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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 October 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,
“Repurchase of Shares in AstraZeneca PLC”, dated 1 October
2008.
2.
Press release entitled,
“Repurchase of Shares in AstraZeneca PLC”, dated 2 October
2008.
3.
Press release entitled,
“AstraZeneca and Pozen Informed of FDA Internal Review of Gastric Ulcers
as a Primary Endpoint in Trials“, dated 17 October
2008.
4.
Press release entitled,
“AstraZeneca’s third quarter and nine months results 2008”, dated 29
October 2008.
5.
Press release entitled,
“AstraZeneca PLC Third Quarter and Nine Months Results 2008” (front half),
dated 30 October 2008.
6.
Press release
entitled, “AstraZeneca PLC Third Quarter and Nine Months Results 2008 –
Condensed Consolidated Income Statement” (back half), dated 30 October
2008.
7.
Press release
entitled, “Transparency Directive Voting Rights and Capital”, dated 31
October 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: 4 November
2008
By:
/s/ Justin
Hoskins
Name:
Justin
Hoskins
Title:
Deputy Company
Secretary
Item 1
REPURCHASE
OF SHARES IN ASTRAZENECA PLC
AstraZeneca PLC
announced that on 30 September 2008, it purchased for cancellation 1,053,640
ordinary shares of AstraZeneca PLC at a price of 2450 pence per
share.
Some of these shares
were purchased under the terms of the previously announced irrevocable,
non-discretionary share repurchase programme for the period 5 August 2008 to 1
October 2008.
Upon the
cancellation of these shares, the number of shares in issue will be
1,446,544,833.
G H R
Musker
Company
Secretary
1 October
2008
Item 2
REPURCHASE
OF SHARES IN ASTRAZENECA PLC
Further to the
announcement of its irrevocable, non-discretionary share repurchase programme
for the period 5 August 2008 to 1 October 2008, AstraZeneca PLC announced that
under the terms of that programme it purchased for cancellation 199,258 ordinary
shares of AstraZeneca PLC at a price of 2508 pence per share on 1 October 2008.
Upon the cancellation of these shares, the number of shares in issue will be
1,446,345,575.
G H R
Musker
Company
Secretary
2 October
2008
Item 3
ASTRAZENECA
AND POZEN INFORMED OF FDA INTERNAL REVIEW OF GASTRIC ULCERS AS A PRIMARY
ENDPOINT IN TRIALS
AstraZeneca and
POZEN Inc., co-development partner for the investigational compound PN 400, have
announced today that the U.S. Food and Drug Administration (FDA) has informed
POZEN that it is conducting an internal review on the acceptability of
endoscopic gastric ulcers as a primary endpoint in clinical
studies. The FDA has not indicated when their internal review will be
completed, although an FDA internal meeting has been scheduled to review this
subject during the first quarter of 2009.
At the completion of
the Special Protocol Assessment (SPA) for the PN 200 compound, POZEN had reached
an agreement with the FDA on the design of its pivotal trials for PN 200
(omeprazole 20 mg and naproxen 500 mg), which specified the primary endpoint as
the reduction in gastric ulcers versus enteric coated naproxen. The
FDA confirmed that the development programme for PN 200 also applied to PN
400.
It is unclear at
this time what impact, if any, the FDA’s internal review will
have. However, the PN 400 clinical programme will continue to
progress under the SPA agreed development plan with the FDA.
About
PN 400:
PN 400 is an
investigational compound under co-development by AstraZeneca and POZEN, Inc.
that combines the pain reliever naproxen (a non-steroidal anti-inflammatory
drug, or NSAID) with esomeprazole – a proton pump inhibitor (PPI), for the
treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in
patients who are at risk of developing gastric ulcers.
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
Media
Enquiries:
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 20 7304
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
17
October 2008
-
ENDS -
Item 4
AstraZeneca’s third quarter
and nine months results 2008
Tomorrow, Thursday,
30 October, AstraZeneca will be announcing third quarter and nine months results
for 2008 at 11:00 (GMT), 12:00 (CET), 07:00 (EDT).
There will be an
analyst teleconference at 13:00(GMT), 14:00(CET), 09:00 (EDT), for which the
numbers are in the UK: 0808 100 5150, for International: +44 (0)844 8000 920,
for Sweden: 0200 110 487 and for the US: 1 866 804 8688. These numbers, as well
as details of the replay facility available through Friday, 14 November 2008,
are available on the Investors section of the AstraZeneca website at www.astrazeneca.com.
Item 5
AstraZeneca
PLC
Third
Quarter and Nine Months Results 2008
-
Robust third quarter performance.
-Third quarter sales
increased by 3 percent at constant exchange rates (CER). Core EPS
increased by 20 percent at CER to $1.32.
-Third quarter sales
in Emerging Markets increased by 18 percent at CER to $1.1
billion. Sales in China increased by 35 percent.
-Crestor sales up 28 percent
(CER) in the third quarter. US sales increased by 23 percent fuelled
by atherosclerosis indication. Crestor is the only branded
statin to gain market share in the US this year.
-
Nine months sales increased by 3 percent and Core EPS by 8 percent at
CER.
-
Core EPS target for the year increased to reflect stronger operational and
financial performance as well as additional currency benefit.
-Revised target
range for Core EPS is $4.90 to $5.05.*
-
No further share repurchases will take place in 2008 in order to maintain the
flexibility to invest in the business.
Financial
Summary
Group
3rd
Quarter
2008
$m
3rd
Quarter
2007
$m
Actual
%
CER
%
9
Months
2008
$m
9
Months
2007
$m
Actual
%
CER
%
Sales
7,775
7,150
+9
+3
23,408
21,389
+9
+3
Reported
Operating
Profit
2,522
2,022
+25
+19
7,252
6,165
+18
+8
Profit
before Tax
2,443
1,888
+29
+22
6,865
6,146
+12
+1
Earnings
per Share
$1.20
$0.91
+32
+24
$3.34**
$2.88
+16
+5
Core***
Operating
Profit
2,771
2,298
+21
+15
8,273
6,981
+19
+10
Profit
before Tax
2,692
2,164
+24
+18
7,886
6,962
+13
+4
Earnings
per Share
$1.32
$1.04
+27
+20
$3.85
$3.28
+17
+8
*
For
the fourth quarter of 2008 guidance is based on original assumptions for
currency: fourth quarter 2007 average rates.
**
Included
in Reported EPS for Nine Months 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: “AstraZeneca has delivered a robust
set of results that deliver on our performance commitments despite an
increasingly challenging environment for the pharmaceutical sector and business
in general. We continue to make good progress on reshaping our cost
base, including advancing innovation in our research and development activities
with greater productivity and efficiency. I am pleased to be able to
raise our financial guidance for the full year on the back of these
results.”
London, 30 October
2008
AstraZeneca PLC
Business
Highlights All narrative in this section refers
to growth rates at constant exchange rates (CER) unless otherwise
indicated
Third
Quarter
Sales in the third
quarter increased by 3 percent at CER, or 9 percent on an as reported
basis. Sales in the US were unchanged, as the $141 million decline in
sales of Toprol-XL
from generic competition was offset by 5 percent growth in the rest of the US
business. Sales in the Rest of World were up 6 percent. Sales
in Established Markets were up 2 percent. The strong
performance in Emerging Markets continues, with sales up 18 percent to $1,116
million, and this accounted for two thirds of the Rest of World sales
increase.
Core operating
profit in the third quarter was up 15 percent to $2,771 million, chiefly as a
result of the sales increase, improvement in Core gross margin and R&D
efficiencies. Reported operating profit increased by 19 percent to $2,522
million.
Core earnings per
share in the third quarter were $1.32 compared with $1.04 in the third quarter
2007, a 20 percent increase at CER. In addition to the increase in
Core operating profit, Core earnings per share benefited from lower net interest
expense, the result of a fair value gain relating to certain long term bonds in
issue, and a lower number of shares outstanding. Reported earnings
per share in the third quarter were $1.20, an increase of 24
percent.
Nine
Months
Sales for the nine
months increased by 3 percent at CER, or 9 percent on an as reported
basis. Sales in the US were unchanged as the sales decline in Toprol-XL was largely offset
by the inclusion of MedImmune and modest growth in the rest of the US
business. Sales in the Rest of World were up 6
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 by 10 percent to $8,273 million, as a result of improvements in
gross margin and R&D efficiencies that more than offset the effect of lower
other income and a slight increase in SG&A costs. Reported
operating profit increased by 8 percent to $7,252 million.
Core earnings per
share for the nine months were $3.85, an increase of 8
percent. Reported earnings per share for the nine months were $3.34,
a 5 percent increase compared to last year.
Research and Development
Update
A comprehensive
update of the AstraZeneca R&D pipeline was presented in conjunction with the
Half Year 2008 results and the pipeline table remains available on the Company’s
website, www.astrazeneca.com,
under information for investors.
Developments since
this last update include:
·
On 15
September, AstraZeneca and Targacept announced top line results from the
first Phase IIb study of AZD3480 in Alzheimer’s disease. In the
12-week placebo-controlled study, known as the Sirocco trial, neither the
active comparator donepezil nor AZD3480 met the trial’s criteria for
statistical significance on the primary outcome measure, ADAS-Cog
(Alzheimer’s Disease Assessment Scale – Cognition Subscale.) Both results were
impacted by an improvement in the placebo group. Analyses of
the full data set from the Sirocco trial are
ongoing. AstraZeneca and Targacept plan to discuss the data with leading
medical experts and to present and publish more detailed results
over the coming
months. A decision by AstraZeneca with respect to
potential further development of AZD3480 is expected in December
2008.
·
On 10 October,
the Company announced that the US FDA approved Seroquel XR for the acute treatment of the
depressive episodes associated with bipolar disorder, the manic and mixed episodes
associated with bipolar I disorder and the maintenance treatment of
bipolar I disorder as adjunctive therapy to lithium or
divalproex. Seroquel XR is the first medication approved
by the FDA for the once-daily acute treatment of both depressive and
manic episodes associated with bipolar disorder.
·
Regulatory submissions for
Seroquel
XR for major
depressive disorder are under review in the US and in Europe, as well as the
US submission for use in generalised
anxiety disorder (GAD). The European submission for GAD was
announced on 21 October.
AstraZeneca PLC
·
In October
2008, AstraZeneca submitted an sNDA for Seroquel to the FDA for
the treatment of schizophrenia in adolescents 13-17 years of age and for
the treatment of acute manic episodes associated with bipolar I disorder
in children and adolescents 10-17 years of age. Seroquel US Prescribing
Information will be updated to include additional safety information for
children and adolescents. Seroquel is not
currently indicated anywhere in the world for the paediatric
population.
·
On 2 September
2008, the US FDA announced that it had accepted the filing for
ONGLYZATM
(saxagliptin), which was submitted by AstraZeneca and its partner
Bristol-Myers Squibb on 30 June.
·
Preparations
for the AZD0837 Phase III clinical programme are well
underway. However, AstraZeneca is investigating a stability
limitation with the AZD0837 tablets required for the Phase III clinical
programme. As a consequence, the start of the programme will be
delayed from the fourth quarter of 2008 until 2009. The start
date will be confirmed once this stability limitation has been
resolved.
·
In October
2008, new marketing authorisation licenses were secured for Crestor in Germany,
Spain, Poland, Norway and Malta. Crestor is now approved
for use in every country in the European Union.
·
It has been
confirmed that presentation of the first results of the Crestor JUPITER study
will take place on 9 November at the American Heart Association 2008
Scientific Sessions in New Orleans,
US.
Enhancing
Productivity
In the third
quarter, restructuring and synergy costs associated with the global programme to
reshape the cost base were $117 million. This brings the cumulative charges
since the inception of the programme to $1,331 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 to
between $4.90 and $5.05 reflecting stronger operational and financial
performance, chiefly from improved gross margin and lower expenditures in
R&D arising from efficiency improvements, as well as the $0.06 per share of
additional currency benefits realised in the third quarter relative to the
currency assumptions upon which the targets were based (i.e. fourth quarter 2007
average exchange rates).
For the fourth
quarter of 2008, guidance is based on the original assumptions for currency,
being fourth quarter 2007 average exchange rates.
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.
AstraZeneca PLC
Sales
All
narrative in this section refers to growth rates at constant exchange rates
(CER) unless otherwise indicated
Gastrointestinal
Third
Quarter
CER
%
Nine
Months
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
Nexium
1,315
1,293
-2
3,876
3,913
-5
Losec/Prilosec
249
268
-15
791
845
-15
Total
1,589
1,581
-4
4,733
4,818
-7
·
In the US,
Nexium sales in
the third quarter were $779 million, an 8 percent decline compared with
last year. Dispensed retail tablet volume grew by 3 percent
compared with the third quarter last year. The back-loaded
phasing of lower price realisation over the course of last year continues
to give rise to a significant price variance, although in the third
quarter this has narrowed to around ten percent. Further
narrowing of this price variance is anticipated in the fourth
quarter.
·
Nexium sales in the US
in the nine months were down 12 percent to $2,269 million.
·
Nexium sales in other
markets in the third quarter were up 11 percent to $536 million, on a 22
percent sales increase in Emerging Markets and a 7 percent increase in
Established Markets.
·
Nexium sales in other
markets were up 8 percent for the nine months to $1,607
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 30 percent in the third quarter and 19 percent year to date
as a result of the recent introduction of generic competition for the 40mg
dosage form.
·
Sales of Losec in the Rest of
World markets were down 11 percent in the third quarter and 13 percent for
the nine months.
Cardiovascular
Third
Quarter
CER
%
Nine
Months
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
Crestor
922
691
+28
2,610
1,997
+24
Seloken /Toprol-XL
204
328
-42
600
1,229
-55
Atacand
386
320
+12
1,120
934
+10
Plendil
65
66
-9
201
205
-10
Zestril
60
72
-24
184
228
-27
Total
1,782
1,621
+4
5,160
5,029
-4
·
In the US,
Crestor sales in
the third quarter were $420 million, a 23 percent increase over last year,
fuelled by promotion of the atherosclerosis indication. While
generic simvastatin continues to gain share in the US statin market, Crestor is the only
branded statin to gain share during 2008; Crestor share of total
prescriptions increased to 9.3 percent in September, up 0.7 points since
December 2007. Crestor prescriptions
increased by 12.3 percent compared with third quarter 2007, nearly three
times the market rate.
·
US sales for
Crestor for the
nine months increased 14 percent to $1,188 million.
·
Crestor sales in the
Rest of World were up 33 percent to $502 million in the third quarter, on
good growth in Western Europe (up 19 percent), Emerging Markets (up 37
percent), Canada (up 26 percent) and Japan (up 79 percent).
·
Crestor sales in the
Rest of World were up 34 percent in the nine months to $1,422
million.
·
US sales of
the Toprol-XL
product range, which includes sales of the authorised generic, were down
66 percent in the third quarter to $72 million. Generic
products accounted for 89 percent of dispensed prescriptions in the third
quarter.
·
Sales of Seloken in other
markets in the third quarter were up 3 percent to $132 million, as good
growth in China (up 37 percent) and other Emerging Markets more than
offset the decline in Western
Europe.
AstraZeneca PLC
·
US sales of Atacand in
the third quarter were up 3 percent to $67 million. Sales in
the Rest of World were up 14 percent to $319
million.
Respiratory and
Inflammation
Third
Quarter
CER
%
Nine
Months
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
Symbicort
501
371
+25
1,490
1,139
+19
Pulmicort
304
286
+3
1,098
1,007
+5
Rhinocort
72
80
-14
244
267
-13
Accolate
18
19
-5
55
57
-5
Oxis
18
18
-11
56
64
-23
Total
951
813
+10
3,069
2,655
+8
·
Symbicort sales in the
US were $64 million in the third quarter. Trial rates among target
specialists are now 85 percent; these specialists are starting nearly 29
percent of patients new to combination therapy on Symbicort. The
trial rate among target primary care physicians has increased to 48
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 10.6 percent in the week
ending 17 October, with market share among patients newly starting
combination treatment running well ahead of this, at 18.4
percent.
·
Symbicort sales in
other markets were $437 million, 9 percent ahead of the third quarter last
year on a 6 percent increase in Western Europe and a 19 percent increase
in Emerging Markets.
·
US sales for
Pulmicort were up
7 percent to $196 million in the third quarter. Pulmicort Respules
sales were up 2 percent in the quarter and were up 11 percent for the nine
months.
·
On 24
September, Ivax Pharmaceuticals’ (IVAX) (now known as Teva Pharmaceutical
Industries Ltd.) Motion for Summary Judgement of no infringement of
AstraZeneca’s patents covering Pulmicort Respules was
denied. The Court has set a 12 January 2009 start date for the
trial.
·
Sales of Pulmicort in the Rest
of World in the third quarter were down 4 percent to $108
million.
Oncology
Third
Quarter
CER
%
Nine
Months
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
Arimidex
486
425
+9
1,406
1,256
+6
Casodex
300
324
-14
974
965
-7
Zoladex
295
273
-
860
797
-2
Iressa
67
55
+13
192
168
+5
Faslodex
67
54
+17
188
156
+12
Nolvadex
20
20
-5
62
59
-5
Ethyol
*
3
19
-84
23
27
n/m
Total
1,256
1,189
-1
3,759
3,480
-
*
Sales
of this MedImmune product were consolidated in AstraZeneca accounts from 1
June 2007. As a result, the prior year to date reflects four
months’ sales.
·
In the US,
sales of Arimidex
were up 16 percent in the third quarter to $193 million. Total
prescriptions increased by 1 percent year on year in the first nine months
in what was essentially an unchanged total market for hormonal treatments
for breast cancer. Sales for the nine months in the US were up
14 percent.
·
Arimidex sales in other
markets were up 5 percent in the third quarter to $293 million, but were
unchanged for the nine months.
·
Casodex sales in the US
were down 1 percent in the third quarter to $71 million, and down 2
percent for the nine months. On 22 September, the Company
announced that the US FDA has granted an additional six-month period of
exclusivity to market Casodex for its
licensed advanced prostate cancer indication until 1 April
2009.
·
Casodex sales in Rest
of World in the third quarter were down 18 percent to $229 million as a
result of generic competition in some markets in Western
Europe. Sales for the nine months were down 9 percent to $759
million.
AstraZeneca PLC
·
Worldwide
sales of Iressa
increased by 13 percent in the third quarter, chiefly as a result of a 56
percent increase in sales in China. Third quarter sales in
Japan were up 4 percent.
·
Faslodex sales in the
third quarter were up 12 percent in the US and increased by 21 percent in
other markets.
Neuroscience
Third
Quarter
CER
%
Nine
Months
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
Seroquel
1,130
1,055
+4
3,292
2,941
+8
Zomig
115
107
+2
336
320
-2
Total
1,476
1,371
+3
4,342
3,891
+6
·
In the US,
Seroquel sales
were down 1 percent to $749 million in the third quarter compared with the
third quarter last year, which included around $80 million of initial
stocking sales for Seroquel
XR. Adjusting for this effect, sales growth would have
been around 10 percent. Total prescriptions were up 7 percent
in the quarter, with 43 percent of the growth attributable to Seroquel
XR. Seroquel is the market
leading antipsychotic, with a total prescription share of 31.7 percent in
September 2008.
·
Seroquel sales in other
markets increased by 18 percent to $381 million in the third quarter, with
sales in Western Europe up 20 percent. Sales in Rest of World
for the nine months were up 18 percent.
·
On 10 October,
the Company announced that the US FDA approved Seroquel XR for the acute treatment of the
depressive episodes associated with bipolar disorder, the manic and mixed episodes
associated with bipolar I disorder and the maintenance treatment of
bipolar I disorder as adjunctive therapy to lithium or divalproex.
·
Sales of Zomig in the third
quarter were up 9 percent in the US and were down 3 percent in other
markets.
Infection and
Other
Third
Quarter
CER
%
Nine
Months
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
Synagis*
124
122
+1
724
138
n/m
Merrem
241
186
+23
680
558
+14
FluMist*
71
-
n/m
71
-
n/m
Total
494
371
+28
1,646
899
n/m
*
Sales
of these MedImmune products were consolidated in AstraZeneca accounts from
1 June 2007. As a result, the prior year to date reflects four
months’ sales.
·
Synagis sales, which
have a pronounced seasonal pattern (with modest sales in the second and
third quarters of the year), were $124 million in the third
quarter.
·
FluMist recorded sales
of $71 million in the quarter. There were no sales in the third
quarter last year as the timing of regulatory approvals pushed sales into
the fourth quarter.
AstraZeneca PLC
Geographic
Sales
Third
Quarter
CER
%
Nine
Months
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
North
America
3,519
3,485
+1
10,705
10,515
+1
US
3,199
3,199
-
9,726
9,701
-
Established
ROW*
3,140
2,791
+2
9,453
8,297
+2
Emerging
ROW
1,116
874
+18
3,250
2,577
+16
*
Established
ROW comprises Western Europe (including France, UK, Germany, Italy,
Sweden, and others), Japan, Australia and New
Zealand.
·
In the US,
sales were unchanged in the third quarter resulting from the loss of $141
million of Toprol-XL sales to
generic competition. Excluding Toprol-XL, sales
increased by 5 percent in the US.
·
Sales in the
Established Rest of World segment were up 2 percent in the third
quarter. Sales in Western Europe were unchanged, as growth in
Crestor, Seroquel and Symbicort were offset
by declines in Casodex and Losec. Sales
in Japan were up 5 percent, chiefly on continued growth for Crestor.
·
Sales in
Emerging Markets were up 18 percent in the third quarter to more than $1.1
billion. The key contributors to sales growth were
Cardiovascular and Oncology portfolios, as well as Nexium. Sales
in China were up 35 percent.
AstraZeneca PLC
Operating
and Financial Review
All
narrative in this section refers to growth rates at constant exchange rates
(CER) unless otherwise indicated
Third
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
7,775
-
-
-
-
7,775
7,150
9
3
Cost of
Sales
(1,529)
72
-
-
-
(1,457)
(1,405)
Gross
Margin
6,246
72
-
-
-
6,318
5,745
10
6
%
sales
80.3%
81.3%
80.3%
+1.0
+1.7
Distribution
(79)
-
-
-
-
(79)
(59)
34
30
%
sales
1.0%
1.0%
0.8%
-0.2
-0.3
R&D
(1,291)
30
-
-
-
(1,261)
(1,327)
(5)
(7)
%
sales
16.6%
16.2%
18.6%
+2.4
+1.9
SG&A
(2,486)
15
76
-
26
(2,369)
(2,258)
5
1
%
sales
32.0%
30.5%
31.6%
+1.1
+0.8
Other
Income
132
-
30
-
-
162
197
(18)
(16)
%
sales
1.7%
2.1%
2.8%
-0.7
-0.5
Operating
Profit
2,522
117
106
-
26
2,771
2,298
21
15
%
sales
32.4%
35.7%
32.1%
+3.6
+3.6
Net Finance
Expense
(79)
-
-
-
-
(79)
(134)
Profit
before Tax
2,443
117
106
-
26
2,692
2,164
24
18
Taxation
(705)
(34)
(31)
-
-
(770)
(613)
Profit
after Tax
1,738
83
75
-
26
1,922
1,551
24
17
Minority
Interests
(8)
-
-
-
-
(8)
(8)
Net
Profit
1,730
83
75
-
26
1,914
1,543
24
17
Weighted
Average Shares
1,452
1,452
1,452
-
1,452
1,452
1,486
Earnings
per Share
1.20
0.06
0.05
-
0.01
1.32
1.04
27
20
Sales increased by 9
percent on a reported basis and by 3 percent on a constant currency
basis. Currency movements increased sales by 6
percent.
Core gross margin of
81.3 percent in the third quarter was 1.7 percentage points higher than last
year in constant currency terms. Principal contributors were lower payments to
Merck (1.0 percentage points), continued efficiency gains and mix factors (1.1
percentage points) with partial offset from higher royalty payments (0.4
percentage points).
Core R&D
expenditure was $1,261 million in the third quarter, 7 percent below last year
as a result of good progress on the delivery of R&D productivity
initiatives, restructuring benefits, portfolio changes and lower charges
relating to intangible asset impairments.
Core SG&A costs
of $2,369 million were 1 percent higher than the third quarter of 2007 as
operational efficiencies and benefits from the Company’s productivity
initiatives largely offset increased investment in our Emerging
Markets.
Core other income of
$162 million was $35 million lower than the third quarter in 2007, chiefly on
expected lower one-time gains.
Core operating
profit was $2,771 million, an increase of 15 percent at CER or up 21 percent on
an as reported basis. Currency movements increased Core operating
profit by 6 percent. In comparison with last year, the dollar was 9 percent
weaker against the euro (increasing sales and costs), 7 percent weaker against
the Swedish krona (increasing costs), but 7 percent stronger against sterling
(reducing costs). On a constant currency basis, Core operating margin
increased by 3.6 percentage points to 35.7 percent of sales, chiefly a result of
improvements in gross margin, lower R&D expense and efficiencies in SG&A
with partial offset from lower other income.
Core earnings per
share in the third quarter were $1.32, up 20 percent at CER, as the increase in
Core operating profit was supplemented by lower net interest expense and the
benefit of a lower number of shares in issue. Core earnings per share
on an as reported basis increased 27 percent.
AstraZeneca PLC
Reported operating
profit was up 19 percent at CER to $2,522 million and reported earnings per
share were $1.20.
Nine
Months
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
23,408
-
-
-
-
23,408
21,389
9
3
Cost of
Sales
(4,486)
128
-
-
-
(4,358)
(4,278)
Gross
Margin
18,922
128
-
-
-
19,050
17,111
11
5
%
sales
80.8%
81.4%
80.0%
+1.4
+1.3
Distribution
(220)
-
-
-
-
(220)
(181)
22
15
%
sales
0.9%
0.9%
0.9%
-
-0.1
R&D
(3,824)
116
-
-
-
(3,708)
(3,693)
-
(3)
%
sales
16.3%
15.8%
17.3%
+1.5
+1.1
SG&A
(8,057)
121
232
257
77
(7,370)
(6,850)
8
3
%
sales
34.4%
31.5%
32.0%
+0.5
+0.2
Other
Income
431
-
90
-
-
521
594
(12)
(12)
%
sales
1.8%
2.2%
2.8%
-0.6
-0.4
Operating
Profit
7,252
365
322
257
77
8,273
6,981
19
10
%
sales
31.0%
35.4%
32.6%
+2.8
+2.1
Net Finance
Expense
(387)
-
-
-
-
(387)
(19)
Profit
before Tax
6,865
365
322
257
77
7,886
6,962
13
4
Taxation
(1,994)
(106)
(94)
(77)
-
(2,271)
(2,010)
Profit
after Tax
4,871
259
228
180
77
5,615
4,952
13
4
Minority
Interests
(18)
-
-
-
-
(18)
(23)
Net
Profit
4,853
259
228
180
77
5,597
4,929
14
5
Weighted
Average Shares
1,455
1,455
1,455
1,455
1,455
1,455
1,505
Earnings
per Share
3.34
0.18
0.16
0.12
0.05
3.85
3.28
17
8
Sales increased by 9
percent on a reported basis and by 3 percent on a constant currency
basis. Currency movements increased sales by 6 percent.
Core gross margin of
81.4 percent in the first nine months was 1.3 percentage points higher than last
year. Principal drivers were lower payments to Merck (1.2 percentage points),
continued efficiency gains and mix factors (0.9 percentage points), partially
offset by higher royalty payments (0.8 percentage points).
Core R&D costs
of $3,708 million were down 3 percent over last year. The inclusion of MedImmune
expense was largely offset by improved productivity and efficiency,
restructuring benefits, portfolio changes and lower charges relating to
intangible asset impairments.
Core SG&A costs
of $7,370 million were 3 percent higher than the first nine months of 2007 due
chiefly to the inclusion of MedImmune, increased investment in our Emerging
Markets and some higher legal expenses.
Core other income of
$521 million was $73 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 $8,273 million was up 10 percent at CER or 19 percent on an as
reported basis. Currency movements increased Core operating profit by 9 percent.
On a constant currency basis, Core operating margin increased by 2.1 percentage
points to 35.4 percent of sales as improvements in gross margin, lower R&D
costs and SG&A efficiencies more than compensated for lower other operating
income.
Core earnings per
share in the first nine months were $3.85, an increase of 8 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 17
percent.
AstraZeneca PLC
Reported operating
profit of $7,252 million was up 8 percent, against 10 percent on a Core basis.
This is in part a result of the first quarter Ethyol impairment charge and
nine months of MedImmune-related amortisation, versus a four month charge
incurred in the prior year period, being only partially offset by lower
restructuring and synergy costs in the first nine months of 2008.
Reported earnings
per share in the first nine months were $3.34, an increase of 5 percent at
CER. Including the currency benefit, reported earnings per share
increased 16 percent.
Finance
Income and Expense
Net finance expense
was $387 million for the year to September, ($79 million for quarter three),
versus $19 million in the first nine months of 2007 ($134 million for quarter
three 2007). Key drivers were the interest payable on additional borrowings
alongside reduced interest received on the lower average cash holdings arising
as a result of the acquisition of MedImmune.
Net finance expense
in the third quarter also included a net fair value gain of $43 million relating
to two long-term bonds. These bonds are swapped to floating
interest rates and accounted for using the fair value option under
IFRS. Under this accounting treatment both the bonds and the related
interest rate swaps are measured at fair value, with changes in fair value
reported in the Income Statement. The fair value of each instrument
reflects changes in market interest rates, which broadly offset, but the bonds
will also reflect changes in credit spreads. As such, the widening
credit spreads seen during the quarter have reduced the fair value of the bonds,
resulting in the net gain noted above. The Company anticipates
that this gain will largely reverse as credit markets stabilise.
Taxation
The effective tax
rate for the third quarter was 28.9 percent (2007 28.4 percent) and 29.0 percent
for the first nine months (2007 29.2 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 $5,951 million in the nine months, compared with $4,512
million in 2007. The increase of $1,439 million was principally driven by an
increase in operating profit before depreciation, amortisation and impairment
costs of $1,476 million, a decrease in tax payments of $545 million, an increase
in interest payments of $286 million and a decrease in non-cash items of $483
million (mainly provisions and exchange on intercompany transactions). The
increase in working capital requirements was $187 million lower than in
2007.
Net cash outflows
from investing activities were $3,424 million in the nine months compared with
$14,460 million in 2007. Stripping out acquisitions of $14,814 million, the
increase in cash outflow of $3,778 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 movement in short term investments and fixed deposits of $847
million, and a decrease in interest received of $164 million.
Cash distributions
to shareholders were $3,224 million through dividend payments of $2,739 million
and net share repurchases of $485 million.
Debt
and Capital Structure
As at 30 September
2008, outstanding gross debt (including loans, short-term borrowings and
overdrafts) was $13,372 million (31 December: $15,156 million), of which $2,546
million is due within one year (31 December: $4,280 million). When
due, the Company currently anticipates repaying this debt from current cash
balances of $3,541 million and business cash flows, without the need to
refinance. Outstanding net debt of $9,749 million has increased by $637 million
from 31 December, principally as a result of the cash outflows described
above.
The $650 million
Floating Rate Note, issued in 2007 and maturing in September 2009 has been
reclassified as due within one year (carrying value $649 million). As
described at the half year, the Company issued a further EUR 500 million
18-month bond during July as part of its refinancing programme, the proceeds of
which have been used to refinance maturing commercial paper.
AstraZeneca PLC
Dividends
and Share Repurchases
During the third
quarter, 8.4 million shares were repurchased for cancellation at a cost of $395
million, bringing the total repurchases for the year to date to 13.4 million
shares at a total cost of $603 million. In the year to date, 2.9 million shares
were issued in consideration of share option exercises for a total of $118
million.
The total number of
shares in issue at 30 September 2008 was 1,447 million.
The Board has
decided that no further share repurchases will take place in 2008 in order to
maintain the flexibility to invest in the business. The Board will
update share repurchase plans for 2009 in light of anticipated market conditions
and business development opportunities in conjunction with the full year 2008
financial results announcement in January.
Calendar
29 January
2009
Announcement
of fourth quarter and full year 2008 results
30 April
2009
Announcement
of first quarter 2009 results
30 April
2009
Annual General
Meeting
30 July
2009
Announcement
of second quarter and half year 2009 results
29 October
2009
Announcement
of third quarter and nine months 2009
results
David
Brennan
Chief Executive
Officer
Media
Enquiries:
Neil
McCrae/Chris Sampson (London)
(020) 7304
5045/5130
Earl Whipple
(Wilmington)
(302) 885
8197
Anne-Charlotte
Knutsson (Södertälje)
(8) 553 213
75
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
Item 6
Condensed
Consolidated Income Statement
For the nine months ended 30
September
2008
$m
2007
$m
Sales
23,408
21,389
Cost of
sales
(4,486
)
(4,598
)
Distribution
costs
(220
)
(181
)
Research and
development
(3,824
)
(3,730
)
Selling,
general and administrative costs
(8,057
)
(7,309
)
Other
operating income and expense
431
594
Operating
profit
7,252
6,165
Finance
income
637
703
Finance
expense
(1,024
)
(722
)
Profit
before tax
6,865
6,146
Taxation
(1,994
)
(1,794
)
Profit
for the period
4,871
4,352
Attributable
to:
Equity holders
of the Company
4,853
4,329
Minority
interests
18
23
4,871
4,352
Basic earnings
per $0.25 Ordinary Share
$
3.34
$
2.88
Diluted
earnings per $0.25 Ordinary Share
$
3.33
$
2.87
Weighted
average number of Ordinary Shares in issue (millions)
1,455
1,505
Diluted
average number of Ordinary Shares in issue (millions)
1,456
1,510
Dividends
declared and paid in the period
2,767
2,658
Condensed
Consolidated Income Statement
For the quarter ended 30
September
2008
$m