TIDMAZN
RNS Number : 9829C
AstraZeneca PLC
14 February 2020
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 medicines(1) 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 CER(2) ) 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 CVRM (3) +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-care(4) 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
----------------------- ------- ------- ----- ------ ------- -----
Reported(5) Operating
Profit 2,924 (14) (16) 577 (46) (56)
Core (6) Operating
Profit 6,436 13 13 1,545 (29) (33)
Reported EPS (7) $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 MSD(9) 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 UNICEF(10) 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. Tagrisso, Imfinzi, Lynparza, Calquence, Farxiga, Brilinta,
Lokelma, Fasenra, Bevespi and Breztri. These new medicines are
pillars in the main therapy areas and are important platforms for
future growth. 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, Brilinta, Lokelma 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 * Imfinzi +/- treme - NSCLC (1st line) (POSEIDON): met
developments 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,
Brilinta, Lokelma 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 % change $m % change
total
---- ----
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), Zoladex, Tudorza /Eklira and Duaklir.
Lynparza 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 % % change $m % change
of
total
------- ------- ------ --------------
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)
Zoladex (33) 813 3 8 13 196 8 9
Iressa 33 423 2 (18) (15) 80 (29) (28)
Arimidex 33 225 1 6 11 51 10 11
Casod ex 33 200 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
Crestor 33 1,278 5 (11) (8) 296 (16) (15)
Seloken /Toprol-XL
33 760 3 7 12 190 18 20
Atacand 33 221 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 a dmission 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 % change $m % change
total
------- ------- ------
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 % change $m % change
total
-------------------- ------- ------- ------
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 % change
$m
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 % change
$m
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 Zoladex, Pulmicort, Nexium 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 : R econciliation of Reported Profit Before Tax to
EBITDA ([38])
FY FY % change Q4 Q4 % change
2019 2018 2019 2018
$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 Diabetes Other Core Core % change
Asset Amortisation Alliance [39] [40]
& Impairments
$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 Diabetes Other Core Core
Asset Alliance (41) (42) % change
Amortisation
& Impairments
$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
Bydureon, Qtern 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 Inderal, Tenormin 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 GBP60.50 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.GBP 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 At
31 Dec 2019 31 Dec 2018
$m $m
------------- -------------
Cash and Cash Equivalents 5,369 4,831
Other Investments 911 895
Cash and Investments 6,280 5,726
Overdrafts and Short-Term Borrowings (225) (755)
Lease Liabilities [42] (675) -
Current Instalments of Loans (1,597) (999)
Loans Due After One Year (15,730) (17,359)
Interest-Bearing Loans and Borrowings (Gross
Debt) (18,227) (19,113)
Net Derivatives 43 384
Net Debt (11,904) (13,003)
------------- -------------
Capital allocation
The Board's aim is to continue to strike a balance between the
interests of the business, financial creditors and the Company's
shareholders. After providing for investment in the business,
supporting the progressive dividend policy and maintaining a
strong, investment-grade credit rating, the Board will keep under
review potential investment in immediately earnings-accretive,
value-enhancing opportunities .
Foreign exchange
The Company's transactional currency exposures on
working-capital balances, which typically extend for up to three
months, are hedged where practicable using forward foreign-exchange
contracts against the individual companies' reporting currency. In
addition, the Company's external dividend payments, paid
principally in pounds sterling and Swedish krona, are fully hedged
from announcement to payment date. Foreign-exchange gains and
losses on forward contracts for transactional hedging are taken to
profit or loss.
Table 22: Currency sensitivities
The Company provides the following currency-sensitivity
information:
Average Exchange Annual Impact of 5% Strengthening in
Rates versus USD Exchange Rate versus USD ($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 17 Oncology
entities * Tagrisso - NSCLC
and major
lifecycle
events for * Imfinzi - multiple cancers
medicines
in Phase
III trials * Lynparza - multiple cancers
or under
regulatory
review * Enhertu - breast and other cancers
* capivasertib - breast cancer
* Calquence - blood cancers
* tremelimumab - multiple cancers
* selumetinib - NF1 [50]
* savolitinib - NSCLC (53)
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 Adjuvant EGFRm NSCLC Placebo or Tagrisso FPCD [52] Recruitment
ADAURA Q4 2015 completed
LPCD [53]
Q1 2019
First data anticipated
2021+ [54]
---------------------------- ---------------------------- ------------------------ --------------------
Phase III Locally advanced, Placebo or Tagrisso FPCD Recruitment
LAURA unresectable EGFRm NSCLC Q4 2018 ongoing
First data anticipated
2021+
---------------------------- ---------------------------- ------------------------ --------------------
Phase III 1st-line EGFRm NSCLC Tagrisso or Tagrisso + FPCD Recruitment ongoing
FLAURA2 platinum-based chemotherapy Q4 2019
doublet
First data anticipated
2021+
---------------------------- ---------------------------- ------------------------ --------------------
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 Neo-adjuvant (before SoC chemotherapy +/- FPCD Recruitment
AEGEAN surgery) NSCLC Imfinzi, Q1 2019 ongoing
followed by
surgery, followed by First data anticipated
placebo or Imfinzi H2 2020
---------------------- ---------------------- ----------------------- ----------------------
Phase III Stage Ib-IIIa NSCLC Placebo or FPCD Recruitment
ADJUVANT BR.31 [55] Imfinzi Q1 2015 completed
LPCD
Q4 2019
First data anticipated
2021
---------------------- ---------------------- ----------------------- ----------------------
Phase III Stage III unresected Placebo or FPCD Recruitment
PACIFIC-2 locally advanced Imfinzi Q2 2018 completed
NSCLC
(concurrent CRT) LPCD
Q3 2019
First data anticipated
H2 2020
---------------------- ---------------------- ----------------------- ----------------------
Phase III Limited-disease stage Concurrent CRT, FPCD Recruitment
ADRIATIC SCLC followed by Q4 2018 ongoing
placebo or
Imfinzi or Imfinzi + First data anticipated
treme 2021
---------------------- ---------------------- ----------------------- ----------------------
Phase III Stage IV, 1st-line SoC chemotherapy or FPCD PFS primary endpoint
POSEIDON NSCLC SoC + Imfinzi or SoC Q2 2017 met
+ Imfinzi + treme
LPCD
Q4 2018
---------------------- ---------------------- ----------------------- ----------------------
Phase III Extensive-disease SoC chemotherapy or FPCD OS primary endpoint
CASPIAN stage SCLC SoC + Imfinzi or SoC Q1 2017 met for Imfinzi
+ Imfinzi + treme monotherapy arm
LPCD
Q2 2018
---------------------- ---------------------- ----------------------- ----------------------
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 Non-muscle invasive SoC BCG [56] or SoC BCG FPCD Recruitment ongoing
POTOMAC bladder cancer + Imfinzi Q4 2018
First data
anticipated
2021+
------------------------- ------------------------- ------------------------ -------------------------
Phase III Muscle-invasive bladder Neo-adjuvant cisplatin FPCD Recruitment ongoing
NIAGARA cancer and gemcitabine SoC Q4 2018
chemotherapy or SoC +
Imfinzi, followed by First data
adjuvant anticipated
placebo or Imfinzi 2021+
------------------------- ------------------------- ------------------------ -------------------------
Phase III Locoregional HCC TACE [57] followed by FPCD Recruitment ongoing
EMERALD-1 placebo or TACE + Q1 2019
Imfinzi, followed by
Imfinzi + First data
bevacizumab or anticipated
TACE + Imfinzi 2021
followed by Imfinzi
------------------------- ------------------------- ------------------------ -------------------------
Phase III Locoregional HCC at high Adjuvant Imfinzi or FPCD Recruitment ongoing
EMERALD-2 risk of recurrence after Imfinzi + bevacizumab Q2 2019
surgery or
radiofrequency ablation First data anticipated
2021+
------------------------- ------------------------- ------------------------ -------------------------
Phase III Locally advanced CRT or CRT + Imfinzi, FPCD Recruitment ongoing
CALLA cervical cancer followed by placebo or Q1 2019
Imfinzi
First data anticipated
2021+
------------------------- ------------------------- ------------------------ -------------------------
Phase III Stage IV, 1st-line SoC chemotherapy or FPCD Recruitment completed
DANUBE cisplatin chemotherapy- Imfinzi or Imfinzi + Q4 2015
eligible/ineligible treme
bladder cancer LPCD
Q1 2017
First data
anticipated
H1 2020
------------------------- ------------------------- ------------------------ -------------------------
Phase III Stage IV, 1st-line SoC chemotherapy or SoC FPCD Recruitment
NILE cisplatin chemotherapy- + Imfinzi or SoC + Q4 2018 ongoing
eligible bladder cancer Imfinzi + treme
First data anticipated
2021+
------------------------- ------------------------- ------------------------ -------------------------
Phase III Stage IV, 1st-line head SoC or Imfinzi or FPCD Recruitment completed
KESTREL and neck squamous cell Imfinzi + treme Q4 2015
carcinoma
LPCD
Q1 2017
First data
anticipated
H1 2020
------------------------- ------------------------- ------------------------ -------------------------
Phase III Stage IV, 1st-line Sorafenib or Imfinzi or FPCD Recruitment
HIMALAYA unresectable HCC Imfinzi + treme Q4 2017 Completed
LPCD Orphan Drug Designation
Q4 2019 (US)
First data
anticipated
H2 2020
------------------------- ------------------------- ------------------------ -------------------------
Phase III Stage IV, 1st-line Gemcitabine and FPCD Recruitment ongoing
TOPAZ-1 biliary-tract cancer cisplatin SoC Q2 2019
chemotherapy or SoC +
Imfinzi First data anticipated
2021+
------------------------- ------------------------- ------------------------ -------------------------
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 Adjuvant BRCAm breast cancer SoC placebo or FPCD Recruitment completed
OlympiA Lynparza Q2 2014
LPCD
Q2 2019
First data
anticipated
2021
------------------------------ ---------------------- ---------------------- ----------------------
Phase III Metastatic SoC (abiraterone or FPCD Primary endpoint met
PROfound castration-resistant enzalutamide) or Q2 2017
2nd-line+ HRRm [58] prostate Lynparza Priority Review (US)
cancer LPCD
Q4 2018
------------------------------ ---------------------- ---------------------- ----------------------
Phase III Advanced 1st - line Bevacizumab FPCD Primary endpoint met
PAOLA-1 [59] ovarian cancer maintenance or Q2 2015
bevacizumab + Priority Review (US)
Lynparza maintenance LPCD
Q2 2018
------------------------------ ---------------------- ---------------------- ----------------------
Phase III Recurrent platinum-sensitive SoC chemotherapy or FPCD Recruitment ongoing
GY004 [60] ovarian cancer Lynparza or cediranib Q1 2016
+ Lynparza
First data
anticipated
H1 2020
------------------------------ ---------------------- ---------------------- ----------------------
Phase II/III Recurrent SoC chemotherapy or FPCD Recruitment ongoing
GY005 (63) platinum-resistant/refractory cediranib or Q2 2016 (Phase III component)
ovarian cancer cediranib + Lynparza (Phase II)
FPCD
Q1 2019
(Phase III)
First data
anticipated
2021+
------------------------------ ---------------------- ---------------------- ----------------------
Phase III Advanced 1st-line Chemotherapy + FPCD Recruitment
DuO-O ovarian cancer bevacizumab or Q1 2019 ongoing
chemotherapy +
bevacizumab + First data
Imfinzi +/- anticipated
Lynparza maintenance 2021+
------------------------------ ---------------------- ---------------------- ----------------------
Phase III Stage IV, advanced, Abiraterone or FPCD Recruitment ongoing
PROpel castration-resistant prostate abiraterone + Q4 2018
cancer Lynparza
First data
anticipated
2021
------------------------------ ---------------------- ---------------------- ----------------------
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 Stage IV, HER2+ (IHC Enhertu (single arm) FPCD Primary objective met
DESTINY-Breast01 [61] 3+ and IHC Q4 2017
2+/ISH [62] +) breast Breakthrough Therapy
cancer post t LPCD Designation (US)
rastuzumab emtansine Q4 2018
Accelerated approval
(US)
---------------------- ----------------------- ----------------------- -----------------------
Phase III Stage IV, HER2+ (IHC SoC chemotherapy or FPCD Recruitment ongoing
DESTINY-Breast02 3+ and IHC 2+/ISH+) Enhertu Q4 2018
breast cancer post
trastuzumab emtansine First data anticipated
2021
---------------------- ----------------------- ----------------------- -----------------------
Phase III Stage IV, HER2+ (IHC Trastuzumab emtansine FPCD Recruitment ongoing
DESTINY-Breast03 3+ and IHC 2+/ISH+) or Enhertu Q4 2018
breast cancer
First data anticipated
2021
---------------------- ----------------------- ----------------------- -----------------------
Phase III Stage IV, HER2-low SoC chemotherapy or FPCD Recruitment ongoing
DESTINY-Breast04 (IHC 1+/2+) breast Enhertu Q4 2018
cancer
First data anticipated
2021
---------------------- ----------------------- ----------------------- -----------------------
Phase II Stage IV, HER2+ (IHC SoC chemotherapy or FPCD Primary endpoint met
DESTINY-Gastric01 3+ and IHC 2+/ISH+) Enhertu Q4 2017
gastric cancer
LPCD
Q2 2019
---------------------- ----------------------- ----------------------- -----------------------
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 ASC 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 Timeline Status
endpoint(s)
Farxiga
----------------- ---------------------------------------------------------------------------------------------------
Phase III c.4,500 patients Arm 1: Farxiga Time to first FPCD Primary endpoint
DAPA-HF with HF and 10mg or 5 mg QD occurrence of CV Q1 2017 met
reduced ejection [63] + SoC death or hHF or
fraction, with an urgent HF LPCD Fast Track
and without T2D Arm 2: placebo + visit Q4 2018 designation (US)
SoC
------------------ ------------------ ------------------ ------------------ -------------------
Phase III c.4,700 patients Arm 1: Farxiga Time to first FPCD
DELIVER with HF and 10mg QD occurrence of CV Q4 2018 Recruitment
preserved death or ongoing
ejection Arm 2: placebo worsening HF First data
fraction, with anticipated 2021+ Fast Track
and without T2D designation (US)
------------------ ------------------ ------------------ ------------------ -------------------
Phase III c.4,000 patients Arm 1: Farxiga Time to first FPCD Fast Track
DAPA-CKD with CKD, with 10mg or 5mg QD occurrence of >= Q1 2017 designation (US)
and without T2D 50% sustained
Arm 2: placebo decline in eGFR First data
or reaching ESRD anticipated 2021
[64] or CV death
or renal death
------------------ ------------------ ------------------ ------------------ -------------------
Brilinta
----------------- ---------------------------------------------------------------------------------------------------
Phase III THEMIS c.19,000 patients Arm 1: Brilinta Composite of CV FPCD Primary endpoint
with T2D and CAD 60mg BID [66] death, non-fatal Q1 2014 met
without a history MI and non-fatal
of MI [65] or Arm 2: placebo stroke LPCD
stroke BID on a Q2 2016
background of
acetylsalicylic
acid if not
contra-indicated
or not
tolerated
------------------ ------------------ ------------------ ------------------ -------------------
Phase III c.11,000 patients Arm 1: Brilinta Prevention of the FPCD Primary endpoint
THALES with acute 90mg BID composite of Q1 2018 met
ischaemic stroke subsequent stroke
or transient Arm 2: placebo and death at 30 LPCD
ischaemic attack BID on a days Q4 2019
background of
acetylsalicylic
acid if not
contra-indicated
or not
tolerated
------------------ ------------------ ------------------ ------------------ -------------------
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 Asthmatic adults Fasenra 30mg Q4W Safety and FPCD Recruitment
MELTEMI (aged SC tolerability Q2 2016 completed
18-75 years) on
ICS plus LABA2 Fasenra 30mg Q8W LPCD
agonist SC Q1 2017
Data anticipated
H2 2020
------------------- ----------------- --------------------- ----------------- -----------------
Phase IIIb Asthmatics (aged Fasenra 30mg Q8W Reduction of OCS FPCD Recruitment
PONENTE 18 years or older) SC dose Q3 2018 completed
receiving
high-dose ICS plus 38-week trial LPCD
LABA and chronic Q3 2019
OCS [70]
with or without Data anticipated
additional asthma H2 2020
controller(s)
------------------- ----------------- --------------------- ----------------- -----------------
Phase III OSTRO Patients (aged Placebo or Nasal-polyposis FPCD Recruitment
18-75 years) with Fasenra 30mg Q8W burden and reported Q1 2018 completed
severe bilateral SC nasal blockage
nasal polyposis; LPCD
symptomatic, Q2 2019
despite SoC
Data anticipated
H2 2020
------------------- ----------------- --------------------- ----------------- -----------------
Phase III Severe Placebo or Annual FPCD Recruitment
MIRACLE eosinophilic Fasenra 30mg Q8W asthma-exacerbation Q4 2017 ongoing
asthma (aged 12-75 SC rate
years) despite Data anticipated
background 2021+
controller
medication, medium
dose and high dose
ICS plus LABA +/-
chronic oral
corticosteroids
(CN)
------------------- ----------------- --------------------- ----------------- -----------------
Phase III Patients with Placebo or Annualised rate of FPCD Recruitment
RESOLUTE moderate to very Fasenra 100mg moderate or severe Q4 2019 ongoing
severe COPD with Q8W SC COPD exacerbations
a history of Data anticipated
frequent COPD 2021+
exacerbations
and elevated
peripheral blood
eosinophils
------------------- ----------------- --------------------- ----------------- -----------------
Phase III Eosinophilic Fasenra 30mg or Proportion of FPCD Recruitment
MANDARA granulomatosis mepolizumab patients who achieve Q4 2019 ongoing
with polyangiitis 3x100mg Q4W remission, defined
as a score [71] =0 Data anticipated Orphan Drug
and an OCS dose <=4 2021+ Designation (US)
mg/day at weeks 36
and 48
------------------- ----------------- --------------------- ----------------- -----------------
Phase III HES [72] Placebo or Time to HES FPCD Recruitment
NATRON Fasenra 30mg Q4W worsening flare or Q4 2019 ongoing
SC any cytotoxic and/or
immuno-suppressive Data anticipated Orphan Drug
therapy increase or 2021+ Designation (US)
hospitalisation
------------------- ----------------- --------------------- ----------------- -----------------
Phase III Eosinophilic Placebo or Proportion of Data anticipated Initiating
MESSINA oesophagitis Fasenra 30mg Q4W patients with a 2021+
SC histologic response Orphan Drug
Designation (US)
Changes from
baseline in
dysphagia PRO [73]
------------------- ----------------- --------------------- ----------------- -----------------
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 Timeline Status
endpoint(s)
Phase III Moderate to Placebo or Response in SLE FPCD Primary endpoint
TULIP 1 severely-active anifrolumab 150mg responder index Q4 2015 not met
SLE patients on or 300mg i.v. at week 52
background SoC Q4W LPCD Fast Track
Q4 2017 designation (US)
------------------ ------------------ ------------------ ------------------ ------------------
Phase III Moderate to Placebo or Response in BICLA FPCD Primary endpoint
TULIP 2 severely-active anifrolumab 300mg at week 52 Q4 2015 met
SLE patients on i.v.
background SoC Q4W LPCD Fast Track
Q4 2017 designation (US)
------------------ ------------------ ------------------ ------------------ ------------------
Phase III Moderate to Placebo or Long-term safety FPCD Recruitment
TULIP LTE ([76]) severely active anifrolumab 300mg over 152 weeks Q2 2016 completed
SLE patients on i.v.
background SoC Q4W LPCD Fast Track
who have Q4 2018 designation (US)
completed a Phase
III Data anticipated
anifrolumab trial 2021+
------------------ ------------------ ------------------ ------------------ ------------------
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) (906)
Other comprehensive loss for the period, net of tax (611) (1,059)
Total comprehensive income for the period 616 991
Profit attributable to:
Owners of the Parent 1,335 2,155
Non-controlling interests (108) (105)
1,227 2,050
Total comprehensive income attributable to:
Owners of the Parent 723 1,097
Non-controlling interests (107) (106)
616 991
Basic earnings per $0.25 Ordinary Share $1.03 $1.70
Diluted earnings per $0.25 Ordinary Share $1.03 $1.70
Weighted average number of Ordinary Shares in issue
(millions) 1,301 1,267
Diluted weighted average number of Ordinary Shares
in issue (millions) 1,301 1,267
--------- ---------
Condensed consolidated statement of comprehensive income - Q4
2019 [77]
2019 2018
For the quarter ended 31 December $m $m
--------
Product Sales 6,250 5,768
Collaboration Revenue 414 649
Total Revenue 6,664 6,417
Cost of sales (1,378) (1,637)
Gross Profit 5,286 4,780
Distribution costs (92) (93)
Research and development expense (2,091) (2,012)
Selling, general and administrative costs (3,026) (2,600)
Other operating income and expense 500 1,002
Operating Profit 577 1,077
Finance income 39 26
Finance expense (351) (337)
Share of after-tax losses in associates and joint
ventures (25) (36)
Profit Before Tax 240 730
Taxation 37 279
Profit for the period 277 1,009
Other comprehensive income
Items that will not be reclassified to profit
or loss
Remeasurement of the defined benefit pension liability (213) (184)
Net gains/(losses) on equity investments measured
at fair value through other comprehensive income 108 (330)
Fair-value movements related to own credit risk
on bonds designated as fair value through profit
or loss (4) 5
Tax on items that will not be reclassified to
profit or loss - 121
(109) (388)
Items that may be reclassified subsequently to
profit or loss
Foreign exchange arising on consolidation 425 (99)
Foreign exchange arising on designating borrowings
in net investment hedges 239 (71)
Fair-value movements on cash flow hedges 55 (42)
Fair-value movements on cash flow hedges transferred
to profit or loss (57) 39
Fair-value movements on derivatives designated
in net investment hedges - (14)
Costs of hedging (12) (19)
Amortisation of loss on cash flow hedge - 1
Tax on items that may be reclassified subsequently
to profit or loss (24) 12
626 (193)
Other comprehensive income/(loss) for the period,
net of tax 517 (581)
Total comprehensive income for the period 794 428
Profit attributable to:
Owners of the Parent 313 1,034
Non-controlling interests (36) (25)
277 1,009
Total comprehensive income attributable to:
Owners of the Parent 830 453
Non-controlling interests (36) (25)
794 428
Basic earnings per $0.25 Ordinary Share $0.24 $0.82
Diluted earnings per $0.25 Ordinary Share $0.24 $0.82
Weighted average number of Ordinary Shares in
issue (millions) 1,312 1,267
Diluted weighted average number of Ordinary Shares
in issue (millions) 1,312 1,267
-------- --------
Condensed consolidated statement of financial position
At 31 Dec At 31 Dec
2019 2018
$m $m
---------- ----------
Assets
Non-current assets
Property, plant and equipment 7,688 7,421
Right-of-use assets 647 -
Goodwill 11,668 11,707
Intangible assets 20,833 21,959
Investments in associates and joint ventures 58 89
Other investments 1,401 833
Derivative financial instruments 61 157
Other receivables 740 515
Deferred tax assets 2,718 2,379
===================================================== ========== ==========
45,814 45,060
===================================================== ========== ==========
Current assets
Inventories 3,193 2,890
Trade and other receivables 5,761 5,574
Other investments 849 849
Derivative financial instruments 36 258
Income tax receivable 285 207
Cash and cash equivalents 5,369 4,831
Assets held for sale 70 982
===================================================== ========== ==========
15,563 15,591
===================================================== ========== ==========
Total assets 61,377 60,651
===================================================== ========== ==========
Liabilities
Current liabilities
Interest-bearing loans and borrowings (1,822) (1,754)
Lease liabilities (188) -
Trade and other payables (13,987) (12,841)
Derivative financial instruments (36) (27)
Provisions (723) (506)
Income tax payable (1,361) (1,164)
===================================================== ========== ==========
(18,117) (16,292)
===================================================== ========== ==========
Non-current liabilities
Interest-bearing loans and borrowings (15,730) (17,359)
Lease liabilities (487) -
Derivative financial instruments (18) (4)
Deferred tax liabilities (2,490) (3,286)
Retirement benefit obligations (2,807) (2,511)
Provisions (841) (385)
Other payables (6,291) (6,770)
===================================================== ========== ==========
(28,664) (30,315)
===================================================== ========== ==========
Total liabilities (46,781) (46,607)
===================================================== ========== ==========
Net assets 14,596 14,044
===================================================== ========== ==========
Equity
Capital and reserves attributable to equity holders
of the Parent
Share capital 328 317
Share premium account 7,941 4,427
Other reserves 2,046 2,041
Retained earnings 2,812 5,683
===================================================== ========== ==========
13,127 12,468
===================================================== ========== ==========
Non-controlling interests 1,469 1,576
===================================================== ========== ==========
Total equity 14,596 14,044
---------- ----------
Condensed consolidated statement of changes in equity
Share Share Other Retained Total attributable Non-controlling Total
capital premium reserves earnings to owners interests equity
account of the parent
$m $m $m $m $m $m $m
--------- --------- ---------- ---------- ------------------- ---------------- --------
At 1 Jan 2018 317 4,393 2,029 8,221 14,960 1,682 16,642
Adoption of new
accounting standards - - - (91) (91) - (91)
Profit for the
period - - - 2,155 2,155 (105) 2,050
Other comprehensive
loss - - - (1,058) (1,058) (1) (1,059)
Transfer to other
reserves - - 12 (12) - - -
Transactions with
owners:
Dividends - - - (3,539) (3,539) - (3,539)
Issue of Ordinary
Shares - 34 - - 34 - 34
Share-based payments
charge for the
period - - - 219 219 - 219
Settlement of
share plan awards - - - (212) (212) - (212)
Net movement - 34 12 (2,538) (2,492) (106) (2,598)
At 31 Dec 2018 317 4,427 2,041 5,683 12,468 1,576 14,044
At 1 Jan 2019 317 4,427 2,041 5,683 12,468 1,576 14,044
Adoption of new
accounting standards
[78] - - - 54 54 - 54
Profit for the
period - - - 1,335 1,335 (108) 1,227
Other comprehensive
loss - - - (612) (612) 1 (611)
Transfer to other
reserves - - 5 (5) - - -
Transactions with
owners:
Dividends - - - (3,579) (3,579) - (3,579)
Issue of Ordinary
Shares [79] 11 3,514 - - 3,525 - 3,525
Share-based payments
charge for the
period - - - 259 259 - 259
Settlement of
share plan awards - - - (323) (323) - (323)
Net movements 11 3,514 5 (2,871) 659 (107) 552
At 31 Dec 2019 328 7,941 2,046 2,812 13 ,127 1,469 14 ,596
--------- --------- ---------- ---------- ------------------- ---------------- --------
Condensed consolidated statement of cash flows
2019 2018
For the year ended 31 December $m $m
-------- --------
Cash flows from operating activities
Profit before tax 1,548 1,993
Finance income and expense 1,260 1,281
Share of after-tax losses of associates and
joint ventures 116 113
Depreciation, amortisation and impairment 3,762 3,753
Increase in working capital and short-term
provisions (346) (639)
Gains on disposal of intangible assets (1,243) (1,885)
Fair value movements on contingent consideration
arising from business combinations (614) (495)
Non-cash and other movements 378 (290)
Cash generated from operations 4,861 3,831
Interest paid (774) (676)
Tax paid (1,118) (537)
Net cash inflow from operating activities 2,969 2,618
Cash flows from investing activities
Payment of contingent consideration from business
combinations (709) (349)
Purchase of property, plant and equipment (979) (1,043)
Disposal of property, plant and equipment 37 12
Purchase of intangible assets (1,481) (328)
Disposal of intangible assets 2,076 2,338
Movement in profit-participation liability 150 -
[80]
Purchase of non-current asset investments (13) (102)
Disposal of non-current asset investments 18 24
Movement in short-term investments, fixed deposits
and other investing instruments 194 405
Payments to associates and joint ventures (74) (187)
Interest received 124 193
Net cash (outflow)/inflow from investing activities (657) 963
Net cash inflow before financing activities 2,312 3,581
Cash flows from financing activities
Proceeds from issue of share capital 3,525 34
Issue of loans 500 2,971
Repayment of loans (1,500) (1,400)
Dividends paid (3,592) (3,484)
Hedge contracts relating to dividend payments 4 (67)
Repayment of obligations under leases (186) -
Movement in short-term borrowings (516) (98)
Net cash outflow from financing activities (1,765) (2,044)
Net increase in cash and cash equivalents in
the period 547 1,537
Cash and cash equivalents at the beginning
of the period 4,671 3,172
Exchange rate effects 5 (38)
Cash and cash equivalents at the end of the
period 5,223 4,671
Cash and cash equivalents consist of:
Cash and cash equivalents 5,369 4,831
Overdrafts (146) (160)
5,223 4,671
-------- --------
Notes to the Condensed Financial Information
1 Basis of preparation and accounting policies
The Condensed Consolidated Financial Statements for the year
ended 31 December 2019 have been prepared in accordance with
International Financial Reporting Standards (IFRSs) as issued by
the International Accounting Standards Board (IASB) and as adopted
by the EU. The UK has yet to announce its post-Brexit IFRS-adoption
process and, for the current time, will follow the EU approval
process.
These Condensed Consolidated Financial Statements comprise the
financial results of AstraZeneca plc for the years to 31 December
2019 and 2018 together with the Statement of financial position as
at 31 December 2019 and 2018. The results for the year to 31
December 2019 have been extracted from the 31 December 2019 audited
Consolidated Financial Statements which have been approved by the
Board of Directors. These have not yet been delivered to the
Registrar of Companies but are expected to be published on 3 March
2020 within the Annual Report and Form 20-F Information 2019.
The financial information set out above does not constitute the
Company's statutory accounts for the years to 31 December 2019 or
2018 but is derived from those accounts. The auditors have reported
on those accounts; their reports (i) were unqualified, (ii) did not
include a reference to any matters to which the auditors drew
attention by way of emphasis without qualifying their report and
(iii) did not contain a statement under section 498 (2) or (3) of
the Companies Act 2006 in respect of the accounts for the year to
31 December 2019 or 31 December 2018. Statutory accounts for the
year to 31 December 2019 were approved by the Board of Directors
for release on 14 February 2020.
The annual financial statements of the Group are prepared in
accordance with IFRSs as issued by the IASB and adopted by the EU.
Except as noted below, the Condensed Consolidated Financial
Statements have been prepared applying the accounting policies that
were applied in the preparation of the Group's published
consolidated financial statements for the year ended 31 December
2018.
IFRS 3
AstraZeneca had proposed to adopt the October 2018 update to
IFRS 3, which changed the definition of a business, from 1 January
2019, and has previously published interim financial statements on
this basis. This was done on the basis that it was considered
highly probable that the amendment would be endorsed by the
European Commission during 2019 before its effective date of 1
January 2020 with early adoption permitted, following a
recommendation from the European Financial Reporting Advisory Group
(EFRAG), the association set up to provide advice to the European
Commission on whether newly issued or revised IFRS Standards meet
the criteria for endorsement for use in the EU.
The change in definition of a business within IFRS 3 introduces
an optional concentration test to perform a simplified assessment
of whether an acquired set of activities and assets is or is not a
business on a transaction by transaction basis. This change is
expected to provide more reliable and comparable information about
certain transactions as it provides more consistency in accounting
in the pharmaceutical industry for substantially similar
transactions that under the previous definition may have been
accounted for in different ways despite limited differences in
substance.
During the year, the EFRAG amended its guidance on the expected
date of endorsement, and the European Commission is expected to
endorse the change during 2020, with application required for
accounting periods beginning on or after 1 January 2020.
Accordingly, this amendment has not been applied in this
preliminary announcement; this has, however, not resulted in a
different accounting treatment for any transactions undertaken
during the year, when compared with the amended version of IFRS 3,
pending endorsement.
IFRS 16
IFRS 16 'Leases' is effective for accounting periods beginning
on or after 1 January 2019 and replaces IAS 17 'Leases'. It
eliminates the classification of leases as either operating leases
or finance leases and, instead, introduces a single lessee
accounting model. The adoption of IFRS 16 resulted in the Group
recognising lease liabilities, and corresponding 'right-of-use'
assets for arrangements that were previously classified as
operating leases.
The Group's principal lease arrangements are for property, most
notably a portfolio of office premises, and for a global car fleet,
utilised primarily by our sales and marketing teams. The Group has
adopted IFRS 16 using a modified retrospective approach with the
cumulative effect of initially applying the standard as an
adjustment to the opening balance of retained earnings at 1 January
2019. The standard permits a choice on initial adoption, on a
lease-by-lease basis, to measure the right-of-use asset at either
its carrying amount as if IFRS 16 had been applied since the
commencement of the lease, or an amount equal to the lease
liability, adjusted for accruals or prepayments. The Group has
elected to measure the right-of-use asset equal to the lease
liability, with the result of no net impact on opening retained
earnings and no restatement of prior period comparatives.
Initial adoption resulted in the recognition of right-of-use
assets of $722m and lease liabilities of $720m. The weighted
average incremental borrowing rate applied to the lease liabilities
on 1 January 2019 was 3%.
The Group is using one or more practical expedients on
transition to leases previously classified as operating leases,
including electing to not apply the retrospective treatment to
leases for which the term ends within 12 months of initial
application, electing to apply a single discount rate to portfolios
of leases with similar characteristics, reliance on previous
assessments on whether arrangements contain a lease and whether
leases are onerous, excluding initial direct costs from the initial
measurement of the right-of-use asset, and using hindsight in
determining the lease term where the contract contains options to
extend or terminate the lease.
Judgements made in calculating the initial impact of adoption
include determining the lease term where extension or termination
options exist. In such instances, all facts and circumstances that
may create an economic incentive to exercise an extension option,
or not exercise a termination option, have been considered to
determine the lease term. Extension periods (or periods after
termination options) are only included in the lease term if the
lease is reasonably certain to be extended (or not terminated).
Estimates include calculating the discount rate which is based on
the incremental borrowing rate.
The Group is applying IFRS 16's low-value and short-term
exemptions. While the IFRS 16 opening lease liability is calculated
differently from the previous operating lease commitment calculated
under the previous standard, there are no material differences
between the positions. The adoption of IFRS 16 has had no impact on
the Group's net cash flows, although a presentation change has been
reflected whereby cash outflows of $186m are now presented as
financing, instead of operating. There is an immaterial benefit to
Operating profit and a corresponding increase in Finance expense
from the presentation of a portion of lease costs as interest
costs. Profit before tax, taxation and EPS have not been materially
impacted.
IFRIC 23
IFRIC 23 'Uncertainty Over Income Tax Treatments' is effective
for accounting periods beginning on or after 1 January 2019 and
provides further clarification on how to apply the recognition and
measurement requirements in IAS 12 'Income Taxes'. It is applicable
where there is uncertainty over income tax treatments. The EU
endorsed IFRIC 23 on 24 October 2018. The adoption of IFRIC 23 has
principally resulted in an adjustment in the value of tax
liabilities because IFRIC 23 requires the Group to measure the
effect of uncertainty on income tax positions using either the most
likely amount or the expected value amount depending on which
method is expected to better reflect the resolution of the
uncertainty.
The Group has retrospectively applied IFRIC 23 from 1 January
2019 recognising the cumulative effect of initially applying the
interpretation as decreases to income tax payable of $51m and to
trade and other payables of $3m, and a corresponding adjustment to
the opening balance of retained earnings of $54m. There is no
restatement of the comparative information as permitted in the
interpretation.
IFRS 9, IAS 39 and IFRS 7
The Group has early adopted the amendments to IFRS 9 'Financial
Instruments', IAS 39 'Financial Instruments: Recognition and
Measurement' and IFRS 7 'Financial Instruments: Disclosures'. These
relate to IBOR reform and were endorsed by the EU on 6 January
2020. The replacement of benchmark interest rates such as LIBOR and
other interbank offered rates ('IBORs') is a priority for global
regulators. The amendments provide relief from applying specific
hedge accounting requirements to hedge relationships directly
affected by IBOR reform and have the effect that IBOR reform should
generally not cause hedge accounting to terminate. There is no
financial impact from the early adoption of these amendments.
The Group has one IFRS 9 designated hedge relationship that is
potentially impacted by IBOR reform: our euro 300m cross currency
interest rate swap in a fair value hedge relationship with euro
300m of our euro 750m 0.875% 2021 non-callable bond. This swap
references three-month USD LIBOR and uncertainty arising from the
Group's exposure to IBOR reform will cease when the swap matures in
2021. The implications on the wider business of IBOR reform will be
assessed during 2020.
Collaboration Revenue
Effective from 1 January 2019, the Group updated the
presentation of an element of Total Revenue within the Statement of
Comprehensive Income and changed the classification of some income
to reflect the increasing importance of collaborations to
AstraZeneca. Historically, Externalisation Revenue formed part of
Total Revenue and only included income arising from collaborative
transactions involving AstraZeneca's medicines, whether internally
developed or previously acquired. Such income included upfront
consideration, milestones receipts, profit share income and
royalties, as well as other income from collaborations. The updated
category of Collaboration Revenue includes all income previously
included within Externalisation Revenue, as well as income of a
similar nature arising from transactions where AstraZeneca has
acquired an interest in a medicine and as part of the acquisition
entered into an active collaboration with the seller. This change
is a result of the growing importance of collaborations to
AstraZeneca. Income arising from all collaborations, other than
Product Sales, will be recognised within the Collaboration Revenue
element of Total Revenue. Historically, there has been no
collaboration income arising from such acquisitions, and therefore
no prior-year restatement of financial results is required as a
result of this change.
Income from royalties and disposals of assets and businesses,
where the Group does not retain a significant element of continued
interest, continue to be recorded in Other Operating Income and
Expense.
Legal proceedings
The information contained in Note 5 updates the disclosures
concerning legal proceedings and contingent liabilities in the
Group's Annual Report and Form 20-F Information 2018.
Going concern
The Group has considerable financial resources available. As at
31 December 2019 the Group has $10.4bn in financial resources (cash
and cash-equivalent balances of $5.4bn, $0.9bn of liquid fixed
income securities and undrawn committed bank facilities of $4.1bn,
of which $3.4bn is available until April 2022, $0.5bn is available
until November 2020 (extendable to November 2021) and $0.2bn is
available until December 2020, with only $2.0bn of borrowings due
within one year). The Group's revenues are largely derived from
sales of medicines which are covered by patents which provide a
relatively high level of resilience and predictability to cash
inflows, although government price interventions in response to
budgetary constraints are expected to continue to adversely affect
revenues in many of the mature markets. The Group, however,
anticipates new revenue streams from both recently launched
medicines in development, and the Group has a wide diversity of
customers and suppliers across different geographic areas.
Consequently, the Directors believe that, overall, the Group is
well placed to manage its business risks successfully.
On the basis of the above paragraph, the going-concern basis has
been adopted in these Condensed Financial Statements.
Financial information
The comparative figures for the financial year ended 31 December
2018 are not the Group's statutory accounts for that financial
year. Those accounts have been reported on by the Group's auditors
and have been delivered to the registrar of companies; their report
was (i) unqualified, (ii) did not include a reference to any
matters to which the auditors drew attention by way of emphasis
without qualifying their report, and (iii) did not contain a
statement under section 498(2) or (3) of the Companies Act
2006.
2 Restructuring costs
Profit before tax for the year ended 31 December 2019 is stated
after charging restructuring costs of $347m ($697m for the year
ended 31 December 2018). These have been charged to profit as
follows:
FY 2019 FY 2018 Q4 2019 Q4 2018
(79) (79)
$m $m $m $m
-------- -------- -------- --------
Cost of sales 73 [81] 432 (49) 355
Research and development
expense 101 94 19 (1)
Selling, general and administrative
costs 173 181 26 71
Other operating income and
expense - (10) - 1
Total 347 697 (4) 426
------------------------------------- -------- -------- --------
3 Net Debt
The table below provides an analysis of net debt and a
reconciliation of net cash flow to the movement in net debt. The
Group monitors net debt as part of its capital management policy as
described in Note 27 of the Annual Report and Form 20-F Information
2018. Net debt is a non-GAAP financial measure.
At 1 Adoption Cash flow Non-cash Exchange At 31
Jan 2019 of new accounting & other movements Dec 2019
standards
[82]
$m $m $m $m $m $m
---------- ------------------- ---------- --------- ----------- ----------
Non-current instalments
of loans (17,359) - - 1,578 51 (15,730)
Non-current instalments
of leases - (557) - 70 - (487)
Total long-term debt (17,359) (557) - 1,648 51 (16,217)
Current instalments
of loans (999) - 1,000 (1,598) - (1,597)
Current instalments
of leases - (163) 206 (231) - (188)
Commercial paper (211) - 211 - - -
Bank collateral (384) - 313 - - (71)
Other short-term borrowings
excluding overdrafts - - (8) - - (8)
Overdraft (160) - 13 - 1 (146)
Total current debt (1,754) (163) 1,735 (1,829) 1 (2,010)
Gross borrowings (19,113) (720) 1,735 (181) 52 (18,227)
Net derivative financial
instruments 384 - (214) (127) - 43
Net borrowings (18,729) (720) 1,521 (308) 52 (18,184)
Cash and cash equivalents 4,831 - 534 - 4 5,369
Other investments -
current 849 - 16 (14) (2) 849
Other investments -
non-current 46 - - 16 - 62
Cash and investments 5,726 - 550 2 2 6,280
Net debt (13,003) (720) 2,071 (306) 54 (11,904)
----------------------------- ------------------- ---------- ----------- ----------
Non-cash movements in the period include fair-value adjustments
under IFRS 9.
Other investments - non-current are included within the balance
of $1,401m (31 December 2018: $833m) in the Statement of Financial
Position. The equivalent GAAP measure to net debt is 'liabilities
arising from financing activities' which excludes the amounts for
cash and overdrafts, other investments and non-financing
derivatives shown above and includes the Acerta Pharma put-option
liability of $2,146m (31 December 2018: $1,838m) shown in
non-current other payables.
4 Financial instruments
As detailed in the Group's most recent annual financial
statements, the principal financial instruments consist of
derivative financial instruments, other investments, trade and
other receivables, cash and cash equivalents, trade and other
payables, leases and interest-bearing loans and borrowings.
There have been no changes of significance to the categorisation
or fair-value hierarchy classification of our financial instruments
from those detailed in the Notes to the Group Financial Statements
in the Group's Annual Report and Form 20-F Information 2018.
The Group holds certain equity investments that are categorised
as Level 3 in the fair-value hierarchy and for which fair-value
gains of $56m have been recognised in the year ended 31 December
2019. These are presented in Net losses on equity investments
measured at fair value through other comprehensive income in the
Condensed Consolidated Statement of Comprehensive Income.
Financial instruments measured at fair value include $2,250m of
other investments, $4,109m held in money market funds, $336m of
loans designated at fair value through profit or loss, $339m of
loans designated in a fair value hedge relationship and $43m of
derivatives as at 31 December 2019. The total fair value of
interest-bearing loans and borrowings at 31 December 2019, which
have a carrying value of $18,227m in the Condensed Consolidated
Statement of Financial Position, was $20,549m. Contingent
consideration liabilities arising on business combinations have
been classified under Level 3 in the fair-value hierarchy and
movements in fair value are shown below:
Diabetes Other Total Total
alliance
2019 2019 2019 2018
$m $m $m $m
---------- ------ ------ ------
At 1 January 3,983 1,123 5,106 5,534
Settlements (454) (255) (709) (349)
Revaluations (516) (98) (614) (495)
Discount unwind 287 69 356 416
At 31 December 3,300 839 4,139 5,106
----------------- ------ ------ ------
Contingent consideration arising from business combinations is
fair-valued using decision-tree analysis, with key inputs including
the probability of success, consideration of potential delays and
the expected levels of future revenues.
The contingent consideration balance relating to BMS's share of
the global diabetes alliance of $3,300m (31 December 2018: $3,983m)
would increase/decrease by $330m with an increase/decrease in sales
of 10%, as compared with the current estimates.
5 Legal proceedings and contingent liabilities
AstraZeneca is involved in various legal proceedings considered
typical to its business, including litigation and investigations
relating to product liability, commercial disputes, infringement of
intellectual property rights, the validity of certain patents,
anti-trust law and sales and marketing practices. The matters
discussed below constitute the more significant developments since
publication of the disclosures concerning legal proceedings in the
Company's Annual Report and Form 20-F Information 2018 and the
interim financial statements for the six months ended 30 June 2019
and the interim financial statements for the three months ended 30
September 2019 (the Disclosures). Unless noted otherwise below or
in the Disclosures, no provisions have been established in respect
of the claims discussed below.
As discussed in the Disclosures, for the majority of claims in
which AstraZeneca is involved, it is not possible to make a
reasonable estimate of the expected financial effect, if any, that
will result from ultimate resolution of the proceedings. In these
cases, AstraZeneca discloses information with respect only to the
nature and facts of the cases, but no provision is made.
In cases that have been settled or adjudicated, or where
quantifiable fines and penalties have been assessed and which are
not subject to appeal, or where a loss is probable and we are able
to make a reasonable estimate of the loss, AstraZeneca records the
loss absorbed or makes a provision for its best estimate of the
expected loss. The position could change over time and the
estimates that the Company made, and upon which the Company have
relied in calculating these provisions are inherently imprecise.
There can, therefore, be no assurance that any losses that result
from the outcome of any legal proceedings will not exceed the
amount of the provisions that have been booked in the accounts. The
major factors causing this uncertainty are described more fully in
the Disclosures and herein.
AstraZeneca has full confidence in, and will vigorously defend
and enforce, its intellectual property.
Matters disclosed in respect of the fourth quarter of 2019 and
to 14 February 2020
Patent litigation
Tagrisso : US patent proceedings
In February of 2020, in response to Paragraph IV notices from
multiple ANDA filers, AstraZeneca filed patent infringement
lawsuits in the US District Court for the District of Delaware. In
its complaint, AstraZeneca alleged that a generic version of
Tagrisso, if approved and marketed, would infringe AstraZeneca's US
Patent No. 10,183,020. No trial date has been set.
Calquence : US patent proceedings
In November 2017, Pharmacyclics LLC (Pharmacyclics, a company in
the AbbVie group) filed a patent infringement lawsuit in the US
District Court for the District of Delaware (the District Court)
against Acerta Pharma and AstraZeneca relating to Calquence.
In April 2018, AstraZeneca and Acerta Pharma filed a complaint
in the District Court against Pharmacyclics and AbbVie alleging
that their medicine, Imbruvica, infringes a US patent owned by
Acerta Pharma. In November 2018, Janssen Biotech, Inc. (Janssen)
intervened as a defendant.
In October 2019, AstraZeneca entered into settlement agreements
with Pharmacyclics and Janssen, resolving all patent litigation
between the parties relating to Calquence and Imbruvica. A
provision was taken.
In October 2019, an amendment to the share purchase and option
agreement (SPOA) with the sellers of Acerta Pharma (originally
entered into in December 2015) came into effect, changing certain
terms of the SPOA on both the timing and also reducing the maximum
consideration that would be required to be made to acquire the
remaining outstanding shares of Acerta Pharma if the options are
exercised. The payments would be made in similar annual instalments
commencing at the earliest from 2022 through to 2024, subject to
the options being exercised. The changes to the terms have been
reflected in the assumptions used to calculate the amortised cost
of the option liability as at 31 December 2019 of $2,146m (FY 2018:
$1,838m, 2017: FY $1,823m).
Faslodex : US patent proceedings
As previously disclosed, AstraZeneca had filed and then resolved
a series of patent infringement lawsuits in the US District Court
for the District of New Jersey (the District Court) relating to
four patents listed in the US FDA Orange Book with reference to
Faslodex after receiving a Paragraph IV notices from several
companies relating to Abbreviated New Drug Applications (ANDA)
seeking US FDA approval to market a generic version of Faslodex
prior to the expiration of AstraZeneca's patents, and the District
Court entered consent judgments ending all of those lawsuits. In
October 2019, AstraZeneca filed a new patent infringement lawsuit
in the District Court after receiving a Paragraph IV letter,
relating to the same four listed patents, from another company that
submitted an ANDA seeking US FDA approval to market a generic
version of Faslodex prior to the expiration of AstraZeneca's
patents.
Onglyza : patent proceedings outside the US
In Canada, in November 2019, Sandoz Canada Inc. sent a Notice of
Allegation to AstraZeneca challenging the validity of Canadian
substance patent no. 2402894 (expiry March 2021) and formulation
patent no. 2568391 (expiry May 2025) related to Onglyza.
AstraZeneca commenced an action in response in January 2020.
Symbicort : US patent proceedings
As previously disclosed, AstraZeneca brought ANDA litigations
against Mylan Pharmaceuticals Inc. (Mylan) and 3M Company (3M) in
the US District Court for the Northern District of West Virginia
and against Teva Pharmaceuticals USA, Inc. (Teva) and Catalent
Pharma Solutions, LLC (Catalent) in the US District Court for the
District of Delaware. In November 2019, AstraZeneca filed an
Amended Complaint in the US District Court for the Northern
District of West Virginia against Mylan and 3M adding allegations
that their proposed generic version of Symbicort, if approved and
marketed, would infringe AstraZeneca's US Patent No. 10,166,247
(the '247 patent) and removing allegations of infringement of US
Patent No. 7,967,011. In November 2019, Mylan and 3M responded to
the Amended Complaint and alleged that their proposed generic
product does not infringe the asserted patents and/or that the
asserted patents are invalid and/or unenforceable. In December
2019, AstraZeneca settled its ANDA action with Teva and Catalent
and that matter is now closed. The trial of the Mylan and 3M matter
has been scheduled for July 2020.
Movantik : US patent proceedings
As previously disclosed, in December 2018, AstraZeneca initiated
ANDA litigation against Apotex, Inc. and Apotex Corp. and against
MSN Laboratories in the US District Court for the District of
Delaware. In its complaint, AstraZeneca alleges that the generic
companies' versions of Movantik, if approved and marketed, would
infringe US Patent No. 9,012,469. A trial has been scheduled for
March 2021.
In November 2019, AstraZeneca initiated ANDA litigation against
Aurobindo Pharma U.S.A. in the US District Court for the District
of Delaware. In its complaint, AstraZeneca alleges that the generic
company's versions of Movantik, if approved and marketed, would
infringe US Patent No. 9,012,469.
Product liability litigation
Farxiga and Xigduo XR
As previously disclosed, in several jurisdictions in the US,
AstraZeneca has been named as a defendant in lawsuits involving
plaintiffs claiming physical injury, including diabetic
ketoacidosis and kidney failure, from treatment with Farxiga and/or
Xigduo XR. In April 2017, the Judicial Panel on Multidistrict
Litigation ordered transfer of any currently pending cases as well
as of any similar, subsequently filed cases to a coordinated and
consolidated pre-trial multidistrict litigation proceeding in the
US District Court for the Southern District of New York. A majority
of these claims have been resolved or dismissed, and the MDL has
been administratively closed.
Nexium and Losec/Prilosec: U S proceedings
As previously disclosed, in the US, AstraZeneca is defending
various lawsuits brought in federal and state courts involving
multiple plaintiffs claiming that they have been diagnosed with
various injuries following treatment with proton pump inhibitors,
including Nexium and Prilosec. In May 2017, counsel for a group of
such plaintiffs claiming that they have been diagnosed with kidney
injuries filed a motion with the Judicial Panel on Multidistrict
Litigation (JPML) seeking the transfer of any currently pending
federal court cases as well as any similar, subsequently filed
cases to a coordinated and consolidated pre-trial multidistrict
litigation (MDL) proceeding. In August 2017, the JPML granted the
motion and consolidated the pending federal court cases in an MDL
proceeding in federal court in New Jersey for pre-trial purposes. A
trial in the MDL has been scheduled for November 2021.
In July 2019, counsel for a similarly defined group of
plaintiffs with claims pending in New Jersey state courts
petitioned the New Jersey State Administrative Director of the
Courts to centralise judicial management of all plaintiffs' claims
alleging kidney injuries pending in that state in a coordinated
multicounty litigation (MCL) proceeding. The MCL has been
centralised in Atlantic County.
Commercial litigation
Amplimmune
As previously disclosed, in June 2017, AstraZeneca was served
with a lawsuit filed by the stockholders' agents for Amplimmune,
Inc (Amplimmune) in Delaware State Court that alleges, among other
things, breaches of contractual obligations relating to a 2013
merger agreement between AstraZeneca and Amplimmune. Trial is
scheduled for February 2020.
Ocimum lawsuit
As previously disclosed, in December 2015, AstraZeneca was
served with a complaint filed by Ocimum Biosciences, Ltd. (Ocimum)
in the Superior Court for the State of Delaware that alleges, among
other things, breaches of contractual obligations and
misappropriation of trade secrets, relating to a now terminated
2001 licensing agreement between AstraZeneca and Gene Logic, Inc.
(Gene Logic), the rights to which Ocimum purports to have acquired
from Gene Logic. In December 2019, the court granted AstraZeneca's
motion for summary judgment and dismissed the case.
Government investigations/proceedings
Crestor
Qui tam litigation
As previously disclosed, in the US, in January and February
2014, AstraZeneca was served with lawsuits filed in the US District
Court for the District of Delaware under the qui tam
(whistle-blower) provisions of the federal False Claims Act and
related state statutes, alleging that AstraZeneca directed certain
employees to promote Crestor off-label and provided unlawful
remuneration to physicians in connection with the promotion of
Crestor. The DOJ and all US states have declined to intervene in
the lawsuits. In March 2019, AstraZeneca filed a motion to dismiss
the complaint. Oral argument on the motion to dismiss is scheduled
for February 2020.
Multi-product litigation
Litigation in Washington state
As previously disclosed, in September 2018, a lawsuit against
AstraZeneca and several other defendants was unsealed in the US
District Court for the Western District of Washington (the District
Court). The complaint alleged that the defendants violated various
laws, including state and federal false claims acts, by offering
clinical educator and reimbursement support programmes. In
September 2018, the government moved to dismiss the lawsuit against
AstraZeneca and similar lawsuits filed against other companies by
relator, Health Choice Alliance. In November 2019, the District
Court granted the government's motion and dismissed the case.
6 Subsequent events
Following the recommendation from an independent Data Monitoring
Committee, AstraZeneca decided in January 2020 to terminate the
Phase III STRENGTH trial for Epanova, due to its low likelihood of
demonstrating a benefit to patients with MDS who are at increased
risk of CV disease. This was considered to be an adjusting event
after the reporting period, resulting in a full impairment of the
Epanova intangible asset of $533m recorded in Reported R&D
Expense in FY 2019, and a provision for inventory and
supply-related costs of $115m recorded in Reported and Core Cost of
Sales, also in FY 2019.
In January 2020, the Company announced that it had agreed to
divest the global commercial rights to a number of established
hypertension medicines, including Inderal, Tenormin 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.
In January 2020, the Company announced that it 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'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 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.
In January 2020, AstraZeneca sold a proportion of its equity
portfolio, receiving consideration of $184m.
7 Product Sales analysis - FY 2019
The table below provides an analysis of year-on-year Product
Sales, with Actual and CER growth rates reflecting year-on-year
growth. Due to rounding, the sum of a number of dollar values and
percentages may not agree to totals. The CER information in respect
of FY 2019 included in the Consolidated Financial Information has
not been audited by PricewaterhouseCoopers LLP. *Denotes a legacy
medicine.
World Emerging Markets US Europe Established RoW
----------------------- ----------------------- --------------- ---------------------- ----------------------
FY Actual CER FY Actual CER FY Actual FY Actual CER FY Actual CER
2019 2019 2019 2019 2019
$m % % $m % % $m % $m % % $m % %
------- ------- ----- ------ ------- ------ ------ ------- ------ ------- ----- ------ ------- -----
Oncology
Tagrisso 3,189 71 74 762 n/m n/m 1,268 46 474 51 59 685 n/m n/m
Imfinzi 1,469 n/m n/m 30 n/m n/m 1,041 85 179 n/m n/m 219 n/m n/m
Lynparza 1,198 85 89 133 n/m n/m 626 81 287 51 59 152 n/m n/m
Calquence 164 n/m n/m 2 n/m n/m 162 n/m - n/m n/m - n/m n/m
Faslodex 892 (13) (11) 198 29 36 328 (39) 229 3 9 137 19 17
Zoladex * 813 8 13 492 20 28 7 (17) 135 2 7 179 (11) (10)
Iressa * 423 (18) (15) 286 - 4 17 (33) 70 (36) (32) 50 (49) (49)
Arimidex * 225 6 11 152 15 21 - n/m 28 (8) (3) 45 (9) (9)
Casodex * 200 - 3 127 13 19 - (88) 16 (20) (15) 57 (15) (15)
Others 94 (18) (17) 29 (6) (3) - n/m 5 (24) (19) 60 (21) (22)
Total Oncology 8,667 44 47 2,211 45 52 3,449 43 1,423 35 42 1,584 53 52
--------------------- ------- ----- ------ ------- ------ ------ ------- ------ ------- ----- ------ ------- -----
BioPharmaceuticals:
CVRM
Farxiga 1,543 11 14 471 40 48 537 (9) 373 18 25 162 9 10
Brilinta 1,581 20 23 462 42 49 710 21 351 1 7 58 (1) 3
Bydureon 549 (6) (5) 11 34 39 459 (3) 66 (19) (14) 13 (32) (28)
Onglyza 527 (3) - 176 3 9 230 3 70 (22) (17) 51 (14) (12)
Byetta 110 (13) (11) 12 47 60 68 (9) 19 (35) (31) 11 (24) (20)
Other diabetes 52 33 35 1 n/m n/m 40 18 9 88 n/m 2 23 33
Lokelma 14 n/m n/m - - - 13 n/m 1 n/m n/m - - -
Crestor * 1,278 (11) (8) 806 (4) - 104 (39) 148 (27) (23) 220 - 1
Seloken/Toprol-XL* 760 7 12 686 7 13 37 (5) 25 31 31 12 (11) (8)
Atacand * 221 (15) (11) 160 2 7 12 (11) 30 (57) (57) 19 1 7
Others 271 (9) (6) 193 (6) (3) (1) (91) 59 (16) (12) 20 (16) (16)
BioPharmaceuticals:
total
CVRM 6,906 3 6 2,978 10 16 2,209 n/m 1,151 (6) (1) 568 (2) n/m
--------------------- ------- ----- ------ ------- ------ ------ ------- ------ ------- ----- ------ ------- -----
BioPharmaceuticals:
Respiratory
Symbicort 2,495 (3) - 547 11 17 829 (4) 678 (12) (7) 441 2 3
Pulmicort 1,466 14 18 1,190 20 24 110 (5) 81 (10) (4) 85 1 1
Fasenra 704 n/m n/m 5 n/m n/m 482 n/m 118 n/m n/m 99 n/m n/m
Daliresp/Daxas 215 14 15 4 (18) (13) 184 19 26 (8) (3) 1 32 35
Duaklir 77 (19) (15) 1 44 49 3 - 71 (22) (17) 2 (65) (64)
Bevespi 42 26 26 - n/m n/m 42 25 - n/m n/m - n/m n/m
Breztri 2 n/m n/m - - - - - - - - 2 n/m n/m
Others 390 (13) (9) 240 62 70 3 (88) 133 (38) (35) 14 (74) (73)
BioPharmaceuticals:
total
Respiratory 5,391 10 13 1,987 21 27 1,653 17 1,107 (10) (5) 644 4 4
--------------------- ------- ----- ------ ------- ------ ------ ------- ------ ------- ----- ------ ------- -----
Other medicines
Nexium 1,483 (13) (11) 748 8 14 218 (29) 63 (73) (72) 454 (4) (4)
Synagis 358 (46) (46) - (100) (100) 46 (84) 312 (17) (17) - n/m n/m
Losec/Prilosec 263 (3) 1 179 11 17 10 43 49 (30) (26) 25 (27) (26)
Seroquel XR/IR 191 (47) (46) 50 (58) (57) 34 (69) 88 (18) (14) 19 (30) (30)
Others 306 (23) (20) 12 (77) (81) 128 (4) 157 (1) 2 9 (84) (67)
Total other
medicines 2,601 (24) (21) 989 (3) 1 436 (48) 669 (29) (28) 507 (14) (12)
--------------------- ------- ----- ------ ------- ------ ------ ------- ------ ------- ----- ------ ------- -----
Total Product Sales 23,565 12 15 8,165 18 24 7,747 13 4,350 (2) 2 3,303 17 18
--------------------- ------- ----- ------ ------- ------ ------ ------- ------ ------- ----- ------ ------- -----
8 Product Sales analysis - Q4 2019
The table below provides an analysis of year-on-year Product
Sales, with Actual and CER growth rates reflecting year-on-year
growth. Due to rounding, the sum of a number of dollar values and
percentages may not agree to totals. The Q4 2019 information in
respect of the three months ended 31 December 2019 included in the
Consolidated Financial Information has not been audited by
PricewaterhouseCoopers LLP. *Denotes a legacy medicine.
World Emerging Markets US Europe Established RoW
--------------------- ---------------------- -------------- --------------------- ----------------------
Q4 Actual CER Q4 Actual CER Q4 Actual Q4 Actual CER Q4 Actual CER
2019 2019 2019 2019 2019
$m % % $m % % $m % $m % % $m % %
----- ------- ----- ----- ------- ------ ----- ------- ----- ------- ----- ----- ------- ------
Oncology
Tagrisso 884 49 49 209 n/m n/m 359 24 137 48 54 179 36 32
Imfinzi 424 62 62 12 n/m n/m 282 31 64 n/m n/m 66 n/m n/m
Lynparza 351 68 69 32 81 86 194 73 79 48 54 46 75 69
Calquence 56 n/m n/m 1 n/m n/m 54 n/m - n/m n/m - n/m n/m
Faslodex 166 (39) (38) 53 24 25 17 (88) 61 20 25 35 8 4
Zoladex * 196 8 9 112 17 20 2 (20) 35 4 8 46 (6) (8)
Iressa * 80 (29) (28) 59 (1) - 3 (40) 9 (63) (62) 8 (64) (65)
Arimidex * 51 10 11 34 28 31 - n/m 7 (12) (9) 11 (15) (18)
Casodex * 43 (6) (5) 28 22 25 - n/m 4 (23) (20) 11 (38) (40)
Others 26 15 12 7 4 4 - n/m - (56) (54) 18 34 29
Total Oncology 2,274 29 29 546 54 57 911 15 396 38 43 421 27 22
------- ----- ----- ------- ------ ----- ------- ----- ------- ----- ----- ------- ------
BioPharmaceuticals:
CVRM
Farxiga 419 6 7 132 40 42 141 (18) 100 18 23 47 (2) (3)
Brilinta 428 14 15 114 21 23 210 18 89 (3) 1 15 7 11
Bydureon 139 1 1 2 n/m n/m 119 3 16 (19) (15) 2 (40) (38)
Onglyza 131 (11) (10) 45 (11) (8) 56 (8) 17 (22) (19) 13 (13) (12)
Byetta 27 (16) (15) 4 90 92 16 (15) 5 (38) (35) 2 (32) (30)
Other diabetes 16 35 36 - n/m n/m 12 13 2 42 49 1 (63) (61)
Lokelma 8 n/m n/m - - - 7 n/m 1 n/m n/m - - -
Crestor * 296 (16) (15) 185 (12) (10) 16 (63) 36 (16) (13) 58 2 (1)
Seloken /Toprol-XL* 190 18 20 173 17 19 7 13 7 n/m n/m 4 2 4
Atacand * 60 3 5 43 (1) - 4 85 8 (1) (1) 5 15 19
Others 72 1 4 54 6 8 (1) - 13 (14) (11) 5 7 5
BioPharmaceuticals:
total
CVRM 1,785 2 4 753 9 11 587 (3) 293 (1) 3 152 (2) (3)
BioPharmaceuticals:
Respiratory
Symbicort 712 12 13 146 12 14 244 18 170 (8) (5) 152 34 32
Pulmicort 413 6 7 345 12 14 21 (40) 21 (2) 2 25 3 -
Fasenra 206 65 65 1 82 88 139 56 37 n/m n/m 29 45 41
Daliresp /Daxas 58 8 8 1 1 3 50 12 7 (19) (16) - n/m n/m
Duaklir 22 (2) - - n/m n/m 3 - 18 (12) (11) 1 (119) (120)
Bevespi 12 12 12 - n/m n/m 12 11 - n/m n/m - n/m n/m
Breztri 1 n/m n/m - - - - - - - - 1 n/m n/m
Others 114 (9) (7) 75 29 32 - n/m 35 (37) (36) 4 (69) (68)
BioPharmaceuticals:
total
Respiratory 1,537 13 14 568 14 16 470 22 288 (6) (3) 211 22 20
Other medicines
Nexium 353 (10) (10) 174 5 6 43 (25) 14 (74) (73) 122 10 6
Synagis 63 (75) (75) - (100) (100) 10 (94) 54 (44) (44) - n/m n/m
Losec /Prilosec 46 (24) (23) 34 12 14 3 55 4 (78) (78) 5 (49) (51)
Seroquel XR/IR 40 (27) (27) 9 (27) (27) 7 (49) 21 (20) (17) 4 (13) (15)
Others 151 12 14 8 (42) (47) 29 1 111 27 30 4 (31) (30)
Total other medicines 653 (27) (27) 224 n/m 2 91 (64) 204 (28) (27) 134 3 n/m
------- ----- ----- ------- ------ ----- ------- ----- ------- ----- ----- ------- ------
Total Product Sales 6,250 8 9 2,091 18 20 2,059 1 1,182 1 4 918 16 13
9 Sequential quarterly Product Sales - 2019
The table below provides an analysis of sequential quarterly
Product Sales, with Actual and CER growth rates reflecting
quarter-on-quarter growth. Due to rounding, the sum of a number of
dollar values and percentages may not agree to totals. The
sequential quarterly Product Sales information included in the
Consolidated Financial Information has not been audited by
PricewaterhouseCoopers LLP. *Denotes a legacy medicine.
Q1 2019 Actual CER Q2 2019 Actual CER Q3 2019 Actual CER Q4 2019 Actual CER
Oncology
Tagrisso 630 6 6 784 24 25 891 14 13 884 (1) -
Imfinzi 295 13 13 338 15 15 412 22 22 424 3 4
Lynparza 237 13 13 283 19 20 327 16 15 351 7 8
Calquence 29 21 23 35 21 19 44 27 27 56 25 25
Faslodex 254 (6) (6) 267 5 6 205 (23) (23) 166 (20) (19)
Zoladex * 194 7 6 197 2 1 226 15 16 196 (14) (12)
Iressa * 134 20 18 118 (12) (11) 91 (23) (22) 80 (13) (12)
Arimidex * 51 11 10 60 18 17 63 5 5 51 (20) (18)
Casodex * 48 4 3 57 19 18 52 (8) (6) 43 (18) (17)
Others 20 (13) (14) 28 40 29 20 (27) (22) 26 30 26
Total Oncology 1,892 7 6 2,167 15 15 2,334 8 8 2,274 (3) (2)
BioPharmaceuticals: CVRM
Farxiga 349 (12) (12) 377 8 9 398 5 5 419 5 6
Brilinta 348 (7) (8) 389 12 12 416 7 8 428 3 3
Bydureon 142 3 3 141 (1) - 127 (10) (10) 139 9 10
Onglyza 153 3 3 116 (24) (24) 127 9 11 131 3 4
Byetta 30 (6) (5) 25 (17) (16) 28 10 13 27 (2) (4)
Other diabetes 11 (8) (17) 11 - 8 14 26 22 16 17 17
Lokelma - n/m n/m 2 n/m n/m 4 m/n n/m 8 87 74
Crestor * 335 (5) (6) 310 (7) (7) 337 9 9 296 (12) (11)
Seloken /Toprol-XL* 225 41 38 168 (25) (25) 177 6 8 190 7 8
Atacand * 50 (14) (15) 56 12 14 55 (1) (1) 60 8 9
Others 71 (3) (5) 63 (11) (8) 65 4 2 72 13 16
BioPharmaceuticals: total
CVRM 1,714 (2) (3) 1,658 (3) (3) 1,749 5 6 1,785 2 3
BioPharmaceuticals:
Respiratory
Symbicort 585 (8) (8) 585 - 1 613 5 4 712 16 17
Pulmicort 383 (2) (2) 333 (13) (13) 337 1 3 413 22 23
Fasenra 129 3 4 167 29 30 202 21 21 206 2 2
Daliresp /Daxas 48 (11) (12) 56 17 18 53 (6) (7) 58 10 10
Duaklir 20 (9) (6) 17 (15) (16) 18 7 5 22 19 20
Bevespi 10 - (5) 10 - 2 10 4 8 12 8 5
Breztri - - - - - - 1 - - 1 (74) (73)
Others 108 (14) (16) 84 (22) (23) 84 - 4 114 36 35
BioPharmaceuticals: total
Respiratory 1,283 (6) (6) 1,252 (2) (2) 1,319 5 6 1,537 17 17
Other medicines
Nexium 363 (7) (8) 393 8 8 374 (5) (4) 353 (6) (6)
Synagis 53 (79) (79) 96 81 81 146 52 53 63 (57) (57)
Losec /Prilosec 76 27 26 68 (11) (10) 73 8 9 46 (38) (38)
Seroquel XR/IR 37 (34) (33) 32 (14) (10) 82 n/m n/m 40 (50) (49)
Others 47 (65) (64) 52 11 11 56 8 - 151 n/m n/m
Total other medicines 576 (35) (36) 641 11 12 731 14 14 653 (11) (10)
Total Product Sales 5,465 (5) (6) 5,718 5 5 6,132 7 8 6,250 2 3
Shareholder information
Announcement first quarter 2019 results and 29 April 2020
Annual General Meeting:
Announcement of first half and second quarter 30 July 2020
results
Announcement of year to date and third quarter 5 November 2020
results
Future dividends will normally be paid as follows:
First interim: announced with half-year and second-quarter results
and paid in September
Second interim: announced with full-year and fourth-quarter results
and paid in March
The record date for the 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.
Trademarks of the AstraZeneca group of companies appear
throughout this document in italics. Medical publications also
appear throughout the document in italics. AstraZeneca, the
AstraZeneca logotype and the AstraZeneca symbol are all trademarks
of the AstraZeneca group of companies. Trademarks of companies
other than AstraZeneca that appear in this document include
Atacand, owned by AstraZeneca or Cheplapharm (depending on
geography); Avastin, a trademark of Genentech, Inc.; Duaklir,
Eklira and Tudorza, trademarks of Almirall; Enhertu, a trademark of
Daiichi Sankyo; Epanova, a trademark of Chrysalis Pharma AG.;
Losec, owned by AstraZeneca or Cheplapharm (depending on
geography); Synagis, owned by Arexis AB or AbbVie (depending on
geography).
Information on or accessible through AstraZeneca's websites,
including astrazeneca.com , does not form part of and is not
incorporated into this announcement.
Addresses for correspondence
Registered office Registrar and Swedish Central US depositary
transfer office Securities Depository Deutsche Bank
Trust Company
Americas
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Avenue Aspect House AB PO Box 191 Transfer
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db@astfinancial.com
Cautionary statements regarding forward-looking statements
In order, among other things, to utilise the 'safe harbour'
provisions of the US Private Securities Litigation Reform Act 1995,
we are providing the following cautionary statement:
This document contains certain forward-looking statements with
respect to the operations, performance and financial condition of
the Group, including, among other things, statements about expected
revenues, margins, earnings per share or other financial or other
measures. Although we believe our expectations are based on
reasonable assumptions, any forward-looking statements, by their
very nature, involve risks and uncertainties and may be influenced
by factors that could cause actual outcomes and results to be
materially different from those predicted. The forward-looking
statements reflect knowledge and information available at the date
of preparation of this document and AstraZeneca undertakes no
obligation to update these forward-looking statements. We identify
the forward-looking statements by using the words 'anticipates',
'believes', 'expects', 'intends' and similar expressions in such
statements. Important factors that could cause actual results to
differ materially from those contained in forward-looking
statements, certain of which are beyond our control, include, among
other things: the loss or
expiration of, or limitations to, patents, marketing exclusivity
or trademarks, or the risk of failure to obtain and enforce patent
protection; effects of patent litigation in respect of IP rights;
the impact of any delays in the manufacturing, distribution and
sale of any of our medicines; the impact of any failure by third
parties to supply materials or services; the risk of failure of
outsourcing; the risks associated with manufacturing biologics; the
risk that R&D will not yield new medicines that achieve
commercial success; the risk of delay to new product launches; the
risk that new medicines do not perform as we expect; the risk that
strategic alliances and acquisitions, including licensing and
collaborations, will be unsuccessful; the risks from pressures
resulting from generic competition; the impact of competition,
price controls and price reductions; the risks associated with
developing our business in Emerging Markets; the risk of illegal
trade in our medicines; the difficulties of obtaining and
maintaining regulatory approvals for medicines; the risk that
regulatory approval processes for biosimilars could have an adverse
effect on future commercial prospects; the risk of failure to
successfully implement planned cost reduction measures through
productivity initiatives and restructuring programmes; the risk of
failure of critical processes affecting business continuity;
economic, regulatory and political pressures to limit or reduce the
cost of our medicines; failure to achieve strategic priorities or
to meet targets, expectations, guidance or indications; the risk of
substantial adverse litigation/government investigation claims and
insufficient insurance coverage; the risk of substantial product
liability claims; the risk of failure to adhere to applicable laws,
rules and regulations; the risk of failure to adhere to applicable
laws, rules and regulations relating to anti-competitive behaviour;
the impact of increasing implementation and enforcement of more
stringent anti-bribery and anti-corruption legislation; taxation
risks; exchange rate fluctuations; the risk of an adverse impact of
a sustained economic downturn; political and socio-economic
conditions; the risk of environmental liabilities; the risk of
occupational health and safety liabilities; the risk associated
with pensions liabilities; the impact of failing to attract and
retain key personnel and to successfully engage with our employees;
the risk of misuse of social media platforms and new technology;
and the risk of failure of information technology and cybercrime.
Nothing in this document, or any related presentation / webcast,
should be construed as a profit forecast.
[10] An unresectable tumour is one that cannot be removed
completely through surgery.
[11] Non-small cell lung cancer.
[12] The initial treatment of a cancer in the advanced,
metastatic setting.
([13]) Breast cancer susceptibility genes 1/2 mutation.
[14] Human epidermal growth factor receptor 2 positive.
([15]) Chronic lymphocytic leukaemia.
[16] Type-2 diabetes.
[17] Chronic obstructive pulmonary disease.
([18]) Small cell lung cancer.
[19] Extensive-disease stage.
[20] Neurofibromatosis type 1.
[21] Heart failure.
[22] CV outcomes trial.
[23] Coronary artery disease.
[24] Chronic kidney disease.
[25] Progression-free survival.
[26] Hepatocellular carcinoma (liver cancer).
[27] Overall survival.
[28] Non-alcoholic steatohepatitis (non-alcoholic fatty liver disease).
[29] Systemic lupus erythematosus.
[30] Limited-disease stage.
[31] A group of disorders in which the bone marrow fails to
produce healthy blood cells.
[32] Formerly MEDI8897.
[33] Legacy medicine.
[34] Substitution of threonine (T) with methionine (M) at position 790 of exon 20 mutation.
[35] Gross-to-net adjustments reflect the timing difference
between forecast net Product Sales, based on accrued rebates,
discounts and other adjustments, and recognised net Product
Sales.
[36] Used to decide which medicines to stock at hospitals and
clinics and also to define reimbursement under China's public
healthcare system.
[37] The calculation of Reported and Core Gross Profit Margin
excludes the impact of Collaboration Revenue and any associated
costs, thereby reflecting the underlying performance of Product
Sales.
[38] EBITDA is a non-GAAP financial measure and is defined in
the operating and financial review.
[39] Other adjustments include fair-value adjustments relating
to contingent consideration on business combinations and other
acquisition-related liabilities, discount unwind on
acquisition-related liabilities (see Note 4) and provision
movements related to certain legal matters (see Note 5).
[40] Each of the measures in the Core column in the above table
are non-GAAP financial measures. See the operating and financial
review for related definitions.
[41] Where AstraZeneca does not retain a significant ongoing
interest in medicines or potential new medicines, income from
divestments is reported within Other Operating Income and Expense
in the Company's financial statements.
[42] Reflects the adoption of IFRS 16 (see Note 1).
[43] Based on best prevailing assumptions around currency
profiles.
[44] Based on average daily spot rates in FY 2019.
[45] Based on average daily spot rates from 1 January 2020 to 31
January 2020.
[46] Other currencies include AUD, BRL, CAD, KRW and RUB.
[47] These priorities were determined, along with a set of nine
foundational areas, through a materiality assessment with external
and internal stakeholders, respectively. Combined, they ensure the
maximum possible benefit to patients, the Company, broader society
and the planet. AstraZeneca's sustainability priorities,
foundations and commitments align with the United Nations
Sustainable Development Goals (SDG), and, in particular, SDG three
for 'Good Health'.
[48] An investor effort designed to help companies enhance their
workforce reporting.
[49] Corporate Knights Inc. includes the sustainable-business
magazine Corporate Knights and a research division that produces
rankings and financial-product ratings based on
corporate-sustainability performance.
[50] Phase II trial data, with potential for registration.
[51] Subject to regulatory approvals associated with AbbVie
Inc.'s (AbbVie) proposed acquisition of Allergan plc
(Allergan).
[52] First patient commenced dosing.
[53] Last patient commenced dosing.
[54] Based on current expectations and event rates, data from
the ADAURA trial can be expected in 2022.
[55] Conducted by the Canadian Cancer Trials Group.
[56] Bacillus Calmette-Guerin.
[57] Transarterial chemoembolisation.
[58] HRR mutated.
[59] Conducted by the ARCAGY/Groupe d'Investigateurs National
des Etudes des Cancers Ovariens et du sein.
[60] Conducted by the National Cancer Institute (US).
[61] Immunohistochemistry.
[62] In situ hybridisation.
[63] Quaque die , or once a day.
[64] End-stage renal disease.
[65] Myocardial infarction.
[66] Bis in die, or twice a day.
[67] MACE is defined as all-cause mortality, stroke and
myocardial infarction.
[68] MACE+ is defined as MACE, unstable angina requiring
hospitalisation and congestive heart failure requiring
hospitalisation.
[69] Patients who have been on dialysis for four months or fewer.
[70] O ral corticosteroid.
[71] Birmingham Vasculitis Activity Score.
[72] Hypereosinophilic syndrome.
[73] Patient-reported outcomes.
[74] The Systemic Lupus Erythematosus Responder Index, a primary
outcome measure assessing changes in SLE disease activity without
associated worsening symptoms in other diseases.
[75] The BILAG-Based Composite Lupus Assessment, a composite index measuring disease activity.
[76] Long-term extension.
[77] The Q4 2019 and Q4 2018 information in respect of the three
months ended 31 December 2019 and 31 December 2018 respectively
included in the Condensed Financial Statements has not been audited
by PricewaterhouseCoopers LLP.
[78] The Company adopted IFRIC 23 'Uncertainty over Income Tax
Treatments' from 1 January 2019. See Note 1.
[79] On 2 April 2019, the Company completed an issue of
44,386,214 new ordinary shares of $0.25 each at a price of GBP60.50
per share, resulting in an increase in share capital of $11m and an
increase in share premium of $3,479m, net of transaction costs of
$22m.
[80] The profit-participation liability relates to the rights to
participate in the future cashflows from the US profits or losses
for nirsevimab and forms part of the consideration for the disposal
of the US rights to Synagis to Sobi. This has been recognised as a
financial liability and is presented in Other Payables within
Non-Current Liabilities.
[81] Includes impairment reversals totaling $93m in relation to
biologic-medicine manufacturing sites in Colorado, US.
[82] The Company adopted IFRS 16 'Leases' from 1 January 2019.
See Note 1.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
FR TJMLTMTTBBJM
(END) Dow Jones Newswires
February 14, 2020 02:00 ET (07:00 GMT)
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