REG - AstraZeneca PLC - 9M and Q3 2024 Results
12/11/2024 07:00
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RNS Number : 7959L AstraZeneca PLC 12 November 2024
AstraZeneca
12 November 2024
9M and Q3 2024 results
Upgrade to full year 2024 guidance underpinned by strong underlying growth
momentum
Revenue and EPS summary
9M 2024 % Change Q3 2024 % Change
$m Actual CER 1 $m Actual CER
- Product Sales 37,576 16 19 12,947 18 20
- Alliance Revenue 1,498 49 50 559 48 50
- Collaboration Revenue 108 (66) (66) 59 (39) (40)
Total Revenue 39,182 16 19 13,565 18 21
Reported EPS $3.57 11 21 $0.92 4 17
Core 2 EPS $6.12 5 11 $2.08 20 27
Financial performance for 9M 2024 (Growth numbers at constant exchange rates)
‒ Total Revenue up 19% to $39,182m, driven by a 19% increase in
Product Sales and continued growth in Alliance Revenue from partnered
medicines
‒ Total Revenue growth from Oncology was 22%, CVRM 21%, R&I 24%
and Rare Disease 14%
‒ Core Product Sales Gross Margin 3 of 82%
‒ Core Operating Margin of 32%
‒ Core Tax Rate of 20%
‒ Core EPS increased 11% to $6.12. In the prior year period, Core EPS
included gains totalling $953m from the disposal of Pulmicort Flexhaler US
rights and updated contractual arrangements for Beyfortus
‒ Guidance for FY 2024 Total Revenue and Core EPS growth at CER
upgraded to high teens percentage growth
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
"Our company has continued on its strong growth trajectory in the first nine
months of 2024. Total Revenue and Core EPS were up 21% and 27% respectively in
the third quarter, reflecting the increasing demand for our medicines across
Oncology, BioPharmaceuticals and Rare Disease and supporting an upgrade to our
full year 2024 guidance.
In the year to date we have announced the results for multiple positive
high-value trials and are working to bring these new options to patients as
quickly as possible. Additionally, the quality and impact of our scientific
research was well recognised this quarter with data for AstraZeneca medicines
featuring in an unprecedented five Presidential Plenary sessions at the two
major oncology conferences in September.
We are highly encouraged by the broad-based underlying momentum we are seeing
across our company in 2024, and growth looks set to continue through 2025,
providing a solid foundation to deliver on our 2030 ambition.
Finally, we take the matters in China very seriously. If requested we will
fully cooperate with the authorities. We remain committed to delivering
innovative life-changing medicines to patients in China."
Key milestones achieved since the prior results announcement
‒ Positive read-outs for Tagrisso plus Orpathys in EGFRm NSCLC with
high levels of MET overexpression and/or amplification (SAVANNAH), Calquence
in combination with venetoclax, with or without obinutuzumab in previously
untreated CLL (AMPLIFY), and the next generation propellant for Breztri.
Koselugo in adult patients with NF1-PN (KOMET), Tezspire in severe chronic
rhinosinusitis with nasal polyps (WAYPOINT)
‒ US approvals for Tagrisso in unresectable, Stage III EGFRm NSCLC
(LAURA) and Imfinzi plus chemotherapy in resectable early-stage NSCLC (AEGEAN)
and FluMist for self-administration. EU approvals for Imfinzi plus
chemotherapy followed by Imfinzi alone in mismatch repair deficient
endometrial cancer (DUO-E), Imfinzi plus chemotherapy followed by Lynparza and
Imfinzi in mismatch repair proficient endometrial cancer (DUO-E) and Fasenra
for EGPA (MANDARA). China approvals for Enhertu in unresectable, locally
advanced or metastatic HER2-mutated NSCLC (DESTINY-Lung02, DESTINY-Lung05),
Enhertu in locally advanced or metastatic HER2-positive gastric or
gastroesophageal junction adenocarcinoma (DESTINY-Gastric06), and Fasenra for
severe eosinophilic asthma (MIRACLE)
Guidance
Given the strength of underlying Product Sales and Alliance Revenue, as well
as increased confidence in achieving certain sales-based milestones, the
Company raises its Total Revenue and Core EPS guidance for FY 2024 at CER.
Total Revenue is expected to increase by a high teens percentage (previously a
mid teens percentage)
Core EPS is expected to increase by a high teens percentage (previously a mid
teens percentage)
‒ Other elements of the Income Statement are expected to be broadly
in-line with the indications issued in the Company's H1 2024 earnings
statement
The Company is unable to provide guidance on a Reported basis because it
cannot reliably forecast material elements of the Reported results, including
any fair value adjustments arising on acquisition-related liabilities,
intangible asset impairment charges and legal settlement provisions. Please
refer to the cautionary statements section regarding forward-looking
statements at the end of this announcement.
Currency impact
If foreign exchange rates for October 2024 to December 2024 were to remain at
the average rates seen in September 2024, it is anticipated that FY 2024 Total
Revenue would incur a low single-digit percentage adverse impact compared to
the performance at CER (unchanged from previous guidance), and Core EPS would
incur a mid single-digit percentage adverse impact (unchanged from previous
guidance). The Company's foreign exchange rate sensitivity analysis is
provided in Table 17.
China
As previously disclosed, the Company is aware of a number of individual
investigations by the Chinese authorities into current and former AstraZeneca
employees. To the best of the Company's knowledge, the investigations include
allegations of medical insurance fraud, illegal drug importation and personal
information breaches. Recently Leon Wang, EVP International and AstraZeneca
China President was detained. The Company has not received any notification
that it is itself under investigation. If requested, AstraZeneca will fully
cooperate with the Chinese authorities.
Table 1: Key elements of Total Revenue performance in Q3 2024
% Change
Revenue type $m Actual % CER %
Product Sales 12,947 18 20
Alliance Revenue 559 48 50 * $49m Beyfortus (Q3 2023: $17m)
* $361m Enhertu (Q3 2023: $266m)
* $123m Tezspire (Q3 2023: $74m)
Collaboration Revenue 59 (39) (40) * $56m Beyfortus (Q3 2023: $71m)
Total Revenue 13,565 18 21
Therapy areas $m Actual % CER %
Oncology 5,569 19 22 * Tagrisso up 14% (17% at CER), Calquence up 24% (25% at CER), Enhertu
Total Revenue up 50% (55% at CER)
CVRM( ) 3,159 18 20 * Farxiga up 25% (27% at CER), Lokelma up 40% (42% at CER)
R&I 1,959 26 29 * Breztri up 56% (57% at CER). Saphnelo up 63% (64% at CER), Tezspire up
>2x, Symbicort up 27% (31% CER)
V&I 460 48 49 * Beyfortus Total Revenue up 73% (72% at CER), FluMist up 34% (31% at CER)
Rare Disease( ) 2,148 9 11 · Ultomiris up 33% (35% at CER), partially offset by decline in Soliris of
22% (18% at CER), Strensiq up 20% (21% at CER) and Koselugo up 37% (39% at
CER)
Other Medicines 270 (12) (8)
Total Revenue 13,565 18 21
Regions $m Actual % CER %
US 6,008 23 23
Emerging Markets 3,423 15 23
- China 1,671 15 15
- Ex-China Emerging Markets 1,752 16 31
Europe 2,875 22 22
Established RoW 1,260 (1) 4
Total Revenue 13,565 18 21
Key alliance medicines
‒ Combined sales of Enhertu, recorded by Daiichi Sankyo Company
Limited (Daiichi Sankyo) and AstraZeneca, amounted to $2,729m in 9M 2024 (9M
2023: $1,844m).
‒ Combined sales of Tezspire, recorded by Amgen and AstraZeneca,
amounted to $843m in 9M 2024 (9M 2023: $438m).
Table 2: Key elements of financial performance in Q3 2024
Metric Reported Reported change Core Core Comments 4
change
Total Revenue $13,565m 18% Actual 21% CER $13,565m 18% Actual 21% CER * See Table 1 and the Total Revenue section of this document for further
details
Product Sales Gross Margin 76% -5pp Actual -4pp CER 81% Stable Actual and CER * Variations in Product Sales Gross Margin can be expected between
periods, due to product seasonality (e.g. FluMist and Beyfortus sales are
weighted to the second half of the year), foreign exchange fluctuations and
other effects
‒ Reported Product Sales Gross Margin impacted by PAAGR 5 inventory related
restructuring charges taken in the quarter
R&D $3,115m 21% Actual 21% CER $3,068m 23% Actual 24% CER + Increased investment in the pipeline
expense * Core R&D-to-Total Revenue ratio of 23%
(Q3 2023: 22%)
SG&A expense $5,143m 7% Actual 8% CER $3,605m 8% Actual 9% CER + Market development for recent launches and pre-launch activities
* Core SG&A-to-Total Revenue ratio of 27%
(Q3 2023: 29%)
Other operating income and expense 6 (#_ftn6) $25m -65% Actual -61% CER $24m -65% Actual -61% CER
Operating Margin 16% -1pp Actual Stable CER 32% +1pp Actual +2pp CER * See commentary above on Gross Margin, R&D, SG&A and Other
operating income and expense
Net finance expense $274m -6% Actual -15% CER $329m 46% Actual 35% CER + New debt issued at higher interest rates
+ Higher level of Net debt
Tax rate 22% +5pp Actual +5pp CER 19% Stable Actual and CER * Variations in the tax rate can be expected between periods
EPS $0.92 4% Actual 17% CER $2.08 20% Actual 27% CER * Further details of differences between Reported and Core are shown in
Table 12
Table 3: Pipeline highlights since prior results announcement
Event Medicine Indication / Trial Event
Regulatory approvals and other regulatory actions Tagrisso Unresectable, Stage III EGFRm NSCLC (LAURA) Regulatory approval (US)
Imfinzi Primary advanced or recurrent endometrial cancer with mismatch repair Regulatory approval (EU)
deficiency (DUO-E)
Imfinzi + Lynparza Primary advanced or recurrent endometrial cancer with mismatch repair Regulatory approval (EU)
proficiency (DUO-E)
Imfinzi Resectable early-stage (IIA-IIIB) NSCLC (AEGEAN) Regulatory approval (US)
Enhertu Locally advanced or metastatic HER2-positive gastric or gastroesophageal Regulatory approval (CN)
junction adenocarcinoma (DESTINY-Gastric06)
Enhertu Unresectable locally advanced or metastatic HER2m NSCLC (DESTINY-Lung02, Regulatory approval (CN)
DESTINY-Lung05)
Fasenra EGPA (MANDARA) Regulatory approval (US, EU)
Fasenra Fasenra (MIRACLE) Regulatory approval (CN)
FluMist Self-administration Regulatory approval (US)
Regulatory submissions Tagrisso EGFRm NSCLC (Stage III Regulatory submission (EU, JP, CN)
or acceptances*
unresectable) (LAURA)
Imfinzi Muscle-invasive bladder Regulatory submission (EU)
Cancer (NIAGARA)
Imfinzi NSCLC (neoadjuvant) AEGEAN Regulatory submission (JP)
Imfinzi SCLC (limited stage) (ADRIATIC) Regulatory submission (US, EU, JP, CN)
Calquence Mantle cell lymphoma (1st-line) (ECHO) Regulatory submission (US, EU, JP)
Calquence CLL (ELEVATE-TN) Regulatory submission (CN)
Lynparza mCRPC (PROpel) Regulatory submission (CN)
Enhertu HER2-low breast cancer Regulatory submission (US, EU, JP)
(2nd-line) (DESTINY-Breast06)
Wainua Hereditary transthyretin-mediated amyloid polyneuropathy (NEURO-TTRansform) Regulatory submission (CN)
Breztri and HFO1234ze Moderate to severe COPD Regulatory submission (EU)
Sipavibart Prevention of COVID-19 Regulatory submission (JP)
(SUPERNOVA)
Ultomiris NMOSD (CHAMPION-NMOSD) Regulatory submission (CN)
Phase III / registrational data readouts and other developments Tagrisso + Orpathys EGFRm NSCLC with high levels of MET overexpression and/or amplification Clinically meaningful ORR
(SAVANNAH)
Calquence fixed duration Chronic lymphocytic leukaemia (AMPLIFY) Primary endpoint met
Fasenra Eosinophilic chronic rhinosinusitis with nasal polyps (ORCHID) Primary endpoint not met
Tezspire Severe chronic rhinosinusitis with nasal polyps (WAYPOINT) Primary endpoint met
Koselugo Adults with NF1-PN (KOMET) Primary endpoint met
*US, EU and China regulatory submission denotes filing acceptance
Upcoming pipeline catalysts
For recent trial starts and anticipated timings of key trial readouts, please
refer to the Clinical Trials Appendix, available on
www.astrazeneca.com/investor-relations.html
(https://www.astrazeneca.com/investor-relations.html) .
Corporate and business development
In October 2024, AstraZeneca entered into an exclusive license agreement with
CSPC Pharmaceutical Group Ltd (CSPC) to advance the development of an early
stage, novel small molecule Lipoprotein (a) (Lp(a)) disruptor that has the
potential to offer additional benefits for patients with dyslipidaemia. This
further strengthens the company's cardiovascular portfolio to help address the
major risk factors driving chronic cardiovascular disease. Under the terms of
the agreement, AstraZeneca will receive access to CSPC's pre-clinical
candidate small molecule, YS2302018, an oral Lp(a) disruptor, with the aim of
developing this as a novel lipid-lowering therapy with potential in a range of
cardiovascular disease indications alone or in combination, including with
AstraZeneca's oral small molecule PCSK9 inhibitor, AZD0780. CSPC will receive
an upfront payment of $100 million from AstraZeneca. CSPC is also eligible to
receive up to $1.92 billion for further development and commercialisation
milestones plus tiered royalties.
In October 2024, AstraZeneca entered into an agreement to out-license ALXN1840
(bis-choline tetrathiomolybdate), a drug candidate for Wilson disease to
Monopar Therapeutics Inc (Monopar). Monopar will be responsible for all future
global development and commercialisation activities. AstraZeneca will have a
9.9% beneficial ownership interest in Monopar upon issuance as well as an
upfront cash payment of $4.0 million. AstraZeneca is also eligible to receive
milestones and royalties.
Sustainability highlights
In September, AstraZeneca had a significant presence at Climate Week NYC and
the 79th Session of the UN General Assembly in New York, with a delegation led
by Pam Cheng, Executive Vice President of Global Operations and IT and Chief
Sustainability Officer and the company's US leadership. A programme of more
than 50 engagements with governments, media, NGOs and the private sector
focused on the interconnected issues of the climate crisis, health equity and
health system resilience and the Company's commitment to contribute to more
sustainable, resilient and equitable health systems.
Conference call
A conference call and webcast for investors and analysts will begin today, 12
November 2024, at 14:00 UK time. Details can be accessed via astrazeneca.com
(https://www.astrazeneca.com/) .
Reporting calendar
The Company intends to publish its FY and Q4 2024 results on 6 February 2025.
Operating and financial review
All narrative on growth and results in this section is based on actual
exchange rates, and financial figures are in US$ millions ($m), unless stated
otherwise. The performance shown in this announcement covers the nine-month
period to 30 September 2024 ('the period' or '9M 2024') compared to the
nine-month period to 30 September 2023 ('9M 2023'), or the three-month period
to 30 September 2024 ('the quarter' or 'Q3 2024') compared to the three-month
period to 30 September 2023 ('Q3 2023'), unless stated otherwise.
Core financial measures, EBITDA, Net debt, Product Sales Gross Margin,
Operating Margin and CER are non-GAAP financial measures because they cannot
be derived directly from the Group's Condensed consolidated financial
statements. Management believes that these non-GAAP financial measures, when
provided in combination with Reported results, provide investors and analysts
with helpful supplementary information to understand better the financial
performance and position of the Group on a comparable basis from period to
period. These non-GAAP financial measures are not a substitute for, or
superior to, financial measures prepared in accordance with GAAP.
Core financial measures are adjusted to exclude certain significant items:
‒ Charges and provisions related to our global restructuring
programmes on our capitalised manufacturing assets and IT assets
‒ Amortisation and impairment of intangible assets, including
impairment reversals but excluding any charges relating to IT assets
‒ Other specified items, principally the imputed finance charges and
fair value movements relating to contingent consideration on business
combinations, imputed finance charges and remeasurement adjustments on certain
Other payables arising from intangible asset acquisitions, legal settlements
and remeasurement adjustments relating to certain Other payables and debt
items assumed from the Alexion acquisition
‒ The tax effects of the adjustments above are excluded from the Core
Tax charge
Details on the nature of Core financial measures are provided on page 61 of
the Annual Report and Form 20-F Information 2023.
(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 7
9M 2024 Q3 2024
% Change % Change
$m % Total Actual CER $m % Total Actual CER
Oncology 16,009 41 19 22 5,569 41 19 22
- Tagrisso 4,877 12 11 15 1,674 12 14 17
- Imfinzi 3,463 9 18 22 1,203 9 13 16
- Calquence 2,321 6 26 27 813 6 24 25
- Lynparza 2,228 6 8 10 778 6 11 13
- Enhertu 1,442 4 57 60 510 4 50 55
- Zoladex 845 2 17 24 278 2 12 18
- Imjudo 208 1 30 32 72 1 20 22
- Truqap 267 1 n/m n/m 125 1 n/m n/m
- Orpathys 36 - 5 8 11 - (11) (11)
- Other Oncology 322 1 (18) (12) 106 1 (10) (5)
BioPharmaceuticals: CVRM 9,379 24 18 21 3,159 23 18 20
- Farxiga 5,779 15 32 34 1,943 14 25 27
- Brilinta 992 3 - 1 327 2 (1) (1)
- Crestor 894 2 4 9 304 2 10 14
- Lokelma 392 1 31 34 143 1 40 42
- Seloken/Toprol-XL 466 1 (6) (1) 151 1 (2) 1
- roxadustat 261 1 23 26 95 1 26 25
- Andexxa 159 - 24 26 54 - 36 38
- Wainua 44 - n/m n/m 23 - n/m n/m
- Other CVRM 392 1 (27) (26) 120 1 (22) (20)
BioPharmaceuticals: R&I 5,750 15 22 24 1,959 14 26 29
- Symbicort 2,195 6 19 22 705 5 27 31
- Fasenra 1,218 3 7 8 436 3 12 13
- Breztri 721 2 51 53 266 2 56 57
- Pulmicort 517 1 5 9 138 1 (6) (4)
- Tezspire 471 1 >2x >2x 191 1 >2x >2x
- Saphnelo 327 1 71 72 124 1 63 64
- Airsupra 41 - n/m n/m 21 - n/m n/m
- Other R&I 259 1 (28) (27) 78 1 (32) (32)
BioPharmaceuticals: V&I 811 2 (14) (12) 460 3 48 49
- Beyfortus 319 1 >2x >2x 238 2 73 72
- Synagis 346 1 (10) (4) 93 1 (6) 3
- COVID-19 mAbs 31 - (90) (90) 28 - >10x >10x
- FluMist 109 - 24 21 100 1 34 31
- Other V&I 6 - (79) (80) 0 - (63) n/m
Rare Disease 6,391 16 10 14 2,148 16 9 11
- Ultomiris 2,835 7 32 35 1,031 8 33 35
- Soliris 2,045 5 (16) (11) 606 4 (22) (18)
- Strensiq 996 3 18 19 343 3 20 21
- Koselugo 366 1 49 55 119 1 37 39
- Kanuma 149 - 15 16 49 - 10 9
Other Medicines 843 2 (10) (4) 270 2 (12) (8)
- Nexium 685 2 (8) (2) 216 2 (13) (8)
- Others 157 - (17) (15) 54 - (7) (7)
Total 39,182 100 16 19 13,565 100 18 21
Table 5: Alliance Revenue
9M 2024 Q3 2024
% Change % Change
$m Actual CER $m Actual CER
Enhertu 1,045 41 42 361 36 38
Tezspire 303 69 69 123 65 65
Beyfortus 75 >4x >4x 49 >2x >2x
Other Alliance Revenue 75 11 11 26 29 29
Total 1,498 49 50 559 48 50
Table 6: Collaboration Revenue
9M 2024 Q3 2024
% Change % Change
$m Actual CER $m Actual CER
Farxiga: sales milestones 52 87 87 3 12 14
Beyfortus: sales milestones 56 (21) (23) 56 (21) (23)
Total 108 (66) (66) 59 (39) (40)
Table 7: Total Revenue by therapy area
9M 2024 Q3 2024
% Change % Change
$m % Total Actual CER $m % Total Actual CER
Oncology 16,009 41 19 22 5,569 41 19 22
Biopharmaceuticals 15,940 41 17 20 5,578 41 23 25
CVRM 9,379 24 18 21 3,159 23 18 20
R&I 5,750 15 22 24 1,959 14 26 29
V&I 811 2 (14) (12) 460 3 48 49
Rare Disease 6,391 16 10 14 2,148 16 9 11
Other Medicines 843 2 (10) (4) 270 2 (12) (8)
Total 39,182 100 16 19 13,565 100 18 21
Table 8: Total Revenue by region
9M 2024 Q3 2024
% Change % Change
$m % Total Actual CER $m % Total Actual CER
US 16,703 43 20 20 6,008 44 23 23
Emerging Markets 10,541 27 14 23 3,423 25 15 23
China 5,049 13 12 15 1,671 12 15 15
Emerging Markets ex. China 5,492 14 16 30 1,752 13 16 31
Europe 8,240 21 22 22 2,875 21 22 22
Established ROW 3,698 9 (4) 4 1,260 9 (1) 4
Total 39,182 100 16 19 13,565 100 18 21
Oncology
Oncology Total Revenue of $16,009m in 9M 2024 increased by 19% (22% at CER),
representing 41% of overall Total Revenue (9M 2023: 40%).
Tagrisso
9M 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 4,877 1,996 1,365 956 560
Actual change 11% 19% 8% 16% (10%)
CER change 15% 19% 16% 16% (2%)
Region Drivers and commentary
Worldwide * Strong global demand for Tagrisso in adjuvant (ADAURA) and 1st-line
settings (FLAURA, FLAURA-2)
US * Continued demand growth in both the adjuvant and metastatic settings,
with some additional benefit coming from improved affordability
Emerging Markets * Encouraging demand growth, partly offset by NRDL price reduction in
prior year period
Europe * Continued demand growth across adjuvant and metastatic settings
Established RoW * Continued demand growth across adjuvant and metastatic settings with
year-over-year comparison reflecting price reduction in Japan in June 2023
Imfinzi
9M 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 3,463 1,883 365 695 520
Actual change 18% 18% 37% 30% (3%)
CER change 22% 18% 61% 29% 6%
Region Drivers and commentary
Worldwide * Strong demand growth driven by BTC (TOPAZ-1), HCC (HIMALAYA), and
increased patient share in Stage IV NSCLC (POSEIDON) and extensive-stage SCLC
(CASPIAN)
US * Continued demand growth driven primarily by HCC and extensive-stage
SCLC, having achieved peak market share as established standard of care in BTC
Emerging Markets * Strong demand growth driven across all approved indications, in
particular BTC
Europe * Growth driven by share gains in extensive-stage SCLC as well as new
launches in HCC, BTC and NSCLC
Established RoW * Increased demand in GI indications, with year-over-year comparison
reflecting the 25% and 11% mandatory price reductions in Japan effective from
1 February 2024 and 1 August 2024 respectively
Calquence
9M 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 2,321 1,617 116 489 99
Actual change 26% 21% 68% 38% 23%
CER change 27% 21% 90% 38% 27%
Region Drivers and commentary
Worldwide * Sustained BTKi leadership in front-line CLL (ELEVATE-TN)
US * Growth driven by leading share of new patient starts in front-line CLL,
with some additional favourability coming from improved affordability
Europe * Strong growth momentum in front-line CLL, maintaining share of 1L new
patient starts in competitive environment
Lynparza
9M 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 2,228 954 475 612 187
Actual change 8% 6% 16% 13% (13%)
CER change 10% 6% 25% 12% (7%)
Region Drivers and commentary
Worldwide * Lynparza remains the leading medicine in the PARP inhibitor class
globally across four tumour types (ovarian, breast, prostate, pancreatic), as
measured by total prescription volume
* No Collaboration Revenue for Lynparza was recognised in either 9M 2024
or 9M 2023
US * Continued leadership within competitive PARP inhibitor class, with
demand growth across all indications
Emerging Markets * Volume growth in China from increased share following inclusion of
HRD-positive ovarian cancer (PAOLA-1) on NRDL with no price reduction
Europe * Growth driven by increased market share and additional launches in early
breast cancer (OlympiA) and metastatic prostate cancer (PROpel)
Established RoW * PARP class leadership maintained with year-over-year comparison
reflecting 7.7% price reduction in Japan in November 2023
Enhertu
9M 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 1,442 642 353 400 47
Actual change 57% 24% 97% 95% >2x
CER change 60% 24% >2x 95% >2x
Region Drivers and commentary
Worldwide * Established standard of care in HER2-positive (DESTINY-Breast03) and
HER2-low (DESTINY-Breast04) metastatic breast cancer
* Encouraging early uptake, particularly in gynaecological indications
following tumour-agnostic approval in April 2024 (DESTINY-PanTumor02,
DESTINY-Lung01, DESTINY‑CRC02)
* Combined sales of Enhertu, recorded by Daiichi Sankyo and AstraZeneca,
amounted to $2,729m in 9M 2024 (9M 2023: $1,844m)
US * US in-market sales, recorded by Daiichi Sankyo, amounted to $1,342m in
9M 2024 (9M 2023: $1,087m)
Emerging Markets * Increased demand growth following commercial breast cancer launch in
China in Q1 2024
Europe * Continued demand growth due to increasing adoption in HER2-positive and
HER2-low metastatic breast cancer
Established RoW * AstraZeneca's Alliance Revenue includes a mid single-digit percentage
royalty on Daiichi Sankyo's sales in Japan
Other Oncology medicines
9M 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Zoladex 845 17% 24% * Strong underlying growth in China and Emerging Markets and moderate
growth in Europe with reduced uptake in Japan
Imjudo 208 30% 32% * Continued growth across markets
Truqap 267 n/m n/m * Strong demand growth with strong uptake in biomarker altered subgroup of
HR-positive HER2-negative metastatic breast cancer (CAPItello-291)
Orpathys 36 5% 8% * Demand in China for the treatment of patients with NSCLC with MET exon
14 skipping alterations
Other Oncology 322 (18%) (12%) * Decline in Faslodex Total Revenue due to VBP implementation in China in
March 2024 and generic erosion in Europe
BioPharmaceuticals
BioPharmaceuticals Total Revenue increased by 17% (20% at CER) in 9M 2024 to
$15,940m, representing 41% of overall Total Revenue (9M 2023: 40%).
BioPharmaceuticals - CVRM
CVRM Total Revenue increased by 18% (21% at CER) to $9,379m in 9M 2024 and
represented 24% of overall Total Revenue (9M 2023: 23%).
Farxiga
9M 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 5,779 1,280 2,225 1,903 371
Actual change 32% 28% 34% 40% (2%)
CER change 34% 28% 41% 39% 5%
Region Drivers and commentary
Worldwide * Farxiga volume continued to grow faster than the overall SGLT2 market in
all major regions, driven by continued demand in heart failure and CKD
* SGLT2 class growth underpinned by updated cardiorenal guidelines
US * Growth driven by underlying demand in HFrEF and CKD
* Launch of an authorised generic in the first quarter of 2024
Emerging Markets * Increased reimbursement supporting solid growth despite entry of generic
competition in some markets
Europe * Continued strong class growth and market share gains
Established RoW * Continued demand growth partially offset by generic competition in
Canada
* In Japan, AstraZeneca sells to collaborator Ono Pharmaceutical Co., Ltd,
which records in-market sales
Other CVRM medicines
9M 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Brilinta 992 - 1% * Continued sales growth in Emerging Markets, decline in Est. RoW driven
by generic competition in Canada
Crestor 894 4% 9% * Continued sales growth in Emerging Markets
Seloken 466 (6%) (1%) * Growth in ex-China EM markets offsetting declines in other regions
Lokelma 392 31% 34% * Strong growth in all major regions, particularly in Europe and Emerging
Markets. Continued launches in new markets
Roxadustat 261 23% 26% * Continued patient and volume growth
Andexxa 159 24% 26% * Demand growth
Wainua 44 n/m n/m * Encouraging launch uptake following ATTRv-PN approval in the US in
December 2023
Other CVRM 392 (27%) (26%) * Generic competition
BioPharmaceuticals - R&I
Total Revenue of $5,750m from R&I medicines increased 22% (24% at CER) and
represented 15% of overall Total Revenue (9M 2023: 14%).
Fasenra
9M 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 1,218 750 68 294 106
Actual change 7% 4% 43% 12% (1%)
CER change 8% 4% 52% 11% 6%
Region Drivers and commentary
Worldwide * Continued severe asthma market share leadership in IL-5 class across
major markets
US * Sustained double-digit volume growth
Emerging Markets * Continued strong demand growth driven by launch acceleration across key
markets
Europe * Sustained leadership in severe eosinophilic asthma
Established RoW * In Japan, maintained class leadership in a broadly stable market
Breztri
9M 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 721 367 199 102 53
Actual change 51% 40% 62% 86% 42%
CER change 53% 40% 68% 85% 51%
Region Drivers and commentary
Worldwide * Fastest growing single-inhaler triple medicine within the expanding FDC
triple class
US * Consistent share growth within the expanding FDC triple class
Emerging Markets * Maintained market share leadership in China with strong FDC triple class
penetration
* Further expansion with launches in additional geographies
Europe * Sustained growth across markets driven by new launches
Established RoW * Increased market share in Japan
Tezspire
9M 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 471 303 8 105 55
Actual change >2x 70% n/m >3x >2x
CER change >2x 70% n/m >3x >2x
Region Drivers and commentary
Worldwide * Combined sales of Tezspire, recorded by Amgen and AstraZeneca, amounted
to $843m in 9M 2024 (9M 2023: $438m)
US * Continued growth in total prescriptions, with majority of patients
new-to-biologics
Europe * Achieved and maintained new-to-brand leadership across multiple markets,
new launches continue to progress
Established RoW * Sustained market share growth in Japan and other major geographies, with
continued launches
Symbicort
9M 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 2,195 887 653 415 240
Actual change 19% 51% 9% 2% (2%)
CER change 22% 51% 19% 1% -
Region Drivers and commentary
Worldwide * Symbicort remained the global market leader within a stable ICS/LABA
class
US * Continued strong demand for the authorised generic, limitation of
patient out-of-pocket expenses and favourable channel mix
Emerging Markets * Sustained demand growth across markets
Europe * Continued growth in some markets within mild asthma partially offset
generic erosion and a slowing overall market
Established RoW * Continued generic erosion in Japan
Other R&I medicines
9M 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Saphnelo 327 71% 72% * Demand acceleration in the US, and additional growth driven by ongoing
launches in Europe and Established RoW
Airsupra 41 n/m n/m * Strong US launch momentum and volume uptake. Revenue in the period
reflects introductory discounts as early access continues to build
Pulmicort 517 5% 9% * >80% of revenues from Emerging Markets
Other R&I 259 (28%) (27%) * Continued generic competition
BioPharmaceuticals - V&I
Total Revenue from V&I medicines reduced by 14% (12% at CER) to $811m (9M
2023: $944m) and represented 2% of overall Total Revenue (9M 2023: 3%).
V&I medicines
9M 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Beyfortus 319 >2x >2x * Growth driven increasing demand and expanded production capacity
* Product Sales recognises AstraZeneca's sales of manufactured Beyfortus
product to Sanofi
* Alliance Revenue recognises AstraZeneca's 50% share of gross profits on
sales of Beyfortus in major markets outside the US, and 25% of brand revenues
in rest of world markets
* AstraZeneca has no participation in US profits or losses
Synagis 346 (10%) (4%) * As anticipated, Synagis demand decreased following rapid adoption of
Beyfortus
COVID-19 mAbs 31 (90%) (90%) * Decline in Evusheld sales and Collaboration Revenue (Total Revenue 9M
2023: $306m)
FluMist 109 24% 21% * Demand growth across key markets in particular Europe and benefit from
earlier start in flu season in Q3 2024 compared to prior year
Other V&I 6 (79%) (80%) * Decline in Vaxzevria sales (9M 2023: $28m)
Rare Disease
Total Revenue from Rare Disease medicines increased by 10% (14% at CER) in 9M
2024 to $6,391m, representing 16% of overall Total Revenue (9M 2023: 17%).
Ultomiris
9M 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 2,835 1,629 92 649 465
Actual change 32% 29% 97% 31% 37%
CER change 35% 29% >2x 30% 50%
Region Drivers and commentary
Worldwide * Growth due to increased use in neurology, geographic expansion, further
patient demand and conversion from Soliris
* Ultomiris Total Revenue includes sales of Voydeya, which is approved as
an add‑on treatment to Ultomiris and Soliris for the 10-20% of PNH patients
who experience clinically significant EVH
US * Strong growth in patient demand in gMG (CHAMPION-MG) and NMOSD
(CHAMPION-NMOSD), both new to branded medicines, as well as continued
conversion from Soliris
Emerging Markets * Expansion into new markets and growth in patient demand
Europe * Strong demand growth following recent launches, particularly from
neurology indications, accelerated conversion from Soliris, partially offset
by price reductions to secure reimbursement for new indications
Established RoW * Continued conversion from Soliris and strong demand following new
launches
Soliris
9M 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 2,045 1,170 365 346 164
Actual change (16%) (11%) 8% (35%) (34%)
CER change (11%) (11%) 39% (35%) (31%)
Region Drivers and commentary
US * Decline driven by successful conversion of Soliris patients to Ultomiris
Emerging Markets * Growth driven by patient demand
Europe * Decline driven by biosimilar erosion in PNH and aHUS and successful
conversion from Soliris to Ultomiris
Established RoW * Decline driven by successful conversion from Soliris to Ultomiris
Strensiq
9M 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 996 815 39 73 69
Actual change 18% 18% 34% 15% 8%
CER change 19% 18% 48% 14% 18%
Region Drivers and commentary
Worldwide * Growth driven by strong patient demand
Other Rare Disease medicines
9M 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Koselugo 366 49% 55% * Driven by patient demand and expansion in new markets
Kanuma 149 15% 16% * Continued global demand
Other medicines (outside the main therapy areas)
9M 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Nexium 685 (8%) (2%) * Stable in Emerging Markets, which now accounts for two-thirds of Nexium
revenue, offset by generic erosion in other markets
Others 157 (17%) (15%) * Continued impact of generic competition
Financial performance
Table 9: Reported Profit and Loss
9M 2024 9M 2023 % Change Q3 2024 Q3 2023 % Change
$m $m Actual CER $m $m Actual CER
Total Revenue 39,182 33,787 16 19 13,565 11,492 18 21
- Product Sales 37,576 32,466 16 19 12,947 11,018 18 20
- Alliance Revenue 1,498 1,004 49 50 559 377 48 50
- Collaboration Revenue 108 317 (66) (66) 59 97 (39) (40)
Cost of sales (7,482) (5,960) 26 28 (3,081) (2,095) 47 48
Gross profit 31,700 27,827 14 17 10,484 9,397 12 15
Distribution expense (412) (394) 4 7 (145) (129) 12 15
R&D expense (8,906) (7,862) 13 14 (3,115) (2,584) 21 21
SG&A expense (14,567) (13,845) 5 7 (5,143) (4,800) 7 8
Other operating income & expense 152 1,233 (88) (88) 25 70 (65) (61)
Operating profit 7,967 6,959 14 23 2,106 1,954 8 18
Net finance expense (919) (945) (3) (7) (274) (291) (6) (15)
Joint ventures and associates (23) (12) n/m 97 (4) (11) (53) (54)
Profit before tax 7,025 6,002 17 28 1,828 1,652 11 24
Taxation (1,484) (1,000) 48 62 (395) (274) 44 62
Tax rate 21% 17% 22% 17%
Profit after tax 5,541 5,002 11 21 1,433 1,378 4 17
Earnings per share $3.57 $3.22 11 21 $0.92 $0.89 4 17
Table 10: Reconciliation of Reported Profit before tax to EBITDA
9M 2024 9M 2023 % Change Q3 2024 Q3 2023 % Change
$m $m Actual CER $m $m Actual CER
Reported Profit before tax 7,025 6,002 17 28 1,828 1,652 11 24
Net finance expense 919 945 (3) (7) 274 291 (6) (15)
Joint ventures and associates 23 12 n/m 97 4 11 (53) (54)
Depreciation, amortisation and impairment 4,351 4,060 7 7 1,817 1,282 41 41
EBITDA 12,318 11,019 12 17 3,923 3,236 21 27
Table 11: Reconciliation of Reported to Core financial measures: 9M 2024 8
(#_ftn8)
9M 2024 Reported Restructuring Intangible Asset Amortisation & Impairments Other Core Core
% Change
$m $m $m $m $m Actual CER
Gross profit 31,700 655 24 4 32,383 15 19
Product Sales Gross Margin 80% 82% - -
Distribution expense (412) - - - (412) 4 7
R&D expense (8,906) 221 38 9 (8,638) 17 18
% of Total Revenue 23% 22% - -
SG&A expense (14,567) 180 3,343 291 (10,753) 11 13
% of Total Revenue 37% 27% +1pp +1pp
Total operating expense (23,885) 401 3,381 300 (19,803) 13 15
Other operating income & expense 152 (2) - (1) 149 (87) (87)
Operating profit 7,967 1,054 3,405 303 12,729 8 13
Operating Margin 20% 32% -2pp -2pp
Net finance expense (919) - - 60 (859) 18 13
Taxation (1,484) (189) (621) (67) (2,361) 15 22
EPS $3.57 $0.56 $1.80 $0.19 $6.12 5 11
Table 12: Reconciliation of Reported to Core financial measures: Q3 20247
Q3 2024 Reported Restructuring Intangible Asset Amortisation & Impairments Other Core Core
% Change
$m $m $m $m $m Actual CER
Gross profit 10,484 619 8 1 11,112 18 21
Product Sales Gross Margin 76% 81% - -
Distribution expense (145) - - - (145) 12 15
R&D expense (3,115) 44 1 2 (3,068) 23 24
% of Total Revenue 23% 23% -1pp -1pp
SG&A expense (5,143) 42 1,460 36 (3,605) 8 9
% of Total Revenue 38% 27% +3pp +3pp
Total operating expense (8,403) 86 1,461 38 (6,818) 14 16
Other operating income & expense 25 - - (1) 24 (65) (61)
Operating profit 2,106 705 1,469 38 4,318 22 27
Operating Margin 16% 32% +1pp +2pp
Net finance expense (274) - - (55) (329) 46 35
Taxation (395) (109) (254) 5 (753) 21 28
EPS $0.92 $0.38 $0.78 - $2.08 20 27
Profit and Loss drivers
Gross profit
‒ The calculation of Reported and Core Product Sales Gross Margin
excludes the impact of Alliance Revenue and Collaboration Revenue
‒ The change in Product Sales Gross Margin (Reported and Core) in 9M
2024 was impacted by:
‒ Positive effects from product mix. The increased contribution from
Rare Disease and Oncology medicines had a positive impact on the Product Sales
Gross Margin
‒ Dilutive effects from product mix. The rising contribution of
Product Sales with profit sharing arrangements (Lynparza, Enhertu, Tezspire,
Koselugo) has a negative impact on Product Sales Gross Margin because
AstraZeneca records Product Sales in certain markets and pays away a share of
the gross profits to its collaboration partners. The growth in Beyfortus also
has a dilutive impact on Product Sales Gross Margin, as AstraZeneca is
responsible for manufacturing, and Sanofi is responsible for distribution.
AstraZeneca records its sales to Sanofi as Product Sales, and those sales
generate a lower Product Sales Gross Margin than the Company average
‒ Dilutive effects from geographic mix. In Emerging Markets, the
Product Sales Gross Margin tends to be below the Company
average
‒ The reported Product Sales Gross Margin included inventory and
related contract provisions of $638m recorded in the third quarter related to
Andexxa, which was part of the PAAGR restructuring program (see Note 2 in the
Notes to the interim financial statements section)
‒ Variations in Product Sales Gross Margin performance between periods
can continue to be expected due to product seasonality, foreign exchange
fluctuations, and other effects
R&D expense
‒ The change in R&D expense (Reported and Core) in the period was
impacted by:
‒ Positive data read-outs for several high priority medicines that
have ungated late-stage trials
‒ Investment in platforms, new technology and capabilities to enhance
R&D capabilities
‒ Addition of R&D projects following completion of previously
announced business development activity including Icosavax, Gracell, Fusion
and Amolyt
‒ The change in Reported R&D expense was also impacted by
intangible asset impairments in the prior period
SG&A expense
‒ The change in SG&A expense (Reported and Core) in the period was
driven primarily by market development activities for launches and to support
continued growth in existing brands
‒ The Reported SG&A expense included impairment charges in the
third quarter of $504m recorded against the Andexxa intangible asset
Other operating income and expense
‒ In the prior year period, Other operating income and expense
included a $241m gain on the disposal of the US rights to Pulmicort Flexhaler
and a $712m gain relating to contractual arrangements for Beyfortus
Net finance expense
‒ Core Net finance expense increased 18% (13% increase at CER) due to
the increased level of debt and new debt issued at higher interest rates
Taxation
‒ The effective Reported Tax rate for the nine months to 30 September
2024 was 21% (9M 2023: 17%) and the effective Core Tax rate was 20% (9M 2023:
19%)
‒ The cash tax paid for the nine months to 30 September 2024 was
$1,978m (9M 2023: $1,710m), representing 28% of Reported Profit before tax (9M
2023: 26%)
Table 13: Cash Flow summary
9M 2024 9M 2023 Change
$m $m $m
Reported Operating profit 7,967 6,959 1,008
Depreciation, amortisation and impairment 4,351 4,060 291
Movement in working capital and short-term provisions (543) 150 (693)
Gains on disposal of intangible assets (34) (247) 213
Fair value movements on contingent consideration arising from 251 202 49
business combinations
Non-cash and other movements 15 (623) 638
Interest paid (1,075) (826) (249)
Taxation paid (1,978) (1,710) (268)
Net cash inflow from operating activities 8,954 7,965 989
Net cash inflow before financing activities 2,155 4,978 (2,823)
Net cash inflow/(outflow) from financing activities (3,325) (6,276) 2,951
The change in Net cash inflow before financing activities of $2,823m is
primarily driven by Acquisitions of subsidiaries, net of cash acquired of
$2,771m, and relates to the acquisition of Gracell Biotechnologies, Inc. for
$774m and acquisition of Fusion Pharmaceuticals Inc., for $1,997m as compared
to the acquisition of Neogene Therapeutics, Inc. for $189m in 9M 2023.
The decrease in Net cash outflow from financing activities of $2,951m is
primarily driven by increased issuance of long-term loans of $6,492m in the
period compared to $3,816m issued in the comparative period.
Capital expenditure
Capital expenditure amounted to $1,216m in 9M 2024 (9M 2023: $836m). The
increase of capital expenditure in 2024 is driven by investment in several
major manufacturing projects and continued investment in technology upgrades.
Table 14: Net debt summary
At 30 At 31 At 30
Sep 2024 Dec 2023 Sep 2023
$m $m $m
Cash and cash equivalents 4,797 5,840 4,871
Other investments 133 122 244
Cash and investments 4,930 5,962 5,115
Overdrafts and short-term borrowings (769) (515) (515)
Commercial paper (472) - -
Lease liabilities (1,422) (1,128) (979)
Current instalments of loans (12) (4,614) (4,857)
Non-current instalments of loans (28,887) (22,365) (22,225)
Interest-bearing loans and borrowings (Gross debt) (31,562) (28,622) (28,576)
Net derivatives 284 150 90
Net debt (26,348) (22,510) (23,371)
Net debt increased by $3,838m in the nine months to 30 September 2024 to
$26,348m. Details of the committed undrawn bank facilities are disclosed
within the going concern section of Note 1. Details of the Company's solicited
credit ratings and further details on Net debt are disclosed in Note 3.
Capital allocation
The Company's capital allocation priorities include: investing in the business
and pipeline; maintaining a strong, investment-grade credit rating; potential
value-enhancing business development opportunities; and supporting the
progressive dividend policy. As announced at the Annual General Meeting on 11
April 2024, the total dividend for FY 2024 will increase by $0.20 per share to
$3.10 per share.
In approving the declaration of dividends, the Board considers both the
liquidity of the company and the level of reserves legally available for
distribution. Dividends are paid to shareholders from AstraZeneca PLC, a Group
holding company with no direct operations. The ability of AstraZeneca PLC to
make shareholder distributions is dependent on the creation of profits for
distribution and the receipt of funds from subsidiary companies. The
consolidated Group reserves set out in the Condensed consolidated statement of
financial position do not reflect the profit available for distribution to the
shareholders of AstraZeneca PLC.
Summarised financial information for guarantee of securities of subsidiaries
AstraZeneca Finance LLC ("AstraZeneca Finance") is the issuer of 1.2% Notes
due 2026, 4.8% Notes due 2027, 4.875% Notes due 2028, 1.75% Notes due 2028,
4.85% Notes due 2029, 4.9% Notes due 2030, 4.9% Notes due 2031, 2.25% Notes
due 2031, 4.875% Notes due 2033, 5% Notes due 2034, 3.121% EUR Notes due 2030
and 3.278% EUR Notes due 2033 (the "AstraZeneca Finance Notes"). Each series
of AstraZeneca Finance Notes has been fully and unconditionally guaranteed by
AstraZeneca PLC. AstraZeneca Finance is 100% owned by AstraZeneca PLC and each
of the guarantees issued by AstraZeneca PLC is full and unconditional and
joint and several.
The AstraZeneca Finance Notes are senior unsecured obligations of AstraZeneca
Finance and rank equally with all of AstraZeneca Finance's existing and future
senior unsecured and unsubordinated indebtedness. The guarantee by AstraZeneca
PLC of the AstraZeneca Finance Notes is the senior unsecured obligation of
AstraZeneca PLC and ranks equally with all of AstraZeneca PLC's existing and
future senior unsecured and unsubordinated indebtedness. Each guarantee by
AstraZeneca PLC is effectively subordinated to any secured indebtedness of
AstraZeneca PLC to the extent of the value of the assets securing such
indebtedness. The AstraZeneca Finance Notes are structurally subordinated to
indebtedness and other liabilities of the subsidiaries of AstraZeneca PLC,
none of which guarantee the AstraZeneca Finance Notes.
AstraZeneca PLC manages substantially all of its operations through divisions,
branches and/or investments in subsidiaries and affiliates. Accordingly, the
ability of AstraZeneca PLC to service its debt and guarantee obligations is
also dependent upon the earnings of its subsidiaries, affiliates, branches and
divisions, whether by dividends, distributions, loans or otherwise.
Please refer to the Consolidated financial statements of AstraZeneca PLC in
our Annual Report on Form 20‑F as filed with the SEC and information
contained herein for further financial information regarding AstraZeneca PLC
and its consolidated subsidiaries. For further details, terms and conditions
of the AstraZeneca Finance Notes please refer to AstraZeneca PLC's reports on
Form 6-K furnished to the SEC on 30 July 2024, 22 February 2024, 3 March 2023
and 28 May 2021.
Pursuant to Rule 13-01 and Rule 3-10 of Regulation S-X under the Securities
Act of 1933, as amended (the "Securities Act"), we present below the summary
financial information for AstraZeneca PLC, as Guarantor, excluding its
consolidated subsidiaries, and AstraZeneca Finance, as the issuer, excluding
its consolidated subsidiaries. The following summary financial information of
AstraZeneca PLC and AstraZeneca Finance is presented on a combined basis and
transactions between the combining entities have been eliminated. Financial
information for non-guarantor entities has been excluded. Intercompany
balances and transactions between the obligor group and the non-obligor
subsidiaries are presented on separate lines.
Table 15: Obligor group summarised Statement of comprehensive income
9M 2024 9M 2023
$m $m
Total Revenue - -
Gross profit - -
Operating loss - (2)
Loss for the period (894) (695)
Transactions with subsidiaries that are not issuers or guarantors 1,342 9,758
Table 16: Obligor group summarised Statement of financial position
At 30 Sep 2024 At 30 Sep 2023
$m $m
Current assets 10 6
Non-current assets 84 -
Current liabilities (801) (4,760)
Non-current liabilities (28,906) (22,077)
Amounts due from subsidiaries that are not issuers or guarantors 16,705 12,921
Amounts due to subsidiaries that are not issuers or guarantors - (295)
Foreign exchange
The Company's transactional currency exposures on working capital balances,
which typically extend for up to three months, are hedged where practicable
using forward foreign exchange contracts against the individual companies'
reporting currency. Foreign exchange gains and losses on forward contracts
transacted for transactional hedging are taken to profit or to Other
comprehensive income if the contract is in a designated cashflow hedge. In
addition, the Company's external dividend payments, paid principally in pound
sterling and Swedish krona, are fully hedged from announcement to payment
date.
Table 17: Currency sensitivities
The Company provides the following information on currency-sensitivity:
Average Annual impact ($m) of 5% strengthening (FY 2024 average rate vs. FY 2023
average) (( 9 (#_ftn9) ))
rates vs. USD
Currency Primary Relevance FY YTD Change Sep Change Total Revenue Core Operating Profit
2023 10 (#_ftn10)
2024 11 (#_ftn11)
2024 12 (#_ftn12)
(%) (%)
EUR Total Revenue 0.92 0.92 0 0.90 3 397 179
CNY Total Revenue 7.09 7.21 (2) 7.08 0 322 182
JPY Total Revenue 140.60 151.23 (7) 143.04 (2) 177 119
Other(( 13 (#_ftn13) )) 453 227
GBP Operating expense 0.80 0.78 3 0.76 6 60 (126)
SEK Operating expense 10.61 10.50 1 10.23 4 9 (63)
Sustainability
In September, AstraZeneca had a significant presence at Climate Week NYC and
the 79th Session of the UN General Assembly in New York, with a delegation led
by Pam Cheng, Executive Vice President of Global Operations and IT and Chief
Sustainability Officer and the company's US leadership. A programme of more
than 50 engagements with governments, media, NGOs and the private sector
focused on the interconnected issues of the climate crisis, health equity and
health system resilience and the Company's commitment to contribute to more
sustainable, resilient and equitable health systems.
Related communications included an opinion piece published by the World
Economic Forum (WEF) on how pharmaceutical companies are investing in nature
to improve human and planetary health and an article in Foreign Policy on
building sustainable health systems to manage the burden of non-communicable
diseases.
Access to healthcare
‒ By end of August 2024, the Company's flagship Healthy Heart Africa
programme had conducted more than 61 million blood pressure screenings,
identifying over 12.1 million people with elevated blood pressure and
diagnosing over 4.87 million with high blood pressure
‒ In October, the Company convened the inaugural meeting of its
Global Health Equity Advisory Board (HEAB), a group of 15 external
stakeholders with representation from 11 countries and across disease areas,
to advise on the Company's approach to help improve equitable health outcomes
globally
‒ AstraZeneca Chair Michel Demaré and Executive Vice President,
Vaccines and Immune Therapies, Iskra Reic shared perspectives on health
systems resilience in Health: A Political Choice - Building Resilience and
Trust, a publication launched during the World Health Summit in collaboration
with the World Health Organization
‒ During the quarter, the Partnership for Health System Sustainability
and Resilience (PHSSR) initiative convened an Expert Advisory Group on the
role of EU institutions in supporting sustainable healthcare financing of
Member States. The PHSSR was also active in a session at the European Health
Forum Gastein in collaboration with AstraZeneca, on the importance of
decarbonising care pathways for the health of people and the planet. The
session emphasised the need for early, targeted and patient-centred
interventions within integrated EU and national public policy strategies
‒ In September, through the Young Health Programme (YHP), 24 young
health leaders from around the world received a Fellowship to attend the One
Young World Summit in Montréal, Canada to support their focus on building a
healthier and more equitable future. Additionally, in August, the YHP awarded
scholarships to seven young global leaders who are tackling the health impacts
of the climate crisis to join a Climate Entrepreneurship Academy in New
York. During the quarter, YHP won Corporate Social Responsibility Programme
of the Year at the Pharma Industry UK Awards
Environmental protection
‒ The Company reached a key sustainability milestone in its Ambition
Zero Carbon decarbonisation strategy, with over 50% of its global vehicle
fleet now fully electric, including in Europe, Japan and the US. AstraZeneca
currently has over 10,000 battery electric vehicles (BEVs), with fully
electric fleets in the Netherlands, Greece and Georgia
‒ AstraZeneca's manufacturing site in Södertälje, Sweden - the
Company's largest manufacturing site globally - has reduced its Scope 1 and 2
greenhouse (GHG) gas emissions by 98% since 2015, making it the Company's
sixth site to have achieved this goal ahead of schedule. With this milestone,
all locations in Sweden, including the strategic R&D Centre in Gothenburg,
have now achieved their Scope 1 and 2 Ambition Zero Carbon Targets
‒ Through the Sustainable Markets Initiative Health Systems Task
Force, chaired by CEO Pascal Soriot, the Company contributed to the launch of
the European Network on Climate and Health Education which took place at the
World Health Summit in Berlin. The network brings together 25 leading
universities from across Europe which are committed to training 10,000 medical
students with skills to address the health impacts of climate change and
deliver sustainable healthcare
‒ The Company received the Net Zero: Operations Transformation award
at the 2024 Reuters Sustainability Awards in October, recognising its
commitment to drive deep decarbonisation across its operations and fleet
through the Ambition Zero Carbon strategy. The WEF also recognised two of the
Company's advanced manufacturing sites in Wuxi (China) and Södertälje
(Sweden) as Fourth Industrial Revolution (4IR) Lighthouses, part of its Global
Lighthouse Network which spotlights organisations harnessing advanced
technologies such as digital and AI to drive next-generation operational
excellence, environmental sustainability and workforce development
‒ In August, the Company was recognised with awards by My Green Lab
and the International Institute for Sustainable Laboratories - the 2024
Freezer Challenge Winning Streak Award for Biotech & Pharmaceuticals, for
being at the top of the sector and surpassing 2023 energy savings, and the Top
Small Lab Award - Pharmaceutical and Biotech Sector - awarded to AZ Gothenburg
Regional HBS Centre
‒ The Company completed studies to support the first regulatory
filings for the transition of Breztri/Trixeo Aerosphere to an innovative,
next-generation propellant with 99.9% lower Global Warming Potential than
propellants used in currently available inhaled medicines. Reducing the carbon
impact of pressurised-metered dose inhalers is a key product-related element
of AstraZeneca's Ambition Zero Carbon strategy, alongside the Company's
commitment to improving patient outcomes
Ethics and transparency
‒ In September, AstraZeneca was included in the TIME World's Best
Companies 2024, ranking first among pharmaceutical companies for
sustainability transparency and in the top 70 out of 1,000 overall
‒ In Mexico, AstraZeneca was third in the Great Place to Work (GPTW)
ranking and the Company's Guadalajara Global Innovation & Technology
Centre was number one in the GPTW Western Region for companies with
>500-5,000 employees for the fourth year in a row
‒ AstraZeneca and 33 other partner organisations announced the launch
of the VICT3R project, a public-private partnership that aims to reduce the
number of animals used in experimental studies through Virtual Control Groups
(VCGs) created using cutting edge statistical and artificial intelligence (AI)
techniques. The project aims to transform drug and chemical safety evaluation
while promoting ethical research practices and environmental sustainability
Research and development
This section covers R&D events and milestones that have occurred since the
prior results announcement on 25 July 2024, up to and including events on 11
November 2024.
A comprehensive view of AstraZeneca's pipeline of medicines in human trials
can be found in the latest Clinical Trials Appendix, available on
www.astrazeneca.com/investor-relations
(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 IASLC 2024 World Conference on Lung Cancer (WCLC) hosted by
the International Association for the Study of Lung Cancer and the 2024
European Society for Medical Oncology (ESMO) Congress. Across the two
meetings, more than 130 abstracts were presented featuring 17 approved and
potential new medicines including five Presidential Symposia and 41 oral
presentations.
Tagrisso
Event Commentary
Approval US For the treatment of adult patients with unresectable, Stage III EGFRm NSCLC
whose disease has not progressed during or following concurrent or sequential
platinum-based chemoradiation therapy. (LAURA, September 2024)
Phase II registrational trial readout SAVANNAH Tagrisso plus Orpathys demonstrated a high, clinically meaningful and durable
objective response rate for patients with EGFRm NSCLC with high levels of
mesenchymal epithelial transition factor (MET) overexpression and/or
amplification, defined as IHC90+ and/or FISH10+, whose disease progressed on
treatment with Tagrisso. (October 2024)
Imfinzi and Imjudo
Event Commentary
Approval Europe Imfinzi plus chemotherapy followed by Imfinzi alone has been approved for
patients with mismatch repair deficient disease. (DUO-E, August 2024)
Approval Europe Imfinzi plus chemotherapy as 1st-line treatment followed by Lynparza and
Imfinzi for patients with mismatch repair proficient disease. (DUO-E, August
2024)
Priority Review US Imfinzi for limited-stage small cell lung cancer whose disease has not
progressed following platinum-based concurrent chemoradiotherapy. (ADRIATIC,
August 2024)
Approval US Imfinzi in combination with chemotherapy for the treatment of adult patients
with resectable early-stage (IIA-IIIB) NSCLC and no known EGFR mutations or
ALK rearrangements. (AEGEAN, August 2024)
Phase III presentation: ESMO NIAGARA In a planned interim analysis, patients treated with the Imfinzi perioperative
regimen showed a 32% reduction in the risk of disease progression, recurrence,
not undergoing surgery, or death versus the comparator arm (EFS HR 0.68; 95%
CI 0.56-0.82, p<0.0001). Estimated median EFS was not yet reached for the
Imfinzi arm versus 46.1 months for the comparator arm. In addition, Imfinzi
perioperative regimen reduced the risk of death by 25% versus neoadjuvant
chemotherapy with radical cystectomy (OS HR 0.75; 95% CI 0.59-0.93, p=0.0106).
(September 2024)
Phase III presentation: ESMO HIMALAYA At five years of follow-up, latest exploratory analysis of HIMALAYA showed
that a single priming dose of Imjudo added to Imfinzi, called the STRIDE
regimen (Single Tremelimumab Regular Interval Durvalumab), reduced the risk of
death by 24% compared to sorafenib (HR 0.76, 95% CI 0.65-0.89). An estimated
19.6% of patients treated with the STRIDE regimen were alive at five years
versus 9.4% of those treated with sorafenib. (September 2024)
Lynparza
Event Commentary
Approval Europe Imfinzi plus chemotherapy as 1st-line treatment followed by Lynparza and
Imfinzi for patients with mismatch repair proficient disease. (DUO-E, August
2024)
Enhertu
Event Commentary
Approval China Conditional approval as monotherapy for the treatment of adult patients with
locally advanced or metastatic HER2-positive gastric or gastroesophageal
junction adenocarcinoma who have received two or more prior treatment
regimens. (DESTINY-Gastric06, August 2024)
Phase IIIb/IV presentation: ESMO DESTINY-Breast12 Enhertu demonstrated substantial overall and intracranial clinical activity in
a large cohort of patients with HER2-positive metastatic breast cancer who
have brain metastases and received no more than two prior lines of therapy in
the metastatic setting with a 12-month PFS rate of 61.6%. (September 2024)
Priority Review US For the treatment of adult patients with unresectable or metastatic HER2-low
(IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast
cancer who have received at least one endocrine therapy in the metastatic
setting. (DESTINY-Breast06, October 2024)
Approval China Conditional approval as monotherapy for the treatment of adult patients with
unresectable, locally advanced or metastatic NSCLC whose tumours have
activating HER2 mutations and who have received a prior systemic therapy.
(DESTINY-Lung02, DESTINY-Lung05, October 2024)
Calquence
Event Commentary
Phase III trial readout AMPLIFY Interim analysis of AMPLIFY Phase III trial showed a fixed duration of
Calquence in combination with venetoclax, with or without obinutuzumab,
demonstrated a statistically significant and clinically meaningful improvement
in PFS compared to standard-of-care chemoimmunotherapy in previously untreated
adult patients with chronic lymphocytic leukaemia. (July 2024)
Priority Review US For the treatment of adult patients with previously untreated mantle cell
lymphoma. (ECHO, October 2024)
Datopotamab deruxtecan (Dato-DXd)
Event Commentary
Phase III presentation: WCLC TROPION-Lung01 Exploratory analysis of the TROPION-Lung01 Phase III trial showed TROP2 as
measured by AstraZeneca's proprietary computational pathology platform,
quantitative continuous scoring, was predictive of clinical outcomes in
patients with advanced or metastatic NSCLC who were treated with Dato-DXd.
(September 2024)
Phase III presentation: WCLC TROPION-Lung01 Demonstrated a clinically meaningful, but not statistically significant, trend
toward improving OS with Dato-DXd compared to docetaxel in patients with
locally advanced or metastatic non-squamous NSCLC treated with at least one
prior line of therapy (14.6 versus 12.3 months; HR 0.84; 95% CI 0.68-1.05). In
the overall trial population, OS results numerically favoured Dato-DXd
compared to docetaxel (12.9 versus 11.8 months) but did not reach statistical
significance (HR 0.94, 95% CI 0.78-1.14, p=0.530). (September 2024)
Phase III trial readout TROPION-Breast01 TROPION-Breast01 Phase III trial of Dato-DXd compared to investigator's choice
of chemotherapy, which previously met the dual primary endpoint of PFS, did
not achieve statistical significance in the final OS analysis in patients with
inoperable or metastatic hormone receptor-positive, HER2-low or negative (IHC
0, IHC 1+ or IHC 2+/ISH-) breast cancer previously treated with
endocrine-based therapy and at least one systemic therapy. (September 2024)
Regulatory update US Submission of a new Biologics License Application for accelerated approval for
Dato-DXd for the treatment of adult patients with locally advanced or
metastatic EGFRm NSCLC who have received prior systemic therapies, including
an EGFR-directed therapy. Voluntarily withdrawal of the Biologics License
Application for Dato-DXd for patients with advanced or metastatic non-squamous
NSCLC based on the TROPION-Lung01 Phase III trial. An additional trial in
biomarker-positive patients in the 2nd line non-squamous NSCLC setting is also
planned. (TROPION-Lung05, TROPION-PanTumor01, TROPION-Lung01, November 2024)
Zoladex
Event Commentary
Approval China Zoladex 10.8mg for breast cancer in pre- and perimenopausal women suitable for
hormonal manipulation. (Study 11, October 2024)
BioPharmaceuticals - CVRM
Wainua
Event Commentary
CHMP positive opinion EU For the treatment of hereditary transthyretin-mediated amyloidosis in adult
patients with stage 1 or stage 2 polyneuropathy, commonly referred to as
hATTR-PN or ATTRv-PN. (NEURO-TTRansform, October 2024)
BioPharmaceuticals - R&I
Airsupra
Event Commentary
Phase III trial readout BATURA Interim analysis of the Phase IIIb BATURA trial showed Airsupra met the
primary endpoint, demonstrating a statistically significant and clinically
meaningful reduction in the risk of a severe exacerbation when used as an
as-needed rescue medication in response to symptoms compared to as-needed
albuterol. (October 2024)
Breztri
Event Commentary
Clinical program completion NGP Completion of the clinical programme to support the transition of Breztri to
next-generation propellant with near-zero Global Warming Potential. (September
2024) A Marketing Authorisation Application for Breztri with the
next-generation propellant has been accepted by the European Medicines Agency
(November 2024). Additional submissions in the UK and China expected before
the end of 2024. (November 2024)
Fasenra
Event Commentary
Approval US For the treatment of adult patients with eosinophilic granulomatosis with
polyangiitis. (MANDARA, September 2024)
CHMP positive opinion EU As an add-on treatment for adult patients with relapsing or refractory
eosinophilic granulomatosis with polyangiitis. (MANDARA, September 2024)
Approval China For maintenance treatment of patients 12 years of age and older with severe
eosinophilic asthma. (MIRACLE, August 2024)
Phase III trial update ORCHID The Phase III ORCHID trial assessing Fasenra in chronic rhinosinusitis with
nasal polyps and asthma did not meet the primary endpoints of improvement in
the size of nasal polyps and in nasal blockage. The safety and tolerability
profile for Fasenra in the trial was consistent with the known profile of the
treatment. Results from ORCHID will be shared with the scientific community in
the future. (November 2024)
Tezspire
Event Commentary
Phase III trial readout WAYPOINT Tezspire met both co-primary endpoints, demonstrating a statistically
significant and clinically meaningful reduction in nasal polyp size and
improved nasal congestion compared to placebo. (November 2024)
BioPharmaceuticals - V&I
FluMist
Event Commentary
Approval US For self-administration by adults up to 49 years of age or as administered by
a parent/caregiver to individuals 2-17 years of age. FluMist is the only
influenza vaccine approved for self-administration in the US. (September 2024)
Rare Disease
Alexion, AstraZeneca Rare Disease, presented data from its leading gMG
portfolio at the American Association of Neuromuscular & Electrodiagnostic
Medicine Annual Meeting and the Myasthenia Gravis Foundation of America
Scientific Session in October 2024.
The company presented 11 abstracts, spanning clinical and real-world data,
which add to the extensive body of evidence supporting the safety and efficacy
of Ultomiris and Soliris in treating anti-acetylcholine receptor
antibody-positive gMG, and offer new insights to inform clinical practice.
Koselugo
Event Commentary
Phase III trial readout KOMET Positive high-level results of the Phase III KOMET trial in adults with NF1-PN
showed that Koselugo met its primary endpoint demonstrating a statistically
significant and clinically meaningful ORR versus placebo in these adult
patients. (November 2024)
Interim financial statements
Table 18: Condensed consolidated statement of comprehensive income: 9M 2024
For the nine months ended 30 September 2024 2023
$m $m
Total Revenue 39,182 33,787
Product Sales 37,576 32,466
Alliance Revenue 1,498 1,004
Collaboration Revenue 108 317
Cost of sales (7,482) (5,960)
Gross profit 31,700 27,827
Distribution expense (412) (394)
Research and development expense (8,906) (7,862)
Selling, general and administrative expense (14,567) (13,845)
Other operating income and expense 152 1,233
Operating profit 7,967 6,959
Finance income 394 236
Finance expense (1,313) (1,181)
Share of after tax losses in associates and joint ventures (23) (12)
Profit before tax 7,025 6,002
Taxation (1,484) (1,000)
Profit for the period 5,541 5,002
Other comprehensive income:
Items that will not be reclassified to profit or loss:
Remeasurement of the defined benefit pension liability 136 (1)
Net gains on equity investments measured at fair value through other 264 45
comprehensive income
Fair value movements related to own credit risk on bonds designated as fair 12 5
value through profit or loss
Tax on items that will not be reclassified to profit or loss (50) -
362 49
Items that may be reclassified subsequently to profit or loss:
Foreign exchange arising on consolidation 543 (201)
Foreign exchange arising on designated liabilities in net investment hedges (84) (63)
Fair value movements on cash flow hedges (42) 62
Fair value movements on cash flow hedges transferred to profit and loss 1 28
Fair value movements on derivatives designated in net investment hedges 13 47
Gains/(costs) of hedging 2 (3)
Tax on items that may be reclassified subsequently to profit or loss 16 (7)
449 (137)
Other comprehensive income/(expense), net of tax 811 (88)
Total comprehensive income for the period 6,352 4,914
Profit attributable to:
Owners of the Parent 5,535 4,995
Non-controlling interests 6 7
5,541 5,002
Total comprehensive income attributable to:
Owners of the Parent 6,346 4,907
Non-controlling interests 6 7
6,352 4,914
Basic earnings per $0.25 Ordinary Share $3.57 $3.22
Diluted earnings per $0.25 Ordinary Share $3.54 $3.20
Weighted average number of Ordinary Shares in issue (millions) 1,550 1,549
Diluted weighted average number of Ordinary Shares in issue (millions) 1,562 1,560
Table 19: Condensed consolidated statement of comprehensive income: Q3 2024
For the quarter ended 30 September
2024 2023
$m $m
Total Revenue 13,565 11,492
Product Sales 12,947 11,018
Alliance Revenue 559 377
Collaboration Revenue 59 97
Cost of sales (3,081) (2,095)
Gross profit 10,484 9,397
Distribution expense (145) (129)
Research and development expense (3,115) (2,584)
Selling, general and administrative expense (5,143) (4,800)
Other operating income and expense 25 70
Operating profit 2,106 1,954
Finance income 183 101
Finance expense (457) (392)
Share of after tax losses in associates and joint ventures (4) (11)
Profit before tax 1,828 1,652
Taxation (395) (274)
Profit for the period 1,433 1,378
Other comprehensive income:
Items that will not be reclassified to profit or loss:
Remeasurement of the defined benefit pension liability 35 (8)
Net gains on equity investments measured at fair value through other 175 93
comprehensive income
Fair value movements related to own credit risk on bonds designated as fair - 1
value through profit or loss
Tax on items that will not be reclassified to profit or loss (23) 5
187 91
Items that may be reclassified subsequently to profit or loss:
Foreign exchange arising on consolidation 1,097 (306)
Foreign exchange arising on designated liabilities in net investment hedges 12 38
Fair value movements on cash flow hedges 96 (27)
Fair value movements on cash flow hedges transferred to profit and loss (101) 99
Fair value movements on derivatives designated in net investment hedges (32) 7
Costs of hedging (12) (2)
Tax on items that may be reclassified subsequently to profit or loss (22) (19)
1,038 (210)
Other comprehensive income/(expense), net of tax 1,225 (119)
Total comprehensive income for the period 2,658 1,259
Profit attributable to:
Owners of the Parent 1,429 1,374
Non-controlling interests 4 4
1,433 1,378
Total comprehensive income attributable to:
Owners of the Parent 2,654 1,255
Non-controlling interests 4 4
2,658 1,259
Basic earnings per $0.25 Ordinary Share $0.92 $0.89
Diluted earnings per $0.25 Ordinary Share $0.91 $0.88
Weighted average number of Ordinary Shares in issue (millions) 1,550 1,549
Diluted weighted average number of Ordinary Shares in issue (millions) 1,562 1,560
Table 20: Condensed consolidated statement of financial position
At 30 Sep At 31 Dec At 30 Sep
2024 2023 2023
$m $m $m
Assets
Non-current assets
Property, plant and equipment 10,135 9,402 8,723
Right-of-use assets 1,378 1,100 977
Goodwill 21,139 20,048 19,939
Intangible assets 39,394 38,089 37,687
Investments in associates and joint ventures 290 147 62
Other investments 1,855 1,530 1,228
Derivative financial instruments 319 228 151
Other receivables 915 803 761
Deferred tax assets 5,342 4,718 4,057
80,767 76,065 73,585
Current assets
Inventories 5,662 5,424 5,292
Trade and other receivables 11,879 12,126 11,300
Other investments 133 122 244
Derivative financial instruments 16 116 97
Income tax receivable 1,668 1,426 697
Cash and cash equivalents 4,797 5,840 4,871
24,155 25,054 22,501
Total assets 104,922 101,119 96,086
Liabilities
Current liabilities
Interest-bearing loans and borrowings (1,253) (5,129) (5,372)
Lease liabilities (317) (271) (235)
Trade and other payables (21,684) (22,374) (20,542)
Derivative financial instruments (17) (156) (83)
Provisions (1,187) (1,028) (1,193)
Income tax payable (1,468) (1,584) (1,163)
(25,926) (30,542) (28,588)
Non-current liabilities
Interest-bearing loans and borrowings (28,887) (22,365) (22,225)
Lease liabilities (1,105) (857) (744)
Derivative financial instruments (34) (38) (75)
Deferred tax liabilities (3,568) (2,844) (2,752)
Retirement benefit obligations (1,361) (1,520) (1,048)
Provisions (1,063) (1,127) (1,189)
Income tax payable (174) - -
Other payables (1,999) (2,660) (2,244)
(38,191) (31,411) (30,277)
Total liabilities (64,117) (61,953) (58,865)
Net assets 40,805 39,166 37,221
Equity
Capital and reserves attributable to equity holders of the Parent
Share capital 388 388 387
Share premium account 35,203 35,188 35,166
Other reserves 1,990 2,065 2,078
Retained earnings 3,138 1,502 (434)
40,719 39,143 37,197
Non-controlling interests 86 23 24
Total equity 40,805 39,166 37,221
Table 21: Condensed consolidated statement of changes in equity
Share capital Share premium account Other reserves Retained earnings Total attributable to owners of the parent Non-controlling interests Total equity
$m $m $m $m $m $m $m
At 1 Jan 2023 387 35,155 2,069 (574) 37,037 21 37,058
Profit for the period - - - 4,995 4,995 7 5,002
Other comprehensive expense - - - (88) (88) - (88)
Transfer to other reserves - - 9 (9) - - -
Transactions with owners
Dividends - - - (4,487) (4,487) - (4,487)
Dividends paid to non-controlling interests - - - - - (4) (4)
Issue of Ordinary Shares - 11 - - 11 - 11
Share-based payments charge for the period - - - 429 429 - 429
Settlement of share plan awards - - - (700) (700) - (700)
Net movement - 11 9 140 160 3 163
At 30 Sep 2023 387 35,166 2,078 (434) 37,197 24 37,221
At 1 Jan 2024 388 35,188 2,065 1,502 39,143 23 39,166
Profit for the period - - - 5,535 5,535 6 5,541
Other comprehensive income - - - 811 811 - 811
Transfer to other reserves - - 1 (1) - - -
Transactions with owners
Dividends - - - (4,602) (4,602) - (4,602)
Dividends paid to non-controlling interests - - - - - (4) (4)
Issue of Ordinary Shares - 15 - - 15 - 15
Changes in non-controlling interests - - - - - 61 61
Movement in shares held by Employee Benefit Trust - - (76) - (76) - (76)
Share-based payments charge for the period - - - 487 487 - 487
Settlement of share plan awards - - - (594) (594) - (594)
Net movement - 15 (75) 1,636 1,576 63 1,639
At 30 Sep 2024 388 35,203 1,990 3,138 40,719 86 40,805
Table 22: Condensed consolidated statement of cash flows: 9M 2024
For the nine months ended 30 September 2024 2023
$m $m
Cash flows from operating activities
Profit before tax 7,025 6,002
Finance income and expense 919 945
Share of after tax losses of associates and joint ventures 23 12
Depreciation, amortisation and impairment 4,351 4,060
Movement in working capital and short-term provisions (543) 150
Gains on disposal of intangible assets (34) (247)
Fair value movements on contingent consideration arising from business 251 202
combinations
Non-cash and other movements 15 (623)
Cash generated from operations 12,007 10,501
Interest paid (1,075) (826)
Tax paid (1,978) (1,710)
Net cash inflow from operating activities 8,954 7,965
Cash flows from investing activities
Acquisition of subsidiaries, net of cash acquired (2,771) (189)
Payments upon vesting of employee share awards attributable to business - (84)
combinations
Payment of contingent consideration from business combinations (737) (610)
Purchase of property, plant and equipment (1,216) (836)
Disposal of property, plant and equipment 53 131
Purchase of intangible assets (2,415) (1,996)
Disposal of intangible assets 107 288
Movement in profit-participation liability - 190
Purchase of non-current asset investments (96) (109)
Disposal of non-current asset investments 73 32
Movement in short-term investments, fixed deposits and other investing 67 (12)
instruments
Payments to associates and joint ventures (158) -
Disposal of investments in associates and joint ventures 13 -
Interest received 281 208
Net cash (outflow) from investing activities (6,799) (2,987)
Net cash inflow before financing activities 2,155 4,978
Cash flows from financing activities
Proceeds from issue of share capital 15 12
Own shares purchased by Employee Benefit Trust (81) -
Issue of loans and borrowings 6,492 3,816
Repayment of loans and borrowings (4,647) (4,655)
Dividends paid (4,626) (4,479)
Hedge contracts relating to dividend payments 16 (19)
Repayment of obligations under leases (233) (194)
Movement in short-term borrowings 572 110
Payment of Acerta Pharma share purchase liability (833) (867)
Net cash (outflow) from financing activities (3,325) (6,276)
Net (decrease) in Cash and cash equivalents in the period (1,170) (1,298)
Cash and cash equivalents at the beginning of the period 5,637 5,983
Exchange rate effects (32) (66)
Cash and cash equivalents at the end of the period 4,435 4,619
Cash and cash equivalents consist of:
Cash and cash equivalents 4,797 4,871
Overdrafts (362) (252)
4,435 4,619
Notes to the Interim financial statements
Note 1: Basis of preparation and accounting policies
These unaudited condensed consolidated Interim financial statements for the
nine months ended 30 September 2024 have been prepared in accordance with
International Accounting Standard 34, 'Interim Financial Reporting' (IAS 34),
as issued by the International Accounting Standards Board (IASB), IAS 34 as
adopted by the European Union, UK-adopted IAS 34 and the Disclosure Guidance
and Transparency Rules sourcebook of the United Kingdom's Financial Conduct
Authority and with the requirements of the Companies Act 2006 as applicable to
companies reporting under those standards.
The unaudited Interim financial statements for the nine months ended 30
September 2024 were approved by the Board of Directors for publication on 12
November 2024.
This results announcement does not constitute statutory accounts of the Group
within the meaning of sections 434(3) and 435(3) of the Companies Act 2006.
The annual financial statements of the Group for the year ended 31 December
2023 were prepared in accordance with UK-adopted international accounting
standards and with the requirements of the Companies Act 2006. The annual
financial statements also comply fully with IFRS Accounting Standards as
issued by the IASB and International Accounting Standards as adopted by the
European Union. Except for the estimation of the interim income tax charge,
the Interim financial statements have been prepared applying the accounting
policies that were applied in the preparation of the Group's published
consolidated financial statements for the year ended 31 December 2023.
The comparative figures for the financial year ended 31 December 2023 are not
the Group's statutory accounts for that financial year. Those accounts have
been reported on by the Group's auditors and have been delivered to the
Registrar of Companies; their report was (i) unqualified, (ii) did not include
a reference to any matters to which the auditors drew attention by way of
emphasis without qualifying their report, and (iii) did not contain a
statement under section 498(2) or (3) of the Companies Act 2006.
Going concern
The Group has considerable financial resources available. As at 30 September
2024, the Group has $11.7bn in financial resources (cash and cash equivalent
balances of $4.8bn and undrawn committed bank facilities of $6.9bn, with
$1.6bn of borrowings due within one year). These facilities contain no
financial covenants and were undrawn at 30 September 2024. There are $4.9bn of
undrawn committed bank facilities are available until April 2029.
Additionally, there are a further $2.0bn undrawn committed bank facilities
available until February 2025.
The Group's revenues are largely derived from sales of medicines covered by
patents, which provide a relatively high level of resilience and
predictability to cash inflows, although government price interventions in
response to budgetary constraints are expected to continue to adversely affect
revenues in some of our significant markets. The Group, however, anticipates
new revenue streams from both recently launched medicines and those in
development, and the Group has a wide diversity of customers and suppliers
across different geographic areas.
Consequently, the Directors believe that, overall, the Group is well placed to
manage its business risks successfully. Accordingly, they continue to adopt
the going concern basis in preparing the Interim financial statements.
Legal proceedings
The information contained in Note 6 updates the disclosures concerning legal
proceedings and contingent liabilities in the Group's Annual Report and Form
20-F Information 2023.
(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 10 June
2024, AstraZeneca obtained control and commenced consolidation of the EBT.
Accordingly, cash paid on purchases of AstraZeneca Ordinary shares or American
Depositary Receipts is presented within Financing activities in the Cash flow
statement.
Note 2: Intangible assets
In accordance with IAS 36 'Impairment of Assets', reviews for triggers of
impairment or impairment reversals at an individual asset or cash generating
unit level were conducted, and impairment tests carried out where triggers
were identified. Following a strategic review of our portfolio priorities, the
business decision was made to cease promotional activity for Andexxa
resulting in impairment charges of $504m recorded against the Andexxa
intangible asset under value in use model applying a discount rate of 7.5%
(revised carrying amount: $nil), total net impairment charges of $525m have
been recorded against intangible assets during the nine months ended 30
September 2024 (9M 2023: $376m net charge). In 9M 2023, net impairment charges
included the $244m impairment of the ALXN1840 intangible asset, following the
decision to discontinue this development programme in Wilson's disease.
The acquisition of Icosavax, Inc. completed on 19 February 2024. The
transaction is recorded as an asset acquisition based on the concentration
test permitted under IFRS 3 'Business Combinations', with consideration of
$841m principally relating to $639m of intangible assets, $141m of cash and
cash equivalents and $51m of marketable securities. Contingent consideration
of up to $300m could be paid on achievement of regulatory and sales
milestones; these potential liabilities would be recorded when the relevant
recognition event for a regulatory or sales milestone is achieved.
The acquisition of Amolyt Pharma completed on 15 July 2024. The transaction is
recorded as an asset acquisition based on the concentration test permitted
under IFRS 3 'Business Combinations', with consideration of $857m principally
relating to $800m of intangible assets and $98m of cash and cash equivalents.
Contingent consideration of up to $250m could be paid on achievement of a
regulatory milestone; this potential liability would be recorded when the
relevant recognition event for a regulatory milestone is achieved.
Note 3: Net debt
The table below provides an analysis of Net debt and a reconciliation of Net
Cash flow to the movement in Net debt. The Group monitors Net debt as part of
its capital management policy as described in Note 28 of the Annual Report and
Form 20-F Information 2023
(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 Sep 2024
& other
$m $m $m $m $m $m
Non-current instalments of loans (22,365) (6,499) (3) 69 (89) (28,887)
Non-current instalments of leases (857) 1 (12) (233) (4) (1,105)
Total long-term debt (23,222) (6,498) (15) (164) (93) (29,992)
Current instalments of loans (4,614) 4,586 (9) (3) 28 (12)
Current instalments of leases (271) 271 (6) (311) - (317)
Commercial paper - (472) - - - (472)
Collateral received from derivative counterparties (72) - - - (287)
(215)
Other short-term borrowings excluding overdrafts (28) - (1) 6 (120)
(97)
Overdrafts (203) (158) - 1 (2) (362)
Total current debt (5,400) 4,127 (15) (314) 32 (1,570)
Gross borrowings (28,622) (2,371) (30) (478) (61) (31,562)
Net derivative financial instruments 150 41 - 93 - 284
Net borrowings (28,472) (2,330) (30) (385) (61) (31,278)
Cash and cash equivalents 5,840 (1,254) 242 (1) (30) 4,797
Other investments - current 122 (67) 87 - (9) 133
Cash and investments 5,962 (1,321) 329 (1) (39) 4,930
Net debt (22,510) (3,651) 299 (386) (100) (26,348)
Net debt increased by $3,838m in the nine months to $26,348m. Details of the
committed undrawn bank facilities are disclosed within the going concern
section of Note 1. Non-cash movements in the period include fair value
adjustments under IFRS 9 'Financial Instruments'.
In February 2024, AstraZeneca issued the following:
- $1,250m of fixed-rate notes with a coupon of 4.8% maturing in
February 2027
- $1,250m of fixed-rate notes with a coupon of 4.85% maturing in
February 2029
- $1,000m of fixed-rate notes with a coupon of 4.9% maturing in
February 2031
- $1,500m of fixed-rate notes with a coupon of 5% maturing in February
2034
In August 2024, AstraZeneca issued the following:
- €650m of fixed-rate notes with a coupon of 3.121% maturing in
August 2030
- €750m of fixed-rate notes with a coupon of 3.278% maturing in
August 2033
AstraZeneca repaid two bonds of carrying value $2,569m and floating rate bank
loans of $2,000m during the nine months which are included in the cash outflow
from Repayment of loans and borrowings of $4,647m.
The Group has agreements with some bank counterparties whereby the parties
agree to post cash collateral on financial derivatives, for the benefit of the
other, equivalent to the market valuation of the derivative positions above a
predetermined threshold. The carrying value of such cash collateral held by
the Group at 30 September 2024 was $287m (31 December 2023: $215m) and the
carrying value of such cash collateral posted by the Group at 30 September
2024 was $68m (31 December 2023: $102m).
The equivalent GAAP measure to Net debt is 'liabilities arising from financing
activities', which excludes the amounts for cash and overdrafts, other
investments and non-financing derivatives shown above and includes the Acerta
Pharma share purchase liability of $nil (31 December 2023: $833m).
During the quarter ended 30 September 2024, Standard and Poor's upgraded the
Company's solicited long term credit rating to A+ from A. The short term
rating remained at A-1. There were no changes to Moody's credit ratings (long
term: A2; short term: P-1).
Note 4: Financial Instruments
As detailed in the Group's most recent annual financial statements, the
principal financial instruments consist of derivative financial instruments,
other investments, trade and other receivables, cash and cash equivalents,
trade and other payables, lease liabilities and interest-bearing loans and
borrowings.
The Group has certain equity investments that are categorised as Level 3 in
the fair value hierarchy that are held at $370m (31 December 2023: $313m) and
for which a fair value gain of $nil has been recognised in the nine months
ended 30 September 2024 (9M 2023: $17m). In the absence of specific market
data, these unlisted investments are held at fair value based on the cost of
investment and adjusted as necessary for impairments and revaluations on new
funding rounds, which are seen to approximate the fair value. All other fair
value gains and/or losses that are presented in Net gains on equity
investments measured at fair value through other comprehensive income, in the
Condensed consolidated statement of comprehensive income for the nine months
ended 30 September 2024, are Level 1 fair value measurements, valued based on
quoted prices in active markets.
Financial instruments measured at fair value include $1,920m of other
investments, $3,408m held in money-market funds and $284m of derivatives as at
30 September 2024. With the exception of derivatives being Level 2 fair
valued, and certain equity instruments of $379m categorised as Level 3, the
aforementioned balances are Level 1 fair valued. Financial instruments
measured at amortised cost include $68m of cash collateral pledged to
counterparties. The total fair value of interest-bearing loans and borrowings
at 30 September 2024, which have a carrying value of $31,562m in the Condensed
consolidated statement of financial position, was $31,396m.
Table 24: Financial instruments - contingent consideration
2024 2023
Diabetes alliance Other Total Total
$m $m $m $m
At 1 January 1,945 192 2,137 2,222
Additions through business combinations - 198 198 60
Settlements (736) (1) (737) (610)
Revaluations 220 32 252 202
Discount unwind 77 8 85 99
At 30 September 1,506 429 1,935 1,973
Contingent consideration arising from business combinations is fair valued
using decision-tree analysis, with key inputs including the probability of
success, consideration of potential delays and the expected levels of future
revenues.
The contingent consideration balance relating to BMS's share of the global
diabetes alliance of $1,506m (31 December 2023: $1,945m) would
increase/decrease by $151m with an increase/decrease in sales of 10%, as
compared with the current estimates.
Note 5: Business combinations
Gracell
On 22 February 2024, AstraZeneca completed the acquisition of Gracell
Biotechnologies Inc. (Gracell), a global clinical-stage biopharmaceutical
company developing innovative cell therapies for the treatment of cancer and
autoimmune diseases.
The purchase price allocation review has been completed, currently there are
no changes to the amounts reported in the H1 and Q2 2024 results announcement.
The transaction is recorded as a business combination using the acquisition
method of accounting in accordance with IFRS 3 'Business Combinations'.
The total consideration fair value of $1,037m includes cash consideration of
$983m and future regulatory milestone-based consideration of $54m. Intangible
assets recognised relate to products in development, principally AZD0120.
Goodwill of $136m has been recognised. Gracell's results have been
consolidated into the Group's results from 22 February 2024.
Fusion
On 4 June 2024, AstraZeneca completed the acquisition of Fusion
Pharmaceuticals Inc., (Fusion) a clinical-stage biopharmaceutical company
developing next-generation radioconjugates.
The purchase price allocation review has been completed, currently there are
no changes to the amounts reported in the H1 and Q2 2024 results announcement.
The transaction is recorded as a business combination using the acquisition
method of accounting in accordance with IFRS 3 'Business Combinations'.
The total consideration fair value of $2,195m includes cash consideration of
$2,051m and future regulatory milestone-based consideration of $144m.
Intangible assets relating to products in development comprise the FPI-2265
($848m), FPI-2059 ($165m) and AZD2068 ($313m) programmes. Goodwill of $947m
has been recognised. Fusion's results have been consolidated into the Group's
results from 4 June 2024.
Note 6: Legal proceedings and contingent liabilities
AstraZeneca is involved in various legal proceedings considered typical to its
business, including litigation and investigations, including Government
investigations, relating to product liability, commercial disputes,
infringement of intellectual property (IP) rights, the validity of certain
patents, anti-trust law and sales and marketing practices. The matters
discussed below constitute the more significant developments since publication
of the disclosures concerning legal proceedings in the Company's Annual Report
and Form 20-F Information 2023 and the Interim Financial Statements for the
six months ended 30 June 2024 (the Disclosures). Information about the nature
and facts of the cases is disclosed in accordance with IAS 37.
As discussed in the Disclosures, the majority of claims involve highly complex
issues. Often these issues are subject to substantial uncertainties and,
therefore, the probability of a loss, if any, being sustained and/or an
estimate of the amount of any loss is difficult to ascertain.
In cases that have been settled or adjudicated, or where quantifiable fines
and penalties have been assessed and which are not subject to appeal, or where
a loss is probable and we are able to make a reasonable estimate of the loss,
AstraZeneca records the loss absorbed or makes a provision for its best
estimate of the expected loss. The position could change over time and the
estimates that the Company made, and upon which the Company have relied in
calculating these provisions are inherently imprecise. There can, therefore,
be no assurance that any losses that result from the outcome of any legal
proceedings will not exceed the amount of the provisions that have been booked
in the accounts. The major factors causing this uncertainty are described more
fully in the Disclosures and herein.
AstraZeneca has full confidence in, and will vigorously defend and enforce,
its IP.
Matters disclosed in respect of the third quarter of 2024 and to 12 November
2024
Table 25: Patent litigation
Legal proceedings brought against AstraZeneca
Faslodex patent proceedings, Japan * In 2021 in Japan, AstraZeneca received notice from the Japan Patent
Office (JPO) that Sandoz K.K. (Sandoz) and Sun Pharma Japan Ltd. (Sun) were
seeking to invalidate the Faslodex formulation patent.
Considered to be a contingent asset * AstraZeneca defended the challenged patent and Sun withdrew from the JPO
patent challenge.
* In July 2023, the JPO issued a final decision upholding various claims
of the challenged patent and determining that other patent claims were
invalid.
* In August 2023, Sandoz appealed the JPO decision to the Japan IP High
Court (High Court).
* In October 2024, the High Court affirmed the decision by the JPO.
Tagrisso patent proceedings, US * 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.
Considered to be a contingent liability * In March 2024, the District Court dismissed Puma.
* The jury trial, with Wyeth as the plaintiff, took place in May 2024. The
jury found Wyeth's patents infringed and awarded Wyeth $107.5m in past
damages. The jury also found that the infringement was not wilful.
* In proceedings following the jury award, the District Court rejected
AstraZeneca's indefiniteness and equitable defences but granted judgment as a
matter of law in favour of AstraZeneca on the grounds that the patents were
invalid for lack of written description and enablement. Wyeth has filed an
appeal.
Legal proceedings brought by AstraZeneca
Lokelma patent proceedings, US * In August 2022, in response to Paragraph IV notices, AstraZeneca
initiated ANDA litigation against multiple generic filers in the US District
Court for the District of Delaware (District Court). AstraZeneca alleged that
a generic version of Lokelma would infringe patents that are owned or licensed
Considered to be a contingent asset by AstraZeneca.
* AstraZeneca has entered into separate settlement agreements with four
generic manufacturers which resulted in dismissal of the corresponding
litigations.
* Additional proceedings with the remaining generic manufacturer are
ongoing in the District Court. Trial is scheduled for March 2025.
Soliris patent proceedings, Canada * In May 2023, Alexion initiated patent litigation in Canada alleging that
Amgen Pharmaceuticals, Inc.'s (Amgen) biosimilar eculizumab product will
infringe Alexion patents.
Considered to be a contingent asset * In September 2023, Alexion initiated patent litigations in Canada
alleging that Samsung Bioepis Co. Ltd.'s (Samsung) biosimilar eculizumab
product will infringe Alexion patents. The filing of the litigation triggered
an automatic 24-month stay of the approval of each defendant's biosimilar
eculizumab product.
* Trial against Amgen is scheduled to begin in January 2025 while trial
against Samsung is scheduled to begin in June 2025.
* In July and August 2023, in Canada, both Amgen and Samsung brought
actions challenging the validity of Alexion's patent relating to the use of
eculizumab in treating aHUS. Trial is scheduled to begin in November 2025.
Soliris patent proceedings, US * In January 2024, Alexion initiated patent infringement litigation
against Samsung Bioepis Co. Ltd. (Samsung) in the US District Court for the
District of Delaware (District Court) alleging that Samsung's biosimilar
eculizumab product, for which Samsung is currently seeking FDA approval, will
Matter concluded infringe six Soliris-related patents.
* Five of the six asserted patents were also the subject of inter partes
review proceedings before the US Patent and Trademark Office.
* Alexion filed a motion for a preliminary injunction seeking to enjoin
Samsung from launching its biosimilar eculizumab product upon FDA approval.
The District Court denied Alexion's motion and Alexion appealed that decision.
* In August 2024, the parties reached resolution of the matter. All legal
proceedings in the US courts have terminated, as have the inter partes review
proceedings.
Tagrisso patent proceedings, Russia * In Russia, in August 2023, AstraZeneca filed lawsuits in the Arbitration
Court of the Moscow Region (Court) against the Ministry of Health of the
Russian Federation and Axelpharm LLC (Axelpharm) related to Axelpharm's
improper use of AstraZeneca's information to obtain authorisation to market a
Considered to be a contingent asset generic version of Tagrisso. In December 2023, the Court dismissed the lawsuit
against the Ministry of Health of the Russian Federation. The appellate court
affirmed the dismissal in March 2024. AstraZeneca filed a further appeal,
which was dismissed in July 2024. The lawsuit against Axelpharm was dismissed
in September 2024, and AstraZeneca appealed.
* In November 2023, Axelpharm filed a compulsory licensing action against
AstraZeneca in the Court related to a patent that covers Tagrisso. The
compulsory licensing action remains pending. AstraZeneca has also challenged
before the Russian Patent and Trademark Office (PTO) the validity of the
Axelpharm patent on which the compulsory licensing action is predicated; in
August 2024, the PTO determined that Axelpharm's patent is invalid.
* In July 2024, AstraZeneca filed a patent infringement lawsuit, which
remains pending, and an unfair competition claim with the Federal
Anti-Monopoly Service of Russia (FAS) against AxelPharm and others related to
the securing of state contracts in Russia for its generic version of
Osimertinib.
* In August 2024, FAS initiated an unfair competition case against
Axelpharm and OncoTarget based on AstraZeneca's unfair competition claim.
* In November 2024, FAS determined that Axelpharm had committed unfair
competition and that OncoTarget had not; FAS ordered Axelpharm to cease sales
of its generic osimertinib and pay the Russian government the income it
received from its sales of its generic osimertinib.
Table 26: Commercial litigation
Legal proceedings brought against AstraZeneca
Amyndas Trade Secrets Litigation, US * AstraZeneca has been defending a matter filed
by Amyndas Pharmaceuticals Member P.C. and Amyndas Pharmaceuticals, LLC,
in the US District Court for the District of Massachusetts alleging trade
secret misappropriation and breach of contract claims against Alexion and
Considered to be a contingent liability Zealand Pharma U.S. Inc. related to Amyndas' C3 inhibitor candidate.
* No trial date has been set.
Caelum Trade Secrets Litigation, US * AstraZeneca has been defending a matter filed by the University of
Tennessee Research Foundation in the US District Court for the Eastern
District of Tennessee related to CAEL-101.
Matter concluded * In September 2024, the parties resolved the matter by settlement.
Seroquel XR Antitrust Litigation, US * In 2019, AstraZeneca was named in several related complaints now
proceeding in US District Court in Delaware (District Court), including
several putative class action lawsuits that were purportedly brought on behalf
of classes of direct purchasers or end payors of Seroquel XR, that allege
Considered to be a contingent liability AstraZeneca and generic drug manufacturers violated US antitrust laws when
settling patent litigation related to Seroquel XR.
* In July 2022, the District Court dismissed claims relating to one of the
generic manufacturers while allowing claims relating to the second generic
manufacturer to proceed.
* In September 2024, AstraZeneca reached a settlement agreement with one
of the plaintiff classes and the parties are now seeking judicial review and
approval of the settlement.
* Trial with the remaining class of plaintiffs is currently scheduled for
May 2025.
Syntimmune Milestone Litigation, US * In connection with Alexion's acquisition of Syntimmune, Inc.
(Syntimmune) in December 2020, Alexion was served with a lawsuit filed by the
stockholders' representative for Syntimmune in Delaware state court that
alleged, among other things, breaches of the 2018 merger agreement.
Considered to be a contingent liability
* The stockholders' representative alleges that Alexion failed to meet its
obligations under the merger agreement to use commercially reasonable efforts
to achieve the milestones. Alexion also filed a claim for breach of the
representations in the 2018 merger agreement.
* A trial was held in July 2023.
* The court issued a partial decision in September 2024, concluding that
the first milestone was achieved, and that Alexion had breached its
contractual obligation to use commercially reasonable efforts to achieve the
milestones. The court has requested additional briefing regarding damages and
further proceedings regarding Alexion's claim for breach.
Viela Bio, Inc. Shareholder Litigation, US * In February 2023, AstraZeneca was served with a lawsuit filed in the
Delaware state court against AstraZeneca and certain officers (collectively,
Defendants), on behalf of a putative class of Viela Bio, Inc. (Viela)
shareholders. The complaint alleged that the Defendants breached their
Considered to be a contingent liability fiduciary duty to Viela shareholders in the course of Viela's 2021 merger with
Horizon Therapeutics, plc.
* In July 2024, the Court granted with prejudice AstraZeneca's motion to
dismiss.
* In August 2024, plaintiffs appealed the dismissal.
Table 27: Government investigations and proceedings
Legal proceedings brought by AstraZeneca
340B State Litigation, US * AstraZeneca has filed lawsuits against Arkansas, Kansas, Louisiana,
Maryland, Minnesota, Mississippi, Missouri, and West Virginia challenging the
constitutionality of each state's 340B statute.
Considered to be a contingent asset * In the Arkansas matter, trial is scheduled for April 2025. An intervenor
has moved to dismiss AstraZeneca's complaint.
* In the Louisiana matter, the Court granted the state's motion for
summary judgment. AstraZeneca has filed an appeal.
* In the Maryland matter, the Court has rejected AstraZeneca's preliminary
injunction motion. The state's motion to dismiss remains pending.
* In the Minnesota matter, the state has moved to dismiss AstraZeneca's
complaint.
* In the Mississippi matter, AstraZeneca has moved for a preliminary
injunction.
* The remaining matters are in their preliminary stages.
Other
Additional government inquiries
As is true for most, if not all, major prescription pharmaceutical companies,
AstraZeneca is currently involved in multiple inquiries into drug marketing
and pricing practices. In addition to the investigations described above,
various law enforcement offices have, from time to time, requested information
from the Group. There have been no material developments in those matters.
Note 7
Table 28: 9M 2024 - Product Sales year-on-year analysis 14
World US Emerging Markets Europe Established RoW
$m Act % chg CER % chg $m % chg $m Act % chg CER % chg $m Act % chg CER % chg $m Act % chg CER % chg
Oncology 14,934 18 21 6,870 22 3,445 18 28 3,000 24 23 1,619 (4) 4
Tagrisso 4,877 11 15 1,996 19 1,365 8 16 956 16 16 560 (10) (2)
Imfinzi 3,463 18 22 1,883 18 365 37 61 695 30 29 520 (3) 6
Calquence 2,321 26 27 1,617 21 116 68 90 489 38 38 99 23 27
Lynparza 2,228 8 10 954 6 475 16 25 612 13 12 187 (13) (7)
Enhertu 397 n/m n/m - - 258 n/m n/m 92 n/m n/m 47 n/m n/m
Zoladex 817 17 24 11 (4) 622 19 28 111 14 13 73 7 15
Imjudo 208 30 32 134 25 11 n/m n/m 26 n/m n/m 37 (8) 1
Truqap 267 n/m n/m 260 n/m 2 n/m n/m 2 n/m n/m 3 n/m n/m
Orpathys 34 4 7 - - 34 4 7 - - - - - -
Others 322 (18) (12) 15 5 197 (18) (13) 17 (34) (34) 93 (15) (7)
BioPharmaceuticals: CVRM 9,316 18 21 2,221 13 4,146 18 24 2,385 31 30 564 (3) 5
Farxiga 5,723 31 34 1,278 28 2,225 35 41 1,903 40 39 317 (9) (1)
Brilinta 992 - 1 543 (1) 232 4 11 203 - (1) 14 (21) (18)
Crestor 892 4 9 33 (18) 726 7 12 32 (22) (22) 101 - 9
Seloken/Toprol-XL 465 (6) (1) - 84 452 (6) (1) 10 27 27 3 (47) (45)
Lokelma 392 31 34 181 16 68 84 90 66 61 61 77 17 30
roxadustat 257 23 26 - - 257 23 26 - - - - - -
Andexxa 159 24 26 61 7 3 n/m n/m 60 38 37 35 25 39
Wainua 44 n/m n/m 44 n/m - - - - - - - - -
Others 392 (27) (26) 81 (52) 183 (19) (14) 111 (16) (15) 17 11 9
BioPharmaceuticals: R&I 5,431 20 23 2,419 27 1,489 13 20 1,026 21 20 497 9 14
Symbicort 2,195 19 22 887 51 653 9 19 415 2 1 240 (2) -
Fasenra 1,218 7 8 750 4 68 43 52 294 12 11 106 (1) 6
Pulmicort 517 5 9 13 (39) 427 9 14 51 4 2 26 (13) (9)
Breztri 721 51 53 367 40 199 62 68 102 86 85 53 42 51
Tezspire 168 n/m n/m - - 8 n/m n/m 105 n/m n/m 55 n/m n/m
Saphnelo 327 71 72 294 65 5 n/m n/m 17 n/m n/m 11 66 82
Airsupra 41 n/m n/m 41 n/m - - - - - - - - -
Others 244 (26) (25) 67 (48) 129 (15) (12) 42 4 3 6 (13) (11)
BioPharmaceuticals: V&I 680 2 5 201 n/m 168 (7) 1 189 (6) (8) 122 (48) (44)
Synagis 346 (10) (4) (1) n/m 168 6 15 80 (26) (27) 99 (15) (7)
Beyfortus 188 n/m n/m 148 n/m - n/m n/m 39 n/m n/m 1 n/m n/m
FluMist 109 40 37 26 61 - n/m n/m 61 5 1 22 n/m n/m
COVID-19 mAbs 31 (75) (75) 28 n/m - n/m n/m 3 (59) (60) - n/m n/m
Others 6 (79) (80) - - - (99) n/m 6 (43) (45) - n/m n/m
Rare Disease 6,391 10 14 3,842 11 628 29 56 1,189 2 1 732 9 18
Ultomiris 2,835 32 35 1,629 29 92 97 n/m 649 31 30 465 37 50
Soliris 2,045 (16) (11) 1,170 (11) 365 8 39 346 (35) (35) 164 (34) (31)
Strensiq 996 18 19 815 18 39 34 48 73 15 14 69 8 18
Koselugo 366 49 55 156 9 108 n/m n/m 74 93 93 28 81 99
Kanuma 149 15 16 72 15 24 (1) 7 47 25 25 6 8 16
Other medicines 824 (9) (4) 87 (17) 564 (3) 5 75 12 12 98 (38) (33)
Nexium 670 (9) (2) 77 (13) 458 - 9 40 12 10 95 (37) (33)
Others 154 (12) (10) 10 (35) 106 (13) (10) 35 13 13 3 (53) (49)
Total Product Sales 37,576 16 19 15,640 19 10,440 16 25 7,864 20 20 3,632 (4) 3
Table 29: Q3 2024 - Product Sales year-on-year analysis 15
World US Emerging Markets Europe Established RoW
$m Act % chg CER % chg $m % chg $m Act % chg CER % chg $m Act % chg CER % chg $m Act % chg CER % chg
Oncology 5,197 18 21 2,484 25 1,145 18 28 1,032 22 22 536 (8) (3)
Tagrisso 1,674 14 17 714 24 446 9 16 328 17 17 186 (6) (1)
Imfinzi 1,203 13 16 680 19 120 40 66 236 16 16 167 (19) (15)
Calquence 813 24 25 570 22 41 47 70 169 32 32 33 11 14
Lynparza 778 11 13 347 8 155 18 24 214 21 21 62 (12) (8)
Enhertu 148 n/m n/m - - 97 n/m n/m 35 n/m n/m 16 83 86
Zoladex 268 12 18 4 (34) 207 14 21 33 8 10 24 16 21
Imjudo 72 20 22 46 15 4 n/m n/m 10 99 n/m 12 (15) (10)
Truqap 125 n/m n/m 119 n/m 1 - - 2 - - 3 - -
Orpathys 10 (16) (16) - - 10 (16) (16) - - - - - -
Others 106 (10) (5) 4 2 64 (14) (8) 5 (27) (26) 33 (1) 5
BioPharmaceuticals: CVRM 3,152 17 20 739 7 1,396 20 25 826 26 26 191 9 14
Farxiga 1,938 25 27 411 12 750 30 35 670 32 32 107 4 8
Brilinta 327 (1) (1) 189 (2) 66 3 6 67 (1) (1) 5 (11) (16)
Crestor 304 10 14 11 (18) 252 15 18 10 4 2 31 (6) -
Seloken/Toprol-XL 150 (2) 1 - n/m 145 (3) 1 4 n/m 98 1 (58) (58)
Lokelma 143 40 42 66 28 26 99 n/m 25 61 61 26 18 27
roxadustat 93 26 25 - - 93 26 26 - - - - - -
Andexxa 54 36 38 19 (4) 1 n/m n/m 20 39 39 14 n/m n/m
Wainua 23 n/m n/m 23 n/m - - - - - - - - -
Others 120 (22) (20) 20 (57) 63 3 6 30 (28) (26) 7 50 40
BioPharmaceuticals: R&I 1,830 26 28 852 40 457 8 14 346 30 30 175 13 18
Symbicort 705 27 31 289 86 203 4 13 130 5 6 83 2 5
Fasenra 436 12 13 271 9 27 41 50 102 19 19 36 1 5
Pulmicort 138 (6) (4) 5 7 110 (8) (5) 14 10 9 9 (11) (8)
Breztri 266 56 57 142 45 68 62 65 37 98 98 19 61 68
Tezspire 68 n/m n/m - - 3 n/m n/m 43 n/m n/m 22 n/m n/m
Saphnelo 124 63 64 110 55 3 n/m n/m 7 n/m n/m 4 37 67
Airsupra 21 n/m n/m 21 n/m - - - - - - - - -
Others 72 (21) (21) 14 (54) 43 (8) (8) 13 7 7 2 (16) (14)
BioPharmaceuticals: V&I 355 59 61 145 n/m 37 18 37 108 23 20 65 18 23
Synagis 93 (6) 3 - n/m 37 16 36 13 (19) (20) 43 (15) (9)
Beyfortus 134 n/m n/m 95 n/m - - - 39 n/m n/m - - -
FluMist 100 34 31 22 43 - - - 56 - (3) 22 n/m n/m
COVID-19 mAbs 28 n/m n/m 28 n/m - n/m n/m - - - - - -
Others - n/m n/m - - - - - - - - - - -
Rare Disease 2,148 9 11 1,325 12 174 7 29 395 - - 254 8 14
Ultomiris 1,031 33 35 597 34 26 53 84 238 30 30 170 30 37
Soliris 606 (22) (18) 362 (14) 110 (11) 14 86 (47) (47) 48 (36) (33)
Strensiq 343 20 21 286 21 8 52 55 25 17 17 24 15 23
Koselugo 119 37 39 55 2 25 n/m n/m 29 90 94 10 52 62
Kanuma 49 10 9 25 11 5 (27) (29) 17 27 23 2 1 7
Other medicines 265 (11) (7) 35 (3) 179 (6) - 22 18 16 29 (45) (41)
Nexium 212 (13) (9) 30 3 140 (9) (2) 14 31 29 28 (45) (41)
Others 53 - (1) 5 (28) 39 7 8 8 (1) (1) 1 (52) (51)
Total Product Sales 12,947 18 20 5,580 23 3,388 15 23 2,729 20 20 1,250 - 5
Table 30: Alliance Revenue
9M 2024 9M 2023
$m $m
Enhertu 1,045 741
Tezspire 303 179
Beyfortus 75 16
Other Alliance Revenue 75 68
Total 1,498 1,004
Table 31: Collaboration Revenue
9M 2024 9M 2023
$m $m
Farxiga: sales milestones 52 28
Beyfortus: sales milestones 56 71
COVID-19 mAbs licence fees - 180
Other Collaboration Revenue - 38
Total 108 317
Table 32: Other operating income and expense
9M 2024 9M 2023
$m $m
brazikumab licence termination funding - 75
Divestment of US rights to Pulmicort Flexhaler - 241
Update to the contractual relationships for Beyfortus (nirsevimab) - 712
Other 152 205
Total 152 1,233
Other shareholder information
Financial calendar
Announcement of FY and Q4 2024 results: 6 February 2025
Announcement of Q1 2025 results: 29 April
2025
Dividends are normally paid as follows:
First interim: Announced with the half year results and paid
in September
Second interim: Announced with the full year results and paid in March
Contacts
For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.
Addresses for correspondence
Registered office Registrar and transfer office Swedish Central Securities Depository US depositary
Deutsche Bank Trust Company Americas
1 Francis Crick Avenue Equiniti Limited Euroclear Sweden AB PO Box 191 American Stock Transfer
Cambridge Biomedical Campus Aspect House SE-101 23 Stockholm 6201 15th Avenue
Cambridge Spencer Road Brooklyn
CB2 0AA Lancing NY 11219
West Sussex
BN99 6DA
United Kingdom United Kingdom Sweden United States
+44 (0) 20 3749 5000 0800 389 1580 +46 (0) 8 402 9000 +1 (888) 697 8018
+44 (0) 121 415 7033 +1 (718) 921 8137
db@astfinancial.com (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 gene
EVH Extravascular
haemolysis
FDA Food and Drug
Agency (US)
FDC Fixed dose
combination
FISH Fluorescence in
situ hybridization, as in FISH10+
g
Germline, e.g. gBRCAm
GAAP Generally Accepted
Accounting Principles
GEJ Gastro
oesophageal junction
GI
Gastrointestinal
GLP1 / -RA Glucagon-like peptide-1 /
receptor agonist
gMG Generalised
myasthenia gravis
HCC Hepatocellular
carcinoma
HER2 / +/- / low / m Human epidermal growth factor receptor 2 / positive /
negative / low level expression / gene mutant
HF/ pEF / rEF Heart failure / with preserved ejection
fraction / with reduced ejection fraction
hMPV Human metapneumovirus
HR Hazard ratio
HR / + / - Hormone receptor /
positive / negative
HRD Homologous
recombination deficiency
HRR / m Homologous recombination
repair gene / mutation
i.m. Intramuscular
injection
i.v.
Intravenous injection
IAS / B International
Accounting
Standards / Board
ICS Inhaled
corticosteroid
IFRS International
Financial Reporting Standards
IgAN Immunoglobulin A
neuropathy
IHC
Immunohistochemistry, as in IHC90+, etc
IL-5, IL-33, etc Interleukin-5, Interleukin-33, etc
IP
Intellectual Property
IVIg Intravenous
immune globulin
LABA Long-acting
beta-agonist
LAMA Long-acting
muscarinic-agonist
LS-SCLC Limited stage small cell lung
cancer
LRTD Lower respiratory
tract disease
m
Metastatic, e.g. mBTC , mCRPC, mCSPC
mAb Monoclonal
antibody
MDL Multidistrict
litigation
MET Mesenchymal
epithelial transition
NF1-PN Neurofibromatosis type 1
with plexiform neurofibromas
n/m Not meaningful
NMOSD Neuromyelitis optica
spectrum disorder
NRDL National
reimbursement drug list
NSCLC Non-small cell lung cancer
OECD Organisation for
Economic
Co-operation and Development
OOI Other
operating income
ORR Overall response
rate
OS Overall
survival
PAAGR Post Alexion Acquisition
Group Review
PARP / i / -1sel Poly ADP ribose polymerase / inhibitor
/-1 selective
pCR Pathologic
complete response
PCSK9 Proprotein convertase
subtilisin/kexin type 9
PD Progressive
disease
PD-1 Programmed cell
death protein 1
PD-L1 Programmed cell death
ligand 1
PDUFA Prescription Drug User Fee
Act
PHSSR Partnership for Health
System Sustainability and Resilience
PFS Progression free
survival
PIK3CA
Phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha gene
PMDI Pressure metered
dose inhaler
PNH / -EVH Paroxysmal nocturnal haemoglobinuria
/ with extravascular haemolysis
PPI Proton pump
inhibitors
PSR Platinum
sensitive relapse
PTEN Phosphatase and
tensin homologue gene
Q3W, Q4W, etc Every three weeks, every four weeks, etc
R&D Research and
development
R&I
Respiratory & Immunology
RSV Respiratory
syncytial virus
sBLA Supplemental
biologics license application (US)
SCLC Small cell lung
cancer
s.c.
Subcutaneous injection
SEA Severe
eosinophilic asthma
SEC Securities
Exchange Commission (US)
SG&A Sales, general
and administration
SGLT2 Sodium-glucose
cotransporter 2
SLL Small
lymphocytic lymphoma
SMI Sustainable
Markets Initiative
sNDA Supplemental new drug
application
SPA Share Purchase
Agreement
T2D Type-2 diabetes
TACE Transarterial
chemoembolization
THP A treatment
regimen: docetaxel, trastuzumab and pertuzumab
TNBC Triple negative
breast cancer
TNF Tumour necrosis
factor
TOP1 Topoisomerase I
TROP2 Trophoblast cell surface
antigen 2
USPTO US Patent and Trademark
Office
V&I Vaccines
& Immune Therapies
VBP Volume-based
procurement
VLP Virus like
particle
- End of document -
1 Constant exchange rates. The differences between Actual Change and CER
Change are due to foreign exchange movements between periods in 2024 vs. 2023.
CER financial measures are not accounted for according to generally accepted
accounting principles (GAAP) because they remove the effects of currency
movements from Reported results.
2 Core financial measures are adjusted to exclude certain items. The
differences between Reported and Core measures are primarily due to costs
relating to the amortisation of intangibles, impairments, legal settlements
and restructuring charges. A full reconciliation between Reported EPS and Core
EPS is provided in Table 11 and Table 12 in the Financial performance section
of this document.
3 The calculations for Reported and Core Product Sales Gross Margin exclude
the impact of Alliance Revenue and Collaboration Revenue.
4 In Table 2, the plus and minus symbols denote the directional impact of
the item being discussed, e.g. a '+' symbol next to a comment related to the
R&D expense indicates that the item resulted in an increase in the R&D
spend relative to the prior year.
5 Post Alexion Acquisition Group Review. In conjunction with the acquisition
of Alexion, the Post Alexion Acquisition Group Review Group initiated a
comprehensive review, aimed at integrating systems, structure and processes,
optimising the global footprint and prioritising resource allocations and
investments. These activities are expected to be substantially complete by the
end of 2026.
6 Income from disposals of assets and businesses, where the Group does not
retain a significant ongoing economic interest, continue to be recorded in
Other operating income and expense in the Company's financial statements.
7 The presentation of Table 4 has been updated to show Total Revenue by
medicine, by including Alliance Revenue and Collaboration Revenue within each
revenue figure. Previously, this table showed Product Sales for each medicine
and therapy area, and the Company's total Alliance Revenue and Collaboration
Revenue were shown as separate lines at the bottom of the table.
8 The presentation of this table has been updated by removing the
"Acquisition of Alexion" column due to immateriality of items in this category
9 Based on best prevailing assumptions around currency profiles.
10 Based on average daily spot rates 1 Jan 2023 to 31 Dec 2023.
11 Based on average daily spot rates 1 Jan 2024 to 30 Sep 2024.
12 Based on average daily spot rates 1 Sep 2024 to 30 Sep 2024.
13 Other currencies include AUD, BRL, CAD, KRW and RUB.
14 The table provides an analysis of year-on-year Product Sales, with Actual
and CER growth rates reflecting year-on-year growth. Due to rounding, the sum
of a number of dollar values and percentages may not agree to totals.
15 The table provides an analysis of year-on-year Product Sales, with Actual
and CER growth rates reflecting year-on-year growth. Due to rounding, the sum
of a number of dollar values and percentages may not agree to totals.
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