REG - AstraZeneca PLC - AZN: Year-To-Date and Q3 2017 Results Announcement <Origin Href="QuoteRef">AZN.L</Origin> - Part 3
09/11/2017 07:07
- Part 3: For the preceding part double click ID:nRSI9871Vb
of a second Complete Response Letter from the US FDA, as announced on 17 March 2017. During the period,
the Company made further progress in addressing the manufacturing deficiencies identified by the FDA inspection and expects
to be able to accommodate a new manufacturing inspection in due course.
e) Roxadustat (anaemia)
During the period, the Company and its partner FibroGen Inc. (Fibrogen) announced the regulatory submission of an NDA for
roxadustat with the China FDA, concluding the rolling submission initiated in Q4 2016. The NDA was based on two
Fibrogen-led Phase III trials, conducted in China, that met their primary efficacy endpoints in January 2017 respectively.
If approved, roxadustat will be a first-in-class medicine, with China being the first approval country, ahead of other
major markets.
RESPIRATORY
AstraZeneca's Respiratory portfolio is aimed at transforming the treatment of asthma and COPD through combination 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. 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 co-suspension Delivery Technology, a focus of AstraZeneca's future-platform development for
respiratory-disease combination therapies.
a) Symbicort (COPD)
On 11 September 2017, the US FDA approved Symbicort for the reduction of exacerbations in patients with COPD. The approval
was based on data that evaluated COPD exacerbations as the primary endpoint in two Phase IIIb trials (RISE and Study 003),
supported by data from two legacy Phase IIIa trials (SUN and SHINE). The approval meant Symbicort was indicated to reduce
exacerbations; the medicine is also used as a maintenance treatment for airflow obstruction in patients with COPD. The RISE
data was published in Respiratory Medicine.
Following clinical data from the Phase III SYGMA trials, examining SymbicortTurbuhaler prescribed as an anti-inflammatory
reliever as needed in patients with mild asthma, the primary objectives in severe-asthma exacerbation rates and asthma
control were met. A full evaluation of the SYGMA primary and secondary objectives is ongoing and the results will be
presented at a forthcoming medical meeting.
b) Duaklir (COPD)
On 7 September 2017, AstraZeneca announced positive top-line results from the Phase III AMPLIFY trial for Duaklir, which
met its primary endpoints and demonstrated a statistically-significant improvement in lung function in patients with
moderate to very-severe stable COPD, compared to each individual component (either aclidinium bromide or formoterol). A
full evaluation of the AMPLIFY data is ongoing and further results will be presented at a forthcoming medical meeting.
c) Bevespi (COPD)
On 25 September 2017, the Company announced positive top-line results of the Phase III PINNACLE 4 trial. The trial
demonstrated a statistically-significant improvement in lung function as measured by trough forced expiratory volume in one
second (FEV1), compared to its monotherapy components and placebo, all administered twice daily via pMDI to patients with
moderate to very severe COPD. AstraZeneca will make regulatory submissions for BevespiAerosphere in Japan and China in
2018, based on data from PINNACLE 4, as well as previously-reported trials.
During the period, the first patient was randomised into AERISTO, a head-to-head trial that is assessing the efficacy and
safety of Bevespi Aerosphere relative to the competing dual bronchodilator, a fixed-dose combination of umeclidinium and
vilanterol, for patients with moderate to very severe COPD.
d) Benralizumab (severe, uncontrolled asthma)
On 11 September 2017, results from a sub-group analysis of the SIROCCO and CALIMA Phase III trials were presented at the
aforementioned ERS Congress. The results confirmed benralizumab's efficacy and identified key predictive factors of those
patients suffering from severe, uncontrolled asthma that would respond best to treatment with benralizumab. The results
were published simultaneously in The Lancet Respiratory Medicine.
Benralizumab is under regulatory review in the US, EU, Japan and several other countries, with a US PDUFA date during the
final quarter of 2017. Regulatory decisions are anticipated elsewhere during H1 2018.
e) Tralokinumab (severe, uncontrolled asthma)
On 1 November 2017, AstraZeneca announced the top-line results of the Phase III STRATOS 2 and TROPOS trials for
tralokinumab, an anti-interleukin-13 human monoclonal antibody, in severe, uncontrolled asthma.
STRATOS 1 and 2 were Phase III multi-centre, randomised, double-blinded, parallel-group, placebo-controlled trials designed
to evaluate the efficacy and safety of a regular, subcutaneous administration of tralokinumab for 52 weeks in adult and
adolescent patients with severe, inadequately-controlled asthma, despite treatment with inhaled corticosteroids plus LABA.
In the STRATOS 2 trial, tralokinumab did not achieve a statistically-significant reduction in the annual asthma
exacerbation rate, the primary endpoint, in patients with severe, uncontrolled asthma and elevated levels of a biomarker,
Fractional exhaled Nitric Oxide, compared to placebo. In TROPOS, tralokinumab did not achieve a statistically-significant
reduction in oral corticosteroid (OCS) use, the primary endpoint, when added to the standard of care, in patients dependent
on OCS. Full data from STRATOS 1, STRATOS 2 and TROPOS will be presented at a forthcoming medical meeting.
f) Tezepelumab (asthma)
At the aforementioned ERS Congress, AstraZeneca and Amgen Inc. presented results from the PATHWAY Phase IIb trial of
tezepelumab, a first-in-class treatment that blocks thymic stromal lymphopoietin (TSLP), an upstream driver of inflammation
in asthma. The trial met its primary efficacy endpoint and the data demonstrated significant and clinically-meaningful
annual asthma exacerbation-rate reductions of 61%, 71% and 66% in the tezepelumab arms receiving either 70mg or 210mg every
four weeks or 280mg every two weeks, respectively, independent of baseline blood eosinophil count or other type-2
inflammatory biomarkers. Tezepelumab also demonstrated improvements in lung function at all doses and in asthma control at
the two higher doses. The trial results were simultaneously published in the New England Journal of Medicine.
OTHER
a) Tezepelumab (atopic dermatitis)
During the period, the ALLEVIAD Phase IIa trial data showed that tezepelumab did not meet statistical significance on the
primary endpoint (EASI 50) of the 12-week exploratory trial that evaluated tezepelumab in moderate to severe atopic
dermatitis (AD) as add-on treatment to regular medium-to-high strength topical glucocorticosteroids. Numeric differences in
favour of tezepelumab, however, were observed across a number of disease activity endpoints (EASI, IGA and SCORAD response)
compared to placebo.
b) Anifrolumab (lupus)
During the period, the Company completed the enrolment of the second Phase III trial (TULIP 2) of anifrolumab in patients
with moderate-to-severe systemic lupus erythematosus (SLE, or lupus). Data readouts from both the TULIP 1 and TULIP 2
trials are expected in H2 2018, with anticipated regulatory submissions in 2019.
In addition, the Company also completed enrolment during the period of the Phase II SLE trial of a sub-cutaneous route of
administration of anifrolumab.
c)Lanabecestat (Alzheimer's disease)
During the period, the Company and Lilly completed enrolment of the Phase II/III AMARANTH trial investigating the safety
and efficacy of lanabecestat compared with placebo in the treatment of early Alzheimer's disease. A data readout from the
lanabecestat clinical programme is anticipated in 2019.
Development Pipeline 30 September 2017
________________________________________________________________________________________
AstraZeneca-sponsored or -directed trials
Phase III / Pivotal Phase II / Registration
New Molecular Entities (NMEs) and significant additional indications
Regulatory submission dates shown for assets 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.
Oncology
Calquence#(acalabrutinib) BTK inhibitor B-cell malignancy Q1 2015 Approved
Calquence#(acalabrutinib) BTK inhibitor 1st-line chronic lymphocytic leukaemia Q3 2015 2020(Orphan Drug Designation) 2020(Orphan designation)
Calquence#(acalabrutinib) BTK inhibitor relapsed/refractory chronic lymphocytic leukaemia, high risk Q4 2015 2020(Orphan Drug Designation) 2020(Orphan designation)
Calquence#(acalabrutinib) BTK inhibitor 1st-line mantle cell lymphoma Q1 2017 2023
savolitinib#SAVOIR MET inhibitor papillary renal cell carcinoma Q3 2017 2020 2020
selumetinib MEK inhibitor differentiated thyroid cancer Q3 2013 H2 2018(Orphan Drug Designation) H2 2018
ASTRA
moxetumomab pasudotox#PLAIT anti-CD22 recombinant hairy cell leukaemia Q2 2013 H1 2018(Orphan Drug Designation)
immunotoxin
Imfinzi# +tremelimumab PD-L1 mAb + CTLA-4 mAb 3rd-line NSCLC Q2 2015 H1 2018 H1 2018 H1 2018
ARCTIC
Imfinzi#+ tremelimumabMYSTIC PD-L1 mAb + CTLA-4 mAb 1st-lineNSCLC Q3 2015 H2 2018 H2 2018 H2 2018
Imfinzi#+ tremelimumabNEPTUNE PD-L1 mAb + CTLA-4 mAb 1st-lineNSCLC Q4 2015 2019 2019 2019 2020
Imfinzi#PACIFIC PD-L1 mAb locally-advanced (Stage III), NSCLC Q2 2014 Accepted(Breakthrough Therapy Designation & Priority Review) Accepted Accepted
Imfinzi# + tremelimumab + chemotherapyPOSEIDON PD-L1 mAb + CTLA-4 mAb 1st-lineNSCLC Q2 2017 2019 2019 2019 2020
Imfinzi#+ tremelimumab + SoCCASPIAN PD-L1 mAb + CTLA-4 mAb + SoC 1st-line small cell lung cancer Q1 2017 2020 2020 2020
Imfinzi#+ tremelimumab PD-L1 mAb + CTLA-4 mAb 1st-line HNSCC Q4 2015 H2 2018 H2 2018 H2 2018
KESTREL
Imfinzi# + tremelimumab PD-L1 mAb + CTLA-4 mAb 2nd-line HNSCC Q4 2015 H2 2018 H2 2018 H2 2018
EAGLE
Imfinzi#+ tremelimumabDANUBE PD-L1 mAb + CTLA-4 mAb 1st-line bladder cancer Q4 2015 2019 2019 2019
Lynparza#¶+ cediranibCONCERTO PARP inhibitor + VEGF inhibitor recurrent platinum-resistant ovarian cancer Q1 2017 2019
CVMD
Epanova omega-3 carboxylic acids severe hypertriglycerid-aemia Approved 2020
ZS-9 (sodium zirconium cyclosilicate) potassium binder hyperkalaemia - Accepted1 2019
roxadustat# OLYMPUS (US) ROCKIES (US) hypoxia-inducible factor prolyl hydroxylase inhibitor anaemia in CKD / end-stage renal disease Q3 2014 H2 2018 Accepted2
Respiratory
Bevespi Aerosphere (PT003) LABA/LAMA COPD Launched Accepted H2 2018 H2 2018
benralizumab#CALIMA SIROCCO ZONDABISEBORAGREGALE IL-5R mAb severe, uncontrolled asthma Accepted Accepted Accepted 2021
benralizumab#TERRANOVA GALATHEA IL-5R mAb COPD Q3 2014 H2 2018 H2 2018 2019
PT010 LABA/LAMA/ ICS COPD Q3 2015 2019 2019 H2 2018 H2 2018
tralokinumabSTRATOS 1,2TROPOSMESOS IL-13 mAb severe, uncontrolled asthma Q3 2014 - - -
Other
anifrolumab# TULIP IFN-alphaR mAb systemic lupus erythematosus Q3 2015 2019(Fast Track) 2019 2019
lanabecestat#AMARANTH + extension, DAYBREAK-ALZ beta-secretase inhibitor Alzheimer's disease Q2 2016 2020(Fast Track) 2020 2020
Alzheimer's disease
Q2 2016
2020(Fast Track)
2020
2020
¶ Registrational Phase IItrial
# Collaboration
1 CHMP positive opinion received
2 Fibrogen completed rolling regulatory submission in China
Phases I and II
NMEs and significant additional indications
Oncology
Imfinzi# PD-L1 mAb solid tumours II Q3 2014
Imfinzi# + tremelimumab PD-L1 mAb + CTLA-4 mAb HCC II Q4 2016
Imfinzi# + tremelimumab PD-L1 mAb + CTLA-4 mAb gastric cancer II Q2 2015
Imfinzi# + AZD5069 PD-L1 mAb + CXCR2 antagonist pancreatic ductal adenocarcinoma II Q2 2017
Imfinzi# + AZD5069 or Imfinzi# + AZD9150# PD-L1 mAb + CXCR2 antagonist or PD-L1 mAb + STAT3 inhibitor HNSCC II Q3 2015
Imfinzi# + dabrafenib + trametinib PD-L1 mAb + BRAF inhibitor + MEK inhibitor melanoma I Q1 2014
Imfinzi# + AZD1775# PD-L1 mAb + Wee1 inhibitor solid tumours I Q4 2015
Imfinzi# + MEDI0680 PD-L1 mAb + PD-1 mAb solid tumours II Q3 2016
Imfinzi# or Imfinzi# + (tremelimumab or AZD9150#) PD-L1 mAb or PD-L1 mAb + (CTLA-4 mAb or STAT3 inhibitor) diffuse large B-cell lymphoma I Q3 2016
Imfinzi#+ Iressa PD-L1 mAb + EGFR inhibitor NSCLC I Q2 2014
Imfinzi#+ MEDI0562# PD-L1 mAb + humanised OX40 agonist solid tumours I Q2 2016
Imfinzi# + MEDI9197# PD-L1 mAb + TLR 7/8 agonist solid tumours I Q2 2017
Imfinzi# + MEDI9447 PD-L1 mAb + CD73 mAb solid tumours I Q1 2016
Imfinzi# + monalizumab PD-L1 mAb + NKG2a mAb solid tumours I Q1 2016
Imfinzi#+ selumetinib PD-L1 mAb + MEK inhibitor solid tumours I Q4 2015
Imfinzi# + tremelimumab PD-L1 mAb + CTLA-4 mAb solid tumours I Q4 2013
tremelimumab + MEDI0562# CTLA-4 mAb + humanised OX40 agonist solid tumours I Q2 2016
Imfinzi# + azacitidine PD-L1 mAb + azacitidine myelodysplastic syndrome I Q2 2016
Imfinzi#+ MEDI0457# PD-L1 mAb + DNA HPV vaccine HNSCC I Q3 2017
Lynparza#+ AZD6738 PARP inhibitor + ATR inhibitor gastric cancer II Q3 2016
Lynparza# + AZD1775# PARP inhibitor + Wee1 inhibitor solid tumours I Q3 2015
Lynparza# + ImfinziMEDIOLA PARP inhibitor + PD-L1 mAb solid tumours II Q2 2016
Tagrisso + (selumetinib# or savolitinib#)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
AZD1775#+ chemotherapy Wee1 inhibitor + chemotherapy ovarian cancer II Q4 2012
AZD1775# Wee1 inhibitor solid tumours II Q1 2016
vistusertib mTOR inhibitor solid tumours II Q1 2013
AZD5363# AKT inhibitor breast cancer II Q1 2014
AZD4547 FGFR inhibitor solid tumours II Q4 2011
MEDI-573# IGF mAb metastatic breast cancer II Q2 2012
AZD0156 ATM inhibitor solid tumours I Q4 2015
AZD2811# Aurora B inhibitor solid tumours I Q4 2015
AZD4635 A2aR inhibitor solid tumours I Q2 2016
AZD4785 KRAS inhibitor solid tumours I Q2 2017
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
MEDI-565# CEA BiTE mAb solid tumours I Q1 2011
MEDI0562# humanised OX40 agonist solid tumours I Q1 2015
MEDI0680 PD-1 mAb solid tumours I Q4 2013
MEDI1873 GITR agonist fusion protein solid tumours I Q4 2015
MEDI3726# PSMA antibody drug conjugate prostate cancer I Q1 2017
MEDI4276 HER2 bi-specific antibody drug conjugate solid tumours I Q4 2015
MEDI5083 immune activator solid tumours I Q1 2017
MEDI7247 antibody drug conjugate haematological malignancies I Q2 2017
MEDI9197# TLR 7/8 agonist solid tumours I Q4 2015
MEDI9447 CD73 mAb solid tumours I Q3 2015
CVMD
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 I Q1 2016
AZD8601# VEGF-A CV disease I Q1 2017
MEDI5884# cholesterol modulation CV disease I Q1 2017
Respiratory
abediterol# LABA asthma / COPD II Q4 2007
tezepelumab# TSLP mAb asthma / atopic dermatitis II Q2 2014
AZD1419# inhaled TLR9 agonist asthma II Q4 2016
AZD7594 inhaled SGRM asthma / COPD II Q3 2015
AZD8871# MABA COPD II Q1 2017
PT010 LABA/LAMA/ICS asthma II Q2 2014
AZD5634 inhaled ENaC cystic fibrosis I Q1 2016
AZD7594 + abediterol# inhaled SGRM + LABA asthma / COPD I Q4 2016
AZD7986# DPP1 COPD I Q4 2014
AZD9567 oral SGRM rheumatoid arthritis / respiratory I Q4 2015
AZD9898# LTC4S asthma I Q2 2017
MEDI3506 IL-33 mAb COPD I Q2 2017
Other
anifrolumab# IFN-alphaR mAb lupus nephritis II Q4 2015
anifrolumab# IFN-alphaR mAb systemic lupus erythematosus (subcutaneous) II Q1 2017
inebilizumab# CD19 mAb neuromyelitis optica II(Orphan drug US, EU) Q1 2015
mavrilimumab# GM-CSFR mAb rheumatoid arthritis II Q1 2010
MEDI3902 Psl/PcrV bispecific mAb prevention of nosocomial Pseudomonas aeruginosa pneumonia II(Fast Track, US) Q2 2016
MEDI4893 mAb binding to S. aureus toxin prevention of nosocomial Staphylococcus aureuspneumonia II(Fast Track, US) Q4 2014
MEDI5872# B7RP1 mAb primary Sjögren's syndrome II Q3 2015
MEDI8852 influenza A mAb influenza A treatment II(Fast Track, US) Q4 2015
MEDI8897# RSV mAb-YTE passive RSV prophylaxis II(Fast Track, US) Q1 2015
AZD0284 RORg psoriasis / respiratory I Q4 2016
MEDI0700# BAFF/B7RP1 bispecific mAb systemic lupus erythematosus I Q1 2016
MEDI1814# amyloid beta mAb Alzheimer's disease I Q2 2014
MEDI4920 anti-CD40L-Tn3 fusion protein primary Sjögren's syndrome I Q2 2014
MEDI7352 NGF/TNF bi-specific mAb osteoarthritis pain I Q1 2016
MEDI7734 ILT7 mAb myositis I Q3 2016
MEDI9314 IL-4R mAb atopic dermatitis I Q1 2016
Q3 2016
MEDI9314
IL-4R mAb
atopic dermatitis
I
Q1 2016
# Collaboration
Significant Lifecycle Management
Oncology
FaslodexFALCON oestrogen receptor antagonist 1st-line hormone receptor +ve advanced breast cancer Approved Approved Approved H2 2017
Imfinzi#PEARL (China) PD-L1 mAb 1st-lineNSCLC Q1 2017 2020
Lynparza# OlympiAD PARP inhibitor gBRCA metastatic breast cancer Q2 2014 Accepted(Priority Review) H1 2018 Accepted(Orphan drug designation, Priority Review) H2 2018
Lynparza# PARP inhibitor 2nd-line or greater BRCAm PSR ovarian cancer, maintenance monotherapy Q3 2013 Approved(Priority Review) Accepted Accepted(Orphan drug designation) H1 2018
SOLO-2
Lynparza# PARP inhibitor 1st-line BRCAm ovarian cancer Q3 2013 H2 2018 H2 2018 H2 2018 2019
SOLO-1
Lynparza# PARP inhibitor gBRCA PSR ovarian cancer Q1 2015 H2 2018
SOLO-3
Lynparza# PARP inhibitor pancreatic cancer Q1 2015 2019 2019
POLO
Lynparza#PROfound PARP inhibitor prostate cancer Q1 2017 2020(Breakthrough Therapy Designation) 2020 2020 2020
Lynparza#OlympiA PARP inhibitor gBRCA adjuvant breast cancer Q2 2014 2020 2020 2020
Tagrisso FLAURA EGFR inhibitor 1st-line advanced EGFRm NSCLC Q1 2015 H2 2017(Breakthrough Therapy designation) H2 2017 H2 2017 2018
Tagrisso ADAURA EGFR inhibitor adjuvant EGFRm NSCLC Q4 2015 2022 2022 2022 2022
CVMD
Brilinta1THEMIS P2Y12 receptor antagonist CV outcomes trial in patients with type-2 diabetes and coronary artery disease without a previous history ofMI or stroke Q1 2014 2019 2019 2019 2020
Brilinta1HESTIA P2Y12 receptor antagonist prevention of vaso-occlusive crises in paediatric patients with sickle cell disease Q1 2014 2021 2021
Kombiglyze XR/Komboglyze2 DPP-4 inhibitor / metformin FDC type-2 diabetes Launched Launched Launched
Farxiga3 SGLT2 inhibitor CV outcomes trial in patients with type-2 diabetes Q2 2013 2019 2019
DECLARE-
TIMI 58
Farxiga3 SGLT2 inhibitor type-1 diabetes Q4 2014 H2 2018 H1 2018 H2 2018
Farxiga3 SGLT2 inhibitor worsening HF or CV death in patients with chronic HF Q1 2017 2020 2020 2020 2020
Farxiga3 SGLT2 inhibitor renal outcomes and CVmortality in patients with CKD Q1 2017 2021 2021 N/A 2021
Xigduo XR/Xigduo4 SGLT2 inhibitor/ metformin FDC type-2 diabetes Launched Launched 2020
Qtern DPP-4 inhibitor / SGLT2 inhibitor FDC type-2 diabetes Approved Launched
Bydureon GLP-1 receptor agonist type-2 diabetes Q1 2013 Approved Accepted
BCise (autoinjector)
Bydureon EXSCEL GLP-1 receptor agonist type-2 diabetes outcomes trial Q2 2010 H2 2017 H2 2017 H2 2018
saxagliptin/dapagliflozin/metformin DPP-4 inhibitor / SGLT2 inhibitor type-2 diabetes Q2 2017 H1 2018 H1 2018
EpanovaSTRENGTH 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
SymbicortSYGMA ICS/LABA as-needed use in mild asthma Q4 2014 2018 2019
Duaklir Genuair# LAMA/LABA COPD H1 2018 Launched 2019
Other
Nexium proton-pump inhibitor stress ulcer prophylaxis Accepted
Nexium proton-pump inhibitor paediatrics Launched Launched Accepted
linaclotide# GC-C receptor peptide agonist irritable bowel syndrome with constipation Accepted
(IBS-C)
Launched
Launched
Accepted
linaclotide#
GC-C receptor peptide agonist
irritable bowel syndrome with constipation
(IBS-C)
Accepted
# Collaboration
1 Brilinta in the US and Japan; Brilique in ROW
2 Kombiglyze XR in the US; Komboglyze in the EU
3 Farxiga in the US; Forxiga in ROW
4 Xigduo XR in the US; Xigduo in the EU
Terminations (discontinued projects: 1 July 2017 to 30 September 2017)
NME / Line Extension Compound Reason for Discontinuation Area Under Investigation
NME MEDI8111 strategic trauma / bleeding
Completed Projects/Divestitures (1 July 2017 to 30 September 2017)
Compound Mechanism Area Under Investigation Completed/Divested Estimated Regulatory Submission Acceptance
US EU Japan China
AZD9150 STAT3 inhibitor haematological malignancies Completed - - - -
# Collaboration
Condensed Consolidated Statement of Comprehensive Income
Product sales 14,665 16,059
Externalisation revenue 2,023 1,358
Total revenue 16,688 17,417
Cost of sales (3,093) (2,966)
Gross profit 13,595 14,451
Distribution costs (225) (243)
Research and development expense (4,206) (4,347)
Selling, general and administrative costs (7,155) (8,027)
Other operating income and expense 982 535
Operating profit 2,991 2,369
Finance income 71 44
Finance expense (1,199) (1,022)
Share of after tax losses in associates and joint ventures (43) (22)
Profit before tax 1,820 1,369
Taxation (213) 220
Profit for the period 1,607 1,589
Other comprehensive income/(loss)
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability (146) (1,127)
Tax on items that will not be reclassified to profit or loss 23 256
(123) (871)
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation 531 (690)
Foreign exchange arising on designating borrowings in net investment hedges 622 (194)
Fair value movements on cash flow hedges 226 (26)
Fair value movements on cash flow hedges transferred to profit or loss (281) 41
Fair value movements on derivatives designated in net investment hedges (39) (96)
Amortisation of loss on cash flow hedge 1 1
Net available for sale (losses)/gains taken to equity (36) 126
Tax on items that may be reclassified subsequently to profit or loss (125) 63
899 (775)
Other comprehensive income/(loss) for the period, net of tax 776 (1,646)
Total comprehensive income/(loss) for the period 2,383 (57)
Profit attributable to:
Owners of the Parent 1,700 1,657
Non-controlling interests (93) (68)
1,607 1,589
Total comprehensive income/(loss) attributable to:
Owners of the Parent 2,476 12
Non-controlling interests (93) (69)
2,383 (57)
Basic earnings per $0.25 Ordinary Share $1.34 $1.31
Diluted earnings per $0.25 Ordinary Share $1.34 $1.31
Weighted average number of Ordinary Shares in issue (millions) 1,266 1,265
Diluted weighted average number of Ordinary Shares in issue (millions) 1,266 1,266
Diluted weighted average number of Ordinary Shares in issue (millions)
1,266
1,266
Condensed Consolidated Statement of Comprehensive Income
For the quarter ended 30 September 2017 $m 2016 $m
Product sales 4,882 5,025
Externalisation revenue 1,350 674
Total revenue 6,232 5,699
Cost of sales (1,249) (900)
Gross profit 4,983 4,799
Distribution costs (76) (76)
Research and development expense (1,404) (1,402)
Selling, general and administrative costs (2,497) (2,403)
Other operating income and expense 143 110
Operating profit 1,149 1,028
Finance income 32 13
Finance expense (418) (355)
Share of after tax losses in associates and joint ventures (17) (10)
Profit before tax 746 676
Taxation (97) 319
Profit for the period 649 995
Other comprehensive income/(loss)
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability 125 (285)
Tax on items that will not be reclassified to profit or loss (48) 21
77 (264)
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation 154 (167)
Foreign exchange arising on designating borrowings in net investment hedges 239 (127)
Fair value movements on cash flow hedges 99 77
Fair value movements on cash flow hedges transferred to profit or loss (81) (19)
Fair value movements on derivatives designated in net investment hedges (4) (17)
Net
- More to follow, for following part double click ID:nRSI9871VdRecent news on AstraZeneca
See all newsRCS - LHH - LHH, EZRA's AI Leadership Transformation Program
AnnouncementREG - AstraZeneca PLC - Baxdrostat met primary endpoint in Bax24 Ph3 trial
AnnouncementREG - AstraZeneca PLC - Datroway improved OS and PFS in TROPION-Breast02
AnnouncementREG - AstraZeneca PLC - Total Voting Rights
AnnouncementREG - AstraZeneca PLC - Enhertu improved IDFS in early BC in DB-05
Announcement