FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
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the
Securities Exchange Act of 1934
For the
month of November
2021
Commission
File Number: 001-11960
AstraZeneca PLC
1
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United
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AZN: Year to date and Q3 2021 results
AstraZeneca PLC
12 November 2021 07:00 GMT
Year to date and Q3 2021 results
AstraZeneca reinforces its scientific leadership through
exceptional
pipeline delivery and the addition of Alexion in the
quarter
-
Total Revenue in the year to date, including Alexion from 21 July
2021, was $25,406m, representing growth of 32% (28% at CER). Total
Revenue in the third quarter increased by 50% (48% at CER) to
$9,866m
-
Excluding the pandemic COVID-19 vaccine, Total Revenue
increased 21% (17% at CER) in the year to date to $23,187m,
and by 34% (32% at CER) in the quarter to $8,816m
-
Eight positive Phase III results since June, with potential to
change standard of care in several diseases
-
Alexion integration progressing well, creating new opportunities in
rare diseases
-
Operating Expenses in the quarter reflected the addition of
Alexion, as well increased R&D expenses across multiple
programs, investment in our COVID-19 medicines, and increased
SG&A from pre-launch activities following successful pipeline
delivery
-
Earnings guidance for the full year is unchanged
In the year to date, AstraZeneca delivered double-digit revenue
growth from its Oncology, CVRM1 and
R&I2 medicines,
and established its Rare Disease capability with the acquisition of
Alexion Pharmaceuticals Inc. (Alexion). Rare disease is a
high-growth area with rapid innovation and significant unmet
medical need.
Since June, AstraZeneca has made significant progress with its
late-stage pipeline, reporting eight positive Phase III trial
results and the approval of Saphnelo (anifrolumab) in the US for the treatment of
systemic lupus erythematosus, and Ultomiris in the EU for children and adolescents
with paroxysmal nocturnal
haemoglobinuria. Enhertu received a Breakthrough Therapy Designation
from the US FDA3 following
ground-breaking results from the DESTINY-Breast03 trial. The
Company also announced positive results
for Lynparza in
prostate cancer, Imfinzi plus tremelimumab in liver
cancer, Imfinzi in biliary tract cancer, PT027 in asthma,
ALXN1840 in Wilson disease, and AZD7442 in COVID-19 prophylaxis and
treatment.
Pascal Soriot, Chief Executive Officer, commented:
"AstraZeneca's scientific leadership continues to provide strong
revenue growth and exceptional pipeline delivery, with eight
positive late-stage readouts across seven medicines since June,
including our long acting antibody combination showing promise in
both prevention and treatment of COVID-19. The addition of Alexion
furthers our commitment to bring transformative therapies to
patients around the world, and I am proud of our colleagues'
ongoing dedication and focus.
Our broad portfolio of medicines and diversified geographic
exposure provides a robust platform for long-term sustainable
growth. Following accelerated investment in upcoming launches after
positive data flow, we expect a solid finish to the year and our
earnings guidance is unchanged."
Table 1: Revenue and EPS summary
|
|
YTD 2021
|
Q3 2021
|
|
|
|
Actual %
|
CER4 %
|
|
Actual %
|
CER %
|
|
|
$m
|
Change
|
change
|
$m
|
Change
|
change
|
- Product Sales
|
|
25,043
|
33
|
29
|
9,741
|
49
|
47
|
- Collaboration Revenue
|
|
363
|
10
|
10
|
125
|
n/m
|
n/m
|
Total Revenue
|
|
25,406
|
32
|
28
|
9,866
|
50
|
48
|
- Less pandemic COVID-19 vaccine5
|
|
2,219
|
n/m6
|
n/m
|
1,050
|
n/m
|
n/m
|
Total Revenue ex-pandemic vaccine7
|
|
23,187
|
21
|
17
|
8,816
|
34
|
32
|
Reported8 EPS9
|
|
$0.33
|
(80)
|
(65)
|
$(1.10)
|
n/m
|
n/m
|
Core10 EPS
|
|
$3.59
|
22
|
23
|
$1.08
|
14
|
15
|
Impact of pandemic vaccine on EPS
|
|
$(0.03)
|
n/m
|
n/m
|
$0.01
|
n/m
|
n/m
|
Key elements of Total Revenue performance in the year-to-date
included:
-
An increase in Product Sales of 33% (29% at CER) to
$25,043m
-
The first contribution from Rare Disease, which generated $1,311m
of revenue in the period following completion of the Alexion
acquisition on 21 July 2021
-
Oncology growth of 19% (16% at CER) to $9,744m, CVRM growth of 14%
(10% at CER) to $6,028m and R&I growth of 16% (12% at CER) to
$4,456m
- An increase in Emerging
Markets revenue of 33% (28% at CER) to $8,618m. In China, revenue
increased 17% (8% CER) to $4,699m in the year to date and by 10%
(2% CER) in the quarter. China revenues in the year to date were
impacted by pricing pressure associated with
NRDL11 and
VBP12 programmes.
- Tagrisso's sequential quarterly performance in China was
impacted by inventory phasing and stock compensation relating to
NRDL changes in March. In future periods, volume growth from
increased patient access is expected to compensate for the lower
NRDL price
- Revenue in ex-China Emerging
Markets increased 60% in the year to date to $3,919m. Excluding
vaccine revenue of $1,139m, revenue in ex-China Emerging Markets
increased by 13% in the year to date (14% at CER) to $2,780m and by
30% in the quarter to $1,018m, driven by Oncology medicines
and Farxiga
-
In the US, Total Revenue increased by 29% to $8,305m and in Europe
by 40% (31% at CER) to $5,178m, including pandemic COVID-19 vaccine
revenue of $736m
Guidance
The Company provides further details on its FY 2021 guidance at
CER.
Total revenue excluding the COVID-19 vaccine is expected to grow by
a low-twenties percentage, in line with prior guidance. Including
vaccine revenues in Q4 2021, revenue is expected to grow by a
mid-to-high twenties percentage.
Growth in Core EPS13 to
$5.05 to $5.40, in line with prior guidance.
Prior guidance excluded the revenue and profit impact of sales of
the pandemic vaccine. The Company is now expecting to progressively
transition the vaccine to modest profitability as new orders are
received. COVID-19 vaccine sales in Q4 2021 are expected to be a
blend of the original pandemic agreements and new orders, with the
large majority coming from pandemic agreements. The limited profit
contribution from the vaccine in Q4 2021 is expected to offset
costs relating to the Company's long acting antibody combination
(AZD7442), resulting in no change to Core EPS guidance. Core Tax
Rate guidance is unchanged at 18-22%.
In general, AstraZeneca continues to recognise the heightened risks
and uncertainties from the effects of COVID-19. 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
If foreign-exchange rates for October to December 2021 were to
remain at the average of rates seen in the year to date, it is
anticipated that there would be a low single-digit favourable
impact on Total Revenue and an immaterial impact on Core EPS versus
CER data. The Company's foreign-exchange rate sensitivity analysis
is contained within the operating and financial
review.
Financial summary
-
Variances across periods are based on a comparison of the Group's
performance in the year to date and the quarter, including Alexion
from 21 July 2021, with the Group's performance in the comparative
prior periods, which do not include Alexion. Pro forma total
revenue growth rates have been presented only for Q3 2021 Rare
Disease and its constituent medicines, and do not impact any Group
totals
-
Total Revenue, comprising Product Sales and Collaboration Revenue,
increased by 32% in the year to date (28% at CER) to $25,406m.
Total Revenue included $2,219m from the pandemic COVID-19
vaccine
- Reported Gross
Profit14 Margin
in the year to date declined eleven percentage points to 68.8%;
Core Gross Profit Margin declined six percentage points in the year
to date to 74.1%, predominantly reflecting the equitable supply, at
no profit to AstraZeneca, of the pandemic COVID-19 vaccine,
together with an increasing impact from profit-sharing arrangements
(primarily Lynparza and roxadustat) and the impact of the NRDL
and VBP programmes in China. These effects were partially offset by
the contribution of Alexion from 21 July 2021, a higher
proportion of Oncology sales, and increasing patient access in
China. Reported Gross Profit Margin was also impacted by $1,044m
due to the unwind of the fair value adjustment to Alexion
inventories at the date of acquisition. Variations in gross margin
performance between periods can be expected to
continue
-
Reported Total Operating Expense increased in the year to date by
39% (34% at CER) to $17,591m. Core Total Operating Expense
increased by 24% (20% at CER) to $13,649m and represented 54% of
Total Revenue (YTD 2020: 57%)
-
Reported R&D Expense increased in the year to date by 67% (63%
at CER) to $7,152m including an impairment charge of $1,172m
recognised in the quarter on an intangible asset related to the
acquisition of Ardea Biosciences, Inc. in 2012, following the
decision to discontinue the development of verinurad. Core R&D
Expense increased in the year to date by 34% (30% at CER) to
$5,591m with increases in both Reported and Core R&D Expense
reflecting the Company's continued investment in its COVID-19
vaccine and AZD7442, investment in several late-stage Oncology
trials and the advancement of a number of Phase II clinical
development programmes in BioPharmaceuticals
-
Reported SG&A Expense increased in the year to date by 25% (21%
at CER) to $10,117m and includes the increased amortisation of
intangible assets related to the Alexion acquisition. Core SG&A
Expense increased by 19% (14% at CER) to $7,736m, reflecting the
addition of Alexion SG&A expenses from 21 July 2021, investment
in Oncology-medicine launches, the launch of several new
BioPharmaceuticals medicines, particularly in the US, AstraZeneca's
further expansion in Emerging Markets, and the existing
infrastructure base in China
- Reported and Core Other
Operating Income and Expense15 increased
in the year to date by 51% (50% at CER) to $1,345m and $1,346m
respectively, and included $776m income from the divestment of
AstraZeneca's 26.7% share of Viela Bio, Inc. (Viela) in March
2021
-
The Reported Operating Profit Margin declined fourteen percentage
points (thirteen at CER) to 5.3%, reflecting the aforementioned
intangible impairments and other factors. The Core Operating Profit
Margin declined two percentage points (one percentage point at CER)
in the year to date to 26.0% driven by the aforementioned increase
in R&D and SG&A expenses
-
Reported EPS in the year to date declined 80% (65% at CER) to
$0.33. Core EPS increased by 22% (23% at CER) to $3.59. Reported
and Core EPS were adversely affected by $0.03 due to the pandemic
COVID-19 vaccine
Table 2: Select Medicines Total Revenue performance
Further details of the individual medicine performances are
provided in the Total Revenue section.
|
|
|
YTD 2021
|
Q3 2021
|
|
|
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
|
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
Tagrisso
|
Oncology
|
|
3,701
|
17
|
13
|
1,247
|
8
|
7
|
Imfinzi
|
|
|
1,778
|
20
|
17
|
618
|
16
|
15
|
Lynparza
|
|
|
1,719
|
21
|
18
|
588
|
27
|
25
|
Calquence
|
|
|
843
|
n/m
|
n/m
|
354
|
n/m
|
n/m
|
Enhertu
|
|
|
147
|
n/m
|
n/m
|
57
|
n/m
|
n/m
|
Farxiga
|
CVRM
|
|
2,156
|
57
|
51
|
797
|
51
|
48
|
Brilinta
|
|
|
1,124
|
(9)
|
(11)
|
375
|
(3)
|
(4)
|
Bydureon
|
|
|
293
|
(10)
|
(11)
|
95
|
(13)
|
(13)
|
roxadustat
|
|
|
148
|
n/m
|
n/m
|
56
|
n/m
|
n/m
|
Lokelma
|
|
|
122
|
n/m
|
n/m
|
49
|
n/m
|
n/m
|
Symbicort
|
R&I
|
|
2,047
|
-
|
(3)
|
676
|
13
|
11
|
Fasenra
|
|
|
901
|
35
|
32
|
322
|
34
|
33
|
Pulmicort
|
|
|
714
|
14
|
7
|
217
|
44
|
36
|
Breztri
|
|
|
130
|
n/m
|
n/m
|
47
|
n/m
|
n/m
|
Soliris16
|
Rare
|
|
798
|
n/m
|
n/m
|
798
|
(3)
|
(2)
|
Ultomiris16
|
Disease16
|
|
297
|
n/m
|
n/m
|
297
|
31
|
31
|
Strensiq16
|
|
|
159
|
n/m
|
n/m
|
159
|
7
|
8
|
PandemicCOVID-19 vaccine
|
COVID-19
|
|
2,219
|
n/m
|
n/m
|
1,050
|
n/m
|
n/m
|
Table 3: Regional Total Revenue performance
Further details of the regional performances are provided in the
Regional Total Revenue section.
|
|
YTD 2021
|
Q3 2021
|
|
|
|
% of
|
Actual %
|
CER %
|
|
Actual %
|
CER %
|
|
|
$m
|
total
|
change
|
change
|
$m
|
change
|
change
|
Emerging Markets
|
|
8,618
|
34
|
33
|
28
|
3,159
|
48
|
42
|
US
|
|
8,305
|
33
|
29
|
29
|
3,471
|
53
|
53
|
Europe
|
|
5,178
|
20
|
40
|
31
|
1,918
|
52
|
49
|
Established RoW
|
|
3,305
|
13
|
28
|
24
|
1,318
|
45
|
46
|
Total
|
|
25,406
|
100
|
32
|
28
|
9,866
|
50
|
48
|
Total Revenue from Emerging Markets increased 33% (28% CER) to
$8,618m, of which $1,139m came from the pandemic COVID-19 vaccine.
Excluding the COVID-19 vaccine, Total Revenue from Emerging Markets
increased by 16% (10% at CER) in the year to date to
$7,479m.
Corporate and business development
In 2019, Caelum Biosciences (Caelum) and Alexion entered into a
collaboration to develop CAEL-101 for light chain amyloidosis,
whereby Alexion acquired a minority equity interest and an
exclusive option to acquire the remaining equity in Caelum.
AstraZeneca has treated Caelum as a subsidiary from the date of
acquisition of Alexion, reflecting a non-controlling interest of
$150m. On 5 October 2021, the Group completed the acquisition of
the remaining shares of Caelum and paid its shareholders the option
exercise price of $150m, with the potential for additional payments
of up to $350m upon achievement of regulatory and commercial
milestones.
In November 2021, AstraZeneca agreed to transfer its global rights
to Eklira, known as Tudorza in the US, and Duaklir to Covis Pharma Group for $270m payable on
completion, which is expected in the fourth quarter of 2021. Covis
Pharma Group will also cover certain ongoing development costs
related to the medicines. The income arising from the upfront
payment will be fully offset by a charge for derecognition of the
associated intangible asset and therefore no Other Operating Income
will be recognised in AstraZeneca's financial
statements.
Sustainability summary
a) Access to healthcare
In the third quarter of 2021, the Company delivered approximately
67 million doses of its pandemic COVID-19 vaccine through
COVAX17.
As of 30 September 2021, the Company and its sublicensee Serum
Institute of India Pvt. Ltd. (SII) have delivered more than 145
million doses with COVAX to over 125 countries, approximately half
of all COVAX supply. The majority of the doses have gone to low and
middle-income countries. Globally, AstraZeneca and its
sub-licensing partners have released more than 1.5 billion vaccine
doses as of the 30 September 2021, for supply in over 170
countries.
b) Environmental protection
On 3 November 2021, at the 26th UN Climate Change Conference
(COP26), HRH The Prince of Wales named AstraZeneca as one of the
first holders of the Terra Carta Seal, in recognition of the
company's efforts to lead and accelerate action for a more
sustainable future. In addition, Pascal Soriot was recognised as
the Champion of the new Sustainable Markets Initiative (SMI) Health
System Taskforce, which was launched at COP26 with HRH The Prince
of Wales and with health systems leaders, with the shared ambition
to accelerate the delivery of net zero, sustainable
healthcare.
A more extensive sustainability update is provided later in this
announcement.
Notes
The following notes refer to pages one to five.
1.
Cardiovascular, Renal & Metabolism
2.
Respiratory & Immunology
3.
US Food and Drug Administration
4.
Constant exchange rates. These are financial measures that are not
accounted for according to generally accepted accounting principles
(GAAP) because they remove the effects of currency movements from
Reported results.
5.
The pandemic COVID-19 vaccine Total Revenue includes $83m of
Collaboration Revenue of which $80m is receivable from the Serum
Institute of India Pvt. Ltd. (SII) with an equivalent charge
included within Other Operating Income and Expense in relation to
consequent obligations under the license agreement with Oxford
University Innovation (OUI).
6.
Not meaningful.
7. Total Revenue ex-pandemic
vaccine is a non-GAAP
measure, which excludes the revenue impact from sales of the
pandemic COVID-19 vaccine during the pandemic period to help
facilitate a comparison to guidance.
8.
Reported financial measures are the financial results presented in
accordance with UK-adopted International Accounting Standards and
EU-adopted International Financial Reporting Standards (IFRSs), and
IFRS as issued by the International Accounting Standards Board
(IASB).
9.
Earnings per share.
10.
Core financial measures. These are non-GAAP financial measures
because, unlike Reported performance, they cannot be derived
directly from the information in the Group's Financial Statements.
See the Operating and financial review for a definition of Core
financial measures and a reconciliation of Core to Reported
financial measures.
11.
China's National Reimbursement Drug List.
12.
Volume-based procurement.
13.
The calculation of Core EPS for guidance is based on 1,418 million
weighted average number of shares outstanding during 2021. The
number of shares in issue as of the close of the Alexion
acquisition was 1,549 million.
14.
Gross Profit is defined as Total Revenue minus Cost of Sales. The
calculation of Reported and Core Gross Profit Margin excludes the
impact of Collaboration Revenue and any associated costs, thereby
reflecting the underlying performance of Product
Sales.
15.
Where AstraZeneca does not retain a significant ongoing interest in
medicines or potential new medicines, income from divestments is
reported within Reported and Core Other Operating Income and
Expense in the Company's financial statements.
16.
Growth rates on Rare Disease medicines have been calculated on a
pro forma basis by comparing post-acquisition revenues from
21 July 2021 with the corresponding prior year pre-acquisition
Q3 revenues previously published by Alexion adjusted pro rata to
match the post-acquisition period. Pro forma Total Revenue growth
rates have been presented only for Q3 2021 Rare Disease area and
constituent medicines, and do not impact any Group
totals.
17.
COVID-19 Vaccines Global Access (COVAX) is a coalition co-led by
CEPI, the Coalition for Epidemic Preparedness Innovations, Gavi,
the Vaccine Alliance (Gavi), and the WHO. It is the only global
initiative bringing governments and manufacturers together to
ensure that safe and effective COVID-19 vaccines are available
worldwide to both higher-income and lower-income
countries.
Upcoming pipeline news
The following table highlights developments in the late-stage
pipeline since the prior results announcement.
Table 4: Pipeline highlights
|
Medicine
|
Indication / Trial
|
Event
|
Regulatory approvalsor otherregulatory actions
|
Forxiga
|
CKD[18]
|
Approval (EU, JP)
|
roxadustat
|
Anaemia in CKD
|
Complete response letter from the US FDA
|
Saphnelo
|
SLE[19]
|
Approval (US, JP)
|
Ultomiris
|
PNH[20]
|
Approval (paediatric) (EU)
|
Regulatory submissions acceptance and/or submissions
|
Tagrisso
|
EGFRm[21] NSCLC[22] (adjuvant)
|
Regulatory submission (JP)
|
Enhertu
|
HER2+[23] breast
cancer (2nd-line)
|
RTOR[24] regulatory
submission (US)
|
Enhertu
|
HER2+ breast cancer (2nd-line)
|
Regulatory submission (EU)
|
Enhertu
|
HER2+ gastric cancer (2nd-line)
|
Regulatory submission (EU)
|
AZD7442
|
COVID-19 prophylaxis
|
EUA[25] regulatory
submission (US)
|
Major Phase III data readoutsor other
significant developments
|
Imfinzi
|
Biliary tract cancer (1st-line)(TOPAZ-1)
|
Phase III primary endpoint met
|
Imfinzi +
tremelimumab
|
Liver cancer (1st-line) (HIMALAYA)
|
Phase III primary endpoint met
|
Lynparza
|
mCRPC[26] (1st-line)
(PROpel)
|
Phase III primary endpoint met
|
Enhertu
|
HER2+ breast cancer (2nd-line) (DESTINY-Breast03)
|
Phase III primary endpoint met
|
Enhertu
|
HER2+ breast cancer (2nd-line) (DESTINY-Breast03)
|
Breakthrough Therapy Designation (US)
|
Fasenra
|
EG[27]
|
Orphan Drug Designation (US)
|
Fasenra
|
EG +/- EGE
|
Fast Track Designation (US)
|
Fasenra
|
Eosinophilic gastroenteritis
|
Orphan Drug Designation (US)
|
tezepelumab
|
EoE[28]
|
Orphan Drug Designation (US)
|
PT027
|
Asthma (MANDALA, DENALI)
|
Phase III primary endpoints met
|
Ultomiris
|
ALS[29] (CHAMPION)
|
Phase III trial stopped for futility
|
ALXN1840
|
Wilson disease (FoCus)
|
Phase III primary endpoint met
|
AZD7442
|
COVID-19 prophylaxis (PROVENT)
|
Phase III primary endpoint met
|
AZD7442
|
COVID-19 treatment (TACKLE)
|
Phase III primary endpoint met
|
Table 5: Pipeline anticipated major news flow
Timing
|
Medicine
|
Indication / Trial
|
Event
|
|
Imfinzi +
tremelimumab
|
NSCLC (1st-Line)
|
Regulatory submission
|
Q4 2021
|
Lynparza
|
BRCAm HER2-negative breast cancer (adjuvant)
|
Regulatory submission
|
Lynparza
|
mCRPC (1st-line)
|
Regulatory submission
|
Enhertu
|
HER2+ breast cancer(2nd-line)
|
Regulatory submission
|
Ultomiris
|
s.c[30] formulation
in PNHand aHUS[31]
|
Regulatory submission
|
Ultomiris
|
gMG[32]
|
Regulatory submission
|
AZD2816
|
COVID-19 (variants of concern)
|
Data readout
|
AZD7442
|
COVID-19 outpatient treatment (TACKLE)
|
EUA regulatory submission (US),
|
AZD7442
|
COVID-19 pre-exposure prophylaxis (PROVENT)
|
EUA regulatory decision (US)
CMA regulatory decision (EU)
Regulatory decision (JP)
|
H1 2022
|
Imfinzi
|
NSCLC (unresectable, Stage III) (PACIFIC-2)
|
Data readout
|
Imfinzi
|
NSCLC (1st-line) (PEARL)
|
Data readout
|
Imfinzi
|
Cervical cancer (CALLA)
|
Data readout
|
Imfinzi
|
Biliary tract cancer
|
Regulatory submission
|
Imfinzi +/-
tremelimumab
|
Liver cancer (1st-line)
|
Regulatory submission
|
Enhertu
|
HER2-low breast cancer (DESTINY-Breast04)
|
Data readout, regulatory submission
|
Calquence
|
CLL[33]
|
Regulatory submission (JP)
|
Koselugo
|
NF1[34]
|
Regulatory submission (JP, CN)
|
Forxiga
|
CKD
|
Regulatory decision (CN)
|
Farxiga
|
HFpEF[35]
(DELIVER)
|
Data readout, regulatory submission
|
Brilique
|
Stroke
|
Regulatory decision (EU, CN)
|
Fasenra
|
Nasal polyps
|
Regulatory decision (US)
|
Saphnelo
|
SLE
|
Regulatory decision (EU)
|
tezepelumab
|
Asthma
|
Regulatory decision (US, EU, JP)
|
PT027
|
Asthma
|
Regulatory submission (US)
|
Ultomiris
|
NMOSD[36]
|
Data readout
|
nirsevimab
|
RSV[37]
|
Regulatory submission
|
Vaxzevria
|
COVID-19
|
Regulatory submission (US)
|
H2 2022
|
Tagrisso
|
EGFRm NSCLC (adjuvant)
|
Regulatory decision (JP)
|
Imfinzi
|
LS-SCLC[38] (ADRIATIC)
|
Data readout
|
Imfinzi
|
NSCLC (unresectable, Stage III)
|
Regulatory submission
|
Imfinzi
|
NSCLC (1st-line)
|
Regulatory submission
|
Imfinzi
|
Cervical cancer
|
Regulatory submission
|
Imfinzi
|
Locoregional liver cancer (EMERALD-1)
|
Data readout, regulatory submission
|
Enhertu
|
HER2+ breast cancer (3rd-line) (DESTINY-Breast02)
|
Data readout, regulatory submission
|
Enhertu
|
HER2+ gastric cancer(2nd-line)
|
Regulatory decision (EU)
|
Fasenra
|
HES[39] (NATRON)
|
Data readout
|
Fasenra
|
EoE
(MESSINA)
|
Data readout, regulatory submission
|
Fasenra
|
Chronic spontaneous
urticaria (ARROYO)
|
Data readout
|
Fasenra
|
Atopic dermatitis
(HILLIER)
|
Data readout
|
ALXN1840
|
Wilson
disease
|
Regulatory submission
|
Ultomiris
|
NMOSD
|
Regulatory submission
|
danicopan (ALXN2040)
|
PNH-EVH[40]
|
Data readout
|
acoramidis (ALXN2060)
|
ATTR-CM[41]
|
Data readout, regulatory submission
|
Conference call
A conference call and webcast for investors and analysts will begin
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 10 February 2022.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Disease, and BioPharmaceuticals, including
Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. Please visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team,
please click
here. For Media
contacts, click
here.
Operating and financial review
All narrative on growth and results in this section is based on
actual exchange rates, and financial figures are in US$ millions
($m), unless stated otherwise. The performance shown in this
announcement covers the nine-month period to 30 September 2021
('the year to date' or 'YTD 2021') and the three-month period to 30
September 2021 ('the quarter', 'the third quarter' or 'Q3 2021')
compared to the nine-month period to 30 September 2020 (YTD 2020)
and the three-month period to 30 September 2020 (Q3 2020)
respectively, unless stated otherwise.
Following the acquisition of Alexion, the Group has made a number
of changes to presented performance:
-
A new disease area, Rare Disease, presents the performance of
medicines acquired with Alexion
- The Group has ceased reporting
New Medicines as a performance metric (Tagrisso, Imfinzi, Lynparza, Calquence, Enhertu, Koselugo, Farxiga, Brilinta, Lokelma, roxadustat, Fasenra, Bevespi and Breztri). In line with practice these medicines will be
reported within their respective disease areas
- The Group has ceased reporting
New CVRM as a performance metric (Brilinta, Renal and Diabetes medicines). In line with
practice these medicines will be reported within the CVRM disease
area
Comparative performance relating to previous reporting periods will
be presented in line with the new presentation. This approach is
representative of the strategic priorities of the enlarged
Group.
Core financial measures, EBITDA, Net Debt, 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
-
Other specified items, principally acquisition-related costs, which
include fair-value adjustments and the imputed finance charge
relating to contingent consideration on business combinations and
legal settlements
Details on the nature of Core financial measures are provided on
page 84 of the Annual Report and Form 20-F Information 2020.
Following the Alexion acquisition and in line with its policies,
the Group will exclude the following acquisition-related items in
the current and future periods from its Core results:
-
The Group recognised significant additional intangible assets
reflecting the fair value of acquired launched medicines and
medicines in development. Future amortisation charges on these
assets will be excluded from the Group's Core results, similar to
the treatment of other intangible assets
-
The fair value of inventory acquired on completion was
significantly higher than historical cost. The adjustment to
increase the inventory to fair value is held in inventory until the
product is sold, at which time it is released to the Income
Statement in Cost of Sales. This results in a lower gross margin in
the first turn of inventory and this temporary effect, which is
expected over approximately 18 months post acquisition in line with
revenues, will be excluded from the Group's Core
results
-
The fair value of replacement employee share awards is higher than
both the value of the Alexion awards the employees were originally
granted and the expected value of future awards to those employees.
As a result, the Group will recognise an inflated expense during
the remaining vesting period of these awards. This temporary
increase in operating expenses, when compared with the expected
expense based on the grant-date value, will be excluded from the
Group's Core results
-
Other acquisition-related items to be excluded from the Group's
Core results include professional fees, retention bonuses included
in the acquisition agreement and the effect of unwinding other
acquisition-related fair value adjustments over time
Further details of these costs are included in Note 5, Acquisition
of Alexion. All the amounts above are presented in the 'Acquisition
of Alexion' column on the Reconciliation of Core to Reported
Financial Measures, except for intangible asset amortisation, which
is presented in the 'Intangible Asset Amortisation &
Impairments' column.
Reference should be made to the Reconciliation of Reported to Core
financial measures table included in the financial performance
section in this announcement.
Total Revenue ex-pandemic vaccine is a non-GAAP financial measure introduced
in the first quarter of 2021 to enable management to explain the
financial impact of the pandemic COVID-19 vaccine on the Group's
Total Revenue.
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 may not agree to totals.
Total Revenue
The performance of the Company's medicines is shown below, with
more details available from Note 8.
Table 6: Total Revenue by disease area
|
|
YTD 2021
|
Q3 2021
|
|
|
|
% of
|
Actual %
|
CER %
|
|
% of
|
Actual %
|
CER %
|
|
|
$m
|
total
|
change
|
Change
|
$m
|
total
|
change
|
change
|
Oncology
|
|
9,744
|
38
|
19
|
16
|
3,383
|
34
|
18
|
17
|
CVRM
|
|
6,028
|
24
|
14
|
10
|
2,086
|
21
|
16
|
13
|
R&I
|
|
4,456
|
18
|
16
|
12
|
1,486
|
15
|
28
|
25
|
Rare Disease16
|
|
1,311
|
5
|
n/m
|
n/m
|
1,311
|
13
|
5
|
6
|
Other medicines
|
|
1,648
|
6
|
(13)
|
(16)
|
550
|
6
|
(27)
|
(28)
|
COVID-19
|
|
2,219
|
9
|
n/m
|
n/m
|
1,050
|
11
|
n/m
|
n/m
|
Total Revenue
|
|
25,406
|
100
|
32
|
28
|
9,866
|
100
|
50
|
48
|
- Less pandemic COVID-19 vaccine
|
|
2,219
|
9
|
n/m
|
n/m
|
1,050
|
11
|
n/m
|
n/m
|
Total Revenue ex-pandemic vaccine
|
|
23,187
|
91
|
21
|
17
|
8,816
|
89
|
34
|
32
|
Table 7: Disease area and medicine performance
|
|
YTD 2021
|
Q3 2021
|
|
|
$m
|
% of total
|
Actual % change
|
CER % change
|
$m
|
% of total
|
Actual % change
|
CER % change
|
Oncology
|
|
9,593
|
38
|
21
|
17
|
3,326
|
34
|
18
|
16
|
- Tagrisso
|
|
3,701
|
15
|
17
|
13
|
1,247
|
13
|
8
|
7
|
- Imfinzi
|
|
1,778
|
7
|
20
|
17
|
618
|
6
|
16
|
15
|
- Lynparza
|
|
1,719
|
7
|
34
|
31
|
588
|
6
|
27
|
25
|
- Calquence
|
|
843
|
3
|
n/m
|
n/m
|
354
|
4
|
n/m
|
n/m
|
- Koselugo
|
|
74
|
-
|
n/m
|
n/m
|
26
|
-
|
n/m
|
n/m
|
- Enhertu
|
|
10
|
-
|
n/m
|
n/m
|
5
|
-
|
n/m
|
n/m
|
- Orpathys
|
|
10
|
-
|
n/m
|
n/m
|
10
|
-
|
n/m
|
n/m
|
- Zoladex
|
|
716
|
3
|
7
|
1
|
250
|
3
|
9
|
5
|
- Faslodex
|
|
329
|
1
|
(27)
|
(29)
|
103
|
1
|
(26)
|
(27)
|
- Iressa
|
|
149
|
1
|
(26)
|
(31)
|
41
|
-
|
(23)
|
(29)
|
- Casodex
|
|
120
|
-
|
(9)
|
(15)
|
38
|
-
|
(13)
|
(18)
|
- Arimidex
|
|
106
|
-
|
(29)
|
(31)
|
33
|
-
|
(20)
|
(20)
|
- Others
|
|
38
|
-
|
-
|
(2)
|
13
|
-
|
2
|
1
|
BioPharmaceuticals: CVRM
|
|
6,017
|
24
|
15
|
10
|
2,082
|
21
|
16
|
13
|
- Farxiga
|
|
2,152
|
8
|
57
|
51
|
796
|
8
|
51
|
48
|
- Brilinta
|
|
1,124
|
4
|
(9)
|
(11)
|
375
|
4
|
(3)
|
(4)
|
- Bydureon
|
|
293
|
1
|
(10)
|
(11)
|
95
|
1
|
(13)
|
(13)
|
- Onglyza
|
|
284
|
1
|
(22)
|
(25)
|
84
|
1
|
(23)
|
(25)
|
- Byetta
|
|
45
|
-
|
(10)
|
(10)
|
13
|
-
|
(11)
|
(6)
|
- Other diabetes
|
|
43
|
-
|
24
|
20
|
14
|
-
|
24
|
26
|
- roxadustat
|
|
144
|
1
|
n/m
|
n/m
|
55
|
1
|
n/m
|
n/m
|
- Lokelma
|
|
122
|
-
|
n/m
|
n/m
|
49
|
-
|
n/m
|
n/m
|
- Crestor
|
|
837
|
3
|
(5)
|
(9)
|
298
|
3
|
(1)
|
(4)
|
- Seloken/Toprol-XL
|
|
749
|
3
|
21
|
14
|
234
|
2
|
4
|
(2)
|
- Atacand
|
|
76
|
-
|
(58)
|
(58)
|
19
|
-
|
(65)
|
(65)
|
- Others
|
|
148
|
1
|
2
|
(3)
|
50
|
1
|
29
|
23
|
BioPharmaceuticals: R&I
|
|
4,444
|
17
|
16
|
12
|
1,483
|
15
|
28
|
25
|
- Symbicort
|
|
2,047
|
8
|
-
|
(3)
|
676
|
7
|
13
|
11
|
- Fasenra
|
|
901
|
4
|
35
|
32
|
322
|
3
|
34
|
33
|
- Pulmicort
|
|
714
|
3
|
14
|
7
|
217
|
2
|
44
|
36
|
- Daliresp
|
|
168
|
1
|
3
|
3
|
54
|
1
|
(5)
|
(6)
|
- Breztri
|
|
130
|
1
|
n/m
|
n/m
|
47
|
-
|
n/m
|
n/m
|
- Bevespi
|
|
39
|
-
|
8
|
7
|
13
|
-
|
(9)
|
(10)
|
- Saphnelo
|
|
1
|
-
|
n/m
|
n/m
|
1
|
-
|
n/m
|
n/m
|
- Others
|
|
444
|
2
|
62
|
53
|
153
|
2
|
70
|
64
|
Rare Disease16
|
|
1,311
|
5
|
n/m
|
n/m
|
1,311
|
13
|
5
|
6
|
- Soliris16
|
|
798
|
3
|
n/m
|
n/m
|
798
|
8
|
(3)
|
(2)
|
- Ultomiris16
|
|
297
|
1
|
n/m
|
n/m
|
297
|
3
|
31
|
31
|
- Strensiq16
|
|
159
|
1
|
n/m
|
n/m
|
159
|
2
|
7
|
8
|
- Andexxa16
|
|
29
|
-
|
n/m
|
n/m
|
29
|
-
|
(6)
|
(5)
|
- Kanuma16
|
|
28
|
-
|
n/m
|
n/m
|
28
|
-
|
26
|
26
|
Other medicines
|
|
1,542
|
6
|
(17)
|
(19)
|
539
|
5
|
(27)
|
(27)
|
- Nexium
|
|
999
|
4
|
(10)
|
(13)
|
259
|
3
|
(35)
|
(36)
|
- Synagis
|
|
170
|
1
|
(42)
|
(41)
|
122
|
1
|
3
|
5
|
- Losec/Prilosec
|
|
138
|
1
|
(4)
|
(10)
|
38
|
-
|
(16)
|
(21)
|
- FluMist
|
|
75
|
-
|
(35)
|
(37)
|
72
|
1
|
(37)
|
(39)
|
- Seroquel
XR/IR
|
|
74
|
-
|
(25)
|
(24)
|
24
|
-
|
(32)
|
(30)
|
- Others
|
|
86
|
-
|
(2)
|
(6)
|
24
|
-
|
23
|
20
|
COVID-19
|
|
2,136
|
8
|
n/m
|
n/m
|
1,000
|
10
|
n/m
|
n/m
|
Pandemic COVID-19 vaccine
|
|
2,136
|
8
|
n/m
|
n/m
|
1,000
|
10
|
n/m
|
n/m
|
Product Sales
|
|
25,043
|
99
|
33
|
29
|
9,741
|
99
|
49
|
47
|
Collaboration Revenue
|
|
363
|
1
|
10
|
10
|
125
|
1
|
n/m
|
n/m
|
Total Revenue
|
|
25,406
|
100
|
32
|
28
|
9,866
|
100
|
50
|
48
|
Total Revenue ex-pandemic vaccine
|
|
23,187
|
91
|
21
|
17
|
8,816
|
89
|
34
|
32
|
Table 8: Collaboration Revenue
|
|
YTD 2021
|
Q3 2021
|
|
|
$m
|
% of total
|
Actual % change
|
CER % change
|
$m
|
% of total
|
Actual % change
|
CER % change
|
Enhertu: share of gross
profits
|
|
134
|
37
|
n/m
|
n/m
|
51
|
41
|
95
|
95
|
roxadustat: share of gross profits
|
|
4
|
1
|
(78)
|
(80)
|
1
|
1
|
(83)
|
(84)
|
Other Collaboration Revenue
|
|
225
|
62
|
(9)
|
(10)
|
73
|
58
|
n/m
|
n/m
|
Total
|
|
363
|
100
|
10
|
10
|
125
|
100
|
n/m
|
n/m
|
Other Collaboration Revenue included contributions
from Movantik, Zoladex, Eklira, Duaklir,
Forxiga, Nexium OTC[39] and
other royalties. In addition, Other Collaboration Revenue also
included $80m receivable from SII for the pandemic COVID-19
vaccine; an equivalent charge has been included within Other
Operating Income and Expense in relation to consequent obligations
under the license agreement with Oxford University Innovation
(OUI). Initial Collaboration Revenue of $75m was recorded in the
year to date following the agreement to out-license the authorised generic rights
to Nexium in Japan.
Total Revenue summary
Oncology
Total Revenue of $9,744m in the year to date; an increase of 19%
(16% at CER). Oncology represented 38% of overall Total Revenue
(YTD 2020: 43%).
Tagrisso
Tagrisso has received
regulatory approval in 64 countries, including the US, China, and
in the EU, for use as an adjuvant treatment of EGFRm NSCLC
patients, with 13 reimbursements granted so far. This expands upon
the patient benefit from use in the 1st-line treatment of patients
with EGFRm NSCLC with regulatory approval in 91 countries,
including the US, China, in the EU and Japan. To date, 47
reimbursements have been granted in this setting, with further
decisions anticipated. These developments
followed Tagrisso's regulatory approval in 91 countries, including
the US, China, in the EU and Japan, to treat patients with EGFR
T790M[40] NSCLC,
an indication in which 67 reimbursements have been
granted.
Total Revenue, entirely comprising Product Sales, amounted to
$3,701m in the year to date and represented growth of 17% (13% at
CER). Sales in Q3 increased 8% (7% at CER) to $1,247m.
Sales in the US increased by 13% in the year to date to $1,294m and
increased 5% to $441m in Q3. Performance in Q3 was impacted by the
cumulative effect of lower levels of lung cancer diagnosis and
biomarker testing during the COVID-19 pandemic. This was partially
offset by increased use of Tagrisso for the adjuvant treatment of Stage IB to
IIIA EGFRm NSCLC patients following the US Food and Drug
Administration (FDA) approval in 2020. Current levels of diagnosis,
biomarker testing and treatment of NSCLC continue to improve, but
remain below pre-COVID levels.
Tagrisso sales in Emerging
Markets increased by 6% in the year to date (1% at CER) to $1,012m;
the performance was impacted by the admission of the medicine to
the China NRDL in March 2021 for the 1st-line setting and the
renewal in the 2nd-line setting. During the year to date,
additional demand from increased patient access in China has not
yet completely offset the NRDL price reduction which came into
effect in March 2021. Emerging Markets sales of $315m in Q3
represented a decline of 11% (15% at CER) driven by lower sales in
China, partially offset by growth in ex-China Emerging Markets. In
Q3 2021, sales in China were lower than the prior quarter, with the
phasing of inventory movements around the aforementioned NRDL
changes more than offsetting the continued benefit of volume
increases from expansion into 1st-line treatment. Sales in Japan
increased by 9% (8% at CER) to $568m in the year to date. In
Europe, sales of $727m in the year to date represented an increase
of 45% (35% at CER), driven by greater adoption in the 1st-line
setting, as more reimbursements were granted.
Imfinzi
Imfinzi has received
regulatory approval in 74 countries, including the US, China, in
the EU, and Japan, with 35 reimbursements granted, to treat
patients with unresectable Stage III NSCLC, whose disease has not
progressed following platinum-based CRT[41]. Imfinzi has
also been approved to treat ES-SCLC[42] patients
in 63 countries, with nine reimbursements
granted.
Total Revenue, entirely comprising Product Sales, amounted to
$1,778m in the year to date and represented growth of 20% (17% at
CER); the performance reflected the increased use
of Imfinzi to treat patients with ES-SCLC. US sales
increased by 3% to $916m, despite the continued COVID-19 related
decrease in lung cancer diagnoses. In Japan, growth of 34% (33% at
CER) represented sales of $257m. Europe sales increased by 37% (27%
at CER) to $347m, reflecting a growing number of reimbursements in
the region. Sales in Emerging Markets increased to $211m,
representing a growth of 87% (77% at CER) following recent
regulatory approvals and launches, including in
China.
Lynparza
Lynparza has received
regulatory approval in 86 countries for the treatment of ovarian
cancer; it has also been approved in 84 countries for the treatment
of metastatic breast cancer, and in 68 countries for the treatment
of pancreatic cancer. Lynparza has received regulatory approval in 70
countries for the 2nd-line treatment of certain prostate-cancer
patients.
Total Revenue, entirely comprising Product Sales in the year to
date, amounted to $1,719m, reflecting growth of 21% (18% at CER)
benefiting from further launches across multiple cancer types
globally. US Product Sales increased by 26% to $793m, predominantly
due to growth in 2nd-line HRRm mCRPC and 1st-line
HRD+[43] ovarian
cancer. Lynparza is the leading medicine in the
PARP[44] inhibitor
class globally across four tumour types, as measured by total
prescription volumes. Product Sales in Europe increased by 47% (36%
at CER) to $456m, reflecting additional reimbursements and
increasing BRCAm-testing rates, as well as successful 1st-line
BRCAm ovarian and 2nd-line HRRm[45] prostate
cancer launches.
Sales in Japan amounted to $145m, representing growth of 22%.
Emerging Markets Product Sales were $282m, up by 44% (40% at CER);
in Q3 sales increased 28% (23% at CER) to $96m. In
China, Lynparza was admitted to the NRDL as a 1st-line
treatment for BRCAm[46] ovarian
cancer patients with effect from March 2021.
Enhertu
Total Revenue, predominately comprising Collaboration Revenue,
increased by 134% in the year to date to $147m. Global in-market
sales, excluding Japan, amounted to $293m in the year to date. In
Japan, AstraZeneca receives a mid-single-digit percentage royalty
on sales made by Daiichi Sankyo Company Limited (Daiichi Sankyo).
US in-market sales, recorded by Daiichi Sankyo, amounted to $253m
in the year to date and $92m in the quarter.
Calquence
Calquence has received
regulatory approvals for the treatment patients with CLL in 70
countries and in 34 countries for the treatment of patients with
R/R mantle cell lymphoma with reimbursement obtained in 20 and 13
countries, respectively.
Total Revenue, entirely comprising Product Sales, amounted to $843m
in the year to date and represented growth of 148% (146% at CER).
US sales increased by 124% in the year to date to $752m,
representing the majority of sales, with the performance
benefitting from increased market share. In Europe, Product Sales
of $69m (YTD 2020: $nil) reflected the ongoing launch of the
medicine.
Koselugo
Total Revenue, predominately comprising Product Sales in the US,
amounted to $74m (YTD 2020: $20m) in the year to date, following
its launch in the second quarter of 2020 to treat the rare disease
NF1[47] in
paediatric patients aged two years and older who have symptomatic,
inoperable plexiform neurofibromas.
Orpathys
In June 2021, AstraZeneca and HUTCHMED's Orpathys was granted conditional approval in China to
treat patients with NSCLC with MET exon 14
skipping[48] alterations
that have progressed following prior systemic therapy or are unable
to receive chemotherapy. Total Revenue entirely comprising Product
Sales was $10m (YTD 2020: $nil).
Zoladex
Total Revenue, predominantly comprising Product Sales, amounted to
$729m in the year to date and represented an increase of 2% (a
decline of 3% at CER).
Emerging Markets sales of Zoladex increased by 9% (3% at CER) to $465m. Sales
in Europe increased by 7% (declined by 1% at CER) to $112m while,
in the Established RoW region, sales declined by 5% (8% at CER) to
$128m.
Faslodex
Total Revenue, entirely comprising Product Sales, amounted to $329m
in the year to date and represented a decline of 27% (29% at CER)
due to increasing competition from several generic versions of the
medicine.
Emerging Markets sales decreased by 14% (17% at CER) to $122m,
while US sales declined by 47% to $24m; in Europe, sales fell by
45% (49% at CER) to $93m. In Japan, sales increased 2% (1% at CER)
to $87m.
Iressa
Total Revenue, entirely comprising Product Sales, amounted to $149m
in the year to date and represented a decline of 26% (31% at CER).
Emerging Markets sales fell by 25% (30% at CER) to
$122m.
BioPharmaceuticals: CVRM
Total Revenue increased by 14% in the year to date (10% at CER) to
$6,028m and represented 24% of Total Revenue (YTD 2020: 27%),
reflecting the strong performance of Farxiga in the period.
Farxiga
Total Revenue, predominantly comprising Product Sales, amounted to
$2,156m in the year to date and represented growth of 57% (51% at
CER). The performance of Farxiga benefitted from growth in the
SGLT2[49] inhibitor
class in many regions, with volume share increasing faster than the
overall market in most major regions.
Emerging Markets sales increased by 80% (74% at CER) to $877m in
the year to date, still benefitting from the addition
of Forxiga to the China NRDL in 2020. The initial price
impact has been more than offset by increased access for
patients. Forxiga's NRDL status is due for renegotiation in the
fourth quarter of 2021.
In the US, sales increased by 31% in the year to date to $504m,
reflecting the benefit of the regulatory approval in May 2020 for
HFrEF and more recently the approval for the treatment of CKD which
was obtained in May 2021. Both approvals include patients with and
without T2D[50].
Sales in Europe increased by 61% (50% at CER) to $584m in the year
to date. The performance reflected SGLT2 inhibitor class growth,
the beneficial addition of CV outcomes trial data to the label, the
HFrEF regulatory approval in November 2020, and CKD approval in
August 2021. In Japan, sales to collaborator Ono Pharmaceutical
Co., Ltd, which records in-market sales, increased by 40% (39% at
CER) to $108m.
Brilinta
Total Revenue, entirely comprising Product Sales, amounted to
$1,124m in the year to date, representing a decrease of 9% (11% at
CER). Emerging Markets sales declined by 35% (37% at CER) to $256m,
reflecting the implementation of China's VBP programme, resulting
in significantly lower market access for the medicine, and a
mandatory price cut. In the US, sales increased by 4% to $558m
partly reflecting the recent launch of Brilinta as a treatment to reduce the risk of stroke
in patients following an acute ischaemic stroke or high-risk
transient ischaemic attack. Sales of Brilique in Europe increased by 2% (declined by 5% at
CER) to $263m. The overall performance in the year to date
continued to be adversely impacted by fewer elective procedures due
to the effects of COVID-19.
Onglyza
Total Revenue, entirely comprising Product Sales, amounted to $284m
in the year to date and represented a decline of 22% (25% at CER).
Sales in Emerging Markets decreased by 2% (6% at CER) to $151m. US
sales of Onglyza fell by 53% in the year to $62m as the
DPP-4[51] inhibitor
class continues to decline, whereas in Europe sales increased by
10% (2% at CER) to $47m.
Bydureon
Total Revenue, entirely comprising Product Sales, amounted to $293m
in the year to date, representing a decline of 10% (11% at CER). US
sales decreased by 12% in the year to date to $243m following the
withdrawal of the dual-chamber pen and lower demand for
the Bydureon
BCise auto-injector
device. Sales in Europe increased by 12% (4% at CER) to $43m; the
performance reflected the growth of the overall glucagon-like
peptide-1 receptor class.
Lokelma
Total Revenue, entirely comprising Product Sales, amounted to $122m
in the year to date, representing an increase of 153% (151% at
CER). Sales in the US increased by 119% to $82m, reflecting the
growth in the potassium binder class. Lokelma continued to be the branded market share
leader.
Sales in Japan increased to $28m in the year to date (YTD 2020:
$5m) despite Ryotanki, a regulation that restricts prescriptions to
two weeks' supply in the first year of launch. The restriction
lifted in June 2021 and no longer applies. During the period,
expansion in Europe continued with launches in several new markets;
sales amounted to $8m (YTD 2020: $3m).
Roxadustat
Total Revenue in China, predominantly comprising Product Sales,
amounted to $148m in the year to date (YTD 2020: $19m). From
January 2021, AstraZeneca started recognising the overwhelming
majority of China revenue as Product Sales following an amendment
in July 2020 to the existing licence agreement with FibroGen, Inc.
(FibroGen).
Crestor
Total Revenue, primarily comprising Product Sales, amounted to
$838m in the year to date and represented a decline of 5% (9% at
CER).
In Emerging Markets, sales increased by 7% (2% at CER) to $597m,
despite the adverse impact of China's VBP programme. US sales
declined by 17% to $59m, whereas in Europe, revenue decreased by
54% (57% at CER) in the year to date to $45m following the February
2021 divestment of European rights in more than 30 countries to
Grünenthal GmbH (Grünenthal). In Japan, where AstraZeneca
collaborates with Shionogi Co., Ltd, sales declined by 10% to
$109m.
BioPharmaceuticals: Respiratory & Immunology
Total Revenue, which included Ongoing Collaboration Revenue of $12m
from Duaklir, Eklira and other medicines, increased by 16% in the
year to date (12% at CER) to $4,456m and represented 18% of Total
Revenue (YTD 2020: 20%). Due to the adverse effect of COVID-19
on Pulmicort sales in the first nine months of 2020, the
year-on-year comparison was favourably
impacted.
Symbicort
Total Revenue, entirely comprising Product Sales, was stable at
$2,047m in the year to date (a decline of 3% at
CER). Symbicort remains the global market-volume and value
leader within the ICS[52] /
LABA[53] class.
Growth in the global ICS/LABA class has been limited, due to the
continued impact of COVID-19 on the prevalence and diagnosis rates
of respiratory diseases, lower levels of respiratory symptoms, and
reduced use of medicines.
In the US, sales increased by 6% in the year to date to $804m. The
positive performance benefitted from early signs of a recovery in
the ICS/LABA market and a stable market share, offset by managed
markets.
Emerging Markets sales increased by 8% (4% at CER) to $457m,
following several additional approvals of Symbicort as a medicine to treat patients with asthma
on an as-needed basis, and despite COVID-19 related pressures on
class growth. In Europe, sales decreased by 4% (11% at CER) in the
year to date to $499m. Sales in Japan declined by 34% (35% at CER)
to $95m in the year to date due to the ongoing adverse impact of
generic competition and a contracting ICS/LABA
market.
Pulmicort
Total Revenue, entirely comprising Product Sales, amounted to $714m
in the year to date and represented an increase of 14% (7% at
CER).
Emerging Markets, where Pulmicort sales increased by 20% (13% at CER) in the
year to date to $578m, represented 81% of the global
total. Pulmicort was included in the latest round of VBP
announced in June 2021, which will result in significantly lower
market access and a mandatory price reduction for the medicine in
future periods. Implementation of the programme
for Pulmicort, began after the end of Q3 2021, in October
2021.
Sales in the US decreased by 1% in the year to date to $53m due to
managed markets. Europe sales decreased by 10% (17% at CER) to
$49m. In Japan, sales decreased by 25% in the year to date to $17m
following increasing generic competition.
Fasenra
Total Revenue, entirely comprising Product Sales, increased by 35%
(32% at CER) in the year to date to $901m.
Sales in the US increased by 31% in the year to date to $555m due
to a partial recovery of the severe asthma biologic market. In
Europe, sales increased by 51% (40% at CER) in the year to date to
$211m; the performance primarily due to growth in new patient
starts. Sales in Emerging Markets increased 55% (52% at CER) to
$15m.
Daliresp
Total Revenue, entirely comprising Product Sales, amounted to $168m
in the year to date and represented an increase of 3%. US sales
increased by 9% to $153m.
Breztri
Breztri has received
regulatory approval in 36 countries, including the US, in the EU,
China, and Japan, to treat patients with COPD; further regulatory
reviews are ongoing. Breztri has achieved reimbursement in
14 countries.
Total Revenue, entirely comprising Product Sales, amounted to $130m
in the year to date (YTD 2020: $21m). Sales in the US amounted to
$68m (YTD 2020: $3m), following encouraging market share growth in
the fixed-dose triple market. Emerging Markets sales amounted to
$40m in the year to date (YTD 2020: $14m), with the performance
benefitting from inclusion of the medicine into China's NRDL in
March 2021, which has significantly increased the number of
patients with access to Breztri in China. Sales in Japan amounted to $17m
(YTD 2020: $4m). In Europe, under the name Trixeo, sales amounted to $4m in the year to date (YTD
2020: $nil).
Saphnelo (anifrolumab)
Saphnelo has received
regulatory approval in the US and Japan to treat SLE; further
regulatory reviews are ongoing.
Total Revenue, entirely comprising Product Sales in the US,
amounted to $1m in the year to date.
Rare Disease
Total Revenue recorded post-acquisition from 21 July 2021, entirely
comprising Product Sales, amounted to $1,311m representing a pro
rata increase of 5% (6% at CER) in Q3 2021. Pro forma pro rata
growth rates on Rare Disease medicines for Q3 2021 have been
calculated by comparing post-acquisition revenues from 21 July 2021
with the corresponding prior year pre-acquisition Q3 revenues
previously published by Alexion, adjusted pro rata to match the
post-acquisition period.
Soliris
Total Revenue amounted to $798m. This represented a pro rata
decline on a pro forma basis of 3% (2% at CER) in Q3
2021.
In the US, Total Revenue amounted to $460m, representing a pro
forma pro rata increase of 4% in Q3 2021. Sales benefitted from
growing use in neurology indications, including gMG and NMOSD,
offset by patient conversion to Ultomiris in PNH and aHUS.
Outside the US, Total Revenue amounted to $338m. Performance during
the period was driven by underlying growth in neurology
indications, gMG and NMOSD, and impacted by the successful
conversion to Ultomiris, which offers patients a lower average annual
treatment cost, and a more convenient dosing schedule with every
eight week dosing versus Soliris's every two week regimen.
Ultomiris
Total Revenue amounted to $297m, representing a pro rata increase
of 31% in Q3 2021. In the US, Total Revenue amounted to
$167m, representing a pro rata increase of 25% in Q3 2021.
Outside the US, Total Revenue amounted to $130m. Performance
was driven by strong conversion from Soliris in PNH and aHUS, as well as new country
launches in the quarter. Quarter on quarter variability can be
expected due to the every eight week dosing
schedule.
Strensiq
Total Revenue amounted to $159m, representing a pro forma pro
rata increase of 7% (8% at CER) in Q3 2021.
In the US, Total Revenue amounted $124m, representing pro
forma pro rata growth of 6%. This was driven by underlying volume
gains, partly offset by a one-time true-up payment.
Other medicines (outside the main disease areas)
Total Revenue, primarily comprising Product Sales, amounted to
$1,648m in the year to date, a decrease of 13% (16% at CER). This
does not include revenue from the COVID-19 vaccine, which is
covered in the COVID-19 commentary. Other medicines Total Revenue
represented 6% of overall Total Revenue (YTD 2020:
10%).
Nexium
Total Revenue, predominantly comprising Product Sales, declined by
4% (7% at CER) in the year to date to $1,091m. Revenue in Emerging
Markets increased by 3% (declined 1% at CER) in the year to date to
$576m, reflecting the impact of the inclusion
of Nexium (oral) in China's VBP programme in February
2021 resulting in significantly lower market access and a mandatory
price reduction. Nexium (i.v.) was included in the fifth round of
VBP with implementation occurring after the end of Q3 2021, in
October.
In Japan, where AstraZeneca collaborates with Daiichi Sankyo, Total
Revenue declined by 5% (6% at CER) in the year to date to $306m. In
Q3 2021, Total Revenue in Japan declined 63% (62% at CER) to $44m
reflecting phasing of orders from Daiichi Sankyo ahead of the
previously announced conclusion of the joint sales promotion by the
two companies. From 15 September 2021, AstraZeneca was solely
responsible for marketing, distributing, and
promoting Nexium in Japan. Total Revenue in the US declined
by 19% to $115m, and in Europe, it decreased by 24% (30% at CER) to
$47m.
Synagis
Total Revenue, entirely comprising Product Sales, decreased by 42%
(41% at CER) in the year to date to $170m. Sales in the quarter
increased by 3% (5% at CER) to $122m.
Sales in Europe declined by 67% in the year to date to $81m. This
performance reflected the phasing of orders from AbbVie Inc.
(AbbVie) prior to the expiry of the ex-US commercial rights
agreement between AstraZeneca and AbbVie on 30 June 2021 and
changes as a result of the reversion of ex-US rights to AstraZeneca
thereafter. Prior to the expiry of the agreement on 30 June 2021,
sales made to AbbVie were reported in Europe. During the quarter,
AstraZeneca began recording revenues in regions that had been
covered by the aforementioned agreement including in Q3, sales in
Emerging Markets of $15m (Q3 2020: $nil), sales in Europe of $38m
(Q3 2020: $97m) and sales in Established Rest of World of $53m (Q3
2020: $nil).
FluMist
Total Revenue, entirely comprising of Product Sales, declined 35%
(37% at CER) to $75m in the year to date due to a one-off
supplemental order in the US in 2020 causing an unfavourable
comparison to the prior year. Sales in the US declined by 65% to
$23m as a result. Sales in Europe in the year to date increased 5%
(1% at CER) to $51m.
COVID-19
Pandemic COVID-19 vaccine
Total Revenue, predominantly comprised of Product Sales, amounted
to $2,219m in the year to date reflecting the delivery of c. 580m
doses worldwide by AstraZeneca[54].
Sales in Europe were $736m, Emerging Markets sales were $1,139m,
and in Established RoW sales amounted to $344m.
Regional Total Revenue
A geographical split of Product Sales is shown in Note
8.
Table 9: Regional Total Revenue
|
|
YTD 2021
|
Q3 2021
|
|
|
|
|
% of
|
Actual %
|
CER %
|
|
Actual %
|
CER %
|
|
|
$m
|
total
|
change
|
change
|
$m
|
change
|
change
|
Emerging Markets
|
|
8,618
|
34
|
33
|
28
|
3,159
|
48
|
42
|
- China
|
|
4,699
|
18
|
17
|
8
|
1,490
|
10
|
2
|
- Ex-China
|
|
3,919
|
15
|
60
|
60
|
1,669
|
113
|
112
|
US
|
|
8,305
|
33
|
29
|
29
|
3,471
|
53
|
53
|
Europe
|
|
5,178
|
20
|
40
|
31
|
1,918
|
52
|
49
|
Established RoW
|
|
3,305
|
13
|
28
|
24
|
1,318
|
45
|
46
|
- Japan
|
|
2,360
|
9
|
24
|
24
|
946
|
41
|
46
|
- Canada
|
|
536
|
2
|
17
|
8
|
205
|
28
|
19
|
- Other Established
RoW
|
|
409
|
2
|
81
|
61
|
167
|
n/m
|
99
|
Total
|
|
25,406
|
100
|
32
|
28
|
9,866
|
50
|
48
|
|
|
|
|
|
|
|
|
|
|
Table 10: Emerging Markets Total Revenue disease-area
performance
|
|
YTD 2021
|
Q3 2021
|
|
|
|
% of
|
Actual %
|
CER %
|
|
Actual %
|
CER %
|
|
|
$m
|
total
|
change
|
change
|
$m
|
change
|
change
|
Oncology
|
|
2,438
|
28
|
9
|
4
|
812
|
5
|
-
|
CVRM
|
|
2,916
|
34
|
19
|
14
|
992
|
20
|
14
|
R&I
|
|
1,305
|
15
|
24
|
17
|
420
|
44
|
35
|
Rare Disease16
|
|
65
|
1
|
n/m
|
n/m
|
65
|
(34)
|
(31)
|
Other medicines
|
|
755
|
9
|
4
|
-
|
219
|
(9)
|
(12)
|
COVID-19
|
|
1,139
|
13
|
n/m
|
n/m
|
651
|
n/m
|
n/m
|
Total
|
|
8,618
|
100
|
33
|
28
|
3,159
|
48
|
42
|
Table 11: Ex-China Emerging Markets Total Revenue
|
|
YTD 2021
|
Q3 2021
|
|
|
|
Actual %
|
CER %
|
|
Actual %
|
CER %
|
|
|
$m
|
change
|
change
|
$m
|
change
|
change
|
Ex-China Emerging Markets
|
|
3,919
|
60
|
60
|
1,669
|
113
|
112
|
- Russia
|
|
308
|
30
|
36
|
127
|
n/m
|
n/m
|
- Brazil
|
|
450
|
91
|
98
|
169
|
n/m
|
n/m
|
- Ex-Brazil Latin America
|
|
665
|
n/m
|
n/m
|
341
|
n/m
|
n/m
|
- Ex-China Asia Pacific
|
|
1,634
|
82
|
77
|
709
|
n/m
|
n/m
|
- Middle East and Africa
|
|
862
|
12
|
15
|
323
|
36
|
38
|
China Total Revenue comprised 55% of Emerging Markets Total Revenue
(YTD 2020: 62%) and increased by 17% (8% at CER) in the year to
date to $4,699m.
Ex-China Emerging Markets Total Revenue, primarily comprising
Product Sales, increased by 60% in the year to date to $3,919m.
Excluding the COVID-19 vaccine, Total Revenue increased by 13% (14%
at CER) to $2,780m in the year to date and by 30% in the quarter to
$1,019m.
Financial performance
Table 12: Reported Profit and Loss - YTD 2021
|
|
YTD 2021
|
YTD 2020
|
Actual
|
CER
|
|
|
$m
|
$m
|
% change
|
% change
|
Total Revenue
|
|
25,406
|
19,207
|
32
|
28
|
- Product Sales
|
|
25,043
|
18,879
|
33
|
29
|
- Collaboration Revenue
|
|
363
|
328
|
10
|
10
|
Cost of Sales
|
|
(7,812)
|
(3,774)
|
n/m
|
99
|
Gross Profit
|
|
17,594
|
15,433
|
14
|
11
|
Gross Profit Margin
|
|
68.8%
|
80.0%
|
-11
|
-11
|
Distribution Expense
|
|
(322)
|
(290)
|
11
|
5
|
% Total Revenue
|
|
1.3%
|
1.5%
|
-
|
-
|
R&D Expense
|
|
(7,152)
|
(4,272)
|
67
|
63
|
% Total Revenue
|
|
28.2%
|
22.2%
|
-6
|
-6
|
SG&A Expense
|
|
(10,117)
|
(8,084)
|
25
|
21
|
% Total Revenue
|
|
39.8%
|
42.1%
|
+2
|
+2
|
Other Operating Income & Expense
|
|
1,345
|
888
|
51
|
50
|
% Total Revenue
|
|
5.3%
|
4.6%
|
+1
|
+1
|
Operating Profit
|
|
1,348
|
3,675
|
(63)
|
(57)
|
Operating Margin
|
|
5.3%
|
19.1%
|
-14
|
-13
|
Net Finance Expense
|
|
(922)
|
(905)
|
2
|
-
|
Joint Ventures and Associates
|
|
(55)
|
(21)
|
n/m
|
n/m
|
Profit Before Tax
|
|
371
|
2,749
|
(86)
|
(77)
|
Taxation
|
|
90
|
(610)
|
n/m
|
n/m
|
Tax Rate
|
|
-24%
|
22%
|
|
|
Profit After Tax
|
|
461
|
2,139
|
(78)
|
(63)
|
Earnings per share
|
|
$0.33
|
$1.66
|
(80)
|
(65)
|
Table 13: Reported Profit and Loss - Q3 2021
|
|
Q3 2021
|
Q3 2020
|
Actual
|
CER
|
|
|
$m
|
$m
|
% change
|
% change
|
Total Revenue
|
|
9,866
|
6,578
|
50
|
48
|
- Product Sales
|
|
9,741
|
6,520
|
49
|
47
|
- Collaboration Revenue
|
|
125
|
58
|
n/m
|
n/m
|
Cost of Sales
|
|
(3,757)
|
(1,370)
|
n/m
|
n/m
|
Gross Profit
|
|
6,109
|
5,208
|
17
|
16
|
Gross Profit Margin
|
|
61.4%
|
79.0%
|
-18
|
-18
|
Distribution Expense
|
|
(120)
|
(99)
|
21
|
18
|
% Total Revenue
|
|
1.2%
|
1.5%
|
-
|
-
|
R&D Expense
|
|
(3,610)
|
(1,495)
|
n/m
|
n/m
|
% Total Revenue
|
|
36.6%
|
22.7%
|
-14
|
-14
|
SG&A Expense
|
|
(4,090)
|
(2,730)
|
50
|
47
|
% Total Revenue
|
|
41.5%
|
41.5%
|
-
|
-
|
Other Operating Income & Expense
|
|
37
|
287
|
(87)
|
(87)
|
% Total Revenue
|
|
0.4%
|
4.4%
|
-4
|
-4
|
Operating (Loss)/Profit
|
|
(1,674)
|
1,171
|
n/m
|
n/m
|
Operating Margin
|
|
-17.0%
|
17.8%
|
-35
|
-35
|
Net Finance Expense
|
|
(320)
|
(317)
|
1
|
(1)
|
Joint Ventures and Associates
|
|
(7)
|
(1)
|
n/m
|
n/m
|
(Loss)/Profit Before Tax
|
|
(2,001)
|
853
|
n/m
|
n/m
|
Taxation
|
|
350
|
(202)
|
n/m
|
n/m
|
Tax Rate
|
|
-18%
|
24%
|
|
|
(Loss)/Profit After Tax
|
|
(1,651)
|
651
|
n/m
|
n/m
|
(Loss)/Earnings per share
|
|
$(1.10)
|
$0.49
|
n/m
|
n/m
|
Table 14: Reconciliation of Reported Profit Before Tax to EBITDA -
YTD 2021
|
|
YTD 2021
|
YTD 2020
|
Actual
|
CER
|
|
|
$m
|
$m
|
% change
|
% change
|
Reported Profit Before Tax
|
|
371
|
2,749
|
(86)
|
(77)
|
Net Finance Expense
|
|
922
|
905
|
2
|
-
|
Joint Venture and Associates
|
|
55
|
21
|
n/m
|
n/m
|
Depreciation, Amortisation and Impairment
|
|
4,338
|
2,352
|
84
|
77
|
EBITDA
|
|
5,686
|
6,027
|
(6)
|
(6)
|
EBITDA of $5,686m in the year to date (YTD 2020: $6,027m) has been
negatively impacted by the $1,044m (YTD 2020: $nil) unwind of
inventory fair value uplift recognised on acquisition of Alexion.
The unwind of inventory fair value is expected to depress EBITDA
over approximately 18 months post-acquisition in line with
revenues.
Table 15: Reconciliation of Reported (Loss)/Profit Before Tax to
EBITDA - Q3 2021
|
|
Q3 2021
|
Q3 2020
|
Actual
|
CER
|
|
|
$m
|
$m
|
% change
|
% change
|
Reported (Loss)/Profit Before Tax
|
|
(2,001)
|
853
|
n/m
|
n/m
|
Net Finance Expense
|
|
320
|
317
|
1
|
(1)
|
Joint Venture and Associates
|
|
7
|
1
|
n/m
|
n/m
|
Depreciation, Amortisation and Impairment
|
|
2,788
|
801
|
n/m
|
n/m
|
EBITDA
|
|
1,114
|
1,972
|
(43)
|
(45)
|
EBITDA of $1,114m in the quarter to date (Q3 2020: $1,972m) has
been negatively impacted by the $1,044m (YTD 2020: $nil) unwind of
inventory fair value uplift recognised on acquisition of Alexion.
The unwind of inventory fair value is expected to depress EBITDA
over approximately 18 months post-acquisition in line with
revenues.
Table 16: Reconciliation of Reported to Core financial measures -
YTD 2021
YTD 2021
|
Reported
|
Restructuring
|
Intangible Asset Amortisation & Impairments
|
Acquisition of Alexion[55]
|
Other[56]
|
Core[57]
|
Core
% change
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
Gross Profit
|
17,594
|
221
|
47
|
1,049
|
2
|
18,913
|
22
|
19
|
Gross Profit Margin
|
68.8%
|
|
|
|
|
74.1%
|
-6
|
-6
|
Distribution Expense
|
(322)
|
-
|
-
|
-
|
-
|
(322)
|
11
|
5
|
R&D Expense
|
(7,152)
|
155
|
1,395
|
10
|
1
|
(5,591)
|
34
|
30
|
SG&A Expense
|
(10,117)
|
172
|
1,977
|
166
|
66
|
(7,736)
|
19
|
14
|
Total Operating Expense
|
(17,591)
|
327
|
3,372
|
176
|
67
|
(13,649)
|
24
|
20
|
Other Operating Income & Expense
|
1,345
|
-
|
1
|
-
|
-
|
1,346
|
51
|
50
|
Operating Profit
|
1,348
|
548
|
3,420
|
1,225
|
69
|
6,610
|
21
|
23
|
Operating Margin
|
5.3%
|
|
|
|
|
26.0%
|
-2
|
-1
|
Net Finance Expense
|
(922)
|
-
|
-
|
-
|
294
|
(628)
|
9
|
10
|
Taxation
|
90
|
(93)
|
(697)
|
(242)
|
(55)
|
(997)
|
(2)
|
(1)
|
EPS
|
$0.33
|
$0.33
|
$1.99
|
$0.72
|
$0.22
|
$3.59
|
22
|
23
|
Table 17: Reconciliation of Reported to Core financial measures -
Q3 2021
Q3 2021
|
Reported
|
Restructuring
|
Intangible Asset Amortisation & Impairments
|
Acquisition of Alexion55
|
Other56
|
Core57
|
Core
% change
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
Gross Profit
|
6,109
|
208
|
14
|
1,049
|
2
|
7,382
|
41
|
39
|
Gross Profit Margin
|
61.4%
|
|
|
|
|
74.5%
|
-5
|
-5
|
Distribution Expense
|
(120)
|
-
|
-
|
-
|
-
|
(120)
|
21
|
18
|
R&D Expense
|
(3,610)
|
123
|
1,324
|
10
|
1
|
(2,152)
|
48
|
46
|
SG&A Expense
|
(4,090)
|
97
|
1,013
|
124
|
(10)
|
(2,866)
|
32
|
29
|
Total Operating Expense
|
(7,820)
|
220
|
2,337
|
134
|
(9)
|
(5,138)
|
38
|
35
|
Other Operating Income & Expense
|
37
|
-
|
-
|
-
|
-
|
37
|
(87)
|
(87)
|
Operating (Loss)/Profit
|
(1,674)
|
428
|
2,351
|
1,183
|
(7)
|
2,281
|
27
|
28
|
Operating Margin
|
-17.0%
|
|
|
|
|
23.1%
|
-4
|
-4
|
Net Finance Expense
|
(320)
|
-
|
-
|
-
|
101
|
(219)
|
5
|
4
|
Taxation
|
350
|
(69)
|
(468)
|
(242)
|
(14)
|
(443)
|
29
|
31
|
EPS
|
$(1.10)
|
$0.24
|
$1.26
|
$0.63
|
$0.05
|
$1.08
|
14
|
15
|
Profit and Loss summary
a)
Gross Profit
Reported Gross Profit Margin in the year to date declined eleven
percentage points to 68.8%; Core Gross Profit Margin declined six
percentage points in the year to date to 74.1% predominantly
reflecting the equitable supply, at no profit to AstraZeneca, of
the pandemic COVID-19 vaccine, together with an increasing impact
from profit-sharing arrangements
(primarily Lynparza and
roxadustat) and the impact of the NRDL and VBP programmes in China.
These effects were partially offset by the contribution from
Alexion from 21 July 2021, a higher proportion of Oncology sales,
and increasing patient access in China. Reported Gross Profit
Margin has also been 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 over the 18 months post-acquisition, and in Q3 2021, the
impact of the fair value uplift unwind on Cost of Sales was
$1,044m. Variations in gross margin performance between periods can
be expected to continue.
b)
Total Operating Expense
Reported Total Operating Expense increased in the year to date by
39% (34% at CER) to $17,591m. Core Total Operating Expense
increased by 24% (20% at CER) to $13,649m and represented 54% of
Total Revenue (YTD 2020: 57%).
Reported R&D Expense increased in the year to date by 67% (63%
at CER) to $7,152m including an impairment charge of $1,172m
recognised in the quarter on an intangible asset related to the
acquisition of Ardea Biosciences, Inc. in 2012, following the
decision to discontinue the development of verinurad. Core R&D
Expense increased in the year to date by 34% (30% at CER) to
$5,591m with increases in both Reported and Core R&D Expense
reflecting the Company's continued investment in its COVID-19
vaccine and AZD7442, and other costs related to COVID-19, such as
personal protective equipment and colleague COVID-19 testing across
the Company. The increases also reflected the investment in several
late-stage Oncology trials and the advancement of a number of Phase
II clinical development programmes in BioPharmaceuticals, mainly in
CVRM. In the year to date, grant income of $451m has been
recognised, of which $281m has been offset against the US clinical
trial costs for AZD1222 and $170m offset against costs for
AZD7442.
Reported SG&A Expense increased in the year to date by 25% (21%
at CER) to $10,117m including the increased amortisation of
intangible assets related to the Alexion acquisition. Core SG&A
Expense increased by 19% (14% at CER) to $7,736m, reflecting the
investment in Oncology-medicine launches, the launch of several new
BioPharmaceuticals medicines, particularly in the US, AstraZeneca's
further expansion in Emerging Markets, and the existing
infrastructure base in China.
Restructuring charges primarily comprise supply chain restructuring
charges, exit costs for de-prioritised R&D projects, and
severance payments.
c) Other Operating Income and
Expense
Reported and Core Other Operating Income and Expense increased in
the year to date by 51% (50% at CER) to $1,345m and $1,346m
respectively, and included:
-
Income from the divestment of AstraZeneca's 26.7% share of Viela as
part of the acquisition by Horizon Therapeutics plc. AstraZeneca
received cash proceeds and profit of $776m upon closing with the
profit being recorded as other operating income
- $309m of income from an
agreement with Grünenthal to divest commercial rights
to Crestor in over 30 countries in Europe, except in
the UK and Spain
d)
Net Finance Expense
Reported Net Finance Expense increased in the year to date by 2%
(stable at CER) to $922m, principally reflecting lower interest
income on cash and cash equivalents driven by lower interest rates,
financing costs related to the facilities and debt for the Alexion
transaction, partly offset by lower discount unwind costs on
acquisition-related liabilities, including the Diabetes Alliance.
Core Net Finance Expense increased in the year to date by 9% (10%
at CER) to $628m and was principally driven by the aforementioned
lower interest income and Alexion-related financing
costs.
e)
Taxation
The Reported Tax Rate for the year to date was -24% (YTD 2020:
22%), and the Core Tax Rate was 17% (YTD 2020: 21%). These tax
rates benefitted from the following one-off favourable impacts
which arose in prior quarters:
-
A non-taxable gain on the divestment of the investment in Viela
Bio, Inc. (Viela); and
-
A reduction of tax liabilities arising from updates to estimates of
prior period tax liabilities following settlements with tax
authorities partially offset by a tax charge on recalculation of UK
deferred tax balances following substantive enactment of the UK
Corporation Tax rate increase
Excluding these net benefits, the Core Tax Rate would have been
approximately 21%. The Reported tax rate for the year to date has
been impacted by the above and the level of Reported Profit Before
Tax.
The net cash tax paid in the year to date was $1,198m (YTD 2020:
$1,221m).
f)
EPS
Reported EPS in the year to date declined 80% (65% at CER) to
$0.33. Core EPS increased by 22% (23% at CER) to $3.59. Reported
and Core EPS were adversely affected by $0.03 due to the pandemic
COVID-19 vaccine.
Table 18: Cash Flow Summary
|
|
YTD 2021
|
YTD 2020
|
Change
|
|
$m
|
$m
|
$m
|
Reported Operating Profit
|
|
1,348
|
3,675
|
(2,327)
|
Depreciation, Amortisation and Impairment
|
|
4,338
|
2,352
|
1,986
|
Decrease/(increase) in Working Capital and Short-term
Provisions
|
|
2,063
|
(255)
|
2,318
|
Gains on Disposal of Intangible Assets
|
|
(371)
|
(535)
|
164
|
Gains on Disposal of Investments in Associates and Joint
Ventures
|
|
(776)
|
-
|
(776)
|
Non-Cash and Other Movements
|
|
(337)
|
(498)
|
161
|
Interest Paid
|
|
(522)
|
(517)
|
(5)
|
Taxation Paid
|
|
(1,198)
|
(1,221)
|
23
|
Net Cash Inflow from Operating Activities
|
|
4,545
|
3,001
|
1,544
|
Net Cash (Outflow)/Inflow before Financing Activities
|
|
(5,600)
|
2,578
|
(8,178)
|
Net Cash Inflow from Financing Activities
|
|
4,700
|
7
|
4,693
|
The increase in Net Cash Inflow from Operating Activities of
$1,544m was primarily driven by the decrease in working capital, of
which $497m related to the movement in pandemic COVID-19 vaccine
working capital balances within trade and other payables, trade and
other receivables and inventories in the year to date, with the key
movement being a $298m increase in vaccine contract liabilities to
$1,914m as at 30 September 2021.
The decrease in Net Cash (Outflow)/Inflow before Financing
activities of $8,178m is principally due to the Alexion
acquisition, specifically the upfront payment of $13,349m, less
cash and cash equivalents acquired of $4,086m, and $203m of
payments upon vesting of employee share awards. This decrease is
partially offset by the aforementioned improvement in Net Cash
Inflow from Operating Activities.
Capital Expenditure
Capital Expenditure amounted to $768m in the year to date (YTD
2020: $598m). This included investment in the new AstraZeneca
R&D centre on the Biomedical Campus in Cambridge, UK, to which
a number of colleagues have begun relocation.
The Company anticipates an increase in Capital Expenditure, partly
driven by an expansion in its capacity for growth across several
limited-sized projects.
Table 19: Net Debt summary
|
|
At 30 Sep 2021
|
At 31 Dec 2020
|
At 30 Sep 2020
|
|
$m
|
$m
|
$m
|
Cash
and cash equivalents
|
|
7,067
|
7,832
|
8,072
|
Other
investments
|
|
82
|
160
|
374
|
Cash and investments
|
|
7,149
|
7,992
|
8,446
|
Overdrafts
and short-term borrowings
|
|
(605)
|
(658)
|
(1,216)
|
Lease
liabilities
|
|
(962)
|
(681)
|
(666)
|
Current
instalments of loans
|
|
(2,139)
|
(1,536)
|
(2,186)
|
Non-current
instalments of loans
|
|
(28,206)
|
(17,505)
|
(18,271)
|
Interest-bearing loans and borrowings
(Gross Debt)
|
|
(31,912)
|
(20,380)
|
(22,339)
|
Net
derivatives
|
|
90
|
278
|
131
|
Net Debt
|
|
(24,673)
|
(12,110)
|
(13,762)
|
Net Debt increased by $12,563m in the nine months to $24,673m
primarily due to financing the Alexion acquisition. Details of the
committed undrawn bank facilities are disclosed within the going
concern section of Note 1. Details in regards to the funding of the
Alexion acquisition are provided within Note 5.
In July 2021, following the acquisition of Alexion, S&P Global
Ratings upgraded AstraZeneca's long-term credit rating to
A-. Other than this, there were no changes to the Company's
solicited credit ratings during the nine months to 30 September
2021. At 30 September 2021, the Company's solicited credit
ratings from S&P were A- (long term) and A-2 (short term) and
from Moody's were A3 (long term) and P-2 (short term).
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.
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 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 20: Obligor group summarised Statement of Comprehensive
income
|
|
YTD 2021
|
FY 2020
|
YTD 2020
|
|
$m
|
$m
|
$m
|
Total revenue
|
|
-
|
-
|
-
|
Gross profit
|
|
-
|
-
|
-
|
Operating loss
|
|
(131)
|
(45)
|
(1)
|
Loss for the period
|
|
(553)
|
(663)
|
(463)
|
Transactions with subsidiaries that are not issuers or
guarantors
|
|
5,731
|
2,637
|
484
|
Table 21: Obligor group summarised Statement of Financial position
information
|
|
At 30 Sep 2021
|
At 31 Dec 2020
|
At 30 Sep 2020
|
|
$m
|
$m
|
$m
|
Current assets
|
|
12
|
26
|
1
|
Non-current assets
|
|
-
|
4
|
-
|
Current liabilities
|
|
(2,347)
|
(1,720)
|
(961)
|
Non-current liabilities
|
|
(25,721)
|
(17,161)
|
(17,913)
|
Amounts due from subsidiaries that are not issuers or
guarantors
|
|
12,137
|
7,011
|
6,484
|
Amounts due to subsidiaries that are not issuers or
guarantors
|
|
(299)
|
(290)
|
(295)
|
Foreign exchange
The Company's transactional currency exposures on working-capital
balances, which typically extend for up to three months, are hedged
where practicable using forward foreign-exchange contracts against
the individual companies' reporting currency. Foreign-exchange
gains and losses on forward contracts for transactional hedging are
taken to profit or loss. In addition, the Company's external
dividend payments, paid principally in pounds sterling and Swedish
krona, are fully hedged from announcement to payment
date.
Table 22: Currency sensitivities
The Company provides the following currency-sensitivity
information:
|
|
|
Average Exchange
Rates versus USD
|
|
Annual Impact of 5%
Strengthening in Exchange Rate versus USD ($m)[58]
|
Currency
|
Primary Relevance
|
|
FY 2020[59]
|
YTD 2021[60]
|
% change
|
Product Sales
|
Core Operating Profit
|
CNY
|
Product Sales
|
|
6.90
|
6.44
|
7
|
312
|
186
|
EUR
|
Product Sales
|
|
0.88
|
0.84
|
5
|
214
|
75
|
JPY
|
Product Sales
|
|
106.74
|
108.52
|
(2)
|
154
|
102
|
Other[61]
|
|
|
|
|
|
250
|
116
|
GBP
|
Operating Expense
|
|
0.78
|
0.72
|
7
|
35
|
(81)
|
SEK
|
Operating Expense
|
|
9.20
|
8.49
|
8
|
5
|
(59)
|
Sustainability
AstraZeneca's sustainability approach has three priority
areas[62],
aligned with the Company's purpose and business
strategy:
-
Access to healthcare
-
Environmental protection
-
Ethics and transparency
Recent developments and progress against the Company's priorities
are reported below.
The AstraZeneca Board established a Sustainability Committee to
monitor the execution of the Company's sustainability strategy,
oversee communication of sustainability activities with
stakeholders, and provide input to the Board and other Board
Committees on sustainability matters. The members of the Committee
are Nazneen Rahman, Chairman of the Committee, Sheri McCoy, Andreas
Rummelt and Marcus Wallenberg.
a)
Access to healthcare
In the third quarter of 2021, the Company delivered approximately
67 million doses of its pandemic COVID-19 vaccine through COVAX. As
of 30 September 2021, the Company and its sublicensee SII have
delivered more than 145 million doses with COVAX to over 125
countries, approximately half of all COVAX supply. The majority of
the doses have gone to low and middle-income countries. Globally,
AstraZeneca and its sub-licensing partners have released more than
1.5 billion vaccine doses as of the 30 September 2021, for
supply in over 170 countries.
AstraZeneca launched phase two of the Partnership for Health System
Sustainability and Resilience (PHSSR)
policy programme, expanding into 13 new countries plus a regional
hub in the Central, Eastern Europe and Baltics Area (CEEBA),
building on the success of the pilot phase launched in 2020.
Additional information on the pilot phase and its outcomes, please
see the interim report here.
The PHSSR is an ambitious global-level partnership between
AstraZeneca, the World Economic Forum (WEF), the London School of
Economics, and others, with the aim of delivering practical
solutions to make health systems more resilient and
sustainable.
On 23 September 2021, the Lung Ambition Alliance (a
global coalition of AstraZeneca, Guardant Health, the
International Association for the Study of Lung Cancer and the
Global Lung Cancer Coalition) and WEF launched a new collaboration
and held an affiliated session on lung cancer at the Sustainable
Development Impact Summit, which brought together high-level
non-governmental organisation representatives, healthcare leaders
and industry to drive multi-sector collaboration for the
elimination of lung cancer as a leading cause of premature cancer
death. This partnership adds significant strength and voice to the
ongoing efforts of the Lung Ambition Alliance to eliminate lung
cancer as a cause of death.
AstraZeneca also contributed to an event run alongside the UN
General Assembly (UNGA), on the topic of Transforming Global Health
Partnerships for the Sustainable Development Goals, in
collaboration with the World Health Organization. The session
focused on strengthening global health systems and increasing early
detection and treatment for non-communicable diseases.
The Company's Healthy Heart
Africa (HHA) programme expanded into the Republic of Rwanda, and is
now active in eight countries in East and West Africa. Since the
programme launched in 2015, HHA has conducted over 21 million blood
pressure screenings, identified over four million elevated
readings, activated over 900 sites and trained over 8,500
healthcare workers and volunteers.
The Company's Young Health Programme (YHP), in collaboration with
Plan International UK and various public sector bodies, reached
almost 400,000 young people with health information, including a
new health education module on nutrition released in partnership
with UNICEF. To date, the UNICEF modules released in 2021 have
reached almost two million young people. The YHP received more than
1,000 applications for its One Young World Scholarship, which
strives to identify the most impactful young leaders from every
country in the world, from which 15 scholars will be selected to
attend a youth leadership summit in Tokyo in May 2022.
b)
Environmental protection
AstraZeneca marked World Water Week from 23-27 August, including
participating in a panel hosted by the Climate Disclosure
Standards Board, with
a case
study on assessing and
disclosing water risk and work done in preparation for the
company's Task Force on Climate Disclosure Framework (TCFD) 2020
Report.
Aligned with Climate Week 2021 and the UNGA, AstraZeneca
contributed to global dialogue at the WEF SDI Summit, by publishing
a blog by Chief Executive Officer Pascal Soriot on 21 September on
"Urgency, Innovation and Partnership: applying lessons from
COVID-19 to tackle the climate crisis".
AstraZeneca reinforced its commitment to the
1t.org Trillion Trees Corporate Alliance, a
cross-industry forest conservation and restoration coalition led by
WEF, as one of 20 global companies making an
initial pledge to conserve, restore and grow more
than 2.5 billion trees in over 50 countries by 2030. Our AZ Forest
programme recognises the strong connection between a healthy planet
and healthy people, as well as the value of nature-based solutions
to mitigating the negative impacts of climate change, part of our
broader Ambition Zero Carbon
strategy.
On 28 October 2021, the Science Based Targets initiative announced
that AstraZeneca is one of the first seven companies worldwide, and
the only pharmaceutical company, to have their science-based, net
zero targets verified as in line with their new Net Zero
Standard.
On 3 November 2021, at the 26th UN Climate Change Conference
(COP26), HRH The Prince of Wales named AstraZeneca as one of the
first holders of the Terra Carta Seal, in recognition of the
company's efforts to lead and accelerate action for a more
sustainable future. In addition, Pascal Soriot was recognised as
the Champion of the new Sustainable Markets Initiative (SMI) Health
System Taskforce, which was launched at COP26 with HRH The Prince
of Wales and with health systems leaders, with the shared ambition
to accelerate the delivery of net zero, sustainable
healthcare.
On 4 November 2021, at COP26, it was announced that AstraZeneca is
one of 10 leading pharmaceutical companies to be part of the
Energize programme, a collaboration to encourage suppliers to
purchase renewable energy at scale, in support of climate action
and the decarbonisation of the pharmaceutical value
chain.
c)
Ethics and transparency
AstraZeneca has launched a Materiality Assessment survey inviting
internal and external stakeholders to contribute to shaping the
future of sustainability at the Company. The results of the
Assessment will help AstraZeneca to prioritise issues where
it can have the most positive impacts on patients, healthcare
systems, the environment and society. The Company will use the
results to update the previous Materiality
Assessment carried out in
2018 and review the overall sustainability strategy and
priorities.
For more details on AstraZeneca's sustainability ambition, approach
and targets, please refer to the latest Sustainability Report
2020 and Sustainability Data
Summary 2020. Additional
information is available within AstraZeneca's analyst interactive
reporting centre or alternatively at astrazeneca.com/sustainability.
Research and development
A comprehensive breakdown of AstraZeneca's pipeline of medicines in
human trials can be found in the latest clinical-trials appendix,
available on astrazeneca.com/investor-relations.html.
Highlights of the Company's late-stage pipeline development since
the prior results announcement are discussed
below.
Table 23: Late-stage pipeline
New molecular entities and major lifecycle events for medicines in
Phase III trials or under regulatory review
|
28
|
Oncology
- Tagrisso - NSCLC
- Imfinzi - multiple cancers
- Lynparza - multiple cancers
- Enhertu - multiple cancers
- Calquence - blood cancers
- Orpathys - NSCLC
-
tremelimumab - multiple cancers
-
capivasertib - breast, prostate cancer
-
monalizumab - head & neck cancer
-
camizestrant - breast cancer
-
datopotamab deruxtecan - lung cancer
CVRM
- Farxiga - multiple indications
-
roxadustat - anaemia in MDS
- Lokelma - hyperkalaemia in CKD
Respiratory & Immunology
- Fasenra - multiple indications
- Breztri - asthma
-
tezepelumab - multiple indications
-
PT027 - asthma
- Saphnelo (anifrolumab) - SLE
-
brazikumab - inflammatory bowel disease
Rare Disease
- Ultomiris - multiple indications
-
ALXN1840 - Wilson disease
-
CAEL-101 - AL amyloidosis
-
acoramidis (ALXN2060) - ATTR-CM
-
danicopan (ALXN2040) - PNH with EVH
Other
-
nirsevimab - RSV
COVID-19
- Vaxzevria
-
AZD7442
|
Total projects
in clinical development
|
159
|
|
Total projects
in total pipeline
|
175
|
|
Oncology
In September 2021, AstraZeneca presented new data across its
diverse portfolio of cancer medicines at the International
Association for the Study of Lung Cancer (IASLC) 2021 World
Conference on Lung Cancer (WCLC) and the 2021 European Society for
Medical Oncology (ESMO) Congress. Fourteen approved and potential
new medicines were featured across more than 100 abstracts at the
two meetings. Across both WCLC and ESMO, AstraZeneca medicines
featured in 25 oral presentations including a Presidential
Symposium at each congress.
Tagrisso
Table 24: Key Tagrisso Phase III trials
Trial (population)
|
Design
|
Timeline
|
Status
|
NeoADAURA
(neo-adjuvant EGFRm NSCLC)
|
Placebo or Tagrisso
|
FPCD[63]:
Q1 2021
First data anticipated: 2022+
|
Recruitment ongoing
|
ADAURA
(adjuvant EGFRm NSCLC)
|
Placebo or Tagrisso
|
FPCD: Q4 2015
LPCD[64]:
Q1 2019
|
Trial unblinded early due to overwhelming efficacy
Regulatory approval(US, EU, CN)
|
LAURA
(locally advanced, unresectable EGFRm NSCLC)
|
Placebo or Tagrisso
|
FPCD: Q4 2018
First data anticipated: 2022+
|
Recruitment ongoing
|
FLAURA2
(EGFRm NSCLC, 1st-line)
|
Tagrisso or Tagrisso + platinum-based chemotherapy
doublet
|
FPCD: Q4 2019
First data anticipated: 2022+
|
Recruitment ongoing
|
Imfinzi
At WCLC 2021, positive results from the POSEIDON Phase III trial
were presented during a Presidential
Symposium. Imfinzi plus tremelimumab demonstrated statistically
significant and clinically meaningful improvement in
OS[65] and
PFS[66] compared
to chemotherapy alone in the 1st-line treatment of patients with
Stage IV (metastatic) NSCLC. Patients treated with tremelimumab in
addition to Imfinzi and chemotherapy experienced a 23% reduction
in the risk of death versus a range of chemotherapy options
(HR[67] 0.77;
95% CI[68] 0.65-0.92;
p=0.00304) with a median OS of 14.0 months versus 11.7 months. An
estimated 33% of patients were alive at two years versus 22% for
chemotherapy. The combination also reduced the risk of disease
progression or death by 28% compared to chemotherapy alone (HR
0.72; 95% CI 0.60-0.86; p=0.00031) with a median PFS of 6.2 months
versus 4.8 months, respectively.
At ESMO 2021, positive results from the COAST Phase II trial were
presented. Oleclumab, an anti-CD73 monoclonal antibody, or
monalizumab, an anti-NKG2A monoclonal antibody, in combination
with Imfinzi improved PFS and ORR[69] compared
to Imfinzi alone in patients with unresectable, Stage
III NSCLC who had not progressed after cCRT[70].
After a median follow-up of 11.5 months, Imfinzi plus oleclumab reduced the risk of disease
progression or death by 56% (HR of 0.44; 95% CI 0.26-0.75),
and Imfinzi in combination with monalizumab by 35% (HR
of 0.65; 95% CI 0.49-0.85), when compared
to Imfinzi alone. The 10-month PFS rate was 64.8%
for Imfinzi plus oleclumab and 72.7%
for Imfinzi plus monalizumab, versus 39.2%
with Imfinzi alone.
During the period, AstraZeneca announced the HIMALAYA Phase III
trial for Imfinzi plus tremelimumab in 1st-line treatment of
unresectable hepatocellular carcinoma, the most common type of
liver cancer, had met its primary endpoint. A single, high priming
dose of tremelimumab added to Imfinzi demonstrated a statistically significant and
clinically meaningful OS benefit versus sorafenib as a 1st-line
treatment for patients not eligible for localised treatment. This
novel dose and schedule of tremelimumab, an anti-CTLA4 antibody,
and Imfinzi is called the STRIDE regimen (Single
Tremelimumab Regular Interval Durvalumab). The combination
demonstrated a favourable safety profile, and the addition of
tremelimumab to Imfinzi did not increase severe hepatic
toxicity.
During the period, AstraZeneca announced that the TOPAZ-1 Phase III
trial evaluating the use of Imfinzi in combination with standard of care
chemotherapy in 1st-line advanced biliary tract cancer, had met its
primary endpoint. At a predefined interim analysis, the Independent
Data Monitoring Committee concluded that the trial met the primary
endpoint by demonstrating an improvement in overall survival in
patients treated with Imfinzi plus chemotherapy versus chemotherapy alone.
The combination also demonstrated an improvement in
progression-free survival and overall response rate which were key
secondary endpoints. Imfinzi plus chemotherapy was well tolerated, had a
similar safety profile versus the comparator arm and did not
increase the discontinuation rate due to adverse events compared to
chemotherapy alone.
Table 25: Key Imfinzi Phase III trials in lung
cancer
Trial (population)
|
Design
|
Timeline
|
Status
|
AEGEAN
(neo-adjuvant NSCLC)
|
SoC[71] chemotherapy
+/- Imfinzi, followed by surgery, followed by placebo
or Imfinzi
|
FPCD: Q1 2019
First data anticipated: 2022+
|
Recruitment ongoing
|
ADJUVANT BR.31[72]
(Stage IB-IIIA resected NSCLC)
|
Placebo or Imfinzi
|
FPCD: Q1 2015
LPCD: Q1 2020
First data anticipated: 2022+
|
Recruitment completed
|
MERMAID-1
(Stage II-III
resected NSCLC)
|
SoC chemotherapy +/- Imfinzi
|
FPCD: Q3 2020
First data anticipated: 2022+
|
Recruitment ongoing
|
MERMAID-2
(Stage II-III
NSCLC with minimal residual disease)
|
Placebo or Imfinzi
|
FPCD: Q3 2021
First data anticipated: 2022+
|
Recruitment ongoing
|
PACIFIC-2
(Stage III unresectable locally advanced NSCLC
(concurrent CRT))
|
Placebo or
Imfinzi
|
FPCD: Q2 2018
LPCD: Q3 2019
First data anticipated:H2 2021
|
Recruitment completed
|
ADRIATIC
(LS-SCLC)
|
cCRT, followed by placebo or Imfinzi or Imfinzi + tremelimumab
|
FPCD: Q4 2018
LPCD: Q3 2021
First data anticipated:H2 2022
|
Recruitment completed
|
PEARL
(Stage IV NSCLC, 1st-line)
|
SoC chemotherapy or Imfinzi
|
FPCD: Q1 2017
LPCD: Q1 2019
First data anticipated:H1 2022
|
Recruitment completed
|
POSEIDON
(Stage IV NSCLC, 1st-line)
|
SoC chemotherapy or SoC + Imfinzi or SoC + Imfinzi + tremelimumab
|
FPCD: Q2 2017
LPCD: Q4 2018
|
PFS primary endpoint met; OS primary endpoint met
for Imfinzi + tremelimumab
|
Table 26: Key Imfinzi Phase III trials in tumour types other than
lung cancer
Trial (population)
|
Design
|
Timeline
|
Status
|
POTOMAC
(non-muscle invasive bladder cancer)
|
SoC BCG[73] +/- Imfinzi
|
FPCD: Q4 2018
LPCD: Q4 2020
First data anticipated: 2022+
|
Recruitment completed
|
NIAGARA
(muscle-invasive bladder cancer)
|
Neo-adjuvant cisplatin and gemcitabine SoC chemotherapy or SoC
+ Imfinzi, followed by adjuvant placebo
or Imfinzi
|
FPCD: Q4 2018LPCD: Q3 2021
First data anticipated: 2022+
|
Recruitment completed
|
EMERALD-1
(locoregional HCC[74])
|
TACE[75] followed
by placebo or TACE + Imfinzi, followed by Imfinzi + bevacizumab or TACE
+ Imfinzi followed by Imfinzi
|
FPCD: Q1 2019LPCD: Q3 2021
First data anticipated:H2 2022
|
Recruitment completed
|
EMERALD-2
(locoregional HCC at high risk of recurrence after surgery or
radiofrequency ablation)
|
Adjuvant Imfinzi or Imfinzi + bevacizumab
|
FPCD: Q2 2019
First data anticipated: 2022+
|
Recruitment ongoing
|
CALLA
(locally advanced cervical cancer)
|
CRT +/- Imfinzi, followed by placebo or Imfinzi
|
FPCD: Q1 2019
LPCD: Q4 2020
First data anticipated:H1 2022
|
Recruitment completed
|
MATTERHORN
(resectable gastric and gastroesophageal cancer)
|
Neoadjuvant Imfinzi + FLOT[76] chemotherapy
+/- adjuvant Imfinzi
|
FPCD: Q4 2020
First data anticipated: 2022+
|
Recruitment ongoing
|
KUNLUN
(locally advanced, unresectable oesophageal squamous cell
carcinoma)
|
Definitive CRT or CRT +/- Imfinzi
|
FPCD: Q4 2020
First data anticipated: 2022+
|
Recruitment ongoing
|
NILE(Stage IV cisplatin chemotherapy- eligible bladder cancer,
1st-line)
|
SoC chemotherapy orSoC + Imfinzi orSoC + Imfinzi + tremelimumab
|
FPCD: Q4 2018LPCD: Q2 2021
First data anticipated: 2022+
|
Recruitment completed
|
VOLGA
(Muscle invasive bladder cancer ineligible to
cisplatin)
|
SoC cystectomy or Imfinzi + tremelimumab + enfortumab vedotin
or Imfinzi + enfortumab vedotin
|
FPCD: Q4 2021
First data anticipated: 2022+
|
Recruitment ongoing
|
HIMALAYA
(Stage IV unresectable HCC, 1st-line)
|
Sorafenib or Imfinzi or Imfinzi + tremelimumab
|
FPCD: Q4 2017
LPCD: Q4 2019
|
Primary endpoint met
Orphan Drug Designation (US)
|
TOPAZ-1
(Stage IV biliary-tract cancer, 1st-line)
|
Gemcitabine and cisplatin SoC chemotherapy or SoC
+ Imfinzi
|
FPCD: Q2 2019
LPCD: Q4 2020
|
Primary endpoint metOrphan Drug Designation (US)
|
Lynparza
In September 2021, the Company announced that the PROpel Phase III
trial for Lynparza in combination with abiraterone in 1st-line
mCRPC in men with or without homologous recombination repair gene
mutations, had met its primary endpoint, demonstrating a
statistically significant and clinically meaningful improvement in
radiographic PFS versus standard-of-care
abiraterone.
During the period, the National Comprehensive Cancer Network
guidelines were updated to recommend Lynparza for the adjuvant treatment of BRCAm, high
risk, HER2-negative early breast cancer based on the results of the
Phase III OlympiA trial.
Table 27: Key Lynparza Phase III trials
Trial (population)
|
Design
|
Timeline
|
Status
|
OlympiA
(adjuvant BRCAm[77] breast
cancer)
|
Placebo or Lynparza
|
FPCD: Q2 2014
LPCD: Q2 2019
|
Primary endpoint met
|
MONO-OLA1
(BRCAwt[78] advanced
ovarian cancer 1L maintenance)
|
Placebo or Lynparza
|
FPCD: Q3 2021
First data anticipated: 2022+
|
Recruitment ongoing
|
DuO-O
(advanced ovarian cancer, 1st-line)
|
Chemotherapy + bevacizumab or chemotherapy + bevacizumab
+ Imfinzi +/- Lynparza maintenance
|
FPCD: Q1
2019
First data anticipated: 2022+
|
Recruitment ongoing
|
DuO-E
(advanced endometrial cancer, 1st-line)
|
Chemotherapy or chemotherapy + Imfinzi + Imfinzi maintenance or chemotherapy
+ Imfinzi followed by Imfinzi + Lynparza maintenance
|
FPCD: Q2
2020
First data anticipated: 2022+
|
Recruitment ongoing
|
PROpel
(Stage IV, castration-resistant prostate cancer)
|
Abiraterone orabiraterone + Lynparza
|
FPCD: Q4 2018
|
Primary endpoint met
|
Enhertu
In August 2021, AstraZeneca announced that
the Enhertu the AstraZeneca and Daiichi Sankyo Company,
Limited (Daiichi Sankyo) HER2-directed ADC[79] Phase
III DESTINY-Breast03 trial in HER2-positive metastatic breast
cancer met the primary endpoint. The results were presented at a
Presidential Symposium at ESMO 2021 and showed
that Enhertu reduced the risk of disease progression or
death compared to T-DM1 by 72% (HR 0.28; 95% CI 0.22-0.37;
p<0.0001). There was a strong trend towards improved OS
with Enhertu (HR 0.56; 95% CI 0.36-0.86; nominal
p=0.007172), however this analysis is not yet mature and is not
statistically significant. A consistent PFS benefit was observed in
key subgroups of patients treated with Enhertu, including those with a history of stable brain
metastases.
The safety profile of Enhertu was consistent with previous clinical
trials, with no new safety concerns identified and no Grade 4 or 5
treatment-related interstitial lung disease
events.
In October 2021, the US FDA granted Breakthrough Therapy
Designation for Enhertu for the treatment of adult patients with
unresectable or metastatic HER2-positive breast cancer who have
received one or more prior anti-HER2-based
regimens.
In October 2021, updated ESMO Clinical Practice Guidelines were
published in Annals
of Oncology adding Enhertu as the new standard of care in 2nd-line
therapy in HER2+ metastatic breast cancer.
At ESMO 2021, the Company also presented detailed results of key
Phase II trials of Enhertu in gastric and lung
cancer.
Results from the Phase II DESTINY-Gastric02 trial presented during
a late-breaking mini-oral presentation showed
that Enhertu provided a clinically meaningful and durable
tumour response in patients with HER2-positive metastatic and/or
unresectable gastric or GEJ[80] previously
treated with a trastuzumab-containing regimen.
In the primary analysis of DESTINY-Gastric02, the first trial
of Enhertu specifically in Western patients with
HER2-positive metastatic gastric cancer or GEJ
adenocarcinoma, Enhertu (6.4 mg/kg) demonstrated a confirmed ORR of
38% as assessed by independent central review. Three (3.8%)
complete responses and 27 (34.2%) partial responses were observed
in patients treated with Enhertu. These results were consistent with those from
the registrational DESTINY-Gastric01 Phase II trial previously
published in The New England Journal of
Medicine. After a median
follow-up of 5.7 months, the median DoR[81] of Enhertu was
8.1 months (95% CI 4.1-NE). The median progression-free survival
(PFS) was 5.5 months (95% CI 4.2-7.3). An exploratory endpoint of
confirmed disease control rate of 81% (95% CI; 70.6-89.0) was
seen.
Results from the Phase II DESTINY-Lung01 trial presented during a
late-breaking Proffered Paper session showed a robust and durable
tumour response in previously treated patients with HER2-mutant
(HER2m) unresectable and/or metastatic non-squamous non-small cell
lung cancer.
Primary results from the HER2m cohort (cohort 2) of DESTINY-Lung01
in previously treated HER2m NSCLC demonstrated a confirmed ORR of
54.9% in patients treated with Enhertu (6.4 mg/kg) as assessed by independent
central review. One (1.1%) complete response and 49 (53.8%) partial
responses were observed. A confirmed disease control rate of 92.3%
was seen with a reduction in tumour size observed in most patients.
After a median follow-up of 13.1 months, the median DoR
for Enhertu was 9.3 months. The median PFS was 8.2
months and the median OS was 17.8 months.
Table 28: Key Enhertu trials
Trial (population)
|
Design
|
Timeline
|
Status
|
DESTINY-Breast02-U301, Phase III
(Stage IV, HER2+ breast cancer post trastuzumab
emtansine)
|
SoC chemotherapy or Enhertu
|
FPCD: Q3 2018
LPCD: Q4 2020
First data anticipated: H2 2022
|
Recruitment completed
|
DESTINY-Breast03-U302, Phase III
(Stage IV, HER2+ breast cancer, 2nd-line)
|
Trastuzumab emtansine or Enhertu
|
FPCD: Q3 2018
LPCD: Q2 2020
|
Primary endpoint met
Breakthrough Therapy Designation (US)
|
DESTINY-Breast04, Phase III
(Stage IV, HER2-low breast cancer, 2nd-line)
|
SoC chemotherapy or Enhertu
|
FPCD: Q4 2018
LPCD: Q4 2020
First data anticipated: H1 2022
|
Recruitment completed
|
DESTINY-Breast05, Phase III
(high-risk HER2+ breast cancer, post-neoadjuvant)
|
Trastuzumab emtansine or Enhertu
|
FPCD Q4 2020First data anticipated: 2022+
|
Recruitment ongoing
|
DESTINY-Breast06, Phase III
(Stage IV, HER2-low breast cancer, post endocrine
therapy)
|
SoC chemotherapy or Enhertu
|
FPCD: Q3 2020
First data anticipated: 2022+
|
Recruitment ongoing
|
DESTINY-Breast09, Phase III
(Stage IV, HER2+ breast cancer, 1st-line)
|
SoC chemotherapy + trastuzumab + pertuzumab
or Enhertu + pertuzumab or Enhertu
|
FPCD: Q2 2021First data anticipated: 2022+
|
Recruitment ongoing
|
DESTINY-Gastric01, Phase II
(Stage IV, HER2+ gastric cancer)
|
SoC chemotherapy or Enhertu
|
FPCD: Q4 2017
LPCD: Q2 2019
|
Primary endpoint met
Breakthrough Therapy Designation (US)
Regulatory approval (US, JP)
|
DESTINY-Gastric02, Phase II
(Stage IV, HER2+ gastric cancer)
|
Enhertu
|
FPCD: Q4 2019LPCD: Q4 2020
|
Positive data readoutRecruitment completed
|
DESTINY-Gastric04, Phase III
(Stage IV, HER2+ gastric cancer, 2nd-line)
|
Paclitaxel + ramucirumab or Enhertu
|
FPCD: Q2 2021First data anticipated: 2022+
|
Recruitment ongoing
|
DESTINY-Lung04,Phase III
(Stage III, HER2 mutated NSCLC, 1st-line)
|
SoC platinum chemotherapy, pemetrexed and pembrolizumab
or Enhertu
|
Initiating
First data anticipated: 2022+
|
Initiating
|
Calquence
Table 29: Key Calquence Phase III trials
Trial (population)
|
Design
|
Timeline
|
Status
|
ESCALADE
(Diffuse large B-cell lymphoma)
|
SoC R-CHOP[82] +/- Calquence
|
FPCD: Q2 2020
Data anticipated: 2022+
|
Recruitment ongoing
|
Orpathys
During the period, HUTCHMED announced the initiation of the SAMETA
Phase III trial of AstraZeneca and
HUTCHMED's Orpathys, in combination with Imfinzi in unresectable, locally advanced or
metastatic PRCC[83].
Camizestrant
Table 30: Camizestrant Phase III trials
Trial (population)
|
Design
|
Timeline
|
Status
|
SERENA-4
(ER+, HER2-, advanced breast cancer)
|
Palbociclib + anastrazole or albociclib + camizestrant
|
FPCD: Q1 2021
First data anticipated: 2022+
|
Recruitment ongoing
|
SERENA-6
(HR+, HER2-, metastatic breast cancer)
|
Palbociclib or abemaciclib + camizestrant, or anastrozole or
letrozole + albociclib or abemaciclib
|
FPCD: Q3 2021
First data anticipated: 2022+
|
Recruitment ongoing
|
Datopotamab deruxtecan
Table 31: Datopotamab deruxtecan Phase III trials
Trial (population)
|
Design
|
Timeline
|
Status
|
TROPION-Lung01
(Stage IV NSCLC,2nd-line)
|
SoC chemotherapy or datopotamab deruxtecan
|
FPCD: Q1 2021First data anticipated: 2022+
|
Recruitment ongoing
|
TROPION-Breast01
|
SoC chemotherapy or datopotamab deruxtecan
|
InitiatingFirst data anticipated: 2022+
|
Initiating
|
BioPharmaceuticals - CVRM
Farxiga
During the period, Forxiga received regulatory approval in both the EU
and in Japan for the treatment of CKD. The approvals were based on
results from the DAPA-CKD Phase III trial
where Farxiga, on top of standard of care, reduced the
composite measure of worsening of renal function or risk of
cardiovascular or renal death by 39%, compared to placebo in
patients with CKD Stages 2-4 and elevated urinary albumin
excretion.
During the period, Forxiga was one of two SGLT-2 inhibitors added to
the European Society of Cardiology's guidelines for the treatment
of chronic heart failure with reduced ejection fraction with a
Class 1 recommendation.
In October, AstraZeneca voluntarily withdrew the indication
for Forxiga 5mg in the EU for the treatment of adults
with insufficiently controlled T1D[84].
The decision does not impact the indication outside of the EU and
does not impact other approved Farxiga indications or the 10mg dose within or
outside of the EU. The decision followed discussions with the
EMA[85] regarding
product information changes needed post-approval
for Forxiga 5mg specific to T1D, which might cause
confusion among physicians treating patients with
T2D[86],
HFrEF or CKD.
Table 32: Key CVRM Phase III trials
Trial (population)
|
Design
|
Timeline
|
Status
|
Brilinta
|
THALES
(c.11,000 patients with acute ischaemic stroke[87] or
transient ischaemic attack)
|
Aspirin plus placebo or aspirin plus Brilinta 90mg BID
|
FPCD: Q1 2018
LPCD: Q4 2019
|
Primary endpoint met
Regulatory approval (US)
|
Farxiga
|
DELIVER
(c.6,300 patients with HF (HFpEF) with and without
T2D)
|
Placebo or Farxiga 10mg QD
|
FPCD: Q4 2018
LPCD: Q4 2020
First data anticipated: H1 2022
|
Recruitment completed
Fast Track[88] designation
(US)
|
DAPA-MI
(c.6,400 patients with confirmed MI, either
STEMI[89] or
NSTEMI[90],
within the preceding seven days)
|
Placebo or Farxiga 10mg QD
|
FPCD: Q4 2020
First data anticipated: 2022+
|
Recruitment ongoing
|
Roxadustat
During the period, AstraZeneca and its partner FibroGen Inc.
(FibroGen) received a complete response letter from the US FDA,
asking for an additional clinical trial on the safety of roxadustat
in both the non-dialysis and dialysis dependent populations.
AstraZeneca is working with FibroGen to evaluate next
steps.
Lokelma
Table 33Error! No sequence
specified.:
Key Lokelma Phase
III trials
Trial (population)
|
Design
|
Timeline
|
Status
|
DIALIZE
(c.2,300 patients with recurrent hyperkalaemia on chronic
haemodialysis)
|
Placebo or Lokelma 10mg QD for 4 weeks on non-dialysis days, thereafter
adjusted monthly
|
FPCD: Q3 2021
First data anticipated: 2022+
|
Recruitment ongoing
|
STABILIZE-CKD
(c.1,360 patients
with CKD and hyperkalaemia or at risk of
hyperkalaemia)
|
Placebo or Lokelma 5g QOD to 15g QD plus lisonopril or
valsartan
|
FPCD: Q4 2021
First data anticipated: 2022+
|
Recruitment ongoing
|
BioPharmaceuticals - Respiratory & Immunology
Breztri
Table 34: Key Breztri Phase III trials
Trial (population)
|
Design
|
Timeline
|
Status
|
KALOS
(asthma)
|
Budesonide/formoterol or Breztri
|
FPCD: Q1 2021
First data anticipated: 2022+
|
Recruitment ongoing
|
LOGOS
(asthma)
|
Budesonide/formoterol or Breztri
|
FPCD: Q1 2021
First data anticipated: 2022+
|
Recruitment ongoing
|
Fasenra
During the quarter, Fasenra was granted Orphan Drug Designations in EGE
and EG, and a Fast Track Designation for the treatment of EG with
or without EGE in the US by the FDA. A Phase III trial (HUDSON) is
planned for later this year. EG and EGE are rare, chronic relapsing
conditions that may co-exist or be independent. These diseases have
symptoms that are primarily related to eosinophilic tissue
inflammation, which can cause tissue injury and remodelling of the
gastrointestinal tract.
Table 35: Key Fasenra lifecycle management Phase III
trials
Trial (population)
|
Design
|
Timeline
|
Status
|
OSTRO
(severe bilateral nasal polyps)
|
Placebo or Fasenra 30mg
Q8W[91] s.c.
|
FPCD: Q1 2018
LPCD: Q2 2019
|
Co-primary endpoints met
|
RESOLUTE
(moderate to very severe COPD with a history of exacerbations and
elevated peripheral blood eosinophils)
|
Placebo or Fasenra 100mg Q8W s.c.
|
FPCD: Q4 2019
First data anticipated: 2022+
|
Recruitment ongoing
|
MANDARA
(eosinophilic granulomatosis with polyangiitis)
|
Mepolizumab 3x100mg Q4W[92] or Fasenra 30mg
s.c.
|
FPCD: Q4 2019
First data anticipated: 2022+
|
Recruitment ongoing
Orphan Drug Designation (US)
|
NATRON
(HES)
|
Placebo or Fasenra 30mg Q4W s.c.
|
FPCD: Q3 2020
First data anticipated:
H2 2022
|
Recruitment ongoing
Orphan Drug Designation (US)
|
MESSINA
(EoE)
|
Placebo or Fasenra 30mg Q4W s.c.
|
FPCD: Q4 2020
First data anticipated:
H2 2022
|
Recruitment ongoing
Orphan Drug Designation (US)
|
FJORD
(bullous pemphigoid)
|
Placebo or Fasenra 30mg Q4W s.c.
|
FPCD: Q2 2021
First data anticipated: 2022+
|
Recruitment ongoing
|
MAHALE
(non-cystic fibrosis bronchiectasis)
|
Placebo or Fasenra 30mg Q4W s.c.
|
FPCD: Q3 2021
First data anticipated: 2022+
|
Recruitment ongoing
|
HUDSON (EG/EGE)
|
Placebo or Fasenra 30mg Q4W s.c.
|
First data anticipated: 2022+
|
Initiating
|
Tezepelumab
In July 2021, tezepelumab received US regulatory submission
acceptance for its Biologics License Application and was also
granted Priority Review for the treatment of asthma. The PDUFA date
is anticipated to be during the first quarter of 2022. In October
2021, tezepelumab was granted Orphan Drug Designation in the US by
the FDA for the treatment of EoE; a Phase III trial is
planned.
Table 36: Key tezepelumab Phase III trials
Trial (population)
|
Design
|
Timeline
|
Status
|
NAVIGATOR
(asthma)
|
Placebo or tezepelumab 210mg Q4W s.c.
|
FPCD: Q1 2018
LPCD: Q3 2019
|
Primary endpoint met
Breakthrough Therapy Designation (US)
|
WAYPOINT
(chronic rhinosinusitis with nasal polyps)
|
Placebo or tezepelumab 210mg Q4W s.c.
|
FPCD: Q2 2021
First data anticipated: 2022+
|
Recruitment ongoing
|
PT027
In September 2021, AstraZeneca and Avillion LLC, announced positive
high-level results from the MANDALA and DENALI Phase III
trials for PT027, a fixed-dose combination of albuterol
(salbutamol) and budesonide. The trials met all primary endpoints
demonstrating statistically significant benefits in patients with
asthma versus PT027's individual components.
Table 37: Key PT027 Phase III trials
Trial
|
Design
|
Timeline
|
Status
|
TYREE
(asthma withexercise-induced broncho constriction)
|
Placebo or PT027 160/180mcg, single dose
|
FPCD: Q1 2020
LPCD: Q3 2020
|
Primary endpoint met
|
MANDALA
(asthma)
|
Albuterol or PT027 80/180mcg or PT027 160/180mcg (all 'as
needed')
|
FPCD: Q4 2018
LPCD: Q1 2021
|
Primary endpoint met
|
DENALI
(asthma)
|
Placebo or albuterol 180mcg or budesonide 160mcg or PT027 80/180mcg
or PT027 160/180mcg QID
|
FPCD: Q2 2019
LPCD: Q2 2021
|
Dual primary endpoints met
|
Saphnelo (anifrolumab)
During the period, Saphnelo received regulatory approval in the US and
Japan, for the treatment of SLE. The approvals were based on
efficacy and safety data from the Saphnelo clinical development programme, which
included two TULIP Phase III trials and the MUSE Phase II
trial. In these trials, more patients treated
with Saphnelo experienced a reduction in overall disease
activity across organ systems, including skin and joints, and
achieved sustained reduction in oral corticosteroid use compared to
placebo, with both groups receiving standard
therapy.
During the period, the European Medicines Agency (EMA) informed
AstraZeneca that an Ad Hoc Expert Group (AHEG) meeting is planned
for Q4 2021. Given the lack of new medicines submitted for approval
for the treatment of SLE in the past 10 years, the AHEG meeting
provides an opportunity for experts to review the clinical data
available for Saphnelo and provide input to the EMA. The Company
anticipates a regulatory decision for the EU in H1
2022.
Table 38: Key Saphnelo Phase III trials
Trial (population)
|
Design
|
Timeline
|
Status
|
TULIP 1
(moderate to severely active SLE)
|
Placebo or Saphnelo
150mg or 300mg i.v.[93]
Q4W[94]
|
FPCD: Q4 2015
LPCD: Q4 2017
|
Primary endpoint not met
Regulatory approval (US)
|
TULIP 2
(moderate to severely active SLE)
|
Placebo or Saphnelo 300mg i.v. Q4W
|
FPCD: Q4 2015
LPCD: Q4 2017
|
Primary endpoint met
Regulatory approval (US)
|
TULIP-SC (moderate to severely active SLE)
|
Placebo or Saphnelo
120mg s.c. Q1W[95]
|
First data anticipated: 2022+
|
Recruitment ongoing
|
Rare Disease
Ultomiris
In July 2021, AstraZeneca's Alexion received regulatory approval in
the EU for expanded use to include children (10kg or above) and
adolescents with PNH.
The approval was based on positive interim results from the Phase
III clinical trial in children and adolescents that
demonstrated Ultomiris was effective in achieving complete C5
complement inhibition through 26 weeks for the treatment of
patients up to 18 years of age.
In August 2021, Alexion announced discontinuation of the
CHAMPION-ALS Phase III clinical trial of Ultomiris in adults with ALS. The decision was based
on the recommendation of the IDMC[96] following
their review of data from a pre-specified interim analysis. The
IDMC recommended that the trial be discontinued due to lack of
efficacy. No new safety findings were observed and the data were
consistent with the established safety profile
of Ultomiris.
In September 2021, Alexion received US regulatory submission
acceptance for its Biologics License Application for the
subcutaneous formulation of Ultomiris for the treatment of PNH and
aHUS[97].
Table 39: Key Ultomiris Phase III trials
Trial (population)
|
Design
|
Timeline
|
Status
|
NMOSD
|
External placebo-controlled open-label Ultomiris Q8W
|
FPCD: Q4 2019
LPCD: H1 2022
Data anticipated: 1H 2022
|
Recruitment completed
|
gMG
|
Placebo or Ultomiris Q8W
|
FPCD: Q1 2019
LPCD: Q2 2021
|
Primary endpoint met
|
CM-TMA[98]
|
Placebo or Ultomiris Q8W
|
FPCD: Q3 2021
Data anticipated: 2022+
|
Recruitment ongoing
|
HSCT-TMA[99]
Adult
|
Placebo or Ultomiris Q8W
|
FPCD: Q4 2020
Data anticipated: 2022+
|
Recruitment ongoing
|
ALXN1840
In August 2021, positive high-level results from ALXN1840's FoCus
Phase III trial for Wilson disease demonstrated statistically
significant improvement in daily mean copper mobilisation from
tissues, showing superiority compared with SoC
treatments.
The primary endpoint measured the daily mean Area Under the Effect
Curve for directly measured non-ceruloplasmin-bound copper over 48
weeks. ALXN1840 demonstrated three times greater copper
mobilisation than SoC and was generally well-tolerated with most
reported adverse events considered mild to moderate. No
neurological worsening upon initiation of treatment was observed.
Additional analyses, including individual patient-reported outcomes
and clinician-reported functional assessments, are
ongoing.
Andexxa
In October 2021, AstraZeneca's Alexion received a Complete Response
Letter from the US FDA for its sBLA for Andexxa to extend the indication to include patients
treated with edoxaban or enoxaparin, when reversal of
anticoagulation is needed due to life-threatening or uncontrolled
bleeding. Alexion is reviewing the letter and evaluating next
steps.
Other medicines (outside the main disease areas)
Nirsevimab
In September 2021, results from the Phase III MELODY trial were
presented at the 2021 IDWeek Virtual Conference, demonstrating that
a single dose of nirsevimab had efficacy of 74.5% (CI: 49.6-87.1)
in protecting late pre-term and term infants against lower
respiratory tract infection caused by RSV over an RSV season.
Results from the Phase II/III MEDLEY trial presented in November
2021 at the RSV Vaccines for the World Congress showed nirsevimab
had a similar safety and tolerability profile
to Synagis (current SoC) in infants with CHD, CLD and
those born pre-term.
Table 40: Key nirsevimab trials
Trial (population)
|
Design
|
Timeline
|
Status
|
MELODY
(healthy late preterm and term infants)
|
Placebo or nirsevimab IM[100]
|
FPCD: Q3 2019LPCD: Q3 2020
|
Primary endpoint met
Breakthrough therapy designation (US, EU, CN)
|
MEDLEY
(high-risk children)
|
Synagis or nirsevimab
IM
|
FPCD: Q3 2019
LPCD: Q4 2020
|
Safety objective met
|
COVID-19
COVID-19
vaccines
Trial
|
Design
|
Timeline
|
Status
|
COV002 (UK), Phase II/III
|
MenACWY or AZD1222
|
FPCD: Q2 2020
LPCD: Q4 2020
|
Initial data readout
Regulatory authorisation (EU, JP, UK)
|
COV003 (Brazil), Phase II/III
|
MenACWY or AZD1222
|
FPCD: Q2 2020
LPCD: Q4 2020
|
Initial data readout
Regulatory authorisation (EU, JP, UK)
|
COV005 ChAdOx1 nCoV-19 ZA[101] (South
Africa), Phase I/II
|
Placebo or AZD1222
|
FPCD: Q2 2020
LPCD: Q4 2020
|
Initial data readout
|
D8110C00001
(US, global), Phase III
|
Placebo or AZD1222
|
FPCD: Q3 2020
LPCD: Q1 2021
|
Primary endpoint met
|
D7220C00001
(Global), Phase II/III
|
AZD1222 or AZD2816
|
FPCD: Q2 2021
First data anticipated:
Q4 2021
|
Recruitment ongoing
|
AZD7442
In August 2021, AstraZeneca announced that the PROVENT Phase III
trial of long-acting antibody combination AZD7442 in pre-exposure
prophylaxis of COVID-19 demonstrated statistically significant
reduction in the incidence of symptomatic disease. The results were
presented at the aforementioned IDWeek and showed that in a trial
population in which more than 75% of participants had
co-morbidities, including conditions that have been reported to
cause a reduced immune response to vaccination, AZD7442 reduced the
risk of developing symptomatic COVID-19 by 77% compared to
placebo.
In October, the Company announced positive high-level results from
the TACKLE Phase III trial showed AZD7442, achieved a statistically
significant reduction in severe COVID-19 or death compared to
placebo in non-hospitalised patients with mild-to-moderate
symptomatic COVID-19. The trial met the primary endpoint, with a
600mg dose of AZD7442 reducing the risk of developing severe
COVID-19 or death (from any cause) by 50% compared to placebo in
outpatients who had been symptomatic for seven days or less. In a
prespecified analysis of participants who received treatment within
five days of symptom onset, AZD7442 reduced the risk of developing
severe COVID-19 or death (from any cause) by 67% compared to
placebo.
In the period, AstraZeneca submitted an EUA request for AZD7442 to
the US FDA, for the prophylaxis of symptomatic
COVID-19.
Table 41: Key AZD7442 Phase III trials in COVID-19
Trial
|
Design
|
Timeline
|
Status
|
PROVENT
(prophylaxis)
|
Placebo
or AZD7442 300mg i.m.[102]
|
FPCD: Q4 2020
LPCD: Q1 2021
|
Primary endpoint met
|
STORM CHASER
(post-exposure prophylaxis)
|
Placebo
or AZD7442 300mg i.m.
|
FPCD: Q4 2020
LPCD: Q1 2021
|
Primary endpoint not met
|
TACKLE
(outpatient treatment)
|
Placebo
or AZD7442 600mg i.m.
|
FPCD: Q1 2021
LPCD: Q3 2021
|
Primary endpoint met
|
Interim Financial Statements
Table 42: YTD 2021 - Condensed consolidated statement of
comprehensive income
For the nine months ended 30 September
|
2021
|
2020
|
$m
|
$m
|
Total Revenue
|
25,406
|
19,207
|
Product Sales
|
25,043
|
18,879
|
Collaboration Revenue
|
363
|
328
|
Cost of Sales
|
(7,812)
|
(3,774)
|
Gross Profit
|
17,594
|
15,433
|
Distribution costs
|
(322)
|
(290)
|
Research and development expense
|
(7,152)
|
(4,272)
|
Selling, general and administrative costs
|
(10,117)
|
(8,084)
|
Other operating income and expense
|
1,345
|
888
|
Operating Profit
|
1,348
|
3,675
|
Finance income
|
42
|
80
|
Finance expense
|
(964)
|
(985)
|
Share of after tax losses in associates and joint
ventures
|
(55)
|
(21)
|
Profit Before Tax
|
371
|
2,749
|
Taxation
|
90
|
(610)
|
Profit for the period
|
461
|
2,139
|
|
|
|
Other comprehensive income
|
|
|
Items that will not be reclassified to profit or loss
|
|
|
Remeasurement of the defined benefit pension liability
|
592
|
(191)
|
Net gains on equity investments measured at fair value through
other comprehensive income
|
144
|
974
|
Fair value movements related to own credit risk on bonds designated
as fair value through profit or loss
|
4
|
(1)
|
Tax on items that will not be reclassified to profit or
loss
|
71
|
(70)
|
|
811
|
712
|
Items that may be reclassified subsequently to profit or
loss
|
|
|
Foreign exchange arising on consolidation
|
(368)
|
(121)
|
Foreign exchange arising on designated borrowings in net investment
hedges
|
(275)
|
145
|
Fair value movements on cash flow hedges
|
(103)
|
2
|
Fair value movements on cash flow hedges transferred to profit or
loss
|
137
|
(115)
|
Fair value movements on derivatives designated in net investment
hedges
|
22
|
39
|
Costs of hedging
|
(6)
|
10
|
Tax on items that may be reclassified subsequently to profit or
loss
|
37
|
7
|
|
(556)
|
(33)
|
Other comprehensive income for the period, net of tax
|
255
|
679
|
Total comprehensive income for the period
|
716
|
2,818
|
|
|
|
Profit attributable to:
|
|
|
Owners of the Parent
|
459
|
2,184
|
Non-controlling interests
|
2
|
(45)
|
|
461
|
2,139
|
Total comprehensive income attributable to:
|
|
|
Owners of the Parent
|
714
|
2,864
|
Non-controlling interests
|
2
|
(46)
|
|
716
|
2,818
|
Basic earnings per $0.25 Ordinary Share
|
$0.33
|
$1.66
|
Diluted earnings per $0.25 Ordinary Share
|
$0.33
|
$1.66
|
Weighted average number of Ordinary Shares in issue
(millions)
|
1,374
|
1,312
|
Diluted weighted average number of Ordinary Shares in issue
(millions)
|
1,382
|
1,313
|
Table 43: Q3 2021 - Condensed consolidated statement of
comprehensive income
For the quarter ended 30 September
|
2021
|
2020
|
$m
|
$m
|
Total Revenue
|
9,866
|
6,578
|
Product Sales
|
9,741
|
6,520
|
Collaboration Revenue
|
125
|
58
|
Cost of Sales
|
(3,757)
|
(1,370)
|
Gross Profit
|
6,109
|
5,208
|
Distribution costs
|
(120)
|
(99)
|
Research and development expense
|
(3,610)
|
(1,495)
|
Selling, general and administrative costs
|
(4,090)
|
(2,730)
|
Other operating income and expense
|
37
|
287
|
Operating (Loss)/Profit
|
(1,674)
|
1,171
|
Finance income
|
15
|
7
|
Finance expense
|
(335)
|
(324)
|
Share of after tax losses in associates and joint
ventures
|
(7)
|
(1)
|
(Loss)/Profit Before Tax
|
(2,001)
|
853
|
Taxation
|
350
|
(202)
|
(Loss)/Profit for the period
|
(1,651)
|
651
|
|
|
|
Other comprehensive (loss)/income
|
|
|
Items that will not be reclassified to profit or loss
|
|
|
Remeasurement of the defined benefit pension liability
|
(100)
|
14
|
Net gains/(losses) on equity investments measured at fair value
through other comprehensive income
|
171
|
(95)
|
Fair value movements related to own credit risk on bonds designated
as fair value through profit or loss
|
2
|
(7)
|
Tax on items that will not be reclassified to profit or
loss
|
19
|
9
|
|
92
|
(79)
|
Items that may be reclassified subsequently to profit or
loss
|
|
|
Foreign exchange arising on consolidation
|
(427)
|
373
|
Foreign exchange arising on designated borrowings in net investment
hedges
|
(45)
|
162
|
Fair value movements on cash flow hedges
|
(44)
|
133
|
Fair value movements on cash flow hedges transferred to profit or
loss
|
64
|
(114)
|
Fair value movements on derivatives designated in net investment
hedges
|
15
|
(21)
|
Costs of hedging
|
(4)
|
6
|
Tax on items that may be reclassified subsequently to profit or
loss
|
19
|
(22)
|
|
(422)
|
517
|
Other comprehensive (loss)/income for the period, net of
tax
|
(330)
|
438
|
Total comprehensive (loss)/income for the period
|
(1,981)
|
1,089
|
|
|
|
(Loss)/Profit attributable to:
|
|
|
Owners of the Parent
|
(1,652)
|
648
|
Non-controlling interests
|
1
|
3
|
|
(1,651)
|
651
|
Total comprehensive (loss)/income attributable to:
|
|
|
Owners of the Parent
|
(1,982)
|
1,087
|
Non-controlling interests
|
1
|
2
|
|
(1,981)
|
1,089
|
Basic (loss)/earnings per $0.25 Ordinary Share
|
$(1.10)
|
$0.49
|
Diluted (loss)/earnings per $0.25 Ordinary Share
|
$(1.10)
|
$0.49
|
Weighted average number of Ordinary Shares in issue
(millions)
|
1,496
|
1,312
|
Diluted weighted average number of Ordinary Shares in issue
(millions)[103]
|
1,496
|
1,313
|
Table 44: Condensed consolidated statement of financial
position
|
At 30 Sep 2021
|
At 31 Dec2020
|
At 30 Sep 2020
|
$m
|
$m
|
$m
|
Assets
|
|
|
|
Non-current assets
|
|
|
|
Property, plant and equipment
|
9,214
|
8,251
|
7,707
|
Right-of-use assets
|
948
|
666
|
653
|
Goodwill
|
20,081
|
11,845
|
11,711
|
Intangible assets
|
44,104
|
20,947
|
20,613
|
Investments in associates and joint ventures
|
39
|
39
|
42
|
Other investments
|
1,546
|
1,108
|
1,173
|
Derivative financial instruments
|
90
|
171
|
119
|
Other receivables
|
811
|
720
|
685
|
Deferred tax assets
|
3,697
|
3,438
|
3,243
|
|
80,530
|
47,185
|
45,946
|
Current assets
|
|
|
|
Inventories
|
10,528
|
4,024
|
3,683
|
Trade and other receivables
|
8,258
|
7,022
|
5,668
|
Other investments
|
82
|
160
|
374
|
Derivative financial instruments
|
60
|
142
|
37
|
Intangible assets
|
100
|
-
|
-
|
Income tax receivable
|
596
|
364
|
332
|
Cash and cash equivalents
|
7,067
|
7,832
|
8,072
|
|
26,691
|
19,544
|
18,166
|
Total assets
|
107,221
|
66,729
|
64,112
|
|
|
|
|
Liabilities
|
|
|
|
Current liabilities
|
|
|
|
Interest-bearing loans and borrowings
|
(2,744)
|
(2,194)
|
(3,402)
|
Lease liabilities
|
(229)
|
(192)
|
(183)
|
Trade and other payables
|
(18,663)
|
(15,785)
|
(13,406)
|
Derivative financial instruments
|
(54)
|
(33)
|
(9)
|
Provisions
|
(972)
|
(976)
|
(621)
|
Income tax payable
|
(987)
|
(1,127)
|
(1,321)
|
|
(23,649)
|
(20,307)
|
(18,942)
|
Non-current liabilities
|
|
|
|
Interest-bearing loans and borrowings
|
(28,206)
|
(17,505)
|
(18,271)
|
Lease liabilities
|
(733)
|
(489)
|
(483)
|
Derivative financial instruments
|
(6)
|
(2)
|
(16)
|
Deferred tax liabilities
|
(6,400)
|
(2,918)
|
(2,576)
|
Retirement benefit obligations
|
(2,449)
|
(3,202)
|
(2,895)
|
Provisions
|
(726)
|
(584)
|
(854)
|
Other payables
|
(5,140)
|
(6,084)
|
(6,457)
|
|
(43,660)
|
(30,784)
|
(31,552)
|
Total liabilities
|
(67,309)
|
(51,091)
|
(50,494)
|
Net assets
|
39,912
|
15,638
|
13,618
|
Equity
|
|
|
|
Capital and reserves attributable to equity holders of the
Parent
|
|
|
|
Share capital
|
387
|
328
|
328
|
Share premium account
|
35,118
|
7,971
|
7,952
|
Other reserves
|
2,039
|
2,024
|
2,039
|
Retained earnings
|
2,200
|
5,299
|
1,876
|
|
39,744
|
15,622
|
12,195
|
Non-controlling interests
|
168
|
16
|
1,423
|
Total equity
|
39,912
|
15,638
|
13,618
|
Table 45: 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 2020
|
328
|
7,941
|
2,046
|
2,812
|
13,127
|
1,469
|
14,596
|
Profit for the period
|
-
|
-
|
-
|
2,184
|
2,184
|
(45)
|
2,139
|
Other comprehensive income
|
-
|
-
|
-
|
680
|
680
|
(1)
|
679
|
Transfer to other reserves
|
-
|
-
|
(7)
|
7
|
-
|
-
|
-
|
Transactions with owners:
|
|
|
|
|
|
|
|
Dividends
|
-
|
-
|
-
|
(3,669)
|
(3,669)
|
-
|
(3,669)
|
Issue of Ordinary Shares
|
-
|
11
|
-
|
-
|
11
|
-
|
11
|
Share-based payments charge for the period
|
-
|
-
|
-
|
187
|
187
|
-
|
187
|
Settlement of share plan awards
|
-
|
-
|
-
|
(325)
|
(325)
|
-
|
(325)
|
Net movement
|
-
|
11
|
(7)
|
(936)
|
(932)
|
(46)
|
(978)
|
At 30 Sep 2020
|
328
|
7,952
|
2,039
|
1,876
|
12,195
|
1,423
|
13,618
|
At 1 Jan 2021
|
328
|
7,971
|
2,024
|
5,299
|
15,622
|
16
|
15,638
|
Profit for the period
|
-
|
-
|
-
|
459
|
459
|
2
|
461
|
Other comprehensive income
|
-
|
-
|
-
|
255
|
255
|
-
|
255
|
Transfer to other reserves
|
-
|
-
|
15
|
(15)
|
-
|
-
|
-
|
Transactions with owners:
|
|
|
|
|
|
|
|
Dividends
|
-
|
-
|
-
|
(3,884)
|
(3,884)
|
-
|
(3,884)
|
Issue of Ordinary Shares
|
59
|
27,147
|
-
|
-
|
27,206
|
-
|
27,206
|
Changes in non-controlling interest
|
-
|
-
|
-
|
-
|
-
|
150
|
150
|
Share-based payments charge for the period
|
-
|
-
|
-
|
384
|
384
|
-
|
384
|
Settlement of share plan awards
|
-
|
-
|
-
|
(811)
|
(811)
|
-
|
(811)
|
Issue of replacement share awards upon acquisition
|
-
|
-
|
-
|
513
|
513
|
-
|
513
|
Net movement
|
59
|
27,147
|
15
|
(3,099)
|
24,122
|
152
|
24,274
|
At 30 Sep 2021
|
387
|
35,118
|
2,039
|
2,200
|
39,744
|
168
|
39,912
|
Table 46: Condensed consolidated statement of cash
flows
For the nine months ended 30 September
|
2021
|
2020
|
$m
|
$m
|
Cash flows from operating activities
|
|
|
Profit Before Tax
|
371
|
2,749
|
Finance income and expense
|
922
|
905
|
Share of after tax losses of associates and joint
ventures
|
55
|
21
|
Depreciation, amortisation and impairment
|
4,338
|
2,352
|
Decrease/(increase) in working capital and short-term
provisions
|
2,063
|
(255)
|
Gains on disposal of intangible assets
|
(371)
|
(535)
|
Gains on disposal of investments in associates and joint
ventures
|
(776)
|
-
|
Fair value movements on contingent consideration arising from
business combinations
|
33
|
(14)
|
Non-cash and other movements
|
(370)
|
(484)
|
Cash generated from operations
|
6,265
|
4,739
|
Interest paid
|
(522)
|
(517)
|
Tax paid
|
(1,198)
|
(1,221)
|
Net cash inflow from operating activities
|
4,545
|
3,001
|
Cash flows from investing activities
|
|
|
Acquisition of subsidiaries, net of cash acquired
|
(9,263)
|
-
|
Payments upon vesting of employee share awards attributable to
business combinations
|
(203)
|
-
|
Payment of contingent consideration from business
combinations
|
(470)
|
(663)
|
Purchase of property, plant and equipment
|
(768)
|
(598)
|
Disposal of property, plant and equipment
|
10
|
67
|
Purchase of intangible assets
|
(714)
|
(1,460)
|
Disposal of intangible assets
|
584
|
664
|
Purchase of non-current asset investments
|
(190)
|
(119)
|
Disposal of non-current asset investments
|
-
|
1,121
|
Movement in short-term investments, fixed deposits and other
investing instruments
|
120
|
530
|
Payments to associates and joint ventures
|
(55)
|
(8)
|
Disposal of investments in associates and joint
ventures
|
776
|
-
|
Interest received
|
28
|
43
|
Net cash outflow from investing activities
|
(10,145)
|
(423)
|
Net cash (outflow)/inflow before financing activities
|
(5,600)
|
2,578
|
Cash flows from financing activities
|
|
|
Proceeds from issue of share capital
|
10
|
11
|
Repayment of loans
|
(2,934)
|
-
|
Issue of loans
|
11,942
|
2,968
|
Dividends paid
|
(3,856)
|
(3,572)
|
Hedge contracts relating to dividend payments
|
(28)
|
(101)
|
Repayment of obligations under leases
|
(173)
|
(157)
|
Movement in short-term borrowings
|
(261)
|
858
|
Net cash inflow from financing activities
|
4,700
|
7
|
Net (decrease)/increase in cash and cash equivalents in the
period
|
(900)
|
2,585
|
Cash and cash equivalents at the beginning of the
period
|
7,546
|
5,223
|
Exchange rate effects
|
(73)
|
(14)
|
Cash and cash equivalents at the end of the period
|
6,573
|
7,794
|
Cash and cash equivalents consist of:
|
|
|
Cash and cash equivalents
|
7,067
|
8,072
|
Overdrafts
|
(494)
|
(278)
|
|
6,573
|
7,794
|
Notes to the Interim Financial Statements
1) Basis of preparation and accounting policies
These unaudited Interim Financial Statements for the nine months
ended 30 September 2021 have been prepared in accordance with
International Accounting Standard 34, 'Interim Financial Reporting'
(IAS 34), as issued by the International Accounting Standards Board
(IASB), IAS 34 as adopted by the European Union, UK-adopted IAS 34,
and the Disclosure Guidance and Transparency Rules sourcebook of
the United Kingdom's Financial Conduct Authority. On 31 December
2020, EU-adopted IFRS at that date was brought into UK law and
became UK-adopted international accounting standards, with future
changes being subject to endorsement by the UK Endorsement Board.
The Interim Financial Statements have transitioned to UK-adopted
international accounting standards from financial periods beginning
1 January 2021. There was no impact or changes in accounting
policies from the transition.
The unaudited Interim Financial Statements for the nine months
ended 30 September 2021 include Alexion's post-acquisition results
which have been consolidated into the Group's results from 21 July
2021 therefore are not entirely comparable with respective
comparative periods shown. Following the acquisition of Alexion,
the Group has reviewed its assessment of reportable segments under
IFRS 8 'Operating Segments' and concluded that the Group continues
to have one reportable segment.
The unaudited Interim Financial Statements for the nine months
ended 30 September 2021 were approved by the Board of Directors for
publication on 12 November 2021.
The annual financial statements of the Group for the year ended 31
December 2020 were prepared in accordance with international
accounting standards in conformity with the requirements of the
Companies Act 2006, International Financial Reporting Standards
(IFRSs) adopted pursuant to Regulation (EC) No 1606/2002 as it
applies in the EU and IFRSs as issued by the International
Accounting Standards Board (IASB). Except as noted below and for
the estimation of the interim income tax charge, the Interim
Financial Statements have been prepared applying the accounting
policies that were applied in the preparation of the Group's
published consolidated financial statements for the year ended 31
December 2020.
IFRS 9 and IFRS 7
The replacement of benchmark interest rates such as LIBOR and other
interbank offered rates (IBORs) is a priority for global
regulators. Phase 2 amendments to IFRS 9 'Financial Instruments'
and IFRS 7 'Financial Instruments: Disclosures' were issued in
August 2021 and have been adopted by the Group for 2021 reporting.
As at 30 September 2021, the Group had two floating rate notes, a
cross currency swap and a fixed to floating USD interest rate swap
that reference USD LIBOR but these instruments will either have
matured or will have their last LIBOR fixings set before the
relevant USD LIBORs cease publication on 30 June 2023. The
group also has $4bn of term bank loans that currently reference US
LIBOR but these agreements have a mandatory switch from US LIBOR to
an alternative risk free rate on 30 June 2023, should the group not
elect to do so before that date. In addition, arrangements are
being made with other financial institutions for the transition
away from IBOR to alternative rates for other existing
instruments.
COVID-19
AstraZeneca has assessed the impact of the uncertainty presented by
the COVID-19 pandemic on the Interim Financial Statements
comprising the financial results to 30 September 2021 and the
financial position as at 30 September 2021, specifically
considering the impact on key judgements and significant estimates
as detailed on page 180 of the Annual Report and 20-F
Information 2020 along
with several other areas of elevated risk during the pandemic
period.
A detailed assessment has been performed, focussing on the
following areas:
-
recoverable value of goodwill, intangible assets and property,
plant and equipment
-
impact on key assumptions used to estimate contingent consideration
liabilities
-
key assumptions used in estimating the Group's defined benefit
pension obligations
-
basis for estimating clinical trial accruals
-
key assumptions used in estimating rebates, chargebacks and returns
for US Product Sales
-
valuations of unlisted equity investments
-
expected credit losses associated with changes in credit risk
relating to trade and other receivables
-
net realisable value of inventories
-
fair value of certain financial instruments
-
recoverability of deferred tax assets
-
effectiveness of hedge relationships
There were no material accounting impacts identified relating to
the above areas during the nine-month period ended 30 September
2021.
The Group will continue to monitor these areas of increased
judgement, estimation and risk for material changes.
Going concern
The Group has considerable financial resources available. As at 30
September 2021, the Group had $11.2bn in financial resources (cash
and cash-equivalent balances of $7.1bn and undrawn committed bank
facilities of $4.1bn, of which $3.4bn was available until April
2024 and $0.7bn was available until November 2021, with only $3.0bn
of borrowings due within one year). Additionally, as at 30
September 2021, the Group had $1.0bn of available committed
facilities that had been arranged to support the acquisition of
Alexion. All facilities contain no financial covenants and were
undrawn at 30 September 2021.
Subsequent to 30 September 2021, the Group's $3.4bn facilities
available to April 2024 have been increased to $4.9bn and the
maturity date extended by one year to April 2025. These facilities
can be extended in the future by a further one year at the lenders'
discretion. In addition, the $0.7bn facilities available to
November 2021 and the $1bn Alexion related facility have either
expired or have been cancelled.
The directors have considered the impact of COVID-19 on
AstraZeneca's operations and mitigations to these risks. Overall,
the impact of these items would heighten certain risks, such as
those relating to the delivery of the pipeline or launch of new
medicines, the execution of AstraZeneca's commercial strategy, the
manufacturing and supply of medicines and reliance on third-party
goods and services. The Group is continuously monitoring and
mitigating where possible impacts of these risks.
The Group's revenues are largely derived from sales of medicines
covered by patents which provide a relatively high level of
resilience and predictability to cash inflows, although government
price interventions in response to budgetary constraints are
expected to continue to affect adversely revenues in some of our
significant markets. The Group, however, anticipates new revenue
streams from both recently launched medicines and those in
development, and the Group has a wide diversity of customers and
suppliers across different geographic areas.
Consequently, the Directors believe that, overall, the Group is
well-placed to manage its business risks successfully.
Accordingly, the going concern basis has been adopted in these
Interim Financial Statements.
Legal proceedings
The information contained in Note 6 updates the disclosures
concerning legal proceedings and contingent liabilities in the
Group's Annual Report and Form
20-F Information 2020.
Financial information
The comparative figures for the financial year ended 31 December
2020 are not the Group's statutory accounts for that financial
year. Those accounts have been reported on by the Group's auditors
and have been delivered to the registrar of companies; their report
was (i) unqualified, (ii) did not include a reference to any
matters to which the auditors drew attention by way of emphasis
without qualifying their report, and (iii) did not contain a
statement under section 498(2) or (3) of the Companies Act
2006.
2) Intangible assets
In accordance with IAS 36 'Impairment of Assets', reviews for
triggers at an individual asset or cash-generating-unit level were
conducted, and impairment tests carried out where triggers were
identified. As a result and following the Group undertaking a
portfolio prioritisation of development projects, total net
impairment charges of $1,492m have been recorded against intangible
assets during the nine months ended 30 September 2021 (YTD 2020:
$188m). Net impairment charges in respect of launched medicines and
medicines in development were $121m (YTD 2020: $133m) and $1,371m
(YTD 2020: $55m) respectively. Impairments recorded on products in
development included an impairment charge of $1,172m recognised in
the quarter on the Ardea intangible asset as a consequence of the
decision to discontinue the development of verinurad.
3) Net Debt
The table below provides an analysis of Net Debt and a
reconciliation of Net Cash Flow to the movement in Net Debt. The
Group monitors Net Debt as part of its capital-management policy as
described in Note 27 of the Annual Report and Form
20-F Information 2020. Net Debt
is a non-GAAP financial measure.
Table 47: Net Debt
|
At 1 Jan 2021
|
Cash flow
|
Acquisitions
|
Non-cash & other
|
Exchange movements
|
At 30 Sep 2021
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Non-current instalments of loans
|
(17,505)
|
(11,942)
|
(187)
|
1,257
|
171
|
(28,206)
|
Non-current instalments of leases
|
(489)
|
-
|
(228)
|
(29)
|
13
|
(733)
|
Total long-term debt
|
(17,994)
|
(11,942)
|
(415)
|
1,228
|
184
|
(28,939)
|
Current instalments of loans
|
(1,536)
|
2,934
|
(2,336)
|
(1,260)
|
59
|
(2,139)
|
Current instalments of leases
|
(192)
|
183
|
(34)
|
(193)
|
7
|
(229)
|
Bank collateral
|
(288)
|
183
|
-
|
-
|
-
|
(105)
|
Other short-term borrowings excluding overdrafts
|
(84)
|
78
|
-
|
-
|
-
|
(6)
|
Overdraft
|
(286)
|
(219)
|
-
|
-
|
11
|
(494)
|
Total current debt
|
(2,386)
|
3,159
|
(2,370)
|
(1,453)
|
77
|
(2,973)
|
Gross borrowings
|
(20,380)
|
(8,783)
|
(2,785)
|
(225)
|
261
|
(31,912)
|
Net derivative financial instruments
|
278
|
(16)
|
6
|
(178)
|
-
|
90
|
Net borrowings
|
(20,102)
|
(8,799)
|
(2,779)
|
(403)
|
261
|
(31,822)
|
Cash and cash equivalents
|
7,832
|
(4,767)
|
4,086
|
-
|
(84)
|
7,067
|
Other investments - current
|
160
|
(76)
|
-
|
-
|
(2)
|
82
|
Cash and investments
|
7,992
|
(4,843)
|
4,086
|
-
|
(86)
|
7,149
|
Net Debt
|
(12,110)
|
(13,642)
|
1,307
|
(403)
|
175
|
(24,673)
|
Non-cash movements in the period include fair-value adjustments
under IFRS 9.
The Group has agreements with some bank counterparties whereby the
parties agree to post cash collateral on financial derivatives, for
the benefit of the other, equivalent to the market valuation of the
derivative positions above a predetermined threshold. The carrying
value of such cash collateral held by the Group was $105m (YTD
2020: $133m) and the carrying value of such cash collateral posted
by the Group was $21m (YTD 2020: $7m). Cash collateral posted by
the Group is presented within Cash and cash
equivalents.
Other investments - non-current are included within the balance of
$1,546m (31 December 2020: $1,108m) in the Condensed consolidated
statement of financial position. The equivalent GAAP measure to Net
Debt is 'liabilities arising from financing activities', which
excludes the amounts for cash and overdrafts, other investments and
non-financing derivatives shown above and includes the Acerta
Pharma liability of $2,416m (31 December 2020: $2,297m), $904m of
which is shown in current other payables and $1,512m is shown in
non-current other payables. In April 2021, AstraZeneca exercised
its option to acquire the remaining 45% of shares in
Acerta.
Net Debt increased by $12,563m in the nine months to $24,673m
primarily due to financing the Alexion acquisition. Details of the
committed undrawn bank facilities are disclosed within the going
concern section of Note 1. Details in regards to the funding of the
Alexion acquisition are provided within Note 5.
In July 2021, following the acquisition of Alexion, S&P Global
Ratings upgraded AstraZeneca's long-term credit rating to
A-. Other than this, there were no changes to the Company's
solicited credit ratings during the nine months to 30 September
2021. At 30 September 2021, the Company's solicited credit
ratings from S&P were A- (long term) and A-2 (short term) and
from Moody's were A3 (long term) and P-2 (short
term).
4) Financial instruments
As detailed in the Group's most recent annual financial statements,
the principal financial instruments consist of derivative financial
instruments, other investments, trade and other receivables, cash
and cash equivalents, trade and other payables, lease liabilities
and interest-bearing loans and borrowings. During the nine month
period ended 30 September 2021, equity investments previously
categorised as Level 3 in the fair-value hierarchy (carrying value
of $108m at 31 December 2020) are now categorised as Level 1
(carrying value of $128m at 30 September 2021) on availability of
quoted prices in the market. There have been no other changes of
significance to the categorisation or fair-value hierarchy
classification of financial instruments from those detailed in the
Notes to the Group Financial Statements in
the Annual Report and Form
20-F Information 2020.
The Group holds certain equity investments that are categorised as
Level 3 in the fair value hierarchy and for which fair value gains
of $nil (Q3 2020: $63m gain) have been recognised in the nine
months ended 30 September 2021. All other fair value gains and/or
losses that are presented in Net gains on equity investments
measured at fair value through other comprehensive income in the
Condensed consolidated statement of comprehensive income for the
nine months ended 30 September 2021 are Level 1 fair value
measurements.
Financial instruments measured at fair value include $1,628m of
other investments, $5,049m held in money-market funds, $325m of
loans designated at fair value through profit or loss, $349m of
loans designated in a fair-value hedge relationship and $90m of
derivatives as at 30 September 2021. The total fair value of
interest-bearing loans and borrowings at 30 September 2021, which
have a carrying value of $31,912m in the Condensed consolidated
statement of financial position, was $34,758m. Contingent
consideration liabilities arising on business combinations have
been classified under Level 3 in the fair value hierarchy and
movements in fair value are shown below:
Table 48: Financial instruments - contingent
consideration
|
|
2021
|
2020
|
|
Diabetes alliance
|
Other
|
Total
|
Total
|
|
$m
|
$m
|
$m
|
$m
|
At 1 January
|
|
2,932
|
391
|
3,323
|
4,139
|
Additions through business combinations
|
|
-
|
324
|
324
|
-
|
Settlements
|
|
(460)
|
(10)
|
(470)
|
(663)
|
Revaluations
|
|
82
|
(49)
|
33
|
(14)
|
Discount unwind
|
|
148
|
24
|
172
|
212
|
At 30 September
|
|
2,702
|
680
|
3,382
|
3,674
|
Contingent consideration arising from business combinations is
fair-valued using decision-tree analysis, with key inputs including
the probability of success, consideration of potential delays and
the expected levels of future revenues.
The contingent consideration balance relating to BMS's share of the
global diabetes alliance of $2,702m (31 December 2020: $2,932m)
would increase/decline by $270m with an increase/decline in sales
of 10%, as compared with the current estimates.
5) Acquisition of Alexion
On 21 July 2021, AstraZeneca completed the acquisition of 100% of
the issued shares of Alexion Pharmaceuticals, Inc (Alexion), based
in Boston, Massachusetts, US. Alexion is a global biopharmaceutical
company focused on serving patients and families affected by rare
diseases and devastating conditions through the discovery,
development and commercialisation of life-changing
medicines.
At closing, Alexion shareholders received 2.1243 AstraZeneca
American Depository Shares (ADSs) and $60 in cash for each of their
Alexion shares. Unvested Alexion employee share awards were
converted to equivalent AstraZeneca share awards. The fair value of
the purchase consideration was $41,058m, comprising AstraZeneca
ADSs of $27,196m, cash of $13,349m and replacement employee share
awards of $513m.
The Group has funded the cash element of the acquisition with $8bn
of new long-term debt, issued in May and June 2021, $4bn of term
loans drawn in July 2021 under the $17.5bn committed bank
facilities entered into in December 2020 to secure the acquisition
financing, and existing cash balances. The Group cancelled the
remaining $13.5bn of the facilities in June, July and October 2021.
Loans and borrowings of $2.3bn acquired with Alexion were repaid in
full shortly following completion of the acquisition. Changes to
financing balances during the reporting period are included in
Table 47 on Net Debt.
The acquisition has been accounted for as a business combination
using the acquisition method of accounting in accordance with IFRS
3 'Business Combinations' and consequently the Alexion assets
acquired, and liabilities assumed have been recorded by AstraZeneca
at fair value, with any excess of the purchase price over the fair
value of the identifiable assets and liabilities being recognised
as goodwill.
Given the proximity of the completion of the transaction to the
reporting date, the review and finalisation of the fair values is
ongoing. On that basis, the amounts detailed below are
provisional:
Table 49: Alexion acquisition fair values as of 21 July
2021
|
Fair value
$m
|
Non-current assets
|
|
Property, plant and equipment
|
1,134
|
Right-of-use assets
|
264
|
Intangible assets
|
26,691
|
Other non-current assets
|
301
|
|
28,390
|
Current assets
|
|
Inventories
|
6,886
|
Trade and other receivables
|
2,096
|
Intangible assets
|
100
|
Cash and cash equivalents
|
4,086
|
|
13,168
|
Current liabilities
|
|
Interest-bearing loans and borrowings
|
(2,336)
|
Trade and other payables
|
(1,192)
|
Other current liabilities
|
(40)
|
|
(3,568)
|
Non-current liabilities
|
|
Lease liabilities
|
(228)
|
Deferred tax liabilities
|
(4,191)
|
Other non-current liabilities
|
(697)
|
|
(5,116)
|
|
|
Total net assets acquired
|
32,874
|
|
|
Less: non-controlling interests
|
(150)
|
Goodwill
|
8,334
|
Total fair value of consideration
|
41,058
|
|
|
Less: fair value of equity consideration
|
(27,196)
|
Less: fair value of replacement employee share awards
|
(513)
|
Less: cash and cash equivalents acquired
|
(4,086)
|
Net cash outflow
|
9,263
|
Intangible assets principally represent intellectual property
rights over launched medicines and medicines under development,
which were fair valued using the multi-period excess earnings
method. The estimated fair value and useful lives of intangible
assets were as follows:
Table 50: Alexion Intangible asset fair values and useful
lives
|
Fair value
|
Useful lives
|
|
$m
|
Years
|
Launched medicines - C5 franchise (Soliris/Ultomiris)
|
18,355
|
6-15
|
Launched medicines - Strensiq, Kanuma, Andexxa
|
5,232
|
11-17
|
Medicines in development
|
2,704
|
Not amortised
|
Other intangibles
|
500
|
5-10
|
|
26,791
|
|
The fair value of inventory, which includes raw materials, work in
progress and finished goods related to the launched medicines, was
estimated at $6,886m, an uplift of $5,752m on the carrying value
prior to the acquisition. The fair value adjustment relates only to
work in progress and finished goods and was calculated as the
estimated selling price less estimated costs to complete and sell
the inventory, the associated margins on these activities and
holding costs. The fair value adjustment is expected to amortise
over approximately the first 18 months post-acquisition, in line
with revenues.
Property, plant and equipment principally comprises the
manufacturing facilities in Dublin and Athlone, Ireland and was
fair valued using a cost approach. The estimated fair value of
$1,134m represents an uplift of $110m over carrying
value.
The estimated fair value of contingent liabilities was $76m,
relating to various claims and disputes in each case where there is
a possible, but not probable, future financial exposure. This
amount has been included within other non-current liabilities of
$697m.
The estimated fair value of trade and other receivables was
$2,096m, which approximated the contractual cash
flows.
The net tax position reflected an adjustment of $5,215m related to
the deferred tax impact of the fair value uplifts on intangible
assets, inventories, property, plant and equipment and contingent
liabilities as described above.
Goodwill amounting to $8,334m was recognised on acquisition and is
underpinned by a number of elements, which individually could not
be quantified. Most significant amongst these is the premium
attributable to a pre-existing, well positioned business in the
innovation intensive, high growth rare diseases market with a
highly skilled workforce and established reputation. Other
important elements include the potential unidentified products that
future research and development may yield and the core
technological capabilities and knowledge base of the company.
Goodwill is not expected to be deductible for
tax purposes.
Non-controlling interests reflect Alexion's pre-existing minority
equity interest in Caelum Biosciences and have been valued at
$150m, the agreed exercise price for the exclusive option to
acquire the remaining equity. The option was exercised on 5 October
2021.
Alexion's results have been consolidated into the Group's results
from 21 July 2021. For the period from acquisition to
30 September 2021, before reflecting the fair value
adjustments arising on acquisition, Alexion's total revenues were
$1,311m and profit after tax was $378m. If the acquisition had
taken effect at the beginning of the reporting period in which the
acquisition occurred (1 January 2021), on a pro forma basis,
after reflecting the fair value adjustments arising on
consolidation, the total revenue of the combined Group for the nine
months ended 30 September 2021 would have been $29,121m and the
loss after tax would have been $904m. This pro forma information
does not purport to represent the results of the combined Group
that actually would have occurred had the acquisition taken place
on 1 January 2021 and should not be taken to be representative
of future results.
Total acquisition-related costs of $156m have been incurred by the
Group, which include advisory, legal and other professional fees.
These costs are presented in the Statement of Comprehensive Income
within Selling, general and administrative expenses.
The terms of the acquisition include a retention bonus plan for
legacy Alexion employees whereby up to $50m may be used for
retention bonus awards to employees at the level of Vice President
or below. These bonuses will vest and be payable 6 months after the
acquisition, or earlier. In the period since acquisition, a cost of
$10m has been recorded in the Statement of Comprehensive Income
($1m in Cost of Sales, $3m in Research and development expense and
$6m in Selling, general and administrative costs).
Upon completion of the acquisition, all unvested Alexion employee
share awards were converted into AstraZeneca restricted stock
awards that continue to have, and shall be subject to, the same
terms and conditions as applied in the corresponding Alexion awards
immediately prior to completion. Alexion Performance Stock Plan
(PSU) awards that included performance-based vesting conditions
were converted using the greater of the original target level and
Alexion's assessment of the level of achievement immediately prior
to completion (subject to a limit of 175 per cent. for the awards
granted in 2019 and a limit of 150 per cent. for the awards granted
in 2020). In the period since acquisition, a cost of $147m has been
recorded in the Statement of Comprehensive Income ($4m in Cost of
sales, $37m in Research and development expense and $106m in
Selling, general and administrative costs). Payments made upon
vesting of share awards recognised as part of the consideration for
the acquisition of Alexion are recognised within Investing
activities in the Group's statement of cash flows.
6) Legal proceedings and contingent liabilities
AstraZeneca is involved in various legal proceedings considered
typical to its business, including litigation and investigations
relating to product liability, commercial disputes, infringement of
intellectual property (IP) rights, the validity of certain patents,
anti-trust law and sales and marketing practices. The matters
discussed below constitute the more significant developments since
publication of the disclosures concerning legal proceedings in the
Company's Annual Report and Form 20-F Information 2020 and H1 2021
results (the Disclosures). Unless noted otherwise below or in the
Disclosures, no provisions have been established in respect of the
claims discussed below.
As discussed in the disclosures, the majority of claims involve
highly complex issues. Often these issues are subject to
substantial uncertainties and, therefore, the probability of a
loss, if any, being sustained and/or an estimate of the amount of
any loss is difficult to ascertain.
Unless specifically identified below that a provision has been
taken, AstraZeneca considers each of the claims to represent a
contingent liability and discloses information with respect to the
nature and facts of the cases in accordance with IAS
37.
In cases that have been settled or adjudicated, or where
quantifiable fines and penalties have been assessed and which are
not subject to appeal, or where a loss is probable and we are able
to make a reasonable estimate of the loss, AstraZeneca records the
loss absorbed or makes a provision for its best estimate of the
expected loss. The position could change over time and the
estimates that the Company made, and upon which the Company have
relied in calculating these provisions are inherently imprecise.
There can, therefore, be no assurance that any losses that result
from the outcome of any legal proceedings will not exceed the
amount of the provisions that have been booked in the accounts. The
major factors causing this uncertainty are described more fully in
the Disclosures and herein.
AstraZeneca has full confidence in, and will vigorously defend and
enforce, its IP.
Matters disclosed in respect of the third quarter of 2021 and to 12
November 2021
Patent litigation
Enhertu
US patent proceedings
As previously disclosed,
in October 2020, Seagen Inc. (Seagen) filed a complaint
against Daiichi Sankyo Company, Limited in the
US District Court for the Eastern District of Texas (the
Texas Court) alleging that Enhertu infringes US Patent
No. 10,808,039 (the '039
patent). AstraZeneca Pharmaceuticals LP co-commercialises Enhertu with Daiichi Sankyo Inc. in the US.
In July 2021, AstraZeneca Pharmaceuticals LP and AstraZeneca UK
Limited intervened in the Texas action in support of Daiichi
Sanyko. A claim construction hearing took place in August 2021 and
a trial has been scheduled for April 2022.
On 23 December 2020, AstraZeneca and Daiichi
Sankyo, Inc. filed a post -grant review petition with the
US Patent and Trademark Office alleging, inter alia, that the '039 patent is invalid for lack
of written description and enablement. In January 2021,
AstraZeneca and Daiichi Sankyo, Inc filed a second post -grant
review petition with the US Patent and Trademark Office extending
its challenge to additional claims in the '039 patent. In June
2021, the US Patent and Trademark Office declined to institute the
post grant reviews. AstraZeneca and Daiichi Sankyo have requested a
rehearing of their post grant review petitions.
In August 2021, AstraZeneca Pharmaceuticals LP and Daiichi Sankyo,
Inc. filed an action against Andrew Hirshfeld, acting in his
official capacity as Under Secretary of Commerce, and the US Patent
and Trademark Office in the US District Court for the Eastern
District of Virginia seeking judicial review of the US Patent
Office's discretionary authority to deny institution of post-grant
review proceedings.
Faslodex
Patent proceedings outside the US
As previously disclosed, in Japan, in April 2021, AstraZeneca
received notice from the Japan Patent Office that Sandoz K.K. filed
a Request for Invalidation Trial to seek invalidation of
the Faslodex formulation patent. In September 2021,
AstraZeneca filed a response defending the patent. In October 2021,
AstraZeneca received notice that Sun Pharma Japan Ltd. is seeking
to intervene in the Sandoz K.K. Request for
Invalidation.
Farxiga
US patent proceedings
As previously disclosed, in 2018, in response to
Paragraph IV notices, AstraZeneca initiated ANDA litigation against
Zydus Pharmaceuticals (USA) Inc. (Zydus)
in the US District Court for the
District of Delaware (the District Court). In May
2021, trial against Zydus proceeded in the District Court. In
October 2021, the District Court issued a decision finding
AstraZeneca's US Patent No. 6,515,117 as valid and infringed by
Zydus's proposed ANDA product.
Patent proceedings outside the US
In Canada, in January 2021, Sandoz Canada Inc. served three Notices
of Allegation on AstraZeneca alleging invalidity and/or
non-infringement of all three patents listed on the Canadian Patent
Register in relation to Forxiga. AstraZeneca commenced litigation in response. A
trial date has been set for October 2022 with closing argument in
December 2022.
In Canada, in February 2021, Teva Canada Limited served a Notice of
Allegation on AstraZeneca alleging invalidity and/or
non-infringement of all three patents listed on the Canadian Patent
Register in relation to Forxiga. AstraZeneca commenced litigation in response. A
trial date has been set for October 2022 with closing argument in
December 2022.
Onglyza
Patent proceedings outside the US
In Canada, in November 2019, Sandoz Canada Inc. sent a
Notice of Allegation to AstraZeneca challenging the validity of
Canadian substance Patent No. 2402894 (expiry
March 2021) (the '894 patent) and formulation Patent No.
2568391 (expiry May 2025) related to Onglyza. AstraZeneca commenced an action in response
related to the '894 patent in January 2020. In October 2021, the
parties reached an agreement to resolve the dispute. This matter is
now concluded.
Symbicort
US Patent Proceedings
As previously disclosed, AstraZeneca is involved in ongoing ANDA
litigation with Mylan Pharmaceuticals Inc. (Mylan) and Kindeva Drug
Delivery L.P. (Kindeva) brought in the US District Court for the
Northern District of West Virginia (the District Court). In the
action, AstraZeneca alleges that the defendants' generic versions
of Symbicort, if approved and marketed, would infringe various
AstraZeneca patents. In September 2020, Mylan and Kindeva
stipulated to patent infringement to the extent that the asserted
patent claims are found to be valid and enforceable, but reserved
the right to seek a vacatur of the stipulation if the U.S. Court of
Appeals for the Federal Circuit reverses or modifies the District
Court's claim construction. In March 2021, the District Court
decided in favour of AstraZeneca and determined that the asserted
patent claims were not invalid or unenforceable. Mylan and Kindeva
appealed to the United States District Court of Appeals for the
Federal Circuit. Oral argument of the appeal was held in August
2021.
Tagrisso
US patent proceedings
In September 2021, Puma Biotechnology, Inc. and Wyeth LLC filed a
patent infringement lawsuit in the US District Court for the
District of Delaware against AstraZeneca relating
to Tagrisso. Neither a case schedule, nor a trial date have
been set yet.
Patent proceedings outside the US
In Russia, in October 2021, AstraZeneca filed a lawsuit in the
Arbitration Court of the Moscow Region against Axelpharm, LLC to
prevent it from obtaining authorization to market a generic version
of Tagrisso prior to the expiration of AstraZeneca's
patents covering Tagrisso. The lawsuit also names the Ministry of Health of
the Russian Federation as a third party. Neither a case schedule,
nor a trial date have been set.
Ultomiris
US patent proceedings
In November 2018, Chugai Pharmaceutical Co., Ltd. ("Chugai") filed
a lawsuit against Alexion in the Delaware District Court alleging
that Ultomiris infringes a U.S. patent held by Chugai. Upon
issuance of another U.S. patent in November 2019, Chugai filed a
second lawsuit in the same court alleging
that Ultomiris also infringes the second patent. The two
lawsuits were consolidated. A trial is scheduled to occur in
January 2022.
Patent proceedings outside the US
In December 2018, Chugai Pharmaceutical Co., Ltd (Chugai) filed a
lawsuit in the Tokyo District Court against Alexion Pharma GK in
Japan and alleges that Ultomiris infringes two Japanese patents held by
Chugai. Chugai's complaints seek unspecified damages and certain
injunctive relief. On 5 March 2020, the Supreme Court of Japan
dismissed Chugai's appeal against an earlier IP High Court of Japan
decision which held that one of the Chugai patents-in-suit is
invalid. Subsequently, Chugai filed a correction to the claims of
this patents-in-suit and Alexion has countered that the corrected
claims are still invalid and not infringed. In all cases, Alexion
has denied the charges and countered that the patents are neither
valid nor infringed. In October 2021 the Japanese Patent Office
invalidated four Chugai patents, including those asserted in the
Tokyo District Court Case. Chugai has appealed the patent office
decision.
Product liability litigation
Byetta/Bydureon
In the US, Amylin Pharmaceuticals, LLC (a wholly owned subsidiary
of AstraZeneca) and AstraZeneca are among multiple defendants in
various lawsuits filed in federal and state courts involving claims
of physical injury from treatment with Byetta and/or Bydureon. The lawsuits allege several types of injuries
including pancreatic cancer and thyroid cancer. A multidistrict
litigation was established in the US District Court for the
Southern District of California (the District Court) in regard to
the alleged pancreatic cancer cases in federal courts. Further, a
coordinated proceeding has been established in Superior Court in
Los Angeles, California ("the California Court") in regard to the
various lawsuits in California state courts. In October and
December 2020, the District Court and the California Court jointly
heard oral argument on renewed motions filed by Defendants seeking
summary judgment and dismissal of all claims alleging pancreatic
cancer. In March and April 2021, the District Court and the
California Court respectively granted the Defendants' motions, and
dismissed all cases alleging pancreatic cancer with prejudice.
Plaintiffs have dismissed the appeal as to Amylin Pharmaceuticals,
LLC and AstraZeneca. The other claims in both courts, including
those alleging thyroid cancer, remain pending.
Nexium and
Losec/Prilosec
US proceedings
As previously disclosed, in the US, AstraZeneca is defending
various lawsuits brought in federal and state courts involving
multiple plaintiffs claiming that they have been diagnosed with
various injuries following treatment with proton pump inhibitors
(PPIs), including Nexium and Prilosec. The vast majority of those lawsuits relate to
allegations of kidney injuries. In particular, in May 2017, counsel
for a group of such plaintiffs claiming that they have been
diagnosed with kidney injuries filed a motion with the Judicial
Panel on Multidistrict Litigation (JPML) seeking the transfer of
any currently pending federal court
cases as well as any similar, subsequently filed
cases to a coordinated and consolidated pre-trial
multidistrict litigation (MDL) proceeding. In
August 2017, the JPML granted the motion and consolidated
the pending federal court cases in an MDL proceeding in federal
court in New Jersey for pre-trial purposes. A trial in the MDL has
been rescheduled for January 2022. In addition to the MDL
cases, there are cases filed in several state courts around the US;
a trial in Delaware state court has been scheduled for
February 2022.
In addition, AstraZeneca has been defending lawsuits involving
allegations of gastric cancer following treatment with PPIs. One
such claim is filed in the US District Court for the Middle
District of Louisiana, where the court has rescheduled a trial for
November 2022.
Canada proceedings
As previously disclosed, in Canada, in July and August 2017,
AstraZeneca was served with three putative class action lawsuits.
Two of the lawsuits seek authorisation to represent individual
residents in Canada who allegedly suffered kidney injuries from the
use of proton pump inhibitors, including Nexium and Losec. In August 2019, the third lawsuit, filed in
Quebec, was dismissed.
Commercial litigation
AZD1222 Securities Litigation
As previously disclosed, in January 2021, putative securities class
action lawsuits were filed in the US District Court for the
Southern District of New York against AstraZeneca PLC and certain
officers, on behalf of purchasers of AstraZeneca publicly traded
securities during the period 21 May 2020 through 20 November 2020.
The Court appointed co-lead plaintiffs in April 2021 and they filed
an Amended Complaint in July 2021 on behalf of purchasers of
AstraZeneca publicly traded securities during the period 15 June
2020 through 29 January 2021. The Amended Complaint alleges that
defendants made materially false and misleading statements in
connection with the development of AZD1222, AstraZeneca's vaccine
for the prevention of COVID-19. In September 2021,
AstraZeneca moved to dismiss the Amended Complaint.
Amplimmune
As previously disclosed, in the US, in
June 2017, AstraZeneca was
served with a lawsuit filed by the stockholders'
agents for Amplimmune, Inc. (Amplimmune) in Delaware State
Court that alleged, among other things,
breaches of contractual obligations relating to
a 2013 merger agreement between AstraZeneca and
Amplimmune. A trial of the matter was held in February 2020
and post-trial oral argument was heard in August 2020. In
November 2020, the Delaware Court of Chancery decided
in AstraZeneca's favour and subsequently entered
a Final Judgment as to all pending claims in favour of AstraZeneca.
In December 2020, the plaintiffs filed an appeal to the
Delaware Supreme Court. In October 2021, the Delaware Supreme Court
affirmed the Delaware Court of Chancery's decision.
Shareholder Litigation - Alexion
In December 2016, putative securities class action lawsuits were
filed in the US District Court for the District of Connecticut
against Alexion and certain officers and directors, on behalf of
purchasers of Alexion publicly traded securities during the period
30 January 2014 through 26 May 2017. The amended complaint alleges
that defendants engaged in securities fraud, including by making
misrepresentations and omissions in its public disclosures
concerning Alexion's Soliris sales practices, management changes, and
related investigations. In August 2021, the court issued a decision
denying in part Defendants' motion to dismiss the
matter.
Shareholder Litigation - Portola
In connection with Alexion's July 2020 acquisition of Portola
Pharmaceuticals, Inc (Portola), Alexion assumed litigation to which
Portola is a party. In January 2020, putative securities class
action lawsuits were filed in the US District Court for the
Northern District of California against Portola and certain
officers and directors, on behalf of purchasers of Portola publicly
traded securities during the period 8 January 2019 through 26
February 2020. The third amended complaint alleges that defendants
made materially false and/or misleading statements or omissions
about the demand for Andexxa, usage of Andexxa by hospitals and healthcare organisations,
and about Portola's accounting for its return reserves. In August
2021, the court denied in part defendants' motion to dismiss the
case. A trial date has been set in the matter for December
2022.
Anti-Terrorism Act Civil Lawsuit
As previously disclosed, in July 2020, the US District Court
for the District of Columbia granted AstraZeneca's and
certain other pharmaceutical and/or medical device companies'
motion and dismissed a lawsuit filed by US nationals (or their
estates, survivors, or heirs) who were killed or wounded in Iraq
between 2005 and 2011, which had alleged that the defendants
violated the US Anti-Terrorism Act and various state laws by
selling pharmaceuticals and medical
supplies to the Iraqi Ministry of Health.
The plaintiffs are appealing the District Court's order
dismissing the litigation. The DC Circuit Court of Appeals
heard oral argument on the plaintiffs' appeal in September
2021.
Government investigations/proceedings
US 340B Litigations and Proceedings
As previously disclosed, AstraZeneca is involved in several matters
relating to its policy with regard to contract pharmacy recognition
under the 340B Drug Pricing
Program in the US. In October and
November 2020, two lawsuits, one in the US District Court for the
District of Columbia
and one in the US District Court for the Northern
District of California, were filed by covered entities and advocacy
groups against the US Department of Health and Human Services, the
US Health Resources and Services
Administration as well as other US government
agencies and their officials. The complaints
allege, among other things, that these agencies
should enforce an interpretation of the governing statute for the
340B Drug Pricing
Program that would require drug manufacturers
participating in the program to offer their drugs
for purchase at statutorily capped rates by an unlimited number of
contract pharmacies. AstraZeneca has sought to intervene in
the lawsuits. The case in US District Court for the District of
Columbia is currently stayed pending further proceedings and the
case in federal court in California has been dismissed.
Administrative Dispute Resolution (ADR) proceedings have also been
initiated against AstraZeneca before the US Health Resources and
Services Administration.
In February 2021, AstraZeneca received a Civil Investigative
Subpoena from the Attorney General's Office for the State of
Vermont seeking documents and information relating to AstraZeneca's
policy regarding contract pharmacy recognition under the 340B Drug
Pricing Program. AstraZeneca is cooperating with the
inquiry.
In addition, in January 2021, AstraZeneca filed a
separate lawsuit in federal court in
Delaware alleging that a recent Advisory Opinion issued by the Department of Health and Human Services
violates the Administrative Procedure Act. In June 2021, the
Court found in favour of AstraZeneca, invalidating the Advisory
Opinion. Prior to the Court's ruling, however, in May 2021, the US
government issued new and separate letters to AstraZeneca (and
other companies) asserting that our contract pharmacy policy
violates the 340B statute. In July 2021, AstraZeneca amended the
complaint to include allegations challenging the letter sent in
May. In September 2021, the US government issued a follow-up letter
to AstraZeneca (and other companies) asserting that it has referred
the matter to the Office of Inspector General for further review
and consideration. In October 2021, oral arguments were held before
the federal court in Delaware challenging the letters sent in May
and September.
In September 2021, AstraZeneca was served with a class-action
complaint filed in federal court in New York by Mosaic Health on
behalf of a purported class. The complaint alleges that AstraZeneca
conspired with Sanofi-Aventis U.S., LLC, Eli Lilly and Company,
Lilly USA, LLC, and Novo Nordisk Inc to restrict access to 340B
discounts through contract pharmacies.
European Commission Claim Regarding AZD1222
As previously disclosed, in April 2021 and May 2021, the European
Commission (acting on behalf of the European Union and its member
states) initiated two separate legal proceedings against
AstraZeneca AB in the Court of First Instance in Brussels. Both
proceedings related to an Advance Purchase Agreement between the
parties dated 27 August 2020 (the APA) for the supply of AZD1222.
The allegations include claims that AstraZeneca has failed to meet
certain of its obligations under the APA and the European
Commission is seeking, among other things, a Court order to compel
AstraZeneca to supply a specified number of doses before the end of
the second quarter of 2021. In June 2021, the Court issued a
decision in the first proceeding finding that AstraZeneca did not
meet its Best Reasonable Efforts obligation in the APA because
AstraZeneca did not use all of the manufacturers listed in the APA
to supply the member states. The Court ordered AstraZeneca to
provide an additional 50 million doses of vaccine by the end of
September 2021, which AstraZeneca exceeded by the end of June 2021.
The Court denied the remainder of the Commission's claims and
requested relief.
In September 2021, the parties reached an agreement to resolve the
dispute. This matter is now concluded.
COVID-19 Vaccine Supply and Manufacturing Inquiries
As previously disclosed, in June 2021, Argentina's Federal Criminal
Prosecutor's Office (the Prosecutor) contacted AstraZeneca
Argentina seeking documents and electronic records in connection
with a local criminal investigation relating to the public
procurement and supply of Vaxzevria in that country. In October 2021, the
Prosecutor filed a submission with the presiding court requesting
dismissal of the criminal investigation. The request remains
pending.
Turkish Ministry of Health Matter
In Turkey, in July 2020, the Turkish Ministry of Health initiated
an investigation regarding payments to healthcare providers by
Alexion Turkey and former employees and consultants. The
investigation arose from Alexion's disclosure of a civil settlement
with the U.S. Securities & Exchange Commission in July 2020
fully resolving the SEC's investigation into possible violations of
the FCPA. Alexion neither admitted nor denied any wrongdoing in
connection with the settlement but paid US$21.5 million to the SEC,
consisting of amounts attributable to disgorgement, civil
penalties, and pre-judgment interest. AstraZeneca is cooperating
with the investigation by the Turkish agency. In September 2021,
the Ministry of Health completed its draft investigation report,
and referred the matter to the Ankara Public Prosecutor's Office
with a recommendation for further proceedings against certain
former employees.
Canadian Pricing Matter
In October 2017, Alexion filed proceedings in the Federal Court of
Canada to seek judicial review of a determination by the Canadian
Patented Medicine Prices Review Board that Alexion had excessively
priced Soliris in a manner inconsistent with the Canadian
pricing rules and guidelines. In its decision, the PMPRB ordered
Alexion to decrease the price of Soliris to an upper limit based upon pricing in
certain other countries and to forfeit excess revenues for the
period between 2009 and 2017. In May 2019, the Federal Court
dismissed Alexion's application. Alexion appealed the decision to
the Canadian Federal Court of Appeal. On 29 July 2021, the Federal
Court of Appeal of Canada issued its judgment allowing the appeal,
reversing the PMPRB's decision and remitting the matter to the
PMPRB for re-determination with costs to AstraZeneca. In September
2021, the Attorney General of Canada sought leave to appeal the
decision to the Supreme Court of Canada. Pursuant to an order made
by the Federal Court of Canada, as of August 2021, AstraZeneca has
placed approximately US$71.4 million in escrow pending the final
resolution of all appeals in this matter.
Taxation
As previously disclosed in the Annual Report and Form 20-F
Information 2020, AstraZeneca faces a number of audits and reviews
in jurisdictions around the world and, in some cases, is in dispute
with the tax authorities. The issues under discussion are often
complex and can require many years to resolve. Accruals for tax
contingencies require management to make key judgements and
significant estimates with respect to the ultimate outcome of
current and potential future tax audits, and actual results could
vary from these estimates.
The total net accrual to cover the worldwide tax exposure for
transfer pricing and other international tax contingencies of $82m
(31 December 2020: $287m) reflected the progress in those tax
audits and reviews during the year and for those audits where
AstraZeneca and tax authorities are in dispute, AstraZeneca
estimates the potential for reasonably possible additional
liabilities above and beyond the amount provided to be up to $25m,
including associated interest (31 December 2020:
$251m).
There is no material change to other tax exposures.
7) Subsequent Events
In 2019 Caelum and Alexion entered into a collaboration to
develop CAEL-101 for light chain amyloidosis, whereby Alexion
acquired a minority equity interest and an exclusive option to
acquire the remaining equity in Caelum. AstraZeneca has treated
Caelum as a subsidiary from the date of acquisition of Alexion,
reflecting a non-controlling interest of $150m. On 5 October 2021,
the Group completed the acquisition of the remaining shares of
Caelum and paid its shareholders the option exercise price of
$150m, with the potential for additional payments of up to $350m
upon achievement of regulatory and commercial
milestones.
In November 2021, AstraZeneca agreed to transfer its global rights
to Eklira, known as Tudorza in the US, and Duaklir to Covis Pharma Group for $270m payable on
completion, which is expected in the fourth quarter of 2021. Covis
Pharma Group will also cover certain ongoing development costs
related to the medicines. The income arising from the upfront
payment will be fully offset by a charge for derecognition of the
associated intangible asset and therefore no Other Operating Income
will be recognised in AstraZeneca's financial
statements.
8) Table 51: YTD 2021 - Product Sales year-on-year
analysis[104]
|
World
|
Emerging Markets
|
US
|
Europe
|
Established RoW
|
|
|
|
|
|
|
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
Actual
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
$m
|
% change
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
Oncology
|
9,593
|
21
|
17
|
2,438
|
9
|
4
|
3,871
|
26
|
1,823
|
34
|
24
|
1,461
|
16
|
14
|
Tagrisso
|
3,701
|
17
|
13
|
1,012
|
6
|
1
|
1,294
|
13
|
727
|
45
|
35
|
668
|
16
|
14
|
Imfinzi
|
1,778
|
20
|
17
|
211
|
87
|
77
|
916
|
3
|
347
|
37
|
27
|
304
|
29
|
27
|
Lynparza
|
1,719
|
34
|
31
|
282
|
44
|
40
|
793
|
26
|
456
|
47
|
36
|
188
|
32
|
29
|
Calquence
|
843
|
n/m
|
n/m
|
12
|
n/m
|
n/m
|
752
|
n/m
|
69
|
n/m
|
n/m
|
10
|
n/m
|
n/m
|
Koselugo
|
74
|
n/m
|
n/m
|
-
|
-
|
-
|
72
|
n/m
|
2
|
n/m
|
n/m
|
-
|
-
|
-
|
Enhertu
|
10
|
n/m
|
n/m
|
8
|
n/m
|
n/m
|
-
|
-
|
2
|
n/m
|
n/m
|
-
|
-
|
-
|
Orpathys
|
10
|
n/m
|
n/m
|
10
|
n/m
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Zoladex
|
716
|
7
|
1
|
465
|
9
|
3
|
11
|
80
|
112
|
7
|
(1)
|
128
|
(5)
|
(8)
|
Faslodex
|
329
|
(27)
|
(29)
|
122
|
(14)
|
(17)
|
24
|
(47)
|
93
|
(45)
|
(49)
|
90
|
(3)
|
(3)
|
Iressa
|
149
|
(26)
|
(31)
|
122
|
(25)
|
(30)
|
9
|
(13)
|
5
|
(59)
|
(66)
|
13
|
(24)
|
(23)
|
Casodex
|
120
|
(9)
|
(15)
|
92
|
(11)
|
(18)
|
-
|
-
|
2
|
10
|
10
|
26
|
(1)
|
(4)
|
Arimidex
|
106
|
(29)
|
(31)
|
80
|
(34)
|
(37)
|
-
|
-
|
3
|
23
|
31
|
23
|
(11)
|
(11)
|
Others
|
38
|
-
|
(2)
|
22
|
8
|
5
|
-
|
-
|
5
|
32
|
12
|
11
|
(19)
|
(17)
|
BioPharmaceuticals: CVRM
|
6,017
|
15
|
10
|
2,912
|
20
|
15
|
1,548
|
3
|
1,108
|
23
|
15
|
449
|
6
|
1
|
Farxiga
|
2,152
|
57
|
51
|
877
|
80
|
74
|
504
|
31
|
584
|
61
|
50
|
187
|
37
|
31
|
Brilinta
|
1,124
|
(9)
|
(11)
|
256
|
(35)
|
(37)
|
558
|
4
|
263
|
2
|
(5)
|
47
|
7
|
(3)
|
Bydureon
|
293
|
(10)
|
(11)
|
2
|
(24)
|
(17)
|
243
|
(12)
|
43
|
12
|
4
|
5
|
(28)
|
(36)
|
Onglyza
|
284
|
(22)
|
(25)
|
151
|
(2)
|
(6)
|
62
|
(53)
|
47
|
10
|
2
|
24
|
(29)
|
(34)
|
Byetta
|
45
|
(10)
|
(10)
|
11
|
33
|
43
|
20
|
(15)
|
9
|
(16)
|
(21)
|
5
|
(29)
|
(35)
|
Other diabetes
|
43
|
24
|
20
|
12
|
n/m
|
n/m
|
16
|
(20)
|
13
|
47
|
38
|
2
|
24
|
(4)
|
Roxadustat
|
144
|
n/m
|
n/m
|
144
|
n/m
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Lokelma
|
122
|
n/m
|
n/m
|
3
|
(8)
|
(15)
|
82
|
n/m
|
8
|
n/m
|
n/m
|
29
|
n/m
|
n/m
|
Crestor
|
837
|
(5)
|
(9)
|
597
|
7
|
2
|
59
|
(17)
|
43
|
(55)
|
(58)
|
138
|
(12)
|
(14)
|
Seloken/Toprol-XL
|
749
|
21
|
14
|
731
|
23
|
17
|
1
|
(85)
|
9
|
(24)
|
(24)
|
8
|
7
|
(5)
|
Atacand
|
76
|
(58)
|
(58)
|
25
|
(81)
|
(81)
|
3
|
(55)
|
48
|
n/m
|
n/m
|
-
|
n/m
|
n/m
|
Others
|
148
|
2
|
(3)
|
103
|
10
|
3
|
-
|
-
|
41
|
(9)
|
(11)
|
4
|
(32)
|
(34)
|
BioPharmaceuticals: Respiratory & Immunology
|
4,444
|
16
|
12
|
1,305
|
24
|
17
|
1,757
|
24
|
912
|
5
|
(3)
|
470
|
(5)
|
(9)
|
Symbicort
|
2,047
|
-
|
(3)
|
457
|
8
|
4
|
804
|
6
|
499
|
(4)
|
(11)
|
287
|
(16)
|
(21)
|
Fasenra
|
901
|
35
|
32
|
15
|
55
|
52
|
555
|
31
|
211
|
51
|
40
|
120
|
29
|
24
|
Pulmicort
|
714
|
14
|
7
|
578
|
20
|
13
|
53
|
(1)
|
49
|
(10)
|
(17)
|
34
|
(16)
|
(20)
|
Daliresp
|
168
|
3
|
3
|
2
|
(10)
|
6
|
153
|
9
|
12
|
(35)
|
(40)
|
1
|
28
|
(12)
|
Breztri
|
130
|
n/m
|
n/m
|
40
|
n/m
|
n/m
|
68
|
n/m
|
4
|
n/m
|
n/m
|
18
|
n/m
|
n/m
|
Bevespi
|
39
|
8
|
7
|
3
|
n/m
|
n/m
|
29
|
(14)
|
7
|
n/m
|
n/m
|
-
|
-
|
-
|
Saphnelo
|
1
|
n/m
|
n/m
|
-
|
-
|
-
|
1
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
Others
|
444
|
62
|
53
|
210
|
72
|
59
|
94
|
n/m
|
130
|
(2)
|
(9)
|
10
|
(11)
|
(18)
|
Rare disease
|
1,311
|
n/m
|
n/m
|
65
|
n/m
|
n/m
|
785
|
n/m
|
302
|
n/m
|
n/m
|
159
|
n/m
|
n/m
|
Soliris
|
798
|
n/m
|
n/m
|
53
|
n/m
|
n/m
|
460
|
n/m
|
199
|
n/m
|
n/m
|
86
|
n/m
|
n/m
|
Ultomiris
|
297
|
n/m
|
n/m
|
5
|
n/m
|
n/m
|
167
|
n/m
|
69
|
n/m
|
n/m
|
56
|
n/m
|
n/m
|
Strensiq
|
159
|
n/m
|
n/m
|
4
|
n/m
|
n/m
|
124
|
n/m
|
16
|
n/m
|
n/m
|
15
|
n/m
|
n/m
|
Andexxa
|
29
|
n/m
|
n/m
|
-
|
n/m
|
n/m
|
20
|
n/m
|
9
|
n/m
|
n/m
|
-
|
n/m
|
n/m
|
Kanuma
|
28
|
n/m
|
n/m
|
3
|
n/m
|
n/m
|
14
|
n/m
|
9
|
n/m
|
n/m
|
2
|
n/m
|
n/m
|
Other medicines
|
1,542
|
(17)
|
(19)
|
755
|
4
|
(1)
|
180
|
(40)
|
267
|
(38)
|
(40)
|
340
|
(13)
|
(15)
|
Nexium
|
999
|
(10)
|
(13)
|
576
|
2
|
(1)
|
99
|
(22)
|
47
|
(20)
|
(26)
|
277
|
(24)
|
(26)
|
Synagis
|
170
|
(42)
|
(41)
|
15
|
n/m
|
n/m
|
21
|
(54)
|
81
|
(67)
|
(67)
|
53
|
n/m
|
n/m
|
Losec/Prilosec
|
138
|
(4)
|
(10)
|
116
|
(3)
|
(10)
|
-
|
(96)
|
21
|
29
|
29
|
1
|
(85)
|
(87)
|
FluMist
|
75
|
(35)
|
(37)
|
1
|
n/m
|
n/m
|
23
|
(65)
|
51
|
5
|
1
|
-
|
-
|
-
|
Seroquel XR/IR
|
74
|
(25)
|
(24)
|
36
|
(11)
|
(9)
|
13
|
(42)
|
22
|
-
|
-
|
3
|
(78)
|
(75)
|
Others
|
86
|
(2)
|
(6)
|
11
|
85
|
79
|
24
|
(36)
|
45
|
15
|
9
|
6
|
12
|
3
|
COVID-19
|
2,136
|
n/m
|
n/m
|
1,056
|
n/m
|
n/m
|
-
|
-
|
736
|
n/m
|
n/m
|
344
|
n/m
|
n/m
|
Pandemic COVID-19 vaccine
|
2,136
|
n/m
|
n/m
|
1,056
|
n/m
|
n/m
|
-
|
-
|
736
|
n/m
|
n/m
|
344
|
n/m
|
n/m
|
Total Product Sales
|
25,043
|
33
|
29
|
8,531
|
32
|
27
|
8,141
|
29
|
5,148
|
45
|
35
|
3,223
|
25
|
22
|
9) Table 52: Q3 2021 - Product Sales year-on-year
analysis[105]
|
World
|
Emerging Markets
|
US
|
Europe
|
Established RoW
|
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
Actual
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
$m
|
% change
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
Oncology
|
3,326
|
18
|
16
|
812
|
5
|
-
|
1,377
|
22
|
640
|
35
|
31
|
497
|
10
|
13
|
Tagrisso
|
1,247
|
8
|
7
|
315
|
(11)
|
(15)
|
441
|
5
|
259
|
46
|
42
|
232
|
14
|
17
|
Imfinzi
|
618
|
16
|
15
|
78
|
58
|
50
|
319
|
2
|
120
|
38
|
35
|
101
|
19
|
21
|
Lynparza
|
588
|
27
|
25
|
96
|
28
|
23
|
270
|
21
|
155
|
36
|
33
|
67
|
32
|
33
|
Calquence
|
354
|
n/m
|
n/m
|
5
|
n/m
|
n/m
|
308
|
n/m
|
37
|
n/m
|
n/m
|
4
|
n/m
|
n/m
|
Koselugo
|
26
|
n/m
|
n/m
|
-
|
-
|
-
|
25
|
96
|
1
|
n/m
|
n/m
|
-
|
-
|
-
|
Enhertu
|
5
|
n/m
|
n/m
|
4
|
n/m
|
n/m
|
-
|
-
|
1
|
n/m
|
n/m
|
-
|
-
|
-
|
Orpathys
|
10
|
n/m
|
n/m
|
10
|
n/m
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Zoladex
|
250
|
9
|
5
|
169
|
22
|
15
|
3
|
n/m
|
38
|
4
|
1
|
40
|
(25)
|
(24)
|
Faslodex
|
103
|
(26)
|
(27)
|
42
|
1
|
(3)
|
8
|
(33)
|
23
|
(59)
|
(59)
|
30
|
(1)
|
2
|
Iressa
|
41
|
(23)
|
(29)
|
34
|
(22)
|
(27)
|
3
|
21
|
2
|
(34)
|
(52)
|
2
|
(54)
|
(44)
|
Casodex
|
38
|
(13)
|
(18)
|
28
|
(19)
|
(25)
|
-
|
(92)
|
1
|
57
|
34
|
9
|
12
|
11
|
Arimidex
|
33
|
(20)
|
(20)
|
24
|
(23)
|
(26)
|
-
|
-
|
1
|
20
|
56
|
8
|
(12)
|
(7)
|
Others
|
13
|
2
|
1
|
7
|
17
|
15
|
-
|
-
|
2
|
65
|
31
|
4
|
(29)
|
(23)
|
BioPharmaceuticals: CVRM
|
2,082
|
16
|
13
|
991
|
21
|
15
|
561
|
9
|
381
|
22
|
20
|
149
|
(1)
|
(1)
|
Farxiga
|
796
|
51
|
48
|
320
|
76
|
69
|
202
|
36
|
213
|
51
|
48
|
61
|
12
|
11
|
Brilinta
|
375
|
(3)
|
(4)
|
76
|
(25)
|
(28)
|
198
|
7
|
85
|
1
|
(1)
|
16
|
10
|
5
|
Bydureon
|
95
|
(13)
|
(13)
|
-
|
(60)
|
(37)
|
81
|
(13)
|
13
|
(3)
|
(2)
|
1
|
(68)
|
(65)
|
Onglyza
|
84
|
(23)
|
(25)
|
42
|
(22)
|
(26)
|
18
|
(37)
|
17
|
17
|
15
|
7
|
(37)
|
(41)
|
Byetta
|
13
|
(11)
|
(6)
|
3
|
(18)
|
(5)
|
6
|
1
|
3
|
9
|
17
|
1
|
(50)
|
(51)
|
Other diabetes
|
14
|
24
|
26
|
5
|
n/m
|
n/m
|
4
|
(32)
|
4
|
37
|
44
|
1
|
22
|
(27)
|
Roxadustat
|
55
|
n/m
|
n/m
|
55
|
n/m
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Lokelma
|
49
|
n/m
|
n/m
|
1
|
(63)
|
(65)
|
32
|
n/m
|
3
|
n/m
|
n/m
|
13
|
n/m
|
n/m
|
Crestor
|
298
|
(1)
|
(4)
|
225
|
18
|
13
|
18
|
(30)
|
11
|
(65)
|
(65)
|
44
|
(18)
|
(17)
|
Seloken/Toprol-XL
|
234
|
4
|
(2)
|
227
|
5
|
-
|
1
|
(81)
|
3
|
(25)
|
(33)
|
3
|
15
|
1
|
Atacand
|
19
|
(65)
|
(65)
|
5
|
(88)
|
(88)
|
1
|
(52)
|
13
|
80
|
80
|
-
|
n/m
|
n/m
|
Others
|
50
|
29
|
23
|
32
|
13
|
6
|
-
|
-
|
16
|
60
|
55
|
2
|
n/m
|
n/m
|
BioPharmaceuticals: Respiratory & Immunology
|
1,483
|
28
|
25
|
420
|
44
|
35
|
609
|
41
|
295
|
5
|
3
|
159
|
2
|
-
|
Symbicort
|
676
|
13
|
11
|
151
|
14
|
9
|
274
|
39
|
155
|
(6)
|
(8)
|
96
|
(8)
|
(11)
|
Fasenra
|
322
|
34
|
33
|
7
|
n/m
|
n/m
|
199
|
32
|
75
|
45
|
42
|
41
|
20
|
19
|
Pulmicort
|
217
|
44
|
36
|
173
|
59
|
48
|
17
|
1
|
15
|
5
|
5
|
12
|
4
|
5
|
Daliresp
|
54
|
(5)
|
(6)
|
-
|
(61)
|
(14)
|
50
|
(3)
|
3
|
(34)
|
(36)
|
1
|
n/m
|
n/m
|
Breztri
|
47
|
n/m
|
n/m
|
14
|
n/m
|
n/m
|
25
|
n/m
|
2
|
n/m
|
n/m
|
6
|
n/m
|
n/m
|
Bevespi
|
13
|
(9)
|
(10)
|
1
|
68
|
34
|
9
|
(28)
|
3
|
n/m
|
n/m
|
-
|
-
|
-
|
Saphnelo
|
1
|
n/m
|
n/m
|
-
|
-
|
-
|
1
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
Others
|
153
|
70
|
64
|
74
|
78
|
66
|
34
|
n/m
|
42
|
(6)
|
(8)
|
3
|
1
|
-
|
Rare disease*
|
1,311
|
5
|
6
|
65
|
(34)
|
(31)
|
785
|
7
|
302
|
12
|
12
|
159
|
7
|
9
|
Soliris*
|
798
|
(3)
|
(2)
|
53
|
(44)
|
(40)
|
460
|
4
|
199
|
(3)
|
(3)
|
86
|
9
|
10
|
Ultomiris*
|
297
|
31
|
31
|
5
|
n/m
|
n/m
|
167
|
25
|
69
|
78
|
77
|
56
|
2
|
5
|
Strensiq*
|
159
|
7
|
8
|
4
|
87
|
84
|
124
|
6
|
16
|
6
|
5
|
15
|
8
|
11
|
Andexxa*
|
29
|
(6)
|
(5)
|
-
|
-
|
-
|
20
|
(30)
|
9
|
n/m
|
n/m
|
-
|
-
|
-
|
Kanuma*
|
28
|
26
|
26
|
3
|
n/m
|
n/m
|
14
|
13
|
9
|
16
|
16
|
2
|
85
|
63
|
Other medicines
|
539
|
(27)
|
(27)
|
219
|
(10)
|
(13)
|
80
|
(47)
|
122
|
(36)
|
(37)
|
118
|
(21)
|
(19)
|
Nexium
|
259
|
(35)
|
(36)
|
156
|
(19)
|
(21)
|
32
|
(32)
|
11
|
(50)
|
(51)
|
60
|
(57)
|
(56)
|
Synagis
|
122
|
3
|
5
|
15
|
n/m
|
n/m
|
16
|
(36)
|
38
|
(61)
|
(62)
|
53
|
n/m
|
n/m
|
Losec/Prilosec
|
38
|
(16)
|
(21)
|
32
|
(16)
|
(23)
|
-
|
-
|
6
|
(9)
|
(9)
|
-
|
-
|
-
|
FluMist
|
72
|
(37)
|
(39)
|
-
|
-
|
-
|
23
|
(65)
|
49
|
1
|
(2)
|
-
|
n/m
|
n/m
|
Seroquel XR/IR
|
24
|
(32)
|
(30)
|
12
|
(13)
|
(10)
|
3
|
(66)
|
7
|
9
|
8
|
2
|
(69)
|
(64)
|
Others
|
24
|
23
|
20
|
4
|
50
|
39
|
6
|
33
|
11
|
3
|
4
|
3
|
72
|
41
|
COVID-19
|
1,000
|
n/m
|
n/m
|
601
|
n/m
|
n/m
|
-
|
-
|
165
|
n/m
|
n/m
|
234
|
n/m
|
n/m
|
Pandemic COVID-19 vaccine
|
1,000
|
n/m
|
n/m
|
601
|
n/m
|
n/m
|
-
|
-
|
165
|
n/m
|
n/m
|
234
|
n/m
|
n/m
|
Total Product Sales
|
9,741
|
49
|
47
|
3,108
|
46
|
40
|
3,412
|
53
|
1,905
|
51
|
48
|
1,316
|
45
|
47
|
10) Table 53: Q3 2021 - Product Sales quarterly sequential
analysis[106]
|
|
|
Q1 2021
|
|
|
Q2 2021
|
|
|
Q3 2021
|
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
Oncology
|
2,981
|
3
|
1
|
3,286
|
10
|
11
|
3,326
|
1
|
2
|
Tagrisso
|
1,149
|
(1)
|
(3)
|
1,306
|
14
|
14
|
1,247
|
(5)
|
(4)
|
Imfinzi
|
556
|
-
|
(1)
|
604
|
9
|
10
|
618
|
2
|
3
|
Lynparza
|
543
|
9
|
8
|
588
|
8
|
9
|
588
|
-
|
1
|
Calquence
|
209
|
15
|
15
|
280
|
34
|
34
|
354
|
26
|
26
|
Koselugo
|
21
|
23
|
23
|
26
|
23
|
22
|
26
|
-
|
2
|
Enhertu
|
1
|
n/m
|
n/m
|
3
|
n/m
|
n/m
|
5
|
64
|
63
|
Orpathys
|
-
|
-
|
-
|
-
|
-
|
-
|
10
|
n/m
|
n/m
|
Zoladex
|
221
|
2
|
-
|
244
|
10
|
11
|
250
|
2
|
3
|
Faslodex
|
122
|
(6)
|
(8)
|
105
|
(14)
|
(12)
|
103
|
(2)
|
(2)
|
Iressa
|
61
|
(9)
|
(11)
|
47
|
(23)
|
(22)
|
41
|
(11)
|
(14)
|
Casodex
|
42
|
7
|
5
|
41
|
(2)
|
(1)
|
38
|
(7)
|
(8)
|
Arimidex
|
44
|
22
|
18
|
29
|
(34)
|
(33)
|
33
|
16
|
19
|
Others
|
12
|
(4)
|
(6)
|
13
|
13
|
11
|
13
|
(5)
|
(4)
|
BioPharmaceuticals: CVRM
|
1,912
|
4
|
1
|
2,023
|
6
|
6
|
2,082
|
3
|
3
|
Farxiga
|
624
|
6
|
4
|
732
|
17
|
18
|
796
|
9
|
9
|
Brilinta
|
374
|
3
|
1
|
375
|
-
|
1
|
375
|
-
|
1
|
Bydureon
|
103
|
(16)
|
(17)
|
95
|
(8)
|
(7)
|
95
|
1
|
2
|
Onglyza
|
101
|
(3)
|
(6)
|
99
|
(2)
|
(2)
|
84
|
(15)
|
(15)
|
Byetta
|
16
|
(14)
|
(15)
|
16
|
(4)
|
(7)
|
13
|
(15)
|
(7)
|
Other diabetes
|
13
|
7
|
1
|
15
|
14
|
14
|
14
|
(9)
|
(4)
|
Roxadustat
|
39
|
n/m
|
n/m
|
51
|
32
|
32
|
55
|
7
|
7
|
Lokelma
|
33
|
16
|
18
|
39
|
21
|
21
|
49
|
25
|
26
|
Crestor
|
274
|
(8)
|
(9)
|
265
|
(3)
|
(3)
|
298
|
12
|
13
|
Seloken/Toprol-XL
|
250
|
25
|
21
|
266
|
6
|
7
|
234
|
(12)
|
(13)
|
Atacand
|
34
|
(45)
|
(45)
|
23
|
(35)
|
(32)
|
19
|
(15)
|
(18)
|
Others
|
51
|
12
|
10
|
47
|
(7)
|
(10)
|
50
|
6
|
7
|
BioPharmaceuticals: Respiratory & Immunology
|
1,541
|
1
|
(1)
|
1,420
|
(8)
|
(7)
|
1,483
|
4
|
5
|
Symbicort
|
691
|
2
|
-
|
680
|
(2)
|
(1)
|
676
|
(1)
|
-
|
Fasenra
|
260
|
(8)
|
(9)
|
320
|
23
|
23
|
322
|
1
|
1
|
Pulmicort
|
330
|
(10)
|
(13)
|
167
|
(50)
|
(49)
|
217
|
30
|
30
|
Daliresp
|
60
|
11
|
10
|
54
|
(10)
|
(9)
|
54
|
-
|
(2)
|
Breztri
|
27
|
n/m
|
n/m
|
56
|
n/m
|
n/m
|
47
|
(15)
|
(15)
|
Bevespi
|
13
|
7
|
8
|
13
|
1
|
3
|
13
|
(1)
|
(2)
|
Saphnelo
|
-
|
-
|
-
|
-
|
-
|
-
|
1
|
n/m
|
n/m
|
Others
|
160
|
28
|
25
|
130
|
(19)
|
(19)
|
153
|
17
|
19
|
Rare disease†
|
-
|
-
|
-
|
-
|
-
|
-
|
1,311
|
(2)
|
(1)
|
Soliris†
|
-
|
-
|
-
|
-
|
-
|
-
|
798
|
(6)
|
(4)
|
Ultomiris†
|
-
|
-
|
-
|
-
|
-
|
-
|
297
|
7
|
8
|
Strensiq†
|
-
|
-
|
-
|
-
|
-
|
-
|
159
|
(2)
|
(2)
|
Andexxa†
|
-
|
-
|
-
|
-
|
-
|
-
|
29
|
5
|
6
|
Kanuma†
|
-
|
-
|
-
|
-
|
-
|
-
|
28
|
9
|
9
|
Other medicines
|
548
|
(25)
|
(26)
|
454
|
(17)
|
(16)
|
539
|
19
|
20
|
Nexium
|
403
|
7
|
5
|
336
|
(17)
|
(15)
|
259
|
(23)
|
(23)
|
Synagis
|
24
|
(69)
|
(69)
|
24
|
1
|
1
|
122
|
n/m
|
n/m
|
Losec/Prilosec
|
54
|
39
|
36
|
46
|
(14)
|
(15)
|
38
|
(18)
|
(17)
|
FluMist
|
2
|
(99)
|
(99)
|
1
|
(51)
|
(71)
|
72
|
n/m
|
n/m
|
Seroquel XR/IR
|
29
|
51
|
38
|
21
|
(29)
|
(22)
|
24
|
17
|
14
|
Others
|
36
|
(6)
|
(4)
|
26
|
(28)
|
(32)
|
24
|
(8)
|
(5)
|
COVID-19
|
275
|
n/m
|
n/m
|
862
|
n/m
|
n/m
|
1,000
|
16
|
18
|
Pandemic COVID-19 vaccine
|
275
|
n/m
|
n/m
|
862
|
n/m
|
n/m
|
1,000
|
16
|
18
|
Total Product Sales
|
7,257
|
4
|
1
|
8,045
|
11
|
12
|
9,741
|
21
|
22
|
11) Table 54: FY 2020 - Product Sales quarterly sequential
analysis[107]
|
Q1 2020
|
Q2 2020
|
Q3 2020
|
Q4 2020
|
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
Oncology
|
2,502
|
10
|
10
|
2,609
|
4
|
6
|
2,831
|
8
|
6
|
2,908
|
3
|
2
|
Tagrisso
|
982
|
11
|
11
|
1,034
|
5
|
7
|
1,155
|
12
|
9
|
1,157
|
-
|
(1)
|
Imfinzi
|
462
|
9
|
9
|
492
|
6
|
8
|
533
|
8
|
6
|
555
|
4
|
3
|
Lynparza
|
397
|
13
|
13
|
419
|
5
|
7
|
464
|
11
|
8
|
496
|
7
|
6
|
Calquence
|
88
|
58
|
58
|
107
|
21
|
23
|
145
|
36
|
35
|
182
|
25
|
25
|
Koselugo
|
-
|
-
|
-
|
7
|
n/m
|
n/m
|
13
|
75
|
75
|
17
|
34
|
34
|
Zoladex
|
225
|
15
|
15
|
217
|
(3)
|
-
|
230
|
6
|
3
|
216
|
(6)
|
(7)
|
Faslodex
|
166
|
-
|
-
|
146
|
(12)
|
(9)
|
138
|
(5)
|
(8)
|
130
|
(6)
|
(7)
|
Iressa
|
77
|
(3)
|
(4)
|
70
|
(9)
|
(7)
|
54
|
(23)
|
(24)
|
67
|
24
|
19
|
Arimidex
|
50
|
(1)
|
(2)
|
58
|
17
|
16
|
42
|
(28)
|
(27)
|
36
|
(14)
|
(16)
|
Casodex
|
42
|
(2)
|
(3)
|
47
|
14
|
12
|
44
|
(7)
|
(8)
|
39
|
(11)
|
(14)
|
Others
|
13
|
(52)
|
(52)
|
12
|
(11)
|
(1)
|
13
|
4
|
3
|
13
|
2
|
2
|
BioPharmaceuticals: CVRM
|
1,701
|
(5)
|
(5)
|
1,759
|
3
|
6
|
1,794
|
2
|
-
|
1,842
|
3
|
1
|
Farxiga
|
405
|
(3)
|
(3)
|
443
|
9
|
13
|
525
|
19
|
16
|
586
|
11
|
10
|
Brilinta
|
408
|
(5)
|
(5)
|
437
|
7
|
9
|
385
|
(12)
|
(13)
|
363
|
(6)
|
(6)
|
Onglyza
|
141
|
8
|
8
|
115
|
(19)
|
(17)
|
110
|
(6)
|
(6)
|
105
|
(4)
|
(5)
|
Bydureon
|
100
|
(28)
|
(28)
|
116
|
16
|
17
|
109
|
(5)
|
(7)
|
122
|
12
|
11
|
Byetta
|
20
|
(24)
|
(24)
|
15
|
(28)
|
(28)
|
15
|
1
|
4
|
19
|
26
|
24
|
Other diabetes
|
13
|
(22)
|
(22)
|
10
|
(21)
|
(19)
|
11
|
9
|
6
|
12
|
11
|
15
|
Lokelma
|
11
|
42
|
42
|
17
|
56
|
58
|
21
|
22
|
26
|
28
|
37
|
28
|
Crestor
|
301
|
2
|
1
|
281
|
(7)
|
(4)
|
300
|
7
|
5
|
298
|
(1)
|
(4)
|
Seloken/Toprol-XL
|
177
|
(6)
|
(6)
|
218
|
23
|
27
|
225
|
4
|
3
|
200
|
(11)
|
(13)
|
Atacand
|
66
|
11
|
12
|
59
|
(11)
|
(5)
|
54
|
(9)
|
(12)
|
63
|
16
|
14
|
Others
|
59
|
(21)
|
(22)
|
48
|
(18)
|
(16)
|
39
|
(19)
|
(22)
|
46
|
18
|
17
|
BioPharmaceuticals: Respiratory & Immunology
|
1,551
|
1
|
1
|
1,117
|
(28)
|
(26)
|
1,161
|
4
|
1
|
1,528
|
32
|
29
|
Symbicort
|
790
|
11
|
11
|
653
|
(17)
|
(15)
|
599
|
(8)
|
(11)
|
680
|
13
|
13
|
Pulmicort
|
380
|
(8)
|
(9)
|
97
|
(74)
|
(73)
|
151
|
56
|
49
|
368
|
n/m
|
n/m
|
Fasenra
|
199
|
(3)
|
(3)
|
227
|
14
|
15
|
240
|
5
|
4
|
283
|
18
|
17
|
Daliresp
|
53
|
(8)
|
(8)
|
53
|
(1)
|
(3)
|
57
|
8
|
11
|
54
|
(4)
|
(6)
|
Bevespi
|
12
|
9
|
9
|
10
|
(19)
|
(21)
|
14
|
47
|
46
|
12
|
(16)
|
(17)
|
Breztri
|
4
|
n/m
|
n/m
|
7
|
58
|
64
|
10
|
45
|
48
|
6
|
(39)
|
(38)
|
Others
|
113
|
(16)
|
(17)
|
70
|
(38)
|
(36)
|
90
|
27
|
22
|
125
|
39
|
35
|
Other medicines
|
557
|
(15)
|
(15)
|
563
|
1
|
4
|
734
|
30
|
27
|
733
|
-
|
(2)
|
Nexium
|
338
|
(4)
|
(4)
|
377
|
12
|
14
|
401
|
6
|
4
|
377
|
(6)
|
(7)
|
Synagis
|
85
|
35
|
35
|
90
|
6
|
7
|
118
|
31
|
29
|
78
|
(34)
|
(33)
|
FluMist
|
-
|
n/m
|
n/m
|
-
|
n/m
|
n/m
|
116
|
n/m
|
n/m
|
179
|
55
|
50
|
Losec/Prilosec
|
54
|
18
|
17
|
45
|
(15)
|
(15)
|
45
|
-
|
-
|
39
|
(15)
|
(18)
|
Seroquel XR/IR
|
36
|
(12)
|
(12)
|
27
|
(26)
|
(23)
|
35
|
32
|
29
|
19
|
(45)
|
(42)
|
Others
|
44
|
(71)
|
(70)
|
24
|
(46)
|
(42)
|
19
|
(17)
|
(19)
|
41
|
n/m
|
n/m
|
Total Product Sales
|
6,311
|
1
|
1
|
6,048
|
(4)
|
(2)
|
6,520
|
8
|
6
|
7,011
|
8
|
6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Table 55: Collaboration Revenue
|
|
YTD 2021
|
YTD 2020
|
FY 2020
|
FY 2019
|
|
$m
|
$m
|
$m
|
$m
|
Initial Collaboration Revenue
|
|
|
|
|
|
Nexium (Japan)
|
|
75
|
-
|
-
|
-
|
Ongoing Collaboration Revenue
|
|
|
|
|
|
Lynparza: regulatory
milestones
|
|
-
|
135
|
160
|
60
|
Lynparza: sales
milestones
|
|
-
|
-
|
300
|
450
|
Lynparza/Koselugo: option payments
|
|
-
|
-
|
-
|
100
|
Crestor (Spain)
|
|
-
|
-
|
-
|
39
|
Enhertu: share of gross
profits
|
|
134
|
63
|
94
|
-
|
roxadustat: share of gross profits
|
|
4
|
19
|
30
|
-
|
Royalty income
|
|
137
|
47
|
62
|
62
|
Other Ongoing Collaboration Revenue
|
|
13
|
64
|
81
|
108
|
Total
|
|
363
|
328
|
727
|
819
|
|
|
|
|
|
|
|
|
|
|
Table 56: Other Operating Income and Expense
The table below provides an analysis of Reported Other Operating
Income and Expense.
|
|
YTD 2021
|
YTD 2020
|
FY 2020
|
FY 2019
|
|
$m
|
$m
|
$m
|
$m
|
Divestment of Viela Bio, Inc. shareholding
|
|
776
|
-
|
-
|
-
|
Crestor (Europe ex-UK and
Spain)
|
|
309
|
-
|
-
|
-
|
Oxra and Oxramet (India)
|
|
40
|
-
|
-
|
-
|
Hypertension medicines (ex-US, India and Japan)
|
|
-
|
350
|
350
|
-
|
Monetisation of an asset previously licensed
|
|
-
|
120
|
120
|
-
|
brazikumab licence termination funding
|
|
77
|
51
|
107
|
-
|
Inderal, Tenormin, Seloken and Omepral (Japan)
|
|
-
|
51
|
51
|
-
|
Synagis (US)
|
|
-
|
-
|
-
|
515
|
Losec (ex-China, Japan, US
and Mexico)
|
|
-
|
-
|
-
|
243
|
Seroquel and Seroquel XR (US, Canada, Europe and
Russia)
|
|
-
|
-
|
-
|
213
|
Arimidex and Casodex (various countries)
|
|
-
|
-
|
-
|
181
|
Nexium (Europe)
and Vimovo (ex-US)
|
|
-
|
-
|
54
|
-
|
Atacand
|
|
-
|
-
|
400
|
-
|
Other
|
|
143
|
316
|
446
|
389
|
Total
|
|
1,345
|
888
|
1,528
|
1,541
|
Financial calendar and other shareholder information
Trademarks of the AstraZeneca group of companies appear throughout
this document in italics. Medical publications also appear
throughout the document in italics. AstraZeneca, the AstraZeneca
logotype and the AstraZeneca symbol are all trademarks of the
AstraZeneca group of companies. Trademarks of companies other than
AstraZeneca that appear in this document
include Arimidex and Casodex,
owned by AstraZeneca or Juvisé (depending on
geography); Atacand and Atacand
Plus, owned by AstraZeneca or
Cheplapharm (depending on geography); Duaklir and Eklira, trademarks of Almirall,
S.A.; Enhertu, a trademark of Daiichi
Sankyo; Inderal and Tenormin, owned by AstraZeneca, Atnahs Pharma and Taiyo
Pharma Co. Ltd. (depending upon
geography); Losec and Omepral,
owned by AstraZeneca, Cheplapharm or Taiyo Pharma Co., Ltd
(depending on geography); Seloken, owned by AstraZeneca or Taiyo Pharma Co., Ltd
(depending on geography); Synagis, owned by AstraZeneca or AbbVie Inc. (depending
on geography); Vimovo, owned by AstraZeneca or Grünenthal GmbH
(depending on geography).
Information on or accessible through AstraZeneca's websites,
including astrazeneca.com,
does not form part of and is not incorporated into this
announcement.
Addresses for correspondence
|
|
|
|
Registered office
|
Registrar and transfer office
|
Swedish Central Securities Depository
|
US depositary
Deutsche Bank Trust Company Americas
|
1 Francis Crick Avenue
Cambridge Biomedical Campus
Cambridge
CB2 0AA
|
Equiniti Limited
Aspect House
Spencer Road
Lancing
West Sussex
BN99 6DA
|
Euroclear Sweden AB PO Box 191
SE-101 23 Stockholm
|
American Stock Transfer
6201 15th Avenue
Brooklyn
NY 11219
|
United Kingdom
|
United Kingdom
|
Sweden
|
United States
|
|
|
|
|
+44 (0) 20 3749 5000
|
0800 389 1580
|
+46 (0) 8 402 9000
|
+1 (888) 697 8018
|
|
+44 (0) 121 415 7033
|
|
+1 (718) 921 8137
|
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|
|
db@astfinancial.com
|
Cautionary statements regarding forward-looking
statements
In order, among other things, to utilise the 'safe harbour'
provisions of the US Private Securities Litigation Reform Act of
1995, AstraZeneca (hereafter 'the Group') provides the following
cautionary statement:
This document contains certain forward-looking statements with
respect to the operations, performance and financial condition of
the Group, including, among other things, statements about expected
revenues, margins, earnings per share or other financial or other
measures. Although the Group believes its expectations are based on
reasonable assumptions, any forward-looking statements, by their
very nature, involve risks and uncertainties and may be influenced
by factors that could cause actual outcomes and results to be
materially different from those predicted. The forward-looking
statements reflect knowledge and information available at the date
of preparation of this document and the Group undertakes no
obligation to update these forward-looking statements. The Group
identifies the forward-looking statements by using the words
'anticipates', 'believes', 'expects', 'intends' and similar
expressions in such statements. Important factors that could cause
actual results to differ materially from those contained in
forward-looking statements, certain of which are beyond the Group's
control, include, among other things:
-
the risk of failure or delay in delivery of pipeline or launch of
new medicines
-
the risk of failure to meet regulatory or ethical requirements for
medicine development or approval
-
the risk of failure to obtain, defend and enforce effective IP
protection and IP challenges by third parties
-
the impact of competitive pressures including expiry or loss of IP
rights, and generic competition
-
the impact of price controls and reductions
-
the impact of economic, regulatory and political
pressures
-
the risk of failures or delays in the quality or execution of the
Group's commercial strategies
-
the risk of failure to maintain supply of compliant, quality
medicines
-
the risk of illegal trade in the Group's medicines
-
the impact of reliance on third-party goods and
services
-
the risk of failure in information technology, data protection or
cybercrime
-
the risk of failure of critical processes
-
any expected gains from productivity initiatives are
uncertain
-
the risk of failure to attract, develop, engage and retain a
diverse, talented and capable workforce, including following the
completion of the Alexion transaction
-
the risk of failure to adhere to applicable laws, rules and
regulations
-
the risk of the safety and efficacy of marketed medicines being
questioned
-
the risk of adverse outcome of litigation and/or governmental
investigations, including relating to the Alexion
transaction
-
the risk of failure to adhere to increasingly stringent
anti-bribery and anti-corruption legislation
-
the risk of failure to achieve strategic plans or meet targets or
expectations
-
the risk of failure in financial control or the occurrence of
fraud
-
the risk of unexpected deterioration in the Group's financial
position
-
the impact that the COVID-19 global pandemic may have or continue
to have on these risks, on the Group's ability to continue to
mitigate these risks, and on the Group's operations, financial
results or financial condition
- the risk that
AstraZeneca is unable to achieve the synergies and value creation
contemplated by the Alexion transaction, or that AstraZeneca is
unable to promptly and effectively integrate Alexion's
businesses
Nothing in this document, or any related presentation/webcast,
should be construed as a profit forecast.
- End of document -
[18] Chronic kidney
disease.
[19] Systemic lupus
erythematosus.
[20] Paroxysmal nocturnal
haemoglobinuria.
[21] Epidermal growth
factor receptor mutation.
[22] Non-small cell lung
cancer.
[23] Human epidermal
growth factor receptor 2 positive.
[24] Real Time Oncology
Review.
[25] Emergency Use
Authorization.
[26] Metastatic
castration-resistant prostate cancer.
[27] Eosinophilic
gastritis.
[28] Eosinophilic
oesophagitis.
[29] Amyotrophic lateral
sclerosis.
[30] Subcutaneous
injection.
[31] Atypical haemolytic
uraemic syndrome.
[32] Generalised
myasthenia gravis.
[33] Chronic lymphocytic
leukaemia.
[34] Neurofibromatosis
type 1.
[35] Heart failure with
preserved ejection fraction.
[36] Neuromyelitis optica
spectrum disorder.
[37] Respiratory syncytial
virus.
[38] Limited-stage small
cell lung
cancer.
[39] Hyper-eosinophilic
syndrome: a group of rare blood disorders.
[40] Paroxysmal nocturnal
haemoglobinuria with extravascular haemolysis
[41] Transthyretin amyloid
cardiomyopathy.
[39] Over the
counter.
[40] Substitution of
threonine (T) with methionine (M) at position 790 of exon 20
mutation.
[41] Chemoradiation
therapy.
[42] Extensive stage
non-small cell lung cancer.
[43] Homologous
recombination.
[44] Poly ADP ribose
polymerase.
[45] Homologous
recombination repair gene mutation.
[46] A breast cancer gene
mutation.
[47] Neurofibromatosis
type 1.
[48] A targetable gene
alteration found in NSCLC.
[49] Sodium-glucose
co-transporter-2.
[50] Type-2
diabetes.
[51] An enzyme that
destroys the hormone incretin.
[52] Inhaled
corticosteroid.
[53] Long-acting
beta-agonist.
[54] Total doses supplied
to the end of September by AstraZeneca and its sub-licensees,
including SII, amounted to 1.5bn.
[55] In Q3 2021 following
the acquisition of Alexion, a new column has been introduced to
present acquisition-related non-core items, primarily unwind of
fair value uplift on inventories and acquisition
costs.
[56] In previous quarters
a separate column had been included for items pertaining to the
Diabetes Alliance between AstraZeneca and Bristol-Myers Squibb
Company (BMS). From Q3 2021, this column has been removed with
amounts now presented in the Intangible Asset Amortisation &
Impairments and the Other column as applicable.
[57] Core financial
measures are adjusted to exclude certain items. For more
information on the Reported to Core financial adjustments, please
refer to the introduction to the
operating and financial review.
[58] Based on currency
assumptions disclosed in the H1 2021 results
announcement.
[59] Based on average
daily spot rates in FY 2020.
[60] Based on average
daily spot rates from 1 January 2021 to 30 September
2021.
[61] Other currencies
include AUD, BRL, CAD, KRW and RUB.
[62] These priorities were
determined through a materiality assessment conducted in 2018 with
a broad range of external and internal stakeholders, respectively.
Combined, they ensure the maximum possible benefit to patients, the
Company, broader society and the planet. AstraZeneca's
sustainability priorities align with the United Nations Sustainable
Development Goals (SDG), and, in particular, SDG three for 'Good
Health'.
[63] First patient
commenced dosing.
[64] Last patient
commenced dosing.
[65] Overall
survival.
[66] Progression-free
survival.
[67] Hazard
ratio.
[68] Confidence
interval.
[69] Objective Response
Rate.
[70] Concurrent
chemoradiation therapy.
[71] Standard of
Care.
[72] Conducted by the
Canadian Cancer Trials Group.
[73] Bacillus
Calmette-Guerin.
[74] Hepatocellular
carcinoma.
[75] Transarterial
chemoembolisation.
[76] A chemotherapy
regimen comprised of 5-fluorouracil, leucovorin, oxaliplatin and
docetaxel.
[77] A mutation of the
BRCA1 or BRCA2 gene
[78] Unmutated BRCA genes
(wild type)
[79] Antibody drug
conjugate.
[80] Gastroesophageal
junction adenocarcinoma.
[81] Duration of
response.
[82] A chemotherapy
combination comprised of rituximab, clyclophosphamide, doxorubicin
hydrochloride, vincristine and prednisolone.
[83] Papillary renal cell
carcinoma.
[84] Type-1
diabetes.
[85] European Medicines
Agency.
[86] Type-2
diabetes.
[87] Ischaemic strokes are
the most common type of stroke.
[88] A process designed to
facilitate the development and expedite the review of medicines to
treat serious conditions that fill an unmet medical
need.
[89] ST elevation
myocardial infarction
[90] Non-ST elevation
myocardial infarction.
[91] Once every eight
weeks.
[92] Once every four
weeks.
[93] Intravenous.
[94] Once every four
weeks.
[95] Once a
week.
[96] Independent Data
Monitoring Committee.
[97] Atypical haemolytic
uremic syndrome.
[98] Complement-mediated
thrombotic microangiopathy.
[99] Hematopoietic stem
cell transplantation-associated thrombotic
microangiopathy.
[100] Intramuscular.
[101] Conducted by
University of Witwatersrand, South Africa.
[102] Intramuscular
[103] The same weighted
average number of shares was used for the calculation of basic and
diluted loss per share in the quarter as the effect of potentially
dilutive shares outstanding was anti-dilutive
[104] The table provides
an analysis of year-on-year Product Sales, with Actual and CER
growth rates reflecting year-on-year growth. Due to rounding, the
sum of a number of dollar values and percentages may not agree to
totals.
[105] The table provides
an analysis of year-on-year Product Sales, with Actual and CER
growth rates reflecting year-on-year growth. Due to rounding, the
sum of a number of dollar values and percentages may not agree to
totals. *Growth rates on Rare Disease medicines have been
calculated by comparing post-acquisition revenues from 21 July 2021
with the corresponding prior year pre-acquisition Q3 revenues
previously published by Alexion adjusted pro rata to match the
post-acquisition period.
[106] The table provides
an analysis of sequential quarterly Product Sales, with Actual and
CER growth rates reflecting quarter-on-quarter growth. Due to
rounding, the sum of a number of dollar values and percentages may
not agree to totals. † Sequential
growth rates on Rare Disease medicines have been calculated by
comparing post-acquisition revenues from 21 July 2021 with the
prior quarter pre-acquisition Q2 revenues previously published by
Alexion adjusted pro rata to match the post-acquisition
period.
[107] The
table provides an analysis of sequential quarterly Product Sales,
with actual and CER growth rates reflecting quarter-on-quarter
growth. Due to rounding, the sum of a number of dollar values and
percentages may not agree to totals.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
12 November
2021
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|
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