TIDMAZN
RNS Number : 1625S
AstraZeneca PLC
12 November 2021
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, CVRM(1) and R&I(2) 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 FDA(3) 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 CER (4) 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
vaccine(5) 2,219 n/m (6) n/m 1,050 n/m n/m
---------------------------- ------- ------- ------- ------- ------ ------
Total Revenue ex-pandemic
vaccine (7) 23,187 21 17 8,816 34 32
---------------------------- ------- ------- ------- ------- ------ ------
Reported(8) EPS(9) $0.33 (80) (65) $(1.10) n/m n/m
Core(10) 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
NRDL(11) and VBP(12) 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 EPS (13) 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 Profit(14) 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 Expense(15)
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
--------------------------------- ----- -------- -------- ----- -------- --------
Soliris(16) Rare 798 n/m n/m 798 (3) (2)
Ultomiris(16) Disease(16) 297 n/m n/m 297 31 31
Strensiq(16) 159 n/m n/m 159 7 8
--------------------------------- ----- -------- -------- ----- -------- --------
Pandemic
COVID-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 COVAX(17) . 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 Forxiga CKD [18] Approval (EU, JP)
approvals
or other
regulatory
actions
-------------------
roxadustat Anaemia in CKD Complete response letter
from the US FDA
-------------------
Saphnelo SLE [19] Approval (US, JP)
Ultomiris PNH [20] Approval (paediatric)
(EU)
------------------- ------------- -------------------------------- ---------------------------
Regulatory Tagrisso EGFRm [21] NSCLC [22] (adjuvant) Regulatory submission
submissions (JP)
acceptance
and/or submissions
-------------------
Enhertu HER2+ [23] breast cancer RTOR [24] regulatory
(2nd-line) 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 Imfinzi Biliary tract cancer (1st-line) Phase III primary endpoint
III data readouts met
or other (TOPAZ-1)
significant
developments
-------------------
Imfinzi + Liver cancer (1st-line) Phase III primary endpoint
tremelimumab (HIMALAYA) met
-------------------
Lynparza mCRPC [26] (1st-line) (PROpel) Phase III primary endpoint
met
Enhertu HER2+ breast cancer (2nd-line) Phase III primary endpoint
(DESTINY-Breast03) met
Enhertu HER2+ breast cancer (2nd-line) Breakthrough Therapy
(DESTINY-Breast03) 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 Regulatory submission
breast cancer (adjuvant)
-------
Lynparza mCRPC (1st-line) Regulatory submission
-------
Enhertu HER2+ breast cancer Regulatory submission
(2nd-line)
Ultomiris s.c [30] formulation Regulatory submission
in PNH
and aHUS [31]
Ultomiris gMG [32] Regulatory submission
AZD2816 COVID-19 (variants Data readout
of concern)
AZD7442 COVID-19 outpatient EUA regulatory submission
treatment (TACKLE) (US),
AZD7442 COVID-19 pre-exposure EUA regulatory decision
prophylaxis (PROVENT) (US)
CMA regulatory decision
(EU)
Regulatory decision (JP)
------- ------------------------ ------------------------- --------------------------
H1 2022 Imfinzi NSCLC (unresectable, Data readout
Stage III) (PACIFIC-2)
-------
Imfinzi NSCLC (1st-line) Data readout
(PEARL)
-------
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 Data readout, regulatory
(DESTINY-Breast04) 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)
NMOSD [36] Data readout
Ultomiris
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, Regulatory submission
Stage III)
Imfinzi NSCLC (1st-line) Regulatory submission
Imfinzi Cervical cancer Regulatory submission
Imfinzi Locoregional liver Data readout, regulatory
cancer (EMERALD-1) submission
Enhertu HER2+ breast cancer Data readout, regulatory
(3rd-line) (DESTINY-Breast02) submission
Enhertu HER2+ gastric cancer Regulatory decision (EU)
(2nd-line)
Fasenra HES [39] (NATRON) Data readout
Fasenra EoE (MESSINA) Data readout, regulatory
submission
Fasenra Chronic spontaneous Data readout
urticaria (ARROYO)
Fasenra Atopic dermatitis Data readout
(HILLIER)
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 Disease(16) 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
--------------------------------- ---------------------------------
% of Actual CER % % of Actual CER %
$m total % change change $m total % change 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 Disease
(16) 1,311 5 n/m n/m 1,311 13 5 6
---------------------- ------ --- ---- ---- ----- --- ---- ----
- Soliris (16) 798 3 n/m n/m 798 8 (3) (2)
- Ultomiris
(16) 297 1 n/m n/m 297 3 31 31
- Strensiq (16) 159 1 n/m n/m 159 2 7 8
- Andexxa (16) 29 - n/m n/m 29 - (6) (5)
- Kanuma (16) 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
------------------------------- -------------------------------
% of Actual CER % % of Actual CER %
$m total % change change $m total % change 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 Disease(16) 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 Acquisition of Other [56] Core [57] Core
Amortisation & Alexion [55] % change
Impairments
------------------
$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 Acquisition of Other (56) Core (57) Core
Amortisation & Alexion (55) % change
Impairments
------------------
$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 $m
----------------------------------------------------------------- -------------- -------------- --------------
Current assets 12 26 1
Non-current assets - 4 -
Current liabilities (2,347) (1,720) (961)
Non-current liabilities (25,721) (17,161) (17,913)
Amounts due from subsidiaries that are not issuers or guarantors 12,137 7,011 6,484
Amounts due to subsidiaries that are not issuers or guarantors (299) (290) (295)
------------------------------------------------------------------ -------------- -------------- --------------
Foreign exchange
The Company's transactional currency exposures on
working-capital balances, which typically extend for up to three
months, are hedged where practicable using forward foreign-exchange
contracts against the individual companies' reporting currency.
Foreign-exchange gains and losses on forward contracts for
transactional hedging are taken to profit or loss. In addition, the
Company's external dividend payments, paid principally in pounds
sterling and Swedish krona, are fully hedged from announcement to
payment date.
Table 22: Currency sensitivities
The Company provides the following currency-sensitivity
information:
Average Exchange Annual Impact of 5% Strengthening in
Rates versus USD Exchange Rate versus USD ($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 28 Oncology
medicines in Phase III trials or under * Tagrisso - NSCLC
regulatory review
* 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 Placebo or Tagrisso FPCD [63] : Q1 2021 Recruitment ongoing
(neo-adjuvant First data anticipated: 2022+
EGFRm NSCLC)
------------------ ----------------------------------------------------------- ------------------------------- --------------------
ADAURA Placebo or Tagrisso FPCD: Q4 2015 Trial unblinded
(adjuvant EGFRm LPCD ([64]) : Q1 2019 early due to
NSCLC) overwhelming
efficacy
Regulatory approval
(US, EU, CN )
------------------ ----------------------------------------------------------- ------------------------------- --------------------
LAURA Placebo or Tagrisso FPCD: Q4 2018 Recruitment ongoing
(locally advanced, First data anticipated: 2022+
unresectable EGFRm
NSCLC)
------------------ ----------------------------------------------------------- ------------------------------- --------------------
FLAURA2 Tagrisso or Tagrisso + platinum-based chemotherapy doublet FPCD: Q4 2019 Recruitment ongoing
(EGFRm NSCLC, 1s First data anticipated: 2022+
t-line)
------------------ ----------------------------------------------------------- ------------------------------- --------------------
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 SoC [71] chemotherapy +/- FPCD: Q1 2019 Recruitment ongoing
(neo-adjuvant NSCLC) Imfinzi, followed by First data anticipated: 2022+
surgery, followed by placebo
or Imfinzi
--------------------------- ---------------------------- ------------------------------ ---------------------------
ADJUVANT BR.31 [72] Placebo or Imfinzi FPCD: Q1 2015 Recruitment completed
(Stage IB-IIIA resected LPCD: Q1 2020
NSCLC) First data anticipated: 2022+
--------------------------- ---------------------------- ------------------------------ ---------------------------
MERMAID-1 SoC chemotherapy +/- Imfinzi FPCD: Q3 2020 Recruitment ongoing
(Stage II-III First data anticipated: 2022+
resected NSCLC)
--------------------------- ---------------------------- ------------------------------ ---------------------------
MERMAID-2 Placebo or Imfinzi FPCD: Q3 2021 Recruitment ongoing
(Stage II-III First data anticipated: 2022+
NSCLC with minimal residual
disease)
--------------------------- ---------------------------- ------------------------------ ---------------------------
PACIFIC-2 Placebo or FPCD: Q2 2018 Recruitment completed
(Stage III unresectable Imfinzi LPCD: Q3 2019
locally advanced NSCLC First data anticipated:
(concurrent CRT)) H2 2021
--------------------------- ---------------------------- ------------------------------ ---------------------------
ADRIATIC cCRT, followed by placebo or FPCD: Q4 2018 Recruitment completed
(LS-SCLC) Imfinzi or Imfinzi + LPCD: Q3 2021
tremelimumab First data anticipated:
H2 2022
--------------------------- ---------------------------- ------------------------------ ---------------------------
PEARL SoC chemotherapy or Imfinzi FPCD: Q1 2017 Recruitment completed
(Stage IV NSCLC, 1st-line) LPCD: Q1 2019
First data anticipated:
H1 2022
--------------------------- ---------------------------- ------------------------------ ---------------------------
POSEIDON SoC chemotherapy or SoC + FPCD: Q2 2017 PFS primary endpoint met;
(Stage IV NSCLC, 1st-line) Imfinzi or SoC + Imfinzi + LPCD: Q4 2018 OS primary endpoint met for
tremelimumab Imfinzi + tremelimumab
--------------------------- ---------------------------- ------------------------------ ---------------------------
Table 26: Key Imfinzi Phase III trials in tumour types other
than lung cancer
Trial (population) Design Timeline Status
------------------------- ------------------------------------------------ ------------------------ ---------------------
POTOMAC SoC BCG [73] +/- Imfinzi FPCD: Q4 2018 Recruitment completed
(non-muscle invasive LPCD: Q4 2020
bladder cancer) First data anticipated:
2022+
------------------------- ------------------------------------------------ ------------------------ ---------------------
NIAGARA Neo-adjuvant cisplatin and gemcitabine SoC FPCD: Q4 2018 Recruitment completed
(muscle-invasive bladder chemotherapy or SoC + Imfinzi, followed by LPCD: Q3 2021
cancer) adjuvant First data anticipated:
placebo or Imfinzi 2022+
------------------------- ------------------------------------------------ ------------------------ ---------------------
EMERALD-1 TACE [75] followed by placebo or TACE + Imfinzi, FPCD: Q1 2019 Recruitment completed
followed by Imfinzi + bevacizumab or TACE
+ Imfinzi followed by Imfinzi
(locoregional HCC [74] ) LPCD: Q3 2021
First data anticipated:
H2 2022
------------------------- ------------------------------------------------ ------------------------ ---------------------
EMERALD-2 Adjuvant Imfinzi or Imfinzi + bevacizumab FPCD: Q2 2019 Recruitment ongoing
(locoregional HCC at high First data anticipated:
risk of recurrence after 2022+
surgery or radiofrequency
ablation)
------------------------- ------------------------------------------------ ------------------------ ---------------------
CALLA CRT +/- Imfinzi, followed by placebo or Imfinzi FPCD: Q1 2019 Recruitment completed
(locally advanced LPCD: Q4 2020
cervical cancer) First data anticipated:
H1 2022
------------------------- ------------------------------------------------ ------------------------ ---------------------
MATTERHORN Neoadjuvant Imfinzi + FLOT [76] chemotherapy +/- FPCD: Q4 2020 Recruitment ongoing
(resectable gastric and adjuvant Imfinzi First data anticipated:
gastroesophageal cancer) 2022+
------------------------- ------------------------------------------------ ------------------------ ---------------------
KUNLUN Definitive CRT or CRT +/- Imfinzi FPCD: Q4 2020 Recruitment ongoing
(locally advanced, First data anticipated:
unresectable oesophageal 2022+
squamous cell carcinoma)
------------------------- ------------------------------------------------ ------------------------ ---------------------
NILE SoC chemotherapy or FPCD: Q4 2018 Recruitment completed
(Stage IV cisplatin SoC + Imfinzi or LPCD: Q2 2021
chemotherapy- eligible SoC + Imfinzi + tremelimumab First data anticipated:
bladder cancer, 1st-line) 2022+
------------------------- ------------------------------------------------ ------------------------ ---------------------
VOLGA SoC cystectomy or Imfinzi + tremelimumab + FPCD: Q4 2021 Recruitment ongoing
(Muscle invasive bladder enfortumab vedotin or Imfinzi + enfortumab First data anticipated:
cancer ineligible to vedotin 2022+
cisplatin)
------------------------- ------------------------------------------------ ------------------------ ---------------------
HIMALAYA Sorafenib or Imfinzi or Imfinzi + tremelimumab FPCD: Q4 2017 Primary endpoint met
(Stage IV unresectable LPCD: Q4 2019 Orphan Drug
HCC, 1(st) -line) Designation (US)
------------------------- ------------------------------------------------ ------------------------ ---------------------
TOPAZ-1 Gemcitabine and cisplatin SoC chemotherapy or FPCD: Q2 2019 Primary endpoint met
(Stage IV biliary-tract SoC + Imfinzi LPCD: Q4 2020 Orphan Drug
cancer, 1(st) -line) 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 Placebo or Lynparza FPCD: Q2 2014 Primary endpoint met
(a djuvant BRCAm [77] breast LPCD: Q2 2019
cancer)
------------------------------- ------------------------------- ------------------------------ --------------------
MONO-OLA1 Placebo or Lynparza FPCD: Q3 2021 Recruitment ongoing
(BRCAwt [78] advanced ovarian First data anticipated: 2022+
cancer 1L maintenance)
------------------------------- ------------------------------- ------------------------------ --------------------
DuO-O Chemotherapy + bevacizumab or FPCD : Q1 2019 Recruitment ongoing
(advanced ovarian cancer, chemotherapy + bevacizumab + First data anticipated: 2022+
1st-line) Imfinzi +/- Lynparza
maintenance
------------------------------- ------------------------------- ------------------------------ --------------------
DuO-E Chemotherapy or chemotherapy + FPCD : Q2 2020 Recruitment ongoing
(advanced endometrial cancer, Imfinzi + Imfinzi maintenance First data anticipated: 2022+
1st-line) or chemotherapy + Imfinzi
followed
by Imfinzi + Lynparza
maintenance
------------------------------- ------------------------------- ------------------------------ --------------------
PROpel Abiraterone or FPCD: Q4 2018 Primary endpoint met
( Stage IV, abiraterone + Lynparza
castration-resistant prostate
cancer)
------------------------------- ------------------------------- ------------------------------ --------------------
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 SoC chemotherapy or Enhertu FPCD: Q3 2018 Recruitment completed
III LPCD: Q4 2020
(Stage IV, HER2+ breast First data anticipated: H2
cancer post trastuzumab 2022
emtansine)
---------------------------- ---------------------------- ---------------------------- ----------------------------
DESTINY-Breast03-U302, Phase Trastuzumab emtansine or FPCD: Q3 2018 Primary endpoint met
III Enhertu LPCD: Q2 2020 Breakthrough Therapy
(Stage IV, HER2+ breast Designation (US)
cancer, 2nd-line)
---------------------------- ---------------------------- ---------------------------- ----------------------------
DESTINY-Breast04, Phase III SoC chemotherapy or Enhertu FPCD: Q4 2018 Recruitment completed
(Stage IV, HER2-low breast LPCD: Q4 2020
cancer, 2nd--line) First data anticipated: H1
2022
---------------------------- ---------------------------- ---------------------------- ----------------------------
DESTINY-Breast05, Phase III Trastuzumab emtansine or FPCD Q4 2020 Recruitment ongoing
(high-risk HER2+ breast Enhertu First data anticipated:
cancer, post-neoadjuvant) 2022+
---------------------------- ---------------------------- ---------------------------- ----------------------------
DESTINY-Breast06, Phase III SoC chemotherapy or Enhertu FPCD: Q3 2020 Recruitment ongoing
(Stage IV, HER2-low breast First data anticipated:
cancer, post endocrine 2022+
therapy)
---------------------------- ---------------------------- ---------------------------- ----------------------------
DESTINY-Breast09, Phase III SoC chemotherapy + FPCD: Q2 2021 Recruitment ongoing
(Stage IV, HER2+ breast trastuzumab + pertuzumab or First data anticipated:
cancer, 1st-line) Enhertu + pertuzumab or 2022+
Enhertu
---------------------------- ---------------------------- ---------------------------- ----------------------------
DESTINY-Gastric01, Phase II SoC chemotherapy or Enhertu FPCD: Q4 2017 Primary endpoint met
(Stage IV, HER2+ gastric LPCD: Q2 2019 Breakthrough Therapy
cancer) Designation (US)
Regulatory approval (US, JP)
---------------------------- ---------------------------- ---------------------------- ----------------------------
DESTINY-Gastric02, Phase II Enhertu FPCD: Q4 2019 Positive data readout
(Stage IV, HER2+ gastric LPCD: Q4 2020 Recruitment completed
cancer)
---------------------------- ---------------------------- ---------------------------- ----------------------------
DESTINY-Gastric04, Phase III Paclitaxel + ramucirumab or FPCD: Q2 2021 Recruitment ongoing
(Stage IV, HER2+ gastric Enhertu First data anticipated:
cancer, 2nd-line) 2022+
---------------------------- ---------------------------- ---------------------------- ----------------------------
DESTINY-Lung04, SoC platinum chemotherapy, Initiating Initiating
Phase III pemetrexed and pembrolizumab First data anticipated:
(Stage III, HER2 mutated or Enhertu 2022+
NSCLC, 1st-line)
---------------------------- ---------------------------- ---------------------------- ----------------------------
Calquence
Table 29: Key Calquence Phase III trials
Trial (population) Design Timeline Status
-------------------------------- ----------------------------- ------------------------ -------------------
ESCALADE SoC R-CHOP [82] +/- Calquence FPCD: Q2 2020 Recruitment ongoing
(Diffuse large B-cell lymphoma) Data anticipated: 2022+
-------------------------------- ----------------------------- ------------------------ -------------------
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 Palbociclib + anastrazole or albociclib + camizestrant FPCD: Q1 2021 Recruitment ongoing
(ER+, HER2-, advanced brea First data anticipated: 2022+
st cancer)
--------------------------- -------------------------------------------------------- ------------------------------ -------------------
SERENA-6 Palbociclib or abemaciclib + camizestrant, or anastrozol FPCD: Q3 2021 Recruitment ongoing
e or letrozole + albociclib or abemaciclib
(HR+, HER2-, metastatic br First data anticipated: 2022+
east cancer)
--------------------------- -------------------------------------------------------- ------------------------------ -------------------
Datopotamab deruxtecan
Table 31: Datopotamab deruxtecan Phase III trials
Trial (population) Design Timeline Status
------------------ ------------------------------------------ ------------------------------- -------------------
TROPION-Lung01 SoC chemotherapy or datopotamab deruxtecan FPCD: Q1 2021 Recruitment ongoing
(Stage IV NSCLC, First data anticipated: 2022+
2nd-line)
------------------ ------------------------------------------ ------------------------------- -------------------
TROPION-Breast01 SoC chemotherapy or datopotamab deruxtecan Initiating Initiating
First data anticipated: 2022+
------------------ ------------------------------------------ ------------------------------- -------------------
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 Aspirin plus placebo or FPCD: Q1 2018 Primary endpoint met
(c.11,000 patients with aspirin plus Brilinta 90mg LPCD: Q4 2019 Regulatory approval (US)
acute ischaemic stroke [87] BID
or
transient ischaemic attack)
---------------------------- ---------------------------- ---------------------------- ----------------------------
Farxiga
----------------------------------------------------------------------------------------------------------------------
DELIVER Placebo or Farxiga 10mg QD FPCD: Q4 2018 Recruitment completed
(c.6,300 patients with HF LPCD: Q4 2020 Fast Track [88] designation
(HFpEF) with and without First data anticipated: H1 (US)
T2D) 2022
---------------------------- ---------------------------- ---------------------------- ----------------------------
DAPA-MI Placebo or Farxiga 10mg QD FPCD: Q4 2020 Recruitment ongoing
( c.6,400 patients with First data anticipated:
confirmed MI, either STEMI 2022+
[89] or NSTEMI [90] , within
the preceding
seven days)
---------------------------- ---------------------------- ---------------------------- ----------------------------
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 Placebo or Lokelma 10mg QD for FPCD: Q3 2021 Recruitment ongoing
(c.2,300 patients with recurrent 4 weeks on non-dialysis days, First data anticipated: 2022+
hyperkalaemia on chronic thereafter adjusted monthly
haemodialysis)
-------------------------------- ------------------------------- ------------------------------ -------------------
STABILIZE-CKD Placebo or Lokelma 5g QOD to FPCD: Q4 2021 Recruitment ongoing
( c. 1,360 patients w ith CKD 15g QD plus lisonopril or First data anticipated: 2022+
and hyperkalaemia or at risk of valsartan
hyperkalaemia )
-------------------------------- ------------------------------- ------------------------------ -------------------
BioPharmaceuticals - Respiratory & Immunology
Breztri
Table 34: Key Breztri Phase III trials
Trial (population) Design Timeline Status
------------------ --------------------- ------------------------ -------------------
KALOS Budesonide/formoterol FPCD: Q1 2021 Recruitment ongoing
(asthma) or Breztri First data anticipated:
2022+
------------------ --------------------- ------------------------ -------------------
LOGOS Budesonide/formoterol FPCD: Q1 2021 Recruitment ongoing
(asthma) or Breztri First data anticipated:
2022+
------------------ --------------------- ------------------------ -------------------
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 Placebo or Fasenra FPCD: Q1 2018 Co-primary endpoints
(severe bilateral 30mg Q8W [91] LPCD: Q2 2019 met
nasal polyps) s.c.
--------------------------- -------------------- ------------------------ ------------------------
RESOLUTE Placebo or Fasenra FPCD: Q4 2019 Recruitment ongoing
(moderate to very 100mg Q8W s.c. First data anticipated:
severe COPD with 2022+
a history of exacerbations
and elevated peripheral
blood eosinophils)
--------------------------- -------------------- ------------------------ ------------------------
MANDARA Mepolizumab 3x100mg FPCD: Q4 2019 Recruitment ongoing
(eosinophilic Q4W [92] or Fasenra First data anticipated: Orphan Drug Designation
granulomatosis 30mg s.c. 2022+ (US)
with polyangiitis)
--------------------------- -------------------- ------------------------ ------------------------
NATRON Placebo or Fasenra FPCD: Q3 2020 Recruitment ongoing
(HES) 30mg Q4W s.c. First data anticipated: Orphan Drug Designation
H2 2022 (US)
--------------------------- -------------------- ------------------------ ------------------------
MESSINA Placebo or Fasenra FPCD: Q4 2020 Recruitment ongoing
(EoE) 30mg Q4W s.c. First data anticipated: Orphan Drug Designation
H2 2022 (US)
--------------------------- -------------------- ------------------------ ------------------------
FJORD Placebo or Fasenra FPCD: Q2 2021 Recruitment ongoing
(bullous pemphigoid) 30mg Q4W s.c. First data anticipated:
2022+
--------------------------- -------------------- ------------------------ ------------------------
MAHALE Placebo or Fasenra FPCD: Q3 2021 Recruitment ongoing
(non-cystic fibrosis 30mg Q4W s.c. First data anticipated:
bronchiectasis) 2022+
--------------------------- -------------------- ------------------------ ------------------------
HUDSON (EG/EGE) Placebo or Fasenra First data anticipated: Initiating
30mg Q4W s.c. 2022+
--------------------------- -------------------- ------------------------ ------------------------
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 Placebo or tezepelumab FPCD: Q1 2018 Primary endpoint met
(asthma) 210mg Q4W s.c. LPCD: Q3 2019 Breakthrough Therapy
Designation (US)
------------------------ ---------------------- ------------------------ ---------------------
WAYPOINT Placebo or tezepelumab FPCD: Q2 2021 Recruitment ongoing
(chronic rhinosinusitis 210mg Q4W s.c. First data anticipated:
with nasal polyps) 2022+
------------------------ ---------------------- ------------------------ ---------------------
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 Placebo or PT027 FPCD: Q1 2020 Primary endpoint
(asthma with 160/180mcg, single LPCD: Q3 2020 met
exercise-induced dose
broncho constriction)
---------------------- --------------------- -------------- ----------------------
MANDALA Albuterol or PT027 FPCD: Q4 2018 Primary endpoint
(asthma) 80/180mcg or PT027 LPCD: Q1 2021 met
160/180mcg (all
'as needed')
---------------------- --------------------- -------------- ----------------------
DENALI Placebo or albuterol FPCD: Q2 2019 Dual primary endpoints
(asthma) 180mcg or budesonide LPCD: Q2 2021 met
160mcg or PT027
80/180mcg or PT027
160/180mcg QID
---------------------- --------------------- -------------- ----------------------
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 Placebo or Saphnelo FPCD: Q4 2015 Primary endpoint
not met
(moderate to severely 150mg or 300mg LPCD: Q4 2017 Regulatory approval
active SLE) i.v. [93] (US)
Q4W [94]
---------------------- ------------------- ----------------------- --------------------
TULIP 2 Placebo or Saphnelo FPCD: Q4 2015 Primary endpoint
300mg i.v. Q4W met
(moderate to severely LPCD: Q4 2017 Regulatory approval
active SLE) (US)
---------------------- ------------------- ----------------------- --------------------
TULIP-SC (moderate Placebo or Saphnelo First data anticipated: Recruitment ongoing
to severely active 120mg s.c. Q1W 2022+
SLE) [95]
---------------------- ------------------- ----------------------- --------------------
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 FPCD: Q4 2019 Recruitment completed
open-label Ultomiris LPCD: H1 2022
Q8W Data anticipated:
1H 2022
------------------ --------------------------- ------------------ ---------------------
gMG Placebo or Ultomiris FPCD: Q1 2019 Primary endpoint
Q8W LPCD: Q2 2021 met
------------------ --------------------------- ------------------ ---------------------
CM-TMA [98] Placebo or Ultomiris FPCD: Q3 2021 Recruitment ongoing
Q8W Data anticipated:
2022+
------------------ --------------------------- ------------------ ---------------------
HSCT-TMA [99] Placebo or Ultomiris FPCD: Q4 2020 Recruitment ongoing
Adult Q8W Data anticipated:
2022+
------------------ --------------------------- ------------------ ---------------------
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 Placebo or nirsevimab IM [100] FPCD: Q3 2019 Primary endpoint met
(healthy late preterm and term LPCD: Q3 2020 Breakthrough therapy designation
infants) (US, EU, CN)
---------------------------------- ------------------------------ -------------- ----------------------------------
MEDLEY Synagis or nirsevimab IM FPCD: Q3 2019 Safety objective met
(high-risk children) LPCD: Q4 2020
---------------------------------- ------------------------------ -------------- ----------------------------------
COVID-19
COVID-19 vaccines
Trial Design Timeline Status
----------------------------------- ------------------ ------------------------ -----------------------------------
COV002 (UK), Phase II/III MenACWY or AZD1222 FPCD: Q2 2020 Initial data readout
LPCD: Q4 2020 Regulatory authorisation (EU, JP,
UK)
----------------------------------- ------------------ ------------------------ -----------------------------------
COV003 (Brazil), Phase II/III MenACWY or AZD1222 FPCD: Q2 2020 Initial data readout
LPCD: Q4 2020 Regulatory authorisation (EU, JP,
UK)
----------------------------------- ------------------ ------------------------ -----------------------------------
COV005 ChAdOx1 nCoV-19 ZA [101] Placebo or AZD1222 FPCD: Q2 2020 Initial data readout
(South Africa), Phase I/II LPCD: Q4 2020
----------------------------------- ------------------ ------------------------ -----------------------------------
D8110C00001 Placebo or AZD1222 FPCD: Q3 2020 Primary endpoint met
(US, global), Phase III LPCD: Q1 2021
----------------------------------- ------------------ ------------------------ -----------------------------------
D7220C00001 AZD1222 or AZD2816 FPCD: Q2 2021 Recruitment ongoing
(Global), Phase II/III First data anticipated:
Q4 2021
----------------------------------- ------------------ ------------------------ -----------------------------------
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 Placebo FPCD: Q4 2020 Primary endpoint met
(prophylaxis) or AZD7442 300mg i.m. [102] LPCD: Q1 2021
---------------------------- ---------------------------- -------------- ------------------------
STORM CHASER Placebo FPCD: Q4 2020 Primary endpoint not met
(post-exposure prophylaxis) or AZD7442 300mg i.m. LPCD: Q1 2021
---------------------------- ---------------------------- -------------- ------------------------
TACKLE Placebo FPCD: Q1 2021 Primary endpoint met
(outpatient treatment) or AZD7442 600mg i.m. LPCD: Q3 2021
---------------------------- ---------------------------- -------------- ------------------------
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 Dec At 30 Sep 2020
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 Share Other Retained Total attributable Non-controlling Total
capital premium reserves earnings to owners interests equity
account of the
parent
$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
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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.
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END
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