REG - AstraZeneca PLC - AZN: Full year and Q4 2021 results
10/02/2022 07:00
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RNS Number : 2236B AstraZeneca PLC 10 February 2022
AstraZeneca PLC
10 February 2022 07:00 GMT
Full year and Q4 2021 results
Total Revenue increased by 41% and Core EPS by 32% in a year of exceptional
pipeline and commercial delivery, coupled with accelerated strategic
transformation through the acquisition of Alexion
· Total Revenue increased 41% (38% at CER(1)) to $37,417m including
COVID-19 vaccine revenues. Total Revenue excluding vaccine increased 26% (23%
at CER) to $33,436m. In Q4 2021, Total Revenue increased 62% (63% CER) to
$12,011m
· Reported(2) EPS(3) of $0.08 (FY 2020: $2.44) and Core(4) EPS of $5.29
(FY 2020: $4.02)
· 14 positive Phase III readouts across nine medicines in 2021, and 22
regulatory approvals and authorisations in major markets including five
NMEs(5)
· FY 2022 guidance at CER of a high-teens percentage increase in Total
Revenue and a mid-to-high twenties percentage increase in Core EPS
· Reflecting increased confidence in future growth and cash generation,
the Board intends to increase the annualised dividend by $0.10 to $2.90, and
has approved a second interim dividend for FY 2021 of $1.97, payable in March
2022. This results in a total dividend declared for FY 2021 of $2.87
Pascal Soriot, Chief Executive Officer, AstraZeneca, said: "AstraZeneca
continued on its strong growth trajectory in 2021, with industry-leading
R&D productivity, five of our medicines crossing new blockbuster
thresholds, and the acquisition and integration of Alexion. We also delivered
on our promise of broad and equitable access to our COVID-19 vaccine with 2.5
billion doses released for supply around the world, and we made good progress
on reducing our greenhouse gas emissions.
Growth was well balanced across our strategic areas of focus, and we saw
double-digit growth in all major regions, including Emerging Markets despite
some headwinds in China.
The positive news from our pipeline, including approvals for Evusheld and
Tezspire, supports the outlook for 2022. This, along with the transformative
acquisition of Alexion, means that we are confident in our long term growth
and profitability. After a landmark year in 2021, we are increasing the
dividend for our shareholders."
Table 1: Revenue and EPS summary
FY 2021 Q4 2021
Actual % CER % Actual % CER %
$m Change change $m Change change
- Product Sales 36,541 41 38 11,498 64 65
- Collaboration Revenue 876 20 20 513 29 29
Total Revenue 37,417 41 38 12,011 62 63
Reported EPS $0.08 (97) (84) $(0.22) n/m(6) n/m
Core EPS $5.29 32 37 $1.67 56 74
The differences between Reported and Core measures are primarily due to items
related to the acquisition of Alexion, amortisation of intangibles, as well as
impairments and restructuring charges, of which $1,030m in the year related to
the Group Review detailed below. A full reconciliation between Reported EPS
and Core EPS is provided in Tables 17 and 18 in the Financial performance
section of this document. The differences between Actual Change and CER Change
are due to foreign exchange movements between corresponding periods in 2021 vs
2020.
Key elements of Total Revenue performance in FY 2021
- An increase in Product Sales of 41% (38% at CER) to $36,541m
- Among AstraZeneca's thirteen(7) blockbuster medicines in 2021, five
medicines crossed new thresholds: Tagrisso ($5bn+), Farxiga ($3bn+), Lynparza
($2bn+), Calquence ($1bn+) and Fasenra ($1bn+)
- Following completion of the Alexion acquisition on 21 July 2021, Rare
Disease medicines generated 8% of AstraZeneca's FY 2021 Total Revenue, growing
8% (9% CER) on a pro-rata basis to $3,071m
- Growth of 19% (17% at CER) in Oncology to $13,663m, 13% (9% at CER) in
CVRM(8) to $8,034m, and 13% (9% at CER) in R&I(9) to $6,049m
- In the US, Total Revenue increased by 38% to $12,228m. In Europe,
Total Revenue increased by 45% (40% at CER) to $8,050m including Vaxzevria(10)
revenue of $1,035m
- An increase in Emerging Markets revenue of 41% (36% at CER) to
$12,281m, including Vaxzevria revenue of $2,304m. In China, Total Revenue
increased by 12% (4% CER) in the year to $6,011m. Pricing pressure associated
with NRDL(11) and VBP(12) programmes led to a decline in growth in the second
half of the year, and in Q4 2021 China Total Revenue was 4% lower (8% at CER)
than in Q4 2020
- Excluding vaccine revenue, Total Revenue in ex-China Emerging Markets
increased by 19% in the year (21% at CER) to $3,977m and by 36% (38% at CER)
in the quarter to $1,197m, driven by Oncology medicines and Farxiga
Post Alexion Acquisition Group Review
In conjunction with the acquisition of Alexion, the enlarged Group initiated a
comprehensive review across the organisation, aimed at integrating systems,
structure and processes, optimising the global footprint and prioritising
resource allocations and investments. These activities are expected to be
substantially complete by the end of 2025, with a number of planned activities
having commenced in late 2021.
The identified activities, including those previously announced regarding the
integration of Alexion, are anticipated to incur one-time restructuring costs
of approximately $2.1bn, of which approximately $1.4bn are cash costs and
$0.7bn are non-cash costs, and capital investments of approximately $0.2bn.
The activities are anticipated to realise run-rate pre-tax benefits, before
reinvestment, of approximately $1.2bn, including previously-announced Alexion
synergies, by the end of 2025. In line with established practice,
restructuring costs will be excluded from our Core (non-GAAP) financial
measures.
Guidance
The Company provides FY 2022 guidance at CER.
Total Revenue is expected to increase by a high teens percentage
Core EPS is expected to increase by a mid-to-high twenties percentage
- The CER growth rates include the full-year contribution of Vaxzevria
in both FY 2021 and FY 2022
- Total Revenue from COVID-19 medicines is anticipated to decline by a
low-to-mid twenties percentage, with an expected decline in sales of Vaxzevria
being partially offset by growth in Evusheld sales. The majority of vaccine
revenue in 2022 is expected to come from initial contracts. The Gross Profit
Margin from the COVID‑19 medicines is expected to be lower than the Company
average
- Core Operating Expenses are expected to increase by a low-to-mid teens
percentage, driven in substantial part by the full year integration of Alexion
expenses
- Emerging Markets Total Revenue, including China, is expected to grow
mid-single-digits in FY 2022. China Total Revenue is expected to decline by a
mid-single-digit percentage in FY 2022, primarily due to continued NRDL and
VBP programme impacting various medicines. The Company remains confident in
the longer term outlook for Emerging Markets, driven by a large market
opportunity, broader patient access and an increased mix of new medicines
- A Core Tax Rate between 18-22%
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 average foreign-exchange rates for January 2022 were seen over the full
year, it is anticipated that there would be a low single-digit adverse impact
on actual Total Revenue and Core EPS versus the financials at CER. The
Company's foreign-exchange rate sensitivity analysis is shown in the Operating
and financial review.
Table 2: Key elements of financial performance
FY 2021
Metric Reported Reported change Core Core Comments(13)
change
Total Revenue $37,417m 41% increase (38% CER) $37,417m 41% increase (38% CER) See Total Revenue commentary above
Gross Profit Margin(14) 66.0% 14 percentage point decline 74.2% 6 percentage point decline + Contribution of Alexion
(13 at CER)
(5 at CER)
+ Increasing mix of oncology sales
‒ Vaxzevria revenues in 2021
‒ China impact of NRDL and VBP
‒ Increasing impact from profit-sharing arrangements
‒ Reported impacted by unwind of Alexion inventory fair value adjustment
R&D Expense $9,736m 62% increase $7,987m 36% increase + Increased investment in pipeline
(59% CER) (33% at CER) + COVID-19 medicines investment and pharmacovigilance
+ Addition of Alexion R&D
+ 14 positive Phase III readouts in 2021
+ Reported also impacted by $1,464m of impairments
SG&A Expense $15,234m 35% increase $11,104m 19% increase + Investments in multiple launches
(32% at CER) (15% at CER) + Addition of Alexion
+ Expansion in Emerging Markets
+ Reported also impacted by amortisation related to Alexion acquisition,
$338m of restructuring and $603m of impairments
Other Operating Income(15) $1,492m 2% decrease $1,492m 3% decrease = Divestment gains at a similar level to FY 2020. See Table 38
(4% at CER) (4% at CER)
Operating Margin 2.8% 17 percentage point decline 26.5% 1 percentage See Gross Margin and Expenses
(15 at CER)
point decline
commentary above
(1 increase at CER)
Net Finance Expense $1,257m 3% increase $862m 10% increase + Alexion debt financing costs
(2% at CER) (11% at CER) ‒ Reported impacted by lower discount unwind on acquisition-related
liabilities
Tax Rate 143% n/m 17% 3 percentage ‒ Benefit from non‑taxable gain on the Viela equity divestment
point decrease
‒ Settlements with tax authorities and expiry of statute of limitations
EPS $0.08 97% decrease $5.29 32% increase Further details of differences between Reported and Core in Table 17
(84% at CER) (37% at CER)
Table 3: Select medicines Total Revenue performance
Further details of the individual medicine performances are provided in the
Total Revenue section.
FY 2021 Q4 2021
Actual CER Actual CER
$m % change % change $m % change % change
Tagrisso Oncology 5,015 16 13 1,314 14 15
Imfinzi 2,412 18 16 634 14 15
Lynparza 2,748 23 21 1,029 25 26
Calquence 1,238 n/m n/m 395 n/m n/m
Enhertu 214 n/m n/m 67 n/m n/m
Farxiga CVRM 3,005 53 49 849 45 46
Brilinta 1,472 (8) (10) 348 (4) (4)
Bydureon 385 (14) (15) 91 (25) (25)
Roxadustat 180 n/m n/m 31 n/m n/m
Lokelma 175 n/m n/m 54 90 95
Symbicort R&I 2,728 - (2) 681 - -
Fasenra 1,258 33 31 357 26 27
Pulmicort 962 (3) (8) 248 (33) (34)
Breztri 203 n/m n/m 73 n/m n/m
Soliris(16) Rare 1,874 1 2 1,076 4 6
Ultomiris(16) Disease(16) 688 27 29 391 24 26
Strensiq(16) 378 13 13 219 17 18
Vaxzevria COVID-19 3,981 n/m n/m 1,762 n/m n/m
Table 4: Regional Total Revenue performance
Further details of the regional performances are provided in the Regional
Total Revenue section.
FY 2021 Q4 2021
% of Actual % CER % Actual % CER %
$m total change change $m change change
Emerging Markets 12,281 33 41 36 3,663 63 61
US 12,228 33 38 38 3,923 64 64
Europe 8,050 22 45 40 2,872 57 58
Established Rest of World 4,858 13 37 37 1,553 64 72
Total 37,417 100 41 38 12,011 62 63
Total Revenue from Emerging Markets increased in the year by 41% (36% CER) to
$12,281m, of which $2,304m came from Vaxzevria. Excluding Vaxzevria, Total
Revenue from Emerging Markets increased by 15% (10% at CER) in the year to
$9,977m.
Corporate and business development
In November 2021, AstraZeneca and Amgen Inc (Amgen) agreed to include AZD8630
in the existing collaboration agreement between the parties. AZD8630 is a
human anti-TSLP Fab(17) for inhaled delivery and entered Phase I in Q1 2022.
AZD8630 becomes part of the collaboration with the companies sharing both
costs and income, with no inventor royalty. AstraZeneca will be the
development/regulatory lead, manufacturing lead, and commercial lead.
AstraZeneca and Amgen will jointly commercialise AZD8630 in North America, and
AstraZeneca will distribute the product and book sales globally, including
from the US. For commercialisation in the US, Amgen will be responsible for
commercial negotiations and contracting (including to payer, pharmacy,
pharmacy support services), rebate processing and US government price
reporting.
In December 2021, AstraZeneca entered into a new global development and
commercialisation agreement with Ionis Pharmaceuticals, Inc. (Ionis) for
eplontersen, a ligand-conjugated antisense potential new medicine currently in
Phase III clinical trials for amyloid transthyretin cardiomyopathy (ATTR-CM)
and hereditary amyloid transthyretin polyneuropathy (hATTR-PN). AstraZeneca
paid Ionis an upfront payment of $200m and will pay additional conditional
payments of up to $485m following regulatory approvals. The Company will also
pay up to $2.9bn of sales-related milestones based on sales thresholds between
$500m and $6bn, plus royalties in the range of low double-digit to
mid-twenties percentage depending on the region.
In January 2022, AstraZeneca entered into an exclusive global collaboration
and licence agreement with Neurimmune AG for NI006, an investigational human
monoclonal antibody currently in Phase Ib development for the treatment of
ATTR-CM. Under the agreement, Alexion will be granted an exclusive worldwide
licence to develop, manufacture and commercialise NI006. Alexion will pay
Neurimmune an upfront payment of $30m with the potential for additional
contingent milestone payments of up to $730m upon achievement of certain
development, regulatory and commercial milestones, as well as low-to-mid teen
royalties on net sales of any approved medicine resulting from the
collaboration.
In January 2022, AstraZeneca completed the sale of the global rights to Eklira
(known as Tudorza in the US) and Duaklir to Covis Pharma GmbH for an upfront
payment of $270m, which will be recorded within Other Operating Income and
Expense. The intangible assets of $368m were held as Assets held for sale as
at 31 December 2021. In 2020, Eklira and Duaklir generated AstraZeneca revenue
of $143m in the countries covered by this agreement.
Sustainability summary
In line with our commitment to access to healthcare, in the fourth quarter of
2021 the Company delivered approximately 102 million doses of its COVID‑19
vaccine through COVAX(18). As at the end of December 2021, the Company and its
sublicensee Serum Institute of India Pvt. Ltd. (SII) had delivered more than
247 million doses with COVAX to 130 countries. AstraZeneca and SII remain the
largest contributor to COVAX. As of February 2022, AstraZeneca and its
sub-licensing partners have released more than 2.6 billion vaccine doses for
supply in over 180 countries, of which approximately two thirds have gone to
low and middle-income countries.
The Company made good progress in reducing its Scope 1 and 2 greenhouse gas
emissions. All imported electricity is now from renewable sources. As at the
end of December 2021, the Company had achieved 59% reduction compared with its
2015 baseline. This includes the full integration of Alexion's carbon
footprint and rebasing 2015. For further details, see the Sustainability
section
Notes
The following notes refer to pages one to five.
1. 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.
2. Reported financial measures are the financial results presented in
accordance with UK-adopted International Accounting Standards and
International Financial Reporting Standards (IFRSs) as issued by the
International Accounting Standards Board (IASB) and International Accounting
Standards as adopted by the European Union
3. Earnings per share.
4. 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.
5. New molecular entities. In FY 2021, first major approvals were granted
for Vaxzevria, Orpathys, Saphnelo, Evusheld and Tezspire.
6. Not meaningful.
7. The thirteen medicines that generated over a billion dollars of sales
in calendar 2021 are Tagrisso, Vaxzevria, Farxiga, Symbicort, Imfinzi,
Lynparza, Soliris, Brilinta, Nexium, Fasenra, Calquence, Crestor and
Ultomiris. This is based on Soliris and Ultomiris sales from 1 January 2021
to 31 December 2021.
8. Cardiovascular, Renal & Metabolism.
9. Respiratory & Immunology.
10. Vaxzevria is AstraZeneca's trademark for the Company's supply of the
AstraZeneca COVID-19 Vaccine. In the financial tables in this report,
'Vaxzevria Product Sales' shows revenue recorded on the Company's direct
sales, and 'Vaxzevria Total Revenue' also includes Collaboration Revenue from
sub-licensees that produce and supply the AstraZeneca COVID-19 Vaccine under
their own trademarks.
11. China's National Reimbursement Drug List.
12. Volume-based procurement.
13. The plus/minus signs in Table 2 align with the increase/decrease of each
metric, e.g. a comment about R&D Expenses which is preceded by a plus sign
discusses an item that increased the R&D Expense compared to the previous
year
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. Year to date growth rates on Rare Disease medicines have been calculated
on a pro rata basis by comparing post-acquisition revenues from 21 July 2021
to 31 December 2021 with the corresponding period in the prior year,
pre-acquisition as previously published by Alexion. Q4 growth rates on Rare
Disease medicines have been calculated on a pro rata basis comparing to the
corresponding period in the prior year, pre-acquisition as previously
published by Alexion. Pro rata Total Revenue growth rates have been presented
for FY 2021 and Q4 2021 Rare Disease area and constituent medicines, and do
not impact Group totals.
17. Thymic stromal lymphopoietin fragment antigen-binding.
18. 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 World Health Organisation (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 5: Pipeline highlights
Event Medicine Indication / Trial Event
Regulatory approvals Saphnelo Lupus (SLE 19 (#_ftn1) ) CHMP 20 (#_ftn2) positive opinion (EU)
or other regulatory action
Tezspire Severe asthma Approval (US)
Evusheld COVID-19 prophylaxis EUA (US)
Regulatory submissions, acceptances Lynparza Breast cancer (adjuvant, BRCAm 21 (#_ftn3) ) Priority Review (US)
Lynparza Breast cancer (adjuvant, BRCAm) Regulatory submission (EU, JP)
Lynparza Ovarian cancer (1st-line) Regulatory submission (CN)
Lynparza Prostate cancer (1st-line) Regulatory submission (EU)
Enhertu HER2+ 22 (#_ftn4) breast cancer (2nd-line) Priority Review (US)
Enhertu HER2+ breast cancer (2nd-line) Regulatory submission (EU, JP)
Imfinzi +/- tremelimumab NSCLC 23 (#_ftn5) (1st-line) Regulatory submission (US, EU, JP)
Koselugo NF1-PN 24 (#_ftn6) Regulatory submission (JP)
Ultomiris Subcutaneous formulation in PNH 25 (#_ftn7) Regulatory submission (US)
and aHUS 26 (#_ftn8)
Ultomiris gMG 27 (#_ftn9) Priority Review (US)
Major Phase III Vaxzevria / AZD2816 COVID-19 Phase III primary endpoint met
data readouts, or
other significant developments
Lynparza Breast cancer (adjuvant, BRCAm) Orphan Drug Designation (JP)
Lokelma Chronic haemodialysis with hyperkalaemia Fast Track Designation (US)
eplontersen hATTR-PN 28 (#_ftn10) and ATTR-CM 29 (#_ftn11) Orphan Drug Designation (US)
Table 6: Pipeline anticipated major news flow
Timing Medicine Indication / Trial Event
Imfinzi Biliary tract cancer (TOPAZ-1) Regulatory submission
Imfinzi NSCLC (1st-line) (PEARL) Data readout
Imfinzi Cervical cancer (CALLA) Data readout
Imfinzi NSCLC (unresectable, Stage III) Data readout
(PACIFIC-2)
Imfinzi +/- tremelimumab Liver cancer (1st-line) (HIMALAYA) Regulatory submission
Lynparza Breast cancer (adjuvant, BRCAm) Regulatory decision (US)
Lynparza Prostate cancer (1st-line) Regulatory submission (US, JP)
Enhertu Breast cancer (2nd-line, HER2+) Regulatory decision (US)
Enhertu Breast cancer (3rd-line, HER2-low) Data readout, regulatory submission
(DESTINY-Breast04)
Brilique Stroke Regulatory decision (CN)
H1 2022 Forxiga Chronic kidney disease Regulatory decision (CN)
Farxiga HFpEF 30 (#_ftn12) (DELIVER) Data readout
Fasenra Nasal polyps Regulatory decision (US)
Saphnelo Lupus (SLE) Regulatory decision (EU)
tezepelumab Asthma Regulatory decision (EU, JP)
PT027 Asthma Regulatory submission (US)
Ultomiris Subcutaneous formulation in PNH and aHUS Regulatory submission (EU)
Ultomiris NMOSD 31 (#_ftn13) Data readout
Ultomiris gMG Regulatory decision (US)
Vaxzevria COVID-19 Regulatory submission (US)
Evusheld COVID-19 outpatient treatment Regulatory submission (EU, JP)
nirsevimab Respiratory syncytial virus Regulatory submission
Tagrisso NSCLC (adjuvant, EGFRm 32 (#_ftn14) ) Regulatory decision (JP)
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
H2 2022 Imfinzi SCLC 33 (#_ftn15) (Limited-stage) (ADRIATIC) Data readout
Imfinzi +/-tremelimumab NSCLC (1st-line) Regulatory decision
Lynparza Ovarian cancer (1st-line) Regulatory decision (CN)
Lynparza Prostate cancer (1st-line) Regulatory decision (EU)
Lynparza Breast cancer (adjuvant) Regulatory decision (EU,JP)
Calquence CLL 34 (#_ftn16) Regulatory submission (JP)
Calquence MCL 35 (#_ftn17) (1st-line) (ECHO) Data readout
Enhertu Breast cancer (2nd-line, HER2+) Regulatory decision (EU,JP)
Enhertu Gastric cancer (2nd-line, HER2+) Regulatory decision (EU)
Enhertu Breast cancer (3rd-line, HER2+) Data readout, regulatory submission
(DESTINY-Breast02)
Farxiga HFpEF Regulatory submission
eplontersen hATTR-PN (NEURO-TTRansform) Data readout, regulatory submission
Fasenra HES 36 (#_ftn18) (NATRON) Data readout
H2 2022 Fasenra EOE 37 (#_ftn19) (MESSINA) Data readout
Ultomiris Subcutaneous formulation in PNH and aHUS Regulatory decision (US)
Ultomiris gMG Regulatory decision (EU,JP)
Ultomiris NMOSD Regulatory submission
ALXN1840 Wilson disease Regulatory submission
acoramidis ATTR-CM Data readout
Koselugo NF1-PN (SPRINT) Regulatory submission (CN)
Koselugo NF1-PN Regulatory decision (JP)
Tagrisso NSCLC (1st-line EGFRm) (FLAURA2) Data readout, regulatory submission
Tagrisso NSCLC (unresectable Stg. III, EGFRm) (LAURA) Data readout, regulatory submission
Imfinzi SCLC (Limited-stage) Regulatory submission
Imfinzi Bladder cancer (1st-line) (NILE) Data readout, regulatory submission
Imfinzi Bladder cancer (MI 38 (#_ftn20) ) (NIAGARA) Data readout, regulatory submission
Imfinzi HCC 39 (#_ftn21) (adjuvant) (EMERALD-2) Data readout, regulatory submission
Imfinzi NSCLC (Neoadjuvant) (AEGEAN) Data readout, regulatory submission
Lynparza Adjuvant breast cancer Regulatory submission (CN)
2023 Lynparza 1st-line CRC 40 (#_ftn22) (LYNK-003) Data readout, regulatory submission
Lynparza + Imfinzi Ovarian cancer (1st-line) (DuO-O) Data readout
Lynparza + Imfinzi Endometrial cancer (1st-line) (DuO-E) Data readout
Enhertu Gastric cancer (HER2oe 41 (#_ftn23) ) Data readout
(DESTINY-Gastric03)
Enhertu NSCLC (unresectable, HER2m) (DESTINY-Lung02) Data readout
Enhertu Breast cancer (2nd-line HER2-low) (DESTINY-Breast06) Data readout
Calquence CLL (Front line) (AC-CL-311) Data readout
datopotamab deruxtecan NSCLC (3rd-line) (TROPION-Lung01) Data readout, regulatory submission
capivasertib TNBC 42 (#_ftn24) (CAPitello-290) Data readout, regulatory submission
capivasertib Breast cancer (HR+/HER2-neg) Data readout, regulatory submission
(CAPitello-291)
camizestrant HR+ HER2-neg BC (SERENA-6) Data readout
Farxiga Myocardial infarction (DAPA-MI) Data readout
roxadustat Anaemia in MDS 43 (#_ftn25) Data readout
Fasenra Eosinophilic oesophagitis Regulatory submission
2023 Fasenra EGPA 44 (#_ftn26) (MANDARA) Data readout, regulatory submission
Fasenra Hyper-eosinophilic syndrome Regulatory submission
Fasenra Severe asthma (MIRACLE) Data readout, regulatory submission (CN)
Fasenra CRwNP 45 (#_ftn27) (ORCHID) Data readout
Fasenra Bullous pemphigoid (FJORD) Data readout
Soliris Guillain-Barre syndrome Data readout (JP)
acoramidis ATTR-CM Data readout (JP)
danicopan PNH with extravascular haemolysis 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 first quarter results on 29 April 2022.
Reporting changes in FY 2022
From Q1 2022, AstraZeneca's Total Revenue and Product Sales tables will
include a new disease area: BioPharmaceuticals: Vaccines & Immune
Therapies (V&I). This will incorporate revenues from Vaxzevria, Evusheld,
FluMist, Synagis and nirsevimab. In the FY 2021 tables, Vaxzevria and Evusheld
are shown under COVID-19, and FluMist, Synagis and nirsevimab are shown under
Other medicines.
In addition, from Q1 2022 Koselugo will move from Oncology to Rare Disease,
and Andexxa will move from Rare Disease to BioPharmaceuticals: CVRM.
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 twelve month
period to 31 December 2021 ('the year' or 'FY 2021') and the three month
period to 31 December 2021 ('the quarter', 'the fourth quarter' or 'Q4 2021')
compared to the twelve month period to 31 December 2020 (FY 2020) and the
three month period to 31 December 2020 (Q4 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 Condensed Consolidated 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
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2020/pdf/AstraZeneca_AR_2020.pdf)
. 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.
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 Condensed 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 to the Condensed Financial Statements.
Table 7: Total Revenue by disease area
FY 2021 Q4 2021
% of Actual % CER % % of Actual % CER %
$m Total change change $m total change change
Oncology 13,663 37 19 17 3,919 33 20 21
BioPharmaceuticals: CVRM 8,034 21 13 9 2,007 17 8 8
BioPharmaceuticals: R&I 6,049 16 13 9 1,593 13 4 3
Rare Disease(16) 3,071 8 8 9 1,760 15 10 11
Other medicines 2,484 7 (6) (7) 835 7 12 14
COVID-19 4,116 11 n/m n/m 1,897 16 n/m n/m
Total Revenue 37,417 100 41 38 12,011 100 62 63
Table 8: Disease area and medicine performance
FY 2021 Q4 2021
$m % of total Actual % change CER% $m % of total Actual % change CER % change
change
Oncology 13,048 35 20 18 3,455 29 19 20
- Tagrisso 5,015 13 16 13 1,314 11 14 15
- Imfinzi 2,412 6 18 16 634 5 14 15
- Lynparza 2,348 6 32 30 629 5 27 28
- Calquence 1,238 3 n/m n/m 395 3 n/m n/m
- Koselugo 108 - n/m n/m 34 - 92 94
- Enhertu 17 - n/m n/m 7 - n/m n/m
- Orpathys 16 - n/m n/m 6 - n/m n/m
- Zoladex 948 3 7 3 232 2 7 7
- Faslodex 431 1 (26) (27) 101 1 (22) (21)
- Iressa 183 - (32) (35) 35 - (49) (47)
- Casodex 143 - (17) (21) 22 - (43) (42)
- Arimidex 139 - (25) (27) 33 - (9) (11)
- Others 50 - 1 (1) 13 - 3 5
BioPharmaceuticals: CVRM 8,020 21 13 10 2,003 17 9 9
- Farxiga 3,000 8 53 49 848 7 45 46
- Brilinta 1,472 4 (8) (10) 348 3 (4) (4)
- Bydureon 385 1 (14) (15) 91 1 (25) (25)
- Onglyza 360 1 (23) (26) 75 1 (28) (29)
- Byetta 55 - (19) (19) 10 - (44) (42)
- Other diabetes 59 - 26 24 17 - 34 34
- Lokelma 175 - n/m n/m 54 - 90 95
- Roxadustat 174 - n/m n/m 30 - n/m n/m
- Crestor 1,096 3 (7) (10) 259 2 (13) (13)
- Seloken/Toprol-XL 951 3 16 10 202 2 1 (2)
- Atacand 97 - (60) (60) 21 - (67) (67)
- Others 196 1 3 (2) 48 - 4 3
BioPharmaceuticals: R&I 6,034 16 13 9 1,590 13 4 4
- Symbicort 2,728 7 - (2) 681 6 - -
- Fasenra 1,258 3 33 31 357 3 26 27
- Pulmicort 962 3 (3) (8) 248 2 (33) (34)
- Daliresp 227 1 5 4 59 - 8 8
- Breztri 203 1 n/m n/m 73 1 n/m n/m
- Bevespi 54 - 12 12 15 - 24 26
- Saphnelo 8 - n/m n/m 7 - n/m n/m
- Others 594 2 49 42 150 1 20 18
Rare Disease(16) 3,070 8 8 9 1,759 15 10 11
- Soliris(16) 1,874 5 1 2 1,076 9 4 6
- Ultomiris(16) 688 2 27 29 391 3 24 26
- Strensiq(16) 378 1 13 13 219 2 17 18
- Andexxa(16) 68 - (3) (3) 39 - - (1)
- Kanuma(16) 62 - 20 21 34 - 16 17
Other medicines 2,367 6 (8) (10) 825 7 13 15
- Nexium 1,326 4 (11) (12) 328 3 (13) (10)
- Synagis 410 1 10 13 239 2 n/m n/m
- FluMist 253 1 (14) (17) 178 1 (1) (4)
- Losec/Prilosec 180 - (2) (7) 41 - 7 6
- Seroquel XR/IR 92 - (21) (20) 19 - (3) (2)
- Others 106 - (16) (19) 20 - (48) (49)
COVID-19 4,002 11 n/m n/m 1,866 16 n/m n/m
- Vaxzevria 3,917 10 n/m n/m 1,781 15 n/m n/m
- Evusheld 85 - n/m n/m 85 1 n/m n/m
Product Sales 36,541 98 41 38 11,498 96 64 65
Collaboration Revenue 876 2 20 20 513 4 29 29
Total Revenue 37,417 100 41 38 12,011 100 62 63
Table 9: Collaboration Revenue
FY 2021 Q4 2021
$m % of total Actual % change CER % change $m % of total Actual % change CER % change
Lynparza: milestone revenue 400 46 (13) (13) 400 78 23 23
Enhertu: share of gross profits 193 22 n/m n/m 59 12 83 83
Roxadustat: share of gross profits 6 1 (81) (83) 2 - (87) (87)
Other Collaboration Revenue 277 32 94 94 52 10 66 73
Total 876 100 20 20 513 100 29 29
Other Collaboration Revenue included contributions from Movantik, Zoladex,
Eklira, Duaklir, Forxiga, Nexium OTC 46 (#_ftn28) and other royalties, and a
$100m receivable from SII.
Total Revenue summary
Oncology
Total Revenue increased by 19% (17% at CER) in the year to $13,663m and
represented 37% of overall Total Revenue (FY 2020: 43%).
Tagrisso
Tagrisso has received regulatory approval in 70 countries, including the US,
China, and in the EU, for use as an adjuvant treatment of EGFRm NSCLC
patients, with 19 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 94 countries, including the US, China, in the EU and
Japan. To date, 52 reimbursements have been granted in this setting, with
further decisions anticipated. These developments followed Tagrisso's
regulatory approval in 94 countries, including the US, China, in the EU and
Japan, to treat patients with EGFR T790M 47 (#_ftn29) NSCLC, an indication in
which 68 reimbursements have been granted.
Total Revenue, entirely comprising Product Sales, amounted to $5,015m in the
year and represented growth of 16% (13% at CER).
Sales in the US increased by 14% in the year to $1,780m and increased by 15%
to $486m in Q4. Performance benefited from greater 1st-line and adjuvant use,
with longer duration of treatment, partially offset by lower 2nd-line use and
a continued negative impact on diagnosis, testing and treatment from the
pandemic. After a recovery during the second and third quarters of 2021, rates
of diagnosis and testing in lung and other cancers have declined as a result
of the latest wave of COVID-19 cases, and remained below pre-pandemic levels
at the end of the year.
Tagrisso sales in Emerging Markets increased by 11% in the year (6% at CER) to
$1,336m; 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, rising demand from increased patient access
in China almost completely offset the NRDL price reduction. Emerging Markets
sales in Q4 increased by 26% (23% at CER) to $325m, driven by growth in both
China and other Emerging Markets.
Sales in Japan increased by 6% (8% at CER) to $775m in the year. In Europe,
sales of $986m in the year represented an increase of 32% (25% at CER), driven
by greater adoption in the 1st-line and adjuvant settings, as more
reimbursements were granted.
Imfinzi
Imfinzi has received regulatory approval in 75 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 48 (#_ftn30) . Imfinzi has also been approved to treat
ES-SCLC 49 (#_ftn31) patients in 67 countries, with nine reimbursements
granted.
Total Revenue, entirely comprising Product Sales, amounted to $2,412m in the
year and represented growth of 18% (16% at CER); the performance reflected the
increased use of Imfinzi to treat patients with ES‑SCLC. US sales in the
year increased by 5% to $1,245m, despite the continued COVID-19-related
decrease in lung cancer diagnoses. In Q4 2021, US sales grew by 10% to $330m.
In Japan, sales of $345m represented growth of 28% (30% at CER), where market
share in ES-SCLC increased. Europe sales increased by 31% (25% at CER) to
$485m, reflecting an increase in ES-SCLC market penetration and an increase in
the number of reimbursed markets. Sales in Emerging Markets in the year
increased to $277m, representing growth of 76% (68% at CER). As a result of
recent launches, Q4 2021 Emerging Market sales grew by 47% (44% at CER) to
$65m.
Lynparza
Lynparza has received regulatory approvals in 89 countries for the treatment
of ovarian cancer; it has also been approved in 86 countries for the treatment
of metastatic breast cancer, and in 73 countries for the treatment of
pancreatic cancer. Lynparza has received regulatory approval in 74 countries
for the 2nd-line treatment of certain prostate-cancer patients.
Total Revenue amounted to $2,748m in the year representing growth of 23% (21%
at CER); this included Collaboration Revenue of $400m comprising a sales
milestone received in Q4 2021.
Product Sales in the year amounted to $2,348m, reflecting growth of 32% (30%
at CER) and benefiting from further launches across multiple cancer types
globally. US Product Sales increased by 24% to $1,087m in the year, due to
growth in use in ovarian, breast and prostate cancers. Lynparza remains the
leading medicine in the PARP 50 (#_ftn32) inhibitor class globally across
four tumour types, as measured by total prescription volumes. Product Sales in
Europe increased by 42% (35% at CER) to $618m, reflecting additional
reimbursements and increasing BRCAm-testing rates, as well as successful
1st-line BRCAm ovarian, 2nd-line HRRm 51 (#_ftn33) prostate and germline
BRCAm HER2-negative advanced breast cancer launches.
Sales in Japan amounted to $199m, representing growth of 19% (21% at CER).
Emerging Markets Product Sales were $384m, up by 45% (41% at CER), benefiting
from increased patient access to Lynparza following admission to the NRDL as a
1st-line treatment for BRCAm ovarian cancer patients with effect from March
2021.
Enhertu
Total Revenue, predominately comprising Collaboration Revenue, increased by
123% in the year to $214m.
Global in-market sales, excluding Japan, amounted to $426m in the year (FY
2020: $202m). 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 $357m in the year (FY
2020: $200m) and $105m in the quarter (Q4 2020: $64m).
Calquence
Calquence has received regulatory approvals for the treatment of patients with
CLL in 76 countries and in 37 countries for the treatment of patients with R/R
mantle cell lymphoma with reimbursement obtained in 25 and 13 countries,
respectively.
Total Revenue, entirely comprising Product Sales, amounted to $1,238m in the
year and represented growth of 137% (136% at CER). US sales increased by 113%
in the year to $1,089m, representing the majority of sales; a strong
performance despite COVID-19 impacts on CLL diagnosis rates, benefitting from
increased new patient market share. In Europe, sales amounted to $111m (FY
2020: $2m) through increased market share in new patient starts after launches
in the region.
Koselugo
Total Revenue, comprising Product Sales predominately in the US, amounted to
$108m (FY 2020: $38m) in the year, following its launch in the second quarter
of 2020. Koselugo treats the rare disease NF1 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 52
(#_ftn34) alterations that have progressed following prior systemic therapy or
are unable to receive chemotherapy. Total Revenue entirely comprising Product
Sales was $16m (FY 2020: $nil).
Zoladex
Total Revenue, predominantly comprising Product Sales, amounted to $966m in
the year and represented an increase of 3% (a decline of 1% at CER).
Emerging Markets sales of Zoladex increased by 10% (5% at CER) to $619m driven
by ex-China markets. In the US, revenue declined by 42% to $32m; while in
Europe, sales increased by 5% (a decline of 1% at CER) to $147m. In Japan,
sales increased by 7% (9% at CER) to $139m.
Faslodex
Total Revenue, entirely comprising Product Sales, amounted to $431m in the
year and represented a decline of 26% (27% at CER) due to increasing
competition from several generic versions of the medicine.
Emerging Markets sales decreased by 8% (10% at CER) to $167m, while US sales
declined by 46% to $30m, and in Europe, sales fell by 49% (52% at CER) to
$113m. In Japan, sales increased 1% (3% at CER) to $118m.
Iressa
Total Revenue, entirely comprising Product Sales, amounted to $183m in the
year and represented a decline of 32% (35% at CER). Emerging Markets sales
fell by 31% (35% at CER) to $151m reflecting generic competition and
increasing patient access to Tagrisso for 1st-line treatment in China, as a
result of NRDL changes.
BioPharmaceuticals: CVRM
Total Revenue increased by 13% (9% at CER) in the year, driven by strong
Farxiga performance, to $8,034m and represented 21% of overall Total Revenue
(FY 2020: 27%).
Farxiga
Total Revenue, predominantly comprising Product Sales, amounted to $3,005m in
the year and represented growth of 53% (49% at CER). The performance of
Farxiga continued to benefit from growth in the SGLT2 53 (#_ftn35) inhibitor
class in many regions, with Farxiga volume growing faster than the overall
SGLT2 market in most major regions.
Emerging Markets sales increased by 74% (70% at CER) to $1,195m in the year,
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. The NRDL status of Forxiga was renewed in the fourth quarter of
2021.
In the US, sales increased by 29% in the year to $732m, reflecting the benefit
of the regulatory approval in May 2020 for HFrEF and the May 2021 approval for
the treatment of CKD. Both approvals include patients with and without T2D 54
(#_ftn36) .
Sales in Europe increased by 60% (52% at CER) to $810m in the year. 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 regulatory approval in August 2021. In Japan, sales to
collaborator Ono Pharmaceutical Co., Ltd, which records in-market sales,
increased by 33% (36% at CER) to $156m.
Brilinta
Total Revenue, entirely comprising Product Sales, amounted to $1,472m in the
year, representing a decrease of 8% (10% at CER). Emerging Markets sales
declined by 29% (31% at CER) to $328m, reflecting the implementation of
China's VBP programme in November 2020, resulting in significantly lower
market access for the medicine, and a mandatory price cut. In the US, sales
increased by 1% to $735m 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. However, US sales in
the fourth quarter declined by 9%, driven by managed markets in addition to
the impact from a new COVID-19 wave. Sales of Brilique in Europe increased by
1% in the year (declined by 4% at CER) to $346m. The overall performance in
the year was adversely impacted by fewer elective procedures due to the
effects of the pandemic.
Onglyza
Total Revenue, entirely comprising Product Sales, amounted to $360m in the
year and represented a decline of 23% (26% at CER). Sales in Emerging Markets
decreased by 11% (14% at CER) to $179m. US sales of Onglyza fell by 47% in the
year to $88m as the DPP-4 55 (#_ftn37) inhibitor class continues to decline,
whereas in Europe sales increased by 5% (1% decrease at CER) to $61m.
Bydureon
Total Revenue, entirely comprising Product Sales, amounted to $385m in the
year, representing a decline of 14% (15% at CER). US sales decreased by 16% in
the year to $321m following the withdrawal of the dual-chamber pen and lower
demand for the Bydureon BCise auto-injector device. Sales in Europe increased
by 5% (stable at CER) to $55m.
Lokelma
Total Revenue, entirely comprising Product Sales, amounted to $175m in the
year, representing an increase of 130%. Sales in the US increased by 102% to
$115m, reflecting the growth in the potassium binder class. Lokelma continued
to be the branded market share leader.
In December 2021, the annual NRDL update was announced in China. Lokelma was
included on the NRDL from 1 January 2022. Sales in Japan increased to $43m in
the year (FY 2020: $10m) despite Ryotanki, a regulation that restricts
prescriptions to two weeks' supply in the first year of launch. The
restriction was lifted in June 2021 and no longer applies. During the period,
expansion in Europe continued with launches in several new markets; sales in
the region amounted to $13m (FY 2020: $4m).
Roxadustat
Total Revenue in China, predominantly comprising Product Sales, amounted to
$180m in the year (FY 2020: $30m). Sales in the fourth quarter were adversely
impacted by stock compensation relating to NRDL renewal. 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.
Crestor
Total Revenue, primarily comprising Product Sales, amounted to $1,098m in the
year and represented a decline of 7% (10% at CER). In Emerging Markets, sales
increased by 4% (stable at CER) to $775m, despite the adverse impact of
China's VBP programme. US sales declined by 13% to $80m, whereas in Europe,
revenue decreased by 59% (61% at CER) in the year to $54m 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 8% (7% at CER) to $151m.
BioPharmaceuticals: Respiratory & Immunology
Total Revenue, which included Ongoing Collaboration Revenue of $15m from
Duaklir, Eklira and other medicines, increased by 13% in the year (9% at CER)
to $6,049m and represented 16% of overall Total Revenue (FY 2020: 20%). In
January 2022, AstraZeneca completed the transfer of global rights
of Eklira and Duaklir to Covis Pharma GmbH.
Symbicort
Total Revenue, entirely comprising Product Sales, was stable at $2,728m in the
year (a decline of 2% at CER). Symbicort remains the global market-volume and
value leader within the ICS 56 (#_ftn38) /LABA 57 (#_ftn39) class, with
market share performance driven by resilience in the US and Europe, and growth
in anti-inflammatory reliever launch markets. The global ICS/LABA market was
stable in the year, due to COVID-19 impacting diagnosis and treatment rates,
while the market remained resilient and showed signs of recovery in second
half of 2021.
In the US, sales increased by 4% in the year to $1,065m. Symbicort maintained
total prescription market share in a declining ICS/LABA market as fixed-dose
triple therapy (LAMA/LABA/ICS) launches continue.
Emerging Markets sales increased by 7% (4% at CER) to $609m, driven by growth
in markets outside China. In Europe, sales decreased by 3% (8% at CER) in the
year to $670m, Symbicort maintained its share in a market that declined
year-on-year due to the favourable COVID-19 impact on FY 2020. Sales in Japan
declined by 34% (33% at CER) to $124m in the year due to continued generic
competition.
Fasenra
Total Revenue, entirely comprising Product Sales, increased by 33% (31% at
CER) in the year to $1,258m as Fasenra expanded its leadership in eosinophilic
asthma. COVID-19 continues to impact total severe asthma market growth with
most regions experiencing a slowing in growth seen in 2020.
Sales in the US increased by 31% to $790m and in Europe by 41% (34% at CER) to
$286m for the year, both regions benefiting from growth in new patient starts.
Sales in Emerging Markets increased 67% to $20m.
Pulmicort
Total Revenue, entirely comprising Product Sales, amounted to $962m in the
year and represented a decrease of 3% (8% at CER). In the fourth quarter,
sales were $248m representing a decrease of 33% (34% at CER), largely as a
result of the inclusion of Pulmicort Respules in the latest round of VBP in
China, implemented in October 2021.
Emerging Markets, where Pulmicort sales decreased by 3% (9% at CER) in the
year to $770m, represented 80% of the global total. The aforementioned VBP
implementation in China resulted in significantly lower market access for the
medicine and a mandatory price reduction. This impact was partially offset by
growth in Emerging Markets ex-China.
Sales in the US increased by 1% in the year to $72m. Europe sales were stable
year-on-year (a decline of 5% at CER) to $73m. In Japan, sales decreased by
24% (22% at CER) in the year to $23m following increasing generic competition.
Breztri
Breztri has received regulatory approval in 39 countries, including the US, in
the EU, China, and Japan, to treat patients with COPD 58 (#_ftn40) ; further
regulatory reviews are ongoing. Breztri has achieved reimbursement in 24
countries.
Total Revenue, entirely comprising Product Sales, amounted to $203m in the
year (FY 2020: $28m). Sales in the US amounted to $115m (FY 2020: $5m),
following market share growth in the fixed-dose triple market. Emerging
Markets sales amounted to $55m in the year (FY 2020: $14m). In China, Breztri
is the market share leader within the fixed-dose triple market, which
continues to gain share from the ICS/LABA class. Sales in Japan amounted to
$25m (FY 2020: $9m). In Europe, under the name Trixeo, sales amounted to $7m
in the year (FY 2020: $nil).
Saphnelo
Saphnelo has received regulatory approval in the US and Japan to treat SLE. In
December 2021, Saphnelo received positive recommendation in the EU from the
CHMP; other regulatory reviews are ongoing.
Total Revenue, entirely comprising Product Sales in the US, amounted to $8m in
the year, following launch in at the end of Q3 2021.
Rare Disease
Total Revenue recorded post-acquisition from 21 July 2021, amounted to $3,071m
representing a pro rata increase of 8% (9% at CER) in the period. Pro rata
growth rates on Rare Disease medicines for the year have been calculated by
comparing post-acquisition revenues from 21 July 2021 with the corresponding
prior year pre-acquisition revenues previously published by Alexion, adjusted
pro rata to match the post-acquisition period.
Soliris
Total Revenue in the year amounted to $1,874m, representing a pro rata
increase of 1% (2% at CER).
In the US, Total Revenue in the year amounted to $1,068m, representing a pro
rata increase of 4%. Sales benefitted from growing use in neurology
indications, gMG and NMOSD, offset by the successful conversion to Ultomiris
in haematological indications PNH and aHUS. Ultomiris offers patients a lower
average annual treatment cost, and a more convenient dosing schedule with
every eight week dosing versus the every two week regimen for Soliris.
Outside of the US, Total Revenue amounted to $806m. Performance during the
period was driven by new country launches and benefitted from order timing in
the fourth quarter.
Ultomiris
Total Revenue in the year amounted to $688m, representing a pro rata increase
of 27% (29% at CER). Quarter on quarter variability can be expected due to the
every eight-week dosing schedule.
In the US, Total Revenue in the year amounted to $381m, representing a pro
rata increase of 20%. Sales benefitted from successful conversion from Soliris
in PNH and aHUS.
Outside of the US, Total Revenue in the year amounted to $307m. Performance
was driven by new country launches in the quarter.
Strensiq
Total Revenue in the year amounted to $378m, representing a pro rata increase
of 13%.
In the US, Total Revenue in the year amounted to $297m, representing pro rata
growth of 13%. Performance benefitted increased demand over the course of the
year as well as channel inventory movements in the fourth quarter.
Other medicines (outside the main disease areas)
Total Revenue, primarily comprising Product Sales, amounted to $2,484m in the
year, a decrease of 6% (7% at CER). This does not include revenue from
Vaxzevria, which is covered in the COVID‑19 commentary below. Other
medicines Total Revenue represented 7% of overall Total Revenue (FY 2020:
10%).
Nexium
Total Revenue, predominantly comprising Product Sales, declined by 7% (8% at
CER) in the year to $1,424m. Revenue in Emerging Markets decreased by 7% (9%
at CER) in the year to $705m, 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 in Q4 2021.
In Japan, where AstraZeneca collaborated with Daiichi Sankyo until September
2021, Product Sales declined by 13% (11% at CER) in the year to $369m. The
quarterly phasing of sales in 2021 was impacted by the phasing of orders from
Daiichi Sankyo ahead of the conclusion of the joint sales promotion by the two
companies in September 2021.
Total Revenue in the US declined by 20% to $150m, and in Europe, it decreased
by 17% (22% at CER) to $62m.
Synagis
Total Revenue, entirely comprising Product Sales, increased by 10% in the year
(13% at CER) to $410m. Sales in Q4 2021 increased by 207% (217% at CER) to
$239m, following an increase in demand in the northern hemisphere due to the
earlier-than-usual RSV 59 (#_ftn41) season in 2021.
Sales in Europe declined by 38% (37% at CER) in the year to $203m. This
performance reflected 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, AstraZeneca's sales to AbbVie were reported in Europe. In Q4
2021, AstraZeneca recorded revenues in regions that, in the prior year, had
been covered by the aforementioned agreement, including sales in Established
Rest of World of $97m (Q4 2020: $nil) and sales in Emerging Markets of $20m
(Q4 2020: $nil).
FluMist
Total Revenue, entirely comprising of Product Sales, declined by 14% (17% at
CER) to $253m in the year 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 62% to $27m as a result. Sales in Europe in the year increased 1%
(declined 2% at CER) to $222m.
COVID-19
Total Revenue of $4,116m included Collaboration Revenue of $114m, of which
$50m was recognised in Q4 2021 for an option agreement to out-license
commercial rights in certain limited geographies for Evusheld, and $10m
related to Collaboration Revenue from a vaccine manufacturer in China.
Vaxzevria
Product Sales amounted to $3,917m in the year, with 963 million doses of
Vaxzevria invoiced worldwide by AstraZeneca. Over half of sales, $2,240m, came
from ex-China Emerging Markets. In Q4 2021, Product Sales of $1,781m came from
a blend of early pandemic contracts and recent orders, and included $64m
recognised as US revenue for vaccine doses that were donated by the US
Government to other nations. In the year, the majority of doses delivered
related to pandemic contracts.
Evusheld
Product Sales contributed $85m, of which $66m came from Europe and $19m from
Emerging Markets. There were no Evusheld sales recorded in the US or
Established Rest of World.
Regional Total Revenue
A geographical split of Product Sales is shown in Note 8 to the Condensed
Financial Statements.
Table 10: Regional Total Revenue
FY 2021 Q4 2021
% of Actual % CER % Actual % CER %
$m total change change $m change change
Emerging Markets 12,281 33 41 36 3,663 63 61
- China 6,011 16 12 4 1,312 (4) (8)
- Ex-China 6,270 17 88 89 2,351 n/m n/m
US 12,228 33 38 38 3,923 64 64
Europe 8,050 22 45 40 2,872 57 58
Established RoW 4,858 13 37 37 1,553 64 72
- Japan 3,498 9 34 37 1,137 58 71
- Canada 772 2 28 19 236 62 54
- Other Established RoW 588 2 90 76 180 n/m n/m
Total 37,417 100 41 38 12,011 62 63
Table 11: Emerging Markets Total Revenue disease area performance
FY 2021 Q4 2021
% of Actual % CER % Actual % CER %
$m total change change $m change change
Oncology 3,223 26 11 6 785 18 15
BioPharmaceuticals: CVRM 3,785 31 17 12 869 10 8
BioPharmaceuticals: R&I 1,749 14 9 4 445 (19) (21)
Rare Disease(16) 196 2 11 18 131 81 91
Other medicines 956 8 (1) (4) 200 (17) (18)
COVID-19 2,372 19 n/m n/m 1,233 n/m n/m
Total 12,281 100 41 36 3,663 63 61
Table 12: Ex-China Emerging Markets Total Revenue
FY 2021 Q4 2021
Actual % CER % Actual % CER %
$m change change $m change change
Ex-China Emerging Markets 6,270 88 89 2,351 n/m n/m
- Russia 445 42 45 138 80 71
- Brazil 973 n/m n/m 523 n/m n/m
- Ex-Brazil Latin America 1,132 n/m n/m 467 n/m n/m
- Ex-China Asia Pacific 2,526 n/m n/m 891 n/m n/m
- Middle East and Africa 1,194 17 20 332 30 38
China Total Revenue comprised 49% of Emerging Markets Total Revenue (FY 2020:
62%) and increased by 12% (4% at CER) in the year to $6,011m.
Excluding Vaxzevria, Ex-China Emerging Markets Total Revenue increased by 19%
in the year (21% at CER) to $3,977m.
Financial performance
Table 13: Reported Profit and Loss - FY 2021
FY 2021 FY 2020 Actual CER
$m $m % change % change
Total Revenue 37,417 26,617 41 38
- Product Sales 36,541 25,890 41 38
- Collaboration Revenue 876 727 20 20
Cost of Sales (12,437) (5,299) n/m n/m
Gross Profit 24,980 21,318 17 17
Gross Profit Margin 66.0% 79.5% -14 -13
Distribution Expense (446) (399) 12 7
% Total Revenue 1.2% 1.5% - -
R&D Expense (9,736) (5,991) 62 59
% Total Revenue 26.0% 22.5% -4 -3
SG&A Expense (15,234) (11,294) 35 32
% Total Revenue 40.7% 42.4% +2 +2
Other Operating Income & Expense 1,492 1,528 (2) (4)
% Total Revenue 4.0% 5.7% -2 -2
Operating Profit 1,056 5,162 (80) (70)
Operating Margin 2.8% 19.4% -17 -15
Net Finance Expense (1,257) (1,219) 3 2
Joint Ventures and Associates (64) (27) n/m n/m
(Loss)/Profit before tax (265) 3,916 n/m (93)
Taxation 380 (772) n/m n/m
Tax rate 143% 20%
Profit after tax 115 3,144 (96) (83)
Earnings per share $0.08 $2.44 (97) (84)
Table 14: Reported Profit and Loss - Q4 2021
Q4 2021 Q4 2020 Actual CER
$m $m % change % change
Total Revenue 12,011 7,410 62 63
- Product Sales 11,498 7,011 64 65
- Collaboration Revenue 513 399 29 29
Cost of Sales (4,625) (1,525) n/m n/m
Gross Profit 7,386 5,885 25 31
Gross Profit Margin 59.8% 78.2% -18 -16
Distribution Expense (124) (109) 14 13
% Total Revenue 1.0% 1.5% - -
R&D Expense (2,584) (1,719) 50 50
% Total Revenue 21.5% 23.2% 2 2
SG&A Expense (5,117) (3,210) 59 59
% Total Revenue 42.6% 43.3% 1 1
Other Operating Income & Expense 147 640 (77) (78)
% Total Revenue 1.2% 8.6% -7 -7
Operating (Loss)/Profit (292) 1,487 n/m n/m
Operating Margin -2.4% 20.1% -22 -20
Net Finance Expense (335) (314) 7 8
Joint Ventures and Associates (9) (6) 53 51
(Loss)/Profit Before Tax (636) 1,167 n/m n/m
Taxation 290 (162) n/m n/m
Tax rate 46% 14%
(Loss)/Profit After Tax (346) 1,005 n/m n/m
(Loss)/Earnings per share $(0.22) $0.78 n/m n/m
Table 15: Reconciliation of Reported (Loss)/Profit Before Tax to EBITDA - FY
2021
FY 2021 FY 2020 Actual CER
$m $m % change % change
Reported (Loss)/Profit Before Tax (265) 3,916 n/m (93)
Net Finance Expense 1,257 1,219 3 2
Joint Venture and Associates 64 27 n/m n/m
Depreciation, Amortisation and Impairment 6,530 3,149 n/m 99
EBITDA 7,586 8,311 (9) (6)
EBITDA of $7,586m in the year (FY 2020: $8,311m) has been negatively impacted
by the $2,198m (FY 2020: $nil) unwind of inventory fair value uplift
recognised on acquisition of Alexion, as well as increased restructuring
charges arising from the Post Alexion Acquisition Group Review. 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 (Loss)/Profit Before Tax to EBITDA - Q4
2021
Q4 2021 Q4 2020 Actual CER
$m $m % change % change
Reported (Loss)/Profit Before Tax (636) 1,167 n/m n/m
Net Finance Expense 335 314 7 8
Joint Venture and Associates 9 6 53 51
Depreciation, Amortisation and Impairment 2,192 797 n/m n/m
EBITDA 1,900 2,284 (17) (8)
EBITDA of $1,900m in the quarter (Q4 2020: $2,284m) has been negatively
impacted by the $1,154m (QTD 2020: $nil) unwind of inventory fair value uplift
recognised on acquisition of Alexion, as well as increased restructuring
charges arising from the Post Alexion Acquisition Group Review. The unwind of
inventory fair value is expected to depress EBITDA over approximately 18
months post-acquisition in line with revenues.
Table 17: Reconciliation of Reported to Core financial measures - FY 2021
FY 2021 Reported Restructuring Intangible Asset Amortisation & Impairments Acquisition of Alexion 60 (#_ftn42) Other 61 (#_ftn43) Core 62 (#_ftn44) Core Reported% change
% change
$m $m $m $m $m $m Actual $m
Gross Profit 24,980 722 66 2,206 (1) 27,973 30 30
Gross Profit Margin 66.0% 74.2% -6 -5
Distribution Expense (446) - - - - (446) 12 7
R&D Expense (9,736) 223 1,496 28 2 (7,987) 36 33
SG&A Expense (15,234) 338 3,584 207 1 (11,104) 19 15
Total Operating Expense (25,416) 561 5,080 235 3 (19,537) 25 22
Other Operating Income & Expense 1,492 - - - - 1,492 (3) (4)
Operating Profit 1,056 1,283 5,146 2,441 2 9,928 35 41
Operating Margin 2.8% 26.5% -1 +1
Net Finance Expense (1,257) - - - 395 (862) 10 11
Taxation 380 (249) (1,024) (531) (70) (1,494) 14 19
EPS $0.08 $0.73 $2.91 $1.34 $0.23 $5.29 32 37
Table 18: Reconciliation of Reported to Core financial measures - Q4 2021
FY 2021 Reported Restructuring Intangible Asset Amortisation & Impairments Acquisition of Alexion(57) Other(58) Core(59) Core Reported% change
% change
$m $m $m $m $m $m Actual $m
Gross Profit 7,386 501 19 1,157 (3) 9,060 53 59
Gross Profit Margin 59.8% 74.3% -4 -2
Distribution Expense (124) - - - - (124) 14 13
R&D Expense (2,584) 68 101 18 1 (2,396) 40 40
SG&A Expense (5,117) 166 1,607 41 (65) (3,368) 19 18
Total Operating Expense (7,825) 234 1,708 59 (64) (5,888) 27 26
Other Operating Income & Expense 147 - (1) - - 146 (77) (78)
Operating Profit (292) 735 1,726 1,216 (67) 3,318 75 94
Operating Margin -2.4% 27.6% +2 +5
Net Finance Expense (335) - - - 102 (233) 14 16
Taxation 290 (156) (327) (289) (15) (497) 67 88
EPS $(0.22) $0.37 $0.91 $0.60 $0.01 $1.67 56 74
Profit and Loss summary
a) Gross Profit
Reported Gross Profit Margin in the year declined 14 (13 at CER) percentage
points to 66%; Core Gross Profit Margin declined six (five at CER) percentage
points in the year to 74.2% 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). These effects were partially offset by the contribution from
Alexion from 21 July 2021 and a larger proportion of Oncology sales. Reported
Gross Profit Margin has also been impacted by restructuring charges and 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 Q4 2021, the impact of
the fair value uplift unwind on Cost of Sales was $1,154m. Variations in gross
margin performance between periods can be expected to continue.
b) Total Operating Expense
Reported Total Operating Expense increased in the year by 44% (40% at CER) to
$25,416m. Core Total Operating Expense increased by 25% (22% at CER) to
$19,537m and represented 52% of Total Revenue (FY 2020: 59%).
Reported R&D Expense increased in the year by 62% (59% at CER) to $9,736m
including intangible asset impairment charges recognised in the year of
$1,464m of which $1,172m relates to the impairment recorded in the third
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 by 36% (33% at CER) to $7,987m with
increases in both Reported and Core R&D Expense reflecting the Company's
continued investment in Vaxzevria and Evusheld, 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, grant income of $533m has been recognised, of which $309m has been
offset against the US clinical trial costs for Vaxzevria and $224m offset
against costs for Evusheld.
Reported SG&A Expense increased in the year by 35% (32% at CER) to
$15,234m including the increased amortisation of intangible assets related to
the Alexion acquisition, increased restructuring charges of $338m primarily
comprise supply chain restructuring, exit costs for de-prioritised R&D
projects, and severance payments. Intangible asset impairment charges of $603m
have been recorded in SG&A, of which $469m relates to the impairment of
Bydureon.
Core SG&A Expense increased by 19% (15% at CER) to $11,104m, reflecting
the investment in Oncology-medicine launches, the launch of several new
BioPharmaceuticals medicines, particularly in the US, and AstraZeneca's
further expansion in Emerging Markets.
c) Other Operating Income and Expense
Reported and Core Other Operating Income and Expense decreased in the year to
$1,492m, by 2% (4% at CER) and by 3% (4% at CER) 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
- $317m 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
In FY 2020, Other Operating Income included divestment gains for the
commercial rights to Atacand and a number of legacy hypertension medicines.
d) Net Finance Expense
Reported Net Finance Expense increased in the year by 3% (2% at CER) to
$1,257m, principally reflecting lower interest income on securities and
short-term deposits 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 by 10% (11%
at CER) to $862m and was principally driven by the aforementioned lower
interest income and Alexion-related financing costs.
e) Taxation
The Reported Tax Rate for the year was 143% (2020: 20%), being a tax benefit
on the Reported Loss Before Tax, and the Core Tax Rate was 17% (2020: 20%).
The Reported and Core tax rates benefitted from the following one-off
favourable impacts:
- A non-taxable gain on the divestment of the investment in Viela; and
- A reduction of tax liabilities arising from updates to estimates of
prior period tax liabilities following settlements with tax authorities and on
expiry of statute of limitations, partially offset by a tax charge on
recalculation of deferred tax balances following substantive enactment of
Dutch and UK Corporation Tax rate increases.
Excluding these net benefits, the Core Tax Rate would have been c.21%.
The net cash tax paid for the year was $1,743m (FY 2020: $1,562m).
f) EPS
Reported EPS in the year declined 97% (84% at CER) to $0.08 (FY 2020: $2.44).
Core EPS increased by 32% (37% at CER) to $5.29.
g) Dividend per share
The Board reaffirms its commitment to the progressive dividend policy. A
second interim dividend of $1.97 per share (145.3 pence, 18.00 SEK) has been
declared, meaning a full-year dividend per share of $2.87 (210.1 pence, 25.77
SEK). Dividend payments are normally paid as follows:
- First interim dividend - announced with half-year and second-quarter
results and paid in September
- Second interim dividend - announced with full-year and fourth-quarter
results and paid in March
The record date for the second interim dividend for 2021, payable on 28 March
2022, will be 25 February 2022. The ex-dividend date will be 24 February 2022.
The record date for the first interim dividend for 2022, payable on 12
September 2022, will be 12 August 2022. The ex-dividend date will be 11 August
2022.
Table 19: Cash Flow Summary
FY 2021 FY 2020 Change
$m $m $m
Reported Operating Profit 1,056 5,162 (4,106)
Depreciation, Amortisation and Impairment 6,530 3,149 3,381
Decrease in Working Capital and Short-term Provisions 2,021 361 1,721
Gains on Disposal of Intangible Assets (513) (1,030) 517
Gains on Disposal of Investments in Associates and Joint Ventures (776) - (776)
Non-Cash and Other Movements 109 (548) 596
Interest Paid (721) (733) 12
Taxation Paid (1,743) (1,562) (181)
Net Cash Inflow from Operating Activities 5,963 4,799 1,164
Net Cash (Outflow)/Inflow before Financing Activities (5,095) 4,514 (9,609)
Net Cash Inflow/(Outflow) from Financing Activities 3,649 (2,203) 5,852
Net Cash Inflow from Operating Activities increased in the year by $1,164m to
$5,963m.
The decrease in Net Cash (Outflow)/Inflow before Financing Activities of
$9,609m is principally due to the Alexion acquisition, specifically the
upfront payment of $13,349m, less cash and cash equivalents acquired of
$4,086m, and $211m of payments upon vesting of employee share awards. This
decrease is partially offset by the aforementioned improvement in Net Cash
Inflow from Operating Activities.
The Reported Operating Profit of $1,056m in FY2021 includes a negative impact
of $2,198m relating to the unwind of the inventory fair value uplift
recognised on acquisition of Alexion. This is offset by a corresponding item
(positive impact of $2,198m) in Decrease in Working Capital and Short-term
Provisions. Overall, the unwind of the fair value uplift has no impact on the
Net Cash Inflow from Operating Activities.
Capital Expenditure
Capital Expenditure amounted to $1,091m in the year (FY 2020: $961m). 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 20: Net Debt summary
At 31 Dec 2021 At 31 Dec 2020
$m $m
Cash and cash equivalents 6,329 7,832
Other investments 69 160
Cash and investments 6,398 7,992
Overdrafts and short-term borrowings (387) (658)
Lease liabilities (987) (681)
Current instalments of loans (1,273) (1,536)
Non-current instalments of loans (28,134) (17,505)
Interest-bearing loans and borrowings (30,781) (20,380)
(Gross Debt)
Net derivatives 61 278
Net Debt (24,322) (12,110)
Net Debt increased by $12,212m in the year to $24,322m 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 year to
31 December 2021. At 31 December 2021, the Company's solicited credit ratings
from S&P were A- (long term) and A-2 (short term), and from Moody's
Investor Service 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 21: Obligor group summarised Statement of Comprehensive income
FY 2021 FY 2020
$m $m
Total revenue - -
Gross profit - -
Operating loss (157) (45)
Loss for the period (773) (663)
Transactions with subsidiaries that are not issuers or guarantors 5,914 2,637
Table 22: Obligor group summarised Statement of Financial position information
At 31 Dec 2021 At 31 Dec 2020
$m $m
Current assets 8 26
Non-current assets - 4
Current liabilities (1,442) (1,720)
Non-current liabilities (25,646) (17,161)
Amounts due from subsidiaries that are not issuers or guarantors 11,510 7,011
Amounts due to subsidiaries that are not issuers or guarantors (293) (290)
Foreign exchange
The Company's transactional currency exposures on working capital balances,
which typically extend for up to three months, are hedged where practicable
using forward foreign-exchange contracts against the individual companies'
reporting currency. Foreign-exchange gains and losses on forward contracts for
transactional hedging are taken to profit or loss. In addition, the Company's
external dividend payments, paid principally in pounds sterling and Swedish
krona, are fully hedged from announcement to payment date.
Table 23: Currency sensitivities
The Company provides the following currency-sensitivity information:
Average exchange Annual impact of 5% strengthening in exchange rate versus USD ($m)(( 63
(#_ftn45) ))
rates versus USD
Currency Primary Relevance FY 2021 64 (#_ftn46) YTD 2022(( 65 (#_ftn47) )) % change Total Revenue Core Operating Profit
CNY Total Revenue 6.43 6.36 1 277 158
EUR Total Revenue 0.85 0.88 (4) 317 160
JPY Total Revenue 109.83 114.90 (5) 229 158
Other(( 66 (#_ftn48) )) 420 196
GBP Operating Expense 0.73 0.74 (1) 61 (93)
SEK Operating Expense 8.58 9.14 (7) 6 (82)
Sustainability
AstraZeneca's sustainability approach has three priority areas 67 (#_ftn49) ,
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.
a) Access to healthcare
In the fourth quarter of 2021, the Company delivered approximately 102 million
doses of its COVID-19 vaccine through COVAX. As of the end December 2021, the
Company and its sublicensee SII had delivered more than 247 million doses with
COVAX to 130 countries. AstraZeneca and its sublicensee SII remain the largest
contributor to COVAX. As of February 2022, AstraZeneca and its sub-licensing
partners have released more than 2.6 billion vaccine doses, for supply in over
180 countries. Approximately two thirds of the doses have gone to low and
middle-income countries.
The Company's Healthy Heart Africa (HHA) programme marked its seventh
anniversary in Kenya at the joint Pan-African Society of Cardiology/Kenya
Cardiac Society (PASCAR/KCS) Congress in Mombasa in November. The HHA
programme featured during a panel session on Health system resilience to
improve and maintain access to cardiovascular diseases care, chaired by
Professor Elijah Ogola, Secretary General of PASCAR and Principal investigator
for the HHA programme. Since the programme launched in 2015, HHA has conducted
over 23 million blood pressure screenings, identified over 4.5 million
elevated readings, activated over 950 sites and trained more than 9,000
healthcare workers and volunteers.
During the quarter, the Company's Young Health Programme (YHP), in
collaboration with Plan International UK and various public sector bodies,
reached more than 815,000 young people with health information and advocacy
initiatives, including successful expansion into Japan, Jordan and Malaysia.
This, along with new reporting from UNICEF, brings the reach of the YHP in
2021 to almost four million young people.
On International Day of the Girl on October 11, 2021, the YHP platform was
used to promote awareness of inclusion and diversity through the global
#GirlsBelongHere campaign which placed more than 50 girls into mentorship
opportunities with Senior Executive Team and Board members, providing a
valuable opportunity to share viewpoints and sharpen internal
awareness on the barriers to women in the workplace.
In collaboration with One Young World, the YHP also hosted a session at COP26
in November, on the intersection of health and climate, with an emphasis on
adolescent health. This focus continued in remarks given by Company Chairman
Leif Johansson at the invitation of UNICEF at the inaugural Global Forum for
Children and Youth (https://www.childrenyouthforum.org/) in December 7. At
this Forum, the Company pledged its commitment to the "Commitment to Children
and Youth Platform", also reinforcing the links to the Sustainable Development
Goals.
Research is now underway in eight of the 13 countries selected as part of
Phase 2 of The Partnership for Health System Sustainability and Resilience
(PHSSR (https://www.weforum.org/phssr) ) policy programme. New partners have
joined the initiative including Philips, KPMG and the European Observatory on
Health Systems and Policies. AstraZeneca convened a hybrid summit on health
system sustainability and resilience at EXPO2020 in Dubai in January, together
with health ministers, key partners and former Heads of State.
b) Environmental protection
The Company made good progress in reducing its Scope 1 and 2 greenhouse gas
emissions. As at the end of December 2021, the Company had achieved 59%
reduction compared with its 2015 baseline. All imported electricity is now
from renewable sources. This includes the full integration of Alexion's carbon
footprint and rebasing 2015.
Following the launch of the Sustainable Markets Initiative (SMI) Health
Systems Taskforce
(https://www.sustainable-markets.org/taskforces/health-systems-taskforce/)
(https://www.sustainable-markets.org/taskforces/health-systems-taskforce/) at
COP26, the Taskforce has convened several times under Chief Executive
Officer Pascal Soriot's leadership, to progress towards its ambition
of accelerating the delivery of net zero healthcare.
In December 2021, AstraZeneca was CDP AA rated for Climate and Water
(https://www.cdp.net/en/companies/companies-scores?linkId=143461431) for the
sixth year in succession, recognised for its environmental leadership in both
climate change and water security. The Company was also rated for the first
time for the restoration of forests and ecosystems, gaining a C rating.
In November 2021, the Company announced a new partnership with Forestry
England and Borders Forest Trust to plant one million trees across the UK
that will support reforestation efforts across England and Southern Scotland.
Through Forestry England, planting efforts will initially be focused on
Thetford Forest, 30 miles from the Company's new Cambridge Discovery Centre,
and in the Goyt Valley, ten miles from AstraZeneca's Macclesfield site, as
both areas have suffered in recent years from the impact of pests and disease.
In Scotland, planting will focus on two 'wild heart' sites, aimed at reviving
the Wild Heart of Southern Scotland and bringing back lost habitats in the
area.
In December 2021, the Company announced a partnership with Future Biogas to
build a new renewable energy plant to generate biomethane, as a substitute for
natural gas, to provide a renewable source of heat and power for AstraZeneca's
UK sites in Macclesfield, Cambridge, Speke, and Luton. This initiative will
help, in part, with the Company's transition to 100% renewable energy for heat
and power, as well as provide additional renewable gas to the UK gas grid.
c) Ethics and transparency
In November 2021, the Company was recognised as one of the most sustainable
pharmaceutical companies with 6(th) position in their sector in the Dow Jones
Sustainability Index (DJSI). In January 2022, for the fifth year in a row, the
Company was ranked amongst the Corporate Knights Global 100 most sustainable
corporations
(https://www.corporateknights.com/rankings/global-100-rankings/2022-global-100-rankings/global-100-companies-prove-sustainability-is-good-for-business/)
, following an assessment of nearly 7,000 public companies.
In January 2022, AstraZeneca's inclusion in the Bloomberg Gender Equality
Index for 2022 was confirmed for the fourth consecutive year. Gender equality
is vitally important to AstraZeneca, as women excelling in scientific careers
is key to ensuring the Company is truly inclusive and representative of the
communities in which it operates.
In collaboration with an independent consultancy, and with input from our
Sustainability Advisory Board (SAB) AstraZeneca used the results of its 2021
Materiality Assessment survey and stakeholder input to prioritise those issues
where it can have the most positive impacts on patients, healthcare systems,
the environment and society. The materiality assessment confirmed the existing
strategic priority pillars and identified nine broader material focus areas,
which will be reflected in the overall sustainability strategy and priorities
going forward. Following this exercise, it was agreed that the SAB had
fulfilled its remit.
Research and development
A comprehensive view of AstraZeneca's pipeline of medicines in human trials
can be found in the latest clinical trials appendix, available on
www.astrazeneca.com/investor-relations
(https://www.astrazeneca.com/investor-relations.html) . The clinical trials
appendix includes tables with details of the ongoing clinical trials for
AstraZeneca medicines and new molecular entities in the pipeline.
Oncology
Significant new trials in Oncology where the first patient was dosed as of 10
February 2022 included, DESTINY-Breast11, a Phase III trial of Enhertu in
neoadjuvant HER2+ breast cancer, and TROPION-Breast01 a Phase III trial of
datopotamab deruxtecan in metastatic HR+, HER2-negative breast cancer.
AstraZeneca presented new data across its diverse portfolio of cancer
medicines at the San Antonio Breast Cancer Symposium (SABCS), the 63rd
American Society of Hematology (ASH) Annual Meeting in December 2021, and at
the American Society of Clinical Oncology Gastrointestinal Cancers Symposium
(ASCO GI) in January 2022.
Data presented at SABCS included 33 abstracts spanning 14 medicines and
potential new medicines including new analyses from the DESTINY-Breast03 Phase
III trial of Enhertu, early data in advanced triple negative breast cancer
from the TROPION-PanTumor01 Phase I trial of datopotamab deruxtecan and the
BEGONIA Phase Ib/II trial of Imfinzi in combination with oleclumab and
capivasertib.
ASH featured more than 25 abstracts across the Company's haematology portfolio
and pipeline, including an oral presentation of three-year follow-up data from
the ASCEND Phase III trial for the use of Calquence in relapsed or refractory
chronic lymphocytic leukaemia.
ASCO GI featured over 20 abstracts, including data from Imfinzi plus
tremelimumab in 1st-line unresectable liver cancer in the HIMALAYA Phase III
trial, as well as initial results for Imfinzi from the TOPAZ-1 Phase III trial
in advanced biliary tract cancer.
Imfinzi
In January 2022, AstraZeneca presented results from the HIMALAYA Phase III
trial at the aforementioned 2022 ASCO GI meeting. The results showed a single
priming dose of tremelimumab added to Imfinzi demonstrated a statistically
significant and clinically meaningful improvement in OS 68 (#_ftn50) versus
sorafenib as a 1st-line treatment for patients with unresectable HCC who had
not received prior systemic therapy and were not eligible for localised
treatment.
Patients on the STRIDE 69 (#_ftn51) regimen saw a 22% reduction in risk of
death versus sorafenib (HR 0.78, 96.02% CI 0.65-0.93; p=0.0035). Median OS was
16.4 months versus 13.8 for sorafenib. An estimated 31% of patients were still
alive at three years versus 20% for sorafenib. Results also showed an increase
in ORR 70 (#_ftn52) with the STRIDE regimen versus sorafenib (20.1% vs.
5.1%). Median DoR 71 (#_ftn53) was 22.3 months with the STRIDE regimen versus
18.4 with sorafenib. The addition of tremelimumab to Imfinzi did not increase
severe liver toxicity, and no bleeding risk was observed.
HIMALAYA also tested Imfinzi monotherapy, which demonstrated non-inferior OS
to sorafenib (HR 0.86; 95.67% CI 0.73-1.03; non-inferiority margin 1.08) with
a median OS of 16.6 months versus 13.8, and an improved tolerability profile
versus sorafenib.
In January 2022, AstraZeneca also presented results from an interim analysis
of TOPAZ-1, where patients treated with Imfinzi in combination with
standard-of-care chemotherapy experienced a 20% reduction in the risk of death
versus chemotherapy alone (HR of 0.80; 95% CI, 0.66-0.97; 2-sided p=0.021).
Median OS was 12.8 months versus 11.5 for chemotherapy. An estimated 25% of
patients were still alive at two years versus 10% for chemotherapy.
Results also showed a 25% reduction in the risk of disease progression or
death with Imfinzi plus chemotherapy (HR, 0.75; 95% CI, 0.64-0.89; 2-sided
p=0.001). Median PFS was 7.2 months for the combination versus 5.7 for
chemotherapy. Patients treated with Imfinzi plus chemotherapy achieved an ORR
of 26.7% versus 18.7% for patients treated with chemotherapy alone. Imfinzi
plus chemotherapy did not increase the discontinuation rate due to AEs
compared to chemotherapy alone.
During the period, AstraZeneca received regulatory submission acceptance in
the US and EU and completed regulatory submission in Japan for Imfinzi +/-
tremelimumab use in the treatment of in 1st-line Stage IV non-small cell lung
cancer based on the results of the POSEIDON Phase III trial.
Lynparza
In November 2021, AstraZeneca announced that the supplemental New Drug
Application (sNDA) for Lynparza had been accepted and granted Priority Review
in the US for the adjuvant treatment of patients with BRCA-mutated
HER2-negative high-risk early breast cancer who have already been treated with
chemotherapy either before or after surgery.
During the period, AstraZeneca received regulatory submission acceptance in
the EU for Lynparza use in the treatment of 1st-line mCRPC based on the
results of the PROpel Phase III trial.
Enhertu
In January 2022, AstraZeneca and Daiichi Sankyo received notification that the
supplemental Biologics License Application (sBLA) for Enhertu had been
accepted and granted Priority Review in the US for the treatment of adult
patients in the US with unresectable or metastatic HER2-positive breast cancer
who have received a prior anti-HER2-based regimen based on the results of the
DESTINY-Breast03 Phase III trial. Regulatory submission acceptance has also
been received in the EU, and submission made in Japan, based on the results of
this trial.
During the period, Enhertu was assigned category 1 status in the NCCN
guidelines for both for the second-line treatment of HER2-positive metastatic
breast cancer, and in the first-line setting for patients whose disease is
rapidly progressing following neoadjuvant or adjuvant therapy.
BioPharmaceuticals - CVRM
Significant new trials in CVRM where the first patient was dosed during the
period included STABILIZE-CKD, a Phase III trial of Lokelma to evaluate the
effect of the medicine as an adjunct to ACEi 72 (#_ftn54) or ARB 73
(#_ftn55) therapy on slowing CKD progression in patients with hyperkalaemia or
at high risk of hyperkalaemia.
Brilinta
During the period, the Company decided to withdraw its EMA regulatory
application seeking approval for Brilique to reduce the risk of stroke in
patients with an acute ischaemic stroke or high-risk transient ischaemic
attack. Brilinta is approved in the aforementioned indication in the US.
Lokelma
In November 2021, AstraZeneca was granted Fast Track Designation in the US for
the investigation of Lokelma to reduce arrhythmia-related cardiovascular
outcomes in patients on chronic haemodialysis with recurrent hyperkalaemia.
The designation is based on the potential of Lokelma to reduce serious
adverse CV outcomes in this patient population. Lokelma is currently being
evaluated in this indication in the ongoing Phase III DIALIZE-Outcomes trial.
Eplontersen
In January 2022, eplontersen was granted ODD by the US FDA 74 (#_ftn56) for
the treatment of transthyretin-mediated amyloidosis. Eplontersen is currently
in Phase III clinical trials for amyloid transthyretin cardiomyopathy
(ATTR-CM) and amyloid transthyretin polyneuropathy (ATTR-PN).
BioPharmaceuticals - Respiratory & Immunology
Tezspire (tezepelumab)
During the period, Tezspire received US regulatory approval following a
Priority Review for the add-on maintenance treatment of adult and paediatric
patients aged 12 years and older with severe asthma. Tezspire is the only
biologic approved for severe asthma with no phenotype (e.g. eosinophilic or
allergic) or biomarker limitation within its approved label. The approval was
based on efficacy and safety data from the PATHFINDER clinical trial
programme. The application included results from the pivotal NAVIGATOR Phase
III trial in which Tezspire demonstrated superiority across every primary and
key secondary endpoint in patients with severe asthma, compared to placebo,
when added to standard therapy.
In October 2021, tezepelumab was granted Orphan Drug Designation by the FDA
for the treatment of eosinophilic esophagitis.
Saphnelo
During the period, Saphnelo was recommended for approval in the EU by the CHMP
of the European Medicines Agency as an add-on therapy for the treatment of
adult patients with moderate to severe, active autoantibody-positive SLE,
despite receiving standard therapy. The positive opinion is based on results
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 all affected organ systems from baseline and achieved sustained
reduction in oral corticosteroid use compared to placebo, with both groups
receiving standard therapy. The Company anticipates a regulatory decision for
the EU in H1 2022.
Rare Disease
Ultomiris
During the period, Alexion announced that its sBLA for Ultomiris had been
accepted and granted Priority Review in the US for the treatment of adults
with generalised myasthenia gravis. The FDA set a Prescription Drug User Fee
Act date during the second quarter of 2022, following use of a priority review
voucher.
COVID-19
COVID-19 vaccines
In January 2022, a preliminary analysis of a safety and immunogenicity trial
(D7220C00001) showed that Vaxzevria, when given as a third dose booster,
increased the immune response to Beta, Delta, Alpha and Gamma SARS-CoV-2
variants, while a separate analysis showed increased antibody response to the
Omicron variant.
Positive interim results of the trial and additional analysis demonstrated
that AZD2816 generated a similar immune response to Vaxzevria against variants
of concern, including Omicron, and AZD2816 and Vaxzevria were found to be
generally well tolerated. Given these data, the low circulation of the Beta
variant and the substantial body of evidence supporting Vaxzevria against
current variants of concern, AstraZeneca has discontinued the AZD2816
development programme and will continue to focus on the supply of Vaxzevria
around the world.
Evusheld (AZD7442, tixagevimab/cilgavimab)
In November, an analysis of the ongoing PROVENT Phase III trial evaluating a
median six months of participant follow-up, showed one 300mg i.m. 75
(#_ftn57) dose of Evusheld reduced the risk of developing symptomatic COVID-19
compared to placebo by 83%.
During the period, Evusheld received Emergency Use Authorisation (EUA) in the
US for the pre-exposure prophylaxis (prevention) of COVID-19 and received
similar authorisations in other markets, including France and Bahrain.
In December, pre-clinical data from 'live' virus neutralisation data from both
University College Oxford, UK and Washington University School of Medicine,
St. Louis, US, published in pre-print
(https://www.biorxiv.org/content/10.1101/2021.12.15.472828v1) , demonstrated
that Evusheld retained neutralising activity against the Omicron SARS-CoV-2
variant (B.1.1.529). Evusheld's Inhibitory Concentration 50 (IC50), a measure
of neutralising potency of an antibody, was within the range of neutralising
antibody titres found in individuals who have been previously infected with
and recovered naturally from COVID‑19.
These findings are in line with pseudovirus neutralising data
(https://opendata.ncats.nih.gov/variant/activity) from independent
investigators at the FDA announced on 16 December 2021, and add to the growing
body of preclinical evidence demonstrating that Evusheld retains activity
against all tested SARS-CoV-2 variants of concern to date.
Condensed Financial Statements
Table 24: FY 2021 - Condensed consolidated statement of comprehensive income
For the year ended 31 December 2021 2020
$m $m
Total Revenue 37,417 26,617
Product Sales 36,541 25,890
Collaboration Revenue 876 727
Cost of Sales (12,437) (5,299)
Gross profit 24,980 21,318
Distribution costs (446) (399)
Research and development expense (9,736) (5,991)
Selling, general and administrative expense (15,234) (11,294)
Other operating income and expense 1,492 1,528
Operating profit 1,056 5,162
Finance income 43 87
Finance expense (1,300) (1,306)
Share of after tax losses in associates and joint ventures (64) (27)
(Loss)/Profit before tax (265) 3,916
Taxation 380 (772)
Profit for the period 115 3,144
Other comprehensive (loss)/income
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability 626 (168)
Net (losses)/gains on equity investments measured at fair value through other (187) 938
comprehensive income
Fair value movements related to own credit risk on bonds designated as fair - (1)
value through profit or loss
Tax on items that will not be reclassified to profit or loss 105 (81)
544 688
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation (483) 443
Foreign exchange arising on designated borrowings in net investment hedges (321) 573
Fair value movements on cash flow hedges (167) 180
Fair value movements on cash flow hedges transferred to profit or loss 208 (254)
Fair value movements on derivatives designated in net investment hedges 34 8
(Costs)/gains of hedging (6) 9
Tax on items that may be reclassified subsequently to profit or loss 46 (39)
(689) 920
Other comprehensive (loss)/income for the period, net of tax (145) 1,608
Total comprehensive (loss)/income for the period (30) 4,752
Profit attributable to:
Owners of the Parent 112 3,196
Non-controlling interests 3 (52)
115 3,144
Total comprehensive income attributable to:
Owners of the Parent (33) 4,804
Non-controlling interests 3 (52)
(30) 4,752
Basic earnings per $0.25 Ordinary Share $0.08 $2.44
Diluted earnings per $0.25 Ordinary Share $0.08 $2.44
Weighted average number of Ordinary Shares in issue (millions) 1,418 1,312
Diluted weighted average number of Ordinary Shares in issue (millions) 1,427 1,313
Table 25: Q4 2021 - Condensed consolidated statement of comprehensive income
For the quarter ended 31 December 2021 2020
$m $m
Total Revenue 12,011 7,410
Product Sales 11,498 7,011
Collaboration Revenue 513 399
Cost of Sales (4,625) (1,525)
Gross profit 7,386 5,885
Distribution costs (124) (109)
Research and development expense (2,584) (1,719)
Selling, general and administrative expense (5,117) (3,210)
Other operating income and expense 147 640
Operating (loss)/profit (292) 1,487
Finance income 1 7
Finance expense (336) (321)
Share of after tax losses in associates and joint ventures (9) (6)
(Loss)/Profit before tax (636) 1,167
Taxation 290 (162)
(Loss)/Profit for the period (346) 1,005
Other comprehensive (loss)/income
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability 34 23
Net losses on equity investments measured at fair value through other (331) (36)
comprehensive income
Fair value movements related to own credit risk on bonds designated as fair (4) -
value through profit or loss
Tax on items that will not be reclassified to profit or loss 34 (11)
(267) (24)
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation (115) 564
Foreign exchange arising on designated borrowings in net investment hedges (46) 428
Fair value movements on cash flow hedges (64) 178
Fair value movements on cash flow hedges transferred to profit or loss 71 (139)
Fair value movements on derivatives designated in net investment hedges 12 (31)
Costs of hedging - (1)
Tax on items that may be reclassified subsequently to profit or loss 9 (46)
(133) 953
Other comprehensive (loss)/income for the period, net of tax (400) 929
Total comprehensive (loss)/income for the period (746) 1,934
(Loss)/Profit attributable to:
Owners of the Parent (347) 1,012
Non-controlling interests 1 (7)
(346) 1,005
Total comprehensive (loss)/income attributable to:
Owners of the Parent (747) 1,940
Non-controlling interests 1 (6)
(746) 1,934
Basic earnings per $0.25 Ordinary Share $(0.22) $0.78
Diluted earnings per $0.25 Ordinary Share $(0.22) $0.78
Weighted average number of Ordinary Shares in issue (millions) 1,547 1,312
Diluted weighted average number of Ordinary Shares in issue (millions) 76 1,547 1,313
(#_ftn58)
Table 26: Condensed consolidated statement of financial position
At 31 Dec 2021 At 31 Dec
2020
$m $m
Assets
Non-current assets
Property, plant and equipment 9,183 8,251
Right-of-use assets 988 666
Goodwill 19,997 11,845
Intangible assets 42,387 20,947
Investments in associates and joint ventures 69 39
Other investments 1,168 1,108
Derivative financial instruments 102 171
Other receivables 895 720
Deferred tax assets 4,330 3,438
79,119 47,185
Current assets
Inventories 8,983 4,024
Trade and other receivables 9,644 7,022
Other investments 69 160
Derivative financial instruments 83 142
Intangible assets 105 -
Income tax receivable 663 364
Cash and cash equivalents 6,329 7,832
Assets held for sale 368 -
26,244 19,544
Total assets 105,363 66,729
Liabilities
Current liabilities
Interest-bearing loans and borrowings (1,660) (2,194)
Lease liabilities (233) (192)
Trade and other payables (18,938) (15,785)
Derivative financial instruments (79) (33)
Provisions (768) (976)
Income tax payable (916) (1,127)
(22,594) (20,307)
Non-current liabilities
Interest-bearing loans and borrowings (28,134) (17,505)
Lease liabilities (754) (489)
Derivative financial instruments (45) (2)
Deferred tax liabilities (6,206) (2,918)
Retirement benefit obligations (2,454) (3,202)
Provisions (956) (584)
Other payables (4,933) (6,084)
(43,482) (30,784)
Total liabilities (66,076) (51,091)
Net assets 39,287 15,638
Equity
Capital and reserves attributable to equity holders of the Parent
Share capital 387 328
Share premium account 35,126 7,971
Other reserves 2,045 2,024
Retained earnings 1,710 5,299
39,268 15,622
Non-controlling interests 19 16
Total equity 39,287 15,638
Table 27: 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 - - - 3,196 3,196 (52) 3,144
Other comprehensive income - - - 1,608 1,608 - 1,608
Transfer to other reserves - - (22) 1,423 1,401 (1,401) -
Transactions with owners:
Dividends - - - (3,668) (3,668) - (3,668)
Issue of Ordinary Shares - 30 - - 30 - 30
Share-based payments charge for the period - - - 277 277 - 277
Settlement of share plan awards - - - (349) (349) - (349)
Net movement - 30 (22) 2,487 2,495 (1,453) 1,042
At 31 Dec 2020 328 7,971 2,024 5,299 15,622 16 15,638
At 1 Jan 2021 328 7,971 2,024 5,299 15,622 16 15,638
Profit for the period - - - 112 112 3 115
Other comprehensive loss - - - (145) (145) - (145)
Transfer to other reserves - - 21 (21) - - -
Transactions with owners:
Dividends - - - (3,882) (3,882) - (3,882)
Issue of Ordinary Shares 59 27,155 - - 27,214 - 27,214
Share-based payments charge for the period - - - 615 615 - 615
Settlement of share plan awards - - - (781) (781) - (781)
Issue of replacement share awards upon acquisition - - - 513 513 - 513
Net movement 59 27,155 21 (3,589) 23,646 3 77 (#_ftn59) 23,649
At 31 Dec 2021 387 35,126 2,045 1,710 39,268 19 39,287
Table 28: Condensed consolidated statement of cash flows
For the year ended 31 December 2021 2020
$m $m
Cash flows from operating activities
(Loss)/Profit before tax (265) 3,916
Finance income and expense 1,257 1,219
Share of after tax losses of associates and joint ventures 64 27
Depreciation, amortisation and impairment 6,530 3,149
Decrease in working capital and short-term provisions 2,021 361
Gains on disposal of intangible assets (513) (1,030)
Gains on disposal of investments in associates and joint ventures (776) -
Fair value movements on contingent consideration arising from business 14 (272)
combinations
Non-cash and other movements 95 (276)
Cash generated from operations 8,427 7,094
Interest paid (721) (733)
Tax paid (1,743) (1,562)
Net cash inflow from operating activities 5,963 4,799
Cash flows from investing activities
Acquisition of subsidiaries, net of cash acquired (9,263) -
Payments upon vesting of employee share awards attributable to business (211) -
combinations
Payment of contingent consideration from business combinations (643) (822)
Purchase of property, plant and equipment (1,091) (961)
Disposal of property, plant and equipment 13 106
Purchase of intangible assets (1,109) (1,645)
Disposal of intangible assets 587 951
Movement in profit-participation liability 20 40
Purchase of non-current asset investments (184) (119)
Disposal of non-current asset investments 9 1,381
Movement in short-term investments, fixed deposits and other investing 96 745
instruments
Payments to associates and joint ventures (92) (8)
Disposal of investments in associates and joint ventures 776 -
Interest received 34 47
Net cash outflow from investing activities (11,058) (285)
Net cash (outflow)/inflow before financing activities (5,095) 4,514
Cash flows from financing activities
Proceeds from issue of share capital 29 30
Issue of loans and borrowings 12,929 2,968
Repayment of loans and borrowings (4,759) (1,609)
Dividends paid (3,856) (3,572)
Hedge contracts relating to dividend payments (29) (101)
Repayment of obligations under leases (240) (207)
Movement in short-term borrowings (276) 288
Payments to acquire non-controlling interests (149) -
Net cash inflow/(outflow) from financing activities 3,649 (2,203)
Net (decrease)/increase in cash and cash equivalents in the period (1,446) 2,311
Cash and cash equivalents at the beginning of the period 7,546 5,223
Exchange rate effects (62) 12
Cash and cash equivalents at the end of the period 6,038 7,546
Cash and cash equivalents consist of:
Cash and cash equivalents 6,329 7,832
Overdrafts (291) (286)
6,038 7,546
Notes to the Condensed Financial Statements
1) Basis of preparation and accounting policies
The Condensed Consolidated Financial Statements for the year ended 31 December
2021 have been prepared in accordance with UK-adopted International Accounting
Standards and with the requirements of the Companies Act 2006 as applicable to
companies reporting under those standards. The Condensed Consolidated
Financial Statements also comply fully with International Financial Reporting
Standards (IFRSs) as issued by the International Accounting Standards Board
(IASB) and International Accounting Standards as adopted by the European
Union. On 31 December 2020, EU-adopted IFRS was brought into UK law and became
UK-adopted international accounting standards, with future changes to IFRS
being subject to endorsement by the UK Endorsement Board. The Condensed
Consolidated Financial Statements transitioned to UK-adopted International
Accounting Standards for financial periods beginning 1 January 2021. This
change constitutes a change in accounting framework. However, there is no
impact on recognition, measurement or disclosure in the period reported as a
result of the change in framework.
The Condensed Consolidated Financial Statements for the year ended 31 December
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.
These Condensed Consolidated Financial Statements comprise the financial
results of AstraZeneca PLC for the years to 31 December 2021 and 2020 together
with the Statement of financial position as at 31 December 2021 and 2020. The
results for the year to 31 December 2021 have been extracted from the 31
December 2021 audited Consolidated Financial Statements which have been
approved by the Board of Directors. These have not yet been delivered to the
Registrar of Companies but are expected to be published on 22 February 2022
within the Annual Report and Form 20-F Information 2021.
The financial information set out above does not constitute the Group's
statutory accounts for the years to 31
December 2021 or 2020 but is derived from those accounts. The auditors have
reported on those accounts;
their reports (i) were 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 in respect of the accounts for the
year to 31 December 2021 or 31 December 2020. Statutory accounts for the year
to 31 December 2021 were approved by the Board of Directors for release on 10
February 2022.
Except as noted below, the Condensed Consolidated 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 31 December 2021, the Group held instruments totalling
$1,439m that reference USD LIBOR but will either have matured or will have
their last LIBOR fixings set before the relevant USD LIBORs cease
publication on 30 June 2023. These instruments include floating rates bonds,
interest rate swaps and other arrangements. 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.
COVID-19
AstraZeneca has assessed the impact of the uncertainty presented by the
COVID-19 pandemic on the Consolidated Financial Statements comprising the
financial results to 31 December 2021 and the financial position as at 31
December 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 year ended 31 December 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 31 December
2021, the Group had $11.2bn in financial resources (cash and cash-equivalent
balances of $6.3bn and undrawn committed bank facilities of $4.9bn available
until April 2025, with only $1.9bn of borrowings due within one year). All
facilities contain no financial covenants and were undrawn at 31 December
2021.
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 Condensed
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 $2,085m have been recorded against intangible
assets during the year ended 31 December 2021 (FY 2020: $240m). Net impairment
charges in respect of launched medicines and medicines in development were
$603m (FY 2020: $185m) and $1,464m (FY 2020: $55m) respectively. Impairments
on launched products included $469m recognised in the quarter on Bydureon
(revised carrying amount of $50m). Impairments recorded on products in
development included an impairment charge of $1,172m recognised in the third
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 29: Net Debt
At 1 Jan 2021 Cash flow Acquisitions Non-cash & other Exchange movements At 31 Dec 2021
$m $m $m $m $m $m
Non-current instalments of loans (17,505) (12,929) (187) 2,244 243 (28,134)
Non-current instalments of leases (489) - (228) (52) 15 (754)
Total long-term debt (17,994) (12,929) (415) 2,192 258 (28,888)
Current instalments of loans (1,536) 4,781 (2,336) (2,268) 86 (1,273)
Current instalments of leases (192) 254 (34) (269) 8 (233)
Bank collateral (288) 195 - - - (93)
Other short-term borrowings excluding overdrafts (84) 81 - - - (3)
Overdraft (286) (31) - - 26 (291)
Total current debt (2,386) 5,280 (2,370) (2,537) 120 (1,893)
Gross borrowings (20,380) (7,649) (2,785) (345) 378 (30,781)
Net derivative financial instruments 278 - 6 (223) - 61
Net borrowings (20,102) (7,649) (2,779) (568) 378 (30,720)
Cash and cash equivalents 7,832 (5,501) 4,086 - (88) 6,329
Other investments - current 160 (89) - - (2) 69
Cash and investments 7,992 (5,590) 4,086 - (90) 6,398
Net Debt (12,110) (13,239) 1,307 (568) 288 (24,322)
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 $93m (FY 2020: $288m) and the carrying value of such cash
collateral posted by the Group was $47m (FY 2020: $11m). Cash collateral
posted by the Group is presented within Cash and cash equivalents.
Other investments - non-current are included within the balance of $1,168m (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 $2,458m (31 December 2020: $2,297m), $920m of which
is shown in current other payables and $1,538m 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 $12,212m in the year to $24,322m 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 year to
31 December 2021. At 31 December 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 year ended 31 December 2021, equity investments
previously categorised as Level 3 in the fair-value hierarchy (carrying value
of $113m at 31 December 2020) are now categorised as Level 1 (carrying value
of $69m at 31 December 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 (FY 2020: $63m
gain) have been recognised in the year ended 31 December 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 year ended 31
December 2021 are Level 1 fair value measurements.
Financial instruments measured at fair value include $1,237m of other
investments, $4,772m held in money-market funds, $320m of loans designated at
fair value through profit or loss and $61m of derivatives as at 31 December
2021. The total fair value of interest-bearing loans and borrowings at 31
December 2021, which have a carrying value of $30,781m in the Condensed
consolidated statement of financial position, was $33,252m. 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 30: 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
Settlements (625) (18) (643) (822)
Revaluations 42 (28) 14 (272)
Reclass to other payables - (55) (55) -
Discount unwind 195 31 226 278
At 31 December 2,544 321 2,865 3,323
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 $2,544m (31 December 2020: $2,932m) would
increase/decrease by $254m 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 29 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.
The fair values assigned to the Alexion business combination in 2021 were:
Table 31: Alexion acquisition fair values as of 21 July 2021
Fair value
$m
Non-current assets
Property, plant and equipment 1,135
Right-of-use assets 263
Intangible assets 26,855
Other non-current assets 301
28,554
Current assets
Inventories 6,769
Trade and other receivables 2,096
Intangible assets 100
Cash and cash equivalents 4,086
13,051
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 32,921
Less: non-controlling interests (150)
Goodwill 8,287
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 32: Alexion Intangible asset fair values and useful lives
Fair value Useful lives
$m Years
Launched medicines - C5 franchise (Soliris/Ultomiris) 18,480 6-15
Launched medicines - Strensiq, Kanuma, Andexxa 5,215 11-17
Medicines in development 2,760 Not amortised
Other intangibles 500 5-10
26,955
The fair value of inventory, which includes raw materials, work in progress
and finished goods related to the launched medicines, was estimated at
$6,769m, an uplift of $5,635m 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 $1,135m represents an uplift of $111m
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 $8,287m 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 28 September 2021 and the acquisition of Caelum
Biosciences closed shortly thereafter 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 31 December 2021, before reflecting
the fair value adjustments arising on acquisition, Alexion's Total Revenues
were $3,071m and Profit after tax was $889m. 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 year ended 31 December 2021 would have been $41,132m and the
Loss after tax would have been $1,152m. 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 $171m 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 expense.
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 six months after the acquisition, or earlier. In the period since
acquisition, a cost of $24m has been recorded in the Statement of
Comprehensive Income ($2m in Cost of Sales, $9m in Research and development
expense and $13m in Selling, general and administrative expense).
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 $257m has been recorded in the Statement of
Comprehensive Income ($9m in Cost of sales, $73m in Research and development
expense and $175m in Selling, general and administrative expense). Payments
made to the Employee Benefit Trust 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, H1
2021 and Q3 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.
There is one matter, which is considered probable that an outflow will be
required, but for which we are unable to make an estimate of the possible loss
or range of possible losses at this stage.
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 fourth quarter of 2021 and to 10 February
2022
Patent litigation
Calquence
US patent proceedings
In February 2022, in response to Paragraph IV notices from multiple
abbreviated New Drug Application (ANDA) filers, AstraZeneca filed patent
infringement lawsuits in the US District Court for the District of Delaware.
In its complaint, AstraZeneca alleged that a generic version of Calquence, if
approved and marketed, would infringe patents listed in the US FDA Orange Book
with reference to Calquence that are owned or licensed by AstraZeneca. No
trial date has been set.
Faslodex
Patent proceedings outside the US
As previously disclosed, in Japan, in October 2021, AstraZeneca received
notice that Sun Pharma Japan Ltd. requested to intervene in the Request for
Invalidation brought by Sandoz K.K seeking invalidation of the Faslodex
formulation patent. The Japan Patent Office has permitted the intervention.
AstraZeneca is defending the challenged patent.
Farxiga/Forxiga
US patent proceedings
As previously disclosed, in 2018, in response to Paragraph IV notices,
AstraZeneca initiated abbreviated New Drug Application (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 the asserted claims of AstraZeneca's US Patent No.
6,515,117 as valid and infringed by Zydus's proposed ANDA product.
Patent proceedings outside the US
As previously disclosed, 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
As previously disclosed 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 abbreviated New
Drug Application (ANDA) litigation regarding Symbicort with Mylan
Pharmaceuticals Inc. (Mylan) and Kindeva Drug Delivery L.P. (Kindeva). In
December 2021, the United States District Court of Appeals for the Federal
Circuit (the Federal Circuit) affirmed the decision by the US District Court
for the Northern District of West Virginia (the District Court) determining
that the asserted patent claims were nonobvious. However, the Federal Circuit
reversed the District Court's claim construction decision, vacated the
stipulated judgment of infringement by Mylan and Kindeva and remanded the
matter back to the District Court for determination of whether their ANDA
product infringes the asserted patent claims under the Federal Circuit's claim
construction. In January 2022, AstraZeneca filed a Combined Petition for Panel
Rehearing and Rehearing En Banc with the Federal Circuit.
Tagrisso
US patent proceedings
As previously disclosed, in February 2020, in response to Paragraph IV notices
from multiple abbreviated New Drug Application (ANDA) filers, AstraZeneca
filed patent infringement lawsuits in the US District Court for the District
of Delaware. In its complaint, AstraZeneca alleged that a generic version of
Tagrisso, if approved and marketed, would infringe a US Orange Book-listed
Tagrisso patent. In the fourth quarter of 2021, AstraZeneca entered into
settlement agreements with Zydus Pharmaceuticals (USA) Inc. and Cadila
Healthcare Limited (collectively, Zydus) and MSN Laboratories Pvt. Ltd. and
MSN Pharmaceuticals Inc. (collectively, MSN), resolving all US patent
litigation with Zydus and MSN relating to Tagrisso. The trial with the
remaining defendant, Alembic Pharmaceuticals Limited, is scheduled for May
2022.
Patent proceedings outside the US
As previously disclosed, 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
As previously disclosed, in November 2018, Chugai Pharmaceutical Co., Ltd.
(Chugai) filed a lawsuit against Alexion in the Delaware District Court
alleging that Ultomiris infringes a US patent held by Chugai. Upon issuance of
another US 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. Trial scheduled to occur in January 2022 has been
postponed until February 2022 due to COVID-19.
Patent proceedings outside the US
As previously disclosed in Japan, 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. In 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
Farxiga and Xigduo XR
In several jurisdictions in the US, AstraZeneca has been named as a defendant
in lawsuits involving plaintiffs claiming physical injury, including
Fournier's Gangrene and necrotising fasciitis, from treatment with Farxiga
and/or Xigduo XR. A majority of these claims are filed in Delaware state court
and remain pending. One case, filed in state court in Minnesota, is scheduled
for trial in January 2023.
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 previously scheduled for
January 2022 has been rescheduled to October 2022. In addition to the MDL
cases, there are cases filed in several state courts around the US; a trial in
Delaware state court previously scheduled for February 2022 is being
rescheduled.
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
scheduled 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 have
been dismissed, one in 2019 and one in 2021. The third lawsuit, filed in
Saskatchewan, seeks authorisation to represent individual residents in Canada
who allegedly suffered kidney injuries from the use of proton pump inhibitors,
including Nexium and Losec.
Onglyza and Kombiglyze
As previously disclosed, in the US, AstraZeneca is defending various lawsuits
alleging heart failure, cardiac injuries, and/or death from treatment with
Onglyza or Kombiglyze. In February 2018, the Judicial Panel on Multidistrict
Litigation ordered the transfer of various pending federal actions to the US
District Court for the Eastern District of Kentucky (the District Court) for
consolidated pre-trial proceedings with the federal actions pending in the
District Court. In the previously disclosed California State Court coordinated
proceeding, AstraZeneca submitted its motion for summary judgment in December
2021.
Commercial litigation
Anti-Terrorism Act Civil Lawsuit
As previously disclosed, in July 2020, the US District Court for the District
of Columbia (the District Court) 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 appealed the District Court's order dismissing the litigation
to the DC Circuit Court of Appeals (the Appellate Court), and in January 2022,
a panel on the Appellate Court reversed the dismissal and remanded the case
back to the District Court. AstraZeneca and the other defendants have filed
petitions requesting en banc review by the entire Appellate Court.
Syntimmune
In connection with Alexion's prior acquisition of Syntimmune, Inc.,
(Syntimmune) a clinical-stage biotechnology company developing an antibody
therapy targeting the FcRn, in the US, in December 2020, Alexion was served
with a lawsuit filed by the stockholders' representative for Syntimmune in
Delaware State Court that alleged, among other things, breaches of contractual
obligations relating to the 2018 merger agreement. The stockholders'
representative alleges that Alexion failed to meet its obligations under the
merger agreement to use commercially reasonable efforts to achieve the
milestones, and the plaintiff has requested payment of all milestone
obligations. Alexion also filed a claim for breach of the representations in
the 2018 merger agreement regarding unusable drug product and drug substance
that Alexion acquired from Syntimmune. Trial in the matter is scheduled for
November 2022.
Government investigations/proceedings
US 340B litigations and proceedings
As previously disclosed, AstraZeneca is involved in several matters relating
to its contract pharmacy recognition policy under the 340B Drug Pricing
Program in the US. In 2020, three lawsuits 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 to an unlimited number of contract pharmacies. AstraZeneca has
sought to intervene in the lawsuits. Two of the three cases are currently
stayed pending further proceedings and the third case has been dismissed.
Administrative Dispute Resolution 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 contract pharmacy recognition policy
under the 340B Drug Pricing Program. AstraZeneca has cooperated with the
inquiry.
In January 2021, AstraZeneca filed a separate lawsuit in federal court in
Delaware alleging that an 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 antitrust
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 in the diabetes market
through contract pharmacies.
US Congressional
In January 2019, AstraZeneca received a letter from the US House of
Representatives Committee on Oversight and Reform (Committee) seeking
information related to pricing practices for Crestor. Similar letters
were sent to 11 other pharmaceutical manufacturers. AstraZeneca cooperated
with the inquiry and produced certain responsive information. In December
2021, the Committee issued a final report culminating the Committee's
pharmaceutical pricing investigation. AstraZeneca's products are not the
subject of the findings in the final report.
7) Subsequent Events
On 4 January 2022, AstraZeneca completed the sale of the global rights to
Tudorza and Duaklir to Covis Pharma GmbH for an upfront payment of $270m,
which will be recorded within Other operating income and expense. The
intangible assets of $368m associated with this transaction were classified as
Assets held for sale as at 31 December 2021.
8) Table 33: FY 2021 - Product Sales year-on-year analysis 78 (#_ftn60)
The CER information in respect of FY 2021 included in the Consolidated
Financial Information has not been audited by PricewaterhouseCoopers LLP.
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 13,048 20 18 3,223 11 6 5,359 26 2,484 28 22 1,982 13 13
Tagrisso 5,015 16 13 1,336 11 6 1,780 14 986 32 25 913 13 14
Imfinzi 2,412 18 16 277 76 68 1,245 5 485 31 25 405 23 23
Lynparza 2,348 32 30 384 45 41 1,087 24 618 42 35 259 29 28
Calquence 1,238 n/m n/m 20 n/m n/m 1,089 n/m 111 n/m n/m 18 n/m n/m
Koselugo 108 n/m n/m 1 n/m n/m 104 n/m 3 n/m n/m - - -
Enhertu 17 n/m n/m 12 n/m n/m - - 4 n/m n/m 1 n/m n/m
Orpathys 16 n/m n/m 16 n/m n/m - - - - - - - -
Zoladex 948 7 3 619 10 5 13 n/m 147 5 (1) 169 (7) (7)
Faslodex 431 (26) (27) 167 (8) (10) 30 (46) 113 (49) (52) 121 (2) (1)
Iressa 183 (32) (35) 151 (31) (35) 11 (23) 5 (58) (60) 16 (26) (26)
Casodex 143 (17) (21) 105 (21) (26) - - 3 (3) 6 35 (3) (3)
Arimidex 139 (25) (27) 106 (28) (31) - - 4 5 7 29 (15) (14)
Others 50 1 (1) 29 3 1 - - 5 51 43 16 (16) (15)
BioPharmaceuticals: CVRM 8,020 13 10 3,780 18 14 2,124 2 1,494 22 16 622 7 5
Farxiga 3,000 53 49 1,195 74 70 732 29 810 60 52 263 34 31
Brilinta 1,472 (8) (10) 328 (29) (31) 735 1 346 1 (4) 63 8 (1)
Bydureon 385 (14) (15) 3 (25) (26) 321 (16) 55 5 - 6 (40) (44)
Onglyza 360 (23) (26) 179 (11) (14) 88 (47) 61 5 (1) 32 (29) (33)
Byetta 55 (19) (19) 12 61 75 26 (31) 11 (20) (25) 6 (36) (38)
Other diabetes 59 26 24 18 n/m n/m 22 (12) 17 35 31 2 11 12
Lokelma 175 n/m n/m 3 (44) (48) 115 n/m 13 n/m n/m 44 n/m n/m
Roxadustat 174 n/m n/m 174 n/m n/m - - - - - - - -
Crestor 1,096 (7) (10) 775 4 - 80 (13) 52 (60) (62) 189 (11) (10)
Seloken/Toprol-XL 951 16 10 928 19 13 1 (89) 11 (33) (33) 11 9 (3)
Atacand 97 (60) (60) 28 (84) (84) 4 (65) 65 87 86 - n/m n/m
Others 196 3 (2) 137 9 3 - - 53 (7) (8) 6 (21) (25)
BioPharmaceuticals: Respiratory & Immunology 6,034 13 9 1,749 9 4 2,404 24 1,247 6 1 634 (2) (5)
Symbicort 2,728 - (2) 609 7 4 1,065 4 670 (3) (8) 384 (12) (17)
Fasenra 1,258 33 31 20 67 67 790 31 286 41 34 162 24 22
Pulmicort 962 (3) (8) 770 (3) (9) 72 1 73 - (5) 47 (13) (15)
Daliresp 227 5 4 4 - (2) 207 9 15 (32) (37) 1 (3) (10)
Breztri 203 n/m n/m 55 n/m n/m 115 n/m 7 n/m n/m 26 n/m n/m
Bevespi 54 12 12 4 n/m n/m 39 (11) 11 n/m n/m - - -
Saphnelo 8 n/m n/m - - - 8 - - - - - - -
Others 594 49 42 287 41 32 108 n/m 185 5 - 14 1 (6)
Rare Disease* 3,070 8 9 196 11 18 1,828 8 682 7 9 364 7 11
Soliris* 1,874 1 2 170 1 8 1,068 4 439 (8) (7) 197 8 11
Ultomiris* 688 27 29 9 n/m n/m 381 20 169 73 74 129 4 11
Strensiq* 378 13 13 10 81 78 297 13 36 2 3 35 9 14
Andexxa* 68 (3) (3) - n/m n/m 50 (21) 18 7 6 - n/m n/m
Kanuma* 62 20 21 7 n/m n/m 32 13 20 7 9 3 14 25
Other medicines 2,367 (8) (10) 954 (2) (5) 221 (39) 596 (17) (19) 596 12 15
Nexium 1,326 (11) (12) 705 (7) (10) 128 (24) 62 (13) (18) 431 (13) (12)
Synagis 410 10 13 35 - - 23 (51) 203 (38) (37) 149 - -
FluMist 253 (14) (17) 2 15 2 27 (62) 222 1 (2) 2 (50) (53)
Losec/Prilosec 180 (2) (7) 152 - (7) 1 (89) 26 32 31 1 (82) (72)
Seroquel XR/IR 92 (21) (20) 46 (17) (15) 12 (30) 29 2 2 5 (71) (67)
Others 106 (16) (19) 14 n/m n/m 30 (45) 54 (5) (9) 8 (13) (19)
COVID-19 4,002 n/m n/m 2,259 n/m n/m 64 n/m 1,101 n/m n/m 578 n/m n/m
Vaxzevria 3,917 n/m n/m 2,240 n/m n/m 64 n/m 1,035 n/m n/m 578 n/m n/m
Evusheld 85 n/m n/m 19 n/m n/m - - 66 n/m n/m - - -
Total Product Sales 36,541 41 38 12,161 40 36 12,000 39 7,604 50 44 4,776 36 36
9) Table 34: Q4 2021 - Product Sales year-on-year analysis(( 79 (#_ftn61) ))
The Q4 2021 information in respect of the three months ended 31 December 2021
included in the Consolidated Financial Information has not been audited by
PricewaterhouseCoopers LLP.
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 3,455 19 20 785 18 15 1,488 27 661 15 17 521 6 12
Tagrisso 1,314 14 15 325 26 23 486 15 258 5 7 245 6 12
Imfinzi 634 14 15 65 47 44 330 10 138 19 21 101 7 14
Lynparza 629 27 28 103 49 46 294 20 161 30 32 71 21 28
Calquence 395 n/m n/m 8 n/m n/m 336 91 43 n/m n/m 8 n/m n/m
Koselugo 34 92 94 - - - 32 82 2 n/m n/m - - -
Enhertu 7 n/m n/m 5 - - - - 2 n/m n/m - - -
Orpathys 6 n/m n/m 6 - - - - - - - - - -
Zoladex 232 7 7 154 15 12 2 n/m 35 (2) (2) 41 (13) (7)
Faslodex 101 (22) (21) 44 15 14 6 (40) 20 (61) (61) 31 (1) 7
Iressa 35 (49) (47) 29 (50) (51) 2 (52) 1 (45) 5 3 (31) (38)
Casodex 22 (43) (42) 13 (55) (56) - - - n/m n/m 9 (9) -
Arimidex 33 (9) (11) 26 (2) (5) - - - n/m n/m 7 (26) (24)
Others 13 3 5 7 (9) (9) - - 1 n/m n/m 5 (8) (11)
BioPharmaceuticals: CVRM 2,003 9 9 868 12 10 576 (1) 386 17 18 173 10 14
Farxiga 848 45 46 318 61 60 228 24 225 57 60 77 28 32
Brilinta 348 (4) (4) 71 3 1 178 (9) 83 (2) (1) 16 9 5
Bydureon 91 (25) (25) 1 (28) (43) 78 (26) 12 (14) (13) - (88) (79)
Onglyza 75 (28) (29) 28 (40) (41) 25 (20) 14 (10) (11) 8 (27) (29)
Byetta 10 (44) (42) 2 n/m n/m 5 (59) 2 (32) (36) 1 (56) (47)
Other diabetes 17 34 34 6 n/m n/m 7 17 4 7 14 - - -
Lokelma 54 90 95 - n/m n/m 34 70 5 n/m n/m 15 n/m n/m
Roxadustat 30 n/m n/m 30 n/m n/m - - - - - - - -
Crestor 259 (13) (13) 178 (6) (7) 21 - 9 (73) (73) 51 (5) 1
Seloken/Toprol-XL 202 1 (2) 197 4 1 - n/m 2 (57) (57) 3 14 3
Atacand 21 (67) (67) 3 (93) (93) - (87) 18 36 33 - n/m n/m
Others 48 4 3 34 5 2 - n/m 12 (2) 1 2 28 18
BioPharmaceuticals: Respiratory & Immunology 1,590 4 4 445 (19) (21) 647 23 335 11 11 163 6 8
Symbicort 681 - - 152 5 3 262 (2) 171 (1) - 96 1 -
Fasenra 357 26 27 5 n/m n/m 234 30 75 19 21 43 12 18
Pulmicort 248 (33) (34) 193 (40) (42) 19 5 23 31 32 13 (2) -
Daliresp 59 8 8 1 24 (24) 54 11 4 (16) (21) - - -
Breztri 73 n/m n/m 15 n/m n/m 47 n/m 3 n/m n/m 8 69 81
Bevespi 15 24 26 1 n/m n/m 10 (3) 4 n/m n/m - - -
Saphnelo 7 n/m n/m - - - 7 - - - - - - -
Others 150 20 18 78 (4) (8) 14 n/m 55 25 26 3 69 62
Rare Disease(†) 1,759 10 11 131 81 91 1,043 8 380 3 5 205 6 12
Soliris(†) 1,076 4 6 117 71 82 608 4 240 (12) (10) 111 7 11
Ultomiris(†) 391 24 26 4 n/m n/m 214 15 100 67 68 73 5 14
Strensiq(†) 219 17 18 6 71 68 173 19 20 (1) 1 20 8 15
Andexxa(†) 39 - (1) - - - 30 (14) 9 n/m n/m - - -
Kanuma(†) 34 16 17 4 n/m n/m 18 12 11 - 3 1 (27) 1
Other medicines 825 13 15 199 (18) (18) 41 (34) 329 14 13 256 85 97
Nexium 328 (13) (10) 129 (33) (33) 30 (29) 15 23 24 154 19 27
Synagis 239 n/m n/m 20 n/m n/m 1 n/m 121 56 58 97 n/m n/m
FluMist 178 (1) (4) 1 (18) (31) 4 (21) 171 1 (3) 2 (44) (35)
Losec/Prilosec 41 7 6 36 9 6 - (78) 5 44 44 - - -
Seroquel XR/IR 19 (3) (2) 10 (33) (31) - (90) 8 6 6 1 (19) (1)
Others 20 (48) (49) 3 n/m n/m 6 (67) 9 (49) (49) 2 (48) (50)
COVID-19 1,866 n/m n/m 1,202 n/m n/m 64 n/m 365 n/m n/m 235 n/m n/m
Vaxzevria 1,781 n/m n/m 1,183 n/m n/m 64 n/m 299 n/m n/m 235 n/m n/m
Evusheld 85 n/m n/m 19 n/m n/m - - 66 n/m n/m - - -
Total Product Sales 11,498 64 65 3,630 63 61 3,859 65 2,456 64 66 1,553 65 73
10) Table 35: Q4 2021 - Product Sales quarterly sequential analysis(( 80
(#_ftn62) ))
The sequential quarterly Product Sales information included in the
Consolidated Financial Information has not been audited by
PricewaterhouseCoopers LLP.
Q1 2021 Q2 2021 Q3 2021 Q4 2021
Actual CER Actual CER Actual CER Actual CER
$m % change % change $m % change % change $m % change % change $m % change % change
Oncology 2,981 3 1 3,286 10 11 3,326 1 2 3,455 4 5
Tagrisso 1,149 (1) (3) 1,306 14 14 1,247 (5) (4) 1,314 5 6
Imfinzi 556 - (1) 604 9 10 618 2 3 634 3 4
Lynparza 543 9 8 588 8 9 588 - 1 629 7 8
Calquence 209 15 15 280 34 34 354 26 26 395 12 12
Koselugo 21 23 23 26 23 22 26 - 2 34 27 27
Enhertu 1 n/m n/m 3 n/m n/m 5 64 63 7 42 41
Orpathys - - - - - - 10 n/m n/m 6 (39) (40)
Zoladex 221 2 - 244 10 11 250 2 3 232 (7) (5)
Faslodex 122 (6) (8) 105 (14) (12) 103 (2) (2) 101 (1) -
Iressa 61 (9) (11) 47 (23) (22) 41 (11) (14) 35 (16) (11)
Casodex 42 7 5 41 (2) (1) 38 (7) (8) 22 (42) (38)
Arimidex 44 22 18 29 (34) (33) 33 16 19 33 (2) (7)
Others 12 (4) (6) 13 13 11 13 (5) (4) 13 (1) 1
BioPharmaceuticals: CVRM 1,912 4 1 2,023 6 6 2,082 3 3 2,003 (4) (3)
Farxiga 624 6 4 732 17 18 796 9 9 848 7 9
Brilinta 374 3 1 375 - 1 375 - 1 348 (7) (7)
Bydureon 103 (16) (17) 95 (8) (7) 95 1 2 91 (4) (5)
Onglyza 101 (3) (6) 99 (2) (2) 84 (15) (15) 75 (11) (10)
Byetta 16 (14) (15) 16 (4) (7) 13 (15) (7) 10 (21) (22)
Other diabetes 13 7 1 15 14 14 14 (9) (4) 17 21 17
Roxadustat 39 n/m n/m 51 32 32 55 7 7 30 (45) (46)
Lokelma 33 16 18 39 21 21 49 25 26 54 9 10
Crestor 274 (8) (9) 265 (3) (3) 298 12 13 259 (13) (12)
Seloken/Toprol-XL 250 25 21 266 6 7 234 (12) (13) 202 (13) (13)
Atacand 34 (45) (45) 23 (35) (32) 19 (15) (18) 21 9 8
Others 51 12 10 47 (7) (10) 50 6 7 48 (4) (4)
BioPharmaceuticals: Respiratory & Immunology 1,541 1 (1) 1,420 (8) (7) 1,483 4 5 1,590 7 8
Symbicort 691 2 - 680 (2) (1) 676 (1) - 681 1 1
Fasenra 260 (8) (9) 320 23 23 322 1 1 357 11 12
Pulmicort 330 (10) (13) 167 (50) (49) 217 30 30 248 14 15
Daliresp 60 11 10 54 (10) (9) 54 - (2) 59 9 10
Breztri 27 n/m n/m 56 n/m n/m 47 (15) (15) 73 54 55
Bevespi 13 7 8 13 1 3 13 (1) (2) 15 15 18
Saphnelo - - - - - - 1 n/m n/m 7 n/m n/m
Others 160 28 25 130 (19) (19) 153 17 19 150 (2) (2)
Rare Disease(‡) - - - - - - 1,311 (2) (1) 1,759 4 6
Soliris(‡) - - - - - - 798 (6) (4) 1,076 4 7
Ultomiris(‡) - - - - - - 297 7 8 391 4 5
Strensiq(‡) - - - - - - 159 (2) (2) 219 8 9
Andexxa(‡) - - - - - - 29 5 6 39 1 -
Kanuma(‡) - - - - - - 28 9 9 34 (7) (4)
Other medicines 548 (25) (26) 454 (17) (16) 539 19 20 825 53 55
Nexium 403 7 5 336 (17) (15) 259 (23) (23) 328 27 31
Synagis 24 (69) (69) 24 1 1 122 n/m n/m 239 97 98
FluMist 2 (99) (99) 1 (51) (71) 72 n/m n/m 178 n/m n/m
Losec/Prilosec 54 39 36 46 (14) (15) 38 (18) (17) 41 9 11
Seroquel XR/IR 29 51 38 21 (29) (22) 24 17 14 19 (22) (23)
Others 36 (6) (4) 26 (28) (32) 24 (8) (5) 20 (16) (17)
COVID-19 275 n/m n/m 862 n/m n/m 1,000 16 18 1,866 87 88
Vaxzevria 275 n/m n/m 862 n/m n/m 1,000 16 18 1,781 78 79
Evusheld - - - - - - - - - 85 n/m n/m
Total Product Sales 7,257 4 1 8,045 11 12 9,741 21 22 11,498 18 19
11) Table 36: FY 2020 - Product Sales quarterly sequential analysis 81
(#_ftn63)
The sequential quarterly Product Sales information included in the
Consolidated Financial Information has not been audited by
PricewaterhouseCoopers LLP.
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 37: Collaboration Revenue
FY 2021 FY 2020 FY 2019
$m $m $m
Initial Collaboration Revenue
Nexium (Japan) 75 - -
Ongoing Collaboration Revenue
Lynparza: regulatory milestones - 160 60
Lynparza: sales milestones 400 300 450
Lynparza/Koselugo: option payments - - 100
Crestor (Spain) - - 39
Enhertu: share of gross profits 193 94 -
Roxadustat: share of gross profits 6 30 -
Royalty income 138 62 62
Other Ongoing Collaboration Revenue 64 81 108
Total 876 727 819
Table 38: Other Operating Income and Expense
The table below provides an analysis of Reported Other Operating Income and
Expense.
FY 2021 FY 2020 FY 2019
$m $m $m
Divestment of Viela Bio, Inc. shareholding 776 - -
Crestor (Europe ex-UK and Spain) 317 - -
Late stage small-molecule antibiotics assets (ex-US) 100 - 75
Hypertension medicines (ex-US, India and Japan) - 350 -
Monetisation of an asset previously licensed - 120 -
Brazikumab licence termination funding 99 107 -
Inderal, Tenormin, Seloken and Omepral (Japan) - 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 200 446 314
Total 1,492 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, 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); Tezspire, a trademark of Amgen,
Inc.; 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.
Announcement of first quarter results:
29 April 2022
Announcement of half year and second quarter results 29
July 2022
Announcement of year to date and third quarter results 10
November 2022
Dividends are normally be paid as follows:
First interim: Announced with the half-year and
second-quarter results and paid in September
Second interim: Announced with full-year and fourth-quarter results and
paid in March
The record date for the second interim dividend for 2021, payable on 28 March
2022, will be 25 February 2022. The ex-dividend date will be 24 February 2022.
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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+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 failures or delays in the quality or execution of the
Group's commercial strategies
- the risk of pricing, affordability, access and competitive pressures
- 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 or cybersecurity
- the risk of failure of critical processes
- the risk of failure to collect and manage data in line with legal and
regulatory requirements and strategic objectives
- the risk of failure to attract, develop, engage and retain a diverse,
talented and capable workforce
- the risk of failure to meet regulatory or ethical expectations on
environmental impact, including climate change
- the risk of the safety and efficacy of marketed medicines being
questioned
- the risk of adverse outcome of litigation and/or governmental
investigations
- intellectual property-related risks to our products
- 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
Nothing in this document, or any related presentation/webcast, should be
construed as a profit forecast.
- End of document -
19 (#_ftnref1) Systemic lupus erythematosus.
20 (#_ftnref2) Committee for Medicinal Products for Human Use.
21 (#_ftnref3) A breast cancer gene mutation.
22 (#_ftnref4) Human epidermal growth factor receptor 2 positive.
23 (#_ftnref5) Non-small cell lung cancer.
24 (#_ftnref6) Neurofibromatosis type 1 (NF1) plexiform neurofibromas (PN).
25 (#_ftnref7) Paroxysmal nocturnal haemoglobinuria.
26 (#_ftnref8) Atypical haemolytic uraemic syndrome.
27 (#_ftnref9) Generalised myasthenia gravis.
28 (#_ftnref10) Hereditary amyloid transthyretin polyneuropathy,
29 (#_ftnref11) Transthyretin amyloid cardiomyopathy.
30 (#_ftnref12) Heart failure with preserved ejection fraction.
31 (#_ftnref13) Neuromyelitis optica spectrum disorder.
32 (#_ftnref14) Epidermal growth factor receptor mutation.
33 (#_ftnref15) Small cell lung cancer.
34 (#_ftnref16) Chronic lymphocytic leukaemia.
35 (#_ftnref17) Mantle cell lymphoma.
36 (#_ftnref18) Hyper-eosinophilic syndrome.
37 (#_ftnref19) Eosinophilic oesophagitis.
38 (#_ftnref20) Muscle invasive.
39 (#_ftnref21) Hepatocellular carcinoma.
40 (#_ftnref22) Colorectal cancer.
41 (#_ftnref23) Human epidermal growth factor receptor 2 over expressing.
42 (#_ftnref24) Triple negative breast cancer.
43 (#_ftnref25) Myelodysplastic syndrome.
44 (#_ftnref26) Eosinophilic granulomatosis with polyangiitis.
45 (#_ftnref27) Chronic rhinosinusitis with nasal polyps.
46 (#_ftnref28) Over the counter.
47 (#_ftnref29) Substitution of threonine (T) with methionine (M) at
position 790 of exon 20 mutation.
48 (#_ftnref30) Chemoradiation therapy.
49 (#_ftnref31) Extensive stage non-small cell lung cancer.
50 (#_ftnref32) Poly ADP ribose polymerase.
51 (#_ftnref33) Homologous recombination repair gene mutation.
52 (#_ftnref34) A targetable gene alteration found in NSCLC.
53 (#_ftnref35) Sodium-glucose co-transporter-2.
54 (#_ftnref36) Type-2 diabetes.
55 (#_ftnref37) An enzyme that destroys the hormone incretin.
56 (#_ftnref38) Inhaled corticosteroid.
57 (#_ftnref39) Long-acting beta-agonist.
58 (#_ftnref40) Chronic obstructive pulmonary disease.
59 (#_ftnref41) Respiratory syncytial virus.
60 (#_ftnref42) In Q3 2021 following the acquisition of Alexion, a new
column was introduced to present acquisition-related non-core items, primarily
unwind of fair value uplift on inventories and acquisition costs.
61 (#_ftnref43) 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.
62 (#_ftnref44) Core financial measures are adjusted to exclude certain
items. For more information on the Reported to Core financial adjustments,
please refer to the Operating and financial review.
63 (#_ftnref45) Based on best prevailing assumptions around currency
profiles.
64 (#_ftnref46) Based on average daily spot rates in FY 2021.
65 (#_ftnref47) Based on average daily spot rates from 1 January 2022 to 31
January 2022.
66 (#_ftnref48) Other currencies include AUD, BRL, CAD, KRW and RUB.
67 (#_ftnref49) 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'.
68 (#_ftnref50) Overall survival.
69 (#_ftnref51) Single tremelimumab regular interval durvalumab.
70 (#_ftnref52) Overall response rate.
71 (#_ftnref53) Duration of response.
72 (#_ftnref54) Angiotensin-converting enzyme inhibitor.
73 (#_ftnref55) Angiotensin-receptor blockers.
74 (#_ftnref56) US Food and Drug Administration.
75 (#_ftnref57) Intramuscular injection.
76 (#_ftnref58) 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
77 (#_ftnref59) As part of the acquisition of Alexion in July 2021, a
pre-existing non-controlling interest in Caelum Biosciences, Inc. was
recognised. This was valued at $150m, the agreed upon exercise price for the
exclusive option to acquire the remaining equity. The option was exercised on
28 September 2021 and the acquisition of Caelum Biosciences closed shortly
thereafter on 5 October 2021. Further details are included in Note 5,
Acquisition of Alexion.
78 (#_ftnref60) 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 revenues previously published by Alexion adjusted
pro rata to match the post-acquisition period.
79 (#_ftnref61) 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 1 October 2021 with the corresponding
prior year pre-acquisition Q4 revenues previously published by Alexion.
80 (#_ftnref62) 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 Q4 revenues with
the prior quarter Q3.
81 (#_ftnref63) 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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