30 July 2015
H1 2015 Results
Financial Summary
+---------------------+------+----+------++-----+----+------+
| |H1 2015 ||Q2 2015 |
+---------------------+------+----+------++-----+----+------+
| |$m |% change ||$m |% change |
+---------------------+------+----+------++-----+----+------+
| | |CER1|Actual|| |CER1|Actual|
+---------------------+------+----+------++-----+----+------+
|Total Revenue2 |12,364|1 |(6) ||6,307|2 |(7) |
+---------------------+------+----+------++-----+----+------+
| | | | || | | |
+---------------------+------+----+------++-----+----+------+
|Core3 Op. Profit |3,618 |(4) |(9) ||1,813|(4) |(11) |
+---------------------+------+----+------++-----+----+------+
|Core EPS |$2.29 |- |(7) ||$1.21|3 |(8) |
+---------------------+------+----+------++-----+----+------+
| | | | || | | |
+---------------------+------+----+------++-----+----+------+
|Reported Op. Profit|1,856 |1 |(5) ||923 |(10)|(17) |
+---------------------+------+----+------++-----+----+------+
|Reported EPS |$0.99 |2 |(4) ||$0.55|(4) |(13) |
+---------------------+------+----+------++-----+----+------+
· Total H1 Revenue up 1%; Core Gross margin over 83%, up 1% point
· Robust top-line performance, supported by externalisation, underpins
accelerated investment in R&D to progress pipeline, up 24% in H1
· Core SG&A efficiency programme - early progress: Core SG&A 35% of Q2 Total
Revenue (Q4 2014: 44%)
- Sales & marketing effectiveness, centralisation of functions, process
improvements, third-party spend, further efficiencies across support areas,
footprint optimisation
· Core H1 EPS stable, up 3% in Q2, enhanced by one-off tax benefit
· FY 2015 Total Revenue guidance at CER improved: Now expected to decline by
low single-digit percent (prior guidance - mid single-digit). Core EPS guidance
at CER is unchanged: Expected to increase by low single-digit percent,
reflecting the continued accelerated investment in R&D
· The Board recommends an unchanged first interim dividend of $0.90
H1 Commercial Highlights
Growth platforms grew by 11%, representing 56% of Total Revenue:
1. Brilinta/Brilique: +42%. Achieved 10% new-to-brand prescription market share
in the US
2. Diabetes: +32%, including 88% sales growth in Emerging Markets
3. Respiratory: +9%, ahead of market growth. Q2 sales up 11%
4. Emerging Markets: +14%. China sales growth of +19%
5. Japan: +2%, with Q2 sales growth of +6%
Achieving Scientific Leadership: Progress since the prior results announcement
+---------------------------------+--------------------------------------------+
|Regulatory Approvals |Iressa - lung cancer (US) Faslodex 500mg -|
| | breast cancer (China) |
+---------------------------------+--------------------------------------------+
|Regulatory Submissions* and/or |saxagliptin/dapagliflozin - diabetes |
|Regulatory Submission Acceptances|(EU)AZD9291 - lung cancer (US*, EU) |
| |cediranib - ovarian cancer (EU)Ceftazidime|
| | Avibactam (CAZ AVI) - serious infections |
| |(EU) |
+---------------------------------+--------------------------------------------+
|Phase III Read-outs |selumetinib - uveal melanoma: Primary |
| |endpoint not met |
+---------------------------------+--------------------------------------------+
|Other Key Developments |Brilinta/Brilique - post-myocardial |
| |infarction (MI):Granted FDA Priority |
| |Review |
+---------------------------------+--------------------------------------------+
Pascal Soriot, Chief Executive Officer, commenting on the results said:
“We made good progress in the period, delivering a robust underlying business
performance. This represents six successive quarters of top-line growth. The
initiatives introduced to increase efficiency are starting to reduce SG&A costs,
supporting our continued strategic investment in science and the acceleration of
our pipeline which has positive momentum across all key areas.
I’m particularly pleased by the pace of progress in Oncology, with new approvals
for both Iressa and Faslodex accompanied by regulatory submissions for AZD9291
and cediranib. The strong performance of the growth platforms and the subsequent
upgrade to top-line guidance, together with increased R&D productivity reaffirm
the confidence we have in our ability to navigate the final impacts from the
loss of exclusivity and meet our revenue targets.”
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 (http://www.astrazeneca.com/Investors) published by the Company on
6 March 2015.
3. See the Operating and Financial Review for a definition of Core financial
measures and a reconciliation of Core to Reported financial measures.
Results Presentation
A presentation for investors and analysts, hosted by management, will begin at
midday BST today. The accompanying live webcast can be accessed via
www.astrazeneca.com/investors.
Reporting Calendar
The Company intends to publish its nine months and third quarter financial
results on 5 November 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 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen +44 20 7604 8199 +44 7818 524185
Eugenia Litz RIA +44 20 7604 8233 +44 7884 735627
Nick Stone CVMD +44 20 7604 8236 +44 7717 618834
Karl Hård Oncology +44 20 7604 8123 +44 7789 654364
Craig Marks ING +44 20 7604 8591 +44 7881 615764
Christer Gruvris +44 20 7604 8126 +44 7827 836825
US
Dial / Toll-Free +1 301 398 3251 +1 866 381 7277
Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and
Metabolic Disease,
ING - Infection, Neuroscience and Gastrointestinal
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 the document.
Progress since the prior results announcement on 24 April 2015:
Regulatory 2 - Iressa - lung cancer (US)
Approvals - Faslodex 500mg - breast
cancer (China)
Regulatory 4 - saxagliptin/dapagliflozin -
Submissions* diabetes (EU)- AZD9291 - lung
and/or cancer (US*, EU) - cediranib -
Regulatory ovarian cancer (EU)- CAZ AVI -
Submission serious infections (EU)
Acceptances
Phase III Read 1 - selumetinib - uveal melanoma:
-outs Primary endpoint not met
Other Key 1 - Brilinta/Brilique - post-MI
Developments (PEGASUS
trial):
Granted FDA Priority Review
Forthcoming 3 - brodalumab - psoriasis, PT003 -
Regulatory COPD, AZD9291 - lung cancer (JP)
Submissions
Forthcoming 5 - lesinurad - gout,
Regulatory saxagliptin/dapagliflozin,
Decisions Brilinta/Brilique, AZD9291, CAZ-AVI
Pivotal Trial 6 - PT010 - COPD-
Starts anifrolumab - lupus- durvalumab
(MEDI4736) + tremelimumab - 2nd-line
SCCHN** (CONDOR trial), 2nd and 3rd
-line gastric cancer, 1st-line NSCLC
(MYSTIC trial)- AZD9291 - 2nd
-line EGFRm NSCLC (CAURAL trial)
New Molecular 15 RIA- lesinurad - gout-
Entities (NMEs) in PT003 - COPD- PT010 - COPD (new)
Pivotal Studies or - brodalumab - psoriasis-
under Regulatory benralizumab - severe asthma-
Review tralokinumab - severe asthma-
anifrolumab - lupus (new)CVMD-
roxadustat - anaemiaOncology -
AZD9291 - lung cancer- cediranib
- ovarian cancer - selumetinib -
lung cancer- tremelimumab -
mesothelioma - durvalumab - lung
cancer - moxetumomab pasudotox -
leukaemia ING - CAZ AVI - serious
infections
Projects in 119
clinical pipeline
**Squamous Cell Carcinoma of the Head and Neck
In the period 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.
1. Respiratory, Inflammation and Autoimmunity (RIA)
Significant progress continues to be made in the RIA pipeline, which now
includes seven programmes in pivotal studies or under 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 a number of
promising assets in inflammatory and autoimmune diseases within areas such as
psoriasis, psoriatic arthritis, gout, systemic lupus and rheumatoid arthritis.
AstraZeneca and Ardea Biosciences had a strong presence at the recent European
League Against Rheumatism annual meeting, with 24 abstracts accepted. Data were
presented on several investigational molecules including lesinurad (gout),
mavrilimumab (rheumatoid arthritis) and brodalumab (psoriatic arthritis).
a) PT010 (COPD)
The first patient has been dosed in the Phase III programme for PT010, a
combination of budesonide, glycopyrronium and formoterol fumarate (BGF) in
development for patients with moderate to severe COPD. PT010 has the potential
in a number of markets to be the first fixed-dose triple-combination medicine to
be delivered in a pressurised metered-dose inhaler using the unique porous
particle co-suspension technology developed by Pearl Therapeutics, acquired by
AstraZeneca in 2013.
The Phase III ETHOS trial is assessing a twice-daily investigational formulation
in more than 8,000 patients with moderate to severe COPD over the course of 52
weeks. More than 750 centres in over 25 countries are expected to participate in
the trial.
ETHOS is a randomised, double-blind, multi-centre, parallel group trial
assessing efficacy and safety of BGF relative to two active comparators - a
fixed-dose combination of the budesonide and formoterol fumarate and a fixed
-dose combination of glycopyrronium and formoterol. The primary endpoint is the
rate of moderate or severe COPD exacerbations.
b) Anifrolumab (lupus)
The first patient has been dosed in the Phase III programme for anifrolumab, a
first-in-class investigational medicine for patients with moderate to severe
systemic lupus erythematosus (SLE, or lupus), and the only anti-type-I IFN
receptor approach currently in development. The Phase III TULIP programme
includes two clinical trials that will evaluate the efficacy and safety of
anifrolumab versus placebo in subjects with moderately to severely active,
autoantibody-positive SLE, while receiving standard of care (SoC) treatment. The
programme will assess the effect of anifrolumab in reducing disease activity (as
measured by the SRI-4), decreasing use of oral corticosteroids, improving skin
manifestations (as measured by CLASI) and reducing flares.
Anifrolumab has been developed with a biomarker test based on the type-I IFN
-inducible gene signature, which is also being investigated as part of the
clinical programme. The Company intends to present full anifrolumab Phase IIb
data at the American College of Rheumatology congress in November 2015.
c) Benralizumab (severe asthma)
The Phase III benralizumab trials CALIMA and SIROCCO have completed enrolment.
These trials are designed to evaluate safety and effectiveness in actively
reducing exacerbations in patients with uncontrolled asthma. The trials also
assess lung function, asthma symptoms and other asthma-control measures, as well
as emergency room and hospitalisation rates.
d) Tralokinumab (severe asthma)
In May 2015 AstraZeneca announced that it had entered an agreement with Abbott
Laboratories, Inc. (Abbott) to develop companion diagnostic tests to identify
patients with severe asthma most likely to benefit from tralokinumab. No
companion diagnostic blood tests have yet been approved for use in asthma.
Under the terms of the agreement, Abbott will develop and commercialise
diagnostic tests to measure serum levels of the proteins periostin and
dipeptidyl peptidase-4 (DPP-4), identified as potential predictive biomarkers of
up-regulated IL-13 in severe asthma. The tests will be developed in conjunction
with the Phase III trials of tralokinumab as a potential treatment for patients
with severe, inadequately-controlled asthma.
e) Brodalumab (psoriasis)
In May 2015 Amgen, Inc. (Amgen) announced the termination of its co-development
and commercialisation agreement with AstraZeneca for brodalumab, an
investigational IL-17 receptor monoclonal antibody in development for patients
with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial
spondyloarthritis.
AstraZeneca has conducted an initial evaluation of the data, which confirms that
brodalumab demonstrated strong efficacy in psoriasis and indicates that the
observations of suicidal ideation and behaviour are unlikely to be causally
related to brodalumab therapy. Whilst continuing the transfer of the programme
from Amgen, the Company is proceeding with a full analysis and evaluating
potential partnering options in parallel. AstraZeneca will communicate its
definitive decision in due course.
1. 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 (CV)
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.
Reporting results of the Company’s research and development in diabetes,
AstraZeneca presented 86 abstracts at the recent American Diabetes Association
(ADA) annual meeting. These abstracts included clinical trial data evaluating
Farxiga/Forxiga, Bydureon, Byetta and Onglyza, as well as the investigational
combination of Onglyza and Farxiga/Forxiga.
Notable late-breaking abstracts included data from a positive Phase III trial
comparing the efficacy and safety of Farxiga/Forxiga versus placebo as an add-on
to Onglyza and metformin immediate release in adults with type-2 diabetes who
had inadequate glycaemic control. The trial met its primary endpoint.
a) Brilinta/Brilique (CV disease)
In April 2015, AstraZeneca announced that the FDA had accepted a supplemental
new-drug application (sNDA) and granted Priority Review for Brilinta for
patients with a history of prior MI. The sNDA was based on the results of
PEGASUS-TIMI 54, a large-scale outcomes trial in more than 21,000 patients that
investigated Brilinta plus low-dose aspirin, compared to placebo plus low-dose
aspirin, for the chronic secondary prevention of atherothrombotic events in
patients who had experienced a heart attack one to three years prior to trial
enrolment.
A Priority Review designation is granted to medicines that the FDA determines
have the potential to provide significant improvements in the treatment,
prevention or diagnosis of a disease.
b) Onglyza (type-2 diabetes)
AstraZeneca is working closely with regulators as part of the ongoing review of
the full SAVOR dataset. The Company is currently awaiting a forthcoming decision
from the FDA on a possible label update for Onglyza and Kombiglyze XR
respectively.
At the recent ADA meeting AstraZeneca announced results from an observational,
retrospective trial which found no evidence of increased risk of hospitalisation
for heart failure (hHF) with Onglyza, compared with sitagliptin, both of which
are DPP-4 inhibitors, in patients with type-2 diabetes. A similar finding was
obtained when comparing the overall DPP-4 class to sulfonylureas. The analysis
included patients with and without prior CV disease and concluded that, among
the latter, DPP-4 treatment was associated with a statistically-significant
lower risk of hHF compared to treatment with sulfonylureas.
c) SGLT2 Inhibitors (type-2 diabetes)
In May 2015, the FDA posted a Drug Safety Communication warning that
sodium/glucose co-transporter-2 (SGLT2) inhibitors, the class to which
Farxiga/Forxiga belongs and is used to treat type-2 diabetes, may lead to
diabetic ketoacidosis (DKA), a medical condition where the body produces high
levels of blood acids called ketones that may require hospitalisation.
Last month the European Medicines Agency (EMA) announced a review of SGLT2
inhibitors to evaluate the risk of DKA. The regulatory authorities will continue
to investigate this safety issue and will determine whether changes are needed
in the prescribing information for this class of drugs. AstraZeneca is committed
to working with the FDA and EMA during their respective reviews of the data.
The DECLARE outcomes trial for Farxiga/Forxiga recently completed its global
patient enrolment around one year ahead of plan. The DECLARE trial is a large CV
outcomes trial designed to assess the impact of Farxiga/Forxiga on CV
risk/benefit, when the medicine is added to a patient’s current anti-diabetes
therapy, on CV events such as heart attack, ischemic stroke and CV-related
death, compared with placebo. The trial involves the enrolment of around 26,000
patients with type-2 diabetes in more than 30 countries with the aim of
randomising over 17,000 patients. It is an event-driven trial and is estimated
to be completed in 2019.
d) Tenapanor (chronic kidney disease)
In June 2015 Ardelyx, Inc. (Ardelyx) announced that it had entered into a
termination agreement with AstraZeneca. Under the agreement all rights to
Ardelyx’s portfolio of NHE3-inhibitors, including Ardelyx’s lead product
candidate, tenapanor will be returned to Ardelyx.
1. 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 between 2013 and 2020. A broad pipeline of next-generation medicines is
focused principally on four disease areas - breast, ovarian, lung and
haematological cancers.
As well as other tumour types, 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.
AstraZeneca hosted an investor science event during the 2015 American Society of
Clinical Oncology (ASCO) meeting in Chicago. Key presentations included:
· Data presented on durvalumab (formerly MEDI4736) as monotherapy in heavily
pre-treated patients with non-small cell lung cancer (NSCLC) or SCCHN were
encouraging and suggested that patients with PD-L1 positive tumours may have an
improved overall response rate (ORR) compared to patients with PD-L1 negative
tumours, highlighting the unmet medical need for the majority of tumours that
are PD-L1 negative
· Data presented on durvalumab plus tremelimumab confirmed the Phase III trial
dose and schedule for this combination. The combination demonstrated an ORR of
38% at doses selected for the Phase III trials versus a 5% ORR for patients
receiving durvalumab monotherapy in the 1108 trial. The combination was well
tolerated with a very low 7% drug-related discontinuation rate
· In addition, durvalumab is demonstrating strong potential to combine with
small molecules
AstraZeneca has an extensive development programme underway across multiple
tumour types and stages of disease, assessing the potential for immunotherapy to
either replace or combine with traditional targeted and chemotherapy treatment.
Today there are six AstraZeneca Oncology NMEs in pivotal studies or under
regulatory review.
Highlights from the late-stage portfolio include:
+------------+--------------+--------------------------------------------------+
| Medicine | Indication | Status |
+------------+--------------+--------------------------------------------------+
|Iressa |Lung cancer |Earlier this month the Company announced that |
| | |the FDA had approved Iressa (gefitinib) tablets,|
| | |a 250mg once-daily 1st-line treatment for patients|
| | |with metastatic epidermal growth-factor receptor|
| | |(EGFR) mutated NSCLC. Iressa was granted Orphan |
| | |Drug Designation by the FDA in 2014. |
+------------+--------------+--------------------------------------------------+
|AZD9291 |Lung cancer |In June 2015, the Company submitted the rolling |
| | |new-drug application (NDA) for AZD9291 as a |
| | |potential medicine for the 2nd-line treatment of|
| | |patients with advanced or metastatic T790M |
| | |-mutated NSCLC. The EMA also accepted the |
| | |regulatory submission for AZD9291.CAURAL, a |
| | |randomised Phase III trial in 2nd-line metastatic |
| | |EGFR T790M-mutation positive NSCLC testing |
| | |AZD9291 plus durvalumab versus AZD9291 |
| | |monotherapy is being prepared for dosing. The |
| | |trial has a primary endpoint of progression-free|
| | |survival (PFS).At the ASCO meeting, preliminary |
| | |efficacy and safety data for AZD9291 in the 1st |
| | |-line treatment of EGFRm-positive advanced NSCLC|
| | |were presented. Data showed that 81% (95% |
| | |confidence interval (CI) 68% to 89%) of patients |
| | |on a once-daily dose of AZD9291 were progression|
| | |-free at nine months; the ORR was 73% (95% CI 60% |
| | |to 84%). The longest duration of response was |
| | |ongoing at 13.8 months at the time of data cut |
| | |-off. These data support the ongoing development |
| | |of AZD9291 in 1st-line lung cancer, including |
| | |the Phase III FLAURA trial. |
+------------+--------------+--------------------------------------------------+
|Cediranib |Ovarian cancer|The Company received acceptance from the EU this|
| | |month for the marketing authorisation application |
| | | for cediranib with an intended indication in |
| | |platinum-sensitive relapsed ovarian cancer. The |
| | |application was based on the ICON6 trial. ICON6 |
| | |results showed that, compared to platinum |
| | |chemotherapy alone, cediranib given with |
| | |platinum-based chemotherapy and continued as |
| | |maintenance, significantly improves PFS in women|
| | |with recurrent ovarian cancer. Subsequent |
| | |secondary-efficacy measures supported significant |
| | |sustained efficacy, leading to a strong overall |
| | |survival trend. |
+------------+--------------+--------------------------------------------------+
|Selumetinib |Uveal melanoma|The Phase III SUMIT trial of selumetinib (MEK |
| | |inhibitor) in combination with dacarbazine did not|
| | |meet its primary endpoint of PFS. This |
| | |combination therapy showed an adverse event |
| | |profile generally consistent with current |
| | |knowledge of the safety profiles of dacarbazine |
| | |and selumetinib. A full evaluation of the data |
| | |is ongoing.Outside uveal melanoma, selumetinib is |
| | |in a Phase III trial in 2nd-line KRAS-mutant |
| | |advanced NSCLC in combination with docetaxel, in|
| | |a Phase III trial in differentiated thyroid cancer|
| | |and in a Phase II registration trial in patients|
| | |with neurofibromatosis Type 1. These trials have|
| | |a different scientific rationale and selumetinib |
| | |is being tested in alternative combinations. The|
| | |findings from SUMIT are not expected to have any|
| | |impact on the other studies. |
+------------+--------------+--------------------------------------------------+
+----------+----------------+--------------------------------------------------+
|Durvalumab|Lung cancer |ATLANTIC, a Phase II trial in PD-L1 positive 3rd|
| | |-line metastatic NSCLC, is now fully recruited and|
| | |scheduled to deliver data in the second half. |
| | |This trial could potentially, if positive, |
| | |support the first regulatory submission for |
| | |durvalumab. ARCTIC, a Phase III trial in 3rd-line |
| | |metastatic NSCLC is recruiting patients and |
| | |contains a randomised durvalumab monotherapy sub|
| | |-study for PD-L1 positive patients versus SoC |
| | |and a sub-study with a concurrent-combination |
| | |treatment with tremelimumab versus the |
| | |contribution of components and SoC in PD-L1 |
| | |negative patients.MYSTIC, which is being |
| | |prepared for dosing, is a 1st-line NSCLC |
| | |durvalumab-tremelimumab trial in PD-L1 unselected,|
| | |EGFR/ALK wild-type patients and includes a sub |
| | |-group analysis of PD-L1 positive and PD-L1 |
| | |low/negative patients. The primary endpoint is |
| | |PFS and the trial includes durvalumab monotherapy |
| | |and the durvalumab-tremelimumab combination |
| | |versus SoC. NEPTUNE, a further durvalumab |
| | |-tremelimumab versus SoC trial with overall |
| | |survival (OS) as the primary endpoint |
| | |complements the MYSTIC PFS trial and will commence|
| | |in due course.A third 1st-line NSCLC trial of |
| | |durvalumab plus chemotherapy in PD-L1 |
| | |unselected, EGFR/ALK wild-type NSCLC will also |
| | |be initiated after a lead-in phase.PD-L1 status is|
| | |being assessed by a proprietary (SP263) |
| | |immunohistochemistry diagnostic test jointly |
| | |developed with Ventana Medical Systems, Inc., a |
| | |member of the Roche Group. |
+----------+----------------+--------------------------------------------------+
|Head and |In the CONDOR |
|Neck |trial for |
|cancer |patients with |
| |recurrent or |
| |metastatic SCCHN|
| |the first |
| |patient was |
| |dosed in the |
| |quarter. The |
| |CONDOR trial is |
| |a Phase II, |
| |randomised, |
| |global trial of |
| |durvalumab |
| |monotherapy, |
| |tremelimumab |
| |monotherapy and |
| | durvalumab in |
| |combination with|
| |tremelimumab in |
| |PD-L1 negative |
| |patients. It is |
| |designed to |
| |complement the |
| |HAWK trial which|
| | targets PD-L1 |
| |positive |
| |patients. |
+----------+----------------+--------------------------------------------------+
|Gastric |A Phase II trial|
|cancer |in 2nd and 3rd |
| |-line gastric |
| |cancer was also |
| |initiated in the|
| |period. This |
| |trial explores |
| |durvalumab |
| |-tremelimumab |
| |versus |
| |durvalumab |
| |versus |
| |tremelimumab. |
+----------+----------------+--------------------------------------------------+
|Pancreatic|A pancreatic |
|cancer |cancer |
| |uncontrolled |
| |Phase II trial|
| |will explore |
| |combinations of |
| |immunotherapies,|
| |in particular |
| |durvalumab plus |
| | tremelimumab, |
| |in 2nd-line |
| |metastatic |
| |pancreatic |
| |ductal |
| |adenocarcinoma |
| |(PDAC). In |
| |addition, the |
| |programme will |
| |explore |
| |combinations of |
| |immunotherapy |
| |with both |
| |chemotherapy in |
| |1st-line PDAC |
| |and with |
| |targeted |
| |therapies in 2nd|
| |-line PDAC; |
| |the first |
| |targeted therapy|
| |included in this|
| |trial is AZD5069|
| |(CXCR2). |
+----------+----------------+--------------------------------------------------+
|Bladder |A 1st-line |
|cancer |bladder cancer |
| |Phase III, |
| |randomised and |
| |controlled trial|
| |will evaluate |
| |both durvalumab |
| |monotherapy and |
| | durvalumab |
| |-tremelimumab in|
| |metastatic, |
| |urothelial |
| |bladder cancer. |
+----------+----------------+--------------------------------------------------+
Durvalumab and Ramucirumab (advanced solid tumours)
In May 2015, AstraZeneca and Eli Lilly & Company (Lilly) announced a clinical
-trial collaboration to evaluate the safety and preliminary efficacy of
durvalumab, in combination with ramucirumab, Lilly’s VEGF receptor-2 anti
-angiogenic cancer medicine. The planned trial will assess the combination as a
treatment for patients with advanced solid tumours.
A Phase I trial is expected to establish the safety and a recommended dosing
regimen, with the potential to open expansion cohorts in various tumours of
interest for the combination of durvalumab and ramucirumab. Under the terms of
the agreement, the trial will be sponsored by Lilly.
1. Infection, Neuroscience and Gastrointestinal (ING)
a) CAZ-AVI (serious infections)
In May 2015 the EU submission for CAZ-AVI was validated and accepted by the EMA.
CAZ-AVI is being developed to treat adult hospitalised patients with complicated
intra-abdominal infections, complicated urinary tract infections or nosocomial
pneumonia (including hospital acquired pneumonia and ventilated patients). Full
Phase III results evaluating the safety and efficacy of CAZ-AVI for the global
RECLAIM-1 and RECLAIM-2 studies and the global REPRISE trial were presented at
the 25th European Congress of Clinical Microbiology and Infectious Diseases.
CAZ-AVI is anticipated as the first choice for the treatment of Gram-negative
pathogens that are increasingly becoming resistant to prevailing standards of
care, leading to greater numbers of life-threatening infections and additional
healthcare costs.
b) AZD3293 (Alzheimer’s disease)
AZD3293 is an oral, potent and selective small-molecule inhibitor designed as a
novel treatment for patients suffering from early Alzheimer’s disease. A global
co-development and co-commercialisation agreement was established with Lilly in
2014 for this important potential medicine.
Under the terms of the agreement, Lilly will pay AstraZeneca up to $500m in
development and regulatory milestone payments. The first progress milestone was
met in July 2015 and, as such, $50m of Externalisation Revenue from Lilly to
AstraZeneca will be recognised in the third quarter.
Scientific Collaborations
______________________________________________________________________________
Montreal Heart Institute
AstraZeneca announced in May 2015 a collaboration with the Montreal Heart
Institute in Quebec, Canada, to search the genomes of up to 80,000 patients for
genes associated with cardiovascular diseases and diabetes, their complications
and treatment outcomes. This is one of the largest such screens of its type to
date and will drive understanding of the biological mechanisms underlying these
conditions and their complications. The analysis will also uncover which genetic
traits are linked to better treatment outcomes.
Corporate and Business Development Update
___________________________________________________________________________
a) Haematology Collaboration with Celgene
In April 2015 AstraZeneca announced an exclusive collaboration agreement with
Celgene Corporation (Celgene), a global leader in haematological cancers, for
the development and commercialisation of durvalumab across a range of blood
cancers including non-Hodgkin’s lymphoma, myelodysplastic syndrome and multiple
myeloma.
Under the terms of the agreement, Celgene made an upfront payment of $450m in
the second quarter to AstraZeneca. Celgene will lead on development across all
clinical trials within the collaboration and will take on all research and
development costs until the end of 2016, after which it will take on 75% of
these costs. Celgene will also be responsible for global commercialisation of
approved treatments. AstraZeneca will continue to manufacture and book all sales
of durvalumab and will pay a royalty to Celgene on worldwide sales in
haematological indications. The royalty rate will start at 70% and will decrease
to approximately half of the sales of durvalumab in haematological indications
over a period of four years. AstraZeneca may elect to opt out of funding part of
any clinical study prior to its initiation, resulting in an increase of future
royalty rates or a subsequent re-opt in payment.
Within the collaboration, durvalumab will be assessed both as monotherapy and in
combination with other AstraZeneca and Celgene potential and existing cancer
medicines. Over time, the collaboration has the potential to expand and include
other assets.
b) NKG2A Antibody Collaboration with Innate
AstraZeneca entered into a collaboration in the second quarter with Innate
Pharma SA (Innate) to accelerate and broaden the development of Innate’s
proprietary NKG2A antibody, IPH2201, including in combination with durvalumab.
Currently in Phase II development, IPH2201 is a potential first-in-class
humanised IgG4 antibody against NKG2A. NKG2A is a checkpoint receptor that
inhibits the anti-cancer functions of Natural Killer and cytotoxic T-cells.
Under the terms of the agreement, AstraZeneca made an initial payment to Innate
of $250m, which included the consideration for exclusive global rights to co
-develop and commercialise IPH2201 in combination with durvalumab, as well as
access to IPH2201 in monotherapy and other combinations in certain treatment
areas for which AstraZeneca has the option to pay a further $100m prior to
initiation of Phase III development. The agreement also includes additional
regulatory and sales-related milestones. AstraZeneca will book all sales and
will pay Innate double-digit royalties on net sales. The arrangement includes
the right for Innate to co-promote in Europe for a 50% profit share.
c) Joint Venture with Fujifilm Kyowa Kirin Biologics
In July 2015 AstraZeneca entered into an agreement with Fujifilm Kyowa Kirin
Biologics Co., Ltd to establish a joint venture for the development and
commercialisation of FKB238, a biosimilar version of bevacizumab, currently in
Phase I development for the treatment of multiple solid tumours. The Company
plans to use the biosimilar in combination with its portfolio of innovative
oncology investigational and on-market medicines, across a range of cancers and
at different stages of disease.
By developing an interchangeable biosimilar to support the Company’s combination
-focused oncology strategy, AstraZeneca will explore potential new treatment
options for patients, while at the same time keep the cost of those combination
therapies low enough to enable access for the majority of patients.
d) Entocort Divestment
In July 2015 AstraZeneca completed an agreement entered into with Tillotts, part
of the Zeria Group, for the divestment of global rights, outside the US, to
Entocort (budesonide), a gastroenterology medicine for patients with mild
-moderate Crohn’s disease and ulcerative colitis.
Entocort is currently available in over 40 countries, with total product sales
of $53m outside the US in 2014. A regulatory submission for Entocort in Japan is
anticipated in the coming months. Under the terms of the agreement, Tillotts
made an upfront payment to AstraZeneca of $215m upon completion of the
transaction to acquire the rights to sell and develop Entocort capsules and
enema formulations outside the US. The payment will be shown within Other
Operating Income in the Company’s financial statements in the third quarter.
e) Benralizumab: Japan
The Company recently announced an agreement with Kyowa Hakko Kirin Co. Ltd
(Kyowa Hakko Kirin) for an exclusive option to commercialise benralizumab for
asthma and COPD in Japan.
Benralizumab is a monoclonal antibody in Phase III development for the treatment
of severe uncontrolled asthma and COPD. The results for benralizumab in severe
asthma are expected to read out in 2016, with regulatory submissions anticipated
later that year. Phase III results and regulatory filing in COPD are expected in
2018.
Under the terms of the agreement, the Company will make a $45m up-front option
payment and may make subsequent payments for regulatory filing, approval and
commercial milestones, and sales royalties should the option be exercised. Kyowa
Hakko Kirin will continue to be responsible for the research and development of
benralizumab in Japan. On exercising the option, AstraZeneca will be responsible
for all sales and marketing in asthma and COPD in Japan. Kyowa Hakko Kirin will
retain the rights to participate in certain commercial activities alongside
AstraZeneca.
f) Caprelsa Divestment
This month AstraZeneca announced that it had entered into a definitive agreement
with Genzyme Corporation (Genzyme), part of Sanofi S.A., to divest Caprelsa
(vandetanib), a rare-disease medicine. Caprelsa was granted Orphan Drug
Designation by the US FDA in 2005 and is currently available in 28 countries for
the treatment of aggressive and symptomatic medullary thyroid carcinoma, with
global product sales of $48m in 2014.
Under the terms of the agreement, Genzyme will pay AstraZeneca up to $300m,
including an upfront payment of $165m to acquire the global rights to sell and
develop Caprelsa, and further development and sales milestone payments of up to
$135m. The transaction does not include the transfer of any AstraZeneca
employees or facilities. As an asset divestment, the upfront receipt and any
subsequent payments will be reported in Other Operating Income in the Company’s
financial statements.
g) Creation of Antibiotics Business Unit
The Company recently announced the intention to create a new antibiotics
business unit focused on the development of the late-stage pipeline of small
molecules (CAZ-AVI, ATM-AVI and CXL) and on maximising the commercial potential
of the portfolio of small molecule antibiotics (Merrem and Zinforo) across a
number of prioritised markets.
The creation of a new, focused business unit is the best way to enable these
important medicines to reach patients while further increasing the focus on the
Company’s three main therapy areas. The creation of this new internal structure
will have no impact on either the presentation of the Company’s financial
statements or the Company’s biologics Infection business.
h) Change In Senior Executive Team
Briggs Morrison, formerly Executive Vice President, Global Medicines Development
and Chief Medical Officer, left the Company in June having accepted offers to
become the Chief Executive Officer of Syndax Pharmaceuticals, Inc., a privately
-held oncology company, and a Managing Director of venture capital firm, MPM
Capital, Inc.
Pending the appointment of Dr Morrison’s successor, Elisabeth Björk, Vice
President and Head of Development, Cardiovascular, Metabolism and Diabetes was
appointed Interim Chief Medical Officer and took over operational leadership of
Global Medicines Development, and Pascal Soriot became temporary Co-Chairman of
the Late Stage Product Committee, the governance body accountable for post-Phase
II investment decisions.
i) Future Infrastructure
In the half the Company continued both with the construction of its new Global
R&D Centre and Corporate Headquarters on the Cambridge Biomedical Campus and the
move of employees to Cambridge from other UK locations.
AstraZeneca announced in the half that it will invest approximately $285m in a
new high-tech facility for the manufacture of biological medicines in
Södertälje, Sweden. The new plant will be focused on the filling and packaging
of protein therapeutics. It is anticipated that the new facility will supply
medicines for clinical-trial programmes from the end of 2018 and will deliver
finished products for commercial use once fully operational by 2019.
Södertälje is home to AstraZeneca’s largest global tablets and capsules
manufacturing facility and is also a launch-platform site for the Company, with
specialist capabilities on-site that allow large-scale production of new
medicines, working closely with the research and development organisation. By
locating the new manufacturing plant in Södertälje, the Company will combine its
expertise in biologics with the well-established culture of operational
excellence that exists within the Sweden Operations unit.
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 six and
three month periods to 30 June 2015 (the half and the quarter respectively)
compared to the six and three months to 30 June 2014 (the half and the quarter
respectively). 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 (http://www.astrazeneca.com/investors) and Form 20-F Information.
Total Revenue
Total Revenue grew by 1% in the half to $12,364m. Based on actual exchange
rates, Total Revenue declined by 6% reflecting the particular weakness of key
trading currencies against the US dollar.
Product Sales
Product Sales declined by 2% in the half (Q2 2015: down by 1%) reflecting the US
market entry of a Nexium generic product from February 2015 as well as an
adverse impact from the change in accounting for the US Branded Pharmaceutical
Fee following issuance of final regulations in Q3 2014.
Externalisation Revenue
Externalisation Revenue of $780m in the half (H1 2014: $352m) primarily
reflected income from completion of the collaboration agreement in haematology
with Celgene ($450m), together with income from the co-commercialisation
agreement with Daiichi Sankyo Co, Ltd. (Daiichi Sankyo) for Movantik in the US
($200m), plus the co-commercialisation of Nexium in Japan ($55m), also with
Daiichi Sankyo.
Product Sales
________________________________________________________________________________
The performance of a selection of key medicines is shown below. A geographical
split of the performance is shown in Notes 6 and 7.
+----------------------+-----+------+------++-----+------+------+
| |H1 2015 ||Q2 2015 |
+----------------------+-----+------+------++-----+------+------+
| | |% Change || |% Change |
+----------------------+-----+------+------++-----+------+------+
| |$m |CER |Actual||$m |CER |Actual|
+----------------------+-----+------+------++-----+------+------+
| | | | || | | |
+----------------------+-----+------+------++-----+------+------+
|Respiratory, | | | || | | |
|Inflammation and | | | || | | |
|Autoimmunity | | | || | | |
+----------------------+-----+------+------++-----+------+------+
|Symbicort |1,687|- |(9) ||842 |- |(9) |
+----------------------+-----+------+------++-----+------+------+
|Pulmicort |518 |18 |10 ||232 |19 |11 |
+----------------------+-----+------+------++-----+------+------+
|Tudorza/EkliraDaliresp|8539 |n/mn/m|n/mn/m||5532 |n/mn/m|n/mn/m|
+----------------------+-----+------+------++-----+------+------+
|Duaklir |7 |n/m |n/m ||5 |n/m |n/m |
+----------------------+-----+------+------++-----+------+------+
| | | | || | | |
+----------------------+-----+------+------++-----+------+------+
|Cardiovascular and | | | || | | |
|Metabolic Disease | | | || | | |
+----------------------+-----+------+------++-----+------+------+
|Brilinta/Brilique |275 |42 |27 ||144 |38 |23 |
+----------------------+-----+------+------++-----+------+------+
|Onglyza |391 |4 |(2) ||208 |(7) |(13) |
+----------------------+-----+------+------++-----+------+------+
|Bydureon |263 |41 |37 ||140 |29 |25 |
+----------------------+-----+------+------++-----+------+------+
|Byetta |172 |8 |4 ||82 |(1) |(7) |
+----------------------+-----+------+------++-----+------+------+
|Farxiga/Forxiga |205 |n/m |n/m ||129 |n/m |n/m |
+----------------------+-----+------+------++-----+------+------+
| | | | || | | |
+----------------------+-----+------+------++-----+------+------+
|Legacy: | | | || | | |
+----------------------+-----+------+------++-----+------+------+
|Crestor |2,477|(5) |(11) ||1,310|(3) |(10) |
+----------------------+-----+------+------++-----+------+------+
|Seloken/Toprol-XL |378 |7 |(2) ||184 |6 |(5) |
+----------------------+-----+------+------++-----+------+------+
|Atacand |194 |(11) |(26) ||99 |(13) |(29) |
+----------------------+-----+------+------++-----+------+------+
| | | | || | | |
+----------------------+-----+------+------++-----+------+------+
|Oncology | | | || | | |
+----------------------+-----+------+------++-----+------+------+
|Iressa |273 |(3) |(14) ||129 |(1) |(12) |
+----------------------+-----+------+------++-----+------+------+
|Lynparza |30 |n/m |n/m ||21 |n/m |n/m |
+----------------------+-----+------+------++-----+------+------+
| | | | || | | |
+----------------------+-----+------+------++-----+------+------+
|Legacy: | | | || | | |
+----------------------+-----+------+------++-----+------+------+
|Zoladex |409 |9 |(11) ||215 |14 |(9) |
+----------------------+-----+------+------++-----+------+------+
|Faslodex |333 |5 |(5) ||172 |9 |(4) |
+----------------------+-----+------+------++-----+------+------+
|Casodex |139 |(5) |(16) ||69 |(5) |(17) |
+----------------------+-----+------+------++-----+------+------+
|Arimidex |126 |(9) |(19) ||64 |(6) |(18) |
+----------------------+-----+------+------++-----+------+------+
| | | | || | | |
+----------------------+-----+------+------++-----+------+------+
|Infection, | | | || | | |
|Neuroscience and | | | || | | |
|Gastrointestinal | | | || | | |
+----------------------+-----+------+------++-----+------+------+
|Nexium |1,291|(27) |(32) ||647 |(27) |(33) |
+----------------------+-----+------+------++-----+------+------+
|Seroquel XR |526 |(7) |(12) ||264 |(8) |(13) |
+----------------------+-----+------+------++-----+------+------+
|Synagis |270 |(28) |(28) ||66 |40 |40 |
+----------------------+-----+------+------++-----+------+------+
|Losec/Prilosec |181 |(6) |(16) ||85 |(9) |(19) |
+----------------------+-----+------+------++-----+------+------+
|FluMist/Fluenz |21 |75 |75 ||14 |180 |180 |
+----------------------+-----+------+------++-----+------+------+
|Movantik/Moventig |4 |n/m |n/m ||1 |n/m |n/m |
+----------------------+-----+------+------++-----+------+------+
H1 Product Sales Summary
________________________________________________________________________________
During 2014, final regulations relating to the US Branded Pharmaceutical Fee
were issued, affecting how the fee is recognised; AstraZeneca consequently
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, impacting individual brand sales by
an average of 2%.
RIA
Symbicort
Product Sales in the half were stable at $1,687m. The brand continues to
demonstrate strong differentiation in asthma reinforced by guidelines and
ongoing lifecycle management in milder conditions.
In the US, the decline in the half to $717m was limited to 1% with continued
lower net prices reflecting additional access and co-pay assistance. Symbicort’s
share of total prescriptions for fixed-combination medicines increased in the
half, growing by 0.7% points.
In Europe, Product Sales declined by 8% to $582m, reflecting increased
competition from recently-launched analogue medicines. This performance
contrasted with growth of 28% in Emerging Markets to $187m, notably with 64%
growth in China where Product Sales reached $63m.
Pulmicort
Product Sales of Pulmicort in the first half were $518m, up 18%. Growth was
driven primarily by the performance of Pulmicort Respules in Emerging Markets,
which were up 37% at $303m. China Product Sales increased by 43% to $240m,
reflecting sustained investment in supporting asthma and COPD patients for
several years, both in hospitals and more recently at home.
In February 2015, the US District Court for the District of New Jersey ruled the
patent protecting Pulmicort Respules in the US was invalid. The US Court of
Appeals for the Federal Circuit subsequently affirmed the decision (see Note 5).
Consequently a reduced level of sales-related receipts was realised in the
second quarter (within Other Operating Income) from Teva Pharmaceutical
Industries, Ltd.
Tudorza/Eklira
Product Sales in the half were $85m. This included $45m in the US, where the
brand name is Tudorza, following the completion of the acquisition of the
Actavis plc product rights in March 2015.
Rights were also acquired at that time for Daliresp, for which sales amounted to
$39m in the half.
CVMD
Brilinta/Brilique
Product Sales in the half were $275m, up 42%, with consistent strong growth in
each quarter.
Brilinta Product Sales in the US were $101m, up 60%. The brand’s weekly new-to
-brand prescription market share achieved a new high of 10% in June 2015.
In Europe, Brilique continued to perform well, with an increase in Product Sales
of 21% to $110m, reflecting indication leadership across a number of European
markets. Emerging Market sales grew by 80% to $47m as the medicine remains in
launch phase.
Onglyza
Product Sales were up 4% in the half to $391m. Growth of 19% in Q1 was offset by
a 7% decline in Q2, reflecting a reallocation of promotional activities to
Farxiga/Forxiga.
In the US, H1 Product Sales were down 16% at $211m driven primarily by
destocking and competition in the
DPP-4 class, as well as the aforementioned changes in promotional activities.
Product Sales in the Rest of World (ROW) were $180m, with growth in all key
markets, notably in Europe where sales were $71m, up 23%. Product Sales in the
half in Emerging Markets grew by 56% to $77m.
Bydureon/Byetta
Combined sales were $435m in the half, up 26%, with Bydureon representing 60% of
total Bydureon/Byetta sales.
Product Sales in the US were $343m, up 28%. Bydureon total prescriptions grew
22% in the second quarter, reflecting the launch of the Bydureon Pen in
September 2014. Most of the remaining sales of Bydureon/Byetta reside in Europe,
where sales growth of 19% in the half reflected the ongoing successful Pen
launch.
Farxiga/Forxiga
Product Sales were $205m in the half following the recent launch of the brand.
In the US, Product Sales of $115m compared to $26m in the comparative period.
Additional promotional activity underpinned the growth of Farxiga, which
continued to face market share pressures in the period, due to formulary-access
changes.
Product Sales in Europe, at $53m in the half, more than doubled while Emerging
Markets sales stood at $26m.
Crestor
Product Sales declined by 5% in the half to $2,477m. The performance reflected
ongoing generic competition and price pressures.
In the US, Crestor’s H1 Product Sales declined by 7% to $1,374m, with price
pressures exacerbated by lower volumes that were in line with total prescription
share; inventory movements also impacted the performance. Market share was
maintained in the second quarter however, with a 1% point growth in new-to-brand
share since the start of the year. In Europe, Product Sales declined by 7% to
$469m, reflecting prevailing competitive trends.
Crestor consolidated its position as the leading statin in Japan, growing its
sales by 6% in the half. Emerging Markets delivered sales growth of 5% at $352m,
including 21% in China.
Oncology
Iressa
H1 Product Sales declined by 3% to $273m, primarily a function of the
competitive environment in Europe where sales were down by 5%, and in Japan down
by 14%. The latter territory saw a material swing in performance from quarter to
quarter, with year-on-year growth of 9% in Q2.
Emerging Markets grew by 3% with Product Sales of $139m, with particular growth
in China, up 5% and Russia, up 23%.
Lynparza
Product Sales reached $30m 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 mutation. Over 1,000 patients have
already been treated with Lynparza in the US for germline BRCA-advanced ovarian
cancer with three or more lines of chemotherapy.
Zoladex
Product Sales in the half were up 9% to $409m. Notable performances included
growth of 36% in China where Product Sales reached $60m.
Faslodex
Product Sales for the half were up 5% to $333m. A 1% rise in European sales to
$101m was complemented by 2% growth in the US where Product Sales reached $165m.
The notable performance was in Emerging Markets, where sales of $42m represented
a growth rate of 32%, an encouraging result alongside the approval of 500mg
Faslodex in China in May 2015.
ING
Nexium
Overall H1 Product Sales fell 27% to $1,291m, with Q2 sales similarly down 27%
at $647m. The decline was particularly felt in the US, where sales in the half
fell 49% to $479m, reflecting the loss of exclusivity in February 2015 which
directly impacted both pricing and volumes. In Q2 this resulted in an increase
to the estimate for pipeline inventory returns, although the value of the level
of business and volume maintained remains at a high level. Sales in Europe fell
10% in the half to $143m.
Product Sales in markets outside the US delivered a positive result, with H1
Latin American sales up 17%, Japan sales up 16% and China sales up 3%. Emerging
Markets represent a key opportunity for Nexium, with the brand’s sales totalling
$397m in the half.
Seroquel XR
Product Sales declined by 7% in the half to $526m, with similar falls in each
quarter. In the US H1 sales were up 2% to $353m where the performance was mainly
driven by a higher underlying net price.
The majority of the remainder of the brand’s sales are in Europe, where a H1
sales decline of 25% to $113m was driven primarily by competition from generic
products.
Synagis
Product Sales fell 28% in the half to $270m, reflecting the 38% decline in the
US where the majority of sales are made. A significant factor was 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; this is anticipated to
continue in the second half. Product Sales in Europe fell 6% to $110m.
Regional Product Sales
________________________________________________________________________________
++++----------+------+----+------++-----+----+------+++
|| |H1 ||Q2 |||
|| |2015 ||2015 |||
++++----------+------+----+------++-----+----+------+++
|| | |% Chang || |% Chang |||
|| | |e || |e |||
++++----------+------+----+------++-----+----+------+++
|| |$m |CER |Actual||$m |CER |Actual|||
++++----------+------+----+------++-----+----+------+++
||US |4,525 |(9) |(9) ||2,356|(3) |(3) |||
++++----------+------+----+------++-----+----+------+++
|| | | | || | | |||
++++----------+------+----+------++-----+----+------+++
||Europe |2,601 |(5) |(20) ||1,261|(5) |(23) |||
++++----------+------+----+------++-----+----+------+++
|| | | | || | | |||
++++----------+------+----+------++-----+----+------+++
||Established |1,491 |(2) |(15) ||785 |- |(14) |||
|| ROW1 | | | || | | |||
++++----------+------+----+------++-----+----+------+++
|||Japan |977 |2 |(12) ||522 |6 |(10) |||
++++----------+------+----+------++-----+----+------+++
|||Canada |273 |6 |(5) ||138 |5 |(6) |||
++++----------+------+----+------++-----+----+------+++
|||Other |241 |(23)|(33) ||125 |(22)|(34) |||
|||Established| | | || | | |||
|||ROW | | | || | | |||
++++----------+------+----+------++-----+----+------+++
|| | | | || | | |||
++++----------+------+----+------++-----+----+------+++
||Emerging |2,967 |14 |2 ||1,434|9 |(2) |||
||Markets2 | | | || | | |||
++++----------+------+----+------++-----+----+------+++
|| |China |1,309 |19 |18 ||583 |10 |11 |||
++++----------+------+----+------++-----+----+------+++
|| |Ex.China |1,658 |10 |(7) ||851 |8 |(10) |||
++++----------+------+----+------++-----+----+------+++
|| | | | || | | |||
++++----------+------+----+------++-----+----+------+++
||Total |11,584|(2) |(10) ||5,836|(1) |(10) |||
++++----------+------+----+------++-----+----+------+++
|1 Establishe ||
|d ROW ||
|comprises ||
|Japan, ||
|Canada, ||
|Australia ||
|and New ||
|Zealand.2 ||
|Emerging ||
|Markets ||
|comprises ||
|all ||
|remaining ||
|Rest of ||
|World ||
|markets, ||
|including ||
|Brazil, ||
|China, ||
|India, ||
|Mexico, ||
|Russia, and ||
|Turkey. ||
++++----------+------+----+------++-----+----+------+++
||
++++----------+------+----+------++-----+----+------+++
|||| | | | || | | |||
++++----------+------+----+------++-----+----+------+++
US
Product Sales in the half were down 9% to $4,525m, with an encouraging trend in
sales illustrated by only a 3% fall in the second quarter. Excluding the impact
of the change in accounting related to the Branded Pharmaceutical Fee, Product
Sales in the quarter were down 1% versus the comparative period.
The headline decline in sales however reflected the loss of Nexium patent
exclusivity, competition facing Crestor from therapeutic substitution by generic
statins, the adverse impact of the Synagis guideline changes and the
aforementioned change in accounting related to the Branded Pharmaceutical Fee.
Onglyza sales also declined in the second quarter due to ongoing competition in
the diabetes market.
These declines were partly offset by growth in Brilinta, Bydureon, Farxiga,
Lynparza and the inclusion of Tudorza and Daliresp. Brilinta growth was driven
by strong consecutive quarters of growth in total and new-to-brand prescription
market share gains. Bydureon continues to benefit from the launch of the
Bydureon Pen as well as growth in demand in the overall GLP-1 class. A strong
acceleration in Farxiga sales reflected continued growth in demand underpinned
by additional promotional activity. With Lynparza exceeding the 1,000 patient
milestone, it was encouraging to see the early benefit to patients from a
pipeline due to launch a number of important medicines in the US in the near
term.
Europe
Product Sales in the half were down 5% to $2,601m. Strong growth from Forxiga
and Onglyza was more than offset by continued generic competition facing Crestor
and Seroquel XR. An 8% decline in Symbicort sales reflected adverse pricing
movements driven by competition from analogues in key markets.
Established ROW
Product Sales were down 2% in the first half to $1,491m. Following a decline in
the first quarter, Japan Q2 sales increased by 6%, reflecting the passing of the
anniversary of the mandated April 2014 biennial price cut.
Nexium and Crestor continue to grow strongly in Japan, growing by 16% and 6% in
the half, respectively. Crestor’s growth reflected a continued increase in the
usage of the 5mg dosage.
Canada Product Sales grew by 6% to $273m in the half, driven by the performances
of Onglyza and Symbicort.
Emerging Markets
The Company continues to focus on delivering innovative medicines by
accelerating investment in its Emerging Markets’ capabilities, with a focus on
China and other leading markets, such as Russia and Brazil.
Product Sales were up 14% to $2,967m in the half with growth across the region.
China sales in the half increased by 19% to $1,309m, more in line with recent
trends, with the Company’s medicines for respiratory, cardiovascular and
diabetes diseases delivering particularly strong results. Russia sales were up
30% to $116m, while Brazil sales were up 15% to $206m.
Q2 Product Sales were up 9% to $1,434m. China sales were up 10% to $583m, with
slower growth after a 28% growth in Product Sales in the first quarter.
Financial Performance
________________________________________________________________________________
H1 2015 Reported Restructuring IntangibleAmortisation Diabetes
Other1 Core % Chang
& Impairments Alliance
e
H1 2015 H1 20142 CER Actual
Product Sales 11,584 - - - -
11,584 12,870 (2) (10)
Externalisation 780 - - - -
780 352 124 122
Revenue
Total Revenue 12,364 - - - -
12,364 13,222 1 (6)
Cost of Sales (2,336) 101 317 - -
(1,918) (2,349) (7) (18)
Gross Profit 10,028 101 317 - -
10,446 10,873 3 (4)
Gross Margin3 79.8%
83.4% 81.7% +1.0 +1.7
Distribution (161) - - - -
(161) (149) 23 8
% Total Revenue 1.3%
1.3% 1.1% -0.2 -0.2
R&D (2,822) 124 62 - -
(2,636) (2,306) 24 14
% Total Revenue 22.8%
21.3% 17.4% -3.8 -3.9
SG&A (5,765) 223 444 216 298
(4,584) (4,777) 4 (4)
% Total Revenue 46.6%
37.1% 36.1% -0.9 -1.0
Other Operating 576 - 135 -
(158) 553 342 77 62
Income
% Total Revenue 4.7%
4.5% 2.6% +1.9 +1.9
Operating 1,856 448 958 216 140
3,618 3,983 (4) (9)
Profit
% Total Revenue 15.0%
29.3% 30.1% -1.5 -0.8
Net (513) - - 204 59
(250) (267)
FinanceExpense
Joint Ventures (7) - - - -
(7) -
Profit Before 1,336 448 958 420 199
3,361 3,716 (3) (10)
Tax
Taxation (88) (94) (193) (95) (2)
(472) (600)
Tax Rate 6.6%
14.0% 16.1%
Profit After 1,248 354 765 325 197
2,889 3,116 - (7)
Tax
Non-controlling (1) - - - -
(1) (3)
Interests
Net Profit 1,247 354 765 325 197
2,888 3,113 - (7)
Weighted 1,263 1,263 1,263 1,263
1,263 1,263 1,261
Average Shares
Earnings Per 0.99 0.28 0.60 0.26 0.16
2.29 2.47 - (7)
Share
1 Other adjustments include provision charges and settlement income related
to certain legal matters (see Note 5) and fair value adjustments to
contingent consideration liabilities arising on business combinations (see
Note 4).
2 2014 comparatives have been restated to reflect the reclassification of
Externalisation Revenue from Other Operating Income.
3 Gross Margin reflects Gross Profit derived from Product Sales, divided by
Product Sales.
Q2 2015 Reported Restructuring IntangibleAmortisation Diabetes
Other1 Core % Chang
& Impairments Alliance
e
Q2 2015 Q2 20142 CER Actual
Product Sales 5,836 - - - -
5,836 6,454 (1) (10)
Externalisation 471 - - - -
471 308 54 53
Revenue
Total Revenue 6,307 - - - -
6,307 6,762 2 (7)
Cost of Sales (1,067) 58 44 - -
(965) (1,156) (7) (16)
Gross Profit 5,240 58 44 - -
5,342 5,606 4 (5)
Gross Margin3 81.7%
83.5% 82.1% +1.1 +1.4
Distribution (84) - - - -
(84) (77) 27 10
% Total Revenue 1.3%
1.3% 1.1% -0.3 -0.2
R&D (1,466) 62 48 - -
(1,356) (1,208) 23 12
% Total Revenue 23.2%
21.5% 17.9% -3.7 -3.6
SG&A (2,966) 115 242 108 285
(2,216) (2,460) (1) (10)
% Total Revenue 47.0%
35.1% 36.4% +1.2 +1.3
Other Operating 199 - 86 -
(158) 127 170 (12) (25)
Income
% Total Revenue 3.2%
2.0% 2.5% -0.3 -0.5
Operating 923 235 420 108 127
1,813 2,031 (4) (11)
Profit
% Total Revenue 14.6%
28.7% 30.0% -1.7 -1.3
Net (263) - - 100 31
(132) (141)
FinanceExpense
Joint Ventures (2) - - - -
(2) -
Profit Before 658 235 420 208 158
1,679 1,890 (2) (11)
Tax
Taxation 38 (49) (104) (47) 2
(160) (247)
Tax Rate -5.8%
9.5% 13.1%
Profit After 696 186 316 161 160
1,519 1,643 3 (8)
Tax
Non-controlling 1 - - - -
1 (1)
Interests
Net Profit 697 186 316 161 160
1,520 1,642 3 (8)
Weighted 1,264 1,264 1,264 1,264
1,264 1,264 1,262
Average Shares
Earnings Per 0.55 0.15 0.25 0.13 0.13
1.21 1.30 3 (8)
Share
1 Other adjustments include provision charges and settlement income related
to certain legal matters (see Note 5) and fair value adjustments to
contingent consideration liabilities arising on business combinations (see
Note 4).
2 2014 comparatives have been restated to reflect the reclassification of
Externalisation Revenue from Other Operating Income.
3 Gross Margin reflects Gross Profit derived from Product Sales, divided by
Product Sales.
Gross Profit
Core gross profit increased by 3% in the half to $10,446m. Excluding the impact
of externalisation, the Core gross profit margin increased by 1% point. Drivers
of the margin increase included the mix of Product Sales, the contribution from
the growth platforms and additional manufacturing efficiencies.
Operating Expenses
Core R&D costs were up 24% in the half to $2,636m as the Company continued its
accelerated investment in the pipeline. The Company anticipates a lower growth
rate in the second half of the year.
Core SG&A costs were up 4% to $4,584m in the half as the Company continued to
invest in the product launch programme and the growth platforms; costs declined
by 1% in the second quarter, reflecting the third successive quarter of falling
Core SG&A costs as a proportion of Total Revenue. In the second quarter, Core
SG&A costs represented 35% of Total Revenue, compared to 39% in Q1 2015 and 44%
in Q4 2014.
The Company is committed to reducing Core SG&A costs in 2015 versus the prior
year, both in terms of absolute value and, importantly, relative to Total
Revenue. A number of programmes designed to meet this target are in progress.
These initiatives are centred on:
- Sales, marketing and medical-cost effectiveness
- Centralisation of selected functions and process improvements
- Reduced third-party spend
- Additional efficiencies gained across support functions and IT
- Continued footprint optimisation, including presence in the UK and US
Resources are being deployed more opportunistically to meet changing customer
needs and the evolving portfolio, while driving top-line growth more
efficiently.
Other Operating Income
Core Other Operating Income of $553m in the half included gains on the disposal
of Myalept ($193m) and other disposals amounting to $120m, including the US
rights to Tenormin.
Operating Profit
Core Operating Profit was down 4% to $3,618m in the half. Core Operating Margin
declined by 1.5% points to 29.3% of Total Revenue as the Company continued to
invest in the pipeline and the growth platforms.
Finance Expense
Core net finance expense was $250m versus $267m in the first half of 2014.
Reported net finance expense of $513m included a charge of $263m 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
Excluding the one-off tax benefit of $186m following settlement of past years’
US federal tax liabilities, both the Core and Reported tax rates for the half
year were around 20%. Including the impact of this benefit, the Core and
Reported tax rates for the half year were 14% and 7% respectively. The cash tax
paid for the half year was $782m, which is 59% of Reported Profit Before Tax and
23% of Core Profit Before Tax.
The Core and Reported tax rates for the first half of 2014 were 19% and 21%
respectively when excluding the impact of a one-off tax benefit of $117m in
respect of prior periods following the inter-governmental agreement of a
transfer pricing matter. Including the impact of this benefit, the Core and
Reported tax rates for the first half of 2014 were 16% and 13% respectively. The
cash tax paid for the first half of 2014 was $736m, which was 49% of Reported
Profit Before Tax and 20% of Core Profit Before Tax.
Earnings Per Share (EPS)
Core EPS in the half was stable at $2.29, a favourable performance versus Core
Operating Profit due to a one-off tax benefit in the second quarter. Reported
Operating Profit of $1,856m was 1% higher than the first half of 2014. Reported
EPS was up by 2% at $0.99.
Productivity
Restructuring charges of $448m were taken in the first half of 2015, including
$101m incurred on initiatives identified since the announcement of the fourth
wave of restructuring.
The Company continues to make good progress in implementing the fourth wave of
restructuring that was announced in 2013 and expanded in 2014. It remains on
track to incur $3.2bn in one-time restructuring costs and to deliver annualised
benefits of $1.1bn by the end of 2016. In addition to the fourth wave of
restructuring an additional $600m of costs are estimated to be incurred by the
end of 2016 (of which $362m has been incurred to date) associated with
previously-announced site exits (including Avlon in the UK) and the integration
of businesses acquired since the beginning of 2014.
It is anticipated that, once completed, the total annualised benefits of these
additional actions will be $200m, bringing the total annualised benefit of all
ongoing restructuring activities to $1.3bn by the end of 2016.
Cash Flow
The Company generated a cash inflow from operating activities of $1,008m in the
half, compared with an inflow of $3,266m in the first half of 2014, reflecting
the operational performance of the business. Net cash outflows from investing
activities were $1,234m compared with $4,955m in the first half of 2014,
primarily reflecting the acquisition of the BMS share of the global diabetes
alliance last year. The Company has embarked upon an initiative to further
improve cash generation from the business including standardisation of global
processes and payment terms.
Net cash distributions to shareholders were $2,337m through dividends of
$2,357m, offset by proceeds from the issue of shares of $20m due to the exercise
of stock options.
Debt and Capital Structure
At 30 June 2015, outstanding gross debt (interest-bearing loans and borrowings)
was $11,008m (30 June 2014: $10,074m). Of the gross debt outstanding at 30 June
2015, $2,705m was due within one year (30 June 2014: $2,500m).
The Company’s net debt position at 30 June 2015 was $5,994m (30 June 2014:
$3,959m).
Shares in Issue
During the half, 0.5 million shares were issued in respect of share option
exercises for a consideration of $20m. The total number of shares in issue at 30
June 2015 was 1,264 million.
Dividends
The Board has recommended an unchanged first interim dividend of $0.90 (57.5
pence, 7.71 SEK) per Ordinary Share.
For holders of the Company’s American Depositary Shares (ADSs) this equates to
$0.45 per ADS. Following the ratio change to the Company’s NYSE-listed sponsored
Level 2 American Depositary Receipt programme on 27 July 2015, two ADSs equal
one Ordinary Share.
The level of the dividend per share reflects the Board’s aim of setting the
first interim dividend at around a third of the prior-year dividend, which for
FY 2014 was $2.80 per Ordinary Share.
The Board has adopted a progressive dividend policy, by which the Board intends
to maintain or grow the dividend per share each year. In adopting this policy,
the Board recognises that some earnings fluctuations are to be expected as the
Company’s revenue base transitions through a period of exclusivity losses and
new-product launches.
In setting the distribution policy and the overall financial strategy, the
Board’s aim is to continue to strike a balance between the interests of the
business, financial creditors and the Company’s shareholders. After providing
for business investment, funding the progressive dividend policy and meeting
debt-service obligations, the Board will keep under review the opportunity to
return cash in excess of these requirements to shareholders through periodic
share repurchases. However, the Board has decided that no share repurchases will
take place in 2015 in order to maintain the strategic flexibility to invest in
the business.
FY 2015 Guidance
The Company today revises its Total Revenue guidance at CER from that provided
on 24 April 2015. Total Revenue in the full year is now expected to decline by
low single-digit percent versus the prior guidance of a mid single-digit
decline. Core EPS guidance at CER for the year is unchanged and Core EPS is
expected to increase by low single-digit percent, reflecting the continued
accelerated investment in R&D.
The Company also provides the following non-guidance information related to
currency sensitivity: Based on current exchange rates1, Total Revenue is
expected to decline by high single-digit percent with Core EPS expected to be
broadly in line with FY 2014. For additional currency sensitivity information,
please see below:
Average Impact Of
Exchang 5%
e Rates Weakening
Versus In
USD Exchange
Rate
Versus
USD ($m)2
Currency Primary FY H1 20151 Change Total Core
Operating
Relevance 2014 % Revenue Profit
EUR Product 0.75 0.89 (16) (225) (138)
Sales
JPY Product 105.87 120.25 (12) (119) (84)
Sales
CNY Product 6.16 6.22 (1) (115) (49)
Sales
SEK Costs 6.86 8.37 (18) (6) 114
GBP Costs 0.61 0.66 (7) (37) 112
Other3 (242) (139)
1 Based on average daily spot rates YTD to the end of June 2015
2 Based on 2014 actual average exchange rates and group currency exposures
3 Other important currencies include AUD, BRL, CAD, KRW and RUB
Related Party Transactions
There have been no significant related party transactions in the period.
Principal Risks and Uncertainties
It is not anticipated that the nature of the principal risks and uncertainties
that affect the business, and which are set out on pages 205 to 219 of the
Annual Report and Form 20-F Information 2014, will change in respect of the
second six months of the financial year.
In summary, the principal risks and uncertainties listed in the Annual Report
and 20-F Information 2014 are:
a) Product pipeline risks
Failure to meet development targets; difficulties of obtaining and maintaining
regulatory approvals for new products; failure to obtain and enforce effective
intellectual property protection; delay to new product launches; strategic
alliances and acquisitions may be unsuccessful.
b) Commercialisation and business execution risks
Challenges to achieving commercial success of new products; illegal trade in our
products; developing our business in Emerging Markets; expiry or loss of, or
limitations on, intellectual property rights; pressures resulting from generic
competition; effects of patent litigation in respect of intellectual property
rights; price controls and price reductions; economic, regulatory and political
pressures; biosimilars; increasing implementation and enforcement of more
stringent anti-bribery and anti-corruption legislation; any expected gains from
productivity initiatives are uncertain; changes in senior management, failure to
attract and retain key personnel and failure to successfully engage with our
employees; failure of information technology; failure of outsourcing.
c) Supply chain and delivery risks
Manufacturing biologics; difficulties and delays in the manufacturing,
distribution and sale of our products; reliance on third parties for goods.
d) Legal, regulatory and compliance risks
Adverse outcome of litigation and/or governmental investigations; substantial
product liability claims; failure to adhere to applicable laws, rules and
regulations; failure to adhere to laws, rules and regulations relating to anti
-competitive behaviour; environmental and occupational health and safety
liabilities; misuse of social media platforms and new technology.
e) Economic and financial risks
Adverse impact of a sustained economic downturn; political and socio-economic
conditions; impact of fluctuations in exchange rates; limited third party
insurance coverage; taxation; pensions.
Condensed Consolidated Statement of Comprehensive Income
For the half year ended 30 June 2015 $m Restated
2014* $m
Product sales 11,584 12,870
Externalisation revenue 780 352
Total revenue 12,364 13,222
Cost of sales (2,336) (2,760)
Gross profit 10,028 10,462
Distribution costs (161) (149)
Research and development expense (2,822) (2,528)
Selling, general and administrative (5,765) (5,784)
costs
Other operating income and expense 576 (56)
Operating profit 1,856 1,945
Finance income 24 26
Finance expense (537) (467)
Share of after tax losses in joint (7) -
ventures
Profit before tax 1,336 1,504
Taxation (88) (201)
Profit for the period 1,248 1,303
Other comprehensive income
Items that will not be reclassified
to profit or loss
Remeasurement of the defined benefit 242 (288)
pension liability
Tax on items that will not be (57) 85
reclassified to profit or loss
185 (203)
Items that may be reclassified
subsequently to profit or loss
Foreign exchange arising on (11) 64
consolidation
Foreign exchange arising on (217) (122)
designating borrowings in net
investment hedges
Fair value movements on derivatives 20 (11)
designated in net investment hedges
Amortisation of loss on cash flow 1 1
hedge
Net available for sale (losses)/gains (29) 49
taken to equity
Tax on items that may be 43 5
reclassified subsequently to profit or
loss
(193) (14)
Other comprehensive income for the (8) (217)
period, net of tax
Total comprehensive income for the 1,240 1,086
period
Profit attributable to:
Owners of the Parent 1,247 1,300
Non-controlling interests 1 3
1,248 1,303
Total comprehensive income
attributable to:
Owners of the Parent 1,239 1,089
Non-controlling interests 1 (3)
1,240 1,086
Basic earnings per $0.25 Ordinary $0.99 $1.03
Share
Diluted earnings per $0.25 Ordinary $0.99 $1.03
Share
Weighted average number of Ordinary 1,263 1,261
Shares in issue (millions)
Diluted weighted average number of 1,265 1,263
Ordinary Shares in issue (millions)
* 2014 comparatives restated for reclassification of Externalisation revenue
(see Note 1)
Condensed Consolidated Statement of Comprehensive Income
For the 2015 $m Restated 2014* $m
quarter ended 30
June
Product sales 5,836 6,454
Externalisation 471 308
revenue
Total revenue 6,307 6,762
Cost of sales (1,067) (1,307)
Gross profit 5,240 5,455
Distribution (84) (77)
costs
Research and (1,466) (1,328)
development expense
Selling, general (2,966) (3,058)
and administrative
costs
Other operating 199 117
income and expense
Operating profit 923 1,109
Finance income 13 10
Finance expense (276) (253)
Share of after tax (2) -
losses of joint
ventures
Profit before tax 658 866
Taxation 38 (69)
Profit for the 696 797
period
Other comprehensive
income
Items that will
not be reclassified
to profit or loss
Remeasurement of 259 (263)
the defined
benefit
pension liability
Tax on items that (61) 79
will not be
reclassified to
profit or loss
198 (184)
Items that may be
reclassified
subsequently to
profit or loss
Foreign exchange 438 9
arising on
consolidation
Foreign exchange 191 (121)
arising on
designating
borrowings in net
investment hedges
Fair value (1) (2)
movements on
derivatives
designated in net
investment hedges
Amortisation of 1 1
loss on cash flow
hedge
Net available for (48) 47
sale (losses)/gains
taken to equity
Tax on items that (57) 12
may be
reclassified
subsequently to
profit or
loss
524 (54)
Other comprehensive 722 (238)
income for the
period, net of tax
Total comprehensive 1,418 559
income for the
period
Profit attributable
to:
Owners of the 697 796
Parent
Non-controlling (1) 1
interests
696 797
Total comprehensive
income
attributable to:
Owners of the 1,418 558
Parent
Non-controlling - 1
interests
1,418 559
Basic earnings per $0.55 $0.63
$0.25 Ordinary
Share
Diluted earnings $0.55 $0.63
per $0.25
Ordinary
Share
Weighted average 1,264 1,262
number of
Ordinary
Shares in issue
(millions)
Diluted weighted 1,265 1,264
average number of
Ordinary Shares in
issue (millions)
* 2014 comparatives restated for reclassification of Externalisation revenue
(see Note 1)
Condensed Consolidated Statement of Financial Position
At 30 Jun At 31 Dec At 30 Jun
2015 $m 2014 $m 2014 $m
ASSETSNon-current
assets
Property, plant 6,134 6,010 6,150
and equipment
Goodwill 11,467 11,550 11,560
Intangible assets 20,486 20,981 21,150
Derivative 471 465 349
financial
instruments
Investments in 52 59 70
joint ventures
Other investments 448 502 289
Other receivables 957 1,112 1,380
Deferred tax 1,342 1,219 1,387
assets
41,357 41,898 42,335
Current assets
Inventories 2,198 1,960 2,249
Trade and other 6,615 7,232 7,817
receivables
Other investments 531 795 819
Derivative 51 21 1
financial
instruments
Income tax 450 329 360
receivable
Cash and cash 3,967 6,360 4,958
equivalents
13,812 16,697 16,204
Total assets 55,169 58,595 58,539
LIABILITIESCurrent
liabilities
Interest-bearing (2,705) (2,446) (2,500)
loans and
borrowings
Trade and other (10,659) (11,886) (10,304)
payables
Derivative (6) (21) (12)
financial
instruments
Provisions (731) (623) (679)
Income tax payable (2,049) (2,354) (2,827)
(16,150) (17,330) (16,322)
Non-current
liabilities
Interest-bearing (8,303) (8,397) (7,574)
loans and
borrowings
Deferred tax (1,582) (1,796) (2,427)
liabilities
Retirement benefit (2,377) (2,951) (2,634)
obligations
Provisions (479) (484) (580)
Other payables (7,979) (7,991) (6,950)
(20,720) (21,619) (20,165)
Total liabilities (36,870) (38,949) (36,487)
Net assets 18,299 19,646 22,052
EQUITY
Capital and
reserves
attributable to
equity holders of
the Company
Share capital 316 316 316
Share premium 4,281 4,261 4,236
account
Other reserves 2,033 2,021 1,973
Retained earnings 11,649 13,029 15,504
18,279 19,627 22,029
Non-controlling 20 19 23
interests
Total equity 18,299 19,646 22,052
Condensed Consolidated Statement of Cash Flows
For the half year ended 30 2015 $m 2014 $m
June
Cash flows from operating
activities
Profit before tax 1,336 1,504
Finance income and expense 513 441
Share of after tax losses in 7 -
joint ventures
Depreciation, amortisation and 1,565 1,410
impairment
(Increase)/decrease in working (767) 703
capital and short-term provisions
Non-cash and other movements (612) 216
Cash generated from operations 2,042 4,274
Interest paid (252) (272)
Tax paid (782) (736)
Net cash inflow from operating 1,008 3,266
activities
Cash flows from investing
activities
Movement in short-term 273 34
investments and fixed deposits
Purchase of property, plant and (497) (378)
equipment
Disposal of property, plant and 16 133
equipment
Purchase of intangible assets (1,222) (1,490)
Disposal of intangible assets 350 -
Purchase of non-current asset (30) (5)
investments
Disposal of non-current asset 56 -
investments
Payments to joint ventures - (70)
Upfront payments on business - (2,778)
acquisitions
Payment of contingent (239) (449)
consideration on business
acquisitions
Interest received 59 58
Payments made by subsidiaries - (10)
to non-controlling interests
Net cash outflow from investing (1,234) (4,955)
activities
Net cash outflow before financing (226) (1,689)
activities
Cash flows from financing
activities
Proceeds from issue of share 20 254
capital
Repayment of loans (884) (750)
Dividends paid (2,357) (2,425)
Hedge contracts relating to (43) 25
dividend payments
Repayment of obligations under (34) (17)
finance leases
Payments to acquire non - (102)
-controlling interest
Movement in short-term borrowings 910 445
Net cash outflow from financing (2,388) (2,570)
activities
Net decrease in cash and cash (2,614) (4,259)
equivalents in the period
Cash and cash equivalents at the 6,164 8,995
beginning of the period
Exchange rate effects (29) 3
Cash and cash equivalents at the 3,521 4,739
end of the period
Cash and cash equivalents
consists of:
Cash and cash equivalents 3,967 4,958
Overdrafts (446) (219)
3,521 4,739
Condensed Consolidated Statement of Changes in Equity
Share Share Other Retained Total Non
Total
capi prem rese earning $m -
equity
co
n
t
r
r o
v l
t i e l
a u s i
l m * s n
$m acco $m $m g
$m
in
t
e
r
e
s
u t
n s
t
$m $m
At 1 Jan 2014 315 3,983 1,966 16,960 23,224 29
23,253
Profit for - - - 1,300 1,300 3
1,303
the period
Other - - - (211) (211) (6)
(217)
comprehensive
income
Transfer to - - 7 (7) - - -
other
reserves
Transactions
with owners:
Dividends - - - (2,395) (2,395) -
(2,395)
Issue of 1 253 - - 254 -
254
Ordinary
Shares
Share-based - - - (143) (143) -
(143)
payments
Transfer from - - - - - (3)
(3)
non
-controlling
interests to
payables
Net movement 1 253 7 (1,456) (1,195) (6)
(1,201)
At 30 Jun 316 4,236 1,973 15,504 22,029 23
22,052
2014
Share Share Other Retained Total Non
Total
capi prem rese earning $m -
equity
co
n
t
r
r o
v l
t i e l
a u s i
l m * s n
$m acco $m $m g
$m
in
t
e
r
e
s
u t
n s
t
$m $m
At 1 Jan 2015 316 4,261 2,021 13,029 19,627 19
19,646
Profit for - - - 1,247 1,247 1
1,248
the period
Other - - - (8) (8) -
(8)
comprehensive
income
Transfer to - - 12 (12) - -
-
other
reserves
Transactions
with owners:
Dividends - - - (2,400) (2,400) -
(2,400)
Issue of - 20 - - 20 -
20
Ordinary
Shares
Share-based - - - (207) (207) -
(207)
payments
Net movement - 20 12 (1,380) (1,348) 1
(1,347)
At 30 Jun 316 4,281 2,033 11,649 18,279 20
18,299
2015
* Other reserves include the capital redemption reserve and the merger reserve.
Responsibility Statement of the Directors in Respect of the Half-Yearly
Financial Report
We confirm that to the best of our knowledge:
· the condensed set of financial statements has been prepared in accordance
with IAS 34 Interim Financial Reporting as adopted by the European Union and as
issued by the International Accounting Standards Board;
· the half-yearly management report includes a fair review of the information
required by:
(a) DTR 4.2.7R of the Disclosure and Transparency Rules, being an
indication of important events that have occurred during the first six
months of the financial year and their impact on the condensed set of
financial statements; and a description of the principal risks and
uncertainties for the remaining six months of the year; and
(b) DTR 4.2.8R of the Disclosure and Transparency Rules, being related
party transactions that have taken place in the first six months of the
current financial year and that have materially affected the financial
position or performance of the enterprise during that period; and any
changes in the related party transactions described in the last annual
report that could do so.
The Board
The Board of Directors that served during all or part of the six-month period to
30 June 2015 and their respective responsibilities can be found on pages 28 and
29 of the AstraZeneca Annual Report and Form 20-F Information 2014, with the
exception of Cori Bargmann who was elected as Non-Executive Director and
appointed as a member of the Science Committee on 24 April 2015. Also on 24
April 2015, Rudy Markham became Senior independent Non-Executive Director,
Graham Chipchase became Chairman of the Remuneration Committee and a member of
the Nomination and Governance Committee, Bruce Burlington became Chairman of the
Science Committee and a member of the Nomination and Governance Committee and
Geneviève Berger took on the oversight of sustainability matters on behalf of
the Board.
Approved by the Board and signed on its behalf by
Pascal Soriot
Chief Executive Officer
30 July 2015
Independent Review Report to AstraZeneca PLC
Introduction
We have been engaged by the Company to review the condensed set of Interim
Financial Statements in the half-yearly financial report for the six months
ended 30 June 2015 (but not for the quarter ended 30 June 2015 as presented in
the Condensed Consolidated Statement of Comprehensive Income for the quarter
ended 30 June 2015) which comprises Condensed Consolidated Statement of
Comprehensive Income, Condensed Consolidated Statement of Financial Position,
Condensed Consolidated Statement of Cash Flows, Condensed Consolidated Statement
of Changes in Equity and Notes 1 to 6. We have read the other information
contained in the half-yearly financial report and considered whether it contains
any apparent misstatements or material inconsistencies with the information in
the condensed set of financial statements.
This report is made solely to the Company in accordance with the terms of our
engagement to assist the Company in meeting the requirements of the Disclosure
and Transparency Rules ("the DTR") of the UK's Financial Conduct Authority ('the
UK FCA"). Our review has been undertaken so that we might state to the Company
those matters we are required to state to it in this report and for no other
purpose. To the fullest extent permitted by law, we do not accept or assume
responsibility to anyone other than the Company for our review work, for this
report, or for the conclusions we have reached.
Directors' responsibilities
The half-yearly financial report is the responsibility of, and has been approved
by, the Directors. The Directors are responsible for preparing the half-yearly
financial report in accordance with the DTR of the UK FCA.
As disclosed in Note 1, the annual financial statements of the Group are
prepared in accordance with International Financial Reporting Standards
("IFRSs") as adopted by the European Union ("EU") and as issued by the
International Accounting Standards Board ("IASB"). The condensed set of
financial statements included in this half-yearly financial report has been
prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the
EU and as issued by the IASB.
Our responsibility
Our responsibility is to express to the Company a conclusion on the condensed
set of financial statements in the half-yearly financial report based on our
review.
Scope of review
We conducted our review in accordance with International Standard on Review
Engagements (UK and Ireland) 2410 Review of Interim Financial Information
Performed by the Independent Auditor of the Entity issued by the Auditing
Practices Board for use in the UK. A review of interim financial information
consists of making enquiries, primarily of persons responsible for financial and
accounting matters, and applying analytical and other review procedures. A
review is substantially less in scope than an audit conducted in accordance with
International Standards on Auditing (UK and Ireland) and consequently does not
enable us to obtain assurance that we would become aware of all significant
matters that might be identified in an audit.
Accordingly, we do not express an audit opinion.
Conclusion
Based on our review, nothing has come to our attention that causes us to believe
that the condensed set of financial statements in the half-yearly financial
report for the six months ended 30 June 2015 is not prepared, in all material
respects, in accordance with IAS 34 as adopted by the EU and as issued by the
IASB, and the DTR of the UK FCA.
Antony Cates
for and on behalf of KPMG LLP
Chartered Accountants
15 Canada Square
London E14 5GL
30 July 2015
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 six months ended 30 June 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.
Externalisation revenue
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 $352m of income being
reclassified from other operating income to externalisation revenue for the half
year ended 30 June 2014, and $308m for the quarter ended 30 June 2014.
New accounting standards
The Group has adopted the amendments to IAS 19 Employee Benefits, 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 half year ended 30 June 2015.
Legal proceedings
The information contained in Note 5 updates the disclosures concerning legal
proceedings and contingent liabilities in the Group’s Annual Report and Form 20
-F Information 2014.
Going concern
The Group has considerable financial resources available. As at 30 June 2015 the
Group has $4.3bn in financial resources (cash balances of $4.0bn and undrawn
committed bank facilities of $3.0bn which are available until April 2020, with
only $2.7bn 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 a period of at least 12
months. 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 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 half year ended 30 June 2015 is stated after charging
restructuring costs of $448m ($235m for the second quarter of 2015). These have
been charged to profit as follows:
HY 2015 HY 2014 Q2 2015 Q2 2014
$m $m $m $m
Cost of sales 101 24 58 13
Research and 124 190 62 105
development expense
Selling, general and 223 266 115 175
administrative
costs
Other operating - 292 - -
income and expense
Total 448 772 235 293
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 Cash Flow $m Non Exchange
At 30
Jan 2015 $m -cashMovements$m Movements$m
Jun 2015 $m
Loans due (8,337) - 19 62
(8,256)
after one
year
Finance (60) - 12 1
(47)
leases due
after one
year
Total (8,397) - 31 63
(8,303)
long-term
debt
Current (912) 884 - 28
-
instalments
of loans
Current (48) 34 (47) 1
(60)
instalments
of finance
leases
Total (960) 918 (47) 29
(60)
current
debt
Other 795 (286) 28 (6)
531
investments
– current
Net 465 56 (5) -
516
derivative
financial
instruments
Cash and 6,360 (2,363) - (30)
3,967
cash
equivalents
Overdrafts (196) (251) - 1
(446)
Short-term (1,290) (910) 1 -
(2,199)
borrowings
6,134 (3,754) 24 (35)
2,369
Net debt (3,223) (2,836) 8 57
(5,994)
Non-cash movements in the period include fair value adjustments under IAS 39.
4 FINANCIAL INSTRUMENTS
As detailed in the Group’s 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 $979m of other investments, $1,176m of loans, and
$516m of derivatives as at 30 June 2015. The total fair value of interest
-bearing loans and borrowings at 30 June 2015, which have a carrying value of
$11,008m in the Condensed Consolidated Statement of Financial Position, was
$12,039m. Contingent consideration liabilities arising on business combinations
have been classified under Level 3 in the fair value hierarchy and movements in
fair value are shown below:
DiabetesAlliance2015 Other2015 Total2015 Total2014
$m $m $m $m
At 1 January 5,386 1,513 6,899 514
Additions - - - 5,249*
through
business
combinations
Settlements (103) (136) (239) (449)
Revaluations - 82 82 6
Discount 204 59 263 174
unwind
Foreign - - - 6
exchange
At 30 June 5,487 1,518 7,005 5,500
*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 XR product 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 proceedings 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.
Matters disclosed in respect of the second quarter of 2015 and to 30 July 2015.
Patent litigation
Crestor (rosuvastatin)
Patent proceedings outside the US
As previously disclosed, in 2014, in Japan, Shionogi & Co., Ltd. the licensor of
the Crestor patent, received confirmation of a request for trial for patent
invalidation in the Japanese Patent Office (JPO). The request was initiated by
Teva Pharma Japan Inc. (Teva) and relates to the Crestor substance patent. On 29
June 2015, the JPO dismissed Teva’s claim. A second invalidation action relating
to the same patent has been filed by an individual.
As previously disclosed, in 2014, in the Netherlands, AstraZeneca received a
letter from Resolution Chemicals Ltd. (Resolution) indicating that it had sought
marketing authorisation for a rosuvastatin zinc product in the Netherlands. In
April 2014, AstraZeneca received a writ of summons from Resolution alleging
partial invalidity and non-infringement of the supplementary protection
certificate (SPC) related to the Crestor substance patent. On 15 July 2015, the
District Court of the Hague determined that the SPC does not extend to zinc
salts of rosuvastatin and that Resolution's product does not infringe the SPC.
AstraZeneca is considering its response.
Daliresp (roflumilast)
Patent proceedings in the US
As previously disclosed, in April 2015, AstraZeneca received Paragraph IV
Notices challenging certain patents listed in the FDA Orange Book with reference
to Daliresp. AstraZeneca has received notice from ten companies that each has
submitted an Abbreviated New Drug Application (ANDA) seeking to market
roflumilast. In May 2015, AstraZeneca filed a patent infringement lawsuit
against each of the ten companies in the US District Court for the District of
New Jersey.
Faslodex (fulvestrant)
Patent proceedings in the US
As previously disclosed, in June and September 2014 and January 2015,
AstraZeneca filed patent infringement lawsuits against Sandoz Inc. and Sandoz
International GmbH, Sagent Pharmaceuticals, Inc., and Glenmark Generics, Inc.
USA in the US District Court in New Jersey relating to four patents listed in
the FDA Orange Book with reference to Faslodex, after those companies sent
Paragraph IV notices that they are seeking FDA approval to market generic
versions of Faslodex prior to the expiration of AstraZeneca’s patents. In July
2015, AstraZeneca received a Paragraph IV notice from Agila Specialties Inc., on
behalf of Onco Therapies Limited, which is also seeking FDA approval to market a
generic version of Faslodex prior to the expiration of the same four patents.
Patent proceedings outside the US
In July 2015, AstraZeneca was served with two nullity complaints, one filed by
Hexal AG and the other by ratiopharm GmbH, commencing invalidity proceedings
before the Federal Patent Court in Germany, and requesting the revocation of the
German part of the Faslodex formulation use patent, EP 1,250,138.
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 and in 2013, the US
District Court for the Southern District of New York (the District Court)
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. In July 2015, the District Court ordered Apotex
to pay $99m to AstraZeneca. The proceeding is now closed and AstraZeneca has
recognised the settlement income.
Nexium (esomeprazole)
Patent proceedings in the US
In June 2015, AstraZeneca received a Paragraph IV Notice from HEC Pharm Co., Ltd
(HEC) challenging certain patents listed in the FDA Orange Book with reference
to Nexium. HEC submitted an Abbreviated New Drug Application (ANDA) seeking to
market esomeprazole magnesium capsules. AstraZeneca is reviewing HEC’s notice.
In June 2015, AstraZeneca received a Paragraph IV Notice from Lupin Ltd (Lupin)
challenging certain patents listed in the FDA Orange Book with reference to
Nexium 24HR (OTC). Lupin submitted an ANDA seeking to market OTC esomeprazole
magnesium capsules. AstraZeneca is reviewing Lupin’s notice.
As previously disclosed, in March 2012, AstraZeneca filed a patent infringement
lawsuit against Mylan Laboratories Limited and Mylan Inc. (together, Mylan) in
the US District Court for the District of New Jersey. In July 2015, AstraZeneca
filed a motion for preliminary injunction against Mylan’s launch of its ANDA
version of esomeprazole magnesium capsules. The patents-at-issue are US Patent
Nos. 6,369,085 and 7,411,070. Both patents have a date of expiry of 25 May 2018.
Patent proceedings outside the US
As previously disclosed, in July 2014, in Canada, the Federal Court found
Canadian Patent No. 2,139,653 invalid and not infringed by Apotex Inc. On 6 July
2015, AstraZeneca’s appeal was dismissed.
As previously disclosed, in July 2014, in Canada, AstraZeneca received a Notice
of Allegation from Teva Canada Limited (Teva) alleging either that Teva’s
esomeprazole magnesium product would not infringe the patents listed on the
Canadian Patent Register in relation to Nexium or, alternatively, that certain
of the patents were invalid. AstraZeneca commenced a proceeding in 2014, but has
now discontinued its application pursuant to a settlement agreement.
Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin)
Patent proceedings in the US
In June 2015, Mylan Pharmaceuticals, Inc. filed a petition for an Inter Parties
Review with the US Patent Office challenging the validity of the saxagliptin
compound patent, US RE44,186, that is listed in the FDA Orange Book for both
Onglyza and Kombiglyze XR.
Pulmicort Respules (budesonide inhalation suspension)
Patent proceedings in the US
As previously disclosed, in February 2015, the US District Court for the
District of New Jersey (the District Court) determined that the asserted claims
of US Patent No. 7,524,834 was invalid. AstraZeneca appealed that decision and
on 7 May 2015, the US Court of Appeals for the Federal Circuit affirmed the
District Court’s decision and lifted the injunction that was issued pending the
appeal. Since 2009, various injunctions were issued in this matter. Damages
claims based on those injunctions are expected and a provision has been taken in
the first half of 2015.
Seroquel XR (quetiapine fumarate)
Patent proceedings in the US
As previously disclosed, in February 2015, AstraZeneca filed a patent
infringement lawsuit against Macleods Pharmaceuticals, Ltd. Macleods Pharma USA,
Inc. and AB Pharmaceuticals, LLC. (together, Macleods) in the US District Court
for the District of New Jersey. In June 2015, AstraZeneca settled the patent
infringement litigation by granting Macleods a license to the Seroquel XR
product patent effective from 1 November 2016, or earlier in certain
circumstances.
Patent proceedings outside the US
In Italy, in June 2015, following a challenge to the validity of the formulation
patent covering Seroquel XR by Sandoz S.p.A. and Sandoz A/S, the Court of Turin
found the Seroquel XR formulation patent invalid.
Product liability litigation
Nexium (esomeprazole magnesium)
As previously disclosed, of the approximately 1,900 plaintiffs who alleged that
Nexium caused osteoporotic injuries, such as bone deterioration, loss of bone
density and/or bone fractures, approximately 40 claims remained active in
California state court and the rest of the claims were dismissed. In June 2015,
the California state court granted AstraZeneca’s motion for summary judgment and
dismissed the approximately 40 remaining plaintiffs’ claims. In addition, as
previously disclosed, approximately 270 plaintiffs have appealed the dismissals
of their claims and those appeals remain pending.
Commercial litigation
Average Manufacturer’s Price qui tam litigation (Streck)
AstraZeneca was one of several manufacturers named as a defendant in a lawsuit
filed in the US Federal Court in Philadelphia under the qui tam (whistleblower)
provisions of the federal and certain state False Claims Acts alleging
inaccurate reporting of Average Manufacturer’s prices to the Centers for
Medicare and Medicaid Services. The action was initially filed in October 2008
but remained under seal until May 2011. In July 2015, AstraZeneca agreed upon a
negotiated settlement to resolve the dispute. A provision for this amount was
previously taken.
6. product Sales analysis – h1 2015
World US Europe
Established Emerging
ROW
Markets
H1 CER% H1 CER H1 CER% H1
2015$m CER% H1 CER%
2015$m 2015$m % 2015$m
2015$m
Respiratory,
Inflammation
and Autoimmunity:
Symbicort 1,687 - 717 (1) 582 (8) 201
9 187 28
Pulmicort 518 18 108 4 66 (7) 41
(2) 303 37
Tudorza/Eklira 85 n/m 45 n/m 36 n/m 4
n/m - -
Duaklir 7 n/m - n/m 6 n/m 1
n/m - -
Others 171 20 49 188 46 (7) 10
- 66 4
Total 2,468 9 919 9 736 (3) 257
9 556 30
Respiratory,
Inflammation and
Autoimmunity
Cardiovascular
and
Metabolic
disease:
Brilinta/Brilique 275 42 101 60 110 21 17
36 47 80
Onglyza 391 4 211 (16) 71 23 32
30 77 56
Bydureon 263 41 222 35 35 71 3
33 3 200
Byetta 172 8 121 15 30 (13) 10
- 11 33
Farxiga/Forxiga 205 n/m 115 n/m 53 n/m 11
44 26 n/m
Legacy:
Crestor 2,477 (5) 1,374 (7) 469 (7) 282
(3) 352 5
Seloken/Toprol-XL 378 7 48 (9) 49 (3) 7
(20) 274 14
Atacand 194 (11) 18 (10) 53 (33) 15
(23) 108 8
Others 327 (4) 35 (5) 75 (13) 30
(21) 187 6
Total 4,682 4 2,245 2 945 - 407
(2) 1,085 16
Cardiovascular
and
Metabolic
Disease
Oncology:
Iressa 273 (3) - - 66 (5) 68
(11) 139 3
Lynparza 30 n/m 26 n/m 4 n/m -
n/m - n/m
Legacy:
Zoladex 409 9 14 27 85 (15) 133
(2) 177 32
Faslodex 333 5 165 2 101 1 25
4 42 32
Casodex 139 (5) 1 (67) 15 (18) 66
(14) 57 17
Arimidex 126 (9) 7 (22) 25 (27) 40
(15) 54 14
Others 71 23 13 - 15 13 29
79 14 (11)
Total Oncology 1,381 5 226 15 311 (7) 361
(4) 483 18
Infection,
Neuroscience
and
Gastrointestinal:
Nexium 1,291 (27) 479 (49) 143 (10) 272
(6) 397 (1)
Seroquel XR 526 (7) 353 2 113 (25) 14
(30) 46 10
Synagis 270 (28) 160 (38) 110 (6) -
- - n/m
Losec/Prilosec 181 (6) 12 (7) 48 (12) 39
(17) 82 6
FluMist/Fluenz 21 75 21 110 - - -
n/m - -
Movantik/Moventig 4 n/m 4 n/m - n/m -
n/m - n/m
Others 760 (8) 106 (28) 195 (13) 141
1 318 (1)
Total Infection, 3,053 (18) 1,135 (34) 609 (14) 466
(7) 843 -
Neuroscience and
Gastrointestinal
TOTAL PRODUCT 11,584 (2) 4,525 (9) 2,601 (5) 1,491
(2) 2,967 14
SALES
7. product Sales analysis – Q2 2015
World US Europe
Established Emerging
ROW
Markets
Q2 CER% Q2 CER Q2 CER% Q2
2015$m CER% Q2 CER%
2015$m 2015$m % 2015$m
2015$m
Respiratory,
Inflammation
and Autoimmunity:
Symbicort 842 - 375 (1) 276 (9) 102
24 89 16
Pulmicort 232 19 56 8 28 (15) 21
5 127 44
Tudorza/Eklira 55 n/m 35 n/m 18 n/m 2
n/m - n/m
Duaklir 5 n/m - - 4 n/m 1
n/m - -
Others 91 32 37 n/m 21 (16) 7
60 26 (18)
Total 1,225 11 503 16 347 (3) 133
23 242 20
Respiratory,
Inflammation and
Autoimmunity
Cardiovascular
and
Metabolic
disease:
Brilinta/Brilique 144 38 55 57 56 21 9
38 24 59
Onglyza 208 (7) 113 (22) 34 (5) 18
25 43 38
Bydureon 140 29 116 22 19 53 2
50 3 -
Byetta 82 (1) 53 - 15 (22) 6
14 8 60
Farxiga/Forxiga 129 n/m 78 n/m 29 n/m 8
n/m 14 n/m
Legacy:
Crestor 1,310 (3) 760 (1) 226 (9) 150
(4) 174 (1)
Seloken/Toprol-XL 184 6 21 (28) 24 (3) 4
- 135 16
Atacand 99 (13) 7 (22) 23 (38) 8
(9) 61 4
Others 156 (4) 15 (25) 36 (13) 15
(26) 90 12
Total 2,452 4 1,218 3 462 (3) 220
(1) 552 14
Cardiovascular
and
Metabolic Disease
Oncology:
Iressa 129 (1) - - 31 (5) 36
10 62 (4)
Lynparza 21 n/m 18 n/m 3 n/m -
n/m - n/m
Legacy:
Zoladex 215 14 8 60 41 (17) 71
2 95 41
Faslodex 172 9 82 (4) 52 10 13
15 25 50
Casodex 69 (5) 1 (50) 7 (18) 34
(13) 27 20
Arimidex 64 (6) 4 - 12 (25) 21
(7) 27 8
Others 37 20 7 - 7 13 16
90 7 (30)
Total Oncology 707 9 120 17 153 (4) 191
4 243 20
Infection,
Neuroscience
and
Gastrointestinal:
Nexium 647 (27) 254 (44) 69 (14) 144
(9) 180 (16)
Seroquel XR 264 (8) 184 2 50 (30) 7
(18) 23 4
Synagis 66 40 (2) n/m 68 51 -
- - n/m
Losec/Prilosec 85 (9) 5 (17) 22 (15) 20
(14) 38 3
FluMist/Fluenz 14 180 14 180 - - -
- - -
Movantik/Moventig 1 n/m 1 n/m - - -
- - -
Others 375 (11) 59 (19) 90 (18) 70
(13) 156 (2)
Total Infection, 1,452 (17) 515 (28) 299 (12) 241
(10) 397 (8)
Neuroscience and
Gastrointestinal
TOTAL PRODUCT 5,836 (1) 2,356 (3) 1,261 (5) 785
- 1,434 9
SALES
ASTRAZENECA DEVELOPMENT PIPELINE 30 JUNE 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.
† US and EU dates correspond to anticipated acceptance of the regulatory
filing.
# Partnered product.
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
| Compound | Mechanism | Area Under | Date
| Estimated |
| | |Investigation
|Commenced|Filing† |
| | | |Phase |
|
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
| US | EU | Japan | China |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|Respiratory,
|
|Inflammation
|
|and Autoimmunity
|
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|anifrolumab# |IFN-alphaR mAb |SLE |Q3 20151 |2019
|2019 |2019 | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|benralizumab#CALIMA |IL-5R mAb |severe asthma |Q4 2013 |H2
2016 |H2 2016 |N/A |N/A |
|SIROCCO ZONDA BISE | | | |
| | | |
|BORAGREGALE | | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|benralizumab#TERRANOVA|IL-5R mAb |COPD |Q3 2014 |2018
|2018 |N/A |N/A |
|GALATHEA | | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|brodalumab |IL-17R mAb |psoriasis |Q3 2012
|2015++ |2015++ | | |
| AMAGINE-1,2,3 | | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|brodalumab AMVISION |IL-17R mAb |psoriatic |Q1 2014 |++
|++ | | |
|-1,2 | |arthritis | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|lesinurad |selective uric |chronic |Q4 2011 |Filed
|Filed | | |
| CLEAR 1,2 |acid |treatment of | |
| | | |
| CRYSTAL |reabsorption |patients | |
| | | |
| |inhibitor (URAT |with gout | |
| | | |
| |-1) | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|PT003 GFF PINACLE |LABA / LAMA |COPD |Q2 2013 |Q3
2015 |H1 2016 |2017 |2017 |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|PT010 |LABA / LAMA / |COPD |Q3 20151 |2018
|2018 |2018 |2019 |
| |ICS | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|tralokinumabSTRATOS |IL-13 mAb |severe asthma |Q3 2014 |2018
|2018 |2018 | |
|1,2TROPOS | | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|Cardiovascular and
|
|Metabolic Disease
|
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|Brilinta/Brilique2 |P2Y12 receptor |arterial thrombosis |
|Launched |Launched |Filed |Launched|
| |antagonist | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|Epanova# |omega-3 |severe |
|Approved | |2017 |2019 |
| |carboxylic |hypertriglyceridaemia | |
| | | |
| |acids | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|Farxiga/Forxiga3 |SGLT-2 |type-2 diabetes |
|Launched |Launched |Launched|Filed |
| |inhibitor | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|roxadustat# OLYMPUS |hypoxia |anaemia in CKD/ESRD |Q3 2014 |2018
|N/A |N/A |H2 2016 |
|ROCKIES |-inducible | | |
| | | |
| |factor prolyl | | |
| | | |
| |hydroxylase | | |
| | | |
| |inhibitor | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|Oncology
|
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|AZD9291AURA 2,3 |EGFR tyrosine |≥2nd-line advanced |Q2 2014 |Filed
|Filed |Q3 2015 |2017 |
| |kinase |EGFRm T790M NSCLC |
|4(Breakthrough| | | |
| |inhibitor | |
|designation) | | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|AZD9291FLAURA |EGFR tyrosine |1st-line advanced |Q1 2015 |2017
|2017 |2017 |2020 |
| |kinase |EGFRm NSCLC | |
| | | |
| |inhibitor | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|Caprelsa |VEGFR / EGFR |medullary thyroid |
|Launched |Launched |Filed |Filed |
| |tyrosine kinase|cancer | |
| | | |
| |inhibitor with | | |
| | | |
| |RET kinase | | |
| | | |
| |activity | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|cediranibICON 6 |VEGFR tyrosine |PSR ovarian cancer |Q2 2007 |
|Filed5(Orphan| | |
| |kinase | | |
| Drug) | | |
| |inhibitor | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|durvalumab (MEDI4736)#|PD-L1 mAb |stage III NSCLC |Q2 2014 |2017
|2020 |2020 | |
| PACIFIC | | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|durvalumab (MEDI4736)#|PD-L1 mAb |3rd-line NSCLC |Q1 2014 |H1
2016(Fast |2017 |2017 | |
| ATLANTIC¶ | | |
|Track) | | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|durvalumab |PD-L1 mAb + |3rd-line NSCLC |Q2 2015 |2017
|2017 |2017 | |
|(MEDI4736)# |CTLA-4 mAb | | |
| | | |
|+tremelimumab | | | |
| | | |
| ARCTIC | | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|durvalumab |PD-L1 mAb |2nd-line SCCHN (PD |Q1 2015 |H2
2016 |H2 2016 |H2 2016 | |
|(MEDI4736)# | |-L1 positive) | |
| | | |
| HAWK¶ | | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|durvalumab |PD-L1 mAb + |2nd-line SCCHN (PD |Q2 2015 |2017
|2017 |2017 | |
|(MEDI4736)# |CTLA-4 mAb |-L1 negative) | |
| | | |
|+ tremelimumab | | | |
| | | |
| CONDOR¶ | | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|moxetumomab pasudotox#|anti-CD22 |hairy cell leukaemia |Q2 2013 |2018
|2018 | | |
| |recombinant | | |
| | | |
| | immunotoxin | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|selumetinib# |MEK inhibitor |2nd-line KRASm NSCLC |Q4 2013 |2017
|2017 | | |
| SELECT-1 | | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|selumetinib# |MEK inhibitor |differentiated |Q3 2013 |2018
|2018 | | |
| ASTRA | |thyroid cancer | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|tremelimumab¶ |CTLA-4 mAb |mesothelioma |Q2 2014 |H1
2016(Orphan|H2 2016 |H2 2016 | |
|DETERMINE | | | |Drug)
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|Infection,
|
|Neuroscience
|
|and Gastrointestinal
|
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|CAZ AVI#RECLAIM |cephalosporin/be |serious |Q1 2012 |N/A
|Filed | |2017 |
| |ta lactamase |infections | |
| | | |
| |inhibitor | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|CAZ AVI# REPROVE |cephalosporin/ |hospital |Q2 2013 |N/A
|Filed | |2017 |
| |beta lactamase |-acquired | |
| | | |
| |inhibitor |pneumonia/ | |
| | | |
| | |ventilator | |
| | | |
| | |-associated | |
| | | |
| | |pneumonia | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
|Zinforo# |extended |pneumonia/skin| |N/A
|Launched |N/A |Filed |
| |spectrum |infections | |
| | | |
| |cephalosporin | | |
| | | |
| |with affinity | | |
| | | |
| |to penicillin | | |
| | | |
| |-binding | | |
| | | |
| |proteins | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
| | | | | |
| | | |
+----------------------+---------------+---------+--------------+---------+-----
---------+-------------+--------+--------+
# Partnered product.
¶ Registrational Phase II/III study.
++ Amgen recently announced the termination of its co-development and
commercialisation agreement with AstraZeneca for brodalumab; AstraZeneca is
proceeding with the transfer of the programme from Amgen and will communicate
additional decisions in due course.
1 First patient dosed July 2015.
2 Brilinta in the US; Brilique in rest of world.
3 Farxiga in the US; Forxiga in rest of world.
4 AZD9291 filed in Q2. US regulatory submission acceptance anticipated in Q3
2015.
5 Cediranib regulatory submission accepted in Q3 2015.
Phases I and II
NMEs and significant additional indications
+------------------+---------------+---------------+---------+---------+------
-+++-+
|Compound |Mechanism |Area Under |Phase |Date
|Estimated |
| | |Investigation | |Commenced|Filing
|
| | | | |Phase |
|
+------------------+---------------+---------------+---------+---------+------
-+++-+
|US |EU |Japan |China |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|Respiratory,
|
|Inflammation and
|
|Autoimmunity
|
+------------------+---------------+---------------+---------+---------+------
-+++-+
|abediterol |LABA |asthma/COPD |II |Q4 2007 |
||| |
|(AZD0548) | | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD7624 |inhaled P38 |COPD |II |Q4 2014 |
||| |
| |inhibitor | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD9412# |inhaled |asthma/COPD |II |Q1 2010 |
||| |
| |interferon | | | |
||| |
| |beta | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|mavrilimumab# |GM-CSFR mAb |rheumatoid |II |Q1 2010 |
||| |
| | |arthritis | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI-551# |CD19 mAb |neuromyelitis |II |Q1 2015 |
||| |
| | |optica2 | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI2070# |IL-23 mAb |Crohn’s disease|II |Q1 2013 |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|abrilimumab |alpha(4)beta(7)|Crohn’s disease|II |Q4 2012 |
||| |
|(MEDI7183)# |mAb |/ ulcerative | | |
||| |
| | |colitis | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI9929# |TSLP mAb |asthma |II |Q2 2014|
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|PT010 |LABA/LAMA/ICS |asthma |II |Q2 2014|
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|RDEA3170 |selective |chronic |II |Q3 2013 |
||| |
| |uric acid |treatment of | | |
||| |
| |reabsorption |patients | | |
||| |
| |inhibitor |with | | |
||| |
| |(URAT-1) |hyperuricaemia | | |
||| |
| | |or gout | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|sifalimumab# |IFN-alpha mAb |SLE3 |II |Q3 2008 |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|tralokinumab |IL-13 mAb |IPF |II |Q4 2012 |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|tralokinumab |IL-13 mAb |atopic |II |Q1 2015 |
||| |
| | |dermatitis | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|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 |primary |I |Q2 2014 |
||| |
| |fusion |Sjögren’s | | |
||| |
| |protein |syndrome | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI5872# |B7RP1 mAb |SLE |I |Q4 2008 |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI7836 |IL-13 mAb-YTE |asthma |I |Q1 2015 |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|Cardiovascular
|
|and
|
|Metabolism
|
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD4901 |NK3 receptor |polycystic |II |Q2 2013 |
||| |
| |antagonist |ovarian | | |
||| |
| | |syndrome | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI0382 |GLP-1/glucagon |diabetes / |I |Q1 2015 |
||| |
| |dual |obesity | | |
||| |
| |agonist | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI6012 |LCAT |ACS |I |Q1 2012 |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI8111 |Rh-factor II |trauma / |I |Q1 2014 |
||| |
| | |bleeding | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|Oncology
|
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD1775# |WEE-1 inhibitor|ovarian cancer |II |Q4 2012 |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD2014 |mTOR serine/ |solid tumours |II |Q1 2013 |
||| |
| |threonine | | | |
||| |
| |kinase | | | |
||| |
| |inhibitor | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD4547 |FGFR tyrosine |solid tumours |II |Q4 2011 |
||| |
| |kinase | | | |
||| |
| |inhibitor | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI-551# |CD19 mAb |CLL / DLBCL |II |Q1 2012 |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI-573# |IGF mAb |metastatic |II |Q2 2012 |
||| |
| | |breast cancer | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|selumetinib# |MEK inhibitor |2nd-line KRAS |II |Q1 2013 |
||| |
| | |wt NSCLC | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD5363# |AKT kinase |breast cancer |II |Q1 2014 |
||| |
| |inhibitor | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
| Compound | Mechanism | Area Under | Phase | Date
| Estimated|
| | |Investigation | |Commenced|Filing
|
| | | | |Phase |
|
+------------------+---------------+---------------+---------+---------+------
-+++-+
| US | EU | Japan | China |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|durvalumab |PD-L1 mAb |solid tumours |II |Q3 2014 |
||| |
|(MEDI4736)# | | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|durvalumab |PD-L1 mAb + |gastric |II |Q2 2015 |
||| |
|(MEDI4736)# + |CTLA-4 |cancer | | |
||| |
|tremelimumab |mAb | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|moxetumomab |anti-CD22 |pALL |II |Q3 2014 |
||| |
| pasudotox# |recombinant | | | |
||| |
| |immunotoxin | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|savolitinib/voliti|MET tyrosine |papillary renal|II |Q2 2014 |
||| |
|nib |kinase |cell | | |
||| |
|(AZD6094)# |inhibitor |carcinoma | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD3759 |EGFR tyrosine |advanced EGFRm |I |Q4 2014 |
||| |
| |kinase |NSCLC | | |
||| |
| |inhibitor | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD5312# |androgen |solid tumours |I |Q2 2014 |
||| |
| |receptor | | | |
||| |
| |inhibitor | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD6738 |ATR serine / |solid tumours |I |Q4 2013 |
||| |
| |threonine | | | |
||| |
| |kinase | | | |
||| |
| |inhibitor | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD8186 |PI3 kinase beta|solid tumours |I |Q2 2013 |
||| |
| |inhibitor | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD8835 |PI3 kinase |solid tumours |I |Q4 2014 |
||| |
| |alpha | | | |
||| |
| |inhibitor | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD9150# |STAT3 inhibitor|haematological |I |Q1 2012 |
||| |
| | |malignancies | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD9291 + |EGFR tyrosine |advanced EGFRm |I |Q3 2014 |
||| |
|(durvalumab |kinase |NSCLC | | |
||| |
|(MEDI4736)# or |inhibitor + (PD| | | |
||| |
|selumetinib# or |-L1 mAb | | | |
||| |
|volitinib#)TATTON |or | | | |
||| |
| |MEK inhibitor | | | |
||| |
| |or MET | | | |
||| |
| |tyrosine kinase| | | |
||| |
| |inhibitor) | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD9496 |selective |ER+ breast |I |Q4 2014 |
||| |
| |oestrogen |cancer | | |
||| |
| |receptor | | | |
||| |
| |downregulator | | | |
||| |
| |(SERD) | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|durvalumab |PD-L1 mAb |NSCLC |I |Q3 2014 |
||| |
|(MEDI4736)# | + (EGFR | | | |
||| |
|after (AZD9291 or |tyrosine | | | |
||| |
|Iressa |kinase | | | |
||| |
|or (selumetinib# |inhibitor or | | | |
||| |
| |MEK | | | |
||| |
|+docetaxel) or |inhibitor or | | | |
||| |
|tremelimumab) |CTLA-4 | | | |
||| |
| |mAb) | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|durvalumab |PD-L1 mAb |solid tumours |I |Q3 2014 |
||| |
|(MEDI4736)# | | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|durvalumab |PD-L1 mAb + PD |solid tumours |I |Q2 2014 |
||| |
|(MEDI4736)# |-1 mAb | | | |
||| |
|+ MEDI0680 | | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|durvalumab |OX40 agonist + |solid tumours |I |Q2 2015 |
||| |
|(MEDI4736)# |PD-L1 | | | |
||| |
|+ MEDI6383# |mAb | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|durvalumab |PD-L1 mAb + |solid tumours |I |Q3 2014 |
||| |
|(MEDI4736)# |murine OX40 | | | |
||| |
|+ MEDI6469# |agonist | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|durvalumab |PD-L1 mAb+ BRAF|melanoma |I |Q1 2014 |
||| |
|(MEDI4736)# |inhibitor + MEK| | | |
||| |
|+ dabrafenib + |inhibitor | | | |
||| |
|trametinib1 | | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|Iressa + |PD-L1 mAb+ EGFR|NSCLC |I |Q2 2014 |
||| |
|durvalumab |tyrosine kinase| | | |
||| |
|(MEDI4736)# |inhibitor | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|durvalumab |PD-L1 mAb + |solid tumours |I |Q4 2013 |
||| |
|(MEDI4736)# |CTLA-4 mAb | | | |
||| |
|+ tremelimumab | | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI0562# |humanised OX40 |solid tumours |I |Q1 2015 |
||| |
| |agonist | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI-565# |CEA BiTE mAb |solid tumours |I |Q1 2011 |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI0639# |DLL-4 mAb |solid tumours |I |Q2 2012 |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI0680 |PD-1 mAb |solid tumours |I |Q4 2013 |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI3617# |ANG-2 mAb |solid tumours |I |Q4 2010 |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI-551# |CD19 mAb + PD-1|DLBCL |I |Q4 2014 |
||| |
|+MEDI0680 |mAb | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI-551# + |CD19 mAb + CD20|haematological |I |Q2 2014 |
||| |
|rituximab |mAb |malignancies | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI6383# |OX40 agonist |solid tumours |I |Q3 2014 |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI6469# |murine OX40 |solid tumours |I |Q1 2006 |
||| |
| |agonist | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI6469# + |murine OX40 |solid tumours |I |Q1 2015 |
||| |
|rituximab |agonist + | | | |
||| |
| |CD20 mAb | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI6469# |murine OX40 |solid tumours |I |Q4 2014 |
||| |
|+tremelimumab |agonist + | | | |
||| |
| |CTLA-4 mAb | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|Infection,
|
|Neuroscience
|
|and
|
|Gastrointestinal
|
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD3241 |myeloperoxidase|multiple system|II |Q2 2012 |
||| |
| |inhibitor |atrophy | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD3293# |beta-secretase |Alzheimer’s |II |Q4 2014 |
||| |
| |inhibitor |disease | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD5213 |histamine-3 |Tourette’s |II |Q4 2013 |
||| |
| |receptor |syndrome / | | |
||| |
| |antagonist |neuropathic | | |
||| |
| | |pain | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD5847 |oxazolidinone |tuberculosis |II |Q4 2012 |
||| |
| |anti | | | |
||| |
| |-bacterial | | | |
||| |
| |inhibitor | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|AZD8108 |NMDA antagonist|suicidal |I |Q4 2014 |
||| |
| | |ideation | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|CXL# |beta lactamase |MRSA |II |Q4 2010 |
||| |
| |inhibitor / | | | |
||| |
| |cephalosporin | | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI1814 |amyloid beta |Alzheimer’s |I |Q2 2014 |
||| |
| |mAb |disease | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI4893 |MAb binding to |hospital |II |Q4 2014 |(Fast
||| |
| |S. |-acquired | | |Track)
||| |
| |aureus toxin |pneumonia / | | |
||| |
| | |serious S. | | |
||| |
| | |aureus | | |
||| |
| | |infection | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI8897# |RSV mAb-YTE |passive RSV |II |Q1 2015 |(Fast
||| |
| | |prophylaxis | | |Track)
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|ATM AVI# |monobactam/ |targeted |I |Q1 2015 |
||| |
| |beta |serious | | |
||| |
| |lactamase |bacterial | | |
||| |
| |inhibitor |infections | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI-550 |pandemic |pandemic |I |Q2 2006 |
||| |
| |influenza |influenza | | |
||| |
| |virus vaccine |prophylaxis | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI3902 |anti-Psl/PcrV |prevention of |I |Q3 2014 |(Fast
||| |
| | |nosocomial | | |Track)
||| |
| | |pseudomonas | | |
||| |
| | |pneumonia | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI7510 |RSV sF+GLA-SE |prevention of |I |Q2 2014 |
||| |
| | |RSV disease in | | |
||| |
| | |older adults | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
|MEDI8852 |influenza A mAb|influenza A |I |Q1 2015 |
||| |
| | |treatment | | |
||| |
+------------------+---------------+---------------+---------+---------+------
-+++-+
# Partnered product.
1 MedImmune-sponsored study in collaboration with Novartis.
2 Neuromyelitis optica now lead indication. Multiple sclerosis Phase I study
continuing.
3 SLE project stopped but molecule under evaluation for alternative
indications.
Significant Life-Cycle Management
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
| Compound | Mechanism | Area Under | Date Commenced
Phase | Estimated |
| | |Investigation |
|Filing† |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
| US | EU | Japan
| China |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Respiratory,
|
|Inflammation and
|
|Autoimmunity
|
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Duaklir |LAMA/LABA |COPD |
|2018 |Launched|2018 |2018 |
|Genuair# | | |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|SymbicortSYGMA |ICS/LABA |as needed use in |Q4 2014
|N/A |2018 | |2019 |
| | |mild asthma |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Symbicort1 |ICS/LABA |breath actuated |
|2018 | | | |
| | |Inhaler asthma/COPD |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Cardiovascular
|
|and Metabolism
|
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Brilinta/Brilique|P2Y12 |outcomes study in |Q4 2012
|2017 |2017 |2017 |2018 |
|2 EUCLID |receptor |patients with |
| | | | |
| |antagonist |peripheral artery |
| | | | |
| | |disease |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Brilinta/Brilique|P2Y12 |prevention of vaso |Q4 2014
|2020 |2020 | | |
|2 HESTIA |receptor |-occlusive crises in |
| | | | |
| |antagonist |paediatric patients |
| | | | |
| | |with sickle cell |
| | | | |
| | |disease |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Brilinta/Brilique|P2Y12 |outcomes study in |Q4 2010
|Filed |Filed |Q4 2015 |2017 |
|2 |receptor |patients with prior |
|(Priority | | | |
| PEGASUS- |antagonist |myocardial |
|Review) | | | |
| TIMI 54 | |infarction |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Brilinta/Brilique|P2Y12 |outcomes study in |Q1 2014
|H1 2016 |H1 2016 |H2 2016 |2017 |
|2 SOCRATES |receptor |patients with stroke |
| | | | |
| |antagonist |or TIA |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Brilinta/Brilique|P2Y12 |outcomes study in |Q1 2014
|2018 |2018 |2018 |2018 |
|2 THEMIS |receptor |patients with type-2 |
| | | | |
| |antagonist |diabetes and CAD, |
| | | | |
| | |but without a |
| | | | |
| | |previous history of |
| | | | |
| | |MI or stroke |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Bydureon Dual |GLP-1 |type-2 diabetes |
|Launched |Launched|Approved | |
| Chamber Pen |receptor | |
| | | | |
| |agonist | |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Bydureon EXSCEL |GLP-1 |type-2 diabetes |Q2 2010
|2018 |2018 |2018 | |
| |receptor |outcomes study |
| | | | |
| |agonist | |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Bydureon weekly |GLP-1 |type-2 diabetes |Q1 2013
|Q4 2015 |Q4 2015 | | |
| suspension |receptor | |
| | | | |
| |agonist | |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Epanova STRENGTH |omega-3 |outcomes study in |Q4 2014
|2020 |2020 |2020 |2020 |
| |carboxylic |statin-treated |
| | | | |
| |acids |patients at high CV |
| | | | |
| | |risk, with |
| | | | |
| | |persistent |
| | | | |
| | |hypertriglyceridemia |
| | | | |
| | |plus low HDL |
| | | | |
| | |-cholesterol |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Epanova/Farxiga/F|omega-3 |Non-alcoholic fatty |Q1 2015
| | | | |
|orxiga3 |carboxylic |liver disease/non |
| | | | |
| |acids/ SGLT-2|-alcoholic |
| | | | |
| |inhibitor |steatohepatitis |
| | | | |
| | |(NASH) |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Farxiga/Forxiga3 |SGLT-2 |type-2 diabetes |Q2 2013
|2020 |2020 | | |
| |inhibitor |outcomes study |
| | | | |
| DECLARE- | | |
| | | | |
| TIMI 58 | | |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Farxiga/Forxiga3 |SGLT-2 |type-1 diabetes |Q4 2014
|2018 |2017 |2018 | |
| |inhibitor | |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Kombiglyze |DPP-4 |type-2 diabetes |
|Launched |Launched| |Filed |
|XR/Komboglyze4 |inhibitor/ | |
| | | | |
| |metformin FDC| |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Onglyza SAVOR |DPP-4 |type-2 diabetes |Q2 2010
|Filed |Launched| |Q4 2015 |
|-TIMI 53 |inhibitor |outcomes study |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|saxagliptin/dapag|DPP-4 |type-2 diabetes |Q2 2012
|Filed |Filed | | |
|liflozin FDC |inhibitor/ | |
| | | | |
| |SGLT-2 | |
| | | | |
| |inhibitor FDC| |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Xigduo |SGLT-2 |type-2 diabetes |
|Launched |Launched| | |
|XR/Xigduo5 |inhibitor/ | |
| | | | |
| |metformin FDC| |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Oncology
|
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Caprelsa |VEGFR/EGFR tyrosine|differentiated |Q2 2013
|H1 2016 |H1 2016 |H1 2016 | |
| |kinase inhibitor |thyroid cancer |
| | | | |
| |with RET kinase | |
| | | | |
| |activity | |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|FaslodexFALCON |oestrogen receptor |1st-line |Q4 2012
|H2 2016 |H2 2016 |H2 2016 |2017 |
| |antagonist |hormone |
| | | | |
| | |receptor +ve |
| | | | |
| | |advanced |
| | | | |
| | |breast cancer |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Iressa |EGFR tyrosine |EGFRm NSCLC |
|Approved6 |Launched |Launched|Launched|
| |kinase inhibitor | |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Lynparza |PARP inhibitor |1st-line BRCAm |Q3 2013
|2017 |2017 |2017 | |
|(olaparib) SOLO | |ovarian cancer |
| | | | |
|-1 | | |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Lynparza |PARP inhibitor |2nd-line or |Q3 2013
|H1 2016 |H1 2016 |H2 2016 | |
|(olaparib) SOLO | |greater BRCAm |
| | | | |
|-2 | |PSR ovarian |
| | | | |
| | |cancer, |
| | | | |
| | |maintenance |
| | | | |
| | |monotherapy |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Lynparza |PARP inhibitor |gBRCA PSR |Q1 2015
|2018 | | | |
|(olaparib) SOLO | |ovarian cancer |
| | | | |
|-3 | | |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Lynparza |PARP inhibitor |2nd-line |Q3 2013
| | |2017 | |
|(olaparib) GOLD | |gastric cancer |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Lynparza |PARP inhibitor |gBRCA adjuvant |Q2 2014
|2020 |2020 |2020 | |
|(olaparib) | |triple |
| | | | |
|OlympiA | |negative |
| | | | |
| | |breast |
| | | | |
| | |cancer |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Lynparza |PARP inhibitor |gBRCA |Q2 2014
|H2 2016 |H2 2016 |H2 2016 | |
|(olaparib) | |metastatic |
| | | | |
|OlympiAD | |breast cancer |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Lynparza |PARP inhibitor |pancreatic |Q1 2015
|2017 |2017 |2017 | |
|(olaparib) POLO | |cancer |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Lynparza |PARP inhibitor |prostate |Q3 2014
| | | | |
|(olaparib) | |cancer |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Infection,
|
|Neuroscience and
|
|Gastrointestinal
|
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Diprivan# |sedative and |conscious |
|N/A |Launched |Filed |Launched|
| |anaesthetic |sedation |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Entocort |glucocorticoid |Crohn’s |
|Launched |Launched |Q3 |N/A |
| |steroid |disease / |
| | |2015 | |
| | |ulcerative |
| | | | |
| | |colitis |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|linaclotide# |GC-C receptor |irritable |
|N/A |N/A |N/A |Q4 2015 |
| |peptide agonist|bowel |
| | | | |
| | |syndrome |
| | | | |
| | |with |
| | | | |
| | |constipation |
| | | | |
| | | (IBS-C) |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Nexium |proton pump |stress ulcer |
| | | |2017 |
| |inhibitor |prophylaxis |
| | | | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
|Nexium |proton pump |paediatrics |
|Launched |Launched |H2 | |
| |inhibitor | |
| | |2016 | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
| || | | | | |
|| ||| |||| | |
+-----------------++------------+--+---+----------------+-------------+---------
--------------++---------+++------++++-------+--------+
# Partnered product.
1 Development of a new BAI device is ongoing.
2 Brilinta in the US; Brilique in rest of world.
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 Approved by FDA in July 2015.
Faslodex 500 mg approved in China in Q2 for the treatment of postmenopausal
women with oestrogen receptor positive, locally advanced or metastatic breast
cancer (replaces 250mg dose).
Terminations (discontinued projects between 1 April and 30 June 2015)
+---------+------------+---------------+------------------------------------+
|NME / |Compound |Reason for |Area Under Investigation |
|Line | |Discontinuation| |
|Extension| | | |
+---------+------------+---------------+------------------------------------+
|NME |selumetinib#|Safety/efficacy|uveal melanoma |
| |SUMIT | | |
+---------+------------+---------------+------------------------------------+
|NME |tenapanor |Safety/efficacy|ESRD-Pi/CKD with T2DM |
| |(AZD1722)# | | |
+---------+------------+---------------+------------------------------------+
|LCM |Nexium |Regulatory |refractory reflux oesphagitis (JP)|
+---------+------------+---------------+------------------------------------+
Completed Projects / Divestitures
+-------------+---------------------------+-------------+-----+--------+-------
-+++
|Compound |Mechanism |Area Under |Phase|Estimated
|
| | |Investigation| |Filing
|
+-------------+---------------------------+-------------+-----+--------+-------
-+++
|US |EU |Japan |China|
+-------------+---------------------------+-------------+-----+--------+-------
-+++
|Neuroscience
|
+-------------+---------------------------+-------------+-----+--------+-------
-+++
|Movantik/Move|oral peripherally-acting mu|opioid |
|Launched|Launched|||
|ntig#1 |-opioid receptor antagonist|-induced | | |
|||
| | |constipation | | |
|||
+-------------+---------------------------+-------------+-----+--------+-------
-+++
# Partnered product.
1 Movantik in the US; Moventig in EU.
Shareholder Information
+--------------------------+
|Announcements and Meetings|
+--------------------------+
Announcement of nine months and third quarter results 5 November 2015
Announcement of full year and fourth quarter results 4 February 2016
+---------+
|Dividends|
+---------+
Future dividends will normally be paid as follows:
First Announced with half year and second
interim quarter results and paid in September
Second Announced with full year and fourth
interim quarter results and paid in March
The record date for the first interim dividend for 2015, payable on 14 September
2015, will be 14 August 2015. Ordinary Shares listed in London and Stockholm
will trade ex-dividend from 13 August 2015. American Depositary Shares listed in
New York will trade ex-dividend from 12 August 2015.
+-------------+
|ADR Programme|
+-------------+
AstraZeneca announced an intended ratio change to its NYSE-listed sponsored
Level 2 American Depositary Receipt (ADR) programme on 26 June 2015. The prior
ratio was one American Depositary Share (ADS) per one Ordinary Share. Effective
from 27 July 2015 the new ratio became two ADSs per one Ordinary Share. There
was no change to the underlying Ordinary Shares.
ADS holders at the close of business New York time on the record date, 22 July
2015, received a distribution of one additional ADS for every ADS held. The new
ADSs were distributed on 24 July 2015. No action was required by ADS holders to
effect this change.
+----------+
|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 Daliresp, a trademark of Takeda GmbH;
Duaklir Genuair, Duaklir, Eklira, Tudorza and Tudorza Pressair, trademarks of
Almirall, S.A.; Epanova, a trademark of Chrysalis Pharma AG; Imbruvica, a
trademark of Pharmacyclics, Inc.; Zinforo, a trademark of Forest Laboratories;
Zydelig, a trademark of GILEAD SCIENCES IRELAND UC; and Zytiga, a trademark of
Johnson & Johnson.
+----------------------------+
|Addresses for Correspondence|
+----------------------------+
Registrar US Registered Swedish Central
andTransfer DepositaryCitibank Office2 Securities
OfficeEquiniti Shareholder Kingdom DepositoryEuroclear
LimitedAspect ServicesPO Box StreetLondonW2 Sweden ABPO Box 191SE
43077ProvidenceRI 6BDUK -101
HouseSpencer 02940 23 StockholmSweden
RoadLancingWe -3077USA
s
t SussexBN99
6DAUK
Tel Tel: +44 (0)207 500 Tel: +44 (0)20 Tel: +46 (0)8 402 9000
(freephone in 2030or +1 877 248 7604 8000
UK): 4237
0800 389 (1 877-CITI-ADR)/E
1580Tel -mail:
(outside UK): citiadr@citi.com
+44 (0)121
415 7033
+------------------------------------------------------------+
|Cautionary Statements Regarding Forward-Looking Statements|
+------------------------------------------------------------+
In order, among other things, to utilise the 'safe harbour' provisions of the US
Private Securities Litigation Reform Act 1995, we are providing the following
cautionary statement: This document contains certain forward-looking statements
with respect to the operations, performance and financial condition of the
Group, including, among other things, statements about expected revenues,
margins, earnings per share or other financial or other measures. Although we
believe our expectations are based on reasonable assumptions, any forward
-looking statements, by their very nature, involve risks and uncertainties and
may be influenced by factors that could cause actual outcomes and results to be
materially different from those predicted. The forward-looking statements
reflect knowledge and information available at the date of preparation of this
document and AstraZeneca undertakes no obligation to update these forward
-looking statements. We identify the forward-looking statements by using the
words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in
such statements. Important factors that could cause actual results to differ
materially from those contained in forward-looking statements, certain of which
are beyond our control, include, among other things: the loss or expiration of,
or limitations to, patents, marketing exclusivity or trademarks, or the risk of
failure to obtain and enforce patent protection; the risk of substantial adverse
litigation/government investigation claims and insufficient insurance coverage;
effects of patent litigation in respect of IP rights; exchange rate
fluctuations; the risk that R&D will not yield new products that achieve
commercial success; the risk that strategic alliances and acquisitions,
including licensing and collaborations, 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 of
outsourcing; the risks associated with manufacturing biologics; 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 of failure to adhere to applicable laws,
rules and regulations relating to anti-competitive behaviour; the risk that new
products do not perform as we expect; failure to achieve strategic priorities or
to meet targets or expectations; the risk of an adverse impact of a sustained
economic downturn; political and socio-economic conditions; the risk of
environmental liabilities; the risk of occupational health and safety
liabilities; the risk associated with pensions liabilities; the risk of misuse
of social medial platforms and new technology; the risks associated with
developing our business in emerging markets; the risk of illegal trade in our
products; the risks from pressures resulting from generic competition; the risk
of failure to successfully implement planned cost reduction measures through
productivity initiatives and restructuring programmes; economic, regulatory and
political pressures to limit or reduce the cost of our products; 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. Nothing in this presentation / webcast should be construed as a
profit forecast.
Half Yearly Report
| Source: AstraZeneca PLC
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