9M and Q3 2024 Results

Source: RNS
RNS Number : 7959L
AstraZeneca PLC
12 November 2024
 

AstraZeneca

12 November 2024

9M and Q3 2024 results

 

Upgrade to full year 2024 guidance underpinned by strong underlying growth momentum

 

Revenue and EPS summary

 



9M 2024

% Change

Q3 2024

% Change

 

 

$m 

Actual 

CER[1] 

$m 

Actual 

CER 

- Product Sales


37,576 

16 

19 

12,947 

18 

20 

- Alliance Revenue


1,498 

49 

50 

559 

48 

50 

- Collaboration Revenue


108 

(66)

(66)

59 

(39)

(40)

Total Revenue


39,182 

16 

19 

13,565 

18 

21 

Reported EPS


$3.57 

11 

21 

$0.92 

4 

17 

Core[2] EPS


$6.12 

5 

11 

$2.08 

20 

27 

 

Financial performance for 9M 2024 (Growth numbers at constant exchange rates)

 

‒    Total Revenue up 19% to $39,182m, driven by a 19% increase in Product Sales and continued growth in Alliance Revenue from partnered medicines

 

‒    Total Revenue growth from Oncology was 22%, CVRM 21%, R&I 24% and Rare Disease 14%

 

‒    Core Product Sales Gross Margin[3] of 82%

 

‒    Core Operating Margin of 32%

 

‒    Core Tax Rate of 20%

 

‒    Core EPS increased 11% to $6.12. In the prior year period, Core EPS included gains totalling $953m from the disposal of Pulmicort Flexhaler US rights and updated contractual arrangements for Beyfortus

 

‒    Guidance for FY 2024 Total Revenue and Core EPS growth at CER upgraded to high teens percentage growth

 

Pascal Soriot, Chief Executive Officer, AstraZeneca, said:

 

"Our company has continued on its strong growth trajectory in the first nine months of 2024. Total Revenue and Core EPS were up 21% and 27% respectively in the third quarter, reflecting the increasing demand for our medicines across Oncology, BioPharmaceuticals and Rare Disease and supporting an upgrade to our full year 2024 guidance.

 

In the year to date we have announced the results for multiple positive high-value trials and are working to bring these new options to patients as quickly as possible. Additionally, the quality and impact of our scientific research was well recognised this quarter with data for AstraZeneca medicines featuring in an unprecedented five Presidential Plenary sessions at the two major oncology conferences in September.

 

We are highly encouraged by the broad-based underlying momentum we are seeing across our company in 2024, and growth looks set to continue through 2025, providing a solid foundation to deliver on our 2030 ambition.

 

Finally, we take the matters in China very seriously. If requested we will fully cooperate with the authorities. We remain committed to delivering innovative life-changing medicines to patients in China."

 

Key milestones achieved since the prior results announcement

 

‒    Positive read-outs for Tagrisso plus Orpathys in EGFRm NSCLC with high levels of MET overexpression and/or amplification (SAVANNAH), Calquence in combination with venetoclax, with or without obinutuzumab in previously untreated CLL (AMPLIFY), and the next generation propellant for Breztri. Koselugo in adult patients with NF1-PN (KOMET), Tezspire in severe chronic rhinosinusitis with nasal polyps (WAYPOINT)

 

‒    US approvals for Tagrisso in unresectable, Stage III EGFRm NSCLC (LAURA) and Imfinzi plus chemotherapy in resectable early-stage NSCLC (AEGEAN) and FluMist for self-administration. EU approvals for Imfinzi plus chemotherapy followed by Imfinzi alone in mismatch repair deficient endometrial cancer (DUO-E), Imfinzi plus chemotherapy followed by Lynparza and Imfinzi in mismatch repair proficient endometrial cancer (DUO-E) and Fasenra for EGPA (MANDARA). China approvals for Enhertu in unresectable, locally advanced or metastatic HER2-mutated NSCLC (DESTINY-Lung02, DESTINY-Lung05), Enhertu in locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma (DESTINY-Gastric06), and Fasenra for severe eosinophilic asthma (MIRACLE)

 

Guidance

 

Given the strength of underlying Product Sales and Alliance Revenue, as well as increased confidence in achieving certain sales-based milestones, the Company raises its Total Revenue and Core EPS guidance for FY 2024 at CER.

 

Total Revenue is expected to increase by a high teens percentage (previously a mid teens percentage)

Core EPS is expected to increase by a high teens percentage (previously a mid teens percentage)

 

‒    Other elements of the Income Statement are expected to be broadly in-line with the indications issued in the Company's H1 2024 earnings statement

 

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 October 2024 to December 2024 were to remain at the average rates seen in September 2024, it is anticipated that FY 2024 Total Revenue would incur a low single-digit percentage adverse impact compared to the performance at CER (unchanged from previous guidance), and Core EPS would incur a mid single-digit percentage adverse impact (unchanged from previous guidance). The Company's foreign exchange rate sensitivity analysis is provided in Table 17.

 

China

 

As previously disclosed, the Company is aware of a number of individual investigations by the Chinese authorities into current and former AstraZeneca employees. To the best of the Company's knowledge, the investigations include allegations of medical insurance fraud, illegal drug importation and personal information breaches. Recently Leon Wang, EVP International and AstraZeneca China President was detained. The Company has not received any notification that it is itself under investigation. If requested, AstraZeneca will fully cooperate with the Chinese authorities.

 

Table 1: Key elements of Total Revenue performance in Q3 2024

 

 

% Change 

 

 

 

Revenue type 


$m 

Actual % 

CER % 

 

 

Product Sales 


12,947 

18 

20 



Alliance Revenue


559 

48 

50 


*   $49m Beyfortus (Q3 2023: $17m)

*   $361m Enhertu (Q3 2023: $266m)

*   $123m Tezspire (Q3 2023: $74m)

Collaboration Revenue 


59 

(39)

(40)


*   $56m Beyfortus (Q3 2023: $71m)

Total Revenue 


13,565 

18 

21 



Therapy areas 


$m 

Actual %

CER %

 

 

Oncology 


5,569 

19 

22 


*   Tagrisso up 14% (17% at CER), Calquence up 24% (25% at CER), Enhertu Total Revenue up 50% (55% at CER)

CVRM 


3,159 

18 

20 

 

*   Farxiga up 25% (27% at CER), Lokelma up 40% (42% at CER)

R&I 


1,959 

26 

29 


*   Breztri up 56% (57% at CER). Saphnelo up 63% (64% at CER), Tezspire up >2x, Symbicort up 27% (31% CER)

V&I


460 

48 

49 


*   Beyfortus Total Revenue up 73% (72% at CER), FluMist up 34% (31% at CER)

Rare Disease 


2,148 

11 


·  Ultomiris up 33% (35% at CER), partially offset by decline in Soliris of 22% (18% at CER), Strensiq up 20% (21% at CER) and Koselugo up 37% (39% at CER)

Other Medicines 


270 

(12)

(8)



Total Revenue 


13,565 

18 

21 



Regions


$m 

Actual %

CER %

 

 

US 


6,008 

23 

23 



Emerging Markets 


3,423 

15 

23 



- China 

 

1,671 

15 

15 

 

 

- Ex-China Emerging Markets 

 

1,752 

16 

31 

 

 

Europe 


2,875 

22 

22 



Established RoW 


1,260 

(1)



Total Revenue


13,565 

18 

21 



 

Key alliance medicines

 

‒    Combined sales of Enhertu, recorded by Daiichi Sankyo Company Limited (Daiichi Sankyo) and AstraZeneca, amounted to $2,729m in 9M 2024 (9M 2023: $1,844m).

 

‒    Combined sales of Tezspire, recorded by Amgen and AstraZeneca, amounted to $843m in 9M 2024 (9M 2023: $438m).

 

Table 2: Key elements of financial performance in Q3 2024

 

Metric

Reported

Reported change

Core

Core
change


Comments[4]

Total Revenue

$13,565m

18% Actual      21% CER

$13,565m

18% Actual      21% CER


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

Product Sales Gross Margin

76%

-5pp Actual      -4pp CER

81%

Stable Actual      and CER


*   Variations in Product Sales Gross Margin can be expected between periods, due to product seasonality (e.g. FluMist and Beyfortus sales are weighted to the second half of the year), foreign exchange fluctuations and other effects

Reported Product Sales Gross Margin impacted by PAAGR[5] inventory related restructuring charges taken in the quarter

R&D

expense

$3,115m

21% Actual      21% CER

$3,068m

23% Actual      24% CER


+ Increased investment in the pipeline

*   Core R&D-to-Total Revenue ratio of 23%
(Q3 2023: 22%)

SG&A expense

$5,143m

7% Actual      8% CER

$3,605m

8% Actual      9% CER


+ Market development for recent launches and pre-launch activities

*   Core SG&A-to-Total Revenue ratio of 27%
(Q3 2023: 29%)

Other operating income and expense[6]

$25m

-65% Actual      -61% CER

$24m

-65% Actual      -61% CER


 

Operating Margin

16%

-1pp Actual      Stable CER

32%

+1pp Actual      +2pp CER


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

Net finance expense

$274m

-6% Actual      -15% CER

$329m

46% Actual      35% CER


+ New debt issued at higher interest rates

+ Higher level of Net debt

Tax rate

22%

+5pp Actual      +5pp CER

19%

Stable Actual      and CER


*   Variations in the tax rate can be expected between periods

EPS

$0.92

4% Actual      17% CER

$2.08

20% Actual      27% CER


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

 

Table 3: Pipeline highlights since prior results announcement

 

Event

Medicine

Indication / Trial

 

Event

Regulatory approvals and other regulatory actions

Tagrisso

Unresectable, Stage III EGFRm NSCLC (LAURA)

Regulatory approval (US)

Imfinzi

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

Regulatory approval (EU)

Imfinzi + Lynparza

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

Regulatory approval (EU)

Imfinzi

Resectable early-stage (IIA-IIIB) NSCLC (AEGEAN)

Regulatory approval (US)

Enhertu

Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma (DESTINY-Gastric06)

Regulatory approval (CN)

Enhertu

Unresectable locally advanced or metastatic HER2m NSCLC (DESTINY-Lung02, DESTINY-Lung05)

Regulatory approval (CN)

Fasenra

EGPA (MANDARA)

Regulatory approval (US, EU)

Fasenra

Fasenra (MIRACLE)

Regulatory approval (CN)

FluMist

Self-administration

Regulatory approval (US)

Regulatory submissions
or acceptances*

Tagrisso

EGFRm NSCLC (Stage III

unresectable) (LAURA)

Regulatory submission (EU, JP, CN)

Imfinzi

Muscle-invasive bladder

Cancer (NIAGARA)

Regulatory submission (EU)

Imfinzi

NSCLC (neoadjuvant) AEGEAN

Regulatory submission (JP)

Imfinzi

SCLC (limited stage) (ADRIATIC)

Regulatory submission (US, EU, JP, CN)

Calquence

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

Regulatory submission (US, EU, JP)

Calquence

CLL (ELEVATE-TN)

Regulatory submission (CN)

Lynparza

mCRPC (PROpel)

Regulatory submission (CN)

Enhertu

HER2-low breast cancer

(2nd-line) (DESTINY-Breast06)

Regulatory submission (US, EU, JP)

Wainua

Hereditary transthyretin-mediated amyloid polyneuropathy (NEURO-TTRansform)

Regulatory submission (CN)

Breztri and HFO1234ze

Moderate to severe COPD

Regulatory submission (EU)

Sipavibart

Prevention of COVID-19

(SUPERNOVA)

Regulatory submission (JP)

Ultomiris

NMOSD (CHAMPION-NMOSD)

Regulatory submission (CN)

Phase III / registrational data readouts and other developments

Tagrisso + Orpathys

EGFRm NSCLC with high levels of MET overexpression and/or amplification (SAVANNAH)

Clinically meaningful ORR

Calquence fixed duration

Chronic lymphocytic leukaemia (AMPLIFY)

Primary endpoint met

Fasenra

Eosinophilic chronic rhinosinusitis with nasal polyps (ORCHID)

Primary endpoint not met

Tezspire

Severe chronic rhinosinusitis with nasal polyps (WAYPOINT)

Primary endpoint met

Koselugo

Adults with NF1-PN (KOMET)

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.

 

Corporate and business development

 

In October 2024, AstraZeneca entered into an exclusive license agreement with CSPC Pharmaceutical Group Ltd (CSPC) to advance the development of an early stage, novel small molecule Lipoprotein (a) (Lp(a)) disruptor that has the potential to offer additional benefits for patients with dyslipidaemia. This further strengthens the company's cardiovascular portfolio to help address the major risk factors driving chronic cardiovascular disease. Under the terms of the agreement, AstraZeneca will receive access to CSPC's pre-clinical candidate small molecule, YS2302018, an oral Lp(a) disruptor, with the aim of developing this as a novel lipid-lowering therapy with potential in a range of cardiovascular disease indications alone or in combination, including with AstraZeneca's oral small molecule PCSK9 inhibitor, AZD0780. CSPC will receive an upfront payment of $100 million from AstraZeneca. CSPC is also eligible to receive up to $1.92 billion for further development and commercialisation milestones plus tiered royalties.

 

In October 2024, AstraZeneca entered into an agreement to out-license ALXN1840 (bis-choline tetrathiomolybdate), a drug candidate for Wilson disease to Monopar Therapeutics Inc (Monopar). Monopar will be responsible for all future global development and commercialisation activities. AstraZeneca will have a 9.9% beneficial ownership interest in Monopar upon issuance as well as an upfront cash payment of $4.0 million. AstraZeneca is also eligible to receive milestones and royalties.

 

Sustainability highlights

 

In September, AstraZeneca had a significant presence at Climate Week NYC and the 79th Session of the UN General Assembly in New York, with a delegation led by Pam Cheng, Executive Vice President of Global Operations and IT and Chief Sustainability Officer and the company's US leadership. A programme of more than 50 engagements with governments, media, NGOs and the private sector focused on the interconnected issues of the climate crisis, health equity and health system resilience and the Company's commitment to contribute to more sustainable, resilient and equitable health systems.

 

Conference call

 

A conference call and webcast for investors and analysts will begin today, 12 November 2024, at 14:00 UK time. Details can be accessed via astrazeneca.com.

 

Reporting calendar

 

The Company intends to publish its FY and Q4 2024 results on 6 February 2025.

 

Operating and financial review

 

All narrative on growth and results in this section is based on actual exchange rates, and financial figures are in US$ millions ($m), unless stated otherwise. The performance shown in this announcement covers the nine-month period to 30 September 2024 ('the period' or '9M 2024') compared to the nine-month period to 30 September 2023 ('9M 2023'), or the three-month period to 30 September 2024 ('the quarter' or 'Q3 2024') compared to the three-month period to 30 September 2023 ('Q3 2023'), unless stated otherwise.

 

Core financial measures, EBITDA, Net debt, Product Sales Gross Margin, Operating Margin and CER are non-GAAP financial measures because they cannot be derived directly from the Group's Condensed consolidated financial statements. Management believes that these non-GAAP financial measures, when provided in combination with Reported results, provide investors and analysts with helpful supplementary information to understand better the financial performance and position of the Group on a comparable basis from period to period. These non-GAAP financial measures are not a substitute for, or superior to, financial measures prepared in accordance with GAAP.

 

Core financial measures are adjusted to exclude certain significant items:

 

‒    Charges and provisions related to our global restructuring programmes on our capitalised manufacturing assets and IT assets

 

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

 

‒    Other specified items, principally 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 certain Other payables and debt items 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.

 

Total Revenue

 

Table 4: Total Revenue by therapy area and medicine[7]

 

 

 

9M 2024 

Q3 2024 

 

 

 

 

% Change 

 

 

% Change 

           

 

$m 

% Total 

Actual 

CER 

$m 

% Total 

Actual 

CER 

Oncology 


16,009 

41 

19 

22 

5,569 

41 

19 

22 

- Tagrisso 


4,877 

12 

11 

15 

1,674 

12 

14 

17 

- Imfinzi


3,463 

18 

22 

1,203 

13 

16 

- Calquence 


2,321 

26 

27 

813 

24 

25 

- Lynparza 


2,228 

10 

778 

11 

13 

- Enhertu 


1,442 

57 

60 

510 

50 

55 

- Zoladex


845 

17 

24 

278 

12 

18 

- Imjudo


208 

30 

32 

72 

20 

22 

- Truqap


267 

n/m 

n/m 

125 

n/m 

n/m 

- Orpathys 


36 

11 

(11)

(11)

- Other Oncology


322 

(18)

(12)

106 

(10)

(5)

BioPharmaceuticals: CVRM 


9,379 

24 

18 

21 

3,159 

23 

18 

20 

- Farxiga 


5,779 

15 

32 

34 

1,943 

14 

25 

27 

- Brilinta 


992 

327 

(1)

(1)

- Crestor


894 

304 

10 

14 

- Lokelma


392 

31 

34 

143 

40 

42 

- Seloken/Toprol-XL 


466 

(6)

(1)

151 

(2)

- roxadustat


261 

23 

26 

95 

26 

25 

- Andexxa


159 

24 

26 

54 

36 

38 

- Wainua


44 

n/m 

n/m 

23 

n/m 

n/m 

- Other CVRM


392 

(27)

(26)

120 

(22)

(20)

BioPharmaceuticals: R&I 


5,750 

15 

22 

24 

1,959 

14 

26 

29 

- Symbicort 


2,195 

19 

22 

705 

27 

31 

- Fasenra


1,218 

436 

12 

13 

- Breztri


721 

51 

53 

266 

56 

57 

- Pulmicort 


517 

138 

(6)

(4)

- Tezspire


471 

>2x 

>2x 

191 

>2x 

>2x 

- Saphnelo 


327 

71 

72 

124 

63 

64 

- Airsupra


41 

n/m 

n/m 

21 

n/m 

n/m 

- Other R&I 


259 

(28)

(27)

78 

(32)

(32)

BioPharmaceuticals: V&I 


811 

(14)

(12)

460 

48 

49 

- Beyfortus

 

319 

>2x 

>2x 

238 

73 

72 

- Synagis

 

346 

(10)

(4)

93 

(6)

- COVID-19 mAbs


31 

(90)

(90)

28 

>10x 

>10x 

- FluMist


109 

24 

21 

100 

34 

31 

- Other V&I


(79)

(80)

(63)

n/m 

Rare Disease


6,391 

16 

10 

14 

2,148 

16 

11 

- Ultomiris 


2,835 

32 

35 

1,031 

33 

35 

- Soliris


2,045 

(16)

(11)

606 

(22)

(18)

- Strensiq 


996 

18 

19 

343 

20 

21 

- Koselugo 


366 

49 

55 

119 

37 

39 

- Kanuma 


149 

15 

16 

49 

10 

Other Medicines 


843 

(10)

(4)

270 

(12)

(8)

- Nexium 

 

685 

(8)

(2)

216 

(13)

(8)

- Others 


157 

(17)

(15)

54 

(7)

(7)

Total


39,182 

100 

16 

19 

13,565 

100 

18 

21 

 

Table 5: Alliance Revenue

 



9M 2024

Q3 2024



 

% Change


% Change

 

 

$m 

Actual 

CER 

$m 

Actual 

CER 

Enhertu


1,045 

41 

42 

361 

36 

38 

Tezspire


303 

69 

69 

123 

65 

65 

Beyfortus


75 

>4x 

>4x 

49 

>2x 

>2x 

Other Alliance Revenue 


75 

11 

11 

26 

29 

29 

Total 


1,498 

49 

50 

559 

48 

50 

 

Table 6: Collaboration Revenue



9M 2024

Q3 2024



 

% Change


% Change

 

 

$m 

Actual 

CER 

$m 

Actual 

CER 

Farxiga: sales milestones 


52 

87 

87 

12 

14 

Beyfortus: sales milestones


56 

(21)

(23)

56 

(21)

(23)

Total 


108 

(66)

(66)

59 

(39)

(40)

 

Table 7: Total Revenue by therapy area

 



9M 2024

Q3 2024





% Change



% Change



$m 

% Total 

 Actual 

CER 

$m 

% Total 

 Actual 

CER 

Oncology


16,009 

41 

19 

22 

5,569 

41 

19 

22 

Biopharmaceuticals


15,940 

41 

17 

20 

5,578 

41 

23 

25 

CVRM

 

9,379 

24 

18 

21 

3,159 

23 

18 

20 

R&I

 

5,750 

15 

22 

24 

1,959 

14 

26 

29 

V&I

 

811 

(14)

(12)

460 

48 

49 

Rare Disease


6,391 

16 

10 

14 

2,148 

16 

11 

Other Medicines


843 

(10)

(4)

270 

(12)

(8)

Total

 

39,182 

100 

16 

19 

13,565 

100 

18 

21 

 

Table 8: Total Revenue by region

 



9M 2024 

Q3 2024





% Change 



% Change



$m 

% Total 

 Actual 

CER 

$m 

% Total 

 Actual 

CER 

US


16,703 

43 

20 

20 

6,008 

44 

23 

23 

Emerging Markets


10,541 

27 

14 

23 

3,423 

25 

15 

23 

China

 

5,049 

13 

12 

15 

1,671 

12 

15 

15 

Emerging Markets ex. China

 

5,492 

14 

16 

30 

1,752 

13 

16 

31 

Europe


8,240 

21 

22 

22 

2,875 

21 

22 

22 

Established ROW


3,698 

(4)

1,260 

(1)

Total

 

39,182 

100 

16 

19 

13,565 

100 

18 

21 

 

Oncology

 

Oncology Total Revenue of $16,009m in 9M 2024 increased by 19% (22% at CER), representing 41% of overall Total Revenue (9M 2023: 40%).

 

Tagrisso

 

9M 2024, $m


Worldwide


US

Emerging Markets

Europe

Established RoW

Total Revenue


4,877


1,996

1,365

956

560

Actual change


11%


19%

8%

16%

(10%)

CER change


15%


19%

16%

16%

(2%)

 

Region


 Drivers and commentary

Worldwide


*   Strong global demand for Tagrisso in adjuvant (ADAURA) and 1st-line settings (FLAURA, FLAURA-2)

US


*   Continued demand growth in both the adjuvant and metastatic settings, with some additional benefit coming from improved affordability

Emerging Markets


*   Encouraging demand growth, partly offset by NRDL price reduction in prior year period

Europe


*   Continued demand growth across adjuvant and metastatic settings

Established RoW


*   Continued demand growth across adjuvant and metastatic settings with year-over-year comparison reflecting price reduction in Japan in June 2023

 

Imfinzi

 

9M 2024, $m


Worldwide


US

Emerging Markets

Europe

Established RoW

Total Revenue


3,463


1,883

365

695

520

Actual change


18%


18%

37%

30%

(3%)

CER change


22%


18%

61%

29%

6%

 

Region


 Drivers and commentary

Worldwide


*   Strong demand 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 as established standard of care in BTC

Emerging Markets


*   Strong demand growth driven across all approved indications, in particular BTC

Europe


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

Established RoW


*   Increased demand in GI indications, with year-over-year comparison reflecting the 25% and 11% mandatory price reductions in Japan effective from 1 February 2024 and 1 August 2024 respectively

 

Calquence

 

9M 2024, $m


Worldwide


US

Emerging Markets

Europe

Established RoW

Total Revenue


2,321


1,617

116

489

99

Actual change


26%


21%

68%

38%

23%

CER change


27%


21%

90%

38%

27%

 

Region


 Drivers and commentary

Worldwide


*   Sustained BTKi leadership in front-line CLL (ELEVATE-TN)

US


*   Growth driven by leading share of new patient starts in front-line CLL, with some additional favourability coming from improved affordability

Europe


*   Strong growth momentum in front-line CLL, maintaining share of 1L new patient starts in competitive environment

 

Lynparza

 

9M 2024, $m


Worldwide


US

Emerging Markets

Europe

Established RoW

Total Revenue


2,228


954

475

612

187

Actual change


8%


6%

16%

13%

(13%)

CER change


10%


6%

25%

12%

(7%)

 

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 9M 2024 or 9M 2023

US


*   Continued leadership within competitive PARP inhibitor class, with demand growth across all indications

Emerging Markets


*   Volume growth in China from increased share following inclusion of HRD-positive ovarian cancer (PAOLA-1) on NRDL with no price reduction

Europe


*   Growth driven by increased market share and additional launches in early breast cancer (OlympiA) and metastatic prostate cancer (PROpel)

Established RoW


*   PARP class leadership maintained with year-over-year comparison reflecting 7.7% price reduction in Japan in November 2023  

 

 

Enhertu

 

9M 2024, $m


Worldwide


US

Emerging Markets

Europe

Established RoW

Total Revenue


1,442


642

353

400

47

Actual change


57%


24%

97%

95%

>2x

CER change


60%


24%

>2x

95%

>2x

 

Region


 Drivers and commentary

Worldwide


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

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

*   Combined sales of Enhertu, recorded by Daiichi Sankyo and AstraZeneca, amounted to $2,729m in 9M 2024 (9M 2023: $1,844m)

US


*   US in-market sales, recorded by Daiichi Sankyo, amounted to $1,342m in 9M 2024 (9M 2023: $1,087m)

Emerging Markets


*   Increased demand growth following commercial breast cancer launch in China in Q1 2024

Europe


*   Continued demand growth due to increasing adoption in HER2-positive and HER2-low metastatic breast cancer

Established RoW


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

 

Other Oncology medicines

 


9M 2024

Change


Total Revenue


$m

Actual

CER

Drivers and commentary

Zoladex


845

17%

24%

*   Strong underlying growth in China and Emerging Markets and moderate growth in Europe with reduced uptake in Japan

Imjudo


208

30%

32%

*   Continued growth across markets

Truqap


267

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


36

5%

8%

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

Other Oncology


322

(18%)

(12%)

*   Decline in Faslodex Total Revenue due to VBP implementation in China in March 2024 and generic erosion in Europe

 

 

BioPharmaceuticals

 

BioPharmaceuticals Total Revenue increased by 17% (20% at CER) in 9M 2024 to $15,940m, representing 41% of overall Total Revenue (9M 2023: 40%).

 

BioPharmaceuticals - CVRM

 

CVRM Total Revenue increased by 18% (21% at CER) to $9,379m in 9M 2024 and represented 24% of overall Total Revenue (9M 2023: 23%).

 

Farxiga

 

9M 2024, $m


Worldwide


US

Emerging Markets

Europe

Established RoW

Total Revenue


5,779


1,280

2,225

1,903

371

Actual change


32%


28%

34%

40%

(2%)

CER change


34%


28%

41%

39%

5%

 

Region


 Drivers and commentary

Worldwide


*   Farxiga volume continued to grow 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

Europe


*   Continued strong class growth and market share gains

Established RoW


*   Continued demand growth partially offset by generic competition in Canada

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

 

Other CVRM medicines

 


9M 2024

Change


Total Revenue


$m

Actual

CER

Drivers and commentary

Brilinta


992

-

1%

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

Crestor


894

4%

9%

*   Continued sales growth in Emerging Markets

Seloken


466

(6%)

(1%)

*   Growth in ex-China EM markets offsetting declines in other regions

Lokelma


392

31%

34%

*   Strong growth in all major regions, particularly in Europe and Emerging Markets. Continued launches in new markets

Roxadustat


261

23%

26%

*   Continued patient and volume growth

Andexxa


159

24%

26%

*   Demand growth

Wainua


44

n/m

n/m

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

Other CVRM


392

(27%)

(26%)

*   Generic competition

 

BioPharmaceuticals - R&I

 

Total Revenue of $5,750m from R&I medicines increased 22% (24% at CER) and represented 15% of overall Total Revenue (9M 2023: 14%).

 

Fasenra

 

9M 2024, $m


Worldwide


US

Emerging Markets

Europe

Established RoW

Total Revenue


1,218


750

68

294

106

Actual change


7%


4%

43%

12%

(1%)

CER change


8%


4%

52%

11%

6%

                                                          

Region


 Drivers and commentary

Worldwide


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

US


*   Sustained double-digit volume growth

Emerging Markets


*   Continued strong demand growth driven by launch acceleration across key markets 

Europe


*   Sustained leadership in severe eosinophilic asthma  

Established RoW


*   In Japan, maintained class leadership in a broadly stable market

 

Breztri

 

9M 2024, $m


Worldwide


US

Emerging Markets

Europe

Established RoW

Total Revenue


721


367

199

102

53

Actual change


51%


40%

62%

86%

42%

CER change


53%


40%

68%

85%

51%

 

Region


 Drivers and commentary

Worldwide


*   Fastest growing single-inhaler triple medicine within the expanding FDC triple class

US


*   Consistent share growth within the expanding FDC triple class

Emerging Markets


*   Maintained market share leadership in China with strong FDC triple class penetration

*   Further expansion with launches in additional geographies

Europe


*   Sustained growth across markets driven by new launches

Established RoW


*   Increased market share in Japan

 

Tezspire

 

9M 2024, $m


Worldwide


US

Emerging Markets

Europe

Established RoW

Total Revenue


471

 

303

8

105

55

Actual change


>2x

 

70%

n/m

>3x

>2x

CER change


>2x

 

70%

n/m

>3x

>2x

 

Region


 Drivers and commentary

Worldwide


*   Combined sales of Tezspire, recorded by Amgen and AstraZeneca, amounted to $843m in 9M 2024 (9M 2023: $438m)

US


*   Continued growth in total prescriptions, with majority of patients new-to-biologics

Europe


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

Established RoW


*   Sustained market share growth in Japan and other major geographies, with continued launches

 

Symbicort

 

9M 2024, $m


Worldwide


US

Emerging Markets

Europe

Established RoW

Total Revenue


2,195


887

653

415

240

Actual change


19%


51%

9%

2%

(2%)

CER change


22%


51%

19%

1%

-

 

Region


 Drivers and commentary

Worldwide


*   Symbicort remained the global market leader within a stable ICS/LABA class

US


*   Continued strong demand for the authorised generic, limitation of patient out-of-pocket expenses and favourable channel mix

Emerging Markets


*   Sustained demand growth across markets

Europe


*   Continued growth in some markets within mild asthma partially offset generic erosion and a slowing overall market

Established RoW


*   Continued generic erosion in Japan

 

Other R&I medicines

 


9M 2024

   Change


Total Revenue


$m

Actual

CER

Drivers and commentary

Saphnelo

 

327

71%

72%

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

Airsupra

 

41

n/m

n/m

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

Pulmicort

 

517

5%

9%

*   >80% of revenues from Emerging Markets

Other R&I


259

(28%)

(27%)

*   Continued generic competition

 

BioPharmaceuticals - V&I

 

Total Revenue from V&I medicines reduced by 14% (12% at CER) to $811m (9M 2023: $944m) and represented 2% of overall Total Revenue (9M 2023: 3%).

 

V&I medicines

 


9M 2024

Change


Total Revenue


$m

Actual

CER

Drivers and commentary

Beyfortus

 

319

>2x

>2x

*   Growth driven increasing demand and expanded production capacity

*   Product Sales recognises AstraZeneca's sales of manufactured Beyfortus product to Sanofi

*   Alliance Revenue recognises AstraZeneca's 50% share of gross profits on sales of Beyfortus in major markets outside the US, and 25% of brand revenues in rest of world markets

*   AstraZeneca has no participation in US profits or losses

Synagis

 

346

(10%)

(4%)

*   As anticipated, Synagis demand decreased following rapid adoption of Beyfortus

COVID-19 mAbs


31

(90%)

(90%)

*   Decline in Evusheld sales and Collaboration Revenue (Total Revenue 9M 2023: $306m)

FluMist


109

24%

21%

*   Demand growth across key markets in particular Europe and benefit from earlier start in flu season in Q3 2024 compared to prior year

Other V&I


6

(79%)

(80%)

*   Decline in Vaxzevria sales (9M 2023: $28m)

 

Rare Disease

 

Total Revenue from Rare Disease medicines increased by 10% (14% at CER) in 9M 2024 to $6,391m, representing 16% of overall Total Revenue (9M 2023: 17%).

 

Ultomiris

 

9M 2024, $m


Worldwide


US

Emerging Markets

Europe

Established RoW

Total Revenue


2,835


1,629

92

649

465

Actual change


32%


29%

97%

31%

37%

CER change


35%


29%

>2x

30%

50%

 

Region


 Drivers and commentary

Worldwide


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

*   Ultomiris Total Revenue includes sales of Voydeya, which is approved as an add‑on treatment to Ultomiris and Soliris for the 10-20% of PNH patients who experience clinically significant EVH

US


*   Strong growth in patient demand in gMG (CHAMPION-MG) and NMOSD (CHAMPION-NMOSD), both new to branded medicines, as well as continued conversion from Soliris

Emerging Markets


*   Expansion into new markets and growth in patient demand

Europe


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

Established RoW


*   Continued conversion from Soliris and strong demand following new launches

 

 

Soliris

 

9M 2024, $m


Worldwide


US

Emerging Markets

Europe

Established RoW

Total Revenue


2,045


1,170

365

346

164

Actual change


(16%)


(11%)

8%

(35%)

(34%)

CER change


(11%)


(11%)

39%

(35%)

(31%)

 

Region


 Drivers and commentary

US


*   Decline driven by successful conversion of Soliris patients to Ultomiris

Emerging Markets


*   Growth driven by patient demand

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

 

9M 2024, $m


Worldwide


US

Emerging Markets

Europe

Established RoW

Total Revenue


996


815

39

73

69

Actual change


18%


18%

34%

15%

8%

CER change


19%


18%

48%

14%

18%

 

Region


 Drivers and commentary

Worldwide


*   Growth driven by strong patient demand

 

Other Rare Disease medicines

 


9M 2024

Change


Total Revenue


$m

Actual

CER

Drivers and commentary

Koselugo


366

49%

55%

*   Driven by patient demand and expansion in new markets

Kanuma


149

15%

16%

*   Continued global demand

 

Other medicines (outside the main therapy areas)

 


9M 2024

Change


Total Revenue


$m

Actual

CER

Drivers and commentary

Nexium

 

685

(8%)

(2%)

*   Stable in Emerging Markets, which now accounts for two-thirds of Nexium revenue, offset by generic erosion in other markets

Others


157

(17%)

(15%)

*   Continued impact of generic competition

 

Financial performance

 

Table 9: Reported Profit and Loss

 



9M 2024

9M 2023

% Change 

Q3 2024

Q3 2023

% Change

 

 

$m  

$m  

Actual 

CER 

$m 

$m 

Actual 

CER 

Total Revenue

 

39,182 

33,787 

16 

19 

13,565 

11,492 

18 

21  

- Product Sales


37,576 

32,466 

16 

19 

12,947 

11,018 

18 

20  

- Alliance Revenue


1,498 

1,004 

49 

50 

559 

377 

48 

50  

- Collaboration Revenue


108 

317 

(66)

(66)

59 

97 

(39)

(40)

Cost of sales


(7,482)

(5,960)

26 

28 

(3,081)

(2,095)

47 

48  

Gross profit

 

31,700 

27,827 

14 

17 

10,484 

9,397 

12 

15  

Distribution expense


(412)

(394)

(145)

(129)

12 

15  

R&D expense


(8,906)

(7,862)

13 

14 

(3,115)

(2,584)

21 

21  

SG&A expense


(14,567)

(13,845)

(5,143)

(4,800)

8  

Other operating income & expense


152 

1,233 

(88)

(88)

25 

70 

(65)

(61)

Operating profit


7,967 

6,959 

14 

23 

2,106 

1,954 

18 

Net finance expense


(919)

(945)

(3)

(7)

(274)

(291)

(6)

(15)

Joint ventures and associates


(23)

(12)

n/m

97 

(4)

(11)

(53)

(54)

Profit before tax

 

7,025 

6,002 

17 

28 

1,828 

1,652 

11 

24 

Taxation


(1,484)

(1,000)

48 

62 

(395)

(274)

44 

62 

Tax rate

 

21% 

17% 

 


22% 

17% 



Profit after tax

 

5,541 

5,002 

11 

21 

1,433 

1,378 

17 

Earnings per share

 

$3.57 

$3.22 

11 

21 

$0.92 

$0.89 

17 

 

Table 10: Reconciliation of Reported Profit before tax to EBITDA

 



9M 2024

9M 2023

% Change

Q3 2024

Q3 2023

% Change



$m 

$m  

Actual 

CER 

$m 

$m 

Actual 

CER 

Reported Profit before tax 


7,025 

6,002 

17 

28 

1,828 

1,652 

11 

24 

Net finance expense 


919 

945 

(3)

(7)

274 

291 

(6)

(15)

Joint ventures and associates 


23 

12 

n/m

97 

11 

(53)

(54)

Depreciation, amortisation and impairment 


4,351 

4,060 

1,817 

1,282 

41 

41 

EBITDA 


12,318 

11,019 

12 

17 

3,923 

3,236 

21 

27 

 

Table 11: Reconciliation of Reported to Core financial measures: 9M 2024[8]

 

9M 2024


Reported

Restructuring

Intangible Asset Amortisation & Impairments

Other

Core

Core

% Change



$m 

$m 

$m 

$m 

$m 

Actual 

CER 

Gross profit

 

31,700 

655 

24 

32,383 

15

19

Product Sales Gross Margin

 

80% 

 

 

 

82% 

-

-

Distribution expense


(412)

(412)

4

7

R&D expense


(8,906)

221 

38 

(8,638)

17

18

% of Total Revenue


23% 




22% 

-

-

SG&A expense


(14,567)

180 

3,343 

291 

(10,753)

11

13

% of Total Revenue


37% 




27% 

+1pp

+1pp

Total operating expense


(23,885)

401 

3,381 

300 

(19,803)

13

15

Other operating income & expense


152 

(2)

(1)

149 

(87)

(87)

Operating profit

 

7,967 

1,054 

3,405 

303 

12,729 

8

13

Operating Margin

 

20% 

 

 

 

32% 

-2pp

-2pp

Net finance expense


(919)

60 

(859)

18

13

Taxation


(1,484)

(189)

(621)

(67)

(2,361)

15

22

EPS

 

$3.57 

$0.56 

$1.80 

$0.19 

$6.12 

5

11

 

Table 12: Reconciliation of Reported to Core financial measures: Q3 20247

Q3 2024


Reported

Restructuring

Intangible Asset Amortisation & Impairments

Other

Core

Core

% Change



$m 

$m 

$m 

$m 

$m 

Actual 

CER 

Gross profit

 

10,484 

619 

11,112 

18 

21 

Product Sales Gross Margin

 

76% 

 

 

 

81% 

Distribution expense


(145)

(145)

12 

15 

R&D expense


(3,115)

44 

(3,068)

23 

24 

% of Total Revenue


23




23

-1pp 

-1pp 

SG&A expense


(5,143)

42 

1,460 

36 

(3,605)

% of Total Revenue


38




27

+3pp 

+3pp 

Total operating expense


(8,403)

86 

1,461 

38 

(6,818)

14 

16 

Other operating income & expense


25 

(1)

24 

(65)

(61)

Operating profit

 

2,106 

705 

1,469 

38 

4,318 

22 

27 

Operating Margin

 

16

 

 

 

32

+1pp 

+2pp 

Net finance expense


(274)

(55)

(329)

46 

35 

Taxation


(395)

(109)

(254)

(753)

21 

28 

EPS

 

$0.92 

$0.38 

$0.78 

$2.08 

20 

27 

 

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 9M 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           

 

‒    The reported Product Sales Gross Margin included inventory and related contract provisions of $638m recorded in the third quarter related to Andexxa, which was part of the PAAGR restructuring program (see Note 2 in the Notes to the interim financial statements section)

 

‒    Variations in Product Sales Gross Margin performance between periods can continue to be expected due to product seasonality, foreign exchange fluctuations, and other effects

 

R&D expense

 

‒    The change in R&D expense (Reported and Core) in the period was impacted by:

 

‒    Positive data read-outs for 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, Fusion and Amolyt

 

‒    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

 

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

 

Other operating income and expense

 

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

 

Net finance expense

 

‒    Core Net finance expense increased 18% (13% increase at CER) due to the increased level of debt and new debt issued at higher interest rates

 

Taxation

 

‒    The effective Reported Tax rate for the nine months to 30 September 2024 was 21% (9M 2023: 17%) and the effective Core Tax rate was 20% (9M 2023: 19%)

 

‒    The cash tax paid for the nine months to 30 September 2024 was $1,978m (9M 2023: $1,710m), representing 28% of Reported Profit before tax (9M 2023: 26%)

 

Table 13: Cash Flow summary

 



9M 2024 

9M 2023 

Change 



$m 

$m 

$m 

Reported Operating profit


7,967 

6,959 

1,008 

Depreciation, amortisation and impairment


4,351 

4,060 

291 

Movement in working capital and short-term provisions


(543)

150 

(693)

Gains on disposal of intangible assets


(34)

(247)

213 

Fair value movements on contingent consideration arising from

business combinations


251 

202 

49 

Non-cash and other movements


15 

(623)

638 

Interest paid


(1,075)

(826)

(249)

Taxation paid


(1,978)

(1,710)

(268)

Net cash inflow from operating activities


8,954 

7,965 

989 

Net cash inflow before financing activities


2,155 

4,978 

(2,823)

Net cash inflow/(outflow) from financing activities


(3,325)

(6,276)

2,951 

 

The change in Net cash inflow before financing activities of $2,823m is primarily driven by Acquisitions of subsidiaries, net of cash acquired of $2,771m, and relates to the acquisition of Gracell Biotechnologies, Inc. for $774m and acquisition of Fusion Pharmaceuticals Inc., for $1,997m as compared to the acquisition of Neogene Therapeutics, Inc. for $189m in 9M 2023.

 

The decrease in Net cash outflow from financing activities of $2,951m is primarily driven by increased issuance of long-term loans of $6,492m in the period compared to $3,816m issued in the comparative period.

 

Capital expenditure

 

Capital expenditure amounted to $1,216m in 9M 2024 (9M 2023: $836m). The increase of capital expenditure in 2024 is driven by investment in several major manufacturing projects and continued investment in technology upgrades.

 

Table 14: Net debt summary

 


At 30 

 Sep 2024

At 31 

 Dec 2023

At 30 

Sep 2023


$m 

$m 

$m 

Cash and cash equivalents

4,797 

5,840 

4,871 

133 

122 

244 

4,930 

5,962 

5,115 

Overdrafts and short-term borrowings

(769)

(515)

(515)

Commercial paper

(472)

Lease liabilities

(1,422)

(1,128)

(979)

Current instalments of loans

(12)

(4,614)

(4,857)

(28,887)

(22,365)

(22,225)

(31,562)

(28,622)

(28,576)

Net derivatives

284 

150 

90 

(26,348)

(22,510)

(23,371)

 

 

Net debt increased by $3,838m in the nine months to 30 September 2024 to $26,348m. Details of the committed undrawn bank facilities are disclosed within the going concern section of Note 1. Details of the Company's solicited credit ratings and further details on Net debt are disclosed in Note 3.

 

Capital allocation

 

The 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. As announced at the Annual General Meeting on 11 April 2024, the total dividend for FY 2024 will increase by $0.20 per share to $3.10 per share.

 

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 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, 5% Notes due 2034, 3.121% EUR Notes due 2030 and 3.278% EUR Notes due 2033 (the "AstraZeneca Finance Notes"). Each series of AstraZeneca Finance Notes has been fully and unconditionally guaranteed by AstraZeneca PLC. AstraZeneca Finance is 100% owned by AstraZeneca PLC and each of the guarantees issued by AstraZeneca PLC is full and unconditional and joint and several.

 

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

 

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

 

Please refer to the Consolidated financial statements of AstraZeneca PLC in our Annual Report on Form 20‑F 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 30 July 2024, 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

 


 

9M 2024

9M 2023


 

$m 

$m 

Total Revenue


Gross profit


Operating loss


(2)

Loss for the period


(894)

(695)

Transactions with subsidiaries that are not issuers or guarantors


1,342 

9,758 

 

Table 16: Obligor group summarised Statement of financial position

 


 

At 30 Sep 2024 

At 30 Sep 2023 


 

$m 

$m 

Current assets


10 

Non-current assets


84 

Current liabilities


(801)

(4,760)

Non-current liabilities


(28,906)

(22,077)

Amounts due from subsidiaries that are not issuers or guarantors


16,705 

12,921 

Amounts due to subsidiaries that are not issuers or guarantors


(295)

 

Foreign exchange

 

The Company's transactional currency exposures on working capital balances, which typically extend for up to three months, are hedged where practicable using forward foreign exchange contracts against the individual companies' reporting currency. Foreign exchange gains and losses on forward contracts transacted for transactional hedging are taken to profit or to Other comprehensive income if the contract is in a designated cashflow hedge. In addition, the Company's external dividend payments, paid principally in pound sterling and Swedish krona, are fully hedged from announcement to payment date.

 

Table 17: Currency sensitivities

 

The Company provides the following information on currency-sensitivity:

 


 

 


Average

rates vs. USD

 

Annual impact ($m) of 5% strengthening (FY 2024 average rate vs. FY 2023 average) [9]

Currency

Primary Relevance

 

FY    
2023
[10]

YTD   
2024
[11]

Change

 (%)

Sep  
 2024[12]

Change

 (%)

 

Total Revenue

Core Operating Profit

EUR

Total Revenue


0.92 

0.92 

0 

0.90 

3 


397

179 

CNY

Total Revenue


7.09 

7.21 

(2)

7.08 

0 


322

182 

JPY

Total Revenue


140.60 

151.23 

(7)

143.04 

(2)


177

119 

Other[13]









453

227 

GBP

Operating expense


0.80 

0.78 

3 

0.76 

6 


60

(126)

SEK

Operating expense


10.61 

10.50 

1 

10.23 

4 


9

(63)

 

Sustainability

 

In September, AstraZeneca had a significant presence at Climate Week NYC and the 79th Session of the UN General Assembly in New York, with a delegation led by Pam Cheng, Executive Vice President of Global Operations and IT and Chief Sustainability Officer and the company's US leadership. A programme of more than 50 engagements with governments, media, NGOs and the private sector focused on the interconnected issues of the climate crisis, health equity and health system resilience and the Company's commitment to contribute to more sustainable, resilient and equitable health systems.

 

Related communications included an opinion piece published by the World Economic Forum (WEF) on how pharmaceutical companies are investing in nature to improve human and planetary health and an article in Foreign Policy on building sustainable health systems to manage the burden of non-communicable diseases.

 

Access to healthcare

 

‒    By end of August 2024, the Company's flagship Healthy Heart Africa programme had conducted more than 61 million blood pressure screenings, identifying over 12.1 million people with elevated blood pressure and diagnosing over 4.87 million with high blood pressure   

 

‒    In October, the Company convened the inaugural meeting of its Global Health Equity Advisory Board (HEAB), a group of 15 external stakeholders with representation from 11 countries and across disease areas, to advise on the Company's approach to help improve equitable health outcomes globally

 

‒    AstraZeneca Chair Michel Demaré and Executive Vice President, Vaccines and Immune Therapies, Iskra Reic shared perspectives on health systems resilience in Health: A Political Choice - Building Resilience and Trust, a publication launched during the World Health Summit in collaboration with the World Health Organization

 

‒    During the quarter, the Partnership for Health System Sustainability and Resilience (PHSSR) initiative convened an Expert Advisory Group on the role of EU institutions in supporting sustainable healthcare financing of Member States. The PHSSR was also active in a session at the European Health Forum Gastein in collaboration with AstraZeneca, on the importance of decarbonising care pathways for the health of people and the planet. The session emphasised the need for early, targeted and patient-centred interventions within integrated EU and national public policy strategies

 

‒    In September, through the Young Health Programme (YHP), 24 young health leaders from around the world received a Fellowship to attend the One Young World Summit in Montréal, Canada to support their focus on building a healthier and more equitable future. Additionally, in August, the YHP awarded scholarships to seven young global leaders who are tackling the health impacts of the climate crisis to join a Climate Entrepreneurship Academy in New York.  During the quarter, YHP won Corporate Social Responsibility Programme of the Year at the Pharma Industry UK Awards

 

Environmental protection

 

‒    The Company reached a key sustainability milestone in its Ambition Zero Carbon decarbonisation strategy, with over 50% of its global vehicle fleet now fully electric, including in Europe, Japan and the US. AstraZeneca currently has over 10,000 battery electric vehicles (BEVs), with fully electric fleets in the Netherlands, Greece and Georgia

 

‒    AstraZeneca's manufacturing site in Södertälje, Sweden - the Company's largest manufacturing site globally - has reduced its Scope 1 and 2 greenhouse (GHG) gas emissions by 98% since 2015, making it the Company's sixth site to have achieved this goal ahead of schedule. With this milestone, all locations in Sweden, including the strategic R&D Centre in Gothenburg, have now achieved their Scope 1 and 2 Ambition Zero Carbon Targets

 

‒    Through the Sustainable Markets Initiative Health Systems Task Force, chaired by CEO Pascal Soriot, the Company contributed to the launch of the European Network on Climate and Health Education which took place at the World Health Summit in Berlin. The network brings together 25 leading universities from across Europe which are committed to training 10,000 medical students with skills to address the health impacts of climate change and deliver sustainable healthcare

 

‒    The Company received the Net Zero: Operations Transformation award at the 2024 Reuters Sustainability Awards in October, recognising its commitment to drive deep decarbonisation across its operations and fleet through the Ambition Zero Carbon strategy. The WEF also recognised two of the Company's advanced manufacturing sites in Wuxi (China) and Södertälje (Sweden) as Fourth Industrial Revolution (4IR) Lighthouses, part of its Global Lighthouse Network which spotlights organisations harnessing advanced technologies such as digital and AI to drive next-generation operational excellence, environmental sustainability and workforce development

 

‒    In August, the Company was recognised with awards by My Green Lab and the International Institute for Sustainable Laboratories - the 2024 Freezer Challenge Winning Streak Award for Biotech & Pharmaceuticals, for being at the top of the sector and surpassing 2023 energy savings, and the Top Small Lab Award - Pharmaceutical and Biotech Sector - awarded to AZ Gothenburg Regional HBS Centre

 

‒    The Company completed studies to support the first regulatory filings for the transition of Breztri/Trixeo Aerosphere to an innovative, next-generation propellant with 99.9% lower Global Warming Potential than propellants used in currently available inhaled medicines. Reducing the carbon impact of pressurised-metered dose inhalers is a key product-related element of AstraZeneca's Ambition Zero Carbon strategy, alongside the Company's commitment to improving patient outcomes

 

Ethics and transparency

 

‒    In September, AstraZeneca was included in the TIME World's Best Companies 2024, ranking first among pharmaceutical companies for sustainability transparency and in the top 70 out of 1,000 overall

 

‒    In Mexico, AstraZeneca was third in the Great Place to Work (GPTW) ranking and the Company's Guadalajara Global Innovation & Technology Centre was number one in the GPTW Western Region for companies with >500-5,000 employees for the fourth year in a row

 

‒    AstraZeneca and 33 other partner organisations announced the launch of the VICT3R project, a public-private partnership that aims to reduce the number of animals used in experimental studies through Virtual Control Groups (VCGs) created using cutting edge statistical and artificial intelligence (AI) techniques. The project aims to transform drug and chemical safety evaluation while promoting ethical research practices and environmental sustainability

 

Research and development

 

This section covers R&D events and milestones that have occurred since the prior results announcement on 25 July 2024, up to and including events on 11 November 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 IASLC 2024 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer and the 2024 European Society for Medical Oncology (ESMO) Congress. Across the two meetings, more than 130 abstracts were presented featuring 17 approved and potential new medicines including five Presidential Symposia and 41 oral presentations.

 

Tagrisso

 

Event



Commentary

Approval

US


For the treatment of adult patients with unresectable, Stage III EGFRm NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy. (LAURA, September 2024)

Phase II registrational trial readout

SAVANNAH


Tagrisso plus Orpathys demonstrated a high, clinically meaningful and durable objective response rate for patients with EGFRm NSCLC with high levels of mesenchymal epithelial transition factor (MET) overexpression and/or amplification, defined as IHC90+ and/or FISH10+, whose disease progressed on treatment with Tagrisso. (October 2024)

 

Imfinzi and Imjudo

 

Event



Commentary

Approval

Europe

 

Imfinzi plus chemotherapy followed by Imfinzi alone has been approved for patients with mismatch repair deficient disease. (DUO-E, August 2024)

Approval

Europe

 

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

Priority Review

US

 

Imfinzi for limited-stage small cell lung cancer whose disease has not progressed following platinum-based concurrent chemoradiotherapy. (ADRIATIC, August 2024)

Approval

US

 

Imfinzi in combination with chemotherapy for the treatment of adult patients with resectable early-stage (IIA-IIIB) NSCLC and no known EGFR mutations or ALK rearrangements. (AEGEAN, August 2024)

Phase III presentation: ESMO

NIAGARA

 

In a planned interim analysis, patients treated with the Imfinzi perioperative regimen showed a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm (EFS HR 0.68; 95% CI 0.56-0.82, p<0.0001). Estimated median EFS was not yet reached for the Imfinzi arm versus 46.1 months for the comparator arm. In addition, Imfinzi perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy (OS HR 0.75; 95% CI 0.59-0.93, p=0.0106). (September 2024)

Phase III presentation: ESMO

HIMALAYA

 

At five years of follow-up, latest exploratory analysis of HIMALAYA showed that a single priming dose of Imjudo added to Imfinzi, called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab), reduced the risk of death by 24% compared to sorafenib (HR 0.76, 95% CI 0.65-0.89). An estimated 19.6% of patients treated with the STRIDE regimen were alive at five years versus 9.4% of those treated with sorafenib. (September 2024)

 

Lynparza

 

Event



Commentary

Approval

Europe


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

 

Enhertu

 

Event



Commentary

Approval

China

 

Conditional approval as monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more prior treatment regimens. (DESTINY-Gastric06, August 2024)

Phase IIIb/IV presentation: ESMO

DESTINY-Breast12

 

Enhertu demonstrated substantial overall and intracranial clinical activity in a large cohort of patients with HER2-positive metastatic breast cancer who have brain metastases and received no more than two prior lines of therapy in the metastatic setting with a 12-month PFS rate of 61.6%. (September 2024)

Priority Review

US

 

For the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting. (DESTINY-Breast06, October 2024)

Approval

China

 

Conditional approval as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic NSCLC whose tumours have activating HER2 mutations and who have received a prior systemic therapy. (DESTINY-Lung02, DESTINY-Lung05, October 2024)

 

Calquence

 

Event



Commentary

Phase III trial readout

AMPLIFY

 

 

Interim analysis of AMPLIFY Phase III trial showed a fixed duration of Calquence in combination with venetoclax, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in PFS compared to standard-of-care chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukaemia. (July 2024)

Priority Review

US

 

For the treatment of adult patients with previously untreated mantle cell lymphoma. (ECHO, October 2024)

 

Datopotamab deruxtecan (Dato-DXd)

 

Event



Commentary

Phase III presentation: WCLC

TROPION-Lung01

 

 

Exploratory analysis of the TROPION-Lung01 Phase III trial showed TROP2 as measured by AstraZeneca's proprietary computational pathology platform, quantitative continuous scoring, was predictive of clinical outcomes in patients with advanced or metastatic NSCLC who were treated with Dato-DXd. (September 2024)

Phase III presentation: WCLC

TROPION-Lung01

 

 

Demonstrated a clinically meaningful, but not statistically significant, trend toward improving OS with Dato-DXd compared to docetaxel in patients with locally advanced or metastatic non-squamous NSCLC treated with at least one prior line of therapy (14.6 versus 12.3 months; HR 0.84; 95% CI 0.68-1.05). In the overall trial population, OS results numerically favoured Dato-DXd compared to docetaxel (12.9 versus 11.8 months) but did not reach statistical significance (HR 0.94, 95% CI 0.78-1.14, p=0.530). (September 2024)

Phase III trial readout

TROPION-Breast01

 

TROPION-Breast01 Phase III trial of Dato-DXd compared to investigator's choice of chemotherapy, which previously met the dual primary endpoint of PFS, did not achieve statistical significance in the final OS analysis in patients with inoperable or metastatic hormone receptor-positive, HER2-low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer previously treated with endocrine-based therapy and at least one systemic therapy. (September 2024)

Regulatory update

US

 

Submission of a new Biologics License Application for accelerated approval for Dato-DXd for the treatment of adult patients with locally advanced or metastatic EGFRm NSCLC who have received prior systemic therapies, including an EGFR-directed therapy. Voluntarily withdrawal of the Biologics License Application for Dato-DXd for patients with advanced or metastatic non-squamous NSCLC based on the TROPION-Lung01 Phase III trial. An additional trial in biomarker-positive patients in the 2nd line non-squamous NSCLC setting is also planned. (TROPION-Lung05, TROPION-PanTumor01, TROPION-Lung01, November 2024)

 

Zoladex

 

Event



Commentary

Approval

China

 

 

Zoladex 10.8mg for breast cancer in pre- and perimenopausal women suitable for hormonal manipulation. (Study 11, October 2024)

 

BioPharmaceuticals - CVRM

 

Wainua

 

Event



Commentary

CHMP positive opinion

EU

 


For the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy, commonly referred to as hATTR-PN or ATTRv-PN. (NEURO-TTRansform, October 2024)

 

BioPharmaceuticals - R&I

 

Airsupra

 

Event



Commentary

Phase III trial readout

BATURA

 


Interim analysis of the Phase IIIb BATURA trial showed Airsupra met the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of a severe exacerbation when used as an as-needed rescue medication in response to symptoms compared to as-needed albuterol. (October 2024)

 

Breztri

 

Event



Commentary

Clinical program completion

NGP

 


Completion of the clinical programme to support the transition of Breztri to next-generation propellant with near-zero Global Warming Potential. (September 2024) A Marketing Authorisation Application for Breztri with the next-generation propellant has been accepted by the European Medicines Agency (November 2024). Additional submissions in the UK and China expected before the end of 2024. (November 2024)

 

Fasenra

 

Event



Commentary

Approval

US


For the treatment of adult patients with eosinophilic granulomatosis with polyangiitis. (MANDARA, September 2024)

CHMP positive opinion

EU


As an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis. (MANDARA, September 2024)

Approval

China


For maintenance treatment of patients 12 years of age and older with severe eosinophilic asthma. (MIRACLE, August 2024)

Phase III trial update

ORCHID

 


The Phase III ORCHID trial assessing Fasenra in chronic rhinosinusitis with nasal polyps and asthma did not meet the primary endpoints of improvement in the size of nasal polyps and in nasal blockage. The safety and tolerability profile for Fasenra in the trial was consistent with the known profile of the treatment. Results from ORCHID will be shared with the scientific community in the future. (November 2024)

 

Tezspire

 

Event



Commentary

Phase III trial readout

WAYPOINT

 


Tezspire met both co-primary endpoints, demonstrating a statistically significant and clinically meaningful reduction in nasal polyp size and improved nasal congestion compared to placebo. (November 2024)

 

BioPharmaceuticals - V&I

 

FluMist

 

Event



Commentary

Approval

US


For self-administration by adults up to 49 years of age or as administered by a parent/caregiver to individuals 2-17 years of age. FluMist is the only influenza vaccine approved for self-administration in the US. (September 2024)

 

Rare Disease

 

Alexion, AstraZeneca Rare Disease, presented data from its leading gMG portfolio at the American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting and the Myasthenia Gravis Foundation of America Scientific Session in October 2024.

 

The company presented 11 abstracts, spanning clinical and real-world data, which add to the extensive body of evidence supporting the safety and efficacy of Ultomiris and Soliris in treating anti-acetylcholine receptor antibody-positive gMG, and offer new insights to inform clinical practice.

 

Koselugo

 

Event



Commentary

Phase III trial readout

KOMET


Positive high-level results of the Phase III KOMET trial in adults with NF1-PN showed that Koselugo met its primary endpoint demonstrating a statistically significant and clinically meaningful ORR versus placebo in these adult patients. (November 2024)

 

Interim financial statements

 

Table 18: Condensed consolidated statement of comprehensive income: 9M 2024

 

For the nine months ended 30 September

 

2024 

2023 

 

 

$m 

$m 

Total Revenue

 

39,182 

33,787 

Product Sales

 

37,576 

32,466 

Alliance Revenue

 

1,498 

1,004 

Collaboration Revenue

 

108 

317 

Cost of sales


(7,482)

(5,960)

Gross profit

 

31,700 

27,827 

Distribution expense


(412)

(394)

Research and development expense


(8,906)

(7,862)

Selling, general and administrative expense


(14,567)

(13,845)

Other operating income and expense


152 

1,233 

Operating profit

 

7,967 

6,959 

Finance income


394 

236 

Finance expense


(1,313)

(1,181)

Share of after tax losses in associates and joint ventures


(23)

(12)

Profit before tax

 

7,025 

6,002 

Taxation


(1,484)

(1,000)

Profit for the period

 

5,541 

5,002 

Other comprehensive income:

 

 

 

Items that will not be reclassified to profit or loss:

 

 

 

Remeasurement of the defined benefit pension liability


136 

(1)

Net gains on equity investments measured at fair value through other comprehensive income


264 

45 

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


12 

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


(50)

 

 

362 

49 

Items that may be reclassified subsequently to profit or loss:




Foreign exchange arising on consolidation


543 

(201)

Foreign exchange arising on designated liabilities in net investment hedges


(84)

(63)

Fair value movements on cash flow hedges


(42)

62 

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


28 

Fair value movements on derivatives designated in net investment hedges


13 

47 

Gains/(costs) of hedging


(3)

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


16 

(7)



449 

(137)

Other comprehensive income/(expense), net of tax

 

811 

(88)

Total comprehensive income for the period

 

6,352 

4,914 

Profit attributable to:




Owners of the Parent


5,535 

4,995 

Non-controlling interests




5,541 

5,002 

Total comprehensive income attributable to:




Owners of the Parent


6,346 

4,907 

Non-controlling interests




6,352 

4,914 

Basic earnings per $0.25 Ordinary Share


$3.57 

$3.22 

Diluted earnings per $0.25 Ordinary Share


$3.54 

$3.20 

Weighted average number of Ordinary Shares in issue (millions)


1,550 

1,549 

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


1,562 

1,560 

 

Table 19: Condensed consolidated statement of comprehensive income: Q3 2024

 

For the quarter ended 30 September

 

 

 


 

2024 

2023 

 

 

$m 

$m 

Total Revenue

 

13,565 

11,492 

Product Sales

 

12,947 

11,018 

Alliance Revenue

 

559 

377 

Collaboration Revenue

 

59 

97 

Cost of sales


(3,081)

(2,095)

Gross profit

 

10,484 

9,397 

Distribution expense


(145)

(129)

Research and development expense


(3,115)

(2,584)

Selling, general and administrative expense


(5,143)

(4,800)

Other operating income and expense


25 

70 

Operating profit

 

2,106 

1,954 

Finance income


183 

101 

Finance expense


(457)

(392)

Share of after tax losses in associates and joint ventures


(4)

(11)

Profit before tax

 

1,828 

1,652 

Taxation


(395)

(274)

Profit for the period

 

1,433 

1,378 

Other comprehensive income:

 

 

 

Items that will not be reclassified to profit or loss:

 

 

 

Remeasurement of the defined benefit pension liability


35 

(8)

Net gains on equity investments measured at fair value through other comprehensive income


175 

93 

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


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


(23)

 

 

187 

91 

Items that may be reclassified subsequently to profit or loss:




Foreign exchange arising on consolidation


1,097 

(306)

Foreign exchange arising on designated liabilities in net investment hedges


12 

38 

Fair value movements on cash flow hedges


96 

(27)

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


(101)

99 

Fair value movements on derivatives designated in net investment hedges


(32)

Costs of hedging


(12)

(2)

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


(22)

(19)



1,038 

(210)

Other comprehensive income/(expense), net of tax

 

1,225 

(119)

Total comprehensive income for the period

 

2,658 

1,259 

Profit attributable to:




Owners of the Parent


1,429 

1,374 

Non-controlling interests




1,433 

1,378 

Total comprehensive income attributable to:




Owners of the Parent


2,654 

1,255 

Non-controlling interests




2,658 

1,259 

Basic earnings per $0.25 Ordinary Share


$0.92  

$0.89 

Diluted earnings per $0.25 Ordinary Share


$0.91  

$0.88 

Weighted average number of Ordinary Shares in issue (millions)


1,550  

1,549 

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


1,562  

1,560 

 

Table 20: Condensed consolidated statement of financial position

 


 

At 30 Sep

2024

At 31 Dec

2023

At 30 Sep

2023


 

$m 

$m 

$m 

Assets

Non-current assets





Property, plant and equipment


10,135 

9,402 

8,723

Right-of-use assets


1,378 

1,100 

977

Goodwill


21,139 

20,048 

19,939

Intangible assets


39,394 

38,089 

37,687

Investments in associates and joint ventures


290 

147 

62

Other investments


1,855 

1,530 

1,228

Derivative financial instruments


319 

228 

151

Other receivables


915 

803 

761

Deferred tax assets


5,342 

4,718 

4,057


 

80,767 

76,065 

73,585

Current assets





Inventories


5,662 

5,424 

5,292

Trade and other receivables


11,879 

12,126 

11,300

Other investments


133 

122 

244

Derivative financial instruments


16 

116 

97

Income tax receivable


1,668 

1,426 

697

Cash and cash equivalents


4,797 

5,840 

4,871


 

24,155 

25,054 

22,501

Total assets

 

104,922 

101,119 

96,086

Liabilities

Current liabilities

 

 

 

 

Interest-bearing loans and borrowings


(1,253)

(5,129)

(5,372)

Lease liabilities


(317)

(271)

(235)

Trade and other payables


(21,684)

(22,374)

(20,542)

Derivative financial instruments


(17)

(156)

(83)

Provisions


(1,187)

(1,028)

(1,193)

Income tax payable


(1,468)

(1,584)

(1,163)


 

(25,926)

(30,542)

(28,588)

Non-current liabilities





Interest-bearing loans and borrowings


(28,887)

(22,365)

(22,225)

Lease liabilities


(1,105)

(857)

(744)

Derivative financial instruments


(34)

(38)

(75)

Deferred tax liabilities


(3,568)

(2,844)

(2,752)

Retirement benefit obligations


(1,361)

(1,520)

(1,048)

Provisions


(1,063)

(1,127)

(1,189)

Income tax payable


(174)

-

Other payables


(1,999)

(2,660)

(2,244)



(38,191)

(31,411)

(30,277)

Total liabilities

 

(64,117)

(61,953)

(58,865)

Net assets

 

40,805 

39,166 

37,221 

Equity

Capital and reserves attributable to equity holders of the Parent

 



Share capital


388 

388 

387

Share premium account


35,203 

35,188 

35,166

Other reserves


1,990 

2,065 

2,078

Retained earnings


3,138 

1,502 

(434)


 

40,719 

39,143 

37,197 

Non-controlling interests


86 

23 

24 

Total equity

 

40,805 

39,166 

37,221 

 

Table 21: Condensed consolidated statement of changes in equity

 



Share capital

Share premium account

Other reserves

Retained earnings

Total attributable to owners of the parent

Non-controlling interests

Total equity


 

$m 

$m 

$m 

$m 

$m 

$m 

$m 

At 1 Jan 2023

 

387 

35,155 

2,069 

(574)

37,037 

21 

37,058 

Profit for the period


-

-

-

4,995

4,995

7

5,002

Other comprehensive expense 


-

-

-

(88)

(88)

-

(88)

Transfer to other reserves


-

-

9

(9)

-

-

-

Transactions with owners









Dividends


-

-

-

(4,487)

(4,487)

-

(4,487)

Dividends paid to non-controlling interests


-

-

-

-

-

(4)

(4)

Issue of Ordinary Shares


-

11

-

-

11

-

11

Share-based payments charge for the period


-

-

-

429

429

-

429

Settlement of share plan awards


-

-

-

(700)

(700)

-

(700)

Net movement

 

-

11

9

140

160

3

163

At 30 Sep 2023

 

387

35,166

2,078

(434)

37,197

24

37,221

 

 

 

 

 

 

 

 

 

At 1 Jan 2024

 

388

35,188

2,065

1,502

39,143

23

39,166

Profit for the period


-

-

-

5,535

5,535

6

5,541

Other comprehensive income 


-

-

-

811

811

-

811

Transfer to other reserves


-

-

1

(1)

-

-

-

Transactions with owners









Dividends


-

-

-

(4,602)

(4,602)

-

(4,602)

Dividends paid to non-controlling interests


-

-

-

-

-

(4)

(4)

Issue of Ordinary Shares


-

15

-

-

15

-

15

Changes in non-controlling interests


-

-

-

-

-

61

61

Movement in shares held by Employee Benefit Trust


-

-

(76)

-

(76)

-

(76)

Share-based payments charge for the period


-

-

-

487

487

-

487

Settlement of share plan awards


-

-

-

(594)

(594)

-

(594)

Net movement


-

15

(75)

1,636

1,576

63

1,639

At 30 Sep 2024

 

388

35,203

1,990

3,138

40,719

86

40,805

 

Table 22: Condensed consolidated statement of cash flows: 9M 2024

 

For the nine months ended 30 September


2024 

2023 


$m 

$m 

 

Cash flows from operating activities




Profit before tax


7,025 

6,002 

Finance income and expense


919 

945 

Share of after tax losses of associates and joint ventures


23 

12 

Depreciation, amortisation and impairment


4,351 

4,060 

Movement in working capital and short-term provisions


(543)

150 

Gains on disposal of intangible assets


(34)

(247)

Fair value movements on contingent consideration arising from business combinations


251 

202 

Non-cash and other movements


15 

(623)

Cash generated from operations

 

12,007 

10,501 

Interest paid


(1,075)

(826)

Tax paid


(1,978)

(1,710)

Net cash inflow from operating activities

 

8,954 

7,965 

 

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


(84)

Payment of contingent consideration from business combinations


(737)

(610)

Purchase of property, plant and equipment


(1,216)

(836)

Disposal of property, plant and equipment


53 

131 

Purchase of intangible assets


(2,415)

(1,996)

Disposal of intangible assets


107 

288 

Movement in profit-participation liability


190 

Purchase of non-current asset investments


(96)

(109)

Disposal of non-current asset investments


73 

32 

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


67 

(12)

Payments to associates and joint ventures


(158)

Disposal of investments in associates and joint ventures


13 

Interest received


281 

208 

Net cash (outflow) from investing activities


(6,799)

(2,987)

Net cash inflow before financing activities

 

2,155 

4,978 

 

Cash flows from financing activities




Proceeds from issue of share capital


15 

12 

Own shares purchased by Employee Benefit Trust


(81)

Issue of loans and borrowings


6,492 

3,816 

Repayment of loans and borrowings


(4,647)

(4,655)

Dividends paid


(4,626)

(4,479)

Hedge contracts relating to dividend payments


16 

(19)

Repayment of obligations under leases


(233)

(194)

Movement in short-term borrowings


572 

110 

Payment of Acerta Pharma share purchase liability


(833)

(867)

Net cash (outflow) from financing activities

 

(3,325)

(6,276)

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


(1,170)

(1,298)

Cash and cash equivalents at the beginning of the period


5,637 

5,983 

Exchange rate effects


(32)

(66)

Cash and cash equivalents at the end of the period

 

4,435 

4,619 

Cash and cash equivalents consist of:




Cash and cash equivalents


4,797 

4,871 

Overdrafts


(362)

(252)

 

 

4,435 

4,619 

 

Notes to the Interim financial statements

 

Note 1: Basis of preparation and accounting policies

 

These unaudited condensed consolidated Interim financial statements for the nine months ended 30 September 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 nine months ended 30 September 2024 were approved by the Board of Directors for publication on 12 November 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 September 2024, the Group has $11.7bn in financial resources (cash and cash equivalent balances of $4.8bn and undrawn committed bank facilities of $6.9bn, with $1.6bn of borrowings due within one year). These facilities contain no financial covenants and were undrawn at 30 September 2024. There are $4.9bn of undrawn committed bank 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 10 June 2024, AstraZeneca obtained control and commenced consolidation of the EBT. Accordingly, cash paid on purchases of AstraZeneca Ordinary shares or American Depositary Receipts is 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. Following a strategic review of our portfolio priorities, the business decision was made to cease promotional activity for Andexxa resulting in impairment charges of $504m recorded against the Andexxa intangible asset under value in use model applying a discount rate of 7.5% (revised carrying amount: $nil), total net impairment charges of $525m have been recorded against intangible assets during the nine months ended 30 September 2024 (9M 2023: $376m net charge). In 9M 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 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.

 

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

 

Note 3: Net debt

 

The table below provides an analysis of Net debt and a reconciliation of Net Cash flow to the movement in Net debt. The Group monitors Net debt as part of its capital management policy as described in Note 28 of the Annual Report and Form 20-F Information 2023. Net debt is a non-GAAP financial measure.

 

Table 23: Net debt

 


 

At 1 Jan 2024

Cash flow

Acquisitions

Non-cash
& other

Exchange movements

At 30 Sep 2024


 

$m

$m

$m

$m

$m

$m

Non-current instalments of loans


(22,365)

(6,499)

(3)

69

(89)

(28,887)

Non-current instalments of leases


(857)

1

(12)

(233)

(4)

(1,105)

Total long-term debt

 

(23,222)

(6,498)

(15)

(164)

(93)

(29,992)

Current instalments of loans


(4,614)

4,586 

(9)

(3)

28 

(12)

Current instalments of leases


(271)

271 

(6)

(311)

(317)

Commercial paper


(472)

(472)

Collateral received from derivative counterparties


 

(215)

(72)

(287)

Other short-term borrowings excluding overdrafts


 

(97)

(28)

(1)

(120)

Overdrafts


(203)

(158)

(2)

(362)

Total current debt

 

(5,400)

4,127 

(15)

(314)

32 

(1,570)

Gross borrowings

 

(28,622)

(2,371)

(30)

(478)

(61)

(31,562)

Net derivative financial instruments


150 

41 

93 

284 

Net borrowings

 

(28,472)

(2,330)

(30)

(385)

(61)

(31,278)

Cash and cash equivalents


5,840 

(1,254)

242 

(1)

(30)

4,797 

Other investments - current


122 

(67)

87 

(9)

133 

Cash and investments

 

5,962 

(1,321)

329 

(1)

(39)

4,930 

Net debt

 

(22,510)

(3,651)

299 

(386)

(100)

(26,348)

 

Net debt increased by $3,838m in the nine months to $26,348m. Details of the committed undrawn bank facilities are disclosed within the going concern section of Note 1. Non-cash movements in the period include fair value adjustments under IFRS 9 'Financial Instruments'.

 

In February 2024, AstraZeneca issued the following:

 

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

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

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

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

 

In August 2024, AstraZeneca issued the following:

 

-     €650m of fixed-rate notes with a coupon of 3.121% maturing in August 2030

-     €750m of fixed-rate notes with a coupon of 3.278% maturing in August 2033

 

AstraZeneca repaid two bonds of carrying value $2,569m and floating rate bank loans of $2,000m during the nine months which are included in the cash outflow from Repayment of loans and borrowings of $4,647m.

 

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 September 2024 was $287m (31 December 2023: $215m) and the carrying value of such cash collateral posted by the Group at 30 September 2024 was $68m (31 December 2023: $102m).

 

The equivalent GAAP measure to Net debt is 'liabilities arising from financing activities', which excludes the amounts for cash and overdrafts, other investments and non-financing derivatives shown above and includes the Acerta Pharma share purchase liability of $nil (31 December 2023: $833m).

 

During the quarter ended 30 September 2024, Standard and Poor's upgraded the Company's solicited long term credit rating to A+ from A. The short term rating remained at A-1. There were no changes to Moody's credit ratings (long term: A2; short term: P-1).

 

Note 4: Financial Instruments

 

As detailed in the Group's most recent annual financial statements, the principal financial instruments consist of derivative financial instruments, other investments, trade and other receivables, cash and cash equivalents, trade and other payables, lease liabilities and interest-bearing loans and borrowings.

 

The Group has certain equity investments that are categorised as Level 3 in the fair value hierarchy that are held at $370m (31 December 2023: $313m) and for which a fair value gain of $nil has been recognised in the nine months ended 30 September 2024 (9M 2023: $17m). In the absence of specific market data, these unlisted investments are held at fair value based on the cost of investment and adjusted as necessary for impairments and revaluations on new funding rounds, which are seen to approximate the fair value. All other fair value gains and/or losses that are presented in Net gains on equity investments measured at fair value through other comprehensive income, in the Condensed consolidated statement of comprehensive income for the nine months ended 30 September 2024, are Level 1 fair value measurements, valued based on quoted prices in active markets.

 

Financial instruments measured at fair value include $1,920m of other investments, $3,408m held in money-market funds and $284m of derivatives as at 30 September 2024. With the exception of derivatives being Level 2 fair valued, and certain equity instruments of $379m categorised as Level 3, the aforementioned balances are Level 1 fair valued. Financial instruments measured at amortised cost include $68m of cash collateral pledged to counterparties. The total fair value of interest-bearing loans and borrowings at 30 September 2024, which have a carrying value of $31,562m in the Condensed consolidated statement of financial position, was $31,396m.

 

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


(736)

(1)

(737)

(610)

Revaluations


220 

32 

252 

202 

Discount unwind


77 

85 

99 

At 30 September

 

1,506

429

1,935

1,973

 

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 $1,506m (31 December 2023: $1,945m) would increase/decrease by $151m with an increase/decrease in sales of 10%, as compared with the current estimates.

 

Note 5: Business combinations

 

Gracell

 

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

 

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

 

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

 

Fusion

 

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

 

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

 

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

 

Note 6: Legal proceedings and contingent liabilities

 

AstraZeneca is involved in various legal proceedings considered typical to its business, including litigation and investigations, including Government investigations, relating to product liability, commercial disputes, infringement of intellectual property (IP) rights, the validity of certain patents, anti-trust law and sales and marketing practices. The matters discussed below constitute the more significant developments since publication of the disclosures concerning legal proceedings in the Company's Annual Report and Form 20-F Information 2023 and the Interim Financial Statements for the six months ended 30 June 2024 (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 third quarter of 2024 and to 12 November 2024

 

Table 25: Patent litigation

 

Legal proceedings brought against AstraZeneca

Faslodex patent proceedings, Japan

 

Considered to be a contingent asset


*   In 2021 in Japan, AstraZeneca received notice from the Japan Patent Office (JPO) that Sandoz K.K. (Sandoz) and Sun Pharma Japan Ltd. (Sun) were seeking to invalidate the Faslodex formulation patent.

*   AstraZeneca defended the challenged patent and Sun withdrew from the JPO patent challenge. 

*   In July 2023, the JPO issued a final decision upholding various claims of the challenged patent and determining that other patent claims were invalid. 

*   In August 2023, Sandoz appealed the JPO decision to the Japan IP High Court (High Court).

*   In October 2024, the High Court affirmed the decision by the JPO.

Tagrisso patent proceedings, US

 

Considered to be a contingent liability


*   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 jury 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.

*   In proceedings following the jury award, the District Court rejected AstraZeneca's indefiniteness and equitable defences but granted judgment as a matter of law in favour of AstraZeneca on the grounds that the patents were invalid for lack of written description and enablement. Wyeth has filed an appeal.

Legal proceedings brought by AstraZeneca

Lokelma patent proceedings, US

 

Considered to be a contingent asset


*   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 would infringe patents that are owned or licensed by AstraZeneca.

*   AstraZeneca has entered into separate settlement agreements with four generic manufacturers which resulted in dismissal of the corresponding litigations.

*   Additional proceedings with the remaining generic manufacturer are ongoing in the District Court. Trial is scheduled for March 2025.

Soliris patent proceedings, Canada

 

Considered to be a contingent asset


*   In May 2023, Alexion initiated patent litigation in Canada alleging that Amgen Pharmaceuticals, Inc.'s (Amgen) biosimilar eculizumab product will infringe Alexion patents. 

*   In September 2023, Alexion initiated patent litigations in Canada alleging that Samsung Bioepis Co. Ltd.'s (Samsung) biosimilar eculizumab product will infringe Alexion patents. The filing of the litigation triggered an automatic 24-month stay of the approval of each defendant's biosimilar eculizumab product.

*   Trial against Amgen is scheduled to begin in January 2025 while trial against Samsung is scheduled to begin in June 2025.

*   In July and August 2023, in Canada, both Amgen and Samsung brought actions challenging the validity of Alexion's patent relating to the use of eculizumab in treating aHUS. Trial is scheduled to begin in November 2025.

Soliris patent proceedings, US

 

Matter concluded


*   In January 2024, Alexion initiated patent infringement litigation against Samsung Bioepis Co. Ltd. (Samsung) in the US District Court for the District of Delaware (District Court) alleging that Samsung's biosimilar eculizumab product, for which Samsung is currently seeking FDA approval, will infringe six Soliris-related patents.

*   Five of the six asserted patents were also the subject of inter partes review 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 District Court denied Alexion's motion and Alexion appealed that decision.

*   In August 2024, the parties reached resolution of the matter. All legal proceedings in the US courts have terminated, as have the inter partes review proceedings.

Tagrisso patent proceedings, Russia

 

Considered to be a contingent asset


*   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 was dismissed in July 2024. The lawsuit against Axelpharm was dismissed in September 2024, and AstraZeneca appealed.

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

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

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

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

 

Table 26: Commercial litigation

 

Legal proceedings brought against AstraZeneca

Amyndas Trade Secrets Litigation, US

 

Considered to be a contingent liability


*   AstraZeneca has been defending a matter filed by Amyndas Pharmaceuticals Member P.C. and Amyndas Pharmaceuticals, LLC, in the US District Court for the District of Massachusetts alleging trade secret misappropriation and breach of contract claims against Alexion and Zealand Pharma U.S. Inc. related to Amyndas' C3 inhibitor candidate. 

*   No trial date has been set.

Caelum Trade Secrets Litigation, US

 

Matter concluded


*   AstraZeneca has been defending a matter filed by the University of Tennessee Research Foundation in the US District Court for the Eastern District of Tennessee related to CAEL-101. 

*   In September 2024, the parties resolved the matter by settlement.

Seroquel XR Antitrust Litigation, US

 

Considered to be a contingent liability


*   In 2019, AstraZeneca was named in several related complaints now proceeding in US District Court in Delaware (District Court), including several putative class action lawsuits that were purportedly brought on behalf of classes of direct purchasers or end payors of Seroquel XR, that allege AstraZeneca and generic drug manufacturers violated US antitrust laws when settling patent litigation related to Seroquel XR.

*   In July 2022, the District Court dismissed claims relating to one of the generic manufacturers while allowing claims relating to the second generic manufacturer to proceed.

*   In September 2024, AstraZeneca reached a settlement agreement with one of the plaintiff classes and the parties are now seeking judicial review and approval of the settlement.

*   Trial with the remaining class of plaintiffs is currently scheduled for May 2025.

Syntimmune Milestone Litigation, US

 

Considered to be a contingent liability


*   In connection with Alexion's acquisition of Syntimmune, Inc. (Syntimmune) in December 2020, Alexion was served with a lawsuit filed by the stockholders' representative for Syntimmune in Delaware state court that alleged, among other things, breaches of the 2018 merger agreement.

*   The stockholders' representative alleges that Alexion failed to meet its obligations under the merger agreement to use commercially reasonable efforts to achieve the milestones. Alexion also filed a claim for breach of the representations in the 2018 merger agreement. 

*   A trial was held in July 2023.

*   The court issued a partial decision in September 2024, concluding that the first milestone was achieved, and that Alexion had breached its contractual obligation to use commercially reasonable efforts to achieve the milestones. The court has requested additional briefing regarding damages and further proceedings regarding Alexion's claim for breach. 

Viela Bio, Inc. Shareholder Litigation, US

 

Considered to be a contingent liability


*   In February 2023, AstraZeneca was served with a lawsuit filed in the 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.

*   In August 2024, plaintiffs appealed the dismissal.

 

Table 27: Government investigations and proceedings

 

Legal proceedings brought by AstraZeneca

340B State Litigation, US

 

Considered to be a contingent asset


*   AstraZeneca has filed lawsuits against Arkansas, Kansas, Louisiana, Maryland, Minnesota, Mississippi, Missouri, and West Virginia challenging the constitutionality of each state's 340B statute.

*   In the Arkansas matter, trial is scheduled for April 2025. An intervenor has moved to dismiss AstraZeneca's complaint.

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

*   In the Maryland matter, the Court has rejected AstraZeneca's preliminary injunction motion. The state's motion to dismiss remains pending.

*   In the Minnesota matter, the state has moved to dismiss AstraZeneca's complaint.

*   In the Mississippi matter, AstraZeneca has moved for a preliminary injunction.

*   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.

 

Note 7

Table 28: 9M 2024 - Product Sales year-on-year analysis[14]

 

 

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

14,934 

18 

21 

6,870 

22 

3,445 

18 

28 

3,000 

24 

23 

1,619 

(4)

Tagrisso

4,877 

11 

15 

1,996 

19 

1,365 

16 

956 

16 

16 

560 

(10)

(2)

Imfinzi

3,463 

18 

22 

1,883 

18 

365 

37 

61 

695 

30 

29 

520 

(3)

Calquence

2,321 

26 

27 

1,617 

21 

116 

68 

90 

489 

38 

38 

99 

23 

27 

Lynparza

2,228 

10 

954 

475 

16 

25 

612 

13 

12 

187 

(13)

(7)

Enhertu

397 

n/m

n/m

258 

n/m

n/m

92 

n/m

n/m

47 

n/m

n/m

Zoladex

817 

17 

24 

11 

(4)

622 

19 

28 

111 

14 

13 

73 

15 

Imjudo

208 

30 

32 

134 

25 

11 

n/m

n/m

26 

n/m

n/m

37 

(8)

Truqap

267 

n/m

n/m

260 

n/m

n/m

n/m

n/m

n/m

n/m

n/m

Orpathys

34 

34 

Others

322 

(18)

(12)

15 

197 

(18)

(13)

17 

(34)

(34)

93 

(15)

(7)

BioPharmaceuticals: CVRM

9,316 

18 

21 

2,221 

13 

4,146 

18 

24 

2,385 

31 

30 

564 

(3)

Farxiga

5,723 

31 

34 

1,278 

28 

2,225 

35 

41 

1,903 

40 

39 

317 

(9)

(1)

Brilinta

992 

543 

(1)

232 

11 

203 

(1)

14 

(21)

(18)

Crestor

892 

33 

(18)

726 

12 

32 

(22)

(22)

101 

Seloken/Toprol-XL

465 

(6)

(1)

84 

452 

(6)

(1)

10 

27 

27 

(47)

(45)

Lokelma

392 

31 

34 

181 

16 

68 

84 

90 

66 

61 

61 

77 

17 

30 

roxadustat

257 

23 

26 

257 

23 

26 

Andexxa

159 

24 

26 

61 

n/m

n/m

60 

38 

37 

35 

25 

39 

Wainua

44 

n/m

n/m

44 

n/m

Others

392 

(27)

(26)

81 

(52)

183 

(19)

(14)

111 

(16)

(15)

17 

11 

BioPharmaceuticals: R&I

5,431 

20 

23 

2,419 

27 

1,489 

13 

20 

1,026 

21 

20 

497 

14 

Symbicort

2,195 

19 

22 

887 

51 

653 

19 

415 

240 

(2)

Fasenra

1,218 

750 

68 

43 

52 

294 

12 

11 

106 

(1)

Pulmicort

517 

13 

(39)

427 

14 

51 

26 

(13)

(9)

Breztri

721 

51 

53 

367 

40 

199 

62 

68 

102 

86 

85 

53 

42 

51 

Tezspire

168 

n/m

n/m

n/m

n/m

105 

n/m

n/m

55 

n/m

n/m

Saphnelo

327 

71 

72 

294 

65 

n/m

n/m

17 

n/m

n/m

11 

66 

82 

Airsupra

41 

n/m

n/m

41 

n/m

Others

244 

(26)

(25)

67 

(48)

129 

(15)

(12)

42 

(13)

(11)

BioPharmaceuticals: V&I

680 

201 

n/m

168 

(7)

189 

(6)

(8)

122 

(48)

(44)

Synagis

346 

(10)

(4)

(1)

n/m

168 

15 

80 

(26)

(27)

99 

(15)

(7)

Beyfortus

188 

n/m

n/m

148 

n/m

n/m

n/m

39 

n/m

n/m

n/m

n/m

FluMist

109 

40 

37 

26 

61 

n/m

n/m

61 

22 

n/m

n/m

COVID-19 mAbs

31 

(75)

(75)

28 

n/m

n/m

n/m

(59)

(60)

n/m

n/m

Others

(79)

(80)

(99)

n/m

(43)

(45)

n/m

n/m

Rare Disease

6,391 

10 

14 

3,842 

11 

628 

29 

56 

1,189 

732 

18 

Ultomiris

2,835 

32 

35 

1,629 

29 

92 

97 

n/m

649 

31 

30 

465 

37 

50 

Soliris

2,045 

(16)

(11)

1,170 

(11)

365 

39 

346 

(35)

(35)

164 

(34)

(31)

Strensiq

996 

18 

19 

815 

18 

39 

34 

48 

73 

15 

14 

69 

18 

Koselugo

366 

49 

55 

156 

108 

n/m

n/m

74 

93 

93 

28 

81 

99 

Kanuma

149 

15 

16 

72 

15 

24 

(1)

47 

25 

25 

16 

Other medicines

824 

(9)

(4)

87 

(17)

564 

(3)

75 

12 

12 

98 

(38)

(33)

Nexium

670 

(9)

(2)

77 

(13)

458 

40 

12 

10 

95 

(37)

(33)

Others

154 

(12)

(10)

10 

(35)

106 

(13)

(10)

35 

13 

13 

(53)

(49)

Total Product Sales

37,576 

16 

19 

15,640 

19 

10,440 

16 

25 

7,864 

20 

20 

3,632 

(4)

 

 

Table 29: Q3 2024 - Product Sales year-on-year analysis[15]

 

 

World

US

Emerging Markets

Europe

Established RoW

 


$m

Act % chg

CER % chg

$m

% chg

$m

Act % chg

CER % chg

$m

Act % chg

CER % chg

$m

Act % chg

CER % chg

Oncology

5,197 

18 

21 

2,484 

25 

1,145 

18 

28 

1,032 

22 

22 

536 

(8)

(3)

Tagrisso

1,674 

14 

17 

714 

24 

446 

16 

328 

17 

17 

186 

(6)

(1)

Imfinzi

1,203 

13 

16 

680 

19 

120 

40 

66 

236 

16 

16 

167 

(19)

(15)

Calquence

813 

24 

25 

570 

22 

41 

47 

70 

169 

32 

32 

33 

11 

14 

Lynparza

778 

11 

13 

347 

155 

18 

24 

214 

21 

21 

62 

(12)

(8)

Enhertu

148 

n/m

n/m

97 

n/m

n/m

35 

n/m

n/m

16 

83 

86 

Zoladex

268 

12 

18 

(34)

207 

14 

21 

33 

10 

24 

16 

21 

Imjudo

72 

20 

22 

46 

15 

n/m

n/m

10 

99 

n/m

12 

(15)

(10)

Truqap

125 

n/m

n/m

119 

n/m

Orpathys

10 

(16)

(16)

10 

(16)

(16)

Others

106 

(10)

(5)

64 

(14)

(8)

(27)

(26)

33 

(1)

BioPharmaceuticals: CVRM

3,152 

17 

20 

739 

1,396 

20 

25 

826 

26 

26 

191 

14 

Farxiga

1,938 

25 

27 

411 

12 

750 

30 

35 

670 

32 

32 

107 

Brilinta

327 

(1)

(1)

189 

(2)

66 

67 

(1)

(1)

(11)

(16)

Crestor

304 

10 

14 

11 

(18)

252 

15 

18 

10 

31 

(6)

Seloken/Toprol-XL

150 

(2)

n/m

145 

(3)

n/m

98 

(58)

(58)

Lokelma

143 

40 

42 

66 

28 

26 

99 

n/m

25 

61 

61 

26 

18 

27 

roxadustat

93 

26 

25 

93 

26 

26 

Andexxa

54 

36 

38 

19 

(4)

n/m

n/m

20 

39 

39 

14 

n/m

n/m

Wainua

23 

n/m

n/m

23 

n/m

Others

120 

(22)

(20)

20 

(57)

63 

30 

(28)

(26)

50 

40 

BioPharmaceuticals: R&I

1,830 

26 

28 

852 

40 

457 

14 

346 

30 

30 

175 

13 

18 

Symbicort

705 

27 

31 

289 

86 

203 

13 

130 

83 

Fasenra

436 

12 

13 

271 

27 

41 

50 

102 

19 

19 

36 

Pulmicort

138 

(6)

(4)

110 

(8)

(5)

14 

10 

(11)

(8)

Breztri

266 

56 

57 

142 

45 

68 

62 

65 

37 

98 

98 

19 

61 

68 

Tezspire

68 

n/m

n/m

n/m

n/m

43 

n/m

n/m

22 

n/m

n/m

Saphnelo

124 

63 

64 

110 

55 

n/m

n/m

n/m

n/m

37 

67 

Airsupra

21 

n/m

n/m

21 

n/m

Others

72 

(21)

(21)

14 

(54)

43 

(8)

(8)

13 

(16)

(14)

BioPharmaceuticals: V&I

355 

59 

61 

145 

n/m

37 

18 

37 

108 

23 

20 

65 

18 

23 

Synagis

93 

(6)

n/m

37 

16 

36 

13 

(19)

(20)

43 

(15)

(9)

Beyfortus

134 

n/m

n/m

95 

n/m

39 

n/m

n/m

FluMist

100 

34 

31 

22 

43 

56 

(3)

22 

n/m

n/m

COVID-19 mAbs

28 

n/m

n/m

28 

n/m

n/m

n/m

Others

n/m

n/m

Rare Disease

2,148 

11 

1,325 

12 

174 

29 

395 

254 

14 

Ultomiris

1,031 

33 

35 

597 

34 

26 

53 

84 

238 

30 

30 

170 

30 

37 

Soliris

606 

(22)

(18)

362 

(14)

110 

(11)

14 

86 

(47)

(47)

48 

(36)

(33)

Strensiq

343 

20 

21 

286 

21 

52 

55 

25 

17 

17 

24 

15 

23 

Koselugo

119 

37 

39 

55 

25 

n/m

n/m

29 

90 

94 

10 

52 

62 

Kanuma

49 

10 

25 

11 

(27)

(29)

17 

27 

23 

Other medicines

265 

(11)

(7)

35 

(3)

179 

(6)

22 

18 

16 

29 

(45)

(41)

Nexium

212 

(13)

(9)

30 

140 

(9)

(2)

14 

31 

29 

28 

(45)

(41)

Others

53 

(1)

(28)

39 

(1)

(1)

(52)

(51)

Total Product Sales

12,947 

18 

20 

5,580 

23 

3,388 

15 

23 

2,729 

20 

20 

1,250 

 

 

Table 30: Alliance Revenue

 



9M 2024 

9M 2023 



$m 

$m 

Enhertu


1,045 

741 

Tezspire


303 

179 

Beyfortus


75 

16 

Other Alliance Revenue


75 

68 

Total


1,498 

1,004 

 

Table 31: Collaboration Revenue

 



9M 2024 

9M 2023 



$m 

$m 

Farxiga: sales milestones


52 

28 

Beyfortus: sales milestones


56 

71 

COVID-19 mAbs licence fees


180 

Other Collaboration Revenue


38 

Total


108 

317 

 

Table 32: Other operating income and expense

 



9M 2024 

9M 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


152 

205 

Total


152 

1,233 

 

Other shareholder information

 

Financial calendar

 

Announcement of FY and Q4 2024 results:        6 February 2025

Announcement of Q1 2025 results:                    29 April 2025

 

Dividends are normally paid as follows:

 

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

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

 

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.

 

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

 

Glossary

 

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

ADC                             Antibody drug conjugate

aHUS                           Atypical haemolytic uraemic syndrome

AKT                              Protein kinase B

AL amyloidosis          Light chain amyloidosis

ANDA                          Abbreviated New Drug Application (US)

ASO                             Antisense oligonucleotide

ATTR-CM                    Transthyretin-mediated amyloid cardiomyopathy

ATTRv / -PN / -CM     Hereditary transthyretin-mediated amyloid / polyneuropathy / cardiomyopathy

BCMA                          B-cell maturation antigen

BRCA / m                    Breast cancer gene / mutation

BTC                              Biliary tract cancer

BTK                              Bruton tyrosine kinase

C5                                Complement component 5

CAR-T                          Chimeric antigen receptor T-cell

cCRT                            Concurrent chemoradiotherapy

CD19                           A gene expressed in B-cells

CER                             Constant exchange rates

CHMP                          Committee for Medicinal Products for Human Use (EU)

CI                                  Confidence interval

CKD                             Chronic kidney disease

CLL                              Chronic lymphocytic leukaemia

COPD                          Chronic obstructive pulmonary disease

COP28                        28th annual United Nations (UN) climate meeting

CRC                             Colorectal cancer

CRL                              Compete Response Letter

CRPC                          Castration-resistant prostate cancer

CSPC                          Castration-sensitive prostate cancer

CTLA-4                        Cytotoxic T-lymphocyte-associated antigen 4

CVRM                          Cardiovascular, Renal and Metabolism

DDR                             DNA damage response

DNA                             Deoxyribonucleic acid

EBITDA                       Earnings before interest, tax, depreciation and amortisation

EGFR / m                    Epidermal growth factor receptor gene / mutation

EGPA                           Eosinophilic granulomatosis with polyangiitis

EPS                              Earnings per share

ER                                Estrogen receptor         

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

EVH                             Extravascular haemolysis

FDA                              Food and Drug Agency (US)

FDC                             Fixed dose combination

FISH                             Fluorescence in situ hybridization, as in FISH10+

g                                   Germline, e.g. gBRCAm

GAAP                           Generally Accepted Accounting Principles

GEJ                              Gastro oesophageal junction

GI                                  Gastrointestinal

GLP1 / -RA                  Glucagon-like peptide-1 / receptor agonist

gMG                             Generalised myasthenia gravis

HCC                             Hepatocellular carcinoma

HER2 / +/- / low / m   Human epidermal growth factor receptor 2 / positive / negative / low level expression / gene mutant

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

hMPV                           Human metapneumovirus

HR                                Hazard ratio

HR / + / -                      Hormone receptor / positive / negative

HRD                             Homologous recombination deficiency

HRR / m                       Homologous recombination repair gene / mutation

i.m.                               Intramuscular injection

i.v.                                 Intravenous injection

IAS / B                          International Accounting
Standards / Board

ICS                               Inhaled corticosteroid

IFRS                             International Financial Reporting Standards

IgAN                             Immunoglobulin A neuropathy

IHC                               Immunohistochemistry, as in IHC90+, etc

IL-5, IL-33, etc            Interleukin-5, Interleukin-33, etc

IP                                  Intellectual Property

IVIg                               Intravenous immune globulin

LABA                           Long-acting beta-agonist

LAMA                           Long-acting muscarinic-agonist

LS-SCLC                    Limited stage small cell lung cancer

LRTD                           Lower respiratory tract disease

m                                  Metastatic, e.g. mBTC , mCRPC, mCSPC

mAb                             Monoclonal antibody

MDL                             Multidistrict litigation

MET                             Mesenchymal epithelial transition

NF1-PN                       Neurofibromatosis type 1 with plexiform neurofibromas

n/m                               Not meaningful

NMOSD                       Neuromyelitis optica spectrum disorder

NRDL                           National reimbursement drug list

NSCLC                        Non-small cell lung cancer

OECD                          Organisation for Economic
Co-operation and Development

OOI                               Other operating income

ORR                             Overall response rate

OS                                Overall survival

PAAGR                        Post Alexion Acquisition Group Review

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

pCR                              Pathologic complete response

PCSK9                        Proprotein convertase subtilisin/kexin type 9

PD                                Progressive disease

PD-1                            Programmed cell death protein 1

PD-L1                          Programmed cell death ligand 1

PDUFA                        Prescription Drug User Fee Act

PHSSR                        Partnership for Health System Sustainability and Resilience

PFS                              Progression free survival

PIK3CA                       Phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha gene

PMDI                            Pressure metered dose inhaler

PNH / -EVH                Paroxysmal nocturnal haemoglobinuria / with extravascular haemolysis

PPI                               Proton pump inhibitors

PSR                              Platinum sensitive relapse

PTEN                           Phosphatase and tensin homologue gene

Q3W, Q4W, etc          Every three weeks, every four weeks, etc

R&D                             Research and development

R&I                               Respiratory & Immunology

RSV                              Respiratory syncytial virus

sBLA                            Supplemental biologics license application (US)

SCLC                           Small cell lung cancer

s.c.                                Subcutaneous injection

SEA                              Severe eosinophilic asthma

SEC                             Securities Exchange Commission (US)

SG&A                           Sales, general and administration

SGLT2                         Sodium-glucose cotransporter 2

SLL                              Small lymphocytic lymphoma

SMI                               Sustainable Markets Initiative

sNDA                           Supplemental new drug application

SPA                              Share Purchase Agreement

T2D                              Type-2 diabetes

TACE                           Transarterial chemoembolization

THP                              A treatment regimen: docetaxel, trastuzumab and pertuzumab

TNBC                           Triple negative breast cancer

TNF                              Tumour necrosis factor

TOP1                           Topoisomerase I

TROP2                         Trophoblast cell surface antigen 2

USPTO                        US Patent and Trademark Office

V&I                               Vaccines & Immune Therapies

VBP                              Volume-based procurement

VLP                              Virus like particle

 

- End of document -

 



[1] 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] Post Alexion Acquisition Group Review. In conjunction with the acquisition of Alexion, the Post Alexion Acquisition Group Review Group initiated a comprehensive review, aimed at integrating systems, structure and processes, optimising the global footprint and prioritising resource allocations and investments. These activities are expected to be substantially complete by the end of 2026.

[6] 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.

[7] 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.

[8] The presentation of this table has been updated by removing the "Acquisition of Alexion" column due to immateriality of items in this category

[9] Based on best prevailing assumptions around currency profiles.

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

[11] Based on average daily spot rates 1 Jan 2024 to 30 Sep 2024.

[12] Based on average daily spot rates 1 Sep 2024 to 30 Sep 2024.

[13] Other currencies include AUD, BRL, CAD, KRW and RUB.

[14] The table provides an analysis of year-on-year Product Sales, with Actual and CER growth rates reflecting year-on-year growth. Due to rounding, the sum of a number of dollar values and percentages may not agree to totals.

[15] The table provides an analysis of year-on-year Product Sales, with Actual and CER growth rates reflecting year-on-year growth. Due to rounding, the sum of a number of dollar values and percentages may not agree to totals.

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