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SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
Report of Foreign
Issuer
Pursuant to Rule
13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For
July 2008
Commission File
Number: 001-11960
AstraZeneca
PLC
15 Stanhope Gate,
London W1K 1LN, England
Indicate by check
mark whether the registrant files or will file annual reports under cover of
Form 20-F or Form 40-F.
Form 20-F X
Form
40-F __
Indicate by check
mark if the registrant is submitting the Form 6-K in paper as permitted by
Regulation S-T Rule 101(b)(1):
Indicate by check
mark if the registrant is submitting the Form 6-K in paper as permitted by
Regulation S-T Rule 101(b)(7): ______
Indicate by check
mark whether the registrant by furnishing the information contained in this Form
is also thereby furnishing the information to the Commission pursuant to Rule
12g3-2(b) under the Securities Exchange Act of 1934.
Yes __ No
X
If
“Yes” is marked, indicate below the file number assigned to the Registrant in
connection with Rule 12g3-2(b): 82-_____________
AstraZeneca
PLC
INDEX TO
EXHIBITS
1.
Press release
entitled, “Summary Judgment Granted for Seroquel Patent Litigation in the
US”, dated 2 July 2008.
2.
Press release
entitled, “AstraZeneca releases final terms in relation to EUR 500 million
eurobond”, dated 9 July 2008.
3.
Press release
entitled, “AstraZeneca and Bristol-Myers Squibb Submit New Drug
Application in the United States and Marketing Authorisation Application
in Europe for ONGLYZA™ (Saxagliptin) for the Treatment of Type 2
Diabetes”, dated 23 July 2008.
4.
Press release
entitled, “AstraZeneca second quarter and half year results 2008”, dated
30 July 2008.
5.
Press release
entitled, “AstraZeneca PLC Second Quarter and First Half Results 2008”
(front half), dated 31 July 2008.
6.
Press release
entitled, “AstraZeneca PLC Second Quarter and First Half Results 2008
Responsibility Statement of the Directors in Respect of the Half-Yearly
Financial Report” (back half), dated 31 July
2008.
7.
Press release
entitled, “Transparency Directive Voting Rights and Capital”, dated 31
July 2008.
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
AstraZeneca
PLC
Date: 04
August 2008
By:
/s/ Justin
Hoskins
Name:
Justin
Hoskins
Title:
Deputy
Company Secretary
Item
1
SUMMARY
JUDGMENT GRANTED FOR SEROQUEL PATENT LITIGATION IN THE US
AstraZeneca today
announced that the US District Court for the District of New Jersey has granted
the company's Motion for Summary Judgment of No Inequitable
Conduct. AstraZeneca had sued Teva Pharmaceutical Industries Ltd. and
Sandoz, Inc. alleging infringement of AstraZeneca's patent as a result of Teva's
and Sandoz's filings of Abbreviated New Drug Applications (ANDAs). The ANDAs
sought approval to market generic versions of SEROQUEL (quetiapine fumarate)
tablets in the US before SEROQUEL's patent expires in 2011. Since the
Court granted AstraZeneca's motion for Summary Judgment of No Inequitable
Conduct in its entirety, trial is unnecessary.
"We are pleased with
the Court’s decision to uphold our valid intellectual property. SEROQUEL remains
an important part of our company's portfolio benefiting patients and physicians
throughout the world," said David Brennan, CEO of AstraZeneca.
AstraZeneca's Motion
for Summary Judgment of No Inequitable Conduct sought judgment on all of the
remaining liability issues in the case. Teva and Sandoz had already conceded
infringement and the validity of AstraZeneca's patent. Thus, only the
inequitable conduct contentions remained to be resolved. The Court
had previously set a date for trial beginning on 11 August 2008.
2
July 2008
About AstraZeneca
AstraZeneca is a major international
healthcare business engaged in the research, development, manufacture and
marketing of prescription pharmaceuticals and the supply of healthcare services.
It is one of the world's leading pharmaceutical companies with healthcare sales
of $29.55 billion and leading positions in sales of gastrointestinal,
cardiovascular, neuroscience, respiratory, oncology and infection products.
AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as
the FTSE4Good Index.
For more information about AstraZeneca
please visit: www.astrazeneca.com
For further
information:
Media Enquiries:
Neil McCrae, +44 207 304 5045 (24
hours)
Steve Brown, +44 207 304 5033 (24
hours)
Chris Sampson, +44 207 304 5130 (24
hours
Investor Enquiries:
Jonathan Hunt, +44 207 304
5087
Ed Seage, +1 302 886
4065
Karl Hard, +44 207 304
5322
Jorgen Winroth, +1 212 579
0506
Mina Blair, +44 20 7304
5084
Peter Vozzo, (MedImmune) +1 301 398
4358
Item 2
Not
for release, publication or distribution directly or indirectly in or into the
United States, Canada, Australia or Japan
AstraZeneca
releases final terms in relation to EUR 500 million eurobond
Following the
pricing of the EUR 500 million eurobond transaction on 30 June 2008, AstraZeneca
PLC, rated A1 (stable) by Moody's and AA- (stable) by Standard & Poor's,
releases the final terms of the transaction.
To
view the final terms, please click on the attached link.
[●]
9
July 2008
Media
Enquiries:
Steve
Brown
+44 207 304 5033 (24
hours)
Chris
Sampson
+44 20
7304 5130 (24 hours)
Neil
McCrae
+44 207
304 5045 (24 hours)
Investor
Enquiries UK:
Jonathan
Hunt
+44 207
304 5087
mob: +44
7775 704032
Mina
Blair
+44 207
304 5084
mob: +44
7718 581021
Karl
Hard
+44 207
304 5322
mob: +44
7789 654364
Investor
Enquiries US:
Ed
Seage
+1 302
886 4065
mob: +1
302 373 1361
Jorgen
Winroth
+1 212
579 0506
mob: +1
917 612 4043
Peter
Vozzo (MedImmune)
+1 301
398 4358
mob: +1
301 252 7518
About
AstraZeneca
AstraZeneca is a
major international healthcare business engaged in research, development,
manufacturing and marketing of prescription pharmaceuticals and supplier for
healthcare services. AstraZeneca is one of the world's leading pharmaceutical
companies with healthcare sales of US $29.55 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infection product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index. For more Information visit www.astrazeneca.com
About
the announcement
This announcement is
for information only and does not constitute an offer or invitation to subscribe
for or purchase any securities.
The securities have
not been, nor will they be, registered under the U.S. Securities Act of 1933, as
amended (the "Securities Act"), and no securities shall be offered or sold in
the United States or to U.S. persons (as those terms are defined in Regulation
S under the
Securities Act) absent registration or an applicable exemption from the
registration requirements of the Securities Act. There will be no
public offering of the securities in the United States in connection with this
transaction.
-
Ends -
Item 3
AstraZeneca
and Bristol-Myers Squibb Submit New Drug Application in the United States and
Marketing Authorisation Application in Europe for ONGLYZA™ (Saxagliptin) for the
Treatment of Type 2 Diabetes
AstraZeneca and
Bristol-Myers Squibb Company today announced the submission of a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA) on June 30th and
validation of a Marketing Authorisation Application (MAA) to the European
Medicines Agency (EMEA) for ONGLYZA™ (saxagliptin). Saxagliptin, a dipeptidyl
peptidase-4 (DPP-4) enzyme inhibitor, is an investigational drug under joint
development by AstraZeneca and Bristol-Myers Squibb for the treatment of type 2
diabetes. The companies have proposed the name ONGLYZA which, if
approved by the FDA and the EMEA, will serve as the trade name for
saxagliptin.
The NDA and MAA
submissions for saxagliptin are based on data from a comprehensive clinical
trial program conducted in addition to standard therapies, as well as in
treatment naïve patients as a monotherapy. The clinical trial program included
studies that evaluated the drug at up to 80 times therapeutic clinical
doses. The six
core Phase III trials assessing the safety and efficacy of saxagliptin involved more than 4,000
patients, including 3,000 who were treated with saxagliptin.
About
ONGLYZA™ (saxagliptin)
ONGLYZA™
(saxagliptin), a DPP-4 inhibitor, is an investigational drug under joint
development by AstraZeneca and Bristol-Myers Squibb for the treatment of type 2
diabetes. Saxagliptin is being studied in clinical trials as a once-daily
therapy to determine its efficacy and safety. Saxagliptin was
specifically designed to be a selective, reversible inhibitor of the DPP-4
enzyme, with dual routes of clearance. Phase III data for saxagliptin
have previously been presented in combination with metformin, the most commonly
prescribed oral anti-diabetic, as well as when used as monotherapy in
treatment-naïve individuals. Additional Phase III data for
saxagliptin, including when added to a sulfonylurea, a thiazolidinedione and as
initial combination therapy with metformin, are planned for disclosure later
this year.
About
DPP-4 Inhibitors
DPP-4 inhibitors are
a class of compounds that work by affecting the action of natural hormones in
the body called incretins. Incretins decrease elevated blood sugar levels
(glucose) by increasing the body’s utilisation of sugar, mainly through
increasing insulin production in the pancreas, and by reducing the liver’s
production of glucose.
About
Type 2 Diabetes
Diabetes (diabetes
mellitus) is a chronic disease in which the body does not produce or properly
use insulin. Insulin is a hormone that is needed to convert sugar, starches
(carbohydrates) and other nutrients into energy needed for daily life. The cause
of diabetes continues to be investigated, and both genetic and environmental
factors such as obesity and lack of exercise appear to play a role.
Diabetes is associated with long-term complications that affect almost every
part of the body. The disease may lead to blindness, heart and blood vessel
disease, stroke, kidney failure, amputations, and nerve damage.
AstraZeneca
and Bristol-Myers Squibb Collaboration
AstraZeneca and
Bristol-Myers Squibb entered into a collaboration in January 2007 to enable the
companies to research, develop and commercialise two investigational drugs for
type 2 diabetes – saxagliptin and dapagliflozin. The
AstraZeneca/Bristol-
Myers Squibb
Diabetes collaboration is dedicated to global patient care, improving patient
outcomes and creating a new vision for the treatment of type 2
diabetes.
About
Bristol-Myers Squibb
Bristol-Myers Squibb
is a global biopharmaceutical company whose mission is to extend and enhance
human life.
About
AstraZeneca
AstraZeneca is a
major international healthcare business engaged in research, development,
manufacturing and marketing of prescription pharmaceuticals and supplier for
healthcare services. AstraZeneca is one of the world's leading pharmaceutical
companies with healthcare sales of US $29.55 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infection product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index. For more information visit www.astrazeneca.com
ONGLYZA™
(saxagliptin) is a trademark of the Bristol-Myers Squibb
Company
23
July 2008
AstraZeneca
contacts:
Media
Enquiries:
Steve
Brown
+44 207 304 5033 (24
hours)
Chris
Sampson
+44 20
7304 5130 (24 hours)
Neil
McCrae
+44 207
304 5045 (24 hours)
Jim
Minnick
+1 302
886 5135
Investor
Enquiries UK:
Jonathan
Hunt
+44 207
304 5087
mob: +44
7775 704032
Mina
Blair
+44 207
304 5084
mob: +44
7718 581021
Karl
Hard
+44 207
304 5322
mob: +44
7789 654364
Investor
Enquiries US:
Ed
Seage
+1 302
886 4065
mob: +1
302 373 1361
Jorgen
Winroth
+1 212
579 0506
mob: +1
917 612 4043
Peter
Vozzo (MedImmune)
+1 301
398 4358
mob: +1
301 252 7518
Bristol-Myers
Squibb contacts:
Media
enquiries
David M. Rosen: +1
609-252-5675
david.rosen@bms.com
Investors
John Elicker: +1
212-546-3775
john.elicker@bms.com
–
Ends –
Item 4
AstraZeneca second quarter
and half year results 2008
Tomorrow, Thursday,
31 July 2008 AstraZeneca will be releasing its second quarter and half year
results for 2008 at 11:00bst.
An analysts
presentation of the second quarter and half year results will take place at
13:00bst and will be accessible by a choice of two routes:
1) Audio webcast
(available at www.astrazeneca.com). You
will be able to email questions to the presenters during the Q&A
session.
2) Teleconference
with Q&A. Dial in numbers are in the UK: 0800 559 3272, Sweden:
0200 887 737, International: +44 (0)20 7138 0814 and for the US: 1 866 239
0753. Printable pdf versions of slides will be available to download
on the AstraZeneca Investor Relations website (www.astrazeneca.com/node/investor.aspx) 15
minutes before the analysts presentation begins.
Details of the
teleconference and webcast replay facilities are available on the Investor
Relations part of the AstraZeneca website at www.astrazeneca.com.
Item 5
AstraZeneca
PLC
Second
Quarter and First Half Results 2008
-
Solid
performance with sustained progress on the key
priorities.
-First half sales
increased by 3 percent at constant exchange rates (CER). Core EPS
increased by 3 percent at CER to $2.53.
-Second quarter sales
increased by 2 percent at CER. Core EPS down 4 percent at CER to $1.25 on higher
net interest expense.
-Second quarter sales
in Emerging Markets increased by 20 percent at CER and exceeded $1 billion for
the first time in a quarter.
-Core EPS target for
the full year increased by $0.15 to reflect good operational and financial
performance and further currency benefits realised in the year to date*. Revised
target range for Core EPS is $4.60 to $4.90.
-
Continued
progress on strengthening and balancing the
pipeline.
-Two new Phase III
progressions increase late stage development pipeline to twelve projects now in
Phase III/registration.
-Second major
regulatory filing in 2008 accomplished. ONGLYZATM
(saxagliptin) submitted for regulatory approval in US and European Union for the
treatment of type 2 diabetes.
-
Summary
Judgement ruling in US upholds valid intellectual property for Seroquel.
-
The
Board has recommended a first interim dividend of
$0.55.
Financial
Summary
Group
2nd
Quarter
2008
$m
2nd
Quarter
2007
$m
Actual
%
CER
%
Half
Year
2008
$m
Half
Year
2007
$m
Actual
%
CER
%
Sales
7,956
7,273
+9
+2
15,633
14,239
+10
+3
Reported
Operating
Profit
2,473
1,973
+25
+12
4,730
4,143
+14
+3
Profit
before Tax
2,279
1,991
+14
+1
4,422
4,258
+4
-7
Earnings
per Share
$1.11
$0.95
+17
+4
$2.14**
$1.97
+9
-3
Core***
Operating
Profit
2,737
2,409
+14
+3
5,502
4,683
+17
+7
Profit
before Tax
2,543
2,427
+5
-6
5,194
4,798
+8
-2
Earnings
per Share
$1.25
$1.17
+7
-4
$2.53
$2.24
+13
+3
*
For
the second half of 2008 guidance is based on original assumptions for
currency: fourth quarter 2007 average rates.
**
Included
in Reported EPS for Half Year 2008 is a $0.12 charge taken in Q1 08 for
impairment of intangible assets related to Ethyol.
***
Core
financial measures are supplemental non-IFRS measures which management
believe useful to understanding the Company’s performance; it is upon
these measures that financial guidance for 2008 is based. See
pages 8 and 9 for a reconciliation of Core to Reported financial
measures.
David Brennan, Chief
Executive Officer, said: “During the first half of 2008
AstraZeneca has made good progress on three fronts: performance, pipeline and
patents. The business is on track to achieve our increased financial target for
the year and we continue to strengthen the pipeline. In addition, we
have mitigated the biggest near-term financial risks with the Nexium patent settlement and
the successful Summary Judgement Motion for Seroquel.”
London, 31 July
2008
AstraZeneca PLC
Business
Highlights All narrative in this section refers
to growth rates at constant exchange rates (CER) unless otherwise
indicated
Second
Quarter
Sales in the second
quarter increased by 2 percent at CER, or 9 percent on an as reported
basis. Sales in the US were down 4 percent as a result of the decline
in Toprol-XL sales due
to generic competition. Excluding Toprol-XL, sales growth in
the US was 4 percent. Sales in the Rest of World were up 7
percent. Sales in Established Markets were up 2 percent, which
included double-digit sales growth in Japan. Sales in Emerging Markets increased
by 20 percent.
Core operating
profit in the second quarter was up 3 percent to $2,737 million, as improvement
in Core gross margin and efficiencies in R&D were partially offset by the
impact of higher SG&A costs in the quarter and lower other income compared
to second quarter last year. Reported operating profit increased by
12 percent to $2,473 million as a result of lower restructuring and synergy
costs compared to the second quarter 2007.
Core earnings per
share in the second quarter were $1.25 compared with $1.17 in the second quarter
2007, 4 percent lower at CER, as the increase in Core operating profit and the
benefit of a lower number of shares outstanding was more than offset by higher
net interest expense. Reported earnings per share in the second
quarter were $1.11, an increase of 4 percent.
First
Half
Sales in the first
half increased by 3 percent at CER, or 10 percent on an as reported
basis. Sales in the US were unchanged, as the inclusion of MedImmune
sales offset the decline in Toprol-XL sales in the
US. Sales in the Rest of World were up 5 percent. Sales in
Established Markets were up 2 percent, with sales in Western Europe
unchanged. Sales in Emerging Markets were up 16 percent.
Core operating
profit increased 7 percent to $5,502 million as a result of improvements in
gross margin and R&D efficiencies partially offset by lower other operating
income and slightly higher SG&A costs. Reported operating profit
was $4,730 million, up 3 percent, as the benefit arising from lower
restructuring and synergy costs in the current period was partially offset by a
full half-year of MedImmune amortisation expense and the Ethyol impairment charge in
the first quarter 2008.
Core earnings per
share in the first half were $2.53, an increase of 3
percent. Reported earnings per share in the first half were $2.14, a
decrease of 3 percent.
Research and Development
Update
On 23 July 2008,
AstraZeneca and Bristol-Myers Squibb announced that the regulatory submissions
have been made in the US and the European Union for ONGLYZATM
(saxagliptin), a new compound for the treatment of type 2
diabetes. The EU submission was 15 months earlier than originally
planned.
The ONGLYZATM filing
is the second of three submissions for new chemical entities that were planned
for this year. The third filing, for the investigational cancer
treatment Zactima, is
now expected to occur in the first half of next year, as a result of a slow down
in event rates in the clinical trials that support the
registration.
Since the beginning
of 2008 the late stage pipeline has expanded by a further two projects, bringing
the total number of projects in Phase III/registration to twelve:
·
Based on a
successful Phase IIb proof of concept programme, the decision has been
taken to progress the oral direct thrombin inhibitor AZD0837 into Phase
III development for the prevention of stroke in patients with atrial
fibrillation.
·
A Phase III
trial for the heat shock protein 90 (Hsp90) inhibitor MEDI-561/IPI-504 for
the orphan indication of treatment of patients with refractory
gastrointestinal stromal tumours (GIST) is planned to commence in the
third quarter. This compound is being jointly developed by AstraZeneca and
Infinity Pharmaceuticals, Inc.
The AstraZeneca
pipeline now includes 143 projects, including 100 projects in the clinical phase
of development. Since the last update on 31 January 2008, 20 projects
have progressed to their next phase (including 7 molecules entering first human
testing); 15 compounds have been added from Discovery Research; 3 compounds have
been withdrawn.
2
AstraZeneca PLC
Continued progress
has been made in advancing important life cycle management programmes across the
portfolio:
·
The US
submission for Seroquel
XR for use in generalised anxiety disorder was made during the
second quarter. The EU filing is on track for submission in the
fourth quarter 2008.
·
Supplemental
NDAs (sNDA) were submitted in the US for Symbicort use in COPD
and for paediatric asthma in April and June 2008,
respectively.
·
In May 2008,
an sNDA was submitted to the US FDA for Nexium I.V. for
injection, seeking approval for use in patients with peptic ulcer bleeding
following therapeutic endoscopy. This was followed by a
Marketing Authorisation Application (MAA) submission in the European Union
in June, with Sweden as Reference Member State.
·
In May 2008,
an MAA was submitted to the European Medicines Agency seeking approval for
Iressa as a
treatment for locally advanced or metastatic non-small cell lung cancer
(NSCLC) in patients who have been pre-treated with platinum-containing
chemotherapy.
·
The Phase III
Iressa Pan-Asian
Study (IPASS) exceeded its primary objective and demonstrated superior
progression-free survival for Iressa compared to
intravenous carboplatin/paclitaxel chemotherapy. In addition,
Iressa
demonstrated a more favourable tolerability profile. IPASS was
an open-label, randomised parallel-group study which enrolled 1,217
clinically selected Asian patients with advanced NSCLC who had not
received prior chemotherapy, whose tumours had adenocarcinoma histology
and who had either never smoked, or were long-term
ex-smokers. The study data are still being analysed and more
detailed study results will be presented at a forthcoming medical
congress.
An updated R&D
pipeline table has been issued in conjunction with the publication of this press
release. A copy of this table is available on the Company’s website,
www.astrazeneca.com,
under information for investors.
Enhancing
Productivity
In the second
quarter a further $131 million in restructuring and synergy costs associated
with the Company wide programme to reshape the cost base were charged to the
accounts. This brings the cumulative charges since the inception of
the programme to $1,214 million.
The Company remains
on track to deliver two-thirds of the total programme benefits of $1.4 billion
per annum by the end of this year, with the full savings to be realised by
2010.
Future
Prospects
The Company has
increased its target range for Core earnings per share for the full year by
$0.15. Approximately half of the increase reflects the operational and financial
performance of the business in the first half and the outlook for the remainder
of the year; the balance reflects additional currency benefits realised in the
second quarter relative to the currency assumptions upon which the targets were
based (i.e. fourth quarter 2007 average exchange rates).
For the remainder of
2008, guidance is based on original assumptions for currency, being fourth
quarter 2007 average exchange rates. The new target range is between
$4.60 to $4.90 per share.
This revised target
takes no account of the likelihood that average exchange rates for the remainder
of 2008 may differ from the fourth quarter 2007 average rates upon which our
guidance is based. The Company’s estimate of the sales and earnings sensitivity
to movements of our major currencies versus the US dollar was provided in
conjunction with the full year 2007 results announcement, and remains available
on the AstraZeneca website.
It
is not anticipated that the nature of the principal risks and uncertainties that
affect the business, and which are set out on pages 193 - 199 of the Annual
Report and Form 20-F Information 2007, will change in respect of the second six
months of the financial year.
3
AstraZeneca
PLC
Sales
All
narrative in this section refers to growth rates at constant exchange rates
(CER) unless otherwise indicated
Gastrointestinal
Second
Quarter
CER
%
Half
Year
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
Nexium
1,323
1,312
-4
2,561
2,620
-7
Losec/Prilosec
290
298
-13
542
577
-15
Total
1,634
1,630
-6
3,144
3,237
-8
·
In the US,
Nexium sales in
the second quarter were $754 million, a 12 percent decline compared with
last year. Volumes were up 11 percent, chiefly on growth in
lower priced non-retail channels. Dispensed retail tablet volume grew by
0.4 percent. The back-loaded phasing of lower price realisation
over the course of last year will continue to give rise to significant
negative price variances this year until the fourth quarter.
·
Nexium sales in the US
in the first half were down 13 percent to $1,490 million.
·
Nexium sales in other
markets in the second quarter were up 11 percent to $569
million. Sales growth of 36 percent in Emerging Markets was the
key performance driver.
·
Nexium sales in other
markets were up 6 percent in the first half to $1,071
million.
·
The Company
continues to expect a mid-single digit decline for worldwide sales of
Nexium for the
full year.
·
Prilosec sales in the
US were down 15 percent in the second quarter and 14 percent year to
date.
·
Sales of Losec in the Rest of
World markets were down 12 percent in the second quarter and 15 percent in
the first half.
Cardiovascular
Second
Quarter
CER
%
Half
Year
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
Crestor
916
678
+27
1,688
1,306
+22
Seloken /Toprol-XL
206
457
-58
396
901
-59
Atacand
388
318
+10
734
614
+9
Plendil
70
74
-14
136
139
-10
Zestril
65
76
-24
124
156
-28
Total
1,807
1,755
-5
3,378
3,408
-8
·
In the US,
Crestor sales in
the second quarter were $415 million, an 18 percent increase over last
year. Crestor is the only
branded statin to gain share in the US during 2008, fuelled by promotion
of the atherosclerosis indication. Crestor share of total
prescriptions increased to 9.1 percent in June, up 0.5 points since
December 2007. Crestor prescriptions
increased 8.0 percent compared with second quarter 2007, more than twice
the market rate.
·
US sales for
Crestor in the
first half increased 10 percent to $768 million.
·
Crestor sales in the
Rest of World were up 37 percent to $501 million in the second quarter, on
strong growth in Western Europe (up 19 percent), Canada (up 30 percent)
and Japan (up 150 percent).
·
Crestor sales in the
Rest of World were up 35 percent in the first half to $920
million.
·
US sales of
the Toprol-XL
product range, which includes sales of the authorised generic, were down
79 percent in the second quarter to $71 million. Generic
products accounted for 88 percent of dispensed prescriptions in the second
quarter.
4
AstraZeneca
PLC
·
Sales of Seloken in other
markets in the second quarter were up 1 percent, to $135 million, as
growth in China and other Emerging Markets was able to more than offset
the decline in Western Europe.
·
Atacand sales in the
second quarter were up 10 percent in the US. Sales in the Rest
of World were up 11 percent on a 30 percent increase in Emerging
Markets.
Respiratory and
Inflammation
Second
Quarter
CER
%
Half
Year
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
Symbicort
518
414
+12
989
768
+16
Pulmicort
383
320
+14
794
721
+6
Rhinocort
92
95
-8
172
187
-12
Accolate
19
19
-5
37
38
-5
Oxis
21
23
-22
38
46
-28
Total
1,078
911
+9
2,118
1,842
+7
·
Symbicort sales in the
US were $57 million in the second quarter. Key metrics tracking
the progress of the launch continue to show steady
improvements. Trial rates among target specialists is now
approaching 80 percent; these specialists are starting 27 percent of
patients new to combination therapy on Symbicort. The
trial rate among primary care physicians has increased to 34 percent, and
primary care physicians are now using Symbicort in one out of
six patients newly starting combination therapy. Overall, Symbicort share of new
prescriptions for fixed combinations reached 9.1 percent in the week
ending 18 July; market share among patients newly starting combination
treatment has increased to 17.6 percent.
·
Symbicort sales in
other markets were $461 million, 6 percent ahead of the second quarter
last year. A 29 percent increase in Emerging Markets accounts
for more than half of the sales growth.
·
US sales for
Pulmicort were up
24 percent to $251 million in the second quarter. Pulmicort Respules
sales were up 20 percent, with volume growth and price realisation
contributing equally to the sales increase.
·
On 30 June,
Ivax Pharmaceuticals (IVAX) (now known as Teva Pharmaceutical Industries
Ltd.), filed a motion for summary judgement of no infringement of
AstraZeneca’s patents covering Pulmicort
Respules. AstraZeneca will oppose the
motion. A hearing on the motion has been scheduled for 23
September 2008.
·
Sales of Pulmicort in the Rest
of World in the second quarter were down 2 percent to $132
million.
Oncology
Second
Quarter
CER
%
Half
Year
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
Arimidex
490
430
+6
920
831
+4
Casodex
358
331
-2
674
641
-4
Zoladex
310
275
+1
565
524
-2
Iressa
67
61
-
125
113
+2
Faslodex
65
53
+11
121
102
+10
Nolvadex
24
20
+5
42
39
-5
Ethyol
*
6
8
n/m
20
8
n/m
Total
1,338
1,195
+2
2,503
2,291
+1
*
Sales
of this MedImmune product were consolidated in AstraZeneca accounts from 1
June 2007. As a result, the prior period reflects one month’s
sales.
·
In the US,
sales of Arimidex
were up 13 percent in both the second quarter and first
half. Total prescriptions increased by 1.1 percent year on year
in the first half in what was essentially an unchanged total market for
hormonal treatments for breast cancer.
·
Arimidex sales in other
markets were up 1 percent in the second quarter and were down 2 percent
for the first half.
5
AstraZeneca
PLC
·
Casodex sales in the
second quarter were up 4 percent in the US and were down 4 percent in
other markets.
·
Worldwide
sales of Iressa
were unchanged in the second quarter, as a small increase in sales in
Emerging Asian markets offset a small decline in Japan.
·
The 11 percent
increase in second quarter Faslodex sales is
primarily a result of a 19 percent increase in Rest of
World. Sales in the US were up 4
percent.
Neuroscience
Second
Quarter
CER
%
Half
Year
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
Seroquel
1,112
963
+11
2,162
1,886
+10
Zomig
114
106
-1
221
213
-4
Total
1,488
1,293
+9
2,866
2,520
+8
·
In the US,
Seroquel sales
were up 8 percent to $733 million in the second quarter. Total
prescriptions were up 6.4 percent in the quarter, with 40 percent of the
growth attributable to Seroquel
XR. Seroquel is the market
leading antipsychotic, with a total prescription share of 31.6 percent in
June 2008.
·
Seroquel sales in other
markets increased by 18 percent to $379 million in the second quarter,
with sales in Established Markets up 20
percent.
·
Once the
regulatory filing in the European Union seeking approval for Seroquel XR for use in
generalised anxiety disorder is accomplished in the fourth quarter 2008,
then all the major life cycle management filings for Seroquel XR will be
complete, and commercial launches should commence in late 2008 and into
2009.
·
Sales of Zomig in the second
quarter were up 10 percent in the US and were down 8 percent in other
markets.
Infection and
Other
Second
Quarter
CER
%
Half
Year
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
Synagis*
81
16
n/m
600
16
n/m
Merrem
226
194
+7
439
372
+9
FluMist*
-
-
n/m
-
-
n/m
Total
365
276
+25
1,152
528
+111
*
Sales
of these MedImmune products were consolidated in AstraZeneca accounts from
1 June 2007. As a result, the prior period reflects one month’s
sales.
·
Synagis sales, which
have a pronounced seasonal pattern, were only $81 million in the quarter,
with modest sales in the second and third quarters of the
year.
6
AstraZeneca
PLC
Geographic
Sales
Second
Quarter
CER
%
Half
Year
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
North
America
3,463
3,542
-3
7,186
7,030
+1
US
3,126
3,268
-4
6,527
6,502
-
Established
ROW*
3,340
2,842
+2
6,313
5,506
+2
Emerging
ROW
1,153
889
+20
2,134
1,703
+16
*
Established
ROW comprises Western Europe (including France, UK, Germany, Italy,
Sweden, and others), Japan, Australia and New
Zealand.
·
In the US,
sales were down 4 percent in the second quarter resulting from the loss of
$268 million of Toprol-XL sales to
generic competition. Excluding Toprol-XL, sales
increased by 4 percent in the US. Second quarter sales include
approximately $100 million of inventory build in the quarter.
·
Sales in the
Established Rest of World segment were up 2 percent in the second
quarter. Sales in Western Europe were up 1 percent, as growth
in Crestor, Seroquel and the
inclusion of Synagis sales more than
offset declines in Losec, Casodex and
Pulmicort. Sales in Japan were up 10 percent, a rebound
from the soft first quarter result that preceded the implementation of the
biennial price reductions in April.
·
Sales in
Emerging Markets were up 20 percent in the second quarter. This
marks the first time sales in Emerging Markets exceeded $1 billion in a
quarter. The key contributors to sales growth were
Cardiovascular products, Nexium and the
Respiratory portfolio. Sales in China were up 29
percent.
7
AstraZeneca
PLC
Operating
and Financial Review
All
narrative in this section refers to growth rates at constant exchange rates
(CER) unless otherwise indicated
Second
Quarter
All
financial figures, except earnings per share, are in $
millions. Weighted average shares in millions.
Reported
2008
Restructuring
and
Synergy Costs
MedImmune
Amortisation
Ethyol
Impairment
Merck
Amortisation
Core
2008
Core
2007
Actual
%
CER
%
Sales
7,956
-
-
-
-
7,956
7,273
9
2
Cost of
Sales
(1,455)
24
-
-
-
(1,431)
(1,469)
Gross
Margin
6,501
24
-
-
-
6,525
5,804
13
4
%
sales
81.7%
82.0%
79.8%
+2.2
+1.7
Distribution
(75)
-
-
-
-
(75)
(61)
22
14
%
sales
0.9%
0.9%
0.8%
-0.1
-0.1
R&D
(1,297)
32
-
-
-
(1,265)
(1,196)
6
-
%
sales
16.3%
15.9%
16.5%
+0.6
+0.3
SG&A
(2,834)
75
77
-
26
(2,656)
(2,397)
11
5
%
sales
35.6%
33.4%
33.0%
-0.4
-0.9
Other
Income
178
-
30
-
-
208
259
(20)
(19)
%
sales
2.2%
2.6%
3.6%
-1.0
-0.7
Operating
Profit
2,473
131
107
-
26
2,737
2,409
14
3
%
sales
31.1%
34.4%
33.1%
+1.3
+0.3
Net
Finance
(Expense)/Income
(194)
-
-
-
-
(194)
18
Profit
before Tax
2,279
131
107
-
26
2,543
2,427
5
(6)
Taxation
(651)
(37)
(31)
-
-
(719)
(669)
Profit
after Tax
1,628
94
76
-
26
1,824
1,758
4
(7)
Minority
Interests
(8)
-
-
-
-
(8)
(11)
Net
Profit
1,620
94
76
-
26
1,816
1,747
4
(7)
Weighted
Average Shares
1,456
1,456
1,456
-
1,456
1,456
1,503
Earnings
per Share
1.11
0.06
0.06
-
0.02
1.25
1.17
7
(4)
Sales increased by 9
percent on a reported basis and by 2 percent on a constant currency
basis. Currency movements increased sales by 7
percent.
Core gross margin of
82.0 percent in the second quarter was 1.7 percentage points higher than last
year. Principal contributors were lower payments to Merck (1.3 percentage
points), continued efficiency gains and mix effects (0.7 percentage points) with
partial offset from higher royalty payments (0.3 percentage
points).
Core R&D
expenditure was $1,265 million in the second quarter, level with last year as a
result of good progress on the delivery of R&D productivity initiatives,
restructuring benefits and portfolio changes.
Core SG&A costs
of $2,656 million were 5 percent higher than the second quarter of 2007 due to
the inclusion of MedImmune, increased investment in our Emerging Markets and
some higher legal expenses.
Core other income of
$208 million was $51 million lower than the second quarter in 2007. Included
within the current year period were gains, totalling $81 million, realised from
the disposal of non-core products in Scandinavia. This amount was $58 million
lower than that recognised on the disposal of non-core Infection products in the
second quarter of 2007. The inclusion of a full quarter of MedImmune other
income broadly matched lower other one-time gains and royalty
income.
8
AstraZeneca
PLC
Core operating
profit was $2,737 million, an increase of 3 percent at CER or up 14 percent on
an as reported basis. Currency movements increased operating profit
by 11 percent. In comparison with last year, the dollar was 14 percent weaker
against the euro (increasing sales and costs), 13 percent weaker against the
Swedish krona (increasing costs), but 1 percent stronger than sterling (slightly
reducing costs). On a constant currency basis, Core operating margin
increased by 0.3 percentage points to 34.4 percent of sales, chiefly a result of
improvements in gross margin and efficiencies in R&D with partial offset
from higher SG&A costs and lower other income.
Core earnings per
share in the second quarter were $1.25, a CER decrease of 4 percent, as the
increase in Core operating profit and the benefit of a lower number of shares in
issue was more than offset by increased net interest expense. Core
earnings per share on an as reported basis increased 7 percent.
Reported operating
profit was up 12 percent to $2,473 million, as restructuring and synergy costs
in the current quarter were $245 million lower than those incurred in the second
quarter 2007, partially counterbalanced by 3 months of MedImmune-related
amortisation expense this quarter that was $72 million higher than the one
month’s cost incurred in the second quarter last year. Reported earnings per
share were $1.11.
First
Half
All
financial figures in table, except earnings per share, are in $
millions. Weighted average shares in millions.
Reported
2008
Restructuring
and
Synergy Costs
MedImmune
Amortisation
Ethyol
Impairment
Merck
Amortisation
Core
2008
Core
2007
Actual
%
CER
%
Sales
15,633
-
-
-
-
15,633
14,239
10
3
Cost of
Sales
(2,957)
56
-
-
-
(2,901)
(2,873)
Gross
Margin
12,676
56
-
-
-
12,732
11,366
12
5
%
sales
81.1%
81.5%
79.8%
+1.7
+1.2
Distribution
(141)
-
-
-
-
(141)
(122)
15
8
%
sales
0.9%
0.9%
0.9%
-
-
R&D
(2,533)
86
-
-
-
(2,447)
(2,366)
3
(1)
%
sales
16.2%
15.7%
16.6%
+0.9
+0.7
SG&A
(5,571)
106
156
257
51
(5,001)
(4,592)
9
3
%
sales
35.6%
32.0%
32.2%
+0.2
-0.1
Other
Income
299
-
60
-
-
359
397
(10)
(10)
%
sales
1.9%
2.3%
2.8%
-0.5
-0.4
Operating
Profit
4,730
248
216
257
51
5,502
4,683
17
7
%
sales
30.3%
35.2%
32.9%
+2.3
+1.4
Net Finance
(Expense)/Income
(308)
-
-
-
-
(308)
115
Profit
before Tax
4,422
248
216
257
51
5,194
4,798
8
(2)
Taxation
(1,289)
(72)
(63)
(77)
-
(1,501)
(1,397)
Profit
after Tax
3,133
176
153
180
51
3,693
3,401
9
(1)
Minority
Interests
(10)
-
-
-
-
(10)
(15)
Net
Profit
3,123
176
153
180
51
3,683
3,386
9
(1)
Weighted
Average Shares
1,456
1,456
1,456
1,456
1,456
1,456
1,515
Earnings
per Share
2.14
0.12
0.11
0.12
0.04
2.53
2.24
13
3
Sales increased by
10 percent on a reported basis and by 3 percent on a constant currency
basis. Currency movements increased sales by 7 percent.
Core gross margin of
81.5 percent in the first half was 1.2 percentage points higher than last year.
Principal drivers were lower payments to Merck (1.3 percentage points),
continued efficiency gains and mix effects factors (0.8 percentage points),
partially offset by higher royalty payments (0.9 percentage
points).
Core R&D costs
of $2,447 million were down 1 percent over last year. The prior period included
intangible asset impairment charges relating to the collaborations with
AtheroGenics and Avanir. Excluding these impairments, Core R&D
expenditure was up 2 percent in the first half, with the inclusion of MedImmune
expense being largely offset by improved productivity and efficiency,
restructuring benefits and portfolio changes.
Core SG&A costs
of $5,001 million were 3 percent higher than the first half of 2007 due to the
inclusion of
9
AstraZeneca
PLC
MedImmune and
increased investment in our Emerging Markets.
Core other income of
$359 million was $38 million below last year with expected lower one-time gains
and royalty income being only partially offset by MedImmune’s licensing and
royalty income streams.
Core operating
profit of $5,502 million was up 7 percent at CER or 17 percent on an as reported
basis. Currency movements increased operating profit by 10 percent. On a
constant currency basis, Core operating margin increased by 1.4 percentage
points to 35.2 percent of sales as a result of improvements in gross margin and
R&D efficiencies more than compensating for lower other operating income and
higher SG&A costs.
Core earnings per
share in the first half were $2.53, an increase of 3 percent at CER, as the
increase in Core operating profit and the benefit of a lower number of shares
outstanding was partially offset by increased net interest
expense. Core earnings per share on a reported basis increased 13
percent.
Reported operating
profit of $4,730 million was up 3 percent, against 7 percent on a Core basis.
This was a result of the first quarter Ethyol impairment charge and
six months of MedImmune-related amortisation, versus the one month charge
incurred in the first half last year, being only partially offset by lower
restructuring and synergy costs in the first half of 2008.
Reported earnings
per share in the first half were $2.14, a decrease of 3 percent at
CER. Including the currency benefit, Reported earnings per share
increased 9 percent.
Finance
Income and Expense
Net finance expense
was $308 million for the first half ($194 million for quarter two), versus
income of $115 million in the first half of 2007 ($18 million income for quarter
two 2007). Key drivers are the interest payable on additional borrowings, and
reduced interest received on lower average cash holdings, as a result of the
acquisition of MedImmune.
Taxation
The effective tax
rate for the second quarter is 28.6 percent (2007 27.8 percent) and 29.1 percent
for the first half (2007 29.5 percent). For the full year the tax rate is
currently anticipated to be around 29.5 percent, the same as for
2007.
Cash
Flow
Cash generated from
operating activities was $4,292 million in the six months, compared with $3,184
million in 2007. The increase of $1,108 million was principally driven by an
increase in operating profit before depreciation, amortisation and impairment
costs of $1,011 million, a decrease in tax payments of $367 million, with
partial offset from an increase in interest payments of $263
million.
Net cash outflows
from investing activities were $3,199 million in the six months compared with
$14,493 million in 2007. Stripping out the acquisition of MedImmune in 2007 of
$14,391 million, the increase in cash outflow of $3,097 million is due primarily
to the payment of $2,630 million to Merck as part of the partial retirement, a
reduction in the inflow from the movements in short term investments and fixed
deposits of $570 million, and a decrease in interest received of $130
million.
Cash distributions
to shareholders were $2,180 million through the payment of the second interim
dividend from 2007 of $2,007 million and net share repurchases of $173
million.
Investments
As described in note
5, on 17 March, the Company made payments under the provisions of the Merck
agreements of approximately $2.6 billion. These have been recorded as intangible
assets to reflect the benefits accruing in respect of relief from future
contingent payments and the ability to fully exploit our resources and products
within certain therapy areas. There were no other significant investments in the
six months.
10
AstraZeneca
PLC
Debt
and Capital Structure
As at 30 June 2008,
outstanding gross debt (including loans, short-term borrowings and overdrafts)
was $14,873 million (31 December: $15,156 million), of which $11,032 million is
due after one year (31 December: $10,876 million). Outstanding net
debt of $10,359 million has increased by $1,247 million from 31 December,
principally as a result of the cash outflows described above.
In addition, during
July, the Company issued a further EUR 500 million bond as part of its
refinancing programme, the proceeds of which will be used to refinance maturing
commercial paper. The bond has a maturity of 18 months, maturing 4
January 2010 with a coupon of 5.625% and was issued under the Euro Medium Term
Note Programme.
Dividends
and Share Repurchases
The Board’s dividend
policy is unchanged, and is to grow dividends in line with reported earnings
before restructuring and synergy costs. Consistent with this policy,
the Board has recommended a first interim dividend for 2008 of $0.55 per
Ordinary Share (27.8 pence; SEK 3.34).
During the second
quarter, 5.0 million shares were repurchased for cancellation at a total cost of
$208 million. There were no share repurchases in the first quarter. During the
first six months, 0.9 million shares were issued in consideration of share
option exercises and in relation to employee share plans for a total of $35
million.
The total number of
shares in issue at 30 June 2008 was 1,453 million.
The Board’s
distribution policy and its overall financial strategy is to strike a balance
between the interests of the business, our shareholders and our financial
creditors, whilst maintaining a strong investment grade credit rating. The Board
expects to undertake share repurchases in the region of $1 billion in 2008,
subject to business needs.
Related
Party Transactions
There have been no
significant related party transactions in the period.
Calendar
30 October
2008
Announcement
of third quarter and nine months 2008 results
29 January
2009
Announcement
of fourth quarter and full year 2008
results
David
Brennan
Chief Executive
Officer
Media
Enquiries:
Steve
Brown/Chris Sampson (London)
(020) 7304
5033/5130
Earl Whipple
(Wilmington)
(302) 885
8197
Per Lorentz
(Södertälje)
(8) 553
26020
Analyst/Investor
Enquiries
Mina
Blair/Karl Hard (London)
(020) 7304
5084/5322
Jonathan Hunt
(London)
(020) 7304
5087
Peter Vozzo
(MedImmune)
(301) 398
4358
Ed
Seage/Jörgen Winroth (US)
(302) 886
4065/(212) 579 0506
11
Item 6
Responsibility Statement of the
Directors in Respect of the Half-Yearly Financial Report
We confirm that to
the best of our knowledge:
·
the condensed
set of financial statements has been prepared in accordance with IAS 34
Interim Financial
Reporting as adopted by the European
Union;
·
the
half-yearly management report includes a fair review of the information
required by:
(a)
DTR 4.2.7R of
the Disclosure and Transparency Rules, being an indication of important
events that have occurred during the first six months of the financial
year and their impact on the condensed set of financial statements; and a
description of the principal risks and uncertainties for the remaining six
months of the year; and
(b)
DTR 4.2.8R of
the Disclosure and Transparency Rules, being related party transactions
that have taken place in the first six months of the current financial
year and that have materially affected the financial position or
performance of the entity during that period; and any changes in the
related party transactions described in the last annual report that could
do so.
The
Board
The
Board of Directors that served during the six months to 30 June 2008 and their
respective responsibilities can be found on pages 18 and 19 of the AstraZeneca
Annual Report and 20-F Information 2007. In addition, Jean-Philippe
Courtois was appointed as a Non-Executive Director on 18 February
2008.
Approved by the
Board and signed on its behalf by
David
Brennan
Chief Executive
Officer
31
July 2008
12
Independent
Review Report to AstraZeneca PLC
Introduction
We have been engaged
by the Company to review the condensed set of financial statements in the
half-yearly financial report for the six months ended 30 June 2008 (but not for
the quarter ended 30 June 2008) which comprises condensed consolidated income
statement, condensed consolidated balance sheet, condensed consolidated cash
flow statement, condensed consolidated statement of recognised income and
expense and Notes 1 to 5. We have read the other information
contained in the half-yearly financial report and considered whether it contains
any apparent misstatements or material inconsistencies with the information in
the condensed set of financial statements.
This report is made
solely to the Company in accordance with the terms of our engagement to assist
the Company in meeting the requirements of the Disclosure and Transparency Rules
(“the DTR”) of the UK’s Financial Services Authority (“the UK
FSA”). Our review has been undertaken so that we might state to the
Company those matters we are required to state to it in this report and for no
other purpose. To the fullest extent permitted by law, we do not
accept or assume responsibility to anyone other than the Company for our review
work, for this report, or for the conclusions we have reached.
Directors’
responsibilities
The half-yearly
financial report is the responsibility of, and has been approved by, the
Directors. The Directors are responsible for preparing the
half-yearly financial report in accordance with the DTR of the UK
FSA.
As disclosed in Note
1, the annual financial statements of the group are prepared in accordance with
International Financial Reporting Standards (IFRS) as adopted by the European
Union (EU). The condensed set of financial statements included in
this half-yearly financial report has been prepared in accordance with IAS 34
Interim Financial
Reporting as adopted by the EU.
Our
responsibility
Our responsibility
is to express to the Company a conclusion on the condensed set of financial
statements in the half-yearly financial report based on our review.
Scope
of review
We conducted our
review in accordance with International Standard on Review Engagements (UK and
Ireland) 2410 Review of
Interim Financial Information Performed by the Independent Auditor of the
Entity issued by the Auditing Practices Board for use in the
UK. A review of interim financial information consists of making
enquiries, primarily of persons responsible for financial and accounting
matters, and applying analytical and other review procedures. A
review is substantially less in scope than an audit conducted in accordance with
International Standards on Auditing (UK and Ireland) and consequently does not
enable us to obtain assurance that we would become aware of all significant
matters that might be identified in an audit. Accordingly, we do not
express an audit opinion.
Conclusion
Based on our review,
nothing has come to our attention that causes us to believe that the condensed
set of financial statements in the half-yearly financial report for the six
months ended 30 June 2008 is not prepared, in all material respects, in
accordance with IAS 34 as adopted by the EU and the DTR of the UK
FSA.
KPMG
Audit Plc
Chartered
Accountants
8 Salisbury
Square
London EC4Y
8BB
31
July 2008
13
Condensed
Consolidated Income Statement
For the six months ended 30
June
2008
$m
2007
$m
Sales
15,633
14,239
Cost of
sales
(2,957)
(3,154)
Distribution
costs
(141)
(122)
Research and
development
(2,533)
(2,395)
Selling,
general and administrative costs
(5,571)
(4,822)
Other
operating income and expense
299
397
Operating
profit
4,730
4,143