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 November 2022
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
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AstraZeneca PLC
INDEX
TO EXHIBITS
1. YTD and Q3 2022 Results
AstraZeneca
PLC
10
November 2022 07:00 GMT
YTD and Q3 2022 results
Record number of regulatory approvals and guidance uplift
underpinned by strong business performance
Revenue and EPS summary
|
|
|
YTD 2022
|
|
|
Q3 2022
|
|
|
|
|
% Change
|
|
% Change
|
|
|
$m
|
Actual
|
CER[1]
|
$m
|
Actual
|
CER
|
-
Product Sales
|
|
32,200
|
29
|
35
|
10,590
|
9
|
16
|
-
Collaboration Revenue
|
|
944
|
>2x
|
>2x
|
392
|
>3x
|
>3x
|
Total
Revenue
|
|
33,144
|
30
|
37
|
10,982
|
11
|
19
|
|
|
$1.54
|
>4x
|
>4x
|
$1.06
|
n/m
|
n/m
|
Core[4] EPS
|
|
$5.28
|
47
|
52
|
$1.67
|
55
|
70
|
YTD 2022 Financial
performance (growth numbers and commentary at CER[5])
‒ Total
Revenue increased 37% to $33,144m, with growth coming from all
disease areas, and from the addition of Alexion, which was
incorporated into the Group's results from 21 July
2021
‒ Oncology
Total Revenue increased 24%, inclusive of milestone payments from
MSD[6] for Lynparza.
Oncology Product Sales increased 20%. Total Revenue from
R&I[7] increased
4%, CVRM[8] increased
19%[9] and
Rare Disease increased 10%9
‒ Core
Gross Margin of 81%, up six percentage points at CER, reflecting
the lower revenue from initial Vaxzevria contracts and the increased share of
specialty care medicines
‒ Core
Total Operating Expense increased 26%, reflecting the addition of
Alexion, continued investment in new launches and the pipeline, to
deliver sustainable long-term growth
‒ Core
Operating Margin of 32%, up six percentage points at CER,
benefitting from favourable phasing and product
mix
‒ Core
EPS increased 52% to $5.28
‒ FY
2022 Core EPS at constant exchange rates now expected to increase
by a high twenties to low thirties percentage, vs previous guidance
of a mid-to-high twenties increase. At actual exchange rates, FY
2022 Core EPS growth is anticipated to be impacted by a currency
headwind[10] of
a mid-to-high single-digit percentage, versus previous guidance of
a mid single-digit headwind
Key milestones achieved since the prior results
‒ Key
data: Positive Phase III read-outs for danicopan in
PNH-EVH[11] (ALPHA)
and for capivasertib in 2nd-line HR-positive, metastatic breast
cancer (CAPItello-291)
‒ Key
regulatory approvals: 19 approvals in major markets since H1 2022
results, including US approvals for Enhertu in HER2[12]-low
breast cancer (DESTINY-Breast04) and advanced
NSCLC[13] (DESTINY-Lung02), Imjudo and Imfinzi in
advanced liver cancer (HIMALAYA), Imfinzi in advanced biliary tract cancer (TOPAZ-1);
EU approval for Beyfortus for the prevention of RSV[14] lower
respiratory tract disease (MELODY/MEDLEY); EU and Japan approvals
for Ultomiris in gMG[15] (CHAMPION-MG), Tezspire in
severe asthma (NAVIGATOR) and Lynparza in early breast cancer
(OlympiA)
‒ Other
regulatory milestones: US Priority Review
for Lynparza for 1st-line metastatic castration-resistant
prostate cancer (PROpel)
Pascal Soriot, Chief Executive Officer, AstraZeneca,
said:
"AstraZeneca continues to see
the benefit of our sustained investment in R&D,
with 19 major regulatory approvals
since our last earnings call.
After a strong performance in the year to date, we have increased
our Core EPS guidance for the full year 2022. Additionally, recent
encouraging data for several of our pipeline programmes have given
us the confidence to proceed with additional late-stage clinical
trials as we maintain our focus on delivery of our growth
ambitions.
I would also like to highlight the announcement at COP27 to
accelerate the delivery of our net zero strategy. Our company
intends to lead by example on this increasingly important objective
for the world."
Guidance
The Company updates its FY 2022 guidance at CER,
due to the strong performance in the year to date. The guided range
for FY 2022 Core EPS has been increased to a high
twenties to low thirties percentage; the final outcome within that
range will depend on the timing of Evusheld deliveries and collaboration milestones
linked to regulatory events.
At
actual exchange rates, it is anticipated that FY 2022 Total Revenue
growth will also be impacted by a currency headwind of a mid
single-digit percentage, and that FY 2022 Core EPS growth will be
impacted by a currency headwind of a mid-to-high single-digit
percentage (see 'Currency impact', below).
Total Revenue is
expected to increase by a low twenties percentage
(unchanged)
Core EPS is expected to
increase by a high
twenties to low thirties percentage
(previously mid-to-high twenties percentage)
Other
elements of the Income Statement are expected to be broadly in line
with the indications issued in the Company's H1 2022 results
announcement (29 July 2022).
AstraZeneca continues to recognise geopolitical and supply chain
uncertainties on overall business performance. Variations in
performance between quarters can be expected to
continue.
The
Company is unable to provide guidance on a Reported basis because
AstraZeneca cannot reliably forecast material elements of the
Reported result, 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
The
growth numbers in the guidance above are provided at CER, based on
the average exchange rates through 2021.
If
foreign-exchange rates for November to December 2022 were to remain
at the spot rates seen on 31 October 2022, it is anticipated that
FY 2022 Total Revenue would incur a mid single-digit adverse impact
versus the performance at CER, and FY 2022 Core EPS would incur a
mid-to-high single-digit adverse impact (previously a mid
single-digit adverse impact).
The
Company's foreign-exchange rate sensitivity analysis is provided in
Table 17.
Table 1: Key elements of Total Revenue performance in Q3
2022
Revenue type
|
|
$m
|
Actual
|
CER
|
|
|
Product
Sales
|
|
10,590
|
9
|
16
|
|
Strong
Oncology and BioPharmaceuticals sales
$1,734m
from medicines acquired with Alexion
|
Collaboration
Revenue
|
|
392
|
>3x
|
>3x
|
|
$160m for Enhertu (Q3 2021: $52m)
$26m for Tezspire (Q3 2021: $nil)
Milestones of $75m for Lynparza, $62m for Nexium and $40m for
tralokinumab
|
Total
Revenue
|
|
10,982
|
11
|
19
|
|
|
Disease areas
|
|
$m
|
Actual
|
CER
|
|
|
Oncology
|
|
4,039
|
20
|
27
|
|
Good
performance across key medicines and regions
|
CVRM9
|
|
2,351
|
11
|
18
|
|
Farxiga achieved its third consecutive blockbuster
quarter with $1,103m in revenues
|
R&I
|
|
1,499
|
1
|
5
|
|
Growth
across Breztri and Fasenra offsetting
a decline in Pulmicort of
33% (31% at CER) primarily due to the impact of
VBP[16] implementation and
COVID-19 lockdowns in China
|
V&I[17]
|
|
878
|
(29)
|
(24)
|
|
$180m from Vaxzevria[18] (Q3
2021: $1,050m)
$536m from Evusheld (Q3 2021: $nil)
|
Rare Disease9
|
|
1,741
|
4
|
11
|
|
$518m from Ultomiris which was up 37% (47% at
CER)
|
Other
Medicines
|
|
474
|
34
|
50
|
|
Includes a Collaboration Revenue milestone of $62m
for Nexium.
Nexium revenue in Q3 2021
was negatively impacted by a transition in distribution
partners
|
Total
Revenue
|
|
10,982
|
11
|
19
|
|
|
Regions inc. Vaxzevria
|
|
$m
|
Actual
|
CER
|
|
|
Emerging
Markets
|
|
2,856
|
(10)
|
(4)
|
|
Decline due to lower sales
of Vaxzevria (growth rates
excluding Vaxzevria shown below)
|
-
China
|
|
1,541
|
3
|
8
|
|
Q3 2021 was negatively impacted
by Tagrisso inventory
phasing and stock compensation following NRDL[19] changes
|
-
Ex-China Emerging Markets
|
|
1,316
|
(21)
|
(15)
|
|
Decline due to lower sales
of Vaxzevria
|
US
|
|
4,650
|
34
|
34
|
|
|
Europe
|
|
2,065
|
8
|
23
|
|
|
Established
RoW
|
|
1,412
|
7
|
26
|
|
|
Total Revenue inc.
Vaxzevria
|
|
10,982
|
11
|
19
|
|
|
Regions exc. Vaxzevria
|
|
$m
|
Actual
|
CER
|
|
Contribution of medicines acquired with Alexion
|
Emerging
Markets
|
|
2,826
|
13
|
20
|
|
$102m
|
-
China
|
|
1,541
|
3
|
8
|
|
|
-
Ex-China Emerging Markets
|
|
1,285
|
26
|
37
|
|
$102m
|
US
|
|
4,650
|
34
|
34
|
|
$1,069m
|
Europe
|
|
2,002
|
14
|
30
|
|
$351m
|
Established
RoW
|
|
1,325
|
22
|
45
|
|
$212m
|
Total Revenue exc.
Vaxzevria
|
|
10,803
|
23
|
31
|
|
$1,734m
|
|
|
|
|
|
|
|
Table 2: Key elements of financial performance in Q3
2022
Metric
|
Reported
|
Reported change
|
Core
|
Corechange
|
|
Comments[20]
|
Total
Revenue
|
$10,982m
|
11%
Actual 19% CER
|
$10,982m
|
11%
Actual 19% CER
|
|
See
Table 1 and the Total Revenue section of this document for further
details
|
Gross Margin[21]
|
72%
|
10pp
Actual 11pp CER
|
81%
|
6pp
Actual 7pp CER
|
|
+
Addition of Alexion
+
Increasing mix of Oncology sales
‒ Impact
from profit-sharing arrangements(e.g. Lynparza)
‒ Reported
Gross Margin impacted by unwind of Alexion inventory fair value
adjustment
|
R&D
Expense
|
$2,458m
|
-32%
Actual -28% CER
|
$2,357m
|
10%
Actual 16% CER
|
|
+
Addition of Alexion
+
Increased investment in the pipeline following ungating of
additional late-stage trials
Reported
R&D Expense in Q3 2021 included a $1,172m impairment
charge
Core
R&D-to-Total Revenue ratio of 21%(Q3 2021: 22%)
|
SG&A
Expense
|
$4,277m
|
5%
Actual 9% CER
|
$3,160m
|
10%
Actual 16% CER
|
|
+
Addition of Alexion
+ Market development activities for recent
launches, including Evusheld
+
Core SG&A-to-Total Revenue ratio of 29%(Q3 2021:
29%)
|
Other Operating
Income[22]
|
$106m
|
>2x
Actual >2x CER
|
$107m
|
>2x
Actual >3x CER
|
|
Includes
income from royalties and prior transactions
|
Operating
Margin
|
11%
|
28pp
Actual 30pp CER
|
31%
|
8pp
Actual 9pp CER
|
|
See
Gross Margin and Expensescommentary above
|
Net
Finance Expense
|
$324m
|
1%
Actual 2% CER
|
$254m
|
16%
Actual 14% CER
|
|
+
Foreign exchange movements
+
Interest rate increase on floating rate liabilities
Reported
impacted by discount unwind on acquisition-related
liabilities
|
Tax
Rate
|
-78%
|
n/m
|
18%
|
-3pp
Actual -3pp CER
|
|
18%
Core Tax Rate in the quarter reflected geographical mix of profits
and favourable adjustments to prior year tax liabilities in a
number of major jurisdictions
Reported
affected by a $883m deferred tax credit arising from a legal
entity reorganisation to integrate Alexion
Variations
in the tax rate can be expected to continue quarter to
quarter
|
EPS
|
$1.06
|
n/m
|
$1.67
|
55%
Actual 70% CER
|
|
Further
details of differences between Reported and Core are shown in Table
12
|
Table 3: Pipeline highlights since prior results
announcement
Event
|
Medicine
|
Indication / Trial
|
Event
|
Regulatory
approvals and other regulatory actions
|
Tagrisso
|
NSCLC
(adjuvant) (ADAURA)
|
Regulatory
approval (JP)
|
Imfinzi
|
Biliary
tract cancer (TOPAZ-1)
|
Regulatory
approval (US)
|
Imfinzi
|
Liver
cancer (1st-line) (HIMALAYA)
|
Regulatory
approval (US)
|
Lynparza
|
gBRCA[23] breast
cancer (adjuvant) (OlympiA)
|
Regulatory
approval (EU, JP)
|
Lynparza
|
HRD[24]-positive
advanced ovarian cancer (1st-line maint.)
(PAOLA-1)
|
Regulatory
approval (CN)
|
Enhertu
|
HER2-low
breast cancer (3rd-line) (DESTINY-Breast04)
|
Regulatory
approval (US)
|
Enhertu
|
HER2m[25] NSCLC
(2nd-line+) (DESTINY-Lung02)
|
Regulatory
approval (US)
|
Calquence
|
Maleate
tablet formulation
|
Regulatory
approval (US)
|
Forxiga
|
CKD[26] (DAPA-CKD)
|
Regulatory
approval (CN)
|
Tezspire
|
Severe
asthma (NAVIGATOR)
|
Regulatory
approval (EU, JP)
|
Beyfortus
|
RSV
(MELODY/MEDLEY)
|
Regulatory
approval (EU)
|
Evusheld
|
COVID-19
(PROVENT/TACKLE)
|
Regulatory
approval (JP)
|
Evusheld
|
COVID-19
(TACKLE)
|
Regulatory
approval (EU)
|
Soliris
|
PNH and aHUS[27]
|
Regulatory
approval (CN)
|
Ultomiris
|
gMG
(CHAMPION-MG)
|
Regulatory
approval (EU, JP)
|
Koselugo
|
NF1-PN[28] (SPRINT)
|
Regulatory
approval (JP)
|
Regulatory
submissionsor acceptances
|
Lynparza
|
Prostate
cancer (1st-line) (PROpel)
|
Priority
Review (US)
|
Enhertu
|
HER2-low
breast cancer (3rd-line) (DESTINY-Breast04)
|
Regulatory
submission (CN)
|
Farxiga/Forxiga
|
HFpEF[29] (DELIVER)
|
Regulatory
submission (US, EU, JP, CN)
|
Ultomiris
|
NMOSD[30] (CHAMPION-NMOSD)
|
Regulatory
submission (US, EU, JP)
|
Major
Phase III data readouts and other developments
|
capivasertib
|
HR+/HER2-neg
breast cancer (1st-line)
(CAPItello-291)
|
Primary
endpoint met
|
monalizumab
|
Recurrent or metastatic
HNSCC[31](2nd-line)
(INTERLINK-1)
|
Efficacy
threshold not met
|
Fasenra
|
EoE[32] (MESSINA)
|
One
of two dual-primary endpoints not met
|
Soliris
|
Guillain-Barré
syndrome
|
Primary
endpoint not met
|
danicopan
|
PNH
with extravascular haemolysis
|
Primary
endpoint met
|
Corporate and business development
In
October 2022, AstraZeneca entered a definitive agreement to acquire
LogicBio Therapeutics, Inc. (NASDAQ: LOGC), a pioneering
genomic medicine company. The proposed acquisition aims to rapidly
accelerate Alexion's growth in genomic medicines through LogicBio's
unique technology, experienced rare disease R&D team, and
expertise in pre-clinical development.
Sustainability summary
AstraZeneca
attended COP27, where the Sustainable Markets Initiative Health
Systems Task Force collectively made significant commitments to
tackle the climate crisis, setting a benchmark for others to drive
action at scale. Some commitment highlights include supply chain
emissions, which drive approximately 50% of healthcare emissions:
the Task Force members have committed to align on a set of common
supplier standards and jointly explore green transportation
corridors. The patient care pathway drives approximately 45% of
healthcare emissions, and the Task Force has committed to build an
end-to-end care pathway emissions standard to measure emissions
across the care pathway, as well as align and publish product-level
lifecycle management assessment data to increase transparency on
emissions. The Task Force has also committed to leverage digital
health solutions to decarbonise clinical trials.
Conference call
A conference call and webcast for investors and
analysts will begin today, 10 November 2022, at 11:45 GMT. Details
can be accessed via astrazeneca.com.
Reporting calendar
The
Company intends to publish its full year and fourth quarter results
on Thursday 9 February 2022.
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 nine-month period to 30
September 2022 ('the year to date' or 'YTD 2022') compared to the
nine-month period to 30 September 2021 (YTD 2021), or the
three-month period to 30 September 2022 ('the quarter' or 'Q3
2022') compared to the three-month period to 30 September 2021 (Q3
2021).
Core
financial measures, EBITDA, Net Debt, CER, Initial Collaboration
Revenue and Ongoing Collaboration Revenue 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 as well as Post Alexion Acquisition Group
Review items
‒ 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 charge relating to
contingent consideration on business combinations, legal
settlements and the one off deferred tax credit arising from the
internal reorganisation to integrate Alexion
‒ 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 54 of the Annual Report and Form
20-F Information 2021.
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, previously termed Gross Profit 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 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.
Ongoing
Collaboration Revenue is defined as Collaboration Revenue excluding
Initial Collaboration Revenue (which is defined as Collaboration
Revenue that is recognised at the date of completion of an
agreement or transaction, in respect of upfront consideration).
Ongoing Collaboration Revenue comprises, among other items,
royalties, milestone revenue and profit-sharing income. Reference
should be made to the Collaboration Revenue table in this Operating
and financial review.
The
Company strongly encourages investors and analysts not to rely on
any single financial measure, but to review AstraZeneca's financial
statements, including the Notes thereto, and other available
Company reports, carefully and in their entirety.
Due
to rounding, the sum of a number of dollar values and percentages
in this announcement may not agree to totals.
Total Revenue
Table 4: Disease area and medicine
performance
|
|
YTD 2022
|
Q3 2022
|
|
|
|
|
% Change
|
|
|
% Change
|
Product Sales
|
|
$m
|
% Total
|
Actual
|
CER
|
$m
|
% Total
|
Actual
|
CER
|
Oncology
|
|
10,885
|
33
|
14
|
20
|
3,797
|
35
|
15
|
22
|
- Tagrisso
|
|
4,102
|
12
|
11
|
16
|
1,398
|
13
|
12
|
20
|
- Imfinzi
|
|
2,031
|
6
|
14
|
19
|
737
|
7
|
19
|
26
|
- Lynparza
|
|
1,949
|
6
|
13
|
19
|
659
|
6
|
12
|
19
|
- Calquence
|
|
1,469
|
4
|
74
|
77
|
566
|
5
|
60
|
63
|
- Enhertu
|
|
52
|
-
|
>5x
|
>5x
|
23
|
-
|
>4x
|
>4x
|
- Orpathys
|
|
34
|
-
|
>3x
|
>3x
|
11
|
-
|
11
|
16
|
- Zoladex
|
|
717
|
2
|
-
|
6
|
240
|
2
|
(4)
|
5
|
- Faslodex
|
|
259
|
1
|
(21)
|
(14)
|
81
|
1
|
(21)
|
(10)
|
- Iressa
|
|
90
|
-
|
(39)
|
(37)
|
27
|
-
|
(35)
|
(31)
|
- Arimidex
|
|
85
|
-
|
(20)
|
(16)
|
24
|
-
|
(28)
|
(23)
|
- Casodex
|
|
63
|
-
|
(48)
|
(45)
|
21
|
-
|
(46)
|
(40)
|
-
Others
|
|
34
|
-
|
(9)
|
(1)
|
10
|
-
|
(18)
|
(10)
|
BioPharmaceuticals:
CVRM9
|
|
6,907
|
21
|
13
|
18
|
2,348
|
21
|
11
|
19
|
- Farxiga
|
|
3,204
|
10
|
49
|
58
|
1,101
|
10
|
38
|
50
|
- Brilinta
|
|
1,013
|
3
|
(10)
|
(7)
|
338
|
3
|
(10)
|
(7)
|
- Lokelma
|
|
208
|
1
|
71
|
80
|
79
|
1
|
59
|
69
|
-
Roxadustat
|
|
148
|
-
|
2
|
4
|
57
|
1
|
4
|
9
|
- Andexxa9
|
|
111
|
-
|
7
|
14
|
41
|
-
|
5
|
17
|
- Crestor
|
|
824
|
2
|
(2)
|
4
|
277
|
3
|
(7)
|
-
|
- Seloken/Toprol-XL
|
|
705
|
2
|
(6)
|
(2)
|
238
|
2
|
2
|
10
|
- Bydureon
|
|
207
|
1
|
(29)
|
(28)
|
66
|
1
|
(30)
|
(29)
|
- Onglyza
|
|
205
|
1
|
(28)
|
(25)
|
66
|
1
|
(21)
|
(17)
|
-
Others
|
|
282
|
1
|
(9)
|
(7)
|
85
|
1
|
(11)
|
(8)
|
BioPharmaceuticals: R&I
|
|
4,318
|
13
|
(3)
|
-
|
1,427
|
13
|
(4)
|
1
|
- Symbicort
|
|
1,919
|
6
|
(6)
|
(2)
|
630
|
6
|
(7)
|
(1)
|
- Fasenra
|
|
1,015
|
3
|
13
|
17
|
353
|
3
|
10
|
15
|
- Breztri
|
|
282
|
1
|
>2x
|
>2x
|
103
|
1
|
>2x
|
>2x
|
- Saphnelo
|
|
69
|
-
|
>10x
|
>10x
|
33
|
-
|
>10x
|
>10x
|
- Pulmicort
|
|
479
|
1
|
(33)
|
(31)
|
145
|
1
|
(33)
|
(31)
|
- Daliresp
|
|
161
|
-
|
(5)
|
(4)
|
52
|
-
|
(4)
|
(3)
|
- Bevespi
|
|
43
|
-
|
11
|
13
|
14
|
-
|
6
|
8
|
- Others
|
|
350
|
1
|
(21)
|
(20)
|
97
|
1
|
(36)
|
(33)
|
BioPharmaceuticals: V&I
|
|
3,607
|
11
|
51
|
59
|
873
|
8
|
(27)
|
(21)
|
- Vaxzevria
|
|
1,713
|
5
|
(20)
|
(16)
|
173
|
2
|
(83)
|
(81)
|
- Evusheld
|
|
1,451
|
4
|
n/m
|
n/m
|
537
|
5
|
n/m
|
n/m
|
- Synagis
|
|
384
|
1
|
>2x
|
>2x
|
104
|
1
|
(15)
|
(1)
|
- FluMist
|
|
59
|
-
|
(22)
|
(13)
|
59
|
1
|
(19)
|
(10)
|
Rare Disease9
|
|
5,236
|
16
|
4
|
10
|
1,741
|
16
|
4
|
11
|
- Soliris9
|
|
2,918
|
9
|
(7)
|
(2)
|
901
|
8
|
(13)
|
(6)
|
- Ultomiris9
|
|
1,371
|
4
|
27
|
35
|
518
|
5
|
37
|
47
|
- Strensiq9
|
|
687
|
2
|
13
|
15
|
237
|
2
|
17
|
20
|
- Koselugo
|
|
149
|
-
|
>2x
|
>2x
|
48
|
-
|
82
|
81
|
- Kanuma9
|
|
111
|
-
|
6
|
11
|
37
|
-
|
1
|
5
|
Other Medicines
|
|
1,247
|
4
|
(4)
|
4
|
404
|
4
|
17
|
30
|
- Nexium
|
|
986
|
3
|
(1)
|
8
|
311
|
3
|
20
|
36
|
-
Others
|
|
261
|
1
|
(12)
|
(10)
|
93
|
1
|
9
|
13
|
Product Sales
|
|
32,200
|
97
|
29
|
35
|
10,590
|
96
|
9
|
16
|
Collaboration Revenue
|
|
944
|
3
|
>2x
|
>2x
|
392
|
4
|
>3x
|
>3x
|
Total Revenue
|
|
33,144
|
100
|
30
|
37
|
10,982
|
100
|
11
|
19
|
Table 5: Collaboration Revenue
|
|
YTD 2022
|
Q3 2022
|
|
|
|
|
% Change
|
|
|
% Change
|
|
|
$m
|
% Total
|
Actual
|
CER
|
$m
|
% Total
|
Actual
|
CER
|
Enhertu:
alliance revenue[33]
|
|
332
|
35
|
>2x
|
>2x
|
159
|
41
|
>3x
|
>3x
|
Tezspire: alliance revenue
|
|
42
|
4
|
n/m
|
n/m
|
26
|
7
|
n/m
|
n/m
|
Lynparza: regulatory milestones
|
|
250
|
26
|
n/m
|
n/m
|
75
|
19
|
n/m
|
n/m
|
Tralokinumab:
sales milestone
|
|
110
|
12
|
n/m
|
n/m
|
40
|
10
|
n/m
|
n/m
|
Vaxzevria: royalties
|
|
67
|
7
|
(19)
|
(22)
|
6
|
2
|
(87)
|
(87)
|
Other
royalty income
|
|
54
|
6
|
-
|
-
|
18
|
5
|
(4)
|
(3)
|
Other
Collaboration Revenue
|
|
89
|
9
|
(4)
|
12
|
68
|
17
|
>10x
|
>10x
|
Total
|
|
944
|
100
|
>2x
|
>2x
|
392
|
100
|
>3x
|
>3x
|
Table 6: Total Revenue by disease
area
|
|
YTD 2022
|
Q3 2022
|
|
|
|
|
% Change
|
|
|
% Change
|
|
|
$m
|
% Total
|
Actual
|
CER
|
$m
|
% Total
|
Actual
|
CER
|
Oncology
|
|
11,493
|
35
|
19
|
24
|
4,039
|
37
|
20
|
27
|
BioPharmaceuticals9
|
|
15,078
|
45
|
16
|
21
|
4,728
|
43
|
(2)
|
4
|
- CVRM9
|
|
6,927
|
21
|
13
|
19
|
2,351
|
21
|
11
|
18
|
- R&I
|
|
4,478
|
14
|
-
|
4
|
1,499
|
14
|
1
|
5
|
- V&I
|
|
3,673
|
11
|
49
|
56
|
878
|
8
|
(29)
|
(24)
|
Rare Disease9
|
|
5,236
|
16
|
4
|
10
|
1,741
|
16
|
4
|
11
|
Other
Medicines
|
|
1,337
|
4
|
(5)
|
3
|
474
|
4
|
34
|
50
|
Total
|
|
33,144
|
100
|
30
|
37
|
10,982
|
100
|
11
|
19
|
Table 7: Total Revenue by region
|
|
YTD 2022
|
Q3 2022
|
|
|
|
|
% Change
|
|
|
% Change
|
|
|
$m
|
% Total
|
Actual
|
CER
|
$m
|
% Total
|
Actual
|
CER
|
Emerging
Markets
|
|
9,013
|
27
|
5
|
8
|
2,856
|
26
|
(10)
|
(4)
|
- China
|
|
4,597
|
14
|
(2)
|
(1)
|
1,541
|
14
|
3
|
8
|
- Ex-China
|
|
4,415
|
13
|
13
|
20
|
1,316
|
12
|
(21)
|
(15)
|
US
|
|
13,132
|
40
|
58
|
58
|
4,650
|
42
|
34
|
34
|
Europe
|
|
6,429
|
19
|
24
|
37
|
2,065
|
19
|
8
|
23
|
Established
RoW
|
|
4,570
|
14
|
38
|
55
|
1,412
|
13
|
7
|
26
|
Total
|
|
33,144
|
100
|
30
|
37
|
10,982
|
100
|
11
|
19
|
Table 8: Total Revenue by region -
excluding Vaxzevria
|
|
YTD 2022
|
Q3 2022
|
|
|
|
|
% Change
|
|
|
% Change
|
|
|
$m
|
% Total
|
Actual
|
CER
|
$m
|
% Total
|
Actual
|
CER
|
Emerging
Markets
|
|
8,262
|
25
|
10
|
15
|
2,826
|
26
|
13
|
20
|
- China
|
|
4,551
|
14
|
(3)
|
(2)
|
1,541
|
14
|
3
|
8
|
- Ex-China
|
|
3,711
|
11
|
33
|
44
|
1,285
|
12
|
26
|
37
|
US
|
|
13,053
|
39
|
57
|
57
|
4,650
|
42
|
34
|
34
|
Europe
|
|
6,104
|
18
|
37
|
52
|
2,002
|
18
|
14
|
30
|
Established
RoW
|
|
3,945
|
12
|
33
|
50
|
1,325
|
12
|
22
|
45
|
Total
|
|
31,364
|
95
|
35
|
42
|
10,803
|
98
|
23
|
31
|
Oncology
Oncology Total Revenue increased by 19% (24% at
CER) in YTD 2022 to $11,493m and represented 35% of overall Total
Revenue (YTD 2021: 38%). This included Lynparza Collaboration Revenue of $250m
(YTD 2021: $nil) and Enhertu Collaboration Revenue of $335m (YTD 2021:
$137m). Product Sales increased by 14% (20% at CER) in YTD 2022 to
$10,885m, reflecting new launches and increased patient access
for Tagrisso, Imfinzi, Lynparza and Calquence partially offset by declines in some older
medicines. Oncology Total Revenue grew 20% (27% at CER) in Q3
benefiting from new launches for Imfinzi, Calquence and Enhertu and improvement in rates of lung cancer
diagnosis and treatment.
Tagrisso
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
YTD
2022 $m
|
|
4,102
|
|
1,211
|
1,472
|
777
|
642
|
Actual
change
|
|
11%
|
|
20%
|
14%
|
7%
|
(4%)
|
CER
change
|
|
16%
|
|
22%
|
14%
|
19%
|
10%
|
Region
|
|
Drivers
and commentary
|
Worldwide
|
|
Increased use of Tagrisso in adjuvant and 1st-line
setting
|
Emerging
Markets
|
|
Increased
1st-line use in China and continued growth in other Emerging
Markets
Rising
demand from increased patient access in China continues to offset
the impact of the March 2021 NRDL price reduction
Q3
2022 growth of 29% (35% at CER) benefited from the comparison to Q3
2021, which was negatively impacted by inventory phasing and stock
compensation relating to NRDL changes in March 2021
In
China, COVID-19 related lockdowns continued to have an adverse
impact in Q3, though at a lower level than Q2
|
US
|
|
Increased EGFR[34] testing
rates
Greater
use in 1st-line with longer duration of treatment and increasing
adjuvant penetration, partially offset by lower 2nd-line
use
|
Europe
|
|
Greater
use in 1st-line and adjuvant settings, with longer duration of
treatment, partially offset by lower 2nd-line use
|
Established
RoW
|
|
Increased
use in 1st-line setting and launch progress in adjuvant including
Japan
Q3
Total Revenue decline of 12% (growth of 5% at CER) impacted by a
COVID-19 wave in Japan
|
Imfinzi
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
YTD
2022 $m
|
|
2,031
|
|
224
|
1,102
|
402
|
303
|
Actual
change
|
|
14%
|
|
6%
|
20%
|
16%
|
-
|
CER
change
|
|
19%
|
|
9%
|
20%
|
29%
|
14%
|
Region
|
|
Drivers
and commentary
|
Worldwide
|
|
Increased use of Imfinzi to treat patients with
ES-SCLC[35]
Recovery
in rates of diagnosis and treatment following the COVID-19
pandemic
Q3 Worldwide Total Revenue growth of 19% (26% at
CER)
|
Emerging
Markets
|
|
Growth in ex-China, offset by an
adverse impact in CRT[36] rates
and hospital use of infused oncology medicines due to COVID-19
lockdowns in several major cities in China
|
US
|
|
New
patient starts across Stage III NSCLC and ES-SCLC
A
strong launch in biliary tract cancer after approval by the US FDA
in September based on the TOPAZ-1 Phase III trial
|
Europe
|
|
Increased
market penetration in ES-SCLC, growth in the number of reimbursed
markets, an ongoing recovery in rates of diagnosis and
treatment
|
Established
RoW
|
|
New
reimbursements
|
Lynparza
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
YTD
2022 $m
|
|
2,199
|
|
358
|
896
|
743
|
202
|
Actual
change
|
|
28%
|
|
27%
|
13%
|
63%
|
8%
|
CER
change
|
|
33%
|
|
30%
|
13%
|
75%
|
22%
|
Product
Sales
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
YTD
2022 $m
|
|
1,949
|
|
358
|
896
|
493
|
202
|
Actual
change
|
|
13%
|
|
27%
|
13%
|
8%
|
8%
|
CER
change
|
|
19%
|
|
30%
|
13%
|
20%
|
22%
|
Region
|
|
Drivers
and commentary
|
Worldwide
|
|
Lynparza remains the leading medicine in the
PARP[37]-inhibitor
class globally across four tumour types, as measured by total
prescription volume
Total Revenue includes $250m in regulatory
milestones received from MSD and recognised in Europe, in respect
of the approval in the US and EU for the adjuvant treatment of
patients with gBRCAm[38] breast
cancer, based on the data from the OlympiA Phase III
trial
Q3
Product Sales growth of 12% (19% at CER)
|
Emerging
Markets
|
|
Increased patient access
following admission to China's NRDL as a 1st-line maintenance
treatment for BRCAm[39] ovarian
cancer patients, with effect from March 2021; also launches in
other markets
|
US
|
|
US launch in early breast cancer following US
FDA[40] approval
in March based on data from the OlympiA Phase III
trial
Growth
in use in breast, ovarian and prostate cancers
|
Europe
|
|
Increasing HRD testing rates and
use in 1st-line HRD-positive ovarian cancer,
increased Lynparza uptake
in BRCAm mCRPC[41] and
gBRCAm HER2-negative advanced breast cancer and the EU launch in
gBRCAm early breast cancer following EMA[42] approval
in August based on data from the OlympiA Phase III
trial
|
Established
RoW
|
|
New
product launches and high levels of HRD testing in
Japan
|
Enhertu
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
YTD
2022 $m
|
|
387
|
|
51
|
254
|
77
|
4
|
Actual
change
|
|
>2x
|
|
>6x
|
>2x
|
>4x
|
>10x
|
CER
change
|
|
>2x
|
|
>6x
|
>2x
|
>4x
|
>10x
|
Region
|
|
Drivers
and commentary
|
Worldwide
|
|
Excluding Japan, Enhertu global in-market sales recorded by Daiichi
Sankyo Company Limited (Daiichi Sankyo) and AstraZeneca, amounted
to $750m in the year to date (YTD 2021: $293m)
AstraZeneca's
Total Revenue of $387m includes $335m of Collaboration Revenue from
its share of gross profit in territories where Daiichi Sankyo
records product sales and royalties on sales in Japan
Q3
Worldwide Total Revenue growth of >3x
|
Emerging
Markets
|
|
Strong
uptake in early launch markets
|
US
|
|
US
in-market sales, recorded by Daiichi Sankyo, amounted to $532m in
the year to date (YTD 2021: $253m)
US
launches in 2nd-line HER2-positive metastatic breast cancer after
US FDA approval in May based on data from the DESTINY-Breast03
Phase III trial; and in 3rd-line+ HER2-low metastatic breast cancer
after US FDA approval in August based on the DESTINY-Breast04 Phase
III trial
|
Europe
|
|
Growth
in 3rd-line+ HER2-positive metastatic breast and launch in 2nd-line
HER2-positive metastatic breast cancer after EMA approval in July
based on data from the DESTINY-Breast03 Phase III
trial
|
Established
RoW
|
|
In
Japan, AstraZeneca receives a mid-single-digit percentage royalty
on sales made by Daiichi Sankyo
|
Calquence
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
YTD
2022 $m
|
|
1,469
|
|
28
|
1,192
|
200
|
49
|
Actual
change
|
|
74%
|
|
>2x
|
58%
|
>2x
|
>4x
|
CER
change
|
|
77%
|
|
>2x
|
58%
|
>3x
|
>5x
|
Region
|
|
|
Worldwide
|
|
Q3
Worldwide Total Revenue growth of 60% (63% at CER)
|
US
|
|
Increased new patient market share led to a strong
performance, despite continued COVID-19 impacts on
CLL[43] diagnosis
rates
Maleate
tablet formulation launch in August resulted in uptake by patients
taking proton pump inhibitors and demand due to channel inventory
build
|
Europe
|
|
Increased
market share in new patient starts after launches in the
region
|
Orpathys
Orpathys Total Revenue of $35m in the year to date
(YTD 2021: $10m), growth was driven by the 2021 launch in
China, where it is approved for patients with lung cancer and
MET[44] gene
alterations.
Other Oncology medicines
|
YTD
2022
|
%
Change
|
|
Total
Revenue
|
|
$m
|
Actual
|
CER
|
|
Zoladex
|
|
738
|
1%
|
7%
|
Increased
use in ex-China Emerging Markets, offsetting a price cut in
Japan
|
Faslodex
|
|
259
|
(21%)
|
(14%)
|
Generic
competition
|
Iressa
|
|
90
|
(39%)
|
(37%)
|
Continued share loss to next
generation TKIs[45]
|
Arimidex
|
|
85
|
(20%)
|
(16%)
|
|
Casodex
|
|
63
|
(48%)
|
(45%)
|
Ongoing
impact from VBP implementation
|
Other
Oncology
|
|
34
|
(9%)
|
(1%)
|
|
|
|
|
|
|
|
|
BioPharmaceuticals
Including Vaccines & Immune Therapies
medicines, BioPharmaceuticals Total Revenue increased by 16% (21%
at CER) in YTD 2022 to $15,078m, representing 45% of overall Total
Revenue (YTD 2021: 51%). Growth was driven by
strong Farxiga performance and growth
in Evusheld.
Cardiovascular, Renal & Metabolism
CVRM Total Revenue increased by 13% (19% at CER)
to $6,927m in YTD 2022, driven by a strong Farxiga performance, and represented 21% of overall
Total Revenue (YTD 2021: 24%).
Farxiga
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
YTD
2022 $m
|
|
3,208
|
|
1,224
|
748
|
955
|
281
|
Actual
change
|
|
49%
|
|
40%
|
48%
|
64%
|
48%
|
CER
change
|
|
58%
|
|
46%
|
48%
|
82%
|
64%
|
Region
|
|
|
Worldwide
|
|
Farxiga volume is growing faster than the overall
SGLT2[46] market
in all major regions
Additional
benefit from growth in the overall SGLT2 inhibitor
class
Further HF[47] and
CKD launches and updated treatment guidelines including from
ESC[48] and
AHA[49]/ACC[50]/HFSA[51].
HF and CKD indications now launched in >100
markets
|
Emerging
Markets
|
|
Growth
despite generic competition in some markets. Solid growth in
ex-China Emerging Markets, particularly Latin America
In
China, Forxiga's
NRDL status was renewed in the fourth quarter of 2021. Benefit from
uACR[52] and
MRF[53] screening
programs
|
US
|
|
Regulatory approval for HEFrEF[54] in
May 2020, treatment of CKD in May 2021
Both approvals included patients with and without
T2D[55]
Farxiga continued to gain in-class brand share,
driven by HF and CKD launches
|
Europe
|
|
The
beneficial addition of cardiovascular outcomes trial data to the
label, the HFrEF regulatory approval in November 2020, and CKD
regulatory approval in August 2021
Forxiga continued gaining in-class market share in
the period
|
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
|
Brilinta
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
YTD
2022 $m
|
|
1,013
|
|
222
|
538
|
215
|
38
|
Actual
change
|
|
(10%)
|
|
(13%)
|
(4%)
|
(18%)
|
(20%)
|
CER
change
|
|
(7%)
|
|
(11%)
|
(4%)
|
(9%)
|
(16%)
|
Region
|
|
|
Emerging
Markets
|
|
Adverse impact from Brilinta's inclusion in China's VBP
programme
Strong
growth in ex-China Emerging Markets
|
US,
Europe
|
|
Slower
market recovery of oral antiplatelet therapies following the
pandemic
|
Lokelma
Lokelma Total Revenue increased 71% (80% at CER) to
$208m in YTD 2022, driven by Lokelma extending its branded market share lead in
the US and also achieving total potassium binder market share
leadership in the period. Continued progress in Europe from recent
launches across the region where Lokelma extended its market share in the period. In
China, Lokelma admitted to the NRDL with effect from 1
January 2022.
Andexxa
On a pro forma basis, Andexxa Total Revenue increased 17% (24% at CER) to
$121m.
Roxadustat
Total
Revenue increased 2% (4% at CER) to $151m. Total Revenue also
increased quarter-on-quarter, with roxadustat benefitting from
increased volumes in China following NRDL price cuts.
Other CVRM medicines
|
YTD
2022
|
%
Change
|
|
Total
Revenue
|
|
$m
|
Actual
|
CER
|
|
Crestor
|
|
825
|
(2%)
|
4%
|
Sales
growth at CER driven by Emerging Markets, offset by declines in the
US and Europe
|
Seloken
|
|
706
|
(6%)
|
(2%)
|
Emerging Markets sales impacted
by China VBP implementation of Betaloc[56] oral
in H2 2021. Betaloc ZOK VBP
to be implemented in Q4 2022
|
Onglyza
|
|
205
|
(28%)
|
(25%)
|
Ongoing
impact from VBP implementation
|
Bydureon
|
|
207
|
(29%)
|
(28%)
|
Continued
competitive pressures
|
Other
CVRM
|
|
282
|
(9%)
|
(7%)
|
|
|
|
|
|
|
|
|
|
Respiratory & Immunology
Total Revenue from R&I medicines was stable in
YTD 2022 (increased 4% at CER) at $4,478m and represented 14% of
overall Total Revenue (YTD 2021: 18%). In the third quarter,
R&I Total Revenue grew 5% at CER primarily driven by the
performance of recent launch brands,
including Fasenra, Tezspire, Breztri and Saphnelo, and revenue milestones; this growth more than
offset the sustained erosion of Pulmicort revenue following its inclusion in VBP in
China in Q4 2021, and a marginal decline
in Symbicort revenue.
Symbicort
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
YTD
2022 $m
|
|
1,919
|
|
476
|
718
|
445
|
280
|
Actual
change
|
|
(6%)
|
|
4%
|
(11%)
|
(11%)
|
(3%)
|
CER
change
|
|
(2%)
|
|
8%
|
(11%)
|
(1%)
|
3%
|
Region
|
|
|
Worldwide
|
|
Symbicort remains
the global market leader within stable ICS[57]/LABA[58] class
|
Emerging
Markets
|
|
Growth
in Emerging Markets driven primarily by market share growth in
China, Latin America and Asia Area
|
US
|
|
Strong
market share performance, consolidating leadership in a declining
ICS/LABA market, offset by pricing pressure
|
Europe
|
|
Resilient
market share in growing ICS/LABA market, offset by pricing
pressure
|
Established
RoW
|
|
Double
digit growth in Canada and Australia/New Zealand, driven by market
share gain
Sales
in Japan declined due to generic erosion and the annual mandatory
price reduction in April 2022
|
Fasenra
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
YTD
2022 $m
|
|
1,015
|
|
30
|
649
|
229
|
107
|
Actual
change
|
|
13%
|
|
99%
|
17%
|
9%
|
(10%)
|
CER
change
|
|
17%
|
|
95%
|
17%
|
21%
|
-
|
Region
|
|
|
Worldwide
|
|
Fasenra continues to be market leader in severe
eosinophilic asthma in major markets, and leading in the IL-5
class
|
Emerging
Markets
|
|
Strong
volume growth driven by launch acceleration in Brazil and other
markets
|
US
|
|
Maintained
a strong new-to-brand share in the severe uncontrolled asthma
market
|
Europe
|
|
Market
leader in new-to-brand share of the severe uncontrolled asthma
market
|
Established
RoW
|
|
Maintained
market leadership in Japan, partially offset by price erosion and
impact in the dynamic market related to surge in COVID-19
cases
|
Breztri
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
YTD
2022 $m
|
|
282
|
|
71
|
164
|
22
|
25
|
Actual
change
|
|
>2x
|
|
76%
|
>2x
|
>5x
|
43%
|
CER
change
|
|
>2x
|
|
78%
|
>2x
|
>6x
|
66%
|
Region
|
|
|
Worldwide
|
|
Breztri continued to gain market share within
growing fixed-dose triple class across major
markets
|
Emerging
Markets
|
|
In
China, the FDC triple class continued to penetrate the inhaled
maintenance market whose growth has been impacted by
COVID-19
Breztri continued its market share leadership within
the fixed-dose triple class
|
US
|
|
Consistent
new-to-brand and total market share growth within the fixed-dose
triple class
|
Europe
|
|
Sustained
growth across markets as new launches continue to
progress
|
Established
RoW
|
|
Strong new-to-brand market share
performance in Japan within COPD[59],
with the market impacted by access restrictions related to
surge in COVID-19 cases
|
Saphnelo
Total Revenue of $69m in the year to date (YTD
2021: $1m) was driven by sales acceleration in the US, where
Saphnelo achieved NBRx leadership in the i.v.[60] segment
for SLE[61] and
received a permanent J-code facilitating reimbursement. Growth was
further supported by a strong launch in Germany and steady growth
in Japan.
Tezspire
Tezspire is approved in the US, EU and Japan for the
treatment of severe asthma without biomarker or phenotypic
limitation. Total Revenue of $42m in the year to date (YTD 2021:
$nil) was comprised entirely of Collaboration Revenue, and
reflected the strong early launch performance in the US. Amgen
records sales in the US and AstraZeneca records its share of gross
profits in the US as Collaboration Revenue.
Other R&I medicines
|
YTD
2022
|
%
Change
|
|
Total
Revenue
|
|
$m
|
Actual
|
CER
|
|
Pulmicort
|
|
479
|
(33%)
|
(31%)
|
Revenue
from Emerging Markets decreased 41% to $339m, impacted by VBP
implementation in China and lower rates of elective surgery and
limited access to nebulisation centres due to COVID-19
lockdowns
|
Daliresp
|
|
161
|
(5%)
|
(4%)
|
|
Bevespi
|
|
43
|
11%
|
13%
|
|
Other
R&I
|
|
469
|
3%
|
4%
|
Collaboration
Revenue of $118m (YTD 2021: $12m), including $111m of milestones
relating to tralokinumab (YTD 2021: nil)
Product
Sales of $350m decreased 21% (20% at CER)
|
|
|
|
|
|
|
|
|
Vaccines & Immune Therapies
Total
Revenue from V&I medicines increased to $3,673m (YTD 2021:
$2,465m) and represented 11% of overall Total Revenue (YTD 2021:
10%).
Vaxzevria
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
YTD
2022 $m
|
|
1,780
|
|
751
|
79
|
325
|
625
|
Actual
change
|
|
(20%)
|
|
(34%)
|
n/m
|
(56%)
|
82%
|
CER
change
|
|
(16%)
|
|
(35%)
|
n/m
|
(51%)
|
96%
|
Region
|
|
|
Worldwide
|
|
Revenue in the third quarter decreased by 83% (82%
at CER) due to the conclusion of many of the
initial Vaxzevria contracts
|
Emerging
Markets
|
|
$46m
of Collaboration Revenue came from a Chinese sub-licensee producing
vaccines for export
Revenue
in the third quarter decreased by 95% (96% at CER)
|
US
|
|
Purchases
by the US government for donation overseas
No
revenue recorded in the second and third quarters
|
Europe
|
|
Revenue
in the third quarter decreased by 62% (56% at CER) vs Q3
2021
|
Established
RoW
|
|
Sales
in Japan, Canada and Australia
Revenue
in the third quarter decreased by 63% (59% at CER)
|
Evusheld
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
YTD
2022 $m
|
|
1,450
|
|
167
|
850
|
198
|
235
|
Actual
change
|
|
n/m
|
|
n/m
|
n/m
|
n/m
|
n/m
|
CER
change
|
|
n/m
|
|
n/m
|
n/m
|
n/m
|
n/m
|
Region
|
|
|
US
|
|
Evusheld received Emergency Use Authorisation for the
prevention of COVID-19 in December 2021
AstraZeneca
continued to fulfil the US Government's order for 1.7m
units
|
Emerging
Markets
|
|
Multiple
government contracts in Central and Eastern Europe, Latin America
and South East Asia
|
Europe
|
|
Approved
in the EU for prevention of COVID-19 in March 2022 and treatment in
September 2022
|
Established
RoW
|
|
Approved
in Japan for prevention and treatment of COVID-19 in August
2022
|
Other V&I medicines
Total
Revenue
|
|
$m
|
Actual
|
CER
|
|
Synagis
|
|
384
|
>2x
|
>2x
|
Strong
RSV season
Ex-US
rights reverted to AstraZeneca after 30 June 2021, from AbbVie
Inc.
In Q3 2022, Synagis sales decreased by 15% (1%
CER)
|
FluMist
|
|
59
|
(22%)
|
(13%)
|
|
Rare Disease
On
a pro forma basis, Total Revenue from Rare Disease medicines
increased by 4% (10% at CER) in YTD 2022 to $5,236m, representing
16% of overall Total Revenue.
Performance was driven by the durability of the C5
franchise, Soliris and Ultomiris, following Ultomiris gMG launch and expansion into new markets,
and continued Soliris NMOSD growth.
Strensiq and Koselugo performances were driven by continued
patient demand and market expansion efforts,
respectively.
These
tables show pro forma growth rates for each of the medicines
acquired with Alexion, calculated by comparing YTD 2022 revenues
with the medicine's revenues from 1 January 2021 to 30 September
2021.
Soliris
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
YTD
2022 $m
|
|
2,918
|
|
218
|
1,688
|
627
|
385
|
Actual change9
|
|
(7%)
|
|
(29%)
|
(3%)
|
(20%)
|
20%
|
CER change9
|
|
(2%)
|
|
(9%)
|
(3%)
|
(10%)
|
34%
|
Region
|
|
|
US
|
|
Performance impacted by successful conversion
to Ultomiris in PNH, aHUS and gMG, partially offset
by Soliris growth in NMOSD
|
Ex-US
|
|
Growth
driven by continued expansion of neurology indications, gMG and
NMOSD, in new markets
|
Ultomiris
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
YTD
2022 $m
|
|
1,371
|
|
34
|
771
|
347
|
219
|
Actual change9
|
|
27%
|
|
>2x
|
23%
|
55%
|
-
|
CER change9
|
|
35%
|
|
>3x
|
23%
|
74%
|
18%
|
Region
|
|
|
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 with increased
utilisation from complement-naïve patients in
gMG
|
Ex-US
|
|
Rapid
conversion in new launch markets
|
Other Rare Disease medicines
Total
Revenue
|
|
$m
|
Actual
|
CER
|
Commentary
|
Strensiq9
|
|
687
|
13%
|
15%
|
Performance
driven by strong patient demand
|
Koselugo
|
|
149
|
>2x
|
>2x
|
Growth
driven by expansion in new markets and tender market order
timing
|
Kanuma9
|
|
111
|
6%
|
11%
|
Continued
demand growth in ex-US markets
|
Other medicines (outside the main disease areas)
|
YTD
2022
|
%
Change
|
|
Total
Revenue
|
|
$m
|
Actual
|
CER
|
Commentary
|
Nexium
|
|
1,063
|
(3%)
|
7%
|
Collaboration
Revenue of $78m (YTD 2021: $92m)
Nexium (oral) was included in China's VBP programme
implemented in February 2021 and Nexium i.v. was implemented in the fifth round of
VBP in October 2021
|
Others
|
|
273
|
(12%)
|
(10%)
|
|
|
|
|
|
|
|
|
|
Financial
performance
Table 9: Reported Profit and Loss
|
|
YTD 2022
|
YTD 2021
|
% Change
|
Q3 2022
|
Q3 2021
|
% Change
|
|
|
|
$m
|
$m
|
Actual
|
CER
|
$m
|
$m
|
Actual
|
CER
|
Total Revenue
|
|
33,144
|
25,406
|
30
|
37
|
10,982
|
9,866
|
11
|
19
|
- Product Sales
|
|
32,200
|
25,043
|
29
|
35
|
10,590
|
9,741
|
9
|
16
|
- Collaboration Revenue
|
|
944
|
363
|
>2x
|
>2x
|
392
|
125
|
>3x
|
>3x
|
Cost
of Sales
|
|
(9,491)
|
(7,812)
|
21
|
28
|
(2,982)
|
(3,757)
|
(21)
|
(18)
|
Gross Profit
|
|
23,653
|
17,594
|
34
|
40
|
8,000
|
6,109
|
31
|
41
|
Gross Margin
|
|
70.5%
|
68.8%
|
+2pp
|
+2pp
|
71.8%
|
61.4%
|
+10pp
|
+11pp
|
Distribution
Expense
|
|
(380)
|
(322)
|
18
|
25
|
(126)
|
(120)
|
5
|
13
|
% Total Revenue
|
|
1.1%
|
1.3%
|
-
|
-
|
1.1%
|
1.2%
|
-
|
-
|
R&D
Expense
|
|
(7,137)
|
(7,152)
|
-
|
4
|
(2,458)
|
(3,610)
|
(32)
|
(28)
|
% Total Revenue
|
|
21.5%
|
28.2%
|
+7pp
|
+7pp
|
22.4%
|
36.6%
|
+14pp
|
+14pp
|
SG&A
Expense
|
|
(13,798)
|
(10,117)
|
36
|
41
|
(4,277)
|
(4,090)
|
5
|
9
|
% Total Revenue
|
|
41.6%
|
39.8%
|
-2pp
|
-1pp
|
38.9%
|
41.5%
|
+3pp
|
+3pp
|
OOI[62] &
Expense
|
|
325
|
1,345
|
(76)
|
(75)
|
106
|
37
|
>2x
|
>2x
|
% Total Revenue
|
|
1.0%
|
5.3%
|
-4pp
|
-4pp
|
1.0%
|
0.4%
|
+1pp
|
+1pp
|
Operating Profit/(Loss)
|
|
2,663
|
1,348
|
98
|
>2x
|
1,245
|
(1,674)
|
n/m
|
n/m
|
Operating Margin
|
|
8.0%
|
5.3%
|
+3pp
|
+3pp
|
11.3%
|
-17.0%
|
+28pp
|
+30pp
|
Net
Finance Expense
|
|
(936)
|
(922)
|
1
|
6
|
(324)
|
(320)
|
1
|
2
|
Joint
Ventures and Associates
|
|
(4)
|
(55)
|
(93)
|
(91)
|
1
|
(7)
|
n/m
|
n/m
|
Profit/(Loss) before tax
|
|
1,723
|
371
|
>4x
|
>4x
|
922
|
(2,001)
|
n/m
|
n/m
|
Taxation
|
|
668
|
90
|
>7x
|
>7x
|
720
|
350
|
>2x
|
>2x
|
Tax
rate
|
|
-39%
|
-24%
|
|
|
-78%
|
-18%
|
|
|
Profit/(Loss) after tax
|
|
2,391
|
461
|
>5x
|
>5x
|
1,642
|
(1,651)
|
n/m
|
n/m
|
Earnings per share
|
|
$1.54
|
$0.33
|
>4x
|
>4x
|
$1.06
|
$(1.10)
|
n/m
|
n/m
|
|
|
|
|
|
|
|
|
|
|
|
Table 10: Reconciliation of Reported Profit before tax
to EBITDA
|
|
YTD 2022
|
YTD 2021
|
% Change
|
Q3 2022
|
Q3 2021
|
% Change
|
|
|
$m
|
$m
|
Actual
|
CER
|
$m
|
$m
|
Actual
|
CER
|
Reported
Profit/(Loss) before tax
|
|
1,723
|
371
|
>4x
|
>4x
|
922
|
(2,001)
|
n/m
|
n/m
|
Net
Finance Expense
|
|
936
|
922
|
1
|
6
|
324
|
320
|
1
|
2
|
Joint
Ventures and Associates
|
|
4
|
55
|
(93)
|
(91)
|
(1)
|
7
|
n/m
|
n/m
|
Depreciation,
Amortisation and Impairment
|
|
4,000
|
4,338
|
(8)
|
(4)
|
1,334
|
2,788
|
(52)
|
(49)
|
EBITDA
|
|
6,663
|
5,686
|
17
|
26
|
2,579
|
1,114
|
>2x
|
>2x
|
EBITDA
of $6,663m in the year to date (YTD 2021: $5,686m) has been
negatively impacted by the $3,175m (YTD 2021: $1,044m) unwind
of inventory fair value uplift recognised on the acquisition of
Alexion. EBITDA of $2,579m in the quarter (Q3 2021: $1,114m) has
been negatively impacted by the $857m (Q3 2021: $1,044m) unwind of
inventory fair value uplift recognised on the acquisition of
Alexion. The unwind of inventory fair value is expected to depress
EBITDA over the year in line with associated revenues, and by a
smaller amount in 2023.
Table 11: Reconciliation of Reported to Core financial
measures: YTD 2022
YTD 2022
|
|
Reported
|
Restructuring
|
Intangible Asset Amortisation & Impairments
|
Acquisitionof Alexion
|
Other
|
Core
|
Core
% Change
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
Gross Profit
|
|
23,653
|
156
|
24
|
3,186
|
(1)
|
27,018
|
43
|
48
|
Gross Margin
|
|
70.5%
|
|
|
|
|
81.0%
|
+7pp
|
+6pp
|
Distribution
Expense
|
|
(380)
|
2
|
-
|
-
|
-
|
(378)
|
17
|
24
|
R&D
Expense
|
|
(7,137)
|
57
|
83
|
23
|
-
|
(6,974)
|
25
|
29
|
SG&A
Expense
|
|
(13,798)
|
263
|
3,060
|
35
|
1,197[63]
|
(9,243)
|
20
|
24
|
Total
Operating Expense
|
|
(21,315)
|
322
|
3,143
|
58
|
1,197
|
(16,595)
|
22
|
26
|
Other
Operating Income & Expense
|
|
325
|
(8)
|
-
|
-
|
-
|
317
|
(76)
|
(76)
|
Operating Profit
|
|
2,663
|
470
|
3,167
|
3,244
|
1,196
|
10,740
|
63
|
69
|
Operating Margin
|
|
8.0%
|
|
|
|
|
32.4%
|
+6pp
|
+6pp
|
Net
Finance Expense
|
|
(936)
|
-
|
-
|
|
207
|
(729)
|
16
|
21
|
Taxation
|
|
668
|
(93)
|
(581)
|
(748)
|
(1,078)[64]
|
(1,832)
|
84
|
90
|
EPS
|
|
$1.54
|
$0.25
|
$1.67
|
$1.61
|
$0.21
|
$5.28
|
47
|
52
|
Table 12: Reconciliation of Reported to Core financial
measures: Q3 2022
Q3 2022
|
|
Reported
|
Restructuring
|
Intangible Asset Amortisation & Impairments
|
Acquisitionof Alexion
|
Other
|
Core
|
Core
% Change
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
Gross Profit
|
|
8,000
|
75
|
8
|
866
|
(1)
|
8,948
|
21
|
30
|
Gross Margin
|
|
71.8%
|
|
|
|
|
80.8%
|
+6pp
|
+7pp
|
Distribution
Expense
|
|
(126)
|
1
|
-
|
-
|
-
|
(125)
|
5
|
12
|
R&D
Expense
|
|
(2,458)
|
19
|
77
|
5
|
-
|
(2,357)
|
10
|
16
|
SG&A
Expense
|
|
(4,277)
|
65
|
979
|
5
|
68
|
(3,160)
|
10
|
16
|
Total
Operating Expense
|
|
(6,861)
|
85
|
1,056
|
10
|
68
|
(5,642)
|
10
|
16
|
Other
Operating Income & Expense
|
|
106
|
1
|
-
|
-
|
-
|
107
|
>2x
|
>3x
|
Operating Profit
|
|
1,245
|
161
|
1,064
|
876
|
67
|
3,413
|
50
|
63
|
Operating Margin
|
|
11.3%
|
|
|
|
|
31.1%
|
+8pp
|
+9pp
|
Net
Finance Expense
|
|
(324)
|
-
|
-
|
-
|
70
|
(254)
|
16
|
14
|
Taxation
|
|
720
|
(32)
|
(194)
|
(202)
|
(871)
|
(579)
|
31
|
43
|
EPS
|
|
$1.06
|
$0.08
|
$0.56
|
$0.44
|
($0.47)
|
$1.67
|
55
|
70
|
Profit and Loss drivers
Gross Profit
‒ The
Gross Margin (Reported and Core) in the year to date was impacted
by:
‒ Positive
mix effects: the increased contribution from Rare Disease and
Oncology medicines had a positive impact on the Gross
Margin
‒ Negative
mix effects: sales of Vaxzevria and medicines with profit-sharing
arrangements (primarily Lynparza) had a dilutive impact on the Gross
Margin
‒ Pricing
pressure relating to procurement programmes in
China
‒ Reported
Gross Profit was also impacted by the unwind of the fair value
adjustment to Alexion inventories at the date of acquisition. The
fair value uplift is expected to unwind through Reported Cost of
Sales in line with associated revenues, and in YTD 2022, the impact
of the fair value uplift unwind on Cost of Sales was $3,175m (YTD
2021: $1,044m)
‒ Currency
fluctuations had a small positive impact on Gross Margin in the
year to date. Currency fluctuations may have a positive or negative
impact on Gross Margin in future quarters
‒ Variations
in Gross Margin performance between periods can be expected to
continue
R&D Expense
‒ Reported
and Core R&D Expense was impacted by:
‒ The
acquisition of Alexion in July 2021
‒ Recent
positive data read outs for several high priority medicines that
ungated late-stage Oncology trials
‒ The
advancement of a number of mid-stage clinical development
programmes in BioPharmaceuticals
‒ Investment
in platforms, new technology and capabilities to enhance R&D
productivity
‒ The
decrease in Reported R&D Expense is primarily due to the prior
year including an impairment charge of $1,172m, recognised in Q3
2021 on an intangible asset related to the acquisition of Ardea
Biosciences, Inc.
SG&A Expense
‒ The
increase in Reported and Core SG&A Expense was driven
by:
‒ The
acquisition of Alexion
‒ Market
development activities for recent launches
‒ Reported
SG&A Expense was also impacted by amortisation of intangible
assets related to the Alexion acquisition and other acquisitions
and collaborations, and a $775m legal settlement with
Chugai
Other Operating Income
‒ Reported
Other Operating Income of $325m consisted primarily of royalties
and disposal proceeds on small divestments, including the
divestment of rights to Plendil in the second quarter
‒ In
YTD 2021, Reported Other Operating Income of $1,345m included $776m
of divestment gains from AstraZeneca's share of Viela Bio, Inc. and
$309m from the commercial rights to Crestor in over 30 countries in Europe (excluding UK
and Spain)
Net Finance Expense
‒ The
increase in Reported and Core Net Finance Expense in the year to
date was driven by financing costs on debt for the Alexion
transaction , with a reduction in the discount unwind on
acquisition-related liabilities, including the Diabetes Alliance
which impacted Reported Net Finance Expense
‒ In
Q3 2022, the Net Finance Expense was also impacted by rising
interest rates
Taxation
‒ The
effective Reported Tax Rate for the nine months to 30 September
2022 was (39%) and the Core tax rate was 18%, and (24%) and 17%
respectively in the nine months to 30 September
2021
‒ The
Reported Tax Rate for the nine months included a one-time
favourable net adjustment of $883m to deferred taxes arising from
an internal reorganisation to integrate the Alexion organisation
which took place in the quarter. The legal entity reorganisation
did not result in any corporate income tax payable however did
result in an estimated one-off deferred tax adjustment of $883m at
Q3 to reflect the substantively enacted tax effects which would
arise in impacted jurisdictions going forwards. A further $47m
credit movement is included in OCI. This adjustment is based upon
full-year forecast estimates and therefore may change for the full
year results. This adjustment was excluded from the Core tax
charge
‒ 2021
Reported and Core Tax Rates were impacted by one-off items in 2021,
including the non-taxable gain on the divestment of Viela and
updates to estimates of prior period tax liabilities following
settlements with tax authorities
‒ The
net cash paid for the year to date was $1,335m (YTD 2021: $1,198m)
representing 77% of Reported Profit before tax (YTD 2021: 323%).
The cash tax amount increased due to the increase in profits and
the impact of Non-core charges on the level of Reported Profit
before tax and effects of US rules around deferral of tax relief on
R&D costs. The cash tax rate decreased compared to 2021 due to
the impact in YTD 2021 of low Reported Profit before
tax
‒ The
Reported Tax rate of (39%) was lower than the Core Tax Rate of 18%
primarily due to the impact of the aforementioned internal
restructuring. YTD 2022 Reported and Core Tax rates also benefited
from the geographical mix of profits and favourable adjustments to
prior year tax liabilities in a number of major
jurisdictions
‒ On
20 July 2022, the UK Government issued draft legislation in
relation to the new global minimum tax framework, expected to be
brought into effect in the UK from 2024. The UK corporation tax
rate continues to be expected to increase to 25%, effective April
2023. The Company is currently assessing potential impact of these
draft rules upon its financial statements
Table 13: Cash Flow summary
|
|
YTD 2022
|
YTD 2021
|
Change
|
|
|
$m
|
$m
|
$m
|
Reported
Operating Profit
|
|
2,663
|
1,348
|
1,315
|
Depreciation,
Amortisation and Impairment
|
|
4,000
|
4,338
|
(338)
|
Decrease
in Working Capital and Short-term Provisions
|
|
3,458
|
2,063
|
1,395
|
Gains
on Disposal of Intangible Assets
|
|
(88)
|
(371)
|
283
|
Gains
on Disposal of Investments in Associates and Joint
Ventures
|
|
-
|
(776)
|
776
|
Fair
value movements on contingent consideration arising from business
combinations
|
|
293
|
33
|
260
|
Non-Cash
and Other Movements
|
|
(973)
|
(370)
|
(603)
|
Interest
Paid
|
|
(608)
|
(522)
|
(86)
|
Taxation
Paid
|
|
(1,335)
|
(1,198)
|
(137)
|
Net Cash Inflow from Operating Activities
|
|
7,410
|
4,545
|
2,865
|
Net Cash Inflow/(Outflow) before Financing Activities
|
|
4,699
|
(5,600)
|
10,299
|
Net Cash (Outflow)/Inflow from Financing Activities
|
|
(6,465)
|
4,700
|
(11,165)
|
The
increase in Net Cash Inflow from Operating Activities of $2,865m
primarily reflected an underlying
improvement
in business performance, including the contribution from
Alexion.
The
Reported Operating Profit of $2,663m in the period includes a
negative impact of $3,175m relating to the unwind of the inventory
fair value uplift recognised on the acquisition of Alexion. This is
offset by a corresponding item (positive impact of $3,175m) in
Decrease in Working Capital and Short-term Provisions. Overall, the
unwind of the fair value uplift has no impact on Net Cash Inflow
from Operating Activities.
The change in Working Capital and Short-term
Provisions of $1,395m, whilst being positively impacted by the
aforementioned inventory fair value uplift unwind, has been
adversely impacted by the reduction of Vaxzevria working capital balances predominantly
within Trade and other payables.
Capital Expenditure
Capital
Expenditure amounted to $719m in the year to date (YTD 2021: $768m)
including expenditure relating to Alexion. The Company anticipates
stable Capital Expenditure in FY 2022 relative to FY
2021.
Table 14: Net Debt summary
|
|
At 30
Sep 2022
|
At 31
Dec 2021
|
At 30
Sep 2021
|
|
|
$m
|
$m
|
$m
|
Cash
and cash equivalents
|
|
4,458
|
6,329
|
7,067
|
Other
investments
|
|
440
|
69
|
82
|
Cash and investments
|
|
4,898
|
6,398
|
7,149
|
Overdrafts
and short-term borrowings
|
|
(743)
|
(387)
|
(605)
|
Lease
liabilities
|
|
(878)
|
(987)
|
(962)
|
Current
instalments of loans
|
|
(4,665)
|
(1,273)
|
(2,139)
|
Non-current
instalments of loans
|
|
(23,013)
|
(28,134)
|
(28,206)
|
Interest-bearing loans and borrowings (Gross Debt)
|
|
(29,299)
|
(30,781)
|
(31,912)
|
Net
derivatives
|
|
(141)
|
61
|
90
|
Net Debt
|
|
(24,542)
|
(24,322)
|
(24,673)
|
Net
Debt increased by $220m in the year to date to $24,542m. 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 and 2.250%
Notes due 2031 (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[65] 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 Form 6-K furnished to the SEC on 28 May
2021.
Pursuant
to Rule 13-01 and Rule 3-10 of Regulation S-X under the Securities
Act of 1933, as amended (the "Securities Act"), we present below
the summary financial information for AstraZeneca PLC, as
Guarantor, excluding its consolidated subsidiaries, and AstraZeneca
Finance, as the issuer, excluding its consolidated subsidiaries.
The following summary financial information of AstraZeneca PLC and
AstraZeneca Finance is presented on a combined basis and
transactions between the combining entities have been eliminated.
Financial information for non-guarantor entities has been excluded.
Intercompany balances and transactions between the obligor group
and the non-obligor subsidiaries are presented on separate
lines.
Table 15: Obligor group summarised Statement of
comprehensive income
|
|
YTD 2022
|
YTD 2021
|
|
|
$m
|
$m
|
Total
Revenue
|
|
-
|
-
|
Gross
Profit
|
|
-
|
-
|
Operating
loss
|
|
(3)
|
(131)
|
Loss
for the period
|
|
(404)
|
(553)
|
Transactions
with subsidiaries that are not issuers or guarantors
|
|
502
|
5,731
|
Table 16: Obligor group summarised Statement of
financial position
|
|
At 30 Sep 2022
|
At 30 Sep 2021
|
|
|
$m
|
$m
|
Current
assets
|
|
5
|
12
|
Non-current
assets
|
|
-
|
-
|
Current
liabilities
|
|
(3,067)
|
(2,347)
|
Non-current
liabilities
|
|
(22,556)
|
(25,721)
|
Amounts
due from subsidiaries that are not issuers or
guarantors
|
|
7,349
|
12,137
|
Amounts
due to subsidiaries that are not issuers or guarantors
|
|
(301)
|
(299)
|
Foreign exchange
The
Company's transactional currency exposures on working-capital
balances, which typically extend for up to three months, are hedged
where practicable using forward foreign-exchange contracts against
the individual companies' reporting currency. Foreign-exchange
gains and losses on forward contracts for transactional hedging are
taken to profit or loss. In addition, the Company's external
dividend payments, paid principally in pounds sterling and Swedish
krona, are fully hedged from announcement to payment
date.
Table 17: Currency sensitivities
The
Company provides the following currency-sensitivity
information:
|
|
|
Average spot
rates vs USD
|
|
Spot rate vs USD
|
|
Annual impact of 5% strengthening inFY average rate vs USD
($m) [66]
|
Currency
|
Primary Relevance
|
|
FY
2021[67]
|
YTD 2022[68]
|
Change
(%)
|
|
31 Oct 2022
|
Change[69]
(%)
|
|
Total Revenue
|
Core Operating Profit
|
CNY
|
Total
Revenue
|
|
6.43
|
6.62
|
(3)
|
|
7.31
|
(12)
|
|
277
|
158
|
EUR
|
Total
Revenue
|
|
0.85
|
0.94
|
(10)
|
|
1.01
|
(16)
|
|
317
|
160
|
JPY
|
Total
Revenue
|
|
109.83
|
128.34
|
(14)
|
|
148.02
|
(26)
|
|
229
|
158
|
Other[70]
|
|
|
|
|
|
|
|
|
|
420
|
196
|
GBP
|
Operating
Expense
|
|
0.73
|
0.80
|
(9)
|
|
0.86
|
(16)
|
|
61
|
(93)
|
SEK
|
Operating
Expense
|
|
8.58
|
9.92
|
(13)
|
|
10.98
|
(22)
|
|
6
|
(82)
|
Sustainability
Since
the last quarterly report, AstraZeneca:
Access to healthcare
‒ CEO
Pascal Soriot spoke at the UN General Assembly (UNGA)
alongside heads of state and global leaders, including UN Secretary
General António Guterres and World Health Organization (WHO)
Director-General Dr Tedros, on "Ending the COVID-19 Pandemic
through Equitable Access to Vaccines, Tests and
Treatments"
‒ Progressed,
with the Partnership for Health System Sustainability and
Resilience (PHSSR), research in 13 Phase 2 countries, with key
findings to be presented at the Global PHSSR Summit on 22-23
November. PHSSR launch events were held in Saudi
Arabia and Brazil. Vietnam signed a three-year MoU
with the Ministry of Health,
including implementation projects furthering PHSSR
recommendations
‒ Expanded
the Healthy Heart Africa (HHA) programme into Nigeria in
collaboration with the Nigeria Ministry of Health and the National
Primary Healthcare Development Agency, and its implementing partner
PSI. HHA also expanded into Zanzibar in collaboration with the
Zanzibar Ministry of Health and its implementing partner HIPZ. Over
29 million blood pressure screenings have been conducted since
launch in 2015
‒ Supported
the largest delegation at the One Young World Summit in Manchester,
with over 80 Young Health Programme (YHP) scholars and young
AstraZeneca employees attending, together with senior executives
who also hosted a site visit and workshops at the AstraZeneca
Macclesfield site. The Company also announced a US $50,000 Lead2030
grant with One Young World, to support youth-led non-profits
tackling air pollution for healthy people and a healthy
planet
Environmental protection
‒ AstraZeneca
attended COP27, where through the Sustainable Markets Initiative
Health Systems Task Force made significant commitments to tackle
the climate crisis, setting a benchmark for others to drive action
at scale. This is the first time the global health sector has taken
collective action to decarbonise, across our supply chains,
patient care pathways, and clinical trials.
‒ Participated
in the launch of the Sustainable Markets Initiative China Council,
endorsed by President Xi Jinping and HM King Charles III, in his
former role as HRH Prince of Wales.
‒ Attended
the inaugural meeting of the SMI China Council at the CEO and
Senior Executive Team level, which provides an important forum for
cross-sector collaboration on sustainability. The Company was the
only healthcare company invited to attend, offering the opportunity
for a leadership role in accelerating action on climate change and
supporting sustainability goals for a healthy society and
planet
‒ Engaged
at the World Economic Forum Sustainable Development Impact Meetings
in New York during Climate Week, driving thought leadership on a
range of topics including the interconnection of health and
climate, accelerating the delivery of net-zero health systems, the
circular economy and health equity. The Company's integrated
approach to sustainability also included engagements on inclusion
and diversity and health systems resilience
‒ Marked
the fifth anniversary of Climate Group's global electric transport
initiative, EV100, by participating in a Climate Week panel event
on "Steering the global market towards EV100," sharing the
experience of working towards its goal of a fully electric vehicle
fleet by end of 2025 as a key part of the Ambition Zero Carbon
programme
‒ Participated
in a World Water Week event in Stockholm, Sweden, to share its
water stewardship strategy and how it is improving circularity at
its sites to reduce reliance on natural resources and improve water
quality, increasing water efficiency at a local level and building
climate resilience
‒ Spoke
at a Reuters panel discussion "Drive environmental sustainability
across biopharma to create meaningful system-wide change" on the
connection between climate and health, and the industry's role in
accelerating the delivery of net-zero health
systems
‒ Published
a concept letter in collaboration with regulators, academics, and
industry as part of PREMIER, a European Innovative Health
Initiative project led by the Company to find solutions to managing
pharmaceutical pollution. The paper discusses how greener design
could help minimise the impact on the environment of active
pharmaceutical ingredients excreted from
patients
‒ Received
the prestigious Indiana Department of Environmental Management
Governor's Award for Environmental Excellence in the category of
'Five-Year Continuous Improvement' for its manufacturing site in
Mount Vernon, Indiana
Ethics and transparency
‒ Marked
International Day of the Girl with its #GirlsBelongHere2022
initiative in collaboration with Plan International, welcoming more
than 350 young women across 35 countries to step into leadership
positions, join boardroom conversations and participate in
roundtables and masterclasses. All of the Senior Executive Team
participated, including country and regional leadership teams.
Regions and functions also drove their own
initiatives
‒ Furthered
its commitment to gender and health equity through YHP awarding 80%
of "Step Up" grants totalling $160,000 to women-led non-profit
organisations working to improve the health of young people in
their communities
‒ Launched
a #ScienceCan sustainability campaign to shine a spotlight on the
Company's work to drive sustainability across its interconnected
strategic priorities through pioneering science. The campaign
outlines the efforts to build a sustainable future for people,
society, and the planet. All employees are being asked to
crowdsource ideas in teams and identify ways to support the
delivery of the Company's sustainability goals and identify
objectives for 2023, to effect change from the grassroots
level
‒ Celebrated
its annual Power of Diversity day with the launch of a refreshed
Global Inclusion and diversity strategy setting out priorities
across three focus areas - Inclusion, Diversity and External
Impact
‒ Marked
Global Ethics Day with the launch of its annual Code of Ethics
training for all employees, and with the launch of its Supplier
Diversity Programme in Sweden, progressing the target to launch
supplier diversity programmes in 10 countries by 2025 to accelerate
inclusion and growth of local small and diverse
businesses
Research and development
This
section covers R&D events and milestones that have occurred
since the prior results announcement on 29 July 2022, up to and
including events announced on 9 November 2022.
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 IASLC 2022
World Conference on Lung Cancer (WCLC) in August, and the European
Society for Medical Oncology (ESMO) in September. At ESMO, 75
abstracts featured 15 approved and potential new medicines from
AstraZeneca across 13 different tumour types.
Significant new trials in Oncology initiated
during the period included TROPION-Lung07 a Phase III trial of
datopotamab deruxtecan in 1st-line PDL1[71]-low
NSCLC patients with PD-L1 TPS[72]<50%
and LATIFY, a Phase III trial of ceralasertib in combination
with Imfinzi in NSCLC patients whose disease has
progressed on or after prior anti-PD-L1 therapy and platinum-based
chemotherapy.
Tagrisso
At WCLC in August, preliminary results from the
SAVANNAH Phase II trial showed that Tagrisso plus Orpathys demonstrated an ORR[73] of
49% (95% CI[74] 39-59%)
in patients with EGFRm NSCLC with high levels of MET overexpression
and/or amplification, defined as IHC90+[75] and/or
FISH10+[76],
whose disease progressed on treatment with Tagrisso. This combination is being further evaluated in
the SAFFRON Phase III trial.
During the period, Tagrisso was approved in Japan for the adjuvant
treatment of patients with EGFRm NSCLC after surgery based on the
results from the global ADAURA Phase III trial.
Updated results from follow-up of the ADAURA Phase
III trial presented at ESMO in September demonstrated a sustained,
clinically meaningful improvement in disease free survival compared
to placebo in the adjuvant treatment of patients with early-stage
(IB, II and IIIA) EGFRm NSCLC after complete tumour resection, with
nearly three in four patients treated with
adjuvant Tagrisso alive and disease-free at four
years.
Imfinzi and Imjudo
During the period, Imfinzi was approved in the US for the treatment of
patients with locally advanced or metastatic biliary tract cancer,
in combination with chemotherapy, based on the results from the
TOPAZ-1 Phase III trial. In October, Imfinzi in combination with a single priming dose
of Imjudo (tremelimumab) was approved in the US for
the 1st-line treatment of patients with unresectable HCC based on
the results from the HIMALAYA Phase III trial.
At ESMO, updated TOPAZ-1 results
for Imfinzi plus chemotherapy (gemcitabine plus
cisplatin) in biliary tract cancer showed enhanced clinical
efficacy after an additional 6.5 months of follow-up, demonstrating
a 24% reduction in the risk of death versus chemotherapy alone
(based on a hazard ratio of 0.76; 95% CI, 0.64-0.91). Updated
median OS[77] was
12.9 months versus 11.3 with chemotherapy. More than two times as
many patients were estimated to be alive at two years versus
chemotherapy alone (23.6% versus 11.5%).
Lynparza
In August, Lynparza was approved in the European Union for the
adjuvant treatment of patients with gBRCAm high-risk early breast
cancer and in Japan for BRCAm patients in the same setting based on
the results from the OlympiA Phase III trial.
During the period, the Company and MSD received US
regulatory submission acceptance with Priority Review
for Lynparza in combination with abiraterone and
prednisone or prednisolone for the treatment of adult patients with
mCRPC based on the PROpel Phase III trial.
At ESMO, AstraZeneca presented positive long-term
follow-up results from the PAOLA-1 Phase III trial in the
pre-specified descriptive analysis of the HRD-positive subgroup,
and from the SOLO-1 Phase III trial in patients with BRCA mutations
of Lynparza with or without bevacizumab. Both trials
showed clinically meaningful improvements in OS. Further results
showed PFS[78] in
combination with bevacizumab for HRD-positive patients, versus
active comparator, bevacizumab, and as monotherapy for patients
with BRCA mutations, versus placebo, respectively. Five-year
follow-up of the PAOLA-1 Phase III trial demonstrated that 65% of
HRD-positive patients treated with Lynparza plus bevacizumab were alive at five years
versus 48.4% treated with bevacizumab and placebo. Data from the
SOLO-1 Phase III trial demonstrated 67% of advanced ovarian cancer
patients with BRCA mutations treated with Lynparza were alive at seven years versus 47% on
placebo.
In September, Lynparza was approved in China for the maintenance
treatment of HRD-positive patients with advanced ovarian cancer who
are in complete or partial response to 1st-line platinum-based
chemotherapy in combination with bevacizumab, based on the PAOLA-1
Phase III trial.
During the period, AstraZeneca and MSD announced
the voluntary withdrawal of the Lynparza indication for patients with gBRCAm advanced
ovarian cancer who have been treated with three or more lines of
chemotherapy. The decision to withdraw was made in consultation
with the US FDA and based on a recent subgroup analysis that
indicated a potential detrimental effect on OS
for Lynparza compared to the chemotherapy control arm in
the subgroup of patients who had received three or more lines of
chemotherapy.
Calquence
In August, AstraZeneca's new maleate tablet
formulation of Calquence was approved in the US for all current
indications, including adult patients with CLL,
SLL[79] and
for patients with relapsed or refractory MCL[80],
under accelerated approval based on results from the ELEVATE-PLUS
trials. The tablet can be taken with gastric acid-reducing agents,
including proton pump inhibitors, antacids and H2-receptor
antagonists.
Enhertu
In August, AstraZeneca and Daiichi
Sankyo's Enhertu was approved in the US for the treatment of
patients with unresectable or metastatic HER2-low (IHC 1+ or IHC
2+/ISH-) breast cancer who have received a prior chemotherapy in
the metastatic setting or developed disease recurrence during or
within six months of completing adjuvant chemotherapy. The approval
by the US FDA was based on positive results from the
DESTINY-Breast04 Phase III trial.
During the period, Enhertu was also approved in the US for the
treatment of adult patients with unresectable or metastatic NSCLC
whose tumours have activating HER2 mutations and who have received
a prior systemic therapy. The accelerated approval by the US FDA
was based on the results of the DESTINY-Lung02 Phase II
trial.
In August, positive high-level results from the
DESTINY-Breast02 Phase III trial of Enhertu versus physician's choice of treatment
showed the trial met the primary endpoint, demonstrating a
statistically significant and clinically meaningful improvement in
PFS in patients with HER2-positive unresectable and/or metastatic
breast cancer previously treated with trastuzumab emtansine. The
trial also met the key secondary endpoint of improved
OS.
Datopotamab deruxtecan (Dato-DXd)
At
WCLC in August, initial results from the TROPION-Lung02 Phase Ib
trial demonstrated promising clinical activity and a tolerable
safety profile for Dato-DXd in combination with pembrolizumab with
or