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Table of Contents

FORM 6-K/A

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Report of Foreign Issuer

Pursuant to Rule 13a-16 or 15d-16 of

the Securities Exchange Act of 1934

For the month of July 2021

Commission File Number: 001-11960

AstraZeneca PLC

1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, CB2 0AA England

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F 

Form 40-F 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): 

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes 

No 

If Yes is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b): 82-

Table of Contents

EXPLANATORY NOTE

The Company is filing this Amendment on Form 6-K/A (this “Amendment”) to its Report on Form 6-K, dated July 30, 2021 - Film No.: 211129370 (the “Original 6-K”), solely to include the addition of the cover page and signature line, were inadvertently omitted from the original filing. Except as specifically described in this explanatory note, this Amendment does not amend, modify or update any disclosures contained in the Original 6-K, including with respect to any events occurring after the furnishing of the Original 6-K.

AstraZeneca PLC

29 July 2021 07:00 BST

H1 2021 results

Accelerating top-line growth with continued pipeline progress

underpins the transition to long-term sustainable growth

AstraZeneca delivered strong revenue growth of 23% (18% at CER1) in the half to $15,540m while, in the second quarter, revenue increased by 31% (25% at CER) to $8,220m. Excluding the contribution from the pandemic COVID-19 vaccine, revenue increased by 14% (9% at CER) in the half to $14,371m and by 17% (12% at CER) in the quarter to $7,326m. Further pipeline progress and the recent acquisition of Alexion Pharmaceuticals Inc. (Alexion) supports the Company’s transition to long-term sustainable growth. AstraZeneca is updating its full-year 2021 guidance to reflect the contribution of Alexion in the year.

Pascal Soriot, Chief Executive Officer, commented:

“AstraZeneca has delivered another period of strong growth thanks to robust performances across all regions and disease areas, particularly Oncology, New CVRM and Fasenra in Respiratory. As a result, we have delivered further earnings progression, supported ongoing launches, and continued our investment in R&D.

We continue to advance our portfolio of life-changing medicines with further significant progress across disease areas. In Oncology, we recently presented Lynparza’s OlympiA Phase III trial at the plenary session of the 2021 American Society of Clinical Oncology Annual Meeting, and we also shared the final results from Calquence’s head-to-head trial with ibrutinib. In BioPharmaceuticals, the US approved Farxiga for chronic kidney disease and granted tezepelumab Priority Review to treat patients with asthma. Alexion will enable us to enhance our pipeline, extending the Company’s presence in rare diseases and immunology with its complement biology.

Following the successful acquisition of Alexion, we are today updating our full-year 2021 guidance; our long-term goals to accelerate scientific discovery, invest for sustainable growth and deliver more benefits for patients remains unchanged.”

Table 1: Financial summary

H1 2021

Q2 2021

Actual %

CER %

Actual %

CER %

$m

Change

change

  

  

$m

Change

change

- Product Sales

    

15,302

    

24

    

19

8,045

    

33

    

27

- Collaboration Revenue

 

238

 

(12)

 

(12)

175

 

(23)

 

(23)

Total Revenue

 

15,540

 

23

 

18

8,220

 

31

 

25

- Less pandemic COVID‑19 vaccine2

 

1,169

 

n/m3

 

n/m

894

 

n/m

 

n/m

Total Revenue ex-pandemic vaccine4

 

14,371

 

14

 

9

7,326

 

17

 

12

Reported5 EPS6

$

1.61

 

37

 

45

$

0.42

 

(27)

 

(15)

Core7 EPS

$

2.53

 

26

 

27

$

0.90

 

(6)

 

(2)

Impact of pandemic vaccine on EPS

$

(0.04)

 

n/m

 

n/m

$

(0.01)

 

n/m

 

n/m

Highlights of Total Revenue in the half included:

-An increase in Product Sales of 24% (19% at CER) to $15,302m. New medicines8 Total Revenue improved by 31% (27% at CER) in the half to $8,332m, including growth in Emerging Markets of 35% (29% at CER) to $1,895m. Globally, new medicines represented 54% of Total Revenue (H1 2020: 50%)

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-Oncology growth of 19% (15% at CER) to $6,360m and an increase in New CVRM9 of 21% (16% at CER) to $2,731m. Similarly, Respiratory & Immunology (R&I) increased by 11% (6% at CER) to $2,970m, despite the adverse impact of mature, inhaled respiratory medicines on the performance in the half
-An increase in Emerging Markets of 26% (21% at CER) to $5,459m with the performance benefitting from sales of the pandemic COVID-19 vaccine of $455m. China growth of 21% (11% at CER) to $3,209m. In the US, Total Revenue increased by 16% to $4,834m and in Europe by 33% (21% at CER) to $3,261m, also benefitting from sales of the pandemic COVID-19 vaccine of $572m

Alexion, acquired by AstraZeneca on 21 July 2021, does not form any part of the Company’s financial results during the period. Alexion’s post-acquisition results will be consolidated post-completion and included in AstraZeneca’s year-to-date and Q3 2021 results to be announced on 12 November 2021. Details of the acquisition are included in the subsequent events note.

Guidance

Following the completion of the acquisition of Alexion on 21 July 2021 and the issuance of new shares10, the Company is updating its FY 2021 guidance at CER to include the contribution from Alexion and reflect the increase in weighted average number of shares outstanding to 1,418 million. The previous expectations issued by both companies earlier in 2021 remain broadly in line with current assumptions and underpin the updated guidance:

Total revenue is expected to increase by a low-twenties percentage,

accompanied by a faster growth in Core EPS to $5.05 to $5.40.

The guidance does not incorporate any revenue or profit impact from sales of the pandemic COVID-19 vaccine. In general, AstraZeneca continues to recognise the heightened risks and uncertainties from the effects of COVID-19, including the impact from potential new medicines for COVID-19 in clinical development. 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 allocating appropriate resources to continued investment in R&D, the support of newly launched medicines, and patient access in key markets to underpin long-term sustainable growth
-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 July to December 2021 were to remain at the average of rates seen in the half, 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 23% in the half (18% at CER) to $15,540m. Product Sales grew by 24% (19% at CER) to $15,302m, driven primarily by the performances of new medicines across Oncology and BioPharmaceuticals, including Tagrisso, Calquence and Farxiga. Total Revenue included $1,169m of pandemic COVID-19 vaccine sales

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-The Reported Gross Profit Margin11 declined by seven (six at CER) percentage points to 73.5% and the Core Gross Profit Margin declined by seven (six at CER) percentage points in the half to 73.8%. The performance predominantly reflected the significant impact of the equitable supply, at no profit to AstraZeneca, of the pandemic COVID-19 vaccine, together with an increasing impact from profit-sharing arrangements, primarily Lynparza and roxadustat, and the impact of the Chinese National Reimbursement Drug List (NRDL) and the value-based procurement (VBP) patient-access programmes. A higher proportion of Oncology sales and increasing patient access in China partially offsets these impacts. These variations in gross margin performance between periods can be expected to continue
-Reported Total Operating Expense increased by 17% (12% at CER) in the half to $9,771m and represented 63% of Total Revenue (H1 2020: 66%). Core Total Operating Expense increased by 17% (12% at CER) to $8,511m and comprised 55% of Total Revenue (H1 2020: 57%)
-Reported and Core R&D Expense increased in the half by 28% (22% at CER) to $3,542m and by 27% (21% at CER) to $3,439m, respectively. The increases primarily reflected the Company’s continued investment in its COVID-19 vaccine and potential new medicines to prevent and treat COVID-19. The increases also reflected the investment in several late-stage Oncology trials, including datopotamab deruxtecan, and the advancement of a number of Phase II clinical development programmes in BioPharmaceuticals, mainly in CVRM
-Reported SG&A Expense increased by 13% (7% at CER) in the half to $6,027m; Core SG&A Expense increased by 12% (7% at CER) to $4,870m, representing 31% of Total Revenue (H1 2020: 34%). The increases were driven by additional SG&A investment in launches of Oncology medicines, the launch of several BioPharmaceutical medicines, particularly in the US, and AstraZeneca’s further expansion in China
-Reported Other Operating Income and Expense12 increased by 117% (116% at CER) in the half to $1,308m. Core Other Operating Income and Expense increased by 117% (115% at CER) to $1,309m during the period. The growth predominately reflected the $776m of income from the divestment of AstraZeneca’s 26.7% share of Viela Bio, Inc. (Viela) as part of the acquisition by Horizon Therapeutics plc
-The Reported Operating Profit Margin was stable in the half (increased by one percentage point at CER) to 19.4%; the Core Operating Profit Margin decreased by one percentage point (stable at CER) to 27.9%. The performance predominately reflected the aforementioned one-time benefit from Other Operating Income and Expense11
-Reported EPS of $1.61 in the half represented an increase of 37% (45% at CER). Core EPS grew by 26% (27% at CER) to $2.53. Reported and Core EPS were adversely impacted by $0.04 due to the pandemic COVID-19 vaccine
-An unchanged first interim dividend of $0.90 (64.8 pence, 7.77 SEK) per ordinary share

Commercial summary

Oncology

Total Revenue increased by 19% in the half (15% at CER) to $6,360m.

Table 2: Select Oncology medicine Total Revenue performances

    

    

    

    

    

H1 2021

    

    

    

    

Q2 2021

Actual

CER

Actual

CER

$m

% change

% change

  

  

$m

% change

% change

Tagrisso

 

2,454

 

22

 

17

1,306

 

26

 

21

Imfinzi

 

1,160

 

22

 

18

604

 

23

 

19

Lynparza

 

1,131

 

19

 

15

588

 

6

 

2

Calquence

 

490

 

n/m

 

n/m

280

 

n/m

 

n/m

Enhertu

 

89

 

n/m

 

n/m

49

 

n/m

 

n/m

New CVRM

Total Revenue increased by 21% in the half (16% at CER) to $2,731m.

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Table 3: Select New CVRM medicine Total Revenue performances

    

    

    

    

    

H1 2021

    

    

    

    

Q2 2021

Actual

CER

Actual

CER

$m

% change

% change

  

  

$m

% change

% change

Farxiga

 

1,359

 

60

 

53

734

 

65

 

56

Brilinta

 

749

 

(11)

 

(15)

375

 

(14)

 

(18)

Bydureon

 

198

 

(9)

 

(10)

95

 

(18)

 

(20)

Roxadustat

 

92

 

n/m

 

n/m

52

 

n/m

 

n/m

Lokelma

 

72

 

n/m

 

n/m

39

 

n/m

 

n/m

Respiratory & Immunology

Total Revenue increased by 11% in the half (6% at CER) to $2,970m.

Table 4: Select R&I medicine Total Revenue performances

    

    

    

    

    

H1 2021

    

    

    

    

Q2 2021

Actual

CER

Actual

CER

$m

% change

% change

  

  

$m

% change

% change

Symbicort

 

1,371

 

(5)

 

(9)

680

 

4

 

(1)

Pulmicort

 

497

 

4

 

(2)

167

 

72

 

59

Fasenra

 

580

 

36

 

32

320

 

41

 

36

Breztri

 

82

 

n/m

 

n/m

56

 

n/m

 

n/m

COVID-19

Total Revenue increased sequentially from $275m in Q1 2021 to $1,169m in the half.

Table 5: Pandemic COVID-19 vaccine performance

    

    

    

    

    

H1 2021

    

    

    

    

Q2 2021

Actual

CER

Actual

CER

$m

% change

% change

  

  

$m

% change

% change

Pandemic COVID‑19 vaccine

 

1,169

 

n/m

 

n/m

894

 

n/m

 

n/m

Emerging Markets

Total Revenue increased by 26% in the half (21% at CER) to $5,459m, reflecting the growth of Tagrisso and Lynparza in Oncology, Farxiga in CVRM, and the benefit from sales of the pandemic COVID-19 vaccine. The performance, however, was partly offset by the decline of Brilinta, which was adversely impacted by the implementation of China’s VBP programme.

China Total Revenue increased 21% (11% at CER) to $3,209m in the half and comprised 59% of Emerging Markets Total Revenue (H1 2020: 61%). New medicines, primarily driven by Tagrisso in Oncology and Forxiga in New CVRM, delivered particularly encouraging growth. The Total Revenue growth in the half, however, included the aforementioned adverse impact from the reduced sales of Brilinta. Ex-China Total Revenue increased 35% (36% at CER) to $2,250m, reflecting the contribution from sales of the pandemic COVID-19 vaccine. Excluding the sales of the vaccine the performance benefitted from strong growth in Latin America, Brazil and Middle East and Africa.

Business development

Nexium authorised generic in Japan

In June 2021, AstraZeneca entered into an agreement to out-license the authorised generic rights to Nexium in Japan to a local pharmaceutical company. As part of this agreement, Initial Collaboration Revenue of $75m was recorded in the second quarter of 2021.

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Sustainability summary

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

a)    Access to healthcare

During the first half of 2021, the Company and its sublicensee, SII, have in total released for supply over 80 million doses of its pandemic COVID-19 vaccine to more than 125 countries through the COVID-19 Vaccines Global Access (COVAX13) initiative, with its vaccine providing c.90% of COVAX supply as at the end of June 2021. The majority of doses have been made available to low and middle-income countries. At the end of June 2021, more than 700 million doses of the vaccine have been released for supply to over 170 countries by AstraZeneca and its sub-licensing partners.

b)    Environmental protection

In May 2021, the Company was listed as one of Europe’s Climate Leaders 2021 by the Financial Times (FT), which identified European companies that achieved the greatest reduction in their greenhouse gas (GHG) emissions intensity between 2014 and 2019, with emissions intensity defined as tonnes of emissions of CO2-equivalent per €1m of revenue.

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

Management changes

During the period, AstraZeneca announced changes to the Company’s Board to come into effect as of 1 August 2021; Aradhana Sarin, previously Executive Vice-President and Chief Financial Officer of Alexion, will be appointed to Executive Director and Chief Financial Officer (CFO) of AstraZeneca. In addition, Marc Dunoyer will step down as CFO of AstraZeneca, retiring from the Company’s Board, and becoming Chief Executive Officer of Alexion and Chief Strategy Officer of AstraZeneca. Mr Dunoyer will continue to report to Mr Soriot and remain a member of AstraZeneca’s Senior Executive Team.

In June 2021, Susan Galbraith was appointed Executive Vice-President, Oncology Research & Development, from initial discovery through late-stage development. Before this appointment, Dr Galbraith spent ten years as Senior Vice President, Early Oncology, where she was responsible for overseeing the successful progression of seven programmes into Phase III trials, with four new medicines now approved in countries around the world. During this time, she played a pivotal role in the evolution of AstraZeneca’s Oncology strategy, supporting pioneering research, embracing cutting-edge technologies, and forging successful partnerships to transform productivity and scientific output.

Notes

The following notes refer to pages one to five.

1.Constant exchange rates. These are financial measures that are not accounted for according to generally accepted accounting principles (GAAP) because they remove the effects of currency movements from Reported results.
2.The pandemic COVID-19 vaccine Total Revenue includes $33m of Collaboration Revenue received from Serum Institute of India Pvt. Ltd. (SII), an equivalent charge has been included within SG&A in relation to consequent obligations under the license agreement with Oxford University Innovation (OUI).
3.Not meaningful.
4.Total Revenue ex-pandemic vaccine is a non-GAAP measure, which excludes the revenue impact from sales of the pandemic COVID-19 vaccine during the pandemic period to help facilitate a comparison to guidance.
5.Reported financial measures are the financial results presented in accordance with UK-adopted International Accounting Standards and EU-adopted International Financial Reporting Standards (IFRSs), and IFRS as issued by the International Accounting Standards Board (IASB).
6.Earnings per share.
7.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.
8.Tagrisso, Imfinzi, Lynparza, Calquence, Enhertu, Koselugo, Farxiga, Brilinta, Lokelma, roxadustat, Fasenra, Bevespi and Breztri. The new medicines are pillars in the three disease areas (formally referred to as Therapy Areas) of Oncology, Cardiovascular (CV), Renal & Metabolism (CVRM), and R&I and are important platforms for future growth.
9.New CVRM comprises Brilinta, Renal and Diabetes medicines.
10.The calculation of core EPS for guidance is based on 1,418 million weighted average number of shares outstanding during 2021. The number of shares in issue as of the close of the Alexion acquisition was 1,549 million.
11.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.
12.Where AstraZeneca does not retain a significant ongoing interest in medicines or potential new medicines, income from divestments is reported within Reported and Core Other Operating Income and Expense in the Company’s financial statements.
13.COVID-19 Vaccines Global Access (COVAX) is a coalition co-led by CEPI, the Coalition for Epidemic Preparedness Innovations, Gavi, the Vaccine Alliance (Gavi), and the WHO. It is the only global initiative bringing governments and manufacturers together to ensure that safe and effective COVID-19 vaccines are available worldwide to both higher-income and lower-income countries.

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Table 6: Pipeline highlights

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

Regulatory approval or other regulatory action

    

-

Tagrisso - adjuvant NSCLC13 (EGFRm14): approval (EU)

-

Imfinzi - ES-SCLC15: approval (CN)

-

Lynparza - prostate cancer (2nd line) (BRCAm16): approval (CN)

-

Koselugo - NF117: approval (EU)

-

Orpathys - lung cancer (2nd line) (MET exon 1418): approval (CN)

-

Farxiga – CKD19: approval (US)

-

COVID-19 vaccine - COVID-19: approval (JP)

Regulatory submission acceptance and/or submission

-

Symbicort - mild asthma: regulatory submission voluntarily withdrawn (EU)

-

Fasenra - nasal polyps20: regulatory submission (US)

-

tezepelumab - asthma: regulatory submission (US, EU, JP)

Major Phase III data readout or other significant development

-

Imfinzi + tremelimumab - NSCLC (1st line) (POSEIDON): Phase III OS21 primary endpoint met

-

Forxiga - CKD: positive regulatory opinion (EU)

-

roxadustat - CKD: negative outcome from US FDA advisory committee

-

nirsevimab – RSV22: Phase II/III primary safety objective met

-

AZD7442 - SARS-CoV-2 (STORM CHASER): Phase III primary endpoint not met

13Non-small cell lung cancer.
14Epidermal growth factor receptor mutation.
15Extensive-stage small cell lung cancer.
16Breast cancer susceptibility gene 1/2 mutation.
17Neurofibromatosis type 1, a genetic condition causing tumours to grow along nerves in the skin, brain, and other parts of the body.
18MET exon 14 skipping occurs with a c.5% frequency in patients with NSCLC and is seen in both squamous and adenocarcinoma histology.
19Chronic kidney disease.
20Benign soft growths inside the nose.
21Overall survival.
22Respiratory syncytial virus.

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Table 7: Pipeline anticipated major news flow

Timing

    

News flow

H2 2021

-

Imfinzi – unresectable23, Stage III NSCLC (PACIFIC-2): data readout

-

Imfinzi + tremelimumab - NSCLC (1st line) (POSEIDON): regulatory submission

-

Imfinzi +/- treme - liver cancer (1st line): data readout

-

Lynparza - adjuvant breast cancer: regulatory submission

-

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

-

Enhertu - breast cancer (2nd line, HER2+24): data readout25, regulatory submission

-

Calquence – CLL26 (R/R27) (ELEVATE-RR): regulatory submission

-

Forxiga - CKD: regulatory decision (EU, JP)

-

roxadustat - anaemia in CKD: regulatory decision (US)

-

PT027 - asthma: data readout

-

anifrolumab - lupus (SLE28): regulatory decision (US, EU, JP)

-

COVID-19 vaccine - COVID-19: regulatory submission (US)

-

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

H1 2022

-

Imfinzi - unresectable, Stage III NSCLC (PACIFIC-2): regulatory submission

-

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

-

Imfinzi - cervical cancer: data readout

-

Imfinzi +/- treme - liver cancer (1st line): regulatory submission

-

Enhertu - breast cancer (HER2 low): data readout, regulatory submission

-

Calquence - CLL: regulatory submission (CN)

-

Koselugo - NF1: regulatory submission (JP, CN)

-

Forxiga - CKD: regulatory decision (CN)

-

Farxiga – HF29 (HfpEF30): data readout, regulatory submission

-

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

-

roxadustat – MDS31:: data readout

-

Fasenra - nasal polyps: regulatory decision (US)

-

tezepelumab - asthma: regulatory decision (US, EU, JP)

-

PT027 - asthma: regulatory submission (US)

-

nirsevimab - RSV: regulatory submission

23The tumour cannot be removed completely through surgery.
24Human epidermal growth factor receptor 2 positive.
25Based on a planned interim analysis as communicated by Daiichi Sankyo in Q2 of their fiscal year 2021.
26Chronic lymphocytic leukaemia, the most common type of leukaemia in adults.
27Relapsed/refractory.
28Systemic lupus erythematosus, a chronic autoimmune disease that causes inflammation in connective tissues throughout the body.
29Heart failure.
30HF with preserved ejection fraction.
31Myelodysplastic syndrome.

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Timing

    

News flow

H2 2022

-

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

-

Imfinzi - LS-SCLC32: data readout

-

Imfinzi - biliary tract cancer: data readout, regulatory submission

-

Imfinzi - cervical cancer: regulatory submission

-

Imfinzi - liver cancer (locoregional) (EMERALD-1): data readout

-

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

-

roxadustat – MDS33:: regulatory submission

-

Fasenra - hyper-eosinophilic syndrome34: data readout

-

Fasenra - eosinophilic oesophagitis35: data readout, regulatory submission

Conference call

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

Reporting calendar

The Company intends to publish its year-to-date and third-quarter results on Friday 12 November 2021.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

Contacts

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

32Limited-stage small cell lung cancer.
33Myelodysplastic syndrome.
34A group of rare blood disorders.
35White blood cells gather in the lining of the oesophagus.

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Table of contents

Page

Operating and financial review

11

Total Revenue

12

Total Revenue summary

14

Regional Total Revenue

20

Financial performance

21

Profit and Loss summary

24

Sustainability

29

Research and development

31

Interim Financial Statements

43

Notes to the Interim Financial Statements

51

Matters disclosed in respect of the second quarter of 2021 and to 29 July 2021

55

Matters disclosed in respect of the first quarter of 2021 and to 30 April 2021

58

Financial calendar and other shareholder information

68

Addresses for correspondence

68

Cautionary statements regarding forward-looking statements

69

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List of tables

Table 1: Financial summary

1

Table 2: Select Oncology medicine Total Revenue performances

3

Table 3: Select New CVRM medicine Total Revenue performances

4

Table 4: Select R&I medicine Total Revenue performances

4

Table 5: Pandemic COVID-19 vaccine performance

4

Table 6: Pipeline highlights

6

Table 7: Pipeline anticipated major news flow

7

Table 8: Total Revenue by disease area

12

Table 9: Disease area and medicine performance

13

Table 10: Collaboration Revenue

14

Table 11: Regional Total Revenue

20

Table 12: Emerging Markets Total Revenue disease-area performance

20

Table 13: Notable new medicine Total Revenue performances in Emerging Markets

20

Table 14: Ex-China Emerging Markets Total Revenue

21

Table 15: Reported Profit and Loss - H1 2021

21

Table 16: Reported Profit and Loss - Q2 2021

22

Table 17: Reconciliation of Reported Profit Before Tax to EBITDA - H1 2021

22

Table 18: Reconciliation of Reported Profit Before Tax to EBITDA - Q2 2021

22

Table 19: Reconciliation of Reported to Core financial measures - H1 2021

23

Table 20: Reconciliation of Reported to Core financial measures - Q2 2021

23

Table 21: Cash Flow

25

Table 22: Net Debt summary

26

Table 23: Obligor group summarised Statement of Comprehensive income

27

Table 24: Obligor group summarised Statement of Financial position information

27

Table 25: Currency sensitivities

28

Table 26: Late-stage pipeline

31

Table 27: Key Tagrisso Phase III trials

32

Table 28: Key Imfinzi Phase III trials in lung cancer

33

Table 29: Key Imfinzi Phase III trials in tumour types other than lung cancer

34

Table 30: Key Lynparza Phase III trials

35

Table 31: Key Enhertu trials

36

Table 32: Camizestrant Phase III trials

37

Table 33: Datopotamab deruxtecan Phase III trials

37

Table 34: Key large CVRM Phase III outcomes trials

38

Table 35: Key Breztri Phase III trials

39

Table 36: Key Fasenra lifecycle management Phase III trials

39

Table 37: Key tezepelumab Phase III trials

40

Table 38: Key PT027 Phase III trials

40

Table 39: Key anifrolumab Phase III trials

41

Table 40: Key nirsevimab trials

41

Table 41: Key vaccine trials in COVID-19

42

Table 42: Key AZD7442 Phase II/III trials in COVID-19

42

Table 43: H1 2021 - Condensed consolidated statement of comprehensive income

43

Table 44: Q2 2021 - Condensed consolidated statement of comprehensive income

44

Table 45: Condensed consolidated statement of financial position

45

Table 46: Condensed consolidated statement of changes in equity

46

Table 47: Condensed consolidated statement of cash flows

47

Table 48: Net Debt

53

Table 49: Financial instruments - contingent consideration

54

Table 50: H1 2021 - Product Sales year-on-year analysis

63

Table 51: Q2 2021 - Product Sales year-on-year analysis (Unreviewed)

64

Table 52: Q2 2021 - Product Sales quarterly sequential analysis (Unreviewed)

65

Table 53: FY 2020 - Product Sales quarterly sequential analysis (Unreviewed)

66

Table 54: Collaboration Revenue

67

Table 55: Other Operating Income and Expense

67

10

Table of Contents

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 six-month period to 30 June 2021 (the half or H1 2021) and the three-month period to 30 June 2021 (the second quarter or Q2 2021) compared to the six-month period to 30 June 2020 (H1 2020) and the three-month period to 30 June 2020 (Q2 2020) respectively, unless stated otherwise.

Forward-looking statements in this announcement do not reflect the impact of the performance of AstraZeneca’s pandemic COVID-19 vaccine.

Core financial measures, EBITDA, Net Debt, Initial Collaboration Revenue and Ongoing Collaboration Revenue are non-GAAP financial measures because they cannot be derived directly from the Group’s Interim Financial Statements. Management believes that these non-GAAP financial measures, when provided in combination with Reported results, will provide investors and analysts with helpful supplementary information to understand better the financial performance and position of the Group on a comparable basis from period to period. These non-GAAP financial measures are not a substitute for, or superior to, financial measures prepared in accordance with GAAP. Core financial measures are adjusted to exclude certain significant items, such as:

-

Amortisation and impairment of intangible assets, including impairment reversals but excluding any charges relating to IT assets

-

Charges and provisions related to restructuring programmes, which includes charges that relate to the impact of restructuring programmes on capitalised IT assets

-

Other specified items, principally comprising the Diabetes alliance36, acquisition-related costs, which include fair-value adjustments and the imputed finance charge relating to contingent consideration on business combinations and legal settlements

Details on the nature of Core financial measures are provided on page 84 of the Annual Report and Form 20-F Information 2020. Reference should be made to the Reconciliation of Reported to Core financial measures table included in the financial performance section in this announcement.

Total Revenue ex-pandemic vaccine is a non-GAAP financial measure introduced in the first quarter of 2021 to enable management to explain the financial impact of the COVID-19 vaccine on the Group’s Total revenue.

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

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

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

36A prior diabetes alliance between AstraZeneca and Bristol-Myers Squibb Company (BMS). The Company acquired the entirety of BMS’s interests in the alliance in 2014.

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

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

Total Revenue

The performance of the Company’s medicines is shown below, with more details available from Note 7.

Table 8: Total Revenue by disease area

Medicines for use in speciality care, typically in the hospital setting, comprise all Oncology medicines, Brilinta Lokelma, and roxadustat in CVRM, and Fasenra in Respiratory. At 51% of Total Revenue (H1 2020: 53%), speciality-care medicines increased by 18% in the half (14% at CER) to $7,854m.

H1 2021

Q2 2021

% of

Actual %

CER %

% of

Actual %

CER %

    

$m

    

total

    

change

    

change

  

  

$m

    

total

    

change

    

change

Oncology

 

6,360

 

41

 

19

 

15

3,337

 

41

 

19

 

14

BioPharmaceuticals

 

5,701

 

37

 

15

 

11

2,849

 

35

 

25

 

19

- New CVRM

 

2,731

 

18

 

21

 

16

1,425

 

17

 

22

 

16

- R&I

 

2,970

 

19

 

11

 

6

1,424

 

17

 

27

 

21

Other medicines

 

2,310

 

15

 

(2)

 

(6)

1,140

 

14

 

(4)

 

(8)

COVID-19

 

1,169

 

8

 

n/m

 

n/m

894

 

11

 

n/m

 

n/m

Total Revenue

 

15,540

 

100

 

23

 

18

8,220

 

100

 

31

 

25

- Less pandemic COVID-19 vaccine

 

1,169

 

8

 

n/m

 

n/m

894

 

11

 

n/m

 

n/m

Total Revenue ex-pandemic vaccine

 

14,371

 

92

 

14

 

9

7,326

 

89

 

17

 

12

12

Table of Contents

Table 9: Disease area and medicine performance

H1 2021

Q2 2021

% of

Actual %

CER %

% of

Actual %

CER %

    

$m

    

total

    

change

    

change

  

  

$m

    

total

    

change

    

change

Oncology

 

6,267

 

40

 

23

 

18

3,286

 

40

 

26

 

21

- Tagrisso

 

2,454

 

16

 

22

 

17

1,306

 

16

 

26

 

21

- Imfinzi

 

1,160

 

7

 

22

 

18

604

 

7

 

23

 

19

- Lynparza

 

1,131

 

7

 

39

 

34

588

 

7

 

40

 

35

- Calquence

 

490

 

3

 

n/m

 

n/m

280

 

3

 

n/m

 

n/m

- Koselugo

 

48

 

-

 

n/m

 

n/m

26

 

-

 

n/m

 

n/m

- Enhertu

 

4

 

-

 

n/m

 

n/m

3

 

-

 

n/m

 

n/m

- Zoladex37

 

466

 

3

 

5

 

(1)

244

 

3

 

12

 

5

- Faslodex38

 

227

 

1

 

(27)

 

(31)

105

 

1

 

(28)

 

(31)

- Iressa38

 

107

 

1

 

(27)

 

(31)

47

 

1

 

(34)

 

(38)

- Arimidex38

 

73

 

-

 

(32)

 

(35)

29

 

-

 

(50)

 

(53)

- Casodex38

 

82

 

1

 

(7)

 

(13)

41

 

-

 

(14)

 

(19)

- Others

 

25

 

-

 

(1)

 

(4)

13

 

-

 

12

 

6

BioPharmaceuticals: CVRM

 

3,935

 

25

 

14

 

9

2,023

 

25

 

15

 

9

- Farxiga

 

1,356

 

9

 

60

 

53

732

 

9

 

65

 

56

- Brilinta

 

749

 

5

 

(11)

 

(15)

375

 

5

 

(14)

 

(18)

- Onglyza

 

200

 

1

 

(22)

 

(25)

99

 

1

 

(14)

 

(18)

- Bydureon

 

198

 

1

 

(9)

 

(10)

95

 

1

 

(18)

 

(20)

- Byetta

 

32

 

-

 

(9)

 

(12)

16

 

-

 

6

 

-

- Other diabetes

 

29

 

-

 

23

 

17

15

 

-

 

49

 

40

- Roxadustat

 

90

 

1

 

n/m

 

n/m

51

 

1

 

n/m

 

n/m

- Lokelma

 

72

 

-

 

n/m

 

n/m

39

 

-

 

n/m

 

n/m

- Crestor38

 

539

 

3

 

(7)

 

(11)

265

 

3

 

(6)

 

(11)

- Seloken/Toprol-XL38

 

515

 

3

 

30

 

24

266

 

3

 

22

 

14

- Atacand38

 

57

 

-

 

(55)

 

(55)

23

 

-

 

(62)

 

(61)

- Others

 

98

 

1

 

(7)

 

(13)

47

 

1

 

(1)

 

(9)

BioPharmaceuticals: R&I

 

2,961

 

19

 

11

 

6

1,420

 

17

 

27

 

21

- Symbicort

 

1,371

 

9

 

(5)

 

(9)

680

 

8

 

4

 

(1)

- Pulmicort

 

497