REG - AstraZeneca PLC - 1st Quarter Results <Origin Href="QuoteRef">AZN.L</Origin> - Part 1

AstraZenecaAnnouncement

15/07/2015 14:30

RNS Number : 2049L
AstraZeneca PLC
24 April 2015
AstraZeneca PLC
Q1 2015 Results
24 April 2015
Results support reiterated 2015 guidance. 
Delivery of a focused, accelerated and science-based pipeline continues.
Financial Summary


% change

$m
CER1
Actual
Total Revenue2
6,057
1
(6)




Core3 Operating Profit
1,805
(4)
(8)
Core EPS
$1.08
(3)
(7)




Reported Operating Profit
933
15
11
Reported EPS
$0.44
10
9
 Total Revenue grew by 1%
 Core EPS declined by 3%; investment in scientific leadership maintained
 Reported Operating Profit grew by 15%
Commercial Highlights
The focus on further externalisation continued, including a US co-commercialisation agreement for Movantik. Growth platforms grew by 13%, representing 56% of Total Revenue:
1. Brilinta/Brilique:+45%. Publication of encouraging PEGASUS data at the ACC conference last month
2. Diabetes: +47%. Particularly good growth for Farxiga/Forxiga
3. Respiratory: +7%. Symbicort stable as expected with Pulmicort delivering a strong performance
4. Emerging Markets: +18%. China +28%, where Respiratory sales were up by 39%
5. Japan: -2%. The final effects of the biennial price cuts impacted Q1 sales
FY 2015 Guidance is unchanged from that provided on 6 March 2015.
Achieving Scientific Leadership 
Regulatory Approvals
Bydureon Pen - diabetes (JP)
Regulatory Submission Acceptances
lesinurad - gout (US), saxagliptin/dapagliflozin - diabetes (US)
Phase III Read-outs
PT003 - COPD: Positive
Other Key Developments
Brilinta/Brilique - prior myocardial infarction: Positive Phase III publication Onglyza - diabetes: FDA panel recommends label safety update
selumetinib - uveal melanoma: FDA Orphan-Drug designation
tremelimumab - mesothelioma: FDA Orphan-Drug designation 
MEDI4736 - lung cancer: FDA Fast-Track designation
MEDI8897 - RSV: FDA Fast-Track designation


Forthcoming Regulatory Submissions
brodalumab - psoriasis4
AZD9291 - lung cancer, cediranib - ovarian cancer (EU)
Forthcoming Regulatory Decisions
lesinurad 
saxagliptin/dapagliflozin, Brilinta/Brilique
Iressa - lung cancer (US)
Pascal Soriot, Chief Executive Officer, commenting on the results said:
"Our encouraging performance in the quarter supports our full year guidance. Total Revenue grew by 1%, with the growth platforms representing 56%, after particularly strong results in Emerging Markets and with Brilinta/Brilique. Our co-commercialisation agreement for Movantik in the US was a good illustration of how we will bring important medicines to patients and externalisation value to our shareholders.
"Our pipeline progressed well in each of our therapy areas. Highlights included the positive top-line results from the Phase III PINNACLE programme for our respiratory medicine PT003 and data from the PEGASUS study for Brilinta/Brilique in cardiovascular disease. We received two submission acceptances for new medicines, two FDA Orphan-Drug and two Fast-Track designations. We look forward to presenting data through the year. 
"We also continued to reinforce our Oncology franchise and now have 72 trials underway, including 31 in Immuno-Oncology. The latest AZD9291 data, which showed strong clinical benefit of 13.5 months progression-free survival, and the Fast-Track designation by the FDA for MEDI4736, both for patients with lung cancer, illustrate the rapid progress we are making in this area. Our strategic collaboration with Celgene, a leader in haematology, will maximise the potential of our Immuno-Oncology assets in the very important haematology indications, and our collaboration with Innate Pharma will further strengthen our Immuno-Oncology franchise."
Notes
1. All growth rates are shown at constant exchange rates (CER) unless specified otherwise. 
2. Total Revenue defined as Product Sales and Externalisation Revenue. For further details on the presentation of Total Revenue, see the announcement published by the Company on 6 March 2015.
3. See Operating and Financial Review for a definition of Core financial measures and a reconciliation of Core to Reported financial measures.
4. Brodalumab developed in collaboration with Amgen who will be responsible for regulatory submission.
Results Presentation
A conference call and audio webcast for investors and analysts, hosted by management, will start at midday BST today. The webcast can be accessed via www.astrazeneca.com/investors.
Reporting Calendar
The Company intends to publish its half year and second quarter financial results on 30 July 2015.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
Media Enquiries


Esra Erkal-Paler
UK/Global
+44 20 7604 8030
Vanessa Rhodes
UK/Global
+44 20 7604 8037
Ayesha Bharmal
UK/Global
+44 20 7604 8034
Jacob Lund
Sweden
+46 8553260 20
Investor Enquiries



UK



Thomas Kudsk Larsen
Cardiovascular and
Metabolic Disease (CVMD)
+44 20 7604 8199
mob: +44 7818 524185
Eugenia Litz
Respiratory, Inflammation and Autoimmunity (RIA)
+44 20 7604 8233
mob: +44 7884 735627
Karl Hrd
Oncology
+44 20 7604 8123
mob: +44 7789 654364
Craig Marks
Infection, Neuroscience and Gastrointestinal (ING)
+44 20 7604 8591
mob: +44 7881 615764
Christer Gruvris

+44 20 7604 8126
mob: +44 7827 836825
US



Dial / Toll-Free

 +1 301 398 3251
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Contents
Research and Development Update
Corporate and Business Development
Operating and Financial Review
Interim Financial Statements
Development Pipeline
Research and Development Update
_________________________________________________________________________________
A comprehensive update of the AstraZeneca development pipeline is presented in conjunction with this announcement and can be found later in this announcement.
Highlights since the prior results announcement on 5 February 2015:
Regulatory Approvals
1
- Bydureon Pen - diabetes (JP) (LCM)
Regulatory Submissions* and/or Regulatory Submission 
Acceptances**
3
- lesinurad - gout (US)**
- Brilinta/Brilique - prior myocardial infarction*
- saxagliptin/dapagliflozin fixed dose 
combination - diabetes (US) (LCM)**
Phase III Read-outs
1
- PT003 - COPD (PINNACLE 1 & 2 studies)
Pivotal Study starts
2
- AZD9291 - 1L EGFRm NSCLC (FLAURA 
study)
- MEDI4736 - 2L SCCHN (HAWK study)
Major Phase II Read-outs
2
- PT010 - COPD
- anifrolumab - systemic lupus erythematosus 
New Molecular Entities (NMEs) in Pivotal Studies or under Regulatory Review 
13
RIA
- lesinurad - gout
- brodalumab - psoriasis
- PT003 - COPD 
- benralizumab - severe asthma
- tralokinumab - severe asthma
CVMD
- roxadustat - anaemia
Oncology
- AZD9291 - lung cancer 
- cediranib - ovarian cancer
- selumetinib - uveal melanoma
- tremelimumab - mesothelioma 
- MEDI4736 - lung cancer 
- moxetumomab pasudotox - leukaemia 
ING
- CAZ AVI - serious infections
Projects in clinical pipeline
119
Key: LCM - life-cycle management. 
In 2015-2016 AstraZeneca anticipates 12-16 Phase II starts, 14-16 NME and major line-extension regulatory submissions and 8-10 NME and major line-extension approvals. 
There has been notable progress since the last update; highlights are included below. This near-term progress reinforces the longer-term sustainability of the pipeline, supported by a continued shift in focus from rebuilding the late-stage pipeline to regulatory submissions and approvals, whilst continuing to transition high-quality programmes to late stage as rapidly as possible. 
1. Respiratory, Inflammation and Autoimmunity (RIA)
Significant progress was made across the RIA pipeline, which included five programmes in pivotal studies or registration. AstraZeneca holds a unique position in respiratory disease, including asthma, chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF), with a range of differentiated potential medicines in development by leveraging novel combinations, biologics and devices. The pipeline also has several promising assets in inflammatory and autoimmune disease areas such as dermatology, gout, systemic lupus, rheumatoid and psoriatic arthritis.
Lesinurad (SURI)
On 12 March 2015 the US Food and Drug Administration (FDA) notified AstraZeneca that it considered the new drug application (NDA) for lesinurad 200mg tablets sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) goal date is in the fourth quarter. Lesinurad isa selective uric acid re-absorption inhibitor (SURI) developed for the chronic treatment of hyperuricaemia in combination with xanthine oxidase (XO) inhibitors allopurinol or febuxostat in gout patients, when additional therapy is warranted.Between 40 to 80% of patients do not achieve recommended serum uric acid (sUA) goals with the current standard of care of an XO inhibitor alone. AstraZeneca's combination with lesinurad effectively lowers sUA and enables significantly more patients to achieve and maintain target treatment goals to control their disease.
PT003 (LAMA/LABA)
On 18 March 2015 AstraZeneca announced positive top-line results from the Phase III PINNACLE programme, which showed the potential of PT003 as a novel treatment for improving lung function in patients suffering the chronic symptoms of COPD. AstraZeneca's ability to deliver a unique LAMA/LABA formulation in a single pressurised metered dose inhaler (pMDI) is important for helping some 30% of patients around the world who use an aerosol device. 
The successful completion of the PINNACLE 1 and 2 studies marks the first Phase III results from a series of pipeline candidates under development by AstraZeneca using Pearl Therapeutics' novel formulation technology.
Anifrolumab (MEDI-546)
The Company has been exploring interferon (IFN) inhibition in moderate to severe systemic lupus erythematosus (SLE or lupus) via two different approaches in Phase IIb trials, both of which highlight the promise of the Type 1 IFN pathway in treating lupus. Sifalimumab (MEDI-545) binds to interferon- to block IFN- signalling through the Type 1 IFN receptor complex. Anifrolumab (MEDI-546) binds to subunit 1 of the Type 1 IFN receptor, inhibiting activity of all Type 1 IFNs.
In a recent Phase IIb trial, anifrolumab met the primary endpoint of reduction in global disease activity score (SRI-4) at six months, with responders also tapering to <10mg/day steroids. Based on an initial analysis of the current data, the Company believes anifrolumab has a more favourable benefit-risk profile and therefore, has selected anifrolumab as the IFN pathway inhibitory molecule to progress into further development, with a Phase III clinical programme planned to start in 2015. The Company does not currently intend to further develop sifalimumab in lupus, and any future decisions about this molecule in other potential indicationswill be made based on further examination of available data. Full anifrolumab Phase IIb data is expected to be presented at a scientific meeting later in the year. 
2. Cardiovascular and Metabolic Disease (CVMD)
AstraZeneca's strategy in CVMD focuses on ways to reduce morbidity, mortality and organ damage by addressing multiple risk factors across cardiovascular disease, diabetes and chronic kidney disease indications. The patient-centric approach is reinforced by science-led life-cycle management programmes and technologies, including early research into regenerative methods.
Brilinta/Brilique
On 14 March 2015 AstraZeneca announced detailed results from the PEGASUS-TIMI 54 study, which showed that long-term treatment with Brilinta/Brilique 60mg and 90mg tablets twice-daily plus low-dose aspirin reduced thrombotic cardiovascular events in patients with a history of heart attack, compared to placebo. The Company has submitted regulatory filings to the European Medicines Agency and the FDA and looks forward to working with these agencies towards a potential new indication in major markets.
For patients more than one year on from a heart attack, the current standard of care is aspirin alone. Coupled with the PLATO study, PEGASUS-TIMI 54 provides consistent evidence of the benefit Brilinta/Brilique can bring to patients with coronary artery disease in acute and chronic secondary prevention.
On 30 March 2015 the FDA approved a new administration option for acute coronary syndrome patients who are unable to swallow Brilinta 90mg tablets whole. Unlike other P2Y12 inhibitors, Brilinta received FDA approval to be crushed and administered in water by swallowing or via nasogastric tube.
AstraZeneca is committed to enhancing scientific understanding of the role of Brilinta/Brilique in a wide range of cardiovascular disorders, including stroke, myocardial infarction and peripheral arterial disease through PARTHENON, the Company's largest ever cardiovascular outcomes programme involving nearly 80,000 patients.
Onglyza SAVOR Study: FDA Advisory Committee Meeting
The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted on 14 April 2015 that the results of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) study demonstrated that the use of saxagliptin in patients with Type-2 diabetes has an acceptable cardiovascular risk profile. The Committee recommended that the FDA supplement the medicine's labelling to add new safety information.
AstraZeneca will also conduct further investigation to better understand the signal of hospitalisation for heart failure found in the SAVOR results.
SAVOR met the primary safety objective, demonstrating that Onglyza did not increase the risk for cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke when added to a patient's current standard of care, with or without other anti-diabetic therapies, as compared to placebo. The supplemental New Drug Applications (sNDAs), based on the SAVOR results, if approved, will provide prescribers and patients with important additional information about the benefit-risk profile of Onglyza and Kombiglyze XR. 
3. Oncology
AstraZeneca's vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients by the year 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and haematological cancers. The Company is also exploring other tumour types where there is unmet medical need. These are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA-damage repair, and antibody drug conjugates, underpinned by personalised healthcare and biomarker technologies. Today there are six AstraZeneca Oncology NMEs in pivotal studies or under regulatory review.
Iressa Label Update in China
On 2 March 2015 the China Food and Drug Administration (CFDA) approved an update to the Iressa (gefitinib) label to include blood-based diagnostics. The decision means that Iressa is now the first tyrosine kinase inhibitor (TKI) in China to include blood-based diagnostics on its label. Tumour samples gained through biopsy are the primary method for determining a patient's epidermal growth factor receptor (EGFR) mutation status. However almost a quarter of patients with locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) do not have an available or evaluable tumour sample for this method of testing and are therefore ineligible to receive treatment with Iressa. Based on the CFDA decision, doctors will be able to use circulating-tumour DNA obtained from a blood sample to identify lung-cancer patients who are eligible to receive Iressa.
AZD9291 (EGFR)
In March 2015 the first patient was dosed in the FLAURA study ofAZD9291 as a potential treatment for first-line EGFR-mutated NSCLC. FLAURA is a Phase III study designed to assess the safety and efficacy of AZD9291 versus a standard of care EGFR-TKI (gefitinib and erlotinib). 
AZD9291 is on track for a Q2 2015 regulatory submission for the treatment of patients with advanced EGFR-mutated NSCLC who also have the T790M resistance mutation after the failure of standard first-line anti-EGFR treatment.
European Lung Cancer Conference, 15-18 April 2015
On 17 April 2015 AstraZeneca announcedlatest data from the ongoing AURA study of AZD9291 in patients with advanced epidermal growth factor receptor mutation-positive (EGFRm) NSCLC, who also have the T790M-resistance mutation. The data demonstrated a median progression-free survival of 13.5 months (95% confidence interval (CI), 8.3 months to not calculable (NC)).
Selumetinib Granted Orphan-Drug Designation 
On 17 April 2015 AstraZeneca announced that the FDA has granted Orphan-Drug designation for the MEK inhibitor, selumetinib, in the treatment of uveal melanoma. Uveal melanoma is a rare disease in which cancer cells form in the tissues of the eye. It is the most common primary intraocular malignancy in adults and comprises 5% of all melanomas. The Orphan-Drug designation programme provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.
Selumetinib inhibits the MEK pathway in cancer cells to prevent the tumour from growing. Data from a Phase III study evaluating selumetinib in combination with chemotherapy in patients with first-line metastatic uveal melanoma is expected to be available later this year. In addition to uveal melanoma, selumetinib is being investigated in Phase III studies in KRAS mutation-positive lung cancer and thyroid cancer and in Phase II in children with neurofibromatosis Type 1.
Tremelimumab (CTLA-4) Granted Orphan-Drug Designation
On 15 April 2015 AstraZeneca announcedthat the FDA had granted Orphan-Drug designation for the anti-CTLA-4 monoclonal antibody, tremelimumab, for the treatment of malignant mesothelioma. Mesothelioma is a rare, aggressive cancer that affects the lining of the lungs and abdomen. Available treatments for mesothelioma are very limited, particularly for patients with advanced disease. 
Tremelimumab is currently being investigated in a pivotal Phase II randomised study for the potential use as a second-line treatment in patients with undetectable pleural or peritoneal malignant mesothelioma. Detailed results from this study are expected this year.
MEDI4736 (PD-L1) Clinical Trials Update
The FDA recently granted Fast-Track designation to the investigation of the anti-PD-L1 monoclonal antibody MEDI4736 as a monotherapy treatment for certain patients with advanced NSCLC, who have received at least two prior systemic-treatment regimens, do not have EGFR mutations or anaplastic lymphoma kinase (ALK) alterations, and have tumours that are determined to be PD-L1 positive. Fast-Track programmes are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
MEDI4736 is being investigated as a monotherapy in NSCLC and squamous cell carcinoma of head and neck cancer (SCCHN). ATLANTIC, a Phase II trial in third-line PD-L1 positive metastatic NSCLC, is on track to deliver data in 2015 and could potentially, if positive, support a regulatory submission. Additional trials include PACIFIC, a Phase III trial in locally-advanced unresectable NSCLC, ADJUVANT, a Phase III trial in adjuvant NSCLC, and HAWK, a Phase II trial in second-line PD-L1 positive metastatic SCCHN (all recruiting patients). In addition, ARCTIC, a Phase III trial in third-line metastatic NSCLC contains a monotherapy sub-study for PD-L1 positive patients and is recruiting patients.
MEDI4736 is also being tested as a concurrent combination treatment with tremelimumab in NSCLC and SCCHN. ARCTIC contains a substudy for PD-L1 negative patients. Data on dosing selection and scheduling will be presented at the upcoming ASCO meeting. In addition, EAGLE, a Phase III trial and CONDOR, a Phase II trial (both in SCCHN) are being initiated. Several further internal-combination trials are ongoing with MEDI4736, including combinations in NSCLC with Iressa (gefitinib), AZD9291 and selumetinib. 
Pharmacyclics and AstraZeneca have begun PCYC-1135-CA, a multi-centre study that will investigate the use of ibrutinib (Imbruvica) in combination with MEDI4736. The Phase Ib/II study will examine the safety, tolerability and effectiveness of this investigational combination in individuals with relapsed or refractory NSCLC, breast cancer, and pancreatic cancer.
American Association for Cancer Research (AACR), 18-22 April 2015
During the AACR annual meeting in Philadelphia, AstraZeneca and MedImmune presented 62 scientific abstracts, of which 15 were oral presentations. These abstracts demonstrated the strength and depth of the early-stage Oncology pipeline in AstraZeneca and MedImmune.
Key presentations at AACR included:
- Data showing activity of investigational compounds targeting key molecular pathways including OX40, CD73, PI3K, AKT, mTOR, EGFR, SERD and PARP
- Pre-clinical data on the potential combination of AZD9291 and savolitinib (AZD6094, previously known as volitinib) to prevent and treat newly-identified forms of resistance in EGFR-mutated NSCLC
- Data on AZD9496, a novel, selective oestrogen receptor down-regulator (SERD) being studied as a potential treatment for patients with oestrogen receptor positive (ER+) breast cancer 
- Other key data presented at AACR were from clinical trials exploring combinations of AZD2014, a novel dual TORC1/2 kinase inhibitor, with Faslodex in ER+ breast cancer and with chemotherapy in ovarian and lung cancer and pre-clinical research on combination regimens 
American Society of Clinical Oncology (ASCO) Meeting, 29 May-2 June 2015
AstraZeneca will host an investor science event during the ASCO meeting to be held in Chicago, US on 1 June 2015 at 20:30 CDT. Further details will be available at www.astrazeneca.com/investors in due course.
4. Infection, Neuroscience and Gastrointestinal 
MEDI8897 Fast-Track Designation
MedImmune has received Fast-Track designation from the FDA for the development of MEDI8897, an investigational, high-potency, extended half-life monoclonal antibody (MAb) engineered to prevent lower-respiratory tract infection caused by respiratory syncytial virus (RSV) in infants and young children. 
RSV is the most prevalent cause of lower respiratory tract infections among infants and young children, resulting in annual epidemics worldwide. MedImmune is the only company to have discovered, developed and marketed a monoclonal antibody for severe RSV. This is the third Fast-Track designation MedImmune has received in the last six months for its investigational molecules in its Infectious Disease therapy area. 
Scientific Collaborations
_________________________________________________________________________________
On 25 March 2015 AstraZeneca announced that it had entered a five-year research collaboration with the Harvard Stem Cell Institute to develop a technique that creates human beta cells from stem cells for use in screens of AstraZeneca's compound library in the search for new treatments for diabetes, one of AstraZeneca's key platforms as part of its strategy to return to growth. 
On 26 March 2015 AstraZeneca announced that it had joined a public-private consortium with Genomics England to accelerate the development of new diagnostics and treatments arising from the 100,000 Genomes Project. The GENE Consortium (Genomics Network for Enterprises Consortium) is a unique partnership between industry, academia and the National Health Service Genomic Medicine Centres, which aims to transform treatment for patients with cancer and rare diseases, providing faster access to the right therapy and personalised healthcare, establishing the UK as a world leader in this field. AstraZeneca will gain insights into the evolving area of genome science with a view to identifying new genes and biomarkers which could lead to the development of innovative diagnostics and treatments.
Corporate and Business Development
_________________________________________________________________________________
Completion of Actavis Transaction in Respiratory Disease
On 3 March 2015 AstraZeneca completed the acquisition of the rights to Actavis Plc's (Actavis) branded respiratory business in the US and Canada. The transaction strengthens AstraZeneca's respiratory franchise globally and builds on the acquisition of Almirall SA's respiratory portfolio in 2014 by extending the Company's development and commercialisation rights into the US for both Tudorza Pressair and Duaklir Genuair. The transaction also augments AstraZeneca's respiratory franchise with the Actavis oral product, Daliresp.
Immuno-Oncology Clinical Trial Collaboration with Immunocore
On 16 April 2015 AstraZeneca announced that MedImmune has entered into a collaboration to conduct clinical trials in immuno-oncology with Immunocore Limited (Immunocore), a privately-held UK-based biotechnology company. Under the terms of the agreement, Immunocore will conduct a Phase Ib/II clinical trial combining MedImmune's investigational checkpoint inhibitors MEDI4736 and tremelimumab, with IMCgp100, Immunocore's lead T-cell receptor based therapeutic, for the potential treatment of patients with late-stage metastatic melanoma. 
Agreement with Janssen to Test AZD8186 in Combination with Abiraterone in Prostate Cancer
AstraZeneca has entered an agreement with Janssen Research & Development, LLC (Janssen) to conduct a Phase I/IIa study to explore the combination of AstraZeneca's AZD8186 (PI3 kinase beta inhibitor) together with Janssen's Zytiga (abiraterone acetate). The two compounds block complementary molecular pathways in prostate cancer and so have synergistic effects which could help to overcome resistance to monotherapy and improve the benefit-risk profile of either compound alone. The combination will be tested for the treatment of prostate tumours that lack the protein PTEN, a condition that represents a relatively large unmet medical need.
Agreement with Gilead to Test MEDI4736 in Combination with Zydelig in Haematological Cancers or Solid Tumours
AstraZeneca has entered an agreement to conduct a Phase I/II study to explore AstraZeneca's MEDI4736, in combination with Gilead Sciences, Inc.'s Zydelig (idelalisib), an oral phosphoinositide 3-kinase (PI3K) delta inhibitor. PI3K delta is over-expressed in many B-cell malignancies and plays a role in B-cell viability, proliferation and migration. Inhibition of PI3K delta may also play a role in up-regulating the activity of the immune system against cancers. It is hypothesised that the suppression of PD-L1 and PI3K delta signalling may lead to an enhanced anti-tumour immune response. The study will assess the combination as a treatment for patients with haematological cancers or solid tumours including diffuse large B-cell lymphoma, and triple negative breast cancer.
Agreement with Juno Therapeutics to test MEDI4736 in combination with Novel CAR T Cell in non-Hodgkin's lymphoma
MedImmune has entered into an agreement to evaluate the safety, tolerability and preliminary efficacy of MEDI4736 in combination with one of Juno Therapeutics Inc.'s (Juno) investigational chimeric antigen receptor (CAR) T cell candidates in patients with non-Hodgkin's lymphoma. Juno's CAR T candidates are investigational cell-based immunotherapies that utilise genetically engineered T-cells to recognise and kill cancer cells expressing the CD19 protein. The Phase Ib study will explore the potential clinical benefit of combining these two potent therapeutic classes.
Co-Commercialisation Agreement with Daiichi Sankyo for Movantik in the US
On 19 March 2015 AstraZeneca announced a co-commercialisation agreement with Daiichi Sankyo Co, Ltd. (Daiichi Sankyo) for Movantik (naloxegol) in the US, in line with the strategy of delivering value through its own development and commercial capabilities as well as through external collaboration. Movantik is a first-in-class once-daily oral peripherally-acting mu-opioid receptor antagonist for the treatment of opioid-induced constipation in adults with chronic non-cancer pain. Movantik was approved by the FDA in September 2014. It was descheduled in January 2015 and is no longer labelled as a controlled substance. Movantik was launched in the US at the end of March 2015.
Change in Senior Executive Team
David Smith, Executive Vice-President, Operations and Information Systems will retire from AstraZeneca in mid-2015. His successor in that role will be Pam P. Cheng who will join the Company in June as a member of the Senior Executive Team reporting to the Chief Executive Officer. Pam Cheng has extensive experience in pharmaceutical manufacturing, having spent 14 years in global manufacturing and supply chain roles at Merck & Co, Inc. / Merck Sharp & Dohme Corp. (MSD). More recently she gained experience in commercial operations in her current role as President, MSD China.
Operating and Financial Review
_________________________________________________________________________________
All narrative on growth and results in this section relates to Core performance, based on constant exchange rates (CER) unless stated otherwise. Financial figures are in $ millions ($m). The performance shown below covers the three months to 31 March 2015 (the quarter) compared to the three months to 31 March 2014 (the first quarter of 2014). Core measures, which are presented in addition to Reported financial information, are non-GAAP measures provided to enhance understanding of the Company's underlying financial performance. Core financial measures are adjusted to exclude certain significant items, such as:
 amortisation and impairment of intangibles, including impairment reversals but excluding any charges relating to IT assets
 charges and provisions related to our global restructuring programmes (this will include such charges that relate to the impact of our global restructuring programmes on our capitalised IT assets)
 other specified items, principally comprising legal settlements and acquisition-related costs, which include fair-value adjustments and the imputed finance charge relating to contingent consideration on business combinations
More detail on the nature of these measures is given on page 72 of the 2014 Annual Report and Form 20-F Information.
Total Revenue
Total Revenue
Total Revenue grew by 1% in the quarter to $6,057m. Based on actual exchange rates, Total Revenue declined by 6% reflecting the particular weakness of key trading currencies against the US dollar. For the first time a new line of Total Revenue has been presented to include both Product Sales and Externalisation Revenue. For further details on the presentation of Total Revenue, see the announcement published by the Company on 6 March 2015. 
Product Sales
Product Sales declined by 3% in the quarter reflecting the US market entry of a Nexium generic product from mid-February 2015 as well as an adverse impact from the change in accounting for the US Branded Pharmaceutical Fee of $56m following issuance of final regulations in Q3 2014. 
Externalisation Revenue
Externalisation Revenue grew to $309m (Q1 2014: $44m), primarily reflecting income from the co-commercialisation agreement with Daiichi Sankyo for Movantik in the US referred to above ($200m), plus the co-commercialisation of Nexium in Japan ($55m), also with Daiichi Sankyo.
Product Sales
_________________________________________________________________________________
The performance of a selection of key medicines is shown below. 
A geographical split is shown in Note 6.
Q1 2015
Q1 2014
% Change

$m
$m
CER
Actual





Respiratory, Inflammation and Autoimmunity




Symbicort
845
928
-
(9)
Pulmicort
286
263
17
9
Tudorza/Eklira
30
-
n/m
n/m





Cardiovascular and Metabolic Disease




Brilinta/Brilique
131
99
45
32
Onglyza
183
162
19
13
Bydureon
123
80
58
54
Byetta
90
78
19
15
Farxiga/Forxiga
76
13
n/m
n/m





Legacy:




Crestor
1,167
1,332
(7)
(12)
Seloken/Toprol-XL
194
193
8
1
Atacand
95
122
(9)
(22)





Oncology




Iressa
144
169
(5)
(15)
Lynparza
9
-
n/m
n/m





Legacy:




Zoladex
194
221
3
(12)
Faslodex
161
172
2
(6)
Casodex
70
83
(6)
(16)
Arimidex
62
78
(12)
(21)





Infection, Neuroscience and Gastrointestinal




Nexium
644
930
(25)
(31)
Synagis
204
328
(38)
(38)
Seroquel XR
262
292
(6)
(10)
Losec/Prilosec
96
110
(4)
(13)
FluMist/Fluenz
7
7
-
-
Product Sales Summary
_________________________________________________________________________________
During Q3 2014, final regulations relating to the US Branded Pharmaceutical Fee were issued, affecting how the fee is recognised; AstraZeneca consequently now accrues for the obligation as each sale occurs. As the fee is based on actual Product Sales in the current year, the fee is recognised as a deduction from Product Sales rather than a charge to SG&A. As a result, in 2015, Q1 US Product Sales were reduced by $56m, adversely impacting individual brand sales by an average of 2%. 
Respiratory, Inflammation and Autoimmunity
Symbicort
Product Sales in the US declined by 1% to $342m with volume growth more than offset by lower net prices and additional access and co-pay assistance. Symbicort's share of total prescriptions for fixed-combination medicines declined by 0.2 percentage points from December 2014 (exit share) to 32.8%, reflecting adverse formulary changes; however, market share grew sequentially over the final two months of the quarter. In Europe Product Sales declined by 8% to $306m, reflecting increased competition from recently launched analogue medicines. This performance contrasts with growth of 40% in Emerging Markets to $98m, notably with 67% growth in China where Product Sales reached $29m. 
Pulmicort
Product Sales of Pulmicort in the quarter were $286m, up 17%. Growth was driven primarily by the performance of Pulmicort Respules in Emerging Markets, which were up 33% at $176m. China Product Sales increased by 36% to $142m. On 13 February 2015 the US District Court for the District of New Jersey ruled US Patent No. 7,524,834 ('the '834 patent'), protecting Pulmicort Respules in the US, was invalid. On 16 February 2015 the Company filed an appeal and requested an injunction which was granted by the court. As of today, the injunction remains in place.
Tudorza/Eklira
Product Sales in the quarter were $30m and included $10m in the US following the completion of the acquisition of the Actavis product rights on 3 March 2015.
Cardiovascular and Metabolic Disease
Brilinta/Brilique
Product Sales were $131m, up 45%. Brilinta Product Sales in the US were $46m, up 64%. Total prescriptions for Brilinta in the US were 8% higher versus Q4 2014, while weekly new-to-brand market share increased to 9.3% at the end of March 2015, representing the medicine's largest new-to-brand volume growth since launch. In Europe Brilique continues to perform well, with an increase in Product Sales of 21% to $54m reflecting ACS leadership across many European markets; however the increase in penetration rates is slowing in markets where Brilique holds a high market share. Emerging Markets sales grew by 108% to $23m as the medicine remained in its launch phase.
Onglyza
Product Sales were up 19% in the quarter to $183m. In the US, Onglyza Product Sales were down 8% at $98m driven primarily by destocking and competition in the DPP4 class. Product Sales in the Rest of World (ROW) were $85m, up 70%, with growth in all key markets, notably in Europe where sales achieved $37m, up 72%, including the benefit of the metformin-combination products Komboglyze/Kombiglyze XR.
Bydureon/Byetta
Combined Product Sales in the US were $174m, up 44%. Bydureon total prescriptions grew 25% in the quarter reflecting the launch of the Bydureon Pen in September 2014. ROW Product Sales were $39m, up 22% driven by the Bydureon performance in Europe and the ongoing Pen launch.
Farxiga/Forxiga
In the US, Product Sales were $37m (Q1 2014: $4m) including Xigduo XR, launched in the second half of 2014. Total prescriptions increased 18% versus Q4 2014 reflecting strong market growth, while total prescription exit share in March was 27.2%, a 1.4 percentage-point decline versus Q4 2014 due to unfavourable formulary changes with effect from 1 January 2015. Product Sales grew to $39m in ROW, including Europe at $24m and Emerging Markets at $12m.
Crestor
In the US, Crestor Product Sales declined by 13% to $614m, reflecting lower volumes in line with total prescription share, as well as inventory movements. In Europe Product Sales declined by 5% to $243m, reflecting prevailing competitive trends, whilst Emerging Markets delivered growth of 12% at $178m.
Oncology
Iressa
Product Sales declined by 5% to $144m, primarily a function of the competitive environment in Japan. Emerging Markets grew by 9% with Product Sales of $77m.
Lynparza
Product Sales reached $9m following the launch in the US at the end of 2014. Growth has been driven by the pool of eligible patients awaiting treatment as well as patients newly tested for BRCA.
Zoladex
Product Sales for the quarter were up 3% to $194m. Notable performance included growth of 41% in China where Product Sales reached $30m.
Faslodex
Product Sales for the quarter were up 2% to $161m. A decline in sales in Europe of 8% to $49m was more than offset by 9% growth in the US where Product Sales reached $83m.
Infection, Neuroscience and Gastrointestinal
Nexium
In the US, Product Sales in the quarter were $225m, down 53%. The reduction was primarily driven by the loss of exclusivity in the quarter, which adversely impacted brand volumes by 38% and resulted in an increase to the estimate for pipeline inventory returns to reflect the level of business currently retained. Product Sales in markets outside the US were up 5% to $419m, driven by 33% growth in China to $97m and 23% growth in Japan to $89m, partially offset by 8% declines in other markets where Product Sales reduced to $233m due to increased generic competition. 
Synagis
Product Sales in the US were $162m, down 37%. The decline reflected lower demand related to the American Academy of Pediatrics Committee on Infectious Disease guidelines issued in mid-2014. These further restricted patients eligible for preventative therapy with Synagis. While these guidelines were inconsistent with the approved label, demand was significantly impacted. Product Sales were $42m in ROW, down 42% reflecting the phasing of shipments to AbbVie.
Seroquel XR
Product Sales in the US were up 2% to $169m where the performance was mainly driven by a higher underlying net price. Sales of Seroquel XR in the ROW were down 16% to $93m in the quarter, driven primarily by competition from generic products in Europe where sales were down 22% to $63m.
Regional Product Sales
_________________________________________________________________________________

Q1 2015
Q1 2014
% Change

$m
$m
CER
Actual
US
2,169
2,513
(14)
(14)





Europe1
1,340
1,630
(5)
(18)





Established ROW2
706
845
(5)
(16)

Japan
455
537
(2)
(15)

Canada
135
139
8
(3)

Other Established ROW
116
169
(24)
(31)





Emerging Markets3
1,533
1,428
18
7

China
726
584
28
24

Ex.China
807
844
11
(4)





Total
5,748
6,416
(3)
(10)
1Q1 2014 Product Sales in Europe reflect the exclusion of $7m sales relating to several countries now included in Emerging Markets 
2Established ROW comprises Japan, Canada, Australia and New Zealand
3Emerging Markets comprises all remaining ROW markets including Brazil, China, India, Mexico, Russia, and Turkey
US
Product Sales were down 14% to $2,169m. Despite growth from brands such as Brilinta, Farxiga and Bydureon, growth was more than offset by the impact of the loss of exclusivity of Nexium as well as by competition facing Crestor from therapeutic substitution by generic statins. This was compounded by the adverse impact of the Synagis guideline changes and the change in accounting related to the Branded Pharmaceutical Fee which further reduced Product Sales by $56m. 
Europe
Product Sales were down 5% to $1,340m in the quarter. Growth from Forxiga and Onglyza in Europe was more than offset by continued generic competition facing Crestor and Seroquel XR. Symbicort competed alongside analogues in that market and saw small volume growth. The phasing of Synagis sales this year had an adverse impact in the first quarter.
Established ROW
Product Sales were down 5% in the quarter to $706m. Japan declined by 2% to $455m, driven primarily by the mandated April 2014 biennial price cut, which was partially offset by higher volumes delivered by Nexium and Crestor.
Emerging Markets
Product Sales were up 18% to $1,533m with growth delivered across the Emerging Markets business. China sales increased by 28% to $726m, ahead of in-market growth, with the Company's medicines for respiratory and diabetes delivering particularly strong results. 
Financial Performance
_________________________________________________________________________________

Reported
Restructuring
Intangible
Amortisation
Diabetes Alliance
Other
Core
% Change
Q1
2015
Q1 2015
Q1 2014
CER
Actual
Product Sales
5,748
-
-
-
-
5,748
6,416
(3)
(10)
Externalisation Revenue
309
-
-
-
-
309
44
n/m
n/m
Total Revenue
6,057
-
-
-
-
6,057
6,460
1
(6)










Cost of Sales
(1,269)
43
273
-
-
(953)
(1,193)
(8)
(20)










Gross Profit
4,788
43
273
-
-
5,104
5,267
3
(3)
Gross Margin* 
77.9%




83.4%
81.4%












Distribution
(77)
-
-
-
-
(77)
(72)
19
7
% Total Revenue
1.3%




1.3%
1.1%
-0.2
-0.2










R&D
(1,356)
62
14
-
-
(1,280)
(1,098)
24
17
% Total Revenue
22.4%




21.1%
17.0%
-3.9
-4.1










SG&A
(2,799)
108
202
108
13
(2,368)
(2,317)
10
2
% Total Revenue
46.2%




39.1%
35.9%
-3.1
-3.2










Other Operating Income
377
-
49
-
-
426
172
n/m
n/m
% Total Revenue
6.2%




7.0%
2.7%
+4.3
+4.3










Operating Profit
933
213
538
108
13
1,805
1,952
(4)
(8)
% Total Revenue
15.4%




29.8%
30.2%
-1.4
-0.4










Net Finance
Expense
(250)
-
-
104
28
(118)
(126)


Joint Ventures
(5)
-
-
-
-
(5)
-












Profit Before Tax
678
213
538
212
41
1,682
1,826
(4)
(8)
Taxation
(126)
(45)
(89)
(48)
(4)
(312)
(353)


Tax Rate
18.6%




18.5%
19.3%


Profit After Tax
552
168
449
164
37
1,370
1,473
(3)
(7)










Non-controlling Interests
(2)
-
-
-
-
(2)
(2)


Net Profit
550
168
449
164
37
1,368
1,471
(3)
(7)










Weighted Average Shares
1,263
1,263
1,263
1,263
1,263
1,263
1,260












Earnings Per Share
0.44
0.13
0.35
0.13
0.03
1.08
1.17
(3)
(7)
* Gross Margin reflects Gross Profit derived from Product Sales, divided by Product Sales.
Investment Costs
Core R&D investment costs were up 24% to $1,280m, principally as a result of the lower base in the first quarter of 2014, the recent acceleration in the late-stage pipeline, and additional costs incurred on assets acquired through business and corporate development activities. The Company anticipates a lower growth rate over the full year.
Core SG&A investments costs were up 10% to $2,368m, reflecting a relatively low base in the first quarter of 2014. The increase reflected the investment in Sales, Marketing and Medical activities that grew year-on-year as the Company approached the anniversary of the acquisition of BMS's share of the global diabetes alliance. Additional investments were made in the quarter to support recent brand launches, including Farxiga/Forxiga and Lynparza, as well as for pre and post-launch activities for Movantik/Moventig. Investment was also maintained in the pre-launch activities for the late-stage pipeline, including the oncology portfolio. 
For the full year, the Company is committed to reducing Core SG&A investment costs versus the prior year and a number of programmes designed to meet this target have commenced and will accelerate over the year. These initiatives include a focus on sales and marketing effectiveness, including the leveraging of marketing programmes on a global basis. Other programmes are focused on delivering savings across procurement and support functions, including IT and further footprint optimisation.
Other Operating Income
Core Other Operating Income reached $426m in the quarter primarily reflecting gains on disposals including Myalept ($193m) and other disposals amounting to $109m, including the US rights to Tenormin.
Profit
Core Operating Profit was down 4% to $1,805m. Core Operating Margin was down 1.4 percentage points to 29.8% of Total Revenue as the Company continued to invest in the pipeline and the growth platforms. Core Earnings Per Share were down 3% to $1.08, a marginally favourable performance versus Core Operating Profit. Reported Operating Profit of $933m was 15% higher than the first quarter of 2014. Reported EPS was up by 10% at $0.44. 
Productivity 
Restructuring charges of $213m were taken in the quarter. The Company continues to make good progress in implementing the fourth phase of restructuring announced in the first quarter of 2013 and the expansion of this programme announced in the first half of 2014. In addition to costs of this programme, the restructuring charge for the quarter included $53m incurred as a consequence of the decision to exit the Westborough site in the US and costs of other initiatives identified since the announcement of the fourth wave of restructuring.The Company also began construction of its new Global R&D Centre and Corporate Headquarters on the Cambridge Biomedical Campus in the quarter.
Finance Income and Expense
Core net finance expense was $118m versus $126m in the first quarter of 2014. Reported net finance expense of $250m included a charge of $132m relating to the discount unwind on contingent consideration creditors recognised on business combinations, principally relating to the acquisition of BMS's share of the global diabetes alliance last year.
Taxation
Both the Reported and Core tax rates for the quarter ended 31 March 2015 were around 19%. The cash tax paid for the quarter was $245m which is 36% of Reported Profit Before Tax and 15% of Core Profit Before Tax. The Reported and Core tax rates for the quarter ended 31 March 2014 were 21% and 19% respectively.
Cash Flow
The Company generated a cash outflow from operating activities of $72m in the quarter, compared with an inflow of $1,187m in the first quarter of 2014. Net cash outflows from investing activities were $556m compared with $3,777m in the first quarter of 2014, mainly reflecting higher upfront payments on business acquisitions in the first quarter of 2014. Net cash distributions to shareholders were $2,342m through dividends of $2,357m, offset by proceeds from the issue of shares of $15m due to the exercise of stock options.
Debt and Capital Structure
At 31 March 2015, outstanding gross debt (interest-bearing loans and borrowings) was $10,569m (31 March 2014: $10,340m). Of the gross debt outstanding at 31 March 2015, $2,299m was due within one year (31 March 2014: $2,787m). 
The Company's net debt position at 31 March 2015 was $6,373m (31 March 2014: $4,833m).
Shares in Issue
During the quarter, 0.4 million shares were issued in respect of share option exercises for a consideration of $15m. The total number of shares in issue at 31 March 2015 was 1,264 million.
Guidance
The Company reiterates the guidance provided on 6 March 2015:
- FY 2015 Total Revenue is expected to decline by mid single-digit percent at CER
- Core EPS is expected to increase by low single-digit percent at CER
The Company also provides the following non-guidance information related to currency sensitivity: 
- Based on current exchange rates1, Total Revenue is expected to decline by low double-digit percent 
- Core EPS is expected to be broadly in line with FY 2014. For additional currency sensitivity information, please see below:




Average Exchange Rates Versus USD



Impact Of 5% Weakening In Exchange Rate Versus USD ($m)2
Currency

Primary Relevance

2014

YTD
March 20151

Change
%

Total Revenue

Core Operating Profit
EUR

Product Sales

0.75

0.89

(15)

(225)

(138)
JPY

Product Sales

105.87

119.15

(11)

(119)

(84)
CNY

Product Sales

6.16

6.24

(1)

(115)

(49)
SEK

Costs

6.86

8.32

(18)

(6)

114
GBP

Costs

0.61

0.66

(8)

(37)

112
Other3









(242)

(139)













1Based on average daily spot rates YTD to the end of March 2015
2Based on 2014 actual average exchange rates and group currency exposures
3Other important currencies include AUD, BRL, CAD, KRW and RUB 
Condensed Consolidated Statement of Comprehensive Income
For the quarter ended 31 March

2015
$m

Restated 2014
$m
Product sales

5,748

6,416
Externalisation revenue

309

44
Total revenue

6,057

6,460
Cost of sales

(1,269)

(1,453)
Gross profit

4,788

5,007
Distribution costs

(77)

(72)
Research and development expense

(1,356)

(1,200)
Selling, general and administrative expense

(2,799)

(2,726)
Other operating income and expense

377

(173)
Operating profit

933

836
Finance income

11

15
Finance expense

(261)

(213)
Share of after tax losses of joint ventures

(5)

-
Profit before tax

678

638
Taxation 

(126)

(132)
Profit for the period

552

506




Other Comprehensive Income




Items that will not be reclassified to profit or loss




Remeasurement of the defined benefit pension liability

(17)

(25)
Tax on items that will not be reclassified to profit or loss

4

6

(13)

(19)
Items that may be reclassified subsequently to profit or loss




Foreign exchange arising on consolidation

(449)

55
Foreign exchange arising on designating borrowings in net investment hedges

(408)

(1)
Fair value movements on derivatives designated in net investment hedges

21

(9)
Net available for sale gains taken to equity

19

2
Tax on items that may be reclassified subsequently to profit or loss 

100

(7)

(717)

40
Other comprehensive income for the period, net of tax

(730)

21
Total comprehensive income for the period

(178)

527




Profit attributable to:




Owners of the Parent

550

504
Non-controlling interests

2

2

552

506




Total comprehensive income attributable to:




Owners of the Parent

(179)

531
Non-controlling interests

1

(4)

(178)

527




Basic earnings per $0.25 Ordinary Share

$0.44

$0.40
Diluted earnings per $0.25 Ordinary Share

$0.44

$0.40
Weighted average number of Ordinary Shares in issue (millions)

1,263

1,260
Diluted weighted average number of Ordinary Shares in issue (millions)

1,265

1,262
Condensed Consolidated Statement of Financial Position

At 31 Mar 2015
$m

At 31 Dec 2014
$m

At 31 Mar 2014
$m
ASSETS
Non-current assets






Property, plant and equipment

5,913

6,010

6,173
Goodwill

11,387

11,550

11,601
Intangible assets

20,319

20,981

21,532
Derivative financial instruments

491

465

352
Investments in joint ventures

52

59

-
Other investments

490

502

297
Other receivables

977

1,112

1,430
Deferred tax assets

1,381

1,219

1,463

41,010

41,898

42,848
Current assets






Inventories

1,968

1,960

2,163
Trade and other receivables

6,704

7,232

8,579
Other investments

493

795

777
Derivative financial instruments

37

21

8
Income tax receivable

297

329

636
Cash and cash equivalents

3,192

6,360

4,379


12,691

16,697

16,542
Total assets

53,701

58,595

59,390
LIABILITIES
Current liabilities






Interest-bearing loans and borrowings

(2,299)

(2,446)

(2,787)
Trade and other payables

(10,510)

(11,886)

(10,626)
Derivative financial instruments

(17)

(21)

(8)
Provisions

(602)

(623)

(776)
Income tax payable

(2,330)

(2,354)

(3,316)


(15,758)

(17,330)

(17,513)
Non-current liabilities






Interest-bearing loans and borrowings

(8,270)

(8,397)

(7,553)
Derivative financial instruments

-

-

(1)
Deferred tax liabilities

(1,611)

(1,796)

(2,760)
Retirement benefit obligations 

(2,506)

(2,951)

(2,357)
Provisions

(424)

(484)

(586)
Other payables

(8,176)

(7,991)

(7,143)


(20,987)

(21,619)

(20,400)
Total liabilities

(36,745)

(38,949)

(37,913)
Net assets

16,956

19,646

21,477
EQUITY






Capital and reserves attributable to equity holders of the Company






Share capital

316

316

316
Share premium account

4,276

4,261

4,179
Other reserves

2,039

2,021

1,967
Retained earnings

10,305

13,029

14,992

16,936

19,627

21,454
Non-controlling interests

20

19

23
Total equity

16,956

19,646

21,477
Condensed Consolidated Statement of Cash Flows 
For the quarter ended31 March

2015
$m

2014
$m
Cash flows from operating activities




Profit before tax

678

638
Finance income and expense

250

198
Share of after tax losses of joint ventures

5

-
Depreciation, amortisation and impairment

849

712
(Increase)/decrease in working capital and short-term provisions

(664)

30
Non-cash and other movements

(703)

207
Cash generated from operations

415

1,785
Interest paid

(242)

(231)
Tax paid

(245)

(367)
Net cash (outflow)/inflow from operating activities

(72)

1,187
Cash flows from investing activities




Movement in short-term investments and fixed deposits

276

36
Purchase of property, plant and equipment

(227)

(183)
Disposal of property, plant and equipment

8

57
Purchase of intangible assets

(848)

(545)
Disposal of intangible assets

325

-
Purchase of non-current asset investments

(23)

(2)
Disposal of non-current asset investments

37

-
Upfront payments on business acquisitions

-

(2,778)
Payment of contingent consideration on business acquisitions 

(144)

(290)
Interest received

40

30
Payments made by subsidiaries to non-controlling interests

-

(102)
Net cash outflow from investing activities

(556)

(3,777)
Net cash outflow before financing activities

(628)

(2,590)
Cash flows from financing activities




Proceeds from issue of share capital

15

197
Repayment of loans

(884)

-
Dividends paid

(2,357)

(2,425)
Hedge contracts relating to dividend payments

(43)

25
Repayment of obligations under finance leases

(10)

(9)
Movement in short-term borrowings

710

-
Net cash outflow from financing activities

(2,569)

(2,212)
Net decrease in cash and cash equivalents in the period

(3,197)

(4,802)
Cash and cash equivalents at the beginning of the period

6,164

8,995
Exchange rate effects

(19)

(5)
Cash and cash equivalents at the end of the period

2,948

4,188
Cash and cash equivalents consists of:




Cash and cash equivalents

3,192

4,379
Overdrafts

(244)

(191)


2,948

4,188





Condensed Consolidated Statement of Changes in Equity 


Share
capital
$m

Share
premium
account
$m

Other
reserves*
$m

Retained
earnings
$m

Total
$m

Non-
controlling
interests
$m

Total
equity
$m
At 1 Jan 2014 

315

3,983

1,966

16,960

23,224

29

23,253
Profit for the period

-

-

-

504

504

2

506
Other comprehensive income

-

-

-

27

27

(6)

21
Transfer to other reserves

-

-

1

(1)

-

-

-
Transactions with owners:














Dividends

-

-

-

(2,395)

(2,395)

-

(2,395)
Issue of Ordinary Shares

1

196

-

-

197

-

197
Share-based payments

-

-

-

(103)

(103)

-

(103)
Transfer from non-controlling interests to payables

-

-

-

-

-

(2)

(2)
Net movement

1

196

1

(1,968)

(1,770)

(6)

(1,776)
At 31 Mar 2014

316

4,179

1,967

14,992

21,454

23

21,477

















Share
capital
$m

Share
premium
account
$m

Other
reserves*
$m

Retained
earnings
$m

Total
$m

Non-
controlling
interests
$m

Total
equity
$m
At 1 Jan 2015 

316

4,261

2,021

13,029

19,627

19

19,646
Profit for the period

-

-

-

550

550

2

552
Other comprehensive income

-

-

-

(729)

(729)

(1)

(730)
Transfer to other reserves

-

-

18

(18)

-

-

-
Transactions with owners:














Dividends

-

-

-

(2,400)

(2,400)

-

(2,400)
Issue of Ordinary Shares

-

15

-

-

15

-

15
Share-based payments

-

-

-

(127)

(127)

-

(127)
Net movement

-

15

18

(2,724)

(2,691)

1

(2,690)
At 31 Mar 2015

316

4,276

2,039

10,305

16,936

20

16,956
* Other reserves includes the capital redemption reserve and the merger reserve.
Notes to the Interim Financial Statements
1 BASIS OF PREPARATION AND ACCOUNTING POLICIES
These unaudited condensed consolidated interim financial statements ("interim financial statements") for the quarter ended 31 March 2015 have been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the European Union (EU) and as issued by the International Accounting Standards Board (IASB). 
The annual financial statements of the Group are prepared in accordance with International Financial Reporting Standards (IFRSs) as adopted by the EU and as issued by the IASB. Except as detailed below, the interim financial statements have been prepared applying the accounting policies and presentation that were applied in the preparation of the Group's published consolidated financial statements for the year ended 31 December 2014. 
As announced on 6 March 2015, the Group updated its revenue accounting policy with effect from 1 January 2015. The Group's business model now includes an increasing level of externalisation activity to create value from the strong science that exists in the pipeline. Historically, reported revenue reflected only product sales, with externalisation revenue forming part of other operating income presented below gross profit. From 1 January 2015 externalisation revenue, alongside product sales, are included in total revenue. Externalisation revenue includes development, commercialisation, partnership and out-licence revenue, such as royalties and milestone receipts, together with income from services or repeatable licences. Income is recorded as externalisation revenue when the Group has a significant ongoing interest in the product and/or it is repeatable business and there is no derecognition of an intangible asset. Disposals of assets and businesses, where the Group does not retain an interest, will continue to be recorded in other operating income. The updated financial presentation reflects the Group's entrepreneurial approach and provides a clearer picture of this additional revenue stream. The updated revenue accounting policy results in a presentational change to the Statement of Comprehensive Income only, and has no impact on the Group's net results or net assets. The prior period Condensed Consolidated Statement of Comprehensive Income has been restated accordingly, resulting in $44m of income being reclassified from other operating income to externalisation revenue for the quarter ended 31 March 2014. 
The Group has adopted the amendments to IAS 19 Employee Contributions, issued by IASB in November 2013 and effective for periods beginning on or after 1 July 2014. The adoption has not had a significant impact on the Group's profit for the period, net assets or cash flows. There have been no other significant new or revised accounting standards applied in the quarter ended 31 March 2015.
The information contained in Note 5 updates the disclosures concerning legal proceedings and contingent liabilities in the Group's Annual Report and Form 20-F Information 2014. 
The Group has considerable financial resources available. As at 31 March 2015 the Group has $3.9bn in financial resources (cash balances of $3.2bn and undrawn committed bank facilities of $3.0bn which are available until April 2020, with only $2.3bn of debt due within one year). The Group's revenues are largely derived from sales of products which are covered by patents which provide a relatively high level of resilience and predictability to cash inflows, although our revenue is expected to continue to be significantly impacted by the expiry of patents over the medium term. In addition, government price interventions in response to budgetary constraints are expected to continue to adversely affect revenues in many of our mature markets. However, we anticipate new revenue streams from both recently launched medicines and products in development, and the Group has a wide diversity of customers and suppliers across different geographic areas. Consequently, the Directors believe that, overall, the Group is well placed to manage its business risks successfully. 
On the basis of the above paragraph and after making enquiries, the Directors have a reasonable expectation that the Company and the Group have adequate resources to continue in operational existence for the foreseeable future. Accordingly, the interim financial statements have been prepared on a going concern basis.
The comparative figures for the financial year ended 31 December 2014 are not the Company's statutory accounts for that financial year. Those accounts have been reported on by the Group's auditors and will be delivered to the registrar of companies. The report of the auditors was (i) unqualified, (ii) did not include a reference to any matters to which the auditors drew attention by way of emphasis without qualifying their report, and (iii) did not contain a statement under section 498(2) or (3) of the Companies Act 2006.
2 restructuring costs
Profit before tax for the quarter ended 31 March 2015 is stated after charging restructuring costs of $213m ($479m for the first quarter 2014). These have been charged to profit as follows:






Q1 2015
$m

Q1 2014
$m 
Cost of sales





43

11
Research and development expense





62

85
Selling, general and administrative costs





108

91
Other operating income and expense





-

292
Total





213

479
3 Net DEBT
The table below provides an analysis of net debt and a reconciliation of net cash flow to the movement in net debt.


At 1 Jan
2015
$m

Cash
Flow
$m

Non-cash
Movements
$m

Exchange Movements
$m

At 31 Mar
2015
$m
Loans due after one year

(8,337)

-

(3)

125

(8,215)
Finance leases due after one year

(60)

-

3

2

(55)
Total long-term debt

(8,397)

-

-

127

(8,270)











Current instalments of loans

(912)

884

-

28

-
Current instalments of finance leases

(48)

10

(20)

2

(56)
Total current debt

(960)

894

(20)

30

(56)











Other investments - current

795

(289)

23

(36)

493
Net derivative financial instruments

465

56

(10)

-

511
Cash and cash equivalents

6,360

(3,145)

-

(23)

3,192
Overdrafts

(196)

(52)

-

4

(244)
Short-term borrowings

(1,290)

(710)

1

-

(1,999)


6,134

(4,140)

14

(55)

1,953
Net debt

(3,223)

(3,246)

(6)

102

(6,373)
Non-cash movements in the period include fair value adjustments under IAS 39.
4 FINANCIAL INSTRUMENTS
As detailed in our most recent annual financial statements, our principal financial instruments consist of derivative financial instruments, other investments, trade and other receivables, cash and cash equivalents, trade and other payables, and interest-bearing loans and borrowings. As indicated in Note 1, there have been no changes to the accounting policies, including fair value measurement, for financial instruments from those disclosed on pages 140 and 141 of the Company's Annual Report and Form 20-F Information 2014. In addition, there have been no changes of significance to the categorisation or fair value hierarchy of our financial instruments. Financial instruments measured at fair value include $983m of other investments, $1,199m of loans, and $511m of derivatives as at 31 March 2015. The total fair value of interest-bearing loans and borrowings at 31 March 2015, which have a carrying value of $10,569m in the Condensed Consolidated Statement of Financial Position, was $12,039m. Contingent consideration liabilities arising on the Company's acquisitions of business combinations have been classified under Level 3 in the fair value hierarchy and movements in fair value are shown below:


Diabetes
Alliance
2015

Other
2015

Total
2015

Total
2014 


$m

$m

$m

$m
At 1 January 

5,386

1,513

6,899

514
Additions through business combinations

-

-

-

5,249*
Settlements 

(9)

(135)

(144)

(290)
Revaluations 

-

(9)

(9)

-
Discount unwind 

104

28

132

72
Foreign exchange 

-

(3)

(3)

-
At 31 March

5,481

1,394

6,875

5,545
*The preliminary estimate of the fair value of contingent consideration of $5,249m was subsequently revised, in the third quarter of 2014, to $5,169m.
5 legal proceedings and contingent liabilities
AstraZeneca is involved in various legal proceedings considered typical to its business, including litigation and investigations relating to product liability, commercial disputes, infringement of intellectual property rights, the validity of certain patents, anti-trust law and sales and marketing practices. The matters discussed below constitute the more significant developments since publication of the disclosures concerning legal proceedings in the Company's Annual Report and Form 20-F Information 2014 (the 2014 Disclosures). Unless noted otherwise below or in the 2014 Disclosures, no provisions have been established in respect of the claims discussed below.
As discussed in the 2014 Disclosures, for the majority of claims in which AstraZeneca is involved it is not possible to make a reasonable estimate of the expected financial effect, if any, that will result from ultimate resolution of the proceedings. In these cases, AstraZeneca discloses information with respect only to the nature and facts of the cases but no provision is made.
In cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed and which are not subject to appeal, or where a loss is probable and we are able to make a reasonable estimate of the loss, we record the loss absorbed or make a provision for our best estimate of the expected loss.
The position could change over time and the estimates that we have made and upon which we have relied in calculating these provisions are inherently imprecise. There can, therefore, be no assurance that any losses that result from the outcome of any legal proceedings will not exceed the amount of the provisions that have been booked in the accounts. The major factors causing this uncertainty are described more fully in the 2014 Disclosures and herein.
AstraZeneca has full confidence in, and will vigorously defend and enforce, its intellectual property.
Matters disclosed in respect of the first quarter of 2015 and to 24 April 2015.
Patent litigation
Crestor (rosuvastatin)
Patent proceedings outside the US
As previously disclosed, in Australia, in 2011 and 2012, AstraZeneca instituted proceedings against Actavis Australia Pty Ltd, Apotex Pty Ltd and Watson Pharma Pty Ltd asserting infringement of three formulation and method patents for Crestor. In March 2013, the Federal Court of Australia held all three patents at issue invalid. AstraZeneca appealed in relation to two patents. In August 2014, the Full Court of the Federal Court of Australia held the two patents invalid. In March 2015, the High Court granted AstraZeneca leave to appeal in relation to one method patent.
Daliresp (roflumilast)
Patent proceedings in the US
In April 2015, AstraZeneca received several Paragraph IV Notices challenging certain patents listed in the FDA Orange Book with reference to Daliresp. AstraZeneca is reviewing the Notices. 
Faslodex (fulvestrant)
Patent proceedings outside the US
In March 2015, AstraZeneca was served with a writ of summons by which Actavis Group PTC ehf. and Actavis Italy S.p.A (together, Actavis) commenced invalidity and non-infringement proceedings before a court in Turin, Italy relating to two Faslodex formulation patents, European Patent EP 1250138 and Italian Patent IT 1333490. 
Losec/Prilosec (omeprazole)
Patent Proceedings in the US
As previously disclosed, in 2008, Apotex Inc. (Apotex) was found to infringe AstraZeneca's US Patent Nos. 4,786,505 and 4,853,230. In 2013, the US District Court for the Southern District of New York ordered Apotex to pay $76m in damages with an additional sum of $28m in pre-judgment interest, and an unspecified amount of post-judgment interest. Apotex appealed. In April 2015, the US Court of Appeals for the Federal Circuit affirmed the bulk of the damages award, with the exception of a small portion of the award which related to sales post patent expiration during a portion of the paediatric exclusivity period.
 
Patent Proceedings outside the US
As previously disclosed, in Canada, in 2004, AstraZeneca brought proceedings against Apotex Inc. (Apotex) for infringement of several patents related to Losec. In February 2015, the Federal Court of Canada found that Apotex had infringed AstraZeneca's Canadian Patent No. 1,292,693. Apotex have appealed.
Pulmicort Respules (budesonide inhalation suspension) 
Patent proceedings in the US
As previously disclosed, in October 2014, the US District Court for the District of New Jersey (the District Court) held a trial on the merits in respect of US Patent No. 7,524,834 (the '834 Patent) and to determine whether AstraZeneca's request for permanent injunctive relief against Breath Limited, Apotex, Inc. and Apotex Corp., Sandoz, Inc. and Watson Laboratories, Inc. (together, the Generic Challengers) should be granted. On 13 February 2015, the District Court determined that the '834 Patent is invalid and denied the injunction request. Also on 13 February 2015, AstraZeneca filed a motion for an injunction pending an appeal of the District Court's decision, which was denied on the same day. On 16 February 2015, AstraZeneca appealed the District Court's decision to the US Court of Appeals for the Federal Circuit (the Court of Appeals) and filed an Emergency Motion for an Injunction Pending Appeal. On 17 February 2015, the Court of Appeals issued an injunction against the Generic Challengers pending submissions by the parties.On 12 March 2015, the Court of Appeals issued an injunction pending appeal. Oral argument in the appeal is scheduled for 4 May 2015. 
Seroquel XR (quetiapine fumarate)
Patent proceedings in the US
As previously disclosed, in October and November 2014, AstraZeneca filed patent infringement proceedings against Pharmadax, Inc. and Pharmadax USA, Inc. (together, Pharmadax) in the US District Court for the District of New Jersey. In February 2015, AstraZeneca settled the patent infringement litigation by granting Pharmadax a licence to the Seroquel XRproduct patent effective from 1 November 2016, or earlier in certain circumstances. 
In February 2015, AstraZeneca received a Paragraph IV Notice from AB Pharmaceuticals, LLC, the US agent of Macleods Pharmaceuticals, Ltd., (together, Macleods) alleging that the patent listed in the FDA Orange Book with reference to Seroquel XR is invalid, unenforceable and/or is not infringed by Macleods' proposed generic product. Macleods submitted an Abbreviated New Drug Application (ANDA) seeking to market quetiapine fumarate tablets. In February 2015, AstraZeneca filed a patent infringement lawsuit against Macleods and Macleods Pharma USA, Inc. in the US District Court for the District of New Jersey. 
Patent proceeding outside the US
As previously reported, in March 2013, the Federal Court of Canada dismissed AstraZeneca's application to prohibit the Canadian Minister of Health from issuing a notice of compliance to Teva Canada Limited (Teva) for its generic quetiapine fumarate product relating to Seroquel XR. Teva subsequently launched its generic Seroquel XR at risk and filed an action seeking section 8 damages arising from these proceedings. In April 2015, AstraZeneca and Teva entered into a settlement agreement ending the ongoing patent litigation between the parties, as well as the section 8 damages action, and allowing Teva to continue selling generic Seroquel XR.
Vimovo(esomeprazole magnesium/naproxen)
Patent proceedings outside the US
In Canada, in January 2015, AstraZeneca received two Notices of Allegation from Mylan Pharmaceuticals ULC. In response, AstraZeneca and Pozen Inc. (the licensee and patent holder, respectively), commenced proceedings in relation to Canadian Patent No. 2,449,098.
Commercial litigation
Seroquel IR(quetiapine fumarate) 
As previously disclosed, with regard to insurance coverage for the substantial legal defence costs and settlements that have been incurred in connection with the Seroquel IR product liability claims in the US, related to alleged diabetes and/or other related alleged injuries (which now exceed the total amount of insurance coverage available), an arbitration is ongoing against an insurer in respect of the availability of coverage under an insurance policy. The policy has a coverage limit of $50m. AstraZeneca has not recognised an insurance receivable in respect of this legal action.
Synagis(palivizumab)
As previously disclosed, in September 2011, MedImmune filed an action against AbbVie, Inc. (AbbVie) (formerly Abbott International, LLC) in the Circuit Court for Montgomery County, Maryland, seeking a declaratory judgment in a contract dispute. AbbVie's motion to dismiss was granted. In September 2011, AbbVie filed a parallel action against MedImmune in the Illinois State Court, where the case is currently pending. A trial date has been set for 31 August 2015.
Toprol-XL(metoprolol succinate) 
On 30 March 2015, AstraZeneca was served with a state court complaint filed by the Attorney General for the State of Louisiana alleging that, in connection with enforcement of its patents for Toprol-XL, it had engaged in unlawful monopolisation and unfair trade practices, causing the state government to pay increased prices for Toprol-XL. The complaint is very similar to prior class action complaints filed by private parties against AstraZeneca relating to Toprol-XL in 2006 and resolved by settlement in 2012. The State seeks an unspecified amount of trebled damages and pre-judgment interest. AstraZeneca denies these allegations.


6 product Sales analysis


World

US

Europe

Established ROW

Emerging Markets


Q1 2015
$m

CER
%

Q1 2015
$m

CER
%

Q1 2015
$m

CER
%

Q1 2015
$m

CER
%

Q1 2015
$m

CER
%
Respiratory, Inflammation and Autoimmunity: 




















Symbicort

845

-

342

(1)

306

(8)

99

(3)

98

40
Pulmicort

286

17

52

-

38

-

20

(8)

176

33
Tudorza/Eklira

30

n/m

10

n/m

18

n/m

2

n/m

-

n/m
Others

82

16

12

-

27

21

3

(50)

40

29
Total Respiratory, Inflammation and Autoimmunity

1,243

7

416

2

389

(2)

124

(5)

314

35
Cardiovascular and Metabolic disease: 




















Brilinta/Brilique

131

45

46

64

54

21

8

33

23

108
Onglyza

183

19

98

(8)

37

72

14

36

34

85
Bydureon

123

58

106

54

16

100

1

-

-

-
Byetta

90

19

68

31

15

-

4

(20)

3

-
Farxiga/Forxiga

76

n/m

37

n/m

24

n/m

3

n/m

12

n/m
Legacy: 




















Crestor

1,167

(7)

614

(13)

243

(5)

132

(3)

178

12
Seloken/Toprol-XL

194

8

27

13

25

(3)

3

(40)

139

12
Atacand

95

(9)

11

-

30

(29)

7

(36)

47

14
Others

171

(3)

20

18

39

(13)

15

(16)

97

2
Total Cardiovascular and Metabolic Disease

2,230

5

1,027

1

483

4

187

(3)

533

18
Oncology:




















Iressa

144

(5)

-

-

35

(5)

32

(28)

77

9
Lynparza

9

n/m

8

n/m

1

n/m

-

n/m

-

n/m
Legacy:




















Zoladex

194

3

6

-

44

(12)

62

(7)

82

23
Faslodex

161

2

83

9

49

(8)

12

(7)

17

11
Casodex

70

(6)

-

n/m

8

(18)

32

(14)

30

14
Arimidex

62

(12)

3

(40)

13

(29)

19

(22)

27

20
Others

34

26

6

-

8

13

13

67

7

13
Total Oncology

674

1

106

13

158

(10)

170

(12)

240

16
Infection, Neuroscience and Gastrointestinal:




















Nexium

644

(25)

225

(53)

74

(6)

128

(3)

217

15
Synagis

204

(38)

162

(37)

42

(42)

-

-

-

-
Seroquel XR

262

(6)

169

2

63

(22)

7

(42)

23

17
Losec/Prilosec

96

(4)

7

(13)

26

(9)

19

(19)

44

10
FluMist/Fluenz

7

-

7

40

-

-

-

-

-

-
Others

388

(5)

50

(33)

105

(7)

71

18

162

-
Total Infection, Neuroscience and Gastrointestinal

1,601

(19)

620

(37)

310

(16)

225

(1)

446

9
TOTAL PRODUCT SALES

5,748

(3)

2,169

(14)

1,340

(5)

706

(5)

1,533

18

ASTRAZENECA DEVELOPMENT PIPELINE, 31 MARCH 2015
Phase III / Pivotal Phase II / Registration
NMEs and significant additional indications
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.
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Cardiovascular and Metabolic Disease
Brilinta/Brilique1
ADP receptor antagonist
arterial thrombosis

Launched
Launched
Filed
Launched
Epanova#
omega-3 free fatty acids
hypertriglyceridaemia

Approved

2017
2019
Farxiga/Forxiga2
SGLT-2 inhibitor
type 2 diabetes

Launched
Launched
Launched
Filed
roxadustat#
hypoxia-inducible factor prolyl hydroxylase inhibitor
anaemia in CKD / ESRD
Q3 2014
2018
N/A
N/A
H2 2016
Oncology
AZD9291
EGFR tyrosine kinase inhibitor
2L advanced EGFRm T790M NSCLC
Q2 2014
Q2 2015
Q2 2015
Q3 2015
2017
AZD9291
EGFR tyrosine kinase inhibitor
1L advanced EGFRm NSCLC
Q1 2015
2017
2017
2017
2020
Caprelsa
VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity
medullary thyroid cancer 

Launched
Launched
Filed
Filed
cediranib
ICON 6
VEGF inhibitor
PSR ovarian cancer


Q2 2015


MEDI4736#
PACIFIC
anti-PD-L1 MAb
stage III NSCLC
Q2 2014
2017
2020
2020

MEDI4736#
ATLANTIC
anti-PD-L1 MAb
3rd line NSCLC
Q1 2014
H1 2016
2017
2017

MEDI4736#
HAWK
anti-PD-L1 MAb
2nd line SCCHN
Q1 2015
H2 2016
H2 2016
H2 2016

moxetumomab pasudotox#
anti-CD22 recombinant
immunotoxin
hairy cell leukaemia
Q2 2013
2018
2018


selumetinib#
SELECT-1
MEK inhibitor
2nd line KRAS+ NSCLC
Q4 2013
2017
2017


selumetinib#
ASTRA
MEK inhibitor
differentiated thyroid cancer
Q3 2013
2017
2017


selumetinib#
SUMIT
MEK inhibitor
uveal melanoma
Q2 2014
Q4 2015
Q4 2015


tremelimumab
anti-CTLA-4 MAb
mesothelioma
Q2 2014
H1 2016
H2 2016


Phase III / Pivotal Phase II / Registration (continued)
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Respiratory, Inflammation and Autoimmunity
benralizumab#
CALIMA SIROCCO ZONDA BISE BORA
anti-IL-5R MAb
severe asthma
Q4 2013
H2 2016
H2 2016


benralizumab#
TERRANOVA GALATHEA
anti-IL-5R MAb
COPD
Q3 2014
2018
2018


brodalumab#
AMAGINE-1,2,3
anti-IL-17R MAb
psoriasis
Q3 2012
2015++
2015++


brodalumab# AMVISION-1,2
anti-IL-17R MAb
psoriatic arthritis
Q1 2014
++
++


lesinurad
CLEAR 1,2
CRYSTAL
selective uric acid reabsorption inhibitor (SURI) 
chronic treatment of patients with gout
Q4 2011
Filed
Filed


PT003 GFF
LAMA / LABA
COPD
Q2 2013
Q3 2015
H1 2016
2017
2017
tralokinumab
STRATOS 1,2
TROPOS
anti-IL-13 MAb
severe asthma
Q3 2014
2018
2018
2018

Infection
CAZ AVI#
RECLAIM
cephalosporin / beta lactamase inhibitor 
serious infections
Q1 2012
N/A
2015

H2 2016
CAZ AVI# REPROVE
cephalosporin / beta lactamase inhibitor
hospital-acquired pneumonia / ventilator-associated pneumonia
Q2 2013
N/A
2017
2018
Zinforo#
extended spectrum cephalosporin with affinity to penicillin-binding proteins 
pneumonia / skin infections

N/A
Launched
N/A
Filed
Neuroscience
Movantik/
Moventig#3
oral peripherally-acting mu-opioid receptor antagonist
opioid-induced constipation

Launched
Launched


# Partnered product.
 Registrational Phase II / III study.
++ Filing is the responsibility of the partner.
1 Brilinta in the US; Brilique in rest of world.
2 Farxiga in the US; Forxiga in rest of world.
3 Movantik in the US; Moventig in EU.
Phases I and II
NMEs and significant additional indications
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Cardiovascular and Metabolism
tenapanor (AZD1722)#
NHE3 inhibitor
ESRD-Pi / CKD with T2DM 
II
Q1 2013




AZD4901
NK3 receptor antagonist
polycystic ovarian syndrome
II
Q2 2013




MEDI0382
GLP-1 / glucagon dual agonist
diabetes / obesity
I
Q1 2015




MEDI6012
LCAT
ACS
I
Q1 2012




MEDI8111 
Rh-factor II
trauma / bleeding
I
Q1 2014




Oncology
AZD1775#
WEE-1 inhibitor
ovarian cancer
II
Q4 2012




AZD2014
mTOR serine / threonine kinase inhibitor
solid tumours
II
Q1 2013




AZD4547
FGFR tyrosine kinase inhibitor
solid tumours
II
Q4 2011




MEDI-551#
anti-CD19 MAb
CLL / DLBCL
II
Q1 2012




MEDI-573#
anti-IGF MAb
metastatic breast cancer
II
Q2 2012




selumetinib#
MEK inhibitor
2nd line KRAS- NSCLC
II
Q1 2013




AZD5363#
AKT kinase inhibitor
breast cancer
II
Q1 2014




MEDI4736#
anti-PD-L1 MAb
solid tumours
II
Q3 2014




moxetumomab
pasudotox#
anti-CD22 recombinant immunotoxin
pALL
II
Q3 2014




savolitinib/volitinib (AZD6094)#
MET tyrosine kinase inhibitor
papillary renal cell carcinoma
II
Q2 2014




AZD3759
EGFR tyrosine kinase inhibitor
advanced EGFRm NSCLC
I
Q4 2014




AZD5312#
androgen receptor inhibitor
solid tumours
I
Q2 2014




AZD6738
ATR serine / threonine kinase inhibitor
solid tumours
I
Q4 2013




AZD8186
PI3 kinase beta inhibitor
solid tumours
I
Q2 2013




AZD8835
PI3 kinase alpha inhibitor
solid tumours
I
Q4 2014




AZD9150#
STAT3 inhibitor
haematological malignancies
I
Q1 2012




AZD9291 + (MEDI4736# or selumetinib# or volitinib#)
TATTON
EGFR tyrosine kinase inhibitor + (anti-PD-L1 or MEK inhibitor or MET tyrosine kinase inhibitor)
advanced EGFRm NSCLC
I
Q3 2014




Phases I and II (continued)
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Oncology (continued)
AZD9496
selective oestrogen receptor downregulator (SERD)
ER+ breast cancer
I
Q4 2014




MEDI0562#
humanised OX40 agonist 
solid tumours
I
Q1 2015




MEDI4736# after (AZD9291 or Iressa or (selumetinib# +docetaxel) or tremelimumab) 
anti-PD-L1 MAb
+ (EGFR tyrosine kinase inhibitor or MEK inhibitor or anti-CTLA-4 MAb)
NSCLC
I
Q3 2014




MEDI-565#
anti-CEA BiTE MAb
solid tumours
I
Q1 2011




MEDI0639#
anti-DLL-4 MAb
solid tumours
I
Q2 2012




MEDI0680 
anti-PD-1 MAb
solid tumours
I
Q4 2013




MEDI3617#
anti-ANG-2 MAb
solid tumours
I
Q4 2010




MEDI4736#
anti-PD-L1 MAb
solid tumours
I
Q3 2014




MEDI4736# + MEDI0680
anti-PD-L1 MAb + anti-PD-1 MAb
solid tumours
I
Q2 2014




MEDI4736# + MEDI6469#
anti-PD-L1 MAb + murine OX40 agonist
solid tumours
I
Q3 2014




MEDI4736# + dabrafenib + trametinib1
anti-PD-L1 MAb + BRAF inhibitor + MEK inhibitor
melanoma
I
Q1 2014




MEDI4736# + Iressa
anti-PD-L1 MAb + EGFR tyrosine kinase inhibitor
NSCLC
I
Q2 2014




MEDI4736# + tremelimumab
anti-PD-L1 MAb + anti-CTLA-4 MAb
solid tumours
I
Q4 2013




MEDI-551# +
MEDI0680
anti-CD19 MAb + anti-PD-1 MAb
DLBCL
I
Q4 2014




MEDI-551# + rituximab
anti-CD19 MAb + anti-CD20 MAb
haematological malignancies
I
Q2 2014




MEDI6383#
OX40 agonist
solid tumours
I
Q3 2014




MEDI6469#
murine OX40 agonist
solid tumours
I
Q1 2006




MEDI6469# + rituximab
murine OX40 agonist + anti-CD20 MAb
solid tumours
I
Q1 2015




MEDI6469# +
tremelimumab
murine OX40 agonist + anti-CTLA-4 MAb
solid tumours
I
Q4 2014




Respiratory, Inflammation and Autoimmunity
albediterol (AZD0548)
LABA
asthma / COPD
II
Q4 2007




AZD7624
inhaled P38 inhibitor
COPD
II
Q4 2014




AZD9412#
inhaled interferon 
asthma / COPD
II
Q1 2010




anifrolumab#
anti-IFN-alphaR MAb
SLE
II
Q1 2012




mavrilimumab#
anti-GM-CSFR MAb
rheumatoid arthritis
II
Q1 2010




MEDI-551#
anti-CD19 MAb
neuromyelitis optica2
II
Q1 2015




MEDI2070#
anti-IL-23 MAb
Crohn's disease
II
Q1 2013




MEDI7183#
anti-a4b7 MAb
Crohn's disease / ulcerative colitis
II
Q4 2012




MEDI9929#
anti-TSLP MAb
asthma
II
Q2 2014




PT010
LAMA / LABA / ICS
COPD
II
Q2 2014




RDEA3170
selective uric acid reabsorption inhibitor (SURI)
chronic treatment of patients with hyperuricemia or gout
II
Q3 2013




sifalimumab#
anti-IFN-alpha MAb
SLE
II
Q3 2008




tralokinumab
anti-IL-13 MAb
IPF
II
Q4 2012




tralokinumab
anti-IL-13 MAb
atopic dermatitis
II
Q1 2015




Phases I and II (continued)
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Respiratory, Inflammation and Autoimmunity (continued)
AZD1419#
TLR9 agonist
asthma
I
Q3 2013




AZD7594
inhaled SGRM
asthma / COPD
I
Q3 2012




AZD7986
DPP1
COPD
I
Q4 2014




AZD8999
MABA
COPD
I
Q4 2013




MEDI4920
anti-CD40L-Tn3 fusion protein
primary Sjgren's syndrome
I
Q2 2014




MEDI5872#
anti-B7RP1 MAb
SLE
I
Q4 2008




MEDI7836
anti-IL-13 MAb-YTE
asthma
I
Q1 2015




Infection
ATM AVI#
monobactam / beta lactamase inhibitor
targeted serious bacterial infections
II
Q1 2015




AZD5847
oxazolidinone anti-bacterial inhibitor
tuberculosis
II
Q4 2012




CXL#
beta lactamase inhibitor / cephalosporin
MRSA
II
Q4 2010




MEDI4893
MAb binding to S. aureus toxin
hospital-acquired pneumonia / serious S. aureus infection
II
Q4 2014




MEDI8897#
anti-RSV MAb-YTE
passive RSV prophylaxis
II
Q1 2015




MEDI-550
pandemic influenza virus vaccine
pandemic influenza prophylaxis
I
Q2 2006




MEDI3902
anti-Psl/PcrV
Prevention of nosocomial pseudomonas pneumonia
I
Q3 2014




MEDI7510
RSV sF+GLA-SE
prevention of RSV disease in older adults
I
Q2 2014




MEDI8852
influenza A MAb
influenza A treatment
I
Q1 2015




Neuroscience
AZD3241
myeloperoxidase inhibitor
multiple system atrophy
II
Q2 2012




AZD3293#
beta-secretase inhibitor
Alzheimer's disease
II
Q4 2014




AZD5213
histamine-3 receptor antagonist
Tourette's syndrome / neuropathic pain
II
Q4 2013




AZD8108
NMDA antagonist
suicidal ideation
I
Q4 2014




MEDI1814
anti-amyloid beta MAb
Alzheimer's disease
I
Q2 2014




# Partnered product.
1 MedImmune-sponsored study in collaboration with Novartis.
2 Neuromyelitis optica now lead indication. Multiple sclerosis Phase I study continuing. 
Significant Life-Cycle Management
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Cardiovascular and Metabolism
Brilinta / Brilique1 EUCLID
ADP receptor antagonist
outcomes study in patients with peripheral artery disease
Q4 2012
2017
2017
2017
2018 
Brilinta / Brilique1 HESTIA
ADP receptor antagonist
prevention of vaso-occlusive crises in paediatric patients with sickle cell disease
Q4 2014
2020
2020


Brilinta / Brilique1
PEGASUS-
TIMI 54
ADP receptor antagonist
outcomes study in patients with prior myocardial infarction
Q4 2010
Filed2
Filed2
Q4 2015
2017
Brilinta / Brilique1 SOCRATES
ADP receptor antagonist
outcomes study in patients with stroke or TIA
Q1 2014
H1 2016
H1 2016
H2 2016
2017
Brilinta / Brilique1 THEMIS
ADP receptor antagonist
outcomes study in patients with type 2 diabetes and CAD, but without a previous history of MI or stroke
Q1 2014
2017
2017
2018
2018
Bydureon Dual
Chamber Pen
GLP-1 receptor agonist
type 2 diabetes

Launched
Launched
Approved

Bydureon EXSCEL
GLP-1 receptor agonist
type 2 diabetes outcomes study 
Q2 2010
2018
2018
2018

Bydureon weekly
suspension
GLP-1 receptor agonist
type 2 diabetes
Q1 2013
Q4 2015
Q4 2015


Epanova
STRENGTH
omega-3 free fatty acids
outcomes study in statin-treated patients at high CV risk, with persistent hypertriglyceridemia plus low HDL-cholesterol
Q4 2014
2020
2020
2020
2020
Epanova / Farxiga/Forxiga3
omega-3 free fatty acids / SGLT-2 inhibitor
Non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NASH)
Q1 2015




Farxiga / Forxiga3
DECLARE-
TIMI 58
SGLT-2 inhibitor
type 2 diabetes outcomes study
Q2 2013
2020
2020


Farxiga / Forxiga3
SGLT-2 inhibitor
type 1 diabetes
Q4 2014
2018
2017
2018

Kombiglyze XR / Komboglyze4
DPP-4 inhibitor / metformin FDC
type 2 diabetes

Launched
Launched

Filed
Onglyza SAVOR-TIMI 53
DPP-4 inhibitor
type 2 diabetes outcomes study
Q2 2010
Filed
Launched

2015
saxagliptin / dapagliflozin FDC 
DPP-4 inhibitor / SGLT-2 inhibitor FDC
type 2 diabetes
Q2 2012
Filed
Q2 2015


Xigduo XR / Xigduo5
SGLT-2 inhibitor / metformin FDC
type 2 diabetes 

Launched
Launched 


Oncology
Caprelsa
VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity
differentiated thyroid cancer
Q2 2013
H1 2016
H1 2016
H1 2016

Faslodex
FALCON 
oestrogen receptor antagonist
1st line hormone receptor +ve advanced breast cancer
Q4 2012
H2 2016
H2 2016
H2 2016
H2 2016
Iressa 
EGFR tyrosine kinase inhibitor
EGFRm NSCLC

Filed
Launched
Launched
Launched
Lynparza (olaparib) SOLO-1
PARP inhibitor
1st line BRCAm ovarian cancer
Q3 2013
2017
2017
2017

Lynparza (olaparib) SOLO-2
PARP inhibitor
2nd line or greater BRCAm PSR ovarian cancer, maintenance monotherapy
Q3 2013
H1 2016
H1 2016
H2 2016

Lynparza (olaparib) SOLO-3
PARP inhibitor
gBRCA PSR ovarian cancer
Q1 2015
2018



Lynparza (olaparib) GOLD
PARP inhibitor
2nd line gastric cancer
Q3 2013


2017

Lynparza (olaparib) OlympiA
PARP inhibitor
gBRCA adjuvant triple negative breast cancer
Q2 2014
2020
2020
2020

Lynparza (olaparib) OlympiAD
PARP inhibitor
gBRCA metastatic breast cancer
Q2 2014
2016
2016
2016

Lynparza (olaparib) POLO
PARP inhibitor
pancreatic cancer
Q1 2015
2016
2017
2017

Lynparza (olaparib)
PARP inhibitor
prostate cancer
Q3 2014




Respiratory, Inflammation and Autoimmunity 
Duaklir Genuair#
LAMA / LABA
COPD

2018
Launched
2018
2018
Symbicort
SYGMA
ICS / LABA
as needed use in mild asthma
Q4 2014
N/A
2018

2019
Symbicort6
ICS / LABA
Breath Actuated Inhaler asthma / COPD

2018



Life-Cycle Management (continued)
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Neuroscience
Diprivan#
sedative and anaesthetic
conscious sedation

N/A
Launched
Filed
Launched
Movantik / Moventig#
oral peripherally-acting mu-opioid receptor antagonist
paediatrics





Gastrointestinal
Entocort
glucocorticoid steroid
Crohn's disease / ulcerative colitis

Launched
Launched
Q3 2015
N/A
linaclotide#
GC-C receptor peptide agonist
irritable bowel syndrome with constipation
(IBS-C)

N/A
N/A
N/A
Q4 2015
Nexium
proton pump inhibitor
refractory reflux esophagitis



Filed 

Nexium
proton pump inhibitor
stress ulcer prophylaxis




2017
Nexium 
proton pump inhibitor
paediatrics

Launched
Launched
H2 2016

# Partnered product.
1 Brilinta in the US; Brilique in rest of world.
2 Submission made in Q1 2015, acceptance anticipated Q2 2015.
3 Farxiga in the US; Forxiga in rest of world.
4 Kombiglyze XR in the US; Komboglyze in the EU.
5  Xigduo XR in the US; Xigduo in the EU.
6 Development of a new BAI device is ongoing.
Terminations (discontinued projects between 1 January and 31 March 2015)
NME / Line Extension
Compound
Reason for Discontinuation
Area Under Investigation
NME
AZD2115#
Strategic
COPD
NME
MEDI-559
Safety / efficacy
passive RSV prophylaxis
LCM
brodalumab#
Lack of efficacy
asthma
# Partnered product.
Completed Projects / Divestitures
Compound
Mechanism
Area Under Investigation
Phase
Estimated Filing
US
EU
Japan
China
Cardiovascular
Myalept
leptin analogue
lipodystrophy

Launched



Oncology
Lynparza (olaparib) capsule
PARP inhibitor
BRCAm PSR ovarian cancer

Launched
Launched


Infection
AZD0914
GyrAR
serious bacterial infections
II




Shareholder Information
ANNOUNCEMENTS AND MEETINGS
_______________________________________________________________________________________________________________________________________________________________________________________________________________________________
Annual General Meeting
24 April 2015
Announcement of half year and second quarter results
30 July 2015
Announcement of nine months and third quarter results
5 November 2015


DIVIDENDS
_______________________________________________________________________________________________________________________________________________________________________________________________________________________________
Future dividends will normally be paid as follows:
First interim
Announced with half year and second quarter results and paid in September
Second interim
Announced with full year and fourth quarter results and paid in March
On 6 February 2015 the Company transferred its US American Depositary Receipt (ADR) Programme to Citibank, N.A. 
TRADEMARKS
_______________________________________________________________________________________________________________________________________________________________________________________________________________________________
Trademarks of the AstraZeneca group of companies and of companies other than AstraZeneca appear throughout this document in italics. AstraZeneca, the AstraZeneca logotype and the AstraZeneca symbol are all trademarks of the AstraZeneca group of companies. Trademarks of companies other than AstraZeneca that appear in this document include Duaklir Genuair, Duaklir, Eklira, Tudorza and Tudorza Pressair, trademarks of Almirall, S.A.; Tissue Phenomics and Cognition Network Technology, trademarks of Definiens AG; Epanova, a trademark of Chrysalis Pharma AG; Zinforo, a trademark of Forest Laboratories; Zydelig, a trademark of GILEAD SCIENCES IRELAND UC; Zytiga, a trademark of Johnson & Johnson; Imbruvica, a trademark of Pharmacyclics, Inc.; and Daliresp, a trademark of Takeda GmbH.
ADDRESSES FOR CORRESPONDENCE
_______________________________________________________________________________________________________________________________________________________________________________________________________________________________
Registrar and
Transfer Office
Equiniti Limited
Aspect House
Spencer Road
Lancing
West Sussex
BN99 6DA
UK
US Depositary
Citibank Shareholder Services
PO Box 43077
Providence
RI 02940-3077
USA
Registered Office
2 Kingdom Street
London
W2 6BD
UK
Swedish Central Securities Depository
Euroclear Sweden AB
PO Box 191
SE-101 23 Stockholm
Sweden
Tel (freephone in UK):
0800 389 1580
Tel (outside UK):
+44 (0)121 415 7033
Tel: +44 (0)207 500 2030
or +1 877 248 4237 
(1 877-CITI-ADR)/
E-mail: citiadr@citi.com
Tel: +44 (0)20 7604 8000
Tel: +46 (0)8 402 9000
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
_______________________________________________________________________________________________________________________________________________________________________________________________________________________________
In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act 1995, we are providing the following cautionary statement: The interim financial statements contain certain forward-looking statements with respect to the operations, performance and financial condition of the Group. Although we believe our expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of preparation of the interim financial statements and AstraZeneca undertakes no obligation to update these forward-looking statements. We identify the forward-looking statements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in such statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond our control, include, among other things: the loss or expiration of patents, marketing exclusivity or trademarks, or the risk of failure to obtain and enforce patent protection; the risk of substantial adverse litigation/government investigation claims and insufficient insurance coverage; exchange rate fluctuations; the risk that R&D will not yield new products that achieve commercial success; the risk that strategic alliances and acquisitions will be unsuccessful; the impact of competition, price controls and price reductions; taxation risks; the risk of substantial product liability claims; the impact of any delays in the manufacturing, distribution and sale of any of our products; the impact of any failure by third parties to supply materials or services; the risk of failure to manage a crisis; the risk of delay to new product launches; the difficulties of obtaining and maintaining regulatory approvals for products; the risk of failure to adhere to applicable laws, rules and regulations; the risk that new products do not perform as we expect; the risk of environmental liabilities; the risks associated with conducting business in emerging markets; the risk of reputational damage; the risk of illegal trade in our products; the risk of failure to successfully implement planned cost reduction measures through productivity initiatives and restructuring programmes; the risk that regulatory approval processes for biosimilars could have an adverse effect on future commercial prospects; the impact of failing to attract and retain key personnel and to successfully engage with our employees; the impact of increasing implementation and enforcement of more stringent anti-bribery and anti-corruption legislation; and the risk of failure of information technology and cybercrime.

This information is provided by RNS
The company news service from the London Stock Exchange
  END
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