 SEK) has been declared.

21

Graphic

Table 13: Cash Flow summary

    

H1 2024

    

H1 2023

    

Change

$m

$m

$m

Reported Operating profit

 

5,861

 

5,005

 

856

Depreciation, amortisation and impairment

 

2,534

 

2,778

 

(244)

Movement in working capital and short-term provisions

 

(584)

 

(747)

 

163

Gains on disposal of intangible assets

 

(21)

 

(249)

 

228

Fair value movements on contingent consideration arising from business combinations

 

251

 

202

 

49

Non-cash and other movements

 

(550)

 

(594)

 

44

Interest paid

 

(583)

 

(483)

 

(100)

Taxation paid

 

(1,337)

 

(1,061)

 

(276)

Net cash inflow from operating activities

 

5,571

 

4,851

 

720

Net cash inflow before financing activities

 

286

 

3,085

 

(2,799)

Net cash inflow/(outflow) from financing activities

 

806

 

(3,550)

 

4,356

The change in Net cash inflow before financing activities in the half year to 30 June 2024 is primarily driven by the movement in Acquisitions of subsidiaries, net of cash acquired and initial investment, 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 H1 2023.

The increase in Net cash inflow/(outflow) from financing activities of $4,356m is primarily driven by the increase in Issue of loans and borrowings of $1,160m, by the decrease in Repayment of loans and borrowings of $765m and the increase in Movement in short-term borrowings of $2,431m mainly due to the Commercial paper issued during the half year for $2,453m.

Capital expenditure

Capital expenditure amounted to $799m in H1 2024 (H1 2023: $517m). Capital expenditure is expected to increase substantially in 2024, driven by investment in several major manufacturing projects and continued investment in technology upgrades.

Table 14: Net debt summary

    

At 30

    

At 31

    

At 30

 Jun 2024

 Dec 2023

Jun 2023

$m

$m

$m

Cash and cash equivalents

 

6,916

 

5,840

 

5,664

Other investments

 

160

 

122

 

148

Cash and investments

 

7,076

 

5,962

 

5,812

Overdrafts and short-term borrowings

 

(596)

 

(515)

 

(421)

Commercial paper

 

(2,453)

 

 

Lease liabilities

 

(1,241)

 

(1,128)

 

(953)

Current instalments of loans

 

(2,018)

 

(4,614)

 

(4,135)

Non-current instalments of loans

 

(27,225)

 

(22,365)

 

(24,329)

Interest-bearing loans and borrowings (Gross debt)

 

(33,533)

 

(28,622)

 

(29,838)

Net derivatives

 

133

 

150

 

56

Net debt

 

(26,324)

 

(22,510)

 

(23,970)

Net debt increased by $3,814m in the six months to 30 June 2024 to $26,324m. 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.

22

Graphic

Capital allocation

The Board’s aim is to continue to strike a balance between the interests of the business, financial creditors and the Company’s shareholders. The Company’s capital allocation priorities include: investing in the business and pipeline; maintaining a strong, investment-grade credit rating; potential value-enhancing business development opportunities; and supporting the progressive dividend policy.

In approving the declaration of dividends, the Board considers both the liquidity of the company and the level of reserves legally available for distribution. Dividends are paid to shareholders from AstraZeneca PLC, a Group holding company with no direct operations. The ability of AstraZeneca PLC to make shareholder distributions is dependent on the creation of profits for distribution and the receipt of funds from subsidiary companies. The consolidated Group reserves set out in the Condensed consolidated statement of financial position do not reflect the profit available for distribution to the shareholders of AstraZeneca PLC.

Summarised financial information for guarantee of securities of subsidiaries

AstraZeneca Finance LLC (“AstraZeneca Finance”) is the issuer of 0.7% Notes due 2024, 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 Notes”). Each series of AstraZeneca Finance Notes has been fully and unconditionally guaranteed by AstraZeneca PLC. AstraZeneca Finance is 100% owned by AstraZeneca PLC and each of the guarantees issued by AstraZeneca PLC is full and unconditional and joint and several.

The AstraZeneca Finance Notes are senior unsecured obligations of AstraZeneca Finance and rank equally with all of AstraZeneca Finance’s existing and future senior unsecured and unsubordinated indebtedness. The guarantee by AstraZeneca PLC of the AstraZeneca Finance Notes is the senior unsecured obligation of AstraZeneca PLC and ranks equally with all of AstraZeneca PLC’s existing and future senior unsecured and unsubordinated indebtedness. Each guarantee by AstraZeneca PLC is effectively subordinated to any secured indebtedness of AstraZeneca PLC to the extent of the value of the assets securing such indebtedness. The AstraZeneca Finance Notes are structurally subordinated to indebtedness and other liabilities of the subsidiaries of AstraZeneca PLC, none of which guarantee the AstraZeneca Finance Notes.

AstraZeneca PLC manages substantially all of its operations through divisions, branches and/or investments in subsidiaries and affiliates. Accordingly, the ability of AstraZeneca PLC to service its debt and guarantee obligations is also dependent upon the earnings of its subsidiaries, affiliates, branches and divisions, whether by dividends, distributions, loans or otherwise.

Please refer to the Consolidated financial statements of AstraZeneca PLC in our Annual Report on Form 20-F 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 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.

Table 15: Obligor group summarised Statement of comprehensive income

    

H1 2024

    

H1 2023

$m

$m

Total Revenue

 

 

Gross profit

 

 

Operating loss

 

 

(2)

Loss for the period

 

(545)

 

(480)

Transactions with subsidiaries that are not issuers or guarantors

 

964

 

9,487

23

Graphic

Table 16: Obligor group summarised Statement of financial position

    

At 30 Jun 2024

    

At 30 Jun 2023

$m

$m

Current assets

 

13

 

7

Non-current assets

 

 

Current liabilities

 

(4,795)

 

(4,091)

Non-current liabilities

 

(27,133)

 

(24,165)

Amounts due from subsidiaries that are not issuers or guarantors

 

20,730

 

15,761

Amounts due to subsidiaries that are not issuers or guarantors

 

 

(290)

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:

    

    

    

    

    

    

Annual impact ($m) of

5% strengthening

Average

(FY 2024 average rate

rates vs. USD

vs. FY 2023 average) 8

Core

FY

YTD

Change

June

Change

Total

Operating

Currency

Primary Relevance

20239

202410

(%)

202411

(%)

Revenue

Profit

EUR

Total Revenue

0.92

0.93

(0)

0.93

(0)

397

179

CNY

Total Revenue

7.09

    

7.23

    

(2)

    

7.27

(3)

322

182

JPY

    

Total Revenue

    

140.60

152.26

(8)

158.03

    

(11)

    

177

119

Other12

453

227

GBP

 

Operating expense

 

0.80

 

0.79

 

2

 

0.79

 

2

 

60

 

(126)

SEK

 

Operating expense

 

10.61

 

10.54

 

1

 

10.49

 

1

 

9

 

(63)

8

Based on best prevailing assumptions around currency profiles.

9

Based on average daily spot rates 1 Jan 2023 to 31 Dec 2023.

10

Based on average daily spot rates 1 Jan 2024 to 30 Jun 2024.

11

Based on average daily spot rates 1 Jun 2024 to 30 Jun 2024.

12

Other currencies include AUD, BRL, CAD, KRW and RUB.

24

Graphic

Related-party transactions

There have been no significant related-party transactions in the period.

Principal risks and uncertainties

The Principal Risks and uncertainties facing the Group are set out on pages 54 to 57 of the Annual Report and Form 20-F Information 2023, and summarised below. They are not expected to change in respect of the second six months of the financial year and remain appropriate for the Group. In summary, the principal risks and uncertainties listed in the Annual Report and 20-F Information 2023 are:

1.

Product pipeline: failure or delay in the delivery of AstraZeneca’s pipeline or launch of new medicines; failure to meet regulatory or ethical requirements for medicine development or approval

2.

Commercialisation risks: pricing, affordability, access and competitive pressures; failures or delays in the quality or execution of the Group’s commercial strategies

3.

Supply-chain and business-execution risks: failure to maintain supply of compliant, quality medicines; failure in information technology or cybersecurity; failure to attract, develop, engage and retain a diverse, talented and capable workforce

4.

Legal, regulatory and compliance risks: safety and efficacy of marketed medicines is questioned; adverse outcome of litigation and / or governmental investigations; IP risks related to our products

5.

Economic and financial risks: failure to achieve strategic plans or meet targets or expectations; geopolitical and / or macroeconomic volatility disrupts the operation of our global business

25

Graphic

Sustainability

AstraZeneca released its first Sustainability Impact Publication as a complement to its ninth annual Sustainability Report. This publication spotlights the diverse ways in which the Company is contributing to the health of people, society and the planet.

Access to healthcare

At the 77th World Health Assembly (WHA) in Geneva, Switzerland in May, AstraZeneca convened Ministers of Health, industry, civil society and patient groups. Areas of focus for engagement, led by Ruud Dobber, EVP BioPharmaceuticals, included the need to increase early action to prevent, diagnose and treat disease and to accelerate collaboration to build resilient, equitable and net zero health systems

At the WHA, AstraZeneca launched the expansion of its flagship Healthy Heart Africa programme to include chronic kidney disease as well as cardiovascular disease, recognising the growing burden of non-communicable diseases (NCDs) in Africa. As of May 2024, HHA has conducted more than 57 million screenings for high blood pressure and identified more than 11.3 million elevated readings, with 4.5 million patients diagnosed with hypertension since launch

Also at the WHA, the Lung Ambition Alliance, of which the Company is a founding member, launched the Saving Lives from Lung Cancer platform and a calculator tool developed by AstraZeneca to support policymakers and the lung cancer community in identifying high-risk populations for early intervention

The Partnership for Health System Sustainability and Resilience (PHSSR) held its third Summit during the Abu Dhabi Global Healthcare Week in May, bringing together more than 200 healthcare leaders from the Middle East, Africa and beyond including three Ministers of Health and 29 speakers, to drive forward the dialogue on investing in strengthening health systems. PHSSR also hosted local events in Taiwan, Portugal and the Netherlands during the quarter. In addition, insights from the PHSSR Asia-Pacific report were shared with a delegation from Korea at WHA

A survey of more than 600 employees in 16 countries where the Young Health Programme (YHP) is active showed that more than 95% of employees feel proud to be associated with the YHP. With its expansion into the Philippines, the programme is now active in 41 countries globally. In recognition of the impact of the YHP, AstraZeneca was the only corporate partner invited to speak at UNICEF’s Annual Meeting attended by UNICEF’s 33 CEOs and their Board Chairs in high-income countries

In June, the Company expanded its partnership with Direct Relief, approving the humanitarian organisation as a global medicine donation partner, enabling medicine donation to support global humanitarian relief efforts

Environmental protection

AstraZeneca received multiple recognitions for its sustainability leadership this quarter, including retaining its EcoVadis Gold Medal ranking for the second consecutive year. This reflects its place in the top three percent of companies evaluated on environment, labour and human rights, ethics and sustainable procurement. The Company was also recognised in the 2024 FT Europe Climate Leaders list, where it was the top pharmaceutical company for the second year in a row

AstraZeneca is collaborating with the World Business Council for Sustainable Development and its peers to develop a Roadmap to Nature Positive for the pharmaceutical sector, announced in May. The Roadmap will offer sector-specific guidance to accelerate toward nature positive, in alignment with the Taskforce for Nature-related Financial Disclosures, Science-based Targets Network and the EU’s Corporate Sustainability Reporting Directive

Pam Cheng, Executive Vice President of Global Operations and IT and Chief Sustainability Officer, joined a Global Health Leaders panel at the inaugural Climate and Health Day of the US Climate Action Summit. Leaders from government, industry, philanthropy and finance discussed the critical need to drive coordinated action on the climate and health nexus

26

Graphic

Ethics and transparency

AstraZeneca shared a new Diversity in Clinical Trials Standard internally for use across all therapy areas in R&D. This outlines the Company’s mandatory principles on diversity for all AstraZeneca-sponsored clinical trials, in line with regulatory requirements, and reflects the Company’s unwavering commitment to ensuring its clinical trials are representative of diverse populations

Approximately 6,500 colleagues across 10 regions and 16 business units took the time to respond to AstraZeneca’s second employee Ethics Survey. An analysis of 2023 results showed employee feedback continues to be positive, with 97% of respondents confirming they know how to raise an ethical concern and 87% confirming that it is easy to do the right thing in their day-to-day work

The Company released new guidance on the selection, design, installation and maintenance of solar Photovoltaic (PV) power systems, which highlights the importance of conducting due diligence on human rights risks associated with new solar PV projects

27

Graphic

Research and development

This section covers R&D events and milestones that have occurred since the prior results announcement on 25 April 2024, up to and including events on 24 July 2024.

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

Oncology

AstraZeneca presented new data across its diverse portfolio of cancer medicines at two major medical congresses since the prior results announcement: the American Society of Clinical Oncology (ASCO) in May and June 2024 and European Hematology Association (EHA) in June 2024. At ASCO, AstraZeneca presented more than 100 abstracts featuring 25 approved and potential new medicines across the Company’s diverse oncology portfolio and pipeline, including two late-breaking plenary presentations, a special late-breaking abstract session presentation and 15 oral presentations. At EHA, AstraZeneca presented 17 abstracts including one oral presentation and 10 posters across one approved and four investigational products.

Tagrisso

Event

    

Commentary

 

Presentation: ASCO

    

LAURA

Primary analysis of the Phase III LAURA trial, presented at ASCO, showed Tagrisso reduced the risk of disease progression or death by 84% compared to placebo (HR 0.16, 95% CI 0.10-0.24, p<0.001) as assessed by BICR. Median PFS was 39.1 months in patients treated with Tagrisso versus 5.6 months for placebo.

sNDA acceptance and Priority Review

US

For the treatment of adult patients with unresectable, Stage III EGFRm NSCLC after chemoradiotherapy. (LAURA, June 2024)

Approvals

Japan, China

Tagrisso with the addition of pemetrexed and platinum-based chemotherapy for the 1st-line treatment of adult patients with locally advanced or metastatic EGFRm NSCLC whose tumours have exon 19 deletions or exon 21 (L858R) mutations. (FLAURA2, June 2024)

Approval

Europe

Tagrisso with the addition of pemetrexed and platinum-based chemotherapy for the 1st-line treatment of adult patients with advanced EGFRm NSCLC whose tumours have exon 19 deletions or exon 21 (L858R) mutations. (FLAURA2, July 2024)

28

Graphic

Imfinzi and Imjudo

Event

Commentary

 

Presentation: ASCO

    

ADRIATIC

    

Planned interim analysis of the Phase III ADRIATIC trial, presented at ASCO, demonstrated Imfinzi reduced the risk of death by 27% versus placebo (OS HR 0.73, 95% CI 0.57-0.93, p=0.0104) with an estimated 57% of patients treated with Imfinzi alive at three years compared to 48% on placebo. (June 2024)

Approval

US

Imfinzi in combination with carboplatin and paclitaxel followed by Imfinzi monotherapy for treatment for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient. (DUO-E, June 2024)

Phase III data readout

NIAGARA

Met primary endpoint, with Imfinzi in combination with chemotherapy demonstrating a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival and the key secondary endpoint of OS versus neoadjuvant chemotherapy for patients with muscle-invasive bladder cancer. (June 2024)

Trial update

BR.31

BR.31 Phase III trial for Imfinzi in early-stage (IB-IIIA) NSCLC after complete tumour resection in patients whose tumours express PD-L1 on 25% or more tumour cells did not achieve statistical significance for the primary endpoint of disease-free survival versus placebo. (June 2024)

CHMP positive opinion

Europe

Imfinzi plus chemotherapy as 1st-line treatment followed by Lynparza and Imfinzi for patients with mismatch repair proficient disease. Imfinzi plus chemotherapy followed by Imfinzi alone for patients with mismatch repair deficient disease. (DUO-E, July 2024)

Lynparza

Event

Commentary

 

CHMP positive opinion

    

Europe

    

Imfinzi plus chemotherapy as 1st-line treatment followed by Lynparza and Imfinzi for patients with mismatch repair proficient disease. (DUO-E, July 2024)

Enhertu

Event

    

Commentary

 

Phase III readout and presentation: ASCO

    

DESTINY-Breast06

Met primary endpoint, demonstrating Enhertu resulted in a statistically significant and clinically meaningful improvement in PFS in HR-positive, HER2-low metastatic breast cancer following one or more lines of endocrine therapy. (April 2024)

Primary analysis of the Phase III DESTINY-Breast06 trial, presented at ASCO, demonstrated Enhertu resulted in a statistically significant and clinically meaningful improvement in PFS compared to standard-of-care chemotherapy in patients with HR-positive, HER2-low metastatic breast cancer (HR 0.62, 95% CI 0.51-0.74, p<0.0001). Enhertu also demonstrated a statistically significant and clinically meaningful improvement in the overall trial population (patients with HR-positive, HER2-low and HER2-ultralow disease) (HR 0.63, 95% CI 0.53-0.75, p<0.0001). (June 2024)

29

Graphic

Calquence

Event

Commentary

 

Phase III

readout and
presentation:
EHA

    

ECHO

    

Met primary endpoint with Calquence combination regimen demonstrating a statistically significant and clinically meaningful improvement in PFS in 1st-line mantle cell lymphoma. (May 2024)

Interim analysis of the Phase III ECHO trial, presented at EHA, demonstrated Calquence in combination with standard-of-care chemoimmunotherapy, bendamustine and rituximab, resulted in a statistically significant and clinically meaningful 27% reduction in risk of progression or death versus standard of care in previously untreated adult patients with mantle cell lymphoma (HR 0.73, 95% CI 0.57-0.94, p=0.016). The secondary endpoint of OS showed a favourable trend for the Calquence combination compared to chemoimmunotherapy (HR 0.86; 95% CI 0.65-1.13; p=0.2743, not statistically significant, follow-up continues). (June 2024)

Truqap

Event

Commentary

 

Phase III
trial update

    

CAPItello-290

    

CAPItello-290 Phase III trial for Truqap in combination with paclitaxel in patients with locally advanced or metastatic TNBC did not meet the dual primary endpoints of improvement in OS vs paclitaxel in combination with placebo in either the overall trial population or in a subgroup of patients with tumours harbouring specific biomarker alterations (PIK3CA, AKT1 or PTEN). (June 2024)

Approval

Europe

In combination with Faslodex for the treatment of adult patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. (CAPItello-291, June 2024)

Datopotamab deruxtecan (Dato-DXd)

Event

Commentary

 

Phase IIII trial update

    

TROPION-Lung01

    

Dual primary endpoint of improvement in overall survival for Dato-DXd versus docetaxel not met. Numerical improvement in overall survival compared to docetaxel in the overall trial population of patients with locally advanced or metastatic NSCLC. In the prespecified subgroup of patients with non-squamous NSCLC, Dato-DXd showed a clinically meaningful improvement in OS compared to docetaxel. (May 2024)

BioPharmaceuticals – CVRM

Farxiga

Event

Commentary

 

Approval

    

US

    

Improvement of glycaemic control in paediatric patients with type-2 diabetes aged 10 years and older (T2NOW, June 2024)

30

Graphic

AZD0780 (oral PCSK9)

Event

Commentary

 

Presentation:
European
Atherosclerosis
Society

    

Positive Phase I data demonstrating a statistically significant reduction of 52% in LDL-C levels on top of rosuvastatin treatment, with 78% total reduction from baseline, in treatment-naive participants with hypercholesterolaemia. (May 2024)

BioPharmaceuticals – R&I

Tezspire

Event

Commentary

 

Presentation: American Thoracic Society

    

COURSE

    

Results from the COURSE Phase II trial demonstrated that treatment with Tezspire led to a 17% numerical reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo at week 52. In patients with blood eosinophil counts of 150 cell/µl or more, treatment with Tezspire led to a nominally significant reduction of 37% in the rate of moderate or severe exacerbations compared to placebo. (May 2024)

Phase III readout

DIRECTION

Met the primary endpoint, demonstrating a statistically significant reduction in annual asthma exacerbation rate (AAER) over 52 weeks compared to placebo in patients in China with a history of uncontrolled asthma. (July 2024)

BioPharmaceuticals – V&I

sipavibart (COVID-19 mAb)

Event

Commentary

 

Phase III readout

    

SUPERNOVA

    

Positive high-level results from the SUPERNOVA Phase III trial showed sipavibart demonstrated a statistically significant reduction in the incidence of symptomatic COVID-19 in an immunocompromised patient population. The trial was conducted during an evolving variant landscape in which COVID-19 cases captured over the course of the trial were caused by several different SARS-CoV-2 variants. (May 2024)

Rare Disease

AstraZeneca presented new clinical data from the industry’s largest and broadest amyloidosis pipeline at the International Symposium on Amyloidosis (ISA) in May 2024. Clinical data was presented on ALXN2220 and anselamimab, which are being evaluated in Phase III clinical trials for ATTR and light chain (AL) amyloidosis, respectively.

31

Graphic

Interim financial statements

Table 18: Condensed consolidated statement of comprehensive income: H1 2024

For the half year ended 30 June

    

2024

    

2023

$m

$m

Total Revenue

25,617

22,295

Product Sales

24,629

21,448

Alliance Revenue

939

627

Collaboration Revenue

49

220

Cost of sales

(4,401)

(3,865)

Gross profit

21,216

18,430

Distribution expense

(267)

(265)

Research and development expense

(5,791)

(5,278)

Selling, general and administrative expense

(9,424)

(9,045)

Other operating income and expense

127

1,163

Operating profit

5,861

5,005

Finance income

211

141

Finance expense

(856)

(795)

Share of after tax losses in associates and joint ventures

(19)

(1)

Profit before tax

5,197

4,350

Taxation

(1,089)

(726)

Profit for the period

4,108

3,624

Other comprehensive income

Items that will not be reclassified to profit or loss:

Remeasurement of the defined benefit pension liability

101

7

Net gains/(losses) on equity investments measured at fair value through other comprehensive income

89

(48)

Fair value movements related to own credit risk on bonds designated as fair value through profit or loss

12

4

Tax on items that will not be reclassified to profit or loss

(27)

(5)

175

(42)

Items that may be reclassified subsequently to profit or loss:

Foreign exchange arising on consolidation

(554)

105

Foreign exchange arising on designated liabilities in net investment hedges

(96)

(101)

Fair value movements on cash flow hedges

(138)

89

Fair value movements on cash flow hedges transferred to profit and loss

102

(71)

Fair value movements on derivatives designated in net investment hedges

45

40

Gains/(costs) of hedging

14

(1)

Tax on items that may be reclassified subsequently to profit or loss

38

12

(589)

73

Other comprehensive (expense)/income, net of tax

(414)

31

Total comprehensive income for the period

3,694

3,655

Profit attributable to:

Owners of the Parent

4,106

3,621

Non-controlling interests

2

3

4,108

3,624

Total comprehensive income attributable to:

Owners of the Parent

3,692

3,652

Non-controlling interests

2

3

3,694

3,655

Basic earnings per $0.25 Ordinary Share

$

2.65

$

2.34

Diluted earnings per $0.25 Ordinary Share

$

2.63

$

2.32

Weighted average number of Ordinary Shares in issue (millions)

1,549

1,549

Diluted weighted average number of Ordinary Shares in issue (millions)

1,560

1,560

32

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Table 19: Condensed consolidated statement of comprehensive income: Q2 2024

Unreviewed13

Unreviewed

For the quarter ended 30 June

    

2024

    

2023

    

$m

$m

Total Revenue

12,938

11,416

Product Sales

12,452

10,882

Alliance Revenue

482

341

Collaboration Revenue

4

193

Cost of sales

(2,183)

(1,960)

Gross profit

10,755

9,456

Distribution expense

(132)

(131)

Research and development expense

(3,008)

(2,667)

Selling, general and administrative expense

(4,929)

(4,986)

Other operating income and expense

60

784

Operating profit

2,746

2,456

Finance income

100

64

Finance expense

(443)

(431)

Share of after tax losses in associates and joint ventures

(6)

(1)

Profit before tax

2,397

2,088

Taxation

(469)

(268)

Profit for the period

1,928

1,820

Other comprehensive income

Items that will not be reclassified to profit or loss:

Remeasurement of the defined benefit pension liability

(43)

17

Net gains/(losses) on equity investments measured at fair value through other comprehensive income

54

(94)

Fair value movements related to own credit risk on bonds designated as fair value through profit or loss

12

2

Tax on items that will not be reclassified to profit or loss

12

(29)

35

(104)

Items that may be reclassified subsequently to profit or loss:

Foreign exchange arising on consolidation

(39)

(209)

Foreign exchange arising on designated liabilities in net investment hedges

2

(94)

Fair value movements on cash flow hedges

(52)

33

Fair value movements on cash flow hedges transferred to profit and loss

32

4

Fair value movements on derivatives designated in net investment hedges

23

24

Costs of hedging

(1)

(1)

Tax on items that may be reclassified subsequently to profit or loss

3

-

(32)

(243)

Other comprehensive income/(expense), net of tax

3

(347)

Total comprehensive income for the period

1,931

1,473

Profit attributable to:

Owners of the Parent

1,927

1,818

Non-controlling interests

1

2

1,928

1,820

Total comprehensive income attributable to:

Owners of the Parent

1,930

1,471

Non-controlling interests

1

2

1,931

1,473

Basic earnings per $0.25 Ordinary Share

$

1.24

$

1.17

Diluted earnings per $0.25 Ordinary Share

$

1.24

$

1.17

Weighted average number of Ordinary Shares in issue (millions)

1,550

1,550

Diluted weighted average number of Ordinary Shares in issue (millions)

1,560

1,560

13

The Q2 2024 and Q2 2023 information in respect of the three months ended 30 June 2024 and 30 June 2023 respectively included in the Interim financial statements have not been reviewed by PricewaterhouseCoopers LLP.

33

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Table 20: Condensed consolidated statement of financial position

Reviewed14

Audited

Reviewed

At 30 Jun

At 31 Dec

At 30 Jun

    

2024

2023

2023

$m

$m

$m

Assets

Non-current assets

Property, plant and equipment

9,630

9,402

8,675

Right-of-use assets

1,203

1,100

949

Goodwill

21,060

20,048

19,960

Intangible assets

39,426

38,089

38,326

Investments in associates and joint ventures

264

147

72

Other investments

1,607

1,530

1,071

Derivative financial instruments

217

228

163

Other receivables

806

803

752

Deferred tax assets

4,734

4,718

3,736

78,947

76,065

73,704

Current assets

Inventories

5,667

5,424

5,051

Trade and other receivables

11,047

12,126

11,092

Other investments

160

122

148

Derivative financial instruments

28

116

44

Income tax receivable

1,575

1,426

840

Cash and cash equivalents

6,916

5,840

5,664

25,393

25,054

22,839

Total assets

104,340

101,119

96,543

Liabilities

Current liabilities

Interest-bearing loans and borrowings

(5,067)

(5,129)

(4,556)

Lease liabilities

(292)

(271)

(231)

Trade and other payables

(20,463)

(22,374)

(19,738)

Derivative financial instruments

(51)

(156)

(83)

Provisions

(1,168)

(1,028)

(567)

Income tax payable

(1,525)

(1,584)

(1,200)

(28,566)

(30,542)

(26,375)

Non-current liabilities

Interest-bearing loans and borrowings

(27,225)

(22,365)

(24,329)

Lease liabilities

(949)

(857)

(722)

Derivative financial instruments

(61)

(38)

(68)

Deferred tax liabilities

(3,333)

(2,844)

(2,800)

Retirement benefit obligations

(1,326)

(1,520)

(1,078)

Provisions

(1,074)

(1,127)

(1,357)

Other payables

(2,208)

(2,660)

(2,398)

(36,176)

(31,411)

(32,752)

Total liabilities

(64,742)

(61,953)

(59,127)

Net assets

39,598

39,166

37,416

Equity

Capital and reserves attributable to equity holders of the Parent

Share capital

388

388

387

Share premium account

35,199

35,188

35,163

Other reserves

2,078

2,065

2,076

Retained earnings

1,847

1,502

(234)

39,512

39,143

37,392

Non-controlling interests

86

23

24

Total equity

39,598

39,166

37,416

14

The Condensed consolidated statement of financial position as at 30 June 2024 and 30 June 2023 have been reviewed by PricewaterhouseCoopers LLP. The Condensed consolidated statement of financial position as at 31 December 2023 has been audited by PricewaterhouseCoopers LLP.

34

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Table 21: Condensed consolidated statement of changes in equity

    

Total

    

Share

    

    

    

attributable

    

Non-

    

Share

premium

Other

Retained

to owners

controlling

Total

capital

account

reserves

earnings

of the parent

interests

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

-

-

-

3,621

3,621

3

3,624

Other comprehensive income

-

-

-

31

31

-

31

Transfer to other reserves

-

-

7

(7)

-

-

-

Transactions with owners

Dividends

-

-

-

(3,047)

(3,047)

-

(3,047)

Issue of Ordinary Shares

-

8

-

-

8

-

8

Share-based payments charge for the period

-

-

-

274

274

-

274

Settlement of share plan awards

-

-

-

(532)

(532)

-

(532)

Net movement

-

8

7

340

355

3

358

At 30 Jun 2023

387

35,163

2,076

(234)

37,392

24

37,416

    

Total

    

Share

    

    

    

attributable

    

Non-

    

Share

premium

Other

Retained

to owners

controlling

Total

capital

account

reserves

earnings

of the parent

interests

equity

$m

$m

$m

$m

$m

$m

$m

At 1 Jan 2024

 

388

35,188

2,065

1,502

39,143

23

39,166

Profit for the period

-

-

-

4,106

4,106

2

4,108

Other comprehensive expense

-

-

-

(414)

(414)

-

(414)

Transfer to other reserves

-

-

13

(13)

-

-

-

Transactions with owners

Dividends

-

-

-

(3,052)

(3,052)

-

(3,052)

Issue of Ordinary Shares

-

11

-

-

11

-

11

Changes in non-controlling interests

-

-

-

-

-

61

61

Share-based payments charge for the period

-

-

-

307

307

-

307

Settlement of share plan awards

-

-

-

(589)

(589)

-

(589)

Net movement

-

11

13

345

369

63

432

At 30 Jun 2024

388

35,199

2,078

1,847

39,512

86

39,598

35

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Table 22: Condensed consolidated statement of cash flows: H1 2024

For the half year ended 30 June

    

2024

    

2023

$m

$m

Cash flows from operating activities

Profit before tax

5,197

4,350

Finance income and expense

645

654

Share of after tax losses of associates and joint ventures

19

1

Depreciation, amortisation and impairment

2,534

2,778

Movement in working capital and short-term provisions

(584)

(747)

Gains on disposal of intangible assets

(21)

(249)

Fair value movements on contingent consideration arising from business combinations

251

202

Non-cash and other movements

(550)

(594)

Cash generated from operations

7,491

6,395

Interest paid

(583)

(483)

Tax paid

(1,337)

(1,061)

Net cash inflow from operating activities

5,571

4,851

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 combinations

-

(23)

Payment of contingent consideration from business combinations

(474)

(398)

Purchase of property, plant and equipment

(799)

(517)

Disposal of property, plant and equipment

53

126

Purchase of intangible assets

(1,474)

(1,436)

Disposal of intangible assets

75

288

Movement in profit-participation liability

-

175

Purchase of non-current asset investments

(67)

(26)

Disposal of non-current asset investments

51

10

Movement in short-term investments, fixed deposits and other investing instruments

42

90

Payments to associates and joint ventures

(140)

-

Disposal of investments in associates and joint ventures

13

-

Interest received

206

134

Net cash outflow from investing activities

(5,285)

(1,766)

Net cash inflow before financing activities

286

3,085

Cash flows from financing activities

Proceeds from issue of share capital

11

8

Issue of loans and borrowings

4,976

3,816

Repayment of loans and borrowings

(2,643)

(3,408)

Dividends paid

(3,050)

(3,069)

Hedge contracts relating to dividend payments

(8)

27

Repayment of obligations under leases

(150)

(129)

Movement in short-term borrowings

2,503

72

Payment of Acerta Pharma share purchase liability

(833)

(867)

Net cash inflow/(outflow) from financing activities

806

(3,550)

Net increase/(decrease) in Cash and cash equivalents in the period

1,092

(465)

Cash and cash equivalents at the beginning of the period

5,637

5,983

Exchange rate effects

(52)

(47)

Cash and cash equivalents at the end of the period

6,677

5,471

Cash and cash equivalents consist of:

Cash and cash equivalents

6,916

5,664

Overdrafts

(239)

(193)

6,677

5,471

36

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Responsibility statement of the directors in respect of the half-yearly financial report

We confirm that to the best of our knowledge:

the condensed consolidated Interim Financial Statements have been prepared in accordance with IAS 34 ‘Interim Financial Reporting’ as issued by the International Accounting Standards Board (IASB), IAS 34 as adopted by the European Union and UK-adopted IAS 34;

the half-yearly management report gives a true and fair view of the assets, liabilities, financial position and profit or loss of the company;

the half-yearly management report includes a fair review of the information required by:

a)DTR 4.2.7R of the Disclosure and Transparency Rules, being an indication of important events that have occurred during the first six months of the financial year and their impact on the condensed consolidated Interim Financial Statements; and a description of the principal risks and uncertainties for the remaining six months of the year; and

b)DTR 4.2.8R of the Disclosure and Transparency Rules, being related party transactions that have taken place in the first six months of the current financial year and that have materially affected the financial position or performance of the enterprise during that period; and any changes in the related party transactions described in the last annual report that could do so.

The Board

The Board of Directors that served during all or part of the six month period to 30 June 2024 and their respective responsibilities can be found on the Leadership team section of astrazeneca.com.

Approved by the Board and signed on its behalf by

Pascal Soriot

Chief Executive Officer

25 July 2024

37

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Independent review report to AstraZeneca PLC

Report on the Interim financial statements

Our conclusion

We have reviewed AstraZeneca PLC’s Interim financial statements (the “Interim financial statements”) in the half-yearly financial report of AstraZeneca PLC for the six month period ended 30 June 2024 (the “period”).

Based on our review, nothing has come to our attention that causes us to believe that the Interim financial statements are not prepared, in all material respects, in accordance with International Accounting Standard 34, ‘Interim Financial Reporting’ (IAS 34), as issued by the International Accounting Standards Board (IASB), IAS 34 as adopted by the European Union, UK-adopted IAS 34, and the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom’s Financial Conduct Authority.

The Interim financial statements comprise:

the Condensed consolidated statement of financial position as at 30 June 2024;
the Condensed consolidated statement of comprehensive income: H1 2024 for the period then ended;
the Condensed consolidated statement of changes in equity for the period then ended;  
the Condensed consolidated statement of cash flows: H1 2024 for the period then ended; and
the explanatory notes to the Interim financial statements.

The Interim financial statements included in the half-yearly financial report of AstraZeneca PLC have been prepared in accordance with International Accounting Standard 34, ‘Interim Financial Reporting’ (IAS 34), as issued by the International Accounting Standards Board (IASB), IAS 34 as adopted by the European Union, UK-adopted IAS 34, and the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom’s Financial Conduct Authority.

Basis for conclusion

We conducted our review in accordance with International Standard on Review Engagements (UK) 2410, ‘Review of Interim Financial Information Performed by the Independent Auditor of the Entity’ issued by the Financial Reporting Council for use in the United Kingdom (“ISRE (UK) 2410”). A review of interim financial information consists of making enquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures.

A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing (UK) and, consequently, does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.

We have read the other information contained in the half-yearly financial report and considered whether it contains any apparent misstatements or material inconsistencies with the information in the Interim financial statements.

Conclusions relating to going concern

Based on our review procedures, which are less extensive than those performed in an audit as described in the Basis for conclusion section of this report, nothing has come to our attention to suggest that the directors have inappropriately adopted the going concern basis of accounting or that the directors have identified material uncertainties relating to going concern that are not appropriately disclosed. This conclusion is based on the review procedures performed in accordance with ISRE (UK) 2410. However, future events or conditions may cause the group to cease to continue as a going concern.

38

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Independent review report to AstraZeneca PLC (continued)

Responsibilities for the Interim financial statements and the review

Our responsibilities and those of the directors

The half-yearly financial report, including the Interim financial statements, is the responsibility of, and has been approved by the directors. The directors are responsible for preparing the half-yearly financial report in accordance with the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom’s Financial Conduct Authority. In preparing the half-yearly financial report, including the Interim financial statements, the directors are responsible for assessing the group’s ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless the directors either intend to liquidate the group or to cease operations, or have no realistic alternative but to do so.

Our responsibility is to express a conclusion on the Interim financial statements in the half-yearly financial report based on our review. Our conclusion, including our Conclusions relating to going concern, is based on procedures that are less extensive than audit procedures, as described in the Basis for conclusion paragraph of this report. This report, including the conclusion, has been prepared for and only for the company for the purpose of complying with the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom’s Financial Conduct Authority and for no other purpose. We do not, in giving this conclusion, accept or assume responsibility for any other purpose or to any other person to whom this report is shown or into whose hands it may come save where expressly agreed by our prior consent in writing.

PricewaterhouseCoopers LLP

Chartered Accountants

London

25 July 2024

39

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Notes to the Interim financial statements

Note 1:  Basis of preparation and accounting policies

These unaudited condensed consolidated Interim financial statements for the six months ended 30 June 2024 have been prepared in accordance with International Accounting Standard 34, ‘Interim Financial Reporting’ (IAS 34), as issued by the International Accounting Standards Board (IASB), IAS 34 as adopted by the European Union, UK-adopted IAS 34 and the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom’s Financial Conduct Authority and with the requirements of the Companies Act 2006 as applicable to companies reporting under those standards.

The unaudited Interim financial statements for the six months ended 30 June 2024 were approved by the Board of Directors for publication on 25 July 2024.

This results announcement does not constitute statutory accounts of the Group within the meaning of sections 434(3) and 435(3) of the Companies Act 2006. The annual financial statements of the Group for the year ended 31 December 2023 were prepared in accordance with UK-adopted international accounting standards and with the requirements of the Companies Act 2006. The annual financial statements also comply fully with IFRS Accounting Standards as issued by the IASB and International Accounting Standards as adopted by the European Union. Except for the estimation of the interim income tax charge, the Interim 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 30 June 2024, the Group has $11.8bn in financial resources (cash and cash equivalent balances of $6.9bn and undrawn committed bank facilities of $4.9bn, with $5.4bn of borrowings due within one year. These facilities contain no financial covenants and were undrawn at 30 June 2024. The $4.9bn facilities are available until April 2029. Additionally, there are a further $2.0bn undrawn committed bank facilities available until February 2025.

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 Interim 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.

Employee Benefit Trust

Following an amendment to the Employee Benefit Trust (EBT) Deed on 10th June 2024, AstraZeneca obtained control and commenced consolidation of the EBT. Going forward, cash paid on purchases of AstraZeneca Ordinary shares or American Depository Receipts, will be presented within Financing activities in the Cash flow statement.

Note 2:  Intangible assets

In accordance with IAS 36 ‘Impairment of Assets’, reviews for triggers of impairment or impairment reversals at an individual asset or cash generating unit level were conducted, and impairment tests carried out where triggers were identified. As a result, total impairment charge of $26m has been recorded against intangible assets during the six months ended 30 June 2024 (H1 2023: $320m net charge). In H1 2023, net impairment charges included the $244m impairment of the ALXN1840 intangible asset, following the decision to discontinue this development programme in Wilson’s disease.

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

40

Graphic

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.

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. Net debt is a non-GAAP financial measure.

Table 23: Net debt

At 1 Jan

Cash

Non-cash

Exchange

At 30 Jun

2024

flow

Acquisitions

& other

movements

2024

    

$m

    

$m

    

$m

$m

    

$m

    

$m

Non-current instalments of loans

 

(22,365)

(4,973)

(3)

(2)

118

(27,225)

Non-current instalments of leases

(857)

-

(12)

(97)

17

(949)

Total long-term debt

 

(23,222)

(4,973)

(15)

(99)

135

(28,174)

Current instalments of loans

 

(4,614)

2,583

(9)

(5)

27

(2,018)

Current instalments of leases

 

(271)

174

(6)

(197)

8

(292)

Commercial paper

(2,453)

-

-

-

(2,453)

Collateral received from derivative counterparties

 

(215)

13

-

-

-

(202)

Other short-term borrowings excluding overdrafts

(97)

(63)

-

-

5

(155)

Overdrafts

 

(203)

(35)

-

-

(1)

(239)

Total current debt

(5,400)

219

(15)

(202)

39

(5,359)

Gross borrowings

(28,622)

(4,754)

(30)

(301)

174

(33,533)

Net derivative financial instruments

150

65

-

(82)

-

133

Net borrowings

(28,472)

(4,689)

(30)

(383)

174

(33,400)

Cash and cash equivalents

5,840

885

242

-

(51)

6,916

Other investments - current

122

(42)

87

-

(7)

160

Cash and investments

5,962

843

329

-

(58)

7,076

Net debt

(22,510)

(3,846)

299

(383)

116

(26,324)

Net debt increased by $3,814m in the half year to $26,324m. 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

AstraZeneca repaid two bonds of carrying value $2,569m in Q2 2024 included in the cash outflow from Repayment of loans and borrowings of $2,643m. AstraZeneca also issued Commercial paper during the half year and the balance as at 30 June 2024 is $2,453m (H1 2023: $nil).

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 30 June 2024 was $202m (31 December 2023: $215m) and the carrying value of such cash collateral posted by the Group at 30 June 2024 was $97m (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 six months ended 30 June 2024, there have been no changes to the Company’s solicited long term credit ratings. Moody’s credit ratings 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.

41

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The Group has certain equity investments that are categorised as Level 3 in the fair value hierarchy that are held at $337m (31 December 2023: $313m) and for which a fair value gain of $1m has been recognised in the six months ended 30 June 2024 (H1 2023: $1m). 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/(losses) on equity investments measured at fair value through other comprehensive income in the Condensed consolidated statement of comprehensive income for the six months ended 30 June 2024 are Level 1 fair value measurements, valued based on quoted prices in active markets.

Financial instruments measured at fair value include $1,670m of other investments, $5,463m held in money-market funds, and $133m of derivatives as at 30 June 2024. With the exception of derivatives being Level 2 fair valued, and certain equity instruments of $350m categorised as Level 3, the aforementioned balances are Level 1 fair valued. Financial instruments measured at amortised cost include $97m of cash collateral pledged to counterparties. The total fair value of interest-bearing loans and borrowings at 30 June 2024, which have a carrying value of $33,533m in the Condensed consolidated statement of financial position, was $32,231m.

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

 

(473)

(1)

(474)

(398)

Revaluations

220

31

251

202

Discount unwind

 

50

7

57

66

At 30 June

 

1,742

427

2,169

2,152

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 $1,742m (31 December 2023: $1,945m) would increase/decrease by $174m 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. Gracell will operate as a wholly owned subsidiary of AstraZeneca, with operations in China and the US.

The acquisition enriches AstraZeneca’s growing pipeline of cell therapies with AZD0120 (formerly GC012F), a novel, clinical-stage T-cell (CAR-T: therapeutic chimeric antigen receptor) therapy. AZD0120 is a potential new treatment for multiple myeloma, as well as other haematologic malignancies and autoimmune diseases, including Systemic Lupus Erythematosus (SLE).

The transaction is recorded as a business combination using the acquisition method of accounting in accordance with IFRS 3 ‘Business Combinations’. Consequently, the assets acquired, and liabilities assumed are recorded at fair value. Due to the proximity of the acquisition to the reporting date, the purchase price allocation exercise under IFRS 3 is in process, with the following items disclosed on a provisional basis.

Fair values

$m

Intangible assets

1,038

Cash and cash equivalents

212

Net deferred tax liability

(260)

Other immaterial balances

(89)

Total net assets acquired

901

Goodwill

136

Consideration

1,037

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, and were fair valued using the multi-period excess earnings method, which uses several estimates regarding the amount and timing of future cash flows. The key assumptions in the cash flows are PTRS, peak year sales and revenue erosion profiles.

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The net deferred tax liability of $260m principally arises from the deferred tax impact of the uplift in fair value of intangible assets.

Goodwill of $136m has been recognised, which principally comprises the premium attributable to the core technological capabilities and knowledge base of the company. Goodwill is not expected to be deductible for tax purposes.

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 acquisition marks a major step forward in AstraZeneca delivering on its ambition to transform cancer treatment and outcomes for patients by replacing traditional regimens like chemotherapy and radiotherapy with more targeted treatments. As a result of the acquisition, Fusion became a wholly owned subsidiary of AstraZeneca, with operations in Canada and the US.

This acquisition complements AstraZeneca’s leading oncology portfolio with the addition of the Fusion pipeline of radioconjugates, including their most advanced programme, FPI-2265, a potential new treatment for patients with metastatic castration-resistant prostate cancer (mCRPC), and brings new expertise and pioneering R&D, manufacturing and supply chain capabilities in actinium-based radioconjugates to AstraZeneca.

The transaction is recorded as a business combination using the acquisition method of accounting in accordance with IFRS 3 ‘Business Combinations’. Consequently, the assets acquired, and liabilities assumed are recorded at fair value. Due to the proximity of the acquisition to the reporting date, the purchase price allocation exercise under IFRS 3 is in process, with the following items disclosed on a provisional basis.

Fair values

$m

Intangible assets

1,326

Cash and cash equivalents

30

Current investments

87

Net deferred tax liability

(246)

Other immaterial balances

51

Total net assets acquired

1,248

Goodwill

947

Consideration

2,195

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. These were fair valued using the multi-period excess earnings method, which uses several estimates regarding the amount and timing of future cash flows. The key assumptions in the cash flows are PTRS, peak year sales and revenue erosion profiles.

The net deferred tax liability of $246m principally arises from the deferred tax impact of the uplift in fair value of intangible assets.

Goodwill recognised comprises a number of not individually quantifiable elements. These include the premium attributable to a pre-existing well positioned business in the innovation intensive biopharmaceuticals market with a highly skilled workforce, unidentified potential products that future research and development may yield, and the core capabilities and knowledge base of the company including radioisotope supply and manufacturing expertise. Goodwill is not expected to be deductible for tax purposes.

Immediately prior to the acquisition, AstraZeneca held an approximately 1% shareholding in Fusion considered to have a fair value of $24m.

Fusion’s results have been consolidated into the Group’s results from 4 June 2024.

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

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20-F Information 2023 (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 second quarter of 2024 and to 25 July 2024

Patent litigation

Legal proceedings brought against AstraZeneca considered to be contingent liabilities

Enhertu

US patent proceedings

In October 2020, Seagen Inc. (Seagen) filed a complaint against Daiichi Sankyo Company, Limited (Daiichi Sankyo) in the US District Court for the Eastern District of Texas (District Court) alleging that Enhertu infringes a Seagen patent. AstraZeneca co-commercialises Enhertu with Daiichi Sankyo, Inc. in the US. After trial in April 2022, the jury found that the patent was infringed and awarded Seagen $41.82m in past damages.  In July 2022, the District Court entered final judgment and declined to enhance damages on the basis of wilfulness. In October 2023, the District Court entered an amended final judgment that requires Daiichi Sankyo to pay Seagen a royalty of 8% on US sales of Enhertu from 1 April 2022 through to 4 November 2024, in addition to the past damages previously awarded by the District Court.  AstraZeneca and Daiichi Sankyo have appealed the District Court’s decision.

In December 2020 and January 2021, AstraZeneca and Daiichi Sankyo, Inc. filed post-grant review (PGR) petitions with the US Patent and Trademark Office (USPTO) alleging, among other things, that the Seagen patent is invalid for lack of written description and enablement. The USPTO initially declined to institute the PGRs, but, in April 2022, the USPTO granted the rehearing requests and instituted both PGR petitions. Seagen subsequently disclaimed all patent claims at issue in one of the PGR proceedings. In July 2022, the USPTO reversed its institution decision and declined to institute the other PGR petition. AstraZeneca and Daiichi Sankyo, Inc. requested reconsideration of the decision not to institute review of the patent. In February 2023, the USPTO reinstituted the PGR proceeding. In February 2024, the USPTO issued a decision that the claims were unpatentable. Seagen has appealed this decision.

Tagrisso

US patent proceedings

In September 2021, Puma Biotechnology, Inc. (Puma) and Wyeth LLC (Wyeth) filed a patent infringement lawsuit in the US District Court for the District of Delaware (District Court) against AstraZeneca relating to Tagrisso. In March 2024, the District Court dismissed Puma. The trial, with Wyeth as the plaintiff, took place in May 2024. The jury found Wyeth’s patents infringed and awarded Wyeth $107.5m in past damages. The jury also found that the infringement was not wilful. A bench trial on AstraZeneca’s indefiniteness and equitable defenses took place in June 2024. The parties await the court’s decision on the bench trial issues and consideration of post-trial motions.

Legal proceedings brought by AstraZeneca considered to be contingent assets

Calquence

US patent proceedings

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 complaint, AstraZeneca alleged that a generic version of Calquence capsules, if approved 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.

In April 2024, AstraZeneca received a Paragraph IV notice from an ANDA filer relating to patents listed in the FDA Orange Book with reference to Calquence tablets. In May 2024, in response to the Paragraph IV notice, AstraZeneca filed a patent infringement lawsuit against Cipla Limited and Cipla USA, Inc. in the District Court, alleging that a generic version of Calquence tablets, if approved and marketed, would infringe patents that are owned or licensed by AstraZeneca.

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Lokelma

US patent proceedings

In August 2022, in response to Paragraph IV notices, AstraZeneca initiated ANDA litigation against multiple generic filers in the US District Court for the District of Delaware (District Court). AstraZeneca alleged that a generic version of Lokelma, if approved and marketed, would infringe patents that are owned or licensed by AstraZeneca.

AstraZeneca entered into separate settlement agreements with two generic manufacturers which resulted in dismissal of the corresponding litigations. Additional proceedings with the remaining generic manufacturers are ongoing in the District Court. Trial is scheduled for March 2025.  

Lynparza

US patent proceedings

In December 2022, AstraZeneca received a Paragraph IV notice from Natco Pharma Limited (Natco) relating to Lynparza patents. In February 2023, in response to the Paragraph IV notice, AstraZeneca, MSD International Business GmbH, and the University of Sheffield initiated ANDA litigation against Natco in the US District Court for the District of New Jersey (District Court). In the complaint, AstraZeneca alleged that Natco’s generic version of Lynparza, if approved and marketed, would infringe AstraZeneca’s patents. No trial date has been scheduled.

In December 2023, AstraZeneca received a Paragraph IV notice from Sandoz Inc. (Sandoz) relating to Lynparza patents.  In February 2024, in response to the Paragraph IV notice, AstraZeneca, MSD International Business GmbH, and the University of Sheffield initiated ANDA litigation against Sandoz in the District Court. In the complaint, AstraZeneca alleged that Sandoz’s generic version of Lynparza, if approved and marketed, would infringe AstraZeneca’s patents. No trial date has been scheduled.

In May 2024, AstraZeneca filed additional ANDA actions against Natco and Sandoz asserting recently issued patents covering Lynparza. These actions have been consolidated with the earlier filed ANDA actions and no trial date has been scheduled.

In May 2024, AstraZeneca received a Paragraph IV notice from Cipla USA, Inc. and Cipla Limited (collectively, Cipla) relating to Lynparza patents. In June 2024, in response to the Paragraph IV notice, AstraZeneca, MSD International Business GmbH, and the University of Sheffield initiated ANDA litigation against Cipla in the District Court. In the complaint, AstraZeneca alleged that Cipla’s generic version of Lynparza, if approved and marketed, would infringe AstraZeneca’s patents. No trial date has been scheduled.

Soliris

US patent proceedings

In January 2024, Alexion initiated patent infringement litigation against Samsung Bioepis Co. Ltd. (Samsung) in the US District Court for the District of Delaware alleging that Samsung’s biosimilar eculizumab product will infringe six Soliris-related patents. No trial date has been scheduled. Five of the six asserted patents are also the subject of inter partes review (IPR) proceedings before the US Patent and Trademark Office. Alexion filed a motion for a preliminary injunction seeking to enjoin Samsung from launching its biosimilar eculizumab product upon FDA approval. The court denied Alexion’s motion and Alexion has appealed that decision. On 22 July 2024, Samsung announced FDA approval of Samsung's biosimilar.

European patent proceedings

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 on the basis that Amgen’s and Samsung’s biosimilar eculizumab products infringe an Alexion patent. In June 2024 the UPC denied the requested provisional measures. Alexion has appealed this decision. In parallel, Samsung has filed opposition to the patent at the European Patent Office.

UK patent proceedings

In May 2024, Alexion initiated patent infringement proceedings against Amgen Ltd and Samsung Bioepis UK Ltd (Samsung UK) in the UK High Court of Justice alleging that their respective biosimilar eculizumab products infringe an Alexion patent; on the same day, Samsung UK initiated a revocation action for the same patent. Trial has been scheduled for March 2025.

Tagrisso

Russia patent proceedings

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 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 remains pending. The lawsuit against Axelpharm remains pending.

In Russia, 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; that challenge remains pending before the Russian PTO

In July 2024, AstraZeneca filed a patent infringement lawsuit and an unfair competition claim with the Federal Anti-Monopoly Service

45

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of Russia against AxelPharm and others related to the securing of state contracts in Russia for its generic version of osimertinib.  

Commercial litigation

Legal proceedings brought against AstraZeneca considered to be contingent liabilities

Anti-Terrorism Act Civil Lawsuit

US proceedings

In the US, in October 2017, AstraZeneca and certain other pharmaceutical and/or medical device companies were named as defendants in a complaint filed in the US District Court for the District of Columbia (District Court) by US nationals (or their estates, survivors, or heirs) who were killed or wounded in Iraq between 2005 and 2013.  The plaintiffs allege that the defendants violated the US Anti-Terrorism Act and various state laws by selling pharmaceuticals and medical supplies to the Iraqi Ministry of Health.  In July 2020, the District Court granted AstraZeneca’s and the other defendants’ motion to dismiss the lawsuit, which the DC Circuit Court of Appeals (the Appellate Court) reversed in January 2022. In June 2024, the United States Supreme Court issued an order vacating the 2022 decision and granted AstraZeneca’s and the other defendants’ request for a remand to the Appellate Court for reconsideration under new case law.

Employment Litigation

US proceedings

In December 2022, AstraZeneca was served with a lawsuit filed by seven former employees in the US District Court for the District of Delaware (District Court) asserting claims of discrimination on grounds of age and religion, related to AstraZeneca’s vaccination requirement. In March 2023, AstraZeneca filed a partial motion to dismiss certain religious discrimination claims and a motion to strike the class and collective claims. In September 2023, Plaintiffs moved for conditional certification of the collective action. In June 2024, the District Court granted AstraZeneca’s partial motion to dismiss, granted AstraZeneca’s motion to strike, and denied without prejudice Plaintiff’s motion for conditional certification.  

Pay Equity Litigation

US proceedings

AstraZeneca is defending a putative class and collective action in the US District Court for the Northern District of Illinois (District Court) brought by three named plaintiffs, who are former AstraZeneca employees. The case involves claims under the federal and Illinois Equal Pay Acts, with the plaintiffs alleging they were paid less than male employees who performed substantially similar and/or equal work. In May 2024, the District Court conditionally certified a collective under the federal Equal Pay Act and authorised the sending of notice to potential collective action members. The notice was distributed in June 2024.

University of Sheffield Contract Dispute

UK proceedings

In June 2024, AstraZeneca was served with a lawsuit filed by the University of Sheffield (Sheffield). In its complaint, Sheffield alleges that AstraZeneca made misrepresentations to induce Sheffield to amend a patent license relating to Lynparza. AstraZeneca is considering its response.

Viela Bio, Inc. Shareholder Litigation  

US proceedings 

In February 2023, AstraZeneca was served with a lawsuit filed in Delaware state court against AstraZeneca and certain officers (collectively, Defendants), on behalf of a putative class of Viela Bio, Inc. (Viela) shareholders. The complaint alleged that the Defendants breached their fiduciary duty to Viela shareholders in the course of Viela’s 2021 merger with Horizon Therapeutics, plc. In July 2024, the Court granted with prejudice AstraZeneca’s motion to dismiss.

Financial Statements

Legal proceedings brought by AstraZeneca considered to be contingent assets

PARP Inhibitor Royalty Dispute

UK proceedings

In October 2012, Tesaro, Inc. (now wholly owned by GlaxoSmithKline plc, (GSK)) entered into two worldwide, royalty-bearing patent license agreements with AstraZeneca related to GSK’s product niraparib. In May 2021, AstraZeneca filed a lawsuit against GSK in the Commercial Court of England and Wales alleging that GSK had failed to pay all of the royalties due on niraparib sales under the license agreements. In April 2023, after trial, the trial court issued a decision in AstraZeneca’s favour. In February 2024, the Court of Appeal reversed the decision. In March 2024, AstraZeneca filed a request for permission to appeal with the Supreme Court of the United Kingdom. In May 2024, the Supreme Court denied permission to appeal. The case will return to the trial court for further proceedings.

Government investigations/proceedings

Legal proceedings brought against AstraZeneca considered to be contingent liabilities

Boston US Attorney Investigation

US Proceedings

In June 2024, AstraZeneca was served with a subpoena issued by the US Attorney’s Office in Boston, seeking documents and information relating to payments by AstraZeneca to healthcare providers. AstraZeneca is cooperating with this enquiry.

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Turkish Ministry of Health Matter

Turkey proceedings

In Turkey, in July 2020, the Turkish Ministry of Health (Ministry of Health) initiated an investigation regarding payments to healthcare providers by Alexion and former employees and consultants.  The investigation arose from Alexion’s disclosure of a $21.5m civil settlement with the US Securities & Exchange Commission (SEC) in July 2020 fully resolving the SEC’s investigation into possible violations of the US Foreign Corrupt Practices Act.  In September 2021, the Ministry of Health completed its draft investigation report, and referred the matter to the Ankara Public Prosecutor’s Office with a recommendation for further proceedings against certain former employees. In June 2024, the Ankara Public Prosecutor’s Office closed its investigation without further action.

 

Legal proceedings brought by AstraZeneca considered to be contingent assets

Inflation Reduction Act Litigation

US proceedings

In August 2023, AstraZeneca filed a lawsuit in the US District Court for the District of Delaware (District Court) against the US Department of Health and Human Services (HHS) challenging aspects of the drug price negotiation provisions of the Inflation Reduction Act and the implementing guidance and regulations. In March 2024, the District Court granted HHS’ motions and dismissed AstraZeneca’s lawsuit. AstraZeneca has appealed the District Court’s decision.

340B State Litigation

US proceedings

AstraZeneca has filed lawsuits against Arkansas, Kansas, Louisiana, Maryland, Minnesota, Mississippi, and West Virginia challenging the constitutionality of each state’s 340B statute. In the Arkansas matter, trial is scheduled for April 2025. In the Louisiana matter, AstraZeneca and the state have filed motions for summary judgment and a hearing was held in June 2024. The remaining matters are in their 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.

Matters disclosed in respect of the first quarter of 2024 and to 25 April 2024

Patent litigation

Legal proceedings brought against AstraZeneca considered to be contingent liabilities

Forxiga

UK patent proceedings

In the UK, one of AstraZeneca’s patents relating to Forxiga is being challenged by Generics (UK) Limited, Teva Pharmaceutical Industries Limited, and Glenmark Pharmaceuticals Europe Limited. Trial is scheduled for March 2025.

Tagrisso

US patent proceedings

In September 2021, Puma Biotechnology, Inc. (Puma) and Wyeth LLC (Wyeth) filed a patent infringement lawsuit in the US District Court for the District of Delaware (District Court) against AstraZeneca relating to Tagrisso. In March 2024, the District Court dismissed Puma. A trial, with Wyeth as the plaintiff, has been scheduled for May 2024.

Legal proceedings brought by AstraZeneca considered to be contingent assets

Calquence

US patent proceedings

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 complaint, AstraZeneca alleged that a generic version of Calquence capsules, if approved and marketed, would infringe patents that are owned or licensed by AstraZeneca. Trial is scheduled for March 2025.

In March and April 2024, AstraZeneca entered into settlement agreements with generic manufacturers, Sandoz Inc., and Natco Pharma Limited with Natco Pharma Inc., resulting in dismissal of the corresponding Calquence capsule ANDA litigation proceedings. Additional Calquence capsule ANDA litigation proceedings with the remaining three generic manufacturers are ongoing in the District Court.

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In April 2024, AstraZeneca received a Paragraph IV notice from an ANDA filer relating to patents listed in the FDA Orange Book with reference to Calquence tablets. AstraZeneca is considering its response.

Lokelma

US patent proceedings

In August 2022, in response to Paragraph IV notices, AstraZeneca initiated ANDA litigation against multiple generic filers in the US District Court for the District of Delaware (District Court). Trial is scheduled for March 2025.  

AstraZeneca entered into a settlement agreement with a generic manufacturer, Alkem Laboratories, which resulted in dismissal of the corresponding litigation. Additional proceedings with the remaining generic manufacturers are ongoing in the District Court.

Soliris

US patent proceedings

In January 2024, Alexion initiated patent infringement litigation against Samsung Bioepis Co. Ltd. (Samsung) in the US District Court for the District of Delaware alleging that Samsung’s biosimilar eculizumab product, for which Samsung is currently seeking FDA approval, will infringe six Soliris-related patents. No trial date has been scheduled. Five of the six asserted patents are also the subject of inter partes review proceedings before the US Patent and Trademark Office. In February 2024, Alexion filed a motion for a preliminary injunction seeking to enjoin Samsung from launching its biosimilar eculizumab product upon FDA approval. A hearing on Alexion’s preliminary injunction motion is scheduled for May 2024.

European patent proceedings

In March 2024, Alexion filed motions for preliminary injunctions against Amgen and Samsung at the Hamburg Local Division of the Unified Patent Court on the basis that Amgen’s and Samsung’s biosimilar eculizumab products infringe Alexion’s eculizumab molecule patent that is expected to grant in Q2 2024. No hearing date for the preliminary injunction motions has been set.  

Tagrisso

Russia patent proceedings

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 generic version of Tagrisso. In December 2023, the Court dismissed the lawsuit against the Ministry of Health of the Russian Federation. In January 2024, AstraZeneca filed an appeal, and the appellate court affirmed the dismissal in March 2024. The lawsuit against Axelpharm remains pending.

In Russia, 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.  

Product liability litigation

Legal proceedings brought against AstraZeneca for which a provision has been taken

Nexium and Losec/Prilosec

US proceedings

AstraZeneca has been defending lawsuits brought in federal and state courts involving claims that plaintiffs have been diagnosed with various injuries following treatment with proton pump inhibitors (PPIs), including Nexium and Prilosec. Most of the lawsuits alleged kidney injury. In August 2017, the pending federal court cases were consolidated into a multidistrict litigation (MDL) proceeding in the US District Court for the District of New Jersey for pre-trial purposes. Cases alleging kidney injury were also filed in Delaware and New Jersey state courts.

In addition, AstraZeneca has been defending lawsuits involving allegations of gastric cancer following treatment with PPIs, including one such claim in the US District Court for the Middle District of Louisiana (Louisiana District Court).

In October 2023, AstraZeneca resolved all pending claims in the MDL, as well as all pending claims in Delaware and New Jersey state courts, for $425m, for which a provision has been taken. The only remaining case is the one pending in the Louisiana District Court, which is scheduled for trial in January 2025.

Canada proceedings

In Canada, in July and August 2017, AstraZeneca was served with three putative class action lawsuits. Two of the lawsuits have been dismissed, one in 2019 and one in 2021. The third lawsuit seeks authorisation to represent individual residents in Canada who allegedly suffered kidney injuries from the use of proton pump inhibitors, including Nexium and Losec.

Legal proceedings brought against AstraZeneca considered to be contingent liabilities

Onglyza and Kombiglyze

US proceedings

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In the US, AstraZeneca has been defending various lawsuits in both California state court and in a consolidated federal proceeding alleging heart failure, cardiac injuries, and/or death from treatment with Onglyza or Kombiglyze. In the California state court proceeding, the trial court granted summary judgment for AstraZeneca, which the California appellate court affirmed. The California Supreme Court has declined further review, and the California matter has concluded. The consolidated federal cases were dismissed in August 2022 by the US District Court for the Eastern District of Kentucky. That dismissal was affirmed by the US Court of Appeals for the Sixth Circuit in February 2024.  

Vaxzevria

UK proceedings

AstraZeneca is defending lawsuits in the UK involving multiple claimants alleging injuries following vaccination with AstraZeneca’s COVID-19 vaccine. Most of the lawsuits involve claims of thrombosis with thrombocytopenia syndrome. No trial dates have been scheduled.

Commercial litigation

Legal proceedings brought against AstraZeneca considered to be contingent liabilities

340B Antitrust Litigation

US proceedings

In September 2021, AstraZeneca was served with a class-action antitrust complaint filed in the US District Court for the Western District of New York (District Court) by Mosaic Health alleging a conspiracy to restrict access to 340B discounts in the diabetes market through contract pharmacies. In September 2022, the District Court granted AstraZeneca’s motion to dismiss the Complaint. In February 2024, the District Court denied Plaintiffs’ request to file an amended complaint and entered an order closing the matter. In March 2024, Plaintiffs filed an appeal.

Definiens

Germany proceedings

In Germany, in July 2020, AstraZeneca received a notice of arbitration filed with the German Institution of Arbitration from the sellers of Definiens AG (the Sellers) regarding the 2014 Share Purchase Agreement (SPA) between AstraZeneca and the Sellers.  The Sellers claim that they are owed approximately $140m in earn-outs under the SPA. In December 2023, after an arbitration hearing, the arbitration panel made a final award of $46.43m in favour of the Sellers. In March 2024, AstraZeneca filed an application with the Bavarian Supreme Court to set aside the arbitration award.

Financial Statements

Legal proceedings brought by AstraZeneca considered to be contingent assets

PARP Inhibitor Royalty Dispute

UK proceedings

In October 2012, Tesaro, Inc. (now wholly owned by GlaxoSmithKline plc, (GSK)) entered into two worldwide, royalty-bearing patent license agreements with AstraZeneca related to GSK’s product niraparib. In May 2021, AstraZeneca filed a lawsuit against GSK in the Commercial Court of England and Wales alleging that GSK had failed to pay all of the royalties due on niraparib sales under the license agreements. In April 2023, after trial, the trial court issued a decision in AstraZeneca’s favour. In February 2024, Court of Appeal reversed. In March 2024, AstraZeneca filed a request for permission to appeal with the Supreme Court of the United Kingdom.

Government investigations/proceedings

Legal proceedings brought against AstraZeneca considered to be contingent liabilities

340B Qui Tam

US proceedings

In July 2023, AstraZeneca was served with an unsealed civil lawsuit brought by a qui tam relator on behalf of the United States, several states, and the District of Columbia in the US District Court for the Central District of California (District Court). The complaint alleges that AstraZeneca violated the US False Claims Act and state law analogues. In March 2024, the District Court granted AstraZeneca’s motion to dismiss the First Amended Complaint without leave to amend. In April 2024, the relator filed an appeal.

Legal proceedings brought by AstraZeneca considered to be contingent assets

Inflation Reduction Act Litigation

US proceedings

In August 2023, AstraZeneca filed a lawsuit in the US District Court for the District of Delaware (District Court) against the US Department of Health and Human Services (HHS) challenging aspects of the drug price negotiation provisions of the Inflation Reduction Act and the implementing guidance and regulations. In March 2024, the District Court granted HHS’ motions and dismissed AstraZeneca’s lawsuit.

49

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Arkansas 340B Litigation

US proceedings

In March 2024, AstraZeneca filed a lawsuit against the State of Arkansas alleging that the Arkansas’s 340B statute is preempted by federal law and unconstitutional.

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 7 :  Subsequent events

On 15 July 2024, AstraZeneca completed the acquisition of Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases. AstraZeneca acquired all outstanding equity of Amolyt for a total consideration of up to $1.05 billion, on a cash and debt free basis. This includes an initial payment of $800m on deal closing, subject to customary closing adjustments, and a further up to $250m in contingent milestones-based consideration. Due to the timing of the transaction post period end, the accounting and other disclosures will be finalised in the second half of 2024.

50

Graphic

Table 25: H1 2024 - Product Sales year-on-year analysis15

The CER information in respect of H1 2024 included in the Interim financial statements has not been reviewed 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

 

9,737

17

21

4,387

20

2,300

18

28

1,967

25

23

1,083

(2)

8

Tagrisso

 

3,203

10

13

1,282

16

919

8

16

628

16

15

374

(11)

(2)

Imfinzi

 

2,259

20

25

1,202

17

245

35

58

459

38

36

353

7

19

Calquence

1,508

27

28

1,048

21

75

82

n/m

320

42

41

65

30

34

Lynparza

1,450

6

9

607

5

320

15

26

398

9

8

125

(14)

(6)

Enhertu

249

n/m

n/m

161

n/m

n/m

57

n/m

n/m

31

n/m

n/m

Zoladex

549

19

27

8

20

415

22

31

77

16

14

49

2

12

Imjudo

136

35

38

88

30

7

n/m

n/m

16

n/m

n/m

25

(5)

6

Truqap

142

n/m

n/m

141

n/m

1

n/m

n/m

Orpathys

25

14

19

25

14

19

Others

 

216

(21)

(15)

11

6

133

(21)

(15)

12

(36)

(36)

60

(21)

(12)

BioPharmaceuticals: CVRM

 

6,164

18

22

1,483

16

2,749

17

24

1,559

33

32

373

(8)

2

Farxiga

3,785

35

38

867

37

1,474

37

44

1,233

45

44

211

(15)

(5)

Brilinta

665

2

354

(1)

166

4

14

136

(1)

9

(26)

(19)

Crestor

589

1

6

22

(18)

475

4

9

22

(30)

(29)

70

3

13

Seloken/Toprol-XL

 

315

(8)

(1)

n/m

307

(8)

(1)

6

4

7

2

(39)

(37)

Lokelma

 

249

26

30

115

10

42

75

83

41

62

61

51

16

31

roxadustat

 

163

22

27

163

22

27

n/m

n/m

Andexxa

105

18

21

42

14

2

n/m

n/m

40

38

36

21

(9)

4

Wainua

21

n/m

n/m

21

n/m

Others

 

272

(30)

(28)

62

(50)

120

(27)

(22)

81

(10)

(10)

9

(7)

(5)

BioPharmaceuticals: R&I

 

3,601

17

20

1,567

21

1,032

16

23

680

17

16

322

7

12

Symbicort

 

1,491

16

19

598

38

450

11

21

286

(1)

157

(4)

(2)

Fasenra

 

781

5

6

478

2

41

45

53

192

9

8

70

(2)

6

Pulmicort

379

10

14

8

(53)

317

16

22

37

1

(1)

17

(13)

(9)

Breztri

454

48

51

225

37

131

61

69

65

80

79

33

33

44

Tezspire

100

n/m

n/m

5

n/m

n/m

61

n/m

n/m

34

n/m

n/m

Saphnelo

203

77

77

184

71

2

n/m

n/m

10

n/m

n/m

7

86

91

Airsupra

 

21

n/m

n/m

21

n/m

Others

 

172

(27)

(26)

53

(47)

86

(18)

(14)

29

3

2

4

(12)

(10)

BioPharmaceuticals: V&I

 

324

(27)

(24)

55

n/m

131

(12)

(7)

81

(28)

(30)

57

(68)

(65)

Synagis

253

(11)

(6)

(1)

n/m

131

4

10

67

(27)

(29)

56

(15)

(6)

Beyfortus

54

n/m

n/m

53

n/m

(81)

(61)

1

n/m

n/m

FluMist

8

n/m

n/m

3

n/m

5

n/m

97

n/m

n/m

COVID-19 mAbs

3

(98)

(98)

n/m

n/m

3

(58)

(59)

n/m

n/m

Others

6

(79)

(80)

n/m

n/m

6

(41)

(43)

n/m

n/m

Rare Disease

 

4,243

11

15

2,517

10

454

40

70

794

3

2

478

9

20

Ultomiris

 

1,804

32

35

1,032

27

66

n/m

n/m

411

32

31

295

42

58

Soliris

1,439

(13)

(8)

808

(9)

255

19

54

260

(29)

(30)

116

(33)

(30)

Strensiq

653

16

18

529

17

31

30

47

48

14

12

45

4

15

Koselugo

 

247

55

64

101

13

83

n/m

n/m

45

95

92

18

n/m

n/m

Kanuma

100

17

20

47

18

19

7

20

30

24

25

4

11

20

Other medicines

560

(9)

(2)

52

(24)

385

(1)

8

53

10

10

70

(35)

(29)

Nexium

459

(7)

1

47

(22)

318

4

15

26

3

2

68

(34)

(28)

Others

101

(17)

(14)

5

(40)

67

(22)

(18)

27

18

19

2

(53)

(49)

Total Product Sales

 

24,629

15

18

10,061

17

7,051

16

26

5,134

21

19

2,383

(6)

3

15

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.

51

Graphic

Table 26: Q2 2024 - Product Sales year-on-year analysis (Unreviewed)16

The Q2 2024 information in respect of the three months ended 30 June 2024 included in the Interim financial statements has not been reviewed by PricewaterhouseCoopers LLP.

World

US

Emerging Markets

Europe

Established RoW

    

$m

    

Act % chg

    

CER % chg

    

$m

    

% chg

    

$m

    

Act % chg

    

CER % chg

    

$m

    

Act % chg

    

CER % chg

    

$m

    

Act % chg

    

CER % chg

Oncology

 

4,976

14

18

2,302

17

1,098

11

22

1,015

24

24

561

(9)

2

Tagrisso

 

1,608

8

12

658

13

432

6

15

327

15

15

191

(12)

(1)

Imfinzi

 

1,147

13

18

620

15

117

16

39

227

33

33

183

(9)

3

Calquence

790

21

22

554

14

36

51

72

167

42

43

33

20

23

Lynparza

 

744

4

7

319

3

153

8

18

206

10

11

66

(15)

(6)

Enhertu

127

89

99

77

60

72

31

n/m

n/m

19

n/m

n/m

Zoladex

273

17

25

5

29

201

17

28

42

23

21

25

6

17

Imjudo

74

17

19

49

37

4

n/m

n/m

8

64

55

13

(38)

(30)

Truqap

 

92

n/m

n/m

91

n/m

1

n/m

n/m

Orpathys

12

(7)

(3)

12

(7)

(3)

Others

 

109

(17)

(11)

6

24

66

(16)

(10)

7

(11)

(10)

30

(26)

(16)

BioPharmaceuticals: CVRM

 

3,153

18

22

735

11

1,384

17

24

843

38

38

191

(14)

(3)

Farxiga

1,940

29

32

394

16

763

32

39

680

49

49

103

(23)

(14)

Brilinta

 

342

3

5

191

7

78

(1)

6

69

1

1

4

(38)

(23)

Crestor

292

4

11

12

(2)

234

8

14

10

(34)

(32)

36

3

15

Seloken/Toprol-XL

 

150

(8)

n/m

146

(8)

3

46

53

1

(40)

(38)

Lokelma

 

136

36

41

64

29

21

68

78

23

63

64

28

16

33

roxadustat

 

88

20

26

88

20

26

Andexxa

59

29

35

22

34

1

n/m

n/m

22

51

51

14

(6)

8

Wainua

16

n/m

n/m

16

n/m

Others

 

130

(26)

(24)

36

(45)

53

(19)

(14)

36

(9)

(8)

5

(14)

(12)

BioPharmaceuticals: R&I

 

1,797

21

24

830

23

444

23

34

350

21

21

173

8

14

Symbicort

 

722

20

25

299

49

197

12

25

143

4

5

83

(4)

(1)

Fasenra

 

423

4

5

268

19

33

46

99

11

11

37

3

11

Pulmicort

 

155

25

30

3

(53)

126

40

47

17

6

2

9

(18)

(13)

Breztri

235

44

47

120

43

61

42

49

35

68

69

19

26

37

Tezspire

57

n/m

n/m

3

n/m

n/m

35

n/m

n/m

19

n/m

n/m

Saphnelo

112

65

65

101

59

1

28

n/m

6

n/m

n/m

4

90

86

Airsupra

 

14

n/m

n/m

14

n/m

Others

 

79

(24)

(22)

25

(52)

37

7

12

15

2

3

2

(6)

(4)

BioPharmaceuticals: V&I

 

112

28

42

28

n/m

41

(10)

4

7

(55)

(53)

36

36

55

Synagis

81

(6)

8

(1)

n/m

41

(16)

(2)

6

(42)

(42)

35

27

46

Beyfortus

28

n/m

n/m

27

n/m

n/m

(91)

1

n/m

n/m

FluMist

2

n/m

n/m

2

n/m

(26)

(21)

COVID-19 mAbs

1

n/m

n/m

n/m

n/m

1

(65)

(64)

(99)

(99)

Others

n/m

n/m

n/m

n/m

Rare Disease

 

2,147

10

14

1,311

10

203

35

67

392

3

3

241

7

18

Ultomiris

946

33

36

550

27

35

n/m

n/m

209

38

38

152

38

56

Soliris

 

700

(14)

(8)

398

(11)

129

30

74

118

(36)

(36)

55

(36)

(33)

Strensiq

340

13

14

283

14

10

7

15

24

13

13

23

4

17

Koselugo

 

114

43

45

55

13

24

73

80

26

n/m

n/m

9

63

85

Kanuma

47

3

8

25

21

5

(54)

(49)

15

28

33

2

11

41

Other medicines

267

(11)

(5)

28

(13)

179

(3)

5

24

(7)

(7)

36

(38)

(32)

Nexium

219

(12)

(5)

25

(17)

146

(2)

7

13

(5)

(5)

35

(37)

(32)

Others

48

(9)

(6)

3

39

33

(8)

(4)

11

(9)

(9)

1

(54)

(49)

Total Product Sales

 

12,452

14

18

5,234

16

3,349

15

25

2,631

23

23

1,238

(5)

5

16

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.

52

Graphic

Table 27: Alliance Revenue

H1 2024

H1 2023

$m

$m

Enhertu

683

475

Tezspire

180

105

Beyfortus

26

-

Other Alliance Revenue

50

47

Total

939

627

Table 28: Collaboration Revenue

H1 2024

H1 2023

$m

$m

Farxiga: sales milestones

49

25

COVID-19 mAbs: licence fees

-

180

Other Collaboration Revenue

-

15

Total

49

220

Table 29: Other operating income and expense

H1 2024

H1 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

127

135

Total

127

1,163

53

Graphic

Other shareholder information

Financial calendar

Announcement of 9M and Q3 2024 results: 12 November 2024

Announcement of FY and Q4 2024 results: 6 February 2025

Dividends are normally paid as follows:

First interim:announced with half year results and paid in September

Second interim:announced with full year results and paid in March

The record date for the first interim dividend for 2024, payable on 9 September 2024, will be 9 August 2024. The ex-dividend date will be 8 August 2024.

Conclusion of audit tender

Following a rigorous process, the audit tender for the Group’s external audit provider has now concluded. The Audit Committee has recommended, and the Board has endorsed, the appointment of KPMG as the Group’s external auditor for the financial year ending 31 December 2026. A resolution will be put to shareholders at the 2026 Annual General Meeting (AGM) to approve this appointment. It is intended that PwC, who have been the Group’s auditor since the year ended 31 December 2017, will continue as the Group’s auditors for the years ended 31 December 2024 and 2025 and will cease to hold office at the conclusion of the Company’s 2026 AGM.

Contacts

For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.

Addresses for correspondence

Registered office

    

Registrar and 
transfer office

    

Swedish Central 
Securities Depository

    

US depositary
Deutsche Bank Trust 
Company Americas

1 Francis Crick Avenue Cambridge Biomedical Campus Cambridge CB2 0AA

Equiniti Limited Aspect House Spencer Road Lancing West Sussex BN99 6DA

Euroclear Sweden AB PO Box 191 SE-101 23 Stockholm

American Stock Transfer 6201 15th Avenue Brooklyn NY 11219

United Kingdom

United Kingdom

Sweden

United States

+44 (0) 20 3749 5000

0800 389 1580

+46 (0) 8 402 9000

+1 (888) 697 8018

+44 (0) 121 415 7033

+1 (718) 921 8137

db@astfinancial.com

Trademarks

Trademarks of the AstraZeneca group of companies appear throughout this document in italics. Medical publications also appear throughout the document in italics. AstraZeneca, the AstraZeneca logotype and the AstraZeneca symbol are all trademarks of the AstraZeneca group of companies. Trademarks of companies other than AstraZeneca that appear in this document include: Beyfortus, a trademark of Sanofi Pasteur Inc.; Enhertu, a trademark of Daiichi Sankyo; Seloken, owned by AstraZeneca or Taiyo Pharma Co., Ltd (depending on geography); Synagis, owned by AstraZeneca or Sobi aka Swedish Orphan Biovitrum AB (publ). (depending on geography); and Tezspire, a trademark of Amgen, Inc.

Information on or accessible through AstraZeneca’s websites, including astrazeneca.com, does not form part of and is not incorporated into this announcement.

54

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AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @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 in line with legal and regulatory requirements and strategic objectives

the risk of failure to attract, develop, engage and retain a diverse, talented and capable workforce

the risk of failure to meet regulatory or ethical expectations on environmental impact, including climate change

the risk of the safety and efficacy of marketed medicines being questioned

the risk of adverse outcome of litigation and/or governmental investigations

intellectual property-related risks to the Group’s products

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

the risk of failure in financial control or the occurrence of fraud

the risk of unexpected deterioration in the Group’s financial position

the impact that global and/or geopolitical events may have or continue to have on these risks, on the Group’s ability to continue to mitigate these risks, and on the Group’s operations, financial results or financial condition

55

Graphic

Glossary

1L, 2L, etc

First line, second line, etc

GAAP

Generally Accepted Accounting Principles

ADC

Antibody drug conjugate

GEJ

Gastro oesophageal junction

aHUS

Atypical haemolytic uraemic syndrome

GI

Gastrointestinal

AKT

Protein kinase B

GLP1 / -RA

Glucagon-like peptide-1 / receptor agonist

AL amyloidosis

Light chain amyloidosis

gMG

Generalised myasthenia gravis

ANDA

Abbreviated New Drug Application (US)

HCC

Hepatocellular carcinoma

ASO

Antisense oligonucleotide

HER2 / +/- / low / m

Human epidermal growth factor receptor 2 / positive / negative / low level expression / mutant

ATTR-CM

Transthyretin-mediated amyloid cardiomyopathy

HF/ pEF / rEF

Heart failure / with preserved ejection fraction / with reduced ejection fraction

ATTRv / -PN / -CM

Hereditary transthyretin-mediated amyloid / polyneuropathy / cardiomyopathy

hMPV

Human metapneumovirus

BCMA

B-cell maturation antigen

HR

Hazard ratio

BRCA / m

Breast cancer gene / mutation

HR / + / -

Hormone receptor / positive / negative

BTC

Biliary tract cancer

HRD

Homologous recombination deficiency

BTK

Bruton tyrosine kinase

HRR / m

Homologous recombination repair gene / mutation

C5

Complement component 5

i.m.

Intramuscular injection

CAR-T

Chimeric antigen receptor T-cell

i.v.

Intravenous injection

cCRT

Concurrent chemoradiotherapy

IAS / B

International Accounting Standards / Board

CD19

A gene expressed in B-cells

ICS

Inhaled corticosteroid

CER

Constant exchange rates

IFRS

International Financial Reporting Standards

CHMP

Committee for Medicinal Products for Human Use (EU)

IgAN

Immunoglobulin A neuropathy

CI

Confidence interval

IHC

Immunohistochemistry

CKD

Chronic kidney disease

IL-5, IL-33, etc

Interleukin-5, Interleukin-33, etc

CLL

Chronic lymphocytic leukaemia

IP

Intellectual Property

COPD

Chronic obstructive pulmonary disease

IVIg

Intravenous immune globulin

COP28

28th annual United Nations (UN) climate meeting

LABA

Long-acting beta-agonist

CRC

Colorectal cancer

LAMA

Long-acting muscarinic-agonist

CRL

Compete Response Letter

LS-SCLC

Limited stage small cell lung cancer

CRPC

Castration-resistant prostate cancer

LRTD

Lower respiratory tract disease

CSPC

Castration-sensitive prostate cancer

m

Metastatic, e.g. mBTC , mCRPC, mCSPC

CTLA-4

Cytotoxic T-lymphocyte-associated antigen 4

mAb

Monoclonal antibody

CVRM

Cardiovascular, Renal and Metabolism

MDL

Multidistrict litigation

DDR

DNA damage response

MET

Mesenchymal epithelial transition

DNA

Deoxyribonucleic acid

NF1-PN

Neurofibromatosis type 1 with plexiform neurofibromas

EBITDA

Earnings before interest, tax, depreciation and amortisation

n/m

Not meaningful

EGFR / m

Epidermal growth factor receptor / gene mutation

NMOSD

Neuromyelitis optica spectrum disorder

EGPA

Eosinophilic granulomatosis with polyangiitis

NRDL

National reimbursement drug list

EPS

Earnings per share

NSCLC

Non-small cell lung cancer

ER

Estrogen receptor

OECD

Organisation for Economic Co-operation and Development

ERBB2

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

OOI

Other operating income

56

Graphic

EVH

Extravascular haemolysis

ORR

Overall response rate

FDA

Food and Drug Agency (US)

OS

Overall survival

FDC

Fixed dose combination

PARP / i / -1sel

Poly ADP ribose polymerase / inhibitor /-1 selective

g

Germline, e.g. gBRCAm

pCR

Pathologic complete response

PCSK9

Proprotein convertase
subtilisin/kexin type 9

sBLA

Supplemental biologics license
application (US)

PD

Progressive disease

SCLC

Small cell lung cancer

PD-1

Programmed cell death protein 1

s.c.

Subcutaneous injection

PD-L1

Programmed cell death ligand 1

SEA

Severe eosinophilic asthma

PDUFA

Prescription Drug User Fee Act

SEC

Securities Exchange Commission (US)

PHSSR

Partnership for Health System
Sustainability and Resilience

SG&A

Sales, general and administration

PFS

Progression free survival

SGLT2

Sodium-glucose cotransporter 2

PIK3CA

Phosphatidylinositol-4,5-
bisphosphate 3-kinase, catalytic
subunit alpha

SLL

Small lymphocytic lymphoma

SMI

Sustainable Markets Initiative

sNDA

Supplemental new drug application

PMDI

Pressure metered dose inhaler

SPA

Share Purchase Agreement

PNH / -EVH

PPI

Paroxysmal nocturnal haemoglobinuria / with extravascular haemolysis

Proton pump inhibitors

T2D

Type-2 diabetes

TACE

Transarterial chemoembolization

THP

A treatment regimen: docetaxel, trastuzumab and pertuzumab

PSR

Platinum sensitive relapse

TNBC

Triple negative breast cancer

PTEN

Phosphatase and tensin
homologue

TNF

Tumour necrosis factor

TOP1

Topoisomerase I

Q3W, Q4W, etc

Every three weeks, every four
weeks, etc

TROP2

Trophoblast cell surface antigen 2

USPTO

US Patent and Trademark Office

R&D

Research and development

V&I

Vaccines & Immune Therapies

R&I

Respiratory & Immunology

VBP

Volume-based procurement

RSV

Respiratory syncytial virus

VLP

Virus like particle

- End of document –

57

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

    

AstraZeneca PLC

Date: 25th July, 2024

By:

/s/ Adrian Kemp

Name:

Adrian Kemp

Title:

Company Secretary

58