TIDMAZN
RNS Number : 6307E
AstraZeneca PLC
05 November 2015
5 November 2015
Year-To-Date and Q3 2015 Results
Financial Summary
YTD 2015 Q3 2015
-------------------- ------------------------- ------------------------
$m % change $m % change
-------------------- ------- ---------------- ------ ----------------
CER(1) Actual CER(1) Actual
-------------------- ------- ------- ------- ------ ------- -------
Total Revenue(2) 18,309 - (8) 5,945 (2) (10)
-------------------- ------- ------- ------- ------ ------- -------
Core(3) Op. Profit 5,346 - (7) 1,728 7 (2)
-------------------- ------- ------- ------- ------ ------- -------
Core EPS $3.32 2 (6) $1.03 8 (2)
-------------------- ------- ------- ------- ------ ------- -------
Reported Op.
Profit 3,026 31 22 1,170 137 116
-------------------- ------- ------- ------- ------ ------- -------
Reported EPS $1.60 40 30 $0.61 237 203
-------------------- ------- ------- ------- ------ ------- -------
-- Core EPS in the year to date up by 2% with Q3 Core EPS growth of 8%
-- Total Revenue stable in the year to date; Core Gross margin up by 1.0% points to 83.3%
-- Resilient top-line performance underpinned continued
investment in R&D. Core R&D costs up by 18% in Q3,
reflecting the recent start of key Oncology trials
-- Core SG&A costs declined by 3% in the third quarter; increased by 2% in the year to date
-- Upgraded FY 2015 Total Revenue and Core EPS guidance at constant exchange rates
YTD Commercial Highlights
Growth platforms grew by 10%, representing 57% of Total
Revenue:
1. Respiratory: +8%, including 38% Q3 sales growth in Emerging Markets
2. Brilinta/Brilique: +44%; Q3 US growth of 73%
3. Diabetes: +26%, including 73% sales growth in Emerging Markets
4. Emerging Markets: +12%. China sales growth of 17% (Q3 2015: +11%)
5. Japan: +3%, with Q3 sales growth of 6%
Achieving Scientific Leadership: Progress since the prior
results announcement
Regulatory Approvals Brilinta - post-myocardial infarction (MI)
(PEGASUS trial) (US)
----------------------- ------------------------------------------------
Regulatory Submission PT003 - COPD (US)
Acceptances Brilinta - acute coronary syndrome, post-MI
(JP)
AZD9291 - lung cancer (JP)
----------------------- ------------------------------------------------
Other Key Developments saxagliptin/dapaglifozin - type-2 diabetes
(US): Complete Response Letter
AZD9291: Granted Priority Review by FDA and
Japanese MHLW
FDA Fast Track designation: anifrolumab -
lupus, tremelimumab - mesothelioma, durvalumab
- head & neck cancer
----------------------- ------------------------------------------------
Pascal Soriot, Chief Executive Officer, commenting on the
results said:
"I'm pleased with our continued progress as we focus on
executing our plans across our growth platforms and pipeline. While
we have more work to do on the submission of
saxagliptin/dapagliflozin combination in Diabetes, the significant
label update for Brilinta was accompanied by submission acceptances
and accelerated reviews in cancer, respiratory diseases and lupus.
In particular, our exciting Oncology portfolio maintained its
momentum with four Priority Review and Fast Track designations as
well as supportive data at key congresses.
Our financial performance in the year to date, including an 8%
increase in Core EPS in the third quarter, underpinned today's
upgrade to full-year guidance. 2016 will be a pivotal year in our
strategic journey as we face the impact of loss of exclusivity to
Crestor in the US. Looking ahead however, the continued performance
of our growth platforms and upcoming launches will combine with our
increasing focus on costs and cash generation to help offset
short-term headwinds and return AstraZeneca to sustainable
growth."
FY 2015 Guidance
All guidance is shown at CER(1) .
New Old
------------------------ --------------------------------------------- ---------------------------------------------
Total Revenue In line with the prior year A low single-digit percent decline versus
the prior year
------------------------ --------------------------------------------- ---------------------------------------------
Core Earnings Per Share A mid to high single-digit percent increase A low single-digit percent increase versus
versus the prior year the prior year
------------------------ --------------------------------------------- ---------------------------------------------
Non-guidance information is also provided:
Based on average daily spot rates in the nine months to the end
of September 2015, Total Revenue in FY 2015 is expected to decline
by high single-digit percent, with Core EPS expected to be broadly
in line with FY 2014. In addition, the majority of FY 2015
Externalisation Revenue is anticipated to have been realised in the
first half of the year. Core R&D costs are expected to grow at
a lower rate in the final quarter versus the year to date and the
Company is committed to reducing Core SG&A costs in FY 2015
versus the prior year, both in terms of absolute value and relative
to Total Revenue.
Pipeline: Forthcoming Major Newsflow
Q4 2015 lesinurad - gout: Regulatory decision (US)
brodalumab - psoriasis: Regulatory submission
(US, EU)
durvalumab - lung cancer: Data read-out
-------- ---------------------------------------------------
H1 2016 PT003 - COPD: Regulatory decision (US)
benralizumab - severe asthma: Data read-out
Brilinta/Brilique - stroke: Data read-out
AZD9291 - lung cancer: Regulatory decisions
tremelimumab - mesothelioma: Data read-out
Lynparza - breast cancer: Data read-out
-------- ---------------------------------------------------
H2 2016 Brilinta/Brilique - peripheral arterial disease:
Data read-out
saxagliptin/dapaglifozin - type-2 diabetes (EU):
Regulatory decision durvalumab - head & neck
cancer: Data read-out
Lynparza - ovarian cancer: Data read-out
CAZ AVI - serious infections: Regulatory decision
(EU)
-------- ---------------------------------------------------
Notes
1. All growth rates and guidance are shown at constant exchange
rates (CER) unless specified otherwise.
2. Total Revenue defined as Product Sales and Externalisation
Revenue. For further details on the presentation of Total Revenue,
see the announcement published by the Company in 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.
4. The performance shown in this announcement covers the nine
and three month periods to 30 September 2015 (the year to date and
the quarter respectively) compared to the nine and three month
periods to 30 September 2014 (the prior year to date and the prior
quarter respectively).
Results Presentation
A conference call for investors and analysts, hosted by
management, will begin at midday GMT today. Details can be accessed
via www.astrazeneca.com/investors.
Reporting Calendar
The Company intends to publish its full-year financial results
on 4 February 2016.
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.
Contacts at AstraZeneca
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 Oncology +44 7818 524185
Eugenia Litz RIA +44 7884 735627
Nick Stone CVMD +44 7717 618834
Craig Marks Finance +44 7881 615764
Christer Gruvris Consensus Forecasts +44 7827 836825
US
Lindsey Trickett Oncology, ING +1 240 543 7970
Mitchell Chan Oncology +1 240 477 3771
Toll-Free +1 866 381 7277
Key: RIA - Respiratory, Inflammation & Autoimmunity, CVMD -
Cardiovascular & Metabolic Disease,
ING - Infection, Neuroscience & Gastrointestinal
Operating and Financial Review
_____________________________________________________________________________
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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 in this announcement covers the nine and
three-month periods to 30 September 2015 (the year to date and the
third quarter respectively) compared to the nine and three months
to 30 September 2014. Core measures, which are presented in
addition to Reported financial information, are non-GAAP measures
provided to enhance understanding of the Company's underlying
financial performance. Core financial measures are adjusted to
exclude certain significant items, such as:
- amortisation and impairment of intangibles, including
impairment reversals but excluding any charges relating to IT
assets
- charges and provisions related to our global restructuring
programmes (this will include such charges that relate to the
impact of our global restructuring programmes on our capitalised IT
assets)
- other specified items, principally comprising legal
settlements and acquisition-related costs, which include fair value
adjustments and the imputed finance charge relating to contingent
consideration on business combinations
More detail on the nature of these measures is given on page 72
of the 2014 Annual Report and Form 20-F Information.
Total Revenue
Total Revenue was stable in the year to date at $18,309m. The
decline of 2% in the third quarter, compared to recent increases,
reflected a lower level of Externalisation Revenue. Based on actual
exchange rates, Total Revenue declined by 8% in the nine-month
period reflecting the particular weakness of key trading currencies
against the US dollar.
Product Sales
Product Sales declined by 2% in the year to date (Q3 2015: down
by 2%) reflecting the US market entry of Nexium generic products
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 $875m in the year to date (Q3 2015:
$95m) primarily reflected income from completion of the
collaboration agreement in haematology with Celgene Corporation
(Celgene) ($450m), together with income from the
co-commercialisation agreement with Daiichi Sankyo Co., Ltd.
(Daiichi Sankyo) for Movantik in the US ($200m) and 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.
YTD 2015 Q3 2015
--------------------------- ----------------------- ----------------------
% Change % Change
$m CER Actual $m CER Actual
--------------------------- ------- ----- ------- ------ ----- -------
Respiratory, Inflammation
& Autoimmunity
Symbicort 2,535 (2) (10) 848 (4) (12)
Pulmicort 740 17 9 222 16 8
Tudorza/Eklira 143 n/m n/m 58 n/m n/m
Daliresp 72 n/m n/m 33 n/m n/m
Duaklir 15 n/m n/m 8 n/m n/m
Others 193 (5) (15) 61 (6) (15)
--------------------------- ------- ----- ------- ------ ----- -------
TOTAL 3,698 8 (1) 1,230 7 (1)
Cardiovascular &
Metabolic Disease
Brilinta/Brilique 445 44 30 170 48 34
Onglyza 594 2 (4) 203 - (8)
Bydureon 425 38 34 162 34 30
Farxiga/Forxiga 340 180 158 135 107 88
Byetta 244 (1) (5) 72 (17) (22)
Legacy:
Crestor 3,695 (4) (10) 1,218 (3) (9)
Seloken/Toprol-XL 550 4 (6) 172 (2) (13)
Atacand 272 (15) (29) 78 (24) (37)
Others 464 (10) (18) 137 (23) (30)
--------------------------- ------- ----- ------- ------ ----- -------
TOTAL 7,029 3 (4) 2,347 2 (6)
--------------------------- ------- ----- ------- ------ ----- -------
Oncology
Iressa 414 (2) (12) 141 1 (10)
Lynparza 58 n/m n/m 28 n/m n/m
Legacy:
Zoladex 618 8 (11) 209 8 (13)
Faslodex 519 7 (4) 186 11 (1)
Casodex 204 (6) (17) 65 (6) (19)
Arimidex 190 (7) (17) 64 (1) (14)
Others 106 18 3 35 11 (5)
--------------------------- ------- ----- ------- ------ ----- -------
TOTAL 2,109 6 (8) 728 9 (6)
Infection, Neuroscience
& Gastrointestinal
Nexium 1,932 (26) (32) 641 (24) (30)
Seroquel XR 784 (9) (14) 258 (14) (18)
Synagis 387 (22) (22) 117 (3) (3)
Losec/Prilosec 263 (6) (16) 82 (5) (15)
FluMist/Fluenz 97 (39) (40) 76 (48) (49)
Movantik/Moventig 14 n/m n/m 10 n/m n/m
Others 1,121 (6) (18) 361 (2) (15)
--------------------------- ------- ----- ------- ------ ----- -------
TOTAL 4,598 (18) (24) 1,545 (17) (24)
--------------------------- ------- ----- ------- ------ ----- -------
TOTAL PRODUCT SALES 17,434 (2) (10) 5,850 (2) (11)
--------------------------- ------- ----- ------- ------ ----- -------
YTD 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
medicine sales by an average of 2%.
Respiratory, Inflammation & Autoimmunity
Symbicort
Year-to-date Product Sales declined by 2% to $2,535m and the
medicine continues to be competitive.
In the US, the year-to-date decline to $1,110m was limited to 1%
with continued lower net prices reflecting additional access and
co-pay assistance. Robust volume growth was driven by higher market
share within a growing market.
In Europe, Product Sales declined by 13% to $825m with a modest
volume decline and a significant price decline reflecting increased
competition from recently-launched analogue medicines. In contrast,
Emerging Markets' sales grew by 33% to $296m with China sales
growing by 50% to $95m, primarily reflecting volume growth.
Pulmicort
Pulmicort sales in the year to date were $740m, an increase of
17%. Growth was driven primarily by the performance of Pulmicort
Respules in Emerging Markets, which were up 40% at $443m. China
Product Sales increased by 47% to $354m, reflecting sustained
investment in supporting asthma and COPD patients, both in
hospitals and more recently at home.
Tudorza/Eklira
Product Sales in the year to date were $143m, including $77m in
the US, where the brand name is Tudorza. In March 2015 the Company
completed the acquisition of the Actavis plc product rights to the
brand.
Rights were also acquired at that time for Daliresp, for which
sales amounted to $72m in the year to date.
Duaklir
In the third quarter Duaklir continued its successful launch,
principally in Europe. Year-to-date total sales of $15m (Q3 2015:
$8m, Q2 2015: $5m) reflected good progress of this leading
LAMA/LABA medicine, with an encouraging formulary uptake in the UK
and market-share increases in Germany.
Cardiovascular & Metabolic Disease
Brilinta/Brilique
Sales in the year to date were $445m, an increase of 44%, with
the third quarter exhibiting growth driven by strong marketing
execution (Q3 2015: up by 48%, Q2 2015: up by 38%). AstraZeneca
announced on 3 September 2015 that the FDA had approved Brilinta
tablets at a new 60mg dose to be used by patients with a history of
heart attack beyond the first year of treatment.
Sales in the US were $170m, increasing by 65% (Q3 2015: up by
73%, Q2 2015: up by 57%). This reflected higher total-prescription
volumes driven by marketing and other initiatives, together with an
element of stocking for the new 60mg dose.
In Europe, Brilique continued to perform well, with an increase
in Product Sales of 19% to $170m, reflecting indication leadership
across a number of European markets. Emerging Markets sales grew by
93% to $78m with China representing the largest single market for
the medicine.
Onglyza
Sales were up 2% in the nine-month period to $594m despite an
emphasis on the promotion of Farxiga in the US. Sales in the third
quarter were stable year-on-year versus the 7% decline in Q2
2015.
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US sales were down by 15% at $322m in the year to date, due to
competitive pressures in the DPP-4 class driving a lower market
share, as well as a decline in the net price.
Sales in Europe grew by 17% to $108m, while Emerging Markets
sales grew by 47% to $116m.
Farxiga/Forxiga
Sales of Farxiga/Forxiga were up 180% in the year to date to
$340m.
In the US, Product Sales of $184m represented growth of 167%.
Promotional activity underpinned increasing total-prescription
market-share growth in the year to date; this was accompanied by
overall growth in the market.
Sales in Europe reached $89m, up by 159% in the year to date
reflecting the launch phase of the medicine.
Bydureon/Byetta
Combined sales were $669m in the nine-month period, growing by
16%, with Bydureon representing 64% of total Bydureon/Byetta
sales.
In the US, sales were $526m, up by 22%, with higher volumes
driven by market growth and higher net prices. The majority of the
remaining sales of Bydureon/Byetta resided in Europe, where
year-to-date sales reached $101m, reflecting the ongoing successful
Pen launch.
Legacy: Crestor
Sales of Crestor declined in the year to date by 4% to $3,695m,
with volumes marginally falling. The performance reflected
competition from generic statins and price pressures.
In the US, Crestor sales declined by 4% to $2,067m, driven by
lower market share and destocking, which was partially offset by
favourable price movements.
In Europe sales declined by 9% to $691m, reflecting prevailing
competitive trends. Crestor consolidated its position as the
leading statin in Japan, with sales growth of 6% to $337m in the
nine-month period. Sales in China grew by 17% to $202m.
Oncology
Iressa
Sales of Iressa declined by 2% to $414m in the year to date,
driven by the competitive environment in Europe where sales were
down by 6% to $96m; Japan sales declined by 12% to $91m. Since the
US launch in July 2015, Iressa has seen an encouraging increase in
new-patient starts.
Emerging Markets sales grew by 6% to $214m, with China sales
increasing by 8% to $119m and Latin America sales increasing by 11%
to $8m.
Lynparza
Sales of Lynparza reached $58m in the nine-month period. US
sales of $46m followed the launch of the medicine at the end of
2014. Growth was driven by the pool of eligible patients awaiting
treatment as well as patients newly tested for BRCA mutation.
Legacy: Zoladex
Sales increased by 8% to $618m, with a notable performance in
China where sales reached $91m, reflecting growth of 35%.
Legacy: Faslodex
Sales were up 7% to $519m in the year to date. A 4% rise in US
sales to $261m was complemented by stable Europe sales of $154m.
The notable performance was in Emerging Markets, where sales of
$65m represented a growth rate of 46%. With the recent launch of
500mg Faslodex, China sales accelerated in the period to $7m (Q3
2015: up by 50%, H1 2015: up by 33%). AstraZeneca Russia also
achieved federal reimbursement for the medicine.
Infection, Neuroscience & Gastrointestinal
Nexium
Sales of Nexium declined by 26% to $1,932m in the year to
date.
US sales declined by 48% to $727m following the loss of
exclusivity in February 2015, directly impacting both pricing and
volumes. The estimate for pipeline inventory returns was increased
in the third quarter. Sales in Europe declined by 10% to $209m.
Nexium sales in Emerging Markets were stable at $585m, with
growth in Latin America of 19% to $98m, an exception to the overall
performance. Japan sales increased by 16% in the period to
$298m.
Seroquel XR
Sales declined by 9% to $784m in the nine-month period. In the
US, sales were stable at $540m; the performance was mainly driven
by favourable market growth and higher underlying net prices.
Product Sales in Europe declined by 28% to $160m, reflecting
generic-product competition.
Synagis
Sales of Synagis declined by 22% to $387m in the year to date,
with a 41% decline to $157m seen in the US reflecting 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 remainder of the year. Product Sales in Europe to AbbVie
were stable at $230m.
FluMist/Fluenz
Product Sales in the year to date declined by 39% to $97m,
reflecting delays in supply. In the US, Product Sales fell by 38%
to $88m, while in Europe, the decline of 38% resulted in sales of
$9m.
Movantik/Moventig
Product Sales of Movantik were $14m in the year to date (Q3
2015: $10m); the medicine was launched in March 2015. The majority
of Product Sales have been in the US. On 19 March 2015 the Company
announced a co-commercialisation agreement with Daiichi Sankyo for
Movantik in the US.
Regional Product Sales
________________________________________________________________________________
YTD 2015 Q3 2015
-------------------- ------------------------- -----------------------
% Change % Change
-------------------- ------- ---------------- ------ ---------------
$m CER Actual $m CER Actual
-------------------- ------- ----- --------- ------ ----- --------
US 6,902 (8) (8) 2,377 (6) (6)
-------------------- ------- ----- --------- ------ ----- --------
Europe 3,902 (6) (20) 1,301 (8) (21)
-------------------- ------- ----- --------- ------ ----- --------
Established ROW(1) 2,236 (2) (16) 745 - (17)
-------------------- ------- ----- --------- ------ ----- --------
Japan 1,479 3 (12) 502 6 (12)
--------------- ------- ----- --------- ------ ----- --------
Canada 399 5 (8) 126 1 (14)
--------------- ------- ----- --------- ------ ----- --------
Other
Established
ROW 358 (22) (34) 117 (20) (36)
--------------- ------- ----- --------- ------ ----- --------
Emerging Markets(2) 4,394 12 1 1,427 10 (3)
-------------------- ------- ----- --------- ------ ----- --------
China 1,931 17 15 622 11 10
---- -------------- ------- ----- --------- ------ ----- --------
Ex.China 2,463 10 (9) 805 9 (11)
---- -------------- ------- ----- --------- ------ ----- --------
Total 17,434 (2) (10) 5,850 (2) (11)
-------------------- ------- ----- --------- ------ ----- --------
1 Established 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
US Product Sales declined by 8% to $6,902m in the year to date.
Excluding the impact of the change in accounting related to the
Branded Pharmaceutical Fee, Product Sales in the year to date and
third quarter declined by 6% and 4% versus the comparative
period.
The declines reflected the loss of Nexium patent exclusivity,
competition facing Crestor from therapeutic substitution by generic
statins and the adverse impact of the Synagis guideline
changes.
Favourable performances were delivered by Brilinta, Farxiga,
Bydureon and Lynparza as well as the recently-acquired respiratory
medicines Tudorza and Daliresp. Brilinta accelerated its strong
quarterly growth, underpinned by total and new-to-brand
prescription market share gains.
Continued growth in demand for Farxiga was supported by
additional promotional activity. Bydureon continued to benefit from
the launch of the Bydureon Pen as well as growth in demand in the
overall GLP-1 class.
Europe
Sales in Europe declined by 6% to $3,902m in the year to date.
Strong growth from the diabetes medicines Onglyza and Forxiga was
more than offset by continued generic competition facing Crestor
and Seroquel XR. A 13% decline in Symbicort sales to $825m
reflected adverse pricing movements driven by competition from
analogues in key markets. Duaklir more than doubled its first-half
sales in Q3, bringing the year to date total to $14m.
Established ROW
Sales in the Established ROW fell by 2% to $2,236m in the year
to date.
Japan sales increased by 6% in both the second and third
quarters, reflecting the passing of the anniversary of the mandated
April 2014 biennial price cut. Nexium and Crestor continued to grow
in the nine-month period, increasing by 16% to $298m and 6% to
$337m respectively. Crestor growth reflected a continued increase
in the usage of the 5mg dosage. Symbicort sales in the year to date
increased by 3% to $132m; a 3% decline in the third quarter to $47m
however reflected the strong comparative period's performance.
Market share of Symbicort was broadly stable in the third quarter
and in the year to date.
Canada Product Sales grew by 5% to $399m in the year to date,
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. Sales increased by 12% to $4,394m in the
nine-month period with growth delivered across the region. Emerging
Markets sales in the third quarter increased by 10% to $1,427m,
ahead of the Company's long-term forecast of mid-to-high
single-digit growth in the region's Product Sales.
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China sales increased by 17% to $1,931m and by 11% in the third
quarter. In the year to date Brazil sales were up 20% to $304m and
Russia sales were up 22% to $163m.
Financial Performance
________________________________________________________________________________
YTD 2015 Reported Restructuring Intangible Diabetes Other(1) Core % Change
Amortisation & Alliance
Impairments
---------------- -------- ------------------ ------------
YTD 2015 YTD CER Actual
2014(2)
---------------- -------- -------- -------- ---- ------
Product
Sales 17,434 - - - - 17,434 19,412 (2) (10)
Externalisation
Revenue 875 - - - - 875 419 112 109
Total Revenue 18,309 - - - - 18,309 19,831 - (8)
Cost of
Sales (3,377) 124 343 - - (2,910) (3,529) (8) (18)
Gross Profit 14,932 124 343 - - 15,399 16,302 2 (6)
Gross Margin(3) 80.6% 83.3% 81.8% +1.0 +1.5
Distribution (240) - - - - (240) (236) 15 2
% Total
Revenue 1.3% 1.3% 1.2% -0.2 -0.1
R&D (4,251) 180 35 - - (4,036) (3,581) 22 13
% Total
Revenue 23.2% 22.0% 18.1% -3.8 -3.9
SG&A (8,444) 358 684 324 274 (6,804) (7,263) 2 (6)
% Total
Revenue 46.1% 37.2% 36.6% -0.4 -0.6
Other Operating
Income 1,029 - 156 - (158) 1,027 531 105 94
% Total
Revenue 5.6% 5.6% 2.7% +2.8 +2.9
Operating
Profit 3,026 662 1,218 324 116 5,346 5,753 - (7)
% Total
Revenue 16.5% 29.2% 29.0% -0.2 +0.2
Net Finance
Expense (750) - - 305 90 (355) (381)
Joint Ventures (9) - - - - (9) (2)
Profit
Before
Tax 2,267 662 1,218 629 206 4,982 5,370 - (7)
Taxation (249) (139) (247) (141) (14) (790) (921)
Tax Rate 11% 16% 17%
Profit
After Tax 2,018 523 971 488 192 4,192 4,449 2 (6)
Non-controlling
Interests (1) - - - - (1) (2)
Net Profit 2,017 523 971 488 192 4,191 4,447 2 (6)
Weighted
Average
Shares 1,264 1,264 1,264 1,264 1,264 1,264 1,262
Earnings
Per Share 1.60 0.41 0.77 0.39 0.15 3.32 3.52 2 (6)
---------------- -------- ------------- -------------- --------------- -------- -------- -------- ---- ------
(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.
(4) All financial figures, except Earnings Per Share, are in $
millions ($m). Weighted Average Shares are in millions.
Q3 2015 Reported Restructuring Intangible Diabetes Other(1) Core % Change
Amortisation & Alliance
Impairments
---------------- -------- ----------------- ------------
Q3 2015 Q3 CER Actual
2014(2)
---------------- -------- ------- -------- ---- ------
Product Sales 5,850 - - - - 5,850 6,542 (2) (11)
Externalisation
Revenue 95 - - - - 95 67 50 41
Total Revenue 5,945 - - - - 5,945 6,609 (2) (10)
Cost of Sales (1,041) 23 26 - - (992) (1,180) (8) (16)
Gross Profit 4,904 23 26 - - 4,953 5,429 - (9)
Gross Margin(3) 82.2% 83.0% 82.0% +1.1 +1.0
Distribution (79) - - - - (79) (87) 2 (9)
% Total Revenue 1.3% 1.3% 1.3% -0.1 -
R&D (1,429) 56 (27) - - (1,400) (1,275) 18 10
% Total Revenue 24.0% 23.5% 19.3% -3.8 -4.2
SG&A (2,679) 135 240 108 (24) (2,220) (2,486) (3) (11)
% Total Revenue 45.1% 37.3% 37.6% +0.5 +0.3
Other Operating
Income 453 - 21 - - 474 189 156 152
% Total Revenue 7.6% 8.0% 2.9% +4.6 +5.1
Operating Profit 1,170 214 260 108 (24) 1,728 1,770 7 (2)
% Total Revenue 19.7% 29.1% 26.8% +2.4 +2.3
Net Finance
Expense (237) - - 101 31 (105) (114)
Joint Ventures (2) - - - - (2) (2)
Profit Before
Tax 931 214 260 209 7 1,621 1,654 8 (2)
Taxation (161) (45) (54) (46) (12) (318) (321)
Tax Rate 17% 20% 19%
Profit After Tax 770 169 206 163 (5) 1,303 1,333 8 (2)
Non-controlling
Interests - - - - - - 1
Net Profit 770 169 206 163 (5) 1,303 1,334 8 (2)
Weighted Average
Shares 1,264 1,264 1,264 1,264 1,264 1,264 1,263
Earnings Per
Share 0.61 0.13 0.17 0.13 (0.01) 1.03 1.05 8 (2)
---------------- -------- ------------- --------------- --------------- -------- ------- -------- ---- ------
(1) Other adjustments include 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.
(4) All financial figures, except Earnings Per Share, are in $
millions ($m). Weighted Average Shares are in millions.
Profit and Loss
Gross Profit
Core Gross Profit increased by 2% in the nine-month period to
$15,399m. 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 and manufacturing
efficiencies.
Operating Expenses
Core R&D costs were up 22% in the year to date to $4,036m as
the Company continued its focused investment in the pipeline.
Oncology is anticipated to attract over 40% of total Core R&D
costs over the full year, reflecting a number of key new and active
trials.
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After a 1% reduction of Core SG&A costs in Q2 2015,
third-quarter costs declined by 3% to $2,220m. Core SG&A costs
were up 2% to $6,804m in the nine-month period as the Company
continued to invest in the product-launch programme and the growth
platforms.
The Company is committed to reducing Core SG&A costs in FY
2015 versus the prior year, both in terms of absolute value and
relative to Total Revenue. A number of programmes designed to meet
this target are progressing. 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 selectively to meet changing
customer needs and the evolving portfolio, while driving top-line
growth more efficiently.
Other Operating Income
Core Other Operating Income of $1,027m in the year to date
included royalty income of $261m, together with gains on the
disposals of Entocort ($215m), Myalept ($193m), Caprelsa ($165m)
and other disposals, including the US rights to Tenormin.
Operating Profit
Core Operating Profit was stable at $5,346m in the year to date.
The Core Operating Margin declined by 0.2% points to 29.2% of Total
Revenue as the Company continued to invest in the pipeline and the
growth platforms. The increase of 2.4% points in the Core Operating
Margin in the third quarter to 29.1% reflected the 3% decline in
Core SG&A costs and increases in Core Other Operating
Income.
Reported Operating Profit of $3,026m was 31% higher than the
first nine months of 2014.
Finance Expense
The Core Net Finance Expense was $355m versus $381m in the
comparative period. Reported net finance expense of $750m included
a charge of $395m relating to the discount unwind on contingent
consideration liabilities recognised on business combinations,
principally relating to the acquisition of BMS's share of the
global diabetes alliance last year.
Taxation
Excluding the previously disclosed one-off tax benefit of $186m
following agreement of US federal tax liabilities of open years up
to 2008, other provision releases and the benefit of the UK patent
box, the Core tax rate and Reported tax rates for the nine months
were 22% and 24% respectively. Including the impact of these
benefits, the Core and Reported tax rates for the nine months ended
30 September 2015 were 16% and 11% respectively. The cash tax paid
for the nine-month period was $954m, which is 42% of Reported
Profit Before Tax and 19% of Core Profit Before Tax.
The Core and Reported tax rates for the same period in 2014 were
19% and 21% respectively when excluding the impact of the 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 nine months ended 30 September 2014 were 17% and 15%
respectively.
Earnings Per Share (EPS)
Core EPS in the year to date increased by 2% to $3.32. Reported
EPS was up by 40% at $1.60.
Productivity
The Company continued to make good progress in implementing the
fourth wave of restructuring announced in the first quarter of 2013
that was subsequently expanded during 2014 and in the first half of
2015. Restructuring charges of $214m were taken in the third
quarter, bringing the year to date total to $662m.
Cash Flow and Balance Sheet
Cash Flow
The Company generated a cash inflow from operating activities of
$2,753m in the year to date, compared with an inflow of $5,216m in
the comparative period, reflecting the operational performance of
the business and an adverse movement in working capital.
Net cash outflows from investing activities were $1,654m
compared with $5,516m in the first nine months of 2014, the
difference primarily reflecting the acquisition of the BMS share of
the global diabetes alliance in 2014 and the proceeds from
disposals of intangible assets in 2015.
Net cash distributions to shareholders were $3,456m through
dividends of $3,486m, offset by proceeds from the issue of shares
of $30m due to the exercise of stock options.
The Company has embarked upon an initiative to further improve
cash generation from the business including standardisation of
global processes and payment terms.
Debt and Capital Structure
At 30 September 2015, outstanding gross debt (interest-bearing
loans and borrowings) was $10,947m (30 September 2014: $9,926m). Of
the gross debt outstanding at 30 September 2015, $2,671m is due
within one year (30 September 2014: $2,399m).
The Company's net debt position at 30 September 2015 was $5,886m
(30 September 2014: $3,596m).
Shares in Issue
During the year to date, 0.7 million shares were issued in
respect of share option exercises for a consideration of $30m. The
total number of shares in issue at 30 September 2015 was 1,264
million.
Capital Allocation
In setting the dividend distribution policy and the overall
financial strategy, the Board's aim is to continue to strike a
balance between the interests of the business, financial creditors
and the Company's shareholders.
After providing for business investment, funding the progressive
dividend policy and meeting debt-service obligations, the Board
will keep under review the opportunity to return cash in excess of
these requirements to shareholders through periodic share
repurchases. The Board has decided however that no share
repurchases will take place in FY 2015 in order to maintain the
strategic flexibility to invest in the business.
Sensitivity: Foreign-Exchange Rates
The Company provides the following currency sensitivity
information:
Average Exchange Rates Impact Of 5% Weakening In
Versus USD Exchange Rate Versus USD
($m)(2)
--------- ------------------------ ----------------------------
Currency Primary FY YTD Change % Total Core
Relevance 2014 2015(1) Revenue Operating
Profit
--------- ---------- ----------- --------- ---------- ------- ------------
EUR Product Sales 0.75 0.90 (16) (225) (138)
JPY Product Sales 105.87 120.91 (12) (119) (84)
CNY Product Sales 6.16 6.25 (1) (115) (49)
SEK Costs 6.86 8.41 (18) (6) 114
GBP Costs 0.61 0.65 (7) (37) 112
Other(3) (242) (139)
------------------------------ ----------- --------- ---------- ------- ------------
(1) Based on average daily spot rates YTD to the end of
September 2015
(2) Based on 2014 actual average exchange rates and group
currency exposures
(3) Other important currencies include AUD, BRL, CAD, KRW and
RUB
Currency Hedging
AstraZeneca monitors the impact of adverse currency movements on
a portfolio basis, recognising correlation effects. The Company may
hedge to protect against adverse impacts on cash flow over the
short to medium term. As at 30 September 2015 AstraZeneca had
hedged over 90% of forecast short-term currency exposure that
arises between the booking and settlement dates on non-local
currency purchases and Product Sales.
Corporate and Business Development Update
___________________________________________________________________________
a) Purchase of US Biologics Manufacturing Facility
On 11 September 2015 AstraZeneca announced that it had added to
its biologics manufacturing capability in the US with the purchase
of a high-tech biologics bulk manufacturing facility from Amgen
Inc., (Amgen). Over time, the LakeCentre facility, located in
Boulder, Colorado will increase manufacturing and production
capacity to support the Company's extensive portfolio of biologics
medicines.
b) Entocort Divestment
In the third quarter AstraZeneca completed an agreement with
Tillotts, part of Zeria Pharmaceutical Co., Ltd, 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. 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 has been shown within Other Operating Income in
the Company's financial statements in the third quarter.
c) Caprelsa Divestment
In the third quarter AstraZeneca completed an agreement with
Genzyme Corporation (Genzyme), part of Sanofi S.A., for the
divestment of 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.
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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. The upfront payment has
been shown within Other Operating Income in the Company's financial
statements in the third quarter; further development and sales
milestone payments may reach up to $135m and will be reported in
Other Operating Income. The transaction did not include the
transfer of any AstraZeneca employees or facilities.
d) Agreement to Develop Novel Immuno-Oncology Treatments
On 6 August 2015 it was announced that AstraZeneca and Heptares
Therapeutics, the wholly-owned subsidiary of Sosei Group
Corporation, had entered into a licensing agreement under which
AstraZeneca will acquire exclusive global rights to develop,
manufacture and commercialise the adenosine A2A receptor
antagonist, HTL-1071, a small molecule immuno-oncology candidate,
and potential additional A2A receptor-blocking compounds.
AstraZeneca will explore the assets across a range of cancers,
including in combination with its existing portfolio of
immunotherapies.
e) Adding New Combination Clinical Trials to Existing
Immuno-Oncology Research Collaboration
On 22 October 2015 AstraZeneca and Eli Lilly and Company (Lilly)
announced an extension to their existing Immuno-Oncology
collaboration exploring novel combination therapies for the
treatment of patients with solid tumours. Under the terms of the
expanded agreement, AstraZeneca and Lilly will evaluate the safety
and efficacy of a range of additional combinations across the
companies' complementary portfolios.
Durvalumab, AstraZeneca's investigational anti-PD-L1
immune-checkpoint inhibitor, will be combined with Lilly molecules
including a TGF-beta kinase inhibitor, galunisertib; a CXCR4
peptide antagonist; and an anti-CSF-1R monoclonal antibody, which
will be assessed additionally with AstraZeneca's anti-CTLA-4
monoclonal antibody, tremelimumab.
Management Update
___________________________________________________________________________
On 24 August 2015 AstraZeneca announced the appointment of Sean
Bohen MD, PhD, as Executive Vice President of Global Medicines
Development and Chief Medical Officer. He joined the Company on 15
September 2015.
Dr. Bohen is responsible for driving the progress of
AstraZeneca's portfolio of small molecules and biologics
investigational medicines through late-stage development to
regulatory approval. As Chief Medical Officer, he is responsible
for patient safety across the entire AstraZeneca and MedImmune
portfolio.
Dr. Bohen joined AstraZeneca from Genentech where he was most
recently Senior Vice President of Early Development. He oversaw
preclinical and clinical development programmes across all therapy
areas, including oncology, respiratory and autoimmune diseases, to
deliver trial-ready drug candidates to late-stage development.
Before this, he held a number of positions in early and late-stage
development, playing a key role in the growth and progress of the
Genentech/Roche portfolio. Dr. Bohen was instrumental in bringing a
large number of new medicines to patients, in particular for cancer
and led activities to incorporate diagnostics into clinical
programmes.
Prior to joining Genentech, Dr. Bohen was a Clinical Instructor
in Oncology at Stanford University School of Medicine, a research
associate at the Howard Hughes Medical Institute and a postdoctoral
fellow at the National Cancer Institute in the US.
Research and Development Update
________________________________________________________________________________
A comprehensive table with AstraZeneca's pipeline of medicines
in human trials can be found later in this document.
Progress since the prior results announcement on 30 July
2015:
Regulatory Approvals 1
* Brilinta - post-MI (PEGASUS trial) (US)
----------------------------- ---- --------------------------------------------------------------
Regulatory Submission 3
Acceptances * PT003 - COPD (US)
* Brilinta - ACS, post-MI (JP)
* AZD9291 - lung cancer (JP)
----------------------------- ---- --------------------------------------------------------------
Other Key Developments 6
* saxagliptin/dapaglifozin - type-2 diabetes (US):
Complete Response Letter
* AZD9291: Granted Priority Review by FDA and Japanese
MHLW
* FDA Fast Track designation: anifrolumab - lupus (SLE),
tremelimumab - mesothelioma, durvalumab - head & neck
cancer
New Molecular Entities 15 RIA
(NMEs) in Pivotal * lesinurad
Trials or under Regulatory
Review
* PT003
* brodalumab
* benralizumab
* tralokinumab - severe asthma
* PT010 - COPD
* anifrolumab
CVMD
* roxadustat
Oncology
* AZD9291
* cediranib - ovarian cancer
* tremelimumab
* durvalumab
* moxetumomab pasudotox - leukaemia
* selumetinib - lung cancer
ING
* CAZ AVI
----------------------------- ---- --------------------------------------------------------------
Projects in clinical
pipeline 113
----------------------------- ---- --------------------------------------------------------------
Key: RIA - Respiratory, Inflammation & Autoimmunity, CVMD -
Cardiovascular & Metabolic Disease,
ING - Infection, Neuroscience & Gastrointestinal
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 & Autoimmunity (RIA)
Steady progress continues to be made in the RIA pipeline, which
now includes seven programmes in pivotal trials or under
registration. AstraZeneca's respiratory portfolio includes a range
of differentiated potential medicines such as novel combinations,
biologics and devices for the treatment of asthma and chronic
obstructive pulmonary disease (COPD). The pipeline also includes a
number of assets in inflammatory and autoimmune diseases within
areas such as gout, psoriasis, systemic lupus and rheumatoid
arthritis.
At the European Respiratory Society (ERS) meeting in Amsterdam,
Netherlands in September 2015, positive Phase III results were
presented for PT003 for COPD. PT003 could be the first LAMA/LABA
combination to be delivered in a pressurised metered-dose inhaler
using a unique co-suspension technology. Overall 33 abstracts were
presented from across the Respiratory disease portfolio, including
findings from the Company's biologics pipeline and early-science
programmes.
a) Lesinurad (gout)
On 23 October 2015 the FDA's Arthritis Advisory Committee (AAC)
voted 10 to 4 to recommend the approval of lesinurad 200mg tablets
for the treatment of hyperuricemia associated with gout, in
combination with a xanthine-oxidase inhibitor. The AAC reviewed
safety and efficacy data from the pivotal Phase III
combination-therapy programme trials, representing the largest
clinical-trial data set of gout patients treated with combination
urate-lowering therapy.
The FDA is not bound by the AAC's recommendation but takes its
advice into consideration when reviewing the application for a
potential medicine. The Prescription Drug User Fee Act (PDUFA)
target goal date for lesinurad is 29 December 2015. If approved,
lesinurad will be the first selective uric acid reabsorption
inhibitor, or SURI, in the US.
b) PT003 (COPD)
Among key abstracts presented at the ERS meeting were the
positive Phase III efficacy and safety data from the PINNACLE
programme of the novel LAMA (glycopyrronium) and LABA (formoterol
fumarate) combination.
The two pivotal 24-week trials, PINNACLE-1 and PINNACLE-2,
tested the potential to improve lung function in patients with COPD
and showed that PT003 had positive effects on both co-primary and
secondary endpoints. There were no unexpected safety findings, with
adverse events being consistent with previous results from the
development programme.
During the period the FDA accepted the PT003 New Drug
Application for standard full review with an expected PDUFA action
date in Q2 2016, as anticipated.
c) Brodalumub (psoriasis)
Brodalumab is an IL-17 receptor monoclonal antibody in
development for patients with moderate-to-severe plaque
psoriasis.
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On 1 September 2015 AstraZeneca announced that it had entered
into a collaboration agreement with Valeant Pharmaceuticals
International, Inc. (Valeant) under which it will grant an
exclusive license for Valeant to develop and commercialise
brodalumab globally, except in Japan and certain other Asian
countries where rights are held by Kyowa Hakko Kirin Co., Ltd under
a prior arrangement with Amgen, the originator of brodalumab.
Completion of the transaction occurred on 1 October 2015.
Brodalumab is supported by data from the three AMAGINE Phase III
pivotal trials. The results highlighted that brodalumab has an
effective mechanism of action that delivers clinical benefit and
could help a significant number of moderate-to-severe plaque
psoriasis patients achieve total clearance of their skin disease.
At the 210mg dose, brodalumab was shown to be efficacious in total
skin clearance of psoriasis compared to placebo and superior to
ustekinumab at week 12 in two replicate comparator trials,
involving over 3,500 patients.
On 1 October 2015 The New England Journal of Medicine published
positive results from the AMAGINE-2 and AMAGINE-3 Phase III
trials.
d) Anifrolumab (lupus)
Anifrolumab is an investigational, monoclonal antibody that
binds to the type I interferon (IFN)-<ALPHA> receptor and
blocks the biological effects of all type I IFNs. It is currently
in Phase III development for systemic lupus erythematosus; the
first patient was dosed in July 2015. The Company anticipates the
publication of Phase IIb data next week in an oral presentation at
the American College of Rheumatology annual meeting in San
Francisco, California.
In August 2015 the FDA granted Fast Track designation to
anifrolumab, designed to expedite the development and review of
drugs that treat serious conditions and meet an unmet medical
need.
2. Cardiovascular & Metabolic Disease (CVMD)
AstraZeneca's strategy in CVMD focuses on ways to reduce
morbidity, mortality and organ damage by addressing multiple risk
factors across 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.
In the third quarter, AstraZeneca presented 54 abstracts from
the Company's research and development in diabetes at the 51st
Annual Meeting of the European Association for the Study of
Diabetes in Stockholm, Sweden.
The presentations included data on a number of approved products
for the treatment of type-2 diabetes, including Onglyza,
Farxiga/Forxiga, Bydureon and Byetta. Additionally several
abstracts representing AstraZeneca's early-stage and pre-clinical
research explored novel pathways and modalities to address the
underlying pathophysiology of diabetes.
a) Brilinta/Brilique (CV disease)
Brilinta/Brilique is an oral anti-platelet treatment that works
by inhibiting platelet activation and was first approved by the FDA
in July 2011 on the basis of data from the PLATO study. For at
least the first 12 months following a myocardial infarction, it is
superior to clopidogrel and is the first and only oral
anti-platelet medicine to demonstrate superior reductions in
cardiovascular death.
On 29 August 2015, the European Society of Cardiology updated
NSTE-acute coronary syndrome (ACS) guidelines, continuing to
recommend ticagrelor over clopidogrel in ACS for all patients at
moderate to high risk of ischaemic events, regardless of initial
treatment strategy and including those pre-treated with
clopidogrel. The society also guided that dual anti-platelet
therapy (P2Y12-inhibitor plus aspirin) beyond one year may be
considered after careful assessment of the ischaemic and bleeding
risks of patients.
AstraZeneca announced on 3 September 2015 that the FDA had
approved Brilinta tablets at a new 60mg dose to be used in patients
with a history of heart attack beyond the first year.
The SOCRATES trial evaluating the efficacy of Brilinta/Brilique
compared to aspirin in reducing thrombotic events in patients with
acute ischaemic stroke and high-risk transient ischaemic attack saw
its last patient randomised in November 2015. This trial is
scheduled to report data in the first half of 2016. SOCRATES is an
event-driven global clinical trial involving 13,200 patients in 33
countries and is part of the broader PARTHENON lifecycle programme
for Brilinta/Brilique.
b) Saxagliptin/dapagliflozin (type-2 diabetes)
On 15 October 2015 AstraZeneca announced that the FDA had issued
a Complete Response Letter (CRL) regarding the New Drug Application
(NDA) for the investigational fixed-dose combination of saxagliptin
and dapagliflozin for the treatment of adult patients with type-2
diabetes. The CRL stated that more clinical data are required to
support the application. This includes clinical-trial data from
ongoing or completed trials and may require information from new
trials.
AstraZeneca will work closely with the FDA to determine the
appropriate next steps for the NDA and remains committed to the
development of the saxagliptin/dapagliflozin fixed-dose
combination. This announcement did not affect ongoing interactions
with other health authorities as part of individual-application
procedures. Based on the information available, the CRL is not
expected to affect the individual components of saxagliptin or
dapagliflozin, which are approved for the treatment of adult
patients with type-2 diabetes.
c) Onglyza (type-2 diabetes)
AstraZeneca is working closely with regulators as part of the
ongoing review of the full Phase III SAVOR cardiovascular outcomes
trial data-set. The Company is currently awaiting a forthcoming
decision from the FDA on a possible label update for Onglyza and
Kombiglyze XR respectively.
3. Oncology
AstraZeneca continues to make progress in both early and
late-stage programmes toward the goal of eliminating cancer as a
major cause of death. In the third quarter, partnerships and
collaborations were established with Inovio Pharmaceuticals,
Peregrine Pharmaceuticals, Heptares Therapeutics and Mirati
Therapeutics, all operating in the Immuno-Oncology sector. In
parallel, the early portfolio is advancing molecules into human
trials. In the quarter, the first patient was dosed with MEDI9447,
a CD73 monoclonal antibody. Other targets, including GITR and
TLR7/8 are planned to start shortly and will bolster the Company's
ongoing Oncology efforts.
During the third quarter, the Company presented new data for its
Oncology portfolio at the World Conference on Lung Cancer (WCLC)
and the European Cancer Congress (ECC) to share ongoing
progress.
a) AZD9291 (lung cancer)
At the WCLC data on AZD9291 was a major focus. In the 1st-line
EGFR-mutation positive non-small cell lung cancer (NSCLC) setting,
AZD9291 showed an overall response rate of 75%; 72% of patients
were progression-free at 12 months and the longest duration of
response was ongoing at 18 months.
At ECC, data were presented from a pooled analysis of the AURA
Phase II trials (AURA extension and AURA2) in patients with
EGFR-mutated NSCLC who had progressed on an EGFR-targeted treatment
and whose tumours had the T790M resistance mutation. The data
confirmed findings already reported at previous meetings for
AZD9291; data from over 400 pre-treated patients with EGFRm T790M
showed an objective response rate of 66% (95% confidence interval
(CI); 61% to 71%). Preliminary median progression-free survival
(PFS) was 9.7 months (95% CI; 8.3 months to non-calculable) and
median duration of response was non-calculable (95% CI; 8.3 months
to NC).
Furthermore, clinical anecdotes and pre-clinical data recently
presented at the WCLC and the ECC suggest that AZD9291 penetrates
the blood-brain barrier and may have activity on brain metastases.
New data from the BLOOM (NCT02228369) study on the activity of
AZD9291 in the brain is anticipated to be presented at the
forthcoming American Association for Cancer Research NCI-EORTC
International Conference on Molecular Targets and Cancer
Therapeutics in Boston, Massachusetts.
b) Durvalumab (solid and haematological tumours)
Durvalumab, AstraZeneca's cornerstone Immuno-Oncology medicine,
is currently being tested in a number of clinical trials in
monotherapy and in combination with other potential AstraZeneca
medicines such as tremelimumab, with the potential to be part of
the first chemotherapy-free treatment option for first-line
patients across several tumour types.
Anti-PD1/PD-L1 monotherapy is transforming cancer medicine, but
the benefit is largely limited to patients with PD-L1 positive
tumours. Data from the combination of durvalumab and tremelimumab
have demonstrated anti-tumour activity in patients with heavily
pre-treated NSCLC regardless of PD-L1 status, including in patients
with no tumour-cell-membrane PD-L1 staining. A comprehensive
registration programme with durvalumab monotherapy and in
combination with tremelimumab is underway across multiple tumour
types, stages of disease, and lines of therapy. Additional
combination trials of durvalumab with other immunotherapies,
targeted therapies and chemotherapies are also underway.
A development programme for durvalumab in haematological
malignancies in combination with effective therapies through the
alliance with Celgene has also been accelerated.
Finally a new potential biomarker for use with durvalumab was
presented at the ECC, showing that gamma interferon, along with
PD-L1, was shown to be associated with responses to durvalumab
monotherapy in lung-cancer patients.
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The table overleaf illustrates ongoing trials with
durvalumab:
LUNG CANCER Name Phase Line of Population Design Timelines Status
treatment
--------- ------ ---------- --------------- ------------- ------------------ -------------
Early disease
Monotherapy
------------------------------------------------------------------------------------------------
ADJUVANT III N/A Stage Ib-IIIa durvalumab FPD Q1 2015 Recruiting
NSCLC vs placebo
Data expected
2020
--------- ------ ---------- --------------- ------------- ------------------ -------------
PACIFIC III N/A Stage III durvalumab FPD Q2 2014 Recruiting
unresectable vs placebo
NSCLC Data expected
2017
--------- ------ ---------- --------------- ------------- ------------------ -------------
Advanced/metastatic disease
Monotherapy
------------------------------------------------------------------------------------------------
ATLANTIC II 3rd line PD-L1+ NSCLC durvalumab FPD Q1 2014 First data
(single arm) by year-end
LPD Q2 2015 2015
(certain cohorts)
--------- ------ ---------- --------------- ------------- ------------------ -------------
Combination therapy
------------------------------------------------------------------------------------------------
ARCTIC III 3rd line NSCLC durvalumab FPD Q2 2015 Recruiting
vs SoC
(PD-L1+) or Data expected
durvalumab 2017
vs
tremelimumab
vs durva +
treme vs SoC
(PD-L1-)
--------- ------ ---------- --------------- ------------- ------------------ -------------
CAURAL III 2nd line T790M+ NSCLC AZD9291 vs FPD Q3 2015 Initiated
AZD9291 + enrolment;
durvalumab Data expected currently on
2017 partial hold
to
characterise
incidence of
interstitial
lung
disease
--------- ------ ---------- --------------- ------------- ------------------ -------------
MYSTIC III 1st line NSCLC (PFS durvalumab FPD Q3 2015 First
endpoint) vs durva + patient
treme vs SoC Data expected dosed
2017
--------- ------ ---------- --------------- ------------- ------------------ -------------
NEPTUNE III 1st line NSCLC durva + Data expected Awaiting
(OS endpoint) treme vs SoC 2018 first
patient
dosed
--------- ------ ---------- --------------- ------------- ------------------ -------------
- III 1st line NSCLC durvalumab + In
chemotherapy preparation
+/-
tremelimumab
--------- ------ ---------- --------------- ------------- ------------------ -------------
METASTATIC HEAD AND NECK CANCER Name Phase Line of Population Design Timelines Status
treatment
-------- ------ ------------ ------------- ------------- ------------ ------------
Monotherapy
----------------------------------------------------------------------------------------
HAWK II 2nd line PD-L1+ SCCHN durvalumab FPD Q1 2015 Recruiting
(single arm)
Data Indication
expected granted FDA
H2 2016 Fast Track
designation
-------- ------ ------------ ------------- ------------- ------------ ------------
Combination therapy
----------------------------------------------------------------------------------------
CONDOR II 2nd line PD-L1-SCCHN durvalumab FPD Q2 2015 Recruiting
vs
tremelimumab Data
vs durva + expected
treme 2017
-------- ------ ------------ ------------- ------------- ------------ ------------
EAGLE III 2nd line SCCHN durvalumab Data In
vs durva + expected preparation
treme vs SoC 2018
-------- ------ ------------ ------------- ------------- ------------ ------------
KESTREL III 1st line SCCHN durvalumab FPD Q4 2015 In
vs durva + preparation
treme vs SoC Data
expected
2018
-------- ------ ------------ ------------- ------------- ------------ ------------
METASTATIC Bladder CANCER Name Phase Line of Population Design Timelines Status
treatment
------- ------ ------------- ------------ ------------ ------------- -------------
DANUBE III 1st line Cisplatin durvalumab FPD Q4 2015 First
chemo- vs durva + patient
therapy- treme vs Data dosed
eligible/ SoC expected
ineligible 2018
------- ------ ------------- ------------ ------------ ------------- -------------
(MORE TO FOLLOW) Dow Jones Newswires
November 05, 2015 02:02 ET (07:02 GMT)
OTHER TUMOUR TYPES Name Phase Line of Indication Design Timelines Status
treatment
----- ------ -------------- -------------- ------------- ---------- --------------
- II 2nd/ Metastatic durvalumab In
3rd line gastric vs preparation
cancer tremelimumab
vs durva +
treme
----- ------ -------------- -------------- ------------- ---------- --------------
- II 2nd line Unresectable durvalumab In
liver cancer vs preparation
tremelimumab
vs durva +
treme
----- ------ -------------- -------------- ------------- ---------- --------------
ALPS II 2nd line Metastatic durva + In
pancreatic treme preparation
cancer (single arm)
----- ------ -------------- -------------- ------------- ---------- --------------
FPD=First Patient Dosed, LPD=Last Patient Dosed, SoC=Standard of
Care
c) Lynparza (ovarian cancer)
Exploratory biomarker data presented at the ECC from a Phase II
study of Lynparza are contributing to an enhanced scientific
understanding of why some women with ovarian cancer without a
BRCA1/2 mutation demonstrate anti-tumour activity with poly
ADP-ribose polymerase (PARP) inhibitor treatment.
The data suggest that these women have tumours with mutations in
other homologous recombination repair (HRR) genes that behave in a
similar way to BRCA mutations. The potential of Lynparza to target
tumours with HRR mutations beyond those in BRCA genes is under
investigation in ongoing clinical trials.
4. Infection, Neuroscience & Gastrointestinal
a) CAZ AVI (serious infections)
On 2 September 2015 the Company announced that the CAZ AVI
pivotal trials RECAPTURE 1 and RECAPTURE 2 had met the objective of
statistical non-inferiority compared to doripenem for both the EMA
primary and FDA co-primary endpoints. In addition and for the EMA
primary endpoint, CAZ AVI was statistically superior (at the 5%
level) to doripenem. CAZ AVI is being developed to treat a broad
range of Gram-negative bacterial infections which are becoming
increasingly resistant to antibiotics and pose a threat to public
health. CAZ AVI is currently under regulatory review by the EU.
b) FluMist/Fluenz (influenza vaccine)
The Company completed a strategic agreement in the third quarter
with Daiichi Sankyo for the development and commercialisation of
FluMist in the Japanese market.
c) Strategic Alliance to Accelerate New Antibiotic
Development
On 16 September 2015 it was announced that multiple drugs to
combat bioterrorism threats and other life-threatening bacterial
infections will be developed under a public-private partnership
agreement between the U.S. Department of Health and Human Services'
Office of the Assistant Secretary for Preparedness and Response
(ASPR) and AstraZeneca.
ASPR's Biomedical Advanced Research and Development Authority
(BARDA) and AstraZeneca will manage and fund the portfolio over the
next five years. In the arrangement, BARDA initially will provide
$50m toward product development and could provide up to a total of
$170m for development of additional products in the portfolio
during the five-year period. The first candidate medicine in the
portfolio combines two antibiotics, Aztreonam and Avibactam, known
together as ATM AVI. The Phase I trial for ATM AVI was commenced by
the Company in 2012.
ASTRAZENECA DEVELOPMENT PIPELINE 30 SEPTEMBER 2015
Phase III / Pivotal Phase II / Registration
NMEs and significant additional indications
Regulatory submission dates shown for assets in Phase III and
beyond. As disclosure of compound information is balanced by the
business need to maintain confidentiality, information in relation
to some compounds listed here has not been disclosed at this
time.
US and EU dates correspond to anticipated acceptance of the
regulatory submission.
# Partnered product.
Compound Mechanism Area Under Investigation Date Estimated Regulatory Submission / Submission Acceptance
Commenced
----------------------- ------------------- -------------------------------- ---------- --------------------------------------------------------------------------
US EU Japan China
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
Respiratory, Inflammation and Autoimmunity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------
anifrolumab(#) TULIP IFN-alphaR mAb systemic lupus erythematosus Q3 2015 2019 2019 2019
(Fast Track)
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
benralizumab(#) IL-5R mAb severe asthma Q4 2013 H2 2016 H2 2016 N/A N/A
CALIMA SIROCCO ZONDA
BISE BORA
GREGALE
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
benralizumab(#) IL-5R mAb COPD Q3 2014 2018 2018 N/A N/A
TERRANOVA GALATHEA
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
brodalumab(#) IL-17R mAb psoriasis Q3 2012 Q4 2015 Q4 2015 N/A N/A
AMAGINE-1,2,3
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
lesinurad selective uric chronic treatment of Q4 2011 Accepted Accepted
CLEAR 1,2 acid reabsorption hyperuricemia in patients with
CRYSTAL inhibitor (URAT-1) gout
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
PT003 GFF PINNACLE LABA / LAMA COPD Q2 2013 Accepted H2 2016 2017 2017
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
PT010 LABA / LAMA / ICS COPD Q3 2015 2018 2018 2018 2019
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
tralokinumab IL-13 mAb severe asthma Q3 2014 2018 2018 2018
STRATOS 1,2
TROPOS
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
Cardiovascular and Metabolic Disease
----------------------------------------------------------------------------------------------------------------------------------------------------------------------
Brilinta/Brilique(1) P2Y12 receptor arterial thrombosis Launched Launched Submitted Launched
antagonist
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
Epanova(#) omega-3 carboxylic severe hypertrigly-ceridemia Approved 2018 2019
acids
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
Farxiga/Forxiga(2) SGLT2 inhibitor type-2 diabetes Launched Launched Launched Submitted
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
(MORE TO FOLLOW) Dow Jones Newswires
November 05, 2015 02:02 ET (07:02 GMT)
roxadustat(#) OLYMPUS hypoxia-inducible anaemia in CKD/ESRD Q3 2014 2018 N/A N/A H2 2016
ROCKIES factor prolyl
hydroxylase
inhibitor
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
Oncology
----------------------------------------------------------------------------------------------------------------------------------------------------------------------
AZD9291 EGFR tyrosine >=2nd-line advanced EGFRm T790M Q2 2014 Accepted Accepted (Accelerated Accepted 2017
AURA, AURA 2 kinase inhibitor NSCLC (Breakthrough assessment) (Priority Review)
designation,
Priority
Review)
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
AZD9291 EGFR tyrosine 1st-line advanced EGFRm NSCLC Q1 2015 2017 2017 2017 2020
FLAURA kinase inhibitor
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
AZD9291+dur-valumab(#) EGFR tyrosine >=2nd-line advanced EGFRm T790M Q3 2015
CAURAL(3) kinase inhibitor + NSCLC
PD-L1 mAb
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
cediranib VEGFR tyrosine PSR ovarian cancer Q2 2007 Accepted (Orphan Drug)
ICON 6 kinase inhibitor
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
durvalumab(#) PD-L1 mAb 3rd-line NSCLC (PD-L1 positive) Q1 2014 H1 2016 2017 2017
ATLANTIC (Fast Track)
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
durvalumab(#) PACIFIC PD-L1 mAb stage III NSCLC Q2 2014 2017 2020 2020
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
durvalumab(#) PD-L1 mAb 2nd-line SCCHN (PD-L1 positive) Q1 2015 2017 2017 2017
HAWK (Fast Track)
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
durvalumab(#) + PD-L1 mAb + CTLA-4 3rd-line NSCLC Q2 2015 2017 2017 2017
tremelimumab mAb
ARCTIC
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
durvalumab(#) + PD-L1 mAb + CTLA-4 2nd-line SCCHN (PD-L1 negative) Q2 2015 2017 2017 2017
tremelimumab mAb
CONDOR
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
durvalumab(#) + PD-L1 mAb + CTLA-4 1st-line NSCLC Q3 2015 2017 2017 2017
tremelimumab mAb
MYSTIC
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
moxetumomab anti-CD22 hairy cell leukaemia Q2 2013 2018 2018
pasudotox(#) recombinant
immunotoxin
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
selumetinib(#) MEK inhibitor differentiated thyroid cancer Q3 2013 2018 2018
ASTRA
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
selumetinib(#) MEK inhibitor 2nd-line KRASm NSCLC Q4 2013 2017 2017
SELECT-1
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
tremelimumab DETERMINE CTLA-4 mAb mesothelioma Q2 2014 H1 2016 H2 2016 H2 2016
(Orphan Drug,
Fast Track)
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
Infection, Neuroscience and Gastrointestinal
----------------------------------------------------------------------------------------------------------------------------------------------------------------------
CAZ AVI(#) cephalosporin/ serious infections, complicated Q1 2012 N/A Accepted 2017
beta lactamase intra-abdominal infection,
inhibitor complicated urinary tract
infection
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
CAZ AVI(#) cephalos-porin/ hospital-acquired pneumonia/ Q2 2013 N/A Accepted 2017
beta lactamase ventilator-associated pneumonia
inhibitor
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
Zinforo(#) extended spectrum pneumonia/skin infections N/A Launched N/A Submitted
cephalosporin with
affinity to
penicillin-binding
proteins
----------------------- ------------------- -------------------------------- ---------- --------------- ------------------------- ------------------ ----------
Registrational Phase II/III study.
1 Brilinta in the US; Brilique in rest of world.
2 Farxiga in the US; Forxiga in rest of world.
3 Temporarily closed to enrolment.
Phases I and II
NMEs and significant additional indications
Compound Mechanism Area Under Investigation Phase Date Commenced
Phase
----------------------- ------------------ ----------------------------------------------- ------ ------------------
Respiratory, Inflammation and Autoimmunity
------------------------------------------------------------------------------------------------------------------------
abediterol (AZD0548) LABA asthma/COPD II Q4 2007
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD7594 inhaled SGRM asthma/COPD II Q3 2015
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD7624 inhaled P38 COPD II Q4 2014
inhibitor
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD9412(#) inhaled asthma/COPD II Q1 2010
interferon beta
----------------------- ------------------ ----------------------------------------------- ------ ------------------
mavrilimumab(#) GM-CSFR mAb rheumatoid arthritis II Q1 2010
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI-551(#) CD19 mAb neuromyelitis optica(2) II Q1 2015
(MORE TO FOLLOW) Dow Jones Newswires
November 05, 2015 02:02 ET (07:02 GMT)
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI2070(#) IL-23 mAb Crohn's disease II Q1 2013
----------------------- ------------------ ----------------------------------------------- ------ ------------------
abrilumab(#) alpha(4)beta(7) Crohn's disease / ulcerative colitis II Q4 2012
mAb
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI9929(#) TSLP mAb asthma / atopic dermatitis II Q2 2014
----------------------- ------------------ ----------------------------------------------- ------ ------------------
PT010 LABA/LAMA/ICS asthma II Q2 2014
----------------------- ------------------ ----------------------------------------------- ------ ------------------
RDEA3170 selective uric chronic treatment of hyperuricemia in patients II Q3 2013
acid reabsorption with gout
inhibitor
(URAT-1)
----------------------- ------------------ ----------------------------------------------- ------ ------------------
tralokinumab IL-13 mAb idiopathic pulmonary fibrosis II Q4 2012
----------------------- ------------------ ----------------------------------------------- ------ ------------------
tralokinumab IL-13 mAb atopic dermatitis II Q1 2015
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD1419(#) TLR9 agonist asthma I Q3 2013
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD7986 DPP1 COPD I Q4 2014
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD8999 MABA COPD I Q4 2013
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI4920 anti-CD40L-Tn3 primary Sjögren's syndrome I Q2 2014
fusion protein
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI5872(#) B7RP1 mAb systemic lupus erythematosus I Q4 2008
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI7836 IL-13 mAb-YTE asthma I Q1 2015
----------------------- ------------------ ----------------------------------------------- ------ ------------------
Cardiovascular and Metabolic Disease
------------------------------------------------------------------------------------------------------------------------
AZD4901 NK3 receptor polycystic ovarian syndrome II Q2 2013
antagonist
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD9977 selective diabetic kidney disease I Q3 2015
mineralocorticoid
receptor
modulator
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI0382 GLP-1/ diabetes / obesity I Q1 2015
glucagon dual
agonist
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI6012 LCAT ACS I Q1 2012
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI8111 Rh-factor II trauma / bleeding I Q1 2014
----------------------- ------------------ ----------------------------------------------- ------ ------------------
Oncology
------------------------------------------------------------------------------------------------------------------------
AZD1775(#) WEE-1 inhibitor ovarian cancer II Q4 2012
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD2014 mTOR serine/ solid tumours II Q1 2013
threonine kinase
inhibitor
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD4547 FGFR tyrosine solid tumours II Q4 2011
kinase inhibitor
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD5069+durvalumab(#) CXCR2 + PD-L1 mAb SCCHN II Q3 2015
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD9150(#) STAT3 inhibitor +
+durvalumab(#) PD-L1 mAb
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD5363(#) AKT kinase breast cancer II Q1 2014
inhibitor
----------------------- ------------------ ----------------------------------------------- ------ ------------------
durvalumab(#) PD-L1 mAb solid tumours II Q3 2014
----------------------- ------------------ ----------------------------------------------- ------ ------------------
durvalumab(#) + PD-L1 mAb + gastric cancer II Q2 2015
tremelimumab CTLA-4 mAb
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI-551(#) CD19 mAb diffuse B-cell lymphoma II Q1 2012
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI-573(#) IGF mAb metastatic breast cancer II Q2 2012
----------------------- ------------------ ----------------------------------------------- ------ ------------------
savolitinib/ MET tyrosine papillary renal cell carcinoma II Q2 2014
volitinib(#) kinase inhibitor
----------------------- ------------------ ----------------------------------------------- ------ ------------------
selumetinib(#) MEK inhibitor 2nd-line KRAS wt NSCLC II Q1 2013
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD3759 BLOOM EGFR tyrosine brain metastases in advanced EGFRm NSCLC I Q4 2014
kinase inhibitor
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD9291 EGFR tyrosine
BLOOM kinase inhibitor
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD5312(#) androgen receptor solid tumours I Q2 2014
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 alpha solid tumours I Q4 2014
inhibitor
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD9150(#) STAT3 inhibitor haematological malignancies I Q1 2012
----------------------- ------------------ ----------------------------------------------- ------ ------------------
(MORE TO FOLLOW) Dow Jones Newswires
November 05, 2015 02:02 ET (07:02 GMT)
AZD9291 + EGFR tyrosine advanced EGFRm NSCLC I Q3 2014
(durvalumab(#) or kinase inhibitor
selumetinib(#) or + (PD-L1 mAb or
savolitinib(#) ) MEK inhibitor or
TATTON MET tyrosine
kinase inhibitor)
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD9496 selective ER+ breast cancer I Q4 2014
oestrogen
receptor
downregulator
(SERD)
----------------------- ------------------ ----------------------------------------------- ------ ------------------
durvalumab(#) after PD-L1 mAb NSCLC I Q3 2014
(AZD9291 or Iressa or + (EGFR tyrosine
(selumetinib(#) kinase inhibitor
+docetaxel) or or MEK inhibitor
tremelimumab) or CTLA-4 mAb)
----------------------- ------------------ ----------------------------------------------- ------ ------------------
durvalumab(#) PD-L1 mAb solid tumours I Q3 2014
----------------------- ------------------ ----------------------------------------------- ------ ------------------
durvalumab(#) + PD-L1 mAb + PD-1 solid tumours I Q2 2014
MEDI0680 mAb
----------------------- ------------------ ----------------------------------------------- ------ ------------------
durvalumab(#) + OX40 agonist + solid tumours I Q2 2015
MEDI6383(#) PD-L1 mAb
----------------------- ------------------ ----------------------------------------------- ------ ------------------
durvalumab(#) + PD-L1 mAb+ BRAF melanoma I Q1 2014
dabrafenib + inhibitor + MEK
trametinib(1) inhibitor
----------------------- ------------------ ----------------------------------------------- ------ ------------------
durvalumab(#) + PD-L1 mAb + solid tumours I Q4 2013
tremelimumab CTLA-4 mAb
----------------------- ------------------ ----------------------------------------------- ------ ------------------
Iressa + durvalumab(#) PD-L1 mAb+ EGFR NSCLC I Q2 2014
tyrosine kinase
inhibitor
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI0562(#) humanised OX40 solid tumours I Q1 2015
agonist
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI-551(#) + CD19 mAb + CD20 haematological malignancies I Q2 2014
rituximab mAb
----------------------- ------------------ ----------------------------------------------- ------ ------------------
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
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI6383(#) OX40 agonist solid tumours I Q3 2014
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI9447 CD73 mAb solid tumours I Q3 2015
----------------------- ------------------ ----------------------------------------------- ------ ------------------
Infection, Neuroscience and Gastrointestinal
------------------------------------------------------------------------------------------------------------------------
AZD3241 myeloperoxidase multiple system atrophy II Q2 2012
inhibitor
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD3293(#) beta-secretase Alzheimer's disease II Q4 2014
inhibitor
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD5847 oxazolidinone tuberculosis II Q4 2012
anti-bacterial
inhibitor
----------------------- ------------------ ----------------------------------------------- ------ ------------------
CXL(#) beta lactamase methicillin-resistant S. aureus II Q4 2010
inhibitor /
cephalosporin
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI7510 RSV sF+GLA-SE prevention of RSV disease in older adults II Q3 2015
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI8897(#) RSV mAb-YTE passive RSV prophylaxis II Q1 2015
(FDA Fast Track)
----------------------- ------------------ ----------------------------------------------- ------ ------------------
susatoxumab (MEDI4893) MAb binding to S. hospital-acquired pneumonia / serious S. aureu II Q4 2014
aureus toxin s infection
(FDA Fast Track)
----------------------- ------------------ ----------------------------------------------- ------ ------------------
ATM AVI(#) monobactam/ beta targeted serious bacterial infections I Q4 2012
lactamase
inhibitor
----------------------- ------------------ ----------------------------------------------- ------ ------------------
AZD8108 NMDA antagonist suicidal ideation I Q4 2014
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI-550 pandemic pandemic influenza prophylaxis I Q2 2006
influenza virus
vaccine
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI1814 amyloid beta mAb Alzheimer's disease I Q2 2014
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI3902 anti-Psl/PcrV prevention of nosocomial pseudomonas pneumonia I Q3 2014
(FDA Fast Track)
----------------------- ------------------ ----------------------------------------------- ------ ------------------
MEDI8852 influenza A mAb influenza A treatment I Q1 2015
----------------------- ------------------ ----------------------------------------------- ------ ------------------
1 MedImmune-sponsored study in collaboration with Novartis AG.
2 Neuromyelitis optica: Now lead indication. Multiple sclerosis Phase I study continuing.
(MORE TO FOLLOW) Dow Jones Newswires
November 05, 2015 02:02 ET (07:02 GMT)
Significant Life-Cycle Management
Compound Mechanism Area Under Date Estimated Regulatory Submission Acceptance
Investigation Commenced
Phase
--------------------- -------------- ---------------------- ---------- ----------------------------------------------------
US EU Japan China
--------------------- ------------ ---------------------- ---------- ------------------ --------- --------- ----------
Respiratory, Inflammation and Autoimmunity
-------------------------------------------------------------------------------------------------------------------------------
Duaklir Genuair(#) LAMA/LABA COPD 2018 Launched 2018 2018
--------------------- -------------- ---------------------- ---------- ------------------ --------- --------- ----------
Symbicort ICS/LABA as-needed use in mild Q4 2014 N/A 2018 2019
SYGMA asthma
--------------------- -------------- ---------------------- ---------- ------------------ --------- --------- ----------
Symbicort(1) ICS/LABA breath actuated 2018
Inhaler asthma/COPD
--------------------- -------------- ---------------------- ---------- ------------------ --------- --------- ----------
Cardiovascular and Metabolism
-------------------------------------------------------------------------------------------------------------------------------
Brilinta/Brilique(2) P2Y12 outcomes study in Q4 2012 2017 2017 2017 2018
EUCLID receptor patients with
antagonist peripheral artery
disease
--------------------- -------------- ---------------------- ---------- ------------------ --------- --------- ----------
Brilinta/Brilique(2) P2Y12 prevention of Q4 2014 2020 2020
HESTIA receptor vaso-occlusive crises
antagonist in paediatric
patients with sickle
cell disease
--------------------- -------------- ---------------------- ---------- ------------------ --------- --------- ----------
Brilinta/Brilique(2) P2Y12 outcomes study in Q4 2010 Launched Accepted Accepted H2 2016
PEGASUS- receptor patients with prior (Priority Review)
TIMI 54 antagonist myocardial infarction
--------------------- -------------- ---------------------- ---------- ------------------ --------- --------- ----------
Brilinta/Brilique(2) P2Y12 outcomes study in Q1 2014 H1 2016 H1 2016 H2 2016 2017
SOCRATES receptor patients with stroke
antagonist or TIA
--------------------- -------------- ---------------------- ---------- ------------------ --------- --------- ----------
Brilinta/Brilique(2) P2Y12 outcomes study in Q1 2014 2018 2018 2018 2019
THEMIS receptor patients with type-2
antagonist diabetes and CAD, but
without a previous
history of
MI or stroke
--------------------- -------------- ---------------------- ---------- ------------------ --------- --------- ----------
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 omega-3 outcomes study in Q4 2014 2020 2020 2020 2020
STRENGTH carboxylic statin-treated
acids patients at high CV
risk, with persistent
hypertriglyceridemia
plus low
HDL-cholesterol
--------------------- -------------- ---------------------- ---------- ------------------ --------- --------- ----------
Epanova/ omega-3 Non-alcoholic fatty Q1 2015
Farxiga/Forxiga(3) carboxylic liver
acids/ SGLT2 disease/non-alcoholic
inhibitor steatohepatitis
(NASH)
--------------------- -------------- ---------------------- ---------- ------------------ --------- --------- ----------
Farxiga/Forxiga(3) SGLT2 type-2 diabetes Q2 2013 2020 2020
DECLARE- inhibitor outcomes study
TIMI 58
--------------------- -------------- ---------------------- ---------- ------------------ --------- --------- ----------
Farxiga/Forxiga(3) SGLT2 type-1 diabetes Q4 2014 2018 2017 2018
inhibitor
--------------------- -------------- ---------------------- ---------- ------------------ --------- --------- ----------
Kombiglyze DPP-4 type-2 diabetes Launched Launched Submitted
XR/Komboglyze(4) inhibitor/
metformin FDC
--------------------- -------------- ---------------------- ---------- ------------------ --------- --------- ----------
Onglyza SAVOR-TIMI DPP-4 type-2 diabetes Q2 2010 Accepted Launched Q4 2015
53 inhibitor outcomes study
--------------------- -------------- ---------------------- ---------- ------------------ --------- --------- ----------
saxagliptin/ DPP-4 type-2 diabetes Q2 2012 Accepted (5) Accepted
dapagliflozin FDC inhibitor/
SGLT2
inhibitor FDC
--------------------- -------------- ---------------------- ---------- ------------------ --------- --------- ----------
Xigduo XR/ SGLT2 type-2 diabetes Launched Launched
Xigduo(6) inhibitor/
metformin FDC
--------------------- -------------- ---------------------- ---------- ------------------ --------- --------- ----------
Oncology
-------------------------------------------------------------------------------------------------------------------------------
Faslodex oestrogen 1st-line hormone Q4 2012 H2 2016 H2 2016 H1 2016 2020
FALCON receptor receptor +ve advanced
antagonist breast cancer
----------------------- ------------ ---------------------- ---------- ------------------ --------- --------- ----------
Lynparza (olaparib) PARP 1st-line BRCAm Q3 2013 2017 2017 2017
SOLO-1 inhibitor ovarian cancer
----------------------- ------------ ---------------------- ---------- ------------------ --------- --------- ----------
Lynparza (olaparib) PARP 2nd-line or greater Q3 2013 H2 2016 H2 2016 H2 2016
SOLO-2 inhibitor BRCAm PSR ovarian
cancer, maintenance
monotherapy
----------------------- ------------ ---------------------- ---------- ------------------ --------- --------- ----------
Lynparza (olaparib) PARP gBRCA PSR ovarian Q1 2015 2018
SOLO-3 inhibitor cancer
----------------------- ------------ ---------------------- ---------- ------------------ --------- --------- ----------
Lynparza (olaparib) PARP 2nd-line gastric Q3 2013 2017
GOLD inhibitor cancer
----------------------- ------------ ---------------------- ---------- ------------------ --------- --------- ----------
Lynparza (olaparib) PARP gBRCA adjuvant triple Q2 2014 2020 2020 2020
OlympiA inhibitor negative breast
cancer
----------------------- ------------ ---------------------- ---------- ------------------ --------- --------- ----------
Lynparza (olaparib) PARP gBRCA metastatic Q2 2014 H2 2016 H2 2016 H2 2016
OlympiAD inhibitor breast cancer
----------------------- ------------ ---------------------- ---------- ------------------ --------- --------- ----------
Lynparza (olaparib) PARP pancreatic cancer Q1 2015 2018 2018 2018
POLO inhibitor
(MORE TO FOLLOW) Dow Jones Newswires
November 05, 2015 02:02 ET (07:02 GMT)
----------------------- ------------ ---------------------- ---------- ------------------ --------- --------- ----------
Lynparza (olaparib) PARP prostate cancer Q3 2014
inhibitor
----------------------- ------------ ---------------------- ---------- ------------------ --------- --------- ----------
Infection, Neuroscience and Gastrointestinal
-------------------------------------------------------------------------------------------------------------------------------
Diprivan(#) sedative conscious sedation N/A Launched Accepted Launched
and
anaesthetic
----------------------- ------------ ---------------------- ---------- ------------------ --------- --------- ----------
linaclotide(#) GC-C irritable bowel N/A N/A N/A Q4 2015
receptor syndrome with
peptide constipation
agonist (IBS-C)
----------------------- ------------ ---------------------- ---------- ------------------ --------- --------- ----------
Nexium proton pump stress ulcer H2 2016
inhibitor prophylaxis
----------------------- ------------ ---------------------- ---------- ------------------ --------- --------- ----------
Nexium proton pump paediatrics Launched Launched H2 2016 Accepted
inhibitor
----------------------- ------------ ---------------------- ---------- ------------------ --------- --------- ----------
1 Development of a new breath-actuated pressurised metered dose inhaler 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 Complete Response Letter received October 2015.
6 Xigduo XR in the US; Xigduo in the EU.
Terminations (discontinued projects between 1 July and 30
September 2015)
NME / Line Extension Compound Reason for Area Under Investigation
Discontinuation
--------------------- ---------------------------- ------------------ -------------------------
NME AZD5213 Safety / efficacy Tourette's syndrome
/ neuropathic
pain
--------------------- ---------------------------- ------------------ -------------------------
NME MEDI-551(#) + MEDI0680 Safety / efficacy diffuse large
B-cell lymphoma
--------------------- ---------------------------- ------------------ -------------------------
NME MEDI6469(#) Strategic solid tumours
--------------------- ---------------------------- ------------------ -------------------------
NME durvalumab(#) + MEDI6469(#) Strategic solid tumours
--------------------- ---------------------------- ------------------ -------------------------
NME MEDI6469(#) + rituximab Strategic solid tumours
--------------------- ---------------------------- ------------------ -------------------------
NME MEDI6469(#) + tremelimumab Strategic solid tumours
--------------------- ---------------------------- ------------------ -------------------------
NME sifalimumab(#) Strategic systemic lupus
erythematosus(1)
--------------------- ---------------------------- ------------------ -------------------------
LCM MEDI-551(#) Safety / efficacy chronic lymphocytic
leukaemia
--------------------- ---------------------------- ------------------ -------------------------
LCM moxetumomab pasudotox(#) Safety / efficacy paediatric acute
lymphoblastic
leukemia
--------------------- ---------------------------- ------------------ -------------------------
1 SLE project stopped but molecule under evaluation for alternative indications.
Completed Projects / Divestitures
Compound Mechanism Area Under Completed/ Estimated Regulatory Submission Acceptance
Investigation Divested
---------------- --------------- --------------- ------------------- ------------------------------------------------
US EU Japan China
---------------- --------------- --------------- ------------------- ------------ --------- ------------ ---------
Bydureon Dual GLP-1 receptor type-2 Completed Launched Launched Launched
Chamber Pen agonist diabetes
---------------- --------------- --------------- ------------------- ------------ --------- ------------ ---------
brodalumab IL-17R mAb psoriatic Partnered
AMVISION-1,2(1) arthritis
---------------- --------------- --------------- ------------------- ------------ --------- ------------ ---------
Caprelsa(2) VEGFR / EGFR medullary Divested Launched Launched Approved(3) Accepted
tyrosine thyroid cancer
kinase
inhibitor with
RET kinase
activity
---------------- --------------- --------------- ------------------- ------------ --------- ------------ ---------
Caprelsa(2) VEGFR / EGFR differentiated Divested
tyrosine thyroid cancer
kinase
inhibitor with
RET kinase
activity
---------------- --------------- --------------- ------------------- ------------ --------- ------------ ---------
Entocort(4) glucocorticoid Crohn's Completed/Divested Launched Launched Q4 2015 N/A
steroid disease /
ulcerative
colitis
---------------- --------------- --------------- ------------------- ------------ --------- ------------ ---------
Iressa EGFR tyrosine EGFRm NSCLC Completed Launched(5) Launched Launched Launched
kinase
inhibitor
---------------- --------------- --------------- ------------------- ------------ --------- ------------ ---------
1 AstraZeneca has granted Valeant Pharmaceuticals an exclusive
license to develop and commercialise brodalumab.
2 Divested to Genzyme (deal completed October 2015).
3 Approved in Japan in September 2015.
4 Global rights, outside the US, divested to Tillotts Pharma AG
in July 2015. AstraZeneca continues to support the Japanese
regulatory submission.
5 Launched in US Q3 2015.
Condensed Consolidated Statement of Comprehensive Income
Restated
2015 2014*
For the nine months ended 30 September $m $m
---------------------------------------------------- -------- ---------
Product sales 17,434 19,412
Externalisation revenue 875 419
--------------------------------------------------------- -------- ---------
Total revenue 18,309 19,831
Cost of sales (3,377) (4,175)
--------------------------------------------------------- -------- ---------
Gross profit 14,932 15,656
Distribution costs (240) (236)
Research and development expense (4,251) (4,080)
Selling, general and administrative costs (8,444) (8,916)
Other operating income and expense 1,029 62
---------
Operating profit 3,026 2,486
Finance income 33 45
Finance expense (783) (703)
Share of after tax losses in joint ventures (9) (2)
--------------------------------------------------------- -------- ---------
Profit before tax 2,267 1,826
Taxation (249) (270)
--------------------------------------------------------- -------- ---------
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Profit for the period 2,018 1,556
--------------------------------------------------------- -------- ---------
Other comprehensive income
Items that will not be reclassified to profit
or loss
Remeasurement of the defined benefit pension
liability 34 (498)
Tax on items that will not be reclassified
to profit or loss (12) 127
--------------------------------------------------------- -------- ---------
22 (371)
-------- ---------
Items that may be reclassified subsequently
to profit or loss
Foreign exchange arising on consolidation (359) (412)
Foreign exchange arising on designating borrowings
in net investment hedges (322) (292)
Fair value movements on derivatives designated
in net investment hedges 24 36
Amortisation of loss on cash flow hedge 1 1
Net available for sale (losses)/gains taken
to equity (63) 73
Tax on items that may be reclassified subsequently
to profit or loss 84 30
--------------------------------------------------------- -------- ---------
(635) (564)
-------- ---------
Other comprehensive income for the period,
net of tax (613) (935)
--------------------------------------------------------- -------- ---------
Total comprehensive income for the period 1,405 621
--------------------------------------------------------- -------- ---------
Profit attributable to:
Owners of the Parent 2,017 1,554
Non-controlling interests 1 2
--------------------------------------------------------- -------- ---------
2,018 1,556
Total comprehensive income attributable to:
Owners of the Parent 1,405 626
Non-controlling interests - (5)
--------------------------------------------------------- -------- ---------
1,405 621
-------- ---------
Basic earnings per $0.25 Ordinary Share $1.60 $1.23
Diluted earnings per $0.25 Ordinary Share $1.59 $1.23
--------------------------------------------------------- -------- ---------
Weighted average number of Ordinary Shares
in issue (millions) 1,264 1,262
Diluted weighted average number of Ordinary
Shares in issue (millions) 1,265 1,264
--------------------------------------------------------- -------- ---------
* 2014 comparatives restated for reclassification of
Externalisation revenue (see Note 1)
Condensed Consolidated Statement of Comprehensive Income
Restated
2015 2014*
For the quarter ended 30 September $m $m
----------------------------------------------------------------------------- -------- ---------
Product sales 5,850 6,542
Externalisation revenue 95 67
---------------------------------------------------------------------------------- -------- ---------
Total revenue 5,945 6,609
Cost of sales (1,041) (1,415)
---------------------------------------------------------------------------------- -------- ---------
Gross profit 4,904 5,194
Distribution costs (79) (87)
Research and development expense (1,429) (1,552)
Selling, general and administrative costs (2,679) (3,132)
Other operating income and expense 453 118
---------
Operating profit 1,170 541
Finance income 9 19
Finance expense (246) (236)
Share of after tax losses of joint ventures (2) (2)
---------------------------------------------------------------------------------- -------- ---------
Profit before tax 931 322
Taxation (161) (69)
---------------------------------------------------------------------------------- -------- ---------
Profit for the period 770 253
---------------------------------------------------------------------------------- -------- ---------
Other comprehensive income
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability (208) (210)
Tax on items that will not be reclassified to profit or loss 45 42
---------------------------------------------------------------------------------- -------- ---------
(163) (168)
-------- ---------
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation (348) (476)
Foreign exchange arising on designating borrowings in net investment hedges (105) (170)
Fair value movements on derivatives designated in net investment hedges 4 47
Net available for sale (losses)/gains taken to equity (34) 24
Tax on items that may be reclassified subsequently to profit or loss 41 25
---------------------------------------------------------------------------------- -------- ---------
(442) (550)
-------- ---------
Other comprehensive income for the period, net of tax (605) (718)
---------------------------------------------------------------------------------- -------- ---------
Total comprehensive income for the period 165 (465)
---------------------------------------------------------------------------------- -------- ---------
Profit attributable to:
Owners of the Parent 770 254
Non-controlling interests - (1)
---------------------------------------------------------------------------------- -------- ---------
770 253
-------- ---------
Total comprehensive income attributable to:
Owners of the Parent 166 (463)
Non-controlling interests (1) (2)
---------------------------------------------------------------------------------- -------- ---------
165 (465)
-------- ---------
Basic earnings per $0.25 Ordinary Share $0.61 $0.20
Diluted earnings per $0.25 Ordinary Share $0.60 $0.20
---------------------------------------------------------------------------------- -------- ---------
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Weighted average number of Ordinary Shares in issue (millions) 1,264 1,263
Diluted weighted average number of Ordinary Shares in issue (millions) 1,265 1,264
---------------------------------------------------------------------------------- -------- ---------
* 2014 comparatives restated for reclassification of
Externalisation revenue (see Note 1)
Condensed Consolidated Statement of Financial Position
At 30 At 31 Dec 2014 At 30 Sep 2014
Sep $m $m
2015
$m
------------------------------------------------------------ --------- --------------- ---------------
ASSETS Non-current assets
Property, plant and equipment 6,205 6,010 5,989
Goodwill 11,430 11,550 11,368
Intangible assets 19,997 20,981 20,351
Derivative financial instruments 479 465 390
Investments in joint ventures 48 59 66
Other investments 444 502 281
Other receivables 925 1,112 1,239
Deferred tax assets 1,391 1,219 1,408
----------------------------------------------------------------- --------- --------------- ---------------
40,919 41,898 41,092
--------- --------------- ---------------
Current assets
Inventories 2,193 1,960 1,957
Trade and other receivables 5,876 7,232 6,809
Other investments 496 795 804
Derivative financial instruments 30 21 7
Income tax receivable 523 329 349
Cash and cash equivalents 4,081 6,360 5,146
----------------------------------------------------------------- --------- --------------- ---------------
13,199 16,697 15,072
--------- --------------- ---------------
Total assets 54,118 58,595 56,164
----------------------------------------------------------------- --------- --------------- ---------------
LIABILITIES Current liabilities
Interest-bearing loans and borrowings (2,671) (2,446) (2,399)
Trade and other payables (10,593) (11,886) (10,149)
Derivative financial instruments (25) (21) (17)
Provisions (682) (623) (564)
Income tax payable (2,065) (2,354) (2,695)
----------------------------------------------------------------- --------- --------------- ---------------
(16,036) (17,330) (15,824)
--------- --------------- ---------------
Non-current liabilities
Interest-bearing loans and borrowings (8,276) (8,397) (7,527)
Deferred tax liabilities (1,559) (1,796) (2,151)
Retirement benefit obligations (2,542) (2,951) (2,733)
Provisions (381) (484) (557)
Other payables (7,956) (7,991) (6,906)
----------------------------------------------------------------- --------- --------------- ---------------
(20,714) (21,619) (19,874)
--------- --------------- ---------------
Total liabilities (36,750) (38,949) (35,698)
----------------------------------------------------------------- --------- --------------- ---------------
Net assets 17,368 19,646 20,466
----------------------------------------------------------------- --------- --------------- ---------------
EQUITY
Capital and reserves attributable to equity holders of the
Company
Share capital 316 316 316
Share premium account 4,291 4,261 4,245
Other reserves 2,035 2,021 1,991
Retained earnings 10,707 13,029 13,893
----------------------------------------------------------------- --------- --------------- ---------------
17,349 19,627 20,445
Non-controlling interests 19 19 21
----------------------------------------------------------------- --------- --------------- ---------------
Total equity 17,368 19,646 20,466
----------------------------------------------------------------- --------- --------------- ---------------
Condensed Consolidated Statement of Cash Flows
2015 2014
For the nine months ended 30 September $m $m
------------------------------------------------------------------ -------- --------
Cash flows from operating activities
Profit before tax 2,267 1,826
Finance income and expense 750 658
Share of after tax losses in joint ventures 9 2
Depreciation, amortisation and impairment 2,136 2,261
(Increase)/decrease in working capital and short-term provisions (35) 1,752
Non-cash and other movements (987) 208
----------------------------------------------------------------------- -------- --------
Cash generated from operations 4,140 6,707
Interest paid (433) (446)
Tax paid (954) (1,045)
----------------------------------------------------------------------- -------- --------
Net cash inflow from operating activities 2,753 5,216
----------------------------------------------------------------------- -------- --------
Cash flows from investing activities
Movement in short-term investments and fixed deposits 285 (25)
Purchase of property, plant and equipment (874) (621)
Disposal of property, plant and equipment 16 143
Purchase of intangible assets (1,379) (1,662)
Disposal of intangible assets 737 -
Purchase of non-current asset investments (47) (9)
Disposal of non-current asset investments 59 -
Payments to joint ventures - (70)
Upfront payments on business acquisitions - (2,778)
Payment of contingent consideration on business acquisitions (553) (572)
Interest received 102 88
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Payments made by subsidiaries to non-controlling interests - (10)
----------------------------------------------------------------------- -------- --------
Net cash outflow from investing activities (1,654) (5,516)
----------------------------------------------------------------------- -------- --------
Net cash inflow/(outflow) before financing activities 1,099 (300)
----------------------------------------------------------------------- -------- --------
Cash flows from financing activities
Proceeds from issue of share capital 30 263
Repayment of loans (884) (750)
Dividends paid (3,486) (3,521)
Hedge contracts relating to dividend payments (51) (14)
Repayment of obligations under finance leases (40) (27)
Payments to acquire non-controlling interest - (102)
Movement in short-term borrowings 1,025 295
Net cash outflow from financing activities (3,406) (3,856)
----------------------------------------------------------------------- -------- --------
Net decrease in cash and cash equivalents in the period (2,307) (4,156)
Cash and cash equivalents at the beginning of the period 6,164 8,995
Exchange rate effects (70) (30)
----------------------------------------------------------------------- -------- --------
Cash and cash equivalents at the end of the period 3,787 4,809
----------------------------------------------------------------------- -------- --------
Cash and cash equivalents consists of:
Cash and cash equivalents 4,081 5,146
Overdrafts (294) (337)
----------------------------------------------------------------------- -------- --------
3,787 4,809
-------- --------
Condensed Consolidated Statement of Changes in Equity
Share Non-
Share premium Other Retained controlling Total
capital account reserves* earnings Total interests equity
$m $m $m $m $m $m $m
--------------------- --------- --------- ----------- ---------- -------- ------------- --------
At 1 Jan 2014 315 3,983 1,966 16,960 23,224 29 23,253
Profit for the period - - - 1,554 1,554 2 1,556
Other comprehensive
income - - - (928) (928) (7) (935)
Transfer to other
reserves - - 25 (25) - - -
Transactions with
owners:
Dividends - - - (3,532) (3,532) - (3,532)
Issue of Ordinary
Shares 1 262 - - 263 - 263
Share-based payments - - - (136) (136) - (136)
Transfer from
non-controlling
interests to
payables - - - - - (3) (3)
Net movement 1 262 25 (3,067) (2,779) (8) (2,787)
---------------------- --------- --------- ----------- ---------- -------- ------------- --------
At 30 Sep 2014 316 4,245 1,991 13,893 20,445 21 20,466
---------------------- --------- --------- ----------- ---------- -------- ------------- --------
Share Non-
Share premium Other Retained controlling Total
capital account reserves* earnings Total interests equity
$m $m $m $m $m $m $m
--------------------- --------- --------- ----------- ---------- -------- ------------- --------
At 1 Jan 2015 316 4,261 2,021 13,029 19,627 19 19,646
Profit for the period - - - 2,017 2,017 1 2,018
Other comprehensive
income - - - (612) (612) (1) (613)
Transfer to other
reserves - - 14 (14) - - -
Transactions with
owners:
Dividends - - - (3,537) (3,537) - (3,537)
Issue of Ordinary
Shares - 30 - - 30 - 30
Share-based payments - - - (176) (176) - (176)
Net movement - 30 14 (2,322) (2,278) - (2,278)
---------------------- --------- --------- ----------- ---------- -------- ------------- --------
At 30 Sep 2015 316 4,291 2,035 10,707 17,349 19 17,368
---------------------- --------- --------- ----------- ---------- -------- ------------- --------
* Other reserves include the capital redemption reserve and the
merger reserve.
Notes to the Interim Financial Statements
1 BASIS OF PREPARATION AND ACCOUNTING POLICIES
These unaudited condensed consolidated interim financial
statements ("interim financial statements") for the nine months
ended 30 September 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 $419m of income
being reclassified from other operating income to externalisation
revenue for the nine months ended 30 September 2014, and $67m for
the quarter ended 30 September 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 nine months ended 30 September
2015.
Legal proceedings
The information contained in Note 5 updates the disclosures
concerning legal proceedings and contingent liabilities included in
the Group's Annual Report and Form 20-F Information 2014 and
Interim Financial Statements for the six months ended 30 June
2015.
Going concern
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The Group has considerable financial resources available. As at
30 September 2015 the Group has $4.4bn in financial resources (cash
balances of $4.1bn 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.
Comparative figures
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 nine months ended 30 September 2015 is
stated after charging restructuring costs of $662m ($214m for the
third quarter of 2015). These have been charged to profit as
follows:
YTD 2015 YTD 2014 Q3 2015 Q3 2014
$m $m $m $m
------------------------------------------- --------- --------- -------- --------
Cost of sales 124 72 23 48
Research and development expense 180 400 56 210
Selling, general and administrative costs 358 403 135 137
Other operating income and expense - 292 - -
------------------------------------------- --------- --------- -------- --------
Total 662 1,167 214 395
------------------------------------------------ --------- --------- -------- --------
3 Net DEBT
The table below provides an analysis of net debt and a
reconciliation of net cash flow to the movement in net debt.
At 1 Jan Cash Non-cash At 30 Sep
2015 Flow Movements Exchange Movements 2015
$m $m $m $m $m
Loans due after one year (8,337) - 19 82 (8,236)
Finance leases due after one year (60) - 19 1 (40)
----------------------------------- --------- -------- ----------- ------------------- ----------
Total long-term debt (8,397) - 38 83 (8,276)
----------------------------------- --------- -------- ----------- ------------------- ----------
Current instalments of loans (912) 884 - 28 -
Current instalments of finance
leases (48) 40 (57) 2 (63)
----------------------------------- --------- -------- ----------- ------------------- ----------
Total current debt (960) 924 (57) 30 (63)
----------------------------------- --------- -------- ----------- ------------------- ----------
Other investments - current 795 (275) 9 (33) 496
Net derivative financial
instruments 465 41 (22) - 484
Cash and cash equivalents 6,360 (2,205) - (74) 4,081
Overdrafts (196) (102) - 4 (294)
Short-term borrowings (1,290) (1,025) 1 - (2,314)
----------------------------------- --------- -------- ----------- ------------------- ----------
6,134 (3,566) (12) (103) 2,453
--------- -------- ----------- ------------------- ----------
Net debt (3,223) (2,642) (31) 10 (5,886)
----------------------------------- --------- -------- ----------- ------------------- ----------
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
for financial instruments, including fair value measurement, 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 $940m of other investments, $1,175m
of loans, and $484m of derivatives as at 30 September 2015. The
total fair value of interest-bearing loans and borrowings at 30
September 2015, which have a carrying value of $10,947m in the
Condensed Consolidated Statement of Financial Position, was
$12,038m. Contingent consideration liabilities arising on business
combinations have been classified under Level 3 in the fair value
hierarchy and movements in fair value are shown below:
Diabetes Other Total Total
Alliance
2015 2015 2015 2014
$m $m $m $m
At 1 January 5,386 1,513 6,899 514
Additions through business combinations - - - 5,169
Settlements (298) (255) (553) (572)
Revaluations - 58 58 6
Discount unwind 305 90 395 277
Foreign exchange - 2 2 (3)
------------------------------------------- ---------- ------ ------ ------
At 30 September 5,393 1,408 6,801 5,391
------------------------------------------- ---------- ------ ------ ------
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 and Interim
Management Statement 2015 as part of the Company's Half-Yearly
Financial Report for the six-month period to 30 June 2015 (the
Disclosures). Unless noted otherwise below or in the Disclosures,
no provisions have been established in respect of the claims
discussed below.
As discussed in the Disclosures, for the majority of claims in
which AstraZeneca is involved it is not possible to make a
reasonable estimate of the expected financial effect, if any, that
will result from ultimate resolution of the proceedings. In these
cases, AstraZeneca discloses information with respect only to the
nature and facts of the cases but no provision is made.
In cases that have been settled or adjudicated, or where
quantifiable fines and penalties have been assessed and which are
not subject to appeal, or where a loss is probable and we are able
to make a reasonable estimate of the loss, we record the loss
absorbed or make a provision for our best estimate of the expected
loss.
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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 Disclosures and
herein.
AstraZeneca has full confidence in, and will vigorously defend
and enforce, its intellectual property.
Matters disclosed in respect of the third quarter of 2015 to 5
November 2015.
Patent litigation
Brilinta (ticagrelor)
Patent proceedings in the US
In September and October 2015, AstraZeneca received Paragraph IV
notices challenging patents listed in the FDA Orange Book with
reference to Brilinta. AstraZeneca has received notice from 15
companies that each submitted an Abbreviated New Drug Application
(ANDA) seeking to market ticagrelor. In October and November 2015,
in the US District Court for the District of Delaware, AstraZeneca
filed patent infringement lawsuits in response to these Paragraph
IV notices from ANDA filers. Litigation is at an early stage and no
trial dates have been set.
Crestor (rosuvastatin)
Patent proceedings outside the US
As previously disclosed, in April 2014, AstraZeneca received a
writ of summons from Resolution Pharmaceuticals Inc. (Resolution)
alleging partial invalidity and non-infringement of the
supplementary protection certificate (SPC) related to the Crestor
substance patent. In 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 has appealed and the appeal is scheduled to be
heard on 12 November 2015.
In October 2015, in the UK, AstraZeneca received a notice letter
from Resolution Chemicals Ltd. indicating that it has commenced an
action in the UK Patent Courts alleging partial invalidity and
non-infringement of the SPC related to the Crestor substance
patent.
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. In June 2015,
the JPO dismissed Teva's claim. Teva appealed the decision but
subsequently withdrew the appeal.
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. On 2 September 2015, the High Court dismissed AstraZeneca's
appeal.
Faslodex (fulvestrant)
Patent proceedings in the US
As previously disclosed, in June and September 2014 and in
January 2015, AstraZeneca filed patent infringement lawsuits
against Sandoz Inc., 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 seeking FDA approval to market generic
versions of Faslodex prior to the expiration of AstraZeneca's
patents. Also as previously disclosed, in July 2015, AstraZeneca
received a Paragraph IV notice from Agila Specialties Inc. (Agila),
on behalf of Onco Therapies Limited (Onco), which was also seeking
FDA approval to market a generic version of Faslodex prior to the
expiration of the same four patents. In September 2015, AstraZeneca
received a Paragraph IV notice from Mylan Pharmaceuticals, Inc., on
behalf of Mylan Laboratories Limited (collectively, Mylan), after
Agila and Onco assigned their ANDA to Mylan. In September 2015,
AstraZeneca filed patent infringement lawsuits against Agila, Onco,
and Mylan in the US District Court in New Jersey and also against
Mylan in the US District Court in West Virginia relating to all
four Orange Book listed patents. In October 2015, AstraZeneca
received a Paragraph IV notice from Teva Pharmaceuticals USA Inc.,
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
As previously disclosed, in Brazil, in February 2013, Eurofarma
Laboratorios S.A. (Eurofarma) filed a nullity action against a
formulation patent for Faslodex in the 31st Specialized
Intellectual Property Federal Court of Rio de Janeiro. In October
2015, the Court ruled in Eurofarma's favour and invalidated
AstraZeneca's patent. AstraZeneca is considering all available
options, including appeal.
As previously disclosed, in Germany in July 2015, AstraZeneca
was served with a nullity complaint by Hexal AG (Hexal), commencing
invalidity proceedings before the Federal Patent Court, and
requesting the revocation of the German part of the Faslodex
formulation use patent, EP 1,250,138. In September 2015,
AstraZeneca filed a request for a provisional injunction against
Hexal in Regional Court Düsseldorf after Hexal threatened to launch
a generic Faslodex product in the fourth quarter of 2015 which,
following a hearing in October, remains pending.
Movantik (naloxegol)
Patent proceedings in the US
In October 2015, Neptune Generics LLC, an affiliate of Gerchen
Keller Capital LLC, filed for Inter Partes Review (IPR) with the US
Patent Office challenging the validity of one of the six patents
listed in the FDA Orange Book with reference to Movantik. The IPR
relates to US Patent No. 7,786,133, which is licensed to
AstraZeneca from Nektar Therapeutics. AstraZeneca is considering
its response.
Nexium (esomeprazole)
Patent proceedings in the US
In September 2015, AstraZeneca received a Paragraph IV notice
from Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd.
(together Zydus) challenging certain patents listed in the FDA
Orange Book with reference to Nexium oral suspension. Zydus
submitted an ANDA seeking to market esomeprazole magnesium oral
suspension. In October 2015, in response to Zydus' notice,
AstraZeneca filed a patent infringement lawsuit against Zydus in
the US District Court for the District of New Jersey. The
litigation is at an early stage and no trial date has been set.
In October 2015, AstraZeneca received a Paragraph IV notice from
Dr. Reddy's Laboratories Ltd. and Dr. Reddy's Laboratories, Inc.
(together DRL) challenging certain patents listed in the FDA Orange
Book with reference to Nexium 24HR (OTC). DRL has submitted an ANDA
seeking to market OTC esomeprazole magnesium capsules. AstraZeneca
is reviewing DRL's notice.
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.
AstraZeneca has sought leave to appeal to the Supreme Court of
Canada.
Onglyza (saxagliptin) and Kombiglyze (saxagliptin and
metformin)
Patent proceedings in the US
As previously disclosed, AstraZeneca filed lawsuits against a
number of generics companies who sent notices that they had
submitted ANDAs alleging that patents listed in the FDA Orange Book
with reference to Onglyza and Kombiglyze, are invalid,
unenforceable and/or will not be infringed by the products as
described in the ANDAs. In August 2015, Teva Pharmaceuticals USA,
Inc. sent a Paragraph IV certification with respect to the
formulation patent, US Patent No. 8,628,799, on Kombiglyze and in
October 2015 AstraZeneca filed a lawsuit in the US District Court
for the District of Delaware.
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 (the '834 Patent)
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 to recover under those injunctions have
been filed and a provision has been taken.
Seroquel XR (quetiapine fumarate)
Patent proceedings outside the US
As previously disclosed, in Germany, Ratiopharm GmbH, CT
Arzneimittel GmbH and AbZ Pharma GmbH brought a claim for damages
relating to the preliminary injunction issued in April 2012 that
prevented generic Seroquel XR sales by those entities until the
injunction was lifted following a November 2012 Federal Patent
Court decision that held that the Seroquel XR patent was invalid.
That claim has now been settled. AstraZeneca had taken a reserve in
relation to this matter.
In April 2015, Mylan SAS (Mylan) brought a patent invalidation
action against AstraZeneca's French designation of the Seroquel XR
formulation patent, European Patent No. 0 907 364 (the '364
Patent). AstraZeneca is defending that action and has brought a
claim against Mylan for infringement of the '364 Patent. In the
third quarter of 2015, Mylan launched its generic Seroquel XR
product at-risk. As previously disclosed, in July 2014, AstraZeneca
has a similar action pending with Accord Healthcare France SAS and
Accord Healthcare Limited (together, Accord), wherein Accord
asserts that the '364 Patent is invalid. AstraZeneca is defending
against that claim and claims patent infringement.
Product liability litigation
Onglyza (saxagliptin)
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As previously disclosed, in 2014, Amylin Pharmaceuticals, LLC, a
wholly owned subsidiary of AstraZeneca, and/or AstraZeneca are
among multiple defendants in various lawsuits filed in federal and
state courts in the US involving plaintiffs claiming injuries,
including pancreatic cancer. AstraZeneca was recently served with a
case, claiming congestive heart failure, from treatment with
Onglyza.
Commercial litigation
Nexium settlement anti-trust litigation
As previously disclosed, a jury returned a verdict in favour of
AstraZeneca in a Multi-District Litigation class action and
individual lawsuits alleging that AstraZeneca's settlements of
certain patent litigation in the US relating to Nexium violated US
anti-trust law and various state laws. In July 2015, the Court
denied the plaintiffs' motions for a new trial and preliminary
injunction. In September 2015, the Court entered judgment in favour
of AstraZeneca. Plaintiffs have appealed the judgment.
Nexium/Prilosec trademark litigation
In October 2015, AstraZeneca filed separate complaints in the US
Federal District Court in Delaware against Camber Pharmaceuticals,
Inc. (Camber) and Dr. Reddy's Laboratories, Inc. (Dr. Reddy's) to
enforce certain AstraZeneca trademark rights related to Nexium and
Prilosec. The Court has issued a temporary restraining order
against Camber's sales of generic esomeprazole magnesium in purple
capsules and is yet to consider the case against Dr. Reddy's.
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 Illinois State Court
and, as previously disclosed, trial began in August 2015. In
September 2015, a jury returned a verdict in favour of AbbVie and
awarded AbbVie damages in the amount of approximately $93.8m.
MedImmune intends to appeal the jury's verdict.
Government investigations/proceedings
Crestor (rosuvastatin calcium)
As previously disclosed, the DOJ and all US states have declined
to intervene in the civil component of an investigation regarding
Crestor. Prior to September 2015, one additional component of the
investigation remained. In September 2015, AstraZeneca was informed
that the additional component of the investigation has been
closed.
Seroquel IR and Seroquel XR (quetiapine fumarate) Qui Tam
litigation
AstraZeneca has been named as a defendant in a lawsuit filed in
US Federal Court in New York under the qui tam (whistleblower)
provisions of the federal and certain state False Claims Acts. The
lawsuit alleges that the Company misrepresented the safety profile
of and improperly promoted Seroquel IR and Seroquel XR. The US
government and the named states have declined to intervene in this
case.
Other government investigations/proceedings
Foreign Corrupt Practices Act
As previously disclosed, in connection with investigations into
anti-bribery and corruption issues in the pharmaceutical industry,
AstraZeneca has received inquiries from enforcement agencies,
including the DOJ and the Securities and Exchange Committee,
regarding, among other things, sales practices, internal controls,
certain distributors and interactions with healthcare providers and
other government officials in several countries. AstraZeneca is
cooperating with these inquiries. AstraZeneca's investigation has
involved indications of inappropriate conduct in certain countries,
including China. Resolution of these matters could involve the
payment of fines and/or other remedies.
6 product analysis - YTD 2015
World US Europe Established ROW Emerging Markets
-------------------- -------------------- -------------------- -------------------- -------------------- -------------------
YTD 2015 CER YTD 2015 CER YTD 2015 CER YTD 2015 CER YTD 2015 CER
$m % $m % $m % $m % $m %
-------------------- --------- ----- --------- ----- --------- ----- --------- ----- --------- ----
Respiratory,
Inflammation &
Autoimmunity:
Symbicort 2,535 (2) 1,110 (1) 825 (13) 304 5 296 33
Pulmicort 740 17 148 (5) 88 (10) 61 3 443 40
Tudorza/Eklira 143 n/m 77 n/m 57 n/m 7 n/m 2 n/m
Daliresp 72 n/m 72 n/m - n/m - n/m - n/m
Duaklir 15 n/m - - 14 n/m 1 n/m - -
Others 193 (5) 12 (45) 66 (6) 18 (5) 97 4
------------------------- --------- ----- --------- ----- --------- ----- --------- ----- --------- ----
Total Respiratory,
Inflammation &
Autoimmunity 3,698 8 1,419 10 1,050 (5) 391 6 838 32
------------------------- --------- ----- --------- ----- --------- ----- --------- ----- --------- ----
Cardiovascular &
Metabolic disease:
Brilinta/Brilique 445 44 170 65 170 19 27 33 78 93
Onglyza 594 2 322 (15) 108 17 48 29 116 47
Bydureon 425 38 360 33 56 69 6 75 3 33
Farxiga/Forxiga 340 180 184 167 89 159 22 160 45 350
Byetta 244 (1) 166 4 45 (15) 15 (15) 18 24
Legacy:
Crestor 3,695 (4) 2,067 (4) 691 (9) 417 (3) 520 2
Seloken/Toprol-XL 550 4 70 (8) 73 (4) 9 (27) 398 10
Atacand 272 (15) 27 (18) 80 (28) 21 (29) 144 (3)
Others 464 (10) 41 (33) 108 (15) 44 (19) 271 (1)
------------------------- --------- ----- --------- ----- --------- ----- --------- ----- --------- ----
Total Cardiovascular &
Metabolic Disease 7,029 3 3,407 3 1,420 (1) 609 (1) 1,593 11
------------------------- --------- ----- --------- ----- --------- ----- --------- ----- --------- ----
Oncology:
Iressa 414 (2) 2 n/m 96 (6) 102 (11) 214 6
Lynparza 58 n/m 46 n/m 12 n/m - - - -
Legacy:
Zoladex 618 8 22 22 128 (13) 202 (1) 266 29
Faslodex 519 7 261 4 154 - 39 5 65 46
Casodex 204 (6) 1 (80) 23 (13) 98 (11) 82 10
Arimidex 190 (7) 15 25 37 (27) 59 (15) 79 13
Others 106 18 19 (5) 22 4 44 59 21 -
------------------------- --------- ----- --------- ----- --------- ----- --------- ----- --------- ----
Total Oncology 2,109 6 366 20 472 (6) 544 (3) 727 19
------------------------- --------- ----- --------- ----- --------- ----- --------- ----- --------- ----
Infection,
Neuroscience &
Gastrointestinal:
Nexium 1,932 (26) 727 (48) 209 (10) 411 (4) 585 -
Seroquel XR 784 (9) 540 - 160 (28) 20 (32) 64 3
Synagis 387 (22) 157 (41) 230 - - - - -
Losec/Prilosec 263 (6) 18 (5) 71 (13) 55 (19) 119 10
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FluMist/Fluenz 97 (39) 88 (38) 9 (38) - n/m - -
Movantik/Moventig 14 n/m 13 n/m 1 n/m - - - -
Others 1,121 (6) 167 (13) 280 (15) 206 2 468 (1)
------------------------- --------- ----- --------- ----- --------- ----- --------- ----- --------- ----
Total Infection,
Neuroscience &
Gastrointestinal 4,598 (18) 1,710 (33) 960 (14) 692 (5) 1,236 -
------------------------- --------- ----- --------- ----- --------- ----- --------- ----- --------- ----
TOTAL PRODUCT SALES 17,434 (2) 6,902 (8) 3,902 (6) 2,236 (2) 4,394 12
------------------------- --------- ----- --------- ----- --------- ----- --------- ----- --------- ----
7 product Sales analysis - Q3 2015
World US Europe Established ROW Emerging Markets
-------------------- ------------------- -------------------- ------------------- ------------------- -------------------
Q3 2015 CER Q3 2015 CER Q3 2015 CER Q3 2015 CER Q3 2015 CER
$m % $m % $m % $m % $m %
-------------------- -------- ----- -------- ------ -------- ----- -------- ----- -------- -----
Respiratory,
Inflammation &
Autoimmunity:
Symbicort 848 (4) 393 (1) 243 (21) 103 (2) 109 42
Pulmicort 222 16 40 (22) 22 (19) 20 14 140 46
Tudorza/Eklira 58 n/m 32 n/m 21 n/m 3 n/m 2 n/m
Daliresp 33 n/m 33 n/m - n/m - n/m - n/m
Duaklir 8 n/m - n/m 8 n/m - n/m - n/m
Others 61 (6) 2 (60) 20 (4) 8 (10) 31 3
------------------------- -------- ----- -------- ------ -------- ----- -------- ----- -------- -----
Total Respiratory,
Inflammation &
Autoimmunity 1,230 7 500 11 314 (11) 134 3 282 38
------------------------- -------- ----- -------- ------ -------- ----- -------- ----- -------- -----
Cardiovascular &
Metabolic disease:
Brilinta/Brilique 170 48 69 73 60 16 10 30 31 119
Onglyza 203 - 111 (15) 37 7 16 27 39 32
Bydureon 162 34 138 29 21 67 3 200 - (50)
Farxiga/Forxiga 135 107 69 60 36 110 11 n/m 19 213
Byetta 72 (17) 45 (18) 15 (19) 5 (38) 7 13
Legacy:
Crestor 1,218 (3) 693 2 222 (13) 135 (2) 168 (4)
Seloken/Toprol-XL 172 (2) 22 (4) 24 (6) 2 (40) 124 1
Atacand 78 (24) 9 (31) 27 (14) 6 (42) 36 (26)
Others 137 (23) 6 (75) 33 (19) 14 (15) 84 (14)
------------------------- -------- ----- -------- ------ -------- ----- -------- ----- -------- -----
Total Cardiovascular &
Metabolic Disease 2,347 2 1,162 4 475 (2) 202 2 508 2
------------------------- -------- ----- -------- ------ -------- ----- -------- ----- -------- -----
Oncology:
Iressa 141 1 2 n/m 30 (10) 34 (11) 75 13
Lynparza 28 n/m 20 n/m 8 n/m - - - -
Legacy:
Zoladex 209 8 8 14 43 (9) 69 - 89 24
Faslodex 186 11 96 8 53 (2) 14 6 23 78
Casodex 65 (6) - (100) 8 - 32 (5) 25 (4)
Arimidex 64 (1) 8 167 12 (26) 19 (15) 25 12
Others 35 11 6 (14) 7 (11) 15 31 7 25
------------------------- -------- ----- -------- ------ -------- ----- -------- ----- -------- -----
Total Oncology 728 9 140 30 161 (4) 183 (3) 244 20
------------------------- -------- ----- -------- ------ -------- ----- -------- ----- -------- -----
Infection,
Neuroscience &
Gastrointestinal:
Nexium 641 (24) 248 (47) 66 (8) 139 1 188 1
Seroquel XR 258 (14) 187 (4) 47 (34) 6 (36) 18 (12)
Synagis 117 (3) (3) (150) 120 5 - - - n/m
Losec/Prilosec 82 (5) 6 - 23 (16) 16 (23) 37 18
FluMist/Fluenz 76 (48) 67 (50) 9 (38) - - - -
Movantik/Moventig 10 n/m 9 n/m 1 n/m - n/m - n/m
Others 361 (2) 61 36 85 (20) 65 7 150 (2)
------------------------- -------- ----- -------- ------ -------- ----- -------- ----- -------- -----
Total Infection,
Neuroscience &
Gastrointestinal 1,545 (17) 575 (33) 351 (14) 226 (1) 393 -
------------------------- -------- ----- -------- ------ -------- ----- -------- ----- -------- -----
TOTAL PRODUCT SALES 5,850 (2) 2,377 (6) 1,301 (8) 745 - 1,427 10
------------------------- -------- ----- -------- ------ -------- ----- -------- ----- -------- -----
Shareholder Information
Announcements and Meetings
Announcement of full year and fourth quarter results 4 February 2016
Announcement of first quarter 2016 results 29 April 2016
Annual General Meeting 29 April 2016
Announcement of half year and second quarter 2016 results 28 July 2016
Announcement of nine months and third quarter 2016 results 10 November 2016
Dividends
==============================================================================
Future dividends will normally be paid as follows:
First interim Announced with half year and second quarter results
and paid in September
Second interim Announced with full year and fourth quarter results
and paid in March
The record date for the second interim dividend for 2015,
payable on 21 March 2016, will be 19 February 2016. Ordinary Shares
listed in London and Stockholm will trade ex-dividend from 18
February 2016. American Depositary Shares listed in New York will
trade ex-dividend from 17 February 2016.
The record date for the first interim dividend for 2016, payable
on 12 September 2016, will be 12 August 2016. Ordinary Shares
listed in London and Stockholm will trade ex-dividend from 11
August 2016. American Depositary Shares listed in New York will
trade ex-dividend from 10 August 2016.
Trademarks
===========
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