FORM 6-K
 
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
Report of Foreign Issuer
 
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
 
For the month of February 2020
 
Commission File Number: 001-11960
 
AstraZeneca PLC
 
1 Francis Crick Avenue
Cambridge Biomedical Campus
Cambridge CB2 0AA
United Kingdom
 
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
 
Form 20-F X Form 40-F __
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______
 
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
 
Yes __ No X
 
If “Yes” is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b): 82-_____________
 
 
 

 
 
AstraZeneca PLC
 
INDEX TO EXHIBITS
 
 
1.
AZN: Full-year and Q4 2019 results
 
 
 
AstraZeneca PLC
14 February 2020 7:00 GMT
 
Full-year and Q4 2019 results
A year of significant innovation for patients; accelerating the strategic transition
 
AstraZeneca delivered a year of strong revenue growth, supported by the launch of new medicines1 and further good progress on its pipeline, with several approvals and data readouts. These trends are set to continue in 2020, accompanied by growth in earnings and cash. In maintaining its focus on patients and science, the Company remains on track to deliver its strategic ambitions.
 
Full-year Product Sales growth of 12% (15% at CER2) to $23,565m included fourth-quarter Product Sales of $6,250m (+8%, +9% at CER). All three therapy areas and every sales region grew at CER in the quarter and over the full year. Highlights for the year included:
 
-    Sales of new medicines increased by 59% (62% at CER) to $9,906m, including new-medicine growth in Emerging Markets of 75% (84% at CER) to $1,865m. New medicines represented 42% of total Product Sales (FY 2018: 30%)
 
-    Sales growth across the therapy areas: Oncology +44% (+47% at CER) to $8,667m, New CVRM3 +9% (+12% at CER) to $4,376m and Respiratory +10% (+13% at CER) to $5,391m
 
-    For the first time, around half of Product Sales in the year were within the specialty-care4 setting
 
-    Sales growth across regions: total Emerging Markets sales increased by 18% (24% at CER) to $8,165m, with China sales growth of 29% (35% at CER); China sales in the quarter increased by 25% (28% at CER) to $1,189m. US sales increased by 13% in the year to $7,747m; Europe sales declined by 2% in the year (up by 2% at CER) to $4,350m; Japan sales increased by 27% (26% at CER) to $2,548m
 
 
 
FY 2019
Q4 2019
 
$m
% change
$m
% change
 
Actual
CER
Actual
CER
Product Sales
23,565
12
15
6,250
8
9
Collaboration Revenue
819
(21)
(20)
414
(36)
(36)
Total Revenue
24,384
10
13
6,664
4
5
 
 
 
 
 
 
 
Reported5 Operating Profit
2,924
(14)
(16)
577
(46)
(56)
Core6 Operating Profit
6,436
13
13
1,545
(29)
(33)
 
 
 
 
 
 
 
Reported EPS7
$1.03
(40)
(44)
$0.24
(71)
(78)
Core EPS
$3.50
1
-
$0.89
(44)
(46)
 
Pascal Soriot, Chief Executive Officer, commenting on the results said:
"In the first full year of our return to growth, we made good progress in line with our strategy. Results from our new medicines and Emerging Markets accompanied positive news for patients, most recently including regulatory approvals of Enhertu in breast cancer and Calquence in leukaemia. Our collaborations also progressed at pace, including that with Daiichi Sankyo, while there were several regulatory approvals for new medicines in China at the end of the year, such as Lynparza in first-line ovarian cancer.
 
Driven by a strong team, 2020 is anticipated to be another year of progress for AstraZeneca. We are becoming a better-balanced business, both regionally and through our medicines. This transition is a further step towards improving operating leverage and cash generation. As we accelerate our commitments to achieving our long-term climate-change and decarbonisation targets, we will maintain our focus on executing a strategy centred on science and patients."
 
Guidance
The Company provides guidance for FY 2020 at CER; Company guidance is on:
-     Total Revenue, comprising Product Sales and Collaboration Revenue
-     Core EPS
 
Prior guidance was on Product Sales and Core EPS. The change to guiding on Total Revenue and Core EPS reflects the changing nature and growing strategic impact of Collaboration Revenue, which will primarily comprise potential income from existing collaborations as follows:
 
-     A share of gross profits derived from sales of Enhertu (trastuzumab deruxtecan) in several markets, where those sales are recorded by Daiichi Sankyo Company, Limited (Daiichi Sankyo)
-     A share of gross profits derived from sales of roxadustat in China, recorded by FibroGen Inc. (FibroGen)8
-     Milestone revenue from the MSD9 collaboration on Lynparza and selumetinib
-     Smaller amounts of milestone and royalty revenue from other marketed and pipeline medicines
 
All guidance assumes an unfavourable impact from China lasting up to a few months as a result of the recent novel coronavirus (Covid-19) outbreak. The Company will monitor closely the development of the epidemic and anticipates providing an update at the time of the Q1 2020 results.
 

 
Depending on the impact of the Covid-19 epidemic, Total Revenue is expected to increase by a high single-digit to a low double-digit percentage and Core EPS is expected to increase by a mid- to high-teens percentage.
 

 
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 any 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.
 
Indications
The Company provides indications for FY 2020 at CER:
 
-     The Company is focused on improving operating leverage
 
-     A Core Tax Rate of 18-22%. Variations in the Core Tax Rate between quarters are anticipated to continue
 
-     Capital Expenditure is expected to be broadly stable versus the prior year
 
Currency impact
If foreign-exchange rates for February to December 2020 were to remain at the average of rates seen in January 2020, it is anticipated that there would be a neutral impact on Total Revenue and a low single-digit adverse impact on Core EPS, versus the prior year. In addition, the Company's foreign-exchange rate sensitivity analysis is contained within the operating and financial review.
 
Financial summary
 
-     Product Sales increased by 12% in the year (15% at CER) to $23,565m, driven by the performances of new medicines and Emerging Markets
 
-     The Reported Gross Profit Margin increased by three percentage points in the year (two at CER) to 79%, partly reflecting the mix of sales; the Core Gross Profit Margin was stable at 80%. The performance came despite the impact of a provision regarding Epanova for inventory and supply-related costs of $115m, recorded in Reported and Core Cost of Sales
 
-     Reported Operating Expense increased by 11% in the year (14% at CER) to $18,080m and represented 74% of Total Revenue (FY 2018: 74%); part of the rise reflected an increased level of intangible asset impairments. Core Operating Expense increased by 4% (7% at CER) to $14,748m and represented 60% of Total Revenue (FY 2018: 64%); the increase was driven by investment in the launches of new medicines and in Emerging Markets
 
-     The Reported Operating Profit Margin declined in the year by three percentage points (four at CER) to 12%; the Core Operating Profit Margin increased by one percentage point (stable at CER) to 26%
 
-     Reported EPS of $1.03 in the year, based on a weighted-average number of shares of 1,301m, represented a decline of 40% (44% at CER); Core EPS increased by 1% (stable at CER) to $3.50
 
-     The Board has reaffirmed its commitment to the progressive dividend policy; a second interim dividend of $1.90 per share has been declared, taking the unchanged full-year dividend per share to $2.80
 
Commercial summary
 
Oncology
Sales increased by 44% in the year (47% at CER) to $8,667m, including:
 
 
Table 1: Select Oncology sales
 
 
FY 2019
Q4 2019
 
$m
% change
$m
% change
 
Actual
CER
Actual
CER
Tagrisso
3,189
71
74
884
49
49
Imfinzi
1,469
n/m
n/m
424
62
62
Lynparza
1,198
85
89
351
68
69
Calquence
164
n/m
n/m
56
n/m
n/m
 
The strong Oncology performance continued to benefit from new medicines such as Tagrisso, Lynparza and Imfinzi. The full impact of recent regulatory approvals for Calquence and Enhertu is anticipated to favourably affect Total Revenue growth in 2020.
 
The performance from legacy Oncology medicines in the year included a decline in Faslodex sales of 13% (11% at CER) to $892m; the fall in the fourth quarter of 39% (38% at CER) led to sales of Faslodex of $166m. These declines reflected the 2019 launch of multiple generic Faslodex medicines in the US. Iressa sales also declined in the year by 18% (15% at CER) to $423m and in the quarter by 29% (28% at CER) to $80m; Iressa continued to be included on the China volume-based procurement programme in the year. The Company anticipates continued declines for both medicines.
 
Oncology sales increased in Emerging Markets by 45% (52% at CER) to $2,211m.
 
New CVRM
Sales increased by 9% in the year (12% at CER) to $4,376m, including:
 
 
Table 2: Select New CVRM sales
 
 
 
 
FY 2019
Q4 2019
 
$m
% change
$m
% change
 
Actual
CER
Actual
CER
Farxiga
1,543
11
14
419
6
7
Brilinta
1,581
20
23
428
14
15
Bydureon
549
(6)
(5)
139
1
1
 
The Company anticipates reporting on roxadustat sales within Total Revenue in due course.
 
New CVRM sales increased in Emerging Markets by 33% in the year (41% at CER) to $1,133m.
 
Respiratory
Sales increased by 10% in the year (13% at CER) to $5,391m, including:
 
 
Table 3: Select Respiratory sales
 
 
FY 2019
Q4 2019
 
$m
% change
$m
% change
 
Actual
CER
Actual
CER
Symbicort
2,495
(3)
-
712
12
13
Pulmicort
1,466
14
18
413
6
7
Fasenra
704
n/m
n/m
206
65
65
 
Respiratory sales increased in Emerging Markets by 21% (27% at CER) to $1,987m.
 
Emerging Markets
As the Company's largest region, at 35% of total Product Sales, Emerging Markets sales increased by 18% in the year (24% at CER) to $8,165m, including:
 
-     A China sales increase of 29% (35% at CER) to $4,880m
-     An ex-China sales increase of 6% (12% at CER) to $3,285m
 
Sustainability summary
 
Recent developments and progress against the Company's sustainability priorities are reported below:
 
-     Access to healthcare: the Company announced that the Young Health Programme (YHP) will partner with UNICEF10 to prevent non-communicable diseases among young people. AstraZeneca and UNICEF will collaborate on initiatives that will reach more than five million young people, train c.1,000 youth advocates, and potentially help to shape public policy around the world over the next six years
 
-     Environmental protection: AstraZeneca recently unveiled an ambitious programme for zero-carbon emissions from its global operations by 2025 and a carbon-negative value chain by 2030. The strategy brings forward decarbonisation plans by more than a decade. In 2019, the Company was ranked 56th overall, as one of the world's one hundred most sustainable companies by environmental research and media group, Corporate Knights, and second for biopharmaceutical companies
 
-     Ethics and transparency: the Hampton-Alexander independent review body, which works to support improvements in women's representation at board level and in leadership roles two layers below the board, recently published its latest review. In the reviews FTSE 100 ranking, AstraZeneca moved up from seventh place in 2018 to sixth in 2019 for women represented in the top-three layers of management
 
A more extensive sustainability update is provided later in this announcement.
 
Notes
These notes refer to pages one to five.
 
  1.   TagrissoImfinziLynparzaCalquenceFarxigaBrilintaLokelmaFasenraBevespi and Breztri. These new medicines are pillars in the main therapy areas and are important platforms for future growth. Over time, Enhertu and roxadustat will be added to this list.
  2.   Constant exchange rates. These are financial measures that are not accounted for according to generally-accepted accounting principles (GAAP) because they remove the effects of currency movements from Reported results.
  3.   New Cardiovascular (CV), Renal & Metabolism comprises Diabetes medicines, Brilinta and Lokelma. Over time, roxadustat will be added to this list.
  4.   Specialty-care medicines comprise all Oncology medicines, BrilintaLokelma and Fasenra.
  5.   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. The UK is yet to announce its IFRS endorsement process and is anticipated to continue to follow the EU endorsement process for the foreseeable future.
  6.   Core financial measures. These are non-GAAP financial measures because, unlike Reported performance, they cannot be derived directly from the information in the Group's Financial Statements. See the operating and financial review for a definition of Core financial measures and a reconciliation of Core to Reported financial measures.
  7.   Earnings per share.
  8.   FibroGen and AstraZeneca are collaborating on the development and commercialisation of roxadustat in the US, China, and other global markets. FibroGen and Astellas Pharma Inc. (Astellas) are collaborating on the development and commercialisation of roxadustat in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa.
  9.   Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada.
10.  United Nations International Children's Emergency Fund.
 
 
Table 4: pipeline highlights
 
The following table highlights significant developments in the late-stage pipeline since the prior results announcement:
 
 
Regulatory approvals
  -     Imfinzi - unresectable[10], Stage III NSCLC[11] (CN)
  -     Lynparza - ovarian cancer (1st line[12], BRCAm[13]) (SOLO-1) (CN)
  -     Lynparza - pancreatic cancer (1st line, BRCAm) (US)
  -     Enhertu - breast cancer (3rd line, HER2+[14]) (US)
  -     Calquence - CLL[15] (US)
  -     Qtrilmet - T2D[16] (EU)
  -     Lokelma - hyperkalaemia (CN)
  -     Breztri - COPD[17] (CN)
Regulatory submission acceptances and/or submissions
  -     Imfinzi - SCLC[18] (ED[19]): regulatory submission (JP), acceptance (EU), Priority Review (US)
  -     Lynparza - ovarian cancer (1st line) (PAOLA-1): regulatory submission (JP), acceptance (EU), Priority Review (US)
  -     Lynparza - prostate cancer (2nd line): regulatory submission acceptance (EU), Priority Review (US)
  -     Calquence - CLL: regulatory submission (JP), acceptance (EU)
  -     selumetinib - NF1[20]: regulatory submission acceptance, Priority Review (US)
  -     Farxiga - HF[21] CVOT[22]: regulatory submission (JP, CN), acceptance (EU), Priority Review (US)
  -     Brilinta - CAD[23]/T2D CVOT: regulatory submission (JP, CN)
  -     roxadustat - anaemia from CKD[24]: regulatory submission acceptance (US)8
  -     Symbicort - mild asthma: regulatory submission (CN)
Major
Phase III data readouts or other significant developments
  -     Imfinzi +/- treme - NSCLC (1st line) (POSEIDON): met Phase III primary endpoint (PFS[25])
  -     Imfinzi, tremelimumab - HCC[26]: Orphan Drug Designation (US)
  -     Enhertu - gastric cancer (3rd line, HER2+): met Phase II primary and key secondary (OS[27]) endpoints
  -     Brilinta - stroke: met Phase III primary endpoint
  -     Epanova - mixed dyslipidaemia: Phase III terminated as unlikely to meet primary endpoint
  -     roxadustat - anaemia from CKD: met Phase III pooled safety objective
  -     cotadutide - NASH[28]: Fast Track designation (US)
 
Table 5: 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.
 
 
Timing
News flow
H1 2020
-      Imfinzi - SCLC (ED): regulatory decision (US)
-      Imfinzi +/- treme - bladder cancer (1st line) (DANUBE): data readout, regulatory submission
-      Imfinzi +/- treme - head & neck cancer (1st line): data readout, regulatory submission
-      Lynparza - ovarian cancer (1st line) (PAOLA-1): regulatory decision (US)
-      Lynparza - breast cancer (BRCAm): regulatory decision (CN)
-      Lynparza - prostate cancer (2nd line): regulatory decision (US)
-      Lynparza + cediranib - ovarian cancer (2nd line): data readout
-      Enhertu - breast cancer (3rd line, HER2+): regulatory decision (JP)
-      Enhertu - gastric cancer (3rd line, HER2+): regulatory submission
-      selumetinib - NF1: regulatory decision (US)
-      selumetinib - NF1: regulatory submission (EU)
 
-      Forxiga - T2D CVOT: regulatory decision (CN)
-      Farxiga - HF CVOT: regulatory decision (US)
-      Brilinta - stroke (THALES): regulatory submission
-      Lokelma - hyperkalaemia: regulatory decision (JP)
 
-      Symbicort - mild asthma: regulatory submission (EU)
-      Bevespi - COPD: regulatory decision (CN)
H2 2020
-      Imfinzi - unresectable, Stage III NSCLC (PACIFIC-2): data readout
-      Imfinzi - SCLC (ED): regulatory decision (EU, JP)
-      Imfinzi - SCLC (ED): regulatory submission (CN)
-      Imfinzi +/- treme - HCC (1st line): data readout
-      Lynparza - ovarian cancer (1st line) (PAOLA-1): regulatory decision (EU)
-      Lynparza - ovarian cancer (3rd line, BRCAm): regulatory submission (US)
-      Lynparza - pancreatic cancer (1st line, BRCAm): regulatory decision (EU)
-      Lynparza - prostate cancer (2nd line): regulatory decision (EU)
-      Enhertu - breast cancer (3rd line, HER2+): regulatory submission (EU)
-      Calquence - CLL: regulatory decision (EU)
 
-      Forxiga - HF CVOT: regulatory decision (EU, JP, CN)
-      Brilinta/Brilique - CAD/T2D CVOT: regulatory decision (US, EU)
-      roxadustat - anaemia from CKD: regulatory decision (US)
 
-      Symbicort - mild asthma: regulatory decision (CN)
-      Fasenra - nasal polyposis: data readout
-      PT010 - COPD: regulatory decision (US, EU)
-      PT027 - asthma: data readout
-      tezepelumab - severe asthma: data readout
-      anifrolumab - lupus (SLE[29]): regulatory submission
2021
-      Imfinzi - adjuvant NSCLC: data readout, regulatory submission
-      Imfinzi - unresectable, Stage III NSCLC (PACIFIC-2): regulatory submission
-      Imfinzi +/- treme - NSCLC (1st line) (POSEIDON): data readout (OS), regulatory submission
-      Imfinzi +/- treme - SCLC (LD[30]): data readout
-      Imfinzi +/- treme - HCC (1st line): regulatory submission
-      Imfinzi - HCC (locoregional): data readout, regulatory submission
-      Lynparza - adjuvant breast cancer: data readout, regulatory submission
-      Lynparza - prostate cancer (1st line, castration-resistant): data readout, regulatory submission
-      Lynparza + cediranib - ovarian cancer (2nd line): regulatory submission
-      Enhertu - breast cancer (3rd line, HER2+) (Phase III): data readout, regulatory submission
-      Enhertu - breast cancer (2nd line, HER2+): data readout
-      Enhertu - breast cancer (HER2-low): data readout
-      Calquence - CLL: regulatory decision (JP)
 
-      Farxiga - chronic kidney disease: data readout, regulatory submission
-      roxadustat - anaemia from myelodysplastic syndrome[31]: data readout
 
-      Fasenra - nasal polyposis: regulatory submission
-      PT027 - asthma: regulatory submission
-      tezepelumab - severe asthma: regulatory submission
 
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 first quarter financial results on 29 April 2020.
 
AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, CVRM and Respiratory. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.
 
Contacts
For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.
 
 
Operating and financial review
 

All narrative on growth and results in this section is based on actual exchange rates, and financial figures are in US$ millions ($m), unless stated otherwise. The performance shown in this announcement covers the year to 31 December 2019 (the year or FY 2019) and three-month period to 31 December 2019 (the quarter or Q4 2019) compared to the year to 31 December 2018 (FY 2018) and three-month period to 31 December 2018 (Q4 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 Group Condensed Consolidated Financial Statements. Management believes that these non-GAAP financial measures, when provided in combination with Reported results, will provide investors and analysts with helpful supplementary information to understand better the financial performance and position of the Group on a comparable basis from period to period. These non-GAAP financial measures are not a substitute for, or superior to, financial measures prepared in accordance with GAAP. Core financial measures are adjusted to exclude certain significant items, such as:
 
-     Amortisation and impairment of intangible assets, including impairment reversals but excluding any charges relating to IT assets
 
-     Charges and provisions related to restructuring programmes, which includes charges that relate to the impact of restructuring programmes on capitalised IT assets
 
-     Other specified items, principally comprising 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 Consolidated Financial Information 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 dollar values and percentages may not agree to totals.
 
Table 6: Total Revenue
 
 
 
FY 2019
Q4 2019
 
$m
% change
$m
% change
 
Actual
CER
Actual
CER
Product Sales
23,565
12
15
6,250
8
9
Collaboration Revenue
819
(21)
(20)
414
(36)
(36)
 
 
 
 
 
 
 
Total Revenue
24,384
10
13
6,664
4
5
 
Table 7: Product Sales
 
 
 
FY 2019
Q4 2019
 
$m
 
% change
$m
 
% change
 
% of total
Actual
CER
% of total
Actual
CER
Oncology
8,667
37
44
47
2,274
36
29
29
BioPharmaceuticals
9,767
41
10
13
2,705
43
10
11
                        New CVRM
4,376
19
9
12
1,168
19
6
7
                    Respiratory
5,391
23
10
13
1,537
25
13
14
Other medicines
5,131
22
(16)
(13)
1,271
20
(17)
(16)
 
 
 
 
 
 
 
 
 
Total
23,565
100
12
15
6,250
100
8
9
 
Specialty-care medicines comprise all Oncology medicines, BrilintaLokelma and Fasenra. At 47% of Product Sales (FY 2018: 36%), specialty-care medicine sales increased by 43% in the year (47% at CER) to $10,966m.
 
Table 8: Top-ten medicines by Product Sales
 
 
Medicine
Therapy Area
FY 2019
Q4 2019
$m
% of total
% change
$m
% change
Actual
CER
Actual
CER
Tagrisso
Oncology
3,189
14
71
74
884
49
49
Symbicort
Respiratory
2,495
11
(3)
-
712
12
13
Brilinta
CVRM
1,581
7
20
23
428
14
15
Farxiga
CVRM
1,543
7
11
14
419
6
7
Nexium
Other medicines
1,483
6
(13)
(11)
353
(10)
(10)
Imfinzi
Oncology
1,469
6
n/m
n/m
424
62
62
Pulmicort
Respiratory
1,466
6
14
18
413
6
7
Crestor
CVRM
1,278
5
(11)
(8)
296
(16)
(15)
Lynparza
Oncology
1,198
5
85
89
351
68
69
Faslodex
Oncology
892
4
(13)
(11)
166
(39)
(38)
 
 
 
 
 
 
 
 
 
Total
 
16,594
70
20
23
4,446
15
16
 
Table 9: Collaboration Revenue
 
 
 
FY 2019
Q4 2019
 
$m
% of total
% change
$m
% change
 
Actual
CER
Actual
CER
Initial Collaboration Revenue
-
-
-
-
-
-
-
 
 
 
 
 
 
 
 
Ongoing Collaboration Revenue
819
100
(21)
(20)
414
(36)
(36)
                                                                        Royalties
62
8
29
34
18
59
63
                                            Milestones/other: Lynparza
610
74
(23)
(20)
350
(44)
(43)
                                                  Milestones/other: nirsevimab[32]
34
4
n/m
n/m
-
n/m
n/m
                                                    Other Milestones/other
113
14
(19)
(18)
46
n/m
n/m
 
 
 
 
 
 
 
 
Total
819
100
(21)
(20)
414
(36)
(36)
 
Royalties included those associated with Nexium (over-the-counter format), ZoladexTudorza/Eklira and DuaklirLynparza milestone and other receipts in Q4 2019, as part of a collaboration with MSD, comprised sales-milestone income of $250m and a final option-based receipt of $100m.
 
 
Product Sales
 

The performance of the Company's medicines is shown below, with a geographical split shown in Notes 7 & 8.
 
Table 10: Therapy area and medicine performance
 
 
Therapy area
Medicine
FY 2019
Q4 2019
$m
% of total
% change
$m
% change
Actual
CER
Actual
CER
Oncology
Tagrisso
3,189
14
71
74
884
49
49
Imfinzi
1,469
6
n/m
n/m
424
62
62
Lynparza
1,198
5
85
89
351
68
69
Calquence
164
1
n/m
n/m
56
n/m
n/m
Faslodex[33]
892
4
(13)
(11)
166
(39)
(38)
Zoladex33
813
3
8
13
196
8
9
Iressa33
423
2
(18)
(15)
80
(29)
(28)
Arimidex33
225
1
6
11
51
10
11
Casodex33
200
1
-
3
43
(6)
(5)
Others
94
-
(18)
(17)
26
15
12
Total Oncology
8,667
37
44
47
2,274
29
29
BioPharmaceuticals: CVRM
Farxiga
1,543
7
11
14
419
6
7
Brilinta
1,581
7
20
23
428
14
15
Bydureon
549
2
(6)
(5)
139
1
1
Onglyza
527
2
(3)
-
131
(11)
(10)
Byetta
110
-
(13)
(11)
27
(16)
(15)
Other diabetes
52
-
33
35
16
35
36
Lokelma
14
-
n/m
n/m
8
n/m
n/m
Crestor33
1,278
5
(11)
(8)
296
(16)
(15)
Seloken/Toprol-XL33
760
3
7
12
190
18
20
Atacand33
221
1
(15)
(11)
60
3
5
Others
271
1
(9)
(6)
72
1
4
BioPharmaceuticals: total CVRM
6,906
29
3
6
1,785
2
4
BioPharmaceuticals: Respiratory
Symbicort
2,495
11
(3)
-
712
12
13
Pulmicort
1,466
6
14
18
413
6
7
Fasenra
704
3
n/m
n/m
206
65
65
Daliresp/Daxas
215
1
14
15
58
8
8
Duaklir
77
-
(19)
(15)
22
(2)
-
Bevespi
42
-
26
26
12
12
12
Breztri
2
-
n/m
n/m
1
n/m
n/m
Others
390
2
(13)
(9)
114
(9)
(7)
BioPharmaceuticals: total Respiratory
5,391
23
10
13
1,537
13
14
Other medicines
Nexium
1,483
6
(13)
(11)
353
(10)
(10)
Synagis
358
2
(46)
(46)
63
(75)
(75)
Losec/Prilosec
263
1
(3)
1
46
(24)
(23)
Seroquel XR/IR
191
1
(47)
(46)
40
(27)
(27)
Others
306
1
(23)
(20)
151
12
14
Total other medicines
2,601
11
(24)
(21)
653
(27)
(27)
 
Total Product Sales
23,565
100
12
15
6,250
8
9
 
 
Product Sales summary
 

Oncology
Product Sales of $8,667m in the year; an increase of 44% (47% at CER). Oncology Product Sales represented 37% of total Product Sales, up from 29% in 2018.
 
Tagrisso
Tagrisso has been approved in 80 countries, including the US, China, in Europe and Japan for the 1st-line treatment of patients with epidermal growth factor receptor (EGFR)-mutated (EGFRm) NSCLC; to date, reimbursement has been granted in 18 countries, with further reimbursement decisions anticipated throughout 2020, as well as additional regulatory decisions in new countries. The regulatory decisions regarding the 1st-line setting followed Tagrisso's approval and launch in 87 countries, including the US, China, in Europe and Japan for the 2nd-line treatment of patients with Stage IV EGFR T790M[34]-mutated NSCLC.
 
Product Sales in the year of $3,189m represented growth of 71% (74% at CER), partly driven by the aforementioned regulatory approvals and reimbursements in the 1st-line setting; continued growth was also delivered in the 2nd-line setting, for example, within Europe and Emerging Markets. Sales in the US increased by 46% in the year to $1,268m. Q4 2019 sales in the US, however, grew sequentially by only 2% reflecting an increase in inventory movements in Q3 2019 and adverse gross-to-net adjustments[35] in the fourth quarter. Demand continued and Tagrisso is established as the standard of care (SoC) in the 1st-line setting, following regulatory approval in 2018.
 
In Emerging Markets, Tagrisso sales increased by 120% in the year (130% at CER) to $762m, with notable growth in China, following the admission to the China National Drug Reimbursement List (NRDL) in the 2nd line setting, which took place at the start of the year. Sales of Tagrisso in Japan increased by 100% in the year (97% at CER) to $633m; in the final quarter, however, sales were adversely impacted by a 15% mandated price reduction that took effect from 1 November 2019. In Europe, sales of $474m in the year represented an increase of 51% (59% at CER), driven by emerging use in the 1st-line setting as more countries granted reimbursement, as well as continued strong levels of demand in the 2nd-line setting.
 
Imfinzi
Imfinzi is approved in 61 countries, including the US, China, 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 15 countries, including the US.
 
Global Product Sales of Imfinzi increased by 132% in the year (133% at CER) to $1,469m, of which $1,041m were in the US, almost entirely for the treatment of unresectable, Stage III NSCLC; sales in the US increased by 85% in the year. In Japan, sales of $211m (FY 2018: $35m) reflected encouraging levels of demand, supported by higher CRT and treatment rates. Sales in Europe of $179m (FY 2018: $27m) followed recent regulatory approvals and launches.
 
Lynparza
By the end of the year, Lynparza was approved in 73 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 58 countries for the treatment of metastatic breast cancer and, in the US, for the treatment of pancreatic cancer.
 
Product Sales of Lynparza amounted to $1,198m in the year, an increase of 85% (89% at CER). The strong performance was geographically spread, with launches continuing in Emerging Markets and the Established Rest of World region (RoW). Ongoing MSD co-promotion efforts also contributed to sales.
 
US sales increased by 81% to $626m, driven by the launch in the 1st-line BRCAm ovarian cancer setting at the end of 2018. Lynparza remained the leading medicine in the US in the PARP-inhibitor class, as measured by total prescription volumes in both ovarian and breast cancer. Sales in Europe increased by 51% (59% at CER) to $287m, driven by increasing levels of reimbursement and BRCA-testing rates, as well as the recent 1st-line ovarian- and breast-indication launches.
 
Japan sales of Lynparza amounted to $130m in the year, representing growth of 170% (167% at CER). Emerging Markets sales of $133m, up by 161% (177% at CER), 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); Lynparza was recently admitted to the China NRDL for the same indication, with effect from January 2020.
 
Calquence
Product Sales in the year of $164m; an increase of 164%, with most sales in the US. Calquence was recently approved by the US FDA for the treatment of CLL and small lymphocytic lymphoma (SLL) in November 2019.
 
Legacy: Iressa
Product Sales in the year of $423m; a decline of 18% (15% at CER).
 
Emerging Markets sales were stable in the year (up by 4% at CER) at $286m; Iressa continued to be included on the China volume-based procurement programme. Given the growing use of Tagrisso, sales of Iressa in the US declined by 33% to $17m and by 36% (32% at CER) to $70m in Europe. Japan sales amounted to $44m, reflecting a decline of 50%.
 
Legacy: Faslodex
Product Sales in the year of $892m; a decline of 13% (11% at CER).
 
Emerging Markets sales of Faslodex increased by 29% in the year (36% at CER) to $198m. US sales declined by 39% to $328m, reflecting the launch of multiple generic Faslodex medicines; in Q4 2019, Faslodex sales in the US declined by 88% to $17m. In Europe, where generic competitor medicines are established, sales in the year increased by 3% (9% at CER) to $229m, while in Japan, sales increased by 20% (19% at CER) to $131m.
 
Legacy: Zoladex
Product Sales in the year of $813m; an increase of 8% (13% at CER).
 
Emerging Markets sales of Zoladex increased by 20% (28% at CER) in the year to $492m. Sales in Europe increased by 2% (7% at CER) to $135m. In the Established RoW region, sales declined by 11% (10% at CER) to $179m, driven by the effects of increased competition.
 
Further in prostate cancer, the agreement between AstraZeneca and Janssen Pharmaceutical K. K. in Japan for the co-promotion of abiraterone acetate, announced in 2013, recently ceased; sales of abiraterone acetate recorded by AstraZeneca amounted to $36m in the year.
 
 
BioPharmaceuticals: CVRM
 
Total CVRM sales, which include Crestor and other legacy medicines, increased by 3% in the year (6% at CER) to $6,906m and represented 29% of total Product Sales (FY 2018: 32%).
 
New CVRM sales increased by 9% in the year (12% at CER) to $4,376m, reflecting strong performances from Farxiga and Brilinta. New CVRM sales represented 19% of Product Sales in the year (FY 2018: 19%).
 
Farxiga
Product Sales of $1,543m in the year; an increase of 11% (14% at CER).
 
Emerging Markets sales increased by 40% (48% at CER) to $471m, reflecting growth in the sodium-glucose transport protein 2 (SGLT-2) class at the expense of the dipeptidyl-peptidase 4 class; there was also a further improvement in levels of access. Farxiga was admitted to the China NRDL with effect from the start of 2020.
 
US sales declined by 9% to $537m, impacted by changes in formulary access for competitor medicines at the beginning of the year. The level of sales growth in the US in the year was also adversely affected by the impact on price from increased levels of competition, the mix of sales and managed markets. There were favourable movements in the share of new-to-brand prescriptions in the second half, however, a result of a label update in the US to reflect results from the DECLARE CVOT. US sales increased sequentially by 12% from Q3 2019 to Q4 2019.
 
Sales in Europe increased by 18% (25% at CER) to $373m, partly reflecting growth in the SGLT-2 class and an acceleration on new-to-brand prescriptions following the aforementioned DECLARE label update. In Japan, sales to the collaborator, Ono Pharmaceutical Co., Ltd, which records in-market sales, increased by 16% (14% at CER) to $87m.
 
Onglyza
Product Sales of $527m in the year; a decline of 3% (stable at CER).
 
Sales in Emerging Markets increased by 3% (9% at CER) to $176m, driven by the performance in China. Growth in the US was supported by improved pricing; US sales of Onglyza increased by 3% in the year to $230m. The US performance in FY 2018 was adversely impacted by the effect of gross-to-net adjustments, resulting in a favourable comparison for FY 2019. There was also a benefit from the mix of sales and managed markets, offsetting declining class-driven volumes. Europe sales declined by 22% (17% at CER) to $70m, 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 $549m in the year; a decline of 6% (5% at CER).
 
Sales were impacted by production constraints in the first half of the year for the new Bydureon BCise device and declining volumes for the dual-chamber pen; these constraints were resolved in the second half of the year. US sales of $459m represented a decline of 3% in the year, resulting from the pricing impact of managed markets and the transition to the BCise device. Bydureon sales in Europe fell by 19% (14% at CER) to $66m.
 
Brilinta
Product Sales of $1,581m in the year; an increase of 20% (23% 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 42% (49% at CER) to $462m. US sales of Brilinta, at $710m, represented an increase of 21%, 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 increased by 1% in the year (7% at CER) to $351m, driven by performances in Spain, Italy and the UK.
 
Lokelma
Product Sales of $14m in the year (FY 2018: $nil), predominantly in the US, reflecting the recent launch of the medicine. Lokelma represented strong levels of new-to-brand prescriptions by market share at the end of the period in the US. It is also approved in China and in the EU for the treatment of hyperkalaemia; launches in several markets are expected soon.
 
Legacy: Crestor
Product Sales of $1,278m in the year; a decline of 11% (8% at CER).
 
Sales in Emerging Markets declined by 4% (stable at CER) to $806m. The performance was adversely impacted in the final quarter by the effect of volume-based procurement in China; sales of Crestor in Emerging Markets declined by 12% in the quarter (10% at CER) to $185m. US sales declined by 39% to $104m, reflecting the ongoing effect of competition from generic Crestor medicines. In Europe, sales declined by 27% (23% at CER) to $148m, reflecting a similar impact. In Japan, where AstraZeneca collaborates with Shionogi Co. Ltd, sales increased by 3% (2% at CER) to $171m. 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 $5,391m in the year; an increase of 10% (13% at CER). Respiratory represented 23% of total Product Sales (FY 2018: 23%).
 
Symbicort
Product Sales in the year of $2,495m; a decline of 3% (stable at CER).
 
Symbicort continued its global market-volume leadership within the inhaled corticosteroid (ICS) / long-acting beta agonist (LABA) class and became market-value leader. Emerging Markets sales increased by 11% in the year (17% at CER) to $547m, reflecting particularly strong performances in China, Latin America and Asia Pacific. In contrast, however, volume growth in the US was offset by the impact of continued pricing pressure and managed-market rebates; US sales declined by 4% to $829m. This contrasted with US sales of Symbicort in Q4 2019, where sales increased by 18% to $244m, partly driven by a comparison with one-off unfavourable adjustments in Q4 2018. Building on this performance, AstraZeneca entered an agreement in January 2020 with Prasco, LLC to distribute an authorised-generic version of Symbicort in the US.
 
In Europe, sales declined by 12% in the year (7% at CER) to $678m, driven by price competition and government pricing interventions. In Japan, sales increased by 9% in the year (7% at CER) to $226m, supported by the impact of AstraZeneca regaining full rights, following termination earlier in the year of the Astellas co-promotion agreement.
 
Pulmicort
Product Sales in the year of $1,466m; an increase of 14% (18% at CER).
 
Emerging Markets, where sales increased by 20% in the year (24% at CER) to $1,190m, represented 81% of global sales of Pulmicort. The performance in China was strengthened by higher levels of demand and was underpinned by the impact of AstraZeneca's support in China for over 17,500 nebulisation centres. Sales in the US declined by 5% to $110m and sales in Europe declined by 10% (4% at CER) to $81m reflecting the legacy status of the medicine.
 
Fasenra
Fasenra has been approved in 53 countries, including the US, in the EU and Japan for the treatment of severe, uncontrolled eosinophilic asthma, with further regulatory reviews ongoing; Fasenra has achieved reimbursement in 36 countries.
 
Product Sales in the year of $704m, an increase of 137% (139% at CER).
 
Sales in the US increased by 121% in the year to $482m. In patients with severe, uncontrolled asthma, Fasenra ended the year as the leading novel biologic medicine, as measured by new-to-brand prescriptions.
 
In Europe, sales of $118m in the year represented an increase of 268% (287% at CER). Sales in Japan increased by 91% (89% at CER) to $86m in the year, following the medicine's launch in 2018. In its approved indication and among new patients, Fasenra obtained the leading market share of all biologics in the top-five European countries and in Japan.
 
Daliresp/Daxas
Product Sales in the year of $215m; an increase of 14% (15% at CER).
 
US sales, representing 86% of the global total, increased by 19% to $184m in the year, driven by favourable affordability-programme changes and inventory movements.
 
Duaklir
Product Sales in the year of $77m; a decline of 19% (15% at CER).
 
In 2019, the overwhelming majority of sales were in Europe, where sales declined by 22% (17% at CER) to $71m, mainly a result of an adverse performance in Germany. As part of the collaboration agreement announced in March 2017, Circassia Pharmaceuticals plc (Circassia) became responsible for the commercialisation of Duaklir in the US, with AstraZeneca continuing to manufacture and supply the medicine.
 
Bevespi
Product Sales in the year of $42m; an increase of 26%.
 
Bevespi saw prescriptions in the period track in line with other long-acting muscarinic antagonists / LABA launches; the class in the US, however, continued to grow more slowly than anticipated.
 
Breztri
Product Sales in the year of $2m (FY 2018: $nil), entirely in Japan.
 
In December 2019, Breztri received regulatory approval in China as a triple-combination therapy for the treatment of COPD. It also received regulatory approval in Japan earlier in the year.
 
Other medicines (outside the three main therapy areas)
 
Product Sales of $2,601m in the year; a decline of 24% (21% at CER). Other Product Sales represented 11% of total Product Sales, down from 16% in FY 2018 and 21% in FY 2017.
 
Nexium
Product Sales in the year of $1,483m; a decline of 13% (11% at CER).
 
Emerging Markets sales of Nexium increased by 8% (14% at CER) to $748m. In Europe, sales declined by 73% (72% at CER) to $63m, following divestment of prescription medicine rights in 2018. Sales in the US declined by 29% to $218m, reflecting its 2015 loss of exclusivity and, in Japan, where AstraZeneca collaborates with Daiichi Sankyo, sales declined by 1% (2% at CER) to $401m.
 
 
Regional Product Sales
 

Table 11: Regional Product Sales
 
 
 
FY 2019
Q4 2019
$m
% of total
% change
$m
% change
Actual
CER
Actual
CER
Emerging Markets
8,165
35
18
24
2,091
18
20
China
4,880
21
29
35
1,189
25
28
 Ex-China
3,285
14
6
12
902
10
11
 
 
 
 
 
 
 
 
US
7,747
33
13
13
2,059
1
1
 
 
 
 
 
 
 
 
Europe
4,350
18
(2)
2
1,182
1
4
 
 
 
 
 
 
 
 
Established RoW
3,303
14
17
18
918
16
13
Japan
2,548
11
27
26
719
22
17
Canada
470
2
(4)
(1)
126
(4)
(3)
Other Established RoW
285
1
(13)
(4)
73
5
10
 
 
 
 
 
 
 
 
Total
23,565
100
12
15
6,250
8
9
 
Table 12: Emerging Markets Product Sales
 
 
 
FY 2019
Q4 2019
$m
% of total
% change
$m
% change
Actual
CER
Actual
CER
Oncology
2,211
27
45
52
546
54
57
BioPharmaceuticals
3,120
38
25
31
865
18
20
New CVRM
1,133
14
33
41
297
25
27
Respiratory
1,987
24
21
27
568
14
16
Other medicines
2,834
35
(1)
4
680
1
2
 
 
 
 
 
 
 
 
Total
8,165
100
18
24
2,091
18
20
 
 
Table 13: Notable new-medicine performances in Emerging Markets
 
Product Sales
FY 2019
$m
% change
Actual
CER
Tagrisso
762
n/m
n/m
Lynparza
133
n/m
n/m
Farxiga
471
40
48
Brilinta
462
42
49
 
New medicines represented 23% of Emerging Markets sales (FY 2018: 15%). Sales of specialty-care medicines increased by 44% (52% at CER) to $2,678m and comprised 33% of Emerging Markets sales in the year (FY 2018: 27%).
 
Table 14: Notable other performances in Emerging Markets
 
Product Sales
FY 2019
$m
% change
Actual
CER
Zoladex
492
20
28
Pulmicort
1,190
20
24
Symbicort
547
11
17
 
China sales comprised 60% of Emerging Markets sales in the year, increasing by 29% (35% at CER) to $4,880m. China sales in the quarter increased by 25% (28% at CER) to $1,189m, when the performance was adversely impacted by the effect of volume-based procurement in China. New-medicine sales, primarily driven by Tagrisso and Lynparza in Oncology and Brilinta and Farxiga in New CVRM, delivered particularly encouraging growth and represented 19% of China sales (FY 2018: 11%). This performance was augmented by strong sales of ZoladexPulmicortNexium and Symbicort.
 
In early 2019, Tagrisso benefitted from being added to the 2018 NRDL by the China National Healthcare Security Administration (NHSA) as a treatment for patients with Stage IV EGFR T790M-mutated NSCLC. Furthermore, the NHSA published the preliminary 2019 NRDL in the second half of 2019, which included one additional AstraZeneca medicine, namely Kombiglyze for Diabetes. Respiratory medicines Symbicort for asthma and COPD and Nexium for acid reflux also benefitted as reimbursement restrictions were removed. In December 2019, the NHSA published the final 2019 NRDL, which was updated to include a further three AstraZeneca medicines: Lynparza in ovarian cancer, Forxiga in T2D and roxadustat in anaemia from CKD; Faslodex, however, was removed from the list. Since 2012, 15 of the Company's medicines have also been admitted to China's Essential Drugs List[36].
 
Ex-China Emerging Markets sales increased by 6% in the year (12% at CER) to $3,284m. New medicines represented 29% of Product Sales in the year (FY 2018: 21%), increasing by 45% (53% at CER). The performance was underpinned by strong levels of growth at CER in the following regions:
 
 
Table 15: Ex-China Emerging Markets
 
Product Sales
FY 2019
% change
Actual
CER
Russia
35
40
Brazil
(2)
7
Ex-Brazil Latin America
3
16
Ex-China Asia Pacific
8
10
Middle East and Africa
3
8
 
 
Financial performance

 
Table 16: Reported Profit and Loss
 
 
 
FY 2019
FY 2018
% change
Q4 2019
Q4 2018
% change
$m
$m
Actual
CER
$m
$m
Actual
CER
Product Sales
23,565
21,049
12
15
6,250
5,768
8
9
Collaboration Revenue
819
1,041
(21)
(20)
414
649
(36)
(36)
Total Revenue
24,384
22,090
10
13
6,664
6,417
4
5
 
 
 
 
 
 
 
 
 
Cost of Sales
(4,921)
(4,936)
-
5
(1,378)
(1,637)
(16)
(10)
 
 
 
 
 
 
 
 
 
Gross Profit
19,463
17,154
13
16
5,286
4,780
11
10
Gross Profit Margin[37]
79.1%
76.6%
3
2
78.0%
71.6%
6
5
 
 
 
 
 
 
 
 
 
Distribution Expense
(339)
(331)
2
7
(92)
(93)
(2)
-
% Total Revenue
1.4%
1.5%
-
-
1.4%
1.5%
-
-
R&D Expense
(6,059)
(5,932)
2
5
(2,091)
(2,012)
4
5
% Total Revenue
24.8%
26.9%
2
2
31.4%
31.4%
-
-
SG&A Expense
(11,682)
(10,031)
16
20
(3,026)
(2,600)
16
18
% Total Revenue
47.9%
45.4%
(2)
(3)
45.4%
40.5%
(5)
(5)
 
 
 
 
 
 
 
 
 
Total Operating Expenses
(18,080)
(16,294)
11
14
(5,209)
(4,705)
11
12
% Total Revenue
74.1%
73.8%
-
-
78.2%
73.3%
(5)
(5)
 
 
 
 
 
 
 
 
 
Other Operating Income & Expense
1,541
2,527
(39)
(38)
500
1,002
(50)
(50)
% Total Revenue
6.3%
11.4%
(5)
(5)
7.5%
15.6%
(8)
(8)
 
 
 
 
 
 
 
 
 
Operating Profit
2,924
3,387
(14)
(16)
577
1,077
(46)
(56)
Operating Profit Margin
12.0%
15.3%
(3)
(4)
8.7%
16.8%
(8)
(10)
Net Finance Expense
(1,260)
(1,281)
(2)
4
(312)
(311)
-
(1)
Joint Ventures and Associates
(116)
(113)
3
5
(25)
(36)
(30)
(30)
Profit Before Tax
1,548
1,993
(22)
(29)
240
730
(67)
(79)
Taxation
(321)
57
n/m
n/m
37
279
(87)
(81)
Tax Rate
21%
-3%
 
 
-15%
-38%
 
 
Profit After Tax
1,227
2,050
(40)
(45)
277
1,009
(72)
(80)
 
 
 
 
 
 
 
 
 
EPS
1.03
1.70
(40)
(44)
0.24
0.82
(71)
(78)
 
Table 17: Reconciliation of Reported Profit Before Tax to EBITDA[38]
 
 
 
FY 2019
FY 2018
% change
Q4 2019
Q4 2018
% change
 
$m
$m
Actual
CER
$m
$m
Actual
CER
Reported Profit Before Tax
1,548
1,993
(22)
(29)
240
730
(67)
(79)
Net Finance Expense
1,260
1,281
(2)
4
312
311
-
(1)
Joint Ventures and Associates
116
113
3
5
25
36
(30)
(30)
Depreciation, Amortisation and Impairment
3,762
3,753
-
3
1,643
1,662
(1)
-
 
 
 
 
 
 
 
 
 
EBITDA
6,686
7,140
(6)
(6)
2,220
2,739
(19)
(22)
 
Table 18: FY 2019 reconciliation of Reported to Core financial measures
 
 
 
Reported
Restructuring
Intangible Asset Amortisation & Impairments
Diabetes Alliance
Other[39]
Core[40]
Core % change
 
$m
$m
$m
$m
$m
$m
Actual
CER
Gross Profit
19,463
73
87
-
-
19,623
10
13
Gross Profit Margin
79.1%
 
 
 
 
79.8%
-
-
 
 
 
 
 
 
 
 
 
Distribution Expense
(339)
-
-
-
-
(339)
2
7
R&D Expense
(6,059)
101
638
-
-
(5,320)
1
4
SG&A Expense
(11,682)
173
1,771
(126)
775
(9,089)
5
8
Total Operating Expenses
(18,080)
274
2,409
(126)
775
(14,748)
4
7
 
 
 
 
 
 
 
 
 
Other Operating Income & Expense
1,541
-
1
-
19
1,561
(27)
(26)
 
 
 
 
 
 
 
 
 
Operating Profit
2,924
347
2,497
(126)
794
6,436
13
13
Operating Profit Margin
12.0%
 
 
 
 
26.4%
+1
-
 
 
 
 
 
 
 
 
 
Net Finance Expense
(1,260)
-
-
287
208
(765)
4
10
Taxation
(321)
(66)
(519)
(54)
(149)
(1,109)
n/m
n/m
 
 
 
 
 
 
 
 
 
EPS
$1.03
$0.22
$1.52
$0.08
$0.65
$3.50
1
-
 
Table 19: Q4 2019 reconciliation of Reported to Core financial measures
 
 
 
Reported
Restructuring
Intangible Asset
Amortisation & Impairments
Diabetes Alliance
Other41
Core42
Core
% change
$m
$m
$m
$m
$m
$m
Actual
CER
Gross Profit
5,286
(49)
18
-
-
5,255
1
1
Gross Profit Margin
78.0%
 
 
 
 
77.5%
-1
-2
 
 
 
 
 
 
 
 
 
Distribution Expense
(92)
-
-
-
-
(92)
(2)
-
R&D Expense
(2,091)
19
578
-
-
(1,494)
2
4
SG&A Expense
(3,026)
26
762
(420)
33
(2,625)
8
9
Total Operating Expenses
(5,209)
45
1,340
(420)
33
(4,211)
5
7
 
 
 
 
 
 
 
 
 
Other Operating Income & Expense
500
-
(2)
-
3
501
(50)
(50)
 
 
 
 
 
 
 
 
 
Operating Profit
577
(4)
1,356
(420)
36
1,545
(29)
(33)
Operating Profit Margin
8.7%
 
 
 
 
23.2%
-11
-12
 
 
 
 
 
 
 
 
 
Net Finance Expense
(312)
-
-
71
55
(186)
6
-
Taxation
37
8
(279)
52
(13)
(195)
n/m
n/m
EPS
 $0.24
-
 $0.83
 ($0.23)
 $0.05
 $0.89
(44)
(46)
 
 
Profit and Loss summary
 

 
a)   Gross Profit
The increase in Reported and Core Gross Profit for the year was a reflection of the growth in Product Sales. Reported Gross Profit was adversely impacted in the prior year by the recognition of costs associated with the closure of two biologic-medicine manufacturing sites in Colorado, US. A partial reversal of these costs was recorded in the quarter.
 
Following the recommendation from an independent Data Monitoring Committee, AstraZeneca recently decided to terminate the Phase III STRENGTH trial for Epanova (omega-3 carboxylic acids), due to its low likelihood of demonstrating a benefit to patients with mixed dyslipidaemia who are at increased risk of CV disease. This was considered to be an adjusting event after the reporting period, resulting in a provision for inventory and supply-related costs of $115m, recorded in Reported and Core Cost of Sales in FY 2019.
 
b)   Operating Expense
Reported Operating Expense in the year represented 74% of Total Revenue (FY 2018: 74%), Core Operating Expense represented 60% of Total Revenue (FY 2018: 64%).
 
Reported and Core R&D Expense increased partly a result of investment in the development of Enhertu. Reported and Core SG&A Expense grew primarily because of 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 Expense partly reflected fair-value adjustments arising on acquisition-related liabilities recognised in 2019, as well as an increase in legal provisions and intangible asset impairments; the latter included impairments of BydureonQtern and Tudorza/Eklira.
 
The aforementioned STRENGTH-trial termination also resulted in a full impairment of the Epanova intangible asset of $533m, recorded in Reported R&D Expense in FY 2019.
 
c)   Other Operating Income and Expense[41]
Reported and Core Other Operating Income and Expense in the year included:
 
-     $515m, reflecting an agreement to sell US rights to Synagis to Swedish Orphan Biovitrum AB (publ) (Sobi)
-     $243m, reflecting an agreement to divest the global commercial rights, excluding China, Japan, the US and Mexico, for Losec and associated brands to Cheplapharm Arzneimittel GmbH (Cheplapharm)
-     $213m, reflecting agreements to sell its commercial rights to Seroquel and Seroquel XR in the US, Canada, Europe and Russia to Cheplapharm
-     $181m, reflecting an agreement to sell the commercial rights to Arimidex and Casodex in a number of European, African and other countries to Juvisé Pharmaceuticals
 
In January 2020, the Company announced that it had agreed to divest the global commercial rights to a number of established hypertension medicines, including InderalTenormin and Zestril to Atnahs Pharma. Atnahs Pharma will make an upfront payment of $350m to AstraZeneca. AstraZeneca may also receive future sales-contingent payments of up to $40m between 2020 and 2022. Income arising from the upfront and future payments will be reported in AstraZeneca's financial statements within Other Operating Income and Expense. The divestment is expected to complete in the first quarter of 2020.
 
d)   Net Finance Expense
Reported and Core Net Finance Expense increased at CER in the year, partly reflecting an adverse movement in loan interest, as well as the effect of the adoption of IFRS 16 (see Note 1). There was also a discount unwind in respect of the profit-participation financial liability in relation to the aforementioned FY 2019 divestment of the US rights to participate in the future cash flows from the US profits or losses for nirsevimab, impacting Reported and Core Finance Expense.
 
e)   Taxation
The Reported Tax Rate for the year was 21% and the Core Tax Rate was 20% (FY 2018: (3)% and 11% respectively). These tax rates were higher than the UK Corporation Tax Rate due to the impact of the geographical mix of profits.
 
f)    EPS
Reported EPS of $1.03 in the year, based on a weighted-average number of shares of 1,301m, represented a decline of 40% (44% at CER); Core EPS increased by 1% (stable at CER) to $3.50. The difference between the Reported and Core performance partly reflected the impact of a favourable $346m legal settlement in FY 2018 that was recognised as income in Reported Other Operating Income and Expense. It was also a result of an increase in legal provisions and revaluation movements on acquisition-related liabilities in 2019, as well as an increase in intangible asset impairments.
 
In April 2019, the Company completed an issue of 44,386,214 new ordinary shares of $0.25 each at a price of £60.50 per share, resulting in an increase in share capital of $11m and an increase in share premium of $3.5bn, net of transaction costs of $22m.
 
g)   Dividend per share
The Board reaffirms its commitment to the progressive dividend policy; a second interim dividend of $1.90 per share (146.4 pence, 18.32 SEK) has been declared, taking the unchanged full-year dividend per share to $2.80 (218.3 pence, 26.81 SEK). Dividend payments are normally paid as follows:
 
-     First interim dividend - announced with half-year and second-quarter results and paid in September
-     Second interim dividend - announced with full-year and fourth-quarter results and paid in March
 
The record date for the second interim dividend for 2019, payable on 30 March 2020, will be 28 February 2020. The ex-dividend date will be 27 February 2020. The record date for the first interim dividend for 2020, payable on 14 September 2020, will be 14 August 2020. The ex-dividend date will be 13 August 2020.
 
Table 20: Cash Flow
 
 
 
FY 2019
FY 2018
Change
 
$m
$m
$m
Reported Operating Profit
2,924
3,387
(463)
Depreciation, Amortisation and Impairment
3,762
3,753
9
 
 
 
 
Increase in Working Capital and Short-Term Provisions
(346)
(639)
293
Gains on Disposal of Intangible Assets
(1,243)
(1,885)
642
Non-Cash and Other Movements
(236)
(785)
549
Interest Paid
(774)
(676)
(98)
Taxation Paid
(1,118)
(537)
(581)
 
 
 
 
Net Cash Inflow from Operating Activities
2,969
2,618
351
 
 
 
 
Net Cash Inflow before Financing Activities
2,312
3,581
(1,269)
Net Cash Outflow from Financing Activities
(1,765)
(2,044)
279
 
The increase in Net Cash Inflows from Operating Activities in the year primarily reflected an underlying improvement in business performance, combined with favourable working-capital movements and the impact of the adoption of IFRS 16 (Leases) on 1 January 2019. The positive cash performance was partly offset by an increase in Taxation Paid, which represented 72% of Reported Profit Before Tax (FY 2018: 27%); the increase in the amount paid primarily reflected the phasing of tax payments between periods and the impact of refunds in FY 2018, following agreement of prior-period liabilities. The adoption of IFRS 16 resulted in a presentational change within the cash-flow statement, whereby cash outflows of $186m are now presented as financing, instead of operating.
 
The decline in Net Cash Inflows before Financing Activities primarily reflected the Purchase of Intangible Assets, which included:
 
-     The first of two $675m upfront payments to Daiichi Sankyo as part of the agreement on Enhertu
-     The impact of a final true-up net payment of $413m to MSD, based on sales of Nexium and Prilosec from 2014 to 2018; this was accrued over the same period
 
Payments from Pfizer, Inc. totalling $250m were received in the year, 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 an agreement with Luye Pharma Group Ltd, relating to the rights to Seroquel and Seroquel XR in the UK, China and other international markets, announced in June 2018, AstraZeneca received a deferred consideration payment of $240m in the quarter, also recorded within Disposal of Intangible Assets. Other business-development transactions are referred to in the section Other Operating Income and Expense above.
 
The cash payment of contingent consideration, in respect of the former Bristol-Myers Squibb Company share of the global diabetes alliance, amounted to $454m in the year (FY 2018: $349m).
 
As part of the total consideration received in respect of the aforementioned agreement to sell US rights to Synagis, $821m was received and included in Disposal of Intangible Assets and $150m was related to the rights to participate in the future cash flows from the US profits or losses for nirsevimab. This was recognised as a financial liability as the Company did not fully transfer the risks and rewards of the underlying cash flows arising from nirsevimab to Sobi; this was recorded in Other Payables, within Non-current Liabilities. The associated cash flow was presented within Investing Activities as AstraZeneca received the payment in exchange for agreeing to transfer future cashflows relating to an intangible asset.
 
In October 2019, Circassia announced the launch of Duaklir in the US, upon which the Company made a $91m milestone payment to Almirall, S.A. (Almirall). Following the announcement in December 2019 that Enhertu had been approved in the US for patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting, AstraZeneca accrued a first milestone payment to Daiichi Sankyo for $125m; this amount was capitalised upon approval.
 
In April 2019, the Company completed a placing of new Ordinary Shares 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 as to strengthen AstraZeneca's balance sheet. The proceeds from the placing were recorded in the second quarter, supporting a reduced level of Net Debt.
 
h)   Capital expenditure
Capital expenditure amounted to $979m in the year, compared to $1,043m in FY 2018. This included investment in the new AstraZeneca R&D centre on the Biomedical Campus in Cambridge, UK. The Company continues to expect total associated capital expenditure for the project of c.$1.3bn (c.£1bn, translated at average exchange rates for the year).
 
The Company anticipates a broadly stable level of total capital expenditure in FY 2020 (FY 2019: $979m).
 
Table 21: Debt and capital structure
 
 
 
At
31 Dec 2019
At
31 Dec 2018
 
$m
$m
Cash and Cash Equivalents
5,369
4,831
Other Investments
911
895
 
 
 
Cash and Investments
6,280
5,726
 
 
 
Overdrafts and Short-Term Borrowings
(225)
(755)
Lease Liabilities[42]
(675)
-
Current Instalments of Loans
(1,597)
(999)
Loans Due After One Year
(15,730)
(17,359)
 
 
 
Interest-Bearing Loans and Borrowings (Gross Debt)
(18,227)
(19,113)
 
 
 
Net Derivatives
43
384
Net Debt
(11,904)
(13,003)
 
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 22: 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)[43]
Currency
Primary Relevance
FY 2019[44]
YTD 2020[45]
% change
Product Sales
Core Operating Profit
CNY
Product Sales
6.92
6.93
-
288
190
EUR
Product Sales
0.89
0.90
(1)
171
68
JPY
Product Sales
108.98
109.38
-
139
98
Other[46]
 
 
 
 
231
123
 
 
 
 
 
 
 
GBP
Operating Expense
0.78
0.77
2
27
(93)
SEK
Operating Expense
9.46
9.47
-
5
(51)
 
 
Sustainability
 

AstraZeneca's sustainability ambition has three priority areas[47], aligned with the Company's purpose and business strategy:
 
-      Access to healthcare
-      Environmental protection
-      Ethics and transparency
 
Recent developments and progress against the Company's priorities are reported below:
 
a)   Access to healthcare
By the end of December 2019, AstraZeneca's Healthy Heart Africa (HHA) programme, working with collaborators across Kenya, Ethiopia, Tanzania and Ghana, had conducted over 13.5 million blood-pressure screenings and identified over 2.4 million elevated readings since its launch in 2015. In November 2019, the Company extended the programme and launched Healthy Heart Asia in India. The launch was conducted in collaboration with the Ganga Godavari Cancer Screening Programme, AstraZeneca India's sustainability partner.
 
In January 2020, AstraZeneca announced that the YHP would partner with UNICEF to prevent non-communicable diseases among young people. The Company will support UNICEF with a $12.5m grant to support programming which will reach more than five million young people, train approximately 1,000 youth advocates, and potentially help to shape public policy around the world over the next six years. In October 2019, AstraZeneca announced plans to extend the funding for the YHP for a further five years, with a pledge of $35m to help to educate young people on the steps that they can take to reduce the risk of non-communicable diseases.
 
b)   Environmental protection
In January 2020, during the World Economic Forum Annual Meeting in Davos, Switzerland, AstraZeneca announced an ambitious programme for zero-carbon emissions from its global operations by 2025. The Company also announced its commitment to ensuring that its entire value chain is carbon-negative by 2030, bringing forward decarbonisation plans by more than a decade. The 'Ambition Zero Carbon' strategy will accelerate the Company's existing science-based targets, doubling energy productivity and using renewable energy for both power and heat, as well as switching to 100% electric-vehicle fleet five years ahead of schedule.
 
In addition, the Company also announced plans to invest up to $1bn to help achieve these goals and to develop the next-generation respiratory inhalers with near-zero Global Warming Potential propellants. Also included in the plan is 'AZ Forest', a 50-million tree-reforestation initiative that will be rolled out over the next five years.
 
The Company was recently commended by the global environmental impact non-profit organisation, CDP, achieving a place on both the 'A List' for Climate Change and the 'A List' for Water Security, based on data submitted by the Company in 2019. A double 'A List' status was achieved for the fourth consecutive year. AstraZeneca is one of a small number of high-performing companies out of thousands that were scored, and fewer than ten companies worldwide appeared on both 'A Lists' in the last four years.
 
c)   Ethics and transparency
During the period, the Workforce Disclosure Initiative[48] released its 2019 scorecard, underpinned by 138 institutional-investor signatories. The Company participated for the second year, indicating its willingness to work towards increasing the amount of workforce data disclosed.
 
In January 2020, the Company was included, for the second consecutive year, in the Bloomberg 2020 Gender-Equality Index. This year, the index recognised 325 companies which work to advance women in the workplace through measurement and transparency.
 
 
 
During the period, the Hampton-Alexander independent review body, which works to increase the number of women on FTSE 350 boards on a voluntary business-led basis, published its latest review. It has a dual focus on improving women's representation at board level and in leadership roles two layers below board level and covers 23,000 leadership roles across all sectors of British business.
 
In the FTSE 100 ranking, AstraZeneca moved up from seventh place in 2018 to sixth in 2019 for women represented in the top three layers of leadership. With women representing 40% of leaders at this level, the Company was the highest-ranked pharmaceutical company. Having moved from five to four women Board members since 2018, however, AstraZeneca dropped from 12th place to 39th place in 2019, as this particular metric is sensitive to individual appointments.
 
d)   Other developments
During the period, AstraZeneca was ranked 56th overall by Corporate Knights[49], out of more than 7,000 companies, as one of the world's one hundred most sustainable companies, and second among biopharmaceutical companies.
 

 
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. The 2019 Sustainability Report will be availability in due course.
 
 

 
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 23: Update from the late-stage pipeline
 
 
New molecular
entities and major lifecycle events for medicines in Phase III trials or under regulatory review
17
Oncology
-     Tagrisso - NSCLC
-     Imfinzi - multiple cancers
-     Lynparza - multiple cancers
-     Enhertu - breast and other cancers
-     capivasertib - breast cancer
-     Calquence - blood cancers
-     tremelimumab - multiple cancers
-     selumetinib - NF1[50]
-     savolitinib - NSCLC53
 
CV, Renal & Metabolism
-     roxadustat - anaemia from CKD
 
Respiratory (and immunology)
-     Fasenra - multiple indications
-     Breztri - COPD
-     PT027 - asthma
-     tezepelumab - severe asthma
-     nirsevimab - lower respiratory tract infection
-     anifrolumab - lupus
-     brazikumab[51] - inflammatory bowel disease
Total projects
in clinical pipeline
144
 
 
 
Oncology
 
At the 2019 American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, US, the Company presented over 30 abstracts including seven oral presentations. Highlights included the first presentation of data from the pivotal Phase III ELEVATE TN trial, evaluating the long-term efficacy and safety of Calquence in combination with obinutuzumab and Calquence monotherapy versus obinutuzumab combined with chlorambucil chemotherapy in previously untreated CLL.
 
At the 2019 San Antonio Breast Cancer Symposium (SABCS), US, AstraZeneca presented over 30 abstracts, including three oral presentations and two spotlight poster discussions. Highlights included the Enhertu DESTINY-Breast01 Phase II trial data in HER2-positive breast cancer.
 
Oncology: lung cancer
 
a)   Tagrisso
 
Table 24: Key Tagrisso trials in lung cancer
 
 
Trial
Population
Design
Timeline
Status
Phase III
ADAURA
Adjuvant EGFRm NSCLC
Placebo or Tagrisso
FPCD[52]
Q4 2015
 
LPCD[53]
Q1 2019
 
First data anticipated
2021+[54]
Recruitment
completed
Phase III
LAURA
Locally advanced, unresectable EGFRm NSCLC
Placebo or Tagrisso
FPCD
Q4 2018
 
First data anticipated
2021+
Recruitment
ongoing
Phase III
FLAURA2
1st-line EGFRm NSCLC
Tagrisso or Tagrisso + platinum-based chemotherapy doublet
FPCD
Q4 2019
 
First data anticipated
2021+
Recruitment ongoing
 
b)   Imfinzi
In December 2019, AstraZeneca announced that it has received marketing authorisation from the China NMPA for Imfinzi for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent CRT. The approval of Imfinzi was based on results from the primary analysis of PFS, supported by OS data from the Phase III PACIFIC trial.
 
In November 2019, the Company announced that the US Food and Drug Administration (FDA) had accepted a supplemental Biologics License Application and awarded Priority Review status for Imfinzi for the treatment of patients with previously untreated ED SCLC, based on results from the Phase III CASPIAN trial. A Prescription Drug User Fee Act (PDUFA) date is set for the first quarter of 2020. The Company also recently made regulatory submissions for Imfinzi in Japan and received a regulatory submission acceptance in the EU for previously untreated ED SCLC. The submissions were based on the flat dose of 1,500mg of Imfinzi, with four cycles of chemotherapy once every three weeks.
 
During the period, Imfinzi was assigned Category 1 status for the treatment of ED SCLC patients within the US National Comprehensive Cancer Network guidelines.
 
During the period, the Company announced positive PFS results for Imfinzi and tremelimumab, an anti-CTLA4 antibody, when added to chemotherapy, from the Phase III POSEIDON trial in previously-untreated Stage IV (metastatic) NSCLC. The trial met a primary endpoint by showing a statistically significant and clinically meaningful improvement in the final PFS analysis for Imfinzi and chemotherapy, and a key secondary endpoint for PFS of Imfinzi plus tremelimumab and chemotherapy. The safety and tolerability of Imfinzi was consistent with its known safety profile; the triple combination of Imfinzi plus tremelimumab and chemotherapy delivered a broadly similar safety profile. The trial will continue to assess the additional primary endpoint of OS, with data anticipated in 2021.
 
Table 25: Key Imfinzi trials in lung cancer
 
 
Trial
Population
Design
Timeline
Status
Phase III
AEGEAN
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
Phase III
ADJUVANT BR.31[55]
Stage Ib-IIIa NSCLC
Placebo or
Imfinzi
FPCD
Q1 2015
 
LPCD
Q4 2019
 
First data anticipated
2021
Recruitment
completed
Phase III
PACIFIC-2
Stage III unresected locally advanced NSCLC
(concurrent CRT)
Placebo or
Imfinzi
FPCD
Q2 2018
 
LPCD
Q3 2019
 
First data anticipated
H2 2020
Recruitment
completed
Phase III
ADRIATIC
Limited-disease stage SCLC
Concurrent CRT,
followed by
placebo or
Imfinzi or Imfinzi + treme
FPCD
Q4 2018
 
First data anticipated
2021
Recruitment
ongoing
Phase III
POSEIDON
Stage IV, 1st-line NSCLC
SoC chemotherapy or SoC + Imfinzi or SoC + Imfinzi + treme
FPCD
Q2 2017
 
LPCD
Q4 2018
PFS primary endpoint met
Phase III
CASPIAN
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.
 
During the period, the Company announced that Imfinzi and tremelimumab had both been granted Orphan Drug Designation in the US for the treatment of HCC. Imfinzi has now received regulatory approval for the 2nd-line treatment of patients with locally advanced or metastatic urothelial carcinoma (bladder cancer) in 15 countries.
 
Table 26: Key Imfinzi trials in tumour types other than lung cancer
 
 
Trial
Population
Design
Timeline
Status
Phase III
POTOMAC
Non-muscle invasive bladder cancer
SoC BCG[56] or SoC BCG + Imfinzi
FPCD
Q4 2018
 
First data
anticipated
2021+
Recruitment ongoing
Phase III
NIAGARA
Muscle-invasive bladder cancer
Neo-adjuvant cisplatin and gemcitabine SoC chemotherapy or SoC + Imfinzi, followed by adjuvant placebo or Imfinzi
FPCD
Q4 2018
 
First data
anticipated
2021+
Recruitment ongoing
Phase III
EMERALD-1
Locoregional HCC
TACE[57] followed by placebo or TACE + Imfinzi, followed by Imfinzi +
bevacizumab or
TACE + Imfinzi
followed by Imfinzi
FPCD
Q1 2019
 
First data
anticipated
2021
Recruitment ongoing
Phase III
EMERALD-2
Locoregional HCC at high risk of recurrence after surgery or radiofrequency ablation
Adjuvant Imfinzi or Imfinzi + bevacizumab
FPCD
Q2 2019
 
First data anticipated
2021+
Recruitment ongoing
Phase III
CALLA
Locally advanced cervical cancer
CRT or CRT + Imfinzi, followed by placebo or Imfinzi
FPCD
Q1 2019
 
First data anticipated
2021+
Recruitment ongoing
Phase III
DANUBE
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
H1 2020
Recruitment completed
Phase III
NILE
Stage IV, 1st-line cisplatin chemotherapy- eligible bladder cancer
SoC chemotherapy or SoC + Imfinzi or SoC + Imfinzi + treme
FPCD
Q4 2018
 
First data anticipated
2021+
Recruitment
ongoing
Phase III
KESTREL
Stage IV, 1st-line head and neck squamous cell carcinoma
SoC or Imfinzi or Imfinzi + treme
FPCD
Q4 2015
 
LPCD
Q1 2017
 
First data
anticipated
H1 2020
Recruitment completed
Phase III
HIMALAYA
Stage IV, 1st-line unresectable HCC
Sorafenib or Imfinzi or Imfinzi + treme
FPCD
Q4 2017
 
LPCD
Q4 2019
 
First data
anticipated
H2 2020
Recruitment
Completed
 
Orphan Drug Designation (US)
Phase III
TOPAZ-1
Stage IV, 1st-line biliary-tract cancer
Gemcitabine and cisplatin SoC chemotherapy or SoC + Imfinzi
FPCD
Q2 2019
 
First data anticipated
2021+
Recruitment ongoing
 
Oncology: Lynparza (multiple cancers)
In December 2019, AstraZeneca announced that it had received marketing authorisation from the China NMPA for Lynparza as a 1st-line maintenance treatment of adult patients with newly-diagnosed advanced BRCAm epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy. The approval in China was based on results from the Phase III SOLO-1 trial.
 
During the period, the Company announced that Lynparza had been approved in the US for the maintenance treatment of adult patients with germline (inherited) BRCAm metastatic pancreatic adenocarcinoma (pancreatic cancer) whose disease has not progressed for at least 16 weeks of a 1st-line platinum-based chemotherapy regimen. Patients will be selected for therapy based on a US FDA-approved companion diagnostic for Lynparza.
 
The approval followed the recommendation from the US FDA Oncologic Drugs Advisory Committee in December 2019 for Lynparza in this indication and was based on results from the pivotal Phase III POLO trial, published in The New England Journal of Medicine and presented at the 2019 American Society of Clinical Oncology Annual Meeting.
 
In January 2020, the Company announced that a supplemental New Drug Application (sNDA) for Lynparza in combination with bevacizumab has been accepted and granted Priority Review status in the US for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to 1st-line platinum-based chemotherapy with bevacizumab. The Company also made a regulatory submission for the same indication in Japan and achieved regulatory submission acceptance in the EU. During the same period, AstraZeneca also announced that an sNDA for Lynparza had been accepted and granted Priority Review status in the US for patients with metastatic castration-resistant prostate cancer and homologous recombination repair (HRR) gene mutations, who have progressed following prior treatment with a new hormonal agent.
 
At the 21st European Society of Gynaecological Oncology Congress in Athens, Greece, the Company presented further details from the Phase III PAOLA-1 trial of maintenance Lynparza with bevacizumab in patients with newly diagnosed, advanced ovarian cancer treated with platinum-based chemotherapy and bevacizumab as SoC. The updated data demonstrated that, in Stage III patients with primary debulking surgery and residual disease, patients who had received neoadjuvant chemotherapy and Stage IV patients, PFS was 22.0 months versus 16.6 months, with a hazard ratio of 0.65 (95% CI 0.51 - 0.82).
 
The Company continues to pursue the joint-venture agreement entered into in 2015 with Fujifilm Kyowa Kirin Biologics Co., Ltd. to develop biosimilar bevacizumab to enable the continued strategy of novel combinations with vascular endothelial growth factor inhibitors within the pipeline, commencing with Lynparza and other new medicines. The Phase III AVANA trial, which evaluated FKB238 (biosimilar bevacizumab) vs. Avastin (bevacizumab) in patients with advanced/recurrent non-squamous NSCLC, met the primary objective of efficacy equivalence on key clinical parameters.
 
Table 27: Key Lynparza trials
 
 
Trial
Population
Design
Timeline
Status
Phase III
OlympiA
Adjuvant BRCAm breast cancer
SoC placebo or Lynparza
 
FPCD
Q2 2014
 
LPCD
Q2 2019
 
First data anticipated
2021
Recruitment completed
 
Phase III
PROfound
Metastatic castration-resistant 2nd-line+ HRRm[58] prostate cancer
SoC (abiraterone or enzalutamide) or Lynparza
FPCD
Q2 2017
 
LPCD
Q4 2018
Primary endpoint met
 
Priority Review (US)
Phase III
PAOLA-1[59]
Advanced 1st-line
ovarian cancer
Bevacizumab maintenance or
bevacizumab +
Lynparza maintenance
FPCD
Q2 2015
 
LPCD
Q2 2018
Primary endpoint met
 
Priority Review (US)
Phase III
GY004[60]
Recurrent platinum-sensitive ovarian cancer
SoC chemotherapy or Lynparza or cediranib + Lynparza
FPCD
Q1 2016
 
First data
anticipated
H1 2020
Recruitment ongoing
Phase II/III
GY00563
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
2021+
Recruitment ongoing
(Phase III component)
Phase III
DuO-O
Advanced 1st-line
ovarian cancer
Chemotherapy +
bevacizumab or
chemotherapy +
bevacizumab +
Imfinzi +/-
Lynparza maintenance
FPCD
Q1 2019
 
First data
anticipated
2021+
Recruitment
ongoing
Phase III
PROpel
Stage IV, advanced, castration-resistant prostate cancer
Abiraterone or
abiraterone +
Lynparza
FPCD
Q4 2018
 
First data
anticipated
2021
Recruitment ongoing
 
Enhertu (breast and other cancers)
In December 2019, AstraZeneca announced that the US FDA had approved Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. This came under the Accelerated Approval programme, based on tumour-response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
 
High-level results from the positive registrational Phase II trial DESTINY-Gastric01 also showed that Enhertu had achieved a statistically significant and clinically meaningful improvement in the primary endpoint of objective response rate (ORR) and a key secondary endpoint of OS in patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction cancer that had progressed following two or more treatment regimens, including trastuzumab and chemotherapy. In addition to the planned discussion with the Japan Ministry of Health, Labour and Welfare, AstraZeneca and Daiichi Sankyo plan to discuss the data with other health authorities.
 
During the period, the Company presented detailed positive data from the global pivotal Phase II single-arm DESTINY-Breast01 trial at the aforementioned SABCS symposium; an accompanying article appeared in The New England Journal of Medicine. In the trial, Enhertu was investigated in patients with HER2-positive metastatic breast cancer who received two or more prior HER2-targeted regimens. The primary endpoint of ORR, confirmed by independent central review, was 60.9% with Enhertu monotherapy (5.4mg/kg). Patients had a median of six prior therapies for metastatic disease (a range of 2-27); patients achieved a disease control rate of 97.3%, with a median duration of response of 14.8 months and median PFS of 16.4 months. The median OS has not yet been reached, with an estimated survival rate of 86% at one year. The results were consistent across subgroups of patients.
 
Table 28: Key Enhertu trials
 
 
Trial
Population
Design
Timeline
Status
Phase II
DESTINY-Breast01
Stage IV, HER2+ (IHC[61] 3+ and IHC 2+/ISH[62]+) breast cancer post trastuzumab emtansine
Enhertu (single arm)
FPCD
Q4 2017
 
LPCD
Q4 2018
Primary objective met
 
Breakthrough Therapy Designation (US)
 
Accelerated approval (US)
Phase III
DESTINY-Breast02
Stage IV, HER2+ (IHC 3+ and IHC 2+/ISH+) breast cancer post trastuzumab emtansine
SoC chemotherapy or Enhertu
FPCD
Q4 2018
 
First data anticipated
2021
Recruitment ongoing
Phase III
DESTINY-Breast03
Stage IV, HER2+ (IHC 3+ and IHC 2+/ISH+) breast cancer
Trastuzumab emtansine or Enhertu
FPCD
Q4 2018
 
First data anticipated
2021
Recruitment ongoing
Phase III
DESTINY-Breast04
Stage IV, HER2-low (IHC 1+/2+) breast cancer
SoC chemotherapy or Enhertu
FPCD
Q4 2018
 
First data anticipated
2021
Recruitment ongoing
Phase II
DESTINY-Gastric01
Stage IV, HER2+ (IHC 3+ and IHC 2+/ISH+) gastric cancer
SoC chemotherapy or Enhertu
FPCD
Q4 2017
 
LPCD
Q2 2019
Primary endpoint met
 
Calquence (blood cancers)
In November 2019, AstraZeneca announced that the US FDA had approved Calquence for the treatment of adult patients with CLL or SLL. The approval was granted under the administration's Real-Time Oncology Review programme. Reflecting the newly established joint Project Orbis programme, approvals in Australia and Canada followed thereafter and, during the period, the Company also received regulatory submission acceptance in the EU for CLL and made a regulatory submission in Japan, for relapsed/refractory CLL.
 
The approvals were based on positive results from the interim analyses of two-Phase III clinical trials, namely ELEVATE TN in patients with previously untreated CLL, and ASCEND in patients with relapsed or refractory CLL. Together, the trials showed that Calquence, in combination with obinutuzumab or as a monotherapy, significantly reduced the relative risk of disease progression or death versus the comparator arms in both front-line and relapsed or refractory CLL. Across both trials, the safety and tolerability of Calquence were consistent with its established profile.
 
During the period, AstraZeneca presented results from the interim analysis of the ELEVATE TN trial at the aforementioned 2019 ASH meeting. The trial results demonstrated that Calquence, combined with obinutuzumab or as monotherapy, significantly improved PFS compared to chlorambucil plus obinutuzumab, a standard chemo-immunotherapy treatment, in patients with previously untreated CLL. At a median follow-up of 28.3 months, Calquence, in combination with obinutuzumab or as a monotherapy, significantly reduced the risk of disease progression or death by 90% and 80%, respectively, versus chlorambucil plus obinutuzumab.
 
Adverse events (AEs) led to treatment discontinuation in 11.2% of patients treated with Calquence in combination with obinutuzumab and 8.9% of patients treated with Calquence monotherapy versus 14.1% of patients treated with chlorambucil plus obinutuzumab. With over two years of follow-up, 79% of patients in both the Calquence-containing arms remain on Calquence as a monotherapy. In the Calquence combination arm (n=178), the most common AEs of any grade (≥30%) included headache (39.9%), diarrhoea (38.8%) and neutropenia (31.5%). In the Calquence monotherapy arm (n=179), the most common AEs of any grade (≥30%) included headache (36.9%) and diarrhoea (34.6%). In the chlorambucil plus obinutuzumab arm (n=169), the most common AEs of any grade (≥30%) included neutropenia (45.0%), infusion-related reaction (39.6%) and nausea.
 
Selumetinib (NF1)
In November 2019, the Company announced that the US FDA had accepted a New Drug Application (NDA) and granted Priority Review status for selumetinib as a potential new medicine for paediatric patients aged three years and older with NF1 and symptomatic, inoperable plexiform neurofibromas. This was the first acceptance of a regulatory submission for an oral monotherapy for the treatment of NF1, a rare and incurable genetic condition. A PDUFA date is set for the second quarter of 2020.
 
CVRM
 
a)   Farxiga (heart failure)
In January 2020, the Company announced the US FDA had accepted an sNDA and granted Priority Review status for Farxiga to reduce the risk of CV death or the worsening of heart failure in adults with heart failure with reduced ejection fraction, with and without T2D; the PDUFA date is set for the second quarter of 2020. During the period, the Company also received regulatory submission acceptance from the European Medicines Agency (EMA). Regulatory submissions were also achieved in Japan and China during the period.
 
b)   Qtrilmet (T2D)
During the period, the Company announced that the European Commission had approved Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets intended to improve glycaemic control in adults with T2D.
 
c)   Brilinta (stroke)
High-level results from the Phase III THALES trial showed that 90mg Brilinta, used twice daily and taken with aspirin for 30 days, reached a statistically significant and clinically meaningful reduction in the risk of the primary composite endpoint of stroke and death, compared to aspirin alone.
 
d)   Epanova (mixed dyslipidaemia)
Following the recommendation from an independent Data Monitoring Committee, AstraZeneca decided to terminate the Phase III STRENGTH trial for Epanova, due to its low likelihood of demonstrating a benefit to patients with MDL who are at increased risk of CV disease. STRENGTH was a large-scale, global CVOT designed to evaluate the safety and efficacy of Epanova compared to placebo, both in combination with SoC statin medicines.
 
d)   Cotadutide (NASH)
During the period, the US FDA granted Fast Track designation for cotadutide as a treatment for NASH.
 
Table 29: Key large CVRM outcomes trials
 
 
Trial
Population
Design
Primary endpoint(s)
Timeline
Status
Farxiga
 
Phase III
DAPA-HF
c.4,500 patients with HF and reduced ejection fraction, with and without T2D
Arm 1: Farxiga 10mg or 5 mg QD[63] + SoC
 
Arm 2: placebo + SoC
Time to first occurrence of CV death or hHF or an urgent HF visit
FPCD
Q1 2017
 
 LPCD
Q4 2018
Primary endpoint met
 
Fast Track designation (US)
Phase III
DELIVER
c.4,700 patients with HF and preserved ejection fraction, with and without T2D
Arm 1: Farxiga 10mg QD
 
Arm 2: placebo
Time to first occurrence of CV death or worsening HF
FPCD
Q4 2018
 
First data anticipated 2021+
 
Recruitment ongoing
 
Fast Track designation (US)
 
Phase III
DAPA-CKD
c.4,000 patients with CKD, with and without T2D
Arm 1: Farxiga 10mg or 5mg QD
 
Arm 2: placebo
Time to first occurrence of ≥ 50% sustained decline in eGFR or reaching ESRD[64] or CV death or renal death
FPCD
Q1 2017
 
First data anticipated 2021
Fast Track designation (US)
Brilinta
 
Phase III THEMIS
c.19,000 patients with T2D and CAD without a history of MI[65] or stroke
Arm 1: Brilinta 60mg BID[66]
 
Arm 2: placebo BID on a background of acetylsalicylic acid if not contra-indicated or not tolerated
Composite of CV death, non-fatal MI and non-fatal stroke
FPCD
Q1 2014
 
LPCD
Q2 2016
Primary endpoint met
Phase III
THALES
c.11,000 patients with acute ischaemic stroke or transient ischaemic attack
Arm 1: Brilinta 90mg BID
 
Arm 2: placebo BID on a background of acetylsalicylic acid if not contra-indicated or not tolerated
Prevention of the composite of subsequent stroke and death at 30 days
FPCD
Q1 2018
 
LPCD
Q4 2019
Primary endpoint met
 
e)   Roxadustat (anaemia)
In November 2019, AstraZeneca and FibroGen presented, during two oral sessions, detailed results from the Phase III OLYMPUS and ROCKIES trials at the American Society of Nephrology (ASN) Kidney Week 2019 in Washington, DC. The results showed that roxadustat significantly increased haemoglobin levels in non-dialysis dependent (NDD) patients with anaemia from CKD compared to placebo, and dialysis-dependent (DD) patients with anaemia from CKD compared to epoetin alfa, respectively.
 
The companies presented pooled efficacy and CV safety analyses from the pivotal Phase III programme during an oral late-breaking abstract session. The primary efficacy endpoint was achieved in the pooled analyses for NDD and DD patients, and in all individual Phase III trials. The pooled analyses showed that roxadustat did not increase the risk of MACE[67], MACE+[68] and all-cause mortality in NDD patients compared to placebo and DD patients compared to epoetin alfa. In a clinically important predefined subgroup of incident dialysis[69] patients, roxadustat reduced the risk of MACE and MACE+ and showed a trend towards lower risk of all-cause mortality relative to epoetin alfa.
 
In December 2019, FibroGen announced the regulatory submission of an NDA to the US FDA for roxadustat as a potential new medicine for the treatment of anaemia from CKD, in both NDD and DD CKD patients. Data from the pooled analyses, together with other statistical analyses, formed part of the submission. The regulatory submission was subsequently accepted by the US FDA in February 2020 with a PDUFA date set for the fourth quarter of 2020. Roxadustat is approved in China for the treatment of patients with anaemia from CKD, regardless of whether they require dialysis, and in Japan for the treatment of DD patients with anaemia from CKD. In January 2020, FibroGen's collaborator, Astellas, submitted in Japan an sNDA for the approval of roxadustat as a potential treatment of anaemia from CKD in NDD patients.
 
f)    Lokelma (hyperkalaemia)
In January 2020, Lokelma was approved in China for the treatment of adult patients with hyperkalaemia, (elevated levels of potassium in the blood). The approval by the NMPA was based on positive results from the extensive Lokelma clinical-trial programme and a pharmacodynamic trial in China which showed that patients receiving Lokelma experienced a significant, rapid and sustained reduction of potassium levels in the blood. In 2019, the NMPA included Lokelma on the Accelerated Approval list of 'Overseas New Drugs in Clinical Urgent Needs for China', recognising the significant unmet need for effective medicines treating hyperkalaemia. In Japan, a regulatory decision is expected in the first half of the year.
 
 
Respiratory (and immunology)
 
a)   Symbicort (mild asthma)
In December 2019, AstraZeneca made a regulatory submission in China for Symbicort for the treatment of mild asthma which contained data from the Phase III SYGMA programme, looking at the use of Symbicort use as an anti-inflammatory reliever 'as needed'.
 
b)   Breztri (COPD)
In December 2019, AstraZeneca announced that Breztri (budesonide/glycopyrronium/formoterol fumarate) had been approved in China for the maintenance treatment of COPD, becoming the first approval by the NMPA for a triple-combination therapy in a pressurised metered-dose inhaler. The approval followed designation of priority-review status and was based on results from the Phase III KRONOS trial, in which Breztri demonstrated a statistically significant improvement in trough forced expiratory volume in one second (FEV1), the regulatory endpoint for China, compared with dual-combination therapies Bevespi (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate).
 
Breztri was approved and launched in Japan in the third quarter of 2019.
 
c)   Fasenra (eosinophilic diseases)
In the Phase IIIb ANDHI trial, Fasenra, when added to SoC, demonstrated a statistically significant reduction in the annual rate of asthma exacerbations when compared to placebo in patients with baseline blood eosinophil counts greater than or equal to 150 cells per microlitre. Safety and tolerability data were consistent with the known profile of the medicine and full results are expected to be presented at a forthcoming medical meeting.
 
Table 30: Key Fasenra trials
 
 
Trial
Population
Design
Primary endpoint(s)
Timeline
Status
Phase III MELTEMI
Asthmatic adults (aged
18-75 years) on ICS plus LABA2 agonist
Fasenra 30mg Q4W SC
 
Fasenra 30mg Q8W SC
Safety and tolerability
FPCD
Q2 2016
 
LPCD
Q1 2017
 
Data anticipated
H2 2020
Recruitment completed
Phase IIIb PONENTE
Asthmatics (aged 18 years or older) receiving high-dose ICS plus LABA and chronic OCS[70] with or without additional asthma controller(s)
Fasenra 30mg Q8W SC
 
38-week trial
Reduction of OCS dose
FPCD
Q3 2018
 
LPCD
Q3 2019
 
Data anticipated
H2 2020
Recruitment completed
 
Phase III OSTRO
Patients (aged 18-75 years) with severe bilateral nasal polyposis; symptomatic, despite SoC
Placebo or Fasenra 30mg Q8W SC
Nasal-polyposis burden and reported nasal blockage
FPCD
Q1 2018
 
LPCD
Q2 2019
 
Data anticipated
H2 2020
Recruitment completed
Phase III
MIRACLE
Severe eosinophilic asthma (aged 12-75 years) despite background controller medication, medium dose and high dose ICS plus LABA ± chronic oral corticosteroids (CN)
Placebo or Fasenra 30mg Q8W SC
 Annual asthma-exacerbation rate
FPCD
Q4 2017
 
Data anticipated 2021+
Recruitment ongoing
Phase III RESOLUTE
 Patients with moderate to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils
Placebo or Fasenra 100mg Q8W SC
Annualised rate of moderate or severe COPD exacerbations
FPCD
Q4 2019
 
Data anticipated 2021+
Recruitment ongoing
Phase III
MANDARA
Eosinophilic granulomatosis with polyangiitis
Fasenra 30mg or
mepolizumab 3x100mg Q4W​
Proportion of patients who achieve remission, defined as a score[71] =0 and an OCS dose ≤4 mg/day at weeks 36 and 48​
FPCD
Q4 2019
 
Data anticipated
2021+
Recruitment ongoing
 
Orphan Drug Designation (US)
Phase III
NATRON
HES[72]
Placebo or Fasenra 30mg Q4W SC
Time to HES worsening flare or any cytotoxic and/or immuno-suppressive therapy increase or hospitalisation
FPCD
Q4 2019
 
Data anticipated 2021+
Recruitment ongoing
 
Orphan Drug Designation (US)
Phase III
MESSINA
Eosinophilic oesophagitis
Placebo or Fasenra 30mg Q4W SC
Proportion of patients with a histologic response
 
Changes from baseline in dysphagia PRO[73]
Data anticipated 2021+
Initiating
 
Orphan Drug Designation (US)
 
e)   Anifrolumab (lupus)
In November 2019, at the American College of Rheumatology Annual Meeting in Atlanta, US, detailed results were presented from the positive Phase III TULIP 2 trial for anifrolumab, a potential new medicine for the treatment of moderate to severe SLE. The data demonstrated superiority across multiple efficacy endpoints versus placebo, with both arms receiving SoC as background treatment. TULIP 2 data were subsequently published in The New England Journal of Medicine; data from the TULIP 1 trial were also presented and published simultaneously in The Lancet Rheumatology.
 
The TULIP 1 trial did not meet its primary endpoint, based on the SLE Responder Index 4 composite measure[74]. The analyses of secondary endpoints showed, however, efficacy consistent with TULIP 2 on BICLA[75] response, reductions in OCS use, and improvements in skin disease activity. Regulatory submissions for anifrolumab are expected in the second half of 2020.
 
Table 31: Key anifrolumab trials
 
 
Trial
Population
Design
Primary endpoint(s)
Timeline
Status
Phase III
TULIP 1
Moderate to severely-active SLE patients on background SoC
Placebo or anifrolumab 150mg or 300mg i.v.
Q4W
Response in SLE
responder index at week 52
FPCD
Q4 2015
 
LPCD
Q4 2017
Primary endpoint not met
 
Fast Track designation (US)
Phase III
TULIP 2
Moderate to severely-active SLE patients on background SoC
Placebo or anifrolumab 300mg i.v.
Q4W
Response in BICLA at week 52
FPCD
Q4 2015
 
LPCD
Q4 2017
Primary endpoint met
 
Fast Track designation (US)
Phase III
TULIP LTE[76]
Moderate to severely active SLE patients on background SoC who have completed a Phase III anifrolumab trial
Placebo or anifrolumab 300mg i.v.
 Q4W
Long-term safety over 152 weeks
FPCD
Q2 2016
 
LPCD
Q4 2018
 
Data anticipated
2021+
Recruitment completed
 
Fast Track designation (US)
 
f)    Brazikumab (Crohn's disease and ulcerative colitis)
In January 2020, it was announced that AstraZeneca will recover the global rights to brazikumab (formerly MEDI2070), a monoclonal antibody targeting IL-23, from Allergan. Brazikumab is currently in a Phase IIb/III programme in Crohn's disease and a Phase IIb trial in ulcerative colitis. AstraZeneca and Allergan will terminate their existing license agreement and all rights to brazikumab will revert to AstraZeneca. The transaction is expected to complete in the first quarter of 2020, subject to regulatory approvals associated with AbbVie Inc.'s proposed acquisition of Allergan and its timely completion. Under the termination agreement, Allergan will fund up to an agreed amount, estimated to be the total costs expected to be incurred by AstraZeneca until completion of development for brazikumab in Crohn's disease and ulcerative colitis, including the development of a companion diagnostic.
 
Pursuant to the 2012 collaboration between Amgen Inc (Amgen) and AstraZeneca to jointly develop and commercialise a clinical-stage inflammation portfolio, Amgen is entitled to receive a high single-digit to low double-digit royalty on sales of brazikumab if approved and launched. This includes the original inventor royalty. Other than this, AstraZeneca will own all rights and benefits arising from the medicine with no other payments due to Amgen.
 
 

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 - FY 2019
 
 
2019
2018
For the year ended 31 December
$m
$m
Product Sales
23,565
21,049
Collaboration Revenue
819
1,041
 
 
 
Total Revenue
24,384
22,090
Cost of sales
(4,921)
(4,936)
 
 
 
Gross Profit
19,463
17,154
Distribution costs
(339)
(331)
Research and development expense
(6,059)
(5,932)
Selling, general and administrative costs
(11,682)
(10,031)
Other operating income and expense
1,541
2,527
 
 
 
Operating Profit
2,924
3,387
Finance income
172
138
Finance expense
(1,432)
(1,419)
Share of after-tax losses in associates and joint ventures
(116)
(113)
 
 
 
Profit Before Tax
1,548
1,993
Taxation
(321)
57
 
 
 
Profit for the period
1,227
2,050
 
 
 
Other comprehensive income
 
 
Items that will not be reclassified to profit or loss
 
 
Remeasurement of the defined benefit pension liability
(364)
(46)
Net losses on equity investments measured at fair value through other comprehensive income
(28)
(171)
Fair-value movements related to own credit risk on bonds designated as fair-value through profit or loss
(5)
8
Tax on items that will not be reclassified to profit or loss
21
56
 
(376)
(153)
 
 
 
Items that may be reclassified subsequently to profit or loss
 
 
Foreign exchange arising on consolidation
40
(450)
Foreign exchange arising on designating borrowings in net investment hedges
(252)
(520)
Fair-value movements on cash flow hedges
(101)
(37)
Fair-value movements on cash flow hedges transferred to profit or loss
52
111
Fair-value movements on derivatives designated in net investment hedges
35
(8)
Costs of hedging
(47)
(54)
Amortisation of loss on cash flow hedge
-
1
Tax on items that may be reclassified subsequently to profit or loss
38
51
 
(235)