AstraZeneca
25 April 2024
Q1 2024 results
Very strong revenue and EPS growth in the first
quarter coupled with exciting pipeline delivery
Revenue and EPS
summary
|
|
Q1 2024
|
% Change
|
|
|
$m
|
Actual
|
CER[1]
|
|
- Product Sales
|
|
12,177
|
15
|
18
|
|
- Alliance Revenue
|
|
457
|
59
|
59
|
|
- Collaboration Revenue
|
|
45
|
66
|
66
|
|
Total Revenue
|
|
12,679
|
17
|
19
|
|
Reported EPS
|
|
$1.41
|
21
|
30
|
|
Core[2] EPS
|
|
$2.06
|
7
|
13
|
|
|
|
|
|
|
|
|
| |
Financial performance for Q1 2024
(Growth
numbers at CER)
‒
Total Revenue up 19% to $12,679m, driven by an 18% increase
in Product Sales and continued growth in Alliance Revenue from
partnered medicines
‒
Double-digit growth in Total Revenue from Oncology at 26%,
CVRM at 23%, R&I at 17%, and Rare Disease at 16%.
‒
Core Product Sales Gross
Margin[3] of
82%
‒
Core Operating Margin of 34%
‒
Core Tax Rate of 21%
‒
Core EPS increased 13% to $2.06. The increase in Core EPS was
lower than Total Revenue growth principally due to a $241m gain in
the prior year period on the disposal of Pulmicort Flexhaler US
rights
‒ 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
‒
Total Revenue and Core EPS guidance at CER for FY 2024
reiterated
Pascal Soriot, Chief Executive Officer, AstraZeneca,
said:
"AstraZeneca had a very strong
start in 2024 with substantial Total Revenue growth of 19% in the
first quarter.
Our strong pipeline momentum
continued and already this year we announced positive trial results
for Imfinzi and Tagrisso that were unprecedented in lung cancer,
the data from both of these studies will be presented during the
ASCO plenary in June. We are also looking forward to seeing
the results of several other important trials throughout the
year.
At our Annual General Meeting we
were pleased to announce a 7% increase in the annual dividend, and
at our Investor Day on 21 May 2024 we will outline the evolution of
our company, underscoring our confidence in sustaining
industry-leading growth."
Key milestones achieved since the prior results
announcement
‒
Positive read-outs for Tagrisso in unresectable, Stage III
EGFRm NSCLC (LAURA),
Imfinzi in LS-SCLC
(ADRIATIC)
‒ US
approvals for Tagrisso
with the addition of chemotherapy for EGFRm NSCLC (FLAURA2), Enhertu in HER2-positive solid tumours
(DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02) and
Ultomiris for NMOSD. US
and EU approval for Voydeya as an add-on therapy
to Ultomiris or Soliris for PNH with EVH
(ALPHA). Japan approval for Truqap plus Faslodex in unresectable or recurrent
PIK3CA-, AKT1-, or PTEN-altered HR-positive,
HER2-negative breast cancer (CAPItello-291).
‒
Datopotamab deruxtecan BLAs accepted in the US for
non-squamous NSCLC (TROPION-Lung01) and HR-positive, HER2-negative
breast cancer (TROPION-Breast01).
Guidance
The Company reiterates its Total Revenue and
Core EPS guidance for FY 2024 at CER, based on the average foreign
exchange rates through 2023.
Total Revenue is expected to
increase by a low double-digit to
low teens percentage
Core EPS is expected to increase by
a low double-digit to low teens
percentage
‒
Collaboration Revenue is expected to increase substantially,
driven by success-based milestones and certain anticipated
transactions
‒
Other operating income is expected to decrease substantially
(FY 2023 included a $241m gain on the disposal of Pulmicort Flexhaler US rights, and a
$712m one-time gain relating to updates to contractual arrangements
for Beyfortus)
‒
The Core Tax rate is expected to be between 18-22%
The Company is unable to provide guidance on a
Reported basis because it cannot reliably forecast material
elements of the Reported results, including any fair value
adjustments arising on acquisition-related liabilities, intangible
asset impairment charges and legal settlement provisions. Please
refer to the cautionary statements section regarding
forward-looking statements at the end of this
announcement.
Currency impact
If foreign exchange rates for April 2024 to
December 2024 were to remain at the average rates seen in March
2024, compared to the performance at CER it is anticipated that FY
2024 Total Revenue would incur a low single-digit adverse impact
and Core EPS would incur a mid single-digit adverse impact
(previously low single-digit). The Company's foreign exchange rate
sensitivity analysis is provided in Table 16.
Investor Day
AstraZeneca will host
an Investor Day on 21 May 2024. For more information, see
www.astrazeneca.com/investor-relations.html.
Table 1: Key elements of Total Revenue
performance in Q1 2024
Revenue type
|
|
$m
|
Actual
%
|
CER
%
|
|
|
Product Sales
|
|
12,177
|
15
|
18
|
|
|
Alliance Revenue
|
|
457
|
59
|
59
|
|
* $339m
Enhertu (Q1 2023:
$220m)
* $77m
Tezspire (Q1 2023:
$43m)
|
Collaboration Revenue
|
|
45
|
66
|
66
|
|
* $45m
Farxiga (Q1 2023:
$24m)
|
Total Revenue
|
|
12,679
|
17
|
19
|
|
|
Therapy areas
|
|
$m
|
Actual %
|
CER %
|
|
|
Oncology
|
|
5,108
|
23
|
26
|
|
* Strong
performance across all key medicines and regions
|
CVRM
|
|
3,060
|
20
|
23
|
|
* Farxiga up 43% (45%
at CER) with continued demand growth and the launch of an
authorised generic in the US, Lokelma up 16% (19% at CER),
roxadustat up 24% (28% at CER), Brilinta decreased 3% (1% at
CER)
|
R&I
|
|
1,886
|
15
|
17
|
|
*
Continued strong growth from Fasenra up 6% (6% CER), Breztri up 52% (54% CER). Saphnelo up 94% (95% CER) and
Tezspire up >2x (>2x
CER). Symbicort was up 12%
(14% CER)
|
V&I
|
|
232
|
(35)
|
(34)
|
|
* Beyfortus revenue
was $46m (Q1 2023: $nil), which more than offset a $27m decline in
Synagis
* The drop
in V&I revenue was driven by lower sales of COVID-19 mAbs and
Vaxzevria. Vaxzevria
revenues are now included in the 'Other' V&I line
|
Rare Disease
|
|
2,096
|
12
|
16
|
|
* Ultomiris up 32%
(34% at CER), partially offset by decline in Soliris of 11% (8% at CER)
* Strensiq up 20%
(21% at CER) and Koselugo
up 68% (82% at CER) reflecting strong patient demand, and also
tender market order timing
|
Other Medicines
|
|
297
|
(7)
|
-
|
|
|
Total Revenue
|
|
12,679
|
17
|
19
|
|
|
Regions
|
|
$m
|
Actual %
|
CER %
|
|
|
US
|
|
5,124
|
19
|
19
|
|
|
Emerging Markets
|
|
3,732
|
18
|
26
|
|
|
-
China
|
|
1,748
|
9
|
13
|
|
|
- Ex-China
Emerging Markets
|
|
1,984
|
27
|
40
|
|
|
Europe
|
|
2,634
|
22
|
19
|
|
|
Established RoW
|
|
1,189
|
(5)
|
2
|
|
* Decline
in COVID-19 mAbs revenue
|
Total Revenue
|
|
12,679
|
17
|
19
|
|
|
Combined sales of Enhertu, recorded by Daiichi Sankyo
Company Limited (Daiichi Sankyo) and AstraZeneca, amounted to $879m
in Q1 2024 (Q1 2023: $531m).
Combined sales of Tezspire, recorded by Amgen and
AstraZeneca, amounted to $216m in Q1 2024 (Q1 2023:
$105m).
Table 2: Key elements of financial
performance in Q1 2024
Metric
|
Reported
|
Reported
change
|
Core
|
Core
change
|
|
Comments[4]
|
Total Revenue
|
$12,679m
|
17%
Actual 19% CER
|
$12,679m
|
17%
Actual 19% CER
|
|
* See Table 1 and the Total Revenue section of this document
for further details
|
Product Sales Gross Margin
|
82%
|
Stable
|
82%
|
-1pp
Actual -1pp CER
|
|
* Variations in Product Sales Gross Margin can be expected
between periods due to product seasonality, foreign exchange
fluctuations and other effects
|
R&D expense
|
$2,783m
|
7%
Actual 7% CER
|
$2,698m
|
17%
Actual 18% CER
|
|
+ Increased investment in the
pipeline
* Core R&D-to-Total Revenue ratio of 21%
(Q1 2023: 21%)
|
SG&A expense
|
$4,495m
|
11%
Actual 12% CER
|
$3,413m
|
12%
Actual 13% CER
|
|
+ Market development for recent launches and
pre-launch activities
* Core SG&A-to-Total Revenue ratio of 27%
(Q1 2023: 28%)
|
Other operating income and expense[5]
|
$67m
|
-83%
Actual -83% CER
|
$65m
|
-80%
Actual -80% CER
|
|
‒ The prior year
quarter included a $241m gain on the disposal of Pulmicort Flexhaler US rights
|
Operating Margin
|
25%
|
+1pp
Actual +2pp CER
|
34%
|
-2pp
Actual -1pp CER
|
|
* See commentary above on Other operating income and
expense
|
Net finance expense
|
$302m
|
5%
Actual 1% CER
|
$245m
|
2%
Actual -3% CER
|
|
+ Higher rates on floating debt and bond
issuances
‒ Higher interest
received on cash and short-term investments
|
Tax rate
|
22%
|
+2pp
Actual +2pp CER
|
21%
|
+2pp
Actual +2pp CER
|
|
*
Variations in the tax rate can be expected between
periods
|
EPS
|
$1.41
|
21%
Actual 30% CER
|
$2.06
|
7%
Actual 13% CER
|
|
* Further details of differences between Reported and Core are
shown in Table 11
|
Table 3: Pipeline highlights since prior
results announcement
Event
|
Medicine
|
Indication /
Trial
|
Event
|
Regulatory approvals and other regulatory
actions
|
Enhertu
|
HER2-expressing tumours
(DESTINY-PanTumor02)
|
Regulatory approval (US)
|
Tagrisso
|
EGFRm NSCLC (1st-line)
(FLAURA2)
|
Regulatory approval (US)
|
Truqap
|
HR+/HER2-neg breast cancer (2nd-line)
(CAPItello-291)
|
Regulatory approval (JP)
|
Beyfortus
|
RSV (MELODY-MEDLEY)
|
Regulatory approval (JP)
|
Ultomiris
|
NMOSD (CHAMPION-NMOSD)
|
Regulatory approval (US)
|
Voydeya
|
PNH with EVH (ALPHA)
|
Regulatory approval (US, EU)
|
|
|
|
Regulatory submissions
or acceptances*
|
Dato-DXd
|
Non-squamous NSCLC (2nd- and 3rd-line)
(TROPION-Lung01)
|
Regulatory submission (US)
|
Dato-DXd
|
HR+/HER2- breast cancer (inoperable and/or
met.) (TROPION-Breast01)
|
Regulatory submission (US, EU, JP,
CN)
|
acoramidis
|
ATTR-CM (ALXN2060-TAC-302)
|
Regulatory submission (JP)
|
|
|
|
Major Phase III data readouts and other
developments
|
Tagrisso
|
EGFRm
NSCLC (unresectable Stg. III) (LAURA)
|
Primary
endpoint met
|
Imfinzi
|
SCLC
(limited-stage) (ADRIATIC)
|
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 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
acquisition enriches AstraZeneca's growing pipeline of cell
therapies with AZD0120 (formerly GC012F), a novel, clinical-stage
T-cell (CAR-T) therapy. AZD0120 is a potential new treatment for
multiple myeloma, as well as other haematologic malignancies and
autoimmune diseases, including SLE. The upfront cash portion of the
consideration was approximately $1.0 billion. Combined, the upfront
and potential contingent value payments represent, if achieved, a
transaction value of approximately $1.2 billion. AstraZeneca
acquired the cash and cash equivalents on Gracell's balance sheet,
which totalled $209 million at the close of the
transaction.
In February 2024, AstraZeneca
completed the acquisition of Icosavax, Inc., a US-based
clinical-stage biopharmaceutical company focused on developing
differentiated, high-potential vaccines using an innovative,
protein virus-like particle platform. The upfront cash portion of
the consideration was approximately $0.8 billion. Combined, the
upfront and maximum potential contingent value payments represent,
if achieved, a transaction value of approximately $1.1 billion.
AstraZeneca acquired the cash, cash equivalents and marketable
securities on Icosavax's balance sheet, which totalled $192 million
at the close of the transaction.
In March 2024, AstraZeneca announced
that it has entered into a definitive agreement to acquire Amolyt
Pharma, a clinical-stage biotechnology company focused on
developing novel treatments for rare endocrine diseases. The
proposed acquisition will bolster the Rare Disease late-stage
pipeline and expand on its bone metabolism franchise with the
notable addition of eneboparatide (AZP-3601), a Phase III
investigational therapeutic peptide with a novel mechanism of
action designed to meet key therapeutic goals for
hypoparathyroidism. The upfront cash portion of the consideration
is $0.8 billion at deal closing. Combined, the upfront and maximum
potential contingent value payments represent, if achieved, a
transaction value of $1.05 billion. AstraZeneca will acquire all of
Amolyt Pharma's outstanding shares on a cash and debt free basis.
Subject to the satisfaction of customary closing conditions in the
acquisition agreement, including regulatory clearances, the
transaction is expected to close by the end of the third quarter of
2024.
In March 2024, AstraZeneca entered
into a definitive agreement to acquire Fusion Pharmaceuticals Inc.,
a clinical-stage biopharmaceutical company developing
next-generation radioconjugates. This complements AstraZeneca's
leading oncology portfolio with the addition of the Fusion pipeline
of RCs, including their most advanced programme, FPI-2265, a
potential new treatment for patients with mCRPC. The acquisition
marks a major step forward in AstraZeneca delivering on its
ambition to transform cancer treatment and outcomes for patients by
replacing traditional regimens like chemotherapy and radiotherapy
with more targeted treatments. The upfront cash portion of the
consideration is approximately $2 billion. Combined, the upfront
and maximum potential contingent value payments represent, if
achieved, a transaction value of approximately $2.4 billion.
AstraZeneca will acquire the cash, cash equivalents and short term
investments on Fusion's balance sheet, which totalled $234 million
as of 31 December 2023. The transaction is
expected to close in the second quarter of 2024, subject to
customary closing conditions, including the approval of Fusion
shareholders and regulatory clearances.
Sustainability highlights
Our newly announced collaboration with China
Resources Gas and Everbright Environment will supply biomethane and
biomethane-based steam to our Wuxi site. Using domestic waste,
including food and plant waste, this new partnership will enable us
to reduce our greenhouse gas emissions footprint by 80% in
China.
AstraZeneca announced at WEF that it will be
one of the inaugural Early Adopter organisations that intend to
start making disclosures aligned with the Taskforce on
Nature-related Financial Disclosures Recommendations in corporate
reporting.
AstraZeneca also hosted an annual
Sustainability call for shareholders, reiterating its continued
commitment to deliver across our pillars; Access to Healthcare,
Environmental Protection and Ethics and Transparency. A recording
of the call and accompanying materials are available on the
AstraZeneca IR website.
Conference call
A conference call and webcast for investors and
analysts will begin today, 25 April 2024, at 11:45 UK time. Details
can be accessed via astrazeneca.com.
Reporting calendar
The Company intends to publish its H1 and Q2
2024 results on 25 July 2024.
Operating and financial review
All narrative on growth and results in this
section is based on actual exchange rates, and financial figures
are in US$ millions ($m), unless stated otherwise. Unless stated
otherwise, the performance shown in this announcement covers the
three month period to 31 March 2024 ('the quarter' or 'Q1 2024')
compared to the three month period to 31 March 2023 ('Q1 2023').
References to 'first quarter', 'second quarter', 'third quarter'
and fourth quarter' refer to the respective quarters in FY
2024.
Core financial measures, EBITDA, Net debt,
Product Sales Gross Margin, Operating Margin and CER are non-GAAP
financial measures because they cannot be derived directly from the
Group's Condensed consolidated financial statements. Management
believes that these non-GAAP financial measures, when provided in
combination with Reported results, provide investors and analysts
with helpful supplementary information to understand better the
financial performance and position of the Group on a comparable
basis from period to period. These non-GAAP financial measures are
not a substitute for, or superior to, financial measures prepared
in accordance with GAAP.
Core financial measures are adjusted to exclude
certain significant items:
‒
Charges and provisions related to restructuring programmes,
which includes charges that relate to the impact of restructuring
programmes on capitalised IT assets
‒
Amortisation and impairment of intangible assets, including
impairment reversals but excluding any charges relating to IT
assets
‒
Other specified items, principally the imputed finance
charges and fair value movements relating to contingent
consideration on business combinations, imputed finance charges and
remeasurement adjustments on certain Other payables arising from
intangible asset acquisitions, legal settlements and remeasurement
adjustments relating to Other payables assumed from the Alexion
acquisition
‒
The tax effects of the adjustments above are excluded from
the Core Tax charge
Details on the nature of Core financial
measures are provided on page 61 of the
Annual Report and Form 20-F Information 2023.
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[6]
Total
Revenue
|
|
$m
|
% Total
|
Actual
|
CER
|
Oncology
|
|
5,108
|
40
|
23
|
26
|
- Tagrisso
|
|
1,595
|
13
|
12
|
15
|
- Imfinzi
|
|
1,113
|
9
|
29
|
33
|
- Calquence
|
|
718
|
6
|
35
|
35
|
- Lynparza
|
|
705
|
6
|
8
|
11
|
- Enhertu
|
|
461
|
4
|
79
|
79
|
- Zoladex
|
|
285
|
2
|
21
|
28
|
- Imjudo
|
|
62
|
-
|
66
|
70
|
- Truqap
|
|
50
|
-
|
n/m
|
n/m
|
- Orpathys
|
|
12
|
-
|
43
|
49
|
- Other Oncology
|
|
107
|
1
|
(24)
|
(19)
|
BioPharmaceuticals:
CVRM
|
|
3,060
|
24
|
20
|
23
|
- Farxiga
|
|
1,892
|
15
|
43
|
45
|
- Brilinta
|
|
323
|
3
|
(3)
|
(1)
|
- Crestor
|
|
297
|
2
|
(3)
|
2
|
- Seloken/Toprol-XL
|
|
165
|
1
|
(8)
|
(2)
|
- Lokelma
|
|
114
|
1
|
16
|
19
|
- roxadustat
|
|
77
|
1
|
24
|
28
|
- Andexxa
|
|
47
|
-
|
6
|
6
|
- Wainua
|
|
5
|
-
|
n/m
|
n/m
|
- Other CVRM
|
|
141
|
1
|
(33)
|
(31)
|
BioPharmaceuticals:
R&I
|
|
1,886
|
15
|
15
|
17
|
- Symbicort
|
|
769
|
6
|
12
|
14
|
- Fasenra
|
|
358
|
3
|
6
|
6
|
- Pulmicort
|
|
224
|
2
|
1
|
5
|
- Breztri
|
|
219
|
2
|
52
|
54
|
- Tezspire
|
|
120
|
1
|
>2x
|
>2x
|
- Saphnelo
|
|
91
|
1
|
94
|
95
|
- Airsupra
|
|
7
|
-
|
n/m
|
n/m
|
- Other R&I
|
|
98
|
1
|
(30)
|
(29)
|
BioPharmaceuticals:
V&I
|
|
232
|
2
|
(35)
|
(34)
|
- Synagis
|
|
171
|
1
|
(13)
|
(13)
|
- Beyfortus
|
|
46
|
-
|
n/m
|
n/m
|
- FluMist
|
|
7
|
-
|
>2x
|
>2x
|
- COVID-19 mAbs
|
|
2
|
-
|
(99)
|
(99)
|
- Other V&I
|
|
6
|
-
|
(79)
|
(80)
|
Rare Disease
|
|
2,096
|
17
|
12
|
16
|
- Ultomiris
|
|
859
|
7
|
32
|
34
|
- Soliris
|
|
739
|
6
|
(11)
|
(8)
|
- Strensiq
|
|
313
|
2
|
20
|
21
|
- Koselugo
|
|
132
|
1
|
68
|
82
|
- Kanuma
|
|
53
|
-
|
32
|
35
|
Other Medicines
|
|
297
|
2
|
(7)
|
-
|
- Nexium
|
|
243
|
2
|
(2)
|
7
|
- Others
|
|
54
|
-
|
(25)
|
(23)
|
Total Medicines
|
|
12,679
|
100
|
17
|
19
|
Table 5: Alliance
Revenue
|
|
Q1 2024
|
|
|
|
|
% Change
|
|
|
$m
|
% Total
|
Actual
|
CER
|
Enhertu
|
|
339
|
74
|
54
|
54
|
Tezspire
|
|
77
|
17
|
80
|
80
|
Beyfortus
|
|
20
|
4
|
n/m
|
n/m
|
Other Alliance Revenue
|
|
21
|
5
|
(10)
|
(9)
|
Total
|
|
457
|
100
|
59
|
59
|
Table 6: Collaboration
Revenue
|
|
Q1 2024
|
|
|
|
|
% Change
|
|
|
$m
|
% Total
|
Actual
|
CER
|
Farxiga: sales
milestones
|
|
45
|
100
|
86
|
86
|
Other Collaboration Revenue
|
|
-
|
-
|
n/m
|
n/m
|
Total
|
|
45
|
100
|
66
|
66
|
Table 7: Total Revenue by therapy
area
|
|
$m
|
%
Total
|
Actual
|
CER
|
Oncology
|
|
5,108
|
40
|
23
|
26
|
Biopharmaceuticals
|
|
5,178
|
41
|
14
|
16
|
CVRM
|
|
3,060
|
24
|
20
|
23
|
R&I
|
|
1,886
|
15
|
15
|
17
|
V&I
|
|
232
|
2
|
(35)
|
(34)
|
Rare Disease
|
|
2,096
|
17
|
12
|
16
|
Other Medicines
|
|
297
|
2
|
(7)
|
-
|
Total
|
|
12,679
|
100
|
17
|
19
|
Table 8: Total Revenue by
region
|
|
$m
|
%
Total
|
Actual
|
CER
|
US
|
|
5,124
|
40
|
19
|
19
|
Emerging Markets
|
|
3,732
|
29
|
18
|
26
|
China
|
|
1,748
|
14
|
9
|
13
|
Emerging Markets ex. China
|
|
1,984
|
16
|
27
|
40
|
Europe
|
|
2,634
|
21
|
22
|
19
|
Established ROW
|
|
1,189
|
9
|
(5)
|
2
|
Total
|
|
12,679
|
100
|
17
|
19
|
Oncology
Oncology Total Revenue of $5,108m in Q1 2024
increased by 23% (26% at CER), representing 40% of overall Total
Revenue (Q1 2023: 38%). Product Sales increased by 21% (24% at CER)
in Q1 2024 to $4,760m, reflecting new launches and expanded
reimbursement across key brands.
Tagrisso
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1 2024 $m
|
|
1,595
|
|
623
|
488
|
302
|
182
|
Actual change
|
|
12%
|
|
20%
|
10%
|
18%
|
(10%)
|
CER change
|
|
15%
|
|
20%
|
17%
|
15%
|
(2%)
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Strong global demand for Tagrisso in adjuvant (ADAURA) and 1st
-line setting (FLAURA)
|
US
|
|
* Continued strong adjuvant and 1st-line demand
growth
|
Emerging Markets
|
|
* Encouraging demand growth across markets with some positive
impact of hospital ordering dynamics in China
* Strong performance across Latin America and Asia Pacific
markets
|
Europe
|
|
* Continued growth in 1st-line setting and increasing adjuvant
demand
|
Established RoW
|
|
* Increased demand in adjuvant and 1st-line offset by a 10.5%
mandatory price reduction in Japan effective June 2023
|
Imfinzi
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1 2024 $m
|
|
1,113
|
|
582
|
129
|
232
|
170
|
Actual change
|
|
29%
|
|
19%
|
59%
|
43%
|
31%
|
CER change
|
|
33%
|
|
19%
|
83%
|
40%
|
45%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Continued growth driven by BTC (TOPAZ-1), HCC (HIMALAYA), and
increased patient share in Stage IV NSCLC (POSEIDON) and
extensive-stage SCLC (CASPIAN)
|
US
|
|
* Continued demand growth driven by BTC, HCC, and
extensive-stage SCLC
* Growth in BTC slowing with Imfinzi now the clear
standard-of-care
|
Emerging Markets
|
|
* Continued China growth driven by demand in HCC
|
Europe
|
|
* Growth driven by share gains in extensive-stage SCLC and new
indications
|
Established RoW
|
|
* Increased demand from new launches, offset by a 25% mandatory price reduction in Japan effective
1 February 2024
|
Lynparza
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1 2024 $m
|
|
705
|
|
288
|
167
|
191
|
59
|
Actual change
|
|
8%
|
|
7%
|
23%
|
7%
|
(13%)
|
CER change
|
|
11%
|
|
7%
|
33%
|
5%
|
(6%)
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Lynparza
remains the leading medicine in the PARP
inhibitor class globally across four tumour types (ovarian, breast,
prostate, pancreatic), as measured by total prescription
volume
* No Collaboration Revenue for Lynparza was recognised in either Q1
2024 or Q1 2023, hence the Product Sales numbers are identical to
the Total Revenue numbers shown above
|
US
|
|
* Continued leadership within PARPi class despite increasing
competition, negative class pressure and maturity of the
market
|
Emerging Markets
|
|
* Demand growth in China coming from newly diagnosed
BRCA-mutated ovarian cancer (SOLO-1) and inclusion of HRD-positive
ovarian cancer (PAOLA-1) on NRDL with no price reduction
|
Europe
|
|
* Demand growth driven by mCRPC (PROpel) and early breast
cancer (OlympiA)
|
Established RoW
|
|
* Demand growth coming from HRD-positive ovarian cancer,
partially offset by price reduction in Japan effective from
November 2023
|
Enhertu
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1 2024 $m
|
|
461
|
|
202
|
112
|
134
|
13
|
Actual change
|
|
79%
|
|
26%
|
>2x
|
>2x
|
>3x
|
CER change
|
|
79%
|
|
26%
|
>2x
|
>2x
|
>3x
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Combined sales of Enhertu, recorded by Daiichi Sankyo
and AstraZeneca, amounted to $879m in Q1 2024 (Q1 2023:
$531m)
|
US
|
|
* US in-market sales, recorded by Daiichi Sankyo, amounted to
$423m in Q1 2024 (Q1 2023: $336m)
* Strong demand across launched indications
|
Emerging Markets
|
|
* Strong uptake in China following HER2-positive
(DESTINY-Breast03) and HER2-low (DESTINY-Breast04)
launches
* Some launch-related inventory build was observed in China in
Q1 2024
|
Europe
|
|
* Continued growth driven by 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
|
Calquence
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1 2024 $m
|
|
718
|
|
494
|
39
|
153
|
32
|
Actual change
|
|
35%
|
|
29%
|
>2x
|
42%
|
44%
|
CER change
|
|
35%
|
|
29%
|
>2x
|
39%
|
47%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Sustained leadership in front-line CLL with increased global
penetration
|
US
|
|
* Continued market growth and maintaining leading share of new
CLL patient starts in the front line
|
Europe
|
|
* Continued growth supported by launches in further European
markets
|
Other Oncology medicines
Total Revenue
|
|
$m
|
Actual
|
CER
|
Drivers and commentary
|
Zoladex
|
|
285
|
21%
|
28%
|
* Strong underlying growth in China and Emerging Markets and
moderate growth in Europe offset by drop in Japan
|
Imjudo
|
|
62
|
66%
|
70%
|
* Continued growth across markets slightly offset by US
inventory destocking in Q1 2024
|
Truqap
|
|
50
|
n/m
|
n/m
|
* Rapid adoption following US approval in November 2023 for
HR-positive HER2-negative metastatic breast cancer with one or more
biomarker alterations (CAPItello-291)
* Some benefit from later-line use
|
Orpathys
|
|
12
|
43%
|
49%
|
* Demand in in China for the treatment of patients with NSCLC
with MET exon 14 skipping alterations
|
Other Oncology
|
|
107
|
(24%)
|
(19%)
|
* Decline in use of Iressa in China
|
BioPharmaceuticals
BioPharmaceuticals Total Revenue increased by
14% (16% at CER) in Q1 2024 to $5,178m, representing 41% of overall
Total Revenue (Q1 2023: 42%).
BioPharmaceuticals - CVRM
CVRM Total Revenue increased by 20% (23% at
CER) to $3,060m in Q1 2024 and represented 24% of overall Total
Revenue (Q1 2023: 24%).
Farxiga
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1 2024 $m
|
|
1,892
|
|
475
|
711
|
553
|
152
|
Actual change
|
|
43%
|
|
61%
|
43%
|
41%
|
10%
|
CER change
|
|
45%
|
|
61%
|
50%
|
37%
|
18%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Farxiga
volume is growing faster than the overall SGLT2
market in most major regions, fuelled by launches in heart failure
and CKD, and also the launch of an authorised generic in the US.
SGLT2 class growth underpinned by updated cardiorenal
guidelines
|
US
|
|
* Growth driven by heart failure and CKD
* Sales in the quarter benefitted from the introduction of an
authorised generic
|
Emerging Markets
|
|
* Solid growth despite entry of generic competition in some
markets
* Strong momentum in Latin America
* Sales in the quarter benefited from the timing of government
tenders
|
Europe
|
|
*
Continued strong class growth and market share gains fuelled
by HFpEF approval in 2023 and guidelines updates
|
Established RoW
|
|
* In Japan, a milestone payment of $45m was received in the
quarter from AstraZeneca's partner Ono Pharmaceutical Co., Ltd,
which records in-market sales
|
Brilinta
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1 2024 $m
|
|
323
|
|
163
|
88
|
67
|
5
|
Actual change
|
|
(3%)
|
|
(9%)
|
8%
|
(1%)
|
(12%)
|
CER change
|
|
(1%)
|
|
(9%)
|
21%
|
(3%)
|
(14%)
|
Region
|
|
Drivers and commentary
|
US
|
|
* Stable volume but unfavourable gross-to-net adjustments in
the quarter
|
Emerging Markets
|
|
* Growth despite generics pressure in some markets
|
Europe
|
|
* Declining volume
|
Established RoW
|
|
* Sales decline driven by generic entry in Canada
|
Other CVRM medicines
Total Revenue
|
|
$m
|
Actual
|
CER
|
Drivers and commentary
|
Crestor
|
|
297
|
(3%)
|
2%
|
* Continued sales growth in Emerging Markets
|
Seloken
|
|
165
|
(8%)
|
(2%)
|
* Ongoing impact of China VBP implementation
|
Lokelma
|
|
114
|
16%
|
19%
|
* Continued launches in new markets
|
roxadustat
Andexxa
|
|
77
47
|
24%
6%
|
28%
6%
|
* Increased demand in both the dialysis and
non-dialysis-dependent populations. NRDL listing renewed
* Growth driven by Europe
|
Wainua
|
|
5
|
n/m
|
n/m
|
* Approved for ATTRv-PN in the US in December 2023
|
Other CVRM
|
|
141
|
(33%)
|
(31%)
|
|
BioPharmaceuticals - R&I
Total Revenue of $1,886m from R&I medicines
increased 15% (17% at CER) and represented 15% of overall Total
Revenue (Q1 2023: 15%). This reflected growth in Fasenra, Tezspire, Breztri, Saphnelo and Airsupra following its recent
launch.
Fasenra
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1 2024 $m
|
|
358
|
|
210
|
22
|
93
|
33
|
Actual change
|
|
6%
|
|
5%
|
56%
|
6%
|
(6%)
|
CER change
|
|
6%
|
|
4%
|
61%
|
4%
|
-
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Continued asthma market share leadership in IL-5 class across
major markets
|
US
|
|
* Maintained share of a growing market
|
Emerging Markets
|
|
* Continued strong demand growth driven by launch acceleration
across key markets
|
Europe
|
|
* Expanded leadership in severe eosinophilic asthma
|
Established RoW
|
|
* In
Japan, maintained class leadership in a broadly stable
market
|
Breztri
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1 2024 $m
|
|
219
|
|
105
|
70
|
30
|
14
|
Actual change
|
|
52%
|
|
30%
|
83%
|
97%
|
43%
|
CER change
|
|
54%
|
|
30%
|
91%
|
93%
|
53%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Fastest growing medicine within the expanding
FDC triple class, across major markets
|
US
|
|
* Consistent share growth within the FDC triple class in
new-to-brand and the total
market
|
Emerging Markets
|
|
* Maintained market share leadership in China with strong
triple FDC class penetration
* Further expansion with launches in additional
geographies
|
Europe
|
|
* Sustained growth across markets as new launches continue to
progress
|
Established RoW
|
|
* Increased market share within the COPD indication in Japan
and strong launch in Canada
|
Tezspire
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1 2024 $m
|
|
120
|
|
77
|
2
|
27
|
14
|
Actual change
|
|
>2x
|
|
80%
|
n/m
|
>4x
|
>3x
|
CER change
|
|
>2x
|
|
80%
|
n/m
|
>3x
|
>3x
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Combined sales of Tezspire, recorded by Amgen and
AstraZeneca, amounted to $216m in Q1 2024 (Q1 2023:
$105m)
|
US
|
|
* Continued growth in total prescriptions, and maintained
new-to-brand market share with majority of patients new to
biologics
|
Europe
|
|
* Achieved new-to-brand leadership across multiple markets, new
launches continue to progress
|
Established RoW
|
|
* Japan maintained new-to-brand leadership
|
Symbicort
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1 2024 $m
|
|
769
|
|
299
|
253
|
142
|
75
|
Actual change
|
|
12%
|
|
28%
|
11%
|
(3%)
|
(5%)
|
CER change
|
|
14%
|
|
28%
|
18%
|
(6%)
|
(3%)
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Symbicort remained
the global market leader within a stable ICS/LABA class
|
US
|
|
*
Encouraging demand following list price reduction
|
Emerging Markets
|
|
* Strong
underlying demand for Symbicort in both China and Ex-China
Emerging Markets, strengthened position as market leader in the
region
|
Europe
|
|
*
Continued price and volume erosion from generics and a
slowing overall market
|
Established RoW
|
|
*
Continued generic erosion in Japan
|
Other R&I medicines
Total Revenue
|
|
$m
|
Actual
|
CER
|
Drivers and commentary
|
Pulmicort
|
|
224
|
1%
|
5%
|
* >80%
of revenues from Emerging Markets
|
Saphnelo
|
|
91
|
94%
|
95%
|
*
Demand acceleration in the US, and
additional growth driven by ongoing launches in Europe and
Established RoW
|
Airsupra
|
|
7
|
n/m
|
n/m
|
* Strong
launch momentum with increase class penetration and volume uptake.
Revenue in the quarter reflects introductory discounts as early
access continues to build
|
Other R&I
|
|
98
|
(30%)
|
(29%)
|
* Generic
competition
|
BioPharmaceuticals - V&I
Total Revenue from V&I medicines reduced by
35% (34% at CER) to $232m (Q1 2023: $355m) and represented 2% of
overall Total Revenue (Q1 2023: 3%), principally due to a decline
in sales of COVID-19 mAbs.
V&I medicines
Total Revenue
|
|
$m
|
Actual
|
CER
|
Drivers and commentary
|
Beyfortus
|
|
46
|
n/m
|
n/m
|
* 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
|
|
171
|
(13%)
|
(13%)
|
* Decline in Synagis
more than offset by growth in Beyfortus
|
COVID-19 mAbs
|
|
2
|
(99%)
|
(99%)
|
* Decline
in Evusheld sales (Q1
2023: $127m)
|
FluMist
|
|
7
|
>2x
|
>2x
|
* Normal
seasonality
|
Other V&I
|
|
6
|
(79%)
|
(80%)
|
* Decline in Vaxzevria
sales (Q1 2023: $28m)
|
Rare Disease
Total Revenue from Rare Disease
medicines increased by 12% (16% at CER) in Q1 2024 to $2,096m,
representing 17% of overall Total Revenue (Q1 2023:
17%).
Ultomiris
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1 2024 $m
|
|
859
|
|
482
|
32
|
202
|
143
|
Actual change
|
|
32%
|
|
27%
|
>2x
|
27%
|
46%
|
CER change
|
|
34%
|
|
27%
|
>2x
|
24%
|
61%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Growth across neurology, geographic expansion, patient demand
and Soliris
conversion
* Quarter-on-quarter variability in revenue growth can be
expected due to Ultomiris
every eight-week dosing schedule and lower average annual treatment
cost compared to Soliris
|
US
|
|
* Growth in naïve patients in gMG and conversion from
Soliris across shared
indications
|
Emerging Markets
|
|
* Continued growth following launches in new markets
|
Europe
|
|
* Strong demand generation following launches in new markets,
particularly in neurology indications, as well as accelerated
conversion from Soliris in
key markets, partially offset by price reductions to secure
reimbursement for new indications
|
Established RoW
|
|
* Continued conversion from Soliris and strong demand following
new launches
|
Soliris
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1 2024 $m
|
|
739
|
|
411
|
125
|
142
|
61
|
Actual change
|
|
(11%)
|
|
(8%)
|
9%
|
(23%)
|
(30%)
|
CER change
|
|
(8%)
|
|
(8%)
|
37%
|
(24%)
|
(28%)
|
Region
|
|
Drivers and commentary
|
US
|
|
* Decline driven by successful conversion of Soliris patients to Ultomiris in PNH, aHUS and gMG,
partially offset by Soliris growth in NMOSD
|
Emerging Markets
|
|
* Growth driven by patient demand following launches in new
markets
|
Europe
|
|
* Decline driven by successful conversion from Soliris to Ultomiris as well as biosimilar
erosion in PNH and aHUS
|
Established RoW
|
|
* Decline driven by successful conversion from Soliris to Ultomiris
|
Strensiq
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1 2024 $m
|
|
313
|
|
246
|
21
|
24
|
22
|
Actual change
|
|
20%
|
|
20%
|
44%
|
15%
|
4%
|
CER change
|
|
21%
|
|
20%
|
67%
|
12%
|
14%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Growth driven by strong patient demand
|
Other Rare Disease medicines
Total Revenue
|
|
$m
|
Actual
|
CER
|
Drivers and commentary
|
Koselugo
|
|
132
|
68%
|
82%
|
* Driven by patient demand and expansion in new markets. The
quarter benefitted from tender market order timing in Emerging
Markets
|
Kanuma
|
|
53
|
32%
|
35%
|
* Continued global demand
|
Other medicines (outside the main therapy
areas)
Total Revenue
|
|
$m
|
Actual
|
CER
|
Drivers and commentary
|
Nexium
|
|
243
|
(2%)
|
7%
|
* Growth in Emerging Markets offset declines
elsewhere
|
Others
|
|
54
|
(25%)
|
(23%)
|
* Continued impact of generic competition
|
Financial performance
Table 9: Reported Profit and
Loss
|
|
$m
|
$m
|
Actual
|
CER
|
Total
Revenue
|
|
12,679
|
10,879
|
17
|
19
|
- Product Sales
|
|
12,177
|
10,566
|
15
|
18
|
- Alliance Revenue
|
|
457
|
286
|
59
|
59
|
- Collaboration Revenue
|
|
45
|
27
|
66
|
66
|
Cost of sales
|
|
(2,218)
|
(1,905)
|
16
|
18
|
Gross
profit
|
|
10,461
|
8,974
|
17
|
20
|
Distribution expense
|
|
(135)
|
(134)
|
1
|
3
|
R&D expense
|
|
(2,783)
|
(2,611)
|
7
|
7
|
SG&A expense
|
|
(4,495)
|
(4,059)
|
11
|
12
|
Other operating income & expense
|
|
67
|
379
|
(83)
|
(83)
|
Operating
profit
|
|
3,115
|
2,549
|
22
|
31
|
Net finance expense
|
|
(302)
|
(287)
|
5
|
1
|
Joint ventures and associates
|
|
(13)
|
-
|
n/m
|
n/m
|
Profit before
tax
|
|
2,800
|
2,262
|
24
|
34
|
Taxation
|
|
(620)
|
(458)
|
35
|
46
|
Tax
rate
|
|
22%
|
20%
|
|
|
Profit after
tax
|
|
2,180
|
1,804
|
21
|
30
|
Earnings per
share
|
|
$1.41
|
$1.16
|
21
|
30
|
Table 10: Reconciliation of Reported
Profit before tax to EBITDA
|
|
$m
|
$m
|
Actual
|
CER
|
Reported
Profit before tax
|
|
2,800
|
2,262
|
24
|
34
|
Net finance expense
|
|
302
|
287
|
5
|
1
|
Joint ventures and associates
|
|
13
|
-
|
n/m
|
n/m
|
Depreciation, amortisation and
impairment
|
|
1,255
|
1,502
|
(16)
|
(17)
|
EBITDA
|
|
4,370
|
4,051
|
8
|
13
|
Table 11: Reconciliation of Reported to
Core financial measures: Q1 2024[7]
Q1 2024
|
|
Reported
|
Restructuring
|
Intangible Asset Amortisation & Impairments
|
Other
|
Core
|
Core
%
Change
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
Gross
profit
|
|
10,461
|
20
|
10
|
-
|
10,491
|
15
|
18
|
Product Sales
Gross Margin
|
|
82%
|
|
|
|
82%
|
-1pp
|
-1pp
|
Distribution expense
|
|
(135)
|
-
|
-
|
-
|
(135)
|
1
|
3
|
R&D expense
|
|
(2,783)
|
80
|
4
|
1
|
(2,698)
|
17
|
18
|
%
of Total Revenue
|
|
22%
|
|
|
|
21%
|
-
|
-
|
SG&A expense
|
|
(4,495)
|
97
|
941
|
44
|
(3,413)
|
12
|
13
|
%
of Total Revenue
|
|
35%
|
|
|
|
27%
|
+1pp
|
+1pp
|
Total operating expense
|
|
(7,413)
|
177
|
945
|
45
|
(6,246)
|
14
|
15
|
Other operating income & expense
|
|
67
|
(2)
|
-
|
-
|
65
|
(80)
|
(80)
|
Operating
profit
|
|
3,115
|
195
|
955
|
45
|
4,310
|
9
|
15
|
Operating Margin
|
|
25%
|
|
|
|
34%
|
-2pp
|
-1pp
|
Net finance expense
|
|
(302)
|
-
|
-
|
57
|
(245)
|
2
|
(3)
|
Taxation
|
|
(620)
|
(45)
|
(183)
|
(19)
|
(867)
|
19
|
25
|
EPS
|
|
$1.41
|
$0.10
|
$0.50
|
$0.05
|
$2.06
|
7
|
13
|
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 Q1 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, which
generate a lower Product Sales Gross Margin than the Company
average
‒
Dilutive effects from geographic mix. In Emerging Markets,
the Product Sales Gross Margin tends to be below the Company
average
‒
Variations in Product Sales Gross Margin performance between
periods can continue to be expected due to product seasonality,
foreign exchange fluctuations, and other effects
R&D expense
‒
The change in R&D expense (Reported and Core) in the
period was impacted by:
‒
Recent 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 productivity
‒
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
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
Net finance expense
‒
Core Net finance expense increased 2% (3% decrease at CER)
with higher rates on floating debt and bond issuances broadly
offset by higher interest received on cash and short-term
investments
Taxation
‒
The effective Reported Tax rate for the three months to 31
March 2024 was 22% (Q1 2023: 20%) and the effective Core Tax rate
was 21% (Q1 2023: 20%)
‒
The cash tax paid for the three months to 31 March 2024 was
$430m (Q1 2023: $225m), representing 15% of Reported Profit before
tax (Q1 2023: 10%)
Table 12: Cash Flow summary
|
|
Q1
2024
|
Q1
2023
|
Change
|
|
|
$m
|
$m
|
$m
|
Reported Operating profit
|
|
3,115
|
2,549
|
566
|
Depreciation, amortisation and
impairment
|
|
1,255
|
1,502
|
(247)
|
Movement in working capital and short-term
provisions
|
|
(455)
|
242
|
(697)
|
Gains on disposal of intangible
assets
|
|
-
|
(249)
|
249
|
Fair value movements on contingent
consideration arising from
business combinations
|
|
16
|
-
|
16
|
Non-cash and other movements
|
|
(674)
|
(429)
|
(245)
|
Interest paid
|
|
(341)
|
(257)
|
(84)
|
Taxation paid
|
|
(430)
|
(225)
|
(205)
|
Net cash
inflow from operating activities
|
|
2,486
|
3,133
|
(647)
|
Net cash
inflow before financing activities
|
|
73
|
1,887
|
(1,814)
|
Net cash
inflow/(outflow) from financing activities
|
|
2,028
|
(2,031)
|
4,059
|
The change in Net cash inflow before financing
activities in the quarter to 31 March 2024 is primarily driven by
the movement in Acquisitions of subsidiaries, net of cash acquired,
of $537m, and relates to the acquisition of Gracell
Biotechnologies, Inc. for $726m compared to the acquisition of
Neogene Therapeutics, Inc. for $189m in Q1 2023.
The change in Net cash inflow/(outflow) from
financing activities of $4,059m is primarily driven by the increase
in Issue of loans and borrowings of $1,150m, and by the decrease in
Repayment of loans and borrowings of $1,997m.
Capital expenditure
Capital expenditure amounted to $417m in the
three months to 31 March 2024 (Q1 2023: $247m). Capital expenditure
is expected to increase substantially in 2024, driven by investment
in several major manufacturing projects and continued investment in
technology upgrades.
Table 13: Net debt summary
|
At 31
Mar 2024
|
At 31
Dec 2023
|
At 31
Mar 2023
|
|
$m
|
$m
|
$m
|
Cash and cash equivalents
|
7,841
|
5,840
|
6,232
|
Other investments
|
180
|
122
|
230
|
Cash and
investments
|
8,021
|
5,962
|
6,462
|
Overdrafts and short-term borrowings
|
(477)
|
(515)
|
(593)
|
Commercial paper
|
(980)
|
-
|
(74)
|
Lease liabilities
|
(1,242)
|
(1,128)
|
(962)
|
Current instalments of loans
|
(4,593)
|
(4,614)
|
(2,958)
|
Non-current instalments of loans
|
(27,259)
|
(22,365)
|
(26,916)
|
Interest-bearing loans and borrowings
(Gross debt)
|
(34,551)
|
(28,622)
|
(31,503)
|
Net derivatives
|
81
|
150
|
(21)
|
Net
debt
|
(26,449)
|
(22,510)
|
(25,062)
|
Net debt increased by $3,939m in the three
months to 31 March 2024 to $26,449m. Details of the committed
undrawn bank facilities are disclosed within the going concern
section of Note 1. Details of the Company's solicited credit
ratings and further details on Net debt are disclosed in Note
3.
Capital allocation
The Board's aim is to continue to strike a
balance between the interests of the business, financial creditors
and the Company's shareholders. The Company's capital allocation
priorities include: investing in the business and pipeline;
maintaining a strong, investment-grade credit rating; potential
value-enhancing business development opportunities; and supporting
the progressive dividend policy.
In approving the declaration of dividends, the
Board considers both the liquidity of the company and the level of
reserves legally available for distribution. Dividends are paid to
shareholders from AstraZeneca PLC, a Group holding company with no
direct operations. The ability of AstraZeneca PLC to make
shareholder distributions is dependent on the creation of profits
for distribution and the receipt of funds from subsidiary
companies. The consolidated Group reserves set out in the Condensed
consolidated statement of financial position do not reflect the
profit available for distribution to the shareholders of
AstraZeneca PLC.
Summarised financial information for guarantee of
securities of subsidiaries
AstraZeneca Finance LLC ("AstraZeneca Finance")
is the issuer of 0.7% Notes due 2024, 1.2% Notes due 2026, 4.8%
Notes due 2027, 4.875% Notes due 2028, 1.75% Notes due 2028, 4.85%
Notes due 2029, 4.9% Notes due 2030, 4.9% Notes due 2031, 2.25%
Notes due 2031, 4.875% Notes due 2033 and 5% Notes due 2034 (the
"AstraZeneca Finance Notes"). Each series of AstraZeneca Finance
Notes has been fully and unconditionally guaranteed by AstraZeneca
PLC. AstraZeneca Finance is 100% owned by AstraZeneca PLC and each
of the guarantees issued by AstraZeneca PLC is full and
unconditional and joint and several.
The AstraZeneca Finance Notes are senior
unsecured obligations of AstraZeneca Finance and rank equally with
all of AstraZeneca Finance's existing and future senior unsecured
and unsubordinated indebtedness. The guarantee by AstraZeneca PLC
of the AstraZeneca Finance Notes is the senior unsecured obligation
of AstraZeneca PLC and ranks equally with all of AstraZeneca PLC's
existing and future senior unsecured and unsubordinated
indebtedness. Each guarantee by AstraZeneca PLC is effectively
subordinated to any secured indebtedness of AstraZeneca PLC to the
extent of the value of the assets securing such indebtedness. The
AstraZeneca Finance Notes are structurally subordinated to
indebtedness and other liabilities of the subsidiaries of
AstraZeneca PLC, none of which guarantee the AstraZeneca Finance
Notes.
AstraZeneca PLC manages substantially all of
its operations through divisions, branches and/or investments in
subsidiaries and affiliates. Accordingly, the ability of
AstraZeneca PLC to service its debt and guarantee obligations is
also dependent upon the earnings of its subsidiaries, affiliates,
branches and divisions, whether by dividends, distributions, loans
or otherwise.
Please refer to the Consolidated financial
statements of AstraZeneca PLC in our Annual Report on Form 20‑F and
reports on Form 6-K with our quarterly financial results as filed
or furnished with the SEC for further financial information
regarding AstraZeneca PLC and its consolidated subsidiaries. For
further details, terms and conditions of the AstraZeneca Finance
Notes please refer to AstraZeneca PLC's reports on Form 6-K
furnished to the SEC on 22 February 2024, 3 March 2023 and 28 May
2021.
Pursuant to Rule 13-01 and Rule 3-10 of
Regulation S-X under the Securities Act of 1933, as amended (the
"Securities Act"), we present below the summary financial
information for AstraZeneca PLC, as Guarantor, excluding its
consolidated subsidiaries, and AstraZeneca Finance, as the issuer,
excluding its consolidated subsidiaries. The following summary
financial information of AstraZeneca PLC and AstraZeneca Finance is
presented on a combined basis and transactions between the
combining entities have been eliminated. Financial information for
non-guarantor entities has been excluded. Intercompany balances and
transactions between the obligor group and the non-obligor
subsidiaries are presented on separate lines.
Table 14: Obligor group summarised
Statement of comprehensive income
|
|
Q1 2024
|
Q1 2023
|
|
|
$m
|
$m
|
Total Revenue
|
|
-
|
-
|
Gross profit
|
|
-
|
-
|
Operating loss
|
|
-
|
-
|
Loss for the period
|
|
(234)
|
(237)
|
Transactions with subsidiaries that are not
issuers or guarantors
|
|
588
|
7,502
|
Table 15: Obligor group summarised
Statement of financial position
|
|
At 31 Mar
2024
|
At 31 Mar
2023
|
|
|
$m
|
$m
|
Current assets
|
|
12
|
10
|
Non-current assets
|
|
-
|
-
|
Current liabilities
|
|
(5,778)
|
(2,952)
|
Non-current liabilities
|
|
(27,161)
|
(26,747)
|
Amounts due from subsidiaries that are not
issuers or guarantors
|
|
21,242
|
14,067
|
Amounts due to subsidiaries that are not
issuers or guarantors
|
|
-
|
(296)
|
Foreign exchange
The Company's transactional currency exposures
on working capital balances, which typically extend for up to three
months, are hedged where practicable using forward foreign exchange
contracts against the individual companies' reporting currency.
Foreign exchange gains and losses on forward contracts transacted
for transactional hedging are taken to profit or to Other
comprehensive income if the contract is in a designated cashflow
hedge. In addition, the Company's external dividend payments, paid
principally in pound sterling and Swedish krona, are fully hedged
from announcement to payment date.
Table 16: Currency
sensitivities
The Company provides the following information
on currency-sensitivity:
|
|
|
Average
rates vs.
USD
|
|
Annual impact ($m)
of 5% strengthening (FY 2024 average
rate vs. FY 2023 average) [8]
|
Currency
|
Primary Relevance
|
|
FY
2023[9]
|
YTD
2024[10]
|
Change
(%)
|
Mar 2024[11]
|
Change
(%)
|
|
Total Revenue
|
Core Operating Profit
|
EUR
|
Total Revenue
|
|
0.92
|
0.92
|
0
|
0.92
|
0
|
|
397
|
179
|
CNY
|
Total Revenue
|
|
7.09
|
7.20
|
(2)
|
7.22
|
(2)
|
|
322
|
182
|
JPY
|
Total Revenue
|
|
140.60
|
148.49
|
(5)
|
149.87
|
(6)
|
|
177
|
119
|
Other[12]
|
|
|
|
|
|
|
|
|
453
|
227
|
GBP
|
Operating expense
|
|
0.80
|
0.79
|
2
|
0.79
|
2
|
|
60
|
(126)
|
SEK
|
Operating expense
|
|
10.61
|
10.39
|
2
|
10.41
|
2
|
|
9
|
(63)
|
|
|
|
|
|
|
|
|
|
|
|
| |
Sustainability
AstraZeneca published its tenth
annual Sustainability
Report, including a data annex
for performance measures and targets, along with the 2023 Taskforce
on Climate-related Financial Disclosures Statement.
Access to healthcare
‒
Chair Michel Demaré participated in a panel discussion with
global health leaders at the 54th Annual
Meeting of the World Economic Forum (WEF) in Davos on utilising
learnings from the COVID-19 pandemic to prepare for future health
challenges and the importance of investing in strong, resilient
health systems.
‒
Engagements linked to the Partnership
for Health System Sustainability and Resilience (PHSSR), continued in Germany, Belgium,
Switzerland and Japan, highlighting the need for measurable policy
targets for non-communicable disease management. In India, a PHSSR
report was published assessing the sustainability and resilience of
the Indian health system, while in the Netherlands, an academic
publication was launched with policy recommendations to improve
health system resilience.
‒
Healthy Heart Africa (HHA), AstraZeneca's
flagship health equity programme, reached its goal of identifying
more than 10 million people with elevated blood pressure by
2025 nearly two years ahead of target. At the end of February 2024,
more than 11,480 healthcare workers have been trained and more than
52 million blood pressure screenings conducted cumulatively
since the programme launched in 2014, maintaining an average of
more than one million screenings per month since 2023. HHA also
launched a pilot programme in Ghana in March 2024 as a first step
to broadening its scope to include chronic kidney disease
screening.
‒
Since 2021, the Young Health Programme (YHP) has
directly reached more than 10 million youth, influenced 16 policies
and has employee volunteer programmes in 36 countries, exceeding
its core targets for 2021-2025 nearly two years early. YHP
received the Driving Health Equity Award in the 2024 Reuters Pharma
Awards Europe for the programme's work empowering young people to
catalyse a healthier future.
Environmental protection
‒
The Company signed a clean heat agreement in March 2024 to
decarbonise our medicines manufacturing in China. Through the
agreement, biomethane and biomethane-based steam will be supplied
to our Wuxi manufacturing site and we will reduce our Scope 1 and 2
greenhouse gas (GHG) emissions by up to 80% in China, supporting
the broader decarbonisation of the healthcare system.
‒
The Company announced at WEF
that it will be one of the inaugural
Early Adopter organisations that intend to start making disclosures
aligned with the Taskforce on Nature-related Financial
Disclosures (TNFD)
Recommendations in corporate reporting by the fiscal year
2024.
‒
AstraZeneca was one of the five healthcare companies,
convened through the Sustainable Markets
Initiative Health Systems Task Force, that launched an
industry-first multi-party agreement to access renewable power in
China in January 2024. This is the first
time companies from across the global healthcare sector have come
together to decarbonise their operations in China, and the
agreement will result in potential annual emissions savings of
approximately 120,000 tonnes of carbon dioxide equivalent
(CO2e).
‒
AstraZeneca received the Sustainability Award in the 2024
Reuters Pharma Awards Europe for accelerating the electronic
product information industry transition in Europe.
Ethics and transparency
‒
The Company achieved seventh place overall, and third in the
Health Care sector, in the FTSE Women Leaders Review 2023, as one
of the top performers in both the FTSE 100 and FTSE 350 for
representation of women across the organisation.
‒
The Company's latest Modern Slavery Act Statement was
published detailing activities undertaken to mitigate the risks of
modern slavery both within the Company's operations and supply
chain, in line with the Code of Ethics and our commitment to
operating with integrity and in compliance with relevant
legislation.
‒ In
Poland, AstraZeneca was named an 'Ethics Leader' by Bonnier Press
for the third year. This award recognises five companies for their
commitment to upholding high ethical standards, treating business
partners with respect, applying the principles of fair competition,
and building trust and good relationships between employees and
stakeholder groups.
Research and development
This section covers R&D events and
milestones that have occurred since the prior results announcement
on 8 February 2024, up to and including events on 24 April
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 four major medical
congresses since the prior results announcement: the Society of
Gynecologic Oncology Annual Meeting on Women's Cancer (SGO) in
March 2024, the European Lung Cancer Congress (ELCC) in March 2024,
American Association for Cancer Research Annual Meeting (AACR) in
April 2024 and the 2024 Cholangiocarcinoma Foundation Conference
(CFC) in April 2024.
Tagrisso
Event
|
|
|
Commentary
|
Phase III trial read out
|
LAURA
|
|
Met primary endpoint, demonstrating that
Tagrisso
resulted in a statistically significant and highly clinically
meaningful improvement in PFS for patients with unresectable, Stage
III EGFRm NSCLC after chemoradiotherapy compared to
placebo after chemoradiotherapy. (February 2024)
|
Approval
|
US
|
|
Tagrisso with the
addition of chemotherapy for the treatment of adult patients with
locally advanced or metastatic EGFRm NSCLC. (FLAURA2,
February 2024)
|
Presentation: ELCC
|
FLAURA2
|
|
OS interim analysis of the Phase III FLAURA2
trial, presented at ELCC, showed at 41% data maturity, a favourable
trend with the Tagrisso plus
chemotherapy arm (HR 0.75) vs Tagrisso
monotherapy. The OS data were not statistically significant
at this interim analysis and will continue to be assessed as a key
secondary endpoint at final analysis. (March 2024)
|
Imfinzi
and Imjudo
Event
|
|
|
Commentary
|
Phase III trial read out
|
ADRIATIC
|
|
Met primary endpoint, demonstrating that
Imfinzi resulted in a
statistically significant and clinically meaningful improvement in
the dual primary endpoints of OS and PFS in patients with LS-SCLC
who had not progressed following cCRT compared to placebo after
cCRT. (April 2024).
|
Presentation: CFC
|
TOPAZ-1
|
|
Updated exploratory results of the Phase III
TOPAZ-1 trial, presented at CFC, showed Imfinzi in combination with
standard-of-care chemotherapy demonstrated a clinically meaningful
long-term OS benefit at three years for patients with advanced BTC.
(April 2024)
|
Lynparza
Event
|
|
|
Commentary
|
Presentation: SGO
|
DUO-E (Lynparza and Imfinzi)
|
|
Post-hoc exploratory subgroup analysis of the
Phase III DUO-E trial, presented at SGO, assessed patients by
mismatch repair status and demonstrated that median duration of
response in proficient mismatch repair patients in the Lynparza and Imfinzi arm was more than double
versus the control arm (18.7 versus 7.6 months) in patients with
advanced or recurrent endometrial cancer. (March 2024)
|
Enhertu
Event
|
|
|
Commentary
|
Approval
|
US
|
|
For the treatment of adult patients with
unresectable or metastatic HER2-positive (IHC 3+) solid tumours who
have received prior systemic treatment and have no satisfactory
alternative treatment options (DESTINY-PanTumor02, DESTINY-Lung01,
DESTINY-CRC02, April 2024)
|
Truqap
Event
|
|
|
Commentary
|
Approval
|
Japan
|
|
In combination with Faslodex for the treatment of adult
patients with unresectable or recurrent PIK3CA, AKT1, or PTEN-altered HR-positive,
HER2-negative breast cancer following progression after treatment
with endocrine therapy. (CAPItello-291, March 2024)
|
BioPharmaceuticals - R&I
Fasenra
Event
|
|
|
Commentary
|
Label expansion
|
US
|
|
Fasenra's approval
in severe eosinophilic asthma has been expanded to include patients
6 years and older, from the previous 12 years and
older (TATE, April 2024)
|
Publication (Respiratory Medicine)
|
MIRACLE
|
|
Results from the MIRACLE Phase III trial showed
treatment with Fasenra
resulted in a reduction of 74% in annual exacerbation rate in
patients in Asia with severe eosinophilic asthma (April
2024)
|
Rare Disease
AstraZeneca presented new clinical and
real-world data from its leading rare neurology portfolio at the
American Academy of Neurology (AAN) Annual Meeting in Denver, CO,
13 to 18 April 2024. The Company presented 14 abstracts, including
five oral presentations, across both gMG and NMOSD.
Ultomiris
Event
|
|
|
Commentary
|
Approval
|
US
|
|
For the treatment of adult patients with
anti-aquaporin-4 antibody-positive (Ab+) NMOSD. (CHAMPION-NMOSD,
March 2024)
|
Voydeya
Event
|
|
|
Commentary
|
Approval
|
US
|
|
For the treatment of extravascular haemolysis
in adults with paroxysmal nocturnal haemoglobinuria, as add-on
therapy to Ultomiris or
Soliris. (ALPHA, April
2024)
|
Approval
|
EU
|
|
For the treatment of adult patients with
paroxysmal nocturnal haemoglobinuria who have residual haemolytic
anaemia, as an add-on therapy to Ultomiris or Soliris. (ALPHA, February
2024).
|
Interim financial statements
Table 17: Condensed consolidated statement
of comprehensive income: Q1 2024
For the quarter ended 31
March
|
|
2024
|
2023
|
|
|
$m
|
$m
|
Total
Revenue
|
|
12,679
|
10,879
|
Product
Sales
|
|
12,177
|
10,566
|
Alliance
Revenue
|
|
457
|
286
|
Collaboration
Revenue
|
|
45
|
27
|
Cost of sales
|
|
(2,218)
|
(1,905)
|
Gross
profit
|
|
10,461
|
8,974
|
Distribution expense
|
|
(135)
|
(134)
|
Research and development expense
|
|
(2,783)
|
(2,611)
|
Selling, general and administrative
expense
|
|
(4,495)
|
(4,059)
|
Other operating income and expense
|
|
67
|
379
|
Operating
profit
|
|
3,115
|
2,549
|
Finance income
|
|
111
|
78
|
Finance expense
|
|
(413)
|
(365)
|
Share of after tax losses in associates and
joint ventures
|
|
(13)
|
-
|
Profit before
tax
|
|
2,800
|
2,262
|
Taxation
|
|
(620)
|
(458)
|
Profit for the
period
|
|
2,180
|
1,804
|
Other
comprehensive income:
|
|
|
|
Items that will not be reclassified to
profit or loss:
|
|
|
|
Remeasurement of the defined benefit pension
liability
|
|
144
|
(10)
|
Net gains on equity investments measured at
fair value through other comprehensive income
|
|
35
|
46
|
Fair value movements related to own credit risk
on bonds designated as fair value through profit or loss
|
|
-
|
2
|
Tax on items that will not be reclassified to
profit or loss
|
|
(39)
|
24
|
|
|
140
|
62
|
Items that may be
reclassified subsequently to profit or loss:
|
|
|
|
Foreign exchange arising on
consolidation
|
|
(515)
|
314
|
Foreign exchange arising on designated
liabilities in net investment hedges
|
|
(98)
|
(7)
|
Fair value movements on cash flow
hedges
|
|
(86)
|
56
|
Fair value movements on cash flow hedges
transferred to profit and loss
|
|
70
|
(75)
|
Fair value movements on derivatives designated
in net investment hedges
|
|
22
|
16
|
Costs of hedging
|
|
15
|
-
|
Tax on items that may be reclassified
subsequently to profit or loss
|
|
35
|
12
|
|
|
(557)
|
316
|
Other
comprehensive (expense)/income, net of tax
|
|
(417)
|
378
|
Total
comprehensive income for the period
|
|
1,763
|
2,182
|
Profit
attributable to:
|
|
|
|
Owners of the Parent
|
|
2,179
|
1,803
|
Non-controlling interests
|
|
1
|
1
|
|
|
2,180
|
1,804
|
Total
comprehensive income attributable to:
|
|
|
|
Owners of the Parent
|
|
1,762
|
2,181
|
Non-controlling interests
|
|
1
|
1
|
|
|
1,763
|
2,182
|
Basic earnings per $0.25 Ordinary
Share
|
|
$1.41
|
$1.16
|
Diluted earnings per $0.25 Ordinary
Share
|
|
$1.40
|
$1.16
|
Weighted average number of Ordinary
Shares in issue (millions)
|
|
1,549
|
1,549
|
Diluted weighted average number of
Ordinary Shares in issue (millions)
|
|
1,560
|
1,560
|
Table 18: Condensed consolidated statement
of financial position
|
|
At 31 Mar
2024
|
At 31 Dec
2023
|
At 31 Mar
2023
|
|
|
$m
|
$m
|
$m
|
Assets
|
|
|
|
|
Non-current
assets
|
|
|
|
|
Property, plant and equipment
|
|
9,411
|
9,402
|
8,644
|
Right-of-use assets
|
|
1,205
|
1,100
|
955
|
Goodwill
|
|
19,978
|
20,048
|
20,001
|
Intangible assets
|
|
38,834
|
38,089
|
39,291
|
Investments in associates and joint
ventures
|
|
130
|
147
|
77
|
Other investments
|
|
1,565
|
1,530
|
1,157
|
Derivative financial instruments
|
|
213
|
228
|
116
|
Other receivables
|
|
745
|
803
|
682
|
Deferred tax assets
|
|
4,618
|
4,718
|
3,498
|
|
|
76,699
|
76,065
|
74,421
|
Current
assets
|
|
|
|
|
Inventories
|
|
5,337
|
5,424
|
4,967
|
Trade and other receivables
|
|
11,072
|
12,126
|
10,289
|
Other investments
|
|
180
|
122
|
230
|
Derivative financial instruments
|
|
11
|
116
|
40
|
Income tax receivable
|
|
1,153
|
1,426
|
508
|
Cash and cash equivalents
|
|
7,841
|
5,840
|
6,232
|
|
|
25,594
|
25,054
|
22,266
|
Total
assets
|
|
102,293
|
101,119
|
96,687
|
Liabilities
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Interest-bearing loans and
borrowings
|
|
(6,050)
|
(5,129)
|
(3,625)
|
Lease liabilities
|
|
(281)
|
(271)
|
(232)
|
Trade and other payables
|
|
(19,699)
|
(22,374)
|
(19,210)
|
Derivative financial instruments
|
|
(92)
|
(156)
|
(44)
|
Provisions
|
|
(1,148)
|
(1,028)
|
(546)
|
Income tax payable
|
|
(1,631)
|
(1,584)
|
(1,203)
|
|
|
(28,901)
|
(30,542)
|
(24,860)
|
Non-current
liabilities
|
|
|
|
|
Interest-bearing loans and
borrowings
|
|
(27,259)
|
(22,365)
|
(26,916)
|
Lease liabilities
|
|
(961)
|
(857)
|
(730)
|
Derivative financial instruments
|
|
(51)
|
(38)
|
(133)
|
Deferred tax liabilities
|
|
(2,621)
|
(2,844)
|
(2,795)
|
Retirement benefit obligations
|
|
(1,280)
|
(1,520)
|
(1,128)
|
Provisions
|
|
(1,123)
|
(1,127)
|
(914)
|
Other payables
|
|
(2,596)
|
(2,660)
|
(3,400)
|
|
|
(35,891)
|
(31,411)
|
(36,016)
|
Total
liabilities
|
|
(64,792)
|
(61,953)
|
(60,876)
|
Net
assets
|
|
37,501
|
39,166
|
35,811
|
Equity
|
|
|
|
|
Capital and
reserves attributable to equity holders of the
Parent
|
|
|
|
|
Share capital
|
|
388
|
388
|
387
|
Share premium account
|
|
35,194
|
35,188
|
35,159
|
Other reserves
|
|
2,075
|
2,065
|
2,068
|
Retained earnings
|
|
(212)
|
1,502
|
(1,825)
|
|
|
37,445
|
39,143
|
35,789
|
Non-controlling interests
|
|
56
|
23
|
22
|
Total
equity
|
|
37,501
|
39,166
|
35,811
|
Table 19: 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
|
|
-
|
-
|
-
|
1,803
|
1,803
|
1
|
1,804
|
Other comprehensive income
|
|
-
|
-
|
-
|
378
|
378
|
-
|
378
|
Transfer to other reserves
|
|
-
|
-
|
(1)
|
1
|
-
|
-
|
-
|
Transactions
with owners
|
|
|
|
|
|
|
|
|
Dividends
|
|
-
|
-
|
-
|
(3,047)
|
(3,047)
|
-
|
(3,047)
|
Issue of Ordinary Shares
|
|
-
|
4
|
-
|
-
|
4
|
-
|
4
|
Share-based payments charge for the
period
|
|
-
|
-
|
-
|
132
|
132
|
-
|
132
|
Settlement of share plan awards
|
|
-
|
-
|
-
|
(518)
|
(518)
|
-
|
(518)
|
Net movement
|
|
-
|
4
|
(1)
|
(1,251)
|
(1,248)
|
1
|
(1,247)
|
At 31 Mar
2023
|
|
387
|
35,159
|
2,068
|
(1,825)
|
35,789
|
22
|
35,811
|
|
|
|
|
|
|
|
|
|
At 1 Jan
2024
|
|
388
|
35,188
|
2,065
|
1,502
|
39,143
|
23
|
39,166
|
Profit for the period
|
|
-
|
-
|
-
|
2,179
|
2,179
|
1
|
2,180
|
Other comprehensive expense
|
|
-
|
-
|
-
|
(417)
|
(417)
|
-
|
(417)
|
Transfer to other reserves
|
|
-
|
-
|
10
|
(10)
|
-
|
-
|
-
|
Transactions
with owners
|
|
|
|
|
|
|
|
|
Dividends
|
|
-
|
-
|
-
|
(3,052)
|
(3,052)
|
-
|
(3,052)
|
Issue of Ordinary Shares
|
|
-
|
6
|
-
|
-
|
6
|
-
|
6
|
Changes in non-controlling interests
|
|
-
|
-
|
-
|
-
|
-
|
32
|
32
|
Share-based payments charge for the
period
|
|
-
|
-
|
-
|
159
|
159
|
-
|
159
|
Settlement of share plan
awards
|
|
-
|
-
|
-
|
(573)
|
(573)
|
-
|
(573)
|
Net movement
|
|
-
|
6
|
10
|
(1,714)
|
(1,698)
|
33
|
(1,665)
|
At 31 Mar
2024
|
|
388
|
35,194
|
2,075
|
(212)
|
37,445
|
56
|
37,501
|
Table 20: Condensed consolidated statement
of cash flows
For the quarter ended 31
March
|
|
2024
|
2023
|
|
$m
|
$m
|
Cash flows from operating activities
|
|
|
|
Profit before tax
|
|
2,800
|
2,262
|
Finance income and expense
|
|
302
|
287
|
Share of after tax losses of associates and
joint ventures
|
|
13
|
-
|
Depreciation, amortisation and
impairment
|
|
1,255
|
1,502
|
Movement in working capital and short-term
provisions
|
|
(455)
|
242
|
Gains on disposal of intangible
assets
|
|
-
|
(249)
|
Fair value movements on contingent
consideration arising from business combinations
|
|
16
|
-
|
Non-cash and other movements
|
|
(674)
|
(429)
|
Cash generated
from operations
|
|
3,257
|
3,615
|
Interest paid
|
|
(341)
|
(257)
|
Tax paid
|
|
(430)
|
(225)
|
Net cash
inflow from operating activities
|
|
2,486
|
3,133
|
Cash flows from investing activities
|
|
|
|
Acquisition of subsidiaries, net of cash
acquired
|
|
(726)
|
(189)
|
Payments upon vesting of employee share awards
attributable to business combinations
|
|
-
|
(23)
|
Payment of contingent consideration from
business combinations
|
|
(222)
|
(214)
|
Purchase of property, plant and
equipment
|
|
(417)
|
(247)
|
Disposal of property, plant and
equipment
|
|
53
|
125
|
Purchase of intangible assets
|
|
(1,188)
|
(1,223)
|
Disposal of intangible assets
|
|
75
|
264
|
Movement in profit-participation
liability
|
|
-
|
175
|
Purchase of non-current asset
investments
|
|
(41)
|
-
|
Disposal of non-current asset
investments
|
|
9
|
10
|
Movement in short-term investments, fixed
deposits and other investing instruments
|
|
(57)
|
9
|
Disposal of investments in associates and joint
ventures
|
|
8
|
-
|
Interest received
|
|
93
|
67
|
Net cash
outflow from investing activities
|
|
(2,413)
|
(1,246)
|
Net cash
inflow before financing activities
|
|
73
|
1,887
|
Cash flows from financing activities
|
|
|
|
Proceeds from issue of share capital
|
|
6
|
4
|
Issue of loans and borrowings
|
|
4,976
|
3,826
|
Repayment of loans and borrowings
|
|
(7)
|
(2,004)
|
Dividends paid
|
|
(3,033)
|
(3,047)
|
Hedge contracts relating to dividend
payments
|
|
(8)
|
27
|
Repayment of obligations under
leases
|
|
(74)
|
(67)
|
Movement in short-term borrowings
|
|
1,001
|
97
|
Payment of Acerta Pharma share purchase
liability
|
|
(833)
|
(867)
|
Net cash
inflow/(outflow) from financing activities
|
|
2,028
|
(2,031)
|
Net increase/(decrease) in Cash and cash
equivalents in the period
|
|
2,101
|
(144)
|
Cash and cash equivalents at the beginning of
the period
|
|
5,637
|
5,983
|
Exchange rate effects
|
|
(46)
|
(11)
|
Cash and cash
equivalents at the end of the period
|
|
7,692
|
5,828
|
Cash and cash
equivalents consist of:
|
|
|
|
Cash and cash equivalents
|
|
7,841
|
6,232
|
Overdrafts
|
|
(149)
|
(404)
|
|
|
7,692
|
5,828
|
Notes to the Interim financial statements
Note 1: Basis of preparation and accounting
policies
These unaudited condensed consolidated Interim
financial statements for the three months ended 31 March 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 three months ended 31 March 2024 were approved by the Board of
Directors for publication on 25 April 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 will be 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 31 March 2024, the Group has $14.7bn in financial
resources (cash and cash equivalent balances of $7.8bn and undrawn
committed bank facilities of $6.9bn, with $6.3bn of borrowings due
within one year). These facilities contain no financial covenants
and were undrawn at 31 March 2024. $2bn of the facilities are
available until February 2025 and the other $4.9bn are available
until April 2029.
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.
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. This review resulted in $nil impairment charge during
the three months ended 31 March 2024 (31 March 2023: $271m net
charge). In Q1 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 relevant milestones are triggered or performance
conditions satisfied.
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 21: Net debt
|
|
At 1 Jan 2024
|
Cash flow
|
Acquisitions
|
Non-cash
&
other
|
Exchange movements
|
At 31 Mar 2024
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Non-current instalments of loans
|
|
(22,365)
|
(4,976)
|
(3)
|
(2)
|
87
|
(27,259)
|
Non-current instalments of leases
|
|
(857)
|
-
|
(2)
|
(114)
|
12
|
(961)
|
Total
long-term debt
|
|
(23,222)
|
(4,976)
|
(5)
|
(116)
|
99
|
(28,220)
|
Current instalments of loans
|
|
(4,614)
|
7
|
(9)
|
(1)
|
24
|
(4,593)
|
Current instalments of leases
|
|
(271)
|
86
|
(2)
|
(100)
|
6
|
(281)
|
Commercial paper
|
|
-
|
(980)
|
-
|
-
|
-
|
(980)
|
Bank collateral received
|
|
(215)
|
60
|
-
|
-
|
-
|
(155)
|
Other short-term borrowings excluding
overdrafts
|
|
(97)
|
(81)
|
-
|
-
|
5
|
(173)
|
Overdrafts
|
|
(203)
|
54
|
-
|
-
|
-
|
(149)
|
Total current
debt
|
|
(5,400)
|
(854)
|
(11)
|
(101)
|
35
|
(6,331)
|
Gross
borrowings
|
|
(28,622)
|
(5,830)
|
(16)
|
(217)
|
134
|
(34,551)
|
Net derivative financial instruments
|
|
150
|
8
|
-
|
(77)
|
-
|
81
|
Net
borrowings
|
|
(28,472)
|
(5,822)
|
(16)
|
(294)
|
134
|
(34,470)
|
Cash and cash equivalents
|
|
5,840
|
1,837
|
209
|
1
|
(46)
|
7,841
|
Other investments - current
|
|
122
|
57
|
3
|
-
|
(2)
|
180
|
Cash and
investments
|
|
5,962
|
1,894
|
212
|
1
|
(48)
|
8,021
|
Net
debt
|
|
(22,510)
|
(3,928)
|
196
|
(293)
|
86
|
(26,449)
|
Net debt increased by $3,939m in the three
months to 31 March 2024 to $26,449m. 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
-
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 31 March 2024 was $155m (31 December 2023:
$215m) and the carrying value of such cash collateral posted by the
Group at 31 March 2024 was $136m (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 31 March 2024, there
have been no changes to the Company's solicited long term credit
ratings. Moody's credit ratings were long term: A2; short term:
P-1. Standard and Poor's credit ratings were long term: A; short
term: A-1.
Note 4: Financial Instruments
As detailed in the Group's most recent annual
financial statements, the principal financial instruments consist
of derivative financial instruments, other investments, trade and
other receivables, cash and cash equivalents, trade and other
payables, lease liabilities and interest-bearing loans and
borrowings.
The Group has certain equity investments that
are categorised as Level 3 in the fair value hierarchy that are
held at $309m at (31 December 2023: $313m) and for which a fair
value loss of $1m has been recognised in the three months ended 31
March 2024 (31 March 2023: fair value gain of $1m). In the absence
of specific market data, these unlisted investments are held at
fair value based on the cost of investment and adjusted as
necessary for impairments and revaluations on new funding rounds,
which are seen to approximate the fair value. All other fair value
gains and/or losses that are presented in Net gains on equity
investments measured at fair value through other comprehensive
income in the Condensed consolidated statement of comprehensive
income for the three months ended 31 March 2024 are Level 1 fair
value measurements, valued based on quoted prices in active
markets.
Financial instruments measured at fair value
include $1,605m of other investments, $5,504m held in money-market
funds and $81m of derivatives as at 31 March 2024. With the
exception of derivatives being Level 2 fair valued, and certain
equity investments of $320m categorised as Level 3, the
aforementioned balances are Level 1 fair valued. Financial
instruments measured at amortised cost include $136m of cash
collateral pledged to counterparties. The total fair value of
interest-bearing loans and borrowings at 31 March 2024, which have
a carrying value of $34,551m in the Condensed consolidated
statement of financial position, was $33,364m.
Table 22: 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
|
|
-
|
54
|
54
|
60
|
Settlements
|
|
(221)
|
(1)
|
(222)
|
(214)
|
Revaluations
|
|
-
|
16
|
16
|
-
|
Discount unwind
|
|
26
|
2
|
28
|
33
|
At 31
March
|
|
1,750
|
263
|
2,013
|
2,101
|
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 $1,750m
(31 December 2023: $1,945m) would increase/decrease by $175m
with an increase/decrease in sales of 10%, as compared with the
current estimates.
Note 5: Business combinations
The acquisition of Gracell Biotechnologies,
Inc. completed on 22 February 2024 and was recorded as a business
combination using the acquisition method of accounting in
accordance with IFRS 3 'Business Combinations'. Consequently the
assets acquired, and liabilities assumed are recorded at fair
value. Given the proximity of the completion of the transaction to
the reporting date, the identification and determination of the
fair values related to the acquired balance sheet is on-going. This
exercise is expected to complete in Q2 2024 with the majority of
the fair value expected to be allocated to the intangible assets,
as currently reported. The upfront cash portion of the
consideration represents a transaction value of approximately
$1.0bn. Combined, the upfront and potential contingent value
payments if achieved, represent, a transaction value of
approximately $1.2bn. The cash and cash equivalents acquired on
Gracell's balance sheet, totalled to $209m at the close of the
transaction.
Note 6: Legal proceedings and contingent
liabilities
AstraZeneca is involved in various
legal proceedings considered typical to its business, including
litigation and investigations, including Government investigations,
relating to product liability, commercial disputes, infringement
of intellectual property (IP)
rights, the validity of certain patents, anti-trust law and sales
and marketing practices. The matters
discussed below constitute the more significant developments since
publication of the disclosures concerning legal proceedings in the
Company's Annual Report and Form 20-F Information 2023 (the
Disclosures). Information about the nature and facts of the cases
is disclosed in accordance with IAS 37.
As discussed in the Disclosures, the majority
of claims involve highly complex issues. Often these issues are
subject to substantial uncertainties and, therefore, the
probability of a loss, if any, being sustained and/or an estimate
of the amount of any loss is difficult to ascertain.
In cases that have been settled or adjudicated,
or where quantifiable fines and penalties have been assessed and
which are not subject to appeal, or where a loss is probable and we
are able to make a reasonable estimate of the loss, AstraZeneca
records the loss absorbed or makes a provision for its best
estimate of the expected loss. The position could change over time
and the estimates that the Company made, and upon which the Company
have relied in calculating these provisions are inherently
imprecise. There can, therefore, be no assurance that any losses
that result from the outcome of any legal proceedings will not
exceed the amount of the provisions that have been booked in the
accounts. The major factors causing this uncertainty are described
more fully in the Disclosures and herein.
AstraZeneca has full confidence in, and will
vigorously defend and enforce, its IP.
Matters disclosed in respect of the first quarter of
2024 and to 25 April 2024
Patent litigation
Legal proceedings brought against AstraZeneca considered
to be contingent liabilities
Forxiga
UK patent proceedings
In the UK, one of AstraZeneca's patents
relating to Forxiga is
being challenged by Generics (UK) Limited, Teva Pharmaceutical
Industries Limited, and Glenmark Pharmaceuticals Europe Limited.
Trial is scheduled for March 2025.
Tagrisso
US patent proceedings
In September 2021, Puma Biotechnology, Inc.
(Puma) and Wyeth LLC (Wyeth) filed a patent infringement lawsuit in
the US District Court for the District of Delaware (District Court)
against AstraZeneca relating to Tagrisso. In March 2024, the District
Court dismissed Puma. A trial, with Wyeth as the plaintiff, has
been scheduled for May 2024.
Legal proceedings brought by AstraZeneca considered to be
contingent assets
Calquence
US patent proceedings
In February 2022, in response to Paragraph IV
notices from multiple ANDA filers, AstraZeneca filed patent
infringement lawsuits in the US District Court for the District of
Delaware (District Court). In its complaint, AstraZeneca alleged
that a generic version of Calquence capsules, if approved and
marketed, would infringe patents that are owned or licensed by
AstraZeneca. Trial is scheduled for March 2025.
In March and April 2024, AstraZeneca entered
into settlement agreements with generic manufacturers, Sandoz Inc.,
and Natco Pharma Limited with Natco Pharma Inc., resulting in
dismissal of the corresponding Calquence capsule ANDA litigation
proceedings. Additional Calquence capsule ANDA litigation
proceedings with the remaining three generic manufacturers are
ongoing in the District Court.
In April 2024, AstraZeneca received a Paragraph
IV notice from an ANDA filer relating to patents listed in the FDA
Orange Book with reference to Calquence tablets. AstraZeneca is
considering its response.
Lokelma
US patent proceedings
In August 2022, in response to Paragraph IV
notices, AstraZeneca initiated ANDA litigation against multiple
generic filers in the US District Court for the District of
Delaware (District Court). Trial is scheduled for March 2025.
AstraZeneca entered into a settlement agreement
with a generic manufacturer, Alkem Laboratories, which resulted in
dismissal of the corresponding litigation. Additional proceedings
with the remaining generic manufacturers are ongoing in the
District Court.
Soliris
US patent proceedings
In January 2024, Alexion initiated patent
infringement litigation against Samsung Bioepis Co. Ltd. (Samsung)
in the US District Court for the District of Delaware alleging that
Samsung's biosimilar eculizumab product, for which Samsung
is currently seeking FDA approval, will infringe six Soliris-related patents. No trial date
has been scheduled. Five of the six asserted patents are also the
subject of inter partes
review proceedings before the US Patent and Trademark Office. In
February 2024, Alexion filed a motion for a preliminary injunction
seeking to enjoin Samsung from launching its biosimilar
eculizumab product upon
FDA approval. A hearing on Alexion's preliminary injunction motion
is scheduled for May 2024.
European patent proceedings
In March 2024, Alexion filed motions for
preliminary injunctions against Amgen and Samsung at the Hamburg
Local Division of the Unified Patent Court on the basis that
Amgen's and Samsung's biosimilar eculizumab products infringe Alexion's
eculizumab molecule patent
that is expected to grant in Q2 2024. No hearing date for the
preliminary injunction motions has been set.
Tagrisso
Russia patent proceedings
In Russia, in August 2023, AstraZeneca filed
lawsuits in the Arbitration Court of the Moscow Region (Court)
against the Ministry of Health of the Russian Federation and
Axelpharm LLC (Axelpharm) related to Axelpharm's improper use of
AstraZeneca's information to obtain authorisation to market a
generic version of Tagrisso. In December 2023, the Court
dismissed the lawsuit against the Ministry of Health of the Russian
Federation. In January 2024, AstraZeneca filed an appeal, and the
appellate court affirmed the dismissal in March 2024. The lawsuit
against Axelpharm remains pending.
In Russia, in November 2023, Axelpharm filed a
compulsory licensing action against AstraZeneca in the Court
related to a patent that covers Tagrisso. The compulsory licensing
action remains pending.
Product liability litigation
Legal proceedings brought against AstraZeneca for which a
provision has been taken
Nexium
and Losec/Prilosec
US proceedings
AstraZeneca has been defending lawsuits brought
in federal and state courts involving claims that plaintiffs have
been diagnosed with various injuries following treatment with
proton pump inhibitors (PPIs), including Nexium and Prilosec. Most of the lawsuits alleged
kidney injury. In August 2017, the pending federal court cases were
consolidated into a multidistrict litigation (MDL) proceeding in
the US District Court for the District of New Jersey for pre-trial
purposes. Cases alleging kidney injury were also filed in Delaware
and New Jersey state courts.
In addition, AstraZeneca has been defending
lawsuits involving allegations of gastric cancer following
treatment with PPIs, including one such claim in the US District
Court for the Middle District of Louisiana (Louisiana District
Court).
In October 2023, AstraZeneca resolved all
pending claims in the MDL, as well as all pending claims in
Delaware and New Jersey state courts, for $425M, for which a
provision has been taken. The only remaining case is the one
pending in the Louisiana District Court, which is scheduled for
trial in January 2025.
Canada proceedings
In Canada, in July and August 2017, AstraZeneca
was served with three putative class action lawsuits. Two of the
lawsuits have been dismissed, one in 2019 and one in 2021. The
third lawsuit seeks authorisation to represent individual residents
in Canada who allegedly suffered kidney injuries from the use of
proton pump inhibitors, including Nexium and Losec.
Legal proceedings brought against AstraZeneca considered
to be contingent liabilities
Onglyza
and Kombiglyze
US proceedings
In the US, AstraZeneca has been defending
various lawsuits in both California state court and in a
consolidated federal proceeding alleging heart failure, cardiac
injuries, and/or death from treatment with Onglyza or Kombiglyze. In the California state
court proceeding, the trial court granted summary judgment for
AstraZeneca, which the California appellate court affirmed. The
California Supreme Court has declined further review, and the
California matter has concluded. The consolidated federal cases
were dismissed in August 2022 by the US District Court for the
Eastern District of Kentucky. That dismissal was affirmed by the US
Court of Appeals for the Sixth Circuit in February 2024.
Vaxzevria
UK proceedings
AstraZeneca is defending lawsuits in the UK
involving multiple claimants alleging injuries following
vaccination with AstraZeneca's COVID-19 vaccine. Most of the
lawsuits involve claims of thrombosis with thrombocytopenia
syndrome. No trial dates have been scheduled.
Commercial litigation
Legal proceedings brought against AstraZeneca considered
to be contingent liabilities
340B Antitrust Litigation
US proceedings
In September 2021, AstraZeneca was served with
a class-action antitrust complaint filed in the US District Court
for the Western District of New York (District Court) by Mosaic
Health alleging a conspiracy to restrict access to 340B discounts
in the diabetes market through contract pharmacies. In September
2022, the District Court granted AstraZeneca's motion to dismiss
the Complaint. In February 2024, the District Court denied
Plaintiffs' request to file an amended complaint and entered an
order closing the matter. In March 2024, Plaintiffs filed an
appeal.
Definiens
Germany proceedings
In Germany, in July 2020, AstraZeneca received
a notice of arbitration filed with the German Institution of
Arbitration from the sellers of Definiens AG (the Sellers)
regarding the 2014 Share Purchase Agreement (SPA) between
AstraZeneca and the Sellers. The Sellers claim that they are owed
approximately $140m in earn-outs under the SPA. In December
2023, after an arbitration hearing, the
arbitration panel made a final award of $46.43m in favour of the
Sellers. In March 2024, AstraZeneca filed an application with the
Bavarian Supreme Court to set aside the arbitration
award.
Legal proceedings brought by AstraZeneca considered to be
contingent assets
PARP Inhibitor Royalty Dispute
UK proceedings
In October 2012, Tesaro, Inc. (now wholly owned
by GlaxoSmithKline plc, (GSK)) entered into two worldwide,
royalty-bearing patent license agreements with AstraZeneca related
to GSK's product niraparib. In May 2021, AstraZeneca
filed a lawsuit against GSK in the Commercial Court of England and
Wales alleging that GSK had failed to pay all of the royalties due
on niraparib sales under
the license agreements. In April 2023, after trial, the trial
court issued a decision in AstraZeneca's favour. In February 2024,
Court of Appeal reversed. In March 2024, AstraZeneca filed a
request for permission to appeal with the Supreme Court of the
United Kingdom.
Government investigations/proceedings
Legal proceedings brought against AstraZeneca considered
to be contingent liabilities
340B Qui Tam
US proceedings
In July 2023, AstraZeneca was served with an
unsealed civil lawsuit brought by a qui tam relator on behalf of the
United States, several states, and the District of Columbia in the
US District Court for the Central District of California (District
Court). The complaint alleges that AstraZeneca violated the US
False Claims Act and state law analogues. In March 2024, the
District Court granted AstraZeneca's motion to dismiss the First
Amended Complaint without leave to amend. In April 2024, the
relator filed an appeal.
Legal proceedings brought by AstraZeneca considered to be
contingent assets
Inflation Reduction Act Litigation
US proceedings
In August 2023, AstraZeneca filed a lawsuit in
the US District Court for the District of Delaware (District Court)
against the US Department of Health and Human Services (HHS)
challenging aspects of the drug price negotiation provisions of the
Inflation Reduction Act and the implementing guidance and
regulations. In March 2024, the District Court granted HHS' motions
and dismissed AstraZeneca's lawsuit.
Arkansas 340B Litigation
US proceedings
In March 2024, AstraZeneca filed a lawsuit
against the State of Arkansas alleging that the Arkansas's 340B
statute is pre-empted by federal law and
unconstitutional.
Other
Additional government inquiries
As is true for most, if not all, major
prescription pharmaceutical companies, AstraZeneca is currently
involved in multiple inquiries into drug marketing and pricing
practices. In addition to the investigations described above,
various law enforcement offices have, from time to time, requested
information from the Group. There have been no material
developments in those matters.
Note 7
Table 23: Q1 2024 - Product
Sales year-on-year analysis[13]
|
World
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
|
$m
|
Act % chg
|
CER % chg
|
$m
|
% chg
|
$m
|
Act % chg
|
CER % chg
|
$m
|
Act % chg
|
CER % chg
|
$m
|
Act % chg
|
CER % chg
|
Oncology
|
4,760
|
21
|
24
|
2,084
|
22
|
1,202
|
24
|
33
|
953
|
26
|
23
|
521
|
6
|
16
|
Tagrisso
|
1,595
|
12
|
15
|
623
|
20
|
488
|
10
|
17
|
302
|
18
|
15
|
182
|
(10)
|
(2)
|
Imfinzi
|
1,113
|
29
|
33
|
582
|
19
|
129
|
59
|
83
|
232
|
43
|
40
|
170
|
31
|
45
|
Calquence
|
718
|
35
|
35
|
494
|
29
|
39
|
n/m
|
n/m
|
153
|
42
|
39
|
32
|
44
|
47
|
Lynparza
|
705
|
8
|
11
|
288
|
7
|
167
|
23
|
33
|
191
|
7
|
5
|
59
|
(13)
|
(6)
|
Enhertu
|
122
|
n/m
|
n/m
|
-
|
-
|
83
|
n/m
|
n/m
|
26
|
n/m
|
n/m
|
13
|
n/m
|
n/m
|
Zoladex
|
276
|
22
|
28
|
3
|
9
|
214
|
28
|
35
|
35
|
9
|
6
|
24
|
(1)
|
7
|
Imjudo
|
62
|
67
|
70
|
39
|
22
|
4
|
n/m
|
n/m
|
8
|
n/m
|
n/m
|
11
|
n/m
|
n/m
|
Truqap
|
50
|
n/m
|
n/m
|
50
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Orpathys
|
12
|
48
|
53
|
-
|
-
|
12
|
48
|
53
|
-
|
-
|
-
|
-
|
-
|
-
|
Others
|
107
|
(24)
|
(19)
|
5
|
(10)
|
66
|
(24)
|
(20)
|
6
|
(52)
|
(53)
|
30
|
(16)
|
(7)
|
BioPharmaceuticals: CVRM
|
3,012
|
19
|
22
|
748
|
20
|
1,365
|
17
|
24
|
716
|
29
|
26
|
183
|
(2)
|
7
|
Farxiga
|
1,845
|
42
|
45
|
473
|
60
|
711
|
43
|
50
|
553
|
41
|
37
|
108
|
(4)
|
5
|
Brilinta
|
323
|
(3)
|
(1)
|
163
|
(9)
|
88
|
9
|
21
|
67
|
(1)
|
(3)
|
5
|
(17)
|
(14)
|
Crestor
|
297
|
(3)
|
2
|
10
|
(32)
|
241
|
-
|
4
|
12
|
(26)
|
(27)
|
34
|
2
|
11
|
Seloken/Toprol-XL
|
165
|
(8)
|
(2)
|
-
|
(96)
|
161
|
(7)
|
(2)
|
3
|
(23)
|
(23)
|
1
|
(39)
|
(36)
|
Lokelma
|
114
|
16
|
19
|
52
|
(7)
|
21
|
83
|
90
|
18
|
60
|
56
|
23
|
16
|
29
|
roxadustat
|
75
|
24
|
28
|
-
|
-
|
75
|
24
|
28
|
-
|
-
|
-
|
-
|
-
|
-
|
Andexxa
|
47
|
5
|
6
|
20
|
(3)
|
1
|
n/m
|
n/m
|
18
|
24
|
21
|
8
|
(14)
|
(4)
|
Wainua
|
5
|
n/m
|
n/m
|
5
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Others
|
141
|
(33)
|
(31)
|
25
|
(55)
|
67
|
(32)
|
(27)
|
45
|
(11)
|
(12)
|
4
|
3
|
5
|
BioPharmaceuticals: R&I
|
1,804
|
14
|
16
|
737
|
19
|
588
|
10
|
16
|
330
|
13
|
11
|
149
|
6
|
11
|
Symbicort
|
769
|
12
|
14
|
299
|
28
|
253
|
11
|
18
|
142
|
(3)
|
(6)
|
75
|
(5)
|
(3)
|
Fasenra
|
358
|
6
|
6
|
210
|
4
|
22
|
53
|
61
|
93
|
6
|
4
|
33
|
(6)
|
-
|
Pulmicort
|
224
|
2
|
5
|
5
|
(52)
|
191
|
5
|
9
|
20
|
-
|
(3)
|
8
|
(7)
|
(4)
|
Breztri
|
219
|
52
|
54
|
105
|
30
|
70
|
83
|
91
|
30
|
97
|
93
|
14
|
43
|
53
|
Tezspire
|
43
|
n/m
|
n/m
|
-
|
-
|
2
|
n/m
|
n/m
|
27
|
n/m
|
n/m
|
14
|
n/m
|
n/m
|
Saphnelo
|
91
|
94
|
95
|
83
|
89
|
1
|
n/m
|
n/m
|
4
|
n/m
|
n/m
|
3
|
80
|
99
|
Airsupra
|
7
|
n/m
|
n/m
|
7
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Others
|
93
|
(30)
|
(29)
|
28
|
(41)
|
49
|
(30)
|
(27)
|
14
|
3
|
1
|
2
|
(17)
|
(15)
|
BioPharmaceuticals: V&I
|
212
|
(40)
|
(40)
|
27
|
n/m
|
90
|
(13)
|
(12)
|
74
|
(27)
|
(26)
|
21
|
(87)
|
(86)
|
Synagis
|
171
|
(13)
|
(13)
|
(1)
|
76
|
90
|
16
|
18
|
61
|
(25)
|
(27)
|
21
|
(46)
|
(43)
|
Beyfortus
|
26
|
n/m
|
n/m
|
26
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
FluMist
|
7
|
n/m
|
n/m
|
2
|
n/m
|
-
|
59
|
59
|
5
|
n/m
|
n/m
|
-
|
n/m
|
n/m
|
COVID-19 mAbs
|
2
|
(99)
|
(99)
|
-
|
-
|
-
|
n/m
|
n/m
|
2
|
(53)
|
(56)
|
-
|
n/m
|
n/m
|
Others
|
6
|
(79)
|
(80)
|
-
|
-
|
-
|
n/m
|
n/m
|
6
|
(42)
|
(43)
|
-
|
-
|
-
|
Rare Disease
|
2,096
|
12
|
16
|
1,207
|
10
|
251
|
45
|
73
|
401
|
4
|
1
|
237
|
12
|
21
|
Ultomiris
|
859
|
32
|
34
|
482
|
27
|
32
|
n/m
|
n/m
|
202
|
27
|
24
|
143
|
46
|
61
|
Soliris
|
739
|
(11)
|
(8)
|
411
|
(8)
|
125
|
9
|
37
|
142
|
(22)
|
(24)
|
61
|
(30)
|
(28)
|
Strensiq
|
313
|
20
|
21
|
246
|
20
|
21
|
44
|
67
|
24
|
15
|
12
|
22
|
4
|
14
|
Koselugo
|
132
|
68
|
82
|
46
|
13
|
59
|
n/m
|
n/m
|
18
|
72
|
69
|
9
|
n/m
|
n/m
|
Kanuma
|
53
|
30
|
35
|
22
|
13
|
14
|
n/m
|
n/m
|
15
|
19
|
18
|
2
|
(3)
|
2
|
Other medicines
|
293
|
(6)
|
1
|
24
|
(33)
|
206
|
-
|
11
|
29
|
31
|
30
|
34
|
(31)
|
(25)
|
Nexium
|
240
|
(2)
|
7
|
22
|
(27)
|
172
|
10
|
23
|
13
|
13
|
11
|
33
|
(30)
|
(24)
|
Others
|
53
|
(23)
|
(21)
|
2
|
(63)
|
34
|
(31)
|
(29)
|
16
|
52
|
52
|
1
|
(53)
|
(49)
|
Total Product Sales
|
12,177
|
15
|
18
|
4,827
|
19
|
3,702
|
18
|
26
|
2,503
|
18
|
16
|
1,145
|
(7)
|
1
|
Table 24: Alliance Revenue
|
|
Q1 2024
|
Q1 2023
|
|
|
$m
|
$m
|
Enhertu
|
|
339
|
220
|
Tezspire
|
|
77
|
43
|
Beyfortus
|
|
20
|
-
|
Other Alliance Revenue
|
|
21
|
23
|
Total
|
|
457
|
286
|
Table 25: Collaboration Revenue
|
|
Q1 2024
|
Q1 2023
|
|
|
$m
|
$m
|
Farxiga: sales
milestones
|
|
45
|
24
|
Other Collaboration Revenue
|
|
-
|
3
|
Total
|
|
45
|
27
|
Table 26: Other operating income and
expense
|
|
Q1 2024
|
Q1 2023
|
|
|
$m
|
$m
|
brazikumab licence termination
funding
|
|
-
|
38
|
Divestment of US rights to Pulmicort Flexhaler
|
|
-
|
241
|
Other
|
|
67
|
100
|
Total
|
|
67
|
379
|
Other shareholder information
Financial calendar
Announcement of H1 and Q2 2024
results:
25 July 2024
Announcement of 9M and Q3 2024
results:
12 November 2024
Dividends are normally paid as
follows:
First interim:
announced with the half year results and paid in
September
Second interim: announced with 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: FasT CAR owned
by Gracell Biotechnology, Co., Ltd.; Plendil owned by AstraZeneca
or Glenwood GmbH (depending on geography); 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
There can be no guarantees that the conditions
to the closing of the proposed transaction with Fusion will be
satisfied on the expected timetable or at all or that "FPI-2265"
(Ac225-PSMA I&T) or any combination product will receive the
necessary regulatory approvals or prove to be commercially
successful if approved. There can be no guarantees that the
conditions to the closing of the proposed transaction with Amolyt
Pharma will be satisfied on the expected timetable or at all or
that eneboparatide ("AZP-3601") will receive the necessary
regulatory approvals or prove to be commercially successful if
approved.
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 / mutation
EGPA
Eosinophilic granulomatosis with polyangiitis
EPS
Earnings per
share
ERBB2
v-erb-b2 avian erythroblastic leukaemia viral oncogene homologue
2
EVH
Extravascular haemolysis
FDA
Food and Drug Agency (US)
FDC
Fixed dose combination
g
Germline, e.g. gBRCAm
GAAP
Generally Accepted Accounting Principles
GEJ
Gastro oesophageal junction
GI
Gastrointestinal
GLP1 /
-RA
Glucagon-like peptide-1 / receptor agonist
gMG
Generalised myasthenia gravis
HCC
Hepatocellular carcinoma
HER2 / +/- / low / m Human
epidermal growth factor receptor 2 / positive / negative / low
level expression / mutant
HF/ pEF / rEF
Heart failure / with preserved ejection fraction / with reduced
ejection fraction
hMPV
Human metapneumovirus
HR / + /
-
Hormone receptor / positive / negative
HRD
Homologous recombination deficiency
HRRm
Homologous recombination repair gene mutation
i.m.
Intramuscular injection
i.v.
Intravenous injection
IAS /
B
International Accounting Standards / Board
ICS
Inhaled corticosteroid
IFRS
International Financial Reporting Standards
IgAN
Immunoglobulin A neuropathy
IHC
Immunohistochemistry
IL-5, IL-33,
etc
Interleukin-5, Interleukin-33, etc
IP
Intellectual Property
IVIg
Intravenous immune globulin
LABA
Long-acting beta-agonist
LAMA
Long-acting muscarinic-agonist
LS-SCLC
Limited stage small cell lung cancer
LRTD
Lower respiratory tract disease
m
Metastatic, e.g. mBTC , mCRPC, mCSPC
mAb
Monoclonal antibody
MDL
Multidistrict litigation
MET
Mesenchymal epithelial transition
NF1-PN
Neurofibromatosis type 1 with plexiform neurofibromas
n/m
Not meaningful
NMOSD
Neuromyelitis optica spectrum disorder
NRDL
National reimbursement drug list
NSCLC
Non-small cell lung cancer
OECD
Organisation for Economic Co-operation and Development
OOI
Other operating income
ORR
Overall response rate
OS
Overall survival
PARP / i /
-1sel
Poly ADP ribose polymerase / inhibitor /-1 selective
pCR
Pathologic complete response
PCSK9
Proprotein convertase subtilisin/kexin type 9
PD
Progressive disease
PD-1
Programmed cell death protein 1
PD-L1
Programmed cell death ligand 1
PDUFA
Prescription Drug User Fee Act
PHSSR
Partnership for Health System Sustainability and
Resilience
PFS
Progression free survival
PIK3CA
Phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit
alpha
PMDI
Pressure metered dose inhaler
PNH /
-EVH
Paroxysmal nocturnal haemoglobinuria / with extravascular
haemolysis
PPI
Proton pump inhibitors
PSR
Platinum sensitive relapse
PTEN
Phosphatase and tensin homologue
Q3W, Q4W,
etc Every
three weeks, every four weeks, etc
R&D
Research and development
R&I
Respiratory & Immunology
RSV
Respiratory syncytial virus
sBLA
Supplemental biologics license application (US)
SCLC
Small cell lung cancer
s.c.
Subcutaneous injection
SEA
Severe eosinophilic asthma
SEC
Securities Exchange Commission (US)
SG&A
Sales, general and administration
SGLT2
Sodium-glucose cotransporter 2
SLL
Small lymphocytic lymphoma
SMI
Sustainable Markets Initiative
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
-