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AstraZeneca
PLC
INDEX
TO EXHIBITS
1.
Press release entitled,
“Transparency Directive Voting Rights and Capital”, dated 5 January
2009.
2.
Press release entitled,
“Director’s Dealing: Pledge of Shares”, dated 22 January
2009.
3.
Press release entitled,
“AstraZeneca Fourth Quarter and Full Year Results 2008”, dated 28 January
2009.
4.
Press release entitled,
“AstraZeneca’s partner, Pozen informed by FDA that Gastric Ulcers are
valid primary endpoint in PN 400 trials”, dated 29 January
2009.
5.
Press release entitled,
“AstraZeneca provides updated currency sensitivity assumptions as part of
2009 guidance”, dated 29 January 2009.
6.
Press release
entitled, “AstraZeneca PLC Fourth Quarter and Full Year Results 2008”
(front half), dated 29 January 2009.
7.
Press release
entitled, “AstraZeneca PLC Fourth Quarter and Full Year Results 2008
Condensed Consolidated Income Statement” (back half), dated 29 January
2009.
8.
Press release
entitled, “Transparency Directive Voting Rights and Capital”, dated 30
January 2009.
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: 5 February
2009
By: /s/ Adrian C N
Kemp
Name: Adrian C N
Kemp
Title: Company
Secretary
Item
1
Transparency
Directive
Voting
Rights and Capital
The following
notification is made in accordance with the UK Financial Services Authority
Disclosure and Transparency Rule 5.6.1. On 31 December 2008 the
issued share capital of AstraZeneca PLC with voting rights is 1,447,481,548
ordinary shares of US$0.25. No shares are held in Treasury.
Therefore, the total number of voting rights in AstraZeneca PLC is
1,447,481,548.
The above figure
for the total number of voting rights may be used by shareholders as the
denominator for the calculations by which they will determine if they are
required to notify their interest in, or a change to their interest in,
AstraZeneca PLC under the FSA's Disclosure and Transparency Rules.
A
C N Kemp
Company
Secretary
5
January 2009
Item
2
DIRECTOR’S DEALING: PLEDGE OF
SHARES
Following recent clarification by the
Financial Services Authority, in accordance with Disclosure and Transparency
Rule 3.1.2, AstraZeneca PLC (the “Company”) announces that it has received
notification from Marcus
Wallenberg, a Non-Executive Director of the Company, that he has pledged 60,028
shares in the Company owned by him as security against personal
loans.
A C N Kemp
Company Secretary
22 January
2009
Item 3
AstraZeneca Fourth Quarter
and Full Year Results 2008
On Thursday, 29
January 2009, AstraZeneca will release fourth quarter and full year results for
2008 at 11:00GMT.
An analyst
presentation covering the results will be held at 13:30GMT and can be joined,
live, via teleconference on the following numbers:
UK: 0800 012
1327
Sweden: 0200 110
487
US: 1 866 804
8688
International: +44
(0)844 8000 810
Passcode:
“AstraZeneca Analyst Conference”
These numbers, and
details of the replay facility (available until 17:00GMT Friday, 13 February
2009) are available on the Investors section of the AstraZeneca website (www.astrazeneca.com).
A live webcast of
the presentation will also be available on this site.
Item 4
ASTRAZENECA’S
PARTNER, POZEN INFORMED BY FDA THAT GASTRIC ULCERS ARE VALID PRIMARY ENDPOINT IN
PN 400 TRIALS
POZEN Inc.,
AstraZeneca’s co-development partner for the investigational compound PN 400,
has been informed that the US Food and Drug Administration (FDA) has completed
its internal discussions and that there is no change to the previous agreements
that gastric ulcer incidence is an acceptable primary endpoint for the PN 400
Phase III clinical programmes.
In October, the FDA
had announced that they were conducting an internal review on the acceptability
of gastric ulcers as a primary endpoint in clinical studies.
PN 400 is a fixed
dose combination of enteric-coated naproxen with immediate release esomeprazole
for the treatment of the signs and symptoms of osteoarthritis, rheumatoid
arthritis, and ankylosing spondylitis in patients who are at risk of developing
NSAID associated gastric ulcers. The two pivotal ulcer risk reduction studies
have completed and met their primary endpoints. In both studies, patients taking
PN 400 experienced significantly fewer endoscopically confirmed gastric ulcers
compared to subjects receiving enteric-coated naproxen during the six-month
treatment period. Two additional Phase III studies are still
ongoing.
Upon completion of
the entire PN400 Phase III clinical programme, AstraZeneca will make a final
determination regarding regulatory filing. A regulatory submission for PN400 in
the US is currently planned for mid 2009.
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 UK:
Chris
Sampson
+44 20 7304
5130 (24 hours)
Neil
McCrae
+44 207 304
5045 (24 hours)
Sarah
Lindgreen
+44 20 7304
5033 (24 hours)
Media
Enquiries US:
Michele.Pelkowski
+1 302 885
4055
Investor
Enquiries UK:
Jonathan
Hunt
+44 207 304
5087
mob: +44 7775
704032
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
29
January 2009
- ENDS
-
Item 5
AstraZeneca
provides updated currency sensitivity assumptions as part of 2009
guidance
Today, in
conjunction with reporting full year 2008 earnings, AstraZeneca gave earnings
guidance for 2009. The guidance utilised the average daily exchange rates for
January 2009 (to 28th Jan) for its principal functional currencies (sterling,
Euro, Swedish krone and Japanese yen) against the US dollar. This time period
was chosen as it is reflective of significant recent changes in the exchange
rate between these principal currencies and the US dollar.
The Company has
provided an updated currency sensitivity guide for 2009 in order to facilitate
the estimation of the impact of varying exchange rates on 2009 sales and Core
earnings. This can be found in the ‘Investors’ section of the Company’s website
www.astrazeneca.com
Item 6
AstraZeneca
PLC
FOURTH
QUARTER AND FULL YEAR RESULTS 2008
London,
29 January 2009
Sales
for the full year increased by 3 percent at CER; Core operating profit increased
by 9 percent at CER.
-Core operating
margin improved to 34.7 percent of sales on operational
efficiencies.
Sales
in Emerging Markets reached $4,273 million for the full year, a 16 percent
increase at CER.
Core
EPS for the full year increased by 8 percent at constant exchange rates (CER) to
$5.10, in line with the Company’s guidance.
Growth
in Reported EPS for the full year, 2 percent at CER, was lower than Core EPS
growth rate.
-Reflects higher
intangible impairments and a full year of MedImmune amortisation compared with
2007.
New
initiatives extend the scope of restructuring programme to sustain long-term
competitiveness.
-When
fully implemented, annual benefits anticipated to reach $2.5 billion, up from
$1.4 billion.
Continued
progress on the pipeline; up to four new compounds planned for regulatory filing
in 2009.
Dividend
increased by 10 percent to $2.05 for the full year.
Net
debt reduced by $1.9 billion on strong cash performance and investment
discipline.
-No share
repurchases will take place in 2009 in order to maintain the flexibility to
invest in the business.
Financial
Summary
Group
4th
Quarter
2008
$m
4th
Quarter
2007
$m
Actual
%
CER
%
Full
Year
2008
$m
Full
Year
2007
$m
Actual
%
CER
%
Sales
8,193
8,170
-
+4
31,601
29,559
+7
+3
Reported
Operating
Profit
1,892
1,929
-2
-9
9,144
8,094
+13
+4
Profit
before Tax
1,816
1,837
-1
-10
8,681
7,983
+9
-1
Earnings
per Share
$0.86
$0.86
-
-9
$4.20
$3.74
+12
+2
Core*
Operating
Profit
2,685
2,430
+11
+5
10,958
9,411
+16
+9
Profit
before Tax
2,609
2,338
+12
+5
10,495
9,300
+13
+4
Earnings
per Share
$1.25
$1.10
+13
+6
$5.10
$4.38
+16
+8
*
Core
financial measures are supplemental non-GAAP measures which management
believe useful to understanding the Company’s performance; it is upon
these measures that financial guidance for 2009 is based. See
page 9 for a definition of Core financial measures and pages 9 and 10 for
a reconciliation of Core to Reported financial
measures.
David Brennan, Chief
Executive Officer, said: “AstraZeneca has delivered a robust
performance in an increasingly challenging market environment. I am particularly
pleased with our continued success in globalising our business, as shown by our
strong performance in Emerging Markets. We are also making good
headway in further improving the efficiency of our organisation. The
expansion in the scope of our restructuring efforts is another important step
towards sustaining our long-term competitiveness.”
AstraZeneca
PLC
Business
Highlights All narrative in this section refers
to growth rates at constant exchange rates (CER) unless otherwise
indicated
Fourth
Quarter
Sales in the fourth
quarter increased by 4 percent at CER, but were unchanged on an as reported
basis as a result of the negative impact of exchange rate
movements. Sales in the US were up 3 percent, as the adverse impact
from generic competition for Toprol-XL is now
annualised. Sales in the Rest of World were up 5
percent. Sales in Established Markets were up 3
percent. Sales growth in Emerging Markets remained strong, with sales
up 13 percent in the quarter to $1,023 million.
There were a number
of intangible asset impairment charges taken in the fourth quarter, some of
which affected Core operating profit, others which are excluded from Core profit
and only affect reported operating profit. Included within Core
operating profit are intangible asset impairments charges totalling $184
million, the largest of which is a $115 million charge for impairment of
intangible assets relating to Pulmicort Respules following
the at risk generic launch by Teva and the subsequent settlement of patent
litigation. There were a total of $150 million of intangible asset impairments
charged to reported operating profit which are excluded from operating profit on
a Core basis. These intangible assets, arising from the acquisition
of MedImmune, relate to revised forecasts for future royalties related to HPV
vaccines ($90 million) and other items ($60 million) principally related to the
return of rights to the heat shock protein 90 (Hsp90) drug candidates IPI-504
(MEDI-561) and IPI-493 to Infinity Pharmaceuticals.
Core operating
profit in the fourth quarter was up 5 percent to $2,685 million, chiefly as a
result of sales growth and higher other income, partially offset by the
impairment relating to Pulmicort Respules and other
provisions within cost of goods sold. Reported operating profit
decreased by 9 percent to $1,892 million as a result of higher restructuring
costs and intangible asset impairments taken in this quarter compared to the
fourth quarter 2007.
Core earnings per
share in the fourth quarter were $1.25 compared with $1.10 in the fourth quarter
2007, a 6 percent increase at CER. It is estimated that there was 7 cents of
currency benefit to Core EPS in the fourth quarter. 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 fourth quarter were
$0.86, a 9 percent decrease, as a result of higher restructuring and intangible
asset impairment charges.
Full
Year
Sales for the full
year increased by 3 percent at CER, or 7 percent on an as reported
basis. Sales in the US were up 1 percent, as the inclusion of a full
year of MedImmune sales and modest growth in the rest of the US business more
than offset the sales of Toprol-XL lost to generic
competition. Sales in the Rest of World were up 5
percent. Sales in Established Markets were up 2 percent, including a
1 percent increase in sales in Western Europe. Sales in Emerging
Markets were up 16 percent.
Core operating
profit increased by 9 percent to $10,958 million as increased sales,
improvements in gross margin and R&D efficiencies more than offset a modest
increase in SG&A expense. Reported operating profit increased by
4 percent to $9,144 million.
Core earnings per
share for the full year were $5.10, an increase of 8 percent. The
increase in reported earnings per share was 2 percent, to $4.20, with the lower
growth rate versus Core EPS largely attributable to intangible asset impairment
charges and a full year of MedImmune amortisation, which are excluded from Core
EPS.
Research and Development
Update
Strengthening the
pipeline remains a key priority for the Company. The AstraZeneca
pipeline now includes 144 projects, including 98 projects in the clinical phase
of development. There are 10 projects currently in late stage
development, either in Phase III or under regulatory review. Of
particular note, the Phase II pipeline is now more than fifty percent larger
than it was at this time last year. Across the portfolio, 44 projects
have successfully progressed to their next phase (including 17 molecules
entering first human testing); 32 compounds have been added from Discovery
research; 10 compounds have been withdrawn.
2
AstraZeneca
PLC
Four important
projects (including two new molecules) are awaiting registration at this
time:
·
MedImmune
announced on 28 November 2008 the receipt of a Complete Response Letter
(CRL) from the US FDA seeking additional information in connection with
the Biologics License Application (BLA) for motavizumab for the prevention
of serious respiratory syncytial virus disease. MedImmune is confident
that it can respond to the outstanding questions and, based upon the
Company’s current understanding, does not foresee a need to conduct
further trials, but will be submitting data from our already completed
study in full term infants with congenital heart
defects. MedImmune will continue discussions with the FDA
reviewers and, subject to this dialogue, now expects to respond in the
second half of 2009.
·
Reviews of
the regulatory submissions for ONGLYZATM
(saxagliptin), the new diabetes compound developed in collaboration with
Bristol-Myers Squibb, are progressing in the US and in
Europe.
·
Regulatory
review continues for the Marketing Authorization Application submitted to
the European Medicines Agency seeking approval for Iressa as a treatment
for locally advanced or metastatic non-small cell lung cancer in patients
who have been pre-treated with platinum-containing
chemotherapy.
·
On 24 December 2008, AstraZeneca
announced that it received a CRL from the US FDA in conjunction with the
supplemental New Drug Application for Seroquel
XR for the treatment
of Major Depressive Disorder (MDD). AstraZeneca will continue discussions
with the FDA and will provide a response to the agency in due
course. The MDD submission in Europe is also under regulatory
review, as are the applications for Generalised Anxiety Disorder in the
US and in Europe.
Up to four
regulatory filings for new chemical entities are planned for 2009, including:
Zactima for the
treatment of pre-treated advanced non-small cell lung cancer in combination with
chemotherapy; PN400, the combination of enteric coated naproxen and immediate
release esomeprazole for the treatment of arthritic pain in patients at risk of
developing gastric ulcers; Brilinta (formerly known as
AZD6140), the oral antiplatelet agent in development for the treatment of
patients with acute coronary syndrome; and the fixed dose combination product
containing Crestor and
Abbott’s Trilipix, for the management of mixed dyslipidaemia.
On 11 December
2008, the Company announced that it returned worldwide rights to Infinity
Pharmaceuticals for the development and commercialisation of Infinity’s heat
shock protein 90 (Hsp90) drug candidates IPI-504 (MEDI-561) and
IPI-493. MEDI-561 was in Phase III development for the treatment of
patients with refractory gastrointestinal stromal tumours (GIST), a rare tumour
of the gastrointestinal tract.
The first
regulatory submissions for Crestor based on the JUPITER
trial results are planned starting in the second quarter of 2009.
A programme of work
aimed at resolving the stability issues related to AZD0837 tablets remains
underway, however the Company now estimates that the Phase III trial programme
in atrial fibrillation will not start until the second half of
2009. Until then, AZD0837 will be reclassified as a Phase II project
on the Company’s pipeline table.
In late November
2008, the Company received the FDA Complete Response Letter regarding our Nexium I.V. supplemental New
Drug Application for Peptic Ulcer Bleed. The application has not received the
FDA’s approval in its present form. The Company is reviewing their comments and
will respond in due course. The EU submission is still being reviewed by the
European regulatory authorities.
In January 2009,
the US Food and Drug Administration (FDA) granted an additional six-month period
of market exclusivity to Seroquel for its licensed
indications, based on studies the Company conducted in adolescents with
schizophrenia and children and adolescents with bipolar mania. The
Seroquel patent expires
on 26 September 2011. The allowed six-month paediatric exclusivity
period, which takes effect upon expiration of the patent, will extend the
exclusivity of Seroquel
to 26 March 2012. As previously disclosed, Seroquel US Prescribing
Information is being updated to include additional safety information for
children and adolescents. Seroquel is not currently
indicated anywhere in the world for the paediatric population.
A comprehensive
update of the AstraZeneca R&D pipeline is presented in conjunction with this
Full Year 2008 results announcement, and is available on the Company’s website,
www.astrazeneca.com,
under information for investors.
3
AstraZeneca
PLC
Enhancing
Productivity
In the fourth
quarter, a further $516 million in restructuring and synergy costs was charged
to the accounts, bringing the total costs for the full year to $881 million (of
which $219 million are non-cash items). This annual total reflects an
extension in the scope of the previously announced $1,975 million programme
which commenced in 2007. New initiatives include further
rationalisation of the global supply chain, additional restructuring of the
sales and marketing organisation and business infrastructure. When
fully implemented, these and other new business reshaping activities, combined
with revised estimates for the original 2007 programme (7,600 job reductions),
will result in the overall programme delivering a reduction of approximately
15,000 positions by 2013. All reductions in positions are subject to
consultations with works councils, trade unions and other employee
representatives and in accordance with local labour laws.
As a result of the
expanded scope of these business reshaping programmes, total programme charges
for restructuring and synergies are now estimated to reach $2,950 million (up
from $1,975 million). The Company anticipates that most of the
remaining $1.1 billion will be charged by 2010. When fully
implemented, programme benefits are now estimated to reach $2.5 billion per
annum (up from $1.4 billion); with $2.1 billion in savings expected before the
end of 2010, and the balance to be realised by 2013.
Future
Prospects
The Company has set
its financial targets for 2009 in anticipation of the normal range of risks and
opportunities typical for the pharmaceutical sector together with the turmoil in
the financial markets and the broader economy. Management believes
that successful execution of its business plan, underpinned by the underlying
financial and operating strength of the Company, will result in achievement of a
resilient financial performance even in this challenging business
climate.
For 2009 the
Company expects revenues to be in line with 2008 levels in constant currency
terms with the exact outcome dependent, in part, on the extent of the impact of
global economic conditions experienced over the course of the year.
The Company aims to
grow Core earnings per share on a constant currency basis. Core EPS
guidance has been based on January 2009 average exchange rates for our principal
currencies. The target for Core EPS is in the range of $5.15 to
$5.45. Actual performance within this range is dependent on the
extent of the impact of the downside pressures from the global
economy.
This target takes
no account of the likelihood that average exchange rates for 2009 may differ
materially from the January 2009 average rates upon which our earnings guidance
is based. An estimate of the sales and earnings sensitivity to
movements of our major currencies versus the US dollar is provided in
conjunction with this results announcement, and can be found on the AstraZeneca
web site.
This target Core
EPS also takes account of the fact that no share repurchases will be undertaken
in 2009.
4
AstraZeneca
PLC
Sales
All
narrative in this section refers to growth rates at constant exchange rates
(CER) unless otherwise indicated
Gastrointestinal
Fourth
Quarter
CER
%
Full
Year
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
Nexium
1,324
1,303
+6
5,200
5,216
-2
Losec/Prilosec
264
298
-11
1,055
1,143
-14
Total
1,611
1,625
+3
6,344
6,443
-4
·
In the US,
Nexium sales in
the fourth quarter were $832 million, up 2 percent compared with the
fourth quarter last year. Dispensed retail tablet volume grew
by 2.5 percent. As expected, the significant adverse price
variance that was a feature of the performance in the first three quarters
of the year normalised in the fourth quarter, with realised selling prices
broadly flat.
·
Nexium sales in the US
for the full year were down 8 percent to $3,101
million. Dispensed retail tablet volume for the full year
increased by 2 percent. Nexium was the only
major PPI brand to increase volume in 2008. On average over the
course of the full year, realised selling prices declined by around 11
percent.
·
Nexium sales in other
markets in the fourth quarter were up 12 percent to $492
million. There was continued strong growth in Emerging Markets,
where sales were up 20 percent. Sales in Western Europe were up
8 percent despite a significant decrease in Germany.
·
Nexium sales in other
markets were up 9 percent for the full year to $2,099
million.
·
Prilosec sales in the
US were down 43 percent in the fourth quarter and 25 percent for the full
year as a result of the introduction of generic competition for the 40mg
dosage form in the second half of 2008.
·
Sales of
Losec in the Rest
of World were down 3 percent in the fourth quarter and 11 percent for the
full year. Losec sales increased
in China (up 19 percent) and in Japan (up 5 percent) for the full
year.
Cardiovascular
Fourth
Quarter
CER
%
Full
Year
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
Crestor
987
799
+30
3,597
2,796
+26
Seloken /Toprol-XL
207
209
+2
807
1,438
-46
Atacand
351
353
+9
1,471
1,287
+10
Plendil
67
66
+3
268
271
-7
Zestril
52
67
-16
236
295
-24
Total
1,803
1,656
+15
6,963
6,686
-
·
In the US,
Crestor sales in
the fourth quarter were $490 million, a 27 percent increase over last
year. Fuelled by the promotion of the atherosclerosis
indication, Crestor prescriptions
in the fourth quarter increased by 17 percent, more than four times the
market growth rate of 4 percent. The other major branded
statins experienced a nearly 18 percent decline in total prescriptions in
aggregate.
·
US sales for
Crestor for the
full year increased by 18 percent to $1,678 million. Crestor total
prescription share in the US statin market increased by 125 basis points
during the year, to 9.9 percent in December 2008, and was the only branded
statin to gain share.
·
Crestor sales in the
Rest of World were up 32 percent to $497 million in the fourth
quarter. Sales in Western Europe increased by 16
percent. Emerging Market sales increased by 50
percent. There were also strong performances achieved in Canada
(up 29 percent), Japan (up 54 percent) and Australia (up 91
percent).
·
Crestor sales in the
Rest of World were up 34 percent for the full year to $1,919
million.
·
US sales of
the Toprol-XL
product range, which includes sales of the authorised generic, were up 2
percent in the fourth quarter to $88 million, as the onset of full generic
competition has been annualised. Generic products accounted for 89 percent
of dispensed prescriptions in the fourth
quarter.
·
Toprol-XL sales in the
US were down 70 percent for the full year to $295
million.
5
AstraZeneca
PLC
·
Sales of
Seloken in other
markets in the fourth quarter were up 2 percent to $119 million, as the 16
percent growth in Emerging Markets more than offset the 18 percent decline
in Western Europe. For the full year, Seloken sales in the
Rest of World were up 1 percent to $512 million.
·
US sales
for Atacand for
the full year increased 1 percent to $262 million. Sales in
other markets were up 12 percent to $1,209 million, on a 10 percent
increase in Established Markets and an 18 percent increase in Emerging
Markets.
Respiratory and
Inflammation
Fourth
Quarter
CER
%
Full
Year
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
Symbicort
514
436
+29
2,004
1,575
+22
Pulmicort
397
447
-10
1,495
1,454
-
Rhinocort
78
87
-8
322
354
-12
Accolate
18
19
-5
73
76
-5
Oxis
15
22
-27
71
86
-24
Total
1,059
1,056
+6
4,128
3,711
+7
·
Symbicort sales in the
US were $90 million in the fourth quarter and reached $255 million for the
full year. Product trial rate among target specialist
physicians is now approaching 90 percent; these specialists are starting
more than 30 percent of patients new to combination therapy on Symbicort. More
than half of target primary care physicians have tried Symbicort, and their
share of new patient starts is just over 17 percent. Overall,
Symbicort share
of new prescriptions for fixed combinations reached 11.7 percent in the
week ending 16 January, with market share among patients newly starting
combination treatment at 18.3 percent.
·
Symbicort sales in
other markets in the fourth quarter were $424 million, 13 percent ahead of
the fourth quarter last year, chiefly on an 11 percent increase in Western
Europe. Sales in Emerging Markets were up 21
percent. The Symbicort SMART concept
has now been approved in 91 markets.
·
US sales for
Pulmicort were
down 15 percent to $260 million in the fourth quarter. Pulmicort Respules
sales were down 18 percent as a result of the “at risk” launch of generic
budesonide inhalation suspension (BIS) on 18 November. The
patent litigation between Teva and AstraZeneca was subsequently settled on
26 November. The agreement allows Teva to commence sales of BIS
under an exclusive license from AstraZeneca beginning 15 December
2009. The agreement also provided that any product already
shipped by Teva would remain in the market to be further distributed and
dispensed. As a result, Teva product accounted for nearly
15 percent of total prescriptions for BIS products dispensed during the
fourth quarter, including a 40 percent share in December
2008.
·
US sales for
Pulmicort for the
full year were $982 million, a 2 percent increase over 2007. Pulmicort
Respules accounted for around 90 percent of total Pulmicort sales in the
US.
·
Sales of
Pulmicort in the
Rest of World were down 2 percent for the full year to $513
million.
Oncology
Fourth
Quarter
CER
%
Full
Year
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
Arimidex
451
474
-1
1,857
1,730
+4
Casodex
284
370
-24
1,258
1,335
-12
Zoladex
278
307
-6
1,138
1,104
-3
Iressa
73
70
-1
265
238
+3
Faslodex
61
58
+10
249
214
+12
Nolvadex
23
24
-8
85
83
-6
Ethyol
*
5
16
-69
28
43
n/m
Total
1,195
1,339
-9
4,954
4,819
-2
*
Sales
of this MedImmune product were consolidated in AstraZeneca accounts from 1
June 2007. As a result, the prior year reflects seven months’
sales.
·
In the US,
sales of Arimidex
were down 5 percent in the fourth quarter to $177
million. Total prescriptions for Arimidex declined by 3
percent, slightly more than the 1.5 percent decline in the overall market
for hormonal treatments for breast cancer. Arimidex sales for the
full year in the US were up 9 percent to $754
million.
6
AstraZeneca
PLC
·
Arimidex sales in other
markets were up 2 percent in the fourth quarter, and increased by 1
percent for the full year to $1,103 million.
·
Casodex sales in the US
were down 1 percent in the fourth quarter. Sales for the full
year were $292 million, a 2 percent decrease compared with
2007.
·
Casodex sales in the
Rest of World in the fourth quarter were down 30 percent to $207 million
as a result of generic competition in Western Europe, where sales were
down 56 percent. Sales for the full year in the Rest of World
were down 15 percent to $966 million.
·
Worldwide
sales of Iressa
increased by 3 percent to $265 million for the full year, as growth in
China and other Emerging Markets more than offset a 3 percent sales
decline in Japan.
·
Faslodex sales for the
full year were up 5 percent in the US and increased by 18 percent in other
markets.
Neuroscience
Fourth
Quarter
CER
%
Full
Year
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
Seroquel
1,160
1,086
+10
4,452
4,027
+9
Zomig
112
114
+3
448
434
-1
Total
1,495
1,449
+7
5,837
5,340
+6
·
In the US,
Seroquel sales
were up 8 percent to $831 million in the fourth quarter. Total
prescriptions were up 5 percent, in line with the anti-psychotic market
growth. Around 44 percent of Seroquel prescription
growth was attributable to Seroquel
XR. Seroquel remains the
market leader in the US anti-psychotic market, with a total prescription
share of 31.6 percent in December 2008.
·
US sales for
Seroquel for the
full year were $3,015 million, 5 percent ahead of last
year.
·
Seroquel sales in other
markets increased by 14 percent to $329 million in the fourth quarter.
Sales in Western Europe were up 26 percent.
·
For the full
year, Seroquel
sales in the Rest of World increased by 17 percent to $1,437 million, with
value and volume growth well ahead of the market in all
regions.
·
Sales of
Zomig for the
full year were up 6 percent in the US to $187 million. Sales in
the Rest of World were down 5 percent to $261
million.
Infection and
Other
Fourth
Quarter
CER
%
Full
Year
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
Synagis*
506
480
+5
1,230
618
n/m
Merrem
217
215
+10
897
773
+13
FluMist*
33
53
-38
104
53
+96
Total
805
816
+2
2,451
1,714
n/m
*
Sales
of these MedImmune products were consolidated in AstraZeneca accounts from
1 June 2007. As a result, the prior year reflects seven months’
sales.
·
Worldwide
sales of Synagis
in the fourth quarter were $506 million, a 5 percent increase, chiefly on
the 42 percent increase in sales outside the US. Sales in the
US were down 3 percent to $380 million.
·
For the full
year, Synagis
sales were $1,230 million. Sales in 2007 were $618 million, but
only reflect sales since the acquisition of MedImmune in June
2007.
·
FluMist sales were $33
million in the fourth quarter and $104 million for the full
year. In contrast to 2008, all of last year’s FluMist sales of $53
million were realised in the fourth quarter as a result of the timing of
regulatory approvals for the new formulation and expanded
label.
7
AstraZeneca
PLC
Geographic
Sales
Fourth
Quarter
CER
%
Full
Year
CER
%
2008
$m
2007
$m
2008
$m
2007
$m
North
America
4,080
3,996
+3
14,785
14,511
+2
US
3,784
3,665
+3
13,510
13,366
+1
Established
ROW*
3,090
3,194
+3
12,543
11,491
+2
Emerging
ROW
1,023
980
+13
4,273
3,557
+16
*
Established
ROW comprises Western Europe (including France, UK, Germany, Italy,
Sweden, and others), Japan, Australia and New
Zealand.
·
In the US,
sales were up 1 percent for the full year; the inclusion of a full year of
MedImmune sales and growth from Crestor, Symbicort and Seroquel more than
offset the generic erosion to Toprol-XL and the sales
declines in the PPI products Nexium and Prilosec.
·
Sales in the
Established Rest of World segment were up 2 percent for the full
year. Sales in Western Europe were up 1 percent; aside from the
inclusion of a full year of Synagis sales, growth
for Crestor,
Seroquel and
Symbicort helped
offset the declines in Casodex and Losec. Sales
in Japan were up 4 percent chiefly on the contribution for Crestor. Crestor and Nexium fuelled the 18
percent increase in sales in Australia.
·
Sales in
Emerging Markets were up 16 percent for the full year, accounting for more
than 60 percent of the CER sales growth outside the US. Nearly
every franchise showed sales growth in Emerging Markets, with notable
performances for Crestor, Nexium, Seroquel, Symbicort and Zoladex. Sales
in China were up 31 percent to $627 million for the full
year.
8
AstraZeneca
PLC
Operating
and Financial Review
All
narrative in this section refers to growth rates at constant exchange rates
(CER) and on a Core basis unless otherwise indicated. These measures
are non-GAAP measures which management believe useful to understanding the
Group’s performance. The Core financial measure is adjusted to
exclude certain items, such as charges and provisions related to restructuring
and synergy programmes, amortisation and the impairment of the significant
intangibles arising from corporate acquisitions and those related to our current
and future exit arrangements with Merck in the US, and other specified
items.
Fourth
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
and
other
Impairments
Merck
Amortisation
Core
2008
Core
2007
Actual
%
CER
%
Sales
8,193
-
-
-
-
8,193
8,170
-
4
Cost of
Sales
(2,112)
277
-
-
-
(1,835)
(1,726)
Gross
Profit
6,081
277
-
-
-
6,358
6,444
(1)
3
%
sales
74.2%
77.6%
78.9%
-1.3
-0.7
Distribution
(71)
-
-
-
-
(71)
(67)
7
18
%
sales
0.9%
0.8%
0.8%
-
-0.1
R&D
(1,355)
50
-
60
-
(1,245)
(1,396)
(11)
3
%
sales
16.5%
15.2%
17.1%
+1.9
+0.1
SG&A
(2,856)
189
75
-
22
(2,570)
(2,685)
(4)
4
%
sales
34.8%
31.4%
32.9%
+1.5
-
Other
Income
93
-
30
90
-
213
134
60
70
%
sales
1.1%
2.6%
1.6%
+1.0
+1.0
Operating
Profit
1,892
516
105
150
22
2,685
2,430
11
5
%
sales
23.1%
32.8%
29.7%
+3.1
+0.3
Net Finance
Expense
(76)
(76)
(92)
Profit
before Tax
1,816
516
105
150
22
2,609
2,338
12
5
Taxation
(557)
(153)
(31)
(44)
-
(785)
(706)
Profit
after Tax
1,259
363
74
106
22
1,824
1,632
12
5
Minority
Interests
(11)
(11)
(9)
Net
Profit
1,248
363
74
106
22
1,813
1,623
12
5
Weighted
Average Shares
1,447
1,447
1,447
1,447
1,447
1,447
1,464
Earnings
per Share
0.86
0.25
0.05
0.07
0.02
1.25
1.10
13
6
Sales were
unchanged on a reported basis and grew by 4 percent on a constant currency
basis. Currency movements resulted in a negative impact of 4
percent.
Core gross margin
of 77.6 percent in the fourth quarter was 0.7 percentage points lower than last
year in constant currency terms. Intangible asset impairments relating to Pulmicort Respules ($115
million) and other provisions reduced gross margin by 3.0 percentage
points. Higher royalty payments accounted for 0.3 percentage points
of negative variance compared with last year. These were partially
offset by lower payments to Merck (0.6 percentage points) and continued
efficiency gains and mix factors (2.0 percentage points).
Core R&D
expenditure was $1,245 million in the fourth quarter, 3 percent higher than last
year as a result of higher charges relating to intangible asset impairments,
which amounted to $45 million in the fourth quarter 2008, partially offset by
continued delivery of R&D productivity initiatives.
Core SG&A costs
of $2,570 million were 4 percent higher than the fourth quarter of 2007 as a
result of continued investment in Emerging Markets and increased marketing
investment behind Symbicort and Crestor in the US, partially offset by
operational efficiencies.
Core other income
of $213 million was $79 million higher than the fourth quarter of 2007, chiefly
as a result of a number of small one-time gains.
Core operating
profit was $2,685 million, an increase of 5 percent at CER, up 11 percent on an
as reported basis. Currency movements increased Core operating profit by 6
percent. In comparison with last year, the dollar was 10 percent stronger
against the euro (reducing sales and costs), 21 percent stronger against the
Swedish krona (reducing costs), and 30 percent stronger against sterling
(reducing costs). On a constant currency basis, Core operating margin
increased by 0.3 percentage points to 32.8 percent of sales, chiefly a result of
one-time gains in other income partly offset by charges in cost of
sales.
9
AstraZeneca
PLC
Core earnings per
share in the fourth quarter were $1.25, up 6 percent at CER, as the increase in
Core operating profit was supplemented by lower net finance expense and the
benefit of a lower number of shares in issue. Core earnings per share on an as
reported basis, including a currency benefit of 7 percent, increased by 13
percent.
Reported operating
profit was down 9 percent at CER at $1,892 million, reflecting higher
restructuring and synergy costs and the impairment of intangible assets, chiefly
as a result of the return of the rights to the Hsp90 drug candidates to Infinity
Pharmaceuticals and revised forecasts from future royalties relating to HPV
vaccines ($90 million). Reported earnings per share were $0.86.
Full
Year
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
and
other
Impairments
Merck
Amortisation
Core
2008
Core
2007
Actual
%
CER
%
Sales
31,601
-
-
-
-
31,601
29,559
7
3
Cost of
Sales
(6,598)
405
-
-
-
(6,193)
(6,004)
Gross
Profit
25,003
405
-
-
-
25,408
23,555
8
4
%
sales
79.1%
80.4%
79.7%
+0.7
+0.8
Distribution
(291)
-
-
-
-
(291)
(248)
17
16
%
sales
0.9%
0.9%
0.9%
-
-0.1
R&D
(5,179)
166
-
60
-
(4,953)
(5,089)
(3)
(1)
%
sales
16.4%
15.7%
17.2%
+1.5
+0.8
SG&A
(10,913)
310
307
257
99
(9,940)
(9,535)
4
3
%
sales
34.6%
31.4%
32.3%
+0.9
+0.1
Other
Income
524
-
120
90
-
734
728
1
3
%
sales
1.7%
2.3%
2.5%
-0.2
-
Operating
Profit
9,144
881
427
407
99
10,958
9,411
16
9
%
sales
28.9%
34.7%
31.8%
+2.9
+1.6
Net Finance
Expense
(463)
-
-
-
-
(463)
(111)
Profit
before Tax
8,681
881
427
407
99
10,495
9,300
13
4
Taxation
(2,551)
(259)
(125)
(121)
-
(3,056)
(2,716)
Profit
after Tax
6,130
622
302
286
99
7,439
6,584
13
5
Minority
Interests
(29)
-
-
-
-
(29)
(32)
Net
Profit
6,101
622
302
286
99
7,410
6,552
13
5
Weighted
Average Shares
1,453
1,453
1,453
1,453
1,453
1,453
1,495
Earnings
per Share
4.20
0.43
0.21
0.19
0.07
5.10
4.38
16
8
Sales increased by
7 percent on a reported basis and by 3 percent on a constant currency
basis. Currency movements increased sales by 4 percent.
Core gross margin
of 80.4 percent for the full year was 0.8 percentage points higher than last
year in constant currency terms. Principal drivers were lower payments to Merck
(1.0 percentage points), continued efficiency gains and mix factors (1.2
percentage points), partially offset by higher royalty payments (0.6 percentage
points) and intangible asset impairments and other provisions (0.8 percentage
points).
Core R&D costs
of $4,953 million were down 1 percent over last year. The inclusion of MedImmune
for a full year was offset by improved productivity and efficiency,
restructuring benefits, portfolio changes and lower charges relating to
intangible asset impairments ($84 million in 2008) charged to Core R&D
expense.
Core SG&A costs
of $9,940 million were 3 percent higher than 2007 due chiefly to the inclusion
of MedImmune, increased investment in our Emerging Markets and some higher legal
expenses.
Core other income
of $734 million was $6 million higher than last year with MedImmune’s licensing
and royalty income streams offset by expected lower one-time gains and royalty
income.
Core operating
profit of $10,958 million was up 9 percent at CER or 16 percent on an as
reported basis. Currency movements increased Core operating profit by 7 percent.
On a constant currency basis, Core operating margin increased by 1.6 percentage
points to 34.7 percent of sales as a result of improvements in gross margin,
lower R&D costs and SG&A efficiencies.
10
AstraZeneca
PLC
Core earnings per
share in 2008 were $5.10, an increase of 8 percent at CER, as the increase in
Core operating profit and the benefit of a low number of shares outstanding was
partially offset by increased net finance expense. Core earnings per share on a
reported basis increased 16 percent.
Reported
operating profit of $9,144 million was up 4 percent, against 9 percent on a Core
basis. This is in part a result of MedImmune-related intangible asset
impairments, including the $257 million Ethyol
impairment in the first quarter of 2008, and twelve months of MedImmune-related
amortisation (versus a seven month charge incurred in the prior year period),
being only partially offset by slightly lower restructuring and synergy costs in
2008.
Reported earnings
per share in 2008 were $4.20, an increase of 2 percent at
CER. Including the currency benefit, reported earnings per share
increased 12 percent.
Finance
Income and Expense
Net
finance expense was $463 million for the year, ($76 million for quarter four),
versus $111 million in 2007 ($92 million for quarter four 2007). Key drivers for
the full year 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 also included a net fair value gain of $130 million for the full
year ($82 million in the fourth quarter) 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 year 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 fourth quarter was 30.7 percent (2007 30.6 percent) and 29.4
percent for the year (2007 29.5 percent). The full year tax rate for 2009 is
currently anticipated to be around 29.5 percent.
Cash
Flow
Cash generated from
operating activities was $8,742 million in the year, compared with $7,510
million in 2007. The increase of $1,232 million was principally
driven by an increase in operating profit before depreciation, amortisation and
impairment costs of $1,814 million, a decrease in tax payments of $354 million
and lower working capital outflows of $233 million offset by an increase in
interest payments of $355 million and a decrease in non-cash items of $814
million which includes movement on provisions.
Net cash outflows
from investing activities were $3,896 million in the year compared with $14,887
million in 2007. Stripping out acquisitions of $14,891 million, primarily
MedImmune, the increase in cash outflow of $3,900 million is due primarily to
the net payment of $2,630 million to Merck as part of the partial retirement, a
reduction in the inflows from the movement in short term investments and fixed
deposits of $893 million and from the disposal of non-current asset investments
of $389 million, and a decrease in interest received of $209 million, offset by
lower purchases of other intangible assets of $235 million.
Cash distributions
to shareholders were $3,190 million through dividend payments of $2,739 million
and net share repurchases of $451 million.
Debt
and Capital Structure
As at 31 December
2008, outstanding gross debt (including loans, short-term borrowings and
overdrafts) was $11,848 million (31 December 2007: $15,156 million). Of this
debt, $993 million is due within one year (31 December 2007: $4,280 million),
which we currently anticipate repaying from current cash balances of $4,286
million and business cash flows, without the need to refinance. Outstanding net
debt of $7,174 million has decreased by $1,938 million from 31 December
2007.
11
AstraZeneca
PLC
Dividends
and Share Repurchases
The Board has
recommended an 11 percent increase in the second interim dividend to $1.50
(104.8 pence, 12.02 SEK) to be paid on 16 March 2009. This brings the
full year dividend to $2.05 (132.6 pence, 15.36 SEK) an increase of 10
percent.
As announced at Q3,
the Group’s share repurchase programme has been suspended. As a
result, during the fourth quarter, only 0.2 million shares were re-purchased for
cancellation under an irrevocable instruction issued earlier in the
year. The cost associated with the share repurchase programme in the
fourth quarter was $7 million, bringing the total re-purchases for the year to
13.6 million shares at a total cost of $610 million. In the year, 4.1 million
shares were issued in consideration of share option exercises for a total of
$159 million.
The total number of
shares in issue at 31 December 2008 was 1,447 million.
The Board has
decided that no share repurchases will take place in 2009 in order to maintain
the flexibility to invest in the business.
Calendar
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
(London)
(020) 7304
5045
Chris
Sampson/Sarah Lindgreen (London)
(020) 7304
5130/5033
Earl Whipple
(Wilmington)
(302) 885
8197
Anne-Charlotte
Knutsson (Södertälje)
(8) 553 213
75
Analyst/Investor
Enquiries
Karl
Hard/James Mead (London)
(020) 7304
5322/5084
Jonathan Hunt
(London)
(020) 7304
5087
Ed
Seage/Jörgen Winroth (US)
(302) 886
4065/(212) 579 0506
12
Item 7
Condensed
Consolidated Income Statement
For the year ended 31
December
2008
$m
2007
$m
Revenue
31,601
29,559
Cost of
sales
(6,598
)
(6,419
)