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AstraZeneca PLC (AZN)

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Thursday 11 February, 2021

AstraZeneca PLC

AZN: full-year 2020 results

RNS Number : 6947O
AstraZeneca PLC
11 February 2021
 

AstraZeneca PLC

11 February 2021 07:00 GMT

 

Full-year 2020 results

Accelerating the scientific and commercial evolution; 2021 guidance shows continuing progress

 

AstraZeneca delivered strong results in the year, in line with guidance that was reconfirmed during the year. With over half of Total Revenue coming from the fast-growing new medicines1, the Company leveraged its revenue growth to make further progress in profitability, while the strategy of sustainable growth through innovation brought numerous further benefits for patients. AstraZeneca's patient-centric strategy, focus on innovation and capital-allocation priorities remain unchanged, with sustainable long-term growth in revenue, profit and cash generation set to continue.

 

Pascal Soriot, Chief Executive Officer, commented:

"The performance last year marked a significant step forward for AstraZeneca. Despite the significant impact from the pandemic, we delivered double-digit revenue growth to leverage improved profitability and cash generation. The consistent achievements in the pipeline, the accelerating performance of our business and the progress of the COVID-19 vaccine demonstrated what we can achieve, while the proposed acquisition of Alexion is intended to accelerate our scientific and commercial evolution even further.

 

Additional investment in new medicines continued to fuel our rapidly growing oncology and biopharmaceuticals therapy areas. Tagrisso's future was enhanced with its first regulatory approval in early, potentially-curable lung cancer and further national reimbursement in China in advanced disease. Farxiga again expanded its potential beyond diabetes, while tezepelumab promised real hope for patients suffering from severe asthma. Thanks to the focus on an industry-leading pipeline and consistent execution, I am confident that we will continue to deliver more progress for patients and sustained, compelling results."

 

Table 1: Financial summary

 

 

FY 2020

Q4 2020

$m

% change

$m

% change

Actual

CER 2

Actual

CER

Total Revenue

26,617

9

10

7,410

11

10

Product Sales

25,890

10

11

7,011

12

11

Collaboration Revenue

727

(11)

(11)

399

(4)

(4)

 

 

 

 

 

 

 

Reported3 EPS4

$2.44

n/m5

n/m

$0.78

n/m

n/m

Core6 EPS

$4.02

15

18

$1.07

19

24

 

Highlights of Total Revenue in the year included:

 

An increase in Product Sales of 10% (11% at CER) to $25,890m. The quarter was the first for many years with Product Sales in excess of $7,000m. New-medicine Total Revenue improved by 33% in the year to $13,950m, including growth in Emerging Markets of 53% (59% at CER) to $2,845m. Globally, the new medicines represented 52% of Total Revenue (FY 2019: 43%)

 

Oncology growth of 23% (24% at CER) to $11,455m, while New CVRM7 increased by 7% (9% at CER) to $4,702m. Respiratory & Immunology declined by 1% (stable at CER) to $5,375m, a reflection of the impact in China of COVID-19

 

An increase in Emerging Markets of 7% (10% at CER) to $8,711m, with China growth of 10% (11% at CER) to $5,375m. In the US, Total Revenue increased by 13% to $8,833m and in Europe by 10% (9% at CER) to $5,540m. Both regions delivered stronger growth rates in the final quarter compared to the full year - see the Regional Total Revenue section for details

 

Guidance

The Company provides 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 COVID-19 Vaccine AstraZeneca (C19VAZ). The Company intends to report these sales separately from the next quarter. Similarly, the guidance excludes the proposed acquisition by the Company of Alexion Pharmaceuticals, Inc. (Alexion), 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 January 2021 were seen over the full year, 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.

 

Financial summary

-  Total Revenue, comprising Product Sales and Collaboration Revenue, increased by 9% in the year (10% at CER) to $26,617m. Product Sales grew by 10% (11% at CER) to $25,890m, driven primarily by the performances of the new medicines across Oncology and BioPharmaceuticals, including Tagrisso and Farxiga. Total Revenue included $2m of C19VAZ Product Sales within Other medicines; from the next quarter, AstraZeneca intends to report the C19VAZ sales performance separately

 

-  The Reported Gross Profit8 Margin was stable (up by one percentage point at CER) at 80%, while the Core Gross Profit Margin was stable, also at 80%, in line with the Company's expectations

 

-  Reported Total Operating Expense declined by 2% in the year to $17,684m and represented 66% of Total Revenue (FY 2019: 74%). Core Total Operating Expense increased by 6% to $15,633m and comprised 59% of Total Revenue (FY 2019: 60%)

 

-  Reported R&D Expense declined by 1% in the year to $5,991m, primarily reflecting the comparative effect of the $533m impairment of Epanova in FY 2019. Core R&D Expense increased by 10% to $5,872m, representing 22% of Total Revenue (FY 2019: 22%). The increases partly reflected investment in the Oncology pipeline, including the development of datopotamab deruxtecan (DS-1062), and the ending in FY 2019 of the release of the upfront funding of Lynparza development, as part of the collaboration with MSD9

 

-  Reported SG&A Expense declined by 3% in the year to $11,294m; Core SG&A Expense increased by 3% (4% at CER) to $9,362m, representing 35% of Total Revenue (FY 2019: 37%). The difference in the movements partly reflected fair-value adjustments arising on acquisition-related liabilities, as well as an increase in legal provisions recognised in 2019

 

-  Reported Other Income and Expense declined by 1% in the year to $1,528m. Core Other Income and Expense fell by 2% to $1,531m

 

-  The Reported Operating Profit Margin increased by seven percentage points in the year (eight at CER) to 19%. The Core Operating Profit Margin increased by one percentage point (two at CER) to 28% and AstraZeneca anticipates further sustainable expansion in the Core Operating Profit Margin over time

 

-  Reported EPS of $2.44 in the year represented an increase of 137% (142% at CER). Core EPS grew by 15% (18% at CER) to $4.02

 

-  The Board has reaffirmed its commitment to the progressive dividend policy. A stable second interim dividend of $1.90 per share has been declared, keeping the unchanged full-year dividend per share at $2.80

 

-  Net Cash Inflow from Operating Activities of $4,799m in the year, a year-on-year increase of $1,830m, primarily reflected an underlying improvement in business performance and declines in Working Capital and Short-Term Provisions. EBITDA progression continued, with growth of 24% (27% at CER) in the year to $8,311m, while Net Debt of $12,110m represented an increase of $206m

 

Commercial summary

 

Oncology

Total Revenue increased by 23% in the year (24% at CER) to $11,455m.

 

Table 2: Select Oncology medicine performances

 

 

FY 2020

Q4 2020

$m

% change

$m

% change

Actual

CER

Actual

CER

Tagrisso : Product Sales

4,328

36

36

1,157

31

28

Imfinzi : Product Sales

2,042

39

39

555

31

29

Lynparza : Product Sales

1,776

48

49

496

42

40

Lynparza : Collaboration Revenue

460

(25)

(25)

325

(7)

(7)

Calquence : Product Sales

522

n/m

n/m

182

n/m

n/m

Enhertu : Collaboration Revenue

96

n/m

n/m

33

n/m

n/m

 

New CVRM

Total Revenue increased by 7% in the year (9% at CER) to $4,702m.

 

Table 3: Select New CVRM medicine performances

 

 

FY 2020

Q4 2020

$m

% change

$m

% change

Actual

CER

Actual

CER

Farxiga : Total Revenue

1,964

27

30

587

40

40

Brilinta : Product Sales

1,593

1

2

363

(15)

(15)

Bydureon : Product Sales

448

(18)

(18)

122

(12)

(12)

Lokelma : Product Sales

76

n/m

n/m

28

n/m

n/m

Roxadustat: Collaboration Revenue

30

n/m

n/m

11

n/m

n/m

 

Respiratory & Immunology

Total Revenue declined by 1% in the year (stable at CER) to $5,375m. The adverse impact of the decline in Pulmicort sales reduced Respiratory & Immunology Total Revenue growth by 12 percentage points.

 

Table 4: Select Respiratory & Immunology medicine performances

 

 

FY 2020

Q4 2020

$m

% change

$m

% change

Actual

CER

Actual

CER

Symbicort : Product Sales

2,721

9

10

680

(5)

(5)

Pulmicort : Product Sales

996

(32)

(32)

368

(11)

(14)

Fasenra : Product Sales

949

35

34

283

38

35

Breztri : Product Sales

28

n/m

n/m

6

n/m

n/m

 

Emerging Markets

Total Revenue increased by 7% in the year (10% at CER) to $8,711m, including:

 

-  A China increase of 10% (11% at CER) to $5,375m. The strong performance was limited by the adverse impacts of COVID-19 on sales of Pulmicort and the pricing effect of the China volume-based procurement (VBP) programme on Brilinta, Losec and Arimidex. The Company continued to prioritise patient access to its medicines and geographical expansion in the Chinese market; this included additional successful inclusion of a number of medicines on the National Reimbursement Drug List (NRDL). Admission to the list has an immediate adverse impact on pricing; typically, however, this is more than offset by a subsequent favourable effect on volumes

 

-  An ex-China increase of 1% (9% at CER) to $3,336m, with particularly strong performances in Russia and Latin America

 

COVID-19

The ongoing pandemic has had a significant impact on every aspect of life in 2020, and the Company recognises the outstanding contribution of colleagues at AstraZeneca and their unrelenting focus on improving the lives of patients. The largest direct impacts of COVID-19 on the Company's portfolio of medicines included reduced sales of Pulmicort in China on fewer nebulisation-centre visits and reduced elective surgery, and less use globally of infused and injectable medicines, such as Imfinzi and Fasenra. There was also a decline in the number of hospital admissions around the world for the treatment of heart attacks and lower levels of elective percutaneous coronary intervention10, adversely impacting sales of Brilinta. Some medicines, however, may have benefited from shifts in patient care and behaviours, including oral medicines such as Calquence, which saw an element of benefit from the substitution from infused-chemotherapy regimens.

 

AstraZeneca has collaborated to mobilise research efforts to target the SARS-CoV-2 virus, in order to provide protection to societies and people against COVID-19 and to treat patients with severe disease. C19VAZ, developed in collaboration with the University of Oxford, received authorisation in December 2020 for emergency supply from the UK Medicines and Healthcare Products Regulatory Agency (MHRA). Additional regulatory decisions have also been granted by regulatory authorities in a number of individual countries, including India, Argentina, Mexico and Morocco, and by the European Medicines Agency (EMA). In February 2021, the World Health Organization's (WHO) Strategic Advisory Group of Experts on Immunization (SAGE)  also recommended C19VAZ for use in individuals 18 years and over, with a preferred dosing interval of eight to 12 weeks.

 

In addition to C19VAZ, the Company has initiated five Phase III clinical trials of AZD7442, a long-acting antibody (LAAB) combination therapy for the prevention and treatment of COVID-19, to evaluate safety and efficacy in preventing infection and treating patients in outpatient and inpatient settings. Further details of the Company's broad COVID-19 research and development programme are shown in the research and development section of this announcement. Details of AstraZeneca's work with governments and other organisations, including agreements on the supply of C19VAZ, can be found in the comprehensive sustainability section of this announcement.

Sustainability summary

During the period, the Company received recognition of its broad sustainability efforts, featuring in the top five for the sector in the Dow Jones Sustainability Index (DJSI) and inclusion in the Corporate Knights Global 100 Index, which identifies globally sustainable companies.

 

Recent developments and progress against the Company's sustainability priorities are reported below:

 

a)  Access to healthcare

In December 2020, AstraZeneca, through an advanced-purchase agreement with Gavi, the Vaccines Alliance, committed to enabling access to 170m doses of C19VAZ in up to 190 countries worldwide, through the COVAX Facility (COVAX). COVAX is a coalition co-led by CEPI, the Coalition for Epidemic Preparedness Innovations, 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.

 

b)  Environmental protection

During the period, AstraZeneca was recognised for its leadership in sustainability by global environmental non-profit CDP, a charity that runs a global disclosure system for investors, companies, cities, states and regions to manage their environmental impacts. The Company received a place on the 'A List' for both climate action and water security. AstraZeneca was one of only three organisations worldwide to achieve this double A List recognition for five consecutive years. The Company also featured among the top 7% on CDP's 2020 Supplier Engagement Leaderboard, recognising progress in working with suppliers to address their emissions.

 

c)  Ethics and transparency

In January 2021, the Company was recognised for its efforts in promoting inclusion and diversity by the Bloomberg Gender Equality Index (BGEI), which tracks the performance of public companies committed to disclosing their efforts to support gender equality through policy development, representation and transparency. The Company was also listed as a participant in ShareAction's Workforce Disclosure Initiative (WDI), an annual survey that aims to improve corporate transparency and accountability on workforce issues and provide companies and investors with comprehensive and comparable data to help increase the provision of good jobs worldwide.

 

A more extensive sustainability update is provided later in this announcement.

 

Notes

The following notes refer to pages one to five.

 

1.  Tagrisso, Imfinzi, Lynparza, Calquence, Enhertu, Koselugo, Farxiga, Brilinta, Lokelma, roxadustat, Fasenra, Bevespi and Breztri. The new medicines are pillars in the three therapy areas of Oncology, Cardiovascular (CV), Renal & Metabolism (CVRM), and Respiratory & Immunology and are important platforms for future growth. The Total Revenue of Enhertu and roxadustat in the year entirely reflected Collaboration Revenue.

2.  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.

3.  Reported financial measures are the financial results presented in accordance with International Financial Reporting Standards (IFRS), adopted pursuant to Regulation (EC) No 1606/2002 as it applies in the EU and as issued by the International Accounting Standards Board.

4.  Earnings per share.

5.  Not meaningful.

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 for a definition of Core financial measures and a reconciliation of Core to Reported financial measures.

7.  New CVRM comprises Brilinta, Renal and Diabetes medicines.

8.  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.

9.  Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada.

10.  Percutaneous coronary intervention is a nonsurgical procedure intended to improve blood flow to the heart.

 

Table 5: Pipeline highlights

 

The following table highlights significant developments in the late-stage pipeline since the prior results announcement:

 

Regulatory approvals

Tagrisso - adjuvant[11] NSCLC[12] (EGFRm[13]) (US)

Imfinzi - new Q4W[14] dosing (US, EU)

Lynparza - ovarian cancer (1st line[15], HRD+[16]) (PAOLA-1) (EU, JP)

Lynparza - prostate cancer (2nd line, BRCAm[17]) (EU, JP)

Lynparza - pancreatic cancer (1st line, BRCAm) (JP)

Enhertu - gastric cancer (2nd line+, HER2+[18]) (US)

Enhertu - breast cancer (3rd line, HER2+) (EU)

Calquence - CLL[19] (EU, JP)

 

Forxiga - HF[20] CVOT[21] (EU, JP, CN)

Brilinta - stroke (THALES) (US)

 

Symbicort - mild asthma (CN)

Trixeo - COPD[22] (EU)

 

C19VAZ - COVID-19 (UK; authorisation for emergency supply, EU; conditional marketing authorisation)

Regulatory submission acceptances and/or submissions

Tagrisso - adjuvant NSCLC (EGFRm) (EU)

Lynparza - prostate cancer (2nd line, BRCAm) (CN)

 

Farxiga - CKD[23] (US, JP; priority reviews, EU, CN)

 

-  anifrolumab - lupus (SLE[24]) (JP)

Major Phase III data readouts or other significant developments

Imfinzi - biliary tract cancer: Orphan Drug Designation (US)

Imfinzi + treme[25] - head & neck cancer (1st line): Phase III primary endpoint not met

-  tremelimumab - liver cancer: orphan designation (EU)

Calquence - CLL (R/R[26]) (ELEVATE R/R): Phase III primary endpoint met

 

-  tezepelumab - severe asthma: Phase III primary endpoint met

 

Table 6: Pipeline - anticipated major news flow

 

Timing

News flow

H1 2021

Tagrisso - adjuvant NSCLC (EGFRm): regulatory decision (CN)

Imfinzi - unresectable[27], Stage III NSCLC (PACIFIC-2): data readout, regulatory submission

Imfinzi +/- treme - NSCLC (1st line) (POSEIDON): data readout (OS[28])

Lynparza - breast cancer (BRCAm): regulatory decision (CN)

Lynparza - adjuvant breast cancer: data readout

Calquence - CLL (R/R) (ELEVATE R/R): regulatory submission

Koselugo - NF1[29]: regulatory decision (EU)

 

Farxiga - CKD: regulatory decision (US)

Brilique/Brilinta - CAD[30]/T2D[31] CVOT: regulatory decision (EU, JP, CN)

Brilique - stroke (THALES): regulatory decision (EU)

-  roxadustat - anaemia in CKD: regulatory decision (US)

 

Symbicort - mild asthma: regulatory decision (EU)

Fasenra - nasal polyps[32]: regulatory submission

-  tezepelumab - severe asthma: regulatory submission

 

C19VAZ - SARS-CoV-2: data readout, regulatory submission (US)

-  AZD7442 - SARS-CoV-2: data readout, regulatory submission

H2 2021

Tagrisso - adjuvant NSCLC (EGFRm): regulatory decision (EU)

Imfinzi - NSCLC (1st line) (PEARL): data readout, regulatory submission

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, BRCAm): regulatory decision (CN)

Lynparza - prostate cancer (1st line, castration-resistant): data readout, regulatory submission

Enhertu - breast cancer (3rd line, HER2+) (Phase III): data readout

Enhertu - breast cancer (2nd line, HER2+): data readout, regulatory submission

Enhertu - breast cancer (HER2 low[33]): data readout

 

Forxiga - CKD: regulatory decision (EU, JP, CN)

Farxiga - HF (HFpEF[34]): data readout

Brilinta - stroke (THALES): regulatory decision (CN)

 

-  PT027 - asthma: data readout

-  anifrolumab - lupus (SLE): regulatory decision (US, EU, JP)

2022

Imfinzi - ES-SCLC[35]: regulatory decision (CN)

Imfinzi - LS-SCLC[36]: 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): regulatory submission

Enhertu - breast cancer (HER2 low): regulatory submission

Calquence - CLL: regulatory submission (CN)

Koselugo - NF1: regulatory submission (JP, CN)

 

Farxiga - HF (HFpEF): regulatory submission

-  roxadustat - MDS[37]: data readout, regulatory submission

 

-  PT027 - asthma: regulatory submission

-  nirsevimab - RSV[38]: data readout

 

Conference call

A conference call and webcast for investors and analysts will begin at 11:45am UK time today. Details can be accessed via astrazeneca.com.

 

Reporting calendar

The Company intends to publish its first-quarter results on Friday, 30 April 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, primarily for the treatment of diseases in three therapy areas - Oncology, CVRM, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

 

Contacts

For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.

 

 

Operating and financial review

 

All narrative on growth and results in this section is based on actual exchange rates, and financial figures are in US$ millions ($m), unless stated otherwise. The performance shown in this announcement covers the twelve-month period to 31 December 2020 (the year or FY 2020) and the three-month period to 31 December 2020 (the quarter, the fourth quarter or Q4 2020), compared to the twelve-month period to 31 December 2019 (FY 2019) and the three-month period to 31 December 2019 (Q4 2019) respectively, unless stated otherwise.

 

Forward-looking statements in this announcement do not reflect the impact of the performance of C19VAZ 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 Condensed Consolidated 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[39], 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 80 of the Annual Report and Form 20-F Information 2019. Reference should be made to the Reconciliation of Reported to Core financial measures table included in the financial performance section in this announcement.

 

EBITDA is defined as Reported Profit Before Tax after adding back Net Finance Expense, results from Joint Ventures and Associates and charges for Depreciation, Amortisation and Impairment. Reference should be made to the Reconciliation of Reported Profit Before Tax to EBITDA included in the financial performance section in this announcement.

 

Net Debt is defined as Interest-bearing loans and borrowings and Lease liabilities, net of Cash and cash equivalents, Other investments, and net Derivative financial instruments. Reference should be made to Note 3 'Net Debt' included in the Notes to the Condensed Financial Statements in this announcement.

 

Ongoing Collaboration Revenue is defined as Collaboration Revenue excluding Initial Collaboration Revenue (which is defined as Collaboration Revenue that is recognised at the date of completion of an agreement or transaction, in respect of upfront consideration). Ongoing Collaboration Revenue comprises, among other items, royalties, milestone revenue and profit-sharing income. Reference should be made to the Collaboration Revenue table in this operating and financial review.

 

The Company strongly encourages investors and analysts not to rely on any single financial measure, but to review AstraZeneca's financial statements, including the Notes thereto and other available Company reports, carefully and in their entirety.

 

Due to rounding, the sum of a number of dollar values and percentages may not agree to totals.

 

Table 7: Total Revenue by therapy area

Specialty-care medicines comprise all Oncology medicines, Brilinta, Lokelma, roxadustat and Fasenra. At 53% of Total Revenue (FY 2019: 48%), specialty-care medicines increased by 21% in the year (22% at CER) to $14,103m.

 

 

FY 2020

Q4 2020

$m

% of total

% change

$m

% change

Actual

CER

Actual

CER

Oncology

11,455

43

23

24

3,270

24

23

BioPharmaceuticals

10,077

38

3

4

2,786

3

2

New CVRM

4,702

18

7

9

1,252

7

7

Respiratory & Immunology

5,375

20

(1)

-

1,534

(1)

(2)

Other medicines

5,085

19

(4)

(2)

1,354

3

2

 

 

 

 

 

 

 

 

Total

26,617

100

9

10

7,410

11

10

 

Table 8: Top-ten medicines by Total Revenue

 

Medicine

Therapy Area

FY 2020

Q4 2020

$m

% of total

% change

$m

% change

Actual

CER

Actual

CER

Tagrisso

Oncology

4,328

16

36

36

1,157

31

28

Symbicort

Respiratory & Immunology

2,721

10

9

10

680

(5)

(5)

Lynparza

Oncology

2,236

8

24

24

821

17

16

Imfinzi

Oncology

2,042

8

39

39

555

31

29

Farxiga

CVRM

1,964

7

27

30

587

40

40

Brilinta

CVRM

1,593

6

1

2

363

(15)

(16)

Nexium

Other medicines

1,524

6

1

2

384

7

5

Crestor

CVRM

1,182

4

(10)

(9)

298

(9)

(10)

Pulmicort

Respiratory & Immunology

996

4

(32)

(32)

368

(11)

(14)

Fasenra

Respiratory & Immunology

949

4

35

34

283

38

35

 

 

 

 

 

 

 

 

 

Total

 

19,535

73

14

15

5,496

13

11

 

Table 9: Collaboration Revenue

 

 

FY 2020

Q4 2020

$m

% of total

% change

$m

% change

Actual

CER

Actual

CER

Lynparza : regulatory milestone revenue

160

22

n/m

n/m

25

n/m

n/m

Lynparza: sales milestone revenue

300

41

(33)

(33)

300

20

20

Enhertu : share of gross profits

94

13

n/m

n/m

31

n/m

n/m

Roxadustat: share of gross profits

30

4

n/m

n/m

11

n/m

n/m

Other Ongoing Collaboration Revenue

143

20

(32)

(32)

32

(53)

(54)

 

 

 

 

 

 

 

 

Total

727

100

(11)

(11)

399

(4)

(4)

 

Other Collaboration Revenue included Zoladex, Farxiga, Eklira, Nexium OTC[40] and other royalties. No Initial Collaboration Revenue was recorded in the year.

 

 

Total Revenue

 

The performance of the Company's medicines is shown below, with a geographical split of Product Sales shown in Note 7.

 

Table 10: Therapy area and medicine performance - FY 2020

 

Product Sales:

therapy area

Medicine

FY 2020

$m

% of total Product Sales

% change

Actual

CER

Oncology

Tagrisso

4,328

17

36

36

Imfinzi

2,042

8

39

39

Lynparza

1,776

7

48

49

Calquence

522

2

n/m

n/m

Koselugo

38

-

n/m

n/m

Zoladex [41]

888

3

9

13

Faslodex 41

580

2

(35)

(34)

Iressa 41

268

1

(37)

(36)

Arimidex 41

185

1

(18)

(16)

Casodex 41

172

1

(14)

(14)

Others

51

-

(47)

(46)

Total Oncology

10,850

42

25

26

BioPharmaceuticals: CVRM

Farxiga

1,959

8

27

30

Brilinta

1,593

6

1

2

Onglyza

470

2

(11)

(10)

Bydureon

448

2

(18)

(18)

Byetta

68

-

(37)

(36)

Other diabetes

47

-

(10)

(10)

Lokelma

76

-

n/m

n/m

Crestor 41

1,180

5

(8)

(7)

Seloken /Toprol-XL 41

821

3

8

12

Atacand 41

243

1

10

15

Others

191

1

(30)

(30)

BioPharmaceuticals:

total CVRM

7,096

27

3

5

BioPharmaceuticals: Respiratory & Immunology

Symbicort

2,721

11

9

10

Pulmicort

996

4

(32)

(32)

Fasenra

949

4

35

34

Daliresp /Daxas

217

1

1

1

Bevespi

48

-

16

15

Breztri

28

-

n/m

n/m

Others

398

2

(15)

(15)

BioPharmaceuticals: total Respiratory & Immunology

5,357

21

(1)

-

Other medicines

Nexium 41

1,492

6

1

2

Synagis 41

372

1

4

4

FluMist 41

295

1

n/m

n/m

Losec /Prilosec 41

183

1

(30)

(30)

Seroquel XR / IR 41

117

-

(39 )

(37 )

Others

128

-

(33 )

(34 )

Total other medicines

2,587

10

(1)

-

 

Total Product Sales

25,890

100

10

11

Total Collaboration Revenue

727

 

(11)

(11)

Total Revenue

26,617

 

9

10

 

Table 11: Therapy area and medicine performance - Q4 2020

 

Product Sales:

therapy area

Medicine

Q4 2020

$m

% of total Product Sales

% change

Actual

CER

Oncology

Tagrisso

1,157

17

31

28

Imfinzi

555

8

31

29

Lynparza

496

7

42

40

Calquence

182

3

n/m

n/m

Koselugo

17

-

n/m

n/m

Zoladex

216

3

11

13

Faslodex

130

2

(21)

(22)

Iressa

67

1

(16)

(19)

Arimidex

36

1

(29)

(30)

Casodex

39

1

(10)

(13)

Others

13

-

(53)

(52)

Total Oncology

2,908

41

28

26

BioPharmaceuticals: CVRM

Farxiga

586

8

40

40

Brilinta

363

5

(15)

(15)

Onglyza

105

1

(20)

(21)

Bydureon

122

2

(12)

(12)

Byetta

19

-

(31)

(30)

Other diabetes

12

-

(23)

(22)

Lokelma

28

-

n/m

n/m

Crestor

298

4

1

(1)

Seloken /Toprol-XL

200

3

6

7

Atacand

63

1

5

9

Others

46

1

(38)

(40)

BioPharmaceuticals:

total CVRM

1,842

26

3

3

BioPharmaceuticals: Respiratory & Immunology

Symbicort

680

10

(5)

(5)

Pulmicort

368

5

(11)

(14)

Fasenra

283

4

38

35

Daliresp /Daxas

54

1

(6)

(7)

Bevespi

12

-

8

4

Breztri

6

-

n/m

n/m

Others

125

2

(8)

(12)

BioPharmaceuticals: total Respiratory & Immunology

1,528

22

(1)

(2)

Other medicines

Nexium

377

5

7

6

Synagis

78

1

24

24

FluMist

179

3

92

85

Losec /Prilosec

39

1

(15)

(18)

Seroquel XR /IR

19

-

(53)

(49)

Others

41

1

(30)

(31)

Total other medicines

733

10

12

10

 

Total Product Sales

7,011

100

12

11

Total Collaboration Revenue

399

 

(4)

(4)

Total Revenue

7,410

 

11

10

 

 

Total Revenue summary

 

Oncology

 

Total Revenue of $11,455m in the year; an increase of 23% (24% at CER). The performance of Enhertu was reflected entirely in Collaboration Revenue.

 

Oncology represented 43% of overall Total Revenue (FY 2019: 38%).

 

Tagrisso

Tagrisso has received regulatory approval in five countries, including the US, for use as an adjuvant treatment of EGFRm NSCLC patients, with three reimbursements granted so far. This expands upon the patient benefit from use in the 1st-line treatment of patients with EGFRm NSCLC with regulatory approval in 87 countries, including the US, China, in the EU and Japan. To date, reimbursement has been granted in 40 countries in this setting, with further decisions anticipated. These developments followed Tagrisso's regulatory approval in 89 countries, including the US, China, in the EU and Japan for the treatment of patients with EGFR T790M[42] NSCLC, an indication in which 66 reimbursements have been obtained.

 

Total Revenue, entirely comprising Product Sales, amounted to $4,328m in the year and represented growth of 36%. Sales in the US increased by 24% to $1,566m. Approval was granted by the US Food and Drug Administration (FDA) in December 2020 for the adjuvant treatment of Stage Ib to IIIa EGFRm NSCLC patients.

 

In Emerging Markets, Tagrisso sales increased by 59% in the year (63% at CER) to $1,208m, with notable growth in China; admission to the 2021 China NRDL was obtained for the 1st-line and renewed for the 2nd-line setting, commencing in March 2021. Japan increased by 16% (14% at CER) to $731m, despite a Q4 2019 price reduction of 15%. In Europe, sales of $748m in the year represented an increase of 58% (56% at CER), driven by use in the 1st-line setting, as more reimbursements were granted.

 

Imfinzi

Imfinzi has received regulatory approval in 67 countries, including the US, China, in the EU and Japan for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following platinum-based chemoradiation therapy (CRT). The number of reimbursements increased to 28 in the year. Imfinzi has also been approved for the treatment of ES-SCLC patients in 51 countries, with five reimbursements obtained.

 

Total Revenue, entirely comprising Product Sales, amounted to $2,042m in the year and represented growth of 39%, predominantly for the treatment of unresectable, Stage III NSCLC patients. The US increased by 14% to $1,185m; in Japan, growth of 28% (26% at CER) represented sales of $270m. Europe increased by 106% (104% at CER) to $370m, reflecting a growing number of reimbursements, while Emerging Markets increased to $158m (FY 2019: $30m), following recent regulatory approvals and launches, including in China.

 

Lynparza

Lynparza has received regulatory approval in 78 countries for the treatment of ovarian cancer; it has also been approved in 76 countries for the treatment of metastatic breast cancer, and in 55 countries for the treatment of pancreatic cancer. Lynparza has received regulatory approval in 49 countries for the 2nd-line treatment of certain prostate-cancer patients.

 

Lynparza Total Revenue amounted to $2,236m in the year and represented growth of 24%; this included Collaboration Revenue of $460m.

 

Product Sales in the year amounted to $1,776m, reflecting growth of 48% (49% at CER). The strong performance was geographically spread, with further indication launches continuing globally. US Product Sales increased by 40% to $876m, as the launches in prostate cancer and 1st-line HRD+ ovarian cancer started to take effect. Lynparza continued to be the leading medicine in the poly ADP ribose polymerase-inhibitor (PARPi) class, as measured by total prescription volumes. Product Sales in Europe increased by 52% (51% at CER) to $435m, reflecting additional reimbursements and increasing BRCAm-testing rates, as well as successful recent 1st-line BRCAm ovarian cancer launches, including in the UK and Germany.

 

Japan Product Sales of Lynparza amounted to $167m, representing growth of 29% (27% at CER). Emerging Markets Product Sales were $264m, up by 98% (108% at CER). In China, Lynparza was admitted to the NRDL as a 1st-line treatment for BRCAm ovarian cancer patients with effect from March 2021.

 

Enhertu

US sales, recorded by Daiichi Sankyo Company Limited (Daiichi Sankyo), amounted to $200m in the year, including $64m in the quarter. Enhertu was approved at the end of 2019 by the US FDA for the treatment of 3rd-line HER2+ breast cancer. Total Revenue, entirely comprising Collaboration Revenue recorded by AstraZeneca, amounted to $96m in the year, with $33m recorded in the quarter.

 

Calquence

Total Revenue, entirely comprising Product Sales, amounted to $522m in the year and represented growth of 219%, with the overwhelming majority of sales in the US. Calquence was approved by the US FDA for the treatment of CLL in November 2019. In total, Calquence has received regulatory approvals for this indication in 51 countries and in 23 countries for the treatment of patients with R/R mantle cell lymphoma (MCL).

 

Koselugo

Total Revenue, entirely comprising Product Sales in the US, amounted to $38m in the year, following its launch during the second quarter for the treatment of the rare disease NF1 in paediatric patients aged two years and older who have symptomatic, inoperable plexiform neurofibromas.

 

Zoladex

Total Revenue, predominantly comprising Product Sales, amounted to $938m in the year and represented growth of 13% (17% at CER).

 

Emerging Markets Product Sales of Zoladex increased by 14% (20% at CER) to $561m, reflecting increased use and access in prostate cancer. Product Sales in Europe increased by 4% to $140m while, in the Established Rest of World (RoW) region, Product Sales increased by 1% to $182m.

 

Faslodex

Total Revenue, entirely comprising Product Sales, amounted to $580m in the year and represented a decline of 35% (34% at CER).

 

Emerging Markets fell by 9% (4% at CER) to $180m, while US sales declined by 83% to $55m, reflecting the launch in 2019 of multiple generic Faslodex medicines; in Europe, sales fell by 3% to $221m. In Japan, they declined by 11% (13% at CER) to $116m, driven by a mandated price reduction in the second quarter.

 

Iressa

Total Revenue, entirely comprising Product Sales, amounted to $268m in the year and represented a decline of 37% (36% at CER). Emerging Markets fell by 23% (22% at CER) to $221m, driven by the impact of Iressa's inclusion in China's VBP programme and subsequent price reduction.

 

 

BioPharmaceuticals: CVRM

 

Total Revenue increased by 3% in the year (4% at CER) to $7,139m and represented 27% of Total Revenue (FY 2019: 29%). This included roxadustat Collaboration Revenue of $30m, as well as the Product Sales of Crestor and other legacy medicines.

 

New CVRM Total Revenue, which excludes sales of Crestor and other legacy medicines, increased by 7% in the year (9% at CER) to $4,702m, mainly reflecting the strong performance of Farxiga. New CVRM represented 66% of overall CVRM Total Revenue in the year (FY 2019: 63%).

 

Farxiga

Total Revenue, predominantly comprising Product Sales, amounted to $1,964m in the year and represented growth of 27% (30% at CER). Q4 2020 Total Revenue increased by 40% to $587m, reflecting volume growth across the regions.

 

Emerging Markets Product Sales increased by 46% in the year (55% at CER) to $686m. In China, Forxiga was admitted to the NRDL with effect from the start of 2020; as expected, this adversely impacted pricing. This was, however, more than offset by the derived volume uplift.

 

US Product Sales increased by 6% in the year to $569m, partly driven by regulatory approval in May 2020 for the treatment of patients with heart failure with reduced ejection fraction (HFrEF) in both patients with and without T2D, based on the compelling patient benefit seen in the results from the DAPA-HF trial. Sales in the fourth quarter increased by 31% to $184m, reflecting by the comparative effect of an adverse prior-year gross-to-net adjustment.

 

Product Sales in Europe increased by 36% in the year (35% at CER) to $507m, partly reflecting growth in the SGLT2[43] class, the beneficial addition of CVOT data to the label and HFrEF regulatory approval in November 2020. In Japan, sales to collaborator Ono Pharmaceutical Co., Ltd, which records in-market sales, increased by 29% (27% at CER) to $117m.

 

Brilinta

Total Revenue, entirely comprising Product Sales, amounted to $1,593m in the year and represented growth of 1% (2% at CER).

 

Global demand over the year was adversely impacted by the effects of COVID-19, reflected in fewer acute coronary syndrome hospital admissions. Sales in Q4 2020 declined by 15% to $363m, also driven by a VBP-related mandatory price reduction in China in Q3 2020.

 

Emerging Markets sales were stable in the year (up by 4% at CER) at $461m. Sales in the fourth quarter, however, declined by 39% (36% at CER) to $69m, following the aforementioned price reduction in China. US sales, at $732m, represented growth of 3%, with an increase in the average-weighted duration of treatment partly offset by the adverse COVID-19 impact, also reflected in fewer elective procedures. Sales of Brilique in Europe declined by 3% in the year to $342m, with the performance similarly impacted by COVID-19.

 

Onglyza

Total Revenue, entirely comprising Product Sales, amounted to $470m in the year and represented a decline of 11% (10% at CER).

 

Sales in Emerging Markets increased by 14% (18% at CER) to $201m, driven by the performance in China and the growing DPP-4[44] class. US sales of Onglyza fell by 28% in the year to $166m, while Europe sales declined by 16% (17% at CER) to $58m, highlighting the shift away from the class.

 

Bydureon

Total Revenue, entirely comprising Product Sales, amounted to $448m in the year and represented a decline of 18%.

 

US sales of $382m reflected a fall of 17% in the year, resulting from competitive pressures and the impact of managed markets. Sales in Europe declined by 20% to $53m.

 

Lokelma

Total Revenue, entirely comprising Product Sales, amounted to $76m in the year (FY 2019: $14m), an increase of 461% (463% at CER), despite the impact from COVID-19 on the overall market. 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 markets for the treatment of hyperkalaemia, including in the EU, China and Japan, with further launches anticipated in a number of markets soon. In December 2020, the medicine was excluded from the latest round of the China NRDL process.

 

Roxadustat

Total Revenue, entirely comprising Collaboration Revenue, amounted to $30m in the year in China. Q4 2020 revenue of $11m reflected a sequential quarterly increase of 46%. The Company continued to focus in the year on achieving hospital listings and patient access across China.

 

In July 2020, FibroGen Inc. (FibroGen) and AstraZeneca entered into an amendment to revise the existing licence agreement for roxadustat in China. From January 2021, the Company recognised the overwhelming majority of its future revenue in China as Product Sales.

 

Crestor

Total Revenue, predominantly comprising Product Sales, amounted to $1,182m in the year and represented a decline of 10% (9% at CER).

 

Product Sales in Emerging Markets fell by 7% (5% at CER) to $748m. The performance continued to be adversely impacted by the ongoing effects of the aforementioned VBP programme in China. US Product Sales declined by 11% to $92m. In Europe, Total Revenue fell by 31% (32% at CER) to $131m while, in Japan, where AstraZeneca collaborates with Shionogi Co., Ltd, Product Sales declined by 4% (5% at CER) to $164m.

 

In December 2020, it was announced that the Company had agreed to sell the commercial rights to Crestor in over 30 countries in Europe to Grünenthal GmbH. The divestment closed earlier in the first quarter of 2021.

 

BioPharmaceuticals: Respiratory & Immunology

 

Total Revenue declined by 1% in the year (stable at CER) to $5,375m and represented 20% of Total Revenue (FY 2019: 22%). This included Ongoing Collaboration Revenue of $18m from Duaklir, Eklira and other medicines.

 

Symbicort

Total Revenue, entirely comprising Product Sales, amounted to $2,721m in the year and represented an increase of 9% (10% at CER), a result of growth in the US. Q4 2020 Total Revenue declined by 5% to $680m, driven by the impact of generic competition in Europe and Japan.Symbicort remains the global market-volume and value leader within the inhaled corticosteroid (ICS) / long-acting beta agonist (LABA) class.

 

US sales grew by 23% in the year to $1,022m; an authorised-generic version of Symbicort was launched in the US by the Company's collaborator, Prasco LLC (Prasco), in January 2020. The performance in Emerging Markets in the year slowed down versus FY 2019, reflecting a reduction in hospital visits in China due to COVID-19, leading to fewer initiations. Despite this, Emerging Markets sales increased by 4% (9% at CER) to $567m.

 

In Europe, sales increased by 2% in the year to $694m, with positive volume growth seen in the major countries. In Japan, sales declined by 16% (18% at CER) to $189m, driven by the impact of generic competition and an unfavourable price comparison versus 2019, partly reflecting the termination of the Astellas Pharma Inc. co-promotion agreement. This impact in Japan was particularly acute in the fourth quarter, when sales declined by 53% (54% at CER) to $45m.

 

Pulmicort

Total Revenue, entirely comprising Product Sales, amounted to $996m in the year and represented a decline of 32%, as the continued effects of COVID-19 impacted the hospital treatment of respiratory patients. Q4 2020 Total Revenue declined by 11% (14% at CER) to $368m.

 

Emerging Markets, where Pulmicort sales fell by 33% in the year to $798m, represented 80% of the global total. Alongside the effects of COVID-19, the performance in China was impacted by a reduction in the number of paediatric patients attending outpatient nebulisation rooms. In the fourth quarter, however, the volume of adult elective procedures, a smaller use, largely recovered. Pulmicort can be used in this setting when oral corticosteroids (OCS) are unsuitable.

 

Sales in the US declined by 35% in the year to $71m, due to the fall in the use of PulmicortRespules. In Japan, sales declined by 51% (52% at CER) to $30m as a result of generic competition and fell in Europe by 10% to $73m.

 

Fasenra

Fasenra has received regulatory approval in 59 countries, including the US, in the EU and Japan for the treatment of patients with severe, uncontrolled eosinophilic asthma. With further regulatory reviews ongoing, Fasenra has already achieved reimbursement in 47 countries.

 

Total Revenue, entirely comprising Product Sales, amounted to $949m in the year and represented growth of 35% (34% at CER), a result of increased demand, despite the impact of COVID-19 on the level of new-patient starts in several countries. Fasenra remained the leading novel biologic in the majority of markets in the new-to-brand prescription share for patients with severe, uncontrolled asthma.

 

Sales in the US grew by 25% in the year to $603m, due to increased volume demand as a result of the impact of COVID-19 earlier in the year. The adverse effect of COVID-19 on the dynamic market was partially offset by the growth in market share and increased persistency. In Europe, sales of $203m represented an increase of 72% (70% at CER), reflecting ongoing successful launches and additional reimbursement. Sales in Japan increased by 16% (14% at CER) to $100m. In Emerging Markets, sales amounted to $12m (FY 2019: $5m).

 

Daliresp/Daxas

Total Revenue, entirely comprising Product Sales, amounted to $217m in the year and represented an increase of 1%. US sales, comprising 88% of the global total, increased by 3% to $190m.

 

Bevespi

Total Revenue, entirely comprising Product Sales, amounted to $48m in the year and represented an increase of 16% (15% at CER). Bevespi has been launched in the US, in a number of European countries and in Japan. Sales in the US increased by 7% in the year to $44m while, in Europe, sales amounted to $3m (FY 2019: $nil). Bevespi was recently included in the China NRDL, with effect from March 2021.

 

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 four countries.

 

Total Revenue, entirely comprising Product Sales, amounted to $28m in the year (FY 2019: $2m). Sales in the US amounted to $5m (FY 2019: $nil), largely as a result of stocking. Sales in Japan amounted to $9m (FY 2019: $2m) where prescriptions were limited by Ryotanki, a regulation which limits prescriptions to two weeks' supply in the first year of launch. In October 2020, Ryotanki was lifted for Breztri and the restriction no longer applied. Emerging Markets amounted to $14m (FY 2019: $nil). Breztri was recently included in the China NRDL, with effect from March 2021.

 

Other medicines (outside the three main therapy areas)

 

Total Revenue, primarily comprising Product Sales, amounted to $2,649m in the year, representing a decline of 2%. The performance partly reflected the divestment of global rights to Movantik, excluding Europe, Canada and Israel, to RedHill Biopharma in April 2020. Other medicines Total Revenue represented 10% of overall Total Revenue (FY 2019: 11%).

 

Nexium

Total Revenue, predominantly comprising Product Sales, amounted to $1,524m in the year, representing an increase of 1% (2% at CER). Emerging Markets Product Sales of Nexium increased by 1% (4% at CER) to $757m in the year, with particular strength in Q4 2020 when sales of $193m represented an increase of 11%, reflecting later phasing of demand in the year.

 

In Japan, where AstraZeneca collaborates with Daiichi Sankyo, Product Sales increased by 6% (4% at CER) to $423m, while Product Sales in the US declined by 22% to $169m. In Europe, Product Sales increased by 12% (10% at CER) to $71m.

 

Further to the previous VBP-programme round in Q4 2020, China concluded another round in February 2021, including Nexium (oral). The Company, however, chose not to compete on price and consequently accepted a mandatory price reduction of 30%.

 

Losec /Prilosec

Total Revenue, entirely comprising Product Sales, amounted to $183m in the year, representing a decline of 30%. This partly reflected the divestment of global commercial rights, excluding China, Japan, the US and Mexico, to Cheplapharm Arzneimittel GmbH (Cheplapharm) in October 2019. Emerging Markets fell by 15% (14% at CER) to $152m as Losec was subject to a mandatory price reduction as part of the impact of aforementioned VBP programme in China; sales in Europe fell by 59% to $20m.

 

FluMist

Total Revenue, entirely comprising Product Sales, increased by 161% in the year (153% at CER) to $295m, reflecting the greater use of influenza vaccines as health authorities in northern-hemisphere countries expanded seasonal-vaccination programmes beyond typical levels during the ongoing COVID-19 pandemic. In the US, sales increased by 254% in the year to $70m and, in Europe, by 135% (126% at CER) to $219m.

 

Synagis

The commercial rights to the sale and distribution of Synagis outside the US, held by AbbVie Inc (AbbVie) since 1997, will revert to AstraZeneca upon the expiry of the current agreement on 30 June 2021. In general, the Company will solely distribute and promote the medicine outside the US from 1 July 2021. The agreement with Swedish Orphan Biovitrum AB (publ), for the rights to Synagis in the US, was unaffected by this decision.

 

Total Revenue, entirely comprising Product Sales, amounted to $372m in the year, representing an increase of 4%. In Q4 2020, global sales increased by 24% to $78m, reflecting the phasing of orders from AbbVie and preparations for the aforementioned reversion of commercial rights. Sales in Europe, wholly reflecting sales to AbbVie made under the current supply agreement for markets outside the US, amounted to $325m in the year, representing an increase of 4%.

 

 

Regional Total Revenue

 

Table 12 : Regional Total Revenue

 

 

FY 2020

Q4 2020

$m

% of total

% change

$m

% change

Actual

CER

Actual

CER

Emerging Markets

8,711

33

7

10

2,244

7

8

China

5,375

20

10

11

1,362

15

9

Ex-China

3,336

13

1

9

882

(2)

7

 

 

 

 

 

 

 

 

US

8,833

33

13

13

2,388

15

15

 

 

 

 

 

 

 

 

Europe

5,540

21

10

9

1,831

17

12

 

 

 

 

 

 

 

 

Established RoW

3,533

13

6

5

947

2

(1)

Japan

2,620

10

1

-

718

(2)

(5)

Canada

605

2

29

31

146

16

16

Other Est. RoW

308

1

8

10

83

11

7

 

 

 

 

 

 

 

 

Total

26,617

100

9

10

7,410

11

10

 

A geographical split of Product Sales is shown in Note 7. For additional details, refer to Table 49: Historic Collaboration Revenue for Collaboration Revenue recognised during FY 2020 and FY 2019.

 

Table 13 : Emerging Markets therapy-area performance - Total Revenue

 

 

FY 2020

Q4 2020

$m

% of total

% change

$m

% change

Actual

CER

Actual

CER

Oncology

2,906

33

31

36

668

22

24

BioPharmaceuticals

3,007

35

(4)

-

882

2

2

New CVRM

1,407

16

24

31

335

12

17

Respiratory & Immunology

1,600

18

(19)

(18)

547

(4)

(5)

Other medicines

2,798

32

(1)

2

694

2

3

 

 

 

 

 

 

 

 

Total

8,711

100

7

10

2,244

7

8

 

Emerging Markets Total Revenue grew by 7% (10% at CER) to $8,711m in the year and, in the fourth quarter, by 7% (8% at CER) to $2,244m. The new medicines represented 33% of Emerging Markets Total Revenue in the year (FY 2019: 23%). Speciality-care medicines increased by 27% (32% at CER) to $3,414m and comprised 39% of Emerging Markets Total Revenue in the year (FY 2019: 33%).

 

Table 14 : Notable new-medicine performances in Emerging Markets - Total Revenue

 

 

FY 2020

Q4 2020

$m

% of total

% change

$m

% change

Actual

CER

Actual

CER

Tagrisso

1,208

14

59

63

258

23

23

Forxiga

686

8

46

55

198

50

57

Brilinta

461

5

-

4

69

(40)

(37)

Lynparza [45]

264

3

98

n/m

69

n/m

n/m

 

China comprised 62% of Emerging Markets Total Revenue in the year and increased by 10% (11% at CER) to $5,375m. New medicines, primarily driven by Tagrisso and Lynparza in Oncology and Forxiga in New CVRM, delivered particularly encouraging growth and represented 31% of China Total Revenue (FY 2019: 19%); strong sales of Zoladex, Seloken and Symbicort supplemented this performance. The aforementioned decline of Pulmicort in China, however, restricted overall Total Revenue growth in the year.

 

In Q4 2020, China growth of 15% (9% at CER) to $1,362m reflected the impact of a mandatory 30% price reduction for Brilinta, Losec and Arimidex, which were unsuccessful in the latest round of VBP, following the Company's decision not to compete with generic competitor price in the tender process.

 

Table 15 : Ex-China Emerging Markets: Total Revenue

 

 

FY 2020

Q4 2020

$m

% change

$m

% change

Actual

CER

Actual

CER

Ex-China Asia Pacific

1,237

5

6

341

7

5

Middle East and Africa

1,024

(3)

1

256

(12)

(5)

Ex-Brazil Latin America

447

-

18

130

2

21

Russia

314

28

42

77

11

33

Brazil

314

(15)

10

78

(17)

11

 

 

 

 

 

 

 

Total

3,336

1

9

882

(2)

7

 

Ex-China Emerging Markets Total Revenue, primarily comprising Product Sales, increased by 1% in the year (9% at CER) to $3,336m. The new medicines represented 36% of ex-China Emerging Markets Total Revenue (FY 2019: 29%), increasing by 25% (35% at CER) to $1,194m.

 

Notable performances in ex-China Emerging Markets included growth in Russia of 28% (42% at CER) to $314m and a stable performance in ex-Brazil Latin America (growth of 18% at CER), representing Total Revenue of $447m.

 

 

Financial performance

 

Table 16 : Reported Profit and Loss - FY 2020

 

 

FY 2020

FY 2019

% change

$m

$m

Actual

CER

Total Revenue

26,617

24,384

9

10

Product Sales

25,890

23,565

10

11

Collaboration Revenue

727

819

(11)

(11)

 

 

 

 

 

Cost of Sales

(5,299)

(4,921)

8

8

 

 

 

 

 

Gross Profit

21,318

19,463

10

11

Gross Profit Margin

79.5%

79.1%

-

+1

 

 

 

 

 

Distribution Expense

(399)

(339)

18

19

% Total Revenue

1.5%

1.4%

-

-

R&D Expense

(5,991)

(6,059)

(1)

(1)

% Total Revenue

22.5%

24.8%

+2

+3

SG&A Expense

(11,294)

(11,682)

(3)

(3)

% Total Revenue

42.4%

47.9%

+5

+6

 

 

 

 

 

Other Operating Income & Expense

1,528

1,541

(1)

(1)

% Total Revenue

5.7%

6.3%

-1

-1

 

 

 

 

 

Operating Profit

5,162

2,924

77

81

Operating Profit Margin

19.4%

12.0%

+7

+8

 

 

 

 

 

Net Finance Expense

(1,219)

(1,260)

(3)

(4)

Joint Ventures and Associates

(27)

(116)

(77)

(76)

 

 

 

 

 

Profit Before Tax

3,916

1,548

n/m

n/m

 

 

 

 

 

Taxation

(772)

(321)

n/m

n/m

Tax Rate

20%

21%

 

 

 

 

 

 

 

Profit After Tax

3,144

1,227

n/m

n/m

 

 

 

 

 

EPS

$2.44

$1.03

n/m

n/m

 

Table 17: Reported Profit and Loss - Q4 2020

 

 

Q4 2020

Q4 2019

% change

$m

$m

Actual

CER

Total Revenue

7,410

6,664

11

10

Product Sales

7,011

6,250

12

11

Collaboration Revenue

399

414

(4)

(4)

 

 

 

 

 

Cost of Sales

(1,525)

(1,378)

11

5

 

 

 

 

 

Gross Profit

5,885

5,286

11

11

Gross Profit Margin

78.2%

78.0%

-

+1

 

 

 

 

 

Distribution Expense

(109)

(92)

18

16

% Total Revenue

1.5%

1.4%

-

-

R&D Expense

(1,719)

(2,091)

(18)

(19)

% Total Revenue

23.2%

31.4%

+8

+8

SG&A Expense

(3,210)

(3,026)

6

4

% Total Revenue

43.3%

45.4%

+2

+2

 

 

 

 

 

Other Operating Income & Expense

640

500

28

29

% Total Revenue

8.6%

7.5%

+1

+1

 

 

 

 

 

Operating Profit

1,487

577

n/m

n/m

Operating Profit Margin

20.1%

8.7%

+11

+13

 

 

 

 

 

Net Finance Expense

(314)

(312)

1

-

Joint Ventures and Associates

(6)

(25)

(79)

(79)

 

 

 

 

 

Profit Before Tax

1,167

240

n/m

n/m

 

 

 

 

 

Taxation

(162)

37

n/m

n/m

Tax Rate

14%

(15)%

 

 

 

 

 

 

 

Profit After Tax

1,005

277

n/m

n/m

 

 

 

 

 

EPS

$0.78

$0.24

n/m

n/m

 

Table 18 : Reconciliation of Reported Profit Before Tax to EBITDA - FY 2020

 

 

FY 2020

FY 2019

% change

$m

$m

Actual

CER

Reported Profit Before Tax

3,916

1,548

n/m

n/m

 

 

 

 

 

Net Finance Expense

1,219

1,260

(3 )

(4 )

Joint Ventures and Associates

27

116

(77 )

(76 )

Depreciation, Amortisation and Impairment

3,149

3,762

(16)

(16)

 

 

 

 

 

EBITDA

8,311

6,686

24

27

 

Table 19: Reconciliation of Reported Profit Before Tax to EBITDA - Q4 2020

 

 

Q4 2020

Q4 2019

% change

$m

$m

Actual

CER

Reported Profit Before Tax

1,167

240

n/m

n/m

 

 

 

 

 

Net Finance Expense

314

312

1

-

Joint Ventures and Associates

6

25

(79 )

(79 )

Depreciation, Amortisation and Impairment

797

1,643

(52)

(53)

 

 

 

 

 

EBITDA

2,284

2,220

3

6

 

Table 20 : Reconciliation of Reported to Core financial measures - FY 2020

 

FY 2020

Reported

Restructuring

Intangible Asset Amortisation & Impairments

Diabetes Alliance

Other

Core [46]

Core

% change

$m

$m

$m

$m

$m

$m

Actual

CER

Gross Profit

21,318

53

66

-

5

21,442

9

10

Gross Profit Margin

79.5%

 

 

 

 

80.0%

-

-

 

 

 

 

 

 

 

 

 

Distribution Expense

(399)

-

-

-

-

(399)

18

19

R&D Expense

(5,991)

35

84

-

-

(5,872)

10

10

SG&A Expense

(11,294)

162

1,657

310

(197)

(9,362)

3

4

Total Operating Expense

(17,684)

197

1,741

310

(197)

(15,633)

6

6

 

 

 

 

 

 

 

 

 

Other Operating Income & Expense

1,528

1

2

-

-

1,531

(2)

(2)

 

 

 

 

 

 

 

 

 

Operating Profit

5,162

251

1,809

310

(192)

7,340

14

17

Operating Profit Margin

19.4%

 

 

 

 

27.6%

+1

+2

 

 

 

 

 

 

 

 

 

Net Finance Expense

(1,219)

-

-

228

209

(782)

2

2

Taxation

(772)

(50)

(376)

(127)

13

(1,312)

18

21

 

 

 

 

 

 

 

 

 

EPS

$2.44

$0.15

$1.10

$0.31

$0.02

$4.02

15

18

 

Table 21: Reconciliation of Reported to Core financial measures - Q4 2020

 

Q4 2020

Reported

Restructuring

Intangible Asset Amortisation & Impairments

Diabetes Alliance

Other

Core 46

Core

% change

$m

$m

$m

$m

$m

$m

Actual

CER

Gross Profit

5,885

9

16

-

1

5,911

12

12

Gross Profit Margin

78.2%

 

 

 

 

78.6%

+1

+2

 

 

 

 

 

 

 

 

 

Distribution Expense

(109 )

(109 )

18

16

R&D Expense

(1,719 )

5

7

(1,707 )

14

12

SG&A Expense

(3,210 )

95

429

64

(216)

(2,838 )

8

6

Total Operating Expense

(5,038 )

100

436

64

(216)

(4,654 )

11

8

 

 

 

 

 

 

 

 

 

Other Operating Income & Expense

640

2

642

28

29

 

 

 

 

 

 

 

 

 

Operating Profit

1,487

111

452

64

(215)

1,899

23

28

Operating Profit Margin

20.1%

 

 

 

 

25.6%

+2

+4

 

 

 

 

 

 

 

 

 

Net Finance Expense

(314 )

-

54

55

(205 )

10

15

Taxation

(162 )

(22 )

(92 )

(35 )

14

(297 )

52

59

 

 

 

 

 

 

 

 

 

EPS

$0.78

$0.06

$0.28

$0.06

($0.11)

$1.07

19

24

 

 

Profit and Loss summary

 

a)  Gross Profit

The increases in Reported and Core Gross Profit in the year reflected the growth in Product Sales. The Reported Gross Profit Margin was stable (up by one percentage point at CER) at 80%, while the Core Gross Profit Margin was stable at 80%, with a favourable mix of sales offset by increasing pricing pressure in China related to the impacts of the NRDL and the VBP programme. The performance was in line with the Company's expectations.

 

b)  Total Operating Expense

Reported Total Operating Expense declined by 2% in the year to $17,684m and represented 66% of Total Revenue (FY 2019: 74%). Core Total Operating Expense increased by 6% to $15,633m and comprised 59% of Total Revenue (FY 2019: 60%).

 

-  The increase in Reported and Core Distribution Expense in the year was a result of adverse logistics impacts from the COVID-19 pandemic

 

-  The decline in Reported R&D Expense was partly driven by the comparative effect of the $533m impairment of Epanova in FY 2019. The growth in Core R&D Expense included investment in the Oncology pipeline, such as the development of datopotamab deruxtecan and the ending in FY 2019 of the release of the upfront funding of Lynparza development, as part of the aforementioned collaboration with MSD. There were also additional costs related to COVID-19, such as the expense of personal protective equipment and colleague testing

 

-  AstraZeneca also mobilised research efforts to treat patients with severe COVID-19 symptoms; these efforts included the development of AZD7442, the LAAB that may have a role in the prevention and/or treatment of COVID-19. In line with IAS 20 'Accounting for Government Grants and Disclosure of Government Assistance', government grants related to the development of C19VAZ and AZD7442 were recognised in the Consolidated statement of comprehensive income so as to match with the related expenses that they were intended to compensate. Where grants are received in advance of the related expenses, they are initially recognised in the Consolidated statement of financial position and released to match the related expenditure

 

-  The difference in the movements of Reported and Core SG&A Expense partly reflected fair-value adjustments arising on acquisition-related liabilities, as well as an increase in legal provisions recognised in 2019. Within Reported and Core SG&A Expense, pandemic-related savings partly compensated for investment in the launches of new medicines and expansion in China

 

c)  Other Operating Income and Expense[47]

Reported Other Operating Income and Expense in the year of $1,528m reflected a decline of 1%. Core Other Operating Income and Expense in the year, decreasing by 2% to $1,531m, included:

 

$400m of income from the aforementioned agreement to divest of commercial rights to Atacand and Atacand Plus in over 70 countries to Cheplapharm

 

-  $350m of income from an agreement to divest commercial rights to a number of legacy hypertension medicines to Atnahs Pharma

 

-  Income from the monetisation of an asset previously licensed

 

-  Payments from Allergan (part of AbbVie) of $107m in respect of the development of brazikumab

 

d)  Net Finance Expense

The increase in Core Net Finance Expense partly reflected lower interest rates on cash, cash equivalents and other current investments.

 

e)  Taxation

The Reported and Core Tax Rates for the year were both 20% (FY 2019: 21% and 20%, respectively). The net cash tax paid in the year was $1,562m, representing 40% of Reported Profit Before Tax (FY 2019: $1,118m, 72%); the increase partly reflected the growth in Reported Profit Before Tax and the phasing of tax payments.

 

f)  Non-controlling interests

Reported total comprehensive losses attributable to non-controlling interests amounted to $52m in the year

(FY 2019: $108m), of which $55m related to the non-controlling interest in Acerta Pharma.

 

In FY 2016, AstraZeneca acquired a 55% controlling stake in Acerta Pharma, where the non-controlling interests were subject to put and call options; the put option gave rise to a liability at 31 December 2020 of $2,297m (31 December 2019: $2,146m), shown in non-current other payables. The ability of the parties to exercise their respective put and call options, as well as the timing and amount of exercise, was dependent on certain conditions, the last of which was based on the regulatory approval of Calquence in the EU.

 

In November 2020, Calquence received marketing approval in the EU, which removed all remaining conditionality in respect of the options. The minority shareholders were then considered to have no further substantive variability in risk and reward related to their shares, as it was considered highly likely that one of the options will be exercised, and the price of the options were then fixed. Therefore, from November 2020, no further amounts of the consolidated AstraZeneca result were attributed to the minority shareholders of Acerta Pharma and no further impact on non-controlling interests in relation to Acerta Pharma is anticipated. In addition, the non-controlling interests reserve relating to the minority shareholders of Acerta Pharma, totalling $1,401m, has been reclassified into Retained earnings (see Condensed Consolidated Statement of Changes in Equity).

 

g)  Dividend per share

The Board reaffirms its commitment to the progressive dividend policy. A stable second interim dividend of $1.90 per share (137.4 pence, 15.76 SEK) has been declared, meaning a stable full-year dividend per share of $2.80 (207.0 pence, 23.63 SEK). Dividend payments are normally paid as follows:

 

-  First interim dividend - announced with half-year and second-quarter results and paid in September

-  Second interim dividend - announced with full-year and fourth-quarter results and paid in March

 

The record date for the second interim dividend for 2020, payable on 29 March 2021, will be 26 February 2021. The ex-dividend date will be 25 February 2021. 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.

 

h)  EPS

Reported EPS of $2.44 in the year represented an increase of 137% (142% at CER); Core EPS increased by 15% (18% at CER) to $4.02.

 

Table 22 : Cash Flow

 

 

FY 2020

FY 2019

Change

$m

$m

$m

Reported Operating Profit

5,162

2,924

2,238

Depreciation, Amortisation and Impairment

3,149

3,762

(613)

 

 

 

 

Decrease/(increase) in Working Capital and Short-Term Provisions

361

(346)

707

Gains on Disposal of Intangible Assets

(1,030)

(1,243)

213

Non-Cash and Other Movements

(548)

(236)

(312)

Interest Paid

(733)

(774)

41

Taxation Paid

(1,562)

(1,118)

(444)

 

 

 

 

Net Cash Inflow from Operating Activities

4,799

2,969

1,830

 

 

 

 

Net Cash Inflow before Financing Activities

4,514

2,312

2,202

 

 

 

 

Net Cash Outflow from Financing Activities

(2,203)

(1,765)

(438)

 

The increase in Net Cash Inflow from Operating Activities in the year reflected an improvement in Reported Operating Profit while C19VAZ contributions increased Net Cash Inflow from Operating Activities by $1,062m in the year; the movement was primarily related to changes in C19VAZ working-capital balances within trade and other payables, trade and other receivables and inventories. The reduction in Interest Paid was partly a result of a decline on interest paid on bonds, while the increase in Taxation Paid was a reflection of the growth in Reported Profit Before Tax and the phasing of tax payments.

 

The increase in Net Cash Inflow before Financing Activities was a result of the aforementioned improvement in Net Cash Inflow from Operating Activities, as well as a $1,363m increase in the Disposal of Non-Current Asset Investments to $1,381m. AstraZeneca sold part of its equity portfolio in the year, a large proportion of which related to the disposal of its full holding in Moderna Therapeutics, Inc. All related gains were accounted through Other Comprehensive Income.

 

Recorded within the Purchase of Intangible Assets, AstraZeneca made the second of two $675m upfront payments to Daiichi Sankyo, as part of the 2019 agreement on Enhertu. The first of three non-contingent payments were also made to Daiichi Sankyo in respect of the potential new Oncology medicine, datopotamab deruxtecan; the payment amounted to $350m.

 

Under the terms of a past agreement to acquire Pearl Therapeutics Inc., the Company made a $150m milestone payment in the year upon the US regulatory approval of Breztri for the treatment of COPD. This was the final development and regulatory milestone under that agreement. The cash payment of contingent consideration, in respect of the former BMS share of the global diabetes alliance, amounted to $546m in the year.

 

Capital Expenditure

Capital Expenditure amounted to $961m in the year, compared to $979m in FY 2019. 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 a number of limited-sized projects.

 

Table 23 : Net Debt summary

 

 

At 31 Dec 2020

At 31 Dec 2019

$m

$m

Cash and cash equivalents

7,832

5,369

Other investments

160

911

 

 

 

Cash and investments

7,992

6,280

 

 

 

Overdrafts and short-term borrowings

(658)

(225)

Lease liabilities

(681)

(675)

Current instalments of loans

(1,536)

(1,597)

Non-current instalments of loans

(17,505)

(15,730)

 

 

 

Interest-bearing loans and borrowings

(Gross Debt)

(20,380)

(18,227)

 

 

 

Net derivatives

278

43

Net Debt

(12,110)

(11,904)

 

Net Debt of $12,110m represented an increase of $206m in the year. EBITDA increased by 24% in the year (27% at CER) to $8,311m.

 

Details of the committed undrawn bank facilities are disclosed within the going-concern section of Note 1.

 

In the year, 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 24 : Currency sensitivities

The Company provides the following currency-sensitivity information:

 

 

Average Exchange

Rates versus USD

 

Annual Impact of 5% Strengthening in Exchange Rate versus USD ($m) [48]

Currency

Primary Relevance

FY 2020 [49]

YTD 2021 [50]

% change

Product Sales

Core Operating Profit

CNY

Product Sales

6.90

6.47

6

312

186

EUR

Product Sales

0.88

0.82

6

189

58

JPY

Product Sales

106.74

103.70

3

140

91

Other[51]

 

 

 

 

239

108

 

 

 

 

 

 

 

GBP

Operating Expense

0.78

0.73

6

31

(84)

SEK

Operating Expense

9.20

8.29

10

5

(59)

 

 

Sustainability

 

AstraZeneca's sustainability approach has three priority areas[52], 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:

 

During the period, the Company received recognition of its broad sustainability efforts, featuring in the top five for the sector in the DJSI and included in Corporate Knights Global 100 Index, which identifies globally sustainable companies.

 

a)  Access to healthcare

In December 2020, AstraZeneca, through an advanced purchase agreement with Gavi, the Vaccines Alliance, committed to enabling access to 170m doses of C19VAZ in up to 190 countries worldwide through COVAX, a coalition co-led by CEPI, the Coalition for Epidemic Preparedness Innovations, Gavi, and the WHO. It is the only global initiative working with governments and manufacturers to ensure that safe and effective COVID-19 vaccines are available worldwide to both higher-income and lower-income countries. Furthermore, through additional doses announced by licensing partner Serum Institute of India Pvt. Ltd., hundreds of millions of doses of C19VAZ are anticipated to be available via COVAX. At a press conference held to announce the news, Pascal Soriot spoke on the importance of broad, equitable access alongside global leaders, including WHO Director Dr Tedros Adhanom Ghebreyesus, Canadian Minister for International Development, the Rt. Hon. Karina Gould, and UNICEF Executive Director Henrietta Fore, as well as COVAX and industry leadership.

 

AstraZeneca is committed to working with its global manufacturing network to build global vaccine capacity to around three billion doses, pending regulatory approvals. C19VAZ can be stored, transported and handled at normal refrigerated conditions (two to eight degrees Celsius, 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.

 

In November 2020, the Company launched The Partnership for Health System Sustainability and Resilience 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. Part of the WEF's Great Reset initiative, the partnership will bring together a coalition of leading healthcare-system experts in eight countries initially to test, perfect and apply a Framework for Healthcare System Resilience and Sustainability, developed by the LSE. The pilot countries are Germany, France, the UK, Italy, Spain, Vietnam, Russia and Poland. Speaking about the programme at the WEF Davos Agenda event in January 2020, Pascal Soriot emphasised the importance of building crisis-resistant healthcare systems to recover from the pandemic and protect against future shocks.

 

In January 2021, AstraZeneca was recognised in the 2021 Access to Medicines Index, rising two places to rank seventh among peers. The accompanying report highlighted the Company's continued progress, including strengths in access-related governance, compliance and healthcare-system development.

 

During the period, the AstraZeneca Young Health Programme launched in the UK, focused on young people's mental health. The programme will operate in four locations over the next five years and uses youth-centred design, working together with young people, to focus on tackling their urgent mental-health needs and realise their right to good health and wellbeing. Over the five years, the programme will work with over 130,000 young people aged between 10-24 and will initially launch in Manchester, UK.

 

b)  Environmental protection

During the period, AstraZeneca was recognised for its leadership in sustainability by global environmental non-profit CDP. The Company received a place on the 'A List' for both climate action and water security. AstraZeneca was one of only three organisations worldwide to achieve this double A-List recognition for five consecutive years. The Company also featured among the top 7% on CDP's 2020 Supplier Engagement Leaderboard, recognising progress in working with suppliers to address their emissions and driving science-based climate action across AstraZeneca's value chain.

 

Pascal Soriot was listed as an official supporter of the His Royal Highness The Prince of Wales's 'Terra Carta', a ten-point strategy for business to move towards a sustainable future by 2030. Launched at the One Planet Summit in Paris, AstraZeneca will be one of the founding partners looking to put nature, people and planet at the heart of global-value creation.

 

In partnership with government and local non-governmental organisations, AstraZeneca launched the AZ Forest programme in Indonesia, a commitment to support a healthy environment and improve socio-economic development and livelihoods for Indonesians by planting 20 million trees in the country over the next five years. This commitment is part of the global AZ Forest programme, announced at the WEF in January 2020, pledging the plantation of 50 million trees by 2025, in collaboration with One Tree Planted, a non-profit organisation focused on global reforestation. The initiative supports the WEF's '1T.org - The Champions for a Trillion Trees' platform.

 

c)  Ethics and transparency

In January 2021, the Company was recognised for its efforts in promoting inclusion and diversity by the BGEI, which tracks the performance of public companies committed to disclosing their efforts to support gender equality through policy development, representation and transparency. The Company was also listed as a participant in ShareAction's WDI, an annual survey that aims to improve corporate transparency and accountability on workforce issues and provide companies and investors with comprehensive and comparable data to help increase the provision of good jobs worldwide.

 

During the period, AstraZeneca was named as a founding partner to the WEF Partnering for Racial Justice in Business Coalition, joining forces with 47 companies across 13 industries to eradicate racism in the workplace. The Company also held its first Power of Diversity week, an initiative to support all employees with the tools and knowledge needed to create a truly inclusive culture.

 

As part of AstraZeneca's ongoing efforts to make sustainability data transparent and accessible, a new analyst interactive reporting (AIR) centre was launched on the Company's website. AIR provides sustainability data from 2015 onwards, covering global information from key performance indicators for Access to healthcare, Environmental protection and Ethics and transparency.

 

 

 

For more details on AstraZeneca's sustainability ambition, approach and targets, please refer to the latest Sustainability Report 2019 and Sustainability Data Summary 2019. Additional information is available at astrazeneca.com/sustainability.

 

 

 

Research and development

 

As the COVID-19 pandemic persists, the Company will continue to evaluate impacts on the initiation of clinical trials, ongoing recruitment and follow-ups. It is prudent to assume that some delays will arise as a consequence of the pandemic.

 

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/investors. Highlights of developments in the Company's late-stage pipeline since the prior results announcement are shown below:

 

Table 25: Late-stage pipeline

 

New molecular entities and major lifecycle events for medicines in Phase III trials or under regulatory review

22

Oncology

 

Tagrisso - NSCLC

Imfinzi - multiple cancers

Lynparza - multiple cancers

Enhertu - multiple cancers

Calquence - blood cancers

-  tremelimumab - multiple cancers

-  savolitinib - NSCLC[53]

-  capivasertib - breast, prostate cancer

-  monalizumab - head & neck cancer

-  camizestrant (AZD9833) - breast cancer

-  datopotamab deruxtecan - lung cancer

 

CVRM

 

Farxiga - multiple indications

-  roxadustat - anaemia in CKD

 

Respiratory & Immunology

 

Fasenra - multiple indications

Breztri - asthma

-  tezepelumab - severe asthma

-  PT027 - asthma

-  anifrolumab - lupus (SLE)

-  brazikumab - inflammatory bowel disease

-  nirsevimab - RSV

 

COVID-19

 

C19VAZ - SARS-CoV-2

-  AZD7442 - SARS-CoV-2

 

 

Total projects

in clinical development

145

 

Total projects

in total pipeline

171

 

 

 

Oncology

 

The Company presented data at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition in November 2020 , the San Antonio Breast Cancer Symposium (SABCS) in December 2020 and the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC), hosted by the IASLC in January 2021. The data covered the haematology, breast and lung cancer pipelines. Key data at the ASH meeting included 27 abstracts spanning five medicines and potential new medicines, and eight different haematology conditions, including Calquence, MEDI2228 (BCMA ADC) and AZD4320 (dual Bcl-2/xL inhibitor).

 

Highlights from the SABCS symposium included updates to Enhertu in the DESTINY-Breast01 Phase II trial and camizestrant (AZD9833) (oral selective oestrogen receptor degrader) in the SERENA-1 Phase I trial. Key data at the IASLC 2020 WCLC included updated datopotamab deruxtecan Phase I data and new data from the Enhertu DESTINY-Lung01 Phase II trial, both in metastatic NSCLC.

 

a)  Tagrisso

During the period, Tagrisso was approved in the US for the adjuvant treatment of adult patients with early-stage EGFRm NSCLC after tumour resection with curative intent, following the ADAURA Phase III trial. The approval was granted under the US FDA Real-Time Oncology Review pilot programme. Five other countries participated in a concurrent submission and review process through the FDA's Project Orbis.

 

Table 26 : Key Tagrisso Phase III trials

 

Trial

Population

Design

Timeline

Status

NeoADAURA

Neo-adjuvant

 EGFRm

NSCLC

Placebo or

Tagrisso

FPCD[54]

Q1 2021

 

First data anticipated

2022+

Recruitment

ongoing

ADAURA

Adjuvant EGFRm NSCLC

Placebo or Tagrisso

FPCD

Q4 2015

 

LPCD[55]

Q1 2019

Trial unblinded early due to overwhelming efficacy

 

Regulatory approval (US)

LAURA

Locally advanced, unresectable EGFRm NSCLC

Placebo or

Tagrisso

FPCD

Q4 2018

 

First data anticipated

2022+

Recruitment

ongoing

FLAURA2

1st-line EGFRm NSCLC

Tagrisso or

Tagrisso + platinum-based chemotherapy doublet

FPCD

Q4 2019

 

First data anticipated

2022+

Recruitment ongoing

 

b)  Imfinzi

In November 2020, Imfinzi was approved by the US FDA for an additional dosing option, a 1,500mg fixed dose every four weeks in the approved indications of unresectable, Stage III NSCLC after CRT and previously treated advanced bladder cancer. This new option is consistent with the approved Imfinzi dosing in ES-SCLC and will be available to patients weighing more than 30kg as an alternative to the approved weight-based dosing of 10mg/kg every two weeks.

 

During the period, Imfinzi received regulatory approval in the EU for the aforementioned additional dosing option, 1,500mg fixed dose every four weeks, in the approved indication of locally advanced, unresectable Stage III NSCLC in adults whose tumours express PD-L1[56] on at least 1% of tumour cells and whose disease has not progressed following platinum-based CRT.

 

Table 27 : Key Imfinzi Phase III trials in lung cancer

 

Trial

Population

Design

Timeline

Status

AEGEAN

Neo-adjuvant NSCLC

SoC[57] chemotherapy +/- Imfinzi,

followed by

surgery, followed by placebo

or Imfinzi

FPCD

Q1 2019

 

First data anticipated

2022+

Recruitment

ongoing

ADJUVANT BR.31[58]

Stage Ib-IIIa resected NSCLC

Placebo or

Imfinzi

FPCD

Q1 2015

 

LPCD

Q1 2020

 

First data anticipated

2022+

Recruitment

completed

MERMAID-1

Stage II-III

resected NSCLC

SoC chemotherapy +/- Imfinzi

FPCD
Q3 2020

 

First data anticipated

2022+

Recruitment
ongoing

MERMAID-2

Stage II-III

NSCLC with minimal residual disease

Placebo or

Imfinzi

FPCD
Q4 2020

First data anticipated
2022+

Recruitment ongoing

PACIFIC-2

Stage III unresectable locally advanced NSCLC

(concurrent CRT)

Placebo or

Imfinzi

FPCD

Q2 2018

 

LPCD

Q3 2019

 

First data anticipated

H1 2021

Recruitment

completed

ADRIATIC

LS-SCLC

Concurrent CRT,

followed by

placebo or

Imfinzi or

Imfinzi + treme

FPCD

Q4 2018

 

First data anticipated

2022

Recruitment

ongoing

PEARL

Stage IV, 1st-line NSCLC

SoC chemotherapy or Imfinzi

FPCD

Q1 2017

 

LPCD

Q1 2019

 

First data anticipated

2022

Recruitment

completed

POSEIDON

Stage IV, 1st-line NSCLC

SoC chemotherapy or SoC + Imfinzi or SoC + Imfinzi + treme

FPCD

Q2 2017

 

LPCD

Q4 2018

 

OS data anticipated

H1 2021

PFS[59] primary endpoint met

CASPIAN

ES-SCLC

SoC chemotherapy or SoC + Imfinzi or SoC + Imfinzi + treme

FPCD

Q1 2017

 

LPCD

Q2 2018

OS primary endpoint met for Imfinzi

 

OS primary endpoint not met for Imfinzi + treme

 

Regulatory approval

 

Table 28 : Key Imfinzi Phase III trials in tumour types other than lung cancer

 

Trial

Population

Design

Timeline

Status

POTOMAC

Non-muscle invasive bladder cancer

SoC BCG[60] or SoC BCG + Imfinzi

FPCD

Q4 2018

LPCD
Q3 2020

 

First data

anticipated

2022+

Recruitment
completed

NIAGARA

Muscle-invasive bladder cancer

Neo-adjuvant cisplatin and gemcitabine SoC chemotherapy or SoC + Imfinzi, followed by adjuvant placebo or Imfinzi

FPCD

Q4 2018

 

First data

anticipated

2022+

Recruitment ongoing

EMERALD-1

Locoregional HCC[61]

TACE[62] followed by placebo or

TACE + Imfinzi, followed by Imfinzi + bevacizumab or

TACE + Imfinzi

followed by Imfinzi

FPCD

Q1 2019

 

First data

anticipated

2022

Recruitment ongoing

EMERALD-2

Locoregional HCC at high risk of recurrence after surgery or radiofrequency ablation

Adjuvant Imfinzi or Imfinzi + bevacizumab

FPCD

Q2 2019

 

First data anticipated

2022+

Recruitment ongoing

CALLA

Locally advanced cervical cancer

CRT or CRT + Imfinzi, followed by placebo or Imfinzi

FPCD

Q1 2019


LPCD
Q4 2020
 

First data anticipated

2022+

Recruitment completed

MATTERHORN

Resectable gastric and gastroesophageal cancer

Neoadjuvant Imfinzi + FLOT chemotherapy +/- adjuvant Imfinzi

FPCD
Q4 2020

First data anticipated
2022+

Recruitment ongoing

KUNLUN
 

Locally advanced, unresectable oesophageal squamous cell carcinoma

Definitive CRT or CRT + Imfinzi

FPCD
Q4 2020

First data anticipated
2022+

Recruitment
ongoing

NILE

Stage IV, 1st-line cisplatin chemotherapy- eligible bladder cancer

SoC chemotherapy or SoC + Imfinzi or SoC + Imfinzi + treme

FPCD

Q4 2018

 

First data anticipated

2022+

Recruitment

ongoing

KESTREL

Stage IV, 1st-line HNSCC[63]

SoC or Imfinzi or Imfinzi + treme

FPCD

Q4 2015

 

LPCD

Q1 2017

Primary endpoint not met

HIMALAYA

Stage IV, 1st-line unresectable HCC

Sorafenib or Imfinzi or Imfinzi + treme

FPCD

Q4 2017

 

LPCD

Q4 2019

 

First data

anticipated

H2 2021

Recruitment

completed

 

Orphan Drug Designation[64] (US)

TOPAZ-1

Stage IV, 1st-line biliary-tract cancer

Gemcitabine and cisplatin SoC chemotherapy or SoC + Imfinzi

FPCD

Q2 2019

 

First data anticipated

2022

Recruitment ongoing

 

c)  Lynparza (multiple cancers)

During the period, Lynparza received regulatory approval in the EU and Japan for the additional indications of 1st-line maintenance treatment with bevacizumab for patients with HRD+ advanced ovarian cancer and patients with metastatic castration-resistant prostate cancer with mutations, a subpopulation of homologous recombination repair gene mutations (HRRm). Lynparza also received regulatory approval in Japan as a maintenance treatment, after platinum-based chemotherapy for patients with BRCAm unresectable pancreatic cancer, based on positive results from the POLO Phase III trial.

 

Table 29 : Key Lynparza Phase III trials

 

Trial

Population

Design

Timeline

Status

OlympiA

Adjuvant BRCAm breast cancer

SoC placebo or Lynparza

FPCD

Q2 2014

 

LPCD

Q2 2019

 

First data anticipated

H1 2021

Recruitment completed

 

PROfound

Metastatic castration-resistant 2nd-line+ HRRm

prostate cancer

SoC (abiraterone or enzalutamide) or Lynparza

FPCD

Q2 2017

 

LPCD

Q4 2018

Primary endpoint met

 

Regulatory approval

PAOLA-1[65]

Advanced 1st-line

ovarian cancer

Bevacizumab maintenance or

bevacizumab +

Lynparza maintenance

FPCD

Q2 2015

 

LPCD

Q2 2018

Primary endpoint met

 

Regulatory approval

DuO-O

Advanced 1st-line

ovarian cancer

Chemotherapy +

bevacizumab or

chemotherapy +

bevacizumab +

Imfinzi +/-

Lynparza maintenance

FPCD

Q1 2019

 

First data

anticipated

2022+

Recruitment

ongoing

DuO-E

Advanced 1st-line

endometrial cancer

Chemotherapy

or

chemotherapy +

Imfinzi + Imfinzi maintenance or

chemotherapy +

Imfinzi followed by Imfinzi + Lynparza maintenance

FPCD

Q2 2020

 

First data

anticipated

2022+

Recruitment

ongoing

PROpel

Stage IV, advanced, castration-resistant prostate cancer

Abiraterone or

abiraterone +

Lynparza

FPCD

Q4 2018

 

First data

anticipated

H2 2021

Recruitment ongoing

LYNK-003

Stage IV, 1st-line colorectal cancer

Bevacizumab + 5-FU[66] maintenance or bevacizumab + Lynparza maintenance or Lynparza maintenance

First data

anticipated

2022+

Initiating

 

d)  Enhertu (breast and other cancers)

In January 2021, Enhertu was approved by the US FDA for the treatment of adult patients for 2nd line HER2+ gastric cancer. The approval was based on the positive results from the randomised DESTINY-Gastric01 Phase II trial.

 

During the period, AstraZeneca announced that Enhertu had received regulatory approval in the EU as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2+ cancer who have received two or more prior anti-HER2 based regimens. The approval was based on positive results from the single-arm DESTINY-Breast01 Phase II trial.

 

Updated data were presented during the period, in a Spotlight Poster Discussion at the aforementioned SABCS symposium, from the Enhertu DESTINY-Breast01 Phase II trial in patients with HER+ metastatic breast cancer, following two or more prior HER2-based regimens. With a median duration of follow-up of 20.5 months, patients treated with Enhertu (5.4mg/kg) achieved an objective response rate of 61.4% and a median duration of response of 20.8 months; the median PFS was 19.4 months. In an exploratory landmark analysis of OS, evaluated at 35% maturity, an estimated 74% of patients remained alive at 18 months.

 

At the aforementioned IASLC 2020 WCLC, data were presented from the DESTINY-Lung01 Phase II trial, highlighting the potential of Enhertu in HER2-expressing metastatic NSCLC and in metastatic HER2-mutant (HER2m) NSCLC. These are two groups of patients for whom no HER2-directed medicine is currently approved.

 

Table 30 : Key Enhertu trials

 

Trial

Population

Design

Timeline

Status

DESTINY-Breast01-U201

 

Phase II

Stage IV, HER2+[67] breast cancer post trastuzumab emtansine

Enhertu

FPCD

Q4 2017

 

LPCD

Q4 2018

Primary objective met

 

Breakthrough Therapy Designation[68] (US)

 

Regulatory approval (US, EU, JP)

DESTINY-Breast02-U301

 

Phase III

Stage IV, HER2+ breast cancer post trastuzumab emtansine

SoC chemotherapy or Enhertu

FPCD

Q4 2018

 

LPCD
Q4 2020

 

First data anticipated

H2 2021

 Recruitment completed

DESTINY-Breast03-U302

 

Phase III

Stage IV, HER2+ breast cancer

Trastuzumab emtansine or Enhertu

FPCD

Q4 2018

LPCD
Q2 2020

 

First data anticipated

H2 2021

Recruitment completed

DESTINY-Breast04

 

Phase III

Stage IV, HER2-low breast cancer

SoC chemotherapy or Enhertu

FPCD

Q4 2018

 

LPCD
Q4 2020

 

First data anticipated

H2 2021

 Recruitment completed

 

DESTINY-Breast06

 

Phase III

Stage IV, HER2-low breast cancer post endocrine therapy

SoC chemotherapy or Enhertu

FPCD
Q3 2020

 

First data

anticipated

2022+

Recruitment ongoing

DESTINY-Gastric01

 

Phase II

Stage IV, HER2+ gastric cancer

SoC chemotherapy or Enhertu

FPCD

Q4 2017

 

LPCD

Q2 2019

Primary endpoint met

 

Breakthrough Therapy Designation

(US)

 

Regulatory approval (US, JP)

DESTINY-PanTumour02

 

Phase II

HER2-expressing tumours

Enhertu

FPCD

Q3 2020

First data

anticipated

2022+

Recruitment ongoing

DESTINY-

PanTumour01

 

Phase II

HER2m

tumours

Enhertu

FPCD
Q1 2021

First data

anticipated

2022+

Recruitment ongoing

 

e)  Calquence

During the period, Calquence was approved in the EU for the treatment of adult patients with CLL, and in Japan for R/R CLL, the most common type of leukaemia in adults.

 

Positive high-level results from the ELEVATE-RR Phase III trial, published during the period, showed Calquence met the primary endpoint demonstrating non-inferior PFS for adults with previously treated, high-risk CLL, compared to ibrutinib. The trial also met a key secondary endpoint for safety, showing patients treated with Calquence had statistically significantly lower incidence of atrial fibrillation, compared to patients treated with ibrutinib. Overall, the safety and tolerability of Calquence were consistent with the profile seen in the broader Calquence clinical-development programme.

 

At the aforementioned ASH meeting, a pooled analysis of CV safety data for patients treated with Calquence for CLL, across four clinical trials, showed a low incidence of cardiac adverse events (AEs), leading to discontinuation. The analysis included patients with previously untreated and R/R CLL treated with Calquence alone from the ELEVATE-TN and ASCEND Phase III trials, as well as the 15-H-0016 Phase II trial and ACE-CL-001 Phase I/II trial. In the analysis, 129 patients (17%) reported a cardiac AE of any grade at a median follow up of 25.9 months, and seven patients (0.9%) discontinued treatment due to cardiac AEs.

 

At the same meeting, long-term follow-up results from the positive ACE-LY-004 Phase II trial were also presented. Data showed patients with R/R MCL treated with Calquence remained progression-free for a median of 22 months, with median OS not yet reached at three years of follow-up. The safety and tolerability profile remained consistent.

 

f)  Datopotamab deruxtecan

At the aforementioned IASLC 2020 WCLC, updated data were presented from the TROPION-PanTumor01 Phase I trial of datopotamab deruxtecan in metastatic NSCLC, supporting its potential to redefine treatment outcomes in advanced NSCLC.

 

Table 31: Datopotamab deruxtecan

 

Trial

Population

Design

Timeline

Status

TROPION-LUNG01

 

Phase III

Stage IV, NSCLC

SoC chemotherapy or datopotamab deruxtecan

First data anticipated

2022+

Initiating

 

 

CVRM

 

a)  Farxiga (HF, CKD)

In November 2020, Forxiga was approved in the EU and Japan and China for the treatment of symptomatic chronic HFrEF in adults with and without T2D. The approvals were based on results from the DAPA-HF Phase III trial where Farxiga, on top of SoC, reduced the composite of cardiovascular death or worsening of heart failure by 26%. Farxiga was approved in the US for the same indication in May 2020.

 

During the period, Forxiga received regulatory submission acceptance in the EU and China for the treatment of CKD. The submissions were based on results from the DAPA-CKD Phase III trial where Farxiga, on top of SoC, reduced the composite measure of worsening of renal function or risk of CV or renal death by 39%, compared to placebo in patients with CKD stages 2-4 and elevated urinary albumin excretion. In January 2021, Farxiga was accepted for regulatory review and granted priority review in Japan and the US. The Prescription Drug User Fee Action date, the day the US FDA targets for regulatory decision, is anticipated to be during the second quarter of 2021.

 

b)  Brilinta (stroke)

In November 2020, the Company received US FDA approval for Brilinta to reduce the risk of stroke in patients with an acute ischaemic stoke or high-risk transient ischaemic attack. The approval was based on results from the THALES Phase III trial.

 

Table 32 : Key large CVRM Phase III outcomes trials

 

Trial

Population

Design

Primary endpoint(s)

Timeline

Status

Farxiga

 

DAPA-HF

c.4,500 patients with HFrEF, with and without T2D

SoC + placebo or SoC + Farxiga 10mg or 5mg QD[69]

Time to first occurrence of CV death or hospitalisation due to HF or

an urgent HF visit

FPCD

Q1 2017

 

LPCD

Q4 2018

Primary endpoint met

 

Regulatory approval

DELIVER

c.4,700 patients with HF (HFpEF) with and without T2D

Placebo

or Farxiga 10mg QD

Time to first occurrence of CV death or worsening HF

FPCD

Q4 2018

 

First data anticipated
H2 2021

Recruitment ongoing

 

Fast Track[70] designation (US)

DAPA-CKD

c.4,000 patients with CKD, with and without T2D

Placebo or Farxiga 10mg or 5mg QD

Time to first occurrence of ≥ 50% sustained decline in eGFR or reaching ESRD or CV death or renal death

FPCD

Q1 2017

 

LPCD

Q1 2020

Trial stopped early based on recommendation from an IDMC[71]

 

Primary endpoint and secondary endpoints met

 

Fast Track designation (US)

DAPA-MI

c.6,400 patients with confirmed MI, either STEMI or NSTEMI, within the preceding 7 days

Placebo or Farxiga 10mg QD

Time to the first occurrence of any of the components of this composite: hospitalisation for HF or CV death

FPCD

Q4 2020

First data anticipated
2022+

Recruitment ongoing

Brilinta

 

THEMIS

c.19,000 patients with T2D and CAD without a history of MI or stroke

Aspirin plus placebo or aspirin plus Brilinta 60mg BID[72]

Composite of CV death, non-fatal MI and non-fatal stroke

FPCD

Q1 2014

 

LPCD

Q2 2016

Primary endpoint met

 

Regulatory approval (US)

THALES

c.11,000 patients with acute ischaemic stroke[73] or transient ischaemic attack

Aspirin plus placebo or aspirin plus Brilinta 90mg BID

Prevention of the composite of subsequent stroke and death at 30 days

FPCD

Q1 2018

 

LPCD

Q4 2019

Primary endpoint met

 

Regulatory approval (US)

 

c)  Lokelma (hyperkalaemia)

In November 2020, the China National Medical Products Administration (NMPA) approved a dosing-label update for Lokelma to include patients with hyperkalaemia on chronic haemodialysis. The approval was based on results from the DIALIZE Phase IIIb trial, the first-ever randomised, placebo-controlled trial to evaluate a potassium binder in patients on stable haemodialysis. The trial showed sustained potassium control pre-dialysis for patients receiving Lokelma, compared with placebo. In December 2019, the NMPA approved Lokelma to treat adult patients with hyperkalaemia.

 

d)  Roxadustat (anaemia)

In December 2020, the US FDA requested further clarifying analyses to complete its New Drug Application (NDA) review for roxadustat. AstraZeneca and FibroGen submitted the analyses before the end of the year, to assist with the completion of labelling discussions. The NDA remains under regulatory review, and the US FDA has set a new action date of 20 March 2021.

 

In November 2020, the Company and FibroGen presented new data on roxadustat at the aforementioned ASH meeting. The multiple trials evaluated the clinical effectiveness and safety profile of roxadustat in both the dialysis-dependent and non-dialysis dependent anaemia of CKD patient populations. Data were also presented assessing the medicine's efficacy in anaemia associated with lower-risk MDS, regardless of baseline factors; in approximately one in three patients, MDS leads to acute myeloid leukaemia.

 

 

Respiratory & Immunology

 

a)  Symbicort (mild asthma)

In January 2021, AstraZeneca's Symbicort Turbuhaler (budesonide/formoterol 160/4.5mcg) was approved in China as an anti-inflammatory reliever to be taken as needed in response to symptoms to achieve asthma control in patients with mild asthma aged 12 years and older. This new indication for Symbicort aligned to the latest National Asthma Guidelines from the Chinese Thoracic Society, updated in Q4 2020, which recommended a low dose corticosteroid-formoterol combination therapy, taken as-needed, as the preferred reliever therapy in mild asthma.

 

b)  Breztri (COPD)

During the period, Breztri, under the name Trixeo, received regulatory approval in the EU, following the receipt in Q3 2020 of a positive opinion from the EMA's Committee for Medicinal Products for Human Use. Trixeo is indicated for the maintenance treatment in adult patients with moderate to severe chronic COPD who are not adequately treated by a combination of an ICS and a LABA, or a combination of a LABA and a long-acting muscarinic antagonist.

 

c)  Fasenra (eosinophil-driven diseases)

 

Table 33 : Key Fasenra lifecycle management Phase III trials

 

Trial

Population

Design

Primary endpoint(s)

Timeline

Status

OSTRO

 

Patients aged 18-75 years with severe bilateral nasal polyps; symptomatic, despite SoC

Placebo or Fasenra 30mg Q8W[74] SC[75]

Nasal-polyps burden and reported nasal blockage

FPCD

Q1 2018

 

LPCD

Q2 2019

Co-primary endpoints met

RESOLUTE

Patients with moderate to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils

Placebo or Fasenra 100mg Q8W SC

Annualised rate of moderate or severe COPD exacerbations

FPCD

Q4 2019

 

Data anticipated 2022+

Recruitment ongoing

MANDARA

Eosinophilic granulomatosis with polyangiitis[76]

Mepolizumab 3x100mg Q4W or Fasenra 30mg

Proportion of patients who achieve remission, defined as a score[77] =0 and an OCS dose ≤4 mg/day at weeks 36 and 48

FPCD

Q4 2019

 

Data anticipated

2022+

Recruitment ongoing

 

Orphan Drug Designation (US)

NATRON

HES[78]

Placebo or Fasenra 30mg Q4W SC

Time to HES worsening flare or any cytotoxic and/or immuno-suppressive therapy increase or hospitalisation

FPCD

Q3 2020

 

Data anticipated 2022

Recruitment ongoing

 

Orphan Drug Designation (US)

MESSINA

Eosinophilic oesophagitis[79]

Placebo or Fasenra 30mg Q4W SC

Proportion of patients with a histologic response[80]

 

Changes from baseline in dysphagia[81] PRO[82]

FPCD

Q4 2020

 

Data anticipated 2022

Recruitment ongoing

 

Orphan Drug Designation (US)

FJORD

BP[83]

Placebo or Fasenra 30mg Q4W SC

Proportion of patients with partial or

complete remission of BP whilst off OCS for ≥2 months

at Week 36

 

Data anticipated 2022+

Recruitment ongoing

 

d)  Anifrolumab (lupus: SLE)

During the period, a new analysis of the TULIP Phase III clinical-trial programme showed that treatment with anifrolumab resulted in a greater reduction in disease flares while having a sustained reduction in doses of OCS compared to placebo, with both groups of patients receiving SoC. The data were presented in November 2020 at ACR Convergence 2020, the annual meeting of the American College of Rheumatology.

 

The new pooled analysis showed that 40% of patients treated with anifrolumab, plus SoC, had a sustained reduction in OCS use without experiencing a disease flare through 52 weeks (versus 17.3% in placebo plus SoC). Treatment with anifrolumab was associated with lower overall flare rates compared to placebo, and also on the skin and in the mouth (mucocutaneous), as well as in joints (musculoskeletal), the two organ domains most frequently affected at the start of the trial.

 

During the period, the Company completed a regulatory submission for anifrolumab to the Japanese Pharmaceuticals and Medical Devices Agency for the treatment of adult patients with moderate to severe SLE. The submission was based on results from the two TULIP Phase III trials and the MUSE Phase II trial, in which a reduction in disease activity and OCS use, and improvement in lupus skin activity, were observed with anifrolumab added to SoC, compared to placebo and SoC. A regulatory decision is expected in the second half of 2021. Anifrolumab is also currently under regulatory review in the US, in the EU and in other countries.

 

e)  Tezepelumab (severe asthma)

During the period, AstraZeneca, along with its collaborator Amgen Inc., announced positive results from the NAVIGATOR Phase III trial for the potential new medicine tezepelumab in patients with severe, uncontrolled asthma.

 

NAVIGATOR met the primary endpoint with tezepelumab added to SoC, demonstrating a statistically significant and clinically meaningful reduction in the annualised asthma exacerbation rate (AAER) over 52 weeks in the overall patient population, compared to placebo when added to SoC, namely medium- or high- ICS plus at least one additional controller medication with or without OCS.

 

In a subgroup of patients, with baseline eosinophil counts of less than 300 cells per microlitre, the trial also met the primary endpoint, with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER. Similar reductions in AAER were observed in a subgroup of patients with baseline eosinophil counts of less than 150 cells per microlitre. Tezepelumab was very well tolerated in patients with severe asthma. Preliminary analyses showed no clinically meaningful differences in safety results between the tezepelumab and placebo groups.

 

High-level results from the SOURCE Phase III trial also became available, which assessed the efficacy and safety of tezepelumab compared to placebo in 150 severe asthma patients who required maintenance use of OCS on top of SoC. The 48-week trial, which is not required for regulatory submission, did not meet the primary endpoint of a statistically significant reduction in the daily OCS dose, without loss of asthma control, with tezepelumab compared to placebo. Tezepelumab's effect on other efficacy parameters was similar to those observed in previous trials, including the registrational NAVIGATOR Phase III trial.

 

Results from the NAVIGATOR trial will be presented at this year's American Academy of Allergy Asthma and Immunology Annual Meeting. Data from the SOURCE trial will be presented at a forthcoming medical meeting.

 

Table 34: Key tezepelumab Phase III trials

 

Trial

Population

Design

Primary endpoint(s)

Timeline

Status

NAVIGATOR

Severe asthma

Placebo or tezepelumab 210mg Q4W SC

Annual asthma exacerbation rate

FPCD

Q1 2018

 

LPCD

Q3 2019

Primary endpoint met

 

Breakthrough Therapy Designation

(US)

 

f)  PT027 (asthma)

PT027 is a budesonide/albuterol metered-dose inhaler, a potential new medicine for the treatment of asthma as an anti-inflammatory reliever in development in collaboration with Avillion LLP. During the period, the TYREE Phase III trial achieved its primary endpoint. TYREE is a 60 patient, multicentre, randomised, double-blind, single-dose, two-period, crossover trial to evaluate the efficacy and safety of PT027 160/180mcg versus placebo on exercise-induced bronchoconstriction in adult and adolescent patients with asthma. In the trial, PT027 demonstrated superiority over placebo for the primary endpoint of the maximum percentage fall from post-dose, pre-exercise baseline in forced expiratory volume in one second observed up to 60 minutes, post-exercise challenge.

 

Results from the MANDALA and DENALI Phase III trials, intended for regulatory submission in asthma, are anticipated in the second half of 2021.

 

g)  Nirsevimab (RSV)

In January 2021, the China Center for Drug Evaluation (CDE) under the NMPA granted Breakthrough Therapy Designation for nirsevimab, an extended half-life monoclonal antibody being in development as a passive immunisation for the prevention of lower respiratory-tract infection caused by RSV in all infants. This designation was based on the unmet need for a preventative option against RSV for all infants in China where none currently exists and should help to expedite the regulatory review of nirsevimab, following regulatory submission in the country.

 

 

COVID-19

 

a)  COVID-19 Vaccine AstraZeneca (C19VAZ) (SARS-CoV-2)

During the period, the University of Oxford and AstraZeneca continued to enrol participants into the global clinical trials of the recombinant adenovirus vaccine, C19VAZ. Trials in the UK, Brazil, South Africa and the US are fully recruited and total enrolment across the trials amounts to over 55,000 participants.

 

The results of an interim analysis of the Phase III programme, conducted by the University of Oxford with C19VAZ, were peer-reviewed and published in The Lancet in December 2020, demonstrating that the vaccine is safe and effective at preventing symptomatic COVID-19 and that it protects against severe disease and hospitalisation.

 

In December 2020, the UK MHRA provided authorisation for the emergency supply of C19VAZ for the active immunisation of individuals aged 18 years or older. The authorisation recommended two full doses administered with an interval of between four and 12 weeks. This regimen was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose. Additional data on dosing intervals were included in the Summary of Product Characteristics published by the UK MHRA to coincide with the authorisation.

 

In January 2021, C19VAZ received conditional marketing approval from the EMA. Additional authorisations for emergency use have also been provided by regulatory authorities in a number of individual countries, including Argentina, Mexico and Morocco, and our sub-licensee Serum Institute of India has received emergency use authorisation for supply in India.

 

During the period, the primary analysis, conducted by the University of Oxford, of late-stage clinical trials in the UK, Brazil and South Africa was published as a preprint in The Lancet confirming C19VAZ is safe and effective at preventing COVID-19, with no severe cases and no hospitalisations, more than 22 days after the first dose. The results demonstrated vaccine efficacy of 76% (CI 0.59-0.86) after a first dose, with protection maintained to the second dose. With an inter-dose interval of 12 weeks or more, vaccine efficacy increased to 82% (CI 0.63-0.92).

 

In February 2021, the WHO's SAGE recommended two doses of C19VAZ, in individuals aged 18 years and above, including individuals aged 65 and over. The WHO noted that the manufacturer's labelled dosing interval is four to 12 weeks and recommended an interval of eight to 12 weeks between doses. This dosing regimen was shown in clinical trials to be safe and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose. In addition, the WHO SAGE recommended C19VAZ in countries where new variants, including the South African variant, are prevalent.

 

Data on the efficacy of C19VAZ against new variants of the SARS-CoV-2 virus were also published in preprint during the period, showing that the vaccine remains effective against the B.1.1.7 Kent variant. The University of Oxford, however, subsequently announced that a separate exploratory analysis of the COV005 Phase I/II South Africa trial, to be published in preprint in due course, showed that the vaccine had limited efficacy against mild-moderate disease caused by the B.1.351 South African variant. It was not possible to ascertain efficacy against severe disease and hospitalisation caused by this variant, given that subjects in the trial were predominantly young, healthy adults.

 

In collaboration with the University of Oxford, AstraZeneca is focused on adapting C19VAZ to new disease strains if required and hopes to reduce the time needed to reach production at scale to between six to nine months, by utilising existing clinical data and optimising its established supply chain.

 

Further data continue to accrue across the clinical-trial programme, including efficacy, the effect of different dosing intervals, the impact of new variants of SARS-CoV-2 and the duration of protection offered by C19VAZ; we anticipate these be published in due course. AstraZeneca continues to share data with other regulatory authorities around the world.

 

Table 35: Key C19VAZ trials in COVID-19

 

Trial

Population

Design

Timeline

Status

COV001[84]

(UK)

 

Phase I/II

Protection against COVID-19 in participants aged 18-55

MenACWY

or C19VAZ

FPCD

Q2 2020

 

LPCD

Q2 2020

Initial data readout

 

Recruitment completed

 

Regulatory approval (UK, EU)

COV00283

(UK)

 

Phase II/III

Protection against COVID-19 in participants aged 18-55, 55+

MenACWY

or C19VAZ

 

FPCD

Q2 2020

 

LPCD

Q4 2020

Initial data readout

 

Recruitment completed

 

Regulatory approval (UK, EU)

COV003

(Brazil)

 

Phase II/III

Protection against COVID-19 in participants aged 18-55

MenACWY

or C19VAZ

FPCD

Q2 2020

 

LPCD

Q4 2020

Initial data readout

 

Recruitment completed

 

Regulatory approval (UK, EU)

COV005
ChAdOx1 nCoV-19 ZA[85]

(South Africa)

 

Phase I/II

Protection against COVID-19 in participants aged 18-65

HIV+[86] subgroup

Placebo

or C19VAZ

FPCD

Q2 2020

 

LPCD

Q4 2020

 

First data anticipated

H1 2021

 Recruitment completed

D8110C00001

(US, global)

 

Phase III

Protection against

COVID-19 in participants aged 18+

Placebo

or C19VAZ

FPCD

Q3 2020

 

First data anticipated

H1 2021

Recruitment completed

 

b)  AZD7442 (long-acting antibody combination for the prevention and treatment of COVID-19)

AZD7442, a long-acting antibody (LAAB) combination therapy for the prevention and treatment of COVID-19, has advanced into five Phase III clinical trials.

 

The LAAB combination has been engineered with AstraZeneca's proprietary half-life extension technology, which triples the durability of its action compared to conventional antibodies and with a further modification to reduce binding of the Fc (fragment-crystallisable) portion of the antibody to Fc receptors on other cells to reduce the theoretical risk of antibody-dependent enhanced disease.

 

Table36: Key AZD7442 Phase II/III trials in COVID-19

 

Trial

Population

Design

Timeline

Status

PROVENT

Protection against

COVID-19

(prophylaxis)

Placebo

or AZD7442 300mg IM[87]

FPCD

Q4 2020

 

First data anticipated

H2 2021

Recruitment ongoing

STORM CHASER

Protection against

COVID-19

(post-exposure prophylaxis)

Placebo

or AZD7442 300mg IM

FPCD

Q4 2020

 

First data anticipated

H1 2021

Recruitment ongoing

TACKLE

COVID-19 (outpatient treatment)

Placebo

or AZD7442 600mg IM

FPCD

Q1 2021

 

First data anticipated

H1 2021

Recruitment ongoing

ACTIV-2[88]

COVID-19 (outpatient treatment)

Placebo

or AZD7442

FPCD

Q1 2021

Initiating

ACTIV-387

COVID-19 (inpatient

treatment)

Placebo

or AZD7442

FPCD

Q1 2021

Recruitment ongoing

 

c)  Other new and existing medicines in the treatment of COVID-19

During 2020, as well as developing preventative approaches against the SARS-CoV-2 virus, the Company also initiated clinical trials, detailed in the table below, to evaluate AstraZeneca's new and existing medicines to treat the infection, by suppressing the body's overactive immune response or protecting from serious complications, such as organ failure.

 

In November 2020, AstraZeneca announced that the CALAVI Phase II trials for Calquence, in patients hospitalised with respiratory symptoms of COVID-19, did not meet the primary efficacy endpoint. The addition of Calquence to best supportive care did not increase the proportion of patients who remained alive and free of respiratory failure.

 

The Company is continuing to evaluate whether Farxiga can reduce organ failure in COVID-19 in the DARE-19 Phase III trial. Farxiga is also being evaluated, in combination with ambrisentan, in the Cambridge University Hospitals NHS Trust's TACTIC-E Phase II trial. Farxiga is an oral SGLT2 inhibitor, principally used as a treatment for T2D, that has demonstrated benefits in HF and CKD in patients both with and without T2D.

 

AstraZeneca has joined the UK Government's ACCORD proof-of-concept clinical-trial platform, to speed the development of medicines for patients with COVID-19, evaluating the use of IL33 monoclonal antibody medicine MEDI3506 in suppressing the overactive immune response that can characterise COVID-19. The Company is also supplying Pulmicort and Symbicort to externally sponsored research programmes, including the trials detailed in the table below.

 

Table 37: Other key trials in COVID-19[89]

 

Trial

Population

Design

Timeline

Status

Farxiga

DARE-19[90]

 

Phase III

COVID-19

Current SoC

or current SoC +

Farxiga

FPCD

Q2 2020

 

LPCD

Q1 2021

 

First data anticipated

H1 2021

Recruitment completed

TACTIC-E[91]

 

Phase II

COVID-19

Current SoC or current SoC + Farxiga + ambrisentan

FPCD

Q4 2020

 

First data anticipated

H1 2021

Recruitment ongoing

Symbicort

INHASCO[92]

 

Phase IIIa

COVID-19

Current SoC or SoC + Symbicort

FPCD

Q2 2020

 

First data anticipated

H1 2021

Recruitment ongoing

Pulmicort

TACTIC-COVID[93]

 

Phase IIIa

COVID-19

Current SoC or SoC + Pulmicort

FPCD

Q2 2020

 

First data anticipated

H1 2021

Recruitment ongoing

MEDI3506 (IL33 monoclonal antibody)

ACCORD[94]

 

Phase II

COVID-19

Current SoC or current SoC + MEDI3506

FPCD

Q2 2020

 

First data anticipated

H1 2021

Recruitment ongoing

 

 

For more details on the development pipeline, including anticipated timelines for regulatory submission/acceptances, please refer to the latest Clinical Trials Appendix available on astrazeneca.com. For Alexion pipeline updates, please visit alexion.com.

 

 

 

Condensed Financial Statements

 

Table 38: Condensed consolidated statement of comprehensive income - FY 2020

 

For the year ended 31 December

2020

2019

$m

$m

Total Revenue

26,617

24,384

Product Sales

25,890

23,565

Collaboration Revenue

727

819

 

 

 

Cost of Sales

(5,299)

(4,921)

 

 

 

Gross Profit

21,318

19,463

 

 

 

Distribution costs

(399)

(339)

Research and development expense

(5,991)

(6,059)

Selling, general and administrative costs

(11,294)

(11,682)

Other operating income and expense

1,528

1,541

 

 

 

Operating Profit

5,162

2,924

Finance income

87

172

Finance expense

(1,306)

(1,432)

Share of after-tax losses in associates and joint ventures

(27)

(116)

 

 

 

Profit Before Tax

3,916

1,548

Taxation

(772)

(321)

Profit for the period

3,144

1,227

 

 

 

Other comprehensive income

 

 

Items that will not be reclassified to profit or loss

 

 

Remeasurement of the defined benefit pension liability

(168)

(364)

Net gains/(losses) on equity investments measured at fair value through other comprehensive income

938

(28)

Fair value movements related to own credit risk on bonds designated as fair value through profit or loss

(1)

(5)

Tax on items that will not be reclassified to profit or loss

(81)

21

 

688

(376)

Items that may be reclassified subsequently to profit or loss

 

 

Foreign exchange arising on consolidation

443

40

Foreign exchange arising on designated borrowings in net investment hedges

573

(252)

Fair value movements on cash flow hedges

180

(101)

Fair value movements on cash flow hedges transferred to profit or loss

(254)

52

Fair value movements on derivatives designated in net investment hedges

8

35

Gains/(costs) of hedging

9

(47)

Tax on items that may be reclassified subsequently to profit or loss

(39)

38

 

920

(235)

Other comprehensive income/(loss) for the period, net of tax

1,608

(611)

Total comprehensive income for the period

4,752

616

 

 

 

Profit attributable to:

 

 

Owners of the Parent

3,196

1,335

Non-controlling interests

(52)

(108)

 

3,144

1,227

Total comprehensive income attributable to:

 

 

Owners of the Parent

4,804

723

Non-controlling interests

(52)

(107)

 

4,752

616

Basic earnings per $0.25 Ordinary Share

$2.44

$1.03

Diluted earnings per $0.25 Ordinary Share

$2.44

$1.03

 

 

 

Weighted average number of Ordinary Shares in issue (millions)

1,312

1,301

Diluted weighted average number of Ordinary Shares in issue (millions)

1,313

1,301

 

Table39: Condensed consolidated statement of comprehensive income - Q4 2020[95]

 

For the quarter ended 31 December

2020

2019

$m

$m

Total Revenue

7,410

6,664

Product Sales

7,011

6,250

Collaboration Revenue

399

414

 

 

 

Cost of Sales

(1,525)

(1,378)

 

 

 

Gross Profit

5,885

5,286

 

 

 

Distribution costs

(109)

(92)

Research and development expense

(1,719)

(2,091)

Selling, general and administrative costs

(3,210)

(3,026)

Other operating income and expense

640

500

 

 

 

Operating Profit

1,487

577

Finance income

7

39

Finance expense

(321)

(351)

Share of after-tax losses in associates and joint ventures

(6)

(25)

 

 

 

Profit Before Tax

1,167

240

Taxation

(162)

37

Profit for the period

1,005

277

 

 

 

Other comprehensive income

 

 

Items that will not be reclassified to profit or loss

 

 

Remeasurement of the defined benefit pension liability

23

(213)

Net losses on equity investments measured at fair value through other comprehensive income

(36)

108

Fair value movements related to own credit risk on bonds designated as fair value through profit or loss

-

(4)

Tax on items that will not be reclassified to profit or loss

(11)

-

 

(24)

(109)

Items that may be reclassified subsequently to profit or loss

 

 

Foreign exchange arising on consolidation

564

425

Foreign exchange arising on designated borrowings in net investment hedges

428

239

Fair value movements on cash flow hedges

178

55

Fair value movements on cash flow hedges transferred to profit or loss

(139)

(57)

Fair value movements on derivatives designated in net investment hedges

(31)

-

Costs of hedging

(1)

(12)

Tax on items that may be reclassified subsequently to profit or loss

(46)

(24)

 

953

626

Other comprehensive income for the period, net of tax

929

517

Total comprehensive income for the period

1,934

794

 

 

 

Profit attributable to:

 

 

Owners of the Parent

1,012

313

Non-controlling interests

(7)

(36)

 

1,005

277

Total comprehensive income attributable to:

 

 

Owners of the Parent

1,940

830

Non-controlling interests

(6)

(36)

 

1,934

794

Basic earnings per $0.25 Ordinary Share

$0.78

$0.24

Diluted earnings per $0.25 Ordinary Share

$0.78

$0.24

 

 

 

Weighted average number of Ordinary Shares in issue (millions)

1,312

1,312

Diluted weighted average number of Ordinary Shares in issue (millions)

1,313

1,312

 

Table40: Condensed consolidated statement of financial position

 

 

At 31 Dec 2020

At 31 Dec 2019

$m

$m

Assets

 

 

Non-current assets

 

 

Property, plant and equipment

8,251

7,688

Right-of-use assets

666

647

Goodwill

11,845

11,668

Intangible assets

20,947

20,833

Investments in associates and joint ventures

39

58

Other investments

1,108

1,401

Derivative financial instruments

171

61

Other receivables

720

740

Deferred tax assets

3,438

2,718

 

 

 

 

47,185

45,814

 

 

 

Current assets

 

 

Inventories

4,024

3,193

Trade and other receivables

7,022

5,761

Other investments

160

849

Derivative financial instruments

142

36

Income tax receivable

364

285

Cash and cash equivalents

7,832

5,369

Assets held for sale

70

 

19,544

15,563

 

 

 

Total assets

66,729

61,377

 

 

 

Liabilities

 

 

Current liabilities

 

 

Interest-bearing loans and borrowings

(2,194)

(1,822)

Lease liabilities

(192)

(188)

Trade and other payables

(15,785)

(13,987)

Derivative financial instruments

(33)

(36)

Provisions

(976)

(723)

Income tax payable

(1,127)

(1,361)

 

(20,307)

(18,117)

Non-current liabilities

 

 

Interest-bearing loans and borrowings

(17,505)

(15,730)

Lease liabilities

(489)

(487)

Derivative financial instruments

(2)

(18)

Deferred tax liabilities

(2,918)

(2,490)

Retirement benefit obligations

(3,202)

(2,807)

Provisions

(584)

(841)

Other payables

(6,084)

(6,291)

 

(30,784)

(28,664)

Total liabilities

(51,091)

(46,781)

 

 

 

Net assets

15,638

14,596

 

 

 

Equity

 

 

Capital and reserves attributable to equity holders of the Parent

 

 

Share capital

328

328

Share premium account

7,971

7,941

Other reserves

2,024

2,046

Retained earnings

5,299

2,812

 

 

 

 

15,622

13,127

 

 

 

Non-controlling interests

16

1,469

Total equity

15,638

14,596

 

Table41: 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 2019

317

4,427

2,041

5,683

12,468

1,576

14,044

 

 

 

 

 

 

 

 

Adoption of new accounting standards

-

-

-

54

54

Profit for the period

-

-

-

1,335

1,335

(108)

1,227

Other comprehensive loss

-

-

-

(612)

(611)

Transfer to other reserves

-

-

5

(5)

-

-

-

Transactions with owners:

 

 

 

 

 

Dividends

-

-

-

(3,579)

(3,579)

-

(3,579)

Issue of Ordinary Shares

11

3,514

-

-

3,525

Share-based payments charge for the period

-

-

-

259

259

-

259

Settlement of share plan awards

-

-

-

(323)

(323)

 

 

 

 

 

 

 

 

Net movement

11

3,514

5

(2,871)

659

(107)

552

 

 

 

 

 

 

 

 

At 31 Dec 2019

328

7,941

2,046

2,812

14,596

 

 

 

 

 

 

 

 

At 1 Jan 2020

328

7,941

2,046

2,812

13,127

1,469

14,596

 

 

 

 

 

 

 

 

Profit for the period

3,196

3,144

Other comprehensive income

1,608

1,608

1,608

Transfer to other reserves[96]

(22)

1,423

Transactions with owners:

 

 

 

 

 

 

 

Dividends

(3,668)

(3,668)

Issue of Ordinary Shares

30

30

30

Share-based payments charge for the period

277

277

Settlement of share plan awards

(349)

(349)

(349)

 

 

 

 

 

 

 

 

Net movement

30

(22)

2,487

2,495

(1,453)

1,042

 

 

 

 

 

 

 

 

At 31 Dec 2020

328

7,971

2,024

5,299

15,622

16

15,638

 

Table 42: Condensed consolidated statement of cash flows

 

For the year ended 31 December

2020

2019

$m

$m

Cash flows from operating activities

 

 

Profit Before Tax

3,916

1,548

Finance income and expense

1,219

1,260

Share of after-tax losses of associates and joint ventures

27

116

Depreciation, amortisation and impairment

3,149

3,762

Decrease/(increase) in working capital and short-term provisions

361

(346)

Gains on disposal of intangible assets

(1,030)

(1,243)

Fair value movements on contingent consideration arising from business combinations

(272)

(614)

Non-cash and other movements

(276)

378

 

 

 

Cash generated from operations

7,094

4,861

Interest paid

(733)

(774)

Tax paid

(1,562)

(1,118)

 

 

 

Net cash inflow from operating activities

4,799

2,969

 

 

 

Cash flows from investing activities

 

 

Payment of contingent consideration from business combinations

(822)

(709)

Purchase of property, plant and equipment

(961)

(979)

Disposal of property, plant and equipment

106

37

Purchase of intangible assets

(1,645)

(1,481)

Disposal of intangible assets

951

2,076

Movement in profit-participation liability

40

150

Purchase of non-current asset investments

(119)

(13)

Disposal of non-current asset investments

1,381

18

Movement in short-term investments, fixed deposits and other investing instruments

745

194

Payments to associates and joint ventures

(8)

(74)

Interest received

47

124

 

 

 

Net cash outflow from investing activities

(285)

(657)

 

 

 

Net cash inflow before financing activities

4,514

2,312

 

 

 

Cash flows from financing activities

 

 

Proceeds from issue of share capital

30

3,525

Issue of loans

2,968

500

Repayment of loans

(1,609)

(1,500)

Dividends paid

(3,572)

(3,592)

Hedge contracts relating to dividend payments

(101)

4

Repayment of obligations under leases

(207)

(186)

Movement in short-term borrowings

288

(516)

 

 

 

Net cash outflow from financing activities

(2,203)

(1,765)

 

 

 

Net increase in cash and cash equivalents in the period

2,311

547

Cash and cash equivalents at the beginning of the period

5,223

4,671

Exchange rate effects

12

5

 

 

 

Cash and cash equivalents at the end of the period

7,546

5,223

 

 

 

Cash and cash equivalents consist of:

 

 

Cash and cash equivalents

7,832

5,369

Overdrafts

(286)

(146)

 

 

 

 

7,546

5,223

 

 

Notes to the Condensed Financial Statements

 

1)  Basis of preparation and accounting policies

The Condensed Consolidated Financial Statements for the year ended 31 December 2020 have been prepared in accordance with International Financial Reporting Standards (IFRSs) adopted pursuant to Regulation (EC) No 1606/2002 as it applies in the EU and as issued by the International Accounting Standards Board (IASB). On 31 December 2020, EU-adopted IFRS was brought into UK law and became UK-adopted international accounting standards, with future changes to IFRS being subject to endorsement by the UK Endorsement Board. The Condensed Consolidated Financial Statements will transition to UK-adopted international accounting standards for financial periods beginning 1 January 2021.

 

These Condensed Consolidated Financial Statements comprise the financial results of AstraZeneca PLC for the years to 31 December 2020 and 2019 together with the Statement of financial position as at 31 December 2020 and 2019. The results for the year to 31 December 2020 have been extracted from the 31 December 2020 audited Consolidated Financial Statements which have been approved by the Board of Directors. These have not yet been delivered to the Registrar of Companies but are expected to be published on 15 February 2021 within the Annual Report and Form 20-F Information 2020.

 

The financial information set out above does not constitute the Group's statutory accounts for the years to 31 December 2020 or 2019 but is derived from those accounts. The auditors have reported on those accounts; their reports (i) were unqualified, (ii) did not include a reference to any matters to which the auditors drew attention by way of emphasis without qualifying their report and (iii) did not contain a statement under section 498 (2) or (3) of the Companies Act 2006 in respect of the accounts for the year to 31 December 2020 or 31 December 2019. Statutory accounts for the year to 31 December 2020 were approved by the Board of Directors for release on 11 February 2021.

 

Except as noted below, the Condensed Consolidated Financial Statements have been prepared applying the accounting policies that were applied in the preparation of the Group's published consolidated financial statements for the year ended 31 December 2019.

 

IFRS 3

An amendment to IFRS 3 'Business Combinations' relating to the definition of a business was endorsed by the EU in April 2020, with an effective date of 1 January 2020. The change in definition of a business within IFRS 3 introduces an optional concentration test to perform a simplified assessment of whether an acquired set of activities and assets is or is not a business on a transaction-by-transaction basis. This change is expected to result in more consistency in accounting in the pharmaceutical industry for substantially similar transactions for which, under the previous definition, may have been accounted in different ways, despite limited differences in substance. The Group has adopted this amendment from the effective date.

 

IFRS 9, IAS 39 and IFRS 7

The replacement of benchmark interest rates, such as the London Inter-bank Offered Rate (LIBOR) and other interbank offered rates (IBORs) is a priority for global regulators and is expected to be largely completed in 2021. To prepare for this, the Group early adopted the Phase 1 amendments to IFRS 9 'Financial Instruments' and IFRS 7 'Financial Instruments: Disclosures' in 2019. 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. There was no financial impact from the early adoption of these amendments. Further amendments (Phase 2) were issued on 27 August 2020 and the Group will apply these in 2021.

 

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 currently preparing to move to the new benchmark rates in 2021.

 

Government grants

Government grants are recognised in the Consolidated statement of comprehensive income so as to match with the related expenses that they are intended to compensate. Where grants are received in advance of the related expenses, they are initially recognised in the Consolidated statement of financial position under Trade and other payables as deferred income and released to net off against the related expenditure when incurred. Each contract is assessed to determine whether there are both grant elements and supply of product which need to be separated. In each case, contracts set out the specified terms for the supply of the product and the provisions for funding for certain costs, primarily research and development associated with the IP. It is considered whether there are any conditions for the funding to be refunded. The consideration in the contract is allocated between the grant and supply elements. The standalone selling price for the supply of products is determined by reference to observed prices with other customers. The amount allocated as a government grant is determined by reference to the specific agreed costs and activities identified in the contract as being related to activities not directly attributable to the supply of product. Government grants are recorded as an offset to the relevant expense in the Income Statement and are capped to match the relevant costs incurred.

 

COVID-19

AstraZeneca has assessed the impact of the uncertainty presented by the COVID-19 pandemic on the Consolidated Financial Statements comprising the financial results to 31 December 2020 and the financial position as at 31 December 2020, specifically considering the impact on key judgements and significant estimates as detailed on page 173 of the Annual Report and 20-F Information 2019 along with a several other areas of increased risk.

 

A detailed assessment has been performed, focussing on the following areas:

 

-  recoverable value of goodwill, intangible assets and property, plant and equipment

-  impact on key assumptions used to estimate contingent consideration liabilities

-  key assumptions used in estimating the Group's defined benefit pension obligations

-  basis for estimating clinical trial accruals

-  key assumptions used in estimating rebates, chargebacks and returns for US Product Sales

-  valuations of unlisted equity investments

-  expected credit losses associated with changes in credit risk relating to trade and other receivables

-  net realisable value of inventories

-  fair value of certain financial instruments

-  recoverability of deferred tax assets

-  effectiveness of hedge relationships

 

There were no material accounting impacts identified relating to the above areas during the year ended 31 December 2020.

 

The Group will continue to monitor these areas of increased judgement, estimation and risk for material changes.

 

Going concern

The Group has considerable financial resources available. As at 31 December 2020, the Group had $12.1bn in financial resources (cash and cash-equivalent balances of $7.8bn, $0.2bn 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 $2.4bn of borrowings due within one year). To support the financing of the acquisition of Alexion, the Group entered into committed bank facilities totalling $17.5bn during December 2020. 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 December 2020.

 

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 Condensed 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 2019.

 

Financial information

The comparative figures for the financial year ended 31 December 2019 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 $240m being recorded against intangible assets during the year ended 31 December 2020 (2019: $1,033m).

 

Impairment charges in respect of launched products totalled $350m (2019: $425m), including Duaklir ($200m, revised carrying amount of $210m), Bydureon ($102m, revised carrying amount of $581m), and other launched products totalling $48m. If revenue projections for Bydureon were to fall by 15% over the forecast period, this would result in a further impairment charge of c.$110m. Impairment charges recorded against products in development totalled $55m (2019: $609m).

 

The impairments recorded on launched products were a consequence of revised market volume, share and price assumptions. Impairments recorded on products in development were a consequence of failed or poor performing trials, with the individual assets being fully impaired.

 

The Group has performed an assessment on assets which have had impairments recorded in previous periods to determine if any reversals of impairments were required. Impairment reversals of $165m were recorded in 2020 in respect of launched products (2019: $3m in respect of products in development), including FluMist ($147m, revised carrying amount of $300m, driven by expanded vaccination efforts increasing global demand), and other launched products of $18m.

 

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 2019. Net Debt is a non-GAAP financial measure.

 

Table43: Net Debt

 

 

At

1 Jan 2020

Cash flow

Non-cash & other

Exchange movements

At

31 Dec 2020

$m

$m

$m

$m

$m

Non-current instalments of loans

(15,730)

(2,968)

1,394

(201)

(17,505)

Non-current instalments of leases

(487)

-

11

(13)

(489)

 

 

 

 

 

 

Total long-term debt

(16,217)

(2,968)

1,405

(214)

(17,994)

 

 

 

 

 

 

Current instalments of loans

(1,597)

1,609

(1,411)

(137)

(1,536)

Current instalments of leases

(188)

226

(225)

(5)

(192)

Bank collateral

(71)

(217)

-

-

(288)

Other short-term borrowings excluding overdrafts

(8)

(71)

-

(5)

(84)

Overdraft

(146)

(138)

-

(2)

(286)

 

 

 

 

 

 

Total current debt

(2,010)

1,409

(1,636)

(149)

(2,386)

 

 

 

 

 

 

Gross borrowings

(18,227)

(1,559)

(231)

(363)

(20,380)

 

 

 

 

 

 

Net derivative financial instruments

43

101

134

-

278

 

 

 

 

 

 

Net borrowings

(18,184)

(1,458)

(97)

(363)

(20,102)

 

 

 

 

 

 

Cash and cash equivalents

5,369

2,449

-

14

7,832

Other investments - current

849

(745)

61

(5)

160

Other investments - non-current

62

-

(62)

-

-

Cash and investments

6,280

1,704

(1)

9

7,992

 

 

 

 

 

 

Net Debt

(11,904)

246

(98)

(354)

(12,110)

 

Non-cash movements in the period include fair-value adjustments under IFRS 9.

 

Other investments - non-current are included within the balance of $1,108m (31 December 2019: $1,401m) 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 $2,297m (31 December 2019: $2,146m), shown in non-current other payables.

 

Net Debt increased by $206m in the year to $12,110m. Details of the committed undrawn bank facilities are disclosed within the going-concern section of Note 1.

 

During the year to 31 December 2020, 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, leases and interest-bearing loans and borrowings. During the period, equity investments previously categorised as Level 3 in the fair-value hierarchy (carrying value of $103m at 31 December 2019) are now categorised as Level 1 (carrying value of $128m at 31 December 2020) on availability of quoted prices in an active market. There have been no other changes of significance to the categorisation or fair-value hierarchy classification of financial instruments from those detailed in the Notes to the Group Financial Statements in the Annual Report and Form 20-F Information 2019.

 

The Group holds certain equity investments that are categorised as Level 3 in the fair-value hierarchy and for which fair-value gains of $63m have been recognised in the year ended 31 December 2020. 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 year ended 31 December 2020 are Level 1 fair-value measurements.

 

Financial instruments measured at fair value include $1,268m of other investments, $6,602m held in money-market funds, $339m of loans designated at fair value through profit or loss, $371m of loans designated in a fair-value hedge relationship and $278m of derivatives as at 31 December 2020. The total fair value of interest-bearing loans and borrowings at 31 December 2020, which have a carrying value of $20,380m in the Condensed consolidated statement of financial position, was $23,825m. 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:

 

Table44: Financial instruments - contingent consideration

 

 

2020

2019

Diabetes alliance

Other

Total

Total

$m

$m

$m

$m

At 1 January

3,300

839

4,139

5,106

Settlements

(546)

(276)

(822)

(709)

Revaluations

(51)

(221)

(272)

(614)

Discount unwind

229

49

278

356

 

 

 

 

 

At 31 December

2,932

391

3,323

4,139

 

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 $2,932m (31 December 2019: $3,300m) would increase/decline by $293m 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 2019, H1 2020 and Q3 2020 results (the Disclosures). Unless noted otherwise below or in the Disclosures, no provisions have been established in respect of the claims discussed below.

 

As discussed in the disclosures, the majority of claims involve highly complex issues. Often these issues are subject to substantial uncertainties and, therefore, the probability of a loss, if any, being sustained and/or an estimate of the amount of any loss is difficult to ascertain.

 

Unless specifically identified below that a provision has been taken, AstraZeneca considers each of the claims to represent a contingent liability and discloses information with respect to the nature and facts of the cases in accordance with IAS 37.

 

In cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed and which are not subject to appeal, or where a loss is probable and we are able to make a reasonable estimate of the loss, AstraZeneca records the loss absorbed or makes a provision for its best estimate of the expected loss. The position could change over time and the estimates that the Company made, and upon which the Company have relied in calculating these provisions are inherently imprecise. There can, therefore, be no assurance that any losses that result from the outcome of any legal proceedings will not exceed the amount of the provisions that have been booked in the accounts. The major factors causing this uncertainty are described more fully in the Disclosures and herein.

 

AstraZeneca has full confidence in, and will vigorously defend and enforce, its IP.

 

 

Matters disclosed in respect of the fourth quarter of 2020 and to 11 February 2021

 

Patent litigation

 

Enhertu

US patent proceedings

As previously disclosed, in October 2020, Seagen Inc. (Seagen) filed a complaint against Daiichi Sankyo 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 and Daiichi Sankyo Inc. filed a complaint against Seagen in the US District Court for the District of Delaware seeking a declaratory judgment that plaintiffs do not infringe the '039 patent. On 18 December 2020, Seagen filed a motion seeking to stay or dismiss this action.

 

On 23 December 2020, AstraZeneca and Daiichi Sankyo Inc. filed a post grant review petition with the US Patent and Trademark Office alleging, inter alia, that the '039 patent is invalid for lack of written description and entablement. In January 2021, AstraZeneca and Daiichi Sankyo, Inc. filed a second post grant review petition with the US Patent and Trademark Office extending its challenge to additional claims in the '039 patent. A decision on institution of these petitions is expected in July 2021.

 

Symbicort

US patent proceedings

As previously disclosed, AstraZeneca has Abbreviated New Drug Application litigation pending against Mylan Pharmaceuticals Inc. and Kindeva Drug Delivery L.P. in the US District Court for the Northern District of West Virginia. The trial of the matter was held in October 2020 and closing argument was held on 12 January 2021. A decision is awaited.

 

Movantik

US patent proceedings

As previously disclosed, in March 2020, Aether Therapeutics, Inc. filed a patent infringement lawsuit in the US District Court for the District of Delaware against AstraZeneca, Nektar Therapeutics and Daiichi Sankyo, Inc., relating to Movantik. A trial has been set for March 2023.

 

Forxiga

Patent Proceedings outside the US

In Canada, in January 2021, Sandoz Canada Inc. served three Notices of Allegation on AstraZeneca alleging invalidity and/or non-infringement of all three patents listed on the Canadian Patent Register in relation to Forxiga. AstraZeneca is considering its response.

 

Product liability litigation

 

Farxiga and Xigduo XR

As previously disclosed, in several jurisdictions in the US, AstraZeneca has been named as a defendant in lawsuits involving plaintiffs claiming physical injury, including diabetic ketoacidosis and kidney failure, from treatment with Farxiga and/or Xigduo XR. In April 2017, the Judicial Panel on Multidistrict Litigation ordered transfer of any currently pending cases as well as of any similar, subsequently filed cases to a co-ordinated and consolidated pre-trial multidistrict litigation proceeding in the US District Court for the Southern District of New York. All of these claims have been resolved or dismissed, and the multidistrict litigation has been administratively closed.

 

In addition, in several jurisdictions in the US, AstraZeneca has been named as a defendant in lawsuits involving plaintiffs claiming physical injury, including Fournier's Gangrene and necrotising fasciitis, from treatment with Farxiga and/or Xigduo XR. A majority of these claims are filed in Delaware State Court and remain pending.

 

Bydureon/Byetta

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 Bydureon and/or Byetta. The lawsuits allege several types of injuries including pancreatitis, pancreatic cancer, thyroid cancer, and kidney 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 November 2015, the District Court granted the defendants' motion for summary judgment and dismissed all claims alleging pancreatic cancer that accrued prior to 11 September 2015. In November 2017, the US Court of Appeals for the Ninth Circuit vacated the District Court's order and remanded for further discovery. In November 2018, the Court of Appeal for the State of California annulled the judgment from the California state coordinated proceeding and remanded for further discovery. In October and December 2020, the District Court and the California Court jointly heard oral argument on a renewed motion filed by Defendants seeking summary judgment and dismissal of all claims. That motion remains pending.

 

 

Commercial litigation

 

Amplimmune

As previously disclosed, in June 2017, AstraZeneca was served with a lawsuit filed by the stockholders' agents for Amplimmune, Inc. (Amplimmune) in Delaware State Court that alleged, among other things, breaches of contractual obligations relating to a 2013 merger agreement between AstraZeneca and Amplimmune. In November 2020, the Court decided in AstraZeneca's favour and subsequently entered a Final Judgment as to all pending claims in favour of AstraZeneca. In December 2020, the plaintiffs filed an appeal to the Delaware Supreme Court.

 

Definiens

As previously disclosed, in July 2020, AstraZeneca received a notice of arbitration filed with the German Institution of Arbitration from the sellers of Definiens AG (Sellers) regarding the 2014 Share Purchase Agreement (SPA) between AstraZeneca and the Sellers. The Sellers claim they are owed c.$140m in earn-outs under the SPA;  AstraZeneca disputes the claims of the Sellers. The arbitration tribunal has scheduled an oral hearing in July 2022.

 

AZD1222 Securities Litigation

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 (otherwise known as C19VAZ), a potential recombinant adenovirus vaccine for the prevention of COVID-19,and assert claims under sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5.

 

 

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, 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. AstraZeneca filed its opening appellate brief with the Supreme Court in January 2021. A decision on the merits of the appeal remains pending.

 

Crestor

Qui tam litigation

In the US, in January and February 2014, AstraZeneca was served with lawsuits filed in the US District Court for the District of Delaware under the qui tam provisions of the federal False Claims Act and related state statutes, alleging that AstraZeneca directed certain employees to promote Crestor off-label and provided unlawful remuneration to physicians in connection with the promotion of Crestor. The Department of Justice and all US states declined to intervene in the lawsuits. In March 2019, AstraZeneca filed a motion to dismiss the complaint. In February 2020, the District Court partially granted AstraZeneca's motion to dismiss. This matter was resolved and is now concluded.

 

US 340B Litigations and Proceedings

AstraZeneca is involved in several matters relating to its policy with regard to contract pharmacy recognition

under the 340B Drug Pricing Program in the United States. 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  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.

 

Taxation

As previously disclosed in the Annual Report and Form 20-F Information 2019, AstraZeneca faces a number of audits and reviews in jurisdictions around the world and, in some cases, is in dispute with the tax authorities. The issues under discussion are often complex and can require many years to resolve. Accruals for tax contingencies require management to make key judgements and significant estimates with respect to the ultimate outcome of current and potential future tax audits, and actual results could vary from these estimates. The total net accrual to cover the worldwide tax exposure for transfer pricing and other international tax contingencies of $287m (31 December 2019: $140m) reflected the progress in those tax audits and reviews during the year and for those audits where AstraZeneca and tax authorities are in dispute, AstraZeneca estimates the potential for reasonably possible additional liabilities above and beyond the amount provided to be up to $251m, including associated interest (31 December 2019: $76m). The total net accrual to cover the worldwide tax exposure for other tax contingencies of $727m (31 December 2019: $887m) reflected the progress in those tax audits and reviews during the year and expiry of statute of limitations. AstraZeneca estimates the potential for reasonably possible additional liabilities above and beyond the amount provided to be up to $517m, including associated interest (31 December 2019: $327m). The Company believes that it is unlikely that these additional liabilities will arise. It is possible that some of these contingencies may reduce in the future to the extent that any tax authority challenge is concluded, or matters lapse following expiry of the relevant statutes of limitation resulting in a reduction in the tax charge in future periods.

 

6)  Subsequent Events

In December 2020, AstraZeneca and Alexion announced that they had entered into a definitive agreement for AstraZeneca to acquire Alexion for a total consideration of $39bn, partly funded in cash and partly in AstraZeneca American Depository Shares. The boards of directors of both companies have unanimously approved the acquisition. Subject to receipt of regulatory clearances and approval by shareholders of both companies, the acquisition is expected to close in the third quarter of 2021, and upon completion, Alexion shareholders will own c.15% of the combined company. In conjunction with the acquisition, AstraZeneca has entered into committed bank facilities of $17.5bn.

 

In February 2021, AstraZeneca agreed to divest, subject to certain limited exceptions, its 26.7% ownership in Viela Bio, Inc. (Viela), as part of the proposed acquisition of Viela by Horizon Therapeutics plc. AstraZeneca anticipates receiving cash proceeds and profit of c.$760-780m upon closing for the sale of the holding, which will be recorded in Reported and Core Other Operating Income and Expense in the Company's financial statements. The divestment is expected to complete by the end of the first quarter of 2021.

 

In February 2021, AstraZeneca completed its sale of rights to Crestor and associated medicines in certain European countries to Grünenthal for an upfront payment of $320m, which will be recorded within Other operating income and expense. At 31 December 2020, there were no intangible or other assets on the balance sheet relating to the disposal.

 

7) 

Table 45 : Product Sales year-on-year analysis - FY 2020[97]

 

The CER information in respect of FY 2020 included in the Consolidated Financial Information has not been audited by PricewaterhouseCoopers LLP.

 

World

Emerging Markets

US

Europe

Established RoW

$m

% change

$m

% change

$m

% change

$m

% change

$m

% change

Actual

CER

Actual

CER

Actual

Actual

CER

Actual

CER

Oncology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tagrisso

4,328

36

36

1,208

59

63

1,566

24

748

58

56

806

18

16

Imfinzi

2,042

39

39

158

n/m

n/m

1,185

14

370

n/m

n/m

329

51

49

Lynparza

1,776

48

49

264

98

n/m

876

40

435

52

51

201

32

32

Calquence

522

n/m

n/m

6

n/m

n/m

511

n/m

2

n/m 

n/m 

3

n/m

n/m

Koselugo

38

n/m

n/m

-

-

38

n/m

Zoladex*

888

9

13

561

14

20

5

(22)

140

4

4

182

1

1

Faslode x*

580

(35)

(34)

180

(9)

(4)

55

(83)

221

(3)

(3)

124

(10)

(11)

Iressa*

268

(37)

(36)

221

(23)

(22)

14

(21)

12

(82)

(82)

21

(57)

(57)

Arimidex*

185

(18)

(16)

147

(3)

1

-

3

(88)

(88)

35

(23)

(24)

Casodex*

172

(14)

(14)

133

4

6

-

3

(83)

(83)

36

(37)

(38)

Others

51

(47)

(46)

28

(1)

1

-

4

(41)

(40)

19

(69)

(69)

Total Oncology

10,850

25

26

2,906

31

36

4,250

23

1,938

36

35

1,756

11

10

BioPharmaceuticals: CVRM

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Farxiga

1,959

27

30

686

46

55

569

6

507

36

35

197

21

21

Brilinta

1,593

1

2

461

4

732

3

342

(3)

(3)

58

2

Onglyza

470

(11)

(10)

201

14

18

166

(28)

58

(16)

(17)

45

(12)

(11)

Bydureon

448

(18)

(18)

4

(62)

(59)

382

(17)

53

(20)

(20)

9

(32)

(31)

Byetta

68

(37)

(36)

8

(35)

(23)

37

(45)

14

(24)

(24)

9

(18)

(17)

Other diabetes

47

(10)

(10)

7

n/m

n/m

25

(37)

13

38

38

2

26

28

Lokelma

76

n/m

n/m

5

n/m 

n/m 

57

n/m

4

n/m

n/m

10

n/m

n/m

Crestor*

1,180

(8)

(7)

748

(7)

(5)

92

(11)

129

(13)

(15)

211

(4)

(5)

Seloken /Toprol-XL*

821

8

12

782

14

18

13

(66)

16

(35)

(35)

10

(11)

(10)

Atacand *

243

10

15

175

9

17

10

(12)

35

17

17

23

15

15

Others

191

(30)

(30)

126

(35)

(34)

n/m

57

(5)

(4)

8

(60)

(61)

BioPharmaceuticals: total CVRM

7,096

3

5

3,203

8

12

2,083

(6 )

1,228

7

6

582

2

2

BioPharmaceuticals: Respiratory & Immunology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Symbicort

2,721

9

10

567

4

9

1,022

23

694

2

2

438

(1)

Pulmicort

996

(32)

(32)

798

(33)

(33)

71

(35)

73

(10)

(10)

54

(37)

(37)

Fasenra

949

35

34

12

n/m

n/m

603

25

203

72

70

131

33

32

Daliresp /Daxas

217

1

1

4

(9)

(8)

190

3

22

(14)

(13)

1

(10)

(8)

Bevespi

48

16

15

1

n/m 

n/m 

44

7

3

n/m

n/m

-

-

Breztri

28

n/m

n/m

14

n/m 

n/m 

5

n/m 

9

n/m

n/m

Others

398

(15)

(15)

203

(15)

(16)

6

(12)

176

(14)

(15)

13

(15)

(7)

BioPharmaceuticals: total Respiratory & Immunology

5,357

(1)

1,599

(20 )

(18 )

1,941

17

1,171

6

5

646

1

Other medicines

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nexium*

1,492

1

2

757

1

4

169

(22)

71

12

10

495

9

8

Synagis*

372

4

4

47

2

325

4

4

FluMist*

295

n/m

n/m

1

n/m

n/m

70

n/m

219

n/m

n/m

5

n/m

n/m

Losec/Prilosec*

183

(30)

(30)

152

(15)

(14)

6

(44)

20

(59)

(59)

5

(78)

(79)

Seroquel XR/ IR*

117

(39)

(37)

55

11

14

17

(48)

29

(67)

(67)

16

(19)

(18)

Others

128

(33)

(34)

6

(51)

(44)

55

(50)

58

(7)

(8)

9

6

(5)

Total other medicines

2,587

(1 )

971

(2 )

1

364

(17 )

722

8

7

530

5

3

Total Product Sales

25,890

10

11

8,679

6

10

8,638

12

5,059

16

15

3,514

6

6

 

8) 

Table 46 : Product Sales year-on-year analysis - Q4 2020[98]

 

The Q4 2020 information in respect of the three months ended 31 December 2020 included in the Consolidated Financial Information has not been audited by PricewaterhouseCoopers LLP.

 

World

Emerging Markets

US

Europe

Established RoW

$m

% change

$m

% change

$m

% change

$m

% change

$m

% change

Actual

CER

Actual

CER

Actual

Actual

CER

Actual

CER

Oncology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tagrisso

1,157

31

28

258

23

23

422

18

245

80

69

232

29

25

Imfinzi

555

31

29

45

n/m

n/m

300

6

115

78

68

95

44

41

Lynparza

496

42

40

69

n/m

n/m

245

27

124

58

49

58

29

27

Calquence

182

n/m

n/m

2

n/m

n/m

176

n/m

2

n/m 

n/m 

2

n/m

n/m

Koselugo

17

n/m

n/m

17

n/m 

Zoladex*

216

11

13

134

20

27

(1)

n/m

36

2

(3)

47

(4)

Faslodex*

130

(21)

(22)

39

(27)

(22)

10

(40)

50

(17)

(22)

31

(12)

(14)

Iressa*

67

(16)

(19)

58

(2)

(6)

3

(7)

1

(88)

(89)

5

(41)

(43)

Arimidex*

36

(29)

(30)

26

(22)

(23)

-

1

(87)

(88)

9

(9)