FORM 6-K
 
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
Report of Foreign Issuer
 
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
 
For the month of May 2018
 
Commission File Number: 001-11960
 
AstraZeneca PLC
 
1 Francis Crick Avenue
Cambridge Biomedical Campus
Cambridge CB2 0AA
United Kingdom
 
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
 
Form 20-F X Form 40-F __
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______
 
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
 
Yes __ No X
 
If “Yes” is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b): 82-_____________
 
 
 
 
AstraZeneca PLC
 
INDEX TO EXHIBITS
 
 
1.
AZN: Q1 2018 Results
 
 
AstraZeneca PLC
18 May 2018 07:00
Q1 2018 Results
Encouraging launches and the performance of newer medicines underpin reiterated guidance
 
As expected, the Product Sales performance benefitted from strong launches and the continued growth of newer medicines and China, offset by the erosion of Crestor sales. Progress was made on overall cost discipline, while the level of Externalisation Revenue, divestment timing and investment in launches impacted the overall results. Patients continued to benefit from the progress of the pipeline and AstraZeneca’s plans remain on track, with the Company continuing to anticipate Product Sales growth this year, weighted to the second half.
 
Financial Highlights
 
Q1 2018
$m
% change
 
Actual
CER1
Total Revenue
5,178
(4)
(9)
Product Sales
4,985
3
(2)
Externalisation Revenue
193
(66)
(67)
 
 
 
 
Reported Operating Profit2
696
(24)
(21)
Core Operating Profit3
896
(46)
(47)
 
 
 
 
Reported Earnings Per Share (EPS)
$0.27
(37)
(29)
Core EPS
$0.48
(51)
(51)
 
Product Sales increased by 3% (down by 2% at CER). Strong performance of China and newer medicines across all therapy areas was offset by the decline of Crestor sales in Europe and Japan. Total Revenue declined by 4% (9% at CER) to $5,178m, reflecting the level of Externalisation Revenue in the quarter
 
The Reported Gross Margin declined by five percentage points (four at CER) to 77.3%, a result of the favourable impact of manufacturing variances realised in Q1 2017, as well as the agreement on Lynparza with MSD4;the Core Gross Margin fell by five percentage points (four at CER) to 78.8%
 
Good progress on overall cost discipline - Reported Operating Expenses were stable (down by 5% at CER) at $3,817m; Core Operating Expenses increased by 3% (but declined by 1% at CER) to $3,349m. Reported R&D costs declined by 12% (16% at CER) to $1,279m;Core R&D costs declined by 7% (12% at CER) to $1,240m, driven by efficiency savings. Reported SG&A costs increased by 7% (2% at CER) to $2,457m; Core SG&A costs increased by 11% (6% at CER) to $2,028m, reflecting investment in China and new medicine launches
 
Reported Other Operating Income & Expense increased by 99% (97% at CER) to $469m, a result of a legal settlement; Core Other Operating Income & Expense declined by 63% (64% at CER) to $124m, impacted by the timing of divestments
 
Reported EPS of $0.27 and Core EPS of $0.48
 
Capital expenditure reduced to $213m (Q1 2017: $286m). Restructuring costs reduced to $95m (Q1 2017: $312m), supporting an anticipated decline over the full year
 
FY 2018 guidance reiterated and unchanged
 
Pascal Soriot, Chief Executive Officer, commenting on the results said:
“Encouraging launches and strong performances from our newer generation of medicines made a significant contribution to Product Sales in the quarter, paving the way for our anticipated return to growth in 2018. The performance was in line with our expectations and guidance for the year is unchanged. We delivered strong results for Lynparza, Tagrisso and Imfinzi in Oncology, Brilinta and Farxiga in CVRM and a successful launch of Fasenra in Respiratory. Our China sales continued to surpass expectations and we expect that the effects of the Crestor patent expiries in Europe and Japan will recede materially in the second half.
 
AstraZeneca’s pipeline continued to bring significant benefits for patients, most recently with the expanded US approval of Tagrisso for lung cancer and Lynparza for breast cancer. With our transformation coming into sharper commercial focus as the year progresses, we are confident of delivering on our goals.”
Commercial Highlights
Newer medicines5 generated more than $0.4bn in additional sales at CER in the quarter. Product Sales highlights were:
 
Oncology: sales growth of 39% in the quarter (33% at CER) to $1,230m, including:
 
- Lynparza sales of $119m, growth of 109% (100% at CER), driven by regulatory approvals in the US
 
-Tagrisso sales of $338m, growth of 98% (89% at CER) reflecting growth as the new standard of care in the treatment of 2nd-line EGFR6 T790M-mutated7 NSCLC8. Approved in the US in April 2018 in the 1st-line setting
 
- Imfinzi sales of $62m (FY 2017: $19m), a result of the recent US approval for the treatment of unresectable, Stage III NSCLC
 
New CVRM9: 13% growth (8% at CER) to $900m, including:
 
- Brilinta sales of $293m, growth of 31% (24% at CER) due to continued market penetration in acute coronary syndrome (ACS) and high-risk periprocedural myocardial infarction (HR PMI)
 
- Farxiga sales of $299m, growth of 44% (39% at CER) as the medicine continued to lead the market by volume
 
- Bydureon sales of $139m, a decline of 9% (11% at CER). An encouraging BCise device launch, outweighed by the impact of price pressures in the US
 
Respiratory: stable sales of $1,181m (a decline of 6% at CER), including:
 
- A Symbicort sales decline of 6% (12% at CER) to $634m, as competitive class pressures in the US continued
 
- Pulmicort sales growth of 3% (down by 3% at CER) to $346m, reflecting the inflated level of demand in China in Q4 2017 and a supply delay in China
 
- Fasenra sales of $21m. A very strong launch and uptake, especially in the US and Germany
 
Emerging Markets: the largest region by Product Sales, with growth of 13% (8% at CER) to $1,765m, including:
 
- A China sales increase of 31% (22% at CER) to $1,025m. For the first time, quarterly sales of more than $1bn were achieved, underpinned by the launch of Tagrisso
 
- An ex-China sales decline of 5% (7% at CER) to $740m. A robust performance, outweighed by the impact of divested Product Sales and a Russia sales decline of 38% (40% at CER) to $34m
 
Pipeline Highlights
The table below highlights significant developments in the late-stage pipeline since the prior results announcement:
 
Regulatory Approvals
- Lynparza - ovarian cancer (2nd line; tablets) (EU)
- Tagrisso - lung cancer (1st line) (US)
- Imfinzi - lung cancer (Stage III) (US)
- Lokelma (ZS-9) - hyperkalaemia(EU)
 
Regulatory Submissions and/or Acceptances
- Lynparza - breast cancer (EU)
- moxetumomab pasudotox - hairy cell leukaemia (3rd line) (US)
- Forxiga - type-1 diabetes (EU)
 
Major Phase III Data Readouts or Other Major Developments
- Tagrisso - lung cancer (1st line) - priority review status (JP)
- Imfinzi + tremelimumab - lung cancer (3rd line) (ARCTIC trial) - did not meet primary endpoints in PDL1-low/neg. patients
- moxetumomab pasudotox - hairy cell leukaemia (3rd line) - Priority Review (US)
- selumetinib - neurofibromatosis type 1 (NF1) - Orphan Drug Designation (US)
- Fasenra - COPD (GALATHEA trial) - did not meet primary endpoint
 
 
Guidance
Guidance for FY 2018 is reiterated and unchanged. All measures in this section are at CER. Company guidance is on Product Sales and Core EPS only.
 
Product Sales
A low single-digit percentage increase
Core EPS
$3.30 to $3.50
 
The aforementioned anticipated growth in Product Sales is weighted towards the second half of the year. This reflects the remaining impact of generic competition, namely Crestor in Europe and Japan, as well as the growing contribution from newer medicines.
 
Variations in performance between quarters can be expected to continue. The Company is unable to provide guidance and indications on a Reported basis because the Company cannot reliably forecast material elements of the Reported result, including the fair-value adjustments arising on acquisition-related liabilities, intangible-asset impairment charges and legal-settlement provisions. Please refer to the section ‘Cautionary Statements Regarding Forward-Looking Statements’ at the end of this announcement.
 
Additional Commentary
Outside of guidance, the Company today reiterates its additional indications for FY 2018 vs. the prior year:
 
The sum of Externalisation Revenue and Other Operating Income & Expense is anticipated to decline vs. the prior year. As part of its long-term growth strategy, the Company remains committed to focusing on appropriate cash-generating and value-accretive externalisation activities that reflect the ongoing productivity of the pipeline. It is also committed to the continued management of its portfolio through divestments and to increasing the focus on its three main therapy areas over time
 
Core R&D costs in FY 2018 are anticipated to be in the range of a low single-digit percentage decline to stable. This expectation includes the favourable impact on development costs from the MSD collaboration
 
The Company maintains its focus on reducing operational and infrastructure costs. Total Core SG&A costs are, however, expected to increase by a low to mid single-digit percentage in FY 2018, reflecting targeted support for medicine launches, including Imfinzi in Oncology and Fasenra in Respiratory. The Company also anticipates a reduction in restructuring costs in FY 2018 vs. the prior year
 
A Core Tax Rate of 16-20% (FY 2017: 14%)
 
Currency Impact
Based only on average exchange rates in the three months to 31 March 2018 and the Company’s published currency sensitivities, there would be a low single-digit favourable impact from currency movements on Product Sales and Core EPS in FY 2018. Details on currency sensitivities are contained within the Operating and Financial Review.
 
Sustainability
AstraZeneca is committed to being a valued and trusted partner to its stakeholders over the long term. There is a distinct connection between maintaining a strong business and making a positive impact to a fairer, safer and healthier world. AstraZeneca is dedicated to pushing the boundaries of science to deliver sustainable health that transforms the lives of patients around the world.
 
AstraZeneca’s sustainability ambition is founded on making science accessible and operating in a way that recognises the interconnection between business growth, the needs of society and the limitations of the planet. The Company’s sustainability ambition is reinforced by its purpose and values, which are intrinsic to its business model and ensures that the delivery of its strategy broadens access to medicines, minimises the environmental footprint of medicines and processes and ensures that all business activities are underpinned by the highest levels of ethics and transparency.
 
A full update on the Company’s sustainability progress is shown later in this announcement.
 
Notes
The following notes refer to pages 1-3:
 
1.
Constant exchange rates. These are non-GAAP financial measures because they remove the effects of currency movements from Reported results.
 
2.
Reported financial measures are the financial results presented in accordance with IFRS.
 
3.
Core financial measures. These are non-GAAP financial measures because, unlike Reported performance, they cannot be derived directly from the information in the Group Financial Statements. See the Operating and Financial Review for a definition of Core financial measures and a reconciliation of Core to Reported financial measures.
 
4.
Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada.
 
5.
Here, Lynparza, Tagrisso, Imfinzi, Calquence, Brilinta, Farxiga, Lokelma, Bevespi and Fasenra.
 
6.
Epidermal growth factor receptor.
 
7.
Substitution of threonine (T) with methionine (M) at position 790 of exon 20 mutation.
 
8.
Non-small cell lung cancer.
 
9.
New Cardiovascular, Renal and Metabolism, incorporating Brilinta, Diabetes medicines and Lokelma.
 
The performance shown in this announcement covers the three-month period to 31 March 2018 (the quarter or Q1 2018) compared to the three-month period to 31 March 2017 (the prior quarter or Q1 2017), unless stated otherwise.
 
Pipeline - Forthcoming 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 results from the pipeline.
 
Q2 2018
Lynparza - ovarian cancer (1st line): data readout10
Tagrisso - lung cancer: regulatory decision (EU)
 
Lokelma - hyperkalaemia: regulatory decision (US)
 
Duaklir - COPD: regulatory submission (US)
Fasenra - COPD (TERRANOVA): data readout
H2 2018
Lynparza - breast cancer: regulatory decision (JP)
Lynparza - ovarian cancer (1st line): regulatory submission
Tagrisso - lung cancer: regulatory decision (JP)
 
Imfinzi - lung cancer (Stage III): regulatory decision (EU, JP)
Imfinzi +/- treme - lung cancer (1st line) (MYSTIC): data readout (final OS11), regulatory submission
Imfinzi +/- treme - head & neck cancer (1st line) (KESTREL): data readout
Imfinzi +/- treme ­ head & neck cancer (2nd line) (EAGLE): data readout, regulatory submission
 
selumetinib - thyroid cancer: data readout, regulatory submission
moxetumomab pasudutox - hairy cell leukaemia (3rd line): regulatory decision (US)
 
Farxiga - type-2 diabetes (DECLARE): data readout
Bydureon autoinjector - type-2 diabetes: regulatory decision (EU)
roxadustat - anaemia: data readout
 
Bevespi - COPD: regulatory decision (EU)
Bevespi - COPD: regulatory submission (JP)
PT010 - COPD: regulatory submission
Fasenra - COPD: regulatory submission
 
anifrolumab - lupus: data readout
2019
Lynparza - breast cancer: regulatory decision (EU)
Lynparza - pancreatic cancer: data readout, regulatory submission
 
Imfinzi - lung cancer (PACIFIC): data readout (final OS)
Imfinzi +/- treme - head & neck cancer (1st line) (KESTREL): regulatory submission
Imfinzi + treme - lung cancer (NEPTUNE): data readout, regulatory submission
Imfinzi +/- treme - lung cancer (POSEIDON): data readout, regulatory submission
Imfinzi +/- treme - small-cell lung cancer (CASPIAN): data readout, regulatory submission
Imfinzi +/- treme - bladder cancer (DANUBE): data readout, regulatory submission
 
Calquence - Chronic lymphocytic leukaemia (CLL): data readout, regulatory submission
Brilinta - Coronary artery disease (CAD) / type-2 diabetes: data readout, regulatory submission
Farxiga - type-2 diabetes (DECLARE): regulatory submission
Farxiga - heart failure: data readout
roxadustat - anaemia: regulatory submission (US)
 
anifrolumab - lupus: regulatory submission
lanabecestat - Alzheimer's disease: data readout
 
Conference Call
A live presentation and webcast for investors and analysts, hosted by management, will begin at 12pm UK time today. Details can be accessed via astrazeneca.com.
 
Reporting Calendar
The Company intends to publish its first-half and second-quarter financial results on Thursday, 26 July 2018.
 
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, CVRM and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
 
For more information, please visit astrazeneca.com and follow us on Twitter @AstraZeneca.
 
Investor Relations
 
 
Thomas Kudsk Larsen
 
+44 203 749 5712
Craig Marks
Finance; Fixed Income; M&A
+44 7881 615 764
Henry Wheeler
Oncology
+44 203 749 5797
Mitchell Chan
Oncology; Other
+1 240 477 3771
Christer Gruvris
Brilinta; Diabetes
+44 203 749 5711
Nick Stone
Respiratory; Renal
+44 203 749 5716
US toll free
 
+1 866 381 7277
Media Relations
 
 
Gonzalo Viña
UK/Global
+44 203 749 5916
Karen Birmingham
UK/Global
+44 203 749 5634
Rob Skelding
UK/Global
+44 203 749 5821
Matt Kent
UK/Global
+44 203 749 5906
Jacob Lund
Sweden
+46 8 553 260 20
Michele Meixell
US
+1 302 885 2677
 
 
Operating And Financial Review
 
All narrative on growth and results in this section is based on actual exchange rates, unless stated otherwise. Financial figures are in US$ millions ($m). The performance shown in this announcement covers the three-month period to 31 March 2018 (the quarter or Q1 2018) compared to the three-month period to 31 March 2017 (the prior quarter or Q1 2017, respectively). All commentary in the Operating and Financial Review relates to the quarter, unless stated otherwise.
 
Core financial measures, EBITDA, Net Debt, Initial Externalisation Revenue and Ongoing Externalisation 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 better understand the financial performance and position of the Company on a comparable basis from period to period. These non-GAAP financial measures are not a substitute for, or superior to, financial measures prepared in accordance with GAAP. Core financial measures are adjusted to exclude certain significant items, such as:
 
Amortisation and impairment of intangible assets, including impairment reversals but excluding any charges relating to IT assets
Charges and provisions related to global restructuring programmes, which includes charges that relate to the impact of global 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, legal settlements and foreign-exchange gains and losses on certain non-structural intra-group loans
 
Details on the nature of Core financial measures are provided on page 68 of the Annual Report and Form 20-F Information 2017. 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 net of cash and cash equivalents, other investments and net derivative financial instruments. Reference should be made to the Reconciliation of Interest-Bearing Loans and Borrowings to Net Debt included in the Cash Flow and Balance Sheet section of this announcement.
 
Ongoing Externalisation Revenue is defined as Externalisation Revenue excluding Initial Externalisation Revenue (which is defined as Externalisation Revenue that is recognised at the date of completion of an agreement or transaction, in respect of upfront consideration). Ongoing Externalisation Revenue comprises, among other items, royalties, milestone revenue and profit-sharing income. Reference should be made to the Breakdown of Externalisation 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.
 
 
Table 1: Total Revenue
 
Q1 2018
$m
% change
Actual
CER
Total Revenue
5,178
(4)
(9)
 
 
 
 
Product Sales
4,985
3
(2)
Externalisation Revenue
193
(66)
(67)
 
Table 2: Product Sales
 
Q1 2018
$m
% of total12
% change
Actual
CER
Oncology
1,230
25
39
33
New CVRM
900
18
13
8
Respiratory
1,181
24
-
(6)
Other
1,674
34
(15)
(19)
 
 
 
 
 
Total
4,985
100
3
(2)
 
 
Table 3: Breakdown Of Externalisation Revenue
Ongoing Externalisation Revenue of $91m represented 47% of total Externalisation Revenue (Q1 2017: $181m, 32%). The Company anticipates that Ongoing Externalisation Revenue will grow as a proportion of Externalisation Revenue over time. A breakdown of Externalisation Revenue is shown below:
 
 
$m
% of total
% change
Actual
CER
Royalties
8
4
(83)
(84)
Milestones/Other13
83
43
(39)
(38)
 
 
 
 
 
Ongoing Externalisation Revenue
91
47
(50)
(49)
 
 
 
 
 
Initial Externalisation Revenue
102
53
(73)
(75)
 
 
 
 
 
Total Externalisation Revenue
193
100
(66)
(67)
 
Table 4: Initial Externalisation Revenue
Where AstraZeneca retains a significant ongoing interest in medicines or potential new medicines, revenue arising from externalisation agreements is reported as Externalisation Revenue in the Company’s financial statements. A breakdown of Initial Externalisation Revenue is shown below:
 
Medicine
 
Partner
 
Region
 
$m
 
Crestor
 
Almirall, S.A. (Almirall)
Spain
 
61
 
Other
 
 
 
41
 
 
 
 
 
Total
 
 
 
102
 
 
Table 5: Ongoing Externalisation Revenue
A breakdown of Ongoing Externalisation Revenue in the quarter is shown below:
 
Medicine
 
Partner
 
Region
 
$m
 
Lynparza
 
MSD - milestone revenue (breast cancer regulatory approval)
Global
 
70
 
Other
 
 
 
21
 
 
 
 
 
Total
 
 
 
91
 
 
Table 6: Externalised And Divested Medicines
Several AstraZeneca medicines were externalised or divested after Q1 2017, thus adversely impacting the Product Sales performance:
 
 
Completion
 
Medicine
 
Region
 
Q1 201814
 
Q1 2017
 
Difference
 
Adverse Impact on
Q1 2018
Product Sales
 
$m
 
$m
 
$m
 
 
June 2017
 
Seloken
Europe
 
6
 
21
 
(15)
 
 
June 2017
 
Zomig
 
Global (excl. Japan)
 
7
 
19
 
(12)
 
 
October 2017
 
Anaesthetics
 
Global
 
19
 
85
 
(66)
 
 
January 2018
 
Crestor
 
Spain
 
3
 
22
 
(19)
 
 
 
 
 
 
 
 
 
 
Total
 
 
35
 
147
 
(112)
 
2%
 
 
Table 7: Ongoing Externalisation Revenue Agreements
Examples of transactions that include Ongoing Externalisation Revenue are shown below:
 
Completion
Medicine
Partner
Region
Externalisation Revenue
July 2017
Lynparza
MSD
Global
 Initial $1.0bn revenue
 Up to $0.75bn for certain licence options, including $0.25bn paid in Q4 2017
 Up to $6.15bn in regulatory and sales milestones
 
March 2017
MEDI8897
Sanofi Pasteur, Inc.
Global
 Initial €120m revenue
 Up to €495m in sales and development-related milestones
 
March 2017
Zoladex
TerSera Therapeutics LLC (TerSera)
US and Canada
 Initial $250m revenue
 Up to $70m in sales-related milestones
 Mid-teen percentage royalties on sales
 
Product Sales
 
The performance of major medicines is shown below, with a geographical split shown in Note 6.
 
Table 8: Therapy Area And Medicine Performance
Therapy Area
Medicine
Q1 2018
$m
 
% of total15
 
% change
 
Actual
 
CER
 
Oncology
Tagrisso
338
7
98
89
Iressa
132
3
6
(1)
Lynparza
119
2
109
100
Imfinzi
62
1
n/m
n/m
Calquence
8
-
n/m
n/m
Legacy:
 
 
 
 
Faslodex
254
5
19
14
Zoladex
184
4
(1)
(6)
Arimidex
54
1
4
(2)
Casodex
52
1
(7)
(13)
Others
27
1
4
(4)
Total Oncology
1,230
25
39
33
CVRM
 
Brilinta
293
6
31
24
Farxiga
299
6
44
39
Onglyza
129
3
(16)
(19)
Bydureon
139
3
(9)
(11)
Byetta
31
1
(33)
(35)
Symlin
9
-
(36)
(36)
Legacy:
 
 
 
 
Crestor
389
8
(38)
(42)
Seloken/Toprol-XL
200
4
8
3
Atacand
71
1
(5)
(9)
Others
85
2
(4)
(10)
Total CVRM
1,645
33
(8)
(12)
Respiratory
Symbicort
634
13
(6)
(12)
Pulmicort
346
7
3
(3)
Daliresp/Daxas
38
1
(14)
(16)
Tudorza/Eklira
34
1
(8)
(16)
Duaklir
28
1
47
26
Fasenra
21
-
n/m
n/m
Bevespi
5
-
n/m
n/m
Others
75
2
12
3
Total Respiratory
1,181
24
-
(6)
Other
Nexium
448
9
(3)
(7)
Synagis
224
4
(3)
(3)
Losec/Prilosec
69
1
1
(6)
Seroquel XR
53
1
(21)
(25)
Movantik/Moventig
28
1
(7)
(7)
Others
107
2
(25)
(29)
Total Other
929
19
(7)
(10)
 
Total Product Sales
4,985
100
3
(2)
 
 
Product Sales Summary
 
 
ONCOLOGY
Product Sales of $1,230m; an increase of 39% (up 33% at CER). Oncology Product Sales represented 25% of total Product Sales, up from 18% in Q1 2017.
 
Lynparza
Product Sales of $119m; an increase of 109% (100% at CER). The strong performance was spread across the region and was particularly noticeable in the US. To date, the medicine has received regulatory approval in over 50 countries, with reviews underway in a number of additional markets and for new uses.
 
US sales grew by 144% to $66m; the performance partly reflected the H2 2017 launch of Lynparza tablets and regulatory approval as a 2nd-line treatment for ovarian cancer, regardless of BRCA status. The Company announced more recently the approval of Lynparza in the US as a treatment for patients with germline BRCA-mutated breast cancer; this approval was reflected in sequential quarterly US sales growth of 22%, from $54m in Q4 2017. At the end of Q1 2018, Lynparza was the leading medicine in the poly ADP ribose polymerase (PARP)-inhibitor class in the US, as measured by total prescription volumes.
 
Sales in Europe increased by 68% (44% at CER) to $42m, reflecting high BRCA-testing rates, a number of successful launches and encouraging levels of reimbursement. Lynparza sales in Europe in the quarter were for the treatment of ovarian cancer, in capsule formulation. On 8 May 2018, the Company announced that the European Medicines Agency (EMA) had approved Lynparza tablets (300mg twice daily) as a 2nd-line treatment for ovarian cancer, regardless of BRCA status.
 
In July 2017, AstraZeneca and MSD announced a global strategic oncology collaboration to co-develop Lynparza and the potential medicine selumetinib for multiple cancer types as monotherapies and in combinations. The integration of development and commercial activities is progressing well, with both companies co-promoting Lynparza.
 
 
Lung Cancer
 
Tagrisso
Product Sales of $338m; an increase of 98% (89% at CER), partly driven by increased testing rates, led by Japan and the US. The medicine has received regulatory approval in more than 75 countries.
 
Sales in the US grew by 63% to $147m, reflecting an increase in EGFR T790M-mutation testing rates. Sequential quarterly sales increased by 15% from $128m in Q4 2017. In September 2017, US National Comprehensive Cancer Network (NCCN) clinical-practice guidelines were updated to include the use of Tagrisso as a 1st-line treatment of patients with metastatic EGFR-mutated NSCLC. Tagrisso was approved by the US FDA in this setting in April 2018.
 
Within Emerging Markets, Tagrisso sales were $71m (Q1 2017: $6m). Growth in Emerging Markets was led by China, where an encouraging testing rate was observed. Tagrisso was approved in China in March 2017 as the first AstraZeneca medicine under the China FDA’s priority-review pathway; China has a relatively-high prevalence of patients with an EGFR mutation.
 
In Europe, sales of $69m represented growth of 97% (74% at CER), driven by strong levels of demand, positive reimbursement decisions and further growth in testing rates. Tagrisso was reimbursed in more than 15 European markets at the end of the quarter and was under reimbursement review in a number of additional European countries, with positive decisions anticipated in H2 2018. A regulatory decision on Tagrisso as a 1st-line treatment for EGFR-mutated NSCLC is also expected in the coming weeks.
 
Sales in Japan increased by 26% (21% at CER) to $49m. Sequential quarterly sales, however, declined from $61m in Q4 2017, driven by a decline in T790M ctDNA testing rates from c.90% in Q4 2017 to c.70% in Q1 2018. This followed the mandated expiry of free ctDNA testing in 2017, which was concluded after the start of reimbursement and the fulfilment of the bolus of late-line patients. A regulatory decision on Tagrisso as a 1st-line treatment for EGFR-mutated NSCLC is expected in the second half of the year.
 
Imfinzi
Product Sales of $62m;Imfinzi was approved under the US FDA’s Accelerated-Approval pathway in May 2017 and launched on the same day as a fast-to-market, limited commercial opportunity, indicated for the 2nd-line treatment of patients with locally-advanced or metastatic urothelial carcinoma (bladder cancer).
 
In February 2018, immediately following US regulatory approval, the Company launched Imfinzi for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT). The approval followed the award of Priority Review status in 2017. The majority of Imfinzi sales in the quarter were for the treatment of unresectable, Stage III NSCLC.
 
 
Iressa
Product Sales of $132m; an increase of 6% (down by 1% at CER).
 
Emerging Markets sales increased by 16% (8% at CER) to $71m. China sales increased by 29% (21% at CER) to $44m; Iressa was included on the National Reimbursement Drug List (NRDL) in 2017. Sales in the US were stable at $8m and increased in Europe by 15% (4% at CER) to $30m.
 
Other Oncology Medicines
 
Calquence
Product Sales of $8m;Calquence was approved and launched in the US on 31 October 2017. The medicine delivered a promising performance in the quarter, illustrated by the number of new-patient starts in previously-treated mantle cell lymphoma (MCL). The medicine was included within NCCN MCL guidelines on 15 November 2017, which helped to facilitate reimbursement.
 
 
Legacy: Faslodex
Product Sales of $254m; an increase of 19% (14% at CER).
 
Emerging Markets sales grew by 44% (41% at CER) to $39m. China sales grew by 100% (83% at CER) to $12m.
 
US sales increased by 14% to $134m, mainly reflecting a continued strong uptake of the combination with palbociclib, a medicine approved for the treatment of hormone-receptor-positive breast cancer.
 
Europe sales increased by 9% (down by 6% at CER) to $59m, reflecting the impact of generic entrants in certain markets. In June 2017, a label extension, based upon the FALCON trial in the 1st-line setting was approved in Japan, where sales grew by 50% (43% at CER) to $21m.
 
 
 
Legacy: Zoladex
Product Sales of $184m; a decline of 1% (6% at CER).
 
Emerging Markets sales increased by 16% (10% at CER) to $101m. Sales in Europe increased by 6% (down by 3% at CER) to $34m. In the Established Rest Of World (ROW) region, sales declined by 17% (21% at CER) to $48m, driven by the effects of increased competition. On 31 March 2017, the Company completed an agreement with TerSera for the sale of the commercial rights to Zoladex in the US and Canada.
 
 
CVRM
New CVRM sales increased by 13% (8% at CER) to $900m, comprising 18% of total Product Sales. There were further strong performances from Brilinta and Farxiga, after each attained blockbuster-sales status in FY 2017.
 
Total CVRM sales, which includes Crestor and other legacy medicines, amounted to $1,645m and represented a decline of 8% (12% at CER);total CVRM comprised 33% of total Product Sales, down from 37% in Q1 2017.
 
 
Brilinta
Product Sales of $293m; an increase of 31% (24% at CER).
 
Emerging Markets sales of Brilinta grew by 27% (20% at CER) to $76m, reflecting a continued outperformance of branded oral anti-platelet medicines. Encouraging results were delivered in a number of markets.
 
US sales of Brilinta, at $115m, represented an increase of 32%. The performance was driven primarily by an increase in the average duration of therapy and strong growth in the number of patients sent home from hospital with Brilinta. Furthermore, Brilinta achieved a record total-prescription market share at the end of the quarter; days-of-therapy volume market-share data was particularly encouraging.
 
Sales of Brilique in Europe increased by 32% (15% at CER) to $86m, reflecting indication leadership across a number of markets and bolstered by the inclusion within HR PMI guidelines by the European Society of Cardiology in 2017. Improvements were delivered across the major markets; Brilique continued to outperform branded oral anti-platelet medicines in the quarter and gained further reimbursement in key markets in its HR PMI indication with the 60mg dose.
 
 
Farxiga
Product Sales of $299m; an increase of 44% (39% at CER). Farxiga consolidated its global leadership position within the sodium-glucose co-transporter 2 (SGLT2) inhibitor class.
 
Emerging Markets sales increased by 64% (62% at CER) to $69m, reflecting ongoing launches and improved levels of patient access. In March 2017, Forxiga became the first SGLT2-inhibitor medicine to be approved in China, with encouraging initial results in access and performance.
 
US sales increased by 32% to $127m. The performance in Q1 2017 was adversely impacted by the Company’s level of participation in affordability programmes; subsequent changes to the Company’s approach to these programmes, however, helped to deliver a much-improved performance in Q1 2018. Despite slower growth in the US, the SGLT2 class continued to be scientifically underpinned by growing evidence around cardiovascular (CV) benefits, including data from the CVD-REAL series of studies, first published in May 2017.
 
Sales in Europe increased by 48% (30% at CER) to $74m as the medicine continued to gain overall market share; it also retained leadership in a class that had the strongest growth among innovative oral diabetes medicines in 2017. In Japan, where Ono Pharmaceutical Co., Ltd is a partner and records in-market sales, sales to the partner amounted to $11m, representing growth of 57% (43% at CER).
 
 
Bydureon
Product Sales of $139m; a decline of 9% (11% at CER). Sales in the US declined by 13% to $111m, reflecting pricing headwinds that offset an encouraging performance from the recently-launched BCise device. Favourable sales volumes were driven by continued growth in the glucagon-like peptide-1 (GLP-1) class, at the expense of insulin, for more-advanced forms of type-2 diabetes.
 
Bydureon sales in Europe increased by 5% (stable at CER) to $23m, partly reflecting market growth.
 
 
Onglyza
Product Sales of $129m, a decline of 16% (19% at CER). The performance reflected adverse pressures on the dipeptidyl peptidase-4 (DPP-4) class and an acceleration of ongoing Diabetes market dynamics, where patients are moving to medicines and classes of medicines with documented CV benefits. Given the significant future potential of Farxiga, the Company continues to prioritise commercial support for Farxiga.
 
Sales in Emerging Markets increased by 33% (27% at CER) to $40m. Onglyza, after entry onto the NRDL in China in 2017, led the Emerging Markets sales growth at 167% (150% at CER) to $16m. Sales in Europe declined by 15% (26% at CER) to $23m, reflecting the broader trend of a shift away from the DPP-4 class.
 
 
Legacy: Crestor
Product Sales of $389m; a decline of 38% (42% at CER).
 
Sales in China grew by 39% (30% at CER) to $145m, a result of underlying demand and an element of benefit from the removal of the 2nd-line usage restriction. Despite the effect of favourable managed-market adjustments, US sales declined by 59% to $46m, reflecting the impact of multiple Crestor generic medicines. In Europe, sales declined by 67% (70% at CER) to $65m, driven by the effect of generic medicines in various markets. This impact on Europe sales is anticipated to continue in 2018, predominantly weighted to the first half of the year.
 
In Japan, where Shionogi Co. Ltd is a partner, sales declined by 76% (77% at CER) to $26m, reflecting the recent entry of multiple Crestor competitors in the market in the second half of 2017, plus the effect of government incentives for the increased adoption of generic medicines. This impact on Japan sales is anticipated to be broadly in line with the aforementioned timing in Europe.
 
 
 
RESPIRATORY
Product Sales of $1,181m;stable (down by 6% at CER). Respiratory Product Sales represented 24% of total Product Sales, unchanged vs. Q1 2017.
 
Symbicort
Product Sales of $634m; a decline of 6% (12% at CER). Symbicort continued to lead the global market by volume within the inhaled corticosteroid (ICS) / Long-Acting Beta Agonist (LABA) class.
 
Emerging Markets sales grew by 14% (10% at CER) to $128m, partly reflecting growth in China of 38% (29% at CER) to $66m. In contrast, US sales declined by 28% to $183m, reflecting pricing pressure and the timing of government buying. The performance was in line with expectations, with challenging market conditions expected to continue.
 
In Europe, sales increased by 6% (down by 7% at CER) to $212m; the performance reflected the level of competition from other branded and Symbicort-analogue medicines. Symbicort, however, continued to retain its class-leadership position and stabilise its volume market share in the class. In Japan, where Astellas Pharma Co. Ltd assists as a promotional partner, sales declined by 2% (6% at CER) to $50m.
 
 
Pulmicort
Product Sales of $346m; an increase of 3% (down by 3% at CER).
 
Emerging Markets sales increased by 8% (2% at CER) to $270m, reflecting an inflated level of demand in China in Q4 2017; strong underlying volume growth in China, Middle East & Africa and Asia Pacific was unchanged in Q1 2018; growth in China, however, was limited by the impact of a temporary constraint in supply. Emerging Markets represented 78% of global sales.
 
Sales in the US and Europe declined by 29% to $29m and increased by 4% (down by 8% at CER) to $27m, respectively, a consequence of the medicine’s legacy status in these markets.
 
 
Daliresp/Daxas
Product Sales of $38m; a decline of 14% (16% at CER).
 
US sales, representing 76% of global sales, declined by 24% to $29m, driven by a reduced adoption of the medicine. It is the only oral, selective, long-acting inhibitor of phosphodiesterase-4, an inflammatory enzyme associated with COPD. Sales in Europe increased by 40% (20% at CER) to $7m.
 
 
Tudorza/Eklira
Product Sales of $34m; a decline of 8% (16% at CER).
 
Sales in the US declined by 27% to $11m, reflecting lower levels of use of inhaled monotherapy medicines for the treatment of COPD. On 17 March 2017, AstraZeneca announced that it had entered a strategic collaboration with Circassia Pharmaceuticals plc (Circassia) for the development and commercialisation of Tudorza in the US. Circassia began its promotion of Tudorza in the US in May 2017, where AstraZeneca books Product Sales.
 
Sales in Europe were stable (down by 10% at CER) to $20m, impacted by the decline of the overall LAMA-monotherapy class.
 
 
Duaklir
Product Sales of $28m; an increase of 47% (26% at CER).
 
Duaklir, the Company’s first inhaled dual bronchodilator medicine, is now available for patients in over 25 countries, with almost all sales emanating from Europe. The growth in sales was favourably impacted by the performances in Germany and the UK, as well as the recent launch in Italy. The LAMA/LABA class continued to grow strongly, albeit below expectations. Duaklir is expected to be submitted for US regulatory review in Q2 2018; the US trademark is to be confirmed. Duaklir is a registered trademark in certain European countries.
 
 
Bevespi
Product Sales of $5m; launched in the US in Q1 2017.
Prescriptions in the period tracked in line with other LAMA/LABA launches. The overall class in the US, however, continues to grow more slowly than anticipated. Bevespi was the first medicine launched using the Company’s Aerosphere Delivery Technology delivered in a pressurised metered-dose inhaler.
 
Fasenra
Product Sales of $21m.
 
In November 2017, the Company received approval for Fasenra as a treatment for patients with severe, eosinophilic asthma; the approval was followed immediately by the launch of the medicine. IQVIA new-to-brand prescription data showed that Fasenra, a third-to-market medicine, tracked in-line or ahead of prior biologic-medicine launches in asthma. Initial feedback from physicians and patients was particularly encouraging.
 
In Europe and Japan, AstraZeneca received regulatory approval in January 2018, respectively, on a similar basis to that in the US. In Europe, a number of launches were executed, including, the Netherlands, Austria, Denmark and Sweden; the launch and uptake of Fasenra in Germany was especially successful.
 
 
OTHER
Product Sales of $929m; a decline of 7% (10% at CER). Other Product Sales represented 19% of total Product Sales, down from 21% in Q1 2017.
 
Nexium
Product Sales of $448m; a decline of 3% (7% at CER).
 
Emerging Markets sales increased by 4% (down by 1% at CER) to $182m. Despite the benefit of favourable managed-market adjustments, sales in the US declined by 26% to $100m in the quarter. Sales in Europe were stable (down by 13% at CER) at $61m. In Japan, where Daiichi Sankyo is a partner, sales increased by 31% (25% at CER) to $89m.
 
 
Synagis
Product Sales of $224m; a decline of 3%.
 
US sales declined by 15% to $134m, impacted by the prevailing guidelines from the American Academy of Pediatrics Committee on Infectious Diseases, which restrict the number of patients eligible for preventative therapy with Synagis. Product Sales to AbbVie Inc. (AbbVie), responsible for the commercialisation of Synagis in over 80 countries outside the US, increased by 22% to $90m.
 
Seroquel XR
Product Sales of $53m; a decline of 21% (25% at CER).
 
Sales of Seroquel XR in the US, where several competitors launched generic Seroquel XR medicines from November 2016, declined by 33% to $16m. Sales of Seroquel XR in Europe declined by 27% (32% at CER) to $16m, also reflecting the impact of generic-medicine competition.
 
 
Regional Product Sales
Table 9: Regional Product Sales
 
Q1 2018
$m
% of total16
% change
Actual
CER
Emerging Markets17
1,765
35
13
8
 
China
1,025
21
31
22
 
Ex. China
740
15
(5)
(7)
 
 
 
 
 
US
1,487
30
-
-
 
 
 
 
 
Europe
1,121
22
(1)
(12)
 
 
 
 
 
Established ROW
612
12
(8)
(12)
 
Japan
399
8
(11)
(15)
 
Canada
126
3
1
(4)
 
Other Established ROW
87
2
(5)
(10)
 
 
 
 
 
Total
4,985
100
3
(2)
 
Emerging Markets
Product Sales of $1,765m; an increase of 13% (8% at CER).
 
China sales grew by 31% (22% at CER) to $1,025m, representing 58% of total Emerging Markets sales. Onglyza and Iressa were included on the NRDL in China in 2017, as were Brilinta, Faslodex and Seroquel XR; the benefits of this inclusion are anticipated to impact Product Sales favourably in 2018. Crestor also had its 2nd-line usage restriction removed at that time and Zoladex was reclassified from the hormone and endocrine classification to oncology, which is expected to continue to support growth. Tagrisso was launched in China in early 2017.
 
Emerging Markets sales excluding China, however, declined by 5% (7% at CER) to $740m in Q1 2018, partly driven by the aforementioned impact from externalised or divested Product Sales, as well as the decline in Russia sales of 38% (40% at CER) to $34m that resulted from the effect of government intervention in the management of healthcare costs in 2017.
 
 
US
Product Sales of $1,487m;stable.
 
The performance reflected successful ongoing Oncology launches, including Tagrisso and Imfinzi, plus strong sales of Farxiga and Brilinta, offset by the impact of continued competitive intensity on sales of Symbicort, which declined by 28% to $183m. Unfavourable managed-care pricing and generic-medicine launches also had adverse effects on overall US sales. Oncology sales in the US grew by 69% to $426m, primarily driven by encouraging Tagrisso sales growth of 63% to $147m.
 
 
Europe
Product Sales of $1,121m; a decline of 1% (12% at CER).
 
Crestor sales declined by 67% (70% at CER) to $65m, reflecting the entry of generic medicines in various markets in 2017. Excluding sales of Crestor, Europe sales grew by 13% (stable at CER) to $1,056m.
 
The newer medicines delivered an encouraging performance in the quarter. Oncology sales in Europe grew by 33% (18% at CER) to $249m, partly driven by Tagrisso sales growth of 97% (74% at CER) to $69m. Lynparza sales of $42m represented growth of 68% (44% at CER). Brilique growth of 32% (15% at CER) to $86m was accompanied by Forxiga sales growth of 48% (30% at CER) to $74m.
 
 
Established ROW
Product Sales of $612m;a decline of 8% (12% at CER).
 
Japan sales declined by 11% (15% at CER) to $399m. The first generic competitor to Crestor was launched in Japan in Q3 2017 and further generic competition entered the market in the final quarter. Crestor sales in Japan declined by 76% (77% at CER) to $26m. Excluding sales of Crestor, Japan sales grew by 9% (5% at CER) to $373m.
 
As seen in other regions, newer medicines delivered an encouraging performance in the quarter. Tagrisso sales in Japan increased by 26% (21% at CER) to $49m due to an increase in demand; sequential quarterly sales of Tagrisso, however, declined from $61m in Q4 2017, driven by a decline in T790M ctDNA testing rates from c.90% in Q4 2017 to c.70% in Q1 2018. This followed the mandated expiry of free ctDNA testing in 2017, which was concluded after the start of reimbursement and the fulfilment of the bolus of late-line patients.
 
Faslodex sales in Japan were favourably impacted by a new label in 2017, with sales increasing by 50% (43% at CER) to $21m.
 
On 19 January 2018, the Company announced that Lynparza tablets, approved as maintenance treatment for women with platinum-sensitive relapsed ovarian cancer regardless of BRCA-mutation status, were approved in Japan and launched in April 2018. A regulatory decision for Lynparza as treatment for breast cancer is anticipated in the second half of the year.
 
Biennial mandated price reductions became effective in Japan from 1 April 2018.
 
 
Financial Performance
 
 
Table 10: Reported Profit And Loss
 
Reported
Q1 2018
Q1 2017
% change
$m
$m
Actual
CER
Total Revenue
 
5,178
 
5,405
 
(4)
 
(9)
 
Product Sales
 
4,985
 
4,843
 
3
 
(2)
 
Externalisation Revenue
 
193
 
562
 
(66)
 
(67)
 
 
 
 
 
 
Cost of Sales
 
(1,134)
 
(894)
 
27
 
14
 
 
 
 
 
 
Gross Profit
 
4,044
 
4,511
 
(10)
 
(13)
 
Gross Margin18
 
77.3%
 
82.3%
 
-5
 
-4
 
 
 
 
 
 
Distribution Expense
 
(81)
 
(77)
 
6
 
(2)
 
% Total Revenue
 
1.6%
 
1.4%
 
-
 
-
 
R&D Expense
 
(1,279)
 
(1,453)
 
(12)
 
(16)
 
% Total Revenue
 
24.7%
 
26.9%
 
+2
 
+2
 
SG&A Expense
 
(2,457)
 
(2,300)
 
7
 
2
 
% Total Revenue
 
47.5%
 
42.6%
 
-5
 
-5
 
Other Operating Income & Expense
 
469
 
236
 
99
 
97
 
% Total Revenue
 
9.1%
 
4.4%
 
+5
 
+5
 
 
 
 
 
 
Operating Profit
 
696
 
917
 
(24)
 
(21)
 
% Total Revenue
 
13.4%
 
17.0%
 
-4
 
-2
 
Net Finance Expense
 
(308)
 
(322)
 
(4)
 
(11)
 
Joint Ventures and Associates
 
(14)
 
(13)
 
10
 
10
 
Profit Before Tax
 
374
 
582
 
(36)
 
(27)
 
Taxation
 
(58)
 
(70)
 
 
 
Tax Rate
 
16%
 
12%
 
 
 
Profit After Tax
 
316
 
512
 
(38)
 
(30)
 
 
 
 
 
 
Earnings Per Share
$0.27
$0.42
(37)
(29)
 
Table 11: Reconciliation Of Reported Profit Before Tax To EBITDA19
 
Q1 2018
 
 
$m
 
% change
 
Actual
 
CER
 
Reported Profit Before Tax
 
374
 
(36)
 
(27)
 
Net Finance Expense
 
308
 
(4)
 
(11)
 
Joint Ventures and Associates
 
14
 
10
 
10
 
Depreciation, Amortisation and Impairment
 
709
 
8
 
3
 
 
 
 
 
EBITDA
 
1,405
 
(11)
 
(10)
 
 
Table 12: Reconciliation Of Reported To Core Financial Measures
Q1 2018
Reported
Restructuring
Intangible Asset
Amortisation & Impairments
Diabetes Alliance
Other20
Core21
Core
% change
$m
$m
$m
$m
$m
$m
Actual
CER
Gross Profit
 
4,044
 
32
 
45
 
-
 
-
 
4,121
 
(10)
 
(13)
 
Gross Margin22
 
77.3%
 
-
 
-
 
-
 
-
 
78.8%
 
-5
 
-4
 
 
 
 
 
 
 
 
 
 
Distribution Expense
 
(81)
 
-
 
-
 
-
 
-
 
(81)
 
6
 
(2)
 
R&D Expense
 
(1,279)
 
27
 
12
 
-
 
-
 
(1,240)
 
(7)
 
(12)
 
SG&A Expense
 
(2,457)
 
36
 
349
 
107
 
(63)
 
(2,028)
 
11
 
6
 
Other Operating Income & Expense
 
469
 
-
 
1
 
-
 
(346)
 
124
 
(63)
 
(64)
 
 
 
 
 
 
 
 
 
 
Operating Profit
 
696
 
95
 
407
 
107
 
(409)
 
896
 
(46)
 
(47)
 
% Total Revenue
 
13.4%
 
-
 
-
 
-
 
-
 
17.3%
 
-14
 
-13
 
 
 
 
 
 
 
 
 
 
Net Finance Expense
 
(308)
 
-
 
-
 
84
 
53
 
(171)
 
(2)
 
(7)
 
Taxation
 
(58)
 
(20)
 
(80)
 
(41)
 
72
 
(127)
 
(51)
 
(52)
 
 
 
 
 
 
 
 
 
 
Earnings Per Share
 
$0.27
 
$0.06
 
$0.26
 
$0.11
 
$(0.22)
 
$0.48
 
(51)
 
(51)
 
 
 
 
Profit And Loss Commentary
 
Gross Profit
Reported Gross Profit declined by 10% (13% at CER) to $4,044m; Core Gross Profit declined by 10% (13% at CER) to $4,121m. The declines reflected the movement in the Gross Margin, as well as the aforementioned level of Externalisation Revenue.
 
The Reported Gross Margin declined by five percentage points (four at CER) to 77.3%. The Core Gross Margin declined by five percentage points (four at CER) to 78.8%. The movements were a result of the favourable impact of manufacturing variances realised in Q1 2017 and the inclusion of the profit share on the aforementioned collaboration with MSD, as well as the effect of losses of exclusivity on Crestor sales in Europe and Japan.
 
The calculation of Reported and Core Gross Margin excludes the impact of Externalisation Revenue, thereby reflecting the underlying performance of Product Sales. 
 
Operating Expenses
Reported Operating Expenses were stable (down by 5% at CER) at $3,817m. Core Operating Expenses increased by 3% (down by 1% at CER) to $3,349m.
 
Reported R&D costs declined by 12% (16% at CER) to $1,279m, with the Company continuing to focus on resource prioritisation and cost discipline. Core R&D costs declined by 7% (12% at CER) to $1,240m, reflecting productivity improvements across every therapy area and the favourable impact on development costs from the MSD collaboration. Targeted investment in the Company’s R&D programme is a consistent priority; the level of activity was unchanged in the quarter and Core R&D costs represented 24% of Total Revenue.
 
Highlights of the progress made included:
 
Moving late-stage-execution roles to lower-cost locations
Reducing supply waste
Optimising protocols, including a review of the number of procedures, countries involved and in-sourcing a larger proportion of clinical trials
 
Reported SG&A costs increased by 7% (2% at CER) to $2,457m. This reflected investment in medical-affairs capability and capacity in order to support launches and extensions of the newer medicines, including Lynparza, Tagrisso, Imfinzi, Calquence and Fasenra, as well as additional investment to support sales growth in China.
 
Core SG&A costs increased by 11% (6% at CER) to $2,028m, reflecting the investment in the launches, as well as the significant reduction in Core SG&A costs in the comparative period. Q1 2017 was a period when the Company delivered its lowest level of Core SG&A investment for a number of years.
 
 
Other Operating Income & Expense
Where AstraZeneca does not retain a significant ongoing interest in medicines or potential new medicines, income from divestments is reported within Other Operating Income & Expense in the Company’s financial statements. Reported Other Operating Income & Expense increased by 99% (97% at CER) to $469m and included:
 
$346m, resulting from a legal settlement
$63m, representing a gain on the spin-out of six molecules from MedImmune’s early-stage inflammation and autoimmunity programmes into an independent biotech company, as announced on 28 February 2018
 
Core Other Operating Income & Expense declined by 63% (64% at CER) to $124m, with the difference to Reported Other Operating Income & Expense reflecting the aforementioned legal settlement.
 
 
Operating Profit
Reported Operating Profit declined by 24% (21% at CER) to $696m, driven by the declines in Total Revenue and the Reported Gross Margin, as well as the increase in Reported SG&A costs. The Reported Operating Profit margin declined by four percentage points (two at CER) to 13% of Total Revenue. Core Operating Profit declined by 46% (47% at CER) to $896m, driven by the aforementioned factors, as well as the timing of divestments in FY 2018. The Core Operating Profit margin declined by 14 percentage points (13 at CER) to 17% of Total Revenue.
 
Net Finance Expense
Reported Net Finance Expense declined by 4% (11% at CER) to $308m, reflecting reduced levels of discount unwind on the put option over the non-controlling interest in Acerta Pharma B.V. (Acerta Pharma). Excluding the discount-unwind on acquisition-related liabilities, Core Net Finance Expense declined by 2% (7% at CER) to $171m.
 
Profit Before Tax
Reported Profit Before Tax declined by 36% (27% at CER) to $374m, reflecting the level of Externalisation Revenue, the lower Reported Gross Margin and the increase in Reported SG&A costs.
 
Taxation
The Reported and Core tax rates for the quarter were 16% and 18% respectively. These tax rates were lower than the UK Corporation Tax Rate of 19%, mainly due to the impact of the geographical mix of profits. The net cash tax paid was $117m, representing 31% of Reported Profit Before Tax. The Reported and Core tax rates for the comparative period were 12% and 17% respectively. The cash tax paid for the comparative period was $62m, which was 11% of Reported Profit Before Tax.
 
 
Earnings Per Share (EPS)
Reported EPS of $0.27 represented a decline of 37% (29% at CER). The performance reflected a decline in Total Revenue, the Reported Gross Margin and increased Reported SG&A costs. Core EPS declined by 51% to $0.48, impacted by the aforementioned factors as well as the decline in Core Other Operating Income & Expense.
 
Table 13: Cash Flow
 
Q1 2018
 
Q1 2017
 
Change
 
$m
 
$m
 
$m
 
Reported operating profit
 
696
 
917
 
(221)
 
Depreciation, amortisation and impairment
 
709
 
658
 
51
 
 
 
 
 
(Increase)/decrease in working capital and short-term provisions
 
(993)
 
(887)
 
(106)
 
(Gains)/losses on disposal of intangible assets
 
(65)
 
(52)
 
(13)
 
Non-cash and other movements
 
(242)
 
(297)
 
55
 
Interest paid
 
(128)
 
(189)
 
61
 
Tax paid
 
(117)
 
(62)
 
(55)
 
 
 
 
 
Net cash (outflow)/inflow from operating activities
 
(140)
 
88
 
(228)
 
 
The Company saw a net cash outflow from operating activities of $140m in the quarter, compared with an inflow of $88m in Q1 2017. The increase in the movement of working-capital and short-term provisions partly reflected launch support for newer medicines.
 
Net cash inflows from investing activities were $273m, compared with outflows of $146m in Q1 2017. The difference partly reflected the timing of receipts on disposals of intangible assets, as well as a reduction in capital expenditure. The cash payment of contingent consideration in respect of the BMS share of the global Diabetes alliance amounted to $62m.
 
Net cash outflows from financing activities were $663m in the quarter, compared to $2,042m in Q1 2017, reflecting higher short-term borrowings in Q1 2018.
 
 
Capital Expenditure
Capital expenditure amounted to $213m in the quarter compared to $286m in Q1 2017, which included investment in the new global headquarters in Cambridge, UK, as well as strategic biotech manufacturing capacity in Sweden.
 
Table 14: Debt And Capital Structure
 
At 31 March 2018
 
At 31 Dec 2017
 
At 31 March 2017
 
$m
 
$m
 
$m
 
Cash and cash equivalents
 
3,005
 
3,324
 
3,129
 
Other investments
 
868
 
1,300
 
548
 
Net derivatives
 
565
 
504
 
215
 
 
 
 
 
Cash, short-term investments and derivatives
 
4,438
 
5,128
 
3,892
 
 
 
 
 
Overdrafts and short-term borrowings
 
(2,776)
 
(845)
 
(1,000)
 
Finance leases
 
-
 
(5)
 
(80)
 
Current instalments of loans
 
(1,394)
 
(1,397)
 
(1,762)
 
Loans due after one year
 
(15,684)
 
(15,560)
 
(14,560)
 
 
 
 
 
Interest-bearing loans and borrowings (Gross Debt)
 
(19,854)
 
(17,807)
 
(17,402)
 
 
 
 
 
Net Debt
 
(15,416)
 
(12,679)
 
(13,510)
 
 
 
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 Group’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 Group Companies’ reporting currency. In addition, the Group’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.
 
Table 15: Currency Sensitivities
The Company provides the following currency-sensitivity information:
 
 
Average Exchange Rates vs. USD
 
Annual Impact Of 5% Strengthening in Exchange Rate vs. USD ($m)23
Currency
Primary Relevance
FY 2017
Q1 201824
% change
Product Sales
Core Operating Profit
EUR
Product Sales
0.89
0.81
+10
+136
+57
JPY
Product Sales
112.18
106.03
+6
+96
+66
CNY
Product Sales
6.75
6.32
+7
+180
+98
SEK
Operating Expenses
8.54
8.24
+4
+4
-70
GBP
Operating Expenses
0.78
0.72
+8
+25
-75
Other25
 
 
 
 
+88
+44
 
 
Corporate And Business Development Update
 
a) MedImmmune Spin-Out - Early-Stage Inflammation And Autoimmunity Programmes
On 28 February 2018, AstraZeneca announced that its global biologics research and development arm, MedImmune, would spin out six molecules from its early-stage inflammation and autoimmunity programmes into an independent biotech company, Viela Bio. The new company is focusing on developing medicines for severe autoimmune diseases, by targeting the underlying causes of each disease.
 
MedImmune contributed three clinical and three pre-clinical potential new medicines. This included inebilizumab, currently in Phase II trial development for the treatment of neuromyelitis optica, a rare condition that affects the optic nerve and spinal cord in approximately five in 100,000 people. It was granted Orphan Drug Designation by the US FDA in 2016 and by the EMA in 2017. Viela Bio is be based in Gaithersburg, Maryland. It was funded with $250m from a consortium of investors led by Boyu Capital, 6 Dimensions Capital and Hillhouse Capital. AstraZeneca is the largest non-controlling shareholder of Viela Bio.
 
The Company realised a $63m gain in Q1 2018, reflected in the Company’s financial statements within Other Operating Income & Expense.
 
b) Divestment Of Seroquel And Seroquel XR
On 8 May 2018, AstraZeneca announced that it had entered into an agreement with Luye Pharma Group, Ltd. (Luye Pharma) for the sale and licence of the rights to Seroquel and Seroquel XR in the UK, China and other international markets. Seroquel, used primarily to treat the disorders schizophrenia and bipolar, has lost its compound patent protection globally; the Seroquel XR formulation patents have also expired in the vast majority of its markets.
 
Luye Pharma will pay $538m in consideration, including $260m immediately following closure of the transaction. The total consideration, adjusted for time value, will be recorded in Q2 2018 in Other Operating Income & Expense within the Company’s financial statements, subject to the timing of closure of the agreement. This will include a milestone payable on the successful transition of certain activities to Luye Pharma. AstraZeneca will continue to manufacture and supply Seroquel and Seroquel XR to Luye Pharma during a transition period.
 
The transaction is expected to close by the end of Q2 2018, subject to customary closing conditions and regulatory clearances. In FY 2017, Seroquel generated sales of $85m in the markets covered by this agreement, while Seroquel XR generated $63m.
 
 
Sustainability Update
 
AstraZeneca’s sustainability ambition has three priority areas, aligned with the Company’s purpose and business strategy:
 
Access to Healthcare
Environmental Protection
Ethics and Transparency
 
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 benefit to patients, the Company, broader society and the planet. Progress against the three priorities is reported below:
 
a) Access To Healthcare
Healthy Heart Africa (HHA) is an innovative programme committed to tackling hypertension and the increasing burden of CV disease across Africa. In Q1 2018, the programme was ahead of its target for blood-pressure screenings. Since launching in Kenya 2014 and in Ethiopia 2016 respectively, HHA has conducted more than 5.5m blood-pressure screenings.
 
The AstraZeneca Young Health Programme (YHP) is a non-communicable disease (NCD) prevention programme, developed in partnership with John Hopkins Bloomberg School of Public Health and Plan International in the US that has reached 2.25m young patients since its launch in 2010. It aims to reduce the uptake of unhealthy behaviours in young patients to improve their health outcomes as adults and help address the growing burden of NCDs on health systems. During the period, AstraZeneca launched several new three-year programmes:
 
YHP Brazil, which aims to reach more than 740,000 direct and indirect beneficiaries
YHP Serbia, which aims to reach 200,000 school children with advocacy and educational programming on tobacco use
YHP Australia, which aims to provide food and nutrition education to 10 secondary schools in Victoria and New South Wales
Additionally, YHP health camps in India, in partnership with Plan International, delivered engaged employee volunteers and provided screening for diabetes, hypertension, anaemia and respiratory disorders to more than 1,000 patients from marginalised communities in Bangalore, India.
 
During the period, YHP was selected by Global Child Forum, a Swedish not-for-profit foundation, as the subject of a ‘Deep Dive’. Global Child Forum is focused on the advancement of children’s rights, in accordance with the UN Convention on the Rights of the Child. Its aim is to provide businesses with an understanding of how and where their business may impact children. On 11 April 2018, AstraZeneca presented a YHP case study at the 10th Global Child Forum at the Stockholm Royal Palace, Sweden; this was subsequently followed by the publication of the YHP Deep Dive.
 
b) Environmental Protection
AstraZeneca is committed to managing its environmental impact across all business activities, with a focus on Greenhouse Gas (GHG) emissions, energy consumption, waste production and water use. The Company’s approach focuses on science-based targets, mapped to each of the environmental strategic priorities:
 
Reducing GHG emissions to combat climate change
Protecting natural resources through energy, waste and water management
Leading the way to minimise Pharmaceuticals in the Environment
Preserving biodiversity
During the period, the Company received recognition from The Climate Group, an international non-profit organisation, focused on accelerating climate action for its increase in renewable energy usage. AstraZeneca was identified as ‘Biggest Achiever’ for its 300% increase in renewable electricity in a single year. In addition, AstraZeneca was also commended for its use of renewable energy, as one of 122 multinational businesses which have made the RE100 commitment, a collaborative, global initiative uniting influential businesses that are committed to 100% renewable electricity.
 
In Cambridge, UK, the new R&D centre and global headquarters achieved an ‘Excellent’ rating from the world-leading Building Research Establishment Environmental Assessment Methodology (BREEAM) assessment; AstraZeneca also received a credit for innovation. BREEAM assesses a building’s environmental, social and economic sustainability performance. AstraZeneca’s rating status reflected best practice in a number of areas and the Company’s accreditation recognised the efforts to ensure the new site becomes an environment that will not only enhance staff well-being, but also help protect natural resources.
 
c) Ethics And Transparency
During the period, the Third Party Risk Management process, designed to ensure that AstraZeneca can identify and manage risks associated with third-party activities as early and effectively as possible, increased coverage to 79%. In February 2018, a new Counterfeit Medicines Partnership with Chinese company Tencent Holdings Limited was established. The programme involved the development of online tracking systems to fight counterfeit medicines, a particular challenge in China. The Company also implemented an organisational change to bring the functions of Global Compliance, Safety, Health and Environment and the Sustainability Strategy and Engagement team under a new umbrella function called Global Sustainability. The changes signal AstraZeneca’s commitment to sustainability.
 
Other Developments
During the period, AstraZeneca was recognised for its commitment to sustainability with two new external accolades. The Company was listed as one of the 100 most sustainable companies in the world by Corporate Knights, the Toronto-based media and investment advisory firm. During the period, AstraZeneca also received certification from the Top Employers Institute, in recognition of excellent People Management and HR processes across several European markets. The Institute assessed leadership, corporate & social responsibility commitments and how the Company delivers on its commitment to colleague diversity.
 
On 6 March 2018, the Company published its annual Sustainability Report 2017, which shares the results of AstraZeneca’s efforts in the aforementioned priority areas. The report highlighted examples of employee sustainability projects contributing to the Company’s global goals.
 
On 20 March 2018, AstraZeneca published its first gender pay-gap report, providing gender-pay information on the Company in the UK and outlining the Company’s support for women, as well as its focus on diversity and inclusion. AstraZeneca reported a median gap in hourly pay of 13.5%, compared to an overall UK median gap of 18.4%. The reporting of the gender pay gap is an annual requirement for all companies in the UK with 250 or more employees.
 
During the period, the Company commenced a robust programme of training for key areas of the organisation that are responsible for data privacy in preparation for the General Data Protection Regulation (GDPR). GDPR is a new EU regulation, taking effect from 25 May 2018, giving EU and European Economic Area (EEA) citizens and residents better control of their personal data, with one set of data protection rules applicable to all organisations that hold personal data relating to EU/EEA citizens and residents.
 
 
Research And Development Update
 
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 16: Update From The Late-Stage Pipeline
Regulatory Approvals
4
- Lynparza - ovarian cancer (2nd line; tablets) (EU)
- Tagrisso - lung cancer (1st line) (US)
- Imfinzi - lung cancer (Stage III) (US)
- Lokelma - hyperkalaemia (EU)
 
Regulatory Submissions and/or Acceptances
3
- Lynparza - breast cancer (EU)
- moxetumomab pasudotox - hairy cell leukaemia (3rd line) (US)
- Farxiga - type-1 diabetes (EU)
 
Major Phase III
Data Readouts or Other Major Developments
5
- Tagrisso - lung cancer (1st line) - priority review status (JP)
- Imfinzi + tremelimumab - lung cancer (3rd line) (ARCTIC trial) - did not meet primary endpoints in PDL1-low/neg. patients
- moxetumomab pasudotox - hairy cell leukaemia (3rd line) - Priority Review (US)
- selumetinib - NF1 - Orphan Drug Designation (US)
- Fasenra - COPD (GALATHEA trial) - did not meet primary endpoint
 
New Molecular Entitiesand Major Lifecycle Medicines in Phase III Trials or Under Regulatory Review
15
Oncology
- Lynparza - multiple cancers26
- Tagrisso - lung cancer26
- Imfinzi - multiple cancers26
- Calquence - blood cancers
- moxetumomab pasudotox - leukaemia26
- tremelimumab - multiple cancers
- selumetinib - thyroid cancer
- savolitinib - kidney cancer
 
CVRM
- Lokelma - hyperkalaemia26
- roxadustat - anaemia26
 
Respiratory
- Fasenra - COPD
- PT010 - COPD, asthma
- tezepelumab - severe, uncontrolled asthma
 
Other
- anifrolumab - lupus
- lanabecestat - Alzheimer’s disease
 
 
Total Projects in Clinical Pipeline
130
 

 
ONCOLOGY
AstraZeneca has a deep-rooted heritage in Oncology and offers a new generation of medicines that have the potential to transform patients’ lives and the Company’s future. At least six Oncology medicines are expected to be launched between 2014 and 2020, of which Lynparza, Tagrisso, Imfinzi and Calquence are already benefitting patients. An extensive pipeline of small-molecule and biologic medicines is in development and the Company is committed to advancing Oncology, primarily focused on the treatment of lung, ovarian, breast and blood cancers.
 
In April 2018, at the American Association for Cancer Research annual meeting, the Company presented data from the portfolios of DNA Damage Response (DDR), Immuno-Oncology (IO) and Tumour Drivers & Resistance.
 
The Company presented data on its expanded portfolio of potential medicines that exploit DDR dependencies to selectively kill cancer cells across multiple tumour types. The Company reported Lynparza OS data from the pivotal OlympiAD trial in BRCA-mutated, metastatic breast cancer. Data exploring the clinical properties of Lynparza and four other PARP inhibitors were also presented to illustrate clinical efficacy and safety profiles. Data on AZD6738, an Ataxia Telangiectasia and Rad3-related (ATR) inhibitor and AZD0156, an Ataxia Telangiectasia Mutated (ATM) inhibitor, were also presented.
 
The Company also presented data and shared new insights into the science of Imfinzi, including IO-IO combination data from Study 006 in 2nd-line NSCLC and Study 10 in 2nd-line bladder cancer. Beyond Imfinzi, the Company presented data on a novel bi-specific antibody, MEDI5752, designed to target dual checkpoints on immune cells and use the potential synergies of combined mechanisms in immunotherapy.
 
Finally, the Company presented data on AZD4573, a cyclin-dependent kinase 9 (CDK9) inhibitor, which demonstrated rapid cell-death induction in haematological-tumour models through depletion of myeloid leukemia cell differentiation protein Mcl-1. Furthermore, early monotherapy and combination data on the novel extracellular signal-regulated kinase inhibitor AZD0364 showed effects on KRAS-mutated tumours, when used in combination with selumetinib.
 
a) Lynparza (multiple cancers)
On 8 May 2018, the Company announced that the EMA had approved Lynparza tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA status. The approval was based on two randomised trials, SOLO-2 and Study 19, which showed that Lynparza reduced the risk of disease progression or death for platinum-sensitive, relapsed patients, compared to placebo.
 
On 3 April 2018, the Company announced that the EMA had validated for review the Marketing Authorisation Application (MAA) for Lynparza  for use as a treatment of patients with deleterious or suspected deleterious BRCA-mutated, HER2-negative, metastatic breast cancer, who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.
 
At the Society for Gynecological Oncology (SGO) annual meeting in New Orleans, US in March 2018, ovarian-cancer cohort data from the Lynparza + Imfinzi trial, MEDIOLA, was presented, showing promising efficacy and a favourable side-effect profile for the combination of Lynparza + Imfinzi in platinum-sensitive, recurrent (PSR) ovarian-cancer patients. The objective response rate was particularly high among patients who had received one prior line of chemotherapy (77%).
 
 
Table 17: Key Lynparza Combination Trials
Name
Phase
Population
Design
Timelines
Status
PAOLA-127
III
Stage IV, 1st-line ovarian cancer
Lynparza maintenance + bevacizumab vs.
bevacizumab maintenance
FPCD28 Q2 2015
 
First data anticipated 2019
 
Recruitment ongoing
DuO-O
III
Stage IV, 1st-line ovarian cancer
 
Lynparza + Imfinzi
-
Planning(announced at the aforementioned SGO meeting)
MEDIOLA
I/II
Advanced, 2nd-line gBRCA-mutated ovarian cancer
 
Stage IV, 1st to 3rd-line gBRCA-mutated, HER2-negative breast cancer
Stage IV, 2nd-line small cell lung cancer (SCLC)
Stage IV, 2nd-line gastric cancer
 
Lynparza + Imfinzi
FPCD Q2 2016
Recruitment ongoingInitial data from lung, breast, prostate and ovarian-cancer cohorts presented in 2017 and 2018
VIOLETTE
II
Stage IV, advanced, triple-negative breast cancer:
 
-HRRm29 (BRCA)
-HRRm (Non-BRCA)
-Non-HRRm
 
Lynparza + ATR (AZD6738)
 
Lynparza + Wee1 (AZD1775)
 
Lynparza
FPCD Q4 2017
 
 
Recruitment ongoing
Study 8
II
Stage IV, advanced, castration-resistant prostate cancer
Lynparza + abiraterone vs. abiraterone
FPCD Q3 2014
 
LPCD30 Q3 2015
Data to be presented at American Society Of Clinical Oncology annual meeting in June 2018
BAYOU
II
Stage IV, 1st line cis-platinum chemotherapy-ineligible urothelial bladder cancer
 
Lynparza + Imfinzi vs. Imfinzi
FPCD Q1 2018
Recruitment ongoing
 
b) Tagrisso (lung cancer)
On 18 April 2018, AstraZeneca announced that the US FDA had approved Tagrisso as a 1st-line treatment for patients with metastatic NSCLC whose tumours have EGFR mutations, as detected by an approved test. The approval was based on results from the 1st-line NSLCLC Phase III FLAURA trial, which showed that patients’ progression-free survival (PFS) nearly doubled when treated with Tagrisso, compared to patients treated with current standard of care (SoC) EGFR - tyrosine kinase inhibitors (TKIs). Prior to this, Tagrisso received its first regulatory approval as a 1st-line treatment for patients with metastatic EGFR-mutated NSCLC in Brazil.
 
On 27 April 2018, AstraZeneca announced that the CHMP had adopted a positive opinion, recommending a change to the terms of the MAA for Tagrisso to include the 1st-line treatment of adult patients with locally-advanced or metastatic NSCLC with EGFR mutations. A regulatory decision by the EMA is anticipated in Q2 2018, vs. the prior expectation of H2 2018.
 
On 5 February 2018, the Company announced that Tagrisso was granted priority review status, based on the results from the FLAURA trial, by the Ministry of Health, Labor and Welfare in Japan. In March 2016, Tagrisso was approved in Japan for the treatment of EGFR-TKI resistant, EGFR T790M mutation-positive inoperable or relapsed NSCLC. A supplementary new drug application was submitted in November 2017 to expand indications to include 1st-line treatment of EGFR mutation-positive NSCLC patients, regardless of the presence of a T790M mutation.
 
c) Imfinzi (lung and other cancers)
The Company continues to advance multiple monotherapy trials of Imfinzi and combination trials of Imfinzi with tremelimumab and other potential new medicines:
 
Lung Cancer
During the period, the Company announced that the US FDA had approved Imfinzi for the treatment of patients with unresectable, Stage III NSCLC whose disease had not progressed following concurrent platinum-based CRT; this was the second indication approved for Imfinzi. CRT, followed by monitoring for disease progression, has been the SoC in this setting for over two decades and multiple trials have failed to improve upon this. The approval of Imfinzi was based on positive PFS data from the Phase III PACIFIC trial, in which Imfinzi demonstrated an improvement in median PFS of 11.2 months compared to placebo, representing a 48% reduction in relative risk of progression or death vs. placebo in all patients, regardless of PD-L1 status.
 
In May 2018, Health Canada also approved Imfinzi for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval was granted under Health Canada’s accelerated approval framework and was the second global approval for Imfinzi for the treatment of unresectable, Stage III NSCLC. Regulatory submissions, based on the PACIFIC-trial data, are currently under review in both the EU and Japan, where the Company anticipates regulatory decisions in H2 2018. The PACIFIC trial is ongoing, evaluating OS in unresectable, Stage III NSCLC, with data availability anticipated in 2019.
 
The Company recently announced an updated timeline for the final analysis of the Phase III MYSTIC trial of Imfinzi as a potential monotherapy and in combination with tremelimumab, vs. platinum-based SoC chemotherapy in previously-untreated patients with metastatic (Stage IV), 1st-line NSCLC. An increased number of events, required for the OS analysis, means that final OS data is now expected to be available in the second half of 2018, vs. the prior expectation of H1 2018.
 
During the period, the Company also reassessed timelines for the final analysis of data from the Phase III NEPTUNE trial of Imfinzi in combination with tremelimumab, versus platinum-based, SoC chemotherapy in previously-untreated patients with metastatic (Stage IV) 1st-line NSCLC. The trial is now expected to achieve an increased number of required events for OS analysis to be available in 2019, vs. the prior expectation of H2 2018. As previously communicated, the Company has the flexibility to include novel biomarkers in the NEPTUNE statistical-analysis plan.
 
Continued emerging scientific evidence supports the use of OS over PFS as the key, relevant primary endpoint, to characterise correctly the clinical benefit of IO medicines. Accordingly, the Company recently amended trials in the 1st-line NSCLC setting to increase the emphasis on and robustness of OS as a primary endpoint, including the Phase III PEARL trial (Imfinzi monotherapy), which will now focus the primary-efficacy analysis on OS, rather than PFS.
 
In the Stage IV, 3rd-line setting, the Company recently reported data from the Phase III ARCTIC trial in patients with locally-advanced or metastatic NSCLC, who have received at least two prior treatments. This randomised, open-label, multi-centre trial assessed the efficacy and safety of the combination of Imfinzi plus tremelimumab, as well as Imfinzi and tremelimumab monotherapies, versus SoC chemotherapy in patients with PDL1-low/negative NSCLC (sub-study B) and Imfinzi monotherapy versus SoC in patients with PDL1-high NSCLC (sub-study A). In sub-study B, the combination of Imfinzi plus tremelimumab in patients with PD-L1 low/negative NSCLC did not meet the primary endpoints of a statistically-significant and clinically-meaningful improvement in PFS and OS, compared to SoC. Activity and safety data from other arms within sub-study B were consistent with prior published data. Sub-study A was not powered for statistical significance;Imfinzi monotherapy, however, showed a clinically-meaningful reduction in the risk of death, compared to chemotherapy. Full data from the ARCTIC trial will be presented at a forthcoming medical meeting.
 
Table 18: Ongoing Key IO Lung Cancer Late-Stage Trials
Name
Phase
Population
Design
Timelines
Status
Monotherapy
ADJUVANT (BR 31)31
III
Stage Ib-IIIa NSCLC
Imfinzi vs. placebo
FPCD Q1 2015
 
First data anticipated 2020
Recruitment ongoing
PACIFIC
III
Unresectable, Stage III NSCLC
Imfinzi vs. placebo
FPCD Q2 2014
 
LPCD Q2 2016
 
Final OS data anticipated 2019
Recruitment completed
 
PFS primary endpoint met
PACIFIC-2
III
Unresectable, Stage III NSCLC
Concurrent chemoradiation +/- Imfinzi
FPCD Q2 2018
 
First data anticipated 2021
Recruitment ongoing
PEARL
III
Stage IV, 1st line NSCLC (Asia)
Imfinzi vs. SoC chemotherapy
FPCD Q1 2017
 
First data anticipated 2020
Recruitment ongoing
Combination therapy
MYSTIC
III
Stage IV, 1st line NSCLC
Imfinzi, Imfinzi + treme vs. SoC chemotherapy
FPCD Q3 2015
 
LPCD Q3 2016
 
Final OS data anticipated H2 2018
Recruitment completed
 
PFS primary endpoint not met
NEPTUNE
III
Stage IV, 1st line NSCLC
Imfinzi + treme vs. SoC chemotherapy
FPCD Q4 2015
 
LPCD Q2 2017
 
First data anticipated 2019
Recruitment completed
POSEIDON
III
Stage IV, 1st line NSCLC
Imfinzi + SoC, Imfinzi + treme + SoC vs. SoC chemotherapy
FPCD Q2 2017
 
First data anticipated 2019
Recruitment ongoing
CASPIAN
III
Stage IV, 1st line small-cell lung cancer
Imfinzi + SoC, Imfinzi + treme + SoC vs. SoC chemotherapy
FPCD Q1 2017
 
First data anticipated 2019
Recruitment ongoing
 
Other Cancers
During the period, the Pharmaceutical Administration, the Medical Devices Department and the Food & Nutrition Services of the Israel Ministry of Health authority granted approval to Imfinzi as a treatment for patients with locally-advanced or metastatic bladder cancer who have suffered disease progression during or following platinum-containing chemotherapy or who have suffered disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Imfinzi’s approval, based on Phase Ib/II clinical-trial data, was received only 10 months after submission, reflecting the importance of a new treatment option for patients and compelling clinical data. Along with the approval in Israel, Imfinzi is now approved as a 2nd-line treatment for bladder cancer in the US, Canada and Brazil, with a review ongoing in Australia.
 
During the period, the Company amended the Phase III KESTREL trial by focusing the primary-efficacy analysis on OS only, as the primary endpoint. Accordingly, and based on current predictions, the first data are now expected to be available in H2 2018, vs. the prior expectation of H1 2018. Similarly, the timeline for the availability of the first data anticipated for the Phase III EAGLE trial recently moved to H2 2018 vs. the prior expectation of H1 2018.
 
Table 19: Key IO Non-Lung Cancer Late-Stage Trials
Name
Phase
Population
Design
Timelines
Status
DANUBE
III
Stage IV, 1st line cisplatin chemotherapy- eligible/
ineligible bladder cancer
Imfinzi, Imfinzi + treme vs. SoC chemotherapy
FPCD Q4 2015
 
LPCD Q1 2017
 
First data anticipated 2019
 
Recruitment completed
KESTREL
III
Stage IV, 1st line head and neck squamous cell carcinoma (HNSCC, head and neck cancer)
Imfinzi, Imfinzi + treme vs. SoC
FPCD Q4 2015
 
LPCD Q1 2017
 
First data anticipated H2 2018
 
Recruitment completed
EAGLE
III
Stage IV, 2nd-line HNSCC
Imfinzi, Imfinzi + treme vs. SoC
FPCD Q4 2015
 
LPCD Q3 2017
 
First data anticipated H2 2018
 
Recruitment completed
HIMALAYA
III
Stage IV, 1st line hepatocellular carcinoma (HCC, liver cancer)
Imfinzi, Imfinzi + treme (two dosing regimens) vs. sorafenib
FPCD Q4 2017
 
First data anticipated 2020
Recruitment ongoing
 
d) Calquence
On 13 February 2018, the NCCN added Calquence as a category-2A recommended treatment for relapsed / refractory CLL / small lymphocytic lymphoma.
 
e) Moxetumomab Pasudotox
On 3 April 2018, the Company announced that the US FDA had accepted the Biologics License Application (BLA) for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin and potential new medicine for the treatment of adult patients with hairy cell leukaemia who have received at least two prior lines of therapy. The US FDA granted the moxetumomab pasudotox BLA Priority Review status, with a Prescription Drug User Fee Act action date in the third quarter of 2018.
 
f) Selumetinib
On 15 February 2018, the Company announced that the US FDA had granted Orphan Drug Designation for selumetinib, a MEK 1/2 inhibitor, for the treatment of NF1. This is an incurable genetic condition that affects one in 3,000 births, with highly-variable symptoms, including skin, neurological and skeletal manifestations. It can cause secondary complications, including learning difficulties, visual impairment, pain, disfigurement, twisting and curvature of the spine, high blood pressure and epilepsy. NF1 is a devastating condition that can lead to life-threatening complications. There is no known cure for NF1 and there are limited treatment options to manage symptoms.
 
Selumetinib is being investigated by the US National Cancer Institute in a Phase I/II trial, SPRINT, in paediatric patients with symptomatic, NF1-related Plexiform neurofibromas; data is anticipated in Q2 2018.
 
 
CVRM
CV, renal and metabolic diseases are key areas of focus as the Company sets the challenge to better understand how its portfolio of medicines might be used to help address multiple risk factors or co-morbidities. Today, AstraZeneca is delivering life-changing results in the main CV-disease areas and their complications. The Company is investing in science to demonstrate CV and mortality benefits, by slowing the underlying progression of CV-related diseases and protecting the organs of the CV system. Ultimately, AstraZeneca is looking to do more than just slow CV-related disease, by modifying or even halting the natural course of the disease itself and regenerate organs. The net result is a strong, continued commitment to new CVRM-treatment options that have the potential to deliver improved outcomes to hundreds of millions of patients.
 
a) Brilinta (CV disease)
AstraZeneca presented results of a new analysis of the PLATO (A Study of PLATelet Inhibition and Patient Outcomes) trial at the ACC (American College of Cardiology) meeting in Orlando, US in March 2018, showing that there were fewer deaths in patients suffering from ACS who were treated with Brilinta within seven days prior to having heart bypass surgery (coronary artery bypass graft), compared to those treated with clopidogrel. For patients treated with Brilinta, total mortality was reduced by 51% and CV death was reduced by 48%, in comparison to patients treated with clopidogrel.
 
At the meeting, the Company also announced initial results from TREAT (Ticagrelor in Patients With ST Elevation Myocardial Infarction (STEMI) Treated With Pharmacological Thrombolysis), a Phase III, investigator-initiated and academically-led trial, financially supported by AstraZeneca, investigating the safety of Brilinta 90mg compared to clopidogrel 75mg for heart-attack patients treated with pharmacological thrombolysis. The trial demonstrated comparable safety profiles in thrombolysed STEMI patients, as measured by major bleeding at 30 days, between Brilinta and clopidogrel (P<0.001 for non-inferiority). Rates of major CV events were similar between Brilinta and clopidogrel at 30 days, although due to the low number of events, statistical power to assess superiority was limited. Further assessment of safety and efficacy data is planned at 12 months.
 
In February 2018, new data was published in the Journal of the American College of Cardiology. The new data suggested that treatment with Brilinta 60mg significantly reduces the risk of a major adverse cardiac event (MACE) by 19% and coronary death by 36%, in patients who have survived a heart attack and are living with multi-vessel-disease (MVD). The findings from this pre-specified sub-analysis of the PEGASUS-TIMI 54 trial suggested that this high-risk population may benefit from extended, preventative anti-platelet therapy beyond the initial 12-month, post-event period. This sub-analysis also highlighted the increased risk of cardiac events among patients with MVD who have already experienced a heart attack.
 
b) Farxiga (diabetes)
AstraZeneca presented results of its CVD-REAL 2 study at the aforementioned ACC meeting. This new analysis assessed data from more than 400,000 patients, 74% of whom did not have a history of established CV disease. Results showed that, across this broad population of patients with type-2 diabetes, treatment with an SGLT2 inhibitor (Farxiga, empagliflozin, ipragliflozin, canagliflozin, tofogliflozin or luseogliflozin) was associated with a 49% lower risk of acute coronary death (ACD), 36% lower risk of hospitalisation for heart failure (hHF), 19% lower risk of MI and 32% lower risk of stroke (P≤0.001 for all), compared to other type-2 diabetes medicines. There was also a 40% lower risk of the composite endpoint of hHF or ACD (P<0.001). This data was consistent with the data from CVD-REAL study presented at the American Diabetes Association annual meeting in 2017.
 
During the period, the Company announced submission acceptance from the EMA for Forxiga for use as an oral adjunct treatment to insulin in adults with type-1 diabetes. The submission acceptance was based on Phase III data from the DEPICT (Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 diabetes) clinical programme. The safety profile of Forxiga in the DEPICT clinical programme to date was consistent with its established profile in type-2 diabetes, with the exception of a higher number of diabetic ketoacidosis (DKA) events in dapagliflozin-treated patients vs. placebo in these type-1 diabetes trials. DKA is a known complication for patients with diabetes that affects those with type-1 diabetes more frequently than those with type-2 diabetes.
 
c) Bydureon (type-2 diabetes)
On 3 April 2018, AstraZeneca announced that the US FDA had approved Bydureon for injectable suspension as an add-on therapy to basal insulin in adults with type-2 diabetes with inadequate glycemic control. The approval was based on the DURATION-7 trial showing significant HbA1c reduction when Bydureon was added to insulin glargine therapy vs. insulin glargine alone.
 
During the period, the Company received EMA acceptance for Bydureon, based on the CV outcome trial, EXSCEL. This Phase IIIb/IV trial (EXenatide Study of Cardiovascular Event Lowering) compared the effect of once-weekly Bydureon (exenatide extended-release) vs. placebo, when added to usual type-2 diabetes treatments, on the risk of a MACE, a composite endpoint of CV death, non-fatal myocardial infarction (MI) or non-fatal stroke, in adults with type-2 diabetes at a wide range of CV risk. The trial met its primary safety objective of non-inferiority for MACE. Fewer CV events were observed in the Bydureon arm of the trial; the efficacy objective of a superior reduction in MACE, however, did not reach statistical significance.
 
d) Lokelma (hyperkalaemia)
On 22 March 2018, AstraZeneca announced that the EMA had granted the marketing authorisation for Lokelma (formerly ZS-9, sodium zirconium cyclosilicate) for the treatment of adults with hyperkalaemia.
 
During the period, the Company also completed enrolment in the Phase III HARMONIZE global trial. The trial was designed, alongside other country specific trials, to evaluate the safety and efficacy of Lokelma in patients with hyperkalaemia in Japan, South Korea, Russia and Taiwan. It will, along with other trials, support the registration of Lokelma in these countries.
 
e) Roxadustat (anaemia)
During the period, the Company and its partner FibroGen Inc. (Fibrogen) announced an update to roxadustat’s Phase III programme. Data is now anticipated in H2 2018, vs. the prior expectation of H1 2018;a US regulatory submission is anticipated in 2019, vs. the prior expectation of H2 2018.
 
In China, roxadustat was granted priority review by China FDA and the Company continues to anticipate a regulatory decision in H2 2018. If approved, roxadustat will be a first-in-class medicine, with China being the first approval country.
 
Under the terms of the agreement, Fibrogen and AstraZeneca will develop and commercialise roxadustat in the US, China and all major markets excluding Japan, Europe, the Commonwealth of Independent States, the Middle East and South Africa, which are covered by an existing agreement between Fibrogen and Astellas Pharma Inc.
 
In February 2018, the first patient was dosed in the roxadustat 082 MDS trial; the purpose of the trial is to determine whether roxadustat is safe and effective in the treatment of anaemia in patients with lower-risk myelodysplastic syndrome and low red blood-cell transfusion burden. This is the first trial in the lifecycle management programme for roxadustat.
 
Table 20: Major Ongoing Cardiovascular Outcomes Trials
Major ongoing outcomes trials for patients in CVRM are highlighted in the following table:
 
Medicine
Trial
Mechanism
Population
Primary Endpoint
Timeline
Farxiga
DECLARE
SGLT2 inhibitor
c.17,00032 patients with type-2 diabetes
Time to first occurrence of CV death, non-fatal MI or non-fatal stroke
 
Data anticipated H2 2018 (final analysis)
Farxiga
DAPA-HF
SGLT2 inhibitor
c.4,500 patients with HF33
Time to first occurrence of CV death or hHF or an urgent HF visit
 
FPCD
Q1 2017Data anticipated 2019
Farxiga
DAPA-CKD
SGLT2 inhibitor
c.4,000 patients with CKD34
Time to first occurrence of ≥50% sustained decline in eGFR35 or reaching ESRD36 or CV death or renal death
 
FPCD
Q1 2017Data anticipated 2020
Brilinta
THEMIS
P2Y12 receptor antagonist
c.19,000 patients with type-2 diabetes
and CAD
without a history of
MI or stroke
Composite of
CV death, non-fatal MI
and non-fatal stroke
Data anticipated 2019
Brilinta
THALES
P2Y12 receptor antagonist
c.13,000 patients with acute ischaemic stroke or transient ischaemic attack
Prevention of the composite of subsequent stroke and death at 30 days
Data anticipated 2020
Epanova
STRENGTH
Omega-3 carboxylic acids
c.13,000 patients with mixed dyslipidaemia
 
Time to first occurrence of CV death, non-fatal MI or non-fatal stroke
Data anticipated 2019
 
 
RESPIRATORY
AstraZeneca’s Respiratory focus is aimed at transforming the treatment of asthma and COPD through combined inhaled therapies, biologics for the unmet medical needs of specific patient populations and an early pipeline focused on disease modification.
 
The growing range of medicines includes up to four anticipated launches between 2017 and 2020; of these, Bevespi and Fasenra are already benefitting patients. The capability in inhalation technology spans both pressurised, metered-dose inhalers and dry-powder inhalers to serve patient needs, as well as the innovative Aerosphere Delivery Technology, a focus of AstraZeneca’s future-platform development for respiratory-disease combination therapies.
 
a) Symbicort (asthma)
On 17 May 2018, positive results from the Phase III SYGMA trials of Symbicort Turbuhaler were published in the New England Journal of Medicine; they will be presented on 20 May 2018 at the American Thoracic Society International Congress. The trials were designed to evaluate efficacy of Symbicort Turbuhaler, taken only as needed, as an anti-inflammatory reliever vs. SoC medicines for mild asthma. In November 2017, the Company announced that both trials had met their individual primary efficacy outcomes.
 
In March 2018, the China FDA approved Symbicort Turbuhaler as a maintenance and reliever therapy, designed for the treatment of asthma in adolescent patients (12-17 years) in China.
 
b) Daxas (COPD)
In April 2018, the EMA announced approval of a 250mcg tablet for Daxas to be used as a starting-dose treatment for the first four weeks, followed by an increase to the maintenance dosage of 500mcg. Daxas is indicated for maintenance treatment of severe COPD associated with chronic bronchitis in adult patients with a history of frequent exacerbations, as add-on to bronchodilator treatment.
 
c) Bevespi (COPD)
In March 2018, Health Canada granted approval for Bevespi Aerosphere as a long-term treatment for adults with COPD. Canada was the second market, after the US, to approve Bevespi Aerosphere.
 
d) Fasenra (severe, uncontrolled asthma and COPD)
On 11 May 2018, AstraZeneca announced that the GALATHEA Phase III trial did not met its primary endpoint of a statistically-significant reduction of exacerbations in patients with COPD. The trial assessed the safety and efficacy of Fasenra, as an add-on treatment to dual or triple inhaled therapy compared to placebo for patients with moderate to very severe COPD with a history of exacerbations across a range of baseline blood eosinophils. The safety and tolerability findings in GALATHEA were consistent with those previously observed in trials with Fasenra and the results do not impact the approved indication in severe eosinophilic asthma. The second Phase III trial, TERRANOVA, is ongoing and the Company anticipates results in Q2 2018. Following the top-line results of TERRANOVA, AstraZeneca will conduct a full evaluation of both trials to determine the next steps for Fasenra in COPD.
 
In November 2017, Fasenra was approved in the US as a new medicine for patients aged 12 years and older with severe, uncontrolled asthma and with an eosinophilic phenotype. In January 2018, the EMA approved Fasenra as an add-on maintenance treatment in adult patients with severe, inadequately-controlled eosinophilic asthma, despite their treatment with high-dose inhaled corticosteroids plus LABA. In Japan, Fasenra was approved as an add-on treatment for bronchial asthma in patients who continue to experience asthma exacerbations, despite treatment with high-dose inhaled corticosteroid and other asthma controller(s).
 
During the period, the Company also commenced a Phase III trial of Fasenra for the treatment of nasal polyposis.
 
e) PT010 (and PT009) (COPD)
During the period, the Phase III SOPHOS trial read out, which compared PT009 (budesonide/formoterol fumarate) to PT005 (formoterol fumarate) and assessed lung function in patients with moderate to very-severe COPD. The trial, which was designed to qualify PT009 as an active comparator in the PT010 clinical-trial programme, met its primary endpoint, with PT009 delivering superior efficacy to PT005 at morning pre-dose trough FEV137 at Week 24. A full evaluation of the SOPHOS trial data is ongoing and the Company intends to present the data at a forthcoming medical meeting.
 
For more details on the development pipeline, please refer to the latest Clinical Trials Appendix.
 
 
Development Pipeline 31 March 2018
 
AstraZeneca-sponsored or -directed trials
Phase III / Pivotal Phase II / Registration
New Molecular Entities (NMEs) and significant additional indications
 
Regulatory submission dates shown for potential new medicines in Phase III and beyond. As disclosure of compound information is balanced by the business need to maintain confidentiality, information in relation to some compounds listed here has not been disclosed at this time.
 
 
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Regulatory Acceptance Date /Submission Status
US
EU
Japan
China
Oncology
 
 
 
 
 
 
 
Calquence 38
BTK inhibitor
B-cell malignancy
Q1 2015
Launched
 
 
 
savolitinib38
SAVOIR
MET inhibitor
papillary renal cell carcinoma
Q3 2017
2020
2020
 
 
selumetinib ASTRA
MEK inhibitor
differentiated thyroid cancer
Q3 2013
H2 2018
(Orphan Drug Designation)
H2 2018
 
 
moxetumomab pasudotox38
PLAIT
anti-CD22 recombinant immunotoxin
3rd-line hairy cell leukaemia
Q2 2013
Accepted
(Orphan Drug Designation, Priority Review)
 
 
 
Imfinzi38 + tremelimumab
MYSTIC
PD-L1 mAb + CTLA-4 mAb
 
1st-line NSCLC
Q3 2015
H2 2018
H2 2018
H2 2018
 
Imfinzi38 + tremelimumab
NEPTUNE
PD-L1 mAb + CTLA-4 mAb
1st-line NSCLC
Q4 2015
2019
2019
2019
2020
Imfinzi38 + tremelimumab + chemotherapy
POSEIDON
PD-L1 mAb + CTLA-4 mAb
1st-line NSCLC
Q2 2017
2019
2019
2019
2020
Imfinzi38 + tremelimumab + SoC
CASPIAN
PD-L1 mAb + CTLA-4 mAb + SoC
 
1st-line SCLC
Q1 2017
2019
2019
2019
 
Imfinzi38 + tremelimumabKESTREL
PD-L1 mAb + CTLA-4 mAb
 
1st-line HNSCC
Q4 2015
2019
2019
2019
 
Imfinzi38 + tremelimumabEAGLE
PD-L1 mAb + CTLA-4 mAb
 
2nd-line HNSCC
Q4 2015
H2 2018
H2 2018
H2 2018
 
Imfinzi38 + tremelimumab
DANUBE
PD-L1 mAb + CTLA-4 mAb
 
1st-line bladder cancer
Q4 2015
 
2019
2019
 
2019
 
 
Imfinzi38 + tremelimumab HIMALAYA
PD-L1 mAb + CTLA-4 mAb
 
1st-line hepatocellular carcinoma
Q4 2017
 
2021
2021
 
2021
 
2021
Lynparza38, 39+ cediranib
CONCERTO
PARP inhibitor + VEGF inhibitor
 
recurrent platinum-resistant ovarian cancer
Q1 2017
 
2019
 
 
 
CVRM
 
 
 
 
 
Epanova
omega-3 carboxylic acids
severe hypertriglycerid-aemia
 
Approved
 
2020
 
Lokelma (ZS-9) (sodium zirconium cyclosilicate)
potassium binder
hyperkalaemia
 
Accepted
Approved
2019
 
roxadustat38 above
OLYMPUS (US) ROCKIES (US)
hypoxia-inducible factor prolyl hydroxylase inhibitor
anaemia in CKD / end-stage renal disease
Q3 2014
2019
 
 
Accepted40
roxadustat38 above
hypoxia-inducible factor prolyl hydroxylase inhibitor
anaemia in myelodysplastic syndrome
Q1 2018
2021
 
 
2020
Respiratory
 
Bevespi
(PT003)
LABA/LAMA
COPD
 
Launched
 Accepted
H2 2018
H2 2018
Fasenra38
(benralizumab)
CALIMA SIROCCO ZONDA
BISE
BORA
GREGALE
IL-5R mAb
severe, uncontrolled asthma
 
Launched
Launched
Launched
2021
PT010
LABA/LAMA/ ICS
COPD
Q3 2015
2019
2019
H2 2018
H2 2018
tezepelumab
NAVIGATOR
SOURCE
TSLP mAb
severe, uncontrolled asthma
Q1 2018
2021
2021
2021
 
Other
 
 
 
 
 
 
 
anifrolumab38 above TULIP
Type I IFN receptor mAb
systemic lupus erythematosus
Q3 2015
2019
(Fast Track)
2019
2019
 
lanabecestat38 above
AMARANTH + extension, DAYBREAK-ALZ
beta-secretase inhibitor
Alzheimer’s disease
Q2 2016
2020
(Fast Track)
2020
2020
 
 
 
Phases I and II
 
NMEs and significant additional indications
 
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase

Oncology
 
 
 
 
Imfinzi
PD-L1 mAb
solid tumours
II
Q3 2014
Imfinzi38 + tremelimumab
PD-L1 mAb + CTLA-4 mAb
gastric cancer
II
Q2 2015
Imfinzi38 + tremelimumab
PD-L1 mAb + CTLA-4 mAb
biliary tract, osophageal
II
Q4 2013
Imfinzi38 + tremelimumab + chemo
PD-L1 mAb + CTLA-4 mAb
1st-line pancreatic ductal adenocarcinoma, osophageal and SCLC
I
Q2 2016
Imfinzi38 + AZD5069
PD-L1 mAb + CXCR2 antagonist
pancreatic ductal adenocarcinoma
II
Q2 2017
Imfinzi38 + AZD5069 or Imfinzi38 + danvatirsen38 (AZD9150)
PD-L1 mAb + CXCR2 antagonist or PD-L1 mAb + STAT3 inhibitor
HNSCC
II
Q3 2015
Imfinzi38 + dabrafenib + trametinib
PD-L1 mAb + BRAF inhibitor + MEK inhibitor
melanoma
I
Q1 2014
Imfinzi38 + adavosertib38 (AZD1775)
PD-L1 mAb + Wee1 inhibitor
solid tumours
I
Q4 2015
Imfinzi38 + MEDI0680
PD-L1 mAb + PD-1 mAb
solid tumours
II
Q3 2016
Imfinzi38 or Imfinzi38 + (tremelimumab or danvatirsen38 (AZD9150))
PD-L1 mAb or PD-L1 mAb + (CTLA-4 mAb or STAT3 inhibitor)
diffuse large B-cell lymphoma
I
Q3 2016
Imfinzi38 + danvatirsen (AZD9150) + chemotherapy
PD-L1 mAB + STAT3 inhibitor + chemotherapy
solid tumours
I
Q1 2018
Imfinzi38 + Iressa
PD-L1 mAb + EGFR inhibitor
NSCLC
I
Q2 2014
Imfinzi38 + MEDI056238
PD-L1 mAb + humanised OX40 agonist
solid tumours
I
Q2 2016
Imfinzi38+ MEDI919738
PD-L1 mAb + TLR 7/8 agonist
solid tumours
I
Q2 2017
Imfinzi38 + oleclumab
PD-L1 mAb + CD73 mAb
solid tumours
I
Q1 2016
Imfinzi38 + monalizumab
PD-L1 mAb + NKG2a mAb
solid tumours
I
Q1 2016
Imfinzi38 + selumetinib
PD-L1 mAb + MEK inhibitor
solid tumours
I
Q4 2015
Imfinzi38 + tremelimumab
PD-L1 mAb + CTLA-4 mAb
solid tumours
I
Q4 2013
tremelimumab + MEDI056238
CTLA-4 mAb + humanised OX40 agonist
solid tumours
I
Q2 2016
Imfinzi38 + azacitidine
PD-L1 mAb + azacitidine
myelodysplastic syndrome
I
Q2 2016
Imfinzi38 + MEDI045738
PD-L1 mAb + DNA HPV vaccine
HNSCC
II
Q4 2017
Imfinzi38 + RT (platform)
CLOVER
PD-L1 mAb + RT
locally-advanced HNSCC, NSCLC, SCLC
I
Q1 2018
Imfinzi38 +/- Lynparza
BAYOU
PDL-1 mAb + PARP inhibitor
1st-line unresectable stage IV bladder cancer
II
Q1 2018
Lynparza38 + AZD6738
PARP inhibitor + ATR inhibitor
gastric cancer
II
Q3 2016
Lynparza38 + adavosertib38 (AZD1775#)
PARP inhibitor + Wee1 inhibitor
solid tumours
I
Q3 2015
Lynparza38 + Imfinzi38
MEDIOLA
PARP inhibitor + PD-L1 mAb
solid tumours
II
Q2 2016
Tagrisso + (selumetinib38 or savolitinib38)
TATTON
EGFR inhibitor + (MEK inhibitor or MET inhibitor)
advanced EGFRm NSCLC
II
Q2 2016
Tagrisso BLOOM
EGFR inhibitor
CNS metastases in advanced EGFRm NSCLC
II
Q4 2015
adavosertib38 (AZD177538) + chemotherapy
Wee1 inhibitor + chemotherapy
ovarian cancer
II
Q1 2015
adavosertib38 (AZD177538)
Wee1 inhibitor
solid tumours
I
Q3 2015
vistusertib
mTOR inhibitor
solid tumours
II
Q1 2013
capivasertib38 (AZD536338)
AKT inhibitor
breast cancer
II
Q1 2014
AZD4547
FGFR inhibitor
solid tumours
II
Q4 2011
AZD0156
ATM inhibitor
solid tumours
I
Q4 2015
AZD1390
ATM inhibitor
healthy volunteer trial
I
Q4 2017
AZD281138
Aurora B inhibitor
solid tumours
I
Q4 2015
AZD4573
CDK9 inhibitor
haematological malignancies
I
Q4 2017
AZD4635
A2aR inhibitor
solid tumours
I
Q2 2016
AZD4785
KRAS inhibitor
solid tumours
I
Q2 2017
AZD5153
BRD4 inhibitor
solid tumours
I
Q3 2017
AZD5991
MCL1 inhibitor
haematological malignancies
I
Q3 2017
Calquence + vistusertib
BTK inhibitor + mTor inhibitor
haematological malignancies
I
Q3 2017
Calquence + AZD6738
BTK inhibitor + ATR inhibitor
haematological malignancies
I
Q1 2018
AZD6738
ATR inhibitor
solid tumours
I
Q4 2013
AZD8186
PI3k inhibitor
solid tumours
I
Q2 2013
AZD9496
selective oestrogen receptor degrader
oestrogen receptor +ve breast cancer
I
Q4 2014
MEDI056238
humanised OX40 agonist
solid tumours
I
Q1 2015
MEDI1873
GITR agonist fusion protein
solid tumours
I
Q4 2015
MEDI372638
PSMA antibody drug conjugate
prostate cancer
I
Q1 2017
MEDI4276
HER2 bi-specific antibody drug conjugate
solid tumours
I
Q4 2015
MEDI5083
CD40 ligand fusion protein
solid tumours
I
Q1 2017
MEDI7247
antibody drug conjugate
haematological malignancies
I
Q2 2017
MEDI919738
TLR 7/8 agonist
solid tumours
I
Q4 2015
oleclumab
CD73 mAb
solid tumours
I
Q3 2015
CVRM
 
 
 
verinurad
URAT1 inhibitor
CKD
II
Q2 2017
MEDI0382
GLP-1 /
glucagon dual agonist
type-2 diabetes / obesity
II
Q3 2016
MEDI6012
LCAT
CV disease
II
Q4 2015
AZD4831
myeloperoxidase
HF with a preserved ejection fraction
I
Q3 2016
AZD5718
FLAP
coronary artery disease
II
Q4 2017
AZD860138
VEGF-A
CV disease
II
Q1 2018
AZD9977
MCR
CV disease
I
Q1 2018
MEDI588438
cholesterol modulation
CV disease
II
Q4 2017
MEDI7219
anti-diabetic
type-2 diabetes
I
Q1 2018
Respiratory
 
 
 
 
abediterol38
LABA
asthma / COPD
II
Q4 2007
tezepelumab38
TSLP mAb
atopic dermatitis
II
Q2 2015
AZD141938
inhaled TLR9 agonist
asthma
II
Q4 2016
AZD7594
inhaled SGRM
asthma / COPD
II
Q3 2015
AZD887138
MABA
COPD
II
Q1 2017
PT010
LABA/LAMA/ICS
asthma
II
Q2 2014
AZD5634
inhaled ENaC
cystic fibrosis
I
Q1 2016
AZD7594 + abediterol38
inhaled SGRM + LABA
asthma / COPD
I
Q4 2016
AZD798638
DPP1
COPD
II
Q4 2017
AZD9567
oral SGRM
rheumatoid arthritis / respiratory
II
Q1 2018
AZD14038
Inhaled IL-4Ra
asthma
I
Q4 2017
MEDI3506
IL-33 mAb
COPD
I
Q2 2017
Other
 
 
 
 
anifrolumab38
Type 1 IFN receptor mAb
lupus nephritis
II
Q4 2015
anifrolumab38
Type 1 IFN receptor mAb
systemic lupus erythematosus (subcutaneous)
II
Q1 2017
MEDI3902
Psl/PcrV bispecific mAb
prevention of nosocomial Pseudomonas aeruginosa pneumonia
II
(Fast Track, US)
Q2 2016
 
 
suvratoxumab
mAb binding to S. aureus toxin
prevention of nosocomial Staphylococcus aureus pneumonia
II
(Fast Track, US)
Q4 2014
 
 
prezalumab38
B7RP1 mAb
primary Sjögren’s syndrome
II
Q3 2015
MEDI8852
influenza A mAb
influenza A treatment
II
(Fast Track, US)
Q4 2015
 
 
MEDI889738
RSV mAb-YTE
passive RSV prophylaxis
II
(Fast Track, US)
Q1 2015
 
 
AZD0284
RORg
psoriasis / respiratory
I
Q4 2016
MEDI070038
BAFF/B7RP1 bispecific mAb
systemic lupus erythematosus
I
Q1 2016
MEDI181438
amyloid beta mAb
Alzheimer’s disease
I
Q2 2014
MEDI7352
NGF/TNF bi-specific mAb
osteoarthritis pain
I
Q1 2016
MEDI1341
alpha synuclein mAb
Parkinson’s disease
I
Q4 2017
 
 
Significant Lifecycle Management
 
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Regulatory Acceptance Date / Submission Status
US
EU
Japan
China
Oncology
 
 
 
 
 
 
 
Calquence38
BTK inhibitor
1st-line chronic lymphocytic leukaemia
Q3 2015
2020
(Orphan Drug Designation)
2020
(Orphan designation)
 
 
Calquence38
BTK inhibitor
relapsed/refractory chronic lymphocytic leukaemia, high risk
Q4 2015
2019
(Orphan Drug Designation)
2019
(Orphan designation)
 
 
Calquence38
BTK inhibitor
1st-line mantle cell lymphoma
Q1 2017
2023
 
 
 
Imfinzi38PACIFIC
PD-L1 mAb
locally-advanced (Stage III), NSCLC
Q2 2014
Approved
(Breakthrough Therapy Designation & Priority Review)
Accepted
Accepted
 
Imfinzi38
PEARL (China)
PD-L1 mAb
1st-line NSCLC
Q1 2017
 
 
 
2020
Lynparza38 OlympiAD
PARP inhibitor
gBRCA metastatic breast cancer
Q2 2014
Approved
(Priority Review)
Accepted
Accepted
(Orphan drug designation, Priority Review)
H2 2018
Lynparza38SOLO-2
PARP inhibitor
2nd-line or greater BRCAm PSR ovarian cancer, maintenance monotherapy
Q3 2013
Approved
(Priority Review)
Approved
Approved
(Orphan drug designation)
Accepted
Lynparza38SOLO-1
PARP inhibitor
1st-line BRCAm ovarian cancer
Q3 2013
H2 2018
H2 2018
H2 2018
2019
Lynparza38SOLO-3
PARP inhibitor
gBRCA PSR ovarian cancer
Q1 2015
H2 2018
 
 
 
Lynparza38POLO
PARP inhibitor
pancreatic cancer
Q1 2015
2019
2019
 
 
Lynparza38
PROfound
 
 
PARP inhibitor
prostate cancer
Q1 2017
 
 
2020
(Breakthrough Therapy Designation)
2020
2020
2020
Lynparza38
OlympiA
PARP inhibitor
gBRCA adjuvant breast cancer
Q2 2014
2021
2021
2021
 
Tagrisso
FLAURA
EGFR inhibitor
1st-line advanced EGFRm NSCLC
Q1 2015
Approved
(Breakthrough Therapy designation)
Accepted (CHMP positive opinion)
Accepted
H2 2018
Tagrisso
ADAURA
EGFR inhibitor
adjuvant EGFRm NSCLC
Q4 2015
2022
2022
2022
2022
CVRM
 
 
 
 
 
Brilinta41
THALES
P2Y12 receptor antagonist
acute ischaemic stroke or transient ischaemic attack
Q1 2018
2020
2020
 
2020
Brilinta41
THEMIS
P2Y12 receptor antagonist
CV outcomes trial in patients with type-2 diabetes and coronary artery disease without a previous history of MI or stroke
Q1 2014
2019
2019
2019
2020
Brilinta41
HESTIA
P2Y12 receptor antagonist
prevention of vaso-occlusive crises in paediatric patients with sickle cell disease
Q1 2014
2021
2021
 
 
Farxiga42DECLARE-TIMI 58
SGLT2 inhibitor
CV outcomes trial in patients with type-2 diabetes
Q2 2013
2019
2019
 
 
Farxiga42
SGLT2 inhibitor
type-1 diabetes
Q4 2014
H2 2018
Accepted
H2 2018
 
Farxiga42
SGLT2 inhibitor
worsening HF or CV death in patients with chronic HF
Q1 2017
2020
2020
2020
2020
Farxiga42
SGLT2 inhibitor
renal outcomes and CV mortality in patients with CKD
Q1 2017
2021
2021
2021
2021
Xigduo XR/
Xigduo43
SGLT2 inhibitor/ metformin FDC
type-2 diabetes
 
Launched
Launched
 
2020
Qtern
DPP-4 inhibitor / SGLT2 inhibitor FDC
type-2 diabetes
 
Launched
Launched
 
 
BydureonBCise / Bydureon autoinjector44
GLP-1 receptor agonist
type-2 diabetes
Q1 2013
Launched
Accepted
 
 
Bydureon EXSCEL
GLP-1 receptor agonist
type-2 diabetes outcomes trial
Q2 2010
Q2 2018
Accepted
 
H2 2018
saxagliptin/
dapagliflozin/
metformin
DPP-4 inhibitor / SGLT2 inhibitor
type-2 diabetes
Q2 2017
Q2 2018
Q2 2018
 
 
Epanova
STRENGTH
omega-3 carboxylic acids
CV outcomes trial in statin-treated patients at high CV risk, with persistent hypertriglyceridae-mia plus low HDL-cholesterol
Q4 2014
2020
2020
2020
2020
Respiratory
 
 
 
 
 
 
 
Fasenra38
TERRANOVA GALATHEA
IL-5R mAb
COPD
Q3 2014
H2 2018
H2 2018
2019
 
Fasenra38
OSTRO
IL-5R mAb
nasal polyposis
Q1 2018
2020
2020
 
 
Symbicort
SYGMA
ICS/LABA
as-needed use in mild asthma
Q4 2014
 
H2 2018
 
2019
Duaklir Genuair38
LAMA/LABA
COPD
 
Q2 2018
Launched
 
2019
Other
 
 
 
 
 
 
 
Nexium
proton-pump inhibitor
stress ulcer prophylaxis
 
 
 
 
Accepted
Nexium
proton-pump inhibitor
paediatrics
 
Launched
Launched
Launched
 
linaclotide38
GC-C receptor peptide agonist
irritable bowel syndrome with constipation (IBS-C)
 
 
 
 
Accepted
 
 
Terminations (discontinued projects: 1 January to 31 March 2018)
 
NME / Line Extension
Compound
Reason for Discontinuation
Area Under Investigation
NME
MEDI-56538
safety / efficacy
solid tumours
NME
MEDI9314
strategic
atopic dermatitis
 
 
Completed Projects/Divestitures (1 January to 31 March 2018)
 
Compound
Mechanism
Area Under Investigation
Completed/
Divested

Faslodex
(FALCON)
oestrogen receptor antagonist
1st-line hormone receptor +ve advanced breast cancer
Completed
mavrilimumab38
GM-CSFR mAb
rheumatoid arthritis
divested
inebilizumab38
CD19 mAb
neuromyelitis optica
divested
MEDI4920
anti-CD40L-Tn3 fusion protein
primary Sjögren’s syndrome
divested
MEDI7734
ILT7 mAb
myositis
divested
 
 
Condensed Consolidated Statement Of Comprehensive Income
 
For the quarter ended 31 March
 
2018 
$m 
 
2017 
$m 
Product Sales
 
4,985 
 
4,843 
Externalisation Revenue
 
193 
 
562 
Total Revenue
 
5,178 
 
5,405 
Cost of sales
 
(1,134)
 
(894)
Gross profit
 
4,044 
 
4,511 
Distribution costs
 
(81)
 
(77)
Research and development expense
 
(1,279)
 
(1,453)
Selling, general and administrative costs
 
(2,457)
 
(2,300)
Other operating income & expense
 
469 
 
236 
Operating profit
 
696 
 
917 
Finance income
 
35 
 
18 
Finance expense
 
(343)
 
(340)
Share of after tax losses in associates and joint ventures
 
(14)
 
(13)
Profit before tax
 
374 
 
582 
Taxation
 
(58)
 
(70)
Profit for the period
 
316 
 
512 
 
 
 
 
 
Other comprehensive income
 
 
 
 
Items that will not be reclassified to profit or loss
 
 
 
 
Remeasurement of the defined benefit pension liability
 
27 
 
Fair value movements on equity investments
 
118 
 
Fair value movements related to own credit risk on bonds designated as fair value through profit or loss
 
(1)
 
Tax on items that will not be reclassified to profit or loss
 
(27)
 
(1)
 
 
117 
 
Items that may be reclassified subsequently to profit or loss
 
 
 
 
Foreign exchange arising on consolidation
 
167 
 
154 
Foreign exchange arising on designating borrowings in net investment hedges
 
(99)
 
100 
Fair value movements on cash flow hedges
 
101 
 
Fair value movements on cash flow hedges transferred to profit or loss
 
(80)
 
(39)
Fair value movements on derivatives designated in net investment hedges
 
(46)
 
(30)
Fair value movements on equity investments
 
 
(150)
Tax on items that may be reclassified subsequently to profit or loss
 
20 
 
24 
 
 
63 
 
66 
Other comprehensive income for the period, net of tax
 
180 
 
66 
Total comprehensive income for the period
 
496 
 
578 
 
 
 
 
 
Profit attributable to:
 
 
 
 
Owners of the Parent
 
340 
 
537 
Non-controlling interests
 
(24)
 
(25)
 
 
316 
 
512 
 
 
 
 
 
Total comprehensive income attributable to:
 
 
 
 
Owners of the Parent
 
520 
 
603 
Non-controlling interests
 
(24)
 
(25)
 
 
496 
 
578 
 
 
 
 
 
Basic earnings per $0.25 Ordinary Share
 
$0.27 
 
$0.42 
Diluted earnings per $0.25 Ordinary Share