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
change
|
|
Comments[4]
|
Total Revenue
|
$13,565m
|
18%
Actual 21% CER
|
$13,565m
|
18%
Actual 21% CER
|
|
* See Table 1 and the Total Revenue section of this document
for further details
|
Product Sales Gross Margin
|
76%
|
-5pp
Actual -4pp CER
|
81%
|
Stable
Actual and CER
|
|
* Variations in Product Sales Gross Margin can be expected
between periods, due to product seasonality (e.g. FluMist and Beyfortus sales are weighted to the
second half of the year), foreign exchange fluctuations and other
effects
‒ Reported Product
Sales Gross Margin impacted by PAAGR[5]
inventory related restructuring charges taken in the
quarter
|
R&D
expense
|
$3,115m
|
21%
Actual 21% CER
|
$3,068m
|
23%
Actual 24% CER
|
|
+ Increased investment in the
pipeline
* Core R&D-to-Total Revenue ratio of 23%
(Q3 2023: 22%)
|
SG&A expense
|
$5,143m
|
7%
Actual 8% CER
|
$3,605m
|
8%
Actual 9% CER
|
|
+ Market development for recent launches and
pre-launch activities
* Core SG&A-to-Total Revenue ratio of 27%
(Q3 2023: 29%)
|
Other operating income and expense[6]
|
$25m
|
-65%
Actual -61% CER
|
$24m
|
-65%
Actual -61% CER
|
|
|
Operating Margin
|
16%
|
-1pp
Actual Stable CER
|
32%
|
+1pp
Actual +2pp CER
|
|
* See commentary above on Gross Margin, R&D, SG&A and
Other operating income and expense
|
Net finance expense
|
$274m
|
-6%
Actual -15% CER
|
$329m
|
46%
Actual 35% CER
|
|
+ New debt issued at higher interest
rates
+ Higher level of Net debt
|
Tax rate
|
22%
|
+5pp
Actual +5pp CER
|
19%
|
Stable
Actual and CER
|
|
*
Variations in the tax rate can be expected between
periods
|
EPS
|
$0.92
|
4%
Actual 17% CER
|
$2.08
|
20%
Actual 27% CER
|
|
* Further details of differences between Reported and Core are
shown in Table 12
|
Table 3: Pipeline highlights since prior
results announcement
Event
|
Medicine
|
Indication /
Trial
|
Event
|
Regulatory approvals and other regulatory
actions
|
Tagrisso
|
Unresectable, Stage III EGFRm NSCLC (LAURA)
|
Regulatory approval (US)
|
Imfinzi
|
Primary advanced or recurrent
endometrial cancer with mismatch repair deficiency
(DUO-E)
|
Regulatory approval (EU)
|
Imfinzi +
Lynparza
|
Primary advanced or recurrent
endometrial cancer with mismatch repair proficiency
(DUO-E)
|
Regulatory approval (EU)
|
Imfinzi
|
Resectable early-stage (IIA-IIIB) NSCLC
(AEGEAN)
|
Regulatory approval (US)
|
Enhertu
|
Locally advanced or metastatic HER2-positive
gastric or gastroesophageal junction adenocarcinoma
(DESTINY-Gastric06)
|
Regulatory approval (CN)
|
Enhertu
|
Unresectable locally advanced or metastatic
HER2m NSCLC
(DESTINY-Lung02, DESTINY-Lung05)
|
Regulatory approval (CN)
|
Fasenra
|
EGPA (MANDARA)
|
Regulatory approval (US, EU)
|
Fasenra
|
Fasenra
(MIRACLE)
|
Regulatory approval (CN)
|
FluMist
|
Self-administration
|
Regulatory approval (US)
|
Regulatory submissions
or acceptances*
|
Tagrisso
|
EGFRm NSCLC (Stage
III
unresectable) (LAURA)
|
Regulatory submission (EU, JP,
CN)
|
Imfinzi
|
Muscle-invasive bladder
Cancer (NIAGARA)
|
Regulatory submission
(EU)
|
Imfinzi
|
NSCLC (neoadjuvant)
AEGEAN
|
Regulatory submission
(JP)
|
Imfinzi
|
SCLC (limited stage)
(ADRIATIC)
|
Regulatory submission (US, EU, JP,
CN)
|
Calquence
|
Mantle cell lymphoma (1st-line)
(ECHO)
|
Regulatory submission (US, EU,
JP)
|
Calquence
|
CLL (ELEVATE-TN)
|
Regulatory submission
(CN)
|
Lynparza
|
mCRPC (PROpel)
|
Regulatory submission
(CN)
|
Enhertu
|
HER2-low breast cancer
(2nd-line)
(DESTINY-Breast06)
|
Regulatory submission (US, EU,
JP)
|
Wainua
|
Hereditary transthyretin-mediated
amyloid polyneuropathy (NEURO-TTRansform)
|
Regulatory submission (CN)
|
Breztri and
HFO1234ze
|
Moderate to severe COPD
|
Regulatory submission
(EU)
|
Sipavibart
|
Prevention of COVID-19
(SUPERNOVA)
|
Regulatory submission
(JP)
|
Ultomiris
|
NMOSD (CHAMPION-NMOSD)
|
Regulatory submission
(CN)
|
Phase III / registrational data readouts and
other developments
|
Tagrisso +
Orpathys
|
EGFRm NSCLC
with high levels of MET overexpression and/or amplification
(SAVANNAH)
|
Clinically meaningful ORR
|
Calquence fixed
duration
|
Chronic lymphocytic leukaemia
(AMPLIFY)
|
Primary endpoint met
|
Fasenra
|
Eosinophilic chronic rhinosinusitis with nasal
polyps (ORCHID)
|
Primary endpoint not met
|
Tezspire
|
Severe chronic rhinosinusitis with nasal polyps
(WAYPOINT)
|
Primary endpoint met
|
Koselugo
|
Adults with NF1-PN (KOMET)
|
Primary endpoint met
|
*US, EU and China regulatory submission denotes filing
acceptance
Upcoming pipeline catalysts
For recent trial starts and anticipated timings
of key trial readouts, please refer to the Clinical Trials
Appendix, available on www.astrazeneca.com/investor-relations.html.
Corporate and business development
In October 2024, AstraZeneca entered into an
exclusive license agreement with CSPC Pharmaceutical Group Ltd
(CSPC) to advance the development of an early stage, novel small
molecule Lipoprotein (a) (Lp(a)) disruptor that has the potential
to offer additional benefits for patients with dyslipidaemia. This
further strengthens the company's cardiovascular portfolio to help
address the major risk factors driving chronic cardiovascular
disease. Under the terms of the agreement, AstraZeneca will receive
access to CSPC's pre-clinical candidate small molecule, YS2302018,
an oral Lp(a) disruptor, with the aim of developing this as a novel
lipid-lowering therapy with potential in a range of cardiovascular
disease indications alone or in combination, including with
AstraZeneca's oral small molecule PCSK9 inhibitor, AZD0780. CSPC
will receive an upfront payment of $100 million from AstraZeneca.
CSPC is also eligible to receive up to $1.92 billion for further
development and commercialisation milestones plus tiered
royalties.
In October 2024, AstraZeneca entered into an
agreement to out-license ALXN1840 (bis-choline tetrathiomolybdate),
a drug candidate for Wilson disease to Monopar Therapeutics Inc
(Monopar). Monopar will be responsible for all future global
development and commercialisation activities. AstraZeneca will have
a 9.9% beneficial ownership interest in Monopar upon issuance as
well as an upfront cash payment of $4.0 million. AstraZeneca
is also eligible to receive milestones and royalties.
Sustainability highlights
In September, AstraZeneca had a significant
presence at Climate Week NYC and the 79th Session of the UN General
Assembly in New York, with a delegation led by Pam Cheng, Executive
Vice President of Global Operations and IT and Chief Sustainability
Officer and the company's US leadership. A programme of more than
50 engagements with governments, media, NGOs and the private sector
focused on the interconnected issues of the climate crisis, health
equity and health system resilience and the Company's commitment to
contribute to more sustainable, resilient and equitable health
systems.
Conference call
A conference call and webcast for investors and
analysts will begin today, 12 November 2024, at 14:00 UK time.
Details can be accessed via astrazeneca.com.
Reporting calendar
The Company intends to publish its FY and Q4
2024 results on 6 February 2025.
Operating and financial review
All narrative on growth and results in this
section is based on actual exchange rates, and financial figures
are in US$ millions ($m), unless stated otherwise. The performance
shown in this announcement covers the nine-month period to 30
September 2024 ('the period' or '9M 2024') compared to the
nine-month period to 30 September 2023 ('9M 2023'), or the
three-month period to 30 September 2024 ('the quarter' or 'Q3
2024') compared to the three-month period to 30 September 2023 ('Q3
2023'), unless stated otherwise.
Core financial measures, EBITDA, Net debt,
Product Sales Gross Margin, Operating Margin and CER are non-GAAP
financial measures because they cannot be derived directly from the
Group's Condensed consolidated financial statements. Management
believes that these non-GAAP financial measures, when provided in
combination with Reported results, provide investors and analysts
with helpful supplementary information to understand better the
financial performance and position of the Group on a comparable
basis from period to period. These non-GAAP financial measures are
not a substitute for, or superior to, financial measures prepared
in accordance with GAAP.
Core financial measures are adjusted to exclude
certain significant items:
‒
Charges and provisions related to our global restructuring
programmes on our capitalised manufacturing assets and IT
assets
‒
Amortisation and impairment of intangible assets, including
impairment reversals but excluding any charges relating to IT
assets
‒
Other specified items, principally the imputed finance
charges and fair value movements relating to contingent
consideration on business combinations, imputed finance charges and
remeasurement adjustments on certain Other payables arising from
intangible asset acquisitions, legal settlements and remeasurement
adjustments relating to certain Other payables and debt items
assumed from the Alexion acquisition
‒
The tax effects of the adjustments above are excluded from
the Core Tax charge
Details on the nature of Core financial
measures are provided on page 61 of the
Annual Report and Form 20-F Information 2023.
Reference should be made to the Reconciliation
of Reported to Core financial measures table included in the
financial performance section in this announcement.
Product Sales Gross Margin is
calculated by dividing the difference between Product Sales and
Cost of Sales by the Product Sales. The calculation of
Reported and Core Product Sales Gross Margin excludes the impact of
Alliance Revenue and Collaboration Revenue and any associated
costs, thereby reflecting the underlying performance of Product
Sales.
EBITDA is defined as Reported Profit before tax
after adding back Net finance expense, results from Joint ventures
and associates and charges for Depreciation, amortisation and
impairment. Reference should be made to the Reconciliation of
Reported Profit before tax to EBITDA included in the financial
performance section in this announcement.
Operating margin is defined as Operating profit
as a percentage of Total Revenue.
Net debt is defined as Interest-bearing loans
and borrowings and Lease liabilities, net of Cash and cash
equivalents, Other investments, and Net derivative financial
instruments. Reference should be made to Note 3 'Net debt' included
in the Notes to the Interim financial statements in this
announcement.
The Company strongly encourages investors and
analysts not to rely on any single financial measure, but to review
AstraZeneca's financial statements, including the Notes thereto,
and other available Company reports, carefully and in their
entirety.
Due to rounding, the sum of a number of dollar
values and percentages in this announcement may not agree to
totals.
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]
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
|
|
|
|
|
|
|
|
|
|
|
| |
Gross profit
‒
The calculation of Reported and Core Product Sales Gross
Margin excludes the impact of Alliance Revenue and Collaboration
Revenue
‒
The change in Product Sales Gross Margin (Reported and Core)
in 9M 2024 was impacted by:
‒
Positive effects from product mix. The increased contribution
from Rare Disease and Oncology medicines had a positive impact on
the Product Sales Gross Margin
‒
Dilutive effects from product mix. The rising contribution of
Product Sales with profit sharing arrangements (Lynparza, Enhertu, Tezspire, Koselugo) has a negative
impact on Product Sales Gross Margin because AstraZeneca records
Product Sales in certain markets and pays away a share of the gross
profits to its collaboration partners. The growth in Beyfortus also has a dilutive impact
on Product Sales Gross Margin, as AstraZeneca is responsible for
manufacturing, and Sanofi is responsible for distribution.
AstraZeneca records its sales to Sanofi as Product Sales, and those
sales generate a lower Product Sales Gross Margin than the Company
average
‒
Dilutive effects from geographic mix. In Emerging Markets,
the Product Sales Gross Margin tends to be below the Company
average
‒
The reported Product Sales Gross Margin included inventory
and related contract provisions of $638m recorded in the third
quarter related to Andexxa, which was part of the PAAGR
restructuring program (see Note 2 in the Notes to the interim
financial statements section)
‒
Variations in Product Sales Gross Margin performance between
periods can continue to be expected due to product seasonality,
foreign exchange fluctuations, and other effects
R&D expense
‒
The change in R&D expense (Reported and Core) in the
period was impacted by:
‒
Positive data read-outs for several high priority medicines
that have ungated late-stage trials
‒
Investment in platforms, new technology and capabilities to
enhance R&D capabilities
‒
Addition of R&D projects following completion of
previously announced business development activity including
Icosavax, Gracell, Fusion and Amolyt
‒
The change in Reported R&D expense was also impacted by
intangible asset impairments in the prior period
SG&A expense
‒
The change in SG&A expense (Reported and Core) in the
period was driven primarily by market development activities for
launches and to support continued growth in existing
brands
‒
The Reported SG&A expense included impairment charges in
the third quarter of $504m recorded against the Andexxa intangible asset
Other operating income and expense
‒ In
the prior year period, Other operating income and expense included
a $241m gain on the disposal of the US rights to Pulmicort Flexhaler and a $712m gain
relating to contractual arrangements for Beyfortus
Net finance expense
‒
Core Net finance expense increased 18% (13% increase at CER)
due to the increased level of debt and new debt issued at higher
interest rates
Taxation
‒
The effective Reported Tax rate for the nine months to 30
September 2024 was 21% (9M 2023: 17%) and the effective Core Tax
rate was 20% (9M 2023: 19%)
‒
The cash tax paid for the nine months to 30 September 2024
was $1,978m (9M 2023: $1,710m), representing 28% of Reported Profit
before tax (9M 2023: 26%)
Table 13: Cash Flow summary
|
|
9M
2024
|
9M
2023
|
Change
|
|
|
$m
|
$m
|
$m
|
Reported Operating profit
|
|
7,967
|
6,959
|
1,008
|
Depreciation, amortisation and
impairment
|
|
4,351
|
4,060
|
291
|
Movement in working capital and short-term
provisions
|
|
(543)
|
150
|
(693)
|
Gains on disposal of intangible
assets
|
|
(34)
|
(247)
|
213
|
Fair value movements on contingent
consideration arising from
business combinations
|
|
251
|
202
|
49
|
Non-cash and other movements
|
|
15
|
(623)
|
638
|
Interest paid
|
|
(1,075)
|
(826)
|
(249)
|
Taxation paid
|
|
(1,978)
|
(1,710)
|
(268)
|
Net cash
inflow from operating activities
|
|
8,954
|
7,965
|
989
|
Net cash
inflow before financing activities
|
|
2,155
|
4,978
|
(2,823)
|
Net cash
inflow/(outflow) from financing activities
|
|
(3,325)
|
(6,276)
|
2,951
|
The change in Net cash inflow before financing
activities of $2,823m is primarily driven by Acquisitions of
subsidiaries, net of cash acquired of $2,771m, and relates to the
acquisition of Gracell Biotechnologies, Inc. for $774m and
acquisition of Fusion Pharmaceuticals Inc., for $1,997m as compared
to the acquisition of Neogene Therapeutics, Inc. for $189m in 9M
2023.
The decrease in Net cash outflow from financing
activities of $2,951m is primarily driven by increased issuance of
long-term loans of $6,492m in the period compared to $3,816m issued
in the comparative period.
Capital expenditure
Capital expenditure amounted to $1,216m in 9M
2024 (9M 2023: $836m). The increase of capital expenditure in 2024
is driven by investment in several major manufacturing projects and
continued investment in technology upgrades.
Table 14: Net debt summary
|
At 30
Sep 2024
|
At 31
Dec 2023
|
At 30
Sep 2023
|
|
$m
|
$m
|
$m
|
Cash and cash equivalents
|
4,797
|
5,840
|
4,871
|
Other investments
|
133
|
122
|
244
|
Cash and
investments
|
4,930
|
5,962
|
5,115
|
Overdrafts and short-term borrowings
|
(769)
|
(515)
|
(515)
|
Commercial paper
|
(472)
|
-
|
-
|
Lease liabilities
|
(1,422)
|
(1,128)
|
(979)
|
Current instalments of loans
|
(12)
|
(4,614)
|
(4,857)
|
Non-current instalments of loans
|
(28,887)
|
(22,365)
|
(22,225)
|
Interest-bearing loans and borrowings
(Gross debt)
|
(31,562)
|
(28,622)
|
(28,576)
|
Net derivatives
|
284
|
150
|
90
|
Net
debt
|
(26,348)
|
(22,510)
|
(23,371)
|
Net debt increased by $3,838m in the nine
months to 30 September 2024 to $26,348m. Details of the committed
undrawn bank facilities are disclosed within the going concern
section of Note 1. Details of the Company's solicited credit
ratings and further details on Net debt are disclosed in Note
3.
Capital allocation
The Company's capital allocation priorities
include: investing in the business and pipeline; maintaining a
strong, investment-grade credit rating; potential value-enhancing
business development opportunities; and supporting the progressive
dividend policy. As announced at the Annual General Meeting on 11
April 2024, the total dividend for FY 2024 will increase by $0.20
per share to $3.10 per share.
In approving the declaration of dividends, the
Board considers both the liquidity of the company and the level of
reserves legally available for distribution. Dividends are paid to
shareholders from AstraZeneca PLC, a Group holding company with no
direct operations. The ability of AstraZeneca PLC to make
shareholder distributions is dependent on the creation of profits
for distribution and the receipt of funds from subsidiary
companies. The consolidated Group reserves set out in the Condensed
consolidated statement of financial position do not reflect the
profit available for distribution to the shareholders of
AstraZeneca PLC.
Summarised financial information for guarantee of
securities of subsidiaries
AstraZeneca Finance LLC ("AstraZeneca Finance")
is the issuer of 1.2% Notes due 2026, 4.8% Notes due 2027, 4.875%
Notes due 2028, 1.75% Notes due 2028, 4.85% Notes due 2029, 4.9%
Notes due 2030, 4.9% Notes due 2031, 2.25% Notes due 2031, 4.875%
Notes due 2033, 5% Notes due 2034, 3.121% EUR Notes due 2030 and
3.278% EUR Notes due 2033 (the "AstraZeneca Finance Notes"). Each
series of AstraZeneca Finance Notes has been fully and
unconditionally guaranteed by AstraZeneca PLC. AstraZeneca Finance
is 100% owned by AstraZeneca PLC and each of the guarantees issued
by AstraZeneca PLC is full and unconditional and joint and
several.
The AstraZeneca Finance Notes are senior
unsecured obligations of AstraZeneca Finance and rank equally with
all of AstraZeneca Finance's existing and future senior unsecured
and unsubordinated indebtedness. The guarantee by AstraZeneca PLC
of the AstraZeneca Finance Notes is the senior unsecured obligation
of AstraZeneca PLC and ranks equally with all of AstraZeneca PLC's
existing and future senior unsecured and unsubordinated
indebtedness. Each guarantee by AstraZeneca PLC is effectively
subordinated to any secured indebtedness of AstraZeneca PLC to the
extent of the value of the assets securing such indebtedness. The
AstraZeneca Finance Notes are structurally subordinated to
indebtedness and other liabilities of the subsidiaries of
AstraZeneca PLC, none of which guarantee the AstraZeneca Finance
Notes.
AstraZeneca PLC manages substantially all of
its operations through divisions, branches and/or investments in
subsidiaries and affiliates. Accordingly, the ability of
AstraZeneca PLC to service its debt and guarantee obligations is
also dependent upon the earnings of its subsidiaries, affiliates,
branches and divisions, whether by dividends, distributions, loans
or otherwise.
Please refer to the Consolidated financial
statements of AstraZeneca PLC in our Annual Report on Form 20‑F as
filed with the SEC and information contained herein for further
financial information regarding AstraZeneca PLC and its
consolidated subsidiaries. For further details, terms and
conditions of the AstraZeneca Finance Notes please refer to
AstraZeneca PLC's reports on Form 6-K furnished to the SEC on 30
July 2024, 22 February 2024, 3 March 2023 and 28 May
2021.
Pursuant to Rule 13-01 and Rule 3-10 of
Regulation S-X under the Securities Act of 1933, as amended (the
"Securities Act"), we present below the summary financial
information for AstraZeneca PLC, as Guarantor, excluding its
consolidated subsidiaries, and AstraZeneca Finance, as the issuer,
excluding its consolidated subsidiaries. The following summary
financial information of AstraZeneca PLC and AstraZeneca Finance is
presented on a combined basis and transactions between the
combining entities have been eliminated. Financial information for
non-guarantor entities has been excluded. Intercompany balances and
transactions between the obligor group and the non-obligor
subsidiaries are presented on separate lines.
Table 15: Obligor group summarised
Statement of comprehensive income
|
|
9M 2024
|
9M 2023
|
|
|
$m
|
$m
|
Total Revenue
|
|
-
|
-
|
Gross profit
|
|
-
|
-
|
Operating loss
|
|
-
|
(2)
|
Loss for the period
|
|
(894)
|
(695)
|
Transactions with subsidiaries that are not
issuers or guarantors
|
|
1,342
|
9,758
|
Table 16: Obligor group summarised
Statement of financial position
|
|
At 30 Sep
2024
|
At 30 Sep
2023
|
|
|
$m
|
$m
|
Current assets
|
|
10
|
6
|
Non-current assets
|
|
84
|
-
|
Current liabilities
|
|
(801)
|
(4,760)
|
Non-current liabilities
|
|
(28,906)
|
(22,077)
|
Amounts due from subsidiaries that are not
issuers or guarantors
|
|
16,705
|
12,921
|
Amounts due to subsidiaries that are not
issuers or guarantors
|
|
-
|
(295)
|
Foreign exchange
The Company's transactional currency exposures
on working capital balances, which typically extend for up to three
months, are hedged where practicable using forward foreign exchange
contracts against the individual companies' reporting currency.
Foreign exchange gains and losses on forward contracts transacted
for transactional hedging are taken to profit or to Other
comprehensive income if the contract is in a designated cashflow
hedge. In addition, the Company's external dividend payments, paid
principally in pound sterling and Swedish krona, are fully hedged
from announcement to payment date.
Table 17: Currency
sensitivities
The Company provides the following information
on currency-sensitivity:
|
|
|
Average
rates vs.
USD
|
|
Annual impact ($m)
of 5% strengthening (FY 2024 average
rate vs. FY 2023 average) [9]
|
Currency
|
Primary Relevance
|
|
FY
2023[10]
|
YTD
2024[11]
|
Change
(%)
|
Sep 2024[12]
|
Change
(%)
|
|
Total Revenue
|
Core Operating Profit
|
EUR
|
Total Revenue
|
|
0.92
|
0.92
|
0
|
0.90
|
3
|
|
397
|
179
|
CNY
|
Total Revenue
|
|
7.09
|
7.21
|
(2)
|
7.08
|
0
|
|
322
|
182
|
JPY
|
Total Revenue
|
|
140.60
|
151.23
|
(7)
|
143.04
|
(2)
|
|
177
|
119
|
Other[13]
|
|
|
|
|
|
|
|
|
453
|
227
|
GBP
|
Operating expense
|
|
0.80
|
0.78
|
3
|
0.76
|
6
|
|
60
|
(126)
|
SEK
|
Operating expense
|
|
10.61
|
10.50
|
1
|
10.23
|
4
|
|
9
|
(63)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Sustainability
In September, AstraZeneca had a significant
presence at Climate Week NYC and the 79th Session of the UN General
Assembly in New York, with a delegation led by Pam Cheng, Executive
Vice President of Global Operations and IT and Chief Sustainability
Officer and the company's US leadership. A programme of more than
50 engagements with governments, media, NGOs and the private sector
focused on the interconnected issues of the climate crisis, health
equity and health system resilience and the Company's commitment to
contribute to more sustainable, resilient and equitable health
systems.
Related communications included an opinion
piece published by the World Economic Forum (WEF) on how
pharmaceutical companies are investing in nature to improve human
and planetary health and an article in Foreign Policy on building
sustainable health systems to manage the burden of non-communicable
diseases.
Access to healthcare
‒ By
end of August 2024, the Company's flagship Healthy Heart Africa
programme had conducted more than 61 million blood pressure
screenings, identifying over 12.1 million people with elevated
blood pressure and diagnosing over 4.87 million with high blood
pressure
‒ In
October, the Company convened the inaugural meeting of
its Global Health Equity Advisory Board (HEAB), a group of 15
external stakeholders with representation from 11 countries and
across disease areas, to advise on the Company's approach to help
improve equitable health outcomes globally
‒
AstraZeneca Chair Michel Demaré and Executive Vice President,
Vaccines and Immune Therapies, Iskra Reic shared perspectives on
health systems resilience in Health: A Political Choice - Building
Resilience and Trust, a publication launched during the World
Health Summit in collaboration with the World Health
Organization
‒
During the quarter, the Partnership for Health System
Sustainability and Resilience (PHSSR) initiative convened an Expert
Advisory Group on the role of EU institutions in supporting
sustainable healthcare financing of Member States. The PHSSR was
also active in a session at the European Health Forum Gastein in
collaboration with AstraZeneca, on the importance of decarbonising
care pathways for the health of people and the planet. The session
emphasised the need for early, targeted and patient-centred
interventions within integrated EU and national public policy
strategies
‒ In
September, through the Young Health Programme (YHP), 24 young
health leaders from around the world received a Fellowship to
attend the One Young World Summit in Montréal, Canada to support
their focus on building a healthier and more equitable future.
Additionally, in August, the YHP awarded scholarships to seven
young global leaders who are tackling the health impacts of the
climate crisis to join a Climate Entrepreneurship Academy in New
York. During the quarter, YHP won Corporate Social
Responsibility Programme of the Year at the Pharma Industry UK
Awards
Environmental protection
‒
The Company reached a key sustainability milestone in its
Ambition Zero Carbon decarbonisation strategy, with over 50% of its
global vehicle fleet now fully electric, including in Europe, Japan
and the US. AstraZeneca currently has over 10,000 battery electric
vehicles (BEVs), with fully electric fleets in the Netherlands,
Greece and Georgia
‒
AstraZeneca's manufacturing site in Södertälje, Sweden - the
Company's largest manufacturing site globally - has reduced its
Scope 1 and 2 greenhouse (GHG) gas emissions by 98% since 2015,
making it the Company's sixth site to have achieved this goal ahead
of schedule. With this milestone, all locations in Sweden,
including the strategic R&D Centre in Gothenburg, have now
achieved their Scope 1 and 2 Ambition Zero Carbon
Targets
‒
Through the Sustainable Markets Initiative Health Systems
Task Force, chaired by CEO Pascal Soriot, the Company contributed
to the launch of the European Network on Climate and Health
Education which took place at the World Health Summit in Berlin.
The network brings together 25 leading universities from across
Europe which are committed to training 10,000 medical students with
skills to address the health impacts of climate change and deliver
sustainable healthcare
‒
The Company received the Net Zero: Operations Transformation
award at the 2024 Reuters Sustainability Awards in October,
recognising its commitment to drive deep decarbonisation across its
operations and fleet through the Ambition Zero Carbon strategy. The
WEF also recognised two of the Company's advanced manufacturing
sites in Wuxi (China) and Södertälje (Sweden) as Fourth Industrial
Revolution (4IR) Lighthouses, part of its Global Lighthouse Network
which spotlights organisations harnessing advanced technologies
such as digital and AI to drive next-generation operational
excellence, environmental sustainability and workforce
development
‒ In
August, the Company was recognised with awards by My Green Lab and
the International Institute for Sustainable Laboratories - the 2024
Freezer Challenge Winning Streak Award for Biotech &
Pharmaceuticals, for being at the top of the sector and surpassing
2023 energy savings, and the Top Small Lab Award - Pharmaceutical
and Biotech Sector - awarded to AZ Gothenburg Regional HBS
Centre
‒ The Company completed studies
to support the first regulatory filings for the transition
of Breztri/Trixeo
Aerosphere to an innovative, next-generation propellant
with 99.9% lower Global Warming Potential than propellants used in
currently available inhaled medicines. Reducing the carbon impact
of pressurised-metered dose inhalers is a key product-related
element of AstraZeneca's Ambition Zero Carbon strategy, alongside
the Company's commitment to improving patient
outcomes
Ethics and transparency
‒ In
September, AstraZeneca was included in the TIME World's Best
Companies 2024, ranking first among pharmaceutical companies for
sustainability transparency and in the top 70 out of 1,000
overall
‒ In
Mexico, AstraZeneca was third in the Great Place to Work (GPTW)
ranking and the Company's Guadalajara Global Innovation &
Technology Centre was number one in the GPTW Western Region for
companies with >500-5,000 employees for the fourth year in a
row
‒
AstraZeneca and 33 other partner organisations announced the
launch of the VICT3R project, a public-private partnership that
aims to reduce the number of animals used in experimental studies
through Virtual Control Groups (VCGs) created using cutting edge
statistical and artificial intelligence (AI) techniques. The
project aims to transform drug and chemical safety evaluation while
promoting ethical research practices and environmental
sustainability
Research and development
This section covers R&D events and
milestones that have occurred since the prior results announcement
on 25 July 2024, up to and including events on 11 November
2024.
A comprehensive view of AstraZeneca's pipeline
of medicines in human trials can be found in the latest Clinical
Trials Appendix, available on www.astrazeneca.com/investor-relations.
The Clinical Trials Appendix includes tables with details of the
ongoing clinical trials for AstraZeneca medicines and new molecular
entities in the pipeline.
Oncology
AstraZeneca presented new data across its
diverse portfolio of cancer medicines at two major medical
congresses since the prior results announcement: the IASLC 2024
World Conference on Lung Cancer (WCLC) hosted by the International
Association for the Study of Lung Cancer and the 2024 European
Society for Medical Oncology (ESMO) Congress. Across the two
meetings, more than 130 abstracts were presented featuring 17
approved and potential new medicines including five Presidential
Symposia and 41 oral presentations.
Tagrisso
Event
|
|
|
Commentary
|
Approval
|
US
|
|
For the treatment of adult patients with
unresectable, Stage III EGFRm NSCLC whose disease has not
progressed during or following concurrent or sequential
platinum-based chemoradiation therapy. (LAURA, September
2024)
|
Phase II registrational trial
readout
|
SAVANNAH
|
|
Tagrisso
plus Orpathys demonstrated
a high, clinically meaningful and durable objective response rate
for patients with EGFRm
NSCLC with high levels of mesenchymal epithelial transition factor
(MET) overexpression and/or amplification, defined as IHC90+ and/or
FISH10+, whose disease progressed on treatment with Tagrisso. (October 2024)
|
Imfinzi
and Imjudo
Event
|
|
|
Commentary
|
Approval
|
Europe
|
|
Imfinzi plus
chemotherapy followed by Imfinzi alone has
been approved for patients with mismatch repair deficient disease.
(DUO-E, August 2024)
|
Approval
|
Europe
|
|
Imfinzi plus
chemotherapy as 1st-line treatment followed by Lynparza and
Imfinzi
for patients with mismatch repair proficient disease. (DUO-E,
August 2024)
|
Priority Review
|
US
|
|
Imfinzi for
limited-stage small cell lung cancer whose disease has not
progressed following platinum-based concurrent chemoradiotherapy.
(ADRIATIC, August 2024)
|
Approval
|
US
|
|
Imfinzi in
combination with chemotherapy for the treatment of adult patients
with resectable early-stage (IIA-IIIB) NSCLC and no known
EGFR mutations or
ALK rearrangements.
(AEGEAN, August 2024)
|
Phase III presentation: ESMO
|
NIAGARA
|
|
In a planned interim analysis, patients treated
with the Imfinzi
perioperative regimen showed a 32% reduction in the risk of disease
progression, recurrence, not undergoing surgery, or death versus
the comparator arm (EFS HR 0.68; 95% CI 0.56-0.82, p<0.0001).
Estimated median EFS was not yet reached for the Imfinzi arm versus 46.1 months for the
comparator arm. In addition, Imfinzi perioperative regimen reduced
the risk of death by 25% versus neoadjuvant chemotherapy with
radical cystectomy (OS HR 0.75; 95% CI 0.59-0.93, p=0.0106).
(September 2024)
|
Phase III presentation: ESMO
|
HIMALAYA
|
|
At five years of follow-up, latest exploratory
analysis of HIMALAYA showed that a single priming dose of
Imjudo
added to Imfinzi, called the
STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab),
reduced the risk of death by 24% compared to sorafenib (HR 0.76,
95% CI 0.65-0.89). An estimated 19.6% of patients treated with the
STRIDE regimen were alive at five years versus 9.4% of those
treated with sorafenib. (September 2024)
|
Lynparza
Event
|
|
|
Commentary
|
Approval
|
Europe
|
|
Imfinzi plus
chemotherapy as 1st-line treatment followed by Lynparza and
Imfinzi
for patients with mismatch repair proficient disease. (DUO-E,
August 2024)
|
Enhertu
Event
|
|
|
Commentary
|
Approval
|
China
|
|
Conditional approval as monotherapy for the
treatment of adult patients with locally advanced or metastatic
HER2-positive gastric or gastroesophageal junction adenocarcinoma
who have received two or more prior treatment regimens.
(DESTINY-Gastric06, August 2024)
|
Phase IIIb/IV presentation: ESMO
|
DESTINY-Breast12
|
|
Enhertu
demonstrated substantial overall and intracranial clinical
activity in a large cohort of patients with HER2-positive
metastatic breast cancer who have brain metastases and received no
more than two prior lines of therapy in the metastatic setting with
a 12-month PFS rate of 61.6%. (September 2024)
|
Priority Review
|
US
|
|
For the treatment of adult patients with
unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) or
HER2-ultralow (IHC 0 with membrane staining) breast cancer who have
received at least one endocrine therapy in the metastatic setting.
(DESTINY-Breast06, October 2024)
|
Approval
|
China
|
|
Conditional approval as monotherapy for the
treatment of adult patients with unresectable, locally advanced or
metastatic NSCLC whose tumours have activating HER2 mutations and who have received a
prior systemic therapy. (DESTINY-Lung02, DESTINY-Lung05, October
2024)
|
Calquence
Event
|
|
|
Commentary
|
Phase III trial readout
|
AMPLIFY
|
|
Interim analysis of AMPLIFY Phase III trial
showed a fixed duration of Calquence in combination with
venetoclax, with or without obinutuzumab, demonstrated a
statistically significant and clinically meaningful improvement in
PFS compared to standard-of-care chemoimmunotherapy in previously
untreated adult patients with chronic lymphocytic leukaemia. (July
2024)
|
Priority Review
|
US
|
|
For the treatment of adult patients with
previously untreated mantle cell lymphoma. (ECHO, October
2024)
|
Datopotamab deruxtecan (Dato-DXd)
Event
|
|
|
Commentary
|
Phase III presentation: WCLC
|
TROPION-Lung01
|
|
Exploratory analysis of the TROPION-Lung01
Phase III trial showed TROP2 as measured by AstraZeneca's
proprietary computational pathology platform, quantitative
continuous scoring, was predictive of clinical outcomes in patients
with advanced or metastatic NSCLC who were treated with Dato-DXd.
(September 2024)
|
Phase III presentation: WCLC
|
TROPION-Lung01
|
|
Demonstrated a clinically meaningful, but not
statistically significant, trend toward improving OS with Dato-DXd
compared to docetaxel in patients with locally advanced or
metastatic non-squamous NSCLC treated with at least one prior line
of therapy (14.6 versus 12.3 months; HR 0.84; 95% CI 0.68-1.05). In
the overall trial population, OS results numerically favoured
Dato-DXd compared to docetaxel (12.9 versus 11.8 months) but did
not reach statistical significance (HR 0.94, 95% CI 0.78-1.14,
p=0.530). (September 2024)
|
Phase III trial readout
|
TROPION-Breast01
|
|
TROPION-Breast01 Phase III trial of Dato-DXd
compared to investigator's choice of chemotherapy, which previously
met the dual primary endpoint of PFS, did not achieve statistical
significance in the final OS analysis in patients with inoperable
or metastatic hormone receptor-positive, HER2-low or negative (IHC
0, IHC 1+ or IHC 2+/ISH-) breast cancer previously treated with
endocrine-based therapy and at least one systemic therapy.
(September 2024)
|
Regulatory update
|
US
|
|
Submission of a new Biologics License
Application for accelerated approval for Dato-DXd for the treatment
of adult patients with locally advanced or metastatic EGFRm NSCLC who have received prior
systemic therapies, including an EGFR-directed therapy. Voluntarily
withdrawal of the Biologics License Application for Dato-DXd for
patients with advanced or metastatic non-squamous NSCLC based on
the TROPION-Lung01 Phase III trial. An additional trial in
biomarker-positive patients in the 2nd line non-squamous NSCLC
setting is also planned. (TROPION-Lung05, TROPION-PanTumor01,
TROPION-Lung01, November 2024)
|
Zoladex
Event
|
|
|
Commentary
|
Approval
|
China
|
|
Zoladex 10.8mg for
breast cancer in pre- and perimenopausal women suitable for
hormonal manipulation. (Study 11, October 2024)
|
BioPharmaceuticals - CVRM
Wainua
Event
|
|
|
Commentary
|
CHMP positive opinion
|
EU
|
|
For the treatment of hereditary
transthyretin-mediated amyloidosis in adult patients with stage 1
or stage 2 polyneuropathy, commonly referred to as hATTR-PN or
ATTRv-PN. (NEURO-TTRansform, October 2024)
|
BioPharmaceuticals - R&I
Airsupra
Event
|
|
|
Commentary
|
Phase III trial readout
|
BATURA
|
|
Interim analysis of the Phase IIIb BATURA trial
showed Airsupra met the
primary endpoint, demonstrating a statistically significant and
clinically meaningful reduction in the risk of a severe
exacerbation when used as an as-needed rescue medication in
response to symptoms compared to as-needed albuterol. (October
2024)
|
Breztri
Event
|
|
|
Commentary
|
Clinical program completion
|
NGP
|
|
Completion of the clinical programme to support
the transition of Breztri
to next-generation propellant with near-zero Global Warming
Potential. (September 2024) A Marketing Authorisation Application
for Breztri with the
next-generation propellant has been accepted by the European
Medicines Agency (November 2024). Additional submissions in the UK and China expected before
the end of 2024. (November 2024)
|
Fasenra
Event
|
|
|
Commentary
|
Approval
|
US
|
|
For the treatment of adult patients with
eosinophilic granulomatosis with polyangiitis. (MANDARA, September
2024)
|
CHMP positive opinion
|
EU
|
|
As an add-on treatment for adult patients with
relapsing or refractory eosinophilic granulomatosis with
polyangiitis. (MANDARA, September 2024)
|
Approval
|
China
|
|
For maintenance treatment of
patients 12 years of age and older with severe eosinophilic asthma.
(MIRACLE, August 2024)
|
Phase III trial update
|
ORCHID
|
|
The Phase III ORCHID trial assessing
Fasenra in chronic
rhinosinusitis with nasal polyps and asthma did not meet the
primary endpoints of improvement in the size of nasal polyps and in
nasal blockage. The safety and tolerability profile for
Fasenra in the trial was
consistent with the known profile of the treatment. Results from
ORCHID will be shared with the scientific community in the future.
(November 2024)
|
Tezspire
Event
|
|
|
Commentary
|
Phase III trial readout
|
WAYPOINT
|
|
Tezspire met both
co-primary endpoints, demonstrating a statistically significant and
clinically meaningful reduction in nasal polyp size and improved
nasal congestion compared to placebo. (November 2024)
|
BioPharmaceuticals - V&I
FluMist
Event
|
|
|
Commentary
|
Approval
|
US
|
|
For self-administration by adults up to
49 years of age or as administered by a parent/caregiver to
individuals 2-17 years of age. FluMist is the only influenza vaccine
approved for self-administration in the US. (September
2024)
|
Rare Disease
Alexion, AstraZeneca Rare Disease, presented
data from its leading gMG portfolio at the American Association of
Neuromuscular & Electrodiagnostic Medicine Annual Meeting and
the Myasthenia Gravis Foundation of America Scientific Session in
October 2024.
The company presented 11 abstracts, spanning
clinical and real-world data, which add to the extensive body of
evidence supporting the safety and efficacy of Ultomiris and Soliris in treating anti-acetylcholine
receptor antibody-positive gMG, and offer new insights to inform
clinical practice.
Koselugo
Event
|
|
|
Commentary
|
Phase III trial readout
|
KOMET
|
|
Positive high-level results of the Phase III
KOMET trial in adults with NF1-PN showed that Koselugo met its primary endpoint
demonstrating a statistically significant and clinically meaningful
ORR versus placebo in these adult patients. (November
2024)
|
Interim financial statements
Table 18: Condensed consolidated statement
of comprehensive income: 9M 2024
For the nine
months ended 30 September
|
|
2024
|
2023
|
|
|
$m
|
$m
|
Total
Revenue
|
|
39,182
|
33,787
|
Product
Sales
|
|
37,576
|
32,466
|
Alliance
Revenue
|
|
1,498
|
1,004
|
Collaboration
Revenue
|
|
108
|
317
|
Cost of sales
|
|
(7,482)
|
(5,960)
|
Gross
profit
|
|
31,700
|
27,827
|
Distribution expense
|
|
(412)
|
(394)
|
Research and development expense
|
|
(8,906)
|
(7,862)
|
Selling, general and administrative
expense
|
|
(14,567)
|
(13,845)
|
Other operating income and expense
|
|
152
|
1,233
|
Operating
profit
|
|
7,967
|
6,959
|
Finance income
|
|
394
|
236
|
Finance expense
|
|
(1,313)
|
(1,181)
|
Share of after tax losses in associates and
joint ventures
|
|
(23)
|
(12)
|
Profit before
tax
|
|
7,025
|
6,002
|
Taxation
|
|
(1,484)
|
(1,000)
|
Profit for the
period
|
|
5,541
|
5,002
|
Other
comprehensive income:
|
|
|
|
Items that will not be reclassified to
profit or loss:
|
|
|
|
Remeasurement of the defined benefit pension
liability
|
|
136
|
(1)
|
Net gains on equity investments measured at
fair value through other comprehensive income
|
|
264
|
45
|
Fair value movements related to own credit risk
on bonds designated as fair value through profit or loss
|
|
12
|
5
|
Tax on items that will not be reclassified to
profit or loss
|
|
(50)
|
-
|
|
|
362
|
49
|
Items that may be
reclassified subsequently to profit or loss:
|
|
|
|
Foreign exchange arising on
consolidation
|
|
543
|
(201)
|
Foreign exchange arising on designated
liabilities in net investment hedges
|
|
(84)
|
(63)
|
Fair value movements on cash flow
hedges
|
|
(42)
|
62
|
Fair value movements on cash flow hedges
transferred to profit and loss
|
|
1
|
28
|
Fair value movements on derivatives designated
in net investment hedges
|
|
13
|
47
|
Gains/(costs) of hedging
|
|
2
|
(3)
|
Tax on items that may be reclassified
subsequently to profit or loss
|
|
16
|
(7)
|
|
|
449
|
(137)
|
Other
comprehensive income/(expense), net of tax
|
|
811
|
(88)
|
Total
comprehensive income for the period
|
|
6,352
|
4,914
|
Profit
attributable to:
|
|
|
|
Owners of the Parent
|
|
5,535
|
4,995
|
Non-controlling interests
|
|
6
|
7
|
|
|
5,541
|
5,002
|
Total
comprehensive income attributable to:
|
|
|
|
Owners of the Parent
|
|
6,346
|
4,907
|
Non-controlling interests
|
|
6
|
7
|
|
|
6,352
|
4,914
|
Basic earnings per $0.25 Ordinary
Share
|
|
$3.57
|
$3.22
|
Diluted earnings per $0.25 Ordinary
Share
|
|
$3.54
|
$3.20
|
Weighted average number of Ordinary
Shares in issue (millions)
|
|
1,550
|
1,549
|
Diluted weighted average number of
Ordinary Shares in issue (millions)
|
|
1,562
|
1,560
|
Table 19: Condensed consolidated statement
of comprehensive income: Q3 2024
For the quarter ended 30 September
|
|
|
|
|
|
2024
|
2023
|
|
|
$m
|
$m
|
Total
Revenue
|
|
13,565
|
11,492
|
Product
Sales
|
|
12,947
|
11,018
|
Alliance
Revenue
|
|
559
|
377
|
Collaboration
Revenue
|
|
59
|
97
|
Cost of sales
|
|
(3,081)
|
(2,095)
|
Gross
profit
|
|
10,484
|
9,397
|
Distribution expense
|
|
(145)
|
(129)
|
Research and development expense
|
|
(3,115)
|
(2,584)
|
Selling, general and administrative
expense
|
|
(5,143)
|
(4,800)
|
Other operating income and expense
|
|
25
|
70
|
Operating
profit
|
|
2,106
|
1,954
|
Finance income
|
|
183
|
101
|
Finance expense
|
|
(457)
|
(392)
|
Share of after tax losses in associates and
joint ventures
|
|
(4)
|
(11)
|
Profit before
tax
|
|
1,828
|
1,652
|
Taxation
|
|
(395)
|
(274)
|
Profit for the
period
|
|
1,433
|
1,378
|
Other
comprehensive income:
|
|
|
|
Items that will not be reclassified to
profit or loss:
|
|
|
|
Remeasurement of the defined benefit pension
liability
|
|
35
|
(8)
|
Net gains on equity investments measured at
fair value through other comprehensive income
|
|
175
|
93
|
Fair value movements related to own credit risk
on bonds designated as fair value through profit or loss
|
|
-
|
1
|
Tax on items that will not be reclassified to
profit or loss
|
|
(23)
|
5
|
|
|
187
|
91
|
Items that may be
reclassified subsequently to profit or loss:
|
|
|
|
Foreign exchange arising on
consolidation
|
|
1,097
|
(306)
|
Foreign exchange arising on designated
liabilities in net investment hedges
|
|
12
|
38
|
Fair value movements on cash flow
hedges
|
|
96
|
(27)
|
Fair value movements on cash flow hedges
transferred to profit and loss
|
|
(101)
|
99
|
Fair value movements on derivatives designated
in net investment hedges
|
|
(32)
|
7
|
Costs of hedging
|
|
(12)
|
(2)
|
Tax on items that may be reclassified
subsequently to profit or loss
|
|
(22)
|
(19)
|
|
|
1,038
|
(210)
|
Other
comprehensive income/(expense), net of tax
|
|
1,225
|
(119)
|
Total
comprehensive income for the period
|
|
2,658
|
1,259
|
Profit
attributable to:
|
|
|
|
Owners of the Parent
|
|
1,429
|
1,374
|
Non-controlling interests
|
|
4
|
4
|
|
|
1,433
|
1,378
|
Total
comprehensive income attributable to:
|
|
|
|
Owners of the Parent
|
|
2,654
|
1,255
|
Non-controlling interests
|
|
4
|
4
|
|
|
2,658
|
1,259
|
Basic earnings per $0.25 Ordinary
Share
|
|
$0.92
|
$0.89
|
Diluted earnings per $0.25 Ordinary
Share
|
|
$0.91
|
$0.88
|
Weighted average number of Ordinary
Shares in issue (millions)
|
|
1,550
|
1,549
|
Diluted weighted average number of
Ordinary Shares in issue (millions)
|
|
1,562
|
1,560
|
Table 20: Condensed consolidated statement
of financial position
|
|
At 30 Sep
2024
|
At 31 Dec
2023
|
At 30 Sep
2023
|
|
|
$m
|
$m
|
$m
|
Assets
Non-current
assets
|
|
|
|
|
Property, plant and equipment
|
|
10,135
|
9,402
|
8,723
|
Right-of-use assets
|
|
1,378
|
1,100
|
977
|
Goodwill
|
|
21,139
|
20,048
|
19,939
|
Intangible assets
|
|
39,394
|
38,089
|
37,687
|
Investments in associates and joint
ventures
|
|
290
|
147
|
62
|
Other investments
|
|
1,855
|
1,530
|
1,228
|
Derivative financial instruments
|
|
319
|
228
|
151
|
Other receivables
|
|
915
|
803
|
761
|
Deferred tax assets
|
|
5,342
|
4,718
|
4,057
|
|
|
80,767
|
76,065
|
73,585
|
Current
assets
|
|
|
|
|
Inventories
|
|
5,662
|
5,424
|
5,292
|
Trade and other receivables
|
|
11,879
|
12,126
|
11,300
|
Other investments
|
|
133
|
122
|
244
|
Derivative financial instruments
|
|
16
|
116
|
97
|
Income tax receivable
|
|
1,668
|
1,426
|
697
|
Cash and cash equivalents
|
|
4,797
|
5,840
|
4,871
|
|
|
24,155
|
25,054
|
22,501
|
Total
assets
|
|
104,922
|
101,119
|
96,086
|
Liabilities
Current
liabilities
|
|
|
|
|
Interest-bearing loans and
borrowings
|
|
(1,253)
|
(5,129)
|
(5,372)
|
Lease liabilities
|
|
(317)
|
(271)
|
(235)
|
Trade and other payables
|
|
(21,684)
|
(22,374)
|
(20,542)
|
Derivative financial instruments
|
|
(17)
|
(156)
|
(83)
|
Provisions
|
|
(1,187)
|
(1,028)
|
(1,193)
|
Income tax payable
|
|
(1,468)
|
(1,584)
|
(1,163)
|
|
|
(25,926)
|
(30,542)
|
(28,588)
|
Non-current
liabilities
|
|
|
|
|
Interest-bearing loans and
borrowings
|
|
(28,887)
|
(22,365)
|
(22,225)
|
Lease liabilities
|
|
(1,105)
|
(857)
|
(744)
|
Derivative financial instruments
|
|
(34)
|
(38)
|
(75)
|
Deferred tax liabilities
|
|
(3,568)
|
(2,844)
|
(2,752)
|
Retirement benefit obligations
|
|
(1,361)
|
(1,520)
|
(1,048)
|
Provisions
|
|
(1,063)
|
(1,127)
|
(1,189)
|
Income tax payable
|
|
(174)
|
-
|
-
|
Other payables
|
|
(1,999)
|
(2,660)
|
(2,244)
|
|
|
(38,191)
|
(31,411)
|
(30,277)
|
Total
liabilities
|
|
(64,117)
|
(61,953)
|
(58,865)
|
Net
assets
|
|
40,805
|
39,166
|
37,221
|
Equity
Capital and
reserves attributable to equity holders of the
Parent
|
|
|
Share capital
|
|
388
|
388
|
387
|
Share premium account
|
|
35,203
|
35,188
|
35,166
|
Other reserves
|
|
1,990
|
2,065
|
2,078
|
Retained earnings
|
|
3,138
|
1,502
|
(434)
|
|
|
40,719
|
39,143
|
37,197
|
Non-controlling interests
|
|
86
|
23
|
24
|
Total
equity
|
|
40,805
|
39,166
|
37,221
|
Table 21: Condensed
consolidated statement of changes in equity
|
|
Share
capital
|
Share
premium account
|
Other
reserves
|
Retained
earnings
|
Total attributable to owners of the parent
|
Non-controlling interests
|
Total
equity
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
At 1 Jan
2023
|
|
387
|
35,155
|
2,069
|
(574)
|
37,037
|
21
|
37,058
|
Profit for the period
|
|
-
|
-
|
-
|
4,995
|
4,995
|
7
|
5,002
|
Other comprehensive expense
|
|
-
|
-
|
-
|
(88)
|
(88)
|
-
|
(88)
|
Transfer to other reserves
|
|
-
|
-
|
9
|
(9)
|
-
|
-
|
-
|
Transactions
with owners
|
|
|
|
|
|
|
|
|
Dividends
|
|
-
|
-
|
-
|
(4,487)
|
(4,487)
|
-
|
(4,487)
|
Dividends paid to non-controlling
interests
|
|
-
|
-
|
-
|
-
|
-
|
(4)
|
(4)
|
Issue of Ordinary Shares
|
|
-
|
11
|
-
|
-
|
11
|
-
|
11
|
Share-based payments charge for the
period
|
|
-
|
-
|
-
|
429
|
429
|
-
|
429
|
Settlement of share plan awards
|
|
-
|
-
|
-
|
(700)
|
(700)
|
-
|
(700)
|
Net movement
|
|
-
|
11
|
9
|
140
|
160
|
3
|
163
|
At 30 Sep
2023
|
|
387
|
35,166
|
2,078
|
(434)
|
37,197
|
24
|
37,221
|
|
|
|
|
|
|
|
|
|
At 1 Jan
2024
|
|
388
|
35,188
|
2,065
|
1,502
|
39,143
|
23
|
39,166
|
Profit for the period
|
|
-
|
-
|
-
|
5,535
|
5,535
|
6
|
5,541
|
Other comprehensive income
|
|
-
|
-
|
-
|
811
|
811
|
-
|
811
|
Transfer to other reserves
|
|
-
|
-
|
1
|
(1)
|
-
|
-
|
-
|
Transactions with owners
|
|
|
|
|
|
|
|
|
Dividends
|
|
-
|
-
|
-
|
(4,602)
|
(4,602)
|
-
|
(4,602)
|
Dividends paid to non-controlling
interests
|
|
-
|
-
|
-
|
-
|
-
|
(4)
|
(4)
|
Issue of Ordinary Shares
|
|
-
|
15
|
-
|
-
|
15
|
-
|
15
|
Changes in non-controlling interests
|
|
-
|
-
|
-
|
-
|
-
|
61
|
61
|
Movement in shares held by Employee Benefit
Trust
|
|
-
|
-
|
(76)
|
-
|
(76)
|
-
|
(76)
|
Share-based payments charge for the
period
|
|
-
|
-
|
-
|
487
|
487
|
-
|
487
|
Settlement of share plan awards
|
|
-
|
-
|
-
|
(594)
|
(594)
|
-
|
(594)
|
Net movement
|
|
-
|
15
|
(75)
|
1,636
|
1,576
|
63
|
1,639
|
At 30 Sep
2024
|
|
388
|
35,203
|
1,990
|
3,138
|
40,719
|
86
|
40,805
|
Table 22: Condensed consolidated statement
of cash flows: 9M 2024
For the nine
months ended 30 September
|
|
2024
|
2023
|
|
$m
|
$m
|
Cash flows from operating activities
|
|
|
|
Profit before tax
|
|
7,025
|
6,002
|
Finance income and expense
|
|
919
|
945
|
Share of after tax losses of associates and
joint ventures
|
|
23
|
12
|
Depreciation, amortisation and
impairment
|
|
4,351
|
4,060
|
Movement in working capital and short-term
provisions
|
|
(543)
|
150
|
Gains on disposal of intangible
assets
|
|
(34)
|
(247)
|
Fair value movements on contingent
consideration arising from business combinations
|
|
251
|
202
|
Non-cash and other movements
|
|
15
|
(623)
|
Cash generated
from operations
|
|
12,007
|
10,501
|
Interest paid
|
|
(1,075)
|
(826)
|
Tax paid
|
|
(1,978)
|
(1,710)
|
Net cash
inflow from operating activities
|
|
8,954
|
7,965
|
Cash flows from investing activities
|
|
|
|
Acquisition of subsidiaries, net of cash
acquired
|
|
(2,771)
|
(189)
|
Payments upon vesting of employee share awards
attributable to business combinations
|
|
-
|
(84)
|
Payment of contingent consideration from
business combinations
|
|
(737)
|
(610)
|
Purchase of property, plant and
equipment
|
|
(1,216)
|
(836)
|
Disposal of property, plant and
equipment
|
|
53
|
131
|
Purchase of intangible assets
|
|
(2,415)
|
(1,996)
|
Disposal of intangible assets
|
|
107
|
288
|
Movement in profit-participation
liability
|
|
-
|
190
|
Purchase of non-current asset
investments
|
|
(96)
|
(109)
|
Disposal of non-current asset
investments
|
|
73
|
32
|
Movement in short-term investments, fixed
deposits and other investing instruments
|
|
67
|
(12)
|
Payments to associates and joint
ventures
|
|
(158)
|
-
|
Disposal of investments in associates and joint
ventures
|
|
13
|
-
|
Interest received
|
|
281
|
208
|
Net cash
(outflow) from investing activities
|
|
(6,799)
|
(2,987)
|
Net cash
inflow before financing activities
|
|
2,155
|
4,978
|
Cash flows from financing activities
|
|
|
|
Proceeds from issue of share capital
|
|
15
|
12
|
Own shares purchased by Employee Benefit
Trust
|
|
(81)
|
-
|
Issue of loans and borrowings
|
|
6,492
|
3,816
|
Repayment of loans and borrowings
|
|
(4,647)
|
(4,655)
|
Dividends paid
|
|
(4,626)
|
(4,479)
|
Hedge contracts relating to dividend
payments
|
|
16
|
(19)
|
Repayment of obligations under
leases
|
|
(233)
|
(194)
|
Movement in short-term borrowings
|
|
572
|
110
|
Payment of Acerta Pharma share purchase
liability
|
|
(833)
|
(867)
|
Net cash
(outflow) from financing activities
|
|
(3,325)
|
(6,276)
|
Net (decrease) in Cash and cash equivalents in
the period
|
|
(1,170)
|
(1,298)
|
Cash and cash equivalents at the beginning of
the period
|
|
5,637
|
5,983
|
Exchange rate effects
|
|
(32)
|
(66)
|
Cash and cash
equivalents at the end of the period
|
|
4,435
|
4,619
|
Cash and cash
equivalents consist of:
|
|
|
|
Cash and cash equivalents
|
|
4,797
|
4,871
|
Overdrafts
|
|
(362)
|
(252)
|
|
|
4,435
|
4,619
|
Notes to the Interim financial statements
Note 1: Basis of preparation and accounting
policies
These unaudited condensed consolidated Interim
financial statements for the nine months ended 30 September 2024
have been prepared in accordance with International Accounting
Standard 34, 'Interim Financial Reporting' (IAS 34), as issued by
the International Accounting Standards Board (IASB), IAS 34 as
adopted by the European Union, UK-adopted IAS 34 and the Disclosure
Guidance and Transparency Rules sourcebook of the United Kingdom's
Financial Conduct Authority and with the requirements of the
Companies Act 2006 as applicable to companies reporting under those
standards.
The unaudited Interim financial statements for
the nine months ended 30 September 2024 were approved by the Board
of Directors for publication on 12 November 2024.
This results announcement does not constitute
statutory accounts of the Group within the meaning of sections
434(3) and 435(3) of the Companies Act 2006. The annual financial
statements of the Group for the year ended 31 December 2023 were
prepared in accordance with UK-adopted international accounting
standards and with the requirements of the Companies Act 2006. The
annual financial statements also comply fully with IFRS Accounting
Standards as issued by the IASB and International Accounting
Standards as adopted by the European Union. Except for the
estimation of the interim income tax charge, the Interim financial
statements have been prepared applying the accounting policies that
were applied in the preparation of the Group's published
consolidated financial statements for the year ended 31 December
2023.
The comparative figures for the financial year
ended 31 December 2023 are not the Group's statutory accounts for
that financial year. Those accounts have been reported on by the
Group's auditors and have been delivered to the Registrar of
Companies; their report was (i) unqualified, (ii) did not include a
reference to any matters to which the auditors drew attention by
way of emphasis without qualifying their report, and (iii) did not
contain a statement under section 498(2) or (3) of the Companies
Act 2006.
Going concern
The Group has considerable financial resources
available. As at 30 September 2024, the Group has $11.7bn in
financial resources (cash and cash equivalent balances of $4.8bn
and undrawn committed bank facilities of $6.9bn, with $1.6bn of
borrowings due within one year). These facilities contain no
financial covenants and were undrawn at 30 September 2024. There
are $4.9bn of undrawn committed bank facilities are available until
April 2029. Additionally, there are a further $2.0bn undrawn
committed bank facilities available until February 2025.
The Group's revenues are largely derived from
sales of medicines covered by patents, which provide a relatively
high level of resilience and predictability to cash inflows,
although government price interventions in response to budgetary
constraints are expected to continue to adversely affect revenues
in some of our significant markets. The Group, however, anticipates
new revenue streams from both recently launched medicines and those
in development, and the Group has a wide diversity of customers and
suppliers across different geographic areas.
Consequently, the Directors believe that,
overall, the Group is well placed to manage its business risks
successfully. Accordingly, they continue to adopt the going concern
basis in preparing the Interim financial statements.
Legal proceedings
The information contained in Note 6 updates the
disclosures concerning legal proceedings and contingent liabilities
in the Group's
Annual Report and Form 20-F Information 2023.
Employee Benefit Trust
Following an amendment to the Employee Benefit
Trust (EBT) Deed on 10 June 2024, AstraZeneca obtained control and
commenced consolidation of the EBT. Accordingly, cash paid on
purchases of AstraZeneca Ordinary shares or American Depositary
Receipts is presented within Financing activities in the Cash flow
statement.
Note 2: Intangible assets
In accordance with IAS 36 'Impairment of
Assets', reviews for triggers of impairment or impairment reversals
at an individual asset or cash generating unit level were
conducted, and impairment tests carried out where triggers were
identified. Following a strategic review of our portfolio
priorities, the business decision was made to cease
promotional activity for Andexxa resulting in impairment
charges of $504m recorded against the Andexxa intangible asset under value
in use model applying a discount rate of 7.5% (revised carrying
amount: $nil), total net impairment charges of $525m have been
recorded against intangible assets during the nine months ended 30
September 2024 (9M 2023: $376m net charge). In 9M 2023, net
impairment charges included the $244m impairment of the ALXN1840
intangible asset, following the decision to discontinue this
development programme in Wilson's disease.
The acquisition of Icosavax, Inc. completed on
19 February 2024. The transaction is recorded as an asset
acquisition based on the concentration test permitted under IFRS 3
'Business Combinations', with consideration of $841m principally
relating to $639m of intangible assets, $141m of cash and cash
equivalents and $51m of marketable securities. Contingent
consideration of up to $300m could be paid on achievement of
regulatory and sales milestones; these potential liabilities would
be recorded when the relevant recognition event for a regulatory or
sales milestone is achieved.
The acquisition of Amolyt Pharma completed on
15 July 2024. The transaction is recorded as an asset acquisition
based on the concentration test permitted under IFRS 3 'Business
Combinations', with consideration of $857m principally relating to
$800m of intangible assets and $98m of cash and cash equivalents.
Contingent consideration of up to $250m could be paid on
achievement of a regulatory milestone; this potential liability
would be recorded when the relevant recognition event for a
regulatory milestone is achieved.
Note 3: Net debt
The table below provides an analysis of Net debt and a reconciliation of Net Cash flow to
the movement in Net debt. The Group monitors Net debt as part of
its capital management policy as described in Note 28 of the
Annual Report and Form 20-F Information
2023. Net debt is a non-GAAP
financial measure.
Table 23: Net debt
|
|
At 1 Jan 2024
|
Cash flow
|
Acquisitions
|
Non-cash
&
other
|
Exchange movements
|
At 30 Sep 2024
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Non-current instalments of loans
|
|
(22,365)
|
(6,499)
|
(3)
|
69
|
(89)
|
(28,887)
|
Non-current instalments of leases
|
|
(857)
|
1
|
(12)
|
(233)
|
(4)
|
(1,105)
|
Total
long-term debt
|
|
(23,222)
|
(6,498)
|
(15)
|
(164)
|
(93)
|
(29,992)
|
Current instalments of loans
|
|
(4,614)
|
4,586
|
(9)
|
(3)
|
28
|
(12)
|
Current instalments of leases
|
|
(271)
|
271
|
(6)
|
(311)
|
-
|
(317)
|
Commercial paper
|
|
-
|
(472)
|
-
|
-
|
-
|
(472)
|
Collateral received from derivative
counterparties
|
|
(215)
|
(72)
|
-
|
-
|
-
|
(287)
|
Other short-term borrowings excluding
overdrafts
|
|
(97)
|
(28)
|
-
|
(1)
|
6
|
(120)
|
Overdrafts
|
|
(203)
|
(158)
|
-
|
1
|
(2)
|
(362)
|
Total current
debt
|
|
(5,400)
|
4,127
|
(15)
|
(314)
|
32
|
(1,570)
|
Gross
borrowings
|
|
(28,622)
|
(2,371)
|
(30)
|
(478)
|
(61)
|
(31,562)
|
Net derivative financial instruments
|
|
150
|
41
|
-
|
93
|
-
|
284
|
Net
borrowings
|
|
(28,472)
|
(2,330)
|
(30)
|
(385)
|
(61)
|
(31,278)
|
Cash and cash equivalents
|
|
5,840
|
(1,254)
|
242
|
(1)
|
(30)
|
4,797
|
Other investments - current
|
|
122
|
(67)
|
87
|
-
|
(9)
|
133
|
Cash and
investments
|
|
5,962
|
(1,321)
|
329
|
(1)
|
(39)
|
4,930
|
Net
debt
|
|
(22,510)
|
(3,651)
|
299
|
(386)
|
(100)
|
(26,348)
|
Net debt increased by $3,838m in the nine
months to $26,348m. Details of the committed undrawn bank
facilities are disclosed within the going concern section of Note
1. Non-cash movements in the period include fair value adjustments
under IFRS 9 'Financial Instruments'.
In February 2024, AstraZeneca issued the
following:
- $1,250m
of fixed-rate notes with a coupon of 4.8% maturing in February
2027
- $1,250m
of fixed-rate notes with a coupon of 4.85% maturing in February
2029
- $1,000m
of fixed-rate notes with a coupon of 4.9% maturing in February
2031
- $1,500m
of fixed-rate notes with a coupon of 5% maturing in February
2034
In August 2024, AstraZeneca issued the
following:
- €650m
of fixed-rate notes with a coupon of 3.121% maturing in August
2030
- €750m
of fixed-rate notes with a coupon of 3.278% maturing in August
2033
AstraZeneca repaid two bonds of carrying value
$2,569m and floating rate bank loans of $2,000m during the nine
months which are included in the cash outflow from Repayment of
loans and borrowings of $4,647m.
The Group has agreements with some bank
counterparties whereby the parties agree to post cash collateral on
financial derivatives, for the benefit of the other, equivalent to
the market valuation of the derivative positions above a
predetermined threshold. The carrying value of such cash collateral
held by the Group at 30 September 2024 was $287m (31 December 2023:
$215m) and the carrying value of such cash collateral posted by the
Group at 30 September 2024 was $68m (31 December 2023:
$102m).
The equivalent GAAP measure to Net debt is
'liabilities arising from financing activities', which excludes the
amounts for cash and overdrafts, other investments and
non-financing derivatives shown above and includes the Acerta
Pharma share purchase liability of $nil (31 December 2023:
$833m).
During the quarter ended 30 September 2024,
Standard and Poor's upgraded the Company's solicited long term
credit rating to A+ from A. The short term rating remained at A-1.
There were no changes to Moody's credit ratings (long term: A2;
short term: P-1).
Note 4: Financial Instruments
As detailed in the Group's most recent annual
financial statements, the principal financial instruments consist
of derivative financial instruments, other investments, trade and
other receivables, cash and cash equivalents, trade and other
payables, lease liabilities and interest-bearing loans and
borrowings.
The Group has certain equity investments that
are categorised as Level 3 in the fair value hierarchy that are
held at $370m (31 December 2023: $313m) and for which a fair value
gain of $nil has been recognised in the nine months ended 30
September 2024 (9M 2023: $17m). In the absence of specific market
data, these unlisted investments are held at fair value based on
the cost of investment and adjusted as necessary for impairments
and revaluations on new funding rounds, which are seen to
approximate the fair value. All other fair value gains and/or
losses that are presented in Net gains on equity investments
measured at fair value through other comprehensive income, in the
Condensed consolidated statement of comprehensive income for the
nine months ended 30 September 2024, are Level 1 fair value
measurements, valued based on quoted prices in active
markets.
Financial instruments measured at fair value
include $1,920m of other investments, $3,408m held in money-market
funds and $284m of derivatives as at 30 September 2024. With the
exception of derivatives being Level 2 fair valued, and certain
equity instruments of $379m categorised as Level 3, the
aforementioned balances are Level 1 fair valued. Financial
instruments measured at amortised cost include $68m of cash
collateral pledged to counterparties. The total fair value of
interest-bearing loans and borrowings at 30 September 2024, which
have a carrying value of $31,562m in the Condensed consolidated
statement of financial position, was $31,396m.
Table 24: Financial instruments -
contingent consideration
|
|
Diabetes alliance
|
Other
|
Total
|
Total
|
|
|
$m
|
$m
|
$m
|
$m
|
At 1
January
|
|
1,945
|
192
|
2,137
|
2,222
|
Additions through business
combinations
|
|
-
|
198
|
198
|
60
|
Settlements
|
|
(736)
|
(1)
|
(737)
|
(610)
|
Revaluations
|
|
220
|
32
|
252
|
202
|
Discount unwind
|
|
77
|
8
|
85
|
99
|
At 30
September
|
|
1,506
|
429
|
1,935
|
1,973
|
Contingent consideration arising from business
combinations is fair valued using decision-tree analysis, with key
inputs including the probability of success, consideration of
potential delays and the expected levels of future
revenues.
The contingent consideration balance relating
to BMS's share of the global diabetes alliance of $1,506m
(31 December 2023: $1,945m) would increase/decrease by $151m
with an increase/decrease in sales of 10%, as compared with the
current estimates.
Note 5: Business combinations
Gracell
On 22 February 2024, AstraZeneca completed the
acquisition of Gracell Biotechnologies Inc. (Gracell), a global
clinical-stage biopharmaceutical company developing innovative cell
therapies for the treatment of cancer and autoimmune
diseases.
The purchase price allocation review has been
completed, currently there are no changes to the amounts reported
in the H1 and Q2 2024 results announcement. The transaction is
recorded as a business combination using the acquisition method of
accounting in accordance with IFRS 3 'Business
Combinations'.
The total consideration fair value of $1,037m
includes cash consideration of $983m and future regulatory
milestone-based consideration of $54m. Intangible assets recognised
relate to products in development, principally AZD0120. Goodwill of
$136m has been recognised. Gracell's results have been
consolidated into the Group's results from 22 February
2024.
Fusion
On 4 June 2024, AstraZeneca completed the
acquisition of Fusion Pharmaceuticals Inc., (Fusion) a
clinical-stage biopharmaceutical company developing next-generation
radioconjugates.
The purchase price allocation review has been
completed, currently there are no changes to the amounts reported
in the H1 and Q2 2024 results announcement. The transaction is
recorded as a business combination using the acquisition method of
accounting in accordance with IFRS 3 'Business
Combinations'.
The total consideration fair value of $2,195m
includes cash consideration of $2,051m and future regulatory
milestone-based consideration of $144m. Intangible assets relating
to products in development comprise the FPI-2265 ($848m), FPI-2059
($165m) and AZD2068 ($313m) programmes. Goodwill of $947m has been
recognised. Fusion's results have been consolidated into the
Group's results from 4 June 2024.
Note 6: Legal proceedings and contingent
liabilities
AstraZeneca is involved in various
legal proceedings considered typical to its business, including
litigation and investigations, including Government investigations,
relating to product liability, commercial disputes, infringement of
intellectual property (IP) rights, the validity of certain patents,
anti-trust law and sales and marketing practices. The matters
discussed below constitute the more significant developments since
publication of the disclosures concerning legal proceedings in the
Company's Annual Report and Form 20-F Information 2023 and
the Interim Financial Statements for the six months ended 30
June 2024 (the Disclosures). Information
about the nature and facts of the cases is disclosed in accordance
with IAS 37.
As discussed in the Disclosures, the
majority of claims involve highly complex issues. Often these
issues are subject to substantial uncertainties and, therefore, the
probability of a loss, if any, being sustained and/or an estimate
of the amount of any loss is difficult to ascertain.
In cases that have been settled or
adjudicated, or where quantifiable fines and penalties have been
assessed and which are not subject to appeal, or where a loss is
probable and we are able to make a reasonable estimate of the loss,
AstraZeneca records the loss absorbed or makes a provision for its
best estimate of the expected loss. The position could change over
time and the estimates that the Company made, and upon which the
Company have relied in calculating these provisions are inherently
imprecise. There can, therefore, be no assurance that any losses
that result from the outcome of any legal proceedings will not
exceed the amount of the provisions that have been booked in the
accounts. The major factors causing this uncertainty are described
more fully in the Disclosures and herein.
AstraZeneca has full confidence in,
and will vigorously defend and enforce, its IP.
Matters disclosed in respect of the third
quarter of 2024 and to 12 November 2024
Table 25: Patent litigation
Legal proceedings brought against
AstraZeneca
|
Faslodex patent
proceedings, Japan
Considered to be a contingent asset
|
|
* In 2021
in Japan, AstraZeneca received notice from the Japan Patent Office
(JPO) that Sandoz K.K. (Sandoz) and Sun Pharma Japan Ltd. (Sun)
were seeking to invalidate the Faslodex formulation
patent.
*
AstraZeneca defended the challenged patent and Sun withdrew
from the JPO patent challenge.
* In July
2023, the JPO issued a final decision upholding various claims of
the challenged patent and determining that other patent claims were
invalid.
* In
August 2023, Sandoz appealed the JPO decision to the Japan IP High
Court (High Court).
* In
October 2024, the High Court affirmed the decision by the
JPO.
|
Tagrisso patent
proceedings, US
Considered to be a contingent
liability
|
|
* In
September 2021, Puma Biotechnology, Inc. (Puma) and Wyeth LLC
(Wyeth) filed a patent infringement lawsuit in the US District
Court for the District of Delaware (District Court) against
AstraZeneca relating to Tagrisso.
* In March
2024, the District Court dismissed Puma.
* The jury
trial, with Wyeth as the plaintiff, took place in May 2024. The
jury found Wyeth's patents infringed and awarded Wyeth $107.5m in
past damages. The jury also found that the infringement was not
wilful.
* In
proceedings following the jury award, the District Court rejected
AstraZeneca's indefiniteness and equitable defences but granted
judgment as a matter of law in favour of AstraZeneca on the grounds
that the patents were invalid for lack of written description and
enablement. Wyeth has filed an appeal.
|
Legal proceedings brought by
AstraZeneca
|
Lokelma patent
proceedings, US
Considered to be a contingent asset
|
|
* In
August 2022, in response to Paragraph IV notices, AstraZeneca
initiated ANDA litigation against multiple generic filers in the US
District Court for the District of Delaware (District Court).
AstraZeneca alleged that a generic version of Lokelma would infringe patents that
are owned or licensed by AstraZeneca.
*
AstraZeneca has entered into separate settlement agreements
with four generic manufacturers which resulted in dismissal of the
corresponding litigations.
*
Additional proceedings with the remaining generic
manufacturer are ongoing in the District Court. Trial is scheduled
for March 2025.
|
Soliris patent
proceedings, Canada
Considered to be a contingent asset
|
|
* In May
2023, Alexion initiated patent litigation in Canada alleging that
Amgen Pharmaceuticals, Inc.'s (Amgen) biosimilar eculizumab product
will infringe Alexion patents.
* In
September 2023, Alexion initiated patent litigations in Canada
alleging that Samsung Bioepis Co. Ltd.'s (Samsung) biosimilar
eculizumab product will infringe Alexion patents. The filing
of the litigation triggered an automatic 24-month stay of the
approval of each defendant's biosimilar eculizumab
product.
* Trial
against Amgen is scheduled to begin in January 2025 while trial
against Samsung is scheduled to begin in June 2025.
* In July
and August 2023, in Canada, both Amgen and Samsung brought actions
challenging the validity of Alexion's patent relating to the use of
eculizumab in treating aHUS. Trial is scheduled to begin
in November 2025.
|
Soliris patent
proceedings, US
Matter concluded
|
|
* In
January 2024, Alexion initiated patent infringement litigation
against Samsung Bioepis Co. Ltd. (Samsung) in the US District Court
for the District of Delaware (District Court) alleging that
Samsung's biosimilar eculizumab product, for which Samsung is
currently seeking FDA approval, will infringe six Soliris-related patents.
* Five of
the six asserted patents were also the subject of inter partes
review proceedings before the US Patent and Trademark
Office.
* Alexion
filed a motion for a preliminary injunction seeking to enjoin
Samsung from launching its biosimilar eculizumab product upon FDA
approval. The District Court denied Alexion's motion and Alexion
appealed that decision.
* In
August 2024, the parties reached resolution of the matter. All
legal proceedings in the US courts have terminated, as have the
inter partes review proceedings.
|
Tagrisso patent
proceedings, Russia
Considered to be a contingent asset
|
|
* In
Russia, in August 2023, AstraZeneca filed lawsuits in the
Arbitration Court of the Moscow Region (Court) against the Ministry
of Health of the Russian Federation and Axelpharm LLC (Axelpharm)
related to Axelpharm's improper use of AstraZeneca's information to
obtain authorisation to market a generic version of Tagrisso. In December 2023, the Court
dismissed the lawsuit against the Ministry of Health of the Russian
Federation. The appellate court affirmed the dismissal in March
2024. AstraZeneca filed a further appeal, which was dismissed in
July 2024. The lawsuit against Axelpharm was dismissed in September
2024, and AstraZeneca appealed.
* In
November 2023, Axelpharm filed a compulsory licensing action
against AstraZeneca in the Court related to a patent that covers
Tagrisso. The compulsory
licensing action remains pending. AstraZeneca has also challenged
before the Russian Patent and Trademark Office (PTO) the validity
of the Axelpharm patent on which the compulsory licensing action is
predicated; in August 2024, the PTO determined that Axelpharm's
patent is invalid.
* In July
2024, AstraZeneca filed a patent infringement lawsuit, which
remains pending, and an unfair competition claim with the Federal
Anti-Monopoly Service of Russia (FAS) against AxelPharm and others
related to the securing of state contracts in Russia for its
generic version of Osimertinib.
* In
August 2024, FAS initiated an unfair competition case against
Axelpharm and OncoTarget based on AstraZeneca's unfair competition
claim.
* In
November 2024, FAS determined that Axelpharm had committed unfair
competition and that OncoTarget had not; FAS ordered Axelpharm to
cease sales of its generic osimertinib and pay the Russian
government the income it received from its sales of its generic
osimertinib.
|
Table 26: Commercial
litigation
Legal proceedings brought against
AstraZeneca
|
Amyndas Trade Secrets Litigation, US
Considered to be a contingent
liability
|
|
*
AstraZeneca has been defending a matter filed
by Amyndas Pharmaceuticals Member P.C.
and Amyndas Pharmaceuticals, LLC, in the US District
Court for the District of Massachusetts alleging trade secret
misappropriation and breach of contract claims against Alexion and
Zealand Pharma U.S. Inc. related to Amyndas' C3 inhibitor
candidate.
* No trial
date has been set.
|
Caelum Trade Secrets Litigation, US
Matter concluded
|
|
*
AstraZeneca has been defending a matter filed by the
University of Tennessee Research Foundation in the US District
Court for the Eastern District of Tennessee related to
CAEL-101.
* In
September 2024, the parties resolved the matter by
settlement.
|
Seroquel
XR Antitrust Litigation, US
Considered to be a contingent
liability
|
|
* In 2019,
AstraZeneca was named in several related complaints now proceeding
in US District Court in Delaware (District Court), including
several putative class action lawsuits that were purportedly
brought on behalf of classes of direct purchasers or end payors of
Seroquel XR, that allege
AstraZeneca and generic drug manufacturers violated US antitrust
laws when settling patent litigation related to Seroquel XR.
* In July
2022, the District Court dismissed claims relating to one of the
generic manufacturers while allowing claims relating to the second
generic manufacturer to proceed.
* In
September 2024, AstraZeneca reached a settlement agreement with one
of the plaintiff classes and the parties are now seeking judicial
review and approval of the settlement.
* Trial
with the remaining class of plaintiffs is currently scheduled for
May 2025.
|
Syntimmune Milestone Litigation, US
Considered to be a contingent
liability
|
|
* In
connection with Alexion's acquisition of Syntimmune, Inc.
(Syntimmune) in December 2020, Alexion was served with a lawsuit
filed by the stockholders' representative for Syntimmune in
Delaware state court that alleged, among other things, breaches of
the 2018 merger agreement.
* The
stockholders' representative alleges that Alexion failed to meet
its obligations under the merger agreement to use commercially
reasonable efforts to achieve the milestones. Alexion also filed a
claim for breach of the representations in the 2018 merger
agreement.
* A trial
was held in July 2023.
* The
court issued a partial decision in September 2024, concluding that
the first milestone was achieved, and that Alexion had breached its
contractual obligation to use commercially reasonable efforts to
achieve the milestones. The court has requested additional briefing
regarding damages and further proceedings regarding Alexion's claim
for breach.
|
Viela Bio, Inc. Shareholder Litigation,
US
Considered to be a contingent
liability
|
|
* In
February 2023, AstraZeneca was served with a lawsuit filed in the
Delaware state court against AstraZeneca and certain officers
(collectively, Defendants), on behalf of a putative class of Viela
Bio, Inc. (Viela) shareholders. The complaint alleged that the
Defendants breached their fiduciary duty to Viela shareholders in
the course of Viela's 2021 merger with Horizon Therapeutics,
plc.
* In July
2024, the Court granted with prejudice AstraZeneca's motion to
dismiss.
* In
August 2024, plaintiffs appealed the dismissal.
|
Table 27: Government
investigations and proceedings
Legal proceedings
brought by AstraZeneca
|
340B State Litigation, US
Considered to be a
contingent asset
|
|
*
AstraZeneca has filed lawsuits against Arkansas, Kansas,
Louisiana, Maryland, Minnesota, Mississippi, Missouri, and West
Virginia challenging the constitutionality of each state's 340B
statute.
* In the
Arkansas matter, trial is scheduled for April 2025. An intervenor
has moved to dismiss AstraZeneca's complaint.
* In the
Louisiana matter, the Court granted the state's motion for summary
judgment. AstraZeneca has filed an appeal.
* In the
Maryland matter, the Court has rejected AstraZeneca's preliminary
injunction motion. The state's motion to dismiss remains
pending.
* In the
Minnesota matter, the state has moved to dismiss AstraZeneca's
complaint.
* In the
Mississippi matter, AstraZeneca has moved for a preliminary
injunction.
* The
remaining matters are in their preliminary stages.
|
Other
Additional government inquiries
As is true for most, if not all,
major prescription pharmaceutical companies, AstraZeneca is
currently involved in multiple inquiries into drug marketing and
pricing practices. In addition to the investigations described
above, various law enforcement offices have, from time to time,
requested information from the Group. There have been no material
developments in those matters.
Note 7
Table 28: 9M 2024 - Product
Sales year-on-year analysis[14]
|
World
|
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. For Media contacts, click
here.
Addresses for correspondence
Registered office
|
Registrar and transfer
office
|
Swedish Central Securities
Depository
|
US depositary
Deutsche Bank Trust Company
Americas
|
1 Francis Crick
Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
|
Equiniti
Limited
Aspect
House
Spencer
Road
Lancing
West
Sussex
BN99 6DA
|
Euroclear Sweden AB
PO Box 191
SE-101 23
Stockholm
|
American Stock
Transfer
6201 15th
Avenue
Brooklyn
NY 11219
|
United
Kingdom
|
United
Kingdom
|
Sweden
|
United
States
|
+44 (0) 20 3749
5000
|
0800 389
1580
|
+46 (0) 8 402
9000
|
+1 (888) 697
8018
|
|
+44 (0) 121 415
7033
|
|
+1 (718) 921
8137
|
|
|
|
db@astfinancial.com
|
Trademarks of the AstraZeneca group of
companies appear throughout this document in italics. Medical
publications also appear throughout the document in italics.
AstraZeneca, the AstraZeneca logotype and the AstraZeneca symbol
are all trademarks of the AstraZeneca group of companies.
Trademarks of companies other than AstraZeneca that appear in this
document include: Beyfortus, a trademark of Sanofi
Pasteur Inc.; Enhertu, a
trademark of Daiichi Sankyo; Seloken, owned by AstraZeneca or Taiyo
Pharma Co., Ltd (depending on geography); Synagis, owned by AstraZeneca or Sobi
aka Swedish Orphan Biovitrum AB (publ). (depending on geography);
and Tezspire, a trademark
of Amgen, Inc.
Information on or accessible through
AstraZeneca's websites, including astrazeneca.com, does not
form part of and is not incorporated into this
announcement.
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global,
science-led biopharmaceutical company that focuses on the
discovery, development, and commercialisation of prescription
medicines in Oncology, Rare Disease, and BioPharmaceuticals,
including Cardiovascular, Renal & Metabolism, and Respiratory
& Immunology. Based in Cambridge, UK, AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. Please
visit astrazeneca.com
and follow the Company on Social Media
@AstraZeneca.
Cautionary statements regarding forward-looking
statements
In order, among other things, to utilise the
'safe harbour' provisions of the US Private Securities Litigation
Reform Act of 1995, AstraZeneca (hereafter 'the Group') provides
the following cautionary statement:
This document contains certain forward-looking
statements with respect to the operations, performance and
financial condition of the Group, including, among other things,
statements about expected revenues, margins, earnings per share or
other financial or other measures. Although the Group believes its
expectations are based on reasonable assumptions, any
forward-looking statements, by their very nature, involve risks and
uncertainties and may be influenced by factors that could cause
actual outcomes and results to be materially different from those
predicted. The forward-looking statements reflect knowledge and
information available at the date of preparation of this document
and the Group undertakes no obligation to update these
forward-looking statements. The Group identifies the
forward-looking statements by using the words 'anticipates',
'believes', 'expects', 'intends' and similar expressions in such
statements. Important factors that could cause actual results to
differ materially from those contained in forward-looking
statements, certain of which are beyond the Group's control,
include, among other things:
‒
the risk of failure or delay in delivery of pipeline or
launch of new medicines
‒
the risk of failure to meet regulatory or ethical
requirements for medicine development or approval
‒
the risk of failures or delays in the quality or execution of
the Group's commercial strategies
‒
the risk of pricing, affordability, access and competitive
pressures
‒
the risk of failure to maintain supply of compliant, quality
medicines
‒
the risk of illegal trade in the Group's medicines
‒
the impact of reliance on third-party goods and services
‒
the risk of failure in information technology or cybersecurity
‒
the risk of failure of critical processes
‒
the risk of failure to collect and manage data in line with
legal and regulatory requirements and strategic objectives
‒
the risk of failure to attract, develop, engage and retain a
diverse, talented and capable workforce
‒
the risk of failure to meet regulatory or ethical
expectations on environmental impact, including climate
change
‒
the risk of the safety and efficacy of marketed medicines
being questioned
‒
the risk of adverse outcome of litigation and/or governmental
investigations
‒
intellectual property-related risks to the Group's
products
‒
the risk of failure to achieve strategic plans or meet
targets or expectations
‒
the risk of failure in financial control or the occurrence of
fraud
‒
the risk of unexpected deterioration in the Group's financial
position
‒
the impact that global and/or geopolitical events may have or
continue to have on these risks, on the Group's ability to continue
to mitigate these risks, and on the Group's operations, financial
results or financial condition
Glossary
1L, 2L,
etc
First line, second line, etc
ADC
Antibody drug conjugate
aHUS
Atypical haemolytic uraemic syndrome
AKT
Protein kinase B
AL
amyloidosis
Light chain amyloidosis
ANDA
Abbreviated New Drug Application (US)
ASO
Antisense oligonucleotide
ATTR-CM
Transthyretin-mediated amyloid cardiomyopathy
ATTRv / -PN / -CM
Hereditary transthyretin-mediated amyloid / polyneuropathy /
cardiomyopathy
BCMA
B-cell maturation antigen
BRCA /
m
Breast cancer gene / mutation
BTC
Biliary tract cancer
BTK
Bruton tyrosine kinase
C5
Complement component 5
CAR-T
Chimeric antigen receptor T-cell
cCRT
Concurrent chemoradiotherapy
CD19
A gene expressed in B-cells
CER
Constant exchange rates
CHMP
Committee for Medicinal Products for Human Use (EU)
CI
Confidence interval
CKD
Chronic kidney disease
CLL
Chronic lymphocytic leukaemia
COPD
Chronic obstructive pulmonary disease
COP28
28th annual United Nations (UN) climate
meeting
CRC
Colorectal cancer
CRL
Compete Response Letter
CRPC
Castration-resistant prostate cancer
CSPC
Castration-sensitive prostate cancer
CTLA-4
Cytotoxic T-lymphocyte-associated antigen 4
CVRM
Cardiovascular, Renal and Metabolism
DDR
DNA damage response
DNA
Deoxyribonucleic acid
EBITDA
Earnings before interest, tax, depreciation and
amortisation
EGFR /
m
Epidermal growth factor receptor gene / mutation
EGPA
Eosinophilic granulomatosis with polyangiitis
EPS
Earnings per share
ER
Estrogen
receptor
ERBB2
v-erb-b2 avian erythroblastic leukaemia viral oncogene homologue 2
gene
EVH
Extravascular haemolysis
FDA
Food and Drug Agency (US)
FDC
Fixed dose combination
FISH
Fluorescence in situ hybridization, as in FISH10+
g
Germline, e.g. gBRCAm
GAAP
Generally Accepted Accounting Principles
GEJ
Gastro oesophageal junction
GI
Gastrointestinal
GLP1 /
-RA
Glucagon-like peptide-1 / receptor agonist
gMG
Generalised myasthenia gravis
HCC
Hepatocellular carcinoma
HER2 / +/- / low / m Human
epidermal growth factor receptor 2 / positive / negative / low
level expression / gene mutant
HF/ pEF / rEF
Heart failure / with preserved ejection fraction / with reduced
ejection fraction
hMPV
Human metapneumovirus
HR
Hazard ratio
HR / + /
-
Hormone receptor / positive / negative
HRD
Homologous recombination deficiency
HRR /
m
Homologous recombination repair gene / mutation
i.m.
Intramuscular injection
i.v.
Intravenous injection
IAS /
B
International Accounting
Standards / Board
ICS
Inhaled corticosteroid
IFRS
International Financial Reporting Standards
IgAN
Immunoglobulin A neuropathy
IHC
Immunohistochemistry, as in IHC90+, etc
IL-5, IL-33,
etc
Interleukin-5, Interleukin-33, etc
IP
Intellectual Property
IVIg
Intravenous immune globulin
LABA
Long-acting beta-agonist
LAMA
Long-acting muscarinic-agonist
LS-SCLC
Limited stage small cell lung cancer
LRTD
Lower respiratory tract disease
m
Metastatic, e.g. mBTC , mCRPC, mCSPC
mAb
Monoclonal antibody
MDL
Multidistrict litigation
MET
Mesenchymal epithelial transition
NF1-PN
Neurofibromatosis type 1 with plexiform neurofibromas
n/m
Not meaningful
NMOSD
Neuromyelitis optica spectrum disorder
NRDL
National reimbursement drug list
NSCLC
Non-small cell lung cancer
OECD
Organisation for Economic
Co-operation and Development
OOI
Other operating income
ORR
Overall response rate
OS
Overall survival
PAAGR
Post Alexion Acquisition Group Review
PARP / i /
-1sel
Poly ADP ribose polymerase / inhibitor /-1 selective
pCR
Pathologic complete response
PCSK9
Proprotein convertase subtilisin/kexin type 9
PD
Progressive disease
PD-1
Programmed cell death protein 1
PD-L1
Programmed cell death ligand 1
PDUFA
Prescription Drug User Fee Act
PHSSR
Partnership for Health System Sustainability and
Resilience
PFS
Progression free survival
PIK3CA
Phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit
alpha gene
PMDI
Pressure metered dose inhaler
PNH /
-EVH
Paroxysmal nocturnal haemoglobinuria / with extravascular
haemolysis
PPI
Proton pump inhibitors
PSR
Platinum sensitive relapse
PTEN
Phosphatase and tensin homologue gene
Q3W, Q4W,
etc Every
three weeks, every four weeks, etc
R&D
Research and development
R&I
Respiratory & Immunology
RSV
Respiratory syncytial virus
sBLA
Supplemental biologics license application (US)
SCLC
Small cell lung cancer
s.c.
Subcutaneous injection
SEA
Severe eosinophilic asthma
SEC
Securities Exchange Commission (US)
SG&A
Sales, general and administration
SGLT2
Sodium-glucose cotransporter 2
SLL
Small lymphocytic lymphoma
SMI
Sustainable Markets Initiative
sNDA
Supplemental new drug application
SPA
Share Purchase Agreement
T2D
Type-2 diabetes
TACE
Transarterial chemoembolization
THP
A treatment regimen: docetaxel, trastuzumab and
pertuzumab
TNBC
Triple negative breast cancer
TNF
Tumour necrosis factor
TOP1
Topoisomerase I
TROP2
Trophoblast cell surface antigen 2
USPTO
US Patent and Trademark Office
V&I
Vaccines & Immune Therapies
VBP
Volume-based procurement
VLP
Virus like particle
- End of document
-