REG - AstraZeneca PLC - Half-year Report
25/07/2024 07:00
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RNS Number : 7427X AstraZeneca PLC 25 July 2024
AstraZeneca
25 July 2024
H1 and Q2 2024 results
Strong underlying growth supports FY 2024 guidance upgrade, with both Total
Revenue and Core EPS now expected to increase by a mid teens percentage at
CER 1
Revenue and EPS summary
H1 2024 % Change Q2 2024 % Change
$m Actual CER $m Actual CER
- Product Sales 24,629 15 18 12,452 14 18
- Alliance Revenue 939 50 50 482 42 42
- Collaboration Revenue 49 (78) (78) 4 (98) (98)
Total Revenue 25,617 15 18 12,938 13 17
Reported EPS $2.65 13 23 $1.24 6 15
Core 2 EPS $4.03 (1) 5 $1.98 (8) (3)
Financial performance for H1 2024 (Growth numbers at constant exchange rates)
‒ Total Revenue up 18% to $25,617m, driven by an 18% increase in
Product Sales and continued growth in Alliance Revenue from partnered
medicines
‒ Total Revenue growth from Oncology was 22%, CVRM 22%, R&I 22%,
and Rare Disease 15%
‒ Core Product Sales Gross Margin 3 of 82%
‒ Core Operating Margin of 33%
‒ Core Tax Rate of 20%
‒ Core EPS increased 5% to $4.03. The increase in Core EPS was lower
than Total Revenue growth principally due to gains recognised in the prior
year, specifically a $241m gain on the disposal of Pulmicort Flexhaler US
rights (Q1 2023), and a $712m gain relating to updates to contractual
arrangements for Beyfortus (Q2 2023)
‒ Interim dividend increased 7c to $1.00 (77.6 pence, 10.79 SEK) has
been declared
‒ Guidance for FY 2024 increased, with Total Revenue and Core EPS
anticipated to grow by a mid teens percentage at CER (previously a low
double-digit to low teens percentage). An increase in Collaboration Revenue is
not assumed in the upgraded guidance
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
"Building on our strong growth in the first half of the year and continued
underlying demand for our medicines we are upgrading our FY 2024 guidance for
both Total Revenue and Core EPS.
At our Investor Day in May we set out a new revenue ambition to deliver $80
billion of Total Revenue by 2030. This is a clear reflection of the
substantial growth potential we see from both our approved medicines and those
in our late-stage pipeline. Already this year we have announced five positive,
potentially practice-changing Phase III studies that are anticipated to
meaningfully contribute to our growth.
In the year to date we have continued to make encouraging progress with
several disruptive technologies, including antibody drug conjugates,
bispecifics, cell and gene therapies, radioconjugates, and weight management
medicines, all of which have the potential to drive our growth beyond 2030."
Key milestones achieved since the prior results announcement
‒ Positive read-outs for Imfinzi in combination with chemotherapy in
muscle-invasive bladder cancer (NIAGARA), Calquence in untreated mantle cell
lymphoma (ECHO), Enhertu in HR-positive, HER2-low metastatic breast cancer
(DESTINY-Breast06)
‒ US approvals for Imfinzi in combination with chemotherapy followed
by Imfinzi monotherapy for primary advanced or recurrent endometrial cancer
that is mismatch repair deficient (DUO-E). EU approvals for Truqap in
combination with Faslodex for biomarker-positive estrogen receptor-positive,
HER2‑negative advanced breast cancer (CAPItello-291), Tagrisso with the
addition of chemotherapy for 1st‑line EGFRm NSCLC (FLAURA2). Japan and China
approvals for Tagrisso with the addition of chemotherapy for the 1st--‑line
EGFRm NSCLC (FLAURA2)
Guidance
Due to strong underlying growth in Product Sales and Alliance Revenue, the
Company raises its Total Revenue and Core EPS guidance for FY 2024 at CER,
based on the average foreign exchange rates through 2023.
Total Revenue is expected to increase by a mid teens percentage
(previously a low double-digit to low teens percentage)
Core EPS is expected to increase by a mid teens percentage
(previously a low double-digit to low teens percentage)
‒ An increase in Collaboration Revenue is not assumed in the upgraded
guidance (previously assumed a substantial increase)
‒ Other operating income is expected to decrease substantially (FY
2023 included a $241m gain on the disposal of Pulmicort Flexhaler US rights,
and a $712m one-time gain relating to updates to contractual arrangements for
Beyfortus)
‒ The Core Tax rate is expected to be between 18-22%
The Company is unable to provide guidance on a Reported basis because it
cannot reliably forecast material elements of the Reported results, including
any fair value adjustments arising on acquisition-related liabilities,
intangible asset impairment charges and legal settlement provisions. Please
refer to the cautionary statements section regarding forward-looking
statements at the end of this announcement.
Currency impact
If foreign exchange rates for July 2024 to December 2024 were to remain at the
average rates seen in June 2024, it is anticipated that FY 2024 Total Revenue
would incur a low single-digit percentage adverse impact compared to the
performance at CER, and Core EPS would incur a mid single-digit percentage
adverse impact. The Company's foreign exchange rate sensitivity analysis is
provided in Table 17.
Table 1: Key elements of Total Revenue performance in Q2 2024
% Change
Revenue type $m Actual % CER %
Product Sales 12,452 14 18
Alliance Revenue 482 42 42 * $344m Enhertu (Q2 2023: $255m)
* $104m Tezspire (Q2 2023: $62m)
Collaboration Revenue 4 (98) (98) * Q2 2023 included $180m for COVID-19 mAbs
Total Revenue 12,938 13 17
Therapy areas $m Actual % CER %
Oncology 5,331 15 19 * Tagrisso up 8% (12% at CER) due to strong global demand, Calquence up
21% (22% at CER) with sustained leadership in 1L CLL. Enhertu Total Revenue up
46% (49% at CER)
CVRM( ) 3,160 18 22 * Farxiga up 29% (32% at CER), Lokelma up 36% (41% at CER)
R&I 1,905 23 26 * Breztri up 44% (47% at CER). Saphnelo up 65%, Tezspire up 97% (>2x at
CER), Symbicort up 20% (25% CER)
V&I 119 (57) (53) * The drop in V&I revenue was primarily driven by lower Collaboration
Revenue from COVID-19 mAbs
* Beyfortus revenue was $35m (Q2 2023: $2m), which more than offset a $6m
decline in Synagis
Rare Disease( ) 2,147 10 14 * Ultomiris up 33% (36% at CER), partially offset by decline in Soliris of
14% (8% at CER)
* Strensiq up 13% (14% at CER) and Koselugo up 43% (45% at CER)
Other Medicines 276 (11) (5)
Total Revenue 12,938 13 17
Regions $m Actual % CER %
US 5,571 17 17
Emerging Markets 3,386 9 18
- China 1,630 13 18
- Ex-China Emerging Markets 1,756 5 18
Europe 2,732 24 24
Established RoW 1,249 (5) 6
Total Revenue 12,938 13 17
Key partnered medicines
‒ Combined sales of Enhertu, recorded by Daiichi Sankyo Company
Limited (Daiichi Sankyo) and AstraZeneca, amounted $1,772m in H1 2024 (H1
2023: $1,169m).
‒ Combined sales of Tezspire, recorded by Amgen and AstraZeneca,
amounted to $507m in H1 2024 (H1 2023: $257m).
‒
Table 2: Key elements of financial performance in Q2 2024
Metric Reported Reported change Core Core Comments 4
change
Total Revenue $12,938m 13% Actual 17% CER $12,938m 13% Actual 17% CER * See Table 1 and the Total Revenue section of this document for further
details
Product Sales Gross Margin 82% Stable Actual 83% Stable Actual * Variations in Product Sales Gross Margin can be expected between periods
Stable CER
Stable CER due to product seasonality (e.g. FluMist and Beyfortus in H2), foreign
exchange fluctuations and other effects
R&D $3,008m 13% Actual 13% CER $2,872m 12% Actual 13% CER + Increased investment in the pipeline
expense * Core R&D-to-Total Revenue ratio of 22%
(Q2 2023: 22%)
SG&A expense $4,929m -1% Actual 1% CER $3,735m 13% Actual 16% CER + Market development for recent launches and pre-launch activities
* Core SG&A-to-Total Revenue ratio of 29%
(Q2 2023: 29%)
Other operating income and expense 5 $60m -92% Actual -92% CER $60m -92% Actual -92% CER ‒ The prior year quarter included a $712m gain relating to updates to
contractual arrangements for Beyfortus
Operating Margin 21% Stable Actual +1pp CER 32% -6pp Actual -5pp CER * See commentary above on Gross Margin, R&D, SG&A and Other
operating income and expense
Net finance expense $343m -7% Actual -7% CER $285m 10% Actual 10% CER + Higher level of Net debt
Tax rate 20% +7pp Actual +7pp CER 19% +2pp Actual +2pp CER * Variations in the tax rate can be expected between periods
EPS $1.24 6% Actual 15% CER $1.98 -8% Actual -3% CER * Further details of differences between Reported and Core are shown in
Table 12
Table 3: Pipeline highlights since prior results announcement
Event Medicine Indication / Trial Event
Regulatory approvals and other regulatory actions Imfinzi Primary advanced or recurrent endometrial cancer with mismatch repair Regulatory approval (US), CHMP positive opinion (EU)
deficiency (DUO-E)
Imfinzi + Lynparza Primary advanced or recurrent endometrial cancer with mismatch repair CHMP positive opinion (EU)
proficiency (DUO-E)
Tagrisso EGFRm NSCLC (1st-line) Regulatory approval (EU, JP, CN)
(FLAURA2)
Truqap Biomarker-positive ER-positive HER2-negative locally advanced or metastatic Regulatory approval (EU)
breast cancer (CAPItello-291)
Regulatory submissions Tagrisso EGFRm NSCLC (Stage III unresectable) (LAURA) sNDA acceptance and Priority Review (US)
or acceptances*
Dato-DXd Non-squamous NSCLC (2nd- and 3rd-line) (TROPION-Lung01) Regulatory submission (EU)
sipavibart Prevention of COVID-19 Regulatory submission (EU)
(SUPERNOVA)
Major Phase III data readouts and other developments Calquence Mantle cell lymphoma (1st‑line) (ECHO) Primary endpoint met
Dato-DXd Locally advanced or metastatic NSCLC (TROPION-Lung01) Dual primary endpoint OS not met in the intention to treat population
Enhertu HER2-low breast cancer (2nd-line) (DESTINY-Breast-06) Primary endpoint met
Imfinzi Muscle-invasive bladder cancer (NIAGARA) Primary endpoint met
Imfinzi Adjuvant use in early-stage PD-L1 ≥25% NSCLC (Adjuvant BR.31) Primary endpoint not met
Truqap Locally advanced or metastatic TNBC (CAPItello-290) Primary endpoint not met
sipavibart Prevention of COVID-19 (SUPERNOVA) Primary endpoint met
*US, EU and China regulatory submission denotes filing acceptance
Upcoming pipeline catalysts
For recent trial starts and anticipated timings of key trial readouts, please
refer to the Clinical Trials Appendix, available on
www.astrazeneca.com/investor-relations.html
(https://www.astrazeneca.com/investor-relations.html) .
Corporate and business development
In May 2024, AstraZeneca announced its intention to build a $1.5 billion
manufacturing facility in Singapore for antibody drug conjugates (ADCs),
enhancing global supply of its ADC portfolio. ADCs are next-generation
treatments that deliver highly potent cancer-killing agents directly to cancer
cells through a targeted antibody. The planned greenfield facility, supported
by the Singapore Economic Development Board, will be AstraZeneca's first
end-to-end ADC production site, fully incorporating all steps of the
manufacturing process at a commercial scale. Manufacturing of ADCs is a
multi-step process that comprises antibody production, synthesis of
chemotherapy drug and linker, conjugation of drug-linker to the antibody, and
filling of the completed ADC substance.
In May 2024, AstraZeneca completed an additional $140m equity investment in
Cellectis, a clinical-stage biotechnology company. The equity investment and a
research collaboration agreement, announced in November 2023, will leverage
the Cellectis proprietary gene editing technologies and manufacturing
capabilities, to design up to 10 novel cell and gene therapy products for
areas of high unmet need, including oncology, immunology and rare diseases. In
Q4 2023, Cellectis received an initial payment of $105m from AstraZeneca,
which comprised a $25m upfront cash payment under the terms of a research
collaboration agreement and an $80m equity investment. Now that the additional
$140m equity investment has closed, AstraZeneca holds a total equity stake of
c.44% in Cellectis and AstraZeneca continues to treat its investment in
Cellectis as an associate.
In June 2024, AstraZeneca completed the acquisition of Fusion Pharmaceuticals
Inc., a clinical-stage biopharmaceutical company developing next-generation
radioconjugates. The acquisition marks a major step forward in AstraZeneca
delivering on its ambition to transform cancer treatment and outcomes for
patients by replacing traditional regimens like chemotherapy and radiotherapy
with more targeted treatments. The acquisition complements AstraZeneca's
leading oncology portfolio with the addition of the Fusion pipeline of
radioconjugates, including FPI-2265, a potential new treatment for patients
with mCRPC, and brings new expertise and pioneering R&D, manufacturing and
supply chain capabilities in actinium-based radioconjugates to AstraZeneca.
See Note 5 for further information.
In July 2024, AstraZeneca completed the acquisition
(https://www.astrazeneca.com/media-centre/press-releases/2024/astrazeneca-to-acquire-amolyt.html)
of Amolyt Pharma, a clinical-stage biotechnology company focused on
developing novel treatments for rare endocrine diseases. The acquisition
bolsters the Alexion, AstraZeneca Rare Disease late-stage pipeline and expands
on its bone metabolism franchise with the notable addition of eneboparatide
(AZP-3601), a Phase III investigational therapeutic peptide with a novel
mechanism of action designed to meet key therapeutic goals for
hypoparathyroidism. In patients with hypoparathyroidism, a deficiency in
parathyroid hormone production results in significant dysregulation of calcium
and phosphate, which can lead to life-altering symptoms and complications,
including chronic kidney disease. See Note 7 for further information.
Sustainability highlights
At the 77th World Health Assembly in Geneva, Switzerland in May, AstraZeneca
convened Ministers of Health, industry, civil society and patient groups.
Areas of focus for engagement, led by Ruud Dobber, EVP BioPharmaceuticals,
included the need to increase early action to prevent, diagnose and treat
disease and to accelerate collaboration to build resilient, equitable and net
zero health systems.
Conference call
A conference call and webcast for investors and analysts will begin today, 25
July 2024, at 11:45 UK time. Details can be accessed via astrazeneca.com
(https://www.astrazeneca.com/) .
Reporting calendar
The Company intends to publish its 9M and Q3 2024 results on 12 November 2024.
Conclusion of audit tender
Following a rigorous process, the audit tender for the Group's external audit
provider has now concluded. The Audit Committee has recommended, and the Board
has endorsed, the appointment of KPMG as the Group's external auditor for the
financial year ending 31 December 2026. A resolution will be put to
shareholders at the 2026 Annual General Meeting (AGM) to approve this
appointment. It is intended that PwC, who have been the Group's auditor since
the year ended 31 December 2017, will continue as the Group's auditors for the
years ended 31 December 2024 and 2025 and will cease to hold office at the
conclusion of the Company's 2026 AGM.
Operating and financial review
All narrative on growth and results in this section is based on actual
exchange rates, and financial figures are in US$ millions ($m), unless stated
otherwise. Unless stated otherwise, the performance shown in this announcement
covers the six month period to 30 June 2024 ('the half year' or 'H1 2024')
compared to the six month period to 30 June 2023 ('H1 2023').
Core financial measures, EBITDA, Net debt, Product Sales Gross Margin,
Operating Margin and CER are non-GAAP financial measures because they cannot
be derived directly from the Group's Condensed consolidated financial
statements. Management believes that these non-GAAP financial measures, when
provided in combination with Reported results, provide investors and analysts
with helpful supplementary information to understand better the financial
performance and position of the Group on a comparable basis from period to
period. These non-GAAP financial measures are not a substitute for, or
superior to, financial measures prepared in accordance with GAAP.
Core financial measures are adjusted to exclude certain significant items:
‒ Charges and provisions related to restructuring programmes, which
includes charges that relate to the impact of restructuring programmes on
capitalised IT assets
‒ Amortisation and impairment of intangible assets, including
impairment reversals but excluding any charges relating to IT assets
‒ Other specified items, principally the imputed finance charges and
fair value movements relating to contingent consideration on business
combinations, imputed finance charges and remeasurement adjustments on certain
Other payables arising from intangible asset acquisitions, legal settlements
and remeasurement adjustments relating to Other payables assumed from the
Alexion acquisition
‒ The tax effects of the adjustments above are excluded from the Core
Tax charge
Details on the nature of Core financial measures are provided on page 61 of
the Annual Report and Form 20-F Information 2023.
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2023/pdf/AstraZeneca_AR_2023.pdf)
Reference should be made to the Reconciliation of Reported to Core financial
measures table included in the financial performance section in this
announcement.
Product Sales Gross Margin is calculated by dividing the difference between
Product Sales and Cost of Sales by the Product Sales. The calculation of
Reported and Core Product Sales Gross Margin excludes the impact of Alliance
Revenue and Collaboration Revenue and any associated costs, thereby reflecting
the underlying performance of Product Sales.
EBITDA is defined as Reported Profit before tax after adding back Net finance
expense, results from Joint ventures and associates and charges for
Depreciation, amortisation and impairment. Reference should be made to the
Reconciliation of Reported Profit before tax to EBITDA included in the
financial performance section in this announcement.
Operating margin is defined as Operating profit as a percentage of Total
Revenue.
Net debt is defined as Interest-bearing loans and borrowings and Lease
liabilities, net of Cash and cash equivalents, Other investments, and Net
derivative financial instruments. Reference should be made to Note 3 'Net
debt' included in the Notes to the 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 6
H1 2024 Q2 2024
% Change % Change
Total Revenue $m % Total Actual CER $m % Total Actual CER
Oncology 10,440 41 19 22 5,331 41 15 19
- Tagrisso 3,203 13 10 13 1,608 12 8 12
- Imfinzi 2,259 9 20 25 1,147 9 13 18
- Calquence 1,508 6 27 28 790 6 21 22
- Lynparza 1,450 6 6 9 744 6 4 7
- Enhertu 932 4 61 62 472 4 46 49
- Zoladex 567 2 19 26 282 2 17 25
- Imjudo 136 1 35 38 74 1 17 19
- Truqap 142 1 n/m n/m 92 1 n/m n/m
- Orpathys 25 - 14 18 13 - (5) (1)
- Other Oncology 216 1 (21) (15) 109 1 (17) (11)
BioPharmaceuticals: CVRM 6,220 24 19 22 3,160 24 18 22
- Farxiga 3,836 15 35 38 1,945 15 29 32
- Brilinta 665 3 - 2 342 3 3 5
- Crestor 590 2 1 6 293 2 4 11
- Lokelma 249 1 26 30 136 1 36 41
- Seloken/Toprol-XL 315 1 (8) (1) 150 1 (8) -
- roxadustat 167 1 22 27 90 1 20 25
- Andexxa 105 - 18 21 59 - 29 35
- Wainua 21 - n/m n/m 16 - n/m n/m
- Other CVRM 272 1 (30) (28) 130 1 (26) (24)
BioPharmaceuticals: R&I 3,791 15 19 22 1,905 15 23 26
- Symbicort 1,491 6 16 19 722 6 20 25
- Fasenra 781 3 5 6 423 3 4 5
- Breztri 454 2 48 51 235 2 44 47
- Pulmicort 379 1 10 14 155 1 25 30
- Tezspire 280 1 >2x >2x 160 1 97 >2x
- Saphnelo 203 1 77 77 112 1 65 65
- Airsupra 21 - n/m n/m 14 - n/m n/m
- Other R&I 181 1 (26) (25) 83 1 (21) (19)
BioPharmaceuticals: V&I 350 1 (45) (42) 119 1 (57) (53)
- Beyfortus 80 - >10x >10x 35 - >10x >10x
- Synagis 253 1 (11) (6) 81 1 (6) 8
- COVID-19 mAbs 3 - (99) (99) 1 - (99) (99)
- FluMist 8 - (34) (36) 2 - (84) (84)
- Other V&I 6 - (79) (80) - - n/m n/m
Rare Disease 4,243 17 11 15 2,147 17 10 14
- Ultomiris 1,804 7 32 35 946 7 33 36
- Soliris 1,439 6 (13) (8) 700 5 (14) (8)
- Strensiq 653 3 16 18 340 3 13 14
- Koselugo 247 1 55 64 114 1 43 45
- Kanuma 100 - 17 20 47 - 3 8
Other Medicines 573 2 (9) (2) 276 2 (11) (5)
- Nexium 469 2 (6) 2 227 2 (10) (3)
- Others 104 - (21) (18) 49 - (16) (12)
Total 25,617 100 15 18 12,938 100 13 17
Table 5: Alliance Revenue
H1 2024 Q2 2024
% Change % Change
$m % Total Actual CER $m % Total Actual CER
Enhertu 683 73 44 44 344 71 35 36
Tezspire 180 19 72 72 104 22 67 67
Beyfortus 26 3 n/m n/m 7 1 n/m n/m
Other Alliance Revenue 50 5 4 4 27 6 17 17
Total 939 100 50 50 482 100 42 42
Table 6: Collaboration Revenue
H1 2024 Q2 2024
% Change % Change
$m % Total Actual CER $m % Total Actual CER
Farxiga: sales milestones 49 100 96 96 4 100 >5x >5x
COVID-19 mAbs: licence fees - - n/m n/m - - n/m n/m
Other Collaboration Revenue - - (98) (98) - - n/m n/m
Total 49 100 (78) (78) 4 100 (98) (98)
Table 7: Total Revenue by therapy area
H1 2024 Q2 2024
% Change % Change
$m % Total Actual CER $m % Total Actual CER
Oncology 10,440 41 19 22 5,331 41 15 19
Biopharmaceuticals 10,362 40 14 17 5,184 40 15 19
CVRM 6,220 24 19 22 3,160 24 18 22
R&I 3,791 15 19 22 1,905 15 23 26
V&I 350 1 (45) (42) 119 1 (57) (53)
Rare Disease 4,243 17 11 15 2,147 17 10 14
Other Medicines 573 2 (9) (2) 276 2 (11) (5)
Total 25,617 100 15 18 12,938 100 13 17
Table 8: Total Revenue by region
H1 2024 Q2 2024
% Change % Change
$m % Total Actual CER $m % Total Actual CER
US 10,695 42 18 18 5,571 43 17 17
Emerging Markets 7,119 28 13 22 3,386 26 9 18
China 3,378 13 11 15 1,630 13 13 18
Emerging Markets ex. China 3,740 15 16 29 1,756 14 5 18
Europe 5,365 21 23 22 2,732 21 24 24
Established ROW 2,438 10 (5) 4 1,249 10 (5) 6
Total 25,617 100 15 18 12,938 100 13 17
Oncology
Oncology Total Revenue of $10,440m in H1 2024 increased by 19% (22% at CER),
representing 41% of overall Total Revenue (H1 2023: 39%).
Tagrisso
H1 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 3,203 1,282 919 628 374
Actual change 10% 16% 8% 16% (11%)
CER change 13% 16% 16% 15% (2%)
Region Drivers and commentary
Worldwide * Strong global demand for Tagrisso in adjuvant (ADAURA) and 1st-line
settings (FLAURA, FLAURA2)
US * Continued adjuvant and 1st-line demand growth
Emerging Markets * Encouraging demand growth across markets despite local competition in
China
Europe * Continued demand growth in 1st-line and adjuvant settings
Established RoW * Continued growth across indications, impacted by 10.5% mandatory price
reduction in Japan effective from June 2023
Imfinzi
H1 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 2,259 1,202 245 459 353
Actual change 20% 17% 35% 38% 7%
CER change 25% 17% 58% 36% 19%
Region Drivers and commentary
Worldwide * Continued growth driven by BTC (TOPAZ-1), HCC (HIMALAYA), and increased
patient share in Stage IV NSCLC (POSEIDON) and extensive-stage SCLC (CASPIAN)
US * Continued demand growth driven primarily by HCC and extensive-stage
SCLC, having achieved peak market share and stabilisation in BTC
Emerging Markets * New patient share growth across all indications
* China growth driven largely by increasing demand in BTC
Europe * Growth driven by share gains in extensive-stage SCLC and new launches in
HCC, BTC and NSCLC
Established RoW * Increased demand in GI indications, offset by a 25% mandatory price
reduction in Japan effective from 1 February 2024
Calquence
H1 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 1,508 1,048 75 320 65
Actual change 27% 21% 82% 42% 30%
CER change 28% 21% >2x 41% 34%
Region Drivers and commentary
Worldwide * Sustained leadership in front-line CLL (ELEVATE-TN) and increased global
penetration
US * Growth driven by leading share of new patient starts in front-line CLL,
and improved affordability
Europe * Continued strong growth in front-line
Lynparza
H1 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 1,450 607 320 398 125
Actual change 6% 5% 15% 9% (14%)
CER change 9% 5% 26% 8% (6%)
Region Drivers and commentary
Worldwide * Lynparza remains the leading medicine in the PARP inhibitor class
globally across four tumour types (ovarian, breast, prostate, pancreatic), as
measured by total prescription volume
* No Collaboration Revenue for Lynparza was recognised in either H1 2024
or H1 2023, hence the Product Sales numbers are identical to the Total Revenue
numbers shown above
US * Continued leadership within PARP inhibitor class despite competition,
offset by negative class pressure and maturity
Emerging Markets * Volume growth in China from increased share in newly diagnosed
BRCA-mutated ovarian cancer (SOLO-1) and inclusion of HRD-positive ovarian
cancer (PAOLA-1) on NRDL with no price reduction
Europe * Demand growth driven by recent launches in mCRPC (PROpel) and early
breast cancer (OlympiA)
Established RoW * Demand growth from 1st-line ovarian cancer, offset by price reduction in
Japan effective from November 2023
Enhertu
H1 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 932 414 224 263 31
Actual change 61% 22% >2x >2x >3x
CER change 62% 22% >2x >2x >3x
Region Drivers and commentary
Worldwide * Combined sales of Enhertu, recorded by Daiichi Sankyo and AstraZeneca,
amounted to $1,772m in H1 2024 (H1 2023: $1,169m)
US * US in-market sales, recorded by Daiichi Sankyo, amounted to $865m in H1
2024 (H1 2023: $712m)
* Continued demand across all indications with encouraging early launch
following tumour-agnostic approval in April 2024 (DESTINY-PanTumor02,
DESTINY-Lung01, DESTINY‑CRC02)
Emerging Markets * Sustained demand growth, with quarterly phasing impacted by
launch-related inventory build in China in Q1 2024 and subsequent destocking
Europe * Continued demand growth due to increasing adoption in HER2-positive
(DESTINY-Breast03) and HER2-low (DESTINY-Breast04) metastatic breast cancer
Established RoW * AstraZeneca's Alliance Revenue includes a mid single-digit percentage
royalty on Daiichi Sankyo's sales in Japan
Other Oncology medicines
H1 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Zoladex 567 19% 26% * Strong underlying growth in China and Emerging Markets and moderate
growth in Europe offset by drop in Japan
Imjudo 136 35% 38% * Continued growth across markets slightly offset by US inventory
destocking in H1 2024
Truqap 142 n/m n/m * Strong demand growth with strong uptake in biomarker altered subgroup of
HR-positive HER2-negative metastatic breast cancer (CAPItello-291)
Orpathys 25 14% 18% * Demand in China for the treatment of patients with NSCLC with MET exon
14 skipping alterations
Other Oncology 216 (21%) (15%) * Decline in Faslodex Total Revenue due to VBP implementation in China in
March 2024 in addition to ongoing generic erosion in Europe
BioPharmaceuticals
BioPharmaceuticals Total Revenue increased by 14% (17% at CER) in H1 2024 to
$10,362m, representing 40% of overall Total Revenue (H1 2023: 41%).
BioPharmaceuticals - CVRM
CVRM Total Revenue increased by 19% (22% at CER) to $6,220m in H1 2024 and
represented 24% of overall Total Revenue (H1 2023: 24%).
Farxiga
H1 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 3,836 869 1,474 1,233 260
Actual change 35% 37% 37% 45% (5%)
CER change 38% 37% 44% 44% 3%
Region Drivers and commentary
Worldwide * Farxiga volume is growing faster than the overall SGLT2 market in all
major regions, driven by continued demand in heart failure and CKD
* SGLT2 class growth underpinned by updated cardiorenal guidelines
US * Growth driven by underlying demand in HFrEF and CKD
* Launch of an authorised generic in the first quarter of 2024
Emerging Markets * Increased reimbursement supporting solid growth despite entry of generic
competition in some markets
* Strong momentum in Latin America
Europe * Continued strong class growth and market share gains fuelled by HFpEF
approval in 2023 and guidelines updates
Established RoW * Performance impacted by generic competition in Canada
* In Japan, AstraZeneca sells to collaborator Ono Pharmaceutical Co., Ltd,
which records in-market sales
Other CVRM medicines
H1 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Brilinta 665 - 2% * Continued sales growth in Emerging Markets, decline in Est. RoW driven
by generic competition in Canada
Crestor 590 1% 6% * Continued sales growth in Emerging Markets
Seloken 315 (8%) (1%) * Stable following VBP implementation in China in 2022
Lokelma 249 26% 30% * Strong growth in all major regions. Continued launches in new markets
roxadustat 167 22% 27% * Increased demand in both the dialysis and non-dialysis-dependent
populations. NRDL listing renewed
Andexxa 105 18% 21% * Growth in all major regions
Wainua 21 n/m n/m * Encouraging launch uptake following ATTRv-PN approval in the US in
December 2023
Other CVRM 272 (30%) (28%)
BioPharmaceuticals - R&I
Total Revenue of $3,791m from R&I medicines increased 19% (22% at CER) and
represented 15% of overall Total Revenue (H1 2023: 14%). This reflected growth
in Fasenra, Tezspire, Breztri, Saphnelo and Airsupra, following its recent
launch.
Fasenra
H1 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 781 478 41 192 70
Actual change 5% 2% 45% 9% (2%)
CER change 6% 2% 53% 8% 6%
Region Drivers and commentary
Worldwide * Continued asthma market share leadership in IL-5 class across major
markets
US * Maintained share of a growing severe asthma biologics market
Emerging Markets * Continued strong demand growth driven by launch acceleration across key
markets
Europe * Expanded leadership in severe eosinophilic asthma
Established RoW * In Japan, maintained class leadership in a broadly stable market
Breztri
H1 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 454 225 131 65 33
Actual change 48% 37% 61% 80% 33%
CER change 51% 37% 69% 79% 44%
Region Drivers and commentary
Worldwide * Fastest growing medicine within the expanding FDC triple class, across
major markets
US * Consistent share growth within the expanding FDC triple class
Emerging Markets * Maintained market share leadership in China with strong triple FDC class
penetration
* Further expansion with launches in additional geographies
Europe * Sustained growth across markets driven by new launches
Established RoW * Increased market share in Japan
Tezspire
H1 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 280 180 5 61 34
Actual change >2x 72% >10x >3x >2x
CER change >2x 72% >10x >3x >2x
Region Drivers and commentary
Worldwide * Combined sales of Tezspire, recorded by Amgen and AstraZeneca, amounted
to $507m in H1 2024 (H1 2023: $257m)
US * Continued growth in total prescriptions, and maintained new-to-brand
market share with majority of patients new-to-biologics
Europe * Achieved new-to-brand leadership across multiple markets, new launches
continue to progress
Established RoW * Japan maintained new-to-brand leadership
Symbicort
H1 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 1,491 598 450 286 157
Actual change 16% 38% 11% - (4%)
CER change 19% 38% 21% (1%) (2%)
Region Drivers and commentary
Worldwide * Symbicort remained the global market leader within a stable ICS/LABA
class
US * Continued strong demand for the authorised generic and favourable
channel mix
Emerging Markets * Strong demand growth
Europe * Continued price and volume erosion from generics and a slowing overall
market partially offset by growth in some markets within mild asthma
Established RoW * Continued generic erosion in Japan
Other R&I medicines
H1 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Pulmicort 379 10% 14% * >80% of revenues from Emerging Markets
Saphnelo 203 77% 77% * Demand acceleration in the US, and additional growth driven by ongoing
launches in Europe and Established RoW
Airsupra 21 n/m n/m * Strong US launch momentum and volume uptake. Revenue in the period
reflects introductory discounts as early access continues to build
Other R&I 181 (26%) (25%) * Generic competition
BioPharmaceuticals - V&I
Total Revenue from V&I medicines reduced by 45% (42% at CER) to $350m (H1
2023: $632m) and represented 1% of overall Total Revenue (H1 2023: 3%).
Collaboration Revenue was $nil in the period (H1 2023: $190m).
V&I medicines
H1 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Beyfortus 80 >10x >10x * Product Sales recognises AstraZeneca's sales of manufactured Beyfortus
product to Sanofi
* Alliance Revenue recognises AstraZeneca's 50% share of gross profits on
sales of Beyfortus in major markets outside the US, and 25% of brand revenues
in rest of world markets
* AstraZeneca has no participation in US profits or losses
Synagis 253 (11%) (6%) * Decline has been more than offset by Beyfortus growth
COVID-19 mAbs 3 (99%) (99%) * Decline in Evusheld sales and Collaboration Revenue (Total Revenue H1
2023: $306m)
FluMist 8 (34%) (36%)
Other V&I 6 (79%) (80%) * Decline in Vaxzevria sales (H1 2023: $28m)
Rare Disease
Total Revenue from Rare Disease medicines increased by 11% (15% at CER) in H1
2024 to $4,243m, representing 17% of overall Total Revenue (H1 2023: 17%).
Ultomiris
H1 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 1,804 1,032 66 411 295
Actual change 32% 27% >2x 32% 42%
CER change 35% 27% >2x 31% 58%
Region Drivers and commentary
Worldwide * Growth due to increased use in neurology, geographic expansion, further
patient demand and conversion from Soliris
* The reported revenues for Ultomiris include sales of Voydeya, which is
approved as an add‑on treatment to Ultomiris and Soliris for the 10-20% of
PNH patients who experience clinically significant EVH.
* Voydeya is a strategic launch in this small subset of PNH patients.
Voydeya ensures these patients can remain on the standard of care, Ultomiris
US * Patient growth in gMG and newly launched NMOSD, continued conversion
from Soliris
Emerging Markets * Continued growth following launches in new markets
Europe * Strong demand growth following recent launches, particularly from
neurology indications, accelerated conversion from Soliris in key markets,
partially offset by price reductions to secure reimbursement for new
indications
Established RoW * Continued conversion from Soliris and strong demand following new
launches
Soliris
H1 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 1,439 808 255 260 116
Actual change (13%) (9%) 19% (29%) (33%)
CER change (8%) (9%) 54% (30%) (30%)
Region Drivers and commentary
US * Decline driven by successful conversion of Soliris patients to Ultomiris
Emerging Markets * Growth driven by patient demand following launches in new markets
Europe * Decline driven by biosimilar erosion in PNH and aHUS and successful
conversion from Soliris to Ultomiris
Established RoW * Decline driven by successful conversion from Soliris to Ultomiris
Strensiq
H1 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 653 529 31 48 45
Actual change 16% 17% 30% 14% 4%
CER change 18% 17% 47% 12% 15%
Region Drivers and commentary
Worldwide * Growth driven by strong patient demand
Other Rare Disease medicines
H1 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Koselugo 247 55% 64% * Driven by patient demand and expansion in new markets
Kanuma 100 17% 20% * Continued global demand
Other medicines (outside the main therapy areas)
H1 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Nexium 469 (6%) 2% * Growth in Emerging Markets offset declines elsewhere
Others 104 (21%) (18%) * Continued impact of generic competition
Financial performance
Table 9: Reported Profit and Loss
H1 2024 H1 2023 % Change Q2 2024 Q2 2023 % Change
$m $m Actual CER $m $m Actual CER
Total Revenue 25,617 22,295 15 18 12,938 11,416 13 17
- Product Sales 24,629 21,448 15 18 12,452 10,882 14 18
- Alliance Revenue 939 627 50 50 482 341 42 42
- Collaboration Revenue 49 220 (78) (78) 4 193 (98) (98)
Cost of sales (4,401) (3,865) 14 17 (2,183) (1,960) 11 17
Gross profit 21,216 18,430 15 18 10,755 9,456 14 17
Distribution expense (267) (265) 1 3 (132) (131) 1 4
R&D expense (5,791) (5,278) 10 10 (3,008) (2,667) 13 13
SG&A expense (9,424) (9,045) 4 6 (4,929) (4,986) (1) 1
Other operating income & expense 127 1,163 (89) (89) 60 784 (92) (92)
Operating profit 5,861 5,005 17 25 2,746 2,456 12 20
Net finance expense (645) (654) (1) (4) (343) (367) (7) (7)
Joint ventures and associates (19) (1) n/m n/m (6) (1) n/m n/m
Profit before tax 5,197 4,350 19 29 2,397 2,088 15 24
Taxation (1,089) (726) 50 62 (469) (268) 75 90
Tax rate 21% 17% 20% 13%
Profit after tax 4,108 3,624 13 23 1,928 1,820 6 15
Earnings per share $2.65 $2.34 13 23 $1.24 $1.17 6 15
Table 10: Reconciliation of Reported Profit before tax to EBITDA
H1 2024 H1 2023 % Change Q2 2024 Q2 2023 % Change
$m $m Actual CER $m $m Actual CER
Reported Profit before tax 5,197 4,350 19 29 2,397 2,088 15 24
Net finance expense 645 654 (1) (4) 343 367 (7) (7)
Joint ventures and associates 19 1 n/m n/m 6 1 n/m n/m
Depreciation, amortisation and impairment 2,534 2,778 (9) (9) 1,279 1,276 - 1
EBITDA 8,395 7,783 8 13 4,025 3,732 8 14
Table 11: Reconciliation of Reported to Core financial measures: H1 2024 7
H1 2024 Reported Restructuring Intangible Asset Amortisation & Impairments Other Core Core
% Change
$m $m $m $m $m Actual CER
Gross profit 21,216 36 19 - 21,271 14 17
Product Sales Gross Margin 82% 82% -1pp -1pp
Distribution expense (267) - - - (267) 1 3
R&D expense (5,791) 177 39 5 (5,570) 14 15
% of Total Revenue 23% 22% - +1pp
SG&A expense (9,424) 138 1,884 254 (7,148) 13 15
% of Total Revenue 37% 28% +1pp +1pp
Total operating expense (15,482) 315 1,923 259 (12,985) 13 15
Other operating income & expense 127 (2) - - 125 (89) (89)
Operating profit 5,861 349 1,942 259 8,411 2 7
Operating Margin 23% 33% -4pp -3pp
Net finance expense (645) - - 115 (530) 6 3
Taxation (1,089) (80) (368) (71) (1,608) 13 19
EPS $2.65 $0.17 $1.01 $0.20 $4.03 (1) 5
Table 12: Reconciliation of Reported to Core financial measures: Q2 20247
Q2 2024 Reported Restructuring Intangible Asset Amortisation & Impairments Other Core Core
% Change
$m $m $m $m $m Actual CER
Gross profit 10,755 16 9 - 10,780 13 17
Product Sales Gross Margin 82% 83% - -
Distribution expense (132) - - - (132) 1 4
R&D expense (3,008) 97 35 4 (2,872) 12 13
% of Total Revenue 23% 22% - +1pp
SG&A expense (4,929) 41 943 210 (3,735) 13 16
% of Total Revenue 38% 29% - -
Total operating expense (8,069) 138 978 214 (6,739) 12 14
Other operating income & expense 60 - - - 60 (92) (92)
Operating profit 2,746 154 987 214 4,101 (4) 1
Operating Margin 21% 32% -6pp -5pp
Net finance expense (343) - - 58 (285) 10 10
Taxation (469) (35) (185) (52) (741) 7 13
EPS $1.24 $0.08 $0.51 $0.15 $1.98 (8) (3)
Profit and Loss drivers
Gross profit
‒ The calculation of Reported and Core Product Sales Gross Margin
excludes the impact of Alliance Revenue and Collaboration Revenue
‒ The change in Product Sales Gross Margin (Reported and Core) in H1
2024 was impacted by:
‒ Positive effects from product mix. The increased contribution from
Rare Disease and Oncology medicines had a positive impact on the Product Sales
Gross Margin
‒ Dilutive effects from product mix. The rising contribution of
Product Sales with profit sharing arrangements (Lynparza, Enhertu, Tezspire,
Koselugo) has a negative impact on Product Sales Gross Margin because
AstraZeneca records Product Sales in certain markets and pays away a share of
the gross profits to its collaboration partners. The growth in Beyfortus also
has a dilutive impact on Product Sales Gross Margin, as AstraZeneca is
responsible for manufacturing, and Sanofi is responsible for distribution.
AstraZeneca records its sales to Sanofi as Product Sales, and those sales
generate a lower Product Sales Gross Margin than the Company average
‒ Dilutive effects from geographic mix. In Emerging Markets, the
Product Sales Gross Margin tends to be below the Company average
‒ Variations in Product Sales Gross Margin performance between periods
can continue to be expected due to product seasonality, foreign exchange
fluctuations, and other effects
R&D expense
‒ The change in R&D expense (Reported and Core) in the period was
impacted by:
‒ Positive data read-outs for several high priority medicines that
have ungated late-stage trials
‒ Investment in platforms, new technology and capabilities to enhance
R&D capabilities
‒ Addition of R&D projects following completion of previously
announced business development activity including Icosavax, Gracell and Fusion
‒ The change in Reported R&D expense was also impacted by
intangible asset impairments in the prior period
SG&A expense
‒ The change in SG&A expense (Reported and Core) in the period was
driven primarily by market development activities for launches and to support
continued growth in existing brands
Other operating income and expense
‒ In the prior year period, Other operating income and expense
included a $241m gain on the disposal of the US rights to Pulmicort Flexhaler
and a $712m gain relating to updates to contractual arrangements for Beyfortus
Net finance expense
‒ Core Net finance expense increased 6% (3% increase at CER)
principally due to the higher level of gross debt partially offset by the
higher level of cash and short-term investments.
Taxation
‒ The effective Reported Tax rate for the six months to 30 June 2024
was 21% (H1 2023: 17%) and the effective Core Tax rate was 20% (H1 2023: 18%)
‒ The cash tax paid for the six months to 30 June 2024 was $1,337m (H1
2023: $1,061m), representing 26% of Reported Profit before tax (H1 2023: 24%)
Dividend
‒ An Interim dividend of $1 per share (77.6 pence, 10.79 SEK) has been
declared.
Table 13: Cash Flow summary
H1 2024 H1 2023 Change
$m $m $m
Reported Operating profit 5,861 5,005 856
Depreciation, amortisation and impairment 2,534 2,778 (244)
Movement in working capital and short-term provisions (584) (747) 163
Gains on disposal of intangible assets (21) (249) 228
Fair value movements on contingent consideration arising from 251 202 49
business combinations
Non-cash and other movements (550) (594) 44
Interest paid (583) (483) (100)
Taxation paid (1,337) (1,061) (276)
Net cash inflow from operating activities 5,571 4,851 720
Net cash inflow before financing activities 286 3,085 (2,799)
Net cash inflow/(outflow) from financing activities 806 (3,550) 4,356
The change in Net cash inflow before financing activities in the half year to
30 June 2024 is primarily driven by the movement in Acquisitions of
subsidiaries, net of cash acquired and initial investment, of $2,771m, and
relates to the acquisition of Gracell Biotechnologies, Inc. for $774m and
acquisition of Fusion Pharmaceuticals Inc., for $1,997m as compared to the
acquisition of Neogene Therapeutics, Inc. for $189m in H1 2023.
The increase in Net cash inflow/(outflow) from financing activities of $4,356m
is primarily driven by the increase in Issue of loans and borrowings of
$1,160m, by the decrease in Repayment of loans and borrowings of $765m and the
increase in Movement in short-term borrowings of $2,431m mainly due to the
Commercial paper issued during the half year for $2,453m.
Capital expenditure
Capital expenditure amounted to $799m in H1 2024 (H1 2023: $517m). Capital
expenditure is expected to increase substantially in 2024, driven by
investment in several major manufacturing projects and continued investment in
technology upgrades.
Table 14: Net debt summary
At 30 At 31 At 30
Jun 2024 Dec 2023 Jun 2023
$m $m $m
Cash and cash equivalents 6,916 5,840 5,664
Other investments 160 122 148
Cash and investments 7,076 5,962 5,812
Overdrafts and short-term borrowings (596) (515) (421)
Commercial paper (2,453) - -
Lease liabilities (1,241) (1,128) (953)
Current instalments of loans (2,018) (4,614) (4,135)
Non-current instalments of loans (27,225) (22,365) (24,329)
Interest-bearing loans and borrowings (Gross debt) (33,533) (28,622) (29,838)
Net derivatives 133 150 56
Net debt (26,324) (22,510) (23,970)
Net debt increased by $3,814m in the six months to 30 June 2024 to $26,324m.
Details of the committed undrawn bank facilities are disclosed within the
going concern section of Note 1. Details of the Company's solicited credit
ratings and further details on Net debt are disclosed in Note 3.
Capital allocation
The Board's aim is to continue to strike a balance between the interests of
the business, financial creditors and the Company's shareholders. The
Company's capital allocation priorities include: investing in the business and
pipeline; maintaining a strong, investment-grade credit rating; potential
value-enhancing business development opportunities; and supporting the
progressive dividend policy.
In approving the declaration of dividends, the Board considers both the
liquidity of the company and the level of reserves legally available for
distribution. Dividends are paid to shareholders from AstraZeneca PLC, a Group
holding company with no direct operations. The ability of AstraZeneca PLC to
make shareholder distributions is dependent on the creation of profits for
distribution and the receipt of funds from subsidiary companies. The
consolidated Group reserves set out in the Condensed consolidated statement of
financial position do not reflect the profit available for distribution to the
shareholders of AstraZeneca PLC.
Summarised financial information for guarantee of securities of subsidiaries
AstraZeneca Finance LLC ("AstraZeneca Finance") is the issuer of 0.7% Notes
due 2024, 1.2% Notes due 2026, 4.8% Notes due 2027, 4.875% Notes due 2028,
1.75% Notes due 2028, 4.85% Notes due 2029, 4.9% Notes due 2030, 4.9% Notes
due 2031, 2.25% Notes due 2031, 4.875% Notes due 2033 and 5% Notes due 2034
(the "AstraZeneca Finance Notes"). Each series of AstraZeneca Finance Notes
has been fully and unconditionally guaranteed by AstraZeneca PLC. AstraZeneca
Finance is 100% owned by AstraZeneca PLC and each of the guarantees issued by
AstraZeneca PLC is full and unconditional and joint and several.
The AstraZeneca Finance Notes are senior unsecured obligations of AstraZeneca
Finance and rank equally with all of AstraZeneca Finance's existing and future
senior unsecured and unsubordinated indebtedness. The guarantee by AstraZeneca
PLC of the AstraZeneca Finance Notes is the senior unsecured obligation of
AstraZeneca PLC and ranks equally with all of AstraZeneca PLC's existing and
future senior unsecured and unsubordinated indebtedness. Each guarantee by
AstraZeneca PLC is effectively subordinated to any secured indebtedness of
AstraZeneca PLC to the extent of the value of the assets securing such
indebtedness. The AstraZeneca Finance Notes are structurally subordinated to
indebtedness and other liabilities of the subsidiaries of AstraZeneca PLC,
none of which guarantee the AstraZeneca Finance Notes.
AstraZeneca PLC manages substantially all of its operations through divisions,
branches and/or investments in subsidiaries and affiliates. Accordingly, the
ability of AstraZeneca PLC to service its debt and guarantee obligations is
also dependent upon the earnings of its subsidiaries, affiliates, branches and
divisions, whether by dividends, distributions, loans or otherwise.
Please refer to the Consolidated financial statements of AstraZeneca PLC in
our Annual Report on Form 20‑F as filed with the SEC and information
contained herein for further financial information regarding AstraZeneca PLC
and its consolidated subsidiaries. For further details, terms and conditions
of the AstraZeneca Finance Notes please refer to AstraZeneca PLC's reports on
Form 6-K furnished to the SEC on 22 February 2024, 3 March 2023 and 28 May
2021.
Pursuant to Rule 13-01 and Rule 3-10 of Regulation S-X under the Securities
Act of 1933, as amended (the "Securities Act"), we present below the summary
financial information for AstraZeneca PLC, as Guarantor, excluding its
consolidated subsidiaries, and AstraZeneca Finance, as the issuer, excluding
its consolidated subsidiaries. The following summary financial information of
AstraZeneca PLC and AstraZeneca Finance is presented on a combined basis and
transactions between the combining entities have been eliminated. Financial
information for non-guarantor entities has been excluded. Intercompany
balances and transactions between the obligor group and the non-obligor
subsidiaries are presented on separate lines.
Table 15: Obligor group summarised Statement of comprehensive income
H1 2024 H1 2023
$m $m
Total Revenue - -
Gross profit - -
Operating loss - (2)
Loss for the period (545) (480)
Transactions with subsidiaries that are not issuers or guarantors 964 9,487
Table 16: Obligor group summarised Statement of financial position
At 30 Jun 2024 At 30 Jun 2023
$m $m
Current assets 13 7
Non-current assets - -
Current liabilities (4,795) (4,091)
Non-current liabilities (27,133) (24,165)
Amounts due from subsidiaries that are not issuers or guarantors 20,730 15,761
Amounts due to subsidiaries that are not issuers or guarantors - (290)
Foreign exchange
The Company's transactional currency exposures on working capital balances,
which typically extend for up to three months, are hedged where practicable
using forward foreign exchange contracts against the individual companies'
reporting currency. Foreign exchange gains and losses on forward contracts
transacted for transactional hedging are taken to profit or to Other
comprehensive income if the contract is in a designated cashflow hedge. In
addition, the Company's external dividend payments, paid principally in pound
sterling and Swedish krona, are fully hedged from announcement to payment
date.
Table 17: Currency sensitivities
The Company provides the following information on currency-sensitivity:
Average Annual impact ($m) of 5% strengthening (FY 2024 average rate vs. FY 2023
average) (( 8 ))
rates vs. USD
Currency Primary Relevance FY YTD Change June Change Total Revenue Core Operating Profit
2023 9
2024 10
2024 11
(%) (%)
EUR Total Revenue 0.92 0.93 (0) 0.93 (0) 397 179
CNY Total Revenue 7.09 7.23 (2) 7.27 (3) 322 182
JPY Total Revenue 140.60 152.26 (8) 158.03 (11) 177 119
Other(( 12 )) 453 227
GBP Operating expense 0.80 0.79 2 0.79 2 60 (126)
SEK Operating expense 10.61 10.54 1 10.49 1 9 (63)
Related-party transactions
There have been no significant related-party transactions in the period.
Principal risks and uncertainties
The Principal Risks and uncertainties facing the Group are set out on pages 54
to 57 of the Annual Report and Form 20-F Information 2023, and summarised
below. They are not expected to change in respect of the second six months of
the financial year and remain appropriate for the Group. In summary, the
principal risks and uncertainties listed in the Annual Report and 20-F
Information 2023 are:
1. Product pipeline: failure or delay in the delivery of AstraZeneca's
pipeline or launch of new medicines; failure to meet regulatory or ethical
requirements for medicine development or approval
2. Commercialisation risks: pricing, affordability, access and competitive
pressures; failures or delays in the quality or execution of the Group's
commercial strategies
3. Supply-chain and business-execution risks: failure to maintain supply of
compliant, quality medicines; failure in information technology or
cybersecurity; failure to attract, develop, engage and retain a diverse,
talented and capable workforce
4. Legal, regulatory and compliance risks: safety and efficacy of marketed
medicines is questioned; adverse outcome of litigation and / or governmental
investigations; IP risks related to our products
5. Economic and financial risks: failure to achieve strategic plans or meet
targets or expectations; geopolitical and / or macroeconomic volatility
disrupts the operation of our global business
Sustainability
AstraZeneca released its first Sustainability Impact Publication
(https://www.astrazeneca.com/content/dam/az/Sustainability/2024/pdf/AZ-Impact-Publication-2024.pdf)
as a complement to its ninth annual Sustainability Report
(https://www.astrazeneca.com/content/dam/az/Sustainability/2024/pdf/Sustainability-Report-2023.pdf)
. This publication spotlights the diverse ways in which the Company is
contributing to the health of people, society and the planet.
Access to healthcare
‒ At the 77(th) World Health Assembly (WHA) in Geneva, Switzerland in
May, AstraZeneca convened Ministers of Health, industry, civil society and
patient groups. Areas of focus for engagement, led by Ruud Dobber, EVP
BioPharmaceuticals, included the need to increase early action to prevent,
diagnose and treat disease and to accelerate collaboration to build resilient,
equitable and net zero health systems
‒ At the WHA, AstraZeneca launched the expansion of its flagship
Healthy Heart Africa programme to include chronic kidney disease as well as
cardiovascular disease, recognising the growing burden of non-communicable
diseases (NCDs) in Africa. As of May 2024, HHA has conducted more than 57
million screenings for high blood pressure and identified more than 11.3
million elevated readings, with 4.5 million patients diagnosed with
hypertension since launch
‒ Also at the WHA, the Lung Ambition Alliance, of which the Company is
a founding member, launched the Saving Lives from Lung Cancer platform
and a calculator tool developed by AstraZeneca to support policymakers and the
lung cancer community in identifying high-risk populations for early
intervention
‒ The Partnership for Health System Sustainability and
Resilience (PHSSR) held its third Summit during the Abu Dhabi Global
Healthcare Week in May, bringing together more than 200 healthcare leaders
from the Middle East, Africa and beyond including three Ministers of Health
and 29 speakers, to drive forward the dialogue on investing in strengthening
health systems. PHSSR also hosted local events in Taiwan, Portugal and the
Netherlands during the quarter. In addition, insights from the PHSSR
Asia-Pacific report were shared with a delegation from Korea at WHA
‒ A survey of more than 600 employees in 16 countries where the Young
Health Programme (YHP) is active showed that more than 95% of employees feel
proud to be associated with the YHP. With its expansion into the Philippines,
the programme is now active in 41 countries globally. In recognition of the
impact of the YHP, AstraZeneca was the only corporate partner invited to speak
at UNICEF's Annual Meeting attended by UNICEF's 33 CEOs and their Board Chairs
in high-income countries
‒ In June, the Company expanded its partnership with Direct Relief,
approving the humanitarian organisation as a global medicine donation partner,
enabling medicine donation to support global humanitarian relief efforts
Environmental protection
‒ AstraZeneca received multiple recognitions for its sustainability
leadership this quarter, including retaining its EcoVadis Gold Medal ranking
for the second consecutive year. This reflects its place in the top three
percent of companies evaluated on environment, labour and human rights, ethics
and sustainable procurement. The Company was also recognised in the 2024 FT
Europe Climate Leaders list, where it was the top pharmaceutical company for
the second year in a row
‒ AstraZeneca is collaborating with the World Business Council for
Sustainable Development and its peers to develop a Roadmap to Nature Positive
for the pharmaceutical sector, announced in May. The Roadmap will offer
sector-specific guidance to accelerate toward nature positive, in alignment
with the Taskforce for Nature-related Financial Disclosures, Science-based
Targets Network and the EU's Corporate Sustainability Reporting Directive
‒ Pam Cheng, Executive Vice President of Global Operations and IT and
Chief Sustainability Officer, joined a Global Health Leaders panel at the
inaugural Climate and Health Day of the US Climate Action Summit. Leaders from
government, industry, philanthropy and finance discussed the critical need to
drive coordinated action on the climate and health nexus
Ethics and transparency
‒ AstraZeneca shared a new Diversity in Clinical Trials Standard
internally for use across all therapy areas in R&D. This outlines the
Company's mandatory principles on diversity for all AstraZeneca-sponsored
clinical trials, in line with regulatory requirements, and reflects the
Company's unwavering commitment to ensuring its clinical trials
are representative of diverse populations
‒ Approximately 6,500 colleagues across 10 regions and 16 business
units took the time to respond to AstraZeneca's second employee Ethics Survey.
An analysis of 2023 results showed employee feedback continues to be positive,
with 97% of respondents confirming they know how to raise an ethical concern
and 87% confirming that it is easy to do the right thing in their day-to-day
work
‒ The Company released new guidance on the selection, design,
installation and maintenance of solar Photovoltaic (PV) power systems, which
highlights the importance of conducting due diligence on human rights risks
associated with new solar PV projects
Research and development
This section covers R&D events and milestones that have occurred since the
prior results announcement on 25 April 2024, up to and including events on 24
July 2024.
A comprehensive view of AstraZeneca's pipeline of medicines in human trials
can be found in the latest Clinical Trials Appendix, available on
www.astrazeneca.com/investor-relations
(https://www.astrazeneca.com/investor-relations.html) . The Clinical Trials
Appendix includes tables with details of the ongoing clinical trials for
AstraZeneca medicines and new molecular entities in the pipeline.
Oncology
AstraZeneca presented new data across its diverse portfolio of cancer
medicines at two major medical congresses since the prior results
announcement: the American Society of Clinical Oncology (ASCO) in May and June
2024 and European Hematology Association (EHA) in June 2024. At ASCO,
AstraZeneca presented more than 100 abstracts featuring 25 approved and
potential new medicines across the Company's diverse oncology portfolio and
pipeline, including two late-breaking plenary presentations, a special
late-breaking abstract session presentation and 15 oral presentations. At EHA,
AstraZeneca presented 17 abstracts including one oral presentation and 10
posters across one approved and four investigational products.
Tagrisso
Event Commentary
Presentation: ASCO LAURA Primary analysis of the Phase III LAURA trial, presented at ASCO, showed
Tagrisso reduced the risk of disease progression or death by 84% compared to
placebo (HR 0.16, 95% CI 0.10-0.24, p<0.001) as assessed by BICR. Median
PFS was 39.1 months in patients treated with Tagrisso versus 5.6 months for
placebo.
sNDA acceptance and Priority Review US For the treatment of adult patients with unresectable, Stage III EGFRm NSCLC
after chemoradiotherapy. (LAURA, June 2024)
Approvals Japan, China Tagrisso with the addition of pemetrexed and platinum-based chemotherapy for
the 1st-line treatment of adult patients with locally advanced or metastatic
EGFRm NSCLC whose tumours have exon 19 deletions or exon 21 (L858R) mutations.
(FLAURA2, June 2024)
Approval Europe Tagrisso with the addition of pemetrexed and platinum-based chemotherapy for
the 1st-line treatment of adult patients with advanced EGFRm NSCLC whose
tumours have exon 19 deletions or exon 21 (L858R) mutations. (FLAURA2, July
2024)
Imfinzi and Imjudo
Event Commentary
Presentation: ASCO ADRIATIC Planned interim analysis of the Phase III ADRIATIC trial, presented at ASCO,
demonstrated Imfinzi reduced the risk of death by 27% versus placebo (OS HR
0.73, 95% CI 0.57-0.93, p=0.0104) with an estimated 57% of patients treated
with Imfinzi alive at three years compared to 48% on placebo. (June 2024)
Approval US Imfinzi in combination with carboplatin and paclitaxel followed by Imfinzi
monotherapy for treatment for adult patients with primary advanced or
recurrent endometrial cancer that is mismatch repair deficient. (DUO-E, June
2024)
Phase III data readout NIAGARA Met primary endpoint, with Imfinzi in combination with chemotherapy
demonstrating a statistically significant and clinically meaningful
improvement in the primary endpoint of event-free survival and the key
secondary endpoint of OS versus neoadjuvant chemotherapy for patients with
muscle-invasive bladder cancer. (June 2024)
Trial update BR.31 BR.31 Phase III trial for Imfinzi in early-stage (IB-IIIA) NSCLC after
complete tumour resection in patients whose tumours express PD-L1 on 25% or
more tumour cells did not achieve statistical significance for the primary
endpoint of disease-free survival versus placebo. (June 2024)
CHMP positive opinion Europe Imfinzi plus chemotherapy as 1st-line treatment followed by Lynparza and
Imfinzi for patients with mismatch repair proficient disease. Imfinzi plus
chemotherapy followed by Imfinzi alone for patients with mismatch repair
deficient disease. (DUO‑E, July 2024)
Lynparza
Event Commentary
CHMP positive opinion Europe Imfinzi plus chemotherapy as 1st-line treatment followed by Lynparza and
Imfinzi for patients with mismatch repair proficient disease. (DUO-E, July
2024)
Enhertu
Event Commentary
Phase III readout and presentation: ASCO DESTINY-Breast06 Met primary endpoint, demonstrating Enhertu resulted in a statistically
significant and clinically meaningful improvement in PFS in HR-positive,
HER2-low metastatic breast cancer following one or more lines of endocrine
therapy. (April 2024)
Primary analysis of the Phase III DESTINY-Breast06 trial, presented at ASCO,
demonstrated Enhertu resulted in a statistically significant and clinically
meaningful improvement in PFS compared to standard-of-care chemotherapy in
patients with HR-positive, HER2-low metastatic breast cancer (HR 0.62, 95% CI
0.51-0.74, p<0.0001). Enhertu also demonstrated a statistically significant
and clinically meaningful improvement in the overall trial population
(patients with HR-positive, HER2-low and HER2-ultralow disease) (HR 0.63, 95%
CI 0.53-0.75, p<0.0001). (June 2024)
Calquence
Event Commentary
Phase III readout and presentation: EHA ECHO Met primary endpoint with Calquence combination regimen demonstrating a
statistically significant and clinically meaningful improvement in PFS in
1st-line mantle cell lymphoma. (May 2024)
Interim analysis of the Phase III ECHO trial, presented at EHA, demonstrated
Calquence in combination with standard-of-care chemoimmunotherapy,
bendamustine and rituximab, resulted in a statistically significant and
clinically meaningful 27% reduction in risk of progression or death versus
standard of care in previously untreated adult patients with mantle cell
lymphoma (HR 0.73, 95% CI 0.57-0.94, p=0.016). The secondary endpoint of OS
showed a favourable trend for the Calquence combination compared to
chemoimmunotherapy (HR 0.86; 95% CI 0.65-1.13; p=0.2743, not statistically
significant, follow-up continues). (June 2024)
Truqap
Event Commentary
Phase III trial update CAPItello-290 CAPItello-290 Phase III trial for Truqap in combination with paclitaxel in
patients with locally advanced or metastatic TNBC did not meet the dual
primary endpoints of improvement in OS vs paclitaxel in combination with
placebo in either the overall trial population or in a subgroup of patients
with tumours harbouring specific biomarker alterations (PIK3CA, AKT1 or PTEN).
(June 2024)
Approval Europe In combination with Faslodex for the treatment of adult patients with estrogen
receptor-positive, HER2‑negative locally advanced or metastatic breast
cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence
or progression on or after an endocrine-based regimen. (CAPItello-291, June
2024)
Datopotamab deruxtecan (Dato-DXd)
Event Commentary
Phase IIII trial update TROPION-Lung01 Dual primary endpoint of improvement in overall survival for Dato-DXd versus
docetaxel not met. Numerical improvement in overall survival compared to
docetaxel in the overall trial population of patients with locally advanced or
metastatic NSCLC. In the prespecified subgroup of patients with non-squamous
NSCLC, Dato-DXd showed a clinically meaningful improvement in OS compared to
docetaxel. (May 2024)
BioPharmaceuticals - CVRM
Farxiga
Event Commentary
Approval US Improvement of glycaemic control in paediatric patients with type-2 diabetes
aged 10 years and older (T2NOW, June 2024)
AZD0780 (oral PCSK9)
Event Commentary
Presentation: European Atherosclerosis Society Positive Phase I data demonstrating a statistically significant reduction of
52% in LDL-C levels on top of rosuvastatin treatment, with 78% total reduction
from baseline, in treatment-naive participants with hypercholesterolaemia.
(May 2024)
BioPharmaceuticals - R&I
Tezspire
Event Commentary
Presentation: American Thoracic Society COURSE Results from the COURSE Phase II trial demonstrated that treatment with
Tezspire led to a 17% numerical reduction in the annual rate of moderate or
severe COPD exacerbations compared to placebo at week 52. In patients with
blood eosinophil counts of 150 cell/µl or more, treatment with Tezspire led
to a nominally significant reduction of 37% in the rate of moderate or severe
exacerbations compared to placebo. (May 2024)
Phase III readout DIRECTION Met the primary endpoint, demonstrating a statistically significant reduction
in annual asthma exacerbation rate (AAER) over 52 weeks compared to placebo in
patients in China with a history of uncontrolled asthma. (July 2024)
BioPharmaceuticals - V&I
sipavibart (COVID-19 mAb)
Event Commentary
Phase III readout SUPERNOVA Positive high-level results from the SUPERNOVA Phase III trial showed
sipavibart demonstrated a statistically significant reduction in the incidence
of symptomatic COVID‑19 in an immunocompromised patient population. The
trial was conducted during an evolving variant landscape in which COVID-19
cases captured over the course of the trial were caused by several different
SARS-CoV-2 variants. (May 2024)
Rare Disease
AstraZeneca presented new clinical data from the industry's largest and
broadest amyloidosis pipeline at the International Symposium on Amyloidosis
(ISA) in May 2024. Clinical data was presented on ALXN2220 and anselamimab,
which are being evaluated in Phase III clinical trials for ATTR and light
chain (AL) amyloidosis, respectively.
Interim financial statements
Table 18: Condensed consolidated statement of comprehensive income: H1 2024
For the half year ended 30 June 2024 2023
$m $m
Total Revenue 25,617 22,295
Product Sales 24,629 21,448
Alliance Revenue 939 627
Collaboration Revenue 49 220
Cost of sales (4,401) (3,865)
Gross profit 21,216 18,430
Distribution expense (267) (265)
Research and development expense (5,791) (5,278)
Selling, general and administrative expense (9,424) (9,045)
Other operating income and expense 127 1,163
Operating profit 5,861 5,005
Finance income 211 141
Finance expense (856) (795)
Share of after tax losses in associates and joint ventures (19) (1)
Profit before tax 5,197 4,350
Taxation (1,089) (726)
Profit for the period 4,108 3,624
Other comprehensive income:
Items that will not be reclassified to profit or loss:
Remeasurement of the defined benefit pension liability 101 7
Net gains/(losses) on equity investments measured at fair value through other 89 (48)
comprehensive income
Fair value movements related to own credit risk on bonds designated as fair 12 4
value through profit or loss
Tax on items that will not be reclassified to profit or loss (27) (5)
175 (42)
Items that may be reclassified subsequently to profit or loss:
Foreign exchange arising on consolidation (554) 105
Foreign exchange arising on designated liabilities in net investment hedges (96) (101)
Fair value movements on cash flow hedges (138) 89
Fair value movements on cash flow hedges transferred to profit and loss 102 (71)
Fair value movements on derivatives designated in net investment hedges 45 40
Gains/(costs) of hedging 14 (1)
Tax on items that may be reclassified subsequently to profit or loss 38 12
(589) 73
Other comprehensive (expense)/income, net of tax (414) 31
Total comprehensive income for the period 3,694 3,655
Profit attributable to:
Owners of the Parent 4,106 3,621
Non-controlling interests 2 3
4,108 3,624
Total comprehensive income attributable to:
Owners of the Parent 3,692 3,652
Non-controlling interests 2 3
3,694 3,655
Basic earnings per $0.25 Ordinary Share $2.65 $2.34
Diluted earnings per $0.25 Ordinary Share $2.63 $2.32
Weighted average number of Ordinary Shares in issue (millions) 1,549 1,549
Diluted weighted average number of Ordinary Shares in issue (millions) 1,560 1,560
Table 19: Condensed consolidated statement of comprehensive income: Q2 2024
For the quarter ended 30 June Unreviewed 13 Unreviewed
2024 2023
$m $m
Total Revenue 12,938 11,416
Product Sales 12,452 10,882
Alliance Revenue 482 341
Collaboration Revenue 4 193
Cost of sales (2,183) (1,960)
Gross profit 10,755 9,456
Distribution expense (132) (131)
Research and development expense (3,008) (2,667)
Selling, general and administrative expense (4,929) (4,986)
Other operating income and expense 60 784
Operating profit 2,746 2,456
Finance income 100 64
Finance expense (443) (431)
Share of after tax losses in associates and joint ventures (6) (1)
Profit before tax 2,397 2,088
Taxation (469) (268)
Profit for the period 1,928 1,820
Other comprehensive income:
Items that will not be reclassified to profit or loss:
Remeasurement of the defined benefit pension liability (43) 17
Net gains/(losses) on equity investments measured at fair value through other 54 (94)
comprehensive income
Fair value movements related to own credit risk on bonds designated as fair 12 2
value through profit or loss
Tax on items that will not be reclassified to profit or loss 12 (29)
35 (104)
Items that may be reclassified subsequently to profit or loss:
Foreign exchange arising on consolidation (39) (209)
Foreign exchange arising on designated liabilities in net investment hedges 2 (94)
Fair value movements on cash flow hedges (52) 33
Fair value movements on cash flow hedges transferred to profit and loss 32 4
Fair value movements on derivatives designated in net investment hedges 23 24
Costs of hedging (1) (1)
Tax on items that may be reclassified subsequently to profit or loss 3 -
(32) (243)
Other comprehensive income/(expense), net of tax 3 (347)
Total comprehensive income for the period 1,931 1,473
Profit attributable to:
Owners of the Parent 1,927 1,818
Non-controlling interests 1 2
1,928 1,820
Total comprehensive income attributable to:
Owners of the Parent 1,930 1,471
Non-controlling interests 1 2
1,931 1,473
Basic earnings per $0.25 Ordinary Share $1.24 $1.17
Diluted earnings per $0.25 Ordinary Share $1.24 $1.17
Weighted average number of Ordinary Shares in issue (millions) 1,550 1,550
Diluted weighted average number of Ordinary Shares in issue (millions) 1,560 1,560
Table 20: Condensed consolidated statement of financial position
Reviewed 14 Audited Reviewed
At 30 Jun At 31 Dec At 30 Jun
2024 2023 2023
$m $m $m
Assets
Non-current assets
Property, plant and equipment 9,630 9,402 8,675
Right-of-use assets 1,203 1,100 949
Goodwill 21,060 20,048 19,960
Intangible assets 39,426 38,089 38,326
Investments in associates and joint ventures 264 147 72
Other investments 1,607 1,530 1,071
Derivative financial instruments 217 228 163
Other receivables 806 803 752
Deferred tax assets 4,734 4,718 3,736
78,947 76,065 73,704
Current assets
Inventories 5,667 5,424 5,051
Trade and other receivables 11,047 12,126 11,092
Other investments 160 122 148
Derivative financial instruments 28 116 44
Income tax receivable 1,575 1,426 840
Cash and cash equivalents 6,916 5,840 5,664
25,393 25,054 22,839
Total assets 104,340 101,119 96,543
Liabilities
Current liabilities
Interest-bearing loans and borrowings (5,067) (5,129) (4,556)
Lease liabilities (292) (271) (231)
Trade and other payables (20,463) (22,374) (19,738)
Derivative financial instruments (51) (156) (83)
Provisions (1,168) (1,028) (567)
Income tax payable (1,525) (1,584) (1,200)
(28,566) (30,542) (26,375)
Non-current liabilities
Interest-bearing loans and borrowings (27,225) (22,365) (24,329)
Lease liabilities (949) (857) (722)
Derivative financial instruments (61) (38) (68)
Deferred tax liabilities (3,333) (2,844) (2,800)
Retirement benefit obligations (1,326) (1,520) (1,078)
Provisions (1,074) (1,127) (1,357)
Other payables (2,208) (2,660) (2,398)
(36,176) (31,411) (32,752)
Total liabilities (64,742) (61,953) (59,127)
Net assets 39,598 39,166 37,416
Equity
Capital and reserves attributable to equity holders of the Parent
Share capital 388 388 387
Share premium account 35,199 35,188 35,163
Other reserves 2,078 2,065 2,076
Retained earnings 1,847 1,502 (234)
39,512 39,143 37,392
Non-controlling interests 86 23 24
Total equity 39,598 39,166 37,416
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 - - - 3,621 3,621 3 3,624
Other comprehensive income - - - 31 31 - 31
Transfer to other reserves - - 7 (7) - - -
Transactions with owners
Dividends - - - (3,047) (3,047) - (3,047)
Issue of Ordinary Shares - 8 - - 8 - 8
Share-based payments charge for the period - - - 274 274 - 274
Settlement of share plan awards - - - (532) (532) - (532)
Net movement - 8 7 340 355 3 358
At 30 Jun 2023 387 35,163 2,076 (234) 37,392 24 37,416
At 1 Jan 2024 388 35,188 2,065 1,502 39,143 23 39,166
Profit for the period - - - 4,106 4,106 2 4,108
Other comprehensive expense - - - (414) (414) - (414)
Transfer to other reserves - - 13 (13) - - -
Transactions with owners
Dividends - - - (3,052) (3,052) - (3,052)
Issue of Ordinary Shares - 11 - - 11 - 11
Changes in non-controlling interests - - - - - 61 61
Share-based payments charge for the period - - - 307 307 - 307
Settlement of share plan awards - - - (589) (589) - (589)
Net movement - 11 13 345 369 63 432
At 30 Jun 2024 388 35,199 2,078 1,847 39,512 86 39,598
Table 22: Condensed consolidated statement of cash flows: H1 2024
For the half year ended 30 June 2024 2023
$m $m
Cash flows from operating activities
Profit before tax 5,197 4,350
Finance income and expense 645 654
Share of after tax losses of associates and joint ventures 19 1
Depreciation, amortisation and impairment 2,534 2,778
Movement in working capital and short-term provisions (584) (747)
Gains on disposal of intangible assets (21) (249)
Fair value movements on contingent consideration arising from business 251 202
combinations
Non-cash and other movements (550) (594)
Cash generated from operations 7,491 6,395
Interest paid (583) (483)
Tax paid (1,337) (1,061)
Net cash inflow from operating activities 5,571 4,851
Cash flows from investing activities
Acquisition of subsidiaries, net of cash acquired (2,771) (189)
Payments upon vesting of employee share awards attributable to business - (23)
combinations
Payment of contingent consideration from business combinations (474) (398)
Purchase of property, plant and equipment (799) (517)
Disposal of property, plant and equipment 53 126
Purchase of intangible assets (1,474) (1,436)
Disposal of intangible assets 75 288
Movement in profit-participation liability - 175
Purchase of non-current asset investments (67) (26)
Disposal of non-current asset investments 51 10
Movement in short-term investments, fixed deposits and other investing 42 90
instruments
Payments to associates and joint ventures (140) -
Disposal of investments in associates and joint ventures 13 -
Interest received 206 134
Net cash outflow from investing activities (5,285) (1,766)
Net cash inflow before financing activities 286 3,085
Cash flows from financing activities
Proceeds from issue of share capital 11 8
Issue of loans and borrowings 4,976 3,816
Repayment of loans and borrowings (2,643) (3,408)
Dividends paid (3,050) (3,069)
Hedge contracts relating to dividend payments (8) 27
Repayment of obligations under leases (150) (129)
Movement in short-term borrowings 2,503 72
Payment of Acerta Pharma share purchase liability (833) (867)
Net cash inflow/(outflow) from financing activities 806 (3,550)
Net increase/(decrease) in Cash and cash equivalents in the period 1,092 (465)
Cash and cash equivalents at the beginning of the period 5,637 5,983
Exchange rate effects (52) (47)
Cash and cash equivalents at the end of the period 6,677 5,471
Cash and cash equivalents consist of:
Cash and cash equivalents 6,916 5,664
Overdrafts (239) (193)
6,677 5,471
Responsibility statement of the directors in respect of the half-yearly financial report
We confirm that to the best of our knowledge:
‒ the condensed consolidated Interim Financial Statements have been
prepared in accordance with IAS 34
'Interim Financial Reporting' as issued by the International Accounting
Standards Board (IASB), IAS 34 as adopted by the European Union and UK-adopted
IAS 34;
‒ the half-yearly management report gives a true and fair view of the
assets, liabilities, financial position and profit or loss of the company;
‒ the half-yearly management report includes a fair review of the
information required by:
a) DTR 4.2.7R of the Disclosure and Transparency Rules, being an indication
of important events that have occurred during the first six months of the
financial year and their impact on the condensed consolidated Interim
Financial Statements; and a description of the principal risks and
uncertainties for the remaining six months of the year; and
b) DTR 4.2.8R of the Disclosure and Transparency Rules, being related party
transactions that have taken place in the first six months of the current
financial year and that have materially affected the financial position or
performance of the enterprise during that period; and any changes in the
related party transactions described in the last annual report that could do
so.
The Board
The Board of Directors that served during all or part of the six month period
to 30 June 2024 and their respective responsibilities can be found on the
Leadership team section of astrazeneca.com
(https://www.astrazeneca.com/our-company/leadership.html) .
Approved by the Board and signed on its behalf by
Pascal Soriot
Chief Executive Officer
25 July 2024
Independent review report to AstraZeneca PLC
Report on the Interim financial statements
Our conclusion
We have reviewed AstraZeneca PLC's Interim financial statements (the "Interim
financial statements") in the half-yearly financial report of AstraZeneca PLC
for the six month period ended 30 June 2024 (the "period").
Based on our review, nothing has come to our attention that causes us to
believe that the Interim financial statements are not prepared, in all
material respects, in accordance with International Accounting Standard 34,
'Interim Financial Reporting' (IAS 34), as issued by the International
Accounting Standards Board (IASB), IAS 34 as adopted by the European Union,
UK-adopted IAS 34, and the Disclosure Guidance and Transparency Rules
sourcebook of the United Kingdom's Financial Conduct Authority.
The Interim financial statements comprise:
‒ the Condensed consolidated statement of financial position as at 30
June 2024;
‒ the Condensed consolidated statement of comprehensive income: H1
2024 for the period then ended;
‒ the Condensed consolidated statement of changes in equity for the
period then ended;
‒ the Condensed consolidated statement of cash flows: H1 2024 for the
period then ended; and
‒ the explanatory notes to the Interim financial statements.
The Interim financial statements included in the half-yearly financial report
of AstraZeneca PLC have been prepared in accordance with International
Accounting Standard 34, 'Interim Financial Reporting' (IAS 34), as issued by
the International Accounting Standards Board (IASB), IAS 34 as adopted by the
European Union, UK-adopted IAS 34, and the Disclosure Guidance and
Transparency Rules sourcebook of the United Kingdom's Financial Conduct
Authority.
Basis for conclusion
We conducted our review in accordance with International Standard on Review
Engagements (UK) 2410, 'Review of Interim Financial Information Performed by
the Independent Auditor of the Entity' issued by the Financial Reporting
Council for use in the United Kingdom ("ISRE (UK) 2410"). A review of interim
financial information consists of making enquiries, primarily of persons
responsible for financial and accounting matters, and applying analytical and
other review procedures.
A review is substantially less in scope than an audit conducted in accordance
with International Standards on Auditing (UK) and, consequently, does not
enable us to obtain assurance that we would become aware of all significant
matters that might be identified in an audit. Accordingly, we do not express
an audit opinion.
We have read the other information contained in the half-yearly financial
report and considered whether it contains any apparent misstatements or
material inconsistencies with the information in the Interim financial
statements.
Conclusions relating to going concern
Based on our review procedures, which are less extensive than those performed
in an audit as described in the Basis for conclusion section of this report,
nothing has come to our attention to suggest that the directors have
inappropriately adopted the going concern basis of accounting or that the
directors have identified material uncertainties relating to going concern
that are not appropriately disclosed. This conclusion is based on the review
procedures performed in accordance with ISRE (UK) 2410. However, future events
or conditions may cause the group to cease to continue as a going concern.
Independent review report to AstraZeneca PLC (continued)
Responsibilities for the Interim financial statements and the review
Our responsibilities and those of the directors
The half-yearly financial report, including the Interim financial statements,
is the responsibility of, and has been approved by the directors. The
directors are responsible for preparing the half-yearly financial report in
accordance with the Disclosure Guidance and Transparency Rules sourcebook of
the United Kingdom's Financial Conduct Authority. In preparing the half-yearly
financial report, including the Interim financial statements, the directors
are responsible for assessing the group's ability to continue as a going
concern, disclosing, as applicable, matters related to going concern and using
the going concern basis of accounting unless the directors either intend to
liquidate the group or to cease operations, or have no realistic alternative
but to do so.
Our responsibility is to express a conclusion on the Interim financial
statements in the half-yearly financial report based on our review. Our
conclusion, including our Conclusions relating to going concern, is based on
procedures that are less extensive than audit procedures, as described in the
Basis for conclusion paragraph of this report. This report, including the
conclusion, has been prepared for and only for the company for the purpose of
complying with the Disclosure Guidance and Transparency Rules sourcebook of
the United Kingdom's Financial Conduct Authority and for no other purpose. We
do not, in giving this conclusion, accept or assume responsibility for any
other purpose or to any other person to whom this report is shown or into
whose hands it may come save where expressly agreed by our prior consent in
writing.
PricewaterhouseCoopers LLP
Chartered Accountants
London
25 July 2024
Notes to the Interim financial statements
Note 1: Basis of preparation and accounting policies
These unaudited condensed consolidated Interim financial statements for the
six months ended 30 June 2024 have been prepared in accordance with
International Accounting Standard 34, 'Interim Financial Reporting' (IAS 34),
as issued by the International Accounting Standards Board (IASB), IAS 34 as
adopted by the European Union, UK-adopted IAS 34 and the Disclosure Guidance
and Transparency Rules sourcebook of the United Kingdom's Financial Conduct
Authority and with the requirements of the Companies Act 2006 as applicable to
companies reporting under those standards.
The unaudited Interim financial statements for the six months ended 30 June
2024 were approved by the Board of Directors for publication on 25 July 2024.
This results announcement does not constitute statutory accounts of the Group
within the meaning of sections 434(3) and 435(3) of the Companies Act 2006.
The annual financial statements of the Group for the year ended 31 December
2023 were prepared in accordance with UK-adopted international accounting
standards and with the requirements of the Companies Act 2006. The annual
financial statements also comply fully with IFRS Accounting Standards as
issued by the IASB and International Accounting Standards as adopted by the
European Union. Except for the estimation of the interim income tax charge,
the Interim financial statements have been prepared applying the accounting
policies that were applied in the preparation of the Group's published
consolidated financial statements for the year ended 31 December 2023.
The comparative figures for the financial year ended 31 December 2023 are not
the Group's statutory accounts for that financial year. Those accounts have
been reported on by the Group's auditors and have been delivered to the
Registrar of Companies; their report was (i) unqualified, (ii) did not include
a reference to any matters to which the auditors drew attention by way of
emphasis without qualifying their report, and (iii) did not contain a
statement under section 498(2) or (3) of the Companies Act 2006.
Going concern
The Group has considerable financial resources available. As at 30 June 2024,
the Group has $11.8bn in financial resources (cash and cash equivalent
balances of $6.9bn and undrawn committed bank facilities of $4.9bn, with
$5.4bn of borrowings due within one year). These facilities contain no
financial covenants and were undrawn at 30 June 2024. The $4.9bn facilities
are available until April 2029. Additionally, there are a further $2.0bn
undrawn committed bank facilities available until February 2025.
The Group's revenues are largely derived from sales of medicines covered by
patents, which provide a relatively high level of resilience and
predictability to cash inflows, although government price interventions in
response to budgetary constraints are expected to continue to adversely affect
revenues in some of our significant markets. The Group, however, anticipates
new revenue streams from both recently launched medicines and those in
development, and the Group has a wide diversity of customers and suppliers
across different geographic areas.
Consequently, the Directors believe that, overall, the Group is well placed to
manage its business risks successfully. Accordingly, they continue to adopt
the going concern basis in preparing the Interim financial statements.
Legal proceedings
The information contained in Note 6 updates the disclosures concerning legal
proceedings and contingent liabilities in the Group's Annual Report and Form
20-F Information 2023.
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2023/pdf/AstraZeneca_AR_2023.pdf)
Employee Benefit Trust
Following an amendment to the Employee Benefit Trust (EBT) Deed on 10th June
2024, AstraZeneca obtained control and commenced consolidation of the EBT.
Going forward, cash paid on purchases of AstraZeneca Ordinary shares or
American Depository Receipts will be presented within Financing activities in
the Cash flow statement.
Note 2: Intangible assets
In accordance with IAS 36 'Impairment of Assets', reviews for triggers of
impairment or impairment reversals at an individual asset or cash generating
unit level were conducted, and impairment tests carried out where triggers
were identified. As a result, total impairment charge of $26m has been
recorded against intangible assets during the six months ended 30 June 2024
(H1 2023: $320m net charge). In H1 2023, net impairment charges included the
$244m impairment of the ALXN1840 intangible asset, following the decision to
discontinue this development programme in Wilson's disease.
The acquisition of Icosavax, Inc. completed on 19 February 2024. The
transaction is recorded as an asset acquisition based on the concentration
test permitted under IFRS 3 'Business Combinations', with consideration of
$841m principally relating to $639m of intangible assets, $141m of cash and
cash equivalents and $51m of marketable securities. Contingent consideration
of up to $300m could be paid on achievement of regulatory and sales
milestones; these potential liabilities would be recorded when the relevant
recognition event for a regulatory or sales milestone is achieved.
Note 3: Net debt
The table below provides an analysis of Net debt and a reconciliation of Net
Cash flow to the movement in Net debt. The Group monitors Net debt as part of
its capital management policy as described in Note 28 of the Annual Report and
Form 20-F Information 2023
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2023/pdf/AstraZeneca_AR_2023.pdf)
. Net debt is a non-GAAP financial measure.
Table 23: Net debt
At 1 Jan 2024 Cash flow Acquisitions Non-cash Exchange movements At 30 Jun 2024
& other
$m $m $m $m $m $m
Non-current instalments of loans (22,365) (4,973) (3) (2) 118 (27,225)
Non-current instalments of leases (857) - (12) (97) 17 (949)
Total long-term debt (23,222) (4,973) (15) (99) 135 (28,174)
Current instalments of loans (4,614) 2,583 (9) (5) 27 (2,018)
Current instalments of leases (271) 174 (6) (197) 8 (292)
Commercial paper - (2,453) - - - (2,453)
Collateral received from derivative counterparties (215) 13 - - - (202)
Other short-term borrowings excluding overdrafts (97) (63) - - 5 (155)
Overdrafts (203) (35) - - (1) (239)
Total current debt (5,400) 219 (15) (202) 39 (5,359)
Gross borrowings (28,622) (4,754) (30) (301) 174 (33,533)
Net derivative financial instruments 150 65 - (82) - 133
Net borrowings (28,472) (4,689) (30) (383) 174 (33,400)
Cash and cash equivalents 5,840 885 242 - (51) 6,916
Other investments - current 122 (42) 87 - (7) 160
Cash and investments 5,962 843 329 - (58) 7,076
Net debt (22,510) (3,846) 299 (383) 116 (26,324)
Net debt increased by $3,814m in the half year to $26,324m. Details of the
committed undrawn bank facilities are disclosed within the going concern
section of Note 1. Non-cash movements in the period include fair value
adjustments under IFRS 9 'Financial Instruments'.
In February 2024, AstraZeneca issued the following:
- $1,250m of fixed-rate notes with a coupon of 4.8% maturing in
February 2027
- $1,250m of fixed-rate notes with a coupon of 4.85% maturing in
February 2029
- $1,000m of fixed-rate notes with a coupon of 4.9% maturing in
February 2031
- $1,500m of fixed-rate notes with a coupon of 5% maturing in February
2034
AstraZeneca repaid two bonds of carrying value $2,569m in Q2 2024 included in
the cash outflow from Repayment of loans and borrowings of $2,643m.
AstraZeneca also issued Commercial paper during the half year and the balance
as at 30 June 2024 is $2,453m (H1 2023: $nil).
The Group has agreements with some bank counterparties whereby the parties
agree to post cash collateral on financial derivatives, for the benefit of the
other, equivalent to the market valuation of the derivative positions above a
predetermined threshold. The carrying value of such cash collateral held by
the Group at 30 June 2024 was $202m (31 December 2023: $215m) and the carrying
value of such cash collateral posted by the Group at 30 June 2024 was $97m (31
December 2023: $102m).
The equivalent GAAP measure to Net debt is 'liabilities arising from financing
activities', which excludes the amounts for cash and overdrafts, other
investments and non-financing derivatives shown above and includes the Acerta
Pharma share purchase liability of $nil (31 December 2023: $833m).
During the six months ended 30 June 2024, there have been no changes to the
Company's solicited long term credit ratings. Moody's credit ratings were long
term: A2; short term: P-1. Standard and Poor's credit ratings were long term:
A; short term: A-1.
Note 4: Financial Instruments
As detailed in the Group's most recent annual financial statements, the
principal financial instruments consist of derivative financial instruments,
other investments, trade and other receivables, cash and cash equivalents,
trade and other payables, lease liabilities and interest-bearing loans and
borrowings.
The Group has certain equity investments that are categorised as Level 3 in
the fair value hierarchy that are held at $337m (31 December 2023: $313m) and
for which a fair value gain of $1m has been recognised in the six months ended
30 June 2024 (H1 2023: $1m). In the absence of specific market data, these
unlisted investments are held at fair value based on the cost of investment
and adjusted as necessary for impairments and revaluations on new funding
rounds, which are seen to approximate the fair value. All other fair value
gains and/or losses that are presented in Net gains/(losses) on equity
investments measured at fair value through other comprehensive income, in the
Condensed consolidated statement of comprehensive income for the six months
ended 30 June 2024, are Level 1 fair value measurements, valued based on
quoted prices in active markets.
Financial instruments measured at fair value include $1,670m of other
investments, $5,463m held in money-market funds and $133m of derivatives as at
30 June 2024. With the exception of derivatives being Level 2 fair valued, and
certain equity instruments of $350m categorised as Level 3, the aforementioned
balances are Level 1 fair valued. Financial instruments measured at amortised
cost include $97m of cash collateral pledged to counterparties. The total fair
value of interest-bearing loans and borrowings at 30 June 2024, which have a
carrying value of $33,533m in the Condensed consolidated statement of
financial position, was $32,231m.
Table 24: Financial instruments - contingent consideration
2024 2023
Diabetes alliance Other Total Total
$m $m $m $m
At 1 January 1,945 192 2,137 2,222
Additions through business combinations - 198 198 60
Settlements (473) (1) (474) (398)
Revaluations 220 31 251 202
Discount unwind 50 7 57 66
At 30 June 1,742 427 2,169 2,152
Contingent consideration arising from business combinations is fair valued
using decision-tree analysis, with key inputs including the probability of
success, consideration of potential delays and the expected levels of future
revenues.
The contingent consideration balance relating to BMS's share of the global
diabetes alliance of $1,742m (31 December 2023: $1,945m) would
increase/decrease by $174m with an increase/decrease in sales of 10%, as
compared with the current estimates.
Note 5: Business combinations
Gracell
On 22 February 2024, AstraZeneca completed the acquisition of Gracell
Biotechnologies Inc. (Gracell), a global clinical-stage biopharmaceutical
company developing innovative cell therapies for the treatment of cancer and
autoimmune diseases. Gracell will operate as a wholly owned subsidiary of
AstraZeneca, with operations in China and the US.
The acquisition enriches AstraZeneca's growing pipeline of cell therapies with
AZD0120 (formerly GC012F), a novel, clinical-stage T-cell (CAR-T: therapeutic
chimeric antigen receptor) therapy. AZD0120 is a potential new treatment for
multiple myeloma, as well as other haematologic malignancies and autoimmune
diseases, including Systemic Lupus Erythematosus (SLE).
The transaction is recorded as a business combination using the acquisition
method of accounting in accordance with IFRS 3 'Business Combinations'.
Consequently, the assets acquired, and liabilities assumed are recorded at
fair value. Due to the proximity of the acquisition to the reporting date, the
purchase price allocation exercise under IFRS 3 is in process, with the
following items disclosed on a provisional basis.
Fair values
$m
Intangible assets 1,038
Cash and cash equivalents 212
Net deferred tax liability (260)
Other immaterial balances (89)
Total net assets acquired 901
Goodwill 136
Consideration 1,037
The total consideration fair value of $1,037m includes cash consideration of
$983m and future regulatory milestone-based consideration of $54m. Intangible
assets recognised relate to products in development, principally AZD0120, and
were fair valued using the multi-period excess earnings method, which uses
several estimates regarding the amount and timing of future cash flows. The
key assumptions in the cash flows are PTRS, peak year sales and revenue
erosion profiles.
The net deferred tax liability of $260m principally arises from the deferred
tax impact of the uplift in fair value of intangible assets.
Goodwill of $136m has been recognised, which principally comprises the premium
attributable to the core technological capabilities and knowledge base of the
company. Goodwill is not expected to be deductible for tax purposes.
Gracell's results have been consolidated into the Group's results from 22
February 2024.
Fusion
On 4 June 2024, AstraZeneca completed the acquisition of Fusion
Pharmaceuticals Inc., (Fusion) a clinical-stage biopharmaceutical company
developing next-generation radioconjugates. The acquisition marks a major step
forward in AstraZeneca delivering on its ambition to transform cancer
treatment and outcomes for patients by replacing traditional regimens like
chemotherapy and radiotherapy with more targeted treatments. As a result of
the acquisition, Fusion became a wholly owned subsidiary of AstraZeneca, with
operations in Canada and the US.
This acquisition complements AstraZeneca's leading oncology portfolio with the
addition of the Fusion pipeline of radioconjugates, including their most
advanced programme, FPI-2265, a potential new treatment for patients with
metastatic castration-resistant prostate cancer (mCRPC), and brings new
expertise and pioneering R&D, manufacturing and supply chain capabilities
in actinium-based radioconjugates to AstraZeneca.
The transaction is recorded as a business combination using the acquisition
method of accounting in accordance with IFRS 3 'Business Combinations'.
Consequently, the assets acquired, and liabilities assumed are recorded at
fair value. Due to the proximity of the acquisition to the reporting date, the
purchase price allocation exercise under IFRS 3 is in process, with the
following items disclosed on a provisional basis.
Fair values
$m
Intangible assets 1,326
Cash and cash equivalents 30
Current investments 87
Net deferred tax liability (246)
Other immaterial balances 51
Total net assets acquired 1,248
Goodwill 947
Consideration 2,195
The total consideration fair value of $2,195m includes cash consideration of
$2,051m and future regulatory milestone-based consideration of $144m.
Intangible assets relating to products in development comprise the FPI-2265
($848m), FPI-2059 ($165m) and AZD2068 ($313m) programmes. These were fair
valued using the multi-period excess earnings method, which uses several
estimates regarding the amount and timing of future cash flows. The key
assumptions in the cash flows are PTRS, peak year sales and revenue erosion
profiles.
The net deferred tax liability of $246m principally arises from the deferred
tax impact of the uplift in fair value of intangible assets.
Goodwill recognised comprises a number of not individually quantifiable
elements. These include the premium attributable to a pre-existing well
positioned business in the innovation intensive biopharmaceuticals market with
a highly skilled workforce, unidentified potential products that future
research and development may yield, and the core capabilities and knowledge
base of the company including radioisotope supply and manufacturing expertise.
Goodwill is not expected to be deductible for tax purposes.
Immediately prior to the acquisition, AstraZeneca held an approximately 1%
shareholding in Fusion considered to have a fair value of $24m.
Fusion's results have been consolidated into the Group's results from 4 June
2024.
Note 6: Legal proceedings and contingent liabilities
AstraZeneca is involved in various legal proceedings considered typical to its
business, including litigation and investigations, including Government
investigations, relating to product liability, commercial disputes,
infringement of intellectual property (IP) rights, the validity of certain
patents, anti-trust law and sales and marketing practices. The matters
discussed below constitute the more significant developments since publication
of the disclosures concerning legal proceedings in the Company's Annual Report
and Form 20-F Information 2023 (the Disclosures). Information about the nature
and facts of the cases is disclosed in accordance with IAS 37.
As discussed in the Disclosures, the majority of claims involve highly complex
issues. Often these issues are subject to substantial uncertainties and,
therefore, the probability of a loss, if any, being sustained and/or an
estimate of the amount of any loss is difficult to ascertain.
In cases that have been settled or adjudicated, or where quantifiable fines
and penalties have been assessed and which are not subject to appeal, or where
a loss is probable and we are able to make a reasonable estimate of the loss,
AstraZeneca records the loss absorbed or makes a provision for its best
estimate of the expected loss. The position could change over time and the
estimates that the Company made, and upon which the Company have relied in
calculating these provisions are inherently imprecise. There can, therefore,
be no assurance that any losses that result from the outcome of any legal
proceedings will not exceed the amount of the provisions that have been booked
in the accounts. The major factors causing this uncertainty are described more
fully in the Disclosures and herein.
AstraZeneca has full confidence in, and will vigorously defend and enforce,
its IP.
Matters disclosed in respect of the second quarter of 2024 and to 25 July 2024
Patent litigation
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
Enhertu
US patent proceedings
In October 2020, Seagen Inc. (Seagen) filed a complaint against Daiichi Sankyo
Company, Limited (Daiichi Sankyo) in the US District Court for the Eastern
District of Texas (District Court) alleging that Enhertu infringes a Seagen
patent. AstraZeneca co-commercialises Enhertu with Daiichi Sankyo, Inc. in the
US. After trial in April 2022, the jury found that the patent was infringed
and awarded Seagen $41.82m in past damages. In July 2022, the District Court
entered final judgment and declined to enhance damages on the basis of
wilfulness. In October 2023, the District Court entered an amended final
judgment that requires Daiichi Sankyo to pay Seagen a royalty of 8% on US
sales of Enhertu from 1 April 2022 through to 4 November 2024, in addition to
the past damages previously awarded by the District Court. AstraZeneca and
Daiichi Sankyo have appealed the District Court's decision.
In December 2020 and January 2021, AstraZeneca and Daiichi Sankyo, Inc. filed
post-grant review (PGR) petitions with the US Patent and Trademark Office
(USPTO) alleging, among other things, that the Seagen patent is invalid for
lack of written description and enablement. The USPTO initially declined to
institute the PGRs, but, in April 2022, the USPTO granted the rehearing
requests and instituted both PGR petitions. Seagen subsequently disclaimed all
patent claims at issue in one of the PGR proceedings. In July 2022, the USPTO
reversed its institution decision and declined to institute the other PGR
petition. AstraZeneca and Daiichi Sankyo, Inc. requested reconsideration of
the decision not to institute review of the patent. In February 2023, the
USPTO reinstituted the PGR proceeding. In February 2024, the USPTO issued a
decision that the claims were unpatentable. Seagen has appealed this decision.
Tagrisso
US patent proceedings
In September 2021, Puma Biotechnology, Inc. (Puma) and Wyeth LLC (Wyeth) filed
a patent infringement lawsuit in the US District Court for the District of
Delaware (District Court) against AstraZeneca relating to Tagrisso. In March
2024, the District Court dismissed Puma. The trial, with Wyeth as the
plaintiff, took place in May 2024. The jury found Wyeth's patents infringed
and awarded Wyeth $107.5m in past damages. The jury also found that the
infringement was not wilful. A bench trial on AstraZeneca's indefiniteness and
equitable defenses took place in June 2024. The parties await the court's
decision on the bench trial issues and consideration of post-trial motions.
Legal proceedings brought by AstraZeneca considered to be contingent assets
Calquence
US patent proceedings
In February 2022, in response to Paragraph IV notices from multiple ANDA
filers, AstraZeneca filed patent infringement lawsuits in the US District
Court for the District of Delaware (District Court). In its complaint,
AstraZeneca alleged that a generic version of Calquence capsules, if approved
and marketed, would infringe patents that are owned or licensed by
AstraZeneca. In 2024, AstraZeneca entered into settlement agreements with all
five generic manufacturers, resolving the Calquence capsule ANDA litigation
proceedings.
In April 2024, AstraZeneca received a Paragraph IV notice from an ANDA filer
relating to patents listed in the FDA Orange Book with reference to Calquence
tablets. In May 2024, in response to the Paragraph IV notice, AstraZeneca
filed a patent infringement lawsuit against Cipla Limited and Cipla USA, Inc.
in the District Court, alleging that a generic version of Calquence tablets,
if approved and marketed, would infringe patents that are owned or licensed by
AstraZeneca.
Lokelma
US patent proceedings
In August 2022, in response to Paragraph IV notices, AstraZeneca initiated
ANDA litigation against multiple generic filers in the US District Court for
the District of Delaware (District Court). AstraZeneca alleged that a generic
version of Lokelma, if approved and marketed, would infringe patents that are
owned or licensed by AstraZeneca.
AstraZeneca entered into separate settlement agreements with two generic
manufacturers which resulted in dismissal of the corresponding litigations.
Additional proceedings with the remaining generic manufacturers are ongoing in
the District Court. Trial is scheduled for March 2025.
Lynparza
US patent proceedings
In December 2022, AstraZeneca received a Paragraph IV notice from Natco Pharma
Limited (Natco) relating to Lynparza patents. In February 2023, in response to
the Paragraph IV notice, AstraZeneca, MSD International Business GmbH, and the
University of Sheffield initiated ANDA litigation against Natco in the US
District Court for the District of New Jersey (District Court). In the
complaint, AstraZeneca alleged that Natco's generic version of Lynparza, if
approved and marketed, would infringe AstraZeneca's patents. No trial date has
been scheduled.
In December 2023, AstraZeneca received a Paragraph IV notice from Sandoz Inc.
(Sandoz) relating to Lynparza patents. In February 2024, in response to the
Paragraph IV notice, AstraZeneca, MSD International Business GmbH, and the
University of Sheffield initiated ANDA litigation against Sandoz in the
District Court. In the complaint, AstraZeneca alleged that Sandoz's generic
version of Lynparza, if approved and marketed, would infringe AstraZeneca's
patents. No trial date has been scheduled.
In May 2024, AstraZeneca filed additional ANDA actions against Natco and
Sandoz asserting recently issued patents covering Lynparza. These actions have
been consolidated with the earlier filed ANDA actions and no trial date has
been scheduled.
In May 2024, AstraZeneca received a Paragraph IV notice from Cipla USA, Inc.
and Cipla Limited (collectively, Cipla) relating to Lynparza patents. In June
2024, in response to the Paragraph IV notice, AstraZeneca, MSD International
Business GmbH, and the University of Sheffield initiated ANDA litigation
against Cipla in the District Court. In the complaint, AstraZeneca alleged
that Cipla's generic version of Lynparza, if approved and marketed, would
infringe AstraZeneca's patents. No trial date has been scheduled.
Soliris
US patent proceedings
In January 2024, Alexion initiated patent infringement litigation against
Samsung Bioepis Co. Ltd. (Samsung) in the US District Court for the District
of Delaware alleging that Samsung's biosimilar eculizumab product will
infringe six Soliris-related patents. No trial date has been scheduled. Five
of the six asserted patents are also the subject of inter partes review (IPR)
proceedings before the US Patent and Trademark Office. Alexion filed a motion
for a preliminary injunction seeking to enjoin Samsung from launching its
biosimilar eculizumab product upon FDA approval. The court denied Alexion's
motion and Alexion has appealed that decision. On 22 July 2024, Samsung
announced FDA approval of Samsung's biosimilar.
European patent proceedings
In March 2024, Alexion filed motions for provisional measures against Amgen
Pharmaceuticals Inc (Amgen) and Samsung Bioepis Co. Ltd. (Samsung) and their
respective affiliates at the Hamburg Local Division of the Unified Patent
Court on the basis that Amgen's and Samsung's biosimilar eculizumab products
infringe an Alexion patent. In June 2024 the UPC denied the requested
provisional measures. Alexion has appealed this decision. In parallel, Samsung
has filed opposition to the patent at the European Patent Office.
UK patent proceedings
In May 2024, Alexion initiated patent infringement proceedings against Amgen
Ltd and Samsung Bioepis UK Ltd (Samsung UK) in the UK High Court of Justice
alleging that their respective biosimilar eculizumab products infringe an
Alexion patent; on the same day, Samsung UK initiated a revocation action for
the same patent. Trial has been scheduled for March 2025.
Tagrisso
Russia patent proceedings
In Russia, in August 2023, AstraZeneca filed lawsuits in the Arbitration Court
of the Moscow Region (Court) against the Ministry of Health of the Russian
Federation and Axelpharm LLC (Axelpharm) related to Axelpharm's improper use
of AstraZeneca's information to obtain authorisation to market a generic
version of Tagrisso. In December 2023, the Court dismissed the lawsuit against
the Ministry of Health of the Russian Federation. The appellate court affirmed
the dismissal in March 2024. AstraZeneca filed a further appeal, which remains
pending. The lawsuit against Axelpharm remains pending.
In Russia, in November 2023, Axelpharm filed a compulsory licensing action
against AstraZeneca in the Court related to a patent that covers Tagrisso. The
compulsory licensing action remains pending. AstraZeneca has also challenged
before the Russian Patent and Trademark Office ("PTO") the validity of the
Axelpharm patent on which the compulsory licensing action is predicated; that
challenge remains pending before the Russian PTO.
In July 2024, AstraZeneca filed a patent infringement lawsuit and an unfair
competition claim with the Federal Anti-Monopoly Service of Russia against
AxelPharm and others related to the securing of state contracts in Russia for
its generic version of osimertinib.
Commercial litigation
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
Anti-Terrorism Act Civil Lawsuit
US proceedings
In the US, in October 2017, AstraZeneca and certain other pharmaceutical
and/or medical device companies were named as defendants in a complaint filed
in the US District Court for the District of Columbia (District Court) by US
nationals (or their estates, survivors, or heirs) who were killed or wounded
in Iraq between 2005 and 2013. The plaintiffs allege that the defendants
violated the US Anti-Terrorism Act and various state laws by selling
pharmaceuticals and medical supplies to the Iraqi Ministry of Health. In July
2020, the District Court granted AstraZeneca's and the other defendants'
motion to dismiss the lawsuit, which the DC Circuit Court of Appeals (the
Appellate Court) reversed in January 2022. In June 2024, the United States
Supreme Court issued an order vacating the 2022 decision and granted
AstraZeneca's and the other defendants' request for a remand to the Appellate
Court for reconsideration under new case law.
Employment Litigation
US proceedings
In December 2022, AstraZeneca was served with a lawsuit filed by seven former
employees in the US District Court for the District of Delaware (District
Court) asserting claims of discrimination on grounds of age and religion,
related to AstraZeneca's vaccination requirement. In March 2023, AstraZeneca
filed a partial motion to dismiss certain religious discrimination claims and
a motion to strike the class and collective claims. In September 2023,
Plaintiffs moved for conditional certification of the collective action. In
June 2024, the District Court granted AstraZeneca's partial motion to dismiss,
granted AstraZeneca's motion to strike, and denied without prejudice
Plaintiff's motion for conditional certification.
Pay Equity Litigation
US proceedings
AstraZeneca is defending a putative class and collective action in the US
District Court for the Northern District of Illinois (District Court) brought
by three named plaintiffs, who are former AstraZeneca employees. The case
involves claims under the federal and Illinois Equal Pay Acts, with the
plaintiffs alleging they were paid less than male employees who performed
substantially similar and/or equal work. In May 2024, the District Court
conditionally certified a collective under the federal Equal Pay Act and
authorised the sending of notice to potential collective action members. The
notice was distributed in June 2024.
University of Sheffield Contract Dispute
UK proceedings
In June 2024, AstraZeneca was served with a lawsuit filed by the University of
Sheffield (Sheffield). In its complaint, Sheffield alleges that AstraZeneca
made misrepresentations to induce Sheffield to amend a patent license relating
to Lynparza. AstraZeneca is considering its response.
Viela Bio, Inc. Shareholder Litigation
US proceedings
In February 2023, AstraZeneca was served with a lawsuit filed in Delaware
state court against AstraZeneca and certain officers (collectively,
Defendants), on behalf of a putative class of Viela Bio, Inc. (Viela)
shareholders. The complaint alleged that the Defendants breached their
fiduciary duty to Viela shareholders in the course of Viela's 2021 merger with
Horizon Therapeutics, plc. In July 2024, the Court granted with prejudice
AstraZeneca's motion to dismiss.
Legal proceedings brought by AstraZeneca considered to be contingent assets
PARP Inhibitor Royalty Dispute
UK proceedings
In October 2012, Tesaro, Inc. (now wholly owned by GlaxoSmithKline plc, (GSK))
entered into two worldwide, royalty-bearing patent license agreements with
AstraZeneca related to GSK's product niraparib. In May 2021, AstraZeneca filed
a lawsuit against GSK in the Commercial Court of England and Wales alleging
that GSK had failed to pay all of the royalties due on niraparib sales under
the license agreements. In April 2023, after trial, the trial court issued a
decision in AstraZeneca's favour. In February 2024, the Court of Appeal
reversed the decision. In March 2024, AstraZeneca filed a request for
permission to appeal with the Supreme Court of the United Kingdom. In May
2024, the Supreme Court denied permission to appeal. The case will return to
the trial court for further proceedings.
Government investigations/proceedings
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
Boston US Attorney Investigation
US Proceedings
In June 2024, AstraZeneca was served with a subpoena issued by the US
Attorney's Office in Boston, seeking documents and information relating to
payments by AstraZeneca to healthcare providers. AstraZeneca is cooperating
with this enquiry.
Turkish Ministry of Health Matter
Turkey proceedings
In Turkey, in July 2020, the Turkish Ministry of Health (Ministry of Health)
initiated an investigation regarding payments to healthcare providers by
Alexion and former employees and consultants. The investigation arose from
Alexion's disclosure of a $21.5m civil settlement with the US Securities &
Exchange Commission (SEC) in July 2020 fully resolving the SEC's investigation
into possible violations of the US Foreign Corrupt Practices Act. In September
2021, the Ministry of Health completed its draft investigation report, and
referred the matter to the Ankara Public Prosecutor's Office with a
recommendation for further proceedings against certain former employees. In
June 2024, the Ankara Public Prosecutor's Office closed its investigation
without further action.
Legal proceedings brought by AstraZeneca considered to be contingent assets
Inflation Reduction Act Litigation
US proceedings
In August 2023, AstraZeneca filed a lawsuit in the US District Court for the
District of Delaware (District Court) against the US Department of Health and
Human Services (HHS) challenging aspects of the drug price negotiation
provisions of the Inflation Reduction Act and the implementing guidance and
regulations. In March 2024, the District Court granted HHS' motions and
dismissed AstraZeneca's lawsuit. AstraZeneca has appealed the District Court's
decision.
340B State Litigation
US proceedings
AstraZeneca has filed lawsuits against Arkansas, Kansas, Louisiana, Maryland,
Minnesota, Mississippi, and West Virginia challenging the constitutionality of
each state's 340B statute. In the Arkansas matter, trial is scheduled for
April 2025. In the Louisiana matter, AstraZeneca and the state have filed
motions for summary judgment and a hearing was held in June 2024. The
remaining matters are in their preliminary stages.
Other
Additional government inquiries
As is true for most, if not all, major prescription pharmaceutical companies,
AstraZeneca is currently involved in multiple inquiries into drug marketing
and pricing practices. In addition to the investigations described above,
various law enforcement offices have, from time to time, requested information
from the Group. There have been no material developments in those matters.
Matters disclosed in respect of the first quarter of 2024 and to 25 April 2024
Patent litigation
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
Forxiga
UK patent proceedings
In the UK, one of AstraZeneca's patents relating to Forxiga is being
challenged by Generics (UK) Limited, Teva Pharmaceutical Industries Limited,
and Glenmark Pharmaceuticals Europe Limited. Trial is scheduled for March
2025.
Tagrisso
US patent proceedings
In September 2021, Puma Biotechnology, Inc. (Puma) and Wyeth LLC (Wyeth) filed
a patent infringement lawsuit in the US District Court for the District of
Delaware (District Court) against AstraZeneca relating to Tagrisso. In March
2024, the District Court dismissed Puma. A trial, with Wyeth as the plaintiff,
has been scheduled for May 2024.
Legal proceedings brought by AstraZeneca considered to be contingent assets
Calquence
US patent proceedings
In February 2022, in response to Paragraph IV notices from multiple ANDA
filers, AstraZeneca filed patent infringement lawsuits in the US District
Court for the District of Delaware (District Court). In its complaint,
AstraZeneca alleged that a generic version of Calquence capsules, if approved
and marketed, would infringe patents that are owned or licensed by
AstraZeneca. Trial is scheduled for March 2025.
In March and April 2024, AstraZeneca entered into settlement agreements with
generic manufacturers, Sandoz Inc., and Natco Pharma Limited with Natco Pharma
Inc., resulting in dismissal of the corresponding Calquence capsule ANDA
litigation proceedings. Additional Calquence capsule ANDA litigation
proceedings with the remaining three generic manufacturers are ongoing in the
District Court.
In April 2024, AstraZeneca received a Paragraph IV notice from an ANDA filer
relating to patents listed in the FDA Orange Book with reference to Calquence
tablets. AstraZeneca is considering its response.
Lokelma
US patent proceedings
In August 2022, in response to Paragraph IV notices, AstraZeneca initiated
ANDA litigation against multiple generic filers in the US District Court for
the District of Delaware (District Court). Trial is scheduled for March 2025.
AstraZeneca entered into a settlement agreement with a generic manufacturer,
Alkem Laboratories, which resulted in dismissal of the corresponding
litigation. Additional proceedings with the remaining generic manufacturers
are ongoing in the District Court.
Soliris
US patent proceedings
In January 2024, Alexion initiated patent infringement litigation against
Samsung Bioepis Co. Ltd. (Samsung) in the US District Court for the District
of Delaware alleging that Samsung's biosimilar eculizumab product, for which
Samsung is currently seeking FDA approval, will infringe six Soliris-related
patents. No trial date has been scheduled. Five of the six asserted patents
are also the subject of inter partes review proceedings before the US Patent
and Trademark Office. In February 2024, Alexion filed a motion for a
preliminary injunction seeking to enjoin Samsung from launching its biosimilar
eculizumab product upon FDA approval. A hearing on Alexion's preliminary
injunction motion is scheduled for May 2024.
European patent proceedings
In March 2024, Alexion filed motions for preliminary injunctions against Amgen
and Samsung at the Hamburg Local Division of the Unified Patent Court on the
basis that Amgen's and Samsung's biosimilar eculizumab products infringe
Alexion's eculizumab molecule patent that is expected to grant in Q2 2024. No
hearing date for the preliminary injunction motions has been set.
Tagrisso
Russia patent proceedings
In Russia, in August 2023, AstraZeneca filed lawsuits in the Arbitration Court
of the Moscow Region (Court) against the Ministry of Health of the Russian
Federation and Axelpharm LLC (Axelpharm) related to Axelpharm's improper use
of AstraZeneca's information to obtain authorisation to market a generic
version of Tagrisso. In December 2023, the Court dismissed the lawsuit against
the Ministry of Health of the Russian Federation. In January 2024, AstraZeneca
filed an appeal, and the appellate court affirmed the dismissal in March 2024.
The lawsuit against Axelpharm remains pending.
In Russia, in November 2023, Axelpharm filed a compulsory licensing action
against AstraZeneca in the Court related to a patent that covers Tagrisso. The
compulsory licensing action remains pending.
Product liability litigation
Legal proceedings brought against AstraZeneca for which a provision has been taken
Nexium and Losec/Prilosec
US proceedings
AstraZeneca has been defending lawsuits brought in federal and state courts
involving claims that plaintiffs have been diagnosed with various injuries
following treatment with proton pump inhibitors (PPIs), including Nexium and
Prilosec. Most of the lawsuits alleged kidney injury. In August 2017, the
pending federal court cases were consolidated into a multidistrict litigation
(MDL) proceeding in the US District Court for the District of New Jersey for
pre-trial purposes. Cases alleging kidney injury were also filed in Delaware
and New Jersey state courts.
In addition, AstraZeneca has been defending lawsuits involving allegations of
gastric cancer following treatment with PPIs, including one such claim in the
US District Court for the Middle District of Louisiana (Louisiana District
Court).
In October 2023, AstraZeneca resolved all pending claims in the MDL, as well
as all pending claims in Delaware and New Jersey state courts, for $425m, for
which a provision has been taken. The only remaining case is the one pending
in the Louisiana District Court, which is scheduled for trial in January 2025.
Canada proceedings
In Canada, in July and August 2017, AstraZeneca was served with three putative
class action lawsuits. Two of the lawsuits have been dismissed, one in 2019
and one in 2021. The third lawsuit seeks authorisation to represent individual
residents in Canada who allegedly suffered kidney injuries from the use of
proton pump inhibitors, including Nexium and Losec.
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
Onglyza and Kombiglyze
US proceedings
In the US, AstraZeneca has been defending various lawsuits in both California
state court and in a consolidated federal proceeding alleging heart failure,
cardiac injuries, and/or death from treatment with Onglyza or Kombiglyze. In
the California state court proceeding, the trial court granted summary
judgment for AstraZeneca, which the California appellate court affirmed. The
California Supreme Court has declined further review, and the California
matter has concluded. The consolidated federal cases were dismissed in August
2022 by the US District Court for the Eastern District of Kentucky. That
dismissal was affirmed by the US Court of Appeals for the Sixth Circuit in
February 2024.
Vaxzevria
UK proceedings
AstraZeneca is defending lawsuits in the UK involving multiple claimants
alleging injuries following vaccination with AstraZeneca's COVID-19 vaccine.
Most of the lawsuits involve claims of thrombosis with thrombocytopenia
syndrome. No trial dates have been scheduled.
Commercial litigation
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
340B Antitrust Litigation
US proceedings
In September 2021, AstraZeneca was served with a class-action antitrust
complaint filed in the US District Court for the Western District of New York
(District Court) by Mosaic Health alleging a conspiracy to restrict access to
340B discounts in the diabetes market through contract pharmacies. In
September 2022, the District Court granted AstraZeneca's motion to dismiss the
Complaint. In February 2024, the District Court denied Plaintiffs' request to
file an amended complaint and entered an order closing the matter. In March
2024, Plaintiffs filed an appeal.
Definiens
Germany proceedings
In Germany, in July 2020, AstraZeneca received a notice of arbitration filed
with the German Institution of Arbitration from the sellers of Definiens AG
(the Sellers) regarding the 2014 Share Purchase Agreement (SPA) between
AstraZeneca and the Sellers. The Sellers claim that they are owed
approximately $140m in earn-outs under the SPA. In December 2023, after an
arbitration hearing, the arbitration panel made a final award of $46.43m in
favour of the Sellers. In March 2024, AstraZeneca filed an application with
the Bavarian Supreme Court to set aside the arbitration award.
Legal proceedings brought by AstraZeneca considered to be contingent assets
PARP Inhibitor Royalty Dispute
UK proceedings
In October 2012, Tesaro, Inc. (now wholly owned by GlaxoSmithKline plc, (GSK))
entered into two worldwide, royalty-bearing patent license agreements with
AstraZeneca related to GSK's product niraparib. In May 2021, AstraZeneca filed
a lawsuit against GSK in the Commercial Court of England and Wales alleging
that GSK had failed to pay all of the royalties due on niraparib sales under
the license agreements. In April 2023, after trial, the trial court issued a
decision in AstraZeneca's favour. In February 2024, Court of Appeal reversed.
In March 2024, AstraZeneca filed a request for permission to appeal with the
Supreme Court of the United Kingdom.
Government investigations/proceedings
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
340B Qui Tam
US proceedings
In July 2023, AstraZeneca was served with an unsealed civil lawsuit brought by
a qui tam relator on behalf of the United States, several states, and the
District of Columbia in the US District Court for the Central District of
California (District Court). The complaint alleges that AstraZeneca violated
the US False Claims Act and state law analogues. In March 2024, the District
Court granted AstraZeneca's motion to dismiss the First Amended Complaint
without leave to amend. In April 2024, the relator filed an appeal.
Legal proceedings brought by AstraZeneca considered to be contingent assets
Inflation Reduction Act Litigation
US proceedings
In August 2023, AstraZeneca filed a lawsuit in the US District Court for the
District of Delaware (District Court) against the US Department of Health and
Human Services (HHS) challenging aspects of the drug price negotiation
provisions of the Inflation Reduction Act and the implementing guidance and
regulations. In March 2024, the District Court granted HHS' motions and
dismissed AstraZeneca's lawsuit.
Arkansas 340B Litigation
US proceedings
In March 2024, AstraZeneca filed a lawsuit against the State of Arkansas
alleging that the Arkansas's 340B statute is preempted by federal law and
unconstitutional.
Other
Additional government inquiries
As is true for most, if not all, major prescription pharmaceutical companies,
AstraZeneca is currently involved in multiple inquiries into drug marketing
and pricing practices. In addition to the investigations described above,
various law enforcement offices have, from time to time, requested information
from the Group. There have been no material developments in those matters.
Note 7: Subsequent events
On 15 July 2024, AstraZeneca completed the acquisition of Amolyt Pharma, a
clinical-stage biotechnology company focused on developing novel treatments
for rare endocrine diseases. AstraZeneca acquired all outstanding equity of
Amolyt for a total consideration of up to $1.05 billion, on a cash and debt
free basis. This includes an initial payment of $800m on deal closing, subject
to customary closing adjustments, and a further up to $250m in contingent
milestones-based consideration. Due to the timing of the transaction post
period end, the accounting and other disclosures will be finalised in the
second half of 2024.
Note 8
Table 25: H1 2024 - Product Sales year-on-year analysis 15
The CER information in respect of H1 2024 included in the Interim financial
statements has not been reviewed by PricewaterhouseCoopers LLP.
World US Emerging Markets Europe Established RoW
$m Act % chg CER % chg $m % chg $m Act % chg CER % chg $m Act % chg CER % chg $m Act % chg CER % chg
Oncology 9,737 17 21 4,387 20 2,300 18 28 1,967 25 23 1,083 (2) 8
Tagrisso 3,203 10 13 1,282 16 919 8 16 628 16 15 374 (11) (2)
Imfinzi 2,259 20 25 1,202 17 245 35 58 459 38 36 353 7 19
Calquence 1,508 27 28 1,048 21 75 82 n/m 320 42 41 65 30 34
Lynparza 1,450 6 9 607 5 320 15 26 398 9 8 125 (14) (6)
Enhertu 249 n/m n/m - - 161 n/m n/m 57 n/m n/m 31 n/m n/m
Zoladex 549 19 27 8 20 415 22 31 77 16 14 49 2 12
Imjudo 136 35 38 88 30 7 n/m n/m 16 n/m n/m 25 (5) 6
Truqap 142 n/m n/m 141 n/m - - - - - - 1 n/m n/m
Orpathys 25 14 19 - - 25 14 19 - - - - - -
Others 216 (21) (15) 11 6 133 (21) (15) 12 (36) (36) 60 (21) (12)
BioPharmaceuticals: CVRM 6,164 18 22 1,483 16 2,749 17 24 1,559 33 32 373 (8) 2
Farxiga 3,785 35 38 867 37 1,474 37 44 1,233 45 44 211 (15) (5)
Brilinta 665 - 2 354 (1) 166 4 14 136 - (1) 9 (26) (19)
Crestor 589 1 6 22 (18) 475 4 9 22 (30) (29) 70 3 13
Seloken/Toprol-XL 315 (8) (1) - n/m 307 (8) (1) 6 4 7 2 (39) (37)
Lokelma 249 26 30 115 10 42 75 83 41 62 61 51 16 31
roxadustat 163 22 27 - - 163 22 27 - - - - n/m n/m
Andexxa 105 18 21 42 14 2 n/m n/m 40 38 36 21 (9) 4
Wainua 21 n/m n/m 21 n/m - - - - - - - - -
Others 272 (30) (28) 62 (50) 120 (27) (22) 81 (10) (10) 9 (7) (5)
BioPharmaceuticals: R&I 3,601 17 20 1,567 21 1,032 16 23 680 17 16 322 7 12
Symbicort 1,491 16 19 598 38 450 11 21 286 - (1) 157 (4) (2)
Fasenra 781 5 6 478 2 41 45 53 192 9 8 70 (2) 6
Pulmicort 379 10 14 8 (53) 317 16 22 37 1 (1) 17 (13) (9)
Breztri 454 48 51 225 37 131 61 69 65 80 79 33 33 44
Tezspire 100 n/m n/m - - 5 n/m n/m 61 n/m n/m 34 n/m n/m
Saphnelo 203 77 77 184 71 2 n/m n/m 10 n/m n/m 7 86 91
Airsupra 21 n/m n/m 21 n/m - - - - - - - - -
Others 172 (27) (26) 53 (47) 86 (18) (14) 29 3 2 4 (12) (10)
BioPharmaceuticals: V&I 324 (27) (24) 55 n/m 131 (12) (7) 81 (28) (30) 57 (68) (65)
Synagis 253 (11) (6) (1) n/m 131 4 10 67 (27) (29) 56 (15) (6)
Beyfortus 54 n/m n/m 53 n/m - - - - (81) (61) 1 n/m n/m
FluMist 8 n/m n/m 3 n/m - - - 5 n/m 97 - n/m n/m
COVID-19 mAbs 3 (98) (98) - - - n/m n/m 3 (58) (59) - n/m n/m
Others 6 (79) (80) - - - n/m n/m 6 (41) (43) - n/m n/m
Rare Disease 4,243 11 15 2,517 10 454 40 70 794 3 2 478 9 20
Ultomiris 1,804 32 35 1,032 27 66 n/m n/m 411 32 31 295 42 58
Soliris 1,439 (13) (8) 808 (9) 255 19 54 260 (29) (30) 116 (33) (30)
Strensiq 653 16 18 529 17 31 30 47 48 14 12 45 4 15
Koselugo 247 55 64 101 13 83 n/m n/m 45 95 92 18 n/m n/m
Kanuma 100 17 20 47 18 19 7 20 30 24 25 4 11 20
Other medicines 560 (9) (2) 52 (24) 385 (1) 8 53 10 10 70 (35) (29)
Nexium 459 (7) 1 47 (22) 318 4 15 26 3 2 68 (34) (28)
Others 101 (17) (14) 5 (40) 67 (22) (18) 27 18 19 2 (53) (49)
Total Product Sales 24,629 15 18 10,061 17 7,051 16 26 5,134 21 19 2,383 (6) 3
Table 26: Q2 2024 - Product Sales year-on-year analysis (Unreviewed) 16
The Q2 2024 information in respect of the three months ended 30 June 2024
included in the Interim financial statements has not been reviewed by
PricewaterhouseCoopers LLP.
World US Emerging Markets Europe Established RoW
$m Act % chg CER % chg $m % chg $m Act % chg CER % chg $m Act % chg CER % chg $m Act % chg CER % chg
Oncology 4,976 14 18 2,302 17 1,098 11 22 1,015 24 24 561 (9) 2
Tagrisso 1,608 8 12 658 13 432 6 15 327 15 15 191 (12) (1)
Imfinzi 1,147 13 18 620 15 117 16 39 227 33 33 183 (9) 3
Calquence 790 21 22 554 14 36 51 72 167 42 43 33 20 23
Lynparza 744 4 7 319 3 153 8 18 206 10 11 66 (15) (6)
Enhertu 127 89 99 - - 77 60 72 31 n/m n/m 19 n/m n/m
Zoladex 273 17 25 5 29 201 17 28 42 23 21 25 6 17
Imjudo 74 17 19 49 37 4 n/m n/m 8 64 55 13 (38) (30)
Truqap 92 n/m n/m 91 n/m - - - - - - 1 n/m n/m
Orpathys 12 (7) (3) - - 12 (7) (3) - - - - - -
Others 109 (17) (11) 6 24 66 (16) (10) 7 (11) (10) 30 (26) (16)
BioPharmaceuticals: CVRM 3,153 18 22 735 11 1,384 17 24 843 38 38 191 (14) (3)
Farxiga 1,940 29 32 394 16 763 32 39 680 49 49 103 (23) (14)
Brilinta 342 3 5 191 7 78 (1) 6 69 1 1 4 (38) (23)
Crestor 292 4 11 12 (2) 234 8 14 10 (34) (32) 36 3 15
Seloken/Toprol-XL 150 (8) - - n/m 146 (8) - 3 46 53 1 (40) (38)
Lokelma 136 36 41 64 29 21 68 78 23 63 64 28 16 33
roxadustat 88 20 26 - - 88 20 26 - - - - - -
Andexxa 59 29 35 22 34 1 n/m n/m 22 51 51 14 (6) 8
Wainua 16 n/m n/m 16 n/m - - - - - - - - -
Others 130 (26) (24) 36 (45) 53 (19) (14) 36 (9) (8) 5 (14) (12)
BioPharmaceuticals: R&I 1,797 21 24 830 23 444 23 34 350 21 21 173 8 14
Symbicort 722 20 25 299 49 197 12 25 143 4 5 83 (4) (1)
Fasenra 423 4 5 268 - 19 33 46 99 11 11 37 3 11
Pulmicort 155 25 30 3 (53) 126 40 47 17 6 2 9 (18) (13)
Breztri 235 44 47 120 43 61 42 49 35 68 69 19 26 37
Tezspire 57 n/m n/m - - 3 n/m n/m 35 n/m n/m 19 n/m n/m
Saphnelo 112 65 65 101 59 1 28 n/m 6 n/m n/m 4 90 86
Airsupra 14 n/m n/m 14 n/m - - - - - - - - -
Others 79 (24) (22) 25 (52) 37 7 12 15 2 3 2 (6) (4)
BioPharmaceuticals: V&I 112 28 42 28 n/m 41 (10) 4 7 (55) (53) 36 36 55
Synagis 81 (6) 8 (1) n/m 41 (16) (2) 6 (42) (42) 35 27 46
Beyfortus 28 n/m n/m 27 n/m - - - - n/m (91) 1 n/m n/m
FluMist 2 n/m n/m 2 n/m - - - - (26) (21) - - -
COVID-19 mAbs 1 n/m n/m - - - n/m n/m 1 (65) (64) - (99) (99)
Others - n/m n/m - - - - - - n/m n/m - - -
Rare Disease 2,147 10 14 1,311 10 203 35 67 392 3 3 241 7 18
Ultomiris 946 33 36 550 27 35 n/m n/m 209 38 38 152 38 56
Soliris 700 (14) (8) 398 (11) 129 30 74 118 (36) (36) 55 (36) (33)
Strensiq 340 13 14 283 14 10 7 15 24 13 13 23 4 17
Koselugo 114 43 45 55 13 24 73 80 26 n/m n/m 9 63 85
Kanuma 47 3 8 25 21 5 (54) (49) 15 28 33 2 11 41
Other medicines 267 (11) (5) 28 (13) 179 (3) 5 24 (7) (7) 36 (38) (32)
Nexium 219 (12) (5) 25 (17) 146 (2) 7 13 (5) (5) 35 (37) (32)
Others 48 (9) (6) 3 39 33 (8) (4) 11 (9) (9) 1 (54) (49)
Total Product Sales 12,452 14 18 5,234 16 3,349 15 25 2,631 23 23 1,238 (5) 5
Table 27: Alliance Revenue
H1 2024 H1 2023
$m $m
Enhertu 683 475
Tezspire 180 105
Beyfortus 26 -
Other Alliance Revenue 50 47
Total 939 627
Table 28: Collaboration Revenue
H1 2024 H1 2023
$m $m
Farxiga: sales milestones 49 25
COVID-19 mAbs licence fees - 180
Other Collaboration Revenue - 15
Total 49 220
Table 29: Other operating income and expense
H1 2024 H1 2023
$m $m
brazikumab licence termination funding - 75
Divestment of US rights to Pulmicort Flexhaler - 241
Update to the contractual relationships for Beyfortus (nirsevimab) - 712
Other 127 135
Total 127 1,163
Other shareholder information
Financial calendar
Announcement of 9M and Q3 2024 results: 12 November 2024
Announcement of FY and Q4 2024 results: 6 February 2025
Dividends are normally paid as follows:
First interim: announced with half year results and paid in September
Second interim: announced with full year results and paid in March
The record date for the first interim dividend for 2024, payable on 9
September 2024, will be 9 August 2024. The ex-dividend date will be 8 August
2024.
Conclusion of audit tender
Following a rigorous process, the audit tender for the Group's external audit
provider has now concluded. The Audit Committee has recommended, and the Board
has endorsed, the appointment of KPMG as the Group's external auditor for the
financial year ending 31 December 2026. A resolution will be put to
shareholders at the 2026 Annual General Meeting (AGM) to approve this
appointment. It is intended that PwC, who have been the Group's auditor since
the year ended 31 December 2017, will continue as the Group's auditors for the
years ended 31 December 2024 and 2025 and will cease to hold office at the
conclusion of the Company's 2026 AGM.
Contacts
For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.
Addresses for correspondence
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Deutsche Bank Trust Company Americas
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db@astfinancial.com (mailto:db@astfinancial.com)
Trademarks
Trademarks of the AstraZeneca group of companies appear throughout this
document in italics. Medical publications also appear throughout the document
in italics. AstraZeneca, the AstraZeneca logotype and the AstraZeneca symbol
are all trademarks of the AstraZeneca group of companies. Trademarks of
companies other than AstraZeneca that appear in this document include:
Beyfortus, a trademark of Sanofi Pasteur Inc.; Enhertu, a trademark of
Daiichi Sankyo; Seloken, owned by AstraZeneca or Taiyo Pharma Co., Ltd
(depending on geography); Synagis, owned by AstraZeneca or Sobi aka Swedish
Orphan Biovitrum AB (publ). (depending on geography); and Tezspire, a
trademark of Amgen, Inc.
Information on or accessible through AstraZeneca's websites, including
astrazeneca.com (https://www.astrazeneca.com/) , does not form part of and is
not incorporated into this announcement.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical
company that focuses on the discovery, development, and commercialisation of
prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals,
including Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients worldwide.
Please visit astrazeneca.com (http://www.astrazeneca.com/) and follow the
Company on Social Media @AstraZeneca
(https://www.linkedin.com/company/astrazeneca) .
Cautionary statements regarding forward-looking statements
In order, among other things, to utilise the 'safe harbour' provisions of the
US Private Securities Litigation Reform Act of 1995, AstraZeneca (hereafter
'the Group') provides the following cautionary statement:
This document contains certain forward-looking statements with respect to the
operations, performance and financial condition of the Group, including, among
other things, statements about expected revenues, margins, earnings per share
or other financial or other measures. Although the Group believes its
expectations are based on reasonable assumptions, any forward-looking
statements, by their very nature, involve risks and uncertainties and may be
influenced by factors that could cause actual outcomes and results to be
materially different from those predicted. The forward-looking statements
reflect knowledge and information available at the date of preparation of this
document and the Group undertakes no obligation to update these
forward-looking statements. The Group identifies the forward-looking
statements by using the words 'anticipates', 'believes', 'expects', 'intends'
and similar expressions in such statements. Important factors that could cause
actual results to differ materially from those contained in forward-looking
statements, certain of which are beyond the Group's control, include, among
other things:
‒ the risk of failure or delay in delivery of pipeline or launch of
new medicines
‒ the risk of failure to meet regulatory or ethical requirements for
medicine development or approval
‒ the risk of failures or delays in the quality or execution of the
Group's commercial strategies
‒ the risk of pricing, affordability, access and competitive pressures
‒ the risk of failure to maintain supply of compliant, quality
medicines
‒ the risk of illegal trade in the Group's medicines
‒ the impact of reliance on third-party goods and services
‒ the risk of failure in information technology or cybersecurity
‒ the risk of failure of critical processes
‒ the risk of failure to collect and manage data 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
EVH Extravascular
haemolysis
FDA Food and Drug
Agency (US)
FDC Fixed dose
combination
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 / 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
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
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
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
Q3W, Q4W, etc Every three weeks, every four weeks, etc
R&D Research and
development
R&I
Respiratory & Immunology
RSV Respiratory
syncytial virus
sBLA Supplemental
biologics license application (US)
SCLC Small cell lung
cancer
s.c.
Subcutaneous injection
SEA Severe
eosinophilic asthma
SEC Securities
Exchange Commission (US)
SG&A Sales, general
and administration
SGLT2 Sodium-glucose
cotransporter 2
SLL Small
lymphocytic lymphoma
SMI Sustainable
Markets Initiative
sNDA Supplemental new drug
application
SPA Share Purchase
Agreement
T2D Type-2 diabetes
TACE Transarterial
chemoembolization
THP A treatment
regimen: docetaxel, trastuzumab and pertuzumab
TNBC Triple negative
breast cancer
TNF Tumour necrosis
factor
TOP1 Topoisomerase I
TROP2 Trophoblast cell surface
antigen 2
USPTO US Patent and Trademark
Office
V&I Vaccines
& Immune Therapies
VBP Volume-based
procurement
VLP Virus like
particle
- End of document -
1 Constant exchange rates. The differences between Actual
Change and CER Change are due to foreign exchange movements between periods in
2024 vs. 2023. CER financial measures are not accounted for according to
generally accepted accounting principles (GAAP) because they remove the
effects of currency movements from Reported results.
2 Core financial measures are adjusted to exclude certain items. The
differences between Reported and Core measures are primarily due to costs
relating to the amortisation of intangibles, impairments, legal settlements
and restructuring charges. A full reconciliation between Reported EPS and Core
EPS is provided in Table 11 and Table 12 in the Financial performance section
of this document.
3 The calculations for Reported and Core Product Sales Gross Margin exclude
the impact of Alliance Revenue and Collaboration Revenue.
4 In Table 2, the plus and minus symbols denote the directional impact of
the item being discussed, e.g. a '+' symbol next to a comment related to the
R&D expense indicates that the item resulted in an increase in the R&D
spend relative to the prior year.
5 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.
6 The presentation of Table 4 has been updated to show Total Revenue by
medicine, by including Alliance Revenue and Collaboration Revenue within each
revenue figure. Previously, this table showed Product Sales for each medicine
and therapy area, and the Company's total Alliance Revenue and Collaboration
Revenue were shown as separate lines at the bottom of the table.
7 The presentation of this table has been updated by removing the
"Acquisition of Alexion" column due to immateriality of items in this category
8 Based on best prevailing assumptions around currency profiles.
9 Based on average daily spot rates 1 Jan 2023 to 31 Dec 2023.
10 Based on average daily spot rates 1 Jan 2024 to 30 Jun 2024.
11 Based on average daily spot rates 1 Jun 2024 to 30 Jun 2024.
12 Other currencies include AUD, BRL, CAD, KRW and RUB.
13 The Q2 2024 and Q2 2023 information in respect of the three months ended
30 June 2024 and 30 June 2023 respectively included in the Interim financial
statements have not been reviewed by PricewaterhouseCoopers LLP
14 The Condensed consolidated statement of financial position as at 30 June
2024 and 30 June 2023 have been reviewed by PricewaterhouseCoopers LLP. The
Condensed consolidated statement of financial position as at 31 December 2023
has been audited by PricewaterhouseCoopers LLP.
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.
16 The table provides an analysis of year-on-year Product Sales, with Actual
and CER growth rates reflecting year-on-year growth. Due to rounding, the sum
of a number of dollar values and percentages may not agree to totals.
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