FORM
6-K
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
Report
of Foreign Issuer
Pursuant to Rule
13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of April 2023
Commission File
Number: 001-11960
AstraZeneca
PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge CB2
0AA
United
Kingdom
Indicate by check
mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F.
Form
20-F
X
Form 40-F __
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mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(1):
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mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7): ______
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mark whether the registrant by furnishing the information contained
in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange
Act of 1934.
Yes
__
No X
If
“Yes” is marked, indicate below the file number assigned to the
Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca
PLC
INDEX
TO EXHIBITS
1. 1st Quarter Results
AstraZeneca
27 April
2023
Q1
2023 results
Strong start to the year with stable Total Revenue
and 15% growth excluding COVID-19 medicines[1]
Revenue
and EPS summary
|
|
|
Q1 2023
|
|
|
|
|
% Change
|
|
|
$m
|
Actual
|
|
-
Product Sales
|
|
10,566
|
(4)
|
1
|
- Alliance
Revenue[3]
|
|
286
|
88
|
90
|
- Collaboration Revenue3
|
|
27
|
(89)
|
(89)
|
Total
Revenue
|
|
10,879
|
(4)
|
-
|
Total Revenue ex COVID-19
|
|
10,725
|
10
|
15
|
Reported[4] EPS[5]
|
|
$1.16
|
>4x
|
>4x
|
Core[6] EPS
|
|
$1.92
|
1
|
6
|
Financial
performance (Q1 2023
figures unless otherwise stated, growth numbers at CER)
Total
Revenue stable at $10,879m, despite a decline of $1,460m from
COVID-19 medicines
-
Excluding COVID-19 medicines, Total Revenue increased 15% and
Product Sales increased 16%
-
Total Revenue from Oncology medicines
increased 19%, CVRM[7] 22%,
R&I[8] 8%,
and Rare Disease 14%
-
Core Gross margin of 83%, up four percentage points, reflecting the
decline in sales of lower margin COVID-19 medicines, the cost of
production in prior periods, and a mix shift to more speciality
medicines
- Core Operating margin of 36%, up one percentage
point, reflecting a $220m increase in Core Other operating income,
which included a gain from the divestment
of Pulmicort Flexhaler rights in the US
-
Core EPS increased 6% to $1.92
-
Reiterating guidance for FY 2023 Total Revenue and Core
EPS
Pascal Soriot, Chief Executive Officer, AstraZeneca,
said:
"AstraZeneca had a strong start to 2023, with Total Revenue
excluding COVID-19 medicines increasing 15%. Our performance in
Emerging Markets was particularly strong and I am impressed by the
growth and pace of innovation I see in China, which underscores the
competitive advantage of our leading presence in this country.
Our pipeline momentum continued with positive Phase III results for
a Lynparza-plus-Imfinzi combination in ovarian cancer, Imfinzi in
lung cancer, and promising new data for Enhertu across a range of
cancer types. Additionally, in the year to date we have started six
new Phase III trials and are on track to initiate 30 over the
course of 2023.
Finally, I would like to thank Leif Johansson for his outstanding
leadership during his time as Chair of the Board, and his
contribution to our return to growth strategy. Leif has been a
tremendous partner to me, and I look forward to building the same
strong partnership with our new Chair, Michel Demaré."
Key milestones achieved since the prior results
-
Key read outs: positive results
for Lynparza and Imfinzi in ovarian cancer
(DUO-O), Imfinzi in NSCLC[9] (AEGEAN)
and Enhertu in multiple tumour types
(DESTINY-PanTumor02). Tagrisso showed a statistically significant
improvement in overall survival in NSCLC (ADAURA)
-
Key regulatory approvals: EU approvals
for Imfinzi and Imjudo in HCC[10] (HIMALAYA)
and NSCLC (POSEIDON), Calquence maleate tablet formulation, and positive
CHMP recommendation for Ultomiris in NMOSD[11].
China approvals for Enhertu in HER2-positive[12] breast
cancer (DESTINY-Breast03) and Calquence in mantle cell lymphoma
As announced on 11 April 2023, AstraZeneca's
results for Q2 2023 will include a gain of $718m in Core Other
operating income resulting from an update to the contractual
relationships for nirsevimab[13]
Guidance
The
Company reiterates guidance for FY 2023 at CER, based on the
average exchange rates through 2022.
Total Revenue is expected to increase by a low-to-mid single-digit
percentage
Excluding COVID-19 medicines, Total Revenue is expected to increase
by a low double-digit percentage
-
Core EPS is expected to increase by a high single-digit to low
double-digit percentage
- While challenging to forecast, Total Revenue
from COVID-19 medicines (Vaxzevria[14] and
COVID-19 mAbs[15])
is expected to decline significantly in FY 2023, with minimal
revenue from Vaxzevria
-
Total Revenue from China is expected to return to growth and
increase by a low single-digit percentage in FY 2023
-
Alliance Revenue and Collaboration
Revenue are both expected to increase[16],
driven by continued growth of our partnered medicines and
success-based milestones
-
Other operating income is expected to increase
-
Core Operating expenses are expected to increase by a low-to-mid
single-digit percentage, driven by investment in recent launches
and the ungating of new trials following pipeline success
-
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 to December 2023 were to remain at
the average rates seen in the month of March 2023, it is
anticipated that FY 2023 Total Revenue and FY 2023 Core EPS would
both incur a low single-digit adverse impact versus the performance
at CER.
The
Company's foreign exchange rate sensitivity analysis is provided in
Table 18.
Table 1: Key elements of Total Revenue performance in Q1
2023
|
% Change
|
|
|
Revenue type
|
|
$m
|
Actual
|
CER
|
|
|
Product
Sales
|
|
10,566
|
(4)
|
1
|
|
∗ Decline of 4% (1% increase at CER)
impacted by lower sales of COVID-19 medicines
∗ Strong
growth in Oncology, CVRM, R&I and Rare
Disease
|
Alliance
Revenue
|
|
286
|
88
|
90
|
|
∗ $220m
for Enhertu (Q1 2022: $76m)
∗ $43m
for Tezspire (Q1 2022: $3m)
∗ See
Table 6 for further details
|
Collaboration
Revenue
|
|
27
|
(89)
|
(89)
|
|
∗ No
sales or regulatory milestones from Lynparza in the quarter (Q1 2022:
$175m)
∗ See
Table 7 for further details
|
Total
Revenue
|
|
10,879
|
(4)
|
--
|
|
∗ Excluding COVID-19
medicines, Q1 2023
Total Revenue increased by 10% (15% at CER)
|
Therapy areas
|
|
$m
|
Actual %
|
CER %
|
|
|
Oncology
|
|
4,148
|
14
|
19
|
|
∗ Strong
performance across key medicines and regions
∗ No
sales or regulatory milestones from Lynparza in the quarter (Q1 2022:
$175m)
|
CVRM6
|
|
2,557
|
15
|
22
|
|
∗ Farxiga up
32% (39% CER), Lokelma up 56% (64% at CER), roxadustat up 52% (66%
CER), Brilinta up 3% (5% at CER)
|
R&I
|
|
1,633
|
3
|
8
|
|
∗ Fasenra up
10% (13% CER), Breztri up
67% (73% CER). Saphnelo and Tezspire continue to grow rapidly during their launch
phase
∗ Collaboration Revenue of $nil (Q1 2022: $70m,
relating to tralokinumab milestone)
|
V&I[17]
|
|
355
|
(80)
|
(79)
|
|
∗ $127m
from COVID-19 mAbs (Q1 2022: $469m)
∗ $28m
from Vaxzevria (Q1 2022: $1,145m)
|
Rare Disease6
|
|
1,866
|
10
|
14
|
|
∗ Ultomiris up
55% (61% at CER), offset by decline in Soliris of 16% (13% at CER)
∗ Strensiq up
26% (28% at CER) reflecting strong patient demand and geographic
expansion
|
Other
Medicines
|
|
320
|
(26)
|
(21)
|
|
|
Total
Revenue
|
|
10,879
|
(4)
|
-
|
|
|
Regions inc. COVID-19
|
|
$m
|
Actual %
|
CER %
|
|
|
US
|
|
4,299
|
4
|
4
|
|
|
Emerging
Markets
|
|
3,162
|
(6)
|
1
|
|
∗ Growth
rate impacted by lower sales of COVID-19 medicines (numbers ex.
COVID-19 below)
|
- China
|
|
1,602
|
(1)
|
8
|
|
|
- Ex-China Emerging Markets
|
|
1,560
|
(10)
|
(6)
|
|
|
Europe
|
|
2,162
|
(5)
|
-
|
|
|
Established
RoW
|
|
1,256
|
(22)
|
(12)
|
|
|
Total Revenue inc. COVID-19
|
|
10,879
|
(4)
|
-
|
|
|
Regions ex. COVID-19
|
|
$m
|
Actual %
|
CER %
|
|
|
US
|
|
4,299
|
15
|
15
|
|
|
Emerging
Markets
|
|
3,136
|
14
|
22
|
|
|
- China
|
|
1,602
|
2
|
11
|
|
∗ Third
consecutive quarter of growth at CER
∗ Recovery in inhaled products following lifting of
COVID-19 restrictions
|
- Ex-China Emerging Markets
|
|
1,534
|
31
|
38
|
|
∗ Timing
of Rare Disease tender orders
|
Europe
|
|
2,148
|
3
|
9
|
|
|
Established
RoW
|
|
1,142
|
(5)
|
7
|
|
|
Total
Revenue ex. COVID-19
|
|
10,725
|
10
|
15
|
|
|
|
|
|
|
|
|
|
|
|
|
Table 2: Key elements of financial performance in Q1
2023
Metric
|
Reported
|
Reported change
|
Core
|
Corechange
|
|
Comments[18]
|
Total
Revenue
|
$10,879m
|
-4%
Actual stable at CER
|
$10,879m
|
-4%
Actual stable at CER
|
|
∗ Excluding COVID-19 medicines, Q1 2023 Total
Revenue increased by 10% (15% at CER)
∗ See
Table 1 and the Total Revenue section of this document for further
details
|
Gross Margin[19]
|
82%
|
14pp
Actual 14pp CER
|
83%
|
4pp
Actual 4pp CER
|
|
+
Increasing mix of sales from Oncology and Rare Disease
medicines
+ Decreasing mix of Vaxzevria sales
‒ Increasing
mix of products with profit-sharing
arrangements
∗ Variations in Gross Margin can be
expected between periods due to product seasonality, foreign
exchange fluctuations, cost inflation and other
effects
|
R&D
expense
|
$2,611m
|
22%
Actual 28% CER
|
$2,300m
|
5%
Actual 10% CER
|
|
+
Increased investment in the pipeline
+
Reported R&D expense was also impacted by intangible asset
impairments in Q1 2023, and by reversals of impairments in Q1
2022
∗ Core
R&D-to-Total Revenue ratio of 21%(Q1 2022:
19%)
∗ Year-on-year comparisons can be impacted by
differences in cost phasing
|
SG&A
expense
|
$4,059m
|
-16%
Actual -13% CER
|
$3,054m
|
4%
Actual 8% CER
|
|
+
Market development activities for recent launches
+
Core SG&A-to-Total Revenue ratio of 28%(Q1 2022:
26%).
‒ Reported
SG&A in Q1 2022 included a $775m charge for a legal settlement
with Chugai Pharmaceutical Co. Ltd
∗ Year-on-year comparisons can be impacted by
differences in cost phasing
|
Other operating
income[20]
|
$379m
|
>3x
Actual >3x CER
|
$318m
|
>3x
Actual >3x CER
|
|
∗ Reported and Core OOI includes a gain of $241m
from the disposal of US rights to Pulmicort
Flexhaler
|
Operating
Margin
|
23%
|
16pp
Actual 16pp CER
|
36%
|
2pp
Actual 1pp CER
|
|
∗ See
Gross Margin, Expenses and OOIcommentary above
|
Net
finance expense
|
$287m
|
-10%
Actual -8% CER
|
$240m
|
-4%
Actual -3% CER
|
|
∗ Higher
interest received on cash balances, partially offset by higher
rates on floating debt and bond issuances
∗ Reported also impacted by a reduction in the
discount unwind on acquisition-related
liabilities
|
Tax
rate
|
20%
|
-10pp
Actual -10pp CER
|
20%
|
-1pp
Actual -1pp CER
|
|
∗ Variations in the tax rate can be expected between
periods
|
EPS
|
$1.16
|
>4x
Actual >4x CER
|
$1.92
|
1%
Actual 6% CER
|
|
∗ Further
details of differences between Reported and Core are shown in Table
13
|
Table 3: Pipeline highlights since prior results
announcement
Event
|
Medicine
|
Indication / Trial
|
Event
|
Regulatory
approvals and other regulatory actions
|
Imfinzi +/- Imjudo
|
NSCLC
(1st-line) (POSEIDON)
|
Regulatory
approval (EU)
|
Imfinzi + Imjudo
|
Hepatocellular
carcinoma (1st-line) (HIMALAYA)
|
Regulatory
approval (EU)
|
Enhertu
|
HER2-positive
breast cancer (2nd-line) (DESTINY-Breast03)
|
Regulatory
approval (CN)
|
Calquence
|
Maleate
tablet formulation
|
Regulatory
approval (EU)
|
Calquence
|
Mantle
cell lymphoma
|
Regulatory
approval (CN)
|
Ultomiris
|
NMOSD
|
Positive
CHMP opinion (EU)
|
Regulatory
submissionsor acceptances
|
Imfinzi
|
Biliary
tract cancer (TOPAZ-1)
|
Regulatory
submission (CN)
|
Enhertu
|
HER2+
breast cancer (3rd-line) (DESTINY-Breast02)
|
Regulatory
submission (EU)
|
Beyfortus
|
RSV[21] (MELODY/MEDLEY)
|
Regulatory
submission (JP)
|
eplontersen
|
ATTRv-PN[22] (NEURO-TTRansform)
|
Regulatory
submission (US)
|
|
danicopan
|
PNH
with EVH
|
Regulatory
submission (EU)
|
Major
Phase III data readouts and other developments
|
Lynparza + Imfinzi
|
Ovarian
cancer (1st-line) (DUO-O)
|
Primary
endpoint met
|
Imfinzi
|
NSCLC
(neoadjuvant) (AEGEAN)
|
Dual
primary endpoints met
|
Other pipeline updates
The
Phase II/III trial for cotadutide daily formulation in NASH has
been discontinued due to portfolio prioritisation. Development
continues for AZD9550, a weekly injectable
GLP-1/glucagon.
In
April, the ALXN1840 programme in Wilson Disease was terminated. The
decision was based on feedback from regulatory authorities on
review of data from the Wilson Disease programme, including the
Phase III FoCus and two Phase II mechanistic trials.
Table 4: New Phase III trials started since 1 January
2023
Medicine
|
Trial name
|
Indication
|
datopotamab
deruxtecan
|
AVANZAR
|
NSCLC
(1st-line)
|
TROPION-Lung07
|
Non-squamous
NSCLC (1st-line)
|
camizestrant
|
CAMBRIA-1
|
HR-positive[23]/HER2-negative
adjuvant breast cancer
|
Tezspire
|
CROSSING
|
Eosinophilic
oesophagitis
|
AZD3152
|
SUPERNOVA
|
COVID-19
prophylaxis
|
Ultomiris
|
ARTEMIS
|
Cardiac
surgery associated acute kidney injury
|
Corporate and business development
In the quarter, AstraZeneca completed the
previously-announced acquisitions of CinCor Pharma Inc. (CinCor)
and Neogene Therapeutics Inc., and the disposal of US
commercial rights to Pulmicort
Flexhaler to
Cheplapharm.
AstraZeneca
expanded its collaboration with SOPHiA GENETICS to apply their
multimodal technology and expertise to AstraZeneca's oncology
portfolio. The multimodal approach will combine radiomics analysis
of medical imaging data, molecular data, digital pathology,
clinical and biologic data for a more comprehensive assessment of
multimodal signatures.
In March 2023, AstraZeneca signed an investment
agreement with Qingdao High-tech Industrial Development Zone to
build a production and supply site in China
for Breztri pressurised metered-dose inhalers. The
Qingdao plant will address the country's growing COPD burden. China
is home to about 100 million patients with COPD, which is the third
leading cause of death in the country.
In
April 2023, the contractual relationship between AstraZeneca and
Swedish Orphan Biovitrum AB (Sobi) relating to future sales of
nirsevimab in the US was replaced by a royalty relationship between
Sanofi and Sobi. As a result, a liability representing
AstraZeneca's future obligations to Sobi will be eliminated from
AstraZeneca's Statement of Financial Position, and AstraZeneca will
record a gain of $718m in Core Other operating income in Q2
2023.
Sustainability summary
AstraZeneca published its ninth Sustainability
Report and Data Summary, along with the 2022
TCFD[24] Report
and related case studies. AstraZeneca also hosted an annual
Sustainability call for shareholders, reiterating its continued
commitment to deliver across our pillars; Access to Healthcare,
Environmental Protection and Ethics and Transparency. A recording
of the call and accompanying materials are available on the
AstraZeneca IR website.
Management changes
As
previously communicated, Leif Johansson, will retire as Chair at
the conclusion of the Company's Annual General Meeting today, 27
April 2023. Michel Demaré's appointment as Chair will take effect
immediately on Leif's retirement, and Michel will step down as a
member of the Audit Committee.
Conference call
A conference call and webcast for investors and
analysts will begin today, 27 April 2023, at 11:45 UK time. Details
can be accessed via astrazeneca.com.
Reporting calendar
The
Company intends to publish its half-year and second-quarter results
on Friday, 28 July 2023.
Operating and financial review
All
narrative on growth and results in this section is based on actual
exchange rates, and financial figures are in US$ millions ($m),
unless stated otherwise. The performance shown in this announcement
covers the three month period to 31 March 2023 ('the quarter' or
'Q1 2023') compared to the three month period to 31 March 2022 ('Q1
2022'), unless stated otherwise.
Core
financial measures, EBITDA, Net debt, Gross Margin, Operating
Margin and CER are non-GAAP financial measures because they cannot
be derived directly from the Group's Interim 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, such as:
-
Amortisation and impairment of intangible assets, including
impairment reversals but excluding any charges relating to IT
assets
-
Charges and provisions related to restructuring programmes, which
includes charges that relate to the impact of restructuring
programmes on capitalised IT assets
-
Alexion acquisition-related items, primarily fair value adjustments
on acquired inventories and fair value impact of replacement
employee share awards
-
Other specified items, principally the imputed finance charges and
fair value movements relating to contingent consideration on
business combinations or asset acquisitions, legal settlements and
remeasurement adjustments relating to Other payables
-
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 62 of the Annual Report and Form
20-F Information 2022.
Reference
should be made to the Reconciliation of Reported to Core financial
measures table included in the financial performance section in
this announcement.
Gross
Margin is the percentage by which Product Sales exceeds the Cost of
Sales, calculated by dividing the difference between the two by the
sales figure. The calculation of Reported and Core 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.
Net
debt is defined as Interest-bearing loans and borrowings and Lease
liabilities, net of Cash and cash equivalents, Other investments,
and Net derivative financial instruments. Reference should be made
to Note 3 'Net debt' included in the Notes to the Interim Financial
Statements in this announcement.
The
Company strongly encourages investors and analysts not to rely on
any single financial measure, but to review AstraZeneca's financial
statements, including the Notes thereto, and other available
Company reports, carefully and in their entirety.
Due
to rounding, the sum of a number of dollar values and percentages
in this announcement may not agree to totals.
Total Revenue
Table 5: Therapy area and medicine
performance
|
Q1 2023
|
|
|
|
|
% Change
|
|
Product Sales
|
|
$m
|
% Total
|
Actual
|
CER
|
Oncology
|
|
3,920
|
36
|
16
|
21
|
- Tagrisso
|
|
1,424
|
13
|
9
|
15
|
- Imfinzi [25]
|
|
900
|
8
|
50
|
56
|
- Lynparza
|
|
651
|
6
|
5
|
10
|
- Calquence
|
|
532
|
5
|
28
|
31
|
- Enhertu
|
|
37
|
-
|
>3x
|
>3x
|
- Orpathys
|
|
8
|
-
|
(33)
|
(27)
|
- Zoladex
|
|
227
|
2
|
(6)
|
3
|
- Faslodex
|
|
75
|
1
|
(19)
|
(11)
|
-
Others
|
|
66
|
1
|
(32)
|
(27)
|
BioPharmaceuticals: CVRM
|
|
2,530
|
23
|
15
|
21
|
- Farxiga
|
|
1,299
|
12
|
30
|
37
|
- Brilinta
|
|
334
|
3
|
3
|
5
|
- Lokelma
|
|
98
|
1
|
56
|
64
|
-
roxadustat
|
|
61
|
1
|
49
|
63
|
- Andexxa
|
|
44
|
-
|
34
|
42
|
- Crestor
|
|
305
|
3
|
14
|
23
|
- Seloken/Toprol-XL
|
|
179
|
2
|
(27)
|
(20)
|
- Onglyza
|
|
63
|
1
|
(8)
|
(3)
|
- Bydureon
|
|
45
|
-
|
(33)
|
(32)
|
-
Others
|
|
102
|
1
|
4
|
9
|
BioPharmaceuticals: R&I
|
|
1,583
|
15
|
5
|
10
|
- Symbicort
|
|
688
|
6
|
2
|
7
|
- Fasenra
|
|
338
|
3
|
10
|
13
|
- Breztri
|
|
144
|
1
|
67
|
73
|
- Saphnelo
|
|
47
|
-
|
>4x
|
>4x
|
- Tezspire
|
|
11
|
-
|
n/m
|
n/m
|
- Pulmicort
|
|
221
|
2
|
2
|
9
|
- Bevespi
|
|
15
|
-
|
(1)
|
2
|
- Daliresp/Daxas
|
|
13
|
-
|
(75)
|
(75)
|
- Others
|
|
106
|
1
|
(27)
|
(22)
|
BioPharmaceuticals: V&I
|
|
355
|
3
|
(80)
|
(78)
|
-
COVID-19 mAbs
|
|
127
|
1
|
(73)
|
(70)
|
- Vaxzevria
|
|
28
|
-
|
(97)
|
(97)
|
- Synagis
|
|
198
|
2
|
(1)
|
5
|
- FluMist
|
|
2
|
-
|
n/m
|
n/m
|
Rare Disease
|
|
1,866
|
17
|
10
|
14
|
- Soliris
|
|
834
|
8
|
(16)
|
(13)
|
- Ultomiris
|
|
651
|
6
|
55
|
61
|
- Strensiq
|
|
262
|
2
|
26
|
28
|
- Koselugo
|
|
79
|
1
|
>2x
|
>2x
|
- Kanuma
|
|
40
|
-
|
4
|
6
|
Other Medicines
|
|
312
|
3
|
(26)
|
(21)
|
- Nexium
|
|
244
|
2
|
(27)
|
(20)
|
-
Others
|
|
68
|
1
|
(26)
|
(23)
|
Product Sales
|
|
10,566
|
97
|
(4)
|
1
|
Alliance Revenue
|
|
286
|
3
|
88
|
90
|
Collaboration Revenue
|
|
27
|
-
|
(89)
|
(89)
|
Total Revenue
|
|
10,879
|
100
|
(4)
|
-
|
|
|
|
|
|
|
|
|
|
Table 6: Alliance Revenue
|
Q1 2023
|
|
|
|
|
% Change
|
|
|
$m
|
% Total
|
Actual
|
CER
|
Enhertu
|
|
220
|
77
|
>2x
|
>2x
|
Tezspire
|
|
43
|
15
|
n/m
|
n/m
|
Vaxzevria: royalties
|
|
-
|
-
|
n/m
|
n/m
|
Other
royalty income
|
|
20
|
7
|
23
|
24
|
Other
Alliance Revenue
|
|
3
|
1
|
>3x
|
>3x
|
Total
|
|
286
|
100
|
88
|
90
|
Table 7: Collaboration Revenue
|
Q1 2023
|
|
|
|
|
% Change
|
|
|
$m
|
% Total
|
Actual
|
CER
|
Farxiga: sales milestones
|
|
24
|
89
|
n/m
|
n/m
|
Other
Collaboration Revenue
|
|
3
|
11
|
(76)
|
(76)
|
Total
|
|
27
|
100
|
(89)
|
(89)
|
Table 8: Total Revenue by therapy area
|
Q1 2023
|
|
|
|
% Change
|
|
|
|
|
$m
|
% Total
|
Actual
|
CER
|
Oncology
|
|
4,148
|
38
|
14
|
19
|
BioPharmaceuticals
|
|
4,545
|
42
|
(19)
|
(15)
|
- CVRM
|
|
2,557
|
24
|
15
|
22
|
- R&I
|
|
1,633
|
15
|
3
|
8
|
- V&I
|
|
355
|
3
|
(80)
|
(79)
|
Rare
Disease
|
|
1,866
|
17
|
10
|
14
|
Other
Medicines
|
|
320
|
3
|
(26)
|
(21)
|
Total
|
|
10,879
|
100
|
(4)
|
-
|
|
|
|
|
|
|
|
|
Table 9: Total Revenue by region
|
Q1 2023
|
|
|
|
|
% Change
|
|
|
|
$m
|
% Total
|
Actual
|
CER
|
US
|
|
4,299
|
40
|
4
|
4
|
Emerging
Markets
|
|
3,162
|
29
|
(6)
|
1
|
- China
|
|
1,602
|
15
|
(1)
|
8
|
- Ex-China
|
|
1,560
|
14
|
(10)
|
(6)
|
Europe
|
|
2,162
|
20
|
(5)
|
-
|
Established
RoW
|
|
1,256
|
12
|
(22)
|
(12)
|
Total
|
|
10,879
|
100
|
(4)
|
-
|
|
|
|
|
|
|
|
|
|
|
Table 10: Total Revenue by region - excluding COVID-19
medicines
|
|
Q1 2023
|
|
|
|
|
|
% Change
|
|
|
|
$m
|
% Total
|
Actual
|
CER
|
US
|
|
4,299
|
40
|
15
|
15
|
Emerging
Markets
|
|
3,136
|
29
|
14
|
22
|
- China
|
|
1,602
|
15
|
2
|
11
|
- Ex-China
|
|
1,534
|
14
|
31
|
38
|
Europe
|
|
2,148
|
20
|
3
|
9
|
Established
RoW
|
|
1,142
|
11
|
(5)
|
7
|
Total
|
|
10,725
|
100
|
10
|
15
|
|
|
|
|
|
|
|
|
|
|
|
Oncology
Oncology Total Revenue increased by 14% (19% at
CER) in Q1 2023 to $4,148m and represented 38% of overall Total
Revenue (Q1 2022: 32%). There was no Lynparza Collaboration Revenue in the quarter (Q1
2022: $175m) and Enhertu Alliance Revenue was $220m (Q1 2022: $76m).
Product Sales increased by 16% (21% at CER) in Q1 2023 to $3,920m,
reflecting new launches and increased patient access across key
brands; partially offset by declines in legacy
medicines.
Tagrisso
Total
Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1
2023 $m
|
|
1,424
|
|
521
|
444
|
257
|
202
|
Actual
change
|
|
9%
|
|
19%
|
9%
|
2%
|
(2%)
|
CER
change
|
|
15%
|
|
19%
|
17%
|
8%
|
11%
|
Region
|
|
Drivers
and commentary
|
Worldwide
|
|
∗ Increased use of Tagrisso in adjuvant and 1st-line setting and
expansion of reimbursed access
|
US
|
|
∗ Increasing demand in 1st-line and adjuvant
setting, partially offset by unfavourable inventory
movements
|
Emerging
Markets
|
|
∗ Rising
demand from increased patient access in China continues to offset
NRDL[26] renewal
price reductions
∗ Recovery from Q4 2022 ordering dynamics in
China
|
Europe
|
|
∗ Established standard of care in
1st-line and adjuvant setting across EU5[27],
partially offset by pricing clawbacks in certain
markets
|
Established
RoW
|
|
∗ Increased use in 1st-line setting and launch
acceleration in adjuvant, including Japan
|
Imfinzi
Total
Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1
2023 $m
|
|
900
|
|
522
|
81
|
163
|
134
|
Actual
change
|
|
50%
|
|
66%
|
39%
|
31%
|
33%
|
CER
change
|
|
56%
|
|
66%
|
47%
|
38%
|
52%
|
|
|
|
|
|
|
|
|
Region
|
|
Drivers
and commentary
|
Worldwide
|
|
∗ The Imfinzi revenue line includes sales
of Imjudo, which launched in Q4 2022 following
approvals in the US for patients with unresectable liver cancer
(HIMALAYA) and Stage IV NSCLC (POSEIDON)
∗ Increased use
of Imfinzi in
BTC[28] (TOPAZ-1),
liver cancer (HIMALAYA) and lung cancers (POSEIDON,
CASPIAN)
|
US
|
|
∗ Continued growth in new patient starts across
Stage III NSCLC and ES-SCLC[29]
∗ Strong
launch in BTC following September 2022 FDA approval, and growing
penetration of Imfinzi + Imjudo in liver and lung
cancers
|
Emerging
Markets
|
|
∗ Growth
in ex-China driven increased market penetration in ES-SCLC and
NSCLC (PACIFIC), and recovery of diagnosis and treatment rates
following the COVID-19 pandemic
|
Europe
|
|
∗ Increased market penetration in ES-SCLC, launch
trajectory in BTC, growth in the number of reimbursed
markets
|
Established
RoW
|
|
∗ New
reimbursements, strong demand growth in BTC
|
Lynparza
Total
Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1
2023 $m
|
|
651
|
|
268
|
137
|
178
|
68
|
Actual
change
|
|
(18%)
|
|
(1%)
|
13%
|
(47%)
|
2%
|
CER
change
|
|
(14%)
|
|
(1%)
|
19%
|
(44%)
|
16%
|
Product
Sales
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1
2023 $m
|
|
651
|
|
268
|
137
|
178
|
68
|
Actual
change
|
|
5%
|
|
(1%)
|
13%
|
11%
|
2%
|
CER
change
|
|
10%
|
|
(1%)
|
19%
|
18%
|
16%
|
Region
|
|
Drivers
and commentary
|
Worldwide
|
|
∗ Lynparza remains
the leading medicine in the PARP[30] inhibitor
class globally across four tumour types, as measured by total
prescription volume
∗ No
regulatory milestones received in Q1 2023
|
US
|
|
∗ Positive demand growth driven by OlympiA (FDA
approval March 2022) offset by flattening HRD testing rates in
ovarian cancer and destocking following an inventory build in Q4
2022 in anticipation of PROpel launch
|
Emerging
Markets
|
|
∗ Re-enlistment
into China's NRDL
for ovarian cancer indications
(PSR[31] and
BRCAm[32] 1st-line
maintenance) and new enlistment in prostate cancer
(PROfound)
|
Europe
|
|
∗ Growth driven by increased uptake
in 1st-line HRD-positive ovarian cancer, gBRCAm[33] HER2-negative
early breast cancer and BRCAm mCRPC, partially offset by new
indication pricing impact and clawbacks in some
markets
|
Established
RoW
|
|
∗ Growth
continues across tumour types
|
Enhertu
Total
Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1
2023 $m
|
|
257
|
|
161
|
38
|
55
|
3
|
Actual
change
|
|
>2x
|
|
>2x
|
>4x
|
>2x
|
>5x
|
CER
change
|
|
>3x
|
|
>2x
|
>4x
|
>2x
|
>6x
|
Region
|
|
Drivers
and commentary
|
Worldwide
|
|
∗ Combined sales of Enhertu, recorded by Daiichi Sankyo Company Limited
(Daiichi Sankyo) and AstraZeneca, amounted to $508m in the quarter
(Q1 2022: $166m)
∗ AstraZeneca's Total Revenue of $257m includes
$220m of Alliance Revenue from its share of gross profit and
royalties in territories where Daiichi Sankyo records product
sales
|
US
|
|
∗ US
in-market sales, recorded by Daiichi Sankyo, amounted to $336m in
the quarter (Q1 2022: $119m)
∗ Rapid adoption as new standard of
care across all launched indications including HER2-low
mBC[34] with strong
demand continuing from breast cancer launches
|
Emerging
Markets
|
|
∗ Strong
uptake driven by new approvals and launches
|
Europe
|
|
∗ Continued growth in 2nd-line and 3rd-line+
HER2-positive metastatic breast cancer
∗ Increased uptake following launches of 2nd-line+
HER2-positive gastric cancer and 2nd-line+ HER2-low metastatic
breast cancer after EU approvals in December 2022 and January 2023
respectively (DESTINY-Gastric01, DESTINY-Gastric02,
DESTINY-Breast04)
|
Established
RoW
|
|
∗ In
Japan, AstraZeneca receives a mid-single-digit percentage royalty
on sales made by Daiichi Sankyo
|
Calquence
Total
Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1
2023 $m
|
|
532
|
|
384
|
18
|
108
|
22
|
Actual
change
|
|
28%
|
|
13%
|
>2x
|
95%
|
76%
|
CER
change
|
|
31%
|
|
13%
|
>2x
|
>2x
|
91%
|
∗
Region
|
|
Drivers
and commentary
|
Worldwide
|
|
∗ Increased penetration globally;
leading BTKi[35] in
key markets
|
US
|
|
∗ 1st-line patient share broadly stable, some
competitive impact in relapsed refractory
setting
∗ Q1 2023
performance impacted by destocking following inventory build-up
that followed approval of the maleate tablet
formulation
|
|
Orpathys
Total Revenue of $9m (Q1 2022: $11m)
was driven by the 2021 launch in China,
where Orpathys is approved for patients with lung cancer
and MET[36] gene
alterations. Orpathys is now included in the updated NRDL in China
for the treatment of patients with NSCLC with MET exon 14 skipping
alterations.
Other Oncology medicines
|
Q1
2023
|
Change
|
|
Total
Revenue
|
|
$m
|
Actual
|
CER
|
|
Zoladex
|
|
235
|
(5%)
|
4%
|
∗ Increased use in ex-China Emerging
Markets
|
Faslodex
|
|
75
|
(19%)
|
(11%)
|
∗ Generic
competition
|
Other
Oncology
|
|
66
|
(32%)
|
(27%)
|
∗ Includes Iressa, Arimidex, Casodex and other older
medicines
|
|
|
|
|
|
|
|
BioPharmaceuticals
BioPharmaceuticals Total Revenue decreased by 19%
(15% at CER) in Q1 2023 to $4,545m, representing 42% of overall
Total Revenue (Q1 2022: 49%). The decrease was driven by declining
revenues from COVID-19 medicines. Growth
from Farxiga and newer R&I medicines offset decreases
in some older medicines.
BioPharmaceuticals - CVRM
CVRM Total Revenue increased by 15% (22% at CER)
to $2,557m in Q1 2023, driven by a strong Farxiga performance, and represented 24% of overall
Total Revenue (Q1 2022: 19%).
Farxiga
Total
Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1
2023 $m
|
|
1,324
|
|
296
|
498
|
393
|
138
|
Actual
change
|
|
32%
|
|
53%
|
27%
|
24%
|
39%
|
CER
change
|
|
39%
|
|
53%
|
35%
|
31%
|
53%
|
Region
|
|
Drivers
and commentary
|
Worldwide
|
|
∗ Farxiga volume
is growing faster than the overall SGLT2[37] market
in all major regions
∗ Additional benefit from continued growth in the
overall SGLT2 inhibitor class
∗ Further HF[38] and
CKD[39] launches
and supportive updates to treatment guidelines including from
ESC[40] and
AHA[41]/ACC[42]/HFSA[43].
HF and CKD indications now launched in >100
markets
|
US
|
|
∗ Growth
driven by HFrEF[44] and
CKD for patients with and without T2D[45]
∗ Favourable gross-to-net impact in the
quarter
∗ Farxiga continued
to gain in-class brand share, driven by HF and CKD
launches
|
Emerging
Markets
|
|
∗ Growth
despite generic competition in some markets. Solid growth in
ex-China Emerging Markets, particularly Latin
America
|
Europe
|
|
∗ Benefited from the addition of cardiovascular
outcomes trial data to the label, the HFrEF regulatory approval in
November 2020, and CKD regulatory approval in August 2021.
HFpEF[46] approval
in February 2023
∗ Continued strong volume growth in the quarter
partially offset by clawbacks
|
Established
RoW
|
|
∗ In
Japan, AstraZeneca sells to collaborator Ono Pharmaceutical Co.,
Ltd, which records in-market sales. Continued volume growth driven
by HF and CKD launches. A milestone payment from Ono was recorded
in the quarter
|
Brilinta
Total
Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1
2023 $m
|
|
334
|
|
179
|
82
|
67
|
6
|
Actual
change
|
|
3%
|
|
8%
|
19%
|
(12%)
|
(59%)
|
CER
change
|
|
5%
|
|
8%
|
25%
|
(7%)
|
(53%)
|
Region
|
|
Drivers
and commentary
|
US
|
|
∗ Favourable comparison due to COVID-19 impact in Q1
2022
|
Emerging
Markets
|
|
∗ Growth
in all major Emerging Markets regions following COVID-19
recovery
|
Europe
|
|
∗ European sales negatively impacted by
clawbacks
|
Lokelma
Total Revenue increased 56% (64% at CER) to $98m
in Q1 2023. Continued progress in Europe, with strong volume
growth. In China, Lokelma was enlisted to the NRDL in January 2022 and
is now the leading potassium binder in the
country.
roxadustat
Total
Revenue increased 52% (66% at CER) to $62m, with roxadustat
benefitting from increased volumes in China following NRDL renewal
in 2022.
Andexxa
Total
Revenue increased 2% (8% at CER) to $44m.
Other CVRM medicines
|
Q1
2023
|
Change
|
|
Total
Revenue
|
|
$m
|
Actual
|
CER
|
|
Crestor
|
|
306
|
14%
|
23%
|
∗ Strong
sales growth in Emerging Markets, partly offset by declines in the
US and Established RoW
|
Seloken
|
|
179
|
(27%)
|
(20%)
|
∗ Emerging Markets sales impacted
by China VBP implementation of Betaloc[47] oral
in H2 2021. Betaloc ZOK VBP
was implemented in Q4 2022
|
Onglyza
|
|
63
|
(8%)
|
(3%)
|
∗ Continued decline for DPP-IV
class
|
Bydureon
|
|
45
|
(33%)
|
(32%)
|
∗ Continued competitive
pressures
|
Other
CVRM
|
|
102
|
4%
|
9%
|
|
|
|
|
|
|
|
|
BioPharmaceuticals - R&I
Total Revenue of $1,633m from R&I medicines in
Q1 2023 increased 3% (8% at CER) and represented 15% of overall
Total Revenue (Q1 2022: 14%). This reflected growth in launch
brands: Fasenra, Tezspire, Breztri and Saphnelo.
Symbicort
Total
Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1
2023 $m
|
|
688
|
|
233
|
229
|
147
|
79
|
Actual
change
|
|
2%
|
|
(10%)
|
37%
|
(6%)
|
(14%)
|
CER
change
|
|
7%
|
|
(10%)
|
48%
|
(1%)
|
(7%)
|
Region
|
|
Drivers
and commentary
|
Worldwide
|
|
∗ Symbicort remains the global market leader within a
stable ICS[48]/LABA[49] class
|
US
|
|
∗ Market share resilience,
consolidating leadership in a declining ICS/LABA
market
∗ Generic
entry expected in the US in 2023
|
Emerging
Markets
|
|
∗ Post-COVID-19 recovery in China and
channel inventory rebuild
|
Europe
|
|
∗ Resilient market share in growing
ICS/LABA market, offset by pricing pressure
|
Established
RoW
|
|
∗ Inventory destocking in some markets
and generic erosion in Japan
|
Fasenra
Total
Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1
2023 $m
|
|
338
|
|
201
|
14
|
88
|
35
|
Actual
change
|
|
10%
|
|
6%
|
>2x
|
17%
|
(4%)
|
CER
change
|
|
13%
|
|
6%
|
>2x
|
23%
|
7%
|
Region
|
|
Drivers
and commentary
|
Worldwide
|
|
∗ Continues to be market leader in
severe eosinophilic asthma in major markets, and leads in the
IL-5[50] class
|
US
|
|
∗ Strong underlying demand growth,
partially offset in the quarter by inventory dynamics
|
Emerging
Markets
|
|
∗ Strong volume growth driven by
launch acceleration across key markets
|
Europe
|
|
∗ Expanded leadership in severe
eosinophilic asthma
|
Established
RoW
|
|
∗ Maintained leadership of the
dynamic market[51] in
Japan
|
Breztri
Total
Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1
2023 $m
|
|
144
|
|
81
|
38
|
15
|
10
|
Actual
change
|
|
67%
|
|
53%
|
71%
|
>3x
|
52%
|
CER
change
|
|
73%
|
|
53%
|
85%
|
>3x
|
73%
|
Region
|
|
Drivers
and commentary
|
Worldwide
|
|
∗ Continues to gain market share
within the growing FDC[52] triple
class across major markets
|
US
|
|
∗ Consistent share growth within the FDC
triple class in new-to-brand[53] and
total market
|
Emerging
Markets
|
|
∗ Maintained market share
leadership in China within the FDC triple class
|
Europe
|
|
∗ Sustained growth across markets as
new launches continue to progress
|
Established
RoW
|
|
∗ Increasing new-to-brand market share within
COPD plus ACO[54] in
Japan
|
Saphnelo
Total
Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1
2023 $m
|
|
47
|
|
44
|
-
|
1
|
2
|
Actual
change
|
|
>4x
|
|
>4x
|
n/m
|
>3x
|
>4x
|
CER
change
|
|
>4x
|
|
>4x
|
n/m
|
>4x
|
>5x
|
Region
|
|
Drivers
and commentary
|
Worldwide
|
|
∗ Demand acceleration in the US,
where Saphnelo has
new-to-brand leadership in the i.v.[55]
segment for SLE[56],
and the ongoing launches in Europe and Japan
|
Tezspire
Total
Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1
2023 $m
|
|
54
|
|
43
|
-
|
7
|
4
|
Actual
change
|
|
>10x
|
|
>10x
|
n/m
|
n/m
|
n/m
|
CER
change
|
|
>10x
|
|
>10x
|
n/m
|
n/m
|
n/m
|
Region
|
|
Drivers
and commentary
|
Worldwide
|
|
∗ Tezspire is
approved in the US, EU and Japan (as well as other countries) for
the treatment of severe asthma without biomarker or phenotypic
limitation.
∗ Amgen
records sales in the US, and AstraZeneca records its share of US
gross profits as Alliance Revenue
∗ AstraZeneca books Product Sales in markets outside
the US
∗ Combined sales of Tezspire by AstraZeneca and Amgen were $105m in the
quarter
|
US
|
|
∗ Increasing new-to-brand market share with majority
of patients new to biologics
|
Europe
|
|
∗ Achieved and maintained new-to-brand leadership in
key markets
∗ Pre-filled pen approved in January
2023
|
Established
RoW
|
|
∗ Japan
achieved new-to-brand leadership by month two
|
Other R&I medicines
|
Q1
2023
|
%
Change
|
|
Total
Revenue
|
|
$m
|
Actual
|
CER
|
|
Pulmicort
|
|
221
|
2%
|
9%
|
∗ Revenues increased in Emerging
Markets with continued recovery of nebulisation demand post
COVID-19 and market share in China stabilising
∗ Revenue from the US declined
54%
|
Bevespi
|
|
15
|
(1%)
|
2%
|
|
Daliresp
|
|
13
|
(75%)
|
(75%)
|
∗ Impacted by uptake of multiple
generics following loss of exclusivity in the US
|
Other
R&I
|
|
113
|
(48%)
|
(45%)
|
∗ Collaboration Revenue of $nil (Q1 2022:
$70m)
∗ Product
Sales of $106m decreased 27% (22% at CER) due to generic
competition
|
|
|
|
|
|
|
|
|
BioPharmaceuticals - V&I
Total
Revenue from V&I medicines declined by 80% (79% at CER) to
$355m (Q1 2022: $1,814m) and represented 3% of overall Total
Revenue (Q1 2022: 16%).
COVID-19 mAbs
Total
Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1
2023 $m
|
|
127
|
|
-
|
8
|
4
|
115
|
Actual
change
|
|
(73%)
|
|
n/m
|
(91%)
|
(94%)
|
>10x
|
CER
change
|
|
(70%)
|
|
n/m
|
(91%)
|
(94%)
|
>10x
|
Region
|
|
Drivers
and commentary
|
US
|
|
∗ No
revenue in the quarter following the completion of US government
contract deliveries in Q4 2022, and the revision
of Evusheld's emergency use authorisation in January
2023
|
Established
RoW
|
|
∗ Deliveries in Japan
|
Vaxzevria
Total
Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1
2023 $m
|
|
28
|
|
-
|
18
|
10
|
-
|
Actual
change
|
|
(98%)
|
|
n/m
|
(97%)
|
(93%)
|
n/m
|
CER
change
|
|
(97%)
|
|
n/m
|
(97%)
|
(92%)
|
n/m
|
Region
|
|
Drivers
and commentary
|
Worldwide
|
|
∗ Revenue
in the quarter decreased by 98% (97% at CER) due to the conclusion
of Vaxzevria contracts
|
Other V&I medicines
|
Q1
2023
|
%
Change
|
|
Total
Revenue
|
|
$m
|
Actual
|
CER
|
|
Synagis
|
|
198
|
(1%)
|
5%
|
|
FluMist
|
|
2
|
n/m
|
n/m
|
∗ Normal seasonality
|
|
|
|
|
|
|
|
|
Rare Disease
Total
Revenue from Rare Disease medicines increased by 10% (14% at CER)
in Q1 2023 to $1,866m, representing 17% of overall Total Revenue
(Q1 2022: 15%).
Performance was driven by the durability of the
C5[57] franchise, Soliris and Ultomiris growth
in neurology indications and expansion into new
markets.
Soliris
Total
Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1
2023 $m
|
|
834
|
|
448
|
115
|
183
|
88
|
Actual
change
|
|
(16%)
|
|
(24%)
|
63%
|
(17%)
|
(18%)
|
CER
change
|
|
(13%)
|
|
(24%)
|
77%
|
(12%)
|
(10%)
|
Region
|
|
Drivers
and commentary
|
US
|
|
∗ Performance impacted by
successful conversion of Soliris patients
to Ultomiris in
PNH, aHUS[58] and
gMG[59],
partially offset by Soliris growth
in NMOSD
|
Emerging
Markets
|
|
∗ Growth
from expansion into new markets and favourable timing of tender
orders in some markets
|
Europe,Established
RoW
|
|
∗ Decline
driven by successful conversion of Soliris patients to Ultomiris, slightly offset by growth in
NMOSD
|
Ultomiris
Total
Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1
2023 $m
|
|
651
|
|
381
|
13
|
159
|
98
|
Actual
change
|
|
55%
|
|
73%
|
(46%)
|
52%
|
39%
|
CER
change
|
|
61%
|
|
73%
|
(45%)
|
61%
|
61%
|
Region
|
|
Drivers
and commentary
|
Worldwide
|
|
∗ Performance driven by gMG launch in the US and
expansion into new markets
∗ Quarter-on-quarter variability in revenue growth
can be expected due to Ultomiris every eight-week dosing schedule and lower
average annual treatment cost per patient compared
to Soliris
|
US
|
|
∗ Performance driven by successful conversion
from Soliris across PNH, aHUS and gMG
|
Emerging
Markets
|
|
∗ Impacted by inventory movements at third-party
distributors due to AstraZeneca bringing distribution
in-house
|
Europe
|
|
∗ Growth
driven by strong demand generation following new launch
markets
|
Established
RoW
|
|
∗ Rapid
conversion from Soliris in Japan
|
Strensiq
Total
Revenue
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Q1
2023 $m
|
|
262
|
|
205
|
15
|
21
|
21
|
Actual
change
|
|
26%
|
|
28%
|
70%
|
10%
|
7%
|
CER
change
|
|
28%
|
|
28%
|
58%
|
17%
|
22%
|
Region
|
|
Drivers
and commentary
|
Worldwide
|
|
∗ Performance driven by strong patient demand and
geographic expansion
|
Other Rare Disease medicines
|
Q1
2023
|
%
Change
|
|
Total
Revenue
|
|
$m
|
Actual
|
CER
|
Commentary
|
Koselugo
|
|
79
|
>2x
|
>2x
|
∗ Growth
driven by expansion in new markets
|
Kanuma
|
|
40
|
4%
|
6%
|
∗ Continued demand growth in ex-US
markets
|
|
|
|
|
|
|
|
|
Other medicines (outside the main therapy areas)
|
Q1
2023
|
%
Change
|
|
Total
Revenue
|
|
$m
|
Actual
|
CER
|
Commentary
|
Nexium
|
|
248
|
(26%)
|
(20%)
|
∗ Generic
launches in Japan in the latter part of 2022
|
Others
|
|
72
|
(26%)
|
(22%)
|
∗ Continued impact of generic
competition
|
|
|
|
|
|
|
|
|
Financial performance
Table 11: Reported Profit and Loss
|
|
Q1 2023
|
Q1 2022
|
% Change
|
|
|
|
$m
|
$m
|
Actual
|
CER
|
Total Revenue
|
|
10,879
|
11,390
|
(4)
|
-
|
- Product Sales
|
|
10,566
|
10,980
|
(4)
|
1
|
- Alliance Revenue
|
|
286
|
152
|
88
|
90
|
- Collaboration Revenue
|
|
27
|
258
|
(89)
|
(89)
|
Cost
of sales
|
|
(1,905)
|
(3,511)
|
(46)
|
(43)
|
Gross profit
|
|
8,974
|
7,879
|
14
|
19
|
Gross Margin
|
|
82.0%
|
68.0%
|
+14pp
|
+14pp
|
Distribution
expense
|
|
(134)
|
(125)
|
7
|
12
|
% Total Revenue
|
|
1.2%
|
1.1%
|
-
|
-
|
R&D
expense
|
|
(2,611)
|
(2,133)
|
22
|
28
|
% Total Revenue
|
|
24.0%
|
18.7%
|
-5pp
|
-5pp
|
SG&A
expense
|
|
(4,059)
|
(4,840)
|
(16)
|
(13)
|
% Total Revenue
|
|
37.3%
|
42.5%
|
+5pp
|
+5pp
|
OOI[60] &
expense
|
|
379
|
97
|
>3x
|
>3x
|
% Total Revenue
|
|
3.5%
|
0.9%
|
+3pp
|
+2pp
|
Operating profit
|
|
2,549
|
878
|
>2x
|
>2x
|
Operating Margin
|
|
23.4%
|
7.7%
|
+16pp
|
+16pp
|
Net
finance expense
|
|
(287)
|
(319)
|
(10)
|
(8)
|
Joint
ventures and associates
|
|
-
|
(6)
|
(96)
|
(96)
|
Profit before tax
|
|
2,262
|
553
|
>4x
|
>4x
|
Taxation
|
|
(458)
|
(165)
|
>2x
|
>2x
|
Tax
rate
|
|
20%
|
30%
|
|
|
Profit after tax
|
|
1,804
|
388
|
>4x
|
>4x
|
Earnings per share
|
|
$1.16
|
$0.25
|
>4x
|
>4x
|
|
|
|
|
|
|
|
Table 12: Reconciliation of Reported Profit before tax
to EBITDA
|
|
Q1 2023
|
Q1 2022
|
% Change
|
|
|
|
$m
|
$m
|
Actual
|
CER
|
Reported
Profit before tax
|
|
2,262
|
553
|
>4x
|
>4x
|
Net
finance expense
|
|
287
|
319
|
(10)
|
(8)
|
Joint
ventures and associates
|
|
-
|
6
|
(96)
|
(96)
|
Depreciation,
amortisation and impairment
|
|
1,502
|
1,309
|
15
|
18
|
EBITDA
|
|
4,051
|
2,187
|
85
|
92
|
|
|
|
|
|
|
|
EBITDA
for the comparative Q1 2022 was negatively impacted by $1,180m
unwind of inventory fair value uplift recognised on the acquisition
of Alexion. This unwind had $36m negative impact on Q1 2023 and
will continue to be minimal in future quarters.
Table 13: Reconciliation of Reported to Core financial
measures: Q1 2023
Q1 2023
|
|
Reported
|
Restructuring
|
Intangible Asset Amortisation & Impairments
|
Acquisitionof Alexion
|
Other
|
Core
|
Core
% Change
|
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
Gross profit
|
|
8,974
|
95
|
8
|
37
|
2
|
9,116
|
-
|
4
|
Gross Margin
|
|
82.0%
|
|
|
|
|
83.3%
|
+4pp
|
+4pp
|
Distribution
expense
|
|
(134)
|
-
|
-
|
-
|
-
|
(134)
|
8
|
13
|
R&D
expense
|
|
(2,611)
|
30
|
280
|
2
|
(1)
|
(2,300)
|
5
|
10
|
SG&A
expense
|
|
(4,059)
|
41
|
954
|
2
|
8
|
(3,054)
|
4
|
8
|
Total
operating expense
|
|
(6,804)
|
71
|
1,234
|
4
|
7
|
(5,488)
|
4
|
9
|
Other
operating income & expense
|
|
379
|
(61)
|
-
|
-
|
-
|
318
|
>3x
|
>3x
|
Operating profit
|
|
2,549
|
105
|
1,242
|
41
|
9
|
3,946
|
-
|
4
|
Operating Margin
|
|
23.4%
|
|
|
|
|
36.3%
|
+2pp
|
+1pp
|
Net
finance expense
|
|
(287)
|
-
|
-
|
-
|
47
|
(240)
|
(4)
|
(3)
|
Taxation
|
|
(458)
|
(24)
|
(231)
|
(9)
|
(9)
|
(731)
|
(5)
|
(1)
|
EPS
|
|
$1.16
|
$0.05
|
$0.66
|
$0.02
|
$0.03
|
$1.92
|
1
|
6
|
|
|
|
|
|
|
|
|
|
|
|
Profit and Loss drivers
Gross profit
-
The change in Gross Margin (Reported and Core) in the quarter was
impacted by:
-
Positive mix effects. The increased
contribution from Rare Disease and Oncology medicines had a
positive impact on the Gross Margin. Vaxzevria sales, which are also dilutive to gross margin,
declined substantially
-
Negative mix effects. The rising
contribution of Product Sales with profit sharing arrangements
(Lynparza,
Enhertu and Tezspire) has a negative impact on gross margin
because AstraZeneca records product revenues in certain markets but
pays away half of the gross profit to its collaboration partners.
Emerging Markets, where gross margins tend to be below the Company
average, grew as a proportion of Total Revenue excluding COVID-19
medicines
-
Positive impact from cost of production in prior
periods
-
Reported Gross profit was also impacted by a reduction in the
unwind of the fair value adjustment to Alexion inventories at the
date of acquisition. In Q1 2023, the negative impact of the fair
value uplift unwind on Cost of Sales was $36m (Q1
2022: $1,180m)
-
Variations in Gross Margin performance between periods can continue
to be expected, due to product seasonality, foreign exchange
fluctuations, cost inflation and other effects. The full impact of
cost inflation is not seen in the Income Statement until older
inventory built at lower cost has been sold; for some product lines
the lag between inflation and impact can be several quarters
R&D expense
-
The change in R&D expense (Reported and Core) 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
Reported
R&D expense was also impacted by intangible asset impairments
in the quarter, and reversals of intangible asset impairments in Q1
2022
SG&A expense
-
The change in SG&A Expense (Reported and Core) was driven
primarily by market development activities for launches
-
Reported SG&A Expense was also impacted by amortisation of
intangible assets related to the Alexion acquisition and other
acquisitions and collaborations. In Q1 2022, the Reported SG&A
expense included a $775m legal settlement with Chugai
Pharmaceutical Co. Ltd
Other operating income
Reported Other operating income of $379m included
a gain on the disposal of the US rights to Pulmicort Flexhaler, disposal proceeds on the sale of tangible
assets, and royalties on certain medicines
Net finance expense
-
The reduction in Net finance expense (Reported and Core) was
primarily driven by an increase in finance income on cash
investments, which benefited from higher interest rates. That was
partially offset by increased interest expense on floating rate
debt, and the interest on the $3.8bn of bonds issued in the
quarter
-
Reported Net finance expense also benefited from a reduction in the
discount unwind on acquisition related liabilities
Taxation
-
The effective Reported Tax rate for the three months to 31 March
2023 was 20% (Q1 2022: 30%) and the Core Tax rate was 20% (Q1 2022:
21%). The Reported Tax rate in the prior period was impacted by
Non-Core charges on the level of Reported Profit before tax
-
The net cash paid for the quarter was $225m (Q1 2022: $228m)
representing 10% of Reported Profit before tax (Q1 2022: 41%). The
cash tax rate of 10% benefits from the phasing of tax
payments
-
On 23 March 2023, the UK Government presented the draft legislation
in relation to the new global minimum tax framework to the House of
Commons and this is now proceeding through the UK Parliamentary
process. This is expected to be brought into effect in the UK from
2024. The Company is currently assessing the potential impact of
these draft rules upon its financial statements
Table 14: Cash Flow summary
|
|
Q1 2023
|
Q1 2022
|
Change
|
|
|
$m
|
$m
|
$m
|
Reported
Operating profit
|
|
2,549
|
878
|
1,671
|
Depreciation,
amortisation and impairment
|
|
1,502
|
1,309
|
193
|
Decrease
in working capital and short-term provisions
|
|
242
|
1,804
|
(1,562)
|
Gains
on disposal of intangible assets
|
|
(249)
|
(10)
|
(239)
|
Non-cash
and other movements
|
|
(429)
|
(327)
|
(102)
|
Interest
paid
|
|
(257)
|
(194)
|
(63)
|
Taxation
paid
|
|
(225)
|
(228)
|
3
|
Net cash inflow from operating activities
|
|
3,133
|
3,232
|
(99)
|
Net cash inflow before financing activities
|
|
1,887
|
3,064
|
(1,177)
|
Net cash outflow from financing activities
|
|
(2,031)
|
(3,740)
|
1,709
|
In
Q1 2022, the Reported Operating profit of $878m included a negative
impact of $1,180m relating to the unwind of the inventory fair
value uplift recognised on the acquisition of Alexion. This was
offset by a corresponding item (positive impact of $1,180m) in
Decrease in working capital and short-term provisions. Overall, the
unwind of the fair value uplift had no impact on Net cash inflow
from operating activities. This unwind had $36m negative impact on
Q1 2023 and will continue to be minimal in future
quarters.
The
change in Net cash inflow before financing activities is primarily
driven by the movement in Purchase of intangible assets of $1,079m,
including the acquisition of CinCor, in the quarter to 31 March
2023.
The
change in Net cash outflow from financing activities is primarily
driven by the issue of bonds of $3,826m, offset by the repayment of
loans and borrowings of $2,004m and dividends paid of $3,047m in
the quarter to 31 March 2023.
Included
within Net cash inflow before financing activities is a movement in
the profit-participation liability of $175m, resulting from the
cash receipt from Sobi in Q1 2023 after achievement of a regulatory
milestone. The associated cash flow is presented within investing
activities.
Capital expenditure
Capital
expenditure amounted to $247m in the quarter (Q1 2022:
$219m).
Table 15: Net debt summary
|
|
At 31
Mar 2023
|
At 31
Dec 2022
|
At 31
Mar 2022
|
|
|
$m
|
$m
|
$m
|
Cash
and cash equivalents
|
|
6,232
|
6,166
|
5,762
|
Other
investments
|
|
230
|
239
|
61
|
Cash and investments
|
|
6,462
|
6,405
|
5,823
|
Overdrafts
and short-term borrowings
|
|
(667)
|
(350)
|
(805)
|
Lease
liabilities
|
|
(962)
|
(953)
|
(949)
|
Current
instalments of loans
|
|
(2,958)
|
(4,964)
|
(1,264)
|
Non-current
instalments of loans
|
|
(26,916)
|
(22,965)
|
(28,081)
|
Interest-bearing loans and borrowings (Gross debt)
|
|
(31,503)
|
(29,232)
|
(31,099)
|
Net
derivatives
|
|
(21)
|
(96)
|
59
|
Net debt
|
|
(25,062)
|
(22,923)
|
(25,217)
|
Net
debt increased by $2,139m in the quarter to date to $25,062m.
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 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 0.700% Notes
due 2024, 1.200% Notes due 2026, 1.750% Notes due 2028, 4.875%
Notes due 2028, 4.900% Notes due 2030, 2.250% Notes due 2031 and
4.875% Notes due 2033 (the "AstraZeneca Finance Notes"). Each
series of AstraZeneca Finance Notes has been fully and
unconditionally guaranteed by AstraZeneca PLC. AstraZeneca Finance
is 100% owned by AstraZeneca PLC and each of the guarantees 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[61] 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 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 16: Obligor group summarised Statement of
comprehensive income
|
|
Q1 2023
|
Q1 2022
|
|
|
$m
|
$m
|
Total
Revenue
|
|
-
|
-
|
Gross
profit
|
|
-
|
-
|
Operating
loss
|
|
-
|
(1)
|
Loss
for the period
|
|
(237)
|
(155)
|
Transactions
with subsidiaries that are not issuers or guarantors
|
|
7,502
|
164
|
Table 17: Obligor group summarised Statement of
financial position
|
|
At 31 Mar 2023
|
At 31 Mar 2022
|
|
|
$m
|
$m
|
Current
assets
|
|
10
|
19
|
Non-current
assets
|
|
-
|
-
|
Current
liabilities
|
|
(2,952)
|
(1,682)
|
Non-current
liabilities
|
|
(26,747)
|
(25,605)
|
Amounts
due from subsidiaries that are not issuers or
guarantors
|
|
14,067
|
8,652
|
Amounts
due to subsidiaries that are not issuers or guarantors
|
|
(296)
|
(297)
|
Foreign exchange
The
Company's transactional currency exposures on working-capital
balances, which typically extend for up to three months, are hedged
where practicable using forward foreign exchange contracts against
the individual companies' reporting currency. Foreign exchange
gains and losses on forward contracts for transactional hedging are
taken to profit or loss. In addition, the Company's external
dividend payments, paid principally in pounds sterling and Swedish
krona, are fully hedged from announcement to payment
date.
Table 18: Currency sensitivities
The
Company provides the following currency-sensitivity
information:
|
|
|
Average
rates vs USD
|
|
Annual impact
($m) of 5% strengthening (FY2023 average rate vs FY 2022
average) [62]
|
Currency
|
Primary Relevance
|
|
FY
2022[63]
|
YTD 2023[64]
|
Change
(%)
|
Mar
2023[65]
|
Change[66]
(%)
|
|
Total Revenue
|
Core Operating Profit
|
EUR
|
Total
Revenue
|
|
0.95
|
0.93
|
2
|
0.93
|
2
|
|
323
|
159
|
CNY
|
Total
Revenue
|
|
6.74
|
6.85
|
(1)
|
6.90
|
(2)
|
|
309
|
174
|
JPY
|
Total
Revenue
|
|
131.59
|
132.35
|
(1)
|
133.77
|
(2)
|
|
181
|
122
|
Other[67]
|
|
|
|
|
|
|
|
|
385
|
202
|
GBP
|
Operating
expense
|
|
0.81
|
0.82
|
(2)
|
0.82
|
(2)
|
|
46
|
(92)
|
SEK
|
Operating
expense
|
|
10.12
|
10.43
|
(3)
|
10.47
|
(3)
|
|
7
|
(55)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sustainability
Since
the last quarterly report, AstraZeneca:
Access to healthcare
-
Partnership for Health System Sustainability and Resilience (PHSSR)
published country reports in Belgium, Ireland, and the Netherlands,
and key findings were presented at events held in those countries.
PHSSR also launched a health system sustainability index in Germany
in collaboration with key stakeholders. AstraZeneca is a founding
member and one of six global partners of the PHSSR, which is now
active in more than 30 countries worldwide
-
Strengthened healthcare innovation in China, partnering with
government and the healthcare ecosystem, building on the Company's
position as an industry leader and on its 30-year history. During
events attended by CEO Pascal Soriot, the Company made the
following announcements:
-
New investment to build a
manufacturing plant in Qingdao city to
produce Breztri pressurised metered-dose inhalers (pMDI) for
COPD patients in China. The local investment provides increased
access to a life-changing medicine for Chinese patients to meet a
very significant unmet need, and helps to tackle the burden of COPD
on the health system in China
-
Partnership with Shandong province to establish an innovative rare
diseases diagnosis and treatment hub
-
Partnership with the Chinese Red Cross Foundation to revitalise
rural parts of China through an RMB 30 million investment to
enhance health services and support disaster relief
-
Healthy Heart Africa programme launched in eight of 10 new
countries planned by 2024, working with implementing partners ACHAP
and PATH, in addition to the existing nine countries of operation.
Over 34 million blood pressure screenings have been conducted since
screenings began in 2015, with over one million screenings in
February alone, and more than 10,600 healthcare workers trained to
date, as at end of February 2023
-
Renewed Young Health Programme commitments in five countries
(Canada, France, Italy, Israel and Sweden). Directly reached more
than 700,000 young people with health information and trained more
than 35,000 young people, healthcare professionals and others, in
39 countries
-
A.Catalyst Network, AstraZeneca's interconnected and dynamic global
network of more than 20 health innovation hubs, has now launched in
Africa. The Africa health innovation hub will focus on disease
education, early diagnosis, technology and data generation, to
reduce mortality rates and improve patient quality of life. The
Company also signed a partnership with MedSol Ai Solutions to
develop Melusi Breast AI, a state-of-the-art Wi-Fi ultrasound probe
for rapid breast cancer detection
Environmental protection
o
CEO Pascal Soriot convened the SMI Health Systems Task Force which
announced joint minimum climate and sustainability targets for
pharmaceutical suppliers in March 2023, to address greenhouse gas
emissions across the value chain and reduce the complexity for
suppliers of multiple requirements
o
The Company's commitment to reducing its Scope 3 indirect
greenhouse gas emissions is shown by its target of 95% of suppliers
by spend covering purchased goods and services and capital goods,
and 50% of suppliers by spend covering upstream transportation and
distribution and business travel, to have science-based targets by
the end of 2025. AstraZeneca was also recognised in March by CDP as
a 2022 Supplier Engagement Rating Leader
o
Committed to the Business Leaders' Open Call to Accelerate Action
on Water, which coincided with the UN 2023 Water Conference. The
Company's efforts are underpinned by a partnership with the WWF and
membership of the Alliance for Water Stewardship. AstraZeneca works
with suppliers and across sectors to improve water resilience,
focusing on 100 priority water basins. Starting in 2024, the
Company will invest $5 million per year to fund nature restoration
and water stewardship projects in the communities where it
operates. Details are included in the Biodiversity Statement,
published alongside the 2022 Sustainability Report and Data
Summary
o
Marked UN International Day of Forests by reflecting on AZ Forest
progress. AZ Forest is the Company's global initiative to plant and
maintain over 50 million trees worldwide by end of 2025, in
partnership with expert delivery partners focused on forest
landscape restoration, and by investing in community-led projects
adapted to the local context. More than 10.5 million trees have
been planted to date in Australia, Ghana, Indonesia, the UK and the
US
Ethics and transparency
-
Marked International Women's Day (IWD) in March, including an
article published on "championing women in the workplace and
beyond", highlighting what AstraZeneca is doing to champion women
and promote a culture of inclusion and diversity, including
advancing women's careers in science, technology, engineering, and
mathematics (STEM) inside and outside the Company. AstraZeneca also
recognised UN International Day of Women and Girls in Science in
February, a day dedicated to promoting equal access for women and
girls to participate in STEM careers. Currently 39.8% of
STEM-related positions at AstraZeneca are held by women
-
Marked UN International Day for the Elimination of Racial
Discrimination in March, with an update on the progress AstraZeneca
has made against its racial equity commitments since becoming a
founding member of the World Economic Forum Partnering for Racial
Justice in Business initiative
-
Recognised Neurodiversity Celebration Week across the organisation
with events across the organisation including an experience lab
designed to give colleagues an opportunity to experience what it is
like to live with autism, sensory processing disorder and other
neurodiversities
-
Reported the results of the first employee Ethics Survey 2022,
carried out to gain a deeper understanding of employee perspectives
on ethics at AstraZeneca and identify opportunities for
improvement. Almost 7,000 employees participated, 97% of whom know
how to raise a concern, with 88% saying it is easy to do the right
thing in their day-to-day work
Research and development
This
section covers R&D events and milestones that have occurred
since the prior results announcement on 9 February 2023, up to and
including events on 26 April 2023.
A comprehensive view of AstraZeneca's pipeline of
medicines in human trials can be found in the latest clinical
trials appendix, available on www.astrazeneca.com/investor-relations.
The clinical trials appendix includes tables with details of the
ongoing clinical trials for AstraZeneca medicines and new molecular
entities in the pipeline.
Oncology
AstraZeneca
presented new data across its diverse portfolio of cancer medicines
at two major medical congresses during the quarter: the 2023
American Society of Clinical Oncology Genitourinary Cancers
Symposium (ASCO GU) in February and American Association for Cancer
Research (AACR) in April. At ASCO GU, AstraZeneca presented 11
abstracts spanning three approved medicines and four pipeline
medicines. At AACR, AstraZeneca presented 70 abstracts showcasing
new data across 21 pipeline molecules and eight marketed products
across the oncology portfolio.
AstraZeneca
completed an exclusive global license agreement with KYM
Biosciences Inc. for CMG901, a potential first-in-class antibody
drug conjugate targeting Claudin 18.2, a promising therapeutic
target in gastric cancers, with a molecule monomethyl auristatin E
(MMAE) warhead. CMG901 is currently being evaluated in a Phase I
trial for the treatment of Claudin 18.2-positive solid tumours,
including gastric cancer with preliminary results showing an
encouraging profile for CMG901.
-
Significant new trials that achieved first patient dosed during the
period included:
-
CAMBRIA-1, a Phase III trial of camizestrant vs standard endocrine
therapy in ER+/HER2- early breast cancer after at least 2 years of
standard adjuvant endocrine therapy
Tagrisso
Event
|
|
|
Commentary
|
Phase
III trial read out
|
ADAURA
|
|
Met key secondary endpoint
demonstrating statistically significant and clinically
meaningful improvement in OS[68] compared
to placebo in the adjuvant treatment of patients with early-stage
EGFRm[69] NSCLC
after complete tumour resection with curative intent. (March
2023)
|
Imfinzi and Imjudo
Event
|
|
|
Commentary
|
Approval
|
EU
|
|
Imfinzi in combination with Imjudo for the 1st-line treatment of adult patients
with advanced or unresectable HCC. (HIMALAYA, February
2023)
|
|
|
|
Imfinzi in combination with Imjudo for the treatment of adult patients with
metastatic NSCLC. (POSEIDON, February 2023)
|
Presentation:
AACR
|
AEGEAN
|
|
Results from interim EFS analysis of the AEGEAN
Phase III trial, presented at AACR, demonstrated statistically
significant and clinically meaningful 32% reduction in risk of
disease recurrence, progression events or death
for Imfinzi in combination with neoadjuvant chemotherapy
before surgery and as adjuvant monotherapy after surgery versus
neoadjuvant chemotherapy alone followed by surgery for patients
with resectable early-stage NSCLC. (April 2023)
|
Lynparza
Event
|
|
|
Commentary
|
Presentation:
ASCO GU
|
PROpel
final OS
|
|
Results from the final prespecified OS analysis of
the PROpel Phase III trial, presented at ASCO GU,
demonstrated Lynparza in combination with abiraterone resulted in
median OS improvement of 7.4-months vs standard of care in mCRPC
(not statistically significant). (February
2023)
|
FDA
ODAC
|
US
|
|
The FDA will convene a meeting of the ODAC on 28
April 2023 to discuss the sNDA[70] for Lynparza in
combination with abiraterone for the treatment of mCRPC. (PROpel,
March 2023)
|
Phase
III trial read-out
|
DUO-O (Lynparza and Imfinzi)
|
|
Met
primary endpoint demonstrating a statistically significant and
clinically meaningful improvement in PFS versus chemotherapy plus
bevacizumab in newly diagnosed patients with advanced high-grade
epithelial ovarian cancer without tumour BRCA mutations. (April
2023)
|
Calquence
Event
|
|
|
Commentary
|
Approval
|
EU
|
|
Maleate
tablet formulation. (ELEVATE-PLUS, February 2023)
|
Conditional
approval
|
China
|
|
Patients
with mantle cell lymphoma who have received at least one prior
therapy. (ACE-LY-004 and Phase I/II trial in Chinese patients,
March 2023)
|
Enhertu
Event
|
|
|
Commentary
|
Approval
|
China
|
|
Patients
with unresectable or metastatic HER2-positive breast cancer who
have received one or more prior anti-HER2-based regimens, based on
DESTINY-Breast03 trial. (February 2023)
|
Phase
II read out
|
DESTINY-PanTumor02
|
|
Met
the prespecified target for objective response rate and
demonstrated durable response across multiple HER2-expressing
advanced solid tumours in heavily pre-treated patients.
(DESTINY-PanTumor02, March 2023)
|
BioPharmaceuticals - CVRM
eplontersen
Event
|
|
|
Commentary
|
Presentation:
AAN
|
NEURO-TTRansform
|
|
Detailed
results from the NEURO-TTRansform Phase III trial in patients with
hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN)
presented at the American Academy of Neurology (AAN) 2023 Annual
Meeting showed that eplontersen met all co-primary and secondary
endpoints at 66 weeks versus an external placebo group. (April
2023).
|
cotadutide
Event
|
|
|
Commentary
|
Termination
|
PROXYMO
ADVANCE
|
|
Strategic
decision to discontinue the development of once-daily cotadutide
and focus on AZD9550, a once-weekly injectable GLP-1 glucagon
co-agonist, and the broader NASH pipeline. (March
2023)
|
BioPharmaceuticals - R&I
Significant
new trials that achieved first patient dosed during the period
included:
‒ CROSSING, a Phase III trial
of Tezspire in eosinophilic
oesophagitis
Fasenra
Event
|
|
|
Commentary
|
Phase
III trial read-out
|
MIRACLE
|
|
Met
the primary endpoint, demonstrating a statistically significant
reduction in annual asthma exacerbation rate (AAER) over 48 weeks
compared to placebo in patients in China with a history of
uncontrolled asthma.
|
Phase
III trial read-out
|
TATE
|
|
Met
the primary endpoints, demonstrating that the safety and
tolerability profile in severe eosinophilic asthma patients aged 6
to 11 years was consistent with previous trials in patients ages 12
years and older.
|
BioPharmaceuticals - V&I
AstraZeneca
highlighted new data across its Vaccines and Immune Therapies
portfolio at the 33rd European Congress of Clinical Microbiology
& Infectious Diseases (ECCMID) in April 2023. The company
presented 15 abstracts, including four oral
presentations.
AZD3152
Event
|
|
|
Commentary
|
Presentation:
ECCMID 2023
|
US
|
|
AstraZeneca
presented the first in vitro neutralisation data on AZD3152,
including activity against past and currently circulating COVID-19
variants. The data showed that AZD3152 neutralises all known
variants of concern to date. (April 2023)
|
Flumist
Event
|
|
|
Commentary
|
Regulatory
approval
|
Japan
|
|
As previously announced in 2015, Daiichi Sankyo
has responsibility for the development and commercialisation
of FluMist Quadrivalent in
Japan, and holds the marketing authorisation following approval in
Japan in March 2023. AstraZeneca will
supply FluMist Quadrivalent to
Daiichi Sankyo, and will receive development milestones and
sales-related payments post launch. (March
2023)
|
Beyfortus
Event
|
|
|
Commentary
|
Publication:
Nature
|
MELODY
|
|
Serum samples were collected from 2,143 infants to
characterise the duration of RSV nAb[71] levels
following nirsevimab administration. Nirsevimab recipients had RSV
nAb levels >140-fold higher than baseline at day 31, and
remained >50-fold
higher
at day 151 and >7-fold higher at day 361. (April
2023)
|
Presentation:
ECCMID 2023
|
MUSIC
|
|
At
ECCMID 2023, AstraZeneca presented results from the MUSIC trial for
nirsevimab in immunocompromised children ≤ 24 months of age. A
single dose of nirsevimab was well tolerated and no safety concerns
arose over 151 days. (April 2023)
|
Contract
update
|
|
|
In April 2023, AstraZeneca, Sanofi and Sobi
simplified their contractual arrangements relating to the
development and commercialisation of nirsevimab in the US. The
updated arrangements replaced the cash flows from AstraZeneca to
Sobi with a royalty relationship between Sanofi and Sobi. Sanofi
continues to lead commercialisation globally, and AstraZeneca will
co-promote Beyfortus in the UK, Germany, Italy, Spain, Japan and
China. (April 2023)
|
Rare Disease
Alexion,
AstraZeneca Rare Disease, showcased the potential for its
pioneering therapies to redefine the treatment landscape for
certain rare neurological diseases at the American Academy of
Neurology (AAN) Annual Meeting. Alexion presented 18 abstracts,
including seven oral presentations, across generalised myasthenia
gravis (gMG), neuromyelitis optica spectrum disorder (NMOSD) and
dermatomyositis.
-
Significant new trials that achieved first patient dosed during the
period included:
-
ARTEMIS, a Phase III trial assessing
the efficacy of a single dose of Ultomiris compared with placebo in reducing the risk
of the clinical consequences of acute kidney injury in adult
participants with CKD who undergo non-emergent cardiac surgery with
cardiopulmonary bypass.
Ultomiris
Event
|
|
|
Commentary
|
Positive
opinion
|
EU
|
|
Recommended
for approval in the EU by CHMP for the treatment of adults with
NMOSD
|
ALXN1840
Event
|
|
|
Commentary
|
Termination
|
Wilson
Disease programme
|
|
In
April, the ALXN1840 programme in Wilson Disease was terminated. The
decision was based on feedback from regulators, on review of data
from the Wilson Disease programme, including the Phase III FoCus
and two Phase II mechanistic trials
|
Interim Financial Statements
Table 19: Condensed consolidated statement of comprehensive
income: Q1 2023
For the quarter ended 31 March
|
|
2023
|
2022
|
|
|
$m
|
$m
|
Total Revenue[72]
|
|
10,879
|
11,390
|
Product Sales
|
|
10,566
|
10,980
|
Alliance Revenue
|
|
286
|
152
|
Collaboration Revenue
|
|
27
|
258
|
Cost
of sales
|
|
(1,905)
|
(3,511)
|
Gross profit
|
|
8,974
|
7,879
|
Distribution
expense
|
|
(134)
|
(125)
|
Research
and development expense
|
|
(2,611)
|
(2,133)
|
Selling,
general and administrative expense
|
|
(4,059)
|
(4,840)
|
Other
operating income and expense
|
|
379
|
97
|
Operating profit
|
|
2,549
|
878
|
Finance
income
|
|
78
|
17
|
Finance
expense
|
|
(365)
|
(336)
|
Share
of after tax losses in associates and joint ventures
|
|
-
|
(6)
|
Profit before tax
|
|
2,262
|
553
|
Taxation
|
|
(458)
|
(165)
|
Profit for the period
|
|
1,804
|
388
|
Other comprehensive income
|
|
|
|
Items that will not be reclassified to profit or loss
|
|
|
|
Remeasurement
of the defined benefit pension liability
|
|
(10)
|
335
|
Net
gains on equity investments measured at fair value through other
comprehensive income
|
|
46
|
18
|
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
|
|
24
|
(94)
|
|
|
62
|
259
|
Items that may be reclassified subsequently to profit or
loss
|
|
|
|
Foreign
exchange arising on consolidation
|
|
314
|
(219)
|
Foreign
exchange arising on designated liabilities in net investment
hedges
|
|
(7)
|
(32)
|
Fair
value movements on cash flow hedges
|
|
56
|
5
|
Fair
value movements on cash flow hedges transferred to profit and
loss
|
|
(75)
|
11
|
Fair
value movements on derivatives designated in net investment
hedges
|
|
16
|
(8)
|
Tax
on items that may be reclassified subsequently to profit or
loss
|
|
12
|
1
|
|
|
316
|
(242)
|
Other comprehensive income, net of tax
|
|
378
|
17
|
Total comprehensive income for the period
|
|
2,182
|
405
|
Profit attributable to:
|
|
|
|
Owners
of the Parent
|
|
1,803
|
386
|
Non-controlling
interests
|
|
1
|
2
|
|
|
1,804
|
388
|
Total comprehensive income attributable to:
|
|
|
|
Owners
of the Parent
|
|
2,181
|
405
|
Non-controlling
interests
|
|
1
|
-
|
|
|
2,182
|
405
|
Basic
earnings per $0.25 Ordinary Share
|
|
$1.16
|
$0.25
|
Diluted
earnings per $0.25 Ordinary Share
|
|
$1.16
|
$0.25
|
Weighted
average number of Ordinary Shares in issue (millions)
|
|
1,549
|
1,548
|
Diluted
weighted average number of Ordinary Shares in issue
(millions)
|
|
1,560
|
1,561
|
Table 20: Condensed consolidated statement of financial
position
|
|
At 31 Mar
2023
|
At 31 Dec
2022
|
At 31 Mar
2022
|
|
|
$m
|
$m
|
$m
|
Assets
|
|
|
|
|
Non-current assets
|
|
|
|
|
Property,
plant and equipment
|
|
8,644
|
8,507
|
9,061
|
Right-of-use
assets
|
|
955
|
942
|
954
|
Goodwill
|
|
20,001
|
19,820
|
19,963
|
Intangible
assets
|
|
39,291
|
39,307
|
41,265
|
Investments
in associates and joint ventures
|
|
77
|
76
|
63
|
Other
investments
|
|
1,157
|
1,066
|
1,174
|
Derivative
financial instruments
|
|
116
|
74
|
87
|
Other
receivables
|
|
682
|
835
|
864
|
Deferred
tax assets
|
|
3,498
|
3,263
|
4,195
|
|
|
74,421
|
73,890
|
77,626
|
Current assets
|
|
|
|
|
Inventories
|
|
4,967
|
4,699
|
7,624
|
Trade
and other receivables
|
|
10,289
|
10,521
|
8,683
|
Other
investments
|
|
230
|
239
|
61
|
Derivative
financial instruments
|
|
40
|
87
|
54
|
Intangible
assets
|
|
-
|
-
|
96
|
Income
tax receivable
|
|
508
|
731
|
367
|
Cash
and cash equivalents
|
|
6,232
|
6,166
|
5,762
|
Assets
held for sale
|
|
-
|
150
|
-
|
|
|
22,266
|
22,593
|
22,647
|
Total assets
|
|
96,687
|
96,483
|
100,273
|
Liabilities
|
|
|
|
|
Current liabilities
|
|
|
|
|
Interest-bearing
loans and borrowings
|
|
(3,625)
|
(5,314)
|
(2,069)
|
Lease
liabilities
|
|
(232)
|
(228)
|
(225)
|
Trade
and other payables
|
|
(19,210)
|
(19,040)
|
(17,864)
|
Derivative
financial instruments
|
|
(44)
|
(93)
|
(35)
|
Provisions
|
|
(546)
|
(722)
|
(1,423)
|
Income
tax payable
|
|
(1,203)
|
(896)
|
(1,124)
|
|
|
(24,860)
|
(26,293)
|
(22,740)
|
Non-current liabilities
|
|
|
|
|
Interest-bearing
loans and borrowings
|
|
(26,916)
|
(22,965)
|
(28,081)
|
Lease
liabilities
|
|
(730)
|
(725)
|
(724)
|
Derivative
financial instruments
|
|
(133)
|
(164)
|
(47)
|
Deferred
tax liabilities
|
|
(2,795)
|
(2,944)
|
(5,626)
|
Retirement
benefit obligations
|
|
(1,128)
|
(1,168)
|
(1,991)
|
Provisions
|
|
(914)
|
(896)
|
(949)
|
Other
payables
|
|
(3,400)
|
(4,270)
|
(3,756)
|
|
|
(36,016)
|
(33,132)
|
(41,174)
|
Total liabilities
|
|
(60,876)
|
(59,425)
|
(63,914)
|
Net assets
|
|
35,811
|
37,058
|
36,359
|
Equity
|
|
|
|
|
Capital and reserves attributable to equity holders of the
Parent
|
|
|
|
|
Share
capital
|
|
387
|
387
|
387
|
Share
premium account
|
|
35,159
|
35,155
|
35,131
|
Other
reserves
|
|
2,068
|
2,069
|
2,050
|
Retained
earnings
|
|
(1,825)
|
(574)
|
(1,228)
|
|
|
35,789
|
37,037
|
36,340
|
Non-controlling
interests
|
|
22
|
21
|
19
|
Total equity
|
|
35,811
|
37,058
|
36,359
|
Table 21: Condensed consolidated statement of changes in
equity
|
|
Share capital
|
Share premium account
|
Other reserves
|
Retained earnings
|
Total attributable to owners of the parent
|
Non-controlling interests
|
Total equity
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
At 1 Jan 2022
|
|
387
|
35,126
|
2,045
|
1,710
|
39,268
|
19
|
39,287
|
Profit
for the period
|
|
-
|
-
|
-
|
386
|
386
|
2
|
388
|
Other
comprehensive income
|
|
-
|
-
|
-
|
19
|
19
|
(2)
|
17
|
Transfer
to other reserves
|
|
-
|
-
|
5
|
(5)
|
-
|
-
|
-
|
Transactions with owners
|
|
|