REG - AstraZeneca PLC - AZN: Year to date and Q3 2021 results
12/11/2021 07:05
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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 2,219 n/m n/m 1,050 n/m n/m
COVID-19 vaccine
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 approvals Forxiga CKD 18 (#_ftn1) Approval (EU, JP)
or other
regulatory actions
roxadustat Anaemia in CKD Complete response letter from the US FDA
Saphnelo SLE 19 (#_ftn2) Approval (US, JP)
Ultomiris PNH 20 (#_ftn3) Approval (paediatric) (EU)
Regulatory submissions acceptance and/or submissions Tagrisso EGFRm 21 (#_ftn4) NSCLC 22 (#_ftn5) (adjuvant) Regulatory submission (JP)
Enhertu HER2+ 23 (#_ftn6) breast cancer (2nd-line) RTOR 24 (#_ftn7) regulatory submission (US)
Enhertu HER2+ breast cancer (2nd-line) Regulatory submission (EU)
Enhertu HER2+ gastric cancer (2nd-line) Regulatory submission (EU)
AZD7442 COVID-19 prophylaxis EUA 25 (#_ftn8) regulatory submission (US)
Major Phase III data readouts Imfinzi Biliary tract cancer (1st-line) Phase III primary endpoint met
or other
(TOPAZ-1)
significant developments
Imfinzi + tremelimumab Liver cancer (1st-line) (HIMALAYA) Phase III primary endpoint met
Lynparza mCRPC 26 (#_ftn9) (1st-line) (PROpel) Phase III primary endpoint met
Enhertu HER2+ breast cancer (2nd-line) (DESTINY-Breast03) Phase III primary endpoint met
Enhertu HER2+ breast cancer (2nd-line) (DESTINY-Breast03) Breakthrough Therapy Designation (US)
Fasenra EG 27 (#_ftn10) Orphan Drug Designation (US)
Fasenra EG +/- EGE Fast Track Designation (US)
Fasenra Eosinophilic gastroenteritis Orphan Drug Designation (US)
tezepelumab EoE 28 (#_ftn11) Orphan Drug Designation (US)
PT027 Asthma (MANDALA, DENALI) Phase III primary endpoints met
Ultomiris ALS 29 (#_ftn12) (CHAMPION) Phase III trial stopped for futility
ALXN1840 Wilson disease (FoCus) Phase III primary endpoint met
AZD7442 COVID-19 prophylaxis (PROVENT) Phase III primary endpoint met
AZD7442 COVID-19 treatment (TACKLE) Phase III primary endpoint met
Table 5: Pipeline anticipated major news flow
Timing Medicine Indication / Trial Event
Imfinzi + tremelimumab NSCLC (1st-Line) Regulatory submission
Q4 2021 Lynparza BRCAm HER2-negative breast cancer (adjuvant) Regulatory submission
Lynparza mCRPC (1st-line) Regulatory submission
Enhertu HER2+ breast cancer Regulatory submission
(2nd-line)
Regulatory submission
Ultomiris s.c 30 (#_ftn13) formulation in PNH
and aHUS 31 (#_ftn14)
Ultomiris gMG 32 (#_ftn15) Regulatory submission
AZD2816
COVID-19 (variants of concern) Data readout
AZD7442 COVID-19 outpatient treatment (TACKLE) EUA regulatory submission (US),
AZD7442 COVID-19 pre-exposure prophylaxis (PROVENT) EUA regulatory decision (US)
CMA regulatory decision (EU)
Regulatory decision (JP)
H1 2022 Imfinzi NSCLC (unresectable, Stage III) (PACIFIC-2) Data readout
Imfinzi NSCLC (1st-line) (PEARL) Data readout
Imfinzi Cervical cancer (CALLA) Data readout
Imfinzi Biliary tract cancer Regulatory submission
Imfinzi +/- tremelimumab Liver cancer (1st-line) Regulatory submission
Enhertu HER2-low breast cancer (DESTINY-Breast04) Data readout, regulatory submission
Calquence CLL 33 (#_ftn16) Regulatory submission (JP)
Koselugo NF1 34 (#_ftn17) Regulatory submission (JP, CN)
Forxiga CKD Regulatory decision (CN)
Farxiga HFpEF 35 (#_ftn18) (DELIVER) Data readout, regulatory submission
Brilique Stroke Regulatory decision (EU, CN)
Fasenra Nasal polyps Regulatory decision (US)
Saphnelo SLE Regulatory decision (EU)
tezepelumab Asthma Regulatory decision (US, EU, JP)
PT027 Asthma Regulatory submission (US)
Ultomiris NMOSD 36 (#_ftn19) Data readout
nirsevimab RSV 37 (#_ftn20) Regulatory submission
Vaxzevria COVID-19 Regulatory submission (US)
H2 2022 Tagrisso EGFRm NSCLC (adjuvant) Regulatory decision (JP)
Imfinzi LS-SCLC 38 (#_ftn21) (ADRIATIC) Data readout
Imfinzi NSCLC (unresectable, Stage III) Regulatory submission
Imfinzi NSCLC (1st-line) Regulatory submission
Imfinzi Cervical cancer Regulatory submission
Imfinzi Locoregional liver cancer (EMERALD-1) Data readout, regulatory submission
Enhertu HER2+ breast cancer (3rd-line) (DESTINY-Breast02) Data readout, regulatory submission
Enhertu HER2+ gastric cancer Regulatory decision (EU)
(2nd-line)
Fasenra HES 39 (#_ftn22) (NATRON) Data readout
Fasenra EoE (MESSINA) Data readout, regulatory submission
Fasenra Chronic spontaneous urticaria (ARROYO) Data readout
Fasenra Atopic dermatitis (HILLIER) Data readout
ALXN1840 Wilson disease Regulatory submission
Ultomiris NMOSD Regulatory submission
danicopan (ALXN2040) PNH-EVH 40 (#_ftn23) Data readout
acoramidis (ALXN2060) ATTR-CM 41 (#_ftn24) 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
(https://www.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 (http://www.astrazeneca.com/) and follow the
Company on Twitter @AstraZeneca (http://www.twitter.com/AstraZeneca) .
Contacts
For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.
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
$m % of total Actual % change CER % change $m % of total Actual % change CER % change
Oncology 9,593 38 21 17 3,326 34 18 16
- Tagrisso 3,701 15 17 13 1,247 13 8 7
- Imfinzi 1,778 7 20 17 618 6 16 15
- Lynparza 1,719 7 34 31 588 6 27 25
- Calquence 843 3 n/m n/m 354 4 n/m n/m
- Koselugo 74 - n/m n/m 26 - n/m n/m
- Enhertu 10 - n/m n/m 5 - n/m n/m
- Orpathys 10 - n/m n/m 10 - n/m n/m
- Zoladex 716 3 7 1 250 3 9 5
- Faslodex 329 1 (27) (29) 103 1 (26) (27)
- Iressa 149 1 (26) (31) 41 - (23) (29)
- Casodex 120 - (9) (15) 38 - (13) (18)
- Arimidex 106 - (29) (31) 33 - (20) (20)
- Others 38 - - (2) 13 - 2 1
BioPharmaceuticals: CVRM 6,017 24 15 10 2,082 21 16 13
- Farxiga 2,152 8 57 51 796 8 51 48
- Brilinta 1,124 4 (9) (11) 375 4 (3) (4)
- Bydureon 293 1 (10) (11) 95 1 (13) (13)
- Onglyza 284 1 (22) (25) 84 1 (23) (25)
- Byetta 45 - (10) (10) 13 - (11) (6)
- Other diabetes 43 - 24 20 14 - 24 26
- roxadustat 144 1 n/m n/m 55 1 n/m n/m
- Lokelma 122 - n/m n/m 49 - n/m n/m
- Crestor 837 3 (5) (9) 298 3 (1) (4)
- Seloken/Toprol-XL 749 3 21 14 234 2 4 (2)
- Atacand 76 - (58) (58) 19 - (65) (65)
- Others 148 1 2 (3) 50 1 29 23
BioPharmaceuticals: R&I 4,444 17 16 12 1,483 15 28 25
- Symbicort 2,047 8 - (3) 676 7 13 11
- Fasenra 901 4 35 32 322 3 34 33
- Pulmicort 714 3 14 7 217 2 44 36
- Daliresp 168 1 3 3 54 1 (5) (6)
- Breztri 130 1 n/m n/m 47 - n/m n/m
- Bevespi 39 - 8 7 13 - (9) (10)
- Saphnelo 1 - n/m n/m 1 - n/m n/m
- Others 444 2 62 53 153 2 70 64
Rare 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
$m % of total Actual % change CER % change $m % of total Actual % change CER % change
Enhertu: share of gross profits 134 37 n/m n/m 51 41 95 95
roxadustat: share of gross profits 4 1 (78) (80) 1 1 (83) (84)
Other Collaboration Revenue 225 62 (9) (10) 73 58 n/m n/m
Total 363 100 10 10 125 100 n/m n/m
Other Collaboration Revenue included contributions from Movantik, Zoladex,
Eklira, Duaklir, Forxiga, Nexium OTC 39 (#_ftn25) 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 (#_ftn26) 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 (#_ftn27) . Imfinzi has also been approved to treat
ES-SCLC 42 (#_ftn28) 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 (#_ftn29) ovarian cancer. Lynparza is the leading medicine in the
PARP 44 (#_ftn30) 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 (#_ftn31) 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 (#_ftn32) 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 (#_ftn33) 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
(#_ftn34) 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 (#_ftn35) 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 (#_ftn36) .
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 (#_ftn37) 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 (#_ftn38) / LABA 53
(#_ftn39) 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 (#_ftn40) . 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 Amortisation & Impairments Acquisition of Alexion 55 (#_ftn41) Other 56 (#_ftn42) Core 57 (#_ftn43) Core
% change
$m $m $m $m $m $m Actual CER
Gross Profit 17,594 221 47 1,049 2 18,913 22 19
Gross Profit Margin 68.8% 74.1% -6 -6
Distribution Expense (322) - - - - (322) 11 5
R&D Expense (7,152) 155 1,395 10 1 (5,591) 34 30
SG&A Expense (10,117) 172 1,977 166 66 (7,736) 19 14
Total Operating Expense (17,591) 327 3,372 176 67 (13,649) 24 20
Other Operating Income & Expense 1,345 - 1 - - 1,346 51 50
Operating Profit 1,348 548 3,420 1,225 69 6,610 21 23
Operating Margin 5.3% 26.0% -2 -1
Net Finance Expense (922) - - - 294 (628) 9 10
Taxation 90 (93) (697) (242) (55) (997) (2) (1)
EPS $0.33 $0.33 $1.99 $0.72 $0.22 $3.59 22 23
Table 17: Reconciliation of Reported to Core financial measures - Q3 2021
Q3 2021 Reported Restructuring Intangible Asset Amortisation & Impairments Acquisition of Alexion(55) Other(56) Core(57) Core
% change
$m $m $m $m $m $m Actual CER
Gross Profit 6,109 208 14 1,049 2 7,382 41 39
Gross Profit Margin 61.4% 74.5% -5 -5
Distribution Expense (120) - - - - (120) 21 18
R&D Expense (3,610) 123 1,324 10 1 (2,152) 48 46
SG&A Expense (4,090) 97 1,013 124 (10) (2,866) 32 29
Total Operating Expense (7,820) 220 2,337 134 (9) (5,138) 38 35
Other Operating Income & Expense 37 - - - - 37 (87) (87)
Operating (Loss)/Profit (1,674) 428 2,351 1,183 (7) 2,281 27 28
Operating Margin -17.0% 23.1% -4 -4
Net Finance Expense (320) - - - 101 (219) 5 4
Taxation 350 (69) (468) (242) (14) (443) 29 31
EPS $(1.10) $0.24 $1.26 $0.63 $0.05 $1.08 14 15
Profit and Loss summary
a) Gross Profit
Reported Gross Profit Margin in the year to date declined eleven percentage
points to 68.8%; Core Gross Profit Margin declined six percentage points in
the year to date to 74.1% predominantly reflecting the equitable supply, at no
profit to AstraZeneca, of the pandemic COVID-19 vaccine, together with an
increasing impact from profit-sharing arrangements (primarily Lynparza and
roxadustat) and the impact of the NRDL and VBP programmes in China. These
effects were partially offset by the contribution from Alexion from 21 July
2021, a higher proportion of Oncology sales, and increasing patient access in
China. Reported Gross Profit Margin has also been impacted by the unwind of
the fair value adjustment to Alexion inventories at the date of acquisition.
The fair value uplift is expected to unwind through Reported Cost of Sales
over the 18 months post-acquisition, and in Q3 2021, the impact of the fair
value uplift unwind on Cost of Sales was $1,044m. Variations in gross margin
performance between periods can be expected to continue.
b) Total Operating Expense
Reported Total Operating Expense increased in the year to date by 39% (34% at
CER) to $17,591m. Core Total Operating Expense increased by 24% (20% at CER)
to $13,649m and represented 54% of Total Revenue (YTD 2020: 57%).
Reported R&D Expense increased in the year to date by 67% (63% at CER) to
$7,152m including an impairment charge of $1,172m recognised in the quarter on
an intangible asset related to the acquisition of Ardea Biosciences, Inc. in
2012, following the decision to discontinue the development of verinurad. Core
R&D Expense increased in the year to date by 34% (30% at CER) to $5,591m
with increases in both Reported and Core R&D Expense reflecting the
Company's continued investment in its COVID-19 vaccine and AZD7442, and other
costs related to COVID-19, such as personal protective equipment and colleague
COVID-19 testing across the Company. The increases also reflected the
investment in several late-stage Oncology trials and the advancement of a
number of Phase II clinical development programmes in BioPharmaceuticals,
mainly in CVRM. In the year to date, grant income of $451m has been
recognised, of which $281m has been offset against the US clinical trial costs
for AZD1222 and $170m offset against costs for AZD7442.
Reported SG&A Expense increased in the year to date by 25% (21% at CER) to
$10,117m including the increased amortisation of intangible assets related to
the Alexion acquisition. Core SG&A Expense increased by 19% (14% at CER)
to $7,736m, reflecting the investment in Oncology-medicine launches, the
launch of several new BioPharmaceuticals medicines, particularly in the US,
AstraZeneca's further expansion in Emerging Markets, and the existing
infrastructure base in China.
Restructuring charges primarily comprise supply chain restructuring charges,
exit costs for de-prioritised R&D projects, and severance payments.
c) Other Operating Income and Expense
Reported and Core Other Operating Income and Expense increased in the year to
date by 51% (50% at CER) to $1,345m and $1,346m respectively, and included:
- Income from the divestment of AstraZeneca's 26.7% share of Viela as
part of the acquisition by Horizon Therapeutics plc. AstraZeneca received cash
proceeds and profit of $776m upon closing with the profit being recorded as
other operating income
- $309m of income from an agreement with Grünenthal to divest
commercial rights to Crestor in over 30 countries in Europe, except in the UK
and Spain
d) Net Finance Expense
Reported Net Finance Expense increased in the year to date by 2% (stable at
CER) to $922m, principally reflecting lower interest income on cash and cash
equivalents driven by lower interest rates, financing costs related to the
facilities and debt for the Alexion transaction, partly offset by lower
discount unwind costs on acquisition-related liabilities, including the
Diabetes Alliance. Core Net Finance Expense increased in the year to date by
9% (10% at CER) to $628m and was principally driven by the aforementioned
lower interest income and Alexion-related financing costs.
e) Taxation
The Reported Tax Rate for the year to date was -24% (YTD 2020: 22%), and the
Core Tax Rate was 17% (YTD 2020: 21%). These tax rates benefitted from the
following one-off favourable impacts which arose in prior quarters:
- A non-taxable gain on the divestment of the investment in Viela Bio,
Inc. (Viela); and
- A reduction of tax liabilities arising from updates to estimates of
prior period tax liabilities following settlements with tax authorities
partially offset by a tax charge on recalculation of UK deferred tax balances
following substantive enactment of the UK Corporation Tax rate increase
Excluding these net benefits, the Core Tax Rate would have been approximately
21%. The Reported tax rate for the year to date has been impacted by the above
and the level of Reported Profit Before Tax.
The net cash tax paid in the year to date was $1,198m (YTD 2020: $1,221m).
f) EPS
Reported EPS in the year to date declined 80% (65% at CER) to $0.33. Core EPS
increased by 22% (23% at CER) to $3.59. Reported and Core EPS were adversely
affected by $0.03 due to the pandemic COVID-19 vaccine.
Table 18: Cash Flow Summary
YTD 2021 YTD 2020 Change
$m $m $m
Reported Operating Profit 1,348 3,675 (2,327)
Depreciation, Amortisation and Impairment 4,338 2,352 1,986
Decrease/(increase) in Working Capital and Short-term Provisions 2,063 (255) 2,318
Gains on Disposal of Intangible Assets (371) (535) 164
Gains on Disposal of Investments in Associates and Joint Ventures (776) - (776)
Non-Cash and Other Movements (337) (498) 161
Interest Paid (522) (517) (5)
Taxation Paid (1,198) (1,221) 23
Net Cash Inflow from Operating Activities 4,545 3,001 1,544
Net Cash (Outflow)/Inflow before Financing Activities (5,600) 2,578 (8,178)
Net Cash Inflow from Financing Activities 4,700 7 4,693
The increase in Net Cash Inflow from Operating Activities of $1,544m was
primarily driven by the decrease in working capital, of which $497m related to
the movement in pandemic COVID-19 vaccine working capital balances within
trade and other payables, trade and other receivables and inventories in the
year to date, with the key movement being a $298m increase in vaccine contract
liabilities to $1,914m as at 30 September 2021.
The decrease in Net Cash (Outflow)/Inflow before Financing activities of
$8,178m is principally due to the Alexion acquisition, specifically the
upfront payment of $13,349m, less cash and cash equivalents acquired of
$4,086m, and $203m of payments upon vesting of employee share awards. This
decrease is partially offset by the aforementioned improvement in Net Cash
Inflow from Operating Activities.
Capital Expenditure
Capital Expenditure amounted to $768m in the year to date (YTD 2020: $598m).
This included investment in the new AstraZeneca R&D centre on the
Biomedical Campus in Cambridge, UK, to which a number of colleagues have begun
relocation.
The Company anticipates an increase in Capital Expenditure, partly driven by
an expansion in its capacity for growth across several limited-sized projects.
Table 19: Net Debt summary
At 30 Sep 2021 At 31 Dec 2020 At 30 Sep 2020
$m $m $m
Cash and cash equivalents 7,067 7,832 8,072
Other investments 82 160 374
Cash and investments 7,149 7,992 8,446
Overdrafts and short-term borrowings (605) (658) (1,216)
Lease liabilities (962) (681) (666)
Current instalments of loans (2,139) (1,536) (2,186)
Non-current instalments of loans (28,206) (17,505) (18,271)
Interest-bearing loans and borrowings (31,912) (20,380) (22,339)
(Gross Debt)
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 $m
Current assets 12 26 1
Non-current assets - 4 -
Current liabilities (2,347) (1,720) (961)
Non-current liabilities (25,721) (17,161) (17,913)
Amounts due from subsidiaries that are not issuers or guarantors 12,137 7,011 6,484
Amounts due to subsidiaries that are not issuers or guarantors (299) (290) (295)
Foreign exchange
The Company's transactional currency exposures on working-capital balances,
which typically extend for up to three months, are hedged where practicable
using forward foreign-exchange contracts against the individual companies'
reporting currency. Foreign-exchange gains and losses on forward contracts for
transactional hedging are taken to profit or loss. In addition, the Company's
external dividend payments, paid principally in pounds sterling and Swedish
krona, are fully hedged from announcement to payment date.
Table 22: Currency sensitivities
The Company provides the following currency-sensitivity information:
Average Exchange Annual Impact of 5% Strengthening in Exchange Rate versus USD ($m)(( 58
(#_ftn44) ))
Rates versus USD
Currency Primary Relevance FY 2020 59 (#_ftn45) YTD 2021(( 60 (#_ftn46) )) % 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 (#_ftn47) )) 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 (#_ftn48) ,
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
(https://www3.weforum.org/docs/WEF_PHSSR_Interim_Report_of_the_Pilot_Phase.pdf)
. 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
(https://www.astrazeneca.com/media-centre/articles/2020/ambition-zero-carbon-22012020.html)
.
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
(https://www.astrazeneca.com/content/dam/az/Sustainability/2021/pdf/Materiality_assessment_results.pdf)
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
(https://www.astrazeneca.com/content/dam/az/Sustainability/2021/pdf/Sustainability_Report_2020.pdf)
and Sustainability Data Summary 2020
(https://www.astrazeneca.com/content/dam/az/Sustainability/2021/pdf/Sustainability_Data_Summary_2020.pdf)
. Additional information is available within AstraZeneca's analyst interactive
reporting centre or alternatively at astrazeneca.com/sustainability
(https://www.astrazeneca.com/sustainability.html) .
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
(https://www.astrazeneca.com/investor-relations.html) .html. Highlights of the
Company's late-stage pipeline development since the prior results announcement
are discussed below.
Table 23: Late-stage pipeline
New molecular entities and major lifecycle events for medicines in Phase III 28
trials or under regulatory review Oncology
- Tagrisso - NSCLC
- Imfinzi - multiple cancers
- Lynparza - multiple cancers
- Enhertu - multiple cancers
- Calquence - blood cancers
- Orpathys - NSCLC
- tremelimumab - multiple cancers
- capivasertib - breast, prostate cancer
- monalizumab - head & neck cancer
- camizestrant - breast cancer
- datopotamab deruxtecan - lung cancer
CVRM
- Farxiga - multiple indications
- roxadustat - anaemia in MDS
- Lokelma - hyperkalaemia in CKD
Respiratory & Immunology
- Fasenra - multiple indications
- Breztri - asthma
- tezepelumab - multiple indications
- PT027 - asthma
- Saphnelo (anifrolumab) - SLE
- brazikumab - inflammatory bowel disease
Rare Disease
- Ultomiris - multiple indications
- ALXN1840 - Wilson disease
- CAEL-101 - AL amyloidosis
- acoramidis (ALXN2060) - ATTR-CM
- danicopan (ALXN2040) - PNH with EVH
Other
- nirsevimab - RSV
COVID-19
- Vaxzevria
- AZD7442
Total projects 159
in clinical development
Total projects 175
in total pipeline
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 (#_ftn49) : Q1 2021 Recruitment ongoing
(neo-adjuvant EGFRm NSCLC) First data anticipated: 2022+
ADAURA Placebo or Tagrisso FPCD: Q4 2015 Trial unblinded early due to overwhelming efficacy
(adjuvant EGFRm NSCLC) LPCD(( 64 (#_ftn50) )): Q1 2019 Regulatory approval
(US, EU, CN)
LAURA Placebo or Tagrisso FPCD: Q4 2018 Recruitment ongoing
(locally advanced, unresectable EGFRm NSCLC) First data anticipated: 2022+
FLAURA2 Tagrisso or Tagrisso + platinum-based chemotherapy doublet FPCD: Q4 2019 Recruitment ongoing
(EGFRm NSCLC, 1st-line) First data anticipated: 2022+
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 (#_ftn51) and PFS 66 (#_ftn52) 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 (#_ftn53) 0.77; 95% CI 68 (#_ftn54) 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
(#_ftn55) compared to Imfinzi alone in patients with unresectable, Stage III
NSCLC who had not progressed after cCRT 70 (#_ftn56) . 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 (#_ftn57) chemotherapy +/- Imfinzi, followed by surgery, followed by FPCD: Q1 2019 Recruitment ongoing
placebo or Imfinzi
(neo-adjuvant NSCLC) First data anticipated: 2022+
ADJUVANT BR.31 72 (#_ftn58) Placebo or Imfinzi FPCD: Q1 2015 Recruitment completed
(Stage IB-IIIA resected NSCLC) LPCD: Q1 2020
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 locally advanced NSCLC Imfinzi LPCD: Q3 2019
(concurrent CRT)) First data anticipated:
H2 2021
ADRIATIC cCRT, followed by placebo or Imfinzi or Imfinzi + tremelimumab FPCD: Q4 2018 Recruitment completed
(LS-SCLC) LPCD: Q3 2021
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 + Imfinzi or SoC + Imfinzi + tremelimumab FPCD: Q2 2017 PFS primary endpoint met; OS primary endpoint met for Imfinzi + tremelimumab
(Stage IV NSCLC, 1st-line) LPCD: Q4 2018
Table 26: Key Imfinzi Phase III trials in tumour types other than lung cancer
Trial (population) Design Timeline Status
POTOMAC SoC BCG 73 (#_ftn59) +/- Imfinzi FPCD: Q4 2018 Recruitment completed
(non-muscle invasive bladder cancer) LPCD: Q4 2020
First data anticipated: 2022+
NIAGARA Neo-adjuvant cisplatin and gemcitabine SoC chemotherapy or SoC + Imfinzi, FPCD: Q4 2018 Recruitment completed
followed by adjuvant placebo or Imfinzi
LPCD: Q3 2021
(muscle-invasive bladder cancer)
First data anticipated: 2022+
EMERALD-1 TACE 75 (#_ftn61) followed by placebo or TACE + Imfinzi, followed by Imfinzi FPCD: Q1 2019 Recruitment completed
+ bevacizumab or TACE + Imfinzi followed by Imfinzi
LPCD: Q3 2021
(locoregional HCC 74 (#_ftn60) )
First data anticipated:
H2 2022
EMERALD-2 Adjuvant Imfinzi or Imfinzi + bevacizumab FPCD: Q2 2019 Recruitment ongoing
(locoregional HCC at high risk of recurrence after surgery or radiofrequency First data anticipated: 2022+
ablation)
CALLA CRT +/- Imfinzi, followed by placebo or Imfinzi FPCD: Q1 2019 Recruitment completed
(locally advanced cervical cancer) LPCD: Q4 2020
First data anticipated:
H1 2022
MATTERHORN Neoadjuvant Imfinzi + FLOT 76 (#_ftn62) chemotherapy +/- adjuvant Imfinzi FPCD: Q4 2020 Recruitment ongoing
(resectable gastric and gastroesophageal cancer) First data anticipated: 2022+
KUNLUN Definitive CRT or CRT +/- Imfinzi FPCD: Q4 2020 Recruitment ongoing
(locally advanced, unresectable oesophageal squamous cell carcinoma) First data anticipated: 2022+
NILE SoC chemotherapy or FPCD: Q4 2018 Recruitment completed
(Stage IV cisplatin chemotherapy- eligible bladder cancer, 1st-line)
SoC + Imfinzi or
LPCD: Q2 2021
SoC + Imfinzi + tremelimumab
First data anticipated: 2022+
VOLGA SoC cystectomy or Imfinzi + tremelimumab + enfortumab vedotin or Imfinzi + FPCD: Q4 2021 Recruitment ongoing
enfortumab vedotin
(Muscle invasive bladder cancer ineligible to cisplatin) First data anticipated: 2022+
HIMALAYA Sorafenib or Imfinzi or Imfinzi + tremelimumab FPCD: Q4 2017 Primary endpoint met
(Stage IV unresectable HCC, 1(st)-line) LPCD: Q4 2019 Orphan Drug Designation (US)
TOPAZ-1 Gemcitabine and cisplatin SoC chemotherapy or SoC + Imfinzi FPCD: Q2 2019 Primary endpoint met
Orphan Drug Designation (US)
(Stage IV biliary-tract cancer, 1(st)-line) LPCD: Q4 2020
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
(adjuvant BRCAm 77 (#_ftn63) breast cancer) LPCD: Q2 2019
MONO-OLA1 Placebo or Lynparza FPCD: Q3 2021 Recruitment ongoing
(BRCAwt 78 (#_ftn64) advanced ovarian cancer 1L maintenance) First data anticipated: 2022+
DuO-O Chemotherapy + bevacizumab or chemotherapy + bevacizumab + Imfinzi +/- FPCD: Q1 2019 Recruitment ongoing
Lynparza maintenance
(advanced ovarian cancer, 1st-line) First data anticipated: 2022+
DuO-E Chemotherapy or chemotherapy + Imfinzi + Imfinzi maintenance or chemotherapy + FPCD: Q2 2020 Recruitment ongoing
Imfinzi followed by Imfinzi + Lynparza maintenance
(advanced endometrial cancer, 1st-line) First data anticipated: 2022+
PROpel Abiraterone or FPCD: Q4 2018 Primary endpoint met
abiraterone + Lynparza
(Stage IV, 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
(#_ftn65) 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
(https://www.annalsofoncology.org/article/S0923-7534(21)04498-7/fulltext)
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 (#_ftn66) 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 (#_ftn67) of Enhertu was 8.1 months (95% CI 4.1-NE). The median
progression-free survival (PFS) was 5.5 months (95% CI 4.2‑7.3). An
exploratory endpoint of confirmed disease control rate of 81% (95% CI;
70.6-89.0) was seen.
Results from the Phase II DESTINY-Lung01 trial presented during a
late-breaking Proffered Paper session showed a robust and durable tumour
response in previously treated patients with HER2-mutant (HER2m) unresectable
and/or metastatic non-squamous non-small cell lung cancer.
Primary results from the HER2m cohort (cohort 2) of DESTINY-Lung01 in
previously treated HER2m NSCLC demonstrated a confirmed ORR of 54.9% in
patients treated with Enhertu (6.4 mg/kg) as assessed by independent central
review. One (1.1%) complete response and 49 (53.8%) partial responses were
observed. A confirmed disease control rate of 92.3% was seen with a reduction
in tumour size observed in most patients. After a median follow-up of 13.1
months, the median DoR for Enhertu was 9.3 months. The median PFS was 8.2
months and the median OS was 17.8 months.
Table 28: Key Enhertu trials
Trial (population) Design Timeline Status
DESTINY-Breast02-U301, Phase III SoC chemotherapy or Enhertu FPCD: Q3 2018 Recruitment completed
(Stage IV, HER2+ breast cancer post trastuzumab emtansine) LPCD: Q4 2020
First data anticipated: H2 2022
DESTINY-Breast03-U302, Phase III Trastuzumab emtansine or Enhertu FPCD: Q3 2018 Primary endpoint met
(Stage IV, HER2+ breast cancer, 2nd-line) LPCD: Q2 2020 Breakthrough Therapy Designation (US)
DESTINY-Breast04, Phase III SoC chemotherapy or Enhertu FPCD: Q4 2018 Recruitment completed
(Stage IV, HER2-low breast cancer, 2nd‑line) LPCD: Q4 2020
First data anticipated: H1 2022
DESTINY-Breast05, Phase III Trastuzumab emtansine or Enhertu FPCD Q4 2020 Recruitment ongoing
First data anticipated: 2022+
(high-risk HER2+ breast cancer, post-neoadjuvant)
DESTINY-Breast06, Phase III SoC chemotherapy or Enhertu FPCD: Q3 2020 Recruitment ongoing
(Stage IV, HER2-low breast cancer, post endocrine therapy) First data anticipated: 2022+
DESTINY-Breast09, Phase III SoC chemotherapy + trastuzumab + pertuzumab or Enhertu + pertuzumab or Enhertu FPCD: Q2 2021 Recruitment ongoing
First data anticipated: 2022+
(Stage IV, HER2+ breast cancer, 1st-line)
DESTINY-Gastric01, Phase II SoC chemotherapy or Enhertu FPCD: Q4 2017 Primary endpoint met
(Stage IV, HER2+ gastric cancer) LPCD: Q2 2019 Breakthrough Therapy Designation (US)
Regulatory approval (US, JP)
DESTINY-Gastric02, Phase II Enhertu FPCD: Q4 2019 Positive data readout
LPCD: Q4 2020
Recruitment completed
(Stage IV, HER2+ gastric cancer)
DESTINY-Gastric04, Phase III Paclitaxel + ramucirumab or Enhertu FPCD: Q2 2021 Recruitment ongoing
First data anticipated: 2022+
(Stage IV, HER2+ gastric cancer, 2nd-line)
DESTINY-Lung04, SoC platinum chemotherapy, pemetrexed and pembrolizumab or Enhertu Initiating Initiating
Phase III
First data anticipated: 2022+
(Stage III, HER2 mutated NSCLC, 1st-line)
Calquence
Table 29: Key Calquence Phase III trials
Trial (population) Design Timeline Status
ESCALADE SoC R-CHOP 82 (#_ftn68) +/- 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 (#_ftn69) .
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 breast cancer) First data anticipated: 2022+
SERENA-6 Palbociclib or abemaciclib + camizestrant, or anastrozole or letrozole + FPCD: Q3 2021 Recruitment ongoing
albociclib or abemaciclib
(HR+, HER2-, metastatic breast cancer) First data anticipated: 2022+
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
First data anticipated: 2022+
(Stage IV NSCLC,
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
(#_ftn70) . 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
(#_ftn71) regarding product information changes needed post-approval for
Forxiga 5mg specific to T1D, which might cause confusion among physicians
treating patients with T2D 86 (#_ftn72) , HFrEF or CKD.
Table 32: Key CVRM Phase III trials
Trial (population) Design Timeline Status
Brilinta
THALES Aspirin plus placebo or aspirin plus Brilinta 90mg BID FPCD: Q1 2018 Primary endpoint met
(c.11,000 patients with acute ischaemic stroke 87 (#_ftn73) or LPCD: Q4 2019 Regulatory approval (US)
transient ischaemic attack)
Farxiga
DELIVER Placebo or Farxiga 10mg QD FPCD: Q4 2018 Recruitment completed
(c.6,300 patients with HF (HFpEF) with and without T2D) LPCD: Q4 2020 Fast Track 88 (#_ftn74) designation (US)
First data anticipated: H1 2022
DAPA-MI Placebo or Farxiga 10mg QD FPCD: Q4 2020 Recruitment ongoing
(c.6,400 patients with confirmed MI, either STEMI 89 (#_ftn75) or NSTEMI 90 First data anticipated: 2022+
(#_ftn76) , 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 4 weeks on non-dialysis days, thereafter FPCD: Q3 2021 Recruitment ongoing
adjusted monthly
(c.2,300 patients with recurrent hyperkalaemia on chronic haemodialysis) First data anticipated: 2022+
STABILIZE-CKD Placebo or Lokelma 5g QOD to 15g QD plus lisonopril or valsartan FPCD: Q4 2021 Recruitment ongoing
(c.1,360 patients with CKD and hyperkalaemia or at risk of hyperkalaemia) First data anticipated: 2022+
BioPharmaceuticals - Respiratory & Immunology
Breztri
Table 34: Key Breztri Phase III trials
Trial (population) Design Timeline Status
KALOS Budesonide/formoterol or Breztri FPCD: Q1 2021 Recruitment ongoing
(asthma) First data anticipated: 2022+
LOGOS Budesonide/formoterol or Breztri FPCD: Q1 2021 Recruitment ongoing
(asthma) 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 30mg Q8W 91 (#_ftn77) s.c. FPCD: Q1 2018 Co-primary endpoints met
(severe bilateral nasal polyps) LPCD: Q2 2019
RESOLUTE Placebo or Fasenra 100mg Q8W s.c. FPCD: Q4 2019 Recruitment ongoing
(moderate to very severe COPD with a history of exacerbations and elevated First data anticipated: 2022+
peripheral blood eosinophils)
MANDARA Mepolizumab 3x100mg Q4W 92 (#_ftn78) or Fasenra 30mg s.c. FPCD: Q4 2019 Recruitment ongoing
(eosinophilic granulomatosis with polyangiitis) First data anticipated: 2022+ Orphan Drug Designation (US)
NATRON Placebo or Fasenra 30mg Q4W s.c. FPCD: Q3 2020 Recruitment ongoing
(HES) First data anticipated: Orphan Drug Designation (US)
H2 2022
MESSINA Placebo or Fasenra 30mg Q4W s.c. FPCD: Q4 2020 Recruitment ongoing
(EoE) First data anticipated: Orphan Drug Designation (US)
H2 2022
FJORD Placebo or Fasenra 30mg Q4W s.c. FPCD: Q2 2021 Recruitment ongoing
(bullous pemphigoid) First data anticipated: 2022+
MAHALE Placebo or Fasenra 30mg Q4W s.c. FPCD: Q3 2021 Recruitment ongoing
(non-cystic fibrosis bronchiectasis) First data anticipated: 2022+
HUDSON (EG/EGE) Placebo or Fasenra 30mg Q4W s.c. First data anticipated: 2022+ Initiating
Tezepelumab
In July 2021, tezepelumab received US regulatory submission acceptance for its
Biologics License Application and was also granted Priority Review for the
treatment of asthma. The PDUFA date is anticipated to be during the first
quarter of 2022. In October 2021, tezepelumab was granted Orphan Drug
Designation in the US by the FDA for the treatment of EoE; a Phase III trial
is planned.
Table 36: Key tezepelumab Phase III trials
Trial (population) Design Timeline Status
NAVIGATOR Placebo or tezepelumab 210mg Q4W s.c. FPCD: Q1 2018 Primary endpoint met
(asthma) LPCD: Q3 2019 Breakthrough Therapy Designation (US)
WAYPOINT Placebo or tezepelumab 210mg Q4W s.c. FPCD: Q2 2021 Recruitment ongoing
(chronic rhinosinusitis with nasal polyps) First data anticipated: 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 160/180mcg, single dose FPCD: Q1 2020 Primary endpoint met
(asthma with LPCD: Q3 2020
exercise-induced broncho constriction)
MANDALA Albuterol or PT027 80/180mcg or PT027 160/180mcg (all 'as needed') FPCD: Q4 2018 Primary endpoint met
(asthma) LPCD: Q1 2021
DENALI Placebo or albuterol 180mcg or budesonide 160mcg or PT027 80/180mcg or PT027 FPCD: Q2 2019 Dual primary endpoints met
160/180mcg QID
(asthma) LPCD: Q2 2021
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 active SLE) 150mg or 300mg i.v. 93 (#_ftn79) LPCD: Q4 2017 Regulatory approval (US)
Q4W 94 (#_ftn80)
TULIP 2 Placebo or Saphnelo 300mg i.v. Q4W FPCD: Q4 2015 Primary endpoint met
(moderate to severely active SLE) LPCD: Q4 2017 Regulatory approval (US)
TULIP-SC (moderate to severely active SLE) Placebo or Saphnelo First data anticipated: 2022+ Recruitment ongoing
120mg s.c. Q1W 95 (#_ftn81)
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 (#_ftn82) 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 (#_ftn83) .
Table 39: Key Ultomiris Phase III trials
Trial (population) Design Timeline Status
NMOSD External placebo-controlled open-label Ultomiris Q8W FPCD: Q4 2019 Recruitment completed
LPCD: H1 2022
Data anticipated: 1H 2022
gMG Placebo or Ultomiris Q8W FPCD: Q1 2019 Primary endpoint met
LPCD: Q2 2021
CM-TMA 98 (#_ftn84) Placebo or Ultomiris Q8W FPCD: Q3 2021 Recruitment ongoing
Data anticipated: 2022+
HSCT-TMA 99 (#_ftn85) Placebo or Ultomiris Q8W FPCD: Q4 2020 Recruitment ongoing
Adult 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 (#_ftn86) FPCD: Q3 2019 Primary endpoint met
LPCD: Q3 2020
(healthy late preterm and term infants) Breakthrough therapy designation (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 (#_ftn87) (South Africa), Phase I/II Placebo or AZD1222 FPCD: Q2 2020 Initial data readout
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 (#_ftn88) 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 144 974
comprehensive income
Fair value movements related to own credit risk on bonds designated as fair 4 (1)
value through profit or loss
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 171 (95)
comprehensive income
Fair value movements related to own credit risk on bonds designated as fair 2 (7)
value through profit or loss
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
(#_ftn89)
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 capital Share premium account Other reserves Retained earnings Total attributable to owners of the parent Non-controlling interests Total equity
$m $m $m $m $m $m $m
At 1 Jan 2020 328 7,941 2,046 2,812 13,127 1,469 14,596
Profit for the period - - - 2,184 2,184 (45) 2,139
Other comprehensive income - - - 680 680 (1) 679
Transfer to other reserves - - (7) 7 - - -
Transactions with owners:
Dividends - - - (3,669) (3,669) - (3,669)
Issue of Ordinary Shares - 11 - - 11 - 11
Share-based payments charge for the period - - - 187 187 - 187
Settlement of share plan awards - - - (325) (325) - (325)
Net movement - 11 (7) (936) (932) (46) (978)
At 30 Sep 2020 328 7,952 2,039 1,876 12,195 1,423 13,618
At 1 Jan 2021 328 7,971 2,024 5,299 15,622 16 15,638
Profit for the period - - - 459 459 2 461
Other comprehensive income - - - 255 255 - 255
Transfer to other reserves - - 15 (15) - - -
Transactions with owners:
Dividends - - - (3,884) (3,884) - (3,884)
Issue of Ordinary Shares 59 27,147 - - 27,206 - 27,206
Changes in non-controlling interest - - - - - 150 150
Share-based payments charge for the period - - - 384 384 - 384
Settlement of share plan awards - - - (811) (811) - (811)
Issue of replacement share awards upon acquisition - - - 513 513 - 513
Net movement 59 27,147 15 (3,099) 24,122 152 24,274
At 30 Sep 2021 387 35,118 2,039 2,200 39,744 168 39,912
Table 46: Condensed consolidated statement of cash flows
For the nine months ended 30 September 2021 2020
$m $m
Cash flows from operating activities
Profit Before Tax 371 2,749
Finance income and expense 922 905
Share of after tax losses of associates and joint ventures 55 21
Depreciation, amortisation and impairment 4,338 2,352
Decrease/(increase) in working capital and short-term provisions 2,063 (255)
Gains on disposal of intangible assets (371) (535)
Gains on disposal of investments in associates and joint ventures (776) -
Fair value movements on contingent consideration arising from business 33 (14)
combinations
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 (203) -
combinations
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 120 530
instruments
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
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2020/pdf/AstraZeneca_AR_2020.pdf)
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
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2020/pdf/AstraZeneca_AR_2020.pdf)
.
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
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2020/pdf/AstraZeneca_AR_2020.pdf)
. 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
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2020/pdf/AstraZeneca_AR_2020.pdf)
.
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 (#_ftn90)
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 (#_ftn91) ))
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
(#_ftn92) ))
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
(#_ftn93)
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 (https://www.astrazeneca.com/) , does not form part of and is
not incorporated into this announcement.
Addresses for correspondence
Registered office Registrar and transfer office Swedish Central Securities Depository US depositary
Deutsche Bank Trust Company Americas
1 Francis Crick Avenue Equiniti Limited Euroclear Sweden AB PO Box 191 American Stock Transfer
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Cambridge Spencer Road Brooklyn
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+44 (0) 121 415 7033 +1 (718) 921 8137
db@astfinancial.com
Cautionary statements regarding forward-looking statements
In order, among other things, to utilise the 'safe harbour' provisions of the
US Private Securities Litigation Reform Act of 1995, AstraZeneca (hereafter
'the Group') provides the following cautionary statement:
This document contains certain forward-looking statements with respect to the
operations, performance and financial condition of the Group, including, among
other things, statements about expected revenues, margins, earnings per share
or other financial or other measures. Although the Group believes its
expectations are based on reasonable assumptions, any forward-looking
statements, by their very nature, involve risks and uncertainties and may be
influenced by factors that could cause actual outcomes and results to be
materially different from those predicted. The forward-looking statements
reflect knowledge and information available at the date of preparation of this
document and the Group undertakes no obligation to update these
forward-looking statements. The Group identifies the forward-looking
statements by using the words 'anticipates', 'believes', 'expects', 'intends'
and similar expressions in such statements. Important factors that could cause
actual results to differ materially from those contained in forward-looking
statements, certain of which are beyond the Group's control, include, among
other things:
- the risk of failure or delay in delivery of pipeline or launch of new
medicines
- the risk of failure to meet regulatory or ethical requirements for
medicine development or approval
- the risk of failure to obtain, defend and enforce effective IP
protection and IP challenges by third parties
- the impact of competitive pressures including expiry or loss of IP
rights, and generic competition
- the impact of price controls and reductions
- the impact of economic, regulatory and political pressures
- the risk of failures or delays in the quality or execution of the
Group's commercial strategies
- the risk of failure to maintain supply of compliant, quality medicines
- the risk of illegal trade in the Group's medicines
- the impact of reliance on third-party goods and services
- the risk of failure in information technology, data protection or
cybercrime
- the risk of failure of critical processes
- any expected gains from productivity initiatives are uncertain
- the risk of failure to attract, develop, engage and retain a diverse,
talented and capable workforce, including following the completion of the
Alexion transaction
- the risk of failure to adhere to applicable laws, rules and
regulations
- the risk of the safety and efficacy of marketed medicines being
questioned
- the risk of adverse outcome of litigation and/or governmental
investigations, including relating to the Alexion transaction
- the risk of failure to adhere to increasingly stringent anti-bribery
and anti-corruption legislation
- the risk of failure to achieve strategic plans or meet targets or
expectations
- the risk of failure in financial control or the occurrence of fraud
- the risk of unexpected deterioration in the Group's financial position
- the impact that the COVID-19 global pandemic may have or continue to
have on these risks, on the Group's ability to continue to mitigate these
risks, and on the Group's operations, financial results or financial condition
- the risk that AstraZeneca is unable to achieve the synergies and value
creation contemplated by the Alexion transaction, or that AstraZeneca is
unable to promptly and effectively integrate Alexion's businesses
Nothing in this document, or any related presentation/webcast, should be
construed as a profit forecast.
- End of document -
18 (#_ftnref1) Chronic kidney disease.
19 (#_ftnref2) Systemic lupus erythematosus.
20 (#_ftnref3) Paroxysmal nocturnal haemoglobinuria.
21 (#_ftnref4) Epidermal growth factor receptor mutation.
22 (#_ftnref5) Non-small cell lung cancer.
23 (#_ftnref6) Human epidermal growth factor receptor 2 positive.
24 (#_ftnref7) Real Time Oncology Review.
25 (#_ftnref8) Emergency Use Authorization.
26 (#_ftnref9) Metastatic castration-resistant prostate cancer.
27 (#_ftnref10) Eosinophilic gastritis.
28 (#_ftnref11) Eosinophilic oesophagitis.
29 (#_ftnref12) Amyotrophic lateral sclerosis.
30 (#_ftnref13) Subcutaneous injection.
31 (#_ftnref14) Atypical haemolytic uraemic syndrome.
32 (#_ftnref15) Generalised myasthenia gravis.
33 (#_ftnref16) Chronic lymphocytic leukaemia.
34 (#_ftnref17) Neurofibromatosis type 1.
35 (#_ftnref18) Heart failure with preserved ejection fraction.
36 (#_ftnref19) Neuromyelitis optica spectrum disorder.
37 (#_ftnref20) Respiratory syncytial virus.
38 (#_ftnref21) Limited-stage small cell lung cancer.
39 (#_ftnref22) Hyper-eosinophilic syndrome: a group of rare blood
disorders.
40 (#_ftnref23) Paroxysmal nocturnal haemoglobinuria with extravascular
haemolysis
41 (#_ftnref24) Transthyretin amyloid cardiomyopathy.
39 (#_ftnref25) Over the counter.
40 (#_ftnref26) Substitution of threonine (T) with methionine (M) at
position 790 of exon 20 mutation.
41 (#_ftnref27) Chemoradiation therapy.
42 (#_ftnref28) Extensive stage non-small cell lung cancer.
43 (#_ftnref29) Homologous recombination.
44 (#_ftnref30) Poly ADP ribose polymerase.
45 (#_ftnref31) Homologous recombination repair gene mutation.
46 (#_ftnref32) A breast cancer gene mutation.
47 (#_ftnref33) Neurofibromatosis type 1.
48 (#_ftnref34) A targetable gene alteration found in NSCLC.
49 (#_ftnref35) Sodium-glucose co-transporter-2.
50 (#_ftnref36) Type-2 diabetes.
51 (#_ftnref37) An enzyme that destroys the hormone incretin.
52 (#_ftnref38) Inhaled corticosteroid.
53 (#_ftnref39) Long-acting beta-agonist.
54 (#_ftnref40) Total doses supplied to the end of September by AstraZeneca
and its sub-licensees, including SII, amounted to 1.5bn.
55 (#_ftnref41) 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 (#_ftnref42) 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 (#_ftnref43) 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
(#Operating_Review_Hyperlink) .
58 (#_ftnref44) Based on currency assumptions disclosed in the H1 2021
results announcement.
59 (#_ftnref45) Based on average daily spot rates in FY 2020.
60 (#_ftnref46) Based on average daily spot rates from 1 January 2021 to 30
September 2021.
61 (#_ftnref47) Other currencies include AUD, BRL, CAD, KRW and RUB.
62 (#_ftnref48) 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 (#_ftnref49) First patient commenced dosing.
64 (#_ftnref50) Last patient commenced dosing.
65 (#_ftnref51) Overall survival.
66 (#_ftnref52) Progression-free survival.
67 (#_ftnref53) Hazard ratio.
68 (#_ftnref54) Confidence interval.
69 (#_ftnref55) Objective Response Rate.
70 (#_ftnref56) Concurrent chemoradiation therapy.
71 (#_ftnref57) Standard of Care.
72 (#_ftnref58) Conducted by the Canadian Cancer Trials Group.
73 (#_ftnref59) Bacillus Calmette-Guerin.
74 (#_ftnref60) Hepatocellular carcinoma.
75 (#_ftnref61) Transarterial chemoembolisation.
76 (#_ftnref62) A chemotherapy regimen comprised of 5-fluorouracil,
leucovorin, oxaliplatin and docetaxel.
77 (#_ftnref63) A mutation of the BRCA1 or BRCA2 gene
78 (#_ftnref64) Unmutated BRCA genes (wild type)
79 (#_ftnref65) Antibody drug conjugate.
80 (#_ftnref66) Gastroesophageal junction adenocarcinoma.
81 (#_ftnref67) Duration of response.
82 (#_ftnref68) A chemotherapy combination comprised of rituximab,
clyclophosphamide, doxorubicin hydrochloride, vincristine and prednisolone.
83 (#_ftnref69) Papillary renal cell carcinoma.
84 (#_ftnref70) Type-1 diabetes.
85 (#_ftnref71) European Medicines Agency.
86 (#_ftnref72) Type-2 diabetes.
87 (#_ftnref73) Ischaemic strokes are the most common type of stroke.
88 (#_ftnref74) A process designed to facilitate the development and
expedite the review of medicines to treat serious conditions that fill an
unmet medical need.
89 (#_ftnref75) ST elevation myocardial infarction
90 (#_ftnref76) Non-ST elevation myocardial infarction.
91 (#_ftnref77) Once every eight weeks.
92 (#_ftnref78) Once every four weeks.
93 (#_ftnref79) Intravenous.
94 (#_ftnref80) Once every four weeks.
95 (#_ftnref81) Once a week.
96 (#_ftnref82) Independent Data Monitoring Committee.
97 (#_ftnref83) Atypical haemolytic uremic syndrome.
98 (#_ftnref84) Complement-mediated thrombotic microangiopathy.
99 (#_ftnref85) Hematopoietic stem cell transplantation-associated
thrombotic microangiopathy.
100 (#_ftnref86) Intramuscular.
101 (#_ftnref87) Conducted by University of Witwatersrand, South Africa.
102 (#_ftnref88) Intramuscular
103 (#_ftnref89) 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 (#_ftnref90) 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 (#_ftnref91) 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 (#_ftnref92) 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 (#_ftnref93) 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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