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AstraZeneca PLC Interim / Quarterly Report 2024

Nov 12, 2024

5229_ffr_2024-11-12_202fb134-0c9a-4bed-aff7-ca65d1a1d3c6.zip

Interim / Quarterly Report

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6-K 1 a7967l.htm 9M AND Q3 2024 RESULTS Document created using Blueprint(R) - powered by Issuer Direct - www.issuerdirect.com Copyright 2024 Issuer Direct Corporation a7967l

FORM 6-K

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Report of Foreign Issuer

Pursuant to Rule 13a-16 or 15d-16 of

the Securities Exchange Act of 1934

For the month of November 2024

Commission File Number: 001-11960

AstraZeneca PLC

1 Francis Crick Avenue

Cambridge Biomedical Campus

Cambridge CB2 0AA

United Kingdom

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

Form 20-F X Form 40-F __

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

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

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

Yes __ No X

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

AstraZeneca PLC

INDEX TO EXHIBITS

1.

9M and Q3 2024 Results

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 — $m % Change — Actual CER [1] Q3 2024 — $m % Change — 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 EGFR m 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 EGFR m 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 .

line

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)

line

‒ 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

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 9 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) 4
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 Corechange 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 EGFR m 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 HER2 m
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 submissionsor acceptances* Tagrisso EGFR m 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 EGFR m 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 9 18 22 1,203 9 13 16
- Calquence 2,321 6 26 27 813 6 24 25
- Lynparza 2,228 6 8 10 778 6 11 13
- Enhertu 1,442 4 57 60 510 4 50 55
- Zoladex 845 2 17 24 278 2 12 18
- Imjudo 208 1 30 32 72 1 20 22
- Truqap 267 1 n/m n/m 125 1 n/m n/m
- Orpathys 36 - 5 8 11 - (11) (11)
-
Other Oncology 322 1 (18) (12) 106 1 (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 3 - 1 327 2 (1) (1)
- Crestor 894 2 4 9 304 2 10 14
- Lokelma 392 1 31 34 143 1 40 42
- Seloken / Toprol-XL 466 1 (6) (1) 151 1 (2) 1
-
roxadustat 261 1 23 26 95 1 26 25
- Andexxa 159 - 24 26 54 - 36 38
- Wainua 44 - n/m n/m 23 - n/m n/m
-
Other CVRM 392 1 (27) (26) 120 1 (22) (20)
BioPharmaceuticals: R&I 5,750 15 22 24 1,959 14 26 29
- Symbicort 2,195 6 19 22 705 5 27 31
- Fasenra 1,218 3 7 8 436 3 12 13
- Breztri 721 2 51 53 266 2 56 57
- Pulmicort 517 1 5 9 138 1 (6) (4)
- Tezspire 471 1 >2x >2x 191 1 >2x >2x
- Saphnelo 327 1 71 72 124 1 63 64
- Airsupra 41 - n/m n/m 21 - n/m n/m
-
Other R&I 259 1 (28) (27) 78 1 (32) (32)
BioPharmaceuticals: V&I 811 2 (14) (12) 460 3 48 49
- Beyfortus 319 1 >2x >2x 238 2 73 72
- Synagis 346 1 (10) (4) 93 1 (6) 3
-
COVID-19 mAbs 31 - (90) (90) 28 - >10x >10x
- FluMist 109 - 24 21 100 1 34 31
-
Other V&I 6 - (79) (80) 0 - (63) n/m
Rare Disease 6,391 16 10 14 2,148 16 9 11
- Ultomiris 2,835 7 32 35 1,031 8 33 35
- Soliris 2,045 5 (16) (11) 606 4 (22) (18)
- Strensiq 996 3 18 19 343 3 20 21
- Koselugo 366 1 49 55 119 1 37 39
- Kanuma 149 - 15 16 49 - 10 9
Other Medicines 843 2 (10) (4) 270 2 (12) (8)
- Nexium 685 2 (8) (2) 216 2 (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 3 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 2 (14) (12) 460 3 48 49
Rare Disease 6,391 16 10 14 2,148 16 9 11
Other Medicines 843 2 (10) (4) 270 2 (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 9 (4) 4 1,260 9 (1) 4
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

| 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

| 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

| 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

| 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

| 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)

| 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) 4 7 (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 7 (5,143) (4,800) 7 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 8 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 4 17
Earnings per share $3.57 $3.22 11 21 $0.92 $0.89 4 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 4 11 (53) (54)
Depreciation, amortisation and impairment 4,351 4,060 7 7 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 anchor [8]

9M 2024 Reported — $m $m $m $m Core — $m Core % Change — Actual CER
Gross profit 31,700 655 24 4 32,383 15 19
Product Sales Gross Margin 80% 82% - -
Distribution expense (412) - - - (412) 4 7
R&D expense (8,906) 221 38 9 (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 2024 7

Q3 2024 Reported — $m $m $m $m Core — $m Core % Change — Actual CER
Gross profit 10,484 619 8 1 11,112 18 21
Product Sales Gross Margin 76% 81% - -
Distribution expense (145) - - - (145) 12 15
R&D expense (3,115) 44 1 2 (3,068) 23 24
% of Total Revenue 23% 23% -1pp -1pp
SG&A expense (5,143) 42 1,460 36 (3,605) 8 9
% 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) 5 (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
Other investments 133 122 244
Cash and investments 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)
Non-current instalments of loans (28,887) (22,365) (22,225)
Interest-bearing loans and borrowings (Gross debt) (31,562) (28,622) (28,576)
Net derivatives 284 150 90
Net debt (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 6
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:

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 EGFR m 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 EGFR m 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 EGFR m 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 5
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 1 28
Fair value movements on derivatives designated in net investment
hedges 13 47
Gains/(costs) of hedging 2 (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 6 7
5,541 5,002
Total comprehensive income attributable to:
Owners of the Parent 6,346 4,907
Non-controlling interests 6 7
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 - 1
Tax on items that will not be reclassified to profit or
loss (23) 5
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) 7
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 4 4
1,433 1,378
Total comprehensive income attributable to:
Owners of the Parent 2,654 1,255
Non-controlling interests 4 4
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 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) 6 (120)
Overdrafts (203) (158) - 1 (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 8 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 — $m Act % chg CER % chg US — $m % chg Emerging Markets — $m Act % chg CER % chg Europe — $m Act % chg CER % chg Established RoW — $m Act % chg CER % chg
Oncology 14,934 18 21 6,870 22 3,445 18 28 3,000 24 23 1,619 (4) 4
Tagrisso 4,877 11 15 1,996 19 1,365 8 16 956 16 16 560 (10) (2)
Imfinzi 3,463 18 22 1,883 18 365 37 61 695 30 29 520 (3) 6
Calquence 2,321 26 27 1,617 21 116 68 90 489 38 38 99 23 27
Lynparza 2,228 8 10 954 6 475 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 7 15
Imjudo 208 30 32 134 25 11 n/m n/m 26 n/m n/m 37 (8) 1
Truqap 267 n/m n/m 260 n/m 2 n/m n/m 2 n/m n/m 3 n/m n/m
Orpathys 34 4 7 - - 34 4 7 - - - - - -
Others 322 (18) (12) 15 5 197 (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) 5
Farxiga 5,723 31 34 1,278 28 2,225 35 41 1,903 40 39 317 (9) (1)
Brilinta 992 - 1 543 (1) 232 4 11 203 - (1) 14 (21) (18)
Crestor 892 4 9 33 (18) 726 7 12 32 (22) (22) 101 - 9
Seloken / Toprol-XL 465 (6) (1) - 84 452 (6) (1) 10 27 27 3 (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 7 3 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 9
BioPharmaceuticals: R&I 5,431 20 23 2,419 27 1,489 13 20 1,026 21 20 497 9 14
Symbicort 2,195 19 22 887 51 653 9 19 415 2 1 240 (2) -
Fasenra 1,218 7 8 750 4 68 43 52 294 12 11 106 (1) 6
Pulmicort 517 5 9 13 (39) 427 9 14 51 4 2 26 (13) (9)
Breztri 721 51 53 367 40 199 62 68 102 86 85 53 42 51
Tezspire 168 n/m n/m - - 8 n/m n/m 105 n/m n/m 55 n/m n/m
Saphnelo 327 71 72 294 65 5 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 4 3 6 (13) (11)
BioPharmaceuticals: V&I 680 2 5 201 n/m 168 (7) 1 189 (6) (8) 122 (48) (44)
Synagis 346 (10) (4) (1) n/m 168 6 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 1 n/m n/m
FluMist 109 40 37 26 61 - n/m n/m 61 5 1 22 n/m n/m
COVID-19 mAbs 31 (75) (75) 28 n/m - n/m n/m 3 (59) (60) - n/m n/m
Others 6 (79) (80) - - - (99) n/m 6 (43) (45) - n/m n/m
Rare Disease 6,391 10 14 3,842 11 628 29 56 1,189 2 1 732 9 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 8 39 346 (35) (35) 164 (34) (31)
Strensiq 996 18 19 815 18 39 34 48 73 15 14 69 8 18
Koselugo 366 49 55 156 9 108 n/m n/m 74 93 93 28 81 99
Kanuma 149 15 16 72 15 24 (1) 7 47 25 25 6 8 16
Other medicines 824 (9) (4) 87 (17) 564 (3) 5 75 12 12 98 (38) (33)
Nexium 670 (9) (2) 77 (13) 458 - 9 40 12 10 95 (37) (33)
Others 154 (12) (10) 10 (35) 106 (13) (10) 35 13 13 3 (53) (49)
Total Product Sales 37,576 16 19 15,640 19 10,440 16 25 7,864 20 20 3,632 (4) 3

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

World — $m Act % chg CER % chg US — $m % chg Emerging Markets — $m Act % chg CER % chg Europe — $m Act % chg CER % chg Established RoW — $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 9 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 8 155 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 4 (34) 207 14 21 33 8 10 24 16 21
Imjudo 72 20 22 46 15 4 n/m n/m 10 99 n/m 12 (15) (10)
Truqap 125 n/m n/m 119 n/m 1 - - 2 - - 3 - -
Orpathys 10 (16) (16) - - 10 (16) (16) - - - - - -
Others 106 (10) (5) 4 2 64 (14) (8) 5 (27) (26) 33 (1) 5
BioPharmaceuticals: CVRM 3,152 17 20 739 7 1,396 20 25 826 26 26 191 9 14
Farxiga 1,938 25 27 411 12 750 30 35 670 32 32 107 4 8
Brilinta 327 (1) (1) 189 (2) 66 3 6 67 (1) (1) 5 (11) (16)
Crestor 304 10 14 11 (18) 252 15 18 10 4 2 31 (6) -
Seloken / Toprol-XL 150 (2) 1 - n/m 145 (3) 1 4 n/m 98 1 (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) 1 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 3 6 30 (28) (26) 7 50 40
BioPharmaceuticals: R&I 1,830 26 28 852 40 457 8 14 346 30 30 175 13 18
Symbicort 705 27 31 289 86 203 4 13 130 5 6 83 2 5
Fasenra 436 12 13 271 9 27 41 50 102 19 19 36 1 5
Pulmicort 138 (6) (4) 5 7 110 (8) (5) 14 10 9 9 (11) (8)
Breztri 266 56 57 142 45 68 62 65 37 98 98 19 61 68
Tezspire 68 n/m n/m - - 3 n/m n/m 43 n/m n/m 22 n/m n/m
Saphnelo 124 63 64 110 55 3 n/m n/m 7 n/m n/m 4 37 67
Airsupra 21 n/m n/m 21 n/m - - - - - - - - -
Others 72 (21) (21) 14 (54) 43 (8) (8) 13 7 7 2 (16) (14)
BioPharmaceuticals: V&I 355 59 61 145 n/m 37 18 37 108 23 20 65 18 23
Synagis 93 (6) 3 - 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 9 11 1,325 12 174 7 29 395 - - 254 8 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 8 52 55 25 17 17 24 15 23
Koselugo 119 37 39 55 2 25 n/m n/m 29 90 94 10 52 62
Kanuma 49 10 9 25 11 5 (27) (29) 17 27 23 2 1 7
Other medicines 265 (11) (7) 35 (3) 179 (6) - 22 18 16 29 (45) (41)
Nexium 212 (13) (9) 30 3 140 (9) (2) 14 31 29 28 (45) (41)
Others 53 - (1) 5 (28) 39 7 8 8 (1) (1) 1 (52) (51)
Total Product Sales 12,947 18 20 5,580 23 3,388 15 23 2,729 20 20 1,250 - 5

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
[email protected]

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 -

line

[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.

SIGNATURES

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

AstraZeneca PLC

Date: 12 November 2024

| By: /s/
Adrian Kemp |
| --- |
| Name:
Adrian Kemp |
| Title:
Company Secretary |

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