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AstraZeneca PLC   -  AZN   

AZN: H1 2019 Results

Released 07:00 25-Jul-2019

RNS Number : 6399G
AstraZeneca PLC
25 July 2019
 

AstraZeneca PLC

25 July 2019 07:00 BST

H1 2019 Results

Continuing strong top-line performance underpins confidence in sustainable growth

 

First-half Product Sales growth of 12% (17% at CER1) to $11,183m included an acceleration in second-quarter Product Sales to $5,718m (+14%, +19% at CER). The second quarter saw every sales region and all three therapy areas deliver an encouraging performance, including:

 

-       The sustained performance of new medicines2 (+66%, +72% at CER) to $2,385m

 

-       Sales growth by therapy area in the quarter: Oncology +51% (+57% at CER) to $2,167m, New CVRM3 +9% (+13% at CER) to $1,061m and Respiratory +2% (+7% at CER) to $1,252m

 

-       Sales growth by region in the quarter: total Emerging Markets sales grew by 17% (27% at CER) to $1,947m, with China sales growth of 34% (44% at CER) to $1,166m, ahead of recent trends. US sales increased by 16% to $1,877m; Europe sales returned to growth, increasing by 1% (8% at CER) to $1,047m. Japan sales increased by 30% (34% at CER) to $672m

 

These results were accompanied by further positive pipeline developments, with the second half of the year anticipated to be an exceptionally busy period for the pipeline.

 


H1 2019

Q2 2019


$m

% change

$m

% change


Actual

CER

Actual

CER

Product Sales

11,183

12

17

5,718

14

19

Collaboration Revenue

131

(59)

(57)

105

(17)

(12)

Total Revenue

11,314

9

14

5,823

13

18








Reported4 Operating Profit

1,590

9

12

493

(35)

(37)

Core5 Operating Profit

3,011

39

44

1,361

7

8








Reported EPS6

$0.56

3

-

$0.09

(64)

(71)

Core EPS

$1.62

38

40

$0.73

5

1

 

Pascal Soriot, Chief Executive Officer, commenting on the results said:

"The momentum generated last year continued into the first half, consolidating AstraZeneca's return to growth based on the strength of our new medicines. Five of these new medicines are anticipated to be blockbusters this year, supporting sales across both Oncology and BioPharmaceuticals. Emerging Markets, the US and Japan all grew strongly, and we delivered an encouraging turnaround in Europe in the second quarter. Selective investment in sustainable growth also continued, particularly in Emerging Markets and in our launch programmes. Additional regulatory approvals for Lynparza in ovarian cancer in the EU and Japan, together with approvals for Breztri and Bevespi in COPD in Japan, illustrated further progress from our pipeline.

 

Accompanying earnings growth this year, we are pleased to upgrade our Product Sales guidance and we are committed to working on our operating leverage and driving cash generation over the long term."

 

 

Financial summary

 

-      Product Sales increased by 12% in the half (17% at CER) to $11,183m

 

-      The Reported Gross Margin increased by two percentage points in the half to 80%, partly reflecting the mix of Product Sales and manufacturing efficiencies; the Core Gross Margin increased by one percentage point to 81%

 

-      Reported Operating Expenses increased by 5% in the half (10% at CER) to $8,238m and represented 73% of Total Revenue (H1 2018: 76%). Core Operating Expenses increased by 1% (5% at CER) to $6,922m and represented 61% of Total Revenue (H1 2018: 67%), demonstrating operating leverage

 

-      Reported R&D Expenses declined by 1% (an increase of 3% at CER) to $2,622m. Core R&D Expenses declined by 2% (an increase of 2% at CER) to $2,505m

 

-      Reported SG&A Expenses increased by 9% (14% at CER) to $5,457m; Core SG&A Expenses increased by 3% (7% at CER) to $4,258m, primarily reflecting growth in China, as well as ongoing additional support for new medicines

 

-      Reported Other Operating Income and Expense declined by 35% in the half (34% at CER) to $706m; Core Other Operating Income and Expense increased by 1% (2% at CER) to $708m; in the second quarter, Core Other Operating Income and Expense declined by 80% to $114m

 

-      The Reported Operating Margin was stable in the half at 14%; the Core Operating Margin increased by six percentage points (five at CER) to 27%

 

-      Reported EPS of $0.56 in the half, based on a weighted-average number of shares of 1,289m, represented an increase of 3% (stable at CER); Core EPS increased by 38% (40% at CER) to $1.62. The difference between the Reported and Core performance partly reflected the impact of a favourable $346m legal settlement in H1 2018, recognised as income in Reported Other Operating Income and Expense, as well as the commencement of the amortisation of Lokelma and fair-value adjustments arising on acquisition-related liabilities recognised in Reported SG&A Expense in Q2 2019

 

-      The Reported Tax Rate was 25% (H1 2018: 19%); the Core Tax Rate was 21% (H1 2018: 19%). The tax rates in the half reflected the geographical mix of profits and the impact of collaboration and divestment activity

 

-      An unchanged first interim dividend of $0.90 per share

 

-      The Company today upgrades part of its financial guidance for the year (see page four)

 

Commercial summary

 

Oncology

Sales growth of 52% in the half (58% at CER) to $4,059m, including:

 

-    Tagrisso sales of $1,414m, representing growth of 86% in the half (92% at CER) that was driven by 2018 regulatory approvals in the 1st-line EGFR7-mutated (EGFRm) NSCLC8 setting. There was a sequential quarterly increase of 16% in US sales of Tagrisso from the first to the second quarter, partly reflecting continued underlying demand growth. Japan sales increased by 147% (151% at CER) to $291m

 

-    Imfinzi sales of $633m, representing growth of 244% (248% at CER). While the majority of sales were in the US, Europe sales amounted to $60m (H1 2018: $3m), with Japan sales of $86m ($nil in H1 2018)

 

-    Lynparza sales of $520m, representing growth of 93% (100% at CER), driven by expanded use in the treatment of ovarian and breast cancer in the US and Europe. The performance included growth in Emerging Markets of 228% (267% at CER) to $59m and growth in Japan of 480% (490% at CER) to $58m

 

-    The performance from more-mature Oncology medicines in the half included Faslodex growth of 4% (8% at CER) to $521m and an 8% decline in Iressa sales (3% at CER) to $252m. The Company anticipates increased challenges for both medicines in the second half, partly reflecting additional generic Faslodex competition in the US and the pricing impact on Iressa from centralised procurement in China

 

-    Oncology sales growth in Emerging Markets of 40% (52% at CER) to $1,048m

 

New CVRM

Sales growth of 12% in the half (16% at CER) to $2,094m, including:

 

-    Brilinta sales of $737m, representing growth of 21% (26% at CER). Patient uptake continued in the treatment of acute coronary syndrome and high-risk post-myocardial infarction

 

-    Farxiga sales of $726m, with growth of 14% (19% at CER), ahead of an anticipated label update in major markets to reflect results from the DECLARE CV outcomes trial

 

-    Bydureon sales of $283m, a decline of 4% (3% at CER), driven by production constraints that are now resolved

 

-    New CVRM sales growth in Emerging Markets of 31% (44% at CER) to $521m

 

Respiratory

Sales growth of 5% in the half (10% at CER) to $2,535m, including:

 

-    A Symbicort sales decline of 10% (6% at CER) to $1,170m, reflecting continued pricing pressure and the impact of managed-market rebates in the US. This was partially offset by positive volumes from US government-buying patterns

 

-    Pulmicort sales growth of 13% (19% at CER) to $716m; the majority of Pulmicort sales were in Emerging Markets. Q2 2019 global sales increased by 16% (23% at CER) to $333m

 

-    Fasenra sales of $296m, representing growth of 244% (249% at CER). New-to-brand prescription data showed that Fasenra was generally the preferred novel-biologic medicine for the treatment of severe asthma during the period, in markets where Fasenra is established, despite being the third such medicine to launch

 

-    Respiratory sales growth in Emerging Markets of 22% (30% at CER) to $956m

 

Emerging Markets

As the Company's largest region, at 35% of total Product Sales, Emerging Markets sales increased by 15% in the half (24% at CER) to $3,951m, including:

 

-      A China sales increase of 27% in the half (35% at CER) to $2,408m. Highlights included Oncology sales growth of 58% (68% at CER) to $635m and New CVRM growth of 72% (83% at CER) to $218m

 

-    An ex-China sales increase of 1% in the half (10% at CER) to $1,543m. The performance was negatively impacted by product divestments and developments in Brazil. Positive developments, however, included sales of $569m in (non-China) Asia-Pacific (+5%, +9% at CER) and $112m in Russia (+67%, +85% at CER)

 

 

Pipeline highlights

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

 

Regulatory approvals

-     Lynparza - ovarian cancer (1st line, BRCAm9): regulatory approval (EU, JP)

-     Qternmet XR - T2D10: regulatory approval (US)

-     Bevespi - COPD11: regulatory approval (JP)

-     Breztri (formerly PT010) - COPD: regulatory approval (JP)

Regulatory submissions and/or acceptances

-     Lynparza - pancreatic cancer (BRCAm): regulatory submission acceptance (EU)

-     Forxiga - T2D CVOT12: regulatory submission (CN)

-     Lokelma - hyperkalaemia: regulatory submission (JP, CN)

Major Phase III data readouts or other significant developments

-     Imfinzi - SCLC13: met Phase III primary endpoint

-     Imfinzi - SCLC: Orphan Drug Designation (US)

-     trastuzumab deruxtecan - breast cancer (3rd line, HER2+): met pivotal Phase II primary endpoint

-     Calquence - CLL14 (relapsed/refractory): met Phase III primary endpoint

-     Calquence - CLL (treatment-naïve): met Phase III primary endpoint

-     Forxiga - T2D CVOT: positive opinion (EU)

-     Farxiga - T1D15: complete response letter (US)

-     Lokelma - hyperkalaemia: priority review (CN)

-     roxadustat - anaemia of CKD16: pooled Phase III CV safety confirmed

-     Breztri - COPD: priority review (CN)

-     Fasenra - severe asthma (self-administration and auto-injector): positive opinion (EU)

 

Financial priorities, including guidance

All measures in this section are at CER and Company guidance is on Product Sales and Core EPS only.

 

All guidance and indications provided assume that the UK's anticipated exit from the European Union (EU), even in the event of a no-deal exit, proceeds in an orderly manner such that the impact is within the range expected, following the Company's extensive preparations for such an eventuality.

 

AstraZeneca anticipates strong and sustainable long-term Product Sales growth to be accompanied by operating leverage, leading to an improvement in profitability and cash generation.

 

Product Sales

Reflecting the performance in the first half and the return to Product Sales growth in H2 2018, Product Sales in FY 2019 are now expected to increase by a low double-digit percentage; the prior guidance was for a high single-digit percentage increase.

 

Core EPS

As a key part of its long-term growth strategy, the Company is committed to focusing on appropriate cash-generating and value-accretive collaboration activities that reflect the ongoing productivity of the pipeline. Separately, AstraZeneca will, from time to time, also focus its medicine portfolio through divestments.

 

AstraZeneca reiterates its Core EPS guidance of $3.50 to $3.70 over the full year. This guidance includes the anticipation of a lower sum of Collaboration Revenue and Core Other Operating Income and Expense versus the prior year.

 

Variations in performance between quarters can be expected to continue. The Company is unable to provide guidance and indications on a Reported basis because the Company cannot reliably forecast material elements of the Reported result, including the fair-value adjustments arising on acquisition-related liabilities, intangible-asset impairment charges and legal-settlement provisions. Please refer to the section Cautionary Statements Regarding Forward-Looking Statements at the end of this announcement.

 

Operating leverage

The Company expects to deliver significant operating leverage over the long term. Encouraging progress was made in the half, with the Reported Operating Margin stable at 14% and the Core Operating Margin increasing by six percentage points (five at CER) to 27%. Core Operating Profit is anticipated to increase in the year by a mid-teens percentage versus FY 2018, ahead of Product Sales.

 

Cash generation

In FY 2019, the cash performance is expected to include a number of payments relating to prior business-development transactions; the majority of the value of these payments in the year was settled in the first half. AstraZeneca generated a net cash inflow from operating activities of $491m in the half, compared to an outflow of $75m in H1 2018.

 

Other indications

The Company also provides other indications for FY 2019:

 

-      Capital expenditure is expected to be broadly stable and restructuring expenses are targeted to reduce versus the prior year

 

-      A Core Tax Rate of 18-22% (FY 2018: 11%)

 

Currency impact

If foreign-exchange rates were to remain at the average of rates seen in the period from January to June 2019, it is anticipated that there would be a low single-digit percentage adverse impact on Product Sales and Core EPS. In addition, the Company's foreign-exchange rate sensitivity analysis is contained within the operating and financial review.

 

Sustainability

AstraZeneca's sustainability ambition is founded on making science accessible and operating in a way that recognises the interconnection between the health of the business, people and the planet and that each of these impact one another. The Company's sustainability ambition is reinforced by its purpose and values, which are intrinsic to its business model and ensures that the delivery of its strategy broadens access to healthcare, minimises the environmental footprint of its activities and products of medicines and processes and ensures that all business activities are underpinned by the highest levels of ethics and transparency. A full update on the Company's sustainability progress is shown in the Sustainability section of this announcement.

 

Notes

The following notes refer to pages 1-5:

 

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.   Tagrisso, Imfinzi, Lynparza, Calquence, Farxiga, Brilinta, Lokelma, Fasenra, Bevespi and Breztri. These new medicines are pillars in the main therapy areas and are important platforms for future growth.

 

3.   New Cardiovascular (CV), Renal and Metabolism, incorporating Diabetes medicines, Brilinta and Lokelma.

 

4.   Reported financial measures are the financial results presented in accordance with International Financial Reporting Standards, as issued by the International Accounting Standards Board and adopted by the EU.

 

5.   Core financial measures. These are non-GAAP financial measures because, unlike Reported performance, they cannot be derived directly from the information in the Company Financial Statements. See the operating and financial review for a definition of Core financial measures and a reconciliation of Core to Reported financial measures.

 

6.   Earnings per share.

 

7.   Epidermal growth factor receptor.

 

8.   Non-small cell lung cancer.

 

9.   Breast cancer susceptibility genes 1/2, mutated.

 

10.  Type-2 diabetes.

 

11. Chronic obstructive pulmonary disease.

 

12. CV outcomes trial.

 

13. Small cell lung cancer.

 

14. Chronic lymphocytic leukaemia.

 

15. Type-1 diabetes.

 

16. Chronic kidney disease.

 

 

Pipeline: anticipated major news flow

Innovation is critical to addressing unmet patient needs and is at the heart of the Company's growth strategy. The focus on research and development is designed to yield strong and sustainable results from the pipeline.

 

H2 2019

 

-      Tagrisso - NSCLC (1st line, EGFRm): regulatory decision (CN)

-      Tagrisso - NSCLC (1st line, EGFRm): data readout (final OS[17])

-      Imfinzi - unresectable, Stage III NSCLC (PACIFIC): regulatory decision (CN)

-      Imfinzi + treme - NSCLC (1st line) (NEPTUNE): data readout

-      Imfinzi +/- treme - NSCLC (1st line) (POSEIDON): data readout, regulatory submission

-      Imfinzi +/- treme - small cell lung cancer: regulatory submission

-      Imfinzi +/- treme - head & neck cancer (1st line): data readout

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

-      Lynparza - ovarian cancer (1st line, BRCAm) (SOLO-1): regulatory decision (CN)

-      Lynparza - pancreatic cancer (BRCAm): regulatory submission

-      Lynparza - ovarian cancer (3rd line, BRCAm): regulatory submission (US)

-      Lynparza - ovarian cancer (1st line) (PAOLA-1): data readout, regulatory submission

-      Lynparza - prostate cancer (2nd line, castration-resistant): data readout, regulatory submission

-      trastuzumab deruxtecan - advanced/refractory, metastatic breast cancer (HER2[18]-positive): regulatory submission (US)

-      Calquence - CLL: regulatory submission

-      selumetinib - NF1[19]: regulatory submission

 

-      Farxiga - T2D CVOT: regulatory decision (US, EU)

-      Farxiga - heart failure CVOT: data readout

-      Brilinta - CAD[20]/T2D CVOT: regulatory submission

-      roxadustat - anaemia of CKD: regulatory submission (US)

 

-      Symbicort - mild asthma: regulatory submission (CN)

-      Bevespi - COPD: regulatory decision (CN)

-      Fasenra - self-administration and auto-injector: regulatory decision (US)

-      Breztri - COPD: data readout (ETHOS)

 

H1 2020

 

-      Imfinzi + treme - NSCLC (1st line) (NEPTUNE): regulatory submission

-      Imfinzi +/- treme - head & neck cancer (1st line): regulatory submission

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

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

-      Lynparza + cediranib - ovarian cancer (2nd line): data readout, regulatory submission

-      trastuzumab deruxtecan - advanced/refractory, metastatic gastric cancer (HER2-positive): data readout

 

-      Farxiga - heart failure CVOT: regulatory submission

-      Brilinta - stroke (THALES): data readout

-      Lokelma - hyperkalaemia: regulatory decision (JP, CN)

 

-      Breztri - COPD: regulatory decision (US, EU, CN)

 

H2 2020

 

-      Imfinzi - neo-adjuvant NSCLC: data readout

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

-      Imfinzi +/- treme - liver cancer: data readout

 

-      Brilinta - stroke (THALES): regulatory submission

-      Epanova - hypertriglyceridaemia CVOT: data readout

-      roxadustat - anaemia of myelodysplastic syndrome: data readout

 

-      Fasenra - nasal polyposis: data readout, regulatory submission

-      PT027 - asthma: data readout

-      tezepelumab - severe asthma: data readout

 

 

Conference call

A conference call and webcast for investors and analysts will begin at 12pm UK time today. Details can be accessed via astrazeneca.com.

 

Reporting calendar

The Company intends to publish its year-to-date and third-quarter financial results on 24 October 2019.

 

About AstraZeneca

AstraZeneca 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. 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 us on Twitter @AstraZeneca.

 

Investor Relations



Thomas Kudsk Larsen


+44 203 749 5712

Henry Wheeler

Oncology

+44 203 749 5797

Christer Gruvris

BioPharmaceuticals (CV, metabolism)

+44 203 749 5711

Nick Stone

BioPharmaceuticals (respiratory, renal)

+44 203 749 5716

Josie Afolabi

Other medicines

+44 203 749 5631

Craig Marks

Finance, fixed income

+44 7881 615 764

Jennifer Kretzmann

Corporate access, retail investors

+44 203 749 5824

US toll-free


+1 866 381 7277




Media Relations



Gonzalo Viña


+44 203 749 5916

Rob Skelding

Oncology

+44 203 749 5821

Rebecca Einhorn

Oncology

+1 301 518 4122 

Matt Kent

BioPharmaceuticals

+44 203 749 5906

Jennifer Hursit

Other

+44 7384 799 726

Christina Malmberg Hägerstrand

Sweden

+46 8 552 53 106

Michele Meixell

US

+1 302 885 2677

 

 

Operating and financial review

 

All narrative on growth and results in this section is based on actual exchange rates, unless stated otherwise. Financial figures are in US$ millions ($m), unless stated otherwise. The performance shown in this announcement covers the six-month period to 30 June 2019 (the half or H1 2019) and three-month period to 30 June 2019 (the quarter or Q2 2019) compared to the six-month period to 30 June 2018 (H1 2018) and three-month period to 30 June 2018 (Q2 2018) respectively, unless stated otherwise.

 

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 Company 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 Company 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 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 76 of the Annual Report and Form 20-F Information 2018. Reference should be made to the reconciliation of Core to Reported financial information and the Reconciliation of Reported to Core financial measures table included in the financial performance section of 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 of 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 section of 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 percentages may not agree to totals.

 

Table 1: Total Revenue

 


H1 2019

Q2 2019


$m

% change

$m

% change


Actual

CER

Actual

CER

Product Sales

11,183

12

17

5,718

14

19

Collaboration Revenue

131

(59)

(57)

105

(17)

(12)








Total Revenue

11,314

9

14

5,823

13

18

 

Table 2: Product Sales

 


H1 2019

Q2 2019


$m

% of total

% change

$m

% of total

% change


Actual

CER

Actual

CER

Oncology

4,059

36

52

58

2,167

38

51

57










BioPharmaceuticals

 4,629

42

 8

13

2,313 

41

 5

 10

New CVRM

2,094

19

12

16

1,061

19

9

13

Respiratory

2,535

23

5

10

1,252

22

2

7










Other medicines

2,495

22

(19)

(14)

1,238

22

(11)

(6)










Total

11,183

100

12

17

5,718

100

14

19

 

Table 3: Top-ten medicines by Product Sales

 

Medicine

Therapy Area

H1 2019

Q2 2019

$m

% of total

% change

$m

% of total

% change

Actual

CER

Actual

CER

Tagrisso

Oncology

1,414

13

86

92

784

14

86

92

Symbicort

Respiratory

1,170

10

(10)

(6)

585

10

(13)

(9)

Nexium

Other medicines

756

7

(15)

(11)

393

7

(11)

(7)

Brilinta

CVRM

737

7

21

26

389

7

23

28

Farxiga

CVRM

726

6

14

19

377

7

11

16

Pulmicort

Respiratory

716

6

13

19

333

6

16

23

Crestor

CVRM

645

6

(11)

(6)

310

5

(8)

(3)

Imfinzi

Oncology

633

6

n/m

n/m

338

6

n/m

n/m

Faslodex

Oncology

521

5

4

8

267

5

8

12

Lynparza

Oncology

520

5

93

n/m

283

5

89

95











Total


7,838

70

20

25

4,059

71

22

27

 

Table 4: Collaboration Revenue

 


H1 2019

Q2 2019




% change



% change


$m

% of total

Actual

CER

$m

% of total

Actual

CER

Initial Collaboration Revenue

-

-

n/m

n/m

-

-

n/m

n/m










Ongoing Collaboration Revenue

131

100

(40)

(36)

105

100

(17)

(12)

Royalties

32

24

52

60

15

14

19

26

Milestones/Other

99

76

(49)

(47)

90

86

(21)

(16)










Total

131

100

(59)

(57)

105

100

(17)

(12)

 

 

Product Sales

 

The performance of new and legacy medicines is shown below, with a geographical split shown in Note 7.

 

Table 5: H1 2019 therapy area and medicine performance

 

Therapy Area

Medicine

H1 2019

$m

% of

total

% change

 

Actual

CER

 

Oncology

Tagrisso

1,414

13

86

92

 

Imfinzi

633

6

n/m

n/m

 

Lynparza

520

5

93

n/m

 

Iressa

252

2

(8)

(3)

 

Calquence

64

1

n/m

n/m

 

Legacy:





 

Faslodex

521

5

4

8

 

Zoladex

391

3

4

11

 

Arimidex

111

1

-

7

 

Casodex

105

1

1

7

 

Others

48

-

(25)

(23)

 

Total Oncology

4,059

36

52

58

 

BioPharmaceuticals: CVRM

Farxiga

726

6

14

19

 

Brilinta

737

7

21

26

 

Onglyza

269

2

5

10

 

Bydureon

283

3

(4)

(3)

 

Byetta

55

-

(8)

(5)

 

Symlin

15

-

(6)

(6)

 

Legacy:





 

Crestor

645

6

(11)

(6)

 

Seloken/Toprol-XL

393

4

5

14

 

Atacand

106

1

(21)

(16)

 

Others

143

1

(10)

(6)

 

BioPharmaceuticals: total CVRM

3,372

30

3

8

 

BioPharmaceuticals: Respiratory

Symbicort

1,170

10

(10)

(6)

 

Pulmicort

716

6

13

19

 

Fasenra

296

3

n/m

n/m

 

Daliresp/Daxas

104

1

25

27

 

Tudorza/Eklira

33

-

(55)

(52)

 

Duaklir

37

-

(26)

(20)

 

Bevespi

20

-

54

54

 

Others

159

3

(2)

4

 

BioPharmaceuticals: total Respiratory

2,535

23

5

10

 

Other medicines

Nexium

756

7

(15)

(11)

 

Losec/Prilosec

144

1

(1)

6

 

Synagis

149

1

(40)

(40)

 

Seroquel XR/IR

69

1

(70)

(68)

 

Movantik/Moventig

47

-

(10)

(10)

 

Others

52

-

(53)

(49)

 

Total other medicines

1,217

11

(27)

(24)

 


Total Product Sales

11,183

100

12

17

 

 

Specialty-care medicines comprise all Oncology medicines and Fasenra. At 39% of Product Sales (H1 2018: 27%), specialty-care medicine sales increased by 58% in the half (64% at CER) to $4,355m.

 

Table 6: Q2 2019 therapy area and medicine performance

 

Therapy Area

Medicine

Q2 2019

$m

% of

total

% change

 

Actual

CER

 

Oncology

Tagrisso

784

14

86

92

 

Imfinzi

338

6

n/m

n/m

 

Lynparza

283

5

89

95

 

Iressa

118

2

(17)

(13)

 

Calquence

35

1

n/m

n/m

 

Legacy:





 

Faslodex

267

5

8

12

 

Zoladex

197

3

3

10

 

Arimidex

60

1

5

14

 

Casodex

57

1

10

17

 

Others

28

-

(24)

(24)

 

Total Oncology

2,167

38

51

57

 

BioPharmaceuticals: CVRM

Farxiga

377

7

11

16

 

Brilinta

389

7

23

28

 

Onglyza

116

2

(8)

(4)

 

Bydureon

141

2

(9)

(8)

 

Byetta

25

-

(14)

(10)

 

Symlin

8

-

14

14

 

Legacy:





 

Crestor

310

5

(8)

(3)

 

Seloken/Toprol-XL

168

3

(3)

5

 

Atacand

56

1

(14)

(9)

 

Others

68

1

(7)

(4)

 

BioPharmaceuticals: total CVRM

1,658

29

2

7

 

BioPharmaceuticals: Respiratory

Symbicort

585

10

(13)

(9)

 

Pulmicort

333

6

16

23

 

Fasenra

167

3

n/m

n/m

 

Daliresp/Daxas

56

1

24

24

 

Tudorza/Eklira

13

-

(71)

(69)

 

Duaklir

17

-

(23)

(14)

 

Bevespi

10

-

25

25

 

Others

71

1

(13)

7

 

BioPharmaceuticals: total Respiratory

1,252

22

2

7

 

Other medicines

Nexium

393

7

(11)

(7)

 

Losec/Prilosec

68

1

(11)

(4)

 

Synagis

96

2

n/m

n/m

 

Seroquel XR/IR

32

1

(76)

(74)

 

Movantik/Moventig

22

-

(8)

(8)

 

Others

30

1

(36)

(26)

 

Total Other medicines

641

11

(14)

(10)

 


Total Product Sales

5,718

100

14

19

 

 

 

Product Sales summary

 

Oncology

 

Product Sales of $4,059m; an increase of 52% (58% at CER). Oncology Product Sales represented 36% of total Product Sales, up from 27% in H1 2018.

 

Oncology: lung cancer

 

Tagrisso

Tagrisso has been approved and launched in 84 countries, including the US, in Europe, Japan and China for the 2nd-line treatment of patients with Stage IV EGFR T790M[21]-mutated NSCLC. By the end of the half, Tagrisso had been approved in 74 countries, including the US, in Europe and Japan for the 1st-line treatment of patients with EGFRm NSCLC; a number of additional regulatory reviews are also underway.

 

Product Sales in the half of $1,414m represented growth of 86% (92% at CER), partly driven by regulatory approvals and reimbursements in the 1st-line setting. Continued growth was also delivered in the 2nd-line indication in other countries, including in Europe and in Emerging Markets.

 

Sales in the US increased by 64% in the half to $559m. With a high penetration rate, Tagrisso is now established as the standard of care (SoC) in the 1st-line setting, following regulatory approval in 2018. There was a 16% sequential quarterly increase in US sales of Tagrisso within the half, partly reflecting continued underlying demand growth.

 

In Emerging Markets, Tagrisso sales increased by 107% in the half (121% at CER) to $329m, with notable growth in China, where the medicine was added to the National Reimbursement Drug List (NRDL) with effect from January 2019 in the 2nd-line setting. The Asia-Pacific region has a relatively high prevalence of lung-cancer patients with an EGFR mutation; at c.30-40% of the total, this contrasts with c.10-15% in the Western Hemisphere.

 

In Europe, sales of $212m in the half represented an increase of 53% (64% at CER), driven by emerging use in the 1st-line setting as more countries gained reimbursement, as well as continued strong levels of demand in the 2nd-line setting. Sales of Tagrisso in Japan increased by 147% in the half (151% at CER) to $291m, reflecting the increasing use of Tagrisso as a 1st-line treatment, where Tagrisso has reached a very high penetration rate.

 

Imfinzi

Imfinzi is approved in 49 countries, including the US, in Europe and Japan for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following platinum-based chemoradiation therapy (CRT). It is also approved for the 2nd-line treatment of patients with locally-advanced or metastatic urothelial carcinoma (bladder cancer) in 10 countries, including the US.

 

Global Product Sales of Imfinzi increased by 244% in the half (248% at CER) to $633m, of which $473m were in the US, almost entirely for the treatment of unresectable, Stage III NSCLC. Sales of $86m in Japan ($nil in H1 2018) reflected strong demand, supported by higher CRT and treatment rates. Sales in Europe of $60m (H1 2018: $3m) followed recent regulatory approvals and launches; additional regulatory decisions are expected in due course.

 

Iressa

Product Sales in the half of $252m; a decline of 8% (3% at CER).

 

Emerging Markets sales increased by 11% in the half (18% at CER) to $164m; Iressa entered the NRDL in China in 2017 and was included in the China '4+7' pilot tender scheme in 2018. This scheme, focused on centralised procurement, centres on 11 major cities (four municipalities and seven provincial cities). Given the growing use of Tagrisso, sales of Iressa declined by 43% to $8m in the US and by 25% (20% at CER) to $46m in Europe. Japan sales amounted to $31m, reflecting a decline of 34% (32% at CER).

Oncology: Lynparza

 

By the end of the half, Lynparza was approved in 64 countries for the treatment of ovarian cancer. Launches for the treatment of metastatic breast cancer took place in the US and Japan in 2018 and regulatory approval was granted in the EU in April 2019. Lynparza has now been approved in 40 countries for the treatment of metastatic breast cancer.

 

Product Sales of Lynparza amounted to $520m in the half, an increase of 93% (100% at CER). The strong performance was geographically spread, with launches continuing in Emerging Markets and the Established Rest of World region (RoW). Ongoing MSD[22] co-promotion efforts also contributed to sales.

 

US sales increased by 76% to $262m, driven by the launch in the 1st-line BRCAm ovarian cancer indication at the end of 2018 and increased demand that reflected continued growth in the treatment with Lynparza of patients suffering from ovarian or breast cancer. Lynparza remained the leading US medicine in the poly ADP ribose polymerase (PARP)-inhibitor class, as measured by total prescription volumes and in both ovarian and breast cancer.

 

The Company received approval during the period for the 1st-line BRCAm ovarian cancer indication in both Europe and Japan, as well as approval for BRCAm breast cancer in Europe. Sales in Europe increased by 51% (61% at CER) to $131m, driven by increasing levels of reimbursement and BRCA-testing rates; sales also benefitted from clinical-trial supply. The Company continues to implement a number of launches in the broad, 2nd-line, maintenance ovarian-cancer indication, regardless of BRCA-mutation status.

 

Following the initial launch in April 2018, Japan sales of Lynparza, as a treatment for 2nd-line maintenance ovarian cancer and BRCAm breast cancer, amounted to $58m. Emerging Markets sales of $59m reflected the regulatory approval of Lynparza as a 2nd-line maintenance treatment of patients with ovarian cancer by the China National Medical Products Administration (NMPA), resulting in the subsequent launch of Lynparza in China, the first PARP inhibitor to be approved in the country.

 

Oncology: haematology and other Oncology medicines

 

Calquence

Product Sales in the half of $64m; an increase of 220%. The overwhelming majority of sales were in the US.

 

Calquence was approved and launched in the US in October 2017. The medicine delivered a promising performance in the half, with c.45% of new patients now treated with Calquence in the approved indication of 2nd-line mantle cell lymphoma (MCL). At the end of 2018, the first regulatory approvals outside the US for the treatment of patients with MCL were granted.

 

Legacy: Faslodex

Product Sales in the half of $521m; an increase of 4% (8% at CER).

 

Emerging Markets sales of Faslodex increased by 35% in the half (49% at CER) to $96m. US sales declined by 3% to $251m, reflecting the launch of a generic Faslodex medicine in the second quarter; additional generic competition is expected. Europe sales declined by 7% (stable at CER) to $110m, driven by the continued impact of generic medicines in certain countries. In Japan, sales increased by 22% (24% at CER) to $61m.

 

Legacy: Zoladex

Product Sales in the half of $391m; an increase of 4% (11% at CER).

 

Emerging Markets sales of Zoladex increased by 16% (27% at CER) to $235m. Sales in Europe declined by 4% (up by 1% at CER) to $65m. In the Established RoW region, sales declined by 16% (13% at CER) to $87m, driven by the effects of increased competition.

 

BioPharmaceuticals: CVRM

 

Total CVRM sales, which include Crestor and other legacy medicines, increased by 3% in the half (8% at CER) to $3,372m and represented 30% of total Product Sales (H1 2018: 33%).

 

New CVRM sales increased by 12% in the half (16% at CER) to $2,094m, reflecting strong performances from Farxiga and Brilinta. New CVRM sales represented 19% of Product Sales (H1 2018: 19%).

 

CVRM: Diabetes

 

Farxiga

Product Sales in the half of $726m; an increase of 14% (19% at CER).

 

Emerging Markets sales of Forxiga increased by 31% (45% at CER) to $206m, fuelled by growth in China. US sales increased by 2% to $270m, impacted by changes in formulary access for competitor medicines. AstraZeneca anticipates a potential label update in the second half in the US and the EU to reflect results from the DECLARE CVOT.

 

Sales in Europe increased by 17% (26% at CER) to $178m. In Japan, sales to the collaborator, Ono Pharmaceutical Co., Ltd, which records in-market sales in Japan, increased by 32% to $37m.

 

Onglyza 

Product Sales in the half of $269m; an increase of 5% (10% at CER).

 

The performance was partly driven by favourable prior year gross-to-net adjustments in the US, where sales increased by 22% in the half to $120m. Sales in Emerging Markets increased by 7% (16% at CER) to $87m, driven by the performance in China. Europe sales declined by 23% (17% at CER) to $36m, highlighting the broader trend of a shift away from the dipeptidyl peptidase-4 inhibitor class. Given the significant future potential of Farxiga, the Company continues to prioritise commercial support over Onglyza.

 

Bydureon

Product Sales of $283m; a decline of 4% (3% at CER).

 

Sales were adversely impacted by production constraints that are now resolved. US sales of $234m were stable in the period where favourable sales volumes were driven by continued growth in the glucagon-like peptide-1 class, at the expense of insulin, for more-advanced T2D patients. Bydureon sales in Europe declined by 21% (19% at CER) to $34m.

 

CVRM: other medicines

 

Brilinta

Product Sales of $737m; an increase of 21% (26% at CER).

 

Patient uptake continued in the treatment of acute coronary syndrome and high-risk post-myocardial infarction. Emerging Markets sales of Brilinta increased by 47% (58% at CER) to $217m. US sales of Brilinta, at $321m, represented an increase of 24%, driven primarily by increasing levels of demand in both hospital and retail settings, as well as a lengthening in the average-weighted duration of treatment, reflecting the growing impact of 90-day prescriptions. Sales of Brilique in Europe declined by 1% in the half (up by 7% at CER) to $171m.

 

Lokelma

Product Sales of $2m, predominantly in the US, where Lokelma was recently launched.

 

Lokelma is approved in the US and EU for the treatment of hyperkalaemia, a serious condition characterised by elevated potassium levels in the blood associated with CV, renal and metabolic diseases. Launches in a number of other markets are expected soon.

 

Legacy: Crestor

Product Sales of $645m; a decline of 11% (6% at CER).

 

Sales in China declined by 2% (up by 5% at CER) to $234m; the CER growth came despite the impact from the aforementioned '4+7' pilot tender scheme. US sales declined by 40% to $54m, underlining the ongoing effect of generic Crestor medicines. In Europe, sales declined by 32% (27% at CER) to $75m, reflecting a similar impact that began in Europe in 2017. In Japan, where AstraZeneca collaborates with Shionogi Co. Ltd, sales increased by 12% (14% at CER) to $85m. This followed a period of decline resulting from the entry of multiple generic Crestor medicines in the Japan market at the end of 2017.

 

BioPharmaceuticals: Respiratory

 

Product Sales of $2,535m; an increase of 5% (10% at CER). Respiratory represented 23% of total Product Sales (H1 2018: 24%).

 

Symbicort

Product Sales in the half of $1,170m; a decline of 10% (6% at CER).

 

Symbicort continued to lead the global market by volume within the inhaled corticosteroid (ICS) / long-acting beta agonist (LABA) class. Emerging Markets sales of Symbicort increased by 9% (18% at CER) to $263m. In contrast, US sales declined by 13% to $382m, reflecting continued pricing pressure and the impact of managed-market rebates. This was partially offset by positive volumes from government-buying patterns.

 

In Europe, sales declined by 14% in the half (7% at CER) to $354m, reflecting price competition from other branded and Symbicort-analogue medicines, plus government pricing interventions. Symbicort, however, continued to retain its class-leadership position, with volume growth achieved in a number of markets.

 

In Japan, sales declined by 33% (32% at CER) to $67m following destocking by Astellas Pharma Co. Ltd (Astellas). In January 2019, AstraZeneca and Astellas announced that the sale and distribution of Symbicort, conducted by Astellas in Japan was to be transferred back to AstraZeneca and that the co-promotion conducted by Astellas and AstraZeneca will be terminated on 30 July 2019. The Company will solely distribute and promote the medicine in Japan from 31 July 2019. In addition, during the period, the first generic Symbicort medicine received regulatory approval, and multiple generic Symbicort medicines are anticipated to enter the Japanese market in due course.

 

Pulmicort 

Product Sales in the half of $716m; an increase of 13% (19% at CER).

 

Emerging Markets, where sales increased by 20% (27% at CER) to $576m, represented 80% of global sales of Pulmicort. China, making up the overwhelming majority of Pulmicort sales in Emerging Markets, delivered a particularly strong double-digit performance, strengthened by higher demand and underpinned by the impact of AstraZeneca's support to build capacity in over 17,000 nebulisation centres.

 

Sales in the US and Europe declined by 5% to $56m and by 12% (6% at CER) to $44m, respectively, a consequence of the medicine's legacy status.

 

Fasenra

Product Sales of $296m, an increase of 244% (249% at CER).

 

Sales in the US increased by 210% to $208m in the half. New-to-brand prescription data showed that Fasenra was the preferred novel-biologic medicine for the treatment of severe asthma during the period, despite being the third medicine to enter the market.

 

In Europe and Japan, AstraZeneca was granted regulatory approval in January 2018 on a similar basis to that in the US. In Europe, sales of $45m in the half represented an increase of 463% (488% at CER), which included strong sales in Germany. Sales in Japan increased by 245% (255% at CER) to $38m, following its launch in the second quarter of 2018. In addition, Fasenra led the novel severe asthma biologic-medicine class by new patient share in Germany and Japan during the period.

 

Daliresp/Daxas

Product Sales in the half of $104m; an increase of 25% (27% at CER).

 

US sales, representing 86% of the global total, increased by 33% to $89m, driven by favourable affordability-programme changes and inventory movements. It is the only oral, selective, long-acting inhibitor of phosphodiesterase-4, an inflammatory enzyme associated with COPD.

 

Duaklir

Product Sales in the half of $37m; a decline of 26% (20% at CER).

 

Duaklir, the Company's first inhaled dual bronchodilator medicine, is now available for patients in over 25 countries. In the first half, the overwhelming majority of sales were in Europe, where sales declined by 23% (19% at CER) to $36m, predominately as a result of the performance in Germany.

 

In Q1 2019, the medicine received US regulatory approval. As part of the collaboration agreement announced in March 2017, Circassia Pharmaceuticals plc (Circassia) will be responsible for the commercialisation of Duaklir in the US, with AstraZeneca continuing to manufacture and supply the medicine. Circassia expects to launch the medicine in the US in H2 2019.

 

Bevespi

Product Sales in the half of $20m; an increase of 54%.

 

Bevespi saw prescriptions in the period track in line with other LAMA/LABA launches; the class in the US, however, continued to grow more slowly than anticipated previously. Bevespi was the first medicine launched using the Company's proprietary Aerosphere delivery technology.

 

Other medicines (outside the main therapy areas)

 

Product Sales of $1,217m in the half; a decline of 27% (24% at CER), partly reflecting the recent divestment of US rights to Synagis and the divestment of the prescription medicine rights to Nexium in Europe to Grünenthal GmbH. Other Product Sales represented 11% of total Product Sales, down from 17% in H1 2018.

 

Nexium 

Product Sales in the half of $756m; a decline of 15% (11% at CER).

 

Emerging Markets sales of Nexium increased by 8% (15% at CER) to $369m. In Europe, sales declined by 74% to $32m reflecting the aforementioned divestment. Sales in the US declined by 36% to $119m and in Japan, where AstraZeneca collaborates with Daiichi Sankyo Company, Limited (Daiichi Sankyo), sales increased by 1% (3% at CER) to $207m.

 

 

Regional Product Sales

 

Table 7: Regional Product Sales, H1 2019

 


H1 2019

Q2 2019

$m

% of total

% change

$m

% of total

% change

Actual

CER

Actual

CER

Emerging Markets

3,951

35

15

24

1,947

34

17

27

China

2,408

22

27

35

1,166

20

34

44

 Ex-China

1,543

14

1

10

781

14

(1)

7










US

3,663

33

18

18

1,877

33

16

16










Europe

2,029

18

(6)

1

1,047

18

1

8










Established RoW

1,540

14

16

19

847

15

17

21

Japan

1,173

10

28

31

672

12

30

34

Canada

225

2

(8)

(3)

111

2

(6)

(2)

Other Established RoW

142

1

(18)

(11)

64

1

(26)

(20)










Total

11,183

100

12

17

5,718

100

14

19

 

Table 8: Regional Product Sales, Emerging Markets

Product Sales of $3,951m in the half; an increase of 15% (24% at CER), continuing the strong performance seen in prior periods. New medicines represented 21% of Emerging Markets sales (H1 2018: 14%). Notable performances included Tagrisso ($329m, +107%, 121% at CER), Farxiga ($206m, +31%, +45% at CER), Brilinta ($217m, 47%, 58% at CER). Ex-China Emerging Market sales increased by 1% (10% at CER) to $1,543m.

 


H1 2019

Q2 2019

$m

% of total

% change

$m

% of total

% change

Actual

CER

Actual

CER

Oncology

1,048

27

40

52

558

29

45

57










BioPharmaceuticals

2,404

61

13

22

1,139

58

16

25

CVRM

1,448

37

9

18

701

36

10

19

Respiratory

956

24

22

30

438

22

26

36










Other medicines

499

13

(11)

(7)

250

13

(14)

(8)










Total Emerging Markets

3,951

100

15

24

1,947

100

17

27

 

China sales, comprising 61% of total Emerging Markets sales, increased by 27% in the half (35% at CER) to $2,408m. New medicines delivered particularly encouraging sales growth, supported by strong performances from Pulmicort, Seloken, Nexium and Symbicort. New medicines represented 17% of China sales, up from 9% in H1 2018.

 

Table 9: Regional Product Sales, US

Product Sales in the half of $3,663m; an increase in the half of 18%. New medicines represented 59% of US Product Sales, up from 42% in H1 2018. The performance reflected, in particular, the success of the new Oncology medicines, including Tagrisso, Imfinzi and Lynparza, Brilinta in New CVRM, plus the strong performance of Fasenra in Respiratory.

 


H1 2019

Q2 2019

$m

% of total

% change

$m

% of total

% change

Oncology

1,621

44

68

851

45

58








BioPharmaceuticals

1,841

51

8

937

50

-

CVRM

1,085

30

5

527

28

(1)

Respiratory

756

21

12

410

22

1








Other medicines

201

5

(54)

89

5

(37)








Total US

3,663

100

18

1,877

100

16

 

Table 10: Regional Product Sales, Europe

Product Sales in the half of $2,029m; a decline of 6% (up by 1% at CER). This partly reflected adverse continued pricing pressures, the impact of the divestment of the prescription medicine rights to Nexium in H2 2018 and declining sales of Crestor. New medicines represented 39% of Product Sales, up from 26% in H1 2018.

 

In Q2 2019, however, the sales performance was more encouraging. Oncology delivered particularly strong growth, with Tagrisso and Lynparza, representing 53% of Oncology sales in Europe, growing by 60% (73% at CER) to $112m and by 47% (60% at CER) to $66m, respectively. This performance was augmented by the successes of Brilinta and Forxiga in New CVRM and Fasenra in Respiratory.

 


H1 2019

Q2 2019

$m

% of total

% change

$m

% of total

% change

Actual

CER

Actual

CER

Oncology

650

32

29

37

336

32

31

41










BioPharmaceuticals

1,127

56

(12)

(6)

559

53

(10)

(4)

CVRM

566

28

(10)

(5)

283

27

(8)

(1)

Respiratory

561

28

(13)

(7)

276

26

(13)

(7)










Other medicines

252

12

(33)

(28)

152

15

(1)

3










Total Europe

2,029

100

(6)

1

1,047

100

1

8

 

Table 11: Regional Product Sales, Established RoW

Product Sales in the half of $1,540m; an increase of 16% (19% at CER). New medicines represented 40% of Established RoW sales, up from 18% in H1 2018. The performance during the half reflected, in particular, the successes of Tagrisso, Imfinzi and Forxiga.

 


H1 2019

Q2 2019

$m

% of total

% change

$m

% of total

% change

Actual

CER

Actual

CER

Oncology

740

48

65

69

422

50

65

70










BioPharmaceuticals

535

35

(7)

(4)

275

32

(10)

(7)

CVRM

273

18

-

3

147

17

(1)

2

Respiratory

262

17

(14)

(11)

128

15

(18)

(15)










Other medicines

265

17

(14)

(10)

150

18

(6)

(3)










Total Established RoW

1,540

100

16

19

847

100

17

21

 

Japan sales, comprising 76% of total Established RoW, increased by 28% (31% at CER) to $1,173m. Crestor sales in Japan increased by 12% (14% at CER) to $85m and represented 7% of Japan sales. New medicines represented 42% of Japan sales, up from 18% in H1 2018, particularly reflecting the strong performance of Tagrisso as a 1st-line treatment for patients with EGFRm NSCLC, following regulatory approval in this setting in the third quarter of 2018.

 

 

Financial performance

 

Table 12: H1 2019 Reported Profit and Loss

 


Reported

H1 2019

H1 2018

% change

$m

$m

Actual

CER

Product Sales

11,183

10,015

12

17

Collaboration Revenue

131

318

(59)

(57)

Total Revenue

11,314

10,333

9

14






Cost of Sales

(2,192)

(2,146)

2

7






Gross Profit

9,122

8,187

11

16

Gross Margin

80.4%

78.6%

+2

+2






Distribution Expense

(159)

(165)

(4)

3

% Total Revenue

1.4%

1.6%

-

-

R&D Expense

(2,622)

(2,641)

(1)

3

% Total Revenue

23.2%

25.6%

+2

+2

SG&A Expense

(5,457)

(5,008)

9

14

% Total Revenue

48.2%

48.5%

-

-

Other Operating Income & Expense

706

1,086

(35)

(34)

% Total Revenue

6.2%

10.5%

-4

-4






Operating Profit

1,590

1,459

9

12

Operating Profit Margin

14.1%

14.1%

-

-

Net Finance Expense

(632)

(640)

(1)

10

Joint Ventures and Associates

(59)

(33)

78

78

Profit Before Tax

899

786

14

11

Taxation

(229)

(151)

52

47

Tax Rate

25%

19%



Profit After Tax

670

635

6

2






EPS

$0.56

$0.54

3

-

 

Table 12: Q2 2019 Reported Profit and Loss

 


Reported

Q2 2019

Q2 2018

% change

$m

$m

Actual

CER

Product Sales

5,718

5,030

14

19

Collaboration Revenue

105

125

(17)

(12)

Total Revenue

5,823

5,155

13

18






Cost of Sales

(1,063)

(1,012)

5

14






Gross Profit

4,760

4,143

15

19

Gross Margin

81.4%

79.9%

+2

+1






Distribution Expense

(81)

(84)

(4)

3

% Total Revenue

1.4%

1.6%

-

-

R&D Expense

(1,356)

(1,362)

-

4

% Total Revenue

23.3%

26.4%

+3

+3

SG&A Expense

(2,943)

(2,551)

15

21

% Total Revenue

50.6%

49.5%

-1

-1

Other Operating Income & Expense

113

617

(82)

(81)

% Total Revenue

2.0%

12.0%

-10

-10






Operating Profit

493

763

(35)

(37)

Operating Profit Margin

8.5%

14.8%

-6

-7

Net Finance Expense

(320)

(332)

(4)

15

Joint Ventures and Associates

(32)

(19)

69

69

Profit Before Tax

141

412

(66)

(73)

Taxation

(34)

(93)

(64)

(71)

Tax Rate

24%

23%



Profit After Tax

107

319

(66)

(74)






EPS

$0.09

$0.27

(64)

(71)

 

Table 13: H1 2019 reconciliation of Reported Profit Before Tax to EBITDA[23]

 


H1 2019

H1 2018

% change


$m

$m

Actual

CER

Reported Profit Before Tax

899

786

14

11

Net Finance Expense

632

640

(1)

10

Joint Ventures and Associates

59

33

78

78

Depreciation, Amortisation and Impairment

1,403

1,393

1

5






EBITDA

2,993

2,852

5

9

 

Table 14: Q2 2019 reconciliation of Reported Profit Before Tax to EBITDA

 


Q2 2019

Q2 2018

% change


$m

$m

Actual

CER

Reported Profit Before Tax

141

412

(66)

(73)

Net Finance Expense

320

332

(4)

15

Joint Ventures and Associates

32

19

69

69

Depreciation, Amortisation and Impairment

727

684

7

11






EBITDA

1,220

1,447

(16)

(15)

 

Table 15: H1 2019 Reconciliation of Reported to Core financial measures

 


Reported

Restructuring

Intangible Asset

Amortisation & Impairments

Diabetes Alliance

Other[24]

Core[25]

Core

% change

$m

$m

$m

$m

$m

$m

Actual

CER

Gross Profit

9,122

52

51

-

-

9,225

11

15

Gross Margin

80.4%





81.3%

1

1










Distribution Expense

(159)

-

-

-

-

(159)

(4)

3

R&D Expense

(2,622)

64

53

-

-

(2,505)

(2)

2

SG&A Expense

(5,457)

110

682

198

209

(4,258)

3

7

Other Operating Income & Expense

706

-

2

-

-

708

1

2










Operating Profit

1,590

226

788

198

209

3,011

39

44

Operating Profit Margin

14.1%





26.6%

6

5










Net Finance Expense

(632)

-

-

144

101

(387)

6

19

Taxation

(229)

(47)

(165)

(71)

(20)

(532)

61

62










EPS

 $0.56

 $0.14

 $0.49

 $0.21

 $0.22

 $1.62

38

40

 

Table 16: Q2 2019 Reconciliation of Reported to Core financial measures

 


Reported

Restructuring

Intangible Asset

Amortisation & Impairments

Diabetes Alliance

Other[26]

Core[27]

Core

% change

$m

$m

$m

$m

$m

$m

Actual

CER

Gross Profit

4,760

14

26

-

-

4,800

14

18

Gross Margin

81.4%





82.1%

1

-










Distribution Expense

(81)

-

-

-

-

(81)

(4)

3

R&D Expense

(1,356)

30

46

-

-

(1,280)

(3)

1

SG&A Expense

(2,943)

79

345

93

234

(2,192)

3

8

Other Operating Income & Expense

113

-

1

-

-

114

(80)

(80)










Operating Profit

493

123

418

93

234

1,361

7

8

Operating Profit Margin

8.5%





23.4%

(1)

(2)










Net Finance Expense

(320)

-

-

72

51

(197)

-

30

Taxation

(34)

(25)

(90)

(35)

(18)

(202)

(1)

(5)










EPS

 $0.09

 $0.08

 $0.26

 $0.10

 $0.20

 $0.73

5

1

 

Profit and loss commentary

 

Gross Profit

Reported Gross Profit increased by 11% in the half (16% at CER) to $9,122m; Core Gross Profit increased by 11% (15% at CER) to $9,225m, reflecting the growth in Product Sales. The calculation of Reported and Core Gross Margin excludes the impact of Collaboration Revenue and any associated costs, thereby reflecting the underlying performance of Product Sales. The Reported Gross Margin increased by two percentage points to 80.4%, partly reflecting the mix of Product Sales and manufacturing efficiencies; the Core Gross Margin increased by one percentage point to 81.3%.

 

Operating Expenses

Reported Operating Expenses, including Distribution Expenses, increased by 5% in the half (10% at CER) to $8,238m and represented 73% of Total Revenue (H1 2018: 76%). Core Operating Expenses increased by 1% (5% at CER) to $6,922m and represented 61% of Total Revenue (H1 2018: 67%).

 

Reported R&D Expenses declined by 1% in the half (an increase of 3% at CER) to $2,622m. Core R&D Expenses declined by 2% (up by 2% at CER) to $2,505m and represented 22% of Total Revenue (H1 2018: 25%).

 

Reported SG&A Expenses increased by 9% in the half (14% at CER) to $5,457m; Core SG&A Expenses increased by 3% (7% at CER) to $4,258m and represented 38% of Total Revenue (H1 2018: 40%), primarily reflecting investment in additional colleagues to support the China expansion strategy, as well as further support for new medicines. The difference between the growth of Reported and Core SG&A Expenses partly reflected the commencement of the amortisation of Lokelma and fair-value adjustments arising on acquisition-related liabilities recognised in Q2 2019.

 

Other Operating Income and Expense

Where AstraZeneca does not retain a significant ongoing interest in medicines or potential new medicines, income from divestments is reported within Other Operating Income and Expense in the Company's financial statements. Reported Other Operating Income and Expense declined by 35% in the half (34% at CER) to $706m and included $515m that reflected an agreement to sell US rights to Synagis to Swedish Orphan Biovitrum AB (publ) (Sobi). Core Other Operating Income and Expense increased by 1% (2% at CER) to $708m.

 

Operating Profit

Reported Operating Profit increased by 9% in the half (12% at CER) to $1,590m, partly driven by the increases in Product Sales and the Reported Gross Margin; the Reported Operating Margin was stable at 14%. Core Operating Profit increased by 39% (44% at CER) to $3,011m; the Core Operating Margin increased by six percentage points to 27%. The difference between the Reported and Core growth performance partly reflected the impact of a favourable $346m legal settlement, recognised only in Reported Other Operating Income and Expense, in H1 2018 and fair-value adjustments arising on acquisition-related liabilities recognised in Reported SG&A Expense in Q2 2019.

 

Net Finance Expense

Reported Net Finance Expense declined by 1% in the half (up by 10% at CER) to $632m. The charge partly reflected higher Net Debt, as well as the effect of the adoption of IFRS 16 (see Note 1). There was also an adverse impact from a higher cost of debt, plus a higher level of discount unwind due to the profit-participation liability. Excluding the discount-unwind on acquisition-related liabilities, Core Net Finance Expense increased by 6% (19% at CER) to $387m.

 

Profit Before Tax

Reported Profit Before Tax increased by 14% in the half (11% at CER) to $899m, reflecting the growth in Product Sales and the Reported Gross Margin. Core Profit Before Tax increased by 46% (47% at CER) to $2,565m, also a result of the growth in Product Sales and the Core Gross Margin.

 

Taxation

The Reported Tax Rate for the half was 25% and the Core Tax Rate was 21% (both 19% in H1 2018). These tax rates were higher than the UK Corporation Tax Rate due to the impact of the geographical mix of profits and the impact of collaboration and divestment activity. The net cash tax paid for the half was $723m, representing 80% of Reported Profit Before Tax (H1 2018: $288m, 37%). Increased net cash payments primarily reflected phasing of tax payments.

 

EPS

Reported EPS of $0.56 represented an increase of 3% (stable at CER). Core EPS increased by 38% (40% at CER) to $1.62. The difference between the Reported and Core performance partly reflected the impact of the aforementioned favourable $346m legal settlement in H1 2018, recognised as income in Reported Other Operating Income and Expense, as well as the aforementioned commencement of the amortisation of Lokelma and fair-value adjustments arising on acquisition-related liabilities recognised in Reported SG&A Expense in Q2 2019.

 

Dividends

The Board has recommended an unchanged first interim dividend of $0.90 (71.9 pence, 8.49 SEK) per Ordinary Share.

 

Table 17: Cash Flow

 


H1 2019

H1 2018

Change


$m

$m

$m

Reported Operating Profit

1,590

1,459

131

Depreciation, Amortisation and Impairment

1,403

1,393

10





Increase in Working Capital and Short-Term Provisions

(634)

(1,440)

806

Gains on Disposal of Intangible Assets

(590)

(593)

3

Non-Cash and Other Movements

(177)

(310)

133

Interest Paid

(378)

(296)

(82)

Taxation Paid

(723)

(288)

(435)





Net Cash Inflow/(Outflow) From Operating Activities

491

(75)

566

Net Cash (Outflow)/Inflow Before Financing Activities

(298)

102

(400)

Net Cash Inflow/(Outflow) From Financing Activities

941

(481)

1,422

 

A net cash inflow from operating activities of $491m in the half compared to an outflow of $75m in H1 2018, partly a result of movements in Working Capital and Short-Term Provisions. The reduction centred on favourable trends in Trade and other receivables and Trade and other payables. The improvement in the performance was partly offset by an increase in Tax Paid, at $723m (H1 2018: $288m); the increase reflected the phasing of tax payments.

 

Net cash outflows before financing activities of $298m compared with an inflow of $102m in H1 2018. The difference partly reflected the impact of historic business-development transactions and subsequent payments reported within Payment of Contingent Consideration on Business Combinations, as well as within the Purchase of Intangible Assets. The latter included:

 

1.   the first of two $675m upfront payments to Daiichi Sankyo as part of the agreement on trastuzumab deruxtecan, and

2.   the impact of a final true-up net payment of $413m to MSD, based on actual sales of Nexium and Prilosec from 2014 to 2018; this was accrued over the same period

 

A payment from Pfizer, Inc. of $175m was received in the half, recorded within Disposal of Intangible Assets, as part of a prior agreement to sell the commercialisation and development rights to AstraZeneca's late-stage small-molecule antibiotics business in most markets globally outside the US. Reflecting strong sales growth and a pre-defined increase in royalty rates, the cash payment of contingent consideration, in respect of the Bristol-Myers Squibb share of the global Diabetes alliance, amounted to $225m in the half (H1 2018: $151m).

 

As part of the total consideration of $821m included in Disposal of Intangible Assets received in respect of the aforementioned agreement to sell US rights to Synagis, $150m related to the rights to participate in the future cash flows from the US profits or losses for nirsevimab (MEDI8897). This was recognised as financial liability and is presented in Other Payables within Non-current Liabilities. The associated cash flow is presented within Investing Activities.

 

In April 2019, the Company completed an equity placing of $3.5bn, in conjunction with the recent strategic collaboration with Daiichi Sankyo. The purpose of the placing was to fund the initial upfront and near-term milestone commitments arising from the collaboration, as well to strengthen AstraZeneca's balance sheet. The placing was recorded in the second quarter.

 

Capital expenditure

Capital expenditure amounted to $438m in the half, compared to $486m in H1 2018. This included investment in the new AstraZeneca R&D centre on the Biomedical Campus in Cambridge, UK.

 

The Company completed the transition to Mace Group as new construction manager for the aforementioned centre at the end of 2018. Following a detailed review of the construction programme presented to the Board, the targeted initial occupation date is unchanged at late 2020, with an overall full completion of the building expected in late 2021. Partly reflecting an element of remedial work, as well as a longer build phase than originally anticipated, AstraZeneca has revised the expected level of associated capital expenditure to c.$1,270m (c.£980m, translated at average exchange rates in the half); capital expenditure on the project to the end of H1 2019 amounted to c.$840m (c.£650m, translated at average exchange rates in the half). The Company has made other progress on its transition to Cambridge; as of the end of June 2019, c.3,000 colleagues were based in the city.

 

The Company maintains its anticipation of a broadly stable level of total capital expenditure in FY 2019.

 

Table 18: Debt and capital structure

 


At 30 June 2019

At 31 Dec 2018

At 30 June 2018


$m

$m

$m

Cash and Cash Equivalents

5,428

4,831

2,978

Other Investments

875

895

881





Cash and Investments

6,303

5,726

3,859





Overdrafts and Short-Term Borrowings

(629)

(755)

(2,818)

Leases[28]

(720)

-

-

Current Instalments of Loans

(1,000)

(999)

(1,397)

Loans Due After One Year

(17,355)

(17,359)

(15,452)





Interest-Bearing Loans and Borrowings (Gross Debt)

(19,704)

(19,113)

(19,667)





Net Derivatives

321

384

465

Net Debt

(13,080)

(13,003)

(15,343)

 

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. In addition, the Company's external dividend payments, paid principally in pounds sterling and Swedish krona, are fully hedged from announcement to payment date. Foreign-exchange gains and losses on forward contracts for transactional hedging are taken to profit or loss.

 

Table 19: 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)[29]

Currency

Primary Relevance

FY 2018[30]

H1 2019[31]

% change

Product Sales

Core Operating Profit

CNY

Product Sales

6.62

6.80

(3)

221

126

EUR

Product Sales

0.85

0.89

(4)

145

66

JPY

Product Sales

110.45

109.99

-

114

74

Other[32]





216

105








GBP

Operating Expenses

0.75

0.77

(3)

26

(72)

SEK

Operating Expenses

8.69

9.30

(7)

4

(73)

 

Related-Party Transactions

There have been no significant related-party transactions in the period.

 

Principal Risks and Uncertainties

It is not anticipated that the nature of the principal risks and uncertainties that affect the business, and which are set out on pages 70 to 73 of the Annual Report and Form 20-F Information 2018, will change in respect of the second six months of the financial year. The potential impact of Brexit continues to be treated as an integral part of the Principal Risks rather than as a stand-alone risk, as summarised on page 71 of the Annual Report and 20F information 2018. Further information on the Company's key risk-management and assurance processes are set out on pages 220 to 230 of the Annual Report and 20-F Information 2018.

 

On 23 June 2016, the UK held a referendum on continuing membership of the EU, the outcome of which was a decision for the UK to leave the EU (Brexit). Unless and until the Brexit negotiation and parliamentary-ratification processes are complete, it is difficult to anticipate the potential impact on AstraZeneca's market share, sales, profitability and results of operations. The Board reviews the potential impact of Brexit regularly as an integral part of its principal risks rather than as a standalone risk.

 

In summary, the principal risks and uncertainties listed in the Annual Report and 20-F Information 2018 are:

 

1.   Medicine pipeline and intellectual property risks: failure or delay in delivery of pipeline and new medicines; failure to meet quality, regulatory and ethical medicine approval and disclosure requirements; failure to secure and protect medicine intellectual property.

 

2.   Commercialisation risks: competitive pressures including externally-driven demand, pricing and access; failures or delays in quality execution of commercial strategies.

 

3.   Supply-chain and business-execution risks: failure to maintain supply of compliant, quality medicines; failure of information security, data protection and cybercrime; failure to attract, develop, engage and retain talented and capable employees at all levels.

 

4.   Legal, regulatory and compliance risks: safety and efficacy of marketed products is questioned; adverse outcome of defence of product, pricing and practices litigation; failure to meet regulatory and ethical expectations on commercial practices, including bribery and corruption, and scientific exchanges.

 

5.   Economic and financial risks: failure to achieve strategic plans and meet targets and expectations.

 

 

Corporate and business development

 

AstraZeneca and BenevolentAI announce a long-term collaboration

In April 2019, AstraZeneca and BenevolentAI announced a long-term collaboration to use artificial intelligence and machine-learning for the discovery and development of new treatments for CKD and idiopathic pulmonary fibrosis. Scientists from the two organisations will work side-by-side to combine AstraZeneca's genomics, chemistry and clinical data with BenevolentAI's target-identification platform and biomedical knowledge graph - a network of contextualised scientific data (genes, proteins, diseases and compounds) and the relationship between them.

 

 

Sustainability

 

AstraZeneca's sustainability ambition has three priority areas[33], aligned with the Company's purpose and business strategy:

 

-      Access to healthcare

-      Environmental protection

-      Ethics and transparency

 

Recent developments and progress against the priorities are reported below:

 

a) Access to healthcare

During the period, the Company celebrated the expansion of its Healthy Heart Africa (HHA) programme into Ghana with an official launch event in collaboration with the Ghana Health Service, in July 2019 in Accra. Healthy Heart Africa is an innovative programme committed to tackling hypertension and the increasing burden of CV disease across Africa. The event brought together stakeholders from government and the medical community for a panel discussion entitled 'Working in Partnership to combat NCDs' (non-communicable diseases). By the end of May 2019, HHA had conducted over 11 million blood-pressure screenings and identified over two million elevated readings since launch in 2014, working with collaborators across Kenya, Ethiopia and Tanzania.

 

In May 2019, a new report titled 'Adolescent Health: The Missing Population In Universal Health Coverage' was published and shared at the 72nd World Health Organisation's World Health Assembly. The report was produced with funding from the AstraZeneca Young Health Programme (YHP) and added to the body of evidence that calls for increased awareness of, and investment in, the area of adolescent health and disease prevention.

 

In June 2019, the Company launched its YHP in Vietnam in collaboration with the National Youth Centre and Hanoi Centre for Disease Prevention and Control, and with the official approval of the Vietnamese Government. With an aim to reach more than 46,000 young people in two high-risk communities in Hanoi, this was the third programme to be implemented in Asia and the 24th programme to be implemented globally.

 

b) Environmental protection

During the period, the Company received approval from the Science Based Targets initiative that the targets covering greenhouse-gas emissions from elements that directly impact the Company's operations, referred to as Scope 1 (all direct)[34] and Scope 2 (indirect)34 emissions, are consistent with reductions required to keep warming to 1.5 degrees centigrade, the most ambitious goal of the Paris Agreement. In addition, AstraZeneca's Scope 3 (other indirect)[35] emissions, that the Company can influence, are in line with current best practice. AstraZeneca were also announced by the UN Global Compact as a supporter of the Business Ambitions for 1.5°C - Our Only Future campaign

 

During the period, it was announced that the Company had made a commitment to switch its 16,000 business-vehicle fleet in Europe, North America and Japan to electric by 2030. AstraZeneca is the first pharmaceutical company to join the global EV100 initiative[36] from The Climate Group, an international non-profit organisation focused on accelerating climate action. The Company is already a member of The Climate Group's RE100 initiative, in collaboration with CDP (formerly the Carbon Disclosure Project), where it has committed to sourcing 100% renewable electricity by 2020 in Europe and the US, and for its global operations by 2025.

 

c) Ethics and transparency

During the period, the Company continued to evolve its compliance training, ensuring employees are equipped to play a positive role in preserving AstraZeneca's reputation through understanding and empowerment. A new Anti-Bribery, Anti-Corruption (ABAC) standard was published on the Company's website and training was launched to over 32,000 employees, with a completion rate of 38% in the first week. The course, covering topics around perception and identifying red flags, will roll out to other business areas later in the year.

 

During the period, the Company entered into a new collaboration with a member of the Hope for Justice group Slave-Free Alliance, with a view to broadening knowledge of best practices in the industry and constantly challenging the Company's approach to ongoing risk mitigation in the anti-slavery space. AstraZeneca is the first life-sciences company to collaborate with the alliance.

 

Other developments

During the period, the Company celebrated 'Sustainability Matters Week', with thousands of colleagues from over 40 countries actively engaged in sharing local activities and ideas through live events, videos and posts across internal communication and social channels, raising awareness and generating colleague engagement with AstraZeneca's sustainability strategy and focus areas.

 

 

 

For more details on AstraZeneca's sustainability ambition, approach and targets, please refer to the latest Sustainability Report 2018 and Sustainability Data Summary 2018, available at astrazeneca.com/sustainability.

 

 

 

Research and development

 

A comprehensive data pack comprising AstraZeneca's pipeline of medicines in human trials can be found in the clinical-trials appendix, available on astrazeneca.com. Highlights of developments in the Company's late-stage pipeline since the prior results announcement are shown below:

 

Table 20: Update from the late-stage pipeline

 

Regulatory approvals

5

-     Lynparza - ovarian cancer (1st line, BRCAm): regulatory approval (EU, JP)

-     Qternmet XR - T2D: regulatory approval (US)

-     Bevespi - COPD: regulatory approval (JP)

-     Breztri (formerly PT010) - COPD: regulatory approval (JP)

Regulatory submissions and/or acceptances

4

-     Lynparza - pancreatic cancer (BRCAm): regulatory submission acceptance (EU)

-     Forxiga - T2D CVOT: regulatory submission (CN)

-     Lokelma - hyperkalaemia: regulatory submission (JP, CN)

Major Phase III data readouts

or other major developments

11

-     Imfinzi - SCLC: met Phase III primary endpoint

-     Imfinzi - SCLC: Orphan Drug Designation (US)

-     trastuzumab deruxtecan - breast cancer (3rd line, HER2+): met pivotal Phase II primary endpoint

-     Calquence - CLL (relapsed/refractory): met Phase III primary endpoint

-     Calquence - CLL (treatment-naïve): met Phase III primary endpoint

-     Forxiga - T2D CVOT: positive opinion (EU)

-     Farxiga - T1D: complete response (US)

-     Lokelma - hyperkalaemia: priority review (CN)

-     roxadustat - anaemia of CKD: pooled Phase III CV safety confirmed

-     Breztri - COPD: priority review (CN)

-     Fasenra - severe asthma (self-administration and auto-injector): positive opinion (EU)

New molecular

entities and major lifecycle medicines in Phase III trials or under regulatory review

14

Oncology

-     Tagrisso - NSCLC

-     Imfinzi - multiple cancers

-     Lynparza - multiple cancers

-     trastuzumab deruxtecan - breast and other cancers

-     capivasertib - breast cancer

-     Calquence - blood cancers

-     tremelimumab - multiple cancers

-     selumetinib - NF1[37]

-     savolitinib - NSCLC37

CVRM

-     roxadustat - anaemia of CKD

Respiratory

-     Breztri - COPD

-     PT027 - asthma

-     tezepelumab - severe asthma

Other medicines (outside main therapy areas)

-     anifrolumab - lupus

Total projects in clinical pipeline

142


 

Oncology

 

AstraZeneca has a deep-rooted heritage in Oncology and offers a new generation of medicines that have the potential to transform patients' lives and the Company's future. At least six Oncology medicines are expected to be launched between 2014 and 2020, of which Tagrisso, Imfinzi, Lynparza, Calquence and Lumoxiti are already benefitting patients. An extensive pipeline of small-molecule and biologic medicines is in development, and the Company is committed to advancing Oncology medicines, primarily focused on the treatment of patients with lung, ovarian, breast and blood cancers.

 

At the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, the Company presented 93 abstracts spanning multiple tumour types, including 12 oral presentations with one plenary session and four late-breaking abstracts. Highlights included late-breaking results from the Phase III Lynparza POLO trial in metastatic pancreatic cancer, and results of the Phase III Lynparza SOLO3 trial in late-line, germline BRCA-mutated (gBRCAm) advanced ovarian cancer. Three-year OS data from the Imfinzi Phase III PACIFIC trial in unresectable, Stage III NSCLC were also presented.

 

Oncology: lung cancer

 

a) Tagrisso

Tagrisso has now received approval in 74 countries, including in the US, Japan and in the EU, for the 1st-line treatment of patients with Stage IV EGFRm NSCLC. Multiple other similar reviews are underway, including in China, where a decision is anticipated during the second half of 2019, based on a priority review granted in December 2018. Regulatory approvals have been achieved in 84 countries, including the US, in the EU, Japan and in China for the 2nd-line treatment of patients with EGFR T790M-mutated NSCLC.

 

Table 21: Key Tagrisso trials in lung cancer

 

Name

Phase

Population

Design

Timelines

Status

LAURA

III

Locally-advanced, unresectable EGFRm NSCLC

Placebo or Tagrisso

FPCD Q3 2018

 

First data anticipated 2020+

Recruitment
ongoing

ADAURA

III

Adjuvant EGFRm NSCLC

Placebo or Tagrisso

FPCD[38] Q4 2015

 

LPCD[39] Q1 2019

 

First data anticipated 2020+[40]

Recruitment

ongoing

SAVANNAH

II

EGFRm, MET+ locally-advanced or metastatic NSCLC patients who have progressed on Tagrisso

Tagrisso + savolitinib

FPCD Q1 2019

 

First data anticipated 2020+

Recruitment

initiating

ORCHARD

II

1st-line EGFRm NSCLC post Tagrisso

SoC chemotherapy or Tagrisso + savolitinib or Tagrisso + Iressa or Tagrisso + necitumumab or Imfinzi + chemotherapy

FPCD Q2 2019

 

First data anticipated 2020+

Recruitment

initiating

 

b) Imfinzi

During the period, AstraZeneca announced positive OS results from the Phase III CASPIAN trial with Imfinzi in 1st-line, extensive-stage SCLC. A planned interim analysis conducted by an Independent Data Monitoring Committee concluded that the trial had met its primary endpoint, by showing a statistically-significant and clinically-meaningful improvement in OS in patients treated with Imfinzi in combination with etoposide and platinum-based chemotherapy options versus SoC chemotherapy alone. The safety and tolerability for this Imfinzi combination was consistent with the known safety profiles of these medicines. AstraZeneca intends to submit these results for presentation at a forthcoming medical meeting and regulatory interactions are underway. During the period, the Company also announced that the US FDA had granted Orphan Drug Designation to Imfinzi for the treatment of SCLC.

 

AstraZeneca presented three-year OS results from the Phase III PACIFIC trial of Imfinzi in unresectable, Stage III NSCLC during the aforementioned 2019 ASCO Annual Meeting. The results demonstrated a durable and sustained OS benefit for patients with unresectable, Stage III NSCLC who had not progressed following concurrent CRT, a previous SoC treatment. The OS rate was 57% at three years for patients receiving Imfinzi, versus 43.5% for placebo following concurrent CRT. Median OS had not yet been reached with the Imfinzi arm, versus 29.1 months for placebo. The US FDA subsequently approved the inclusion of OS data for patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based CRT on the label.

 

During the period, the Company updated the primary endpoint of the NEPTUNE trial of SoC chemotherapy or Imfinzi + tremelimumab in Stage IV, 1st-line NSCLC to focus on OS with blood tumour mutation burden (bTMB, ≥ 20mut/Mb), an evolving strategy for tremelimumab.

 

Table 22: Key Imfinzi trials in lung cancer

 

Name

Phase

Population

Design

Timelines

Status

AEGEAN

III

Neo-adjuvant (before surgery) NSCLC

SoC chemotherapy +/- Imfinzi,

followed by

surgery followed by placebo or Imfinzi

FPCD Q1 2019

 

First data anticipated

H2 2020

Recruitment
ongoing

ADJUVANT BR.31[41]

III

Stage Ib-IIIa NSCLC

Placebo or

Imfinzi

FPCD Q1 2015

 

First data anticipated 2020+

Recruitment

ongoing

PACIFIC

III

Unresectable, Stage III NSCLC

Concurrent CRT,

followed by

placebo or

Imfinzi

FPCD Q2 2014

 

LPCD Q2 2016

PFS[42] and OS primary endpoints both met

PACIFIC-2

III

Unresectable, Stage III NSCLC

Concurrent CRT concurrent with

placebo or

Imfinzi, followed

by placebo or

Imfinzi

FPCD Q2 2018

 

First data anticipated

H2 2020

Recruitment

ongoing

PACIFIC-4

III

Unresectable, Stage I-II NSCLC

Stereotactic

body radiation

therapy followed

by placebo or

Imfinzi

FPCD Q2 2019

 

First data anticipated 2020+

Recruitment

ongoing

PACIFIC-5

III

Unresectable, Stage III NSCLC

(Asia predominant)

Concurrent or sequential CRT,

followed by

placebo or

Imfinzi

FPCD Q1 2019

 

First data anticipated 2020+

Recruitment

ongoing

ADRIATIC

III

Limited-disease stage SCLC

Concurrent CRT,

followed by

placebo or

Imfinzi or Imfinzi + treme

FPCD Q4 2018

 

First data anticipated 2020+

Recruitment

ongoing

PEARL

III

Stage IV, 1st-line NSCLC (Asia)

SoC chemotherapy or Imfinzi

FPCD Q1 2017

 

LPCD Q1 2019

 

First data anticipated 2020+

Recruitment

ongoing

NEPTUNE

III

Stage IV, 1st-line NSCLC

SoC chemotherapy or Imfinzi +

treme

FPCD Q4 2015

 

LPCD Q2 2017

 

First data anticipated

H2 2019

Recruitment completed

POSEIDON

III

Stage IV, 1st-line NSCLC

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

FPCD Q2 2017

 

LPCD Q3 2018

 

First data anticipated

H2 2019

Recruitment completed

CASPIAN

III

Extensive-disease stage SCLC

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

FPCD Q1 2017

 

LPCD Q2 2018

OS primary endpoint met for Imfinzi monotherapy arm

 

Imfinzi as a potential new medicine in other tumour types

The Company continues to advance multiple monotherapy trials of Imfinzi and combination trials of Imfinzi with tremelimumab and other potential new medicines in tumour types other than lung cancer.

 

Imfinzi has received regulatory approval for the 2nd-line treatment of patients with locally-advanced or metastatic urothelial carcinoma (bladder cancer) in 10 countries.

 

Table 23: Key Imfinzi trials in tumour types other than lung cancer

 

Name

Phase

Population

Design

Timelines

Status

Stage I, II & III (non-metastatic disease)

POTOMAC

III

Non-muscle invasive bladder cancer

SoC BCG[43] or SoC BCG + Imfinzi

FPCD Q3 2018

 

First data

anticipated 2020+

Recruitment ongoing

NIAGARA

III

Muscle-invasive bladder cancer

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

FPCD Q1 2019

 

First data

anticipated 2020+

Recruitment ongoing

EMERALD-1

III

Locoregional hepatocellular carcinoma (liver cancer)

TACE[44] followed by placebo or TACE + Imfinzi followed by Imfinzi +

bevacizumab or

TACE + Imfinzi

followed by Imfinzi

FPCD Q1 2019

 

First data

anticipated 2020+

Recruitment ongoing

EMERALD-2

III

Locoregional hepatocellular carcinoma at high risk of recurrence after surgery or radiofrequency ablation

Adjuvant Imfinzi or Imfinzi + bevacizumab

FPCD Q2 2019

 

First data anticipated 2020+

Recruitment ongoing

CALLA

III

Locally-advanced cervical cancer

CRT or CRT + Imfinzi followed by placebo or Imfinzi

FPCD Q1 2019

 

First data anticipated 2020+

Recruitment ongoing

Stage IV (metastatic disease)

DANUBE

III

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

SoC chemotherapy or Imfinzi or Imfinzi + treme

FPCD Q4 2015

 

LPCD Q1 2017

 

First data

anticipated H2 2019

Recruitment completed

NILE

III

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

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

FPCD Q3 2018

 

First data

anticipated 2020+

Recruitment

ongoing

KESTREL

III

Stage IV, 1st-line HNSCC

SoC or Imfinzi or Imfinzi + treme

FPCD Q4 2015

 

LPCD Q1 2017

 

First data

anticipated H2 2019

Recruitment completed

EAGLE

III

Stage IV, 2nd-line HNSCC

SoC or Imfinzi or Imfinzi + treme

FPCD Q4 2015

 

LPCD Q3 2017

Recruitment completed

 

OS primary endpoints not met

HIMALAYA

III

Stage IV, 1st-line unresectable hepatocellular carcinoma

Sorafenib or Imfinzi or Imfinzi + treme

FPCD Q4 2017

 

LPCD Q3 2019

 

First data

anticipated H2 2020

Recruitment

ongoing

TOPAZ-1

III

Stage IV, 1st-line biliary-tract cancers

Gemcitabine and cisplatin SoC chemotherapy or SoC + Imfinzi

FPCD

Q2 2019

Initiating

 

Oncology: Lynparza (multiple cancers)

In June 2019, AstraZeneca and MSD announced that the European Commission (EC) had approved Lynparza as a 1st-line maintenance treatment for patients with BRCAm advanced ovarian cancer. Following approval in the EU, the two companies announced that Lynparza had been approved in Japan as a maintenance treatment after 1st-line chemotherapy in patients with BRCAm advanced ovarian cancer, as detected by an approved companion-diagnostic test. The approvals were based on data from the pivotal Phase III SOLO-1 trial, which tested Lynparza as maintenance monotherapy compared with placebo in patients with BRCAm advanced ovarian cancer following 1st-line platinum-based chemotherapy.

 

At the aforementioned 2019 ASCO Annual Meeting, AstraZeneca and MSD presented detailed results from two Lynparza Phase III trials in pancreatic and ovarian cancer. In pancreatic cancer, detailed results from the Phase III POLO trial were presented, coinciding with a publication in The New England Journal of Medicine. The POLO trial tested Lynparza tablets as 1st-line maintenance monotherapy for patients with gBRCAm metastatic pancreatic cancer whose disease had not progressed, following SoC platinum-based 1st-line chemotherapy. Results from the trial showed a statistically-significant and clinically-meaningful improvement in PFS for Lynparza versus placebo, improving the time without disease progression by a median of 7.4 months for patients treated with Lynparza versus 3.8 months for those on placebo (HR 0.53 [95% CI, 0.35-0.82], p=0.004). More than twice as many patients showed no disease progression both at one year (34% on Lynparza versus 15% on placebo) and two years (22% versus 10%, respectively). During the period, a regulatory submission based on the data from the POLO trial, was accepted in the EU.

 

In ovarian cancer, the Company presented full results from the Phase III SOLO3 trial, which compared Lynparza with physician's choice of chemotherapy in the treatment of patients with gBRCAm advanced ovarian cancer who had received two or more prior lines of chemotherapy. The results from the trial showed a statistically-significant and clinically-meaningful improvement in objective response rate (ORR) for Lynparza versus SoC chemotherapy (72.2% versus 51.4% [95% CI, 1.40-4.58], p=0.002). ORR measures the proportion of patients with a reduction in tumour burden by a predefined percentage. The trial also met the key secondary endpoint of PFS, demonstrating a statistically-significant and clinically-meaningful improvement in the time patients lived without disease progression for Lynparza (13.4 months) versus chemotherapy (9.2 months [HR 0.62], p=0.013).

 

Table 24: Key Lynparza trials

 

Name

Phase

Population

Design

Timelines

Status

OlympiA

III

Adjuvant BRCAm breast cancer

SoC placebo or Lynparza

 

FPCD Q2 2014

 

LPCD Q2 2019

 

First data anticipated 2020+

Recruitment completed

 

PROfound

III

Metastatic castration-resistant prostate cancer, HRRm 2nd-line+

SoC (abiraterone or enzalutamide) or Lynparza

FPCD Q2 2017

LPCD Q4 2018

First data

anticipated H2 2019

Recruitment completed

PAOLA-1[45]

III

Stage IV, 1st-line

ovarian cancer

Bevacizumab maintenance or

bevacizumab +

Lynparza maintenance

 

FPCD Q2 2015

 

LPCD Q2 2018

 

First data

anticipated H2 2019

Recruitment completed

GY004[46]

III

Recurrent platinum-sensitive ovarian cancer

SoC chemotherapy or cediranib or cediranib + Lynparza

FPCD Q1 2016

First data

anticipated H1 2020

Recruitment ongoing

GY00546

II/III

Recurrent platinum-resistant/refractory ovarian cancer

SoC chemotherapy or cediranib or cediranib + Lynparza

FPCD Q2 2016 (Phase II)

FPCD Q1 2019 (Phase III)


First data

anticipated 2020+

Recruitment ongoing (Phase III component)

DuO-O

III

Stage IV, 1st-line

ovarian cancer

Chemotherapy +

bevacizumab or

chemotherapy +

bevacizumab +

Imfinzi +/-

Lynparza maintenance

FPCD Q1 2019

 

First data

anticipated 2020+

Recruitment
ongoing

MEDIOLA

I/II

Advanced, 2nd-line

gBRCAm ovarian

cancer

 

Stage IV, 1st to 3rd-line

gBRCAm, HER2-

negative breast cancer

 

Stage IV, 2nd-line SCLC

Stage IV, 2nd-line

gastric cancer

Lynparza + Imfinzi

FPCD Q2 2016

 

LPCD Q1 2019
(all except one cohort)

Recruitment

ongoing in one expansion cohort

 

Initial data from lung, breast, prostate and ovarian-cancer cohorts presented in 2017 and 2018

LYNK-002

II

HRRm advanced solid tumours

Lynparza

FPCD Q1 2019

Recruitment

ongoing

VIOLETTE

II

Stage IV, advanced, triple-negative breast cancer:

 

-HRRm[47] (BRCA)

-HRRm (non-BRCA)

-Non-HRRm

Lynparza

 

Lynparza + ATR

(AZD6738)

 

Lynparza + WEE1

(AZD1775)

FPCD Q2 2018

 

First data

anticipated 2020+

 

Recruitment

ongoing

PROpel

III

Stage IV, advanced, castration-resistant prostate cancer

Abiraterone or

abiraterone +

Lynparza

FPCD Q4 2018

 

First data

anticipated 2020+

 

Recruitment ongoing

BAYOU

II

Stage IV, 1st-line cis-platinum chemotherapy-ineligible urothelial

bladder cancer

Imfinzi or

Imfinzi + Lynparza

FPCD Q1 2018

 

First data

anticipated 2020+

Recruitment ongoing

DuO-L
ORION

II

Stage IV, 1st-line

NSCLC

SoC chemotherapy + Imfinzi, followed by Imfinzi or Imfinzi + Lynparza

maintenance

FPCD Q1 2019

 

First data anticipated 2020+

Recruitment ongoing

 

Trastuzumab deruxtecan (breast and other cancers)

During the period, AstraZeneca and Daiichi Sankyo announced positive top-line results for the pivotal Phase II DESTINY-Breast01 trial of trastuzumab deruxtecan, the HER2-targeting antibody drug conjugate for patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine. The safety and tolerability profile of trastuzumab deruxtecan was also consistent with previous experience. These results are expected to support planned global regulatory submissions, including a Biologics License Application with the US FDA anticipated in the second half of 2019.

 

During the period, the Company announced the publication of two manuscripts in The Lancet Oncology, reporting long-term Phase I safety and preliminary efficacy results of trastuzumab deruxtecan in heavily-pretreated patients with HER2-positive metastatic breast cancer and gastric cancer. In the first manuscript, in HER-2 positive metastatic breast-cancer patients previously treated with trastuzumab emtansine, trastuzumab deruxtecan demonstrated a confirmed ORR of 59.5% (95% CI: 49.7, 68.7) and a disease control rate (DCR) of 93.7% (95% CI: 87.4, 97.4). Median duration of response (DoR) was 20.7 months (0.0 to 21.8), median PFS was 22.1 months (0.8 to 27.9), and median OS had not yet been reached in the trial. In the second manuscript, in HER-2 positive advanced gastric-cancer patients previously treated with trastuzumab, trastuzumab deruxtecan demonstrated a confirmed ORR of 43.2% (95% CI: 28.3, 59.0) and a DCR of 79.5% (95% CI: 64.7, 90.2) were seen with trastuzumab deruxtecan. The median DoR was 7.0 months (4.4 to 16.6), median PFS was 5.6 months (95% CI: 3.0, 8.3), and median OS was 12.8 months (1.4 to 25.4).

Table 25: Key trastuzumab deruxtecan trials

 

Name

Phase

Population

Design

Timelines

Status

DESTINY-Breast01

II

Stage IV, HER2-positive breast cancer post trastuzumab emtansine

Trastuzumab deruxtecan

FPCD Q3 2017

 

Data readout

Q2 2019

Breakthrough Therapy Designation (US) status awarded

DESTINY-Breast02

III

Stage IV, HER2-positive breast cancer post trastuzumab emtansine

SoC or trastuzumab deruxtecan

FPCD Q3 2018

 

First data anticipated 2020+

 

Recruitment ongoing

DESTINY-Breast03

III

Stage IV, HER2-positive breast cancer

Trastuzumab emtansine or trastuzumab deruxtecan

FPCD Q3 2018

 

First data anticipated 2020+

Recruitment ongoing

DESTINY-Breast04

III

Stage IV, HER2-low breast cancer

SoC or trastuzumab deruxtecan

FPCD Q4 2018

 

First data anticipated 2020+

Recruitment ongoing

DESTINY-Gastric01

II

Stage IV, HER2-positive gastric cancer

SoC or trastuzumab deruxtecan

FPCD Q4 2017

 

First data anticipated

H1 2020

Recruitment completed

 

Capivasertib (breast cancer)

During the period capivasertib commenced a Phase III trial in 1st-line patients with locally advanced or metastatic triple-negative breast cancer. The trial will randomise c.800 patients to receive placebo and paclitaxel or capivasertib and paclitaxel.

 

Calquence (blood cancers)

During the period, AstraZeneca received regulatory approval for Calquence in relapsed MCL in Mexico and Argentina; approval was achieved in prior periods in the US, Brazil, Qatar and the UAE. The Company also announced positive high-level results from two pivotal Calquence Phase III trials in CLL, in front-line and relapsed/recurrent disease.

 

AstraZeneca recently announced and presented positive results from the Phase III ASCEND trial of Calquence in patients with relapsed/recurrent CLL, where the trial met its primary endpoint. The detailed results were presented at the European Hematology Association Annual Congress in Amsterdam. At a median follow-up of 16.1 months, results from the trial showed a statistically-significant and clinically-meaningful improvement in PFS for patients treated with Calquence versus idelalisib (IdR) or bendamustine (BR), reducing the risk of disease progression or death by 69% (HR, 0.31; 95% CI, 0.20-0.49, p<0.0001). The median time without disease progression for patients treated with Calquence had not yet been reached, versus 16.5 months in the control arm. At 12 months, 88% of patients on Calquence showed no disease progression, compared to 68% for the control arm. The safety and tolerability of Calquence was consistent with its established profile. A summary of the adverse events (AEs) of interest is highlighted below:

 

Table 26: ASCEND adverse events of interest

 

 AEs of interest,

n (%)

Calquence (n=154)

IdR (n=118)

BR (n=35)

Any

Grade ≥3

Any

Grade ≥3

Any

Grade ≥3

Atrial fibrillation

8 (5%)

2 (1%)

4 (3%)

1 (1%)

1 (3%)

1 (3%)

Bleeding

40 (26%)

3 (2%)

9 (8%)

3 (3%)

2 (6%)

1 (3%)

Hypertension

5 (3%)

3 (2%)

5 (4%)

1 (1%)

0

0

SPM[48] excluding NMSC[49]

10 (6%)

5 (3%)

3 (3%)

0

1 (3%)

1 (3%)

 

The Company also announced positive results from the Phase III ELEVATE-TN trial of Calquence in patients with previously-untreated CLL, where the trial met its primary endpoint. Calquence, in combination with obinutuzumab, demonstrated a statistically-significant and clinically-meaningful improvement in PFS when compared with the chemotherapy-based combination of chlorambucil and obinutuzumab. The trial also met a key secondary endpoint, showing Calquence monotherapy achieved a statistically-significant and clinically-meaningful improvement in PFS compared to the chemotherapy and obinutuzumab regimen. The safety and tolerability of Calquence was consistent with its established profile. AstraZeneca plans to present detailed results from ELEVATE-TN at a forthcoming medical meeting.

 

Table 27: Key Calquence trials in CLL

 

Name

Phase

Population

Design

Timelines

Status

ACE-CL-007

ELEVATE-TN

III

Previously-untreated

CLL

Chlorambucil + obinutuzumab

or obinutuzumab + Calquence

or Calquence

FPCD Q2 2015

 

Data readout

Q2 2019

Primary endpoint met

ACE CL-311

III

Previously-untreated

CLL

Fludarabine, cyclophosphamide and rituximab or Calquence + venetoclax +/-

obinutuzumab

FPCD Q2 2019

 

First data anticipated 2020+

Recruitment ongoing

ACE-CL-309

ASCEND

III

Relapsed/refractory CLL

BR or IdR + rituximab or Calquence

FPCD Q3 2016

 

Data readout

Q2 2019

Primary endpoint met

ACE-CL-006 ELEVATE-RR

III

Relapsed/refractory high risk CLL

Ibrutinib or Calquence

FPCD Q2 2015

 

First data anticipated 2020+

Recruitment ongoing

 

CVRM

 

CVRM forms one of AstraZeneca's main therapy areas and a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. The Company's ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CV health for millions of patients.

a) Farxiga (diabetes)

At the recent American Diabetes Association 79th Scientific Sessions in San Francisco, US, the Company presented a pre-specified exploratory analysis of renal data from the Phase III DECLARE-TIMI 58 trial, the broadest CVOT of a sodium-glucose co-transporter 2 (SGLT2) inhibitor, showing that Farxiga reduced the progression of kidney disease or renal death in patients with T2D.

 

Farxiga showed a 47% reduction in the relative risk of the composite renal-specific outcome of kidney-function decline (sustained ≥40% decrease in estimated glomerular filtration rate (eGFR) to <60 mL/min/1.73m2), end-stage renal disease (ESRD), or renal death (excluding CV death) compared to placebo (1.5% versus 2.8%; HR 0.53 [95% CI 0.43-0.66]). Additionally, Farxiga reduced the relative risk of a cardio-renal composite of kidney-function decline, ESRD, or renal or CV death by 24% compared to placebo (4.3% versus 5.6%; HR 0.76 [95% CI 0.67-0.87]).

 

During the period, the Company received submission acceptance from the China NMPA for the application to include CV outcomes data from the DECLARE-TIMI 58 trial for Forxiga. The DECLARE data was also added to Forxiga's label in Brazil during the period. In July 2019, the Company announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) had recommended a change to the European marketing authorisation for Forxiga in patients with T2D to include CV outcomes data from the DECLARE-TIMI 58 trial.

 

During the period, the first of c.700 patients were dosed in the DETERMINE trials. DETERMINE consists of two double-blinded, randomised, placebo-controlled Phase III trials which will evaluate the effect of 16 weeks of treatment with Farxiga compared to placebo, as measured by a six-minute walk test, a standard assessment of exercise capacity in patients with heart failure (HF). The key secondary outcome will be the measurement of a patient-reported outcome, assessing the impact of HF on patient wellbeing and the ability to lead a normal and active life. One trial will enrol HF patients with preserved ejection fraction and the other will enrol HF patients who have reduced ejection fraction.

 

In July 2019, AstraZeneca announced that the US FDA had issued a complete response letter regarding the supplemental New Drug Application (NDA) for Farxiga as an adjunct treatment to insulin to improve glycaemic control in adult patients with T1D, when insulin alone does not provide adequate glycaemic control. The Company will work closely with the US FDA to discuss the next steps. Forxiga was recently approved in Europe (5mg) and Japan (5mg, potential up-titration to 10mg), as an adjunct to insulin in adults with T1D.

 

b) Qternmet XR (T2D)

During the period, the Company received US FDA approval for Qternmet XR as an oral adjunct treatment to diet and exercise to improve glycaemic control in adults with T2D. The approval was based on data from two Phase III trials which evaluated combinations of dapagliflozin and saxagliptin on a background of metformin over 24 weeks, in patients with inadequately-controlled T2D.

 

Table 28: Key large CVRM trials

Major CVRM outcomes trials are highlighted in the following table:

 

Medicine

Trial

Mechanism

Population

Primary endpoint(s)

Timeline

Farxiga

DECLARE

SGLT2 inhibitor

c.17,000[50] patients with type-2 diabetes

Superiority for MACE[51] or superiority for the composite endpoint of CV death or hHF[52]

Primary safety endpoint met

One of two primary efficacy endpoints met

Farxiga

DAPA-HF

SGLT2 inhibitor

c.4,500 patients with HF and reduced ejection fraction, with and without type-2 diabetes

Time to first occurrence of CV death or hHF or an urgent HF visit

FPCD Q1 2017

 

LPCD Q3 2018


First data anticipated
H2 2019

Farxiga

DELIVER

SGLT2 inhibitor

c.4,700 patients with HF and preserved ejection fraction, with and without type-2 diabetes

Time to first occurrence of CV death or worsening heart failure

FPCD Q3 2018


First data anticipated 2020+

Farxiga

DAPA-CKD

SGLT2 inhibitor

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

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

FPCD Q1 2017

LPCD Q1 2019

First data anticipated 2020+

Brilinta

THEMIS

P2Y12 receptor antagonist

c.19,000 patients with T2D and CAD without a history of MI[53] or stroke

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

Primary endpoint met

Details to be presented at a forthcoming medical meeting

Brilinta

THALES

P2Y12 receptor antagonist

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

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

FPCD Q1 2018

 

First data anticipated H1 2020

Epanova

STRENGTH

Omega-3 carboxylic acids

c.13,000 patients with mixed dyslipidaemia/ hypertriglycerid-aemia

 

Time to first occurrence of CV death, non-fatal MI or non-fatal stroke

 

FPCD Q4 2014

 

LPCD Q2 2017

 

First data anticipated

H2 2020

 

c) Lokelma (hyperkalaemia)

In May 2019, AstraZeneca submitted an NDA in Japan for Lokelma to the Pharmaceuticals and Medical Devices Agency. The regulatory submission was based on data from four Phase III trials and the Company anticipates a regulatory decision during H1 2020.

 

In China, the Center for Drug Evaluation (CDE) published its second List of Overseas New Drugs in Urgent Clinical Need, which can use global data to apply to an NDA; Lokelma was included in this list. In June 2019, the Company submitted an NDA for Lokelma that was accepted by the CDE of the NMPA for accelerated approval. The Company anticipates a regulatory decision in H1 2020.

 

During the period, positive results from the Phase IIIb DIALIZE trial were presented as a late-breaking abstract at the 56th European Renal Association - European Dialysis and Transplant Association congress in Budapest, Hungary. The trial demonstrated that 41.2% of patients maintained normal potassium levels (pre-dialysis), compared to 1% receiving placebo; this was a statistically-significant and clinically-meaningful improvement. The data was simultaneously published in the Journal of the American Society of Nephrology. The DIALIZE data has been submitted to both regulatory agencies in the US and EU for potential inclusion in the label.

 

d) Roxadustat (anaemia)

In May 2019, AstraZeneca announced positive top-line results from the pooled CV safety analyses of the global Phase III programme for roxadustat, a first-in-class hypoxia-inducible-factor prolyl hydroxylase inhibitor. The global pivotal Phase III trials evaluated roxadustat for treatment of anaemia in patients with CKD across the non-dialysis-dependent (NDD), incident (newly-initiated) dialysis, and stable-dialysis patient groups.

 

AstraZeneca and its collaborator, FibroGen Inc. anticipate a US FDA regulatory submission in the second half of 2019. Roxadustat is currently approved in China for the treatment of patients with anaemia in dialysis-dependent CKD, with a regulatory decision in NDD anticipated in the second half of 2019.

 

Respiratory

 

AstraZeneca's Respiratory focus is aimed at transforming the treatment of patients with asthma and COPD through combined inhaled therapies and biologic medicines for the unmet medical needs of specific populations and an early pipeline focused on disease modification. The growing range of medicines includes a number of anticipated launches between 2017 and 2020; of these, Bevespi and Fasenra are already benefitting patients, with regulatory reviews for Symbicort as an anti-inflammatory reliever in mild asthma and Breztri in COPD underway. The capability in inhalation technology spans both pressurised metered-dose inhalers (pMDIs) and dry-powder inhalers to serve patient needs, including the innovative Aerosphere delivery technology, a focus of AstraZeneca's future-platform development for respiratory-disease combination therapies.

 

AstraZeneca attended the American Thoracic Society (ATS) International Conference in May 2019 in Dallas, US. The Company presented new data from the Symbicort Novel START trial, among 73 AstraZeneca abstracts accepted for oral or poster presentation.

 

a) Symbicort (asthma)

New data from the aforementioned Novel START, an open-label trial designed to reflect real-world practice, demonstrated the effectiveness of Symbicort as a potential anti-inflammatory reliever in mild asthma. These results were published in The New England Journal of Medicine and were presented at the aforementioned ATS conference.

 

The trial compared Symbicort with two commonly-used treatment regimens in mild asthma. In real-world practice, patients typically use a short-acting beta2-agonist (SABA) reliever in response to symptoms, or daily low-dose ICS maintenance therapy with a SABA reliever. In this trial, patients with mild asthma were randomised to receive either albuterol (a SABA reliever, also known as salbutamol in many countries) taken as-needed, or budesonide (an ICS maintenance treatment) plus albuterol as-needed, or Symbicort used as an anti-inflammatory reliever therapy taken as-needed.

 

Symbicort demonstrated a 51% reduction in the rate of annual asthma exacerbations, compared to albuterol. There was no difference in the exacerbation rate between Symbicort and twice-daily maintenance budesonide plus albuterol, despite a 52% reduction in the mean steroid dose with Symbicort. These data supported the findings of the SYGMA 1 and 2 trials, published in May 2018.

 

Earlier this year, the Global Initiative for Asthma published the updated Global Strategy for Asthma Management and Prevention guidelines, recommending low-dose ICS-formoterol combination therapy as-needed as the preferred reliever therapy across all asthma severities instead of SABA-reliever monotherapy.

 

In Europe, the regulatory submission to expand the indication for Symbicort Turbuhaler as an anti-inflammatory reliever in mild asthma is ongoing. In July 2019, AstraZeneca received a negative assessment from the Medical Products Agency, Sweden, the EU reference member state leading the mutual-recognition procedure. The procedure is expected to complete by 31 July 2019. Symbicort is approved as an anti-inflammatory reliever as-needed in patients with mild asthma in Brazil and Russia and, most recently, in New Zealand and Australia.

 

b) Bevespi (COPD)

In June 2019, the Japanese Ministry of Health, Labour and Welfare granted regulatory approval for Bevespi. This was the first approval for a maintenance fixed-dose, long-acting dual bronchodilator in a pMDI. The approval was based on positive results from the Phase III PINNACLE 4 trial, which demonstrated the efficacy and safety of Bevespi Aerosphere in c.1,800 patients with moderate to very severe COPD across Asia, Europe and the US, as well as the broader PINNACLE clinical programme that involved more than 5,000 patients. Bevespi is approved in the US, the EU, Canada, Australia and other countries for the maintenance treatment of moderate to very severe COPD.

 

c) Breztri (COPD)

During the period, AstraZeneca announced that Breztri, formerly PT010, was approved in Japan as a triple-combination therapy to relieve symptoms of COPD. This was the first global regulatory approval for Breztri and the first approval by the Japanese Ministry of Health, Labour and Welfare for a triple-combination therapy in a pMDI, which uses the innovative Aerosphere delivery technology. The approval was based on positive results from the Phase III KRONOS trial, in which Breztri demonstrated a statistically-significant improvement in trough forced expiratory volume in one second, the primary endpoint for Japan, compared with the dual comparators Bevespi and PT009 (budesonide/formoterol fumarate).

 

During the period, the China NMPA granted a priority review to Breztri, with a regulatory decision anticipated in H1 2020. The medicine is also under regulatory review in the US and the EU, based on data only from the KRONOS trial, with anticipated regulatory decisions in H1 2020.

 

d) Fasenra (severe asthma)

In May 2019, at the aforementioned ATS conference, the Company presented new data from a two-year integrated efficacy and safety analysis from the Fasenra one-year Phase III SIROCCO and CALIMA exacerbation trials, the one-year Phase III BORA extension trial and the 28-week Phase III ZONDA OCS-sparing trial.

 

In July 2019, AstraZeneca announced that the CHMP had issued a positive opinion to add a self-administration option and a new delivery method as a pre-filled, single-use auto-injector to the medicine's product information in the EU. The opinion was implemented without the need for an EC decision, due to the nature of the type-II label variation. AstraZeneca anticipates a regulatory decision by the US FDA on self-administration and the auto-injector in the second half of 2019. Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, in the EU, Japan and other countries.

 

e) Nirsevimab (lower respiratory tract infection)

In May 2019, at the European Society for Paediatric Infectious Diseases Congress, Phase IIb trial results were presented in a satellite symposium for nirsevimab, an extended half-life respiratory syncytial virus (RSV) F monoclonal antibody for the treatment of lower respiratory tract infection. The results showed that nirsevimab had met its primary and secondary endpoints, with a good safety profile. Nirsevimab is being developed in collaboration between AstraZeneca and Sanofi Pasteur (part of Sanofi S.A.). Both collaborators anticipate full data publication in a peer-reviewed journal in the second half of 2019. A Phase III trial has been confirmed to begin imminently, upon which the Company anticipates a €30m milestone payment from Sanofi Pasteur to be recorded within Collaboration Revenue in the third quarter.

 

Other medicines

 

There were no research & development updates for medicines outside of the three main therapy areas in the period.

 

 

 

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.

 

 

 

Condensed consolidated statement of comprehensive income


2019

2018

For the half year ended 30 June

$m

$m

Product Sales

11,183

10,015

Collaboration Revenue

131

318




Total Revenue

11,314

10,333

Cost of sales

(2,192)

(2,146)




Gross Profit

9,122

8,187

Distribution costs

(159)

(165)

Research and development expense

(2,622)

(2,641)

Selling, general and administrative costs

(5,457)

(5,008)

Other operating income and expense

706

1,086




Operating profit

1,590

1,459

Finance income

96

78

Finance expense

(728)

(718)

Share of after-tax losses in associates and joint ventures

(59)

(33)




Profit before tax

899

786

Taxation

(229)

(151)




Profit for the period

670

635




Other comprehensive income



Items that will not be reclassified to profit or loss



Remeasurement of the defined benefit pension liability

(247)

187

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

(54)

156

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

(2)

(2)

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

17

(67)


(286)

274




Items that may be reclassified subsequently to profit or loss



Foreign exchange arising on consolidation

(86)

(284)

Foreign exchange arising on designating borrowings in net investment hedges

(186)

(516)

Fair-value movements on cash flow hedges

(43)

19

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

14

69

Fair-value movements on derivatives designated in net investment hedges

(9)

(4)

Costs of hedging

3

(33)

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

20

55


(287)

(694)




Other comprehensive loss for the period, net of tax

(573)

(420)

Total comprehensive income for the period

97

215




Profit attributable to:



Owners of the Parent

723

690

Non-controlling interests

(53)

(55)


670

635




Total comprehensive income attributable to:



Owners of the Parent

150

270

Non-controlling interests

(53)

(55)


97

215




Basic earnings per $0.25 Ordinary Share

$0.56

$0.54

Diluted earnings per $0.25 Ordinary Share

$0.56

$0.54




Weighted average number of Ordinary Shares in issue (millions)

1,289

1,267

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

1,290

1,267

 

Condensed consolidated statement of comprehensive income


Unreviewed[54]
2019

Unreviewed54
2018

For the quarter ended 30 June

$m

$m

Product Sales

5,718

5,030

Collaboration Revenue

105

125




Total Revenue

5,823

5,155

Cost of sales

(1,063)

(1,012)




Gross Profit

4,760

4,143

Distribution costs

(81)

(84)

Research and development expense

(1,356)

(1,362)

Selling, general and administrative costs

(2,943)

(2,551)

Other operating income and expense

113

617




Operating profit

493

763

Finance income

41

43

Finance expense

(361)

(375)

Share of after-tax losses in associates and joint ventures

(32)

(19)




Profit before tax

141

412

Taxation

(34)

(93)




Profit for the period

107

319




Other comprehensive income



Items that will not be reclassified to profit or loss



Remeasurement of the defined benefit pension liability

(257)

160

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

(174)

38

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

(1)

(1)

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

60

(40)


(372)

157




Items that may be reclassified subsequently to profit or loss



Foreign exchange arising on consolidation

(139)

(451)

Foreign exchange arising on designating borrowings in net investment hedges

(6)

(417)

Fair-value movements on cash flow hedges

11

(92)

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

(33)

149

Fair-value movements on derivatives designated in net investment hedges

(12)

42

Costs of hedging

9

(23)

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

(3)

35


(173)

(757)




Other comprehensive loss for the period, net of tax

(545)

(600)

Total comprehensive loss for the period

(438)

(281)




Profit attributable to:



Owners of the Parent

130

350

Non-controlling interests

(23)

(31)


107

319




Total comprehensive income attributable to:



Owners of the Parent

(415)

(250)

Non-controlling interests

(23)

(31)


(438)

(281)




Basic earnings per $0.25 Ordinary Share

$0.09

$0.27

Diluted earnings per $0.25 Ordinary Share

$0.10

$0.27




Weighted average number of Ordinary Shares in issue (millions)

1,311

1,267

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

1,312

1,267

 

Condensed consolidated statement of financial position


At 30 Jun 2019

At 31 Dec 2018

At 30 Jun 2018


$m

$m

$m

Assets




Non-current assets




Property, plant and equipment

7,442

7,421

7,514

Right-of-use assets

702

-

-

Goodwill

11,668

11,707

11,717

Intangible assets

22,257

21,959

24,887

Investments in associates and joint ventures

73

89

157

Other investments

1,362

833

1,089

Derivative financial instruments

124

157

459

Other receivables

454

515

738

Deferred tax assets

2,588

2,379

2,334


46,670

45,060

48,895

Current assets




Inventories

3,197

2,890

3,118

Trade and other receivables

5,319

5,574

5,257

Other investments

819

849

799

Derivative financial instruments

210

258

33

Income tax receivable

246

207

264

Cash and cash equivalents

5,428

4,831

2,978

Assets held for sale

-

982

-


15,219

15,591

12,449

Total assets

61,889

60,651

61,344





Liabilities




Current liabilities




Interest-bearing loans and borrowings

(1,629)

(1,754)

(4,215)

Lease liabilities

(206)

-

-

Trade and other payables

(12,637)

(12,841)

(10,913)

Derivative financial instruments

(11)

(27)

(23)

Provisions

(410)

(506)

(777)

Income tax payable

(1,141)

(1,164)

(1,273)


(16,034)

(16,292)

(17,201)

Non-current liabilities




Interest-bearing loans and borrowings

(17,355)

(17,359)

(15,452)

Lease liabilities

(514)

-

-

Derivative financial instruments

(2)

(4)

(4)

Deferred tax liabilities

(2,932)

(3,286)

(3,740)

Retirement benefit obligations

(2,632)

(2,511)

(2,209)

Provisions

(376)

(385)

(391)

Other payables

(6,973)

(6,770)

(8,075)


(30,784)

(30,315)

(29,871)

Total liabilities

(46,818)

(46,607)

(47,072)

Net assets

15,071

14,044

14,272

Equity




Capital and reserves attributable to equity holders of the Parent




Share capital

328

317

317

Share premium account

7,911

4,427

4,409

Other reserves

2,044

2,041

2,040

Retained earnings

3,265

5,683

5,879


13,548

12,468

12,645

Non-controlling interests

1,523

1,576

1,627

Total equity

15,071

14,044

14,272

 

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 2018

317

4,393

2,029

8,221

14,960

1,682

16,642









Adoption of new accounting standards

-

-

-

(91)

(91)

-

(91)

Profit for the period

-

-

-

690

690

(55)

635

Other comprehensive loss

-

-

-

(420)

(420)

-

(420)

Transfer to other reserves

-

-

11

(11)

-

-

-

Transactions with owners:








Dividends

-

-

-

(2,402)

(2,402)

-

(2,402)

Issue of Ordinary Shares

-

16

-

-

16

-

16

Share-based payments change for the period

-

-

-

105

105

-

105

Settlement of share plan awards

-

-

-

(213)

(213)

-

(213)









Net movement

-

16

11

(2,342)

(2,315)

(55)

(2,370)









At 30 June 2018

317

4,409

2,040

5,879

12,645

1,627

14,272









At 1 Jan 2019

317

4,427

2,041

5,683

12,468

1,576

14,044









Adoption of new accounting standards[55]

-

-

-

54

54

-

54

Profit for the period

-

-

-

723

723

(53)

670

Other comprehensive loss

-

-

-

(573)

(573)

-

(573)

Transfer to other reserves

-

-

3

(3)

-

-

-

Transactions with owners:








Dividends

-

-

-

(2,403)

(2,403)

-

(2,403)

Issue of Ordinary Shares[56]

11

3,484

-

-

3,495

-

3,495

Share-based payments for the period

-

-

-

102

102

-

102

Settlement of share awards

-

-

-

(318)

(318)

-

(318)









Net movements

11

3,484

3

(2,418)

1,080

(53)

1,027









At 30 June 2019

328

7,911

2,044

3,265

13,548

1,523

15,071

 

 

Condensed consolidated statement of cash flows


2019

2018

For the half year ended 30 June

$m

$m

Cash flows from operating activities



Profit before tax

899

786

Finance income and expense

632

640

Share of after-tax losses of associates and joint ventures

59

33

Depreciation, amortisation and impairment

1,403

1,393

Increase in working capital and short-term provisions

(634)

(1,440)

Gains on disposal of intangible assets

(590)

(593)

Non-cash and other movements

(177)

(310)




Cash generated from operations

1,592

509

Interest paid

(378)

(296)

Tax paid

(723)

(288)




Net cash inflow/(outflow) from operating activities

491

(75)




Cash flows from investing activities



Payment of contingent consideration from business combinations

(368)

(151)

Purchase of property, plant and equipment

(438)

(486)

Disposal of property, plant and equipment

27

12

Purchase of intangible assets

(1,296)

(207)

Disposal of intangible assets

1,071

638

Movement in profit-participation liability[57]

150

-

Purchase of non-current asset investments

(7)

(14)

Disposal of non-current asset investments

18

20

Movement in short-term investments and fixed deposits

21

415

Payments to joint ventures

(39)

(171)

Interest received

72

121




Net cash (outflow)/inflow from investing activities

(789)

177




Net cash (outflow)/inflow before financing activities

(298)

102




Cash flows from financing activities



Proceeds from issue of share capital

3,495

16

Issue of loans

500

-

Repayment of loans

(500)

-

Dividends paid

(2,432)

(2,363)

Hedge contracts relating to dividend payments

26

(47)

Repayment of obligations under leases

(84)

-

Movement in short-term borrowings

(64)

1,913




Net cash inflow/(outflow) from financing activities

941

(481)




Net increase/(decrease) in cash and cash equivalents in the period

643

(379)

Cash and cash equivalents at the beginning of the period

4,671

3,172

Exchange rate effects

16

(27)




Cash and cash equivalents at the end of the period

5,330

2,766




Cash and cash equivalents consist of:



Cash and cash equivalents

5,428

2,978

Overdrafts

(98)

(212)





5,330

2,766

 

 

Responsibility statement of the directors in respect of the half-yearly financial report

 

We confirm that to the best of our knowledge:

·      the condensed interim financial statements have been prepared in accordance with IAS 34 Interim Financial Reporting as issued by the International Accounting Standards Board and adopted by the European Union;

 

·      the half-yearly management report includes a fair review of the information required by:

 

(a)

DTR 4.2.7R of the Disclosure and Transparency Rules, being an indication of important events that have occurred during the first six months of the financial year and their impact on the condensed interim financial statements; and a description of the principal risks and uncertainties for the remaining six months of the year; and

 

(b)

DTR 4.2.8R of the Disclosure and Transparency Rules, being related party transactions that have taken place in the first six months of the current financial year and that have materially affected the financial position or performance of the enterprise during that period; and any changes in the related party transactions described in the last annual report that could do so.

 

The Board

The Board of Directors that served during all or part of the six-month period to 30 June 2019 and their respective responsibilities can be found on the Leadership team section of astrazeneca.com. 

 

Approved by the Board and signed on its behalf by

 

Pascal Soriot

Chief Executive Officer

 

25 July 2019

 

 

Independent review report to AstraZeneca PLC

 

Report on the condensed consolidated interim financial statements

 

Our Conclusion

We have reviewed AstraZeneca PLC's condensed consolidated interim financial statements (the 'interim financial statements') in the half-yearly financial report of AstraZeneca PLC for the 6-month period ended 30 June 2019. Based on our review, nothing has come to our attention that causes us to believe that the interim financial statements are not prepared, in all material respects, in accordance with International Accounting Standard 34, 'Interim Financial Reporting', as issued by the International Accounting Standards Board (IASB) and adopted by the European Union and the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom's Financial Conduct Authority.

 

What we have reviewed

 

The interim financial statements comprise:

 

-      the Condensed Consolidated Statement of Financial Position as at 30 June 2019;

 

-      the Condensed Consolidated Statement of Comprehensive Income for the period then ended;

 

-      the Condensed Consolidated Statement of Cash Flows for the period then ended;

 

-      the Condensed Consolidated Statement of Changes in Equity for the period then ended; and

 

-      the explanatory notes to the interim financial statements.

 

The interim financial statements included in the half-yearly financial report have been prepared in accordance with International Accounting Standard 34, 'Interim Financial Reporting', as issued by the IASB and adopted by the European Union and the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom's Financial Conduct Authority.

 

As disclosed in note 1 to the interim financial statements, the financial reporting framework that has been applied in the preparation of the full annual financial statements of the Group is applicable law and International Financial Reporting Standards (IFRSs) as issued by the IASB and adopted by the European Union.

 

 



 

Responsibilities for the interim financial statements and the review

 

Our responsibilities and those of the directors

The half-yearly financial report, including the interim financial statements, is the responsibility of, and has been approved by, the directors. The directors are responsible for preparing the half-yearly financial report in accordance with the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom's Financial Conduct Authority.

 

Our responsibility is to express a conclusion on the interim financial statements in the half-yearly financial report based on our review. This report, including the conclusion, has been prepared for and only for the company for the purpose of complying with the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom's Financial Conduct Authority and for no other purpose. We do not, in giving this conclusion, accept or assume responsibility for any other purpose or to any other person to whom this report is shown or into whose hands it may come save where expressly agreed by our prior consent in writing.

 

What a review of interim financial statements involves

We conducted our review in accordance with International Standard on Review Engagements (UK and Ireland) 2410, 'Review of Interim Financial Information Performed by the Independent Auditor of the Entity' issued by the Auditing Practices Board for use in the United Kingdom. A review of interim financial information consists of making enquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures.

 

A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing (UK) and, consequently, does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.

 

We have read the other information contained in the half-yearly financial report and considered whether it contains any apparent misstatements or material inconsistencies with the information in the interim financial statements.

 

 

PricewaterhouseCoopers LLP

Chartered Accountants

London

25 July 2019

 

 

Notes to the interim financial statements

 

1   Basis of preparation and accounting policies

These unaudited condensed consolidated interim financial statements (Interim Financial Statements) for the six months ended 30 June 2019 have been prepared in accordance with IAS 34 'Interim Financial Reporting' as issued by the International Accounting Standards Board (IASB) and adopted by the EU.

 

The unaudited condensed consolidated interim financial statements for the six months ended 30 June 2019 were approved by the Board of directors on 25 July 2019.

 

The annual financial statements of the Group are prepared in accordance with IFRSs as issued by the IASB and adopted by the EU. Except as noted below, the interim financial statements have been prepared applying the accounting policies and presentation that were applied in the preparation of the Group's published consolidated financial statements for the year ended 31 December 2018. In addition, from 1 January 2019, AstraZeneca elected to early adopt the October 2018 update to IFRS 3, which changed the definition of a business. The EU has not yet endorsed this update to IFRS 3, but it is considered highly probable that the amendment will be endorsed during 2019 before its effective date of 1 January 2020 with early adoption permitted. The change in definition of a business within IFRS 3 allowed the Group to apply the 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. It is considered that adopting this amendment will provide more reliable and comparable information about certain transactions as it provides more consistency in accounting for substantially similar transactions that under the previous definition may have been accounted for in different ways despite limited differences in substance.

 

IFRS 16

IFRS 16 'Leases' is effective for accounting periods beginning on or after 1 January 2019 and replaces IAS 17 'Leases'. It eliminates the classification of leases as either operating leases or finance leases and, instead, introduces a single lessee accounting model. The adoption of IFRS 16 resulted in the Group recognising lease liabilities, and corresponding 'right-of-use' assets for arrangements that were previously classified as operating leases.

 

The Group's principal lease arrangements are for property, most notably a portfolio of office premises, and for a global car fleet, utilised primarily by our sales and marketing teams. The Group has adopted IFRS 16 using a modified retrospective approach with the cumulative effect of initially applying the standard as an adjustment to the opening balance of retained earnings at 1 January 2019. The standard permits a choice on initial adoption, on a lease-by-lease basis, to measure the right-of-use asset at either its carrying amount as if IFRS 16 had been applied since the commencement of the lease, or an amount equal to the lease liability, adjusted for accruals or prepayments. The Group has elected to measure the right-of-use asset equal to the lease liability, with the result of no net impact on opening retained earnings and no restatement of prior period comparatives.

 

Initial adoption resulted in the recognition of right-of-use assets of $722m and lease liabilities of $720m. The weighted average incremental borrowing rate applied to the lease liabilities on 1 January 2019 was 3%.

 

The Group is using one or more practical expedients on transition to leases previously classified as operating leases, including electing to not apply the retrospective treatment to leases for which the term ends within 12 months of initial application, electing to apply a single discount rate to portfolios of leases with similar characteristics, reliance on previous assessments on whether arrangements contain a lease and whether leases are onerous, excluding initial direct costs from the initial measurement of the right-of-use asset, and using hindsight in determining the lease term where the contract contains options to extend or terminate the lease.

 

Key judgements made in calculating the initial impact of adoption include determining the lease term where extension or termination options exist. In such instances, all facts and circumstances that may create an economic incentive to exercise an extension option, or not exercise a termination option, have been considered to determine the lease term. Extension periods (or periods after termination options) are only included in the lease term if the lease is reasonably certain to be extended (or not terminated). Estimates include calculating the discount rate which is based on the incremental borrowing rate.

 

The Group is applying IFRS 16's low-value and short-term exemptions. While the IFRS 16 opening lease liability is calculated differently from the previous operating lease commitment calculated under the previous standard, there are no material differences between the positions. The adoption of IFRS 16 has had no impact on the Group's net cash flows, although a presentation change has been reflected whereby cash outflows of $84m are now presented as financing, instead of operating. There is an immaterial benefit to Operating profit and a corresponding increase in Finance expense from the presentation of a portion of lease costs as interest costs. Profit before tax, taxation and EPS have not been significantly impacted.

 

IFRIC 23

IFRIC 23 'Uncertainty Over Income Tax Treatments' is effective for accounting periods beginning on or after 1 January 2019 and provides further clarification on how to apply the recognition and measurement requirements in IAS 12 'Income Taxes'. It is applicable where there is uncertainty over income tax treatments. The EU endorsed IFRIC 23 on 24 October 2018. The adoption of IFRIC 23 has principally resulted in an adjustment in the value of tax liabilities because IFRIC 23 requires the Group to measure the effect of uncertainty on income tax positions using either the most likely amount or the expected value amount depending on which method is expected to better reflect the resolution of the uncertainty.

 

The Group has retrospectively applied IFRIC 23 from 1 January 2019 recognising the cumulative effect of initially applying the interpretation as decreases to income tax payable of $51m and to trade and other payables of $3m, and a corresponding adjustment to the opening balance of retained earnings of $54m. There is no restatement of the comparative information as permitted in the interpretation.

 

Collaboration Revenue

Effective from 1 January 2019, the Group updated the presentation of an element of Total Revenue within the Statement of Comprehensive Income and changed the classification of some income to reflect the increasing importance of collaborations to AstraZeneca. Historically, Externalisation Revenue formed part of Total Revenue and only included income arising from collaborative transactions involving AstraZeneca's medicines, whether internally developed or previously acquired. Such income included upfront consideration, milestones receipts, profit share income and royalties, as well as other income from collaborations. The updated category of Collaboration Revenue includes all income previously included within Externalisation Revenue, as well as income of a similar nature arising from transactions where AstraZeneca has acquired an interest in a medicine and as part of the acquisition entered into an active collaboration with the seller. This change is a result of the growing importance of collaborations to AstraZeneca. Income arising from all collaborations, other than product sales, will be recognised within the Collaboration Revenue element of Total Revenue. Historically there has been no collaboration income arising from such acquisitions, and therefore no prior year restatement of financial results is required as a result of this change.

 

Income from royalties and disposals of assets and businesses, where the Group does not retain a significant element of continued interest, continue to be recorded in Other Operating Income and Expense.

 

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 2018.

 

Going concern

The Group has considerable financial resources available. As at 30 June 2019 the Group has $9.5bn in financial resources (cash balances of $5.4bn and undrawn committed bank facilities of $4.1bn, of which $3.4bn is available until April 2022, $0.5bn is available until November 2020 (extendable to November 2021) and $0.2bn is available until December 2019 (extendable to December 2020), with only $1.8bn of debt due within one year). The Group's revenues are largely derived from sales of products which are 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 adversely affect revenues in many of the mature markets. The Group, however, anticipates new revenue streams from both recently launched medicines and products 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.

 

On the basis of the above paragraph, the going concern basis has been adopted in these interim financial statements.

 

Financial information

The comparative figures for the financial year ended 31 December 2018 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   Restructuring costs

Profit before tax for the half year ended 30 June 2019 is stated after charging restructuring costs of $226m ($187m for the half year ended 30 June 2018). These have been charged to profit as follows:

 


H1 2019

H1 2018

Unreviewed[58]
Q2 2019

Unreviewed58
Q2 2018


$m

$m

$m

$m

Cost of sales

52

55

14

23

Research and development expense

64

58

30

31

Selling, general and administrative costs

110

84

79

48

Other operating income and expense

-

(10)

-

(10)






Total

226

187

123

92

 

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 2018. Net debt is a non-GAAP financial measure.

 


At 1 Jan 2019

Adoption of new accounting standards[59]

Cash Flow

Non-cash & Other

Exchange Movements

At 30 Jun 2019


$m

$m

$m

$m

$m

$m

Non-current instalments of loans

(17,359)

-

-

(15)

19

(17,355)

Non-current instalments of leases

-

(557)

-

45

(2)

(514)








Total long-term debt

(17,359)

(557)

-

30

17

(17,869)








Current instalments of loans

(999)

-

-

(1)

-

(1,000)

Current instalments of leases

-

(163)

96

(138)

(1)

(206)

Commercial paper

(211)

-

-

-

-

(211)

Bank collateral

(384)

-

66

-

-

(318)

Other short-term borrowings excluding overdrafts

-

-

(2)

-

-

(2)

Overdraft

(160)

-

59

-

3

(98)








Total current debt

(1,754)

(163)

219

(139)

2

(1,835)








Gross borrowings

(19,113)

(720)

219

(109)

19

(19,704)








Net derivative financial instruments

384

-

(26)

(37)

-

321








Net borrowings

(18,729)

(720)

193

(146)

19

(19,383)








Cash and cash equivalents

4,831

-

584

-

13

5,428

Other investments - current

849

-

(21)

(9)

-

819

Other investments - non-current

46

-

-

10

-

56

Cash and investments

5,726

-

563

1

13

6,303








Net debt

(13,003)

(720)

756

(145)

32

(13,080)

 

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

 

Other investments - non-current are included within the balance of $1,362m (31 December 2018: $833m) in the 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 put option liability of $2,057m (31 December 2018: $1,838m) shown in non-current other payables.

 

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.

 

There have been no changes of significance to the categorisation or fair-value hierarchy classification of our financial instruments from those detailed in the Notes to the Group Financial Statements in the Group's Annual Report and Form 20-F Information 2018.

 

The Group holds certain equity investments that are categorised as Level 3 in the fair-value hierarchy and for which fair-value gains of $50m have been recognised in H1 2019. These are presented in Net gains on equity investments measured at fair value through other comprehensive income in the Condensed Consolidated Statement of Comprehensive Income.

 

Financial instruments measured at fair value include $2,181m of other investments, $3,960m held in money market funds, $337m of loans designated at fair value through profit or loss, $342m of loans designated in a fair value hedge relationship and $321m of derivatives as at 30 June 2019. The total fair value of interest-bearing loans and borrowings at 30 June 2019 which have a carrying value of $18,984m in the Condensed Consolidated Statement of Financial Position, was $20,867m. 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:

 


Diabetes Alliance
2019

Other

2019

Total

2019

Total

2018


$m

$m

$m

$m

At 1 January

3,983

1,123

5,106

5,534

Settlements

(225)

(143)

(368)

(151)

Revaluations

-

-

-

38

Discount unwind

144

35

179

208






At 30 June

3,902

1,015

4,917

5,629

 

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 Global Diabetes Alliance of $3,902m (31 December 2018: $3,983m) would increase/decrease by $390m with an increase/decrease 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 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 2018 (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, for the majority of claims in which AstraZeneca is involved, it is not possible to make a reasonable estimate of the expected financial effect, if any, that will result from ultimate resolution of the proceedings. In these cases, AstraZeneca discloses information with respect only to the nature and facts of the cases, but no provision is made.

 

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 the Company is able to make a reasonable estimate of the loss, AstraZeneca records the loss absorbed or makes a provision for the best estimate of the expected loss.

 

The position could change over time and the estimates that the Company has made, and upon which AstraZeneca has 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 intellectual property.

 

 

Matters disclosed in respect of the second quarter of 2019 and to 25 July 2019

 

Patent litigation

 

Imfinzi

US patent proceedings

As previously disclosed, in July 2017, Bristol-Myers Squibb, E.R. Squibb & Sons LLC, Ono Pharmaceutical Co and Tasuku Honjo filed a patent infringement action in the US District Court for the District of Delaware relating to AstraZeneca's commercialisation of Imfinzi. The case was dismissed without prejudice on 14 June 2019.

 

Faslodex

US patent proceedings

As previously disclosed, in December 2018, AstraZeneca filed a patent infringement lawsuit in the US District Court for the District of New Jersey (the District Court) relating to four patents listed in the FDA Orange Book with reference to Faslodex after receiving a Paragraph IV notice relating to an Abbreviated NDA (ANDA) seeking US FDA approval to market a generic version of Faslodex prior to the expiration of AstraZeneca's patents. In June 2019, AstraZeneca settled this lawsuit against the ANDA filer, and the District Court entered a consent judgment ending the lawsuit. AstraZeneca has now resolved all US patent infringement lawsuits that it had previously filed relating to the four listed patents that reference Faslodex, and the District Court has entered consent judgments ending all of those lawsuits.

 

Patent proceedings outside the US

In Italy, in May 2016, Actavis Group Ptc ehf and Actavis Italy S.p.A filed an action alleging that the Italian part of AstraZeneca's European Patent No. 2,266,573 (the '573 patent) was invalid.  In July 2019, the Court of Milan determined that the '573 patent is invalid.

 

Symbicort

US patent proceedings

As previously disclosed, beginning in October 2018, AstraZeneca initiated ANDA litigation against Mylan Pharmaceuticals Inc. (Mylan) and 3M Company (3M) and, separately, ANDA litigation against Teva Pharmaceuticals USA, Inc. (Teva) and Catalent Pharma Solutions, LLC (Catalent) in the US District Court for the District of Delaware. In May 2019, AstraZeneca filed a Second Amended Complaint in each of those actions adding allegations that their proposed generic versions of Symbicort, if approved and marketed, would infringe AstraZeneca's US Patent No. 10,166,247 (the '247 patent). In June 2019, Teva and Catalent responded to the Second Amended Complaint and alleged that their proposed generic product does not infringe the '247 patent and/or that the '247 patent is invalid and/or unenforceable. AstraZeneca is no longer asserting patent infringement of US Patent No. 7,967,011 against Teva and Catalent. A combined trial of the Mylan and 3M matter and the Teva and Catalent matter has been scheduled for June 2020.

 

Product liability litigation

 

Nexium and Losec/Prilosec

As previously disclosed, in the US, AstraZeneca is defending various lawsuits brought in federal and state courts involving multiple plaintiffs claiming that they have been diagnosed with various injuries following treatment with proton pump inhibitors, including Nexium and Prilosec. In May 2017, counsel for a group of such plaintiffs claiming that they have been diagnosed with kidney injuries filed a motion with the Judicial Panel on Multidistrict Litigation (JPML) seeking the transfer of any currently pending federal court cases as well as any similar, subsequently filed cases to a co-ordinated and consolidated pre-trial multidistrict litigation (MDL) proceeding. In August 2017, the JPML granted the motion and consolidated the pending federal court cases in an MDL proceeding in federal court in New Jersey for pre-trial purposes. In July 2019, counsel for a similarly defined group of plaintiffs with claims pending in New Jersey state courts petitioned the New Jersey State Administrative Director of the Courts to centralise judicial management of all plaintiffs' claims alleging kidney injuries pending in that State in a co-ordinated multicounty litigation proceeding.

 

As previously disclosed, in Canada, in July and August 2017, AstraZeneca was served with three putative class action lawsuits. Two of the lawsuits seek authorisation to represent individual residents in Canada who allegedly suffered kidney injuries from the use of proton pump inhibitors, including Nexium and Losec, and the third, pending in Quebec, seeks authorisation to represent such individual residents in Quebec.

 

 

Government investigations/proceedings

 

Toprol-XL

Louisiana Attorney General Litigation

As previously disclosed, in the US, in April 2019, a Louisiana state court (the Court) granted AstraZeneca's motion for summary judgment dismissing a state court civil complaint filed by the Attorney General for the State of Louisiana (the State), alleging that AstraZeneca had engaged in unlawful monopolisation and unfair trade practices in connection with enforcement of its patents for Toprol-XL causing the State government to pay increased prices for Toprol-XL, and entered judgment in AstraZeneca's favour. The State is appealing the Court's ruling.

 

 

Matters disclosed in respect of the first quarter of 2019 and to 26 April 2019

 

Patent litigation

 

Imfinzi

US patent proceedings

As previously disclosed, in July 2017, Bristol-Myers Squibb, E.R. Squibb & Sons LLC, Ono Pharmaceutical Co and Tasuku Honjo filed a patent infringement action in the US District Court for the District of Delaware (the District Court) relating to AstraZeneca's commercialisation of Imfinzi. A trial has been scheduled for October 2020; discovery is ongoing.

 

Calquence

US patent proceedings

As previously disclosed, in November 2017, Pharmacyclics LLC (Pharmacyclics, a company in the AbbVie group) filed a patent infringement lawsuit in the US District Court for the District of Delaware (the District Court) against Acerta Pharma and AstraZeneca relating to Calquence. A trial has been scheduled for June 2020.

 

In April 2018, AstraZeneca and Acerta Pharma filed a complaint in the District Court against Pharmacyclics and AbbVie, Inc. alleging that their drug, Imbruvica, infringes a US patent owned by Acerta Pharma. In November 2018, Janssen Biotech, Inc. intervened as a defendant. A trial has been scheduled for January 2021.

 

Faslodex

Patent proceedings outside the US

As previously disclosed, in Germany, in January 2017, the German Federal Patent Court declared the German part of European Patent No. EP 1,250,138 (the '138 patent) invalid. In April 2019, the German Federal Court of Justice upheld the January 2017 decision and determined the '138 patent to be invalid.

 

Brilinta

Patent proceedings outside the US

As previously disclosed, in Canada, in September 2017, Apotex Inc. (Apotex) challenged the patents listed on the Canadian Patent Register with reference to Brilinta. AstraZeneca discontinued the proceeding against Apotex in February 2019 after Apotex withdrew its challenge.

 

Farxiga

US patent proceedings

As previously disclosed, in May 2018, AstraZeneca initiated ANDA litigation against Zydus Pharmaceuticals (USA) Inc. (Zydus) in the US District Court for the District of Delaware (the District Court). In January 2019, following a stipulation filed by the parties, the District Court dismissed claims related to US Patent Nos. 7,851,502, 7,919,598, 8,221,786, 8,361,972, 8,501,698, and 8,716,251. AstraZeneca continues to allege that Zydus' generic version of Farxiga, if approved and marketed, would infringe AstraZeneca's US Patents Nos. 6,414,126, 6,515,117, and 8,685,934. A trial is scheduled for February 2021.

 

Symbicort

US patent proceedings

As previously disclosed, in October 2018 AstraZeneca initiated ANDA litigation against Mylan Pharmaceuticals Inc., Mylan Laboratories Limited, Mylan Inc., and Mylan N.V. in the US District Court for the District of Delaware and in the US District Court for the Northern District of West Virginia. In March 2019, following stipulations filed by the parties, the Delaware and West Virginia Courts dismissed without prejudice Mylan Laboratories Limited, Mylan Inc., and Mylan N.V. from those actions.

 

 

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. A majority of these claims have been resolved or dismissed.

 

Nexium and Losec/Prilosec

As previously disclosed, in the US, AstraZeneca is defending various lawsuits brought in federal and state courts involving multiple plaintiffs claiming that they have been diagnosed with various injuries following treatment with proton pump inhibitors, including Nexium and Prilosec. In May 2017, counsel for a group of such plaintiffs claiming that they have been diagnosed with kidney injuries filed a motion with the Judicial Panel on Multidistrict Litigation (JPML) seeking the transfer of any currently pending federal court cases as well as any similar, subsequently filed cases to a co-ordinated and consolidated pre-trial multidistrict litigation (MDL) proceeding. In August 2017, the JPML granted the motion and consolidated the pending federal court cases in an MDL proceeding in federal court in New Jersey for pre-trial purposes.

 

As previously disclosed, in Canada, in July and August 2017, AstraZeneca was served with three putative class action lawsuits. Two of the lawsuits seek authorisation to represent individual residents in Canada who allegedly suffered kidney injuries from the use of proton pump inhibitors, including Nexium and Losec, and the third, pending in Quebec, seeks authorisation to represent such individual residents in Quebec.

 

Commercial litigation

 

Toprol-XL

Aralez litigation

As previously disclosed, in October 2016, AstraZeneca completed its sale of certain assets related to the US rights to Toprol-XL and AstraZeneca's authorised generic metoprolol succinate product to Aralez Pharmaceuticals Trading DAC (Aralez). In August 2018, Aralez commenced voluntary insolvency proceedings and AstraZeneca filed a proof of claim in those proceedings asserting its unsecured claims. In October 2018, Aralez filed a motion in the Bankruptcy Court seeking to sell the US rights to Toprol-XL and its authorised generic and AstraZeneca filed an objection to the proposed sale. In March 2019, AstraZeneca entered into an agreement with the senior secured creditor and the settlement has now been approved by the Bankruptcy Court, bringing this matter to a close.

 

Government investigations/proceedings

 

Toprol-XL

Louisiana Attorney General Litigation

As previously disclosed, in the US, in March 2015, AstraZeneca was served with a state court civil complaint filed by the Attorney General for the State of Louisiana (the State) alleging that, in connection with enforcement of its patents for Toprol-XL, it had engaged in unlawful monopolisation and unfair trade practices, causing the State government to pay increased prices for Toprol-XL. In April 2019, a Louisiana state court heard oral argument on and granted AstraZeneca's motion for summary judgment, ordering the dismissal of the State's complaint and judgment to be entered in AstraZeneca's favour.

 

Synagis

Litigation in New York 

As previously disclosed, in the US, in June 2011, MedImmune received a demand from the US Attorney's Office for the Southern District of New York requesting certain documents related to the sales and marketing activities of Synagis. In July 2011, MedImmune received a similar court order to produce documents from the Office of the Attorney General for the State of New York Medicaid and Fraud Control Unit pursuant to what the government attorneys advised was a joint investigation. MedImmune has cooperated with these inquiries. In March 2017, MedImmune was served with a lawsuit filed in US Federal Court in New York by the Attorney General for the State of New York alleging that MedImmune inappropriately provided assistance to a single specialty-care pharmacy. In September 2018, the US Federal Court in New York denied MedImmune's motion to dismiss the lawsuit brought by the Attorney General for the State of New York.

 

In June 2017, MedImmune was served with a lawsuit in US Federal Court in New York by a relator under the qui tam (whistleblower) provisions of the federal and certain state False Claims Acts. The lawsuit was originally filed under seal in April 2009 and alleges that MedImmune made false claims about Synagis. In November 2017, MedImmune was served with an amended complaint in which the relator set forth additional false claims allegations relating to Synagis. In September 2018, the US Federal Court in New York dismissed the relator's lawsuit. In January 2019, relator appealed the decision of the US Federal Court in New York.

 

Tax

As previously disclosed, on 25 April 2019, the EC issued its decision on the State aid review of UK Controlled Foreign Company Group Financing Exemption (FCPE). The EC has concluded that part of the UK measures were unlawful and incompatible State aid and have instructed recovery of the State aid. The UK Government and the Company have appealed the decision. Given the complexities of the ruling, tax legislation and the ongoing appeal, the Company has been unable to estimate reliably any additional liability at this time; this is not, however, expected to be material.


6   Product Sales analysis - H1 2019

The table below provides an analysis of year-on-year Product Sales, with Actual and CER growth rates reflecting year-on-year growth.


World

Emerging Markets

US

Europe

Established RoW


H1 2019

Actual

CER

H1 2019

Actual

CER

H1 2019

Actual

H1 2019

Actual

CER

H1 2019

Actual

CER


$m

%

%

$m

%

%

$m

%

$m

%

%

$m

%

%

Oncology















Tagrisso

1,414

86

92

329

n/m

n/m

559

64

212

53

64

314

n/m

n/m

Imfinzi

633

n/m

n/m

12

n/m

n/m

473

n/m

60

n/m

n/m

88

n/m

n/m

Lynparza

520

93

n/m

59

n/m

n/m

262

76

131

51

61

68

n/m

n/m

Iressa

252

(8)

(3)

164

11

18

8

(43)

46

(25)

(20)

34

(35)

(33)

Calquence

64

n/m

n/m

-

-

-

64

n/m

-

-

-

-

-

-

Legacy:















Faslodex

521

4

8

96

35

49

251

(3)

110

(7)

-

64

21

23

Zoladex

391

4

11

235

16

27

4

33

65

(4)

1

87

(16)

(13)

Arimidex

111

-

7

72

1

13

-

-

15

-

-

24

(4)

(4)

Casodex

105

1

7

65

10

19

-

-

8

(27)

(27)

32

(6)

(3)

Others

48

(25)

(23)

16

-

6

-

-

3

-

-

29

(36)

(36)

Total Oncology

4,059

52

58

1,048

40

52

1,621

68

650

29

37

740

65

69
















BioPharmaceuticals: CVRM















Farxiga

726

14

19

206

31

45

270

2

178

17

26

72

13

16

Brilinta

737

21

26

217

47

58

321

24

171

(1)

7

28

(7)

-

Onglyza

269

5

10

87

7

16

120

22

36

(23)

(17)

26

(10)

(7)

Bydureon

283

(4)

(3)

7

-

29

234

-

34

(21)

(19)

8

(20)

(20)

Byetta

55

(8)

(5)

4

-

50

35

9

10

(38)

(38)

6

(25)

(25)

Symlin

15

(6)

(6)

-

-

-

15

(6)

-

-

-

-

-

-

Legacy:















Crestor

645

(11)

(6)

407

(4)

2

54

(40)

75

(32)

(27)

109

7

11

Seloken/Toprol-XL

393

5

14

349

6

16

26

-

13

8

8

5

(29)

(29)

Atacand

106

(21)

(16)

76

1

11

6

(40)

15

(63)

(63)

9

(10)

(10)

Others

143

(10)

(6)

95

(13)

(6)

4

n/m

34

(13)

(13)

10

(23)

(23)

BioPharmaceuticals: total CVRM

3,372

3

8

1,448

9

18

1,085

5

566

(10)

(5)

273

-

3
















BioPharmaceuticals: Respiratory















Symbicort

1,170

(10)

(6)

263

9

18

382

(13)

354

(14)

(7)

171

(20)

(17)

Pulmicort

716

13

19

576

20

27

56

(5)

44

(12)

(6)

40

(5)

(2)

Fasenra

296

n/m

n/m

1

n/m

n/m

208

n/m

45

n/m

n/m

42

n/m

n/m

Daliresp/Daxas

104

25

27

2

n/m

n/m

89

33

12

(14)

(7)

1

-

-

Tudorza/Eklira

33

(55)

(52)

(1)

n/m

n/m

-

n/m

31

(18)

(13)

3

(50)

(50)

Duaklir

37

(26)

(20)

-

n/m

-

-

-

36

(23)

(19)

1

(50)

(50)

Bevespi

20

54

54

-

-

-

20

54

-

-

-

-

-

-

Others

159

(2)

4

115

89

n/m

1

n/m

39

(48)

(47)

4

(85)

(85)

BioPharmaceuticals:

total Respiratory

2,535

5

10

956

22

30

756

12

561

(13)

(7)

262

(14)

(11)
















Other medicines















Nexium

756

(15)

(11)

369

8

15

119

(36)

32

(74)

(74)

236

(1)

2

Losec/Prilosec

144

(1)

6

96

9

17

4

-

31

(14)

(8)

13

(24)

(24)

Synagis

149

(40)

(40)

-

-

-

35

(72)

114

(9)

(9)

-

-

-

Seroquel XR/IR

69

(70)

(68)

24

(74)

(72)

(13)

n/m

47

(16)

(13)

11

(39)

(39)

Movantik/Moventig

47

(10)

(10)

-

n/m

n/m

45

(12)

2

n/m

n/m

-

-

-

Others

52

(53)

(49)

10

(70)

n/m

11

57

26

(26)

14

5

(86)

(69)

Total other medicines

1,217

(27)

(24)

499

(11)

(7)

201

(54)

252

(33)

(28)

265

(14)

(10)
















Total Product Sales

11,183

12

17

3,951

15

24

3,663

18

2,029

(6)

1

1,540

16

19

 

7   Product Sales analysis - Q2 2019 (Unreviewed*)

The table below provides an analysis of year-on-year Product Sales, with Actual and CER growth rates reflecting year-on-year growth.

* The Q2 2019 information in respect of the three months ended 30 June 2019 included in the interim financial statements has not been reviewed by PricewaterhouseCoopers LLP.


World

Emerging Markets

US

Europe

Established RoW


Q2 2019

Actual

CER

Q2 2019

Actual

CER

Q2 2019

Actual

Q2 2019

Actual

CER

Q2 2019

Actual

CER


$m

%

%

$m

%

%

$m

%

$m

%

%

$m

%

%

Oncology















Tagrisso

784

86

92

191

n/m

n/m

300

55

112

60

73

181

n/m

n/m

Imfinzi

338

n/m

n/m

6

n/m

n/m

242

n/m

37

n/m

n/m

53

n/m

n/m

Lynparza

283

89

95

33

n/m

n/m

143

72

66

47

60

41

n/m

n/m

Iressa

118

(17)

(13)

78

1

8

4

(33)

20

(35)

(32)

16

(45)

(41)

Calquence

35

n/m

n/m

-

-

-

35

n/m

-

-

-

-

-

-

Legacy:















Faslodex

267

8

12

51

59

75

125

-

56

(5)

2

35

13

16

Zoladex

197

3

10

121

20

31

2

-

30

(12)

(6)

44

(20)

(16)

Arimidex

60

5

14

36

-

14

-

-

9

29

29

15

7

7

Casodex

57

10

17

34

21

32

-

-

4

(20)

(20)

19

-

5

Others

28

(24)

(24)

8

(11)

(11)

-

-

2

-

-

18

(31)

(31)

Total Oncology

2,167

51

57

558

45

57

851

58

336

31

41

422

65

70
















BioPharmaceuticals: CVRM















Farxiga

377

11

16

111

26

40

139

-

89

14

22

38

9

9

Brilinta

389

23

28

120

67

79

168

17

88

2

10

13

(7)

-

Onglyza

116

(8)

(4)

44

7

10

42

(14)

17

(29)

(17)

13

8

17

Bydureon

141

(9)

(8)

5

(29)

(14)

117

(5)

16

(20)

(20)

3

(40)

(40)

Byetta

25

(14)

(10)

3

n/m

n/m

15

(12)

4

(56)

(56)

3

(25)

(25)

Symlin

8

14

14

-

-

-

8

14

-

-

-

-

-

-

Legacy:















Crestor

310

(8)

(3)

182

(2)

4

28

(36)

36

(22)

(13)

64

3

8

Seloken/Toprol-XL

168

(3)

5

156

1

10

3

(63)

7

17

17

2

(50)

(50)

Atacand

56

(14)

(9)

37

(3)

5

4

33

11

(42)

(42)

4

(20)

(20)

Others

68

(7)

(4)

43

(12)

(8)

3

n/m

15

(17)

(17)

7

(13)

(13)

BioPharmaceuticals: total CVRM

1,658

2

7

701

10

19

527

(1)

283

(8)

(1)

147

(1)

2
















BioPharmaceuticals: Respiratory















Symbicort

585

(13)

(9)

130

15

25

206

(20)

172

(14)

(7)

77

(26)

(23)

Pulmicort

333

16

23

262

24

32

32

7

19

(17)

(9)

20

(9)

(5)

Fasenra

167

n/m

n/m

1

n/m

n/m

115

n/m

27

n/m

n/m

24

n/m

n/m

Daliresp/Daxas

56

24

24

1

n/m

n/m

48

26

6

(14)

-

1

-

-

Tudorza/Eklira

13

(71)

(69)

(2)

n/m

n/m

(2)

n/m

15

(17)

(11)

2

(50)

(50)

Duaklir

17

(23)

(14)

(1)

n/m

-

-

-

17

(15)

(15)

1

-

-

Bevespi

10

25

25

-

-

-

10

25

-

-

-

-

-

-

Others

71

(13)

(7)

47

96

n/m

1

-

20

(55)

(55)

3

(79)

(79)

BioPharmaceuticals:

total Respiratory

1,252

2

7

438

26

36

410

1

276

(13)

(7)

128

(18)

(15)
















Other medicines















Nexium

393

(11)

(7)

179

11

19

53

(39)

16

(74)

(74)

145

9

12

Losec/Prilosec

68

(11)

(4)

45

7

17

3

-

13

(35)

(30)

7

(36)

(36)

Synagis

96

n/m

n/m

-

-

-

10

n/m

86

n/m

n/m

-

-

-

Seroquel XR/IR

32

(76)

(74)

10

(81)

(81)

(7)

n/m

24

(14)

(7)

5

(50)

(50)

Movantik/Moventig

22

(8)

(8)

-

n/m

n/m

22

(4)

-

-

-

-

-

-

Others

30

(36)

(26)

16

(53)

(47)

8

n/m

13

30

60

(7)

n/m

n/m

Total other medicines

641

(14)

(10)

250

(14)

(8)

89

(37)

152

(1)

3

150

(6)

(3)
















Total Product Sales

5,718

14

19

1,947

17

27

1,877

16

1,047

1

8

847

17

21

 

8   Sequential quarterly Product Sales - 2019 (Unreviewed*)

The table below provides an analysis of sequential quarterly Product Sales, with Actual and CER growth rates reflecting quarter-on-quarter growth.

* The sequential quarterly product sales information included in the interim financial statements has not been reviewed by PricewaterhouseCoopers LLP.


Q1 2019

Actual

CER

Q2 2019

Actual

CER

Q3 2019

Actual

CER

Q4 2019

Actual

CER


$m

%

%

$m

%

%

$m

%

%

$m

%

%

Oncology













Tagrisso

630

6

5

784

24

25







Imfinzi

295

13

13

338

15

15







Lynparza

237

13

13

283

19

20







Iressa

134

20

19

118

(12)

(13)







Calquence

29

21

21

35

21

21







Legacy:













Faslodex

254

(6)

(6)

267

5

5







Zoladex

194

7

5

197

2

2







Arimidex

51

11

9

60

18

20







Casodex

48

4

4

57

19

17







Others

20

(13)

(17)

28

40

42







Total Oncology

1,892

7

6

2,167

15

15




















BioPharmaceuticals: CVRM













Farxiga

349

(12)

(12)

377

8

9







Brilinta

348

(7)

(8)

389

12

12







Onglyza

153

3

3

116

(24)

(24)







Bydureon

142

3

3

141

(1)

(1)







Byetta

30

(6)

(6)

25

(17)

(17)







Symlin

7

(30)

(30)

8

14

14







Legacy:













Crestor

335

(5)

(6)

310

(7)

(7)







Seloken/Toprol-XL

225

41

39

168

(25)

(25)







Atacand

50

(14)

(15)

56

12

14







Others

75

-

-

68

(9)

(8)







BioPharmaceuticals: total CVRM

1,714

(2)

(3)

1,658

(3)

(3)




















BioPharmaceuticals: Respiratory













Symbicort

585

(8)

(8)

585

-

1







Pulmicort

383

(2)

(2)

333

(13)

(13)







Fasenra

129

3

2

167

29

30







Daliresp/Daxas

48

(11)

(13)

56

17

19







Tudorza/Eklira

20

5

-

13

(35)

(30)







Duaklir

20

(9)

(9)

17

(15)

(14)







Bevespi

10

-

-

10

-

-







Others

88

(20)

(19)

71

(19)

(23)







BioPharmaceuticals: total Respiratory

1,283

(6)

(6)

1,252

(2)

(2)




















Other medicines













Nexium

363

(7)

3

393

8

9







Synagis

53

(79)

(90)

96

81

81







Losec/Prilosec

76

27

27

68

(11)

(11)







Seroquel XR/IR

37

(34)

(32)

32

(14)

(13)







Movantik/Moventig

25

-

-

22

(12)

(12)