REG - AstraZeneca PLC - AZN: First quarter 2021 results
30/04/2021 07:00
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RNS Number : 1424X AstraZeneca PLC 30 April 2021
AstraZeneca PLC
30 April 2021 07:00 BST
First quarter 2021 results
Robust performance supports continued investment for long-term sustainable
growth
AstraZeneca delivered robust revenue growth of 15% (11% at CER(1)) in the
quarter to $7,320m; excluding the contribution from the pandemic COVID-19
vaccine, revenue growth increased by 11% (7% at CER) to $7,045m. The overall
results in the quarter further increased the Company's profitability and cash
generation, while the pipeline demonstrated encouraging progress; the Company
reiterates full-year 2021 guidance.
Pascal Soriot, Chief Executive Officer, commented:
"We delivered solid progress in the first quarter of 2021 and continued to
advance our portfolio of life-changing medicines. Oncology grew 16% and New
CVRM grew 15%. New medicines contributed over half of revenue and all regions
delivered encouraging growth. This performance ensured another quarter of
strong revenue and earnings progression, continued profitability, and
cash-flow generation, despite the pandemic's ongoing negative impact on the
diagnosis and treatment of many conditions. Given the performance in the first
quarter, in line with our expectations, we reiterate our full-year guidance.
We expect the impact of COVID to reduce and anticipate a performance
acceleration in the second half of 2021.
Further significant pipeline advances were achieved as we continued to invest
for long-term sustainable growth, including the OlympiA Phase III trial
demonstrating Lynparza's benefit for certain forms of early breast cancer.
This sustained pipeline progress and accelerating business performance
underlines our commitment to patients and delivering our growth potential,
which will be further complemented by the proposed acquisition of Alexion."
Table 1: Q1 2021 - Financial summary
Actual CER
$m % change % change
- Product Sales 7,257 15 11
- Collaboration Revenue 63 43 42
Total revenue 7,320 15 11
- Less pandemic COVID-19 vaccine 275 n/m(2) n/m
Total revenue ex. pandemic vaccine(3) 7,045 11 7
Reported(4) EPS(5) $1.19 100 97
Core(6) EPS $1.63 55 53
Impact of pandemic vaccine on EPS $(0.03) n/m n/m
Highlights of Total Revenue in the quarter included:
- An increase in Product Sales of 15% (11% at CER) to $7,257m. New
medicines(7) Total Revenue improved by 30% (26% at CER) in the quarter to
$3,891m, including growth in Emerging Markets of 33% (30% at CER) to $874m.
Globally, new medicines represented 53% of Total Revenue (Q1 2020: 47%). Q1
2020 benefitted from a low-to-mid single-digit percentage increase in sales
following short-term inventory increases in the distribution channel, an
indirect effect of the COVID-19 pandemic
- Oncology growth of 20% (16% at CER) to $3,024m, an increase in New CVRM(8)
of 19% (15% at CER) to $1,306m. Respiratory & Immunology (R&I),
however, declined by 1% (4% at CER) to $1,546m, predominately reflecting the
impact of stocking of an authorised generic version of Symbicort in the US
during Q1 2020 and phasing of COVID-19 impacts
- An increase in Emerging Markets of 14% (10% at CER) to $2,592m, with China
growth of 19% (10% at CER) to $1,679m. In the US, Total Revenue increased by
10% to $2,310m and in Europe by 28% (18% at CER) to $1,546m
Guidance
The Company reiterates guidance for FY 2021 at CER.
Total Revenue is expected to increase by a low-teens percentage,
accompanied by faster growth in Core EPS to $4.75 to $5.00.
The guidance does not incorporate any revenue or profit impact from sales of
the pandemic COVID-19 vaccine. Similarly, the guidance excludes the proposed
acquisition of Alexion Pharmaceuticals, Inc. (Alexion) which is intended to
become AstraZeneca's rare disease unit and area of expertise. The acquisition
is anticipated to close in Q3 2021. AstraZeneca recognises the heightened
risks and uncertainties from the impact of COVID-19. Variations in performance
between quarters can be expected to continue.
The Company is unable to provide guidance and indications 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.
Indications
The Company provides indications for FY 2021 at CER:
- AstraZeneca continues its focus on improving operating leverage, while
addressing its most important capital-allocation priority of re-investment in
the business, namely continued investment in R&D and the support of
medicines and patient access in key markets
- A Core Tax Rate of 18-22%. Variations in the Core Tax Rate between quarters
are anticipated to continue
Currency impact
If foreign-exchange rates for April to December 2021 were to remain at the
average of rates seen in the quarter, it is anticipated that there would be a
low single-digit favourable impact on Total Revenue and Core EPS. The
Company's foreign-exchange rate sensitivity analysis is contained within the
operating and financial review (#_Profit_and_Loss) .
Financial summary
- Total Revenue, comprising Product Sales and Collaboration Revenue, increased
by 15% in the quarter (11% at CER) to $7,320m. Product Sales grew by 15% (11%
at CER) to $7,257m, driven primarily by the performances of new medicines
across Oncology and BioPharmaceuticals, including Tagrisso and Farxiga. Total
Revenue included $275m of pandemic COVID-19 vaccine sales
- The Reported Gross Profit Margin(9) declined by three percentage points to
74.3%, and the Core Gross Profit(9) Margin declined by three percentage points
in the quarter to 74.6%. The performance predominantly reflected the
significant impact of equitable supply, at no profit to AstraZeneca, of the
pandemic COVID-19 vaccine, together with an increasing contribution from
profit-sharing arrangements, primarily Lynparza, and the impact of the Chinese
National Reimbursement Drug List (NRDL) and the volume-based procurement (VBP)
patient-access programmes. A higher proportion of Oncology sales and
increasing patient access in China partially offsets these impacts. These
variations in gross margin performance between quarters can be expected to
continue
- Reported Total Operating Expense increased by 13% (9% at CER) in the quarter
to $4,741m and represented 65% of Total Revenue (Q1 2020: 66%). Core Total
Operating Expense increased by 15% (11% at CER) to $4,136m and comprised 57%
of Total Revenue (Q1 2020: 57%)
- Reported and Core R&D Expense increased by 24% (19% at CER) in the
quarter to $1,713m and by 23% (18% at CER) to $1,638m, respectively. The
increases primarily reflected the investment in Phase III and the advancement
to Phase II of several clinical development programmes, particularly in
BioPharmaceuticals. The Company continued to invest in its COVID-19 vaccine
and potential medicines to prevent and treat COVID-19
- Reported SG&A Expense increased by 8% (4% at CER) in the quarter to
$2,929m; Core SG&A Expense increased by 10% (7% at CER) to $2,399m,
representing 33% of Total Revenue (Q1 2020: 34%)
- Reported Other Operating Income and Expense(10) grew by 146% (145% at CER)
in the quarter to $1,180m. Core Other Operating Income and Expense increased
by 147% (146% at CER) to $1,180m during the period. The growth predominately
reflected the $776m of income from divestment of AstraZeneca's 26.7% share of
Viela Bio, Inc. (Viela) as part of the acquisition by Horizon Therapeutics plc
- The Reported Operating Profit Margin increased by seven percentage points in
the quarter (eight at CER) to 26%; the Core Operating Profit Margin increased
by five percentage points (six at CER) to 34%. The performance predominately
reflected the aforementioned one-time benefit from Other Operating Income and
Expense(10)
- Reported EPS of $1.19 in the quarter represented an increase of 100% (97% at
CER). Core EPS grew by 55% (53% at CER) to $1.63. EPS benefitted from a lower
tax rate as a result of a non-taxable gain from the divestment of
AstraZeneca's share of Viela
Commercial summary
Oncology
Total Revenue increased by 20% in the quarter (16% at CER) to $3,024m.
Table 2: Q1 2021 - Select Oncology medicine Total Revenue performances
Actual CER
Medicine $m % change % change
Tagrisso 1,149 17 13
Imfinzi 556 20 17
Lynparza 543 37 33
Calquence 209 n/m n/m
Enhertu 40 n/m n/m
New CVRM
Total Revenue increased by 19% in the quarter (15% at CER) to $1,306m.
Table 3: Q1 2021 - Select New CVRM medicine Total Revenue performances
Actual CER
Medicine $m % change % change
Farxiga 625 54 50
Brilinta 374 (8) (11)
Bydureon 103 3 1
Roxadustat 41 n/m n/m
Lokelma 33 n/m n/m
Respiratory & Immunology
Total Revenue declined by 1% in the quarter (4% at CER) to $1,546m.
Table 4: Q1 2021 - Select R&I medicine Total Revenue performances
Actual CER
Medicine $m % change % change
Symbicort 691 (13) (15)
Pulmicort 330 (13) (18)
Fasenra 260 31 27
Breztri 27 n/m n/m
COVID-19
Total Revenue increased sequentially from $2m in Q4 2020 to $275m in the first
quarter of 2021.
Table 5: Q1 2021 - Pandemic COVID-19 vaccine performance
Actual CER
Medicine $m % change % change
Pandemic COVID-19 vaccine 275 n/m n/m
Emerging Markets
Total Revenue increased by 14% in the quarter (10% at CER) to $2,592m,
however, the performance was offset by the decline of Pulmicort, which
included an adverse impact of four percentage points (four at CER) and
suppressed the overall Total Revenue growth in the quarter.
China increased 19% (10% at CER) to $1,679m in the quarter and comprised 65%
of Emerging Markets Total Revenue. New medicines, primarily driven by Tagrisso
in Oncology and Forxiga in New CVRM, delivered particularly encouraging
growth. The Total Revenue growth in the quarter, however, included an adverse
impact of five percentage points (four at CER) from the reduced sales of
Pulmicort which, restricted overall revenue growth in the quarter. Ex-China
Total Revenue increased 6% (11% at CER) to $913m, with a particularly strong
performance in Middle East and Africa.
Business development
Acquisition of Acerta Pharma B.V. (Acerta) shares
In December 2015, the Company agreed to acquire 55% of the entire issued share
capital of Acerta for an upfront payment of $2.5bn, which was paid in 2016. A
further amount of $1.5bn was paid in 2017 on receipt of the first US
regulatory approval for Calquence. The agreement included options that, if
exercised, provided the opportunity for Acerta shareholders to sell, and
AstraZeneca to buy, the remaining 45% of shares in Acerta. The final condition
for these options to be exercised was satisfied in November 2020 when
Calquence received EU marketing authorisation. AstraZeneca exercised its
option to acquire the remaining 45% of shares in Acerta in April 2021.
The agreement initially provided that the remaining 45% of shares in Acerta
would be acquired at a price of approximately $3bn net of certain costs and
payments incurred by AstraZeneca and net of agreed future adjusting items,
using a pre-agreed pricing mechanism. In October 2019, an amendment agreement
came into effect which was disclosed as part of year-to-date and Q3 2019
results, changing the timing of payments and reducing the maximum
consideration required to be made to acquire the remaining outstanding shares
of Acerta if the options were exercised. The payments are to be made in
similar annual instalments in 2022, 2023 and 2024. The changes to the terms
were reflected in the assumptions that were used to calculate the amortised
cost of the option liability as of 31 March 2021 of $2,336m.
Sustainability summary
Recent developments and progress against the Company's sustainability
priorities are reported below:
a) Access to healthcare
AstraZeneca and its sublicensee, Serum Institute of India Pvt. Ltd. (SII),
delivered over 48 million doses of its pandemic COVID-19 vaccine to more than
120 countries through COVAX(11), the multilateral facility co-led by Gavi, the
Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations, and the
World Health Organization (WHO), with c.80% of the doses going to low and
middle-income countries.
b) Environmental protection
During the period, the Company was recognised for its leadership in building
sustainable business models, as one of the top 7% of companies on CDP
(https://www.linkedin.com/company/cdp-worldwide/) 's 2020 Supplier Engagement
Rating Leaderboard
(https://www.cdp.net/en/research/global-reports/transparency-to-transformation#2c467e4fe623c1b8f23fd3d91d63a52b)
. By working with suppliers to reduce their emissions, AstraZeneca is helping
to drive science-based climate action across the value chain, a key component
of the Company's Ambition Zero Carbon
(https://www.astrazeneca.com/sustainability/environmental-protection/greenhouse-gas-reduction.html)
strategy.
c) Ethics and transparency
The Company released its seventh annual Sustainability Report and
Sustainability Data Summary via its website and social media. The report was
released in conjunction with the Annual Report and Form 20-F Information 2020.
The report outlined progress and challenges and aims for the future.
A more extensive sustainability update is provided later (#_Sustainability) in
this announcement.
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. Not meaningful.
3. Total revenue ex. pandemic vaccine is a non-GAAP measure, which
excludes the revenue impact from sales of the pandemic COVID-19 vaccine during
the pandemic period to help facilitate a comparison to guidance.
4. Reported financial measures are the financial results presented
in accordance with UK and EU-adopted International Financial Reporting
Standards (IFRSs), and IFRS as issued by the International Accounting
Standards Board (IASB).
5. Earnings per share.
6. 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 (#_Operating_and_financial) for a definition of Core
financial measures and a reconciliation of Core to Reported financial
measures.
7. Tagrisso, Imfinzi, Lynparza, Calquence, Enhertu, Koselugo,
Farxiga, Brilinta, Lokelma, roxadustat, Fasenra, Bevespi and Breztri. The new
medicines are pillars in the three disease areas (formally referred to as
Therapy Areas) of Oncology, Cardiovascular (CV), Renal & Metabolism
(CVRM), and R&I and are important platforms for future growth.
8. New CVRM comprises Brilinta, Renal and Diabetes medicines.
9. 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.
10. Where AstraZeneca does not retain a significant ongoing interest
in medicines or potential new medicines, income from divestments is reported
within Other Operating Income and Expense in the Company's financial
statements.
11. 18.4 million doses of AstraZeneca's pandemic COVID-19 vaccine and
29.9 million of SII's Covidshield vaccine.
12. COVID-19 Vaccines Global Access (COVAX) is a coalition co-led by
CEPI, the Coalition for Epidemic Preparedness Innovations, Gavi, the Vaccine
Alliance (Gavi), and the WHO. It is the only global initiative bringing
governments and manufacturers together to ensure that safe and effective
COVID-19 vaccines are available worldwide to both higher-income and
lower-income countries.
Table 6: Pipeline highlights
The following table highlights significant developments in the late-stage
pipeline since the prior results announcement:
Regulatory approval or other regulatory action - Tagrisso - adjuvant NSCLC 13 (#_ftn1) (EGFRm 14 (#_ftn2) ):
approval (CN)
- Tagrisso - adjuvant NSCLC (EGFRm): positive opinion (EU)
- Imfinzi - bladder cancer (2nd line): indication voluntarily
withdrawn (US)
- Koselugo - NF1(( 15 (#_ftn3) )): positive opinion (EU)
Regulatory submission acceptance and/or submission - Lynparza - breast cancer (BRCAm 16 (#_ftn4) ): submission
voluntarily withdrawn (CN)
- Brilique - CAD 17 (#_ftn5) /T2D 18 (#_ftn6) CVOT 19 (#_ftn7) :
submission voluntarily withdrawn (EU, CN)
Major Phase III data readout or other - Lynparza - adjuvant breast cancer (BRCAm): Phase III primary
significant endpoint met
development
- Farxiga - COVID-19: Phase III primary endpoint not met
- roxadustat - anaemia in CKD 20 (#_ftn8) : delay in regulatory
decision due to convening of advisory committee (US)
- nirsevimab - RSV(( 21 (#_ftn9) )): Phase III primary endpoint met
- COVID-19 vaccine - COVID-19: Phase III primary endpoint met (US
trial)
Table 7: Pipeline anticipated major news flow
Timing News flow
H1 2021
- Tagrisso - adjuvant NSCLC (EGFRm): regulatory decision (EU)
- Imfinzi +/- treme - NSCLC (1st line) (POSEIDON): data readout
(OS(( 22 (#_ftn10) )))
- Calquence - CLL 23 (#_ftn11) (R/R 24 (#_ftn12) ) (ELEVATE R/R):
regulatory submission
- Koselugo - NF1 regulatory decision (EU)
- Farxiga - CKD: regulatory decision (US)
- Symbicort - mild asthma: regulatory decision (EU)
- Fasenra - nasal polyps(( 25 (#_ftn13) )): regulatory submission
- tezepelumab - severe asthma: regulatory submission
- COVID-19 vaccine - COVID-19: regulatory submission (US, JP)
- AZD7442 - SARS-CoV-2: data readout, regulatory submission
H2 2021
- Imfinzi - unresectable(( 26 (#_ftn14) )), Stage III NSCLC
(PACIFIC-2): data readout, regulatory submission
- Imfinzi - NSCLC (1st line) (PEARL): data readout
- Imfinzi +/- treme - NSCLC (1st line) (POSEIDON): regulatory
submission
- Imfinzi +/- treme - liver cancer (1st line): data readout,
regulatory submission
- Lynparza - adjuvant breast cancer: regulatory submission
- Lynparza - prostate cancer (2nd line): regulatory decision (CN)
- Lynparza - prostate cancer (1st line, castration-resistant): data
readout, regulatory submission
- Enhertu - breast cancer (2nd line, HER2+ 27 (#_ftn15) ): data
readout 28 (#_ftn16) , regulatory submission
- Forxiga - CKD: regulatory decision (EU, JP, CN)
- Farxiga - HF (HFpEF(( 29 (#_ftn17) ))): data readout
- Brilique - stroke (THALES): regulatory decision (EU, CN)
- roxadustat - anaemia in CKD: regulatory decision (US)
- PT027 - asthma: data readout
- anifrolumab - lupus (SLE 30 (#_ftn18) ): regulatory decision (US,
EU, JP)
- nirsevimab - RSV (MEDLEY): data readout
2022
- Imfinzi - NSCLC (1st line) (PEARL): regulatory submission
- Imfinzi - ES-SCLC(( 31 (#_ftn19) )): regulatory decision (CN)
- Imfinzi - LS-SCLC(( 32 (#_ftn20) )): data readout, regulatory
submission
- Imfinzi - liver cancer (locoregional): data readout, regulatory
submission
- Imfinzi - biliary tract cancer: data readout, regulatory submission
- Lynparza - ovarian cancer (3rd line, BRCAm): regulatory submission
- Enhertu - breast cancer (3rd line, HER2+) (Phase III): data readout,
regulatory submission
- Enhertu - breast cancer (HER2 low): data readout, regulatory
submission
- Calquence - CLL: regulatory submission (CN)
- Koselugo - NF1: regulatory submission (JP, CN)
- Farxiga - HF (HFpEF): regulatory submission
- roxadustat - MDS(( 33 (#_ftn21) ))(:) data readout, regulatory
submission
- PT027 - asthma: regulatory submission
- nirsevimab - RSV: regulatory submission
Conference call
A conference call and webcast for investors and analysts will begin at 11:45
BST. Details can be accessed via astrazeneca.com
(https://www.astrazeneca.com/) .
Reporting calendar
The Company intends to publish its half-year and second-quarter results on
Thursday 29 July 2021.
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 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 three-month
period to 31 March 2021 (the quarter or Q1 2021) compared to the three-month
period to 31 March 2020 (Q1 2020) respectively, unless stated otherwise.
Forward-looking statements in this announcement do not reflect the impact of
the performance of AstraZeneca's COVID-19 vaccine or the proposed acquisition
by the Company of Alexion, which is expected to close in Q3 2021.
Core financial measures, EBITDA, Net Debt, Initial Collaboration Revenue and
Ongoing Collaboration Revenue are non-GAAP financial measures because they
cannot be derived directly from the Group's Interim Financial Statements.
Management believes that these non-GAAP financial measures, when provided in
combination with Reported results, will 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 comprising the Diabetes alliance 34
(#_ftn22) , 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)
. Reference should be made to the Reconciliation of Reported to Core financial
measures table included in the financial performance section
(#_Financial_performance) in this announcement.
Total revenue ex. pandemic vaccine is a new non-GAAP financial measure
introduced in the current period to enable management to explain the financial
impact of the COVID-19 vaccine on the Group's Total revenue.
EBITDA is defined as Reported Profit Before Tax after adding back Net Finance
Expense, results from Joint Ventures and Associates and charges for
Depreciation, Amortisation and Impairment. Reference should be made to the
Reconciliation of Reported Profit Before Tax to EBITDA included in the
financial performance section (#_Financial_performance) in this announcement.
Net Debt is defined as Interest-bearing loans and borrowings and Lease
liabilities, net of Cash and cash equivalents, Other investments, and net
Derivative financial instruments. Reference should be made to Note 3 'Net
Debt' included in the Notes to the Interim Financial Statements
(#_Notes_to_the_1) 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 a geographical
split of Product Sales shown in Note 7.
Table 8: Q1 2021 - Total Revenue by disease area
Specialty-care medicines comprise all Oncology medicines, Brilinta, Lokelma,
roxadustat and Fasenra. At 51% of Total Revenue (Q1 2020: 49%), specialty-care
medicines increased by 19% in the year (15% at CER) to $3,732m.
Actual CER
$m % of total % change % change
Oncology 3,024 41 20 16
BioPharmaceuticals 2,852 39 7 4
- New CVRM 1,306 18 19 15
- R&I 1,546 21 (1) (4)
Other medicines 1,169 16 (1) (4)
COVID-19 275 4 n/m n/m
Total Revenue 7,320 100 15 11
- Less pandemic COVID-19 vaccine 275 4 n/m n/m
Total Revenue ex. pandemic vaccine 7,045 96 11 7
Table 9: Q1 2021 - Disease area and medicine performance
Actual CER
$m % of total % change % change
Oncology 2,981 41 19 15
- Tagrisso 1,149 16 17 13
- Imfinzi 556 8 20 17
- Lynparza 543 7 37 33
- Calquence 209 3 n/m n/m
- Koselugo 21 - n/m n/m
- Enhertu 1 - n/m n/m
- Zoladex 35 (#_ftn23) 221 3 (1) (6)
- Faslodex(35) 122 2 (26) (30)
- Iressa(35) 61 1 (21) (26)
- Arimidex(35) 44 1 (12) (15)
- Casodex(35) 42 1 - (6)
- Others 12 - (12) (12)
BioPharmaceuticals: CVRM 1,912 26 12 9
- Farxiga 624 9 54 50
- Brilinta 374 5 (8) (11)
- Bydureon 103 1 3 1
- Onglyza 101 1 (28) (31)
- Byetta 16 - (20) (20)
- Other diabetes 13 - 3 (1)
- Roxadustat 39 1 n/m n/m
- Lokelma 33 - n/m n/m
- Crestor(35) 274 4 (9) (12)
- Seloken/Toprol-XL(35) 250 3 41 36
- Atacand(35) 34 - (48) (49)
- Others 51 1 (13) (16)
BioPharmaceuticals: R&I 1,541 21 (1) (5)
- Symbicort 691 9 (13) (15)
- Pulmicort 330 5 (13) (18)
- Fasenra 260 4 31 27
- Daliresp/Daxas 60 1 14 12
- Breztri 27 - n/m n/m
- Bevespi 13 - 8 5
- Others 160 2 42 33
Other medicines 548 7 (2) (5)
- Nexium(35) 403 6 19 15
- Synagis(35) 24 - (72) (72)
- Losec/Prilosec(35) 54 1 1 (5)
- Seroquel XR/IR(35) 29 - (20) (22)
- FluMist(35) 2 - n/m n/m
- Others 36 - (19) (20)
COVID-19 275 4 n/m n/m
Pandemic COVID-19 vaccine 275 4 n/m n/m
Product Sales 7,257 99 15 11
Collaboration Revenue 63 1 43 42
Total Revenue 7,320 100 15 11
Total Revenue ex. pandemic vaccine 7,045 96 11 7
Table 10: Q1 2021 - Collaboration Revenue
Actual CER
$m % of total % change % change
Enhertu: share of gross profits 38 60 n/m n/m
Roxadustat: share of gross profits 2 3 (16) (23)
Other Ongoing Collaboration Revenue 23 37 (19) (20)
Total 63 100 43 42
Other Collaboration Revenue included Zoladex, Farxiga, Eklira, Nexium OTC 36
(#_ftn24) and other royalties. No Initial Collaboration Revenue was recorded
in the quarter.
Total Revenue summary
Oncology
Total Revenue of $3,024m in the quarter; an increase of 20% (16% at CER).
Oncology represented 41% of overall Total Revenue (Q1 2020: 40%).
Tagrisso
Tagrisso has received regulatory approval in 17 countries, including the US
and China, for use as an adjuvant treatment of EGFRm NSCLC patients, with four
reimbursements granted so far. This expands upon the patient benefit from use
in the 1(st)-line treatment of patients with EGFRm NSCLC with regulatory
approval in 89 countries, including the US, China, in the EU and Japan. To
date, 43 reimbursements have been granted in this setting, with further
decisions anticipated. These developments followed Tagrisso's regulatory
approval in 91 countries, including the US, China, in the EU and Japan, to
treat patients with EGFR T790M 37 (#_ftn25) NSCLC, an indication in which 67
reimbursements have been granted.
Total Revenue, entirely comprising Product Sales, amounted to $1,149m in the
quarter and represented growth of 17% (13% at CER). Sales in the US increased
by 12% to $415m following the US Food and Drug Administration (FDA) approval
in 2020 for the adjuvant treatment of Stage IB to IIIA EGFRm NSCLC patients,
despite the decrease in lung cancer diagnoses observed due to the impact of
the COVID-19 pandemic.
Tagrisso sales in Emerging Markets increased by 9% in the quarter (5% at CER)
to $306m; the performance was adversely impacted, however, due to the one-time
effects of admission to the China NRDL in March 2021 for the 1(st)-line
setting and the renewal in the 2(nd)-line setting, respectively. Japan
increased by 12% (7% at CER) to $172m. In Europe, sales of $225m in the
quarter represented an increase of 39% (26% at CER), driven by greater
adoption in the 1(st)-line setting, as more reimbursements were granted.
Imfinzi
Imfinzi has received regulatory approval in 71 countries, including the US,
China, in the European Union (EU) and Japan, with 34 reimbursements granted.
Imfinzi is approved to treat patients with unresectable Stage III NSCLC, whose
disease has not progressed following platinum-based chemoradiation therapy
(CRT). Imfinzi has also been approved to treat ES-SCLC patients in 53
countries, with eight reimbursements granted.
Total Revenue, entirely comprising Product Sales, amounted to $556m in the
quarter and represented growth of 20% (17% at CER), predominantly for the
treatment of unresectable, Stage III NSCLC patients. The US increased by 2% to
$292m, despite the COVID-19 related decrease in lung cancer diagnosis. In
Japan, growth of 46% (39% at CER) represented sales of $82m. Europe increased
by 46% (32% at CER) to $109m, reflecting a growing number of reimbursements.
Sales in Emerging Markets increased to $58m, representing a growth of 74% (69%
at CER) following recent regulatory approvals and launches, including in
China.
Lynparza
Lynparza has received regulatory approval in 81 countries for the treatment of
ovarian cancer; it has also been approved in 79 countries for the treatment of
metastatic breast cancer, and in 59 countries for the treatment of pancreatic
cancer. Lynparza has received regulatory approval in 55 countries for the
2(nd)-line treatment of certain prostate-cancer patients.
Total Revenue, entirely comprising Product Sales in the quarter, amounted to
$543m, reflecting growth of 37% (33% at CER). The strong performance was
geographically spread, with further launches across multiple cancer types
continuing globally. US Product Sales increased by 28% to $253m, as the
launches in prostate cancer and 1(st)-line HRD+ ovarian cancer continued to
take effect. Lynparza remained the leading medicine in the poly ADP ribose
polymerase-inhibitor (PARPi) class, as measured by total prescription volumes.
Product Sales in Europe increased by 46% (33% at CER) to $149m, reflecting
additional reimbursements and increasing BRCAm-testing rates, as well as
successful recent 1(st)-line BRCAm ovarian and homologous recombination repair
gene mutation (HRRm) prostate cancer launches.
Japan Product Sales of Lynparza amounted to $42m, representing growth of 23%
(17% at CER). Emerging Markets Product Sales were $87m, up by 54%. In China,
Lynparza was admitted to the NRDL as a 1(st)-line treatment for BRCAm ovarian
cancer patients with effect from March 2021.
Enhertu
Total Revenue, predominately comprising Collaboration Revenue recorded,
amounted to $40m in the quarter. Global sales amounted to $81m in the quarter
(ex. Japan). US sales, recorded by Daiichi Sankyo Company Limited (Daiichi
Sankyo), amounted to $73m. Enhertu was approved at the end of 2019 by the US
FDA to treat 3(rd)-line HER2+ breast cancer.
Calquence
Total Revenue, entirely comprising Product Sales, amounted to $209m in the
quarter and represented growth of 138% (137% at CER), with the overwhelming
majority of sales in the US; the performance benefitted from increased
front-line use. The US FDA approved Calquence for the treatment of CLL in
November 2019. In total, Calquence has received regulatory approvals for this
indication in 61 countries and 28 countries for the treatment of patients with
R/R mantle cell lymphoma.
Koselugo
Total Revenue, entirely comprising Product Sales in the US, amounted to $21m
in the quarter, following its launch during the second quarter of 2020 to
treat the rare disease NF1 in paediatric patients aged two years and older who
have symptomatic, inoperable plexiform neurofibromas (PN).
Zoladex
Total Revenue, predominantly comprising Product Sales, amounted to $226m in
the quarter and represented a decrease of 1% (5% at CER).
Emerging Markets Product Sales of Zoladex decreased by 8% (11% at CER) to
$136m. Product Sales in Europe increased by 6% (declined by 2% at CER) to $37m
while, in the Established Rest of World (RoW) region, Product Sales increased
by 11% (4% at CER) to $43m.
Faslodex
Total Revenue, entirely comprising Product Sales, amounted to $122m in the
quarter and represented a decline of 26% (30% at CER) following the launch of
several generic versions of the medicine.
Emerging Markets fell by 12% (13% at CER) to $43m, while US sales declined by
60% to $9m; in Europe, sales fell by 35% (41% at CER) to $41m. In Japan, sales
declined by 3% (8% at CER) to $28m, driven by a mandated price reduction in
2020.
Iressa
Total Revenue, entirely comprising Product Sales, amounted to $61m in the
quarter and represented a decline of 21% (26% at CER). Emerging Markets fell
by 15% (20% at CER) to $53m, driven by the impact of Iressa's inclusion in
China's VBP programme and subsequent price reduction.
BioPharmaceuticals: CVRM
Total Revenue increased by 12% in the quarter (9% at CER) to $1,916m and
represented 26% of Total Revenue (Q1 2020: 27%).
New CVRM Total Revenue, which excludes Crestor and other legacy medicines'
sales, increased by 19% in the year (15% at CER) to $1,306m, mainly reflecting
the strong performance of Farxiga. New CVRM represented 68% of overall CVRM
Total Revenue in the quarter (Q1 2020: 65%).
Farxiga
Total Revenue, predominantly comprising Product Sales, amounted to $625m in
the quarter and represented growth of 54% (50% at CER), reflecting volume
growth across the regions; Farxiga grew faster than the overall SGLT2 class in
the majority of markets.
Emerging Market sales increased by 84% (85% at CER) to $260m in the quarter.
The performance reflected the addition of Forxiga to the Chinese NRDL in 2020;
the initial price impact has been more than offset by increased access for
patients.
In the US, Product Sales increased by 16% to $131m, benefitting from the
recent regulatory approval to treat patients with heart failure with reduced
ejection fraction (HfrEF) with and without T2D.
Product Sales in Europe increased by 50% (36% at CER) to $174m in the quarter,
partly reflecting growth in the sodium-glucose co-transporter-2 inhibitor
class, the beneficial addition of CVOT data to the label and the recent HfrEF
regulatory approval in November 2020. In Japan, sales to collaborator Ono
Pharmaceutical Co., Ltd, which records in-market sales, increased by 152%
(140% at CER) to $32m.
Brilinta
Total Revenue, entirely comprising Product Sales, amounted to $374m in the
quarter, representing a decline of 8% (11% at CER). Global demand continued to
be adversely impacted by COVID-19, reflected in fewer acute coronary syndrome
hospital admissions and lower demand, particularly in China. The performance
in China, was also affected following VBP in 2020, where the Company chose not
to participate further in the bidding process.
Emerging Markets sales declined by 22% (23% at CER) to $105m, driven by the
aforementioned VBP impact. In the US, sales increased by 1% to $166m with an
increase in the average weighted duration of treatment partly offset by the
adverse effects of COVID-19, reflected in fewer elective procedures. Sales of
Brilique in Europe declined by 6% (14% at CER) to $88m in the quarter, with
the performance similarly impacted by COVID-19.
Onglyza
Total Revenue, entirely comprising Product Sales, amounted to $101m in the
quarter and represented a decline of 28% (31% at CER). Sales in Emerging
Markets, however, increased by 22% (19% at CER) to $58m, driven by China's
performance and the growing domestic DPP-4 38 (#_ftn26) class. US sales of
Onglyza fell by 72% in the year to $19m, while Europe sales increased by 1%
(declined by 8% at CER) to $15m, highlighting the shift away from the class.
Bydureon
Total Revenue, entirely comprising Product Sales, amounted to $103m in the
quarter, representing a growth of 3% (1% at CER).
US sales of $85m reflected an increase of 1% in the quarter. Sales in Europe
increased by 24% (14% at CER) to $15m.
Lokelma
Total Revenue, comprising Product Sales, amounted to $33m in the quarter (Q1
2020: $11m), an increase of 204% (200% at CER), despite the adverse impact of
COVID-19 on market growth. The US represented the overwhelming majority of
sales; Lokelma continued to lead new-to-brand prescription market share in the
US. The medicine has received regulatory approval in several countries to
treat hyperkalaemia, including in the EU, China and Japan, with further
launches anticipated.
Roxadustat
Total Revenue in China, predominantly comprising Product Sales, amounted to
$41m in the quarter. From January 2021, AstraZeneca started recognising the
overwhelming majority of China's revenue as Product Sales following an
amendment to the existing licence agreement entered into in July 2020.
Crestor
Total Revenue, primarily comprising Product Sales, amounted to $274m in the
quarter and represented a decline of 9% (12% at CER).
In Emerging Markets, sales fell by 1% (4% at CER) to $189m. The performance
continued to be adversely impacted by China's VBP programme's ongoing effects.
US sales declined by 22% to $22m. In Europe, sales decreased by 39% (43% at
CER) to $21m while, in Japan, where AstraZeneca collaborates with Shionogi
Co., Ltd, sales declined by 9% (13% at CER) to $31m.
In February 2021, AstraZeneca announced that it had completed an agreement to
sell the rights to Crestor in over 30 countries in Europe except the UK and
Spain to Grünenthal GmbH (Grünenthal).
BioPharmaceuticals: Respiratory & Immunology
Total Revenue, which included Ongoing Collaboration Revenue of $5m from
Duaklir, Eklira and other medicines, declined by 1% in the quarter (4% at CER)
to $1,546m and represented 21% of Total Revenue (Q1 2020: 24%). The adverse
impact of the decline of Pulmicort sales reduced Respiratory & Immunology
Total Revenue growth by four percentage points. In addition, stocking of
respiratory medicines due to COVID-19 and an inventory build for the
authorised generic version of Symbicort in the US by the Company's
collaborator Prasco LLC (Prasco) in Q1 2020, both adversely impacted the
performance comparison in the quarter.
Symbicort
Total Revenue, entirely comprising Product Sales, amounted to $691m in the
quarter and represented a decrease of 13% (15% at CER). The performance
relative to Q1 2020 predominately reflected the aforementioned impact of
stocking of an authorised generic version of Symbicort in the US during Q1
2020 and phasing of COVID-19 impacts. Symbicort remains the global
market-volume and value leader within the inhaled corticosteroid (ICS) /
long-acting beta-agonist (LABA) class. The global ICS/LABA class growth
developed slower, particularly in the US, due to the impact of COVID-19 on the
diagnosis of respiratory diseases, lower levels of respiratory symptoms, and
reduced use of medicines.
US sales fell by 14% in the quarter to $266m due to the stocking effects. In
March 2021, the US District Court for the Northern District of West Virginia
decided in favour of AstraZeneca and determined that the asserted patent
claims by Mylan Pharmaceuticals Inc. (Mylan) and Kindeva Drug Delivery L.P.,
were not invalid or unenforceable.
Emerging Markets sales increased by 6% (3% at CER) to $165m. In Europe, sales
decreased by 14% (21% at CER) in the quarter to $168m. Sales in Japan declined
by 44% (47% at CER) to $31m in the quarter, the performance predominately
reflected the ongoing adverse impact of generic competition and an
unfavourable price comparison due to the termination of the co-promotion
agreement by Astellas Pharma Inc.
Pulmicort
Total Revenue, entirely comprising Product Sales, amounted to $330m in the
quarter and represented a decline of 13% (18% at CER), as the continued
effects of COVID-19 impacted the hospital treatment of respiratory patients.
Emerging Markets, where Pulmicort sales fell by 9% (14% at CER) in the quarter
to $286m, represented 87% of the global total. Alongside the effects of
COVID-19, the performance in China continued to be impacted by a reduction in
the number of paediatric patients attending outpatient nebulisation rooms and
an increasing number of generic versions of Pulmicort.
Sales in the US declined by 25% in the quarter to $17m, due to the fall in the
use of Pulmicort Respules. In Japan, sales declined by 47% (49% at CER) to $5m
as a result of generic competition and fell in Europe by 37% (43% at CER) to
$16m.
Fasenra
Total Revenue, entirely comprising Product Sales, increased by 31% (27% at
CER) to $260m in the quarter. The performance reflected growing demand,
despite the impact of COVID-19 on the level of new-patient starts in several
countries. Fasenra remained the leading novel biologic in most markets in the
new-to-brand prescription share for patients with severe, uncontrolled asthma.
Sales in the US grew by 30% in the quarter to $156m due to increased demand
and patient adherence seen using the Fasenra Pen home administration device.
This performance, however, was again partly offset by the continuing and
adverse effect of COVID-19. In Europe, sales of $63m represented an increase
of 37% (25% at CER); the benefit of ongoing launches and additional
reimbursement was offset by a decline in the dynamic market due to COVID-19
restrictions. Sales in Japan increased by 25% (19% at CER) to $26m due to
increased demand and a partial recovery in the treatment naïve market. In
Emerging Markets, sales decreased 51% (47% at CER) to $3m.
Daliresp/Daxas
Total Revenue, entirely comprising Product Sales, amounted to $60m in the
quarter and represented an increase of 14% (12% at CER). US sales increased by
20% to $54m.
Breztri
Breztri has received regulatory approval in 34 countries, including the US, in
the EU, China and Japan for the treatment of patients with COPD. With further
regulatory reviews ongoing, Breztri has already achieved reimbursement in nine
countries.
Total Revenue, entirely comprising Product Sales, amounted to $27m in the
quarter (Q1 2020: $4m). Sales in the US amounted to $12m (Q1 2020: $nil), with
an encouraging 20% market share in new patient starts. Sales in Japan amounted
to $5m (Q1 2020: $1m). In Europe, under the name Trixeo, sales amounted to $1m
in the quarter (Q1 2020: $nil). Emerging Markets sales amounted to $9m in the
quarter (Q1 2020: $4m). Following inclusion into the China NRDL with effect
from March 2021, the number of patients that have access to Breztri in China
has significantly increased.
Other medicines (outside the main disease areas)
Total Revenue, primarily comprising Product Sales, amounted to $559m in the
quarter, a decline of 3% (6% at CER). Other medicines Total Revenue
represented 8% of overall Total Revenue (Q1 2020: 9%).
Nexium
Total Revenue, predominantly comprising Product Sales, amounted to $409m in
the quarter, an increase of 18% (13% at CER). Emerging Markets Product Sales
of Nexium increased by 25% (21% at CER) to $234m in the quarter, reflecting an
increase in Nexium initiation in the hospital setting in China, as patients
underwent colonoscopy procedures that had been delayed by the pandemic.
China concluded another round of the VBP-programme in February 2021, including
Nexium (oral). The Company, however, having submitted an initial price, chose
not to participate further in the bidding process and consequently accepted a
mandatory price reduction of 10%.
In Japan, where AstraZeneca collaborates with Daiichi Sankyo, Product Sales
increased by 37% (30% at CER) to $103m, due to phasing of orders from Daiichi
Sankyo, while Product Sales in the US declined by 20% to $32m. In Europe,
Product Sales decreased by 18% (26% at CER) to $18m.
In March 2021, AstraZeneca and Daiichi Sankyo announced
(https://www.daiichisankyo.com/files/news/pressrelease/pdf/202103/20210312_E2.pdf)
that the two companies will end the joint sales promotion of Nexium in Japan
on the 14 September 2021, after which date AstraZeneca will market,
distribute, and promote Nexium.
Synagis
Total Revenue, entirely comprising Product Sales, amounted to $24m in the
quarter, representing a decrease of 72%. Sales in Europe, wholly comprising
sales to AbbVie Inc. (AbbVie) made under the current supply agreement for
markets outside the US, amounted to $22m in the quarter, a decrease of 69%
reflecting low levels of RSV infections globally due to the impact of
COVID-19, the phasing of orders from AbbVie and preparations for the reversion
of commercial rights outside the US, held by AbbVie since 1997, to AstraZeneca
upon the expiry of the current agreement on 30 June 2021.
COVID-19
COVID-19 vaccine
Total Revenue, entirely comprised of Product Sales, amounted to $275m in the
quarter, reflecting the delivery of c.68 million 39 (#_ftn27) doses
worldwide. Sales in Europe were $224m, Emerging Markets sales were $43m, and
in Established RoW sales amounted to $8m.
Regional Total Revenue
A geographical split of Product Sales is shown in Note 7. For additional
details, refer to Table 45: Ongoing Collaboration Revenue for Collaboration
Revenue recognised during Q1 2021 and Q1 2020.
Table 11: Q1 2021 - Regional Total Revenue
Actual CER
$m % of total % change % change
Emerging Markets 2,592 35 14 10
- China 1,679 23 19 10
- Ex-China 913 12 6 11
US 2,310 32 10 10
Europe 1,546 21 28 18
Established RoW 872 12 11 5
- Japan 620 8 12 7
- Canada 156 2 - (4)
- Other Established RoW 96 1 23 6
Total 7,320 100 15 11
The performance in Europe benefitted from $224m of sales from the pandemic
COVID-19 vaccine.
Table 12: Q1 2021 - Emerging Markets Total Revenue disease-area performance
Actual CER
$m % of total % change % change
Oncology 762 29 7 4
BioPharmaceuticals 1,014 39 16 13
- New CVRM 472 18 43 41
- R&I 542 21 - (4)
Other medicines 773 30 12 8
COVID-19 43 2 n/m n/m
Total 2,592 100 14 10
Emerging Markets Total Revenue grew by 14% (10% at CER) to $2,592m in the
quarter. New medicines represented 34% of Emerging Markets Total Revenue in
the quarter (Q1 2020: 29%). Speciality-care medicines increased by 7% (3% at
CER) to $912m and comprised 35% of Emerging Markets Total Revenue in the
quarter (Q1 2020: 38%).
Table 13: Q1 2021 - Notable new medicine Total Revenue performances in
Emerging Markets
Actual CER
$m % of total % change % change
Tagrisso 306 12 9 5
Forxiga 260 10 84 85
Brilinta 105 4 (22) (23)
Lynparza 87 3 54 54
China comprised 65% of Emerging Markets Total Revenue in the quarter and
increased by 19% (10% at CER) to $1,679m. New medicines, primarily driven by
Tagrisso in Oncology and Forxiga in New CVRM, delivered particularly
encouraging growth and represented 31% of China Total Revenue (Q1 2020: 27%);
strong sales of Seloken, Nexium and Symbicort supplemented this performance.
The Total Revenue growth in the quarter, however, included an adverse impact
of five percentage points (four at CER) from the reduced sales of Pulmicort
which, restricted overall revenue growth in the quarter.
Table 14: Q1 2021 - Ex-China Emerging Markets Total Revenue
Actual CER
$m % change % change
Ex-China Emerging Markets 913 6 11
- Russia 77 (9) 7
- Brazil 79 (11) 12
- Ex-Brazil Latin America 107 (1) 8
- Ex-China Asia Pacific 324 4 -
- Middle East and Africa 326 23 26
Ex-China Emerging Markets Total Revenue, primarily comprising Product Sales,
increased by 6% in the quarter (11% at CER) to $913m. New medicines
represented 39% of ex-China Emerging Markets Total Revenue (Q1 2020: 32%),
increasing by 26% (33% at CER) to $352m.
Financial performance
Table 15: Reported Profit and Loss
Q1 2021 Q1 2020 Actual CER
$m $m % change % change
Total Revenue 7,320 6,354 15 11
- Product Sales 7,257 6,311 15 11
- Collaboration Revenue 63 43 43 42
Cost of Sales (1,864) (1,420) 31 25
Gross Profit 5,456 4,934 11 7
Gross Margin 74.3% 77.5% -3 -3
Distribution Expense (99) (87) 14 8
% Total Revenue 1.4% 1.4% - -
R&D Expense (1,713) (1,388) 24 19
% Total Revenue 23.4% 21.8% -2 -2
SG&A Expense (2,929) (2,719) 8 4
% Total Revenue 40.0% 42.8% +3 +3
Other Operating Income & Expense 1,180 480 n/m n/m
% Total Revenue 16.1% 7.6% +9 +9
Operating Profit 1,895 1,220 55 54
Operating Profit Margin 25.9% 19.2% +7 +8
Net Finance Expense (283) (281) 1 (1)
Joint Ventures and Associates (4) (4) 6 (1)
Profit Before Tax 1,608 935 72 69
Taxation (46) (185) (75) (76)
Tax Rate 3% 20%
Profit After Tax 1,562 750 n/m n/m
EPS $1.19 $0.59 100 97
Table 16: Reconciliation of Reported Profit Before Tax to EBITDA
Q1 2021 Q1 2020 Actual CER
$m $m % change % change
Reported Profit Before Tax 1,608 935 72 69
Net Finance Expense 283 281 1 (1)
Joint Venture and Associates 4 4 6 (1)
Depreciation, Amortisation and Impairment 797 841 (5) (10)
EBITDA 2,692 2,061 31 29
Table 17: Reconciliation of Reported to Core financial measures
Q1 2021 Reported Restructuring Intangible Asset Amortisation & Impairments Diabetes Alliance Other Core 40 (#_ftn28) Core
% change
$m $m $m $m $m $m Actual CER
Gross Profit 5,456 7 17 - - 5,480 10 7
Gross Profit Margin 74.3% 74.6% (3) (3)
Distribution Expense (99) - - - - (99) 14 8
R&D Expense (1,713) 13 63 - (1) (1,638) 23 18
SG&A Expense (2,929) 30 383 99 18 (2,399) 10 7
Total Operating Expense (4,741) 43 446 99 17 (4,136) 15 11
Other Operating Income & Expense 1,180 - 1 - (1) 1,180 n/m n/m
Operating Profit 1,895 50 464 99 16 2,524 36 34
Operating Profit Margin 25.9% 34.5% +5 +6
Net Finance Expense (283) - - 49 47 (187) 11 16
Taxation (46) (10) (101) (31) (2) (190) (43) (44)
EPS $1.19 $0.03 $0.27 $0.09 $0.05 $1.63 55 53
Profit and Loss summary
a) Gross Profit
The increases in Reported and Core Gross Profit by 11% (7% at CER) and 10% (7%
at CER), respectively, reflected the 15% (11% at CER) growth in Product Sales.
The Reported Gross Profit Margin declined by three percentage points to 74.3%,
and the Core Gross Profit Margin declined by three percentage points in the
quarter to 74.6%. The performance predominantly reflected the significant
impact of equitable supply, at no profit to AstraZeneca, of the pandemic
COVID-19 vaccine, together with an increasing contribution from profit-sharing
arrangements, primarily Lynparza, and the impact of the Chinese National
Reimbursement Drug List (NRDL) and the volume-based procurement (VBP)
patient-access programmes. A higher proportion of Oncology sales and
increasing patient access in China partially offsets these impacts. These
variations in gross margin performance between quarters can be expected to
continue.
b) Total Operating Expense
Reported Total Operating Expense increased by 13% (9% at CER) to $4,741m and
represented 65% of Total Revenue (Q1 2020: 66%). Core Total Operating Expense
increased by 15% (11% at CER) to $4,136m and comprised 57% of Total Revenue
(Q1 2020: 57%).
The increases in Reported and Core R&D Expense primarily reflected
investment in Phase III and the advancement to Phase II of several clinical
development programmes, particularly in BioPharmaceuticals. The Company
continued to invest in its COVID-19 vaccine and potential medicines for the
prevention and treatment of COVID-19, including other related costs, such as
personal protective equipment and colleague COVID-19 testing across the
Company. In the quarter, grant income of $270m has been recognised, of which
$209m has been offset against the US Clinical trial costs for AZD1222.
Reported and Core SG&A Expense grew primarily due to additional select
investment in new medicine launches and the Company's continued expansion in
China.
c) Other Operating Income and Expense
Reported and Core Other Operating Income and Expense of $1,180m reflected an
increase of 146% (145% at CER) and 147% (146% 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
- $309m of income from an agreement with Grünenthal to divest commercial
rights to Crestor in over 30 countries in Europe, except in the UK and Spain
d) Net Finance Expense
Reported Net Finance Expense increased by 1% (declined 1% at CER) in the
quarter to $283m reflecting lower interest rates on cash, cash equivalents and
other current investments and was partially offset by lower discount unwind
costs on acquisition-related liabilities, including the Diabetes Alliance. The
11% (16% at CER) increase in Core Finance Expense was driven by the
aforementioned lower interest rates.
e) Taxation
The Reported Tax Rate for the quarter was 3% (Q1 2020: 20%), and the Core Tax
Rate was 8% (Q1 2020: 20%). These tax rates benefitted from the following
one-off favourable impacts:
- Non-taxable gain on the divestment of the investment in Viela
- Reduction of tax liabilities arising from updates to estimates of prior
period tax liabilities following settlements with tax authorities
Excluding these benefits, the Reported and Core Tax Rates would have been
c.20%, within the indication provided for 2021.
The net cash tax paid for the quarter was $332m (Q1 2020: $477m), representing
21% of Reported Profit Before Tax (Q1 2020: 51%).
In its Spring Budget, the UK Government has announced that UK Corporation Tax
will increase from 19% to 25% from 1 April 2023. It is anticipated that this
will be substantively enacted during Q2 2021, which will result in a tax
charge during that quarter arising from the recalculation of deferred tax
balances to the 25% tax rate.
f) EPS
Reported EPS of $1.19 in the quarter represented an increase of 100% (97% at
CER); Core EPS increased by 55% (53% at CER) to $1.63.
Table 18: Cash Flow
Q1 2021 Q1 2020 Change
$m $m $m
Reported Operating Profit 1,895 1,220 675
Depreciation, Amortisation and Impairment 797 841 (44)
Decrease/(increase) in Working Capital and Short-Term Provisions 1,210 (445) 1,655
Gains on Disposal of Intangible Assets (310) (358) 48
Gains on Disposal of Investments in Associates and Joint Ventures (776) - (776)
Non-Cash and Other Movements (363) (462) 99
Interest Paid (187) (180) (7)
Taxation Paid (332) (477) 145
Net Cash Inflow from Operating Activities 1,934 139 1,795
Net Cash Inflow before Financing Activities 2,489 148 2,341
Net Cash Outflow from Financing Activities (2,731) (2,362) (369)
The increase in Net Cash Inflow from Operating Activities of $1,795m was
primarily driven by the decrease in working capital, of which $996m related to
the movement in pandemic COVID-19 vaccine working capital balances within
trade and other payables, trade and other receivables and inventories.
The increase in Net Cash Inflow before Financing Activities of $2,341m was a
result of the aforementioned improvement in Net Cash Inflow from Operating
Activities, as well as cash proceeds received of $776m from the divestment of
AstraZeneca's 26.7% shareholding in Viela.
Capital Expenditure
Capital Expenditure amounted to $220m in the quarter, compared to $186m in Q1
2020. This included investment in the new AstraZeneca R&D centre on the
Biomedical Campus in Cambridge, UK, to which a number of colleagues are
expected to begin relocation this year.
The Company anticipates an increase in Capital Expenditure, partly driven by
an expansion in its capacity for growth across several limited-sized projects.
Table 19: Net Debt summary
At 31 Mar 2021 At 31 Dec 2020 At 31 Mar 2020
$m $m $m
Cash and cash equivalents 7,636 7,832 3,413
Other investments 129 160 804
Cash and investments 7,765 7,992 4,217
Overdrafts and short-term borrowings (581) (658) (691)
Lease liabilities (680) (681) (653)
Current instalments of loans (1,461) (1,536) (1,598)
Non-current instalments of loans (17,410) (17,505) (15,634)
Interest-bearing loans and borrowings (20,132) (20,380) (18,576)
(Gross Debt)
Net derivatives 162 278 (54)
Net Debt (12,205) (12,110) (14,413)
Net Debt of $12,205m represented an increase of $95m in the year to date.
Details of the committed undrawn bank facilities are disclosed within the
going-concern section of Note 1.
During the three months, there were no changes to the Company's credit ratings
issued by Standard and Poor's (long term: BBB+, short term A-2) and Moody's
(long term: A3, short term P-2).
Capital allocation
The Board's aim is to continue to strike a balance between the interests of
the business, financial creditors and the Company's shareholders. After
providing for investment in the business, supporting the progressive dividend
policy and maintaining a strong, investment-grade credit rating, the Board
will keep under review potential investment in immediately earnings-accretive,
value-enhancing opportunities.
Foreign exchange
The Company's transactional currency exposures on working-capital balances,
which typically extend for up to three months, are hedged where practicable
using forward foreign-exchange contracts against the individual companies'
reporting currency. Foreign-exchange gains and losses on forward contracts for
transactional hedging are taken to profit or loss. In addition, the Company's
external dividend payments, paid principally in pounds sterling and Swedish
krona, are fully hedged from announcement to payment date.
Table 20: Currency sensitivities
The Company provides the following currency-sensitivity information:
Average Exchange Annual Impact of 5% Strengthening in Exchange Rate versus USD ($m)(( 41
(#_ftn29) ))
Rates versus USD
Currency Primary Relevance FY 2020 42 (#_ftn30) YTD 2021(( 43 (#_ftn31) )) % change Product Sales Core Operating Profit
CNY Product Sales 6.90 6.48 6 312 186
EUR Product Sales 0.88 0.83 5 189 58
JPY Product Sales 106.74 105.98 1 140 91
Other(( 44 (#_ftn32) )) 239 108
GBP Operating Expense 0.78 0.73 7 31 (84)
SEK Operating Expense 9.20 8.39 9 5 (59)
Sustainability
AstraZeneca's sustainability approach has three priority areas(( 45 (#_ftn33)
)), 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
AstraZeneca and its sublicensees, including SII, delivered over 48 million
doses of its pandemic COVID-19 vaccine to more than 110 countries through
COVAX, the multilateral facility co-led by Gavi, the Coalition for Epidemic
Preparedness Innovations, and the World Health Organization (WHO), with c.80%
of the doses going to low and middle-income countries.
In April 2021, Chief Executive Officer Pascal Soriot joined Heads of State,
Ministers and global leaders at the Gavi COVAX Advance Market Commitment
investment opportunity to highlight AstraZeneca's commitment to broad and
equitable access, and its collaboration with COVAX.
Following the Company's launch in November 2020 of the Partnership for Health
System Sustainability and Resilience (https://www.weforum.org/phssr) (PHSSR)
with the World Economic Forum (WEF) and the London School of Economics (LSE)
to identify practical solutions that will support more resilient and
sustainable health systems. AstraZeneca co-led the first virtual PHSSR Summit
held between 15-19 March 2021, which brought together over 50 leading experts
from eight pilot countries, including Germany, France, the UK, Italy, Spain,
Vietnam, Russia and Poland. Participants also included representatives from
bodies such as The Organisation for Economic Co-operation and Development, the
WHO, the World Heart Federation, and the International Society of Nephrology
to discuss the future of health in a post-COVID-19 world. Over 1,200 people
registered from more than 65 countries.
During the period, the Company's Healthy Heart Africa (HHA) programme expanded
into the Republic of Côte d'Ivoire, its first French-speaking country of
operation, signing a memorandum of understanding with the country's Ministry
of Health. Since the programme launched in 2015, HHA has conducted over 17
million blood pressure screenings, identified over three million elevated
readings, activated over 900 sites and trained over 7,600 healthcare workers
and volunteers.
In March 2021, the Company's Young Health Programme (YHP) released its annual
report. The report noted that in 2020, the programme directly delivered health
information to more than one million youth, trained 55,000 peer educators and
health professionals, engaged more than 1,300 employees as volunteers and
expanded into six new countries. It also showcased the immediate contribution
of its latest partner, UNICEF, and its focus on advocacy and policy change.
Independent external evaluations of YHP completed in 2020 in Brazil,
Indonesia, and Kenya found YHP's community-based delivery model and peer
educator approach leads to sustained behaviour change among youth. The
assessment also confirmed that when health services are more accessible to
young people, they will use them more often and be more satisfied. Two new
learning modules developed by UNICEF were launched, including substance abuse
and air pollution, respectively.
b) Environmental protection
In April 2021, AstraZeneca launched an interactive EcoPharmacoVigiliance
dashboard
(https://www.astrazeneca.com/sustainability/environmental-protection/pharmaceuticals-in-the-environment.html)
measuring potential environmental risks associated with patient use of the
Company's life-saving medicines. The dashboard is part of the AstraZeneca's
commitment to lead in the environmental safety of its medicines and respond to
stakeholder concerns associated with pharmaceuticals in the environment. The
dashboard collates published measured environmental concentrations of the
active ingredients in AstraZeneca's products and presents data based on
potential risk.
During the period, the Company was recognised for its leadership in building
sustainable business models, as one of the top 7% of companies on CDP
(https://www.linkedin.com/company/cdp-worldwide/) 's 2020 Supplier Engagement
Rating Leaderboard
(https://www.cdp.net/en/research/global-reports/transparency-to-transformation#2c467e4fe623c1b8f23fd3d91d63a52b)
. By working with suppliers to reduce their emissions, AstraZeneca is helping
to drive science-based climate action across the value chain, a key component
of the Company's Ambition Zero Carbon
(https://www.astrazeneca.com/sustainability/environmental-protection/greenhouse-gas-reduction.html)
strategy.
In March 2021, AstraZeneca published its first voluntary disclosure
(https://www.astrazeneca.com/content/dam/az/Sustainability/2021/pdf/AstraZeneca_TCFD_Report_2020.pdf)
in line with the recommendations of the Taskforce on Climate-related Financial
Disclosures (TCFD (https://www.fsb-tcfd.org/) ), describing its progress and
actions as at 31 December 2020. All the Company's business operations
worldwide are in scope unless otherwise stated. Full TCFD disclosure will be
provided according to the UK's Financial Conduct Authority's enhanced listing
rules, which promote better climate-related financial disclosures for UK
premium-listed companies. The rule will apply for accounting periods beginning
on or after 1 January 2021, meaning that AstraZeneca's first annual financial
report to include TCFD would be published in spring 2022.
During the period, the Innovative Medicines Initiative (IMI)
(https://www.imi.europa.eu/) PREMIER project, in which the Company is a
leading participant, launched a novel database and digital assessment system
(https://imi-premier.eu/the-innovative-premier-database/) for characterising
the environmental risks of medicines and making environmental data more
visible and accessible to industry, academia, regulators and the public.
The company joined a new UK collaboration with CPI
(https://www.uk-cpi.com/about) in the Medicines Manufacturing Innovation
Centre
(https://www.uk-cpi.com/news/uk-collaboration-leads-the-way-on-revolutionising-oligonucleotide-medicines-manufacturing)
that aims to revolutionise the development of new manufacturing processes for
oligonucleotides (short DNA or RNA molecules) to achieve sustainable large
scale manufacturing.
The Company was recognised by the UK Government
(https://www.gov.uk/government/news/third-of-uks-biggest-companies-commit-to-net-zero)
in March 2021 as one of 30 FTSE 100 companies to have signed up to the United
Nation's Race to Zero
(https://unfccc.int/climate-action/race-to-zero-campaign) campaign - the
largest ever global alliance committed to achieving net zero carbon emissions
by 2050 at the latest - leading the way in the world's transition to a low
carbon economy, as well as committing to align with UK government ambitions
and eliminate their contribution to climate change by 2050.
In March 2021, the Company was also recognised in the BloombergNEF
(https://www.bloomberg.com/news/articles/2021-04-07/tech-firms-are-setting-the-most-ambitious-net-zero-goals-green-insight?utm_source=flipboard&utm_medium=bd&cmpId=flipboard)
(BNEF) net zero research tool as achieving the top score for its Ambition Zero
Carbon strategy, out of 400 of the largest corporations in heavy-emitting
industries.
c) Ethics and transparency
The Company released its seventh annual Sustainability Report and
Sustainability Data Summary via its website and social media. The report was
released in conjunction with the Annual Report and Form 20-F Information 2020.
The report outlined progress and challenges and aims for the future.
For more details on AstraZeneca's sustainability ambition, approach and
targets, please refer to the latest Sustainability Report 2020
(https://www.astrazeneca.com/content/dam/az/Sustainability/2021/pdf/Sustainability_Report_2020.pdf)
and Sustainability Data Summary 2020
(https://www.astrazeneca.com/content/dam/az/Sustainability/2021/pdf/Sustainability_Data_Summary_2020.pdf)
. Additional information is available within AstraZeneca's analyst interactive
reporting centre (https://www.astrazeneca.com/investor-relations/AIR.html) or
alternatively at astrazeneca.com/sustainability
(https://www.astrazeneca.com/sustainability.html) .
Research and development
As the COVID-19 pandemic persists, the Company continues to evaluate impacts
on the initiation of clinical trials, ongoing recruitment and follow-ups. It
is prudent to assume that some delays will continue to arise.
A comprehensive breakdown of AstraZeneca's pipeline of medicines in human
trials can be found in the latest clinical-trials appendix, available on
astrazeneca.com/investor-relations
(https://www.astrazeneca.com/investor-relations.html) .html. Highlights of
developments in the Company's late-stage pipeline since the prior results
announcement are shown below:
Table 21: Late-stage pipeline
New molecular entities and major lifecycle events for medicines in Phase III 22 Oncology
trials or under regulatory review
- Tagrisso - NSCLC
- Imfinzi - multiple cancers
- Lynparza - multiple cancers
- Enhertu - multiple cancers
- Calquence - blood cancers
- tremelimumab - multiple cancers
- savolitinib - NSCLC 46 (#_ftn34)
- capivasertib - breast, prostate cancer
- monalizumab - head & neck cancer
- camizestrant - breast cancer
- datopotamab deruxtecan - lung cancer
CVRM
- Farxiga - multiple indications
- roxadustat - anaemia in CKD
Respiratory & Immunology
- Fasenra - multiple indications
- Breztri/Trixeo - asthma
- tezepelumab - severe asthma
- PT027 - asthma
- anifrolumab - lupus (SLE)
- brazikumab - inflammatory bowel disease
Other
- nirsevimab - RSV
COVID-19
- COVID-19 vaccine - COVID-19
- AZD7442 - SARS-CoV-2
Total projects 146
in clinical development
Total projects 166
in total pipeline
Oncology
AstraZeneca shared an update on its innovative early oncology pipeline, across
multiple strategic platforms, during the virtual American Association of
Cancer Research Annual Meeting in early April 2021. Highlights included five
presentations for AZD5305, a next-generation PARP1-selective inhibitor.
Additionally, the Company also highlighted research across multiple
presentations that showcased novel technologies, including myeloid gene
expression. These technologies enable early detection of disease recurrence to
inform earlier interventions for patients who are more likely to benefit from
treatment.
a) Tagrisso
In April 2021, Tagrisso was recommended for marketing authorisation in the EU
for the adjuvant treatment of adult patients with early-stage (IB, II and
IIIA) EGFRm NSCLC after complete tumour resection with curative intent. The
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) based its positive opinion on results from the ADAURA
Phase III trial.
During the period, Tagrisso received Chinese regulatory approval for the
adjuvant treatment of patients with early-stage (IB, II and IIIA) EGFRm NSCLC
after tumour resection with curative intent. The approval was based on the
positive results from the ADAURA Phase III trial.
Table 22: Key Tagrisso Phase III trials
Trial (population) Design Timeline Status
NeoADAURA Placebo or Tagrisso FPCD 47 (#_ftn35) : Q1 2021 Recruitment ongoing
(neo-adjuvant EGFRm NSCLC) First data anticipated: 2022+
ADAURA Placebo or Tagrisso FPCD: Q4 2015 Trial unblinded early due to overwhelming efficacy
(adjuvant EGFRm NSCLC) LPCD(( 48 (#_ftn36) )): Q1 2019
Regulatory approval (US, CN)
LAURA Placebo or Tagrisso FPCD: Q4 2018 Recruitment ongoing
(locally advanced, unresectable EGFRm NSCLC) First data anticipated: 2022+
FLAURA2 Tagrisso or Tagrisso + platinum-based chemotherapy doublet FPCD: Q4 2019 Recruitment ongoing
(1st-line EGFRm NSCLC) First data anticipated: 2022+
b) Imfinzi
In February 2021, in consultation with the US FDA, AstraZeneca announced the
voluntary withdrawal of the Imfinzi indication in the US for previously
treated adult patients with locally advanced or metastatic bladder cancer as
the DANUBE Phase III trial did not confirm the efficacy observed from Study
1108, a single-arm Phase I/II trial, the basis for the US accelerated
approval.
Table 23: Key Imfinzi Phase III trials in lung cancer
Trial (population) Design Timeline Status
AEGEAN SoC 49 (#_ftn37) chemotherapy +/- Imfinzi, followed by surgery, followed by FPCD: Q1 2019 Recruitment ongoing
placebo or Imfinzi
(neo-adjuvant NSCLC)
First data anticipated: 2022+
ADJUVANT BR.31 50 (#_ftn38) Placebo or Imfinzi FPCD: Q1 2015 Recruitment completed
(Stage IB-IIIA resected NSCLC) LPCD: Q1 2020
First data anticipated: 2022+
MERMAID-1 SoC chemotherapy +/- Imfinzi FPCD: Q3 2020 Recruitment ongoing
(Stage II-III First data anticipated: 2022+
resected NSCLC)
MERMAID-2 Placebo or Imfinzi FPCD: Q4 2020 Recruitment ongoing
First data anticipated: 2022+
(Stage II-III
NSCLC with minimal residual disease)
PACIFIC-2 Placebo or FPCD: Q2 2018 Recruitment completed
(Stage III unresectable locally advanced NSCLC Imfinzi LPCD: Q3 2019
(concurrent CRT)) First data anticipated: H2 2021
ADRIATIC Concurrent CRT, followed by placebo or Imfinzi or Imfinzi + treme FPCD: Q4 2018 Recruitment ongoing
(LS-SCLC) First data anticipated: 2022
PEARL SoC chemotherapy or Imfinzi FPCD: Q1 2017 Recruitment completed
(Stage IV, 1st-line NSCLC) LPCD: Q1 2019
First data anticipated: H2 2021
POSEIDON SoC chemotherapy or SoC + Imfinzi or SoC + Imfinzi + treme FPCD: Q2 2017 PFS 51 (#_ftn39) primary endpoint met
(Stage IV, 1st-line NSCLC) LPCD: Q4 2018
OS data anticipated: H1 2021
CASPIAN SoC chemotherapy or SoC + Imfinzi or SoC + Imfinzi + treme FPCD: Q1 2017 OS primary endpoint met for Imfinzi
(ES-SCLC) LPCD: Q2 2018 OS primary endpoint not met for Imfinzi + treme
Regulatory approval
Table 24: Key Imfinzi Phase III trials in tumour types other than lung cancer
Trial (population) Design Timeline Status
POTOMAC SoC BCG 52 (#_ftn40) or FPCD: Q4 2018 Recruitment completed
SoC BCG + Imfinzi
(non-muscle invasive bladder cancer) LPCD: Q3 2020
First data anticipated: 2022+
NIAGARA Neo-adjuvant cisplatin and gemcitabine SoC chemotherapy or SoC + Imfinzi, FPCD: Q4 2018 Recruitment ongoing
followed by adjuvant placebo or Imfinzi
(muscle-invasive bladder cancer) First data anticipated: 2022+
EMERALD-1 TACE 54 (#_ftn42) followed by placebo or TACE + Imfinzi, followed by Imfinzi FPCD: Q1 2019 Recruitment ongoing
+ bevacizumab or TACE + Imfinzi followed by Imfinzi
(locoregional HCC 53 (#_ftn41) ) First data anticipated: 2022
EMERALD-2 Adjuvant Imfinzi or Imfinzi + bevacizumab FPCD: Q2 2019 Recruitment ongoing
(locoregional HCC at high risk of recurrence after surgery or radiofrequency First data anticipated: 2022+
ablation)
CALLA CRT or CRT + Imfinzi, followed by placebo or Imfinzi FPCD: Q1 2019 Recruitment completed
(locally advanced cervical cancer) LPCD: Q4 2020
First data anticipated: 2022+
MATTERHORN Neoadjuvant Imfinzi + FLOT chemotherapy +/- adjuvant Imfinzi FPCD: Q4 2020 Recruitment ongoing
(resectable gastric and gastroesophageal cancer) First data anticipated: 2022+
KUNLUN Definitive CRT or CRT + Imfinzi FPCD: Q4 2020 Recruitment ongoing
(locally advanced, unresectable oesophageal squamous cell carcinoma) First data anticipated: 2022+
NILE (Stage IV, 1st-line cisplatin chemotherapy- eligible bladder cancer) SoC chemotherapy or SoC + Imfinzi or SoC + Imfinzi + treme FPCD: Q4 2018 Recruitment ongoing
First data anticipated: 2022+
HIMALAYA Sorafenib or Imfinzi or Imfinzi + treme FPCD: Q4 2017 Recruitment completed
(Stage IV, 1st-line unresectable HCC) LPCD: Q4 2019 Orphan Drug Designation 55 (#_ftn43) (US)
First data anticipated: H2 2021
TOPAZ-1 Gemcitabine and cisplatin SoC chemotherapy or SoC + Imfinzi FPCD: Q2 2019 Recruitment completed
(Stage IV, 1st-line biliary-tract cancer) LPCD: Q4 2020
First data anticipated: 2022
c) Lynparza
During the period, the Company announced that the OlympiA Phase III trial of
Lynparza had demonstrated early efficacy. An independent data monitoring
committee (IDMC) concluded that the trial crossed the superiority boundary for
invasive disease-free survival versus placebo. The initial results
demonstrated a sustainable, clinically relevant treatment effect for Lynparza
versus placebo in patients with germline BRCA-mutated HER2-negative early
breast cancer. As a result, the IDMC intends to move forward with an earlier
than anticipated primary analysis. In China, the Company decided to
voluntarily withdraw the Lynparza regulatory submission for BRCAm advanced
breast cancer due to insufficient regional data from the OlympiAD Phase III
trial.
Table 25: Key Lynparza Phase III trials
Trial (population) Design Timeline Status
OlympiA SoC placebo or Lynparza FPCD: Q2 2014 Recruitment completed
(adjuvant BRCAm breast cancer) LPCD: Q2 2019 Early efficacy readout
PROfound SoC (abiraterone or enzalutamide) or Lynparza FPCD: Q2 2017 Primary endpoint met
(metastatic castration-resistant 2nd-line+ HRRm LPCD: Q4 2018 Regulatory approval
prostate cancer)
DuO-O Chemotherapy + bevacizumab or chemotherapy + bevacizumab + Imfinzi +/- FPCD: Q1 2019 Recruitment ongoing
Lynparza maintenance
(advanced 1st-line First data anticipated: 2022+
ovarian cancer)
DuO-E Chemotherapy or chemotherapy + Imfinzi + Imfinzi maintenance or chemotherapy + FPCD: Q2 2020 Recruitment ongoing
Imfinzi followed by Imfinzi + Lynparza maintenance
(advanced 1st-line First data anticipated: 2022+
endometrial cancer)
PROpel Abiraterone or abiraterone + Lynparza FPCD: Q4 2018 Recruitment ongoing
(Stage IV, advanced, castration-resistant prostate cancer) First data anticipated: H2 2021
d) Enhertu
Table 26: Key Enhertu trials
Trial (population) Design Timeline Status
DESTINY-Breast02-U301, Phase III SoC chemotherapy or Enhertu FPCD: Q4 2018 Recruitment completed
(Stage IV, HER2+ breast cancer post trastuzumab emtansine) LPCD: Q4 2020
First data anticipated: 2022
DESTINY-Breast03-U302, Phase III Trastuzumab emtansine or Enhertu FPCD: Q4 2018 Recruitment completed
(Stage IV, HER2+ 2nd-line breast cancer) LPCD: Q2 2020
First data anticipated: H2 2021
DESTINY-Breast04, Phase III SoC chemotherapy or Enhertu FPCD: Q4 2018 Recruitment completed
(Stage IV, HER2-low 2nd-line breast cancer) LPCD: Q4 2020
First data anticipated: 2022
DESTINY-Breast06, Phase III SoC chemotherapy or Enhertu FPCD: Q3 2020 Recruitment ongoing
(Stage IV, HER2-low breast cancer post endocrine therapy) First data anticipated: 2022+
DESTINY-Breast09, Phase III SoC chemotherapy trastuzumab + pertuzumab or Enhertu + pertuzumab or Enhertu First data anticipated Initiating
(Stage IV, HER2+ 1st-line breast cancer) 2022+
DESTINY-Gastric01, Phase II SoC chemotherapy or Enhertu FPCD: Q4 2017 Primary endpoint met
(Stage IV, HER2+ gastric cancer) LPCD: Q2 2019 Breakthrough Therapy Designation (US)
Regulatory approval (US, JP)
DESTINY-Gastric02, Phase II Enhertu FPCD: Q4 2019 Recruitment ongoing
(Stage IV, HER2+ gastric cancer) First data anticipated: H2 2021
During the period, the timelines for first data from the DESTINY-Breast02 and
DESTINY-Breast04 Phase III trials, were updated from H2 2021 to 2022,
respectively. These changes followed a conversion from initial event rate
assumptions to actual observed event rates in the trials.
e) Camizestrant
Table 27: Camizestrant Phase III trials
Trial (population) Design Timeline Status
SERENA-4 Palbociclib + anastrazole or palbociclib + camizestrant FPCD: Q1 2021 Recruitment ongoing
(ER+, HER2-, advanced breast cancer) First data anticipated: 2022+
f) Datopotamab deruxtecan
Table 28: Datopotamab deruxtecan Phase III trials
Trial (population) Design Timeline Status
TROPION-LUNG01 SoC chemotherapy or datopotamab deruxtecan First data anticipated: 2022+ Initiating
(Stage IV, 2nd-line NSCLC)
g) Koselugo
In April 2021, selumetinib was recommended for conditional marketing
authorisation in the EU for the treatment of symptomatic, inoperable PN in
paediatric patients with NF1 aged three years and above. The CHMP of the EMA
based its positive opinion on results from the National Cancer Institute
Cancer Therapy Evaluation Program-sponsored SPRINT Stratum 1 Phase II trial.
CVRM
a) Brilinta
During the period, AstraZeneca withdrew Brilique's regulatory submissions,
based on the THEMIS Phase III trial, for CAD in Europe and China to prevent
against first heart attack or stroke. The THEMIS Phase III trial showed a
statistically significant reduction in the primary composite endpoint of major
adverse CV events at 36 months with aspirin plus Brilinta 60mg versus aspirin
alone in patients with CAD and type-2 diabetes (T2D) at high risk of a first
heart attack or stroke. The primary composite endpoint was driven by a
reduction in heart attack and stroke, but these benefits were accompanied by
an increased risk of bleeding. The US FDA approved Brilinta in June 2020 for
the treatment of CAD based on the positive results from the THEMIS Phase III
trial.
b) Farxiga
In April 2021, AstraZeneca and Saint Luke's Mid America Heart Institute
announced high-level results of the primary analysis from the DARE-19 Phase
III trial, which assessed the potential of the medicine to treat patients
hospitalised with COVID-19 who are at risk of developing serious
complications. The trial did not achieve statistical significance for the
primary endpoint of prevention measuring organ dysfunction and all-cause
mortality, and the primary endpoint of recovery measuring a change in clinical
status (from early recovery to death), at 30 days. The safety and tolerability
profile observed in the trial was consistent with the known safety profile of
the medicine. The results will be presented at the American College of
Cardiology Scientific Sessions in May 2021.
Table 29: Key large CVRM Phase III outcomes trials
Trial (population) Design Timeline Status
Brilinta
THALES Aspirin plus placebo or aspirin plus Brilinta 90mg BID FPCD: Q1 2018 Primary endpoint met
(c.11,000 patients with acute ischaemic stroke 56 (#_ftn44) or transient LPCD: Q4 2019 Regulatory approval (US)
ischaemic attack)
Farxiga
DELIVER Placebo or Farxiga 10mg QD FPCD: Q4 2018 Recruitment completed
(c.6,300 patients with HF (HFpEF) with and without T2D) LPCD: Q4 2020
First data anticipated: H2 2021 Fast Track 57 (#_ftn45) designation (US)
DAPA-CKD Placebo or Farxiga 10mg QD FPCD: Q1 2017 Trial stopped early based on recommendation from an IDMC
(c.4,300 patients with CKD, with and without T2D) LPCD: Q1 2020 Primary endpoint and secondary endpoints met
Breakthrough Therapy Designation, Priority Review (US)
DAPA-MI Placebo or Farxiga 10mg QD FPCD: Q4 2020 Recruitment ongoing
(c.6,400 patients with confirmed MI, either STEMI or NSTEMI, within the First data anticipated: 2022+
preceding 7 days)
c) Roxadustat
During the period, FibroGen, Inc. (FibroGen) provided an update on certain
prior disclosures relating to the US primary CV safety analyses
(https://investor.fibrogen.com/news-releases/news-release-details/fibrogen-provides-additional-information-roxadustat)
from the roxadustat Phase III programme to treat anaemia of CKD.
In March 2021, AstraZeneca and FibroGen announced that the US FDA would
convene a Cardiovascular and Renal Drugs Advisory Committee meeting to review
the new drug application for roxadustat. The meeting has been tentatively
scheduled for 15 July 2021. Roxadustat is approved in China, Japan, and Chile
to treat anaemia in CKD in non-dialysis dependent and dialysis-dependent adult
patients and is under regulatory review in the EU.
Respiratory & Immunology
a) Fasenra
Table 30: Key Fasenra lifecycle management Phase III trials
During the period, the Company announced that the first patients had commenced
dosing in three trials evaluating Fasenra in dermatological indications, in
reference to the Phase III FJORD trial in bullous pemphigoid and two-Phase II
trials in atopic dermatitis (HILLIER) and chronic spontaneous urticaria
(ARROYO).
Trial (population) Design Timeline Status
OSTRO Placebo or Fasenra 30mg Q8W 58 (#_ftn46) SC 59 (#_ftn47) FPCD: Q1 2018 Co-primary endpoints met
(severe bilateral nasal polyps) LPCD: Q2 2019
RESOLUTE Placebo or Fasenra 100mg Q8W SC FPCD: Q4 2019 Recruitment ongoing
(moderate to very severe COPD with a history of exacerbations and elevated First data anticipated: 2022+
peripheral blood eosinophils)
MANDARA Mepolizumab 3x100mg Q4W or Fasenra 30mg SC FPCD: Q4 2019 Recruitment ongoing
(eosinophilic granulomatosis with polyangiitis 60 (#_ftn48) ) First data anticipated: 2022+ Orphan Drug Designation (US)
NATRON Placebo or Fasenra 30mg Q4W SC FPCD: Q3 2020 Recruitment ongoing
(hyper-eosinophilic syndrome 61 (#_ftn49) First data anticipated: 2022 Orphan Drug Designation (US)
MESSINA Placebo or Fasenra 30mg Q4W SC FPCD: Q4 2020 Recruitment ongoing
(eosinophilic oesophagitis 62 (#_ftn50) ) First data anticipated: 2022 Orphan Drug Designation (US)
FJORD Placebo or Fasenra 30mg Q4W SC FPCD: Q2 2021 Recruitment ongoing
(bullous pemphigoid 63 (#_ftn51) ) First data anticipated: 2022+
b) Breztri
Table 31: Key Breztri Phase III trials
Trial (population) Design Timeline Status
KALOS Budesonide/formoterol or Breztri FPCD: Q1 2021 Recruitment ongoing
(asthma) First data anticipated: 2022+
LOGOS Budesonide/formoterol or Breztri FPCD: Q1 2021 Recruitment ongoing
(asthma) First data anticipated: 2022+
c) Anifrolumab
During the period, the Phase II trial of anifrolumab in lupus nephritis
concluded. Although the primary endpoint was not met, the trial results
provided valuable insights that have informed the Phase III programme, planned
to start in the second half of 2021. The full results from the Phase II trial
will be presented at a forthcoming medical meeting.
Table 32: Key anifrolumab Phase III trials
Trial (population) Design Timeline Status
TULIP 1 Placebo or anifrolumab 150mg or 300mg IV Q4W FPCD: Q4 2015 Primary endpoint not met
(moderate to severely active SLE) LPCD: Q4 2017 Fast Track designation (US)
TULIP 2 Placebo or anifrolumab 300mg IV Q4W FPCD: Q4 2015 Primary endpoint met
(moderate to severely active SLE) LPCD: Q4 2017 Fast Track designation (US)
TULIP LTE Placebo or anifrolumab 300mg IV Q4W FPCD: Q2 2016 Recruitment completed
(moderate to severely active SLE) LPCD: Q4 2018 Fast Track designation (US)
First data anticipated: 2022
d) Tezepelumab (severe asthma)
During the period, AstraZeneca and Amgen Inc. presented positive results from
the NAVIGATOR Phase III trial for tezepelumab at the American Academy of
Allergy Asthma and Immunology Virtual Annual Meeting, held between 26 February
and 1 March 2021.
When added to SoC 64 (#_ftn52) , tezepelumab achieved a 56% reduction
(p<0.001) in annualised asthma exacerbation rate (AAER) over 52 weeks when
compared to placebo. In a pre-planned subgroup analysis, in patients with
baseline eosinophil counts less than 300 cells per microlitre, tezepelumab
achieved a statistically significant and clinically meaningful 41% reduction
(p<0.001) in AAER. Importantly, clinically meaningful AAER reductions were
observed in two additional subgroups; 39% reduction in patients with baseline
eosinophil counts less than 150 cells per microlitre; 70% reduction in
patients with greater than or equal to 300 cells per microlitre.
Clinically meaningful AAER reductions were also observed in the
tezepelumab-treated patients, compared to placebo, irrespective of allergy
status and fractional exhaled nitric oxide level 65 (#_ftn53) . The NAVIGATOR
Phase III trial will form the basis of regulatory submissions for tezepelumab
in severe asthma in H1 2021.
Table 33: Key tezepelumab Phase III trials
Trial (population) Design Timeline Status
NAVIGATOR Placebo or tezepelumab 210mg Q4W SC FPCD: Q1 2018 Primary endpoint met
(severe asthma) LPCD: Q3 2019 Breakthrough Therapy Designation (US)
WAYPOINT Placebo or tezepelumab 210mg Q4W SC First data anticipated 2022+ Initiating
(chronic rhinosinusitis with nasal polyps)
e) PT027 (asthma)
Table 34: Key PT027 Phase III trials
Trial Design Timeline Status
TYREE Placebo or PT027 160/180 μg, single dose FPCD: Q1 2020 Primary endpoint met
(asthma with exercise induced broncho LPCD: Q3 2020
constriction)
MANDALA Albuterol or PT027 80/180 μg or PT027 160/180 μg (all 'as needed') FPCD: Q4 2018 Recruitment ongoing
(moderate to severe asthma) First data anticipated: H2 2021
DENALI Placebo or albuterol 180 μg or budesonide 160 μg or PT027 80/180 μg or FPCD: Q2 2019 Recruitment completed
PT027 160/180 μg QID
(mild to moderate asthma) LPCD: Q2 2021
First data anticipated: H2 2021
Other
a) Nirsevimab (respiratory syncytial virus)
In April 2021, AstraZeneca announced that the MELODY Phase III trial for
nirsevimab had met its primary endpoint of a statistically significant
reduction in the incidence of medically attended lower respiratory tract
infections caused by RSV compared to placebo in healthy late preterm and term
infants (35 weeks or more) during their first RSV season. Nirsevimab becomes
the first potential immunisation to show protection against RSV in the general
infant population in a Phase III trial. Preliminary analysis of the safety
profile for nirsevimab was consistent with previous trial data. No clinically
meaningful differences in safety results between the nirsevimab and placebo
groups have been seen. The trial is ongoing to collect additional safety data.
Results from the MELODY trial will be presented at a forthcoming medical
meeting.
Nirsevimab is also being evaluated in the MEDLEY Phase II/III trial which will
assess the safety and tolerability of nirsevimab compared to Synagis
(palivizumab) among preterm infants and children with chronic lung disease
(CLD) and congenital heart disease (CHD) entering their first and second RSV
seasons. The MEDLEY trial is also expected to read out earlier with first data
anticipated in the second half of 2021. MELODY, MEDLEY and the Phase IIb trial
will form the basis of AstraZeneca's regulatory submissions planned for 2022.
Table 35: Key nirsevimab trials
Trial Design Timeline Status
MELODY Placebo or nirsevimab IM FPCD: Q3 2019 Primary endpoint met
LPCD: Q3 2020
(healthy late preterm and term infants)
MEDLEY Synagis or nirsevimab IM FPCD: Q3 2019 Recruitment completed
(high-risk children) LPCD: Q4 2020
First data anticipated
H2 2021
COVID-19
a) Pandemic COVID-19 vaccine
During the period, AstraZeneca announced positive high-level results from the
US Phase III trial's primary analysis. The results confirmed that vaccine
efficacy was consistent with the previously announced pre-specified interim
analysis. The trial showed 76% (confidence interval (CI): 68% to 82%) vaccine
efficacy at preventing symptomatic COVID-19, occurring 15 days or more after
receiving two doses given four weeks apart. Importantly, these results were
comparable across age groups, with vaccine efficacy of 85% (CI: 58% to 95%) in
adults 65 years and older. A key secondary endpoint, preventing severe or
critical disease and hospitalisation, demonstrated 100% efficacy. In the
coming weeks, the Company will submit to the US FDA a regulatory submission
for Emergency Use Authorisation, incorporating data from both the US and
non-US Phase III clinical trial programme and emerging real-world data.
In March 2021, several regulatory agencies raised concerns about the potential
risk of rare thrombotic events in people administered with the vaccine.
Consequently, The Medicines and Healthcare products Regulatory Agency in the
UK and the European Medicines Agency conducted several analyses that noted a
potential causal link between the vaccine and these events. The agencies,
however, reaffirmed that the vaccine's overall benefits continue to outweigh
the potential risks. AstraZeneca will continue to work closely with health and
regulatory authorities to ensure the appropriate use of the vaccine.
Table 36: Key vaccine trials in COVID-19
Trial Design Timeline Status
COV002 (UK), Phase II/III MenACWY or COVID-19 vaccine FPCD: Q2 2020 Initial data readout
(Protection against COVID-19 in participants aged 18-55, 55+) LPCD: Q4 2020 Regulatory authorisation (UK, EU)
COV003 (Brazil), Phase II/III MenACWY or COVID-19 vaccine FPCD: Q2 2020 Initial data readout
(Protection against COVID-19 in participants aged 18-55) LPCD: Q4 2020 Regulatory authorisation (UK, EU)
COV005 ChAdOx1 nCoV-19 ZA 66 (#_ftn54) (South Africa), Phase I/II Placebo or COVID-19 vaccine FPCD: Q2 2020 Initial data readout
(protection against COVID-19 in participants aged 18-65 LPCD: Q4 2020
HIV+ 67 (#_ftn55) subgroup)
D8110C00001 Placebo or COVID-19 vaccine FPCD: Q3 2020 Initial data readout
(US, global), Phase III LPCD: Q1 2021
(protection against
COVID-19 in participants aged 18+
b) AZD7442
The Company announced
(https://www.astrazeneca.com/media-centre/press-releases/2021/us-supply-agreement-for-additional-azd7442-doses.html)
in March 2021 a modification to the existing agreement with the US Government
to supply up to 500,000 additional doses of AZD7442, a long-acting antibody
(LAAB) combination. AZD7442 is a potential new medicine in late-stage
development for the prevention and treatment of COVID-19. The value of the
extended agreement is $205m. It is contingent on AZD7442 receiving US FDA
Emergency Use Authorisation in preventing COVID-19 in people who have
confirmed exposure to the virus.
Total potential US supplies of AZD7442 under this and prior agreements with
the US Government amount to 700,000; this includes 100,000 doses in 2020 and a
further 600,000 doses in 2021.
Table 37: Key AZD7442 Phase II/III trials in COVID-19
Trial Design Timeline Status
PROVENT Placebo FPCD: Q4 2020 Recruitment completed
(protection against COVID-19 (prophylaxis)) or AZD7442 300mg IM 68 (#_ftn56) LPCD: Q1 2021
First data anticipated: H2 2021
STORM CHASER Placebo FPCD: Q4 2020 Recruitment completed
(protection against or AZD7442 300mg IM LPCD: Q1 2021
COVID-19 First data anticipated: H1 2021
(post-exposure prophylaxis))
TACKLE Placebo FPCD: Q1 2021 Recruitment ongoing
(COVID-19 (outpatient treatment)) or AZD7442 600mg IM First data anticipated: H1 2021
For more details on the development pipeline, including anticipated timelines
for regulatory submission/acceptances, please refer to the latest Clinical
Trials Appendix
(https://www.astrazeneca.com/investor-relations/results-and-presentations.html)
available on astrazeneca.com
(https://www.astrazeneca.com/investor-relations.html) . For Alexion pipeline
updates, please visit alexion.com (https://alexion.com/) .
Interim Financial Statements
Table 38Error! No sequence specified.: Q1 2021 - Condensed consolidated
statement of comprehensive income
For the quarter ended 31 March 2021 2020
$m $m
Total Revenue 7,320 6,354
Product Sales 7,257 6,311
Collaboration Revenue 63 43
Cost of Sales (1,864) (1,420)
Gross Profit 5,456 4,934
Distribution costs (99) (87)
Research and development expense (1,713) (1,388)
Selling, general and administrative costs (2,929) (2,719)
Other operating income and expense 1,180 480
Operating Profit 1,895 1,220
Finance income 20 51
Finance expense (303) (332)
Share of after-tax losses in associates and joint ventures (4) (4)
Profit Before Tax 1,608 935
Taxation (46) (185)
Profit for the period 1,562 750
Other comprehensive income
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability 481 440
Net (losses)/gains on equity investments measured at fair value through other (108) 171
comprehensive income
Fair value movements related to own credit risk on bonds designated as fair 1 21
value through profit or loss
Tax on items that will not be reclassified to profit or loss (94) (66)
280 566
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation (107) (608)
Foreign exchange arising on designated borrowings in net investment hedges (302) (380)
Fair value movements on cash flow hedges (86) (187)
Fair value movements on cash flow hedges transferred to profit or loss 121 45
Fair value movements on derivatives designated in net investment hedges 13 60
Costs of hedging (1) (5)
Tax on items that may be reclassified subsequently to profit or loss 26 73
(336) (1,002)
Other comprehensive loss for the period, net of tax (56) (436)
Total comprehensive income for the period 1,506 314
Profit attributable to:
Owners of the Parent 1,561 780
Non-controlling interests 1 (30)
1,562 750
Total comprehensive income attributable to:
Owners of the Parent 1,506 345
Non-controlling interests - (31)
1,506 314
Basic earnings per $0.25 Ordinary Share $1.19 $0.59
Diluted earnings per $0.25 Ordinary Share $1.18 $0.59
Weighted average number of Ordinary Shares in issue (millions) 1,312 1,312
Diluted weighted average number of Ordinary Shares in issue (millions) 1,319 1,313
Table 39: Condensed consolidated statement of financial position
At 31 Mar 2021 At 31 Dec 2020 At 31 Mar 2020
$m $m $m
Assets
Non-current assets
Property, plant and equipment 8,189 8,251 7,347
Right-of-use assets 660 666 644
Goodwill 11,765 11,845 11,569
Intangible assets 20,347 20,947 19,718
Investments in associates and joint ventures 88 39 44
Other investments 972 1,108 1,476
Derivative financial instruments 115 171 104
Other receivables 549 720 527
Deferred tax assets 3,506 3,438 2,960
46,191 47,185 44,389
Current assets
Inventories 4,278 4,024 3,123
Trade and other receivables 6,281 7,022 5,080
Other investments 129 160 752
Derivative financial instruments 64 142 61
Income tax receivable 347 364 262
Cash and cash equivalents 7,636 7,832 3,413
Assets held for sale - - 131
18,735 19,544 12,822
Total assets 64,926 66,729 57,211
Liabilities
Current liabilities
Interest-bearing loans and borrowings (2,042) (2,194) (2,289)
Lease liabilities (216) (192) (181)
Trade and other payables (17,370) (15,785) (12,633)
Derivative financial instruments (16) (33) (31)
Provisions (875) (976) (649)
Income tax payable (994) (1,127) (1,260)
(21,513) (20,307) (17,043)
Non-current liabilities
Interest-bearing loans and borrowings (17,410) (17,505) (15,634)
Lease liabilities (464) (489) (472)
Derivative financial instruments (1) (2) (188)
Deferred tax liabilities (2,823) (2,918) (2,501)
Retirement benefit obligations (2,545) (3,202) (2,129)
Provisions (576) (584) (807)
Other payables (5,148) (6,084) (6,221)
(28,967) (30,784) (27,952)
Total liabilities (50,480) (51,091) (44,995)
Net assets 14,446 15,638 12,216
Equity
Capital and reserves attributable to equity holders of the Parent
Share capital 328 328 328
Share premium account 7,976 7,971 7,946
Other reserves 2,037 2,024 2,056
Retained earnings 4,089 5,299 448
14,430 15,622 10,778
Non-controlling interests 16 16 1,438
Total equity 14,446 15,638 12,216
Table 40: 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 - - - 780 780 (30) 750
Other comprehensive loss - - - (435) (435) (1) (436)
Transfer to other reserves - - 10 (10) - - -
Transactions with owners:
Dividends - - - (2,489) (2,489) - (2,489)
Issue of Ordinary Shares - 5 - - 5 - 5
Share-based payments charge for the period - - - 53 53 - 53
Settlement of share plan awards - - - (263) (263) - (263)
Net movement - 5 10 (2,364) (2,349) (31) (2,380)
At 31 Mar 2020 328 7,946 2,056 448 10,778 1,438 12,216
At 1 Jan 2021 328 7,971 2,024 5,299 15,622 16 15,638
Profit for the period - - - 1,561 1,561 1 1,562
Other comprehensive loss - - - (55) (55) (1) (56)
Transfer to other reserves - - 13 (13) - - -
Transactions with owners:
Dividends - - - (2,490) (2,490) - (2,490)
Issue of Ordinary Shares - 5 - - 5 - 5
Share-based payments charge for the period - - - 82 82 - 82
Settlement of share plan awards - - - (295) (295) - (295)
Net movement - 5 13 (1,210) (1,192) - (1,192)
At 31 Mar 2021 328 7,976 2,037 4,089 14,430 16 14,446
Table 41: Condensed consolidated statement of cash flows
For the quarter ended 31 March 2021 2020
$m $m
Cash flows from operating activities
Profit Before Tax 1,608 935
Finance income and expense 283 281
Share of after-tax losses of associates and joint ventures 4 4
Depreciation, amortisation and impairment 797 841
Decrease/(increase) in working capital and short-term provisions 1,210 (445)
Gains on disposal of intangible assets (310) (358)
Gains on disposal of investments in associates and joint ventures (776) -
Fair value movements on contingent consideration arising from business - (33)
combinations
Non-cash and other movements (363) (429)
Cash generated from operations 2,453 796
Interest paid (187) (180)
Tax paid (332) (477)
Net cash inflow from operating activities 1,934 139
Cash flows from investing activities
Payment of contingent consideration from business combinations (171) (167)
Purchase of property, plant and equipment (220) (186)
Disposal of property, plant and equipment 4 -
Purchase of intangible assets (249) (190)
Disposal of intangible assets 418 365
Purchase of non-current asset investments - (115)
Disposal of non-current asset investments - 184
Movement in short-term investments, fixed deposits and other investing 28 98
instruments
Payments to associates and joint ventures (55) (8)
Disposal of investments in associates and joint ventures 776 -
Interest received 24 28
Net cash inflow from investing activities 555 9
Net cash inflow before financing activities 2,489 148
Cash flows from financing activities
Proceeds from issue of share capital 5 6
Repayment of loans (4) -
Dividends paid (2,469) (2,398)
Hedge contracts relating to dividend payments (23) (93)
Repayment of obligations under leases (50) (53)
Movement in short-term borrowings (190) 176
Net cash outflow from financing activities (2,731) (2,362)
Net decrease in cash and cash equivalents in the period (242) (2,214)
Cash and cash equivalents at the beginning of the period 7,546 5,223
Exchange rate effects (67) (32)
Cash and cash equivalents at the end of the period 7,237 2,977
Cash and cash equivalents consist of:
Cash and cash equivalents 7,636 3,413
Overdrafts (399) (436)
7,237 2,977
Notes to the Interim Financial Statements
1) Basis of preparation and accounting policies
These unaudited Interim Financial Statements for the three months ended 31
March 2021 have been prepared in accordance with IAS 34 'Interim Financial
Reporting' as issued by the International Accounting Standards Board (IASB)
and as adopted by the UK and the EU. 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 Interim Financial Statements have transitioned to UK-adopted
international accounting standards from financial periods beginning 1 January
2021.
The unaudited Interim Financial Statements for the three months ended 31 March
2021 were approved by the Board of Directors for publication on 30 April 2021.
The annual financial statements of the Group are prepared in accordance with
IFRSs as issued by the IASB and as adopted by the UK and the EU. Except as
noted below, the Interim Financial Statements have been prepared applying the
accounting policies that were applied in the preparation of the Group's
published consolidated financial statements for the year ended 31 December
2020.
IFRS 9 and IFRS 7
The replacement of benchmark interest rates, such as the London Inter-bank
Offered Rate (LIBOR) and other interbank offered rates (IBORs) has been a
priority for global regulators and is expected to be largely completed in
2021, although some benchmark rates will be continued to be published until
mid-2023. To prepare for this, the Group adopted the Phase 1 amendments to
IFRS 9 'Financial Instruments' and IFRS 7 'Financial Instruments: Disclosures'
in 2019 and has adopted the Phase 2 amendments in 2021. These amendments
provide relief from applying specific hedge accounting requirements to hedge
relationships directly affected by IBOR reform and have the effect that the
reform should generally not cause hedge accounting to terminate.
The Group has one IFRS 9 designated hedge relationship that is impacted by
IBOR reform, namely a €300m cross currency interest rate swap in a fair
value hedge relationship with €300m of a €750m 0.875% 2021 non-callable
bond. This swap references three-month USD LIBOR; uncertainty arising from the
Group's exposure to IBOR reform will cease when the swap matures in 2021. The
implications on the wider business of IBOR reform have been assessed and the
Group is working on moving to new benchmark rates in 2021.
COVID-19
AstraZeneca has assessed the impact of the uncertainty presented by the
COVID-19 pandemic on the Interim Financial Statements comprising the financial
results to 31 March 2021 and the financial position as at 31 March 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 a 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 three-month period ended 31 March 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 March 2021,
the Group had $11.8bn in financial resources (cash and cash-equivalent
balances of $7.6bn, $0.1bn of liquid fixed income securities and undrawn
committed bank facilities of $4.1bn, of which $3.4bn is available until April
2024, $0.7bn is available until November 2021 (with a one-year extension
option, exercisable by the Group), with only $2.3bn of borrowings due within
one year). Additionally, as at 31 March 2021, to support the financing of the
acquisition of Alexion, the Group has committed bank facilities totalling
$17.5bn, which are available unit at least December 2022. The facilities are
intended to cover the financing of the cash portion of the acquisition
consideration and associated acquisition costs and to refinance the existing
term loan and revolving credit facilities of Alexion. All facilities contain
no financial covenants and were undrawn at 31 March 2021.
The directors have considered the impact of COVID-19 on AstraZeneca's
operations (including the effects of any governmental or regulatory response
to the pandemic), 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 Company 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
many of the mature markets. The Group, however, anticipates new revenue
streams from both recently launched medicines and those in development, and
the Group has a wide diversity of customers and suppliers across different
geographic areas.
Consequently, the Directors believe that, overall, the Group is well-placed to
manage its business risks successfully.
Accordingly, the going-concern basis has been adopted in these Interim
Financial Statements.
Legal proceedings
The information contained in Note 5 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. This resulted in a total net
impairment charge of $55m being recorded against an intangible asset during
the three months ended 31 March 2021 (Q1 2020: $117m). Net impairment charges
in respect of launched products and products in development were $nil (Q1
2020: $84m) and $55m (Q1 2020: $33m) respectively. Impairments recorded on
products in development were a consequence of failed or poor performing
trials, with the individual assets being fully impaired.
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 42: Net Debt
At Cash flow Non-cash & other Exchange movements At 31 Mar 2021
1 Jan 2021
$m $m $m $m $m
Non-current instalments of loans (17,505) - 1 94 (17,410)
Non-current instalments of leases (489) - 17 8 (464)
Total long-term debt (17,994) - 18 102 (17,874)
Current instalments of loans (1,536) 4 - 71 (1,461)
Current instalments of leases (192) 54 (83) 5 (216)
Bank collateral (288) 114 - - (174)
Other short-term borrowings excluding overdrafts (84) 76 - - (8)
Overdraft (286) (119) - 6 (399)
Total current debt (2,386) 129 (83) 82 (2,258)
Gross borrowings (20,380) 129 (65) 184 (20,132)
Net derivative financial instruments 278 23 (139) - 162
Net borrowings (20,102) 152 (204) 184 (19,970)
Cash and cash equivalents 7,832 (123) - (73) 7,636
Other investments - current 160 (28) - (3) 129
Cash and investments 7,992 (151) - (76) 7,765
Net Debt (12,110) 1 (204) 108 (12,205)
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 $174m (Q1 2020: $163m) and the carrying value of such cash
collateral posted by the Group was $13m (Q1 2020: $190m). Cash collateral
posted by the Group is presented within Cash and cash equivalents.
Other investments - non-current are included within the balance of $972m (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 put option liability of $2,336m (31 December 2020: $2,297m),
$874m of which is shown in current other payables and $1,462m is shown in
non-current other payables. In April 2021, AstraZeneca exercised its option to
acquire the remaining 45% of shares in Acerta, please refer to Note 6 for
further information.
Net Debt increased by $95m in the year to date to $12,205m. Details of the
committed undrawn bank facilities are disclosed within the going-concern
section of Note 1.
During the three months to 31 March 2021, there were no changes to the
Company's credit ratings issued by Standard and Poor's (long term: BBB+, short
term A-2) and Moody's (long term: A3, short term P-2).
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. There have been no 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 (Q1 2020: $6m
gain) have been recognised in the three months ended 31 March 2021. All other
fair-value gains and/or losses that are presented in Net gains/(losses) on
equity investments measured at fair value through other comprehensive income
in the Condensed consolidated statement of comprehensive income for the three
months ended 31 March 2021 are Level 1 fair-value measurements.
Financial instruments measured at fair value include $1,101m of other
investments, $5,712m held in money-market funds, $333m of loans designated at
fair value through profit or loss, $354m of loans designated in a fair-value
hedge relationship and $162m of derivatives as at 31 March 2021. The total
fair value of interest-bearing loans and borrowings at 31 March 2021, which
have a carrying value of $20,132m in the Condensed consolidated statement of
financial position, was $22,437m. 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 43: 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 (166) (5) (171) (167)
Revaluations - - - (33)
Discount unwind 49 6 55 73
At 31 March 2,815 392 3,207 4,012
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 $2,815m (31 December 2020: $2,932m) would
increase/decline by $282m with an increase/decline in sales of 10%, as
compared with the current estimates.
5) 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 (the
Disclosures). Unless noted otherwise below or in the Disclosures, no
provisions have been established in respect of the claims discussed below.
As discussed in the disclosures, the majority of claims involve highly complex
issues. Often these issues are subject to substantial uncertainties and,
therefore, the probability of a loss, if any, being sustained and/or an
estimate of the amount of any loss is difficult to ascertain.
Unless specifically identified below that a provision has been taken,
AstraZeneca considers each of the claims to represent a contingent liability
and discloses information with respect to the nature and facts of the cases in
accordance with IAS 37.
In cases that have been settled or adjudicated, or where quantifiable fines
and penalties have been assessed and which are not subject to appeal, or where
a loss is probable and we are able to make a reasonable estimate of the loss,
AstraZeneca records the loss absorbed or makes a provision for its best
estimate of the expected loss. The position could change over time and the
estimates that the Company made, and upon which the Company have relied in
calculating these provisions are inherently imprecise. There can, therefore,
be no assurance that any losses that result from the outcome of any legal
proceedings will not exceed the amount of the provisions that have been booked
in the accounts. The major factors causing this uncertainty are described more
fully in the Disclosures and herein.
AstraZeneca has full confidence in, and will vigorously defend and enforce,
its IP.
Matters disclosed in respect of the first quarter of 2021 and to 30 April 2021
Patent litigation
Enhertu
US patent proceedings
As previously disclosed, in October 2020, Seagen Inc. (Seagen) filed a
complaint against Daiichi Sankyo Company, Limited in the US District Court for
the Eastern District of Texas alleging that Enhertu infringes US Patent No.
10,808,039 (the '039 patent). AstraZeneca Pharmaceuticals LP co-commercialises
Enhertu with Daiichi Sankyo Inc. in the US. A claim construction hearing has
been scheduled for August 2021 and a trial has been scheduled for April 2022.
In November 2020, AstraZeneca, Daiichi Sankyo Company, Limited and Daiichi
Sankyo Inc. filed a complaint against Seagen in the US District Court for the
District of Delaware (the District Court) seeking a declaratory judgment that
plaintiffs do not infringe the '039 patent. In April 2021, the District Court
stayed this proceeding for up to 90 days.
Faslodex
Patent Proceedings outside the US
In Japan, in April 2021, AstraZeneca received notice from the Japan Patent
Office that Sandoz K.K. filed a Request for Invalidation Trial to seek
invalidation of the Faslodex formulation patent. AstraZeneca is considering
its response.
Farxiga
US patent proceedings
As previously disclosed, in 2018, in response to Paragraph IV notices,
AstraZeneca initiated ANDA litigation against Zydus Pharmaceuticals (USA) Inc.
(Zydus) in the US District Court for the District of Delaware. In the
complaint, AstraZeneca alleged that Zydus' generic version of Farxiga, if
approved and marketed, would infringe patents listed in the FDA Orange Book
with reference to Farxiga. Proceedings are ongoing and trial is scheduled for
May 2021.
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.
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.
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. A trial date is set for May 2022.
Roxadustat
US Patent Proceedings
In April 2021, Akebia Therapeutics, Inc. and Otsuka America Pharmaceutical,
Inc. served AstraZeneca with a complaint seeking a declaration of invalidity
and noninfringement for several of FibroGen method of use patents (U.S. Patent
Nos. 8318703, 8466172, 8614204, 9920011, 8629131, 8604012, 8609646, 8604013,
10626090, 10894774, 10882827, and 10927081) related to HIF prolylhydroxylase
inhibitors. AstraZeneca is the exclusive licensee of FibroGen in the United
States. AstraZeneca is considering its response.
Patent proceedings outside the US
As previously disclosed, in Canada, in May 2018, Akebia Therapeutics, Inc.
filed an impeachment action in the Federal Court of Canada alleging invalidity
of several of FibroGen's method of use patents (Canadian Patent Nos. 2467689;
2468083; and 2526496) related to HIF prolylhydroxylase inhibitors. AstraZeneca
is the exclusive licensee of FibroGen in Canada. AstraZeneca and FibroGen were
defending the action. The parties have settled the action.
Symbicort
US patent proceedings
As previously disclosed, in October 2018, AstraZeneca initiated ANDA
litigation against Mylan and subsequently against 3M Company (3M) in the US
District Court for the Northern District of West Virginia (the District
Court). In the action, AstraZeneca alleges that the defendants' generic
versions of Symbicort, if approved and marketed, would infringe various
AstraZeneca patents. Mylan and 3M alleged that their proposed generic
medicines do not infringe the asserted patents and/or that the asserted
patents are invalid and/or unenforceable. In July 2020, AstraZeneca added
Kindeva Drug Delivery L.P. (Kindeva) as a defendant in the case. In September
2020, Mylan, 3M and Kindeva stipulated to patent infringement to the extent
that the asserted patent claims are found to be valid and enforceable, but
reserved the right to seek a vacatur of the stipulation if the U.S. Court of
Appeals for the Federal Circuit reverses or modifies the District Court's
claim construction. In October 2020, following a stipulation by AstraZeneca,
3M and Kindeva, 3M was dismissed from the action. In March 2021, the District
Court decided in favour of AstraZeneca and determined that the asserted patent
claims were not invalid or unenforceable. Mylan and Kindeva have appealed to
the United States Court of Appeals for the Federal Circuit.
Product liability litigation
Byetta/Bydureon
As previously disclosed, in the US, Amylin Pharmaceuticals, LLC, a wholly
owned subsidiary of AstraZeneca, and/ or AstraZeneca are among multiple
defendants in various lawsuits filed in federal and state courts involving
claims of physical injury from treatment with Byetta and/or Bydureon. The
lawsuits allege several types of injuries including pancreatic cancer and
thyroid cancer. A multidistrict litigation was established in the US District
Court for the Southern District of California (the District Court) in regard
to the alleged pancreatic cancer cases in federal courts. Further, a
coordinated proceeding has been established in Los Angeles (the California
Court), California in regard to the various lawsuits in California state
courts. In October and December 2020, the District Court and the California
Court jointly heard oral argument on renewed motions filed by Defendants
seeking summary judgment and dismissal of all claims alleging pancreatic
cancer. In March and April 2021, the District Court and the California State
Court respectively granted the Defendants' motions, and dismissed all cases
alleging pancreatic cancer with prejudice. The plaintiffs have provided notice
that they intend to appeal. The other claims pending in both courts, including
those alleging thyroid cancer, remains pending.
Nexium and Losec/Prilosec
US proceedings
As previously disclosed, in the US, AstraZeneca is defending various lawsuits
brought in federal and state courts involving multiple plaintiffs claiming
that they have been diagnosed with various injuries following treatment with
proton pump inhibitors (PPIs), including Nexium and Prilosec. The vast
majority of those lawsuits relate to allegations of kidney injuries. In
particular, in May 2017, counsel for a group of such plaintiffs claiming that
they have been diagnosed with kidney injuries filed a motion with the Judicial
Panel on Multidistrict Litigation (JPML) seeking the transfer of any currently
pending federal court cases as well as any similar, subsequently filed cases
to a coordinated and consolidated pre-trial multidistrict litigation (MDL)
proceeding. In August 2017, the JPML granted the motion and consolidated the
pending federal court cases in an MDL proceeding in federal court in New
Jersey for pre-trial purposes. A trial in the MDL has been rescheduled for
January 2022. In addition to the MDL cases, there are cases filed in several
state courts around the US; a trial in Delaware state court has been scheduled
for February 2022.
In addition, AstraZeneca has been defending lawsuits involving allegations of
gastric cancer following treatment with PPIs. All but one of these claims is
filed in the MDL. One claim is filed in the US District Court for the Middle
District of Louisiana, where the court has rescheduled a trial for August
2022.
Commercial litigation
Ocimum lawsuit
As previously disclosed, in the US, in December 2017, AstraZeneca was served
with a complaint filed by Ocimum Biosciences, Ltd. (Ocimum) in the Superior
Court for the State of Delaware (the Delaware Supreme Court) that alleged,
among other things, breaches of contractual obligations and misappropriation
of trade secrets, relating to a now terminated 2001 licensing agreement
between AstraZeneca and Gene Logic, Inc. (Gene Logic), the rights to which
Ocimum purports to have acquired from Gene Logic. In February 2021, the
Delaware Supreme court affirmed the grant of AstraZeneca's motion for summary
judgment. This matter is now concluded.
AZD1222 securities litigation
As previously disclosed, in January 2021, putative securities class action
lawsuits were filed in the US District Court for the Southern District of New
York against AstraZeneca PLC and certain officers, on behalf of purchasers of
AstraZeneca publicly traded securities during the period 21 May 2020 through
20 November 2020. The complaints allege that defendants made materially false
and misleading statements in connection with the development of AZD1222
(pandemic COVID-19 vaccine), a potential recombinant adenovirus vaccine for
the prevention of COVID-19. In March 2021, motions for consolidation of the
pending lawsuits and appointment of a lead plaintiff and its counsel were
filed and remain pending.
Alexion shareholder litigation
In March 2021, several shareholders of Alexion filed individual lawsuits
against Alexion, its management, and/or AstraZeneca and affiliates in federal
district court in New York. The complaints generally allege that the
preliminary registration statement filed with the SEC on 19 February 2021,
omitted certain allegedly material information in connection with
AstraZeneca's proposed acquisition of Alexion (the Acquisition), and one of
the complaints further alleges that the Alexion directors breached their
fiduciary duties in connection with the Acquisition and that AstraZeneca and
the other entity defendants aided and abetted the alleged breaches.
Government investigations/proceedings
Toprol-XL
Louisiana Attorney General litigation
As previously disclosed, in July 2020, the Louisiana First Circuit Court of
Appeals (the Appellate Court) reversed and remanded a Louisiana state trial
court (the Trial Court) ruling that had granted AstraZeneca's motion for
summary judgment and dismissed a state court complaint, brought by the
Attorney General for the State of Louisiana (the State), alleging that
AstraZeneca engaged in unlawful monopolisation and unfair trade practices in
connection with the enforcement of its Toprol-XL patents. In August 2020,
AstraZeneca petitioned the Louisiana Supreme Court (the Supreme Court) to
review the decision of the Appellate Court and reinstate the Trial Court's
summary judgment ruling. In December 2020, the Supreme Court granted
AstraZeneca's petition and agreed to review the Appellate Court's decision.
The Supreme Court heard oral argument on AstraZeneca's appeal in March 2021.
In April 2021, prior to a decision from the Supreme Court, the State
unilaterally moved to dismiss all of its claims with prejudice. That motion
remains pending.
US 340B litigations and proceedings
As previously disclosed, AstraZeneca is involved in several matters relating
to its policy with regard to contract pharmacy recognition under the 340B Drug
Pricing Program in the US. In October and November 2020, two lawsuits, one in
the US District Court for the District of Columbia and one in the US District
Court for the Northern District of California, were filed by covered entities
and advocacy groups against the US Department of Health and Human Services,
the US Health Resources and Services Administration as well as other US
government agencies and their officials. The complaints allege, among other
things, that these agencies should enforce an interpretation of the governing
statute for the 340B Drug Pricing Program that would require drug
manufacturers participating in the program to offer their drugs for purchase
at statutorily capped rates by an unlimited number of contract pharmacies.
AstraZeneca has sought to intervene in the lawsuits. Administrative Dispute
Resolution (ADR) proceedings have also been initiated against AstraZeneca
before the US Health Resources and Services Administration.
In addition, in January 2021, AstraZeneca filed a separate lawsuit in federal
court in Delaware alleging that a recent Advisory Opinion issued by the
Department of Health and Human Services violates the Administrative Procedure
Act. In February 2021, AstraZeneca received a Civil Investigative Subpoena
from the Attorney General's Office for the State of Vermont seeking documents
and information relating to AstraZeneca's policy regarding contract pharmacy
recognition under the 340B Drug Pricing Program.
European Commission Claim Regarding AZD1222
In April 2021, the European Commission (acting on behalf of the European Union
and its member states) initiated legal proceedings against AstraZeneca AB in
the Court of First Instance in Brussels. The proceedings relate to an Advance
Purchase Agreement (APA) between the parties dated 27 August 2020 for the
supply of AZD1222. The allegations include claims that AstraZeneca has failed
to meet certain of its obligations under the APA and the Commission is
seeking, among other things, a Court order to compel AstraZeneca to supply a
specified number of doses before the end of the second quarter of 2021.
6) Subsequent Events
In April 2021, AstraZeneca exercised its option to acquire the remaining 45%
of shares in Acerta, following the final condition for exercising the option
being satisfied in November 2020 when Calquence received EU marketing
authorisation. Following the exercise of the option, payments to acquire the
remaining outstanding shares of Acerta are to be made in similar annual
instalments in 2022, 2023 and 2024. The associated cash flows will be
disclosed as financing activities within the Consolidated Statement of Cash
Flows.
7) Table 44: Q1 2021 - Product Sales year-on-year analysis 69 (#_ftn57)
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 2,981 19 15 762 7 4 1,193 23 575 29 17 451 20 14
Tagrisso 1,149 17 13 306 9 5 415 12 225 39 26 203 20 14
Imfinzi 556 20 17 58 74 69 292 2 109 46 32 97 43 35
Lynparza 543 37 33 87 54 54 253 28 149 46 33 54 29 22
Calquence 209 n/m n/m 2 n/m n/m 195 n/m 9 n/m n/m 3 n/m n/m
Koselugo 21 n/m n/m - - - 21 n/m - - - - - -
Enhertu 1 n/m n/m 1 n/m n/m - - - - - - - -
Zoladex* 221 (1) (6) 136 (8) (11) 5 n/m 37 6 (2) 43 11 4
Faslodex* 122 (26) (30) 43 (12) (13) 9 (60) 41 (35) (41) 29 (6) (10)
Iressa* 61 (21) (26) 53 (15) (20) 3 (22) 2 (70) (72) 3 (47) (50)
Arimidex* 44 (12) (15) 36 (13) (17) - - 1 34 34 7 (10) (14)
Casodex* 42 - (6) 33 - (6) - - 1 (9) (10) 8 - 6
Others 12 (12) (12) 7 (10) (11) - n/m 1 (14) 19 4 11 -
BioPharmaceuticals: CVRM 1,912 12 9 945 22 20 463 (6) 364 18 9 140 9 3
Farxiga 624 54 50 260 84 85 131 16 174 50 36 59 69 60
Brilinta 374 (8) (11) 105 (22) (23) 166 1 88 (6) (14) 15 (5) (12)
Bydureon 103 3 1 - (62) (53) 85 1 15 24 14 3 - (12)
Onglyza 101 (28) (31) 58 22 19 19 (72) 15 1 (8) 9 (19) (23)
Byetta 16 (20) (20) 4 35 50 8 (29) 2 (35) (40) 2 (18) (27)
Other diabetes 13 3 (1) 3 62 55 6 (24) 4 36 25 - (34) (42)
Lokelma 33 n/m n/m 1 n/m n/m 24 n/m 2 n/m n/m 6 n/m n/m
Roxadustat 39 n/m n/m 39 n/m n/m - - - - - - n/m n/m
Crestor* 274 (9) (12) 189 (1) (4) 22 (22) 21 (40) (43) 42 (11) (15)
Seloken/Toprol-XL* 250 41 36 244 47 42 - (90) 3 (26) (26) 3 (13) (23)
Atacand* 34 (48) (49) 5 (89) (89) 2 (15) 27 n/m n/m - (97) n/m
Others 51 (13) (16) 37 - (5) - - 13 (28) (27) 1 (67) (69)
BioPharmaceuticals: Respiratory & Immunology 1,541 (1) (5) 542 1 (4) 551 8 299 (7) (15) 149 (17) (22)
Symbicort 691 (13) (15) 165 6 3 266 (14) 168 (14) (21) 92 (29) (33)
Pulmicort 330 (13) (18) 286 (9) (14) 17 (25) 16 (37) (43) 11 (42) (47)
Fasenra 260 31 27 3 (51) (47) 156 30 63 37 25 38 40 33
Daliresp/Daxas 60 14 12 1 13 13 54 20 5 (35) (47) - - -
Bevespi 13 8 5 1 n/m n/m 10 (15) 2 n/m n/m - - -
Breztri 27 n/m n/m 9 n/m n/m 12 n/m 1 n/m n/m 5 n/m n/m
Others 160 42 33 77 30 20 36 n/m 44 (4) (12) 3 (38) (40)
Other medicines 548 (2) (5) 297 19 15 53 (39) 76 (38) (40) 122 25 18
Nexium* 403 19 15 234 25 21 32 (20) 18 (18) (26) 119 34 27
Synagis* 24 (72) (72) - n/m n/m 2 (75) 22 (69) (69) - - -
Seroquel XR/IR* 29 (20) (22) 14 11 14 7 (46) 7 (3) (8) 1 (66) (89)
Losec/Prilosec* 54 1 (5) 46 6 (2) - n/m 8 64 69 - (95) (95)
FluMist* 2 n/m n/m - - - - n/m 2 n/m n/m - - -
Others 36 (19) (20) 3 92 93 12 (51) 19 25 22 2 (37) (40)
COVID-19 275 n/m n/m 43 n/m n/m - - 224 n/m n/m 8 n/m n/m
Pandemic COVID-19 vaccine 275 n/m n/m 43 n/m n/m - - 224 n/m n/m 8 n/m n/m
Total Product Sales 7,257 15 11 2,589 14 10 2,260 10 1,538 28 18 870 11 5
8) Table 45: Q1 2021 - Product Sales quarterly sequential analysis 70 (#_ftn58)
Actual CER
$m % change % change
Oncology 2,981 3 1
Tagrisso 1,149 (1) (3)
Imfinzi 556 - (1)
Lynparza 543 9 8
Calquence 209 15 15
Koselugo 21 23 23
Enhertu 1 n/m n/m
Zoladex* 221 2 -
Faslodex* 122 (6) (8)
Iressa* 61 (9) (11)
Arimidex* 44 22 18
Casodex* 42 7 5
Others 12 (4) (6)
BioPharmaceuticals: CVRM 1,912 4 1
Farxiga 624 6 4
Brilinta 374 3 1
Bydureon 103 (16) (17)
Onglyza 101 (3) (6)
Byetta 16 (14) (15)
Other diabetes 13 7 1
Lokelma 33 16 18
Roxadustat 39 n/m n/m
Crestor* 274 (8) (9)
Seloken/Toprol-XL* 250 25 21
Atacand* 34 (45) (45)
Others 51 12 10
BioPharmaceuticals: Respiratory & Immunology 1,541 1 (1)
Symbicort 691 2 -
Pulmicort 330 (10) (13)
Fasenra 260 (8) (9)
Daliresp/Daxas 60 11 10
Bevespi 13 7 8
Breztri 27 n/m n/m
Others 160 28 25
Other medicines 548 (25) (26)
Nexium* 403 7 5
Synagis* 24 (69) (69)
Seroquel XR/IR* 29 51 38
Losec/Prilosec* 54 39 36
FluMist* 2 (99) (99)
Others 36 (6) (4)
COVID-19 275 n/m n/m
Pandemic COVID-19 vaccine 275 n/m n/m
Total Product Sales 7,257 4 1
9) Table 46: FY 2020 - Product Sales quarterly sequential analysis 71 (#_ftn59)
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/Daxas 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 47: Ongoing Collaboration Revenue
Q1 2021 Q1 2020 FY 2020 FY 2019
$m $m $m $m
Lynparza: regulatory milestones - - 160 60
Lynparza: sales milestones - - 300 450
Lynparza/Koselugo: option payments - - - 100
Crestor (Spain) - - - 39
Enhertu: share of gross profits 38 14 94 -
Roxadustat: share of gross profits 2 3 30 -
Royalty income 18 17 62 62
Other Collaboration Revenue 5 9 81 108
Total 63 43 727 819
Table 48: Other Operating Income and Expense
The table below provides an analysis of Reported Other Operating Income and
Expense.
Q1 2021 Q1 2020 FY 2020 FY 2019
$m $m $m $m
Divestment of Viela Bio, Inc. shareholding 776 - - -
Crestor (Europe ex UK & Spain) 309 - - -
Hypertension medicines (ex-US, India and Japan) - 350 350 -
Monetisation of an asset previously licensed - - 120 -
Brazikumab licence termination funding 26 - 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 69 130 446 389
Total 1,180 480 1,528 1,541
Financial calendar and other shareholder information
Annual general meeting 11 May 2021
Announcement of half-year and second-quarter results 29 July 2021
Announcement of year-to-date and third-quarter results 12 November 2021
Announcement of full-year and fourth-quarter results (tentative) 10 February 2022
Dividends are normally 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 first interim dividend for 2021, payable on 13
September 2021, will be 13 August 2021. The ex-dividend date will be 12 August
2021.
Trademarks of the AstraZeneca group of companies appear throughout this
document in italics. Medical publications also appear throughout the document
in italics. AstraZeneca, the AstraZeneca logotype and the AstraZeneca symbol
are all trademarks of the AstraZeneca group of companies. Trademarks of
companies other than AstraZeneca that appear in this document
include Arimidex and Casodex, owned by AstraZeneca or Juvisé (depending on
geography); Atacand and Atacand Plus, owned by AstraZeneca or Cheplapharm
(depending on geography); Duaklir and Eklira, trademarks of Almirall,
S.A.; Enhertu, a trademark of Daiichi Sankyo; Inderal and Tenormin, owned
by AstraZeneca, Atnahs Pharma and Taiyo Pharma Co. Ltd. (depending upon
geography); Losec and Omepral, owned by AstraZeneca, Cheplapharm or Taiyo
Pharma Co., Ltd (depending on geography); Seloken, owned by AstraZeneca or
Taiyo Pharma Co., Ltd (depending on geography); Synagis, owned by Arexis AB
or AbbVie Inc. (depending on geography); Vimovo, owned by AstraZeneca or
Grünenthal GmbH (depending on geography.
Information on or accessible through AstraZeneca's websites, including
astrazeneca.com (https://www.astrazeneca.com/) , does not form part of and is
not incorporated into this announcement.
Addresses for correspondence
Registered office Registrar and transfer office Swedish Central Securities Depository US depositary
Deutsche Bank Trust Company Americas
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Cautionary statements regarding forward-looking statements
In order, among other things, to utilise the 'safe harbour' provisions of the
US Private Securities Litigation Reform Act of 1995, AstraZeneca (hereafter
'the Group') provides the following cautionary statement:
This document contains certain forward-looking statements with respect to the
operations, performance and financial condition of the Group, including, among
other things, statements about expected revenues, margins, earnings per share
or other financial or other measures. Although the Group believes its
expectations are based on reasonable assumptions, any forward-looking
statements, by their very nature, involve risks and uncertainties and may be
influenced by factors that could cause actual outcomes and results to be
materially different from those predicted. The forward-looking statements
reflect knowledge and information available at the date of preparation of this
document and the Group undertakes no obligation to update these
forward-looking statements. The Group identifies the forward-looking
statements by using the words 'anticipates', 'believes', 'expects', 'intends'
and similar expressions in such statements. Important factors that could cause
actual results to differ materially from those contained in forward-looking
statements, certain of which are beyond the Group's control, include, among
other things:
- the risk of failure or delay in delivery of pipeline or launch of new
medicines
- the risk of failure to meet regulatory or ethical requirements for medicine
development or approval
- the risk of failure to obtain, defend and enforce effective IP protection
and IP challenges by third parties
- the impact of competitive pressures including expiry or loss of IP rights,
and generic competition
- the impact of price controls and reductions
- the impact of economic, regulatory and political pressures
- the impact of uncertainty and volatility in relation to the UK's exit from
the EU
- the risk of failures or delays in the quality or execution of the Group's
commercial strategies
- the risk of failure to maintain supply of compliant, quality medicines
- the risk of illegal trade in the Group's medicines
- the impact of reliance on third-party goods and services
- the risk of failure in information technology, data protection or cybercrime
- the risk of failure of critical processes
- any expected gains from productivity initiatives are uncertain
- the risk of failure to attract, develop, engage and retain a diverse,
talented and capable workforce, including - - following completion of the
Alexion transaction
- the risk of failure to adhere to applicable laws, rules and regulations
- the risk of the safety and efficacy of marketed medicines being questioned
- the risk of adverse outcome of litigation and/or governmental
investigations, including relating to the Alexion transaction
- the risk of failure to adhere to increasingly stringent anti-bribery and
anti-corruption legislation
- the risk of failure to achieve strategic plans or meet targets or
expectations
- the risk of failure in financial control or the occurrence of fraud
- the risk of unexpected deterioration in the Group's financial position
- the impact that the COVID-19 global pandemic may have or continue to have on
these risks, on the Group's ability to continue to mitigate these risks, and
on the Group's operations, financial results or financial condition
- the risk that a condition to the closing of the transaction with Alexion may
not be satisfied, or that a regulatory approval that may be required for the
transaction is delayed or is obtained subject to conditions that are not
anticipated
- the risk that AstraZeneca is unable to achieve the synergies and value
creation contemplated by the Alexion transaction, or that AstraZeneca is
unable to promptly and effectively integrate Alexion's businesses
- and the risk that management's time and attention are diverted on
transaction-related issues or that disruption from the Alexion transaction
makes it more difficult to maintain business, contractual and operational
relationships
Nothing in this document, or any related presentation/webcast, should be
construed as a profit forecast.
Important additional information
In connection with the proposed transaction, the Group filed a registration
statement on Form F-4 (the Registration Statement), which has been declared
effective by the United States Securities and Exchange Commission (SEC), and
which includes a document that serves as a prospectus of the Group and a proxy
statement of Alexion (the proxy statement/prospectus). Alexion filed the proxy
statement/prospectus as a proxy statement and the Group filed the proxy
statement/prospectus as a prospectus with the SEC on 12 April 2021, and each
party will file other documents regarding the proposed transaction with the
SEC. Investors and security holders of Alexion are urged to carefully read the
entire registration statement and proxy statement/prospectus and other
relevant documents filed with the SEC when they become available, because they
will contain important information. A definitive proxy statement will be sent
to Alexion's shareholders. Investors and security holders will be able to
obtain the Registration Statement and the proxy statement/prospectus free of
charge from the SEC's website or from the Group or Alexion as described in the
paragraphs below.
The documents filed by the Group with the SEC may be obtained free of charge
at the SEC's website at www.sec.gov (http://www.sec.gov) . These documents may
also be obtained free of charge on the Group's website at
http://www.astrazeneca.com (http://www.astrazeneca.com/) under the tab
'Investors'.
The documents filed by Alexion with the SEC may be obtained free of charge at
the SEC's website at www.sec.gov (http://www.sec.gov/) . These documents may
also be obtained free of charge on Alexion's internet website at
http://www.alexion.com (http://www.alexion.com) under the tab, 'Investors' and
under the heading 'SEC Filings' or by contacting Alexion's Investor Relations
Department at investorrelations@alexion.com.
Participants in the solicitation
Alexion, the Group and certain of their directors, executive officers and
employees may be deemed participants in the solicitation of proxies from
Alexion shareholders in connection with the proposed transaction. Information
regarding the persons who may, under the rules of the SEC, be deemed
participants in the solicitation of the shareholders of Alexion in connection
with the proposed transaction, including a description of their direct or
indirect interests, by security holdings or otherwise, is set forth in the
proxy statement/prospectus filed with the SEC on 12 April 2021. Information
about the directors and executive officers of Alexion and their ownership of
Alexion shares is set forth in Alexion's Annual Report on Form 10-K/A, as
previously filed with the SEC on 16 February 2021. Free copies of these
documents may be obtained as described in the paragraphs above.
- End of document -
13 (#_ftnref1) Non-small cell lung cancer.
14 (#_ftnref2) Epidermal growth factor receptor mutation.
15 (#_ftnref3) Neurofibromatosis type 1, a genetic condition causing tumours
to grow along nerves in the skin, brain, and other parts of the body.
16 (#_ftnref4) Breast cancer susceptibility gene 1/2 mutation.
17 (#_ftnref5) Coronary artery disease.
18 (#_ftnref6) Type-2 diabetes.
19 (#_ftnref7) CV outcome trial.
20 (#_ftnref8) Chronic kidney disease.
21 (#_ftnref9) Respiratory syncytial virus.
22 (#_ftnref10) Overall survival.
23 (#_ftnref11) Chronic lymphocytic leukaemia, the most common type of
leukaemia in adults.
24 (#_ftnref12) Relapsed/refractory.
25 (#_ftnref13) Benign soft growths inside the nose.
26 (#_ftnref14) The tumour cannot be removed completely through surgery.
27 (#_ftnref15) Human epidermal growth factor receptor 2 positive.
28 (#_ftnref16) Based on a planned interim analysis as communicated by
Daiichi Sankyo in Q2 of their fiscal year 2021.
29 (#_ftnref17) HF with preserved ejection fraction.
30 (#_ftnref18) Systemic lupus erythematosus, a chronic autoimmune disease
that causes inflammation in connective tissues throughout the body.
31 (#_ftnref19) Extensive-stage small cell lung cancer.
32 (#_ftnref20) Limited-stage small cell lung cancer.
33 (#_ftnref21) Myelodysplastic syndrome.
34 (#_ftnref22) A prior diabetes alliance
(https://www.astrazeneca.com/media-centre/press-releases/2014/astrazeneca-aquisition-bristol-myers-squibb-global-diabetes-alliance-03022014.html)
between AstraZeneca and Bristol-Myers Squibb Company (BMS). The Company
acquired the entirety of BMS's interests in the alliance in 2014.
35 (#_ftnref23) Legacy medicine.
36 (#_ftnref24) Over the counter.
37 (#_ftnref25) Substitution of threonine (T) with methionine (M) at
position 790 of exon 20 mutation.
38 (#_ftnref26) Dipeptidyl peptidase 4.
39 (#_ftnref27) The EU received c.30 million doses, the UK c.26 million
doses, and Gavi and other countries received approximately seven and five
million doses, respectively.
40 (#_ftnref28) Core financial measures are adjusted to exclude certain
items. For more information on the Reported to Core financial adjustments,
please refer to the introduction to the operating and financial review
(#_Operating_and_financial) .
41 (#_ftnref29) Based on currency assumptions disclosed in the full-year
2020 results announcement.
42 (#_ftnref30) Based on average daily spot rates in FY 2020.
43 (#_ftnref31) Based on average daily spot rates from 1 January 2021 to 31
March 2021.
44 (#_ftnref32) Other currencies include AUD, BRL, CAD, KRW and RUB.
45 (#_ftnref33) 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'.
46 (#_ftnref34) Phase II/IIb trial with potential for registration.
47 (#_ftnref35) First patient commenced dosing.
48 (#_ftnref36) Last patient commenced dosing.
49 (#_ftnref37) Standard of Care.
50 (#_ftnref38) Conducted by the Canadian Cancer Trials Group.
51 (#_ftnref39) Progression-free survival.
52 (#_ftnref40) Bacillus Calmette-Guerin.
53 (#_ftnref41) Hepatocellular carcinoma.
54 (#_ftnref42) Transarterial chemoembolisation.
55 (#_ftnref43) The US Orphan Drug Act grants special status to a medicine
or potential medicine to treat a rare disease or condition upon request of a
manufacturer. Designation qualifies the manufacturer of the medicine for
various development incentives.
56 (#_ftnref44) Ischaemic strokes are the most common type of stroke.
57 (#_ftnref45) A process designed to facilitate the development and
expedite the review of medicines to treat serious conditions that fill an
unmet medical need.
58 (#_ftnref46) Once every eight weeks.
59 (#_ftnref47) Subcutaneous injection.
60 (#_ftnref48) A rare autoimmune condition that causes inflammation of
small and medium-sized blood vessels.
61 (#_ftnref49) A group of rare blood disorders.
62 (#_ftnref50) White blood cells gather in the lining of the oesophagus.
63 (#_ftnref51) A skin condition that causes large, itchy, fluid-filled
blisters.
64 (#_ftnref52) Medium- or high-dose ICS plus at least one additional
controller medication with or without OCS.
65 (#_ftnref53) A biomarker used by clinicians to inform treatment options.
66 (#_ftnref54) Conducted by University of Witwatersrand, South Africa.
67 (#_ftnref55) Human immunodeficiency virus-positive.
68 (#_ftnref56) Intramuscular.
69 (#_ftnref57) 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. *Denotes a legacy medicine.
70 (#_ftnref58) 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. *Denotes a legacy medicine.
71 (#_ftnref59) 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. *Denotes a legacy medicine.
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