Final Results - Part 1 of 3
AstraZeneca PLC
02 February 2006
AstraZeneca PLC
Fourth Quarter and Full Year Results 2005
'Strong growth from key products and improved efficiency drive 44 percent
increase in Earnings per Share for 2005.'
Financial Highlights
Group 4th Quarter 4th Quarter Actual CER Full Year Full Year Actual CER
2005 2004 % % 2005 2004 % %
$m $m $m $m
Sales 6,286 5,799 +8 +9 23,950 21,426 +12 +10
Operating Profit 1,636 1,271 +29 +26 6,502 4,547 +43 +39
Profit before Tax 1,689 1,295 +30 +29 6,667 4,844 +38 +34
Earnings per
Share:
Before $0.77 $0.55 +38 +37 $2.91 $2.01* +44 +41
exceptional items
Statutory $0.77 $0.55 +38 +37 $2.91 $2.18 +33 +30
* There were two exceptional items in Q3 2004, which benefited profit before tax
by $219 million and earnings per share by $0.17. Excluding these benefits,
earnings per share increased 44 percent on an as reported basis for the full
year compared with 2004.
All narrative in this section refers to growth rates at constant exchange rates
(CER) unless otherwise indicated
• Sales for the full year increased by 10 percent to $23,950 million.
• Operating profit increased by 39 percent to $6,502 million as a result of the strong sales growth and the
impact of ongoing productivity gains. Operating margin for the year increased to 27.2 percent.
• AstraZeneca product portfolio now has 10 products with annual sales of $1 billion or greater.
• Strong performance from five key products (NexiumTM, SeroquelTM, CrestorTM, ArimidexTM and SymbicortTM), with
combined sales reaching $10,849 million, up 27 percent for the full year.
• Supplemental New Drug Application submitted to US FDA in December for a new indication for SeroquelTM for the
treatment of depressive episodes associated with bipolar disorder.
• Development pipeline strengthened. Four new chemical entities have been entered into Phase III development.
• Development pipeline augmented by three licensing transactions (one Phase III compound and two Phase II
compounds) and the acquisition of KuDOS Pharmaceuticals announced in December.
• Dividend increased by 38 percent to $1.30 for the full year.
• Free cash flow of $6,052 million for the full year. Share repurchases totalled $3,001 million in 2005.
Share repurchases in 2006 are expected to be at a similar level.
• The Company anticipates EPS for 2006 in the range of $3.40 to $3.60. This includes around 45 cents of
earnings related to Toprol-XLTM for the remaining eleven months of 2006.
David Brennan, Chief Executive Officer, said: 'Strong growth from our key
products and further improvements in efficiency have contributed to
AstraZeneca's excellent financial performance. The output from our discovery
organization has grown, and new medicines from both our own and external
research have entered late stage development, including those from recent
licensing transactions. However we will do more to further strengthen our
product pipeline, and this is my number one priority.'
London, 2 February 2006
Media Enquiries: Steve Brown/Edel McCaffrey (London) (020) 7304 5033/5034
Staffan Ternby (Sodertalje) (8) 553 26107
Rachel Bloom-Baglin (Wilmington) (302) 886 7858
Analyst/Investor Enquiries: Mina Blair (London)/ Jonathan Hunt (London) (020) 7304 5084/ 5087
Staffan Ternby (Sodertalje) (8) 553 26107
Ed Seage/Jorgen Winroth (US) (302) 886 4065/(212) 579 0506
Photos of David Brennan, Chief Executive Officer, Jonathan Symonds, Chief
Financial Officer, and Dr. John Patterson, Executive Director Development are
available on www.newscast.co.uk
Business Highlights All narrative in this section refers to growth rates at
constant exchange rates (CER) unless otherwise indicated
Full Year
Sales for the full year increased 10 percent at CER, or 12 percent on an as
reported basis (including an exchange benefit of 2 percent) with good sales
growth in all regions (US up 12 percent; Europe up 8 percent; Japan up 8
percent; Rest of World up 15 percent).
Combined expenditures in R&D and SG&A were up 2 percent at CER (3 percent as
reported). Operating profit for the full year increased by 39 percent.
Earnings per share for the year were $2.91 versus $2.18 in 2004, (which included
$0.17 in exceptional benefits from a disposal gain and a tax credit). Excluding
these items from last year, earnings per share increased 41 percent. The Board
has recommended an increase in the second interim dividend to $0.92, which will
bring the dividend for the full year to $1.30, an increase of 38 percent.
The AstraZeneca portfolio now has ten products with annual sales of greater than
$1 billion. The combined sales of five key products (NexiumTM, SeroquelTM ,
CrestorTM, ArimidexTM and SymbicortTM) grew by 27 percent to $10,849 million.
NexiumTM sales were up 18 percent to $4,633 million. Sales in the US were up 15
percent to $3,125 million, on continued strong volume growth partially offset by
lower price realization. NexiumTM sales in other markets increased 25 percent.
CrestorTM sales reached $1,268 million for the full year, up 38 percent. Sales
in the US were up 34 percent. CrestorTM share of new prescriptions in the US
statin market was 6.9 percent in the week ending 20 January. Sales in other
markets increased by 41 percent on good growth in France, Italy, and Canada.
SymbicortTM sales increased 22 percent to $1,006 million. In November new
clinical trial data were published (the COSMOS dose titration study) which
demonstrate that the novel treatment concept-Symbicort Maintenance and Reliever
TherapyTM-is more effective than fixed dose fluticasone/salmeterol. The
regulatory process seeking European Union approval for Symbicort Maintenance and
Reliever TherapyTM commenced in October 2005.
ArimidexTM sales increased 44 percent to $1,181 million, on strong growth in the
US (up 59 percent) and in other markets (up 35 percent). ArimidexTM value
market share among hormonal treatments for breast cancer is now around 50
percent, more than twice the share of its closest competitor.
SeroquelTM sales reached $2,761 million (up 35 percent) including $2,003 million
in the US (up 33 percent). In the US, SeroquelTM share of new prescriptions in
the antipsychotic market increased to 29.8 percent in December, the only brand
among the top three products to grow market share in 2005. Sales in other
markets increased by 40 percent. On 30 December the Company submitted a
supplemental New Drug Application with the US FDA seeking approval for a new
indication for SeroquelTM for the treatment of patients with depressive episodes
associated with bipolar disorder. If approved, it would be the only single
agent indicated to treat both the depressive and manic episodes associated with
bipolar disorder.
The Company continues to vigorously defend its intellectual property. In
November the Company filed two lawsuits in the United States District Court for
the District of New Jersey. The first was against Teva Pharmaceuticals USA,
Inc. and Teva Pharmaceuticals Industries, Ltd. for wilful infringement of
AstraZeneca's substance patent protecting SeroquelTM. The second lawsuit was
filed against Ranbaxy Laboratories for wilful infringement of AstraZeneca's
patents protecting NexiumTM. On 17 January 2006 the Company received a decision
of Judge Rodney Sippel of the United States District Court for the Eastern
District of Missouri that found that the patents asserted by AstraZeneca that
cover Toprol-XLTM were unenforceable based on the Company's inequitable conduct
in the prosecution of these patents in the US Patent and Trademark Office and
invalid. The Company disagrees with and is disappointed by these conclusions.
The Company maintains that both patents are valid and enforceable and will
appeal the Court's decision.
Fourth Quarter
Sales in the fourth quarter were $6,286 million, up 9 percent at CER, or 8
percent on an as reported basis (including a 1 percent adverse impact from
currency movements). Sales increased 9 percent each in the US and in other
markets. Sales for the five key growth products combined grew by 21 percent,
led by SeroquelTM, NexiumTM, and ArimidexTM.
Operating profit increased by 26 percent at CER in the fourth quarter (29
percent as reported, including a 3 percent benefit from currency). Included in
the fourth quarter of this year were provisions of $105 million for
manufacturing efficiencies, whilst the comparative period included $156 million
provisions in respect of ExantaTM and IressaTM. Earnings per share in the
fourth quarter were $0.77 compared with $0.55 in 2004.
Future Prospects
The Company is determined to further strengthen its product pipeline via a
sustained commitment to discovery and development of new medicines, from within
its own laboratories and from external partnerships. AstraZeneca is in a strong
financial position from which to increase its investment in Research and
Development and utilize its strong cash generation to pursue attractive external
opportunities to augment the pipeline. Continued focus on improved productivity
remains essential to release resources for these priorities.
For 2006, the operating financial leverage stemming from good sales performance
and cost control, and the delivery of productivity gains seen in 2005 are set to
continue. On this basis, the Company expects to deliver earnings per share in
the range of $3.40 to $3.60.
Included in this target, for the remaining eleven months of the year, is around
45 cents of earnings relating to Toprol-XLTM. This represents the maximum
potential impact to earnings from Toprol-XLTM should generic companies receive
final regulatory approval and seek to launch 'at risk' before the conclusion of
the judicial appeals process. This potential impact excludes any one-time asset
or inventory adjustments that may be required.
Disclosure Notice: The preceding forward-looking statements relating to
expectations for earnings and business prospects for AstraZeneca PLC are subject
to risks and uncertainties, which may cause results to differ materially from
those set forth in the forward-looking statements. These include, but are not
limited to: when and if a generic competitor to Toprol-XLTM were introduced in
the US market prior to completion of Appellate Court process, the rate of growth
in sales of generic omeprazole in the US, continued growth in currently marketed
products (in particular CrestorTM, NexiumTM, SeroquelTM, SymbicortTM, ArimidexTM
and CasodexTM), the growth in costs and expenses, interest rate movements,
exchange rate fluctuations and the tax rate. For further details on these and
other risks and uncertainties, see AstraZeneca PLC's Securities and Exchange
Commission filings, including the 2004 Annual Report on Form 20-F.
Sales
All narrative in this section refers to growth rates at constant exchange rates
(CER) unless otherwise indicated. All sales numbers are quoted in $ million.
Gastrointestinal
Fourth Quarter CER % Full Year CER %
2005 2004 2005 2004
LosecTM/ PrilosecTM 411 446 -8 1,652 1,947 -17
NexiumTM 1,247 1,106 +13 4,633 3,883 +18
Total 1,677 1,576 +6 6,355 5,918 +5
• In the US, NexiumTM sales for the full year increased by 15 percent to $3,125 million. NexiumTM market share
of total prescriptions in the US PPI market was 30.3 percent in December, up 3.4 percentage points versus
December 2004. NexiumTM was the only branded PPI to gain market share in 2005.
• In the fourth quarter, US sales for NexiumTM were up 8 percent, as continued strong growth in dispensed
tablets (up 14 percent) was partially offset by lower realized prices resulting from performance-based
contracts and Medicaid.
• Sales of NexiumTM in other markets reached $1,508 million for the full year (up 25 percent) on a 2 point gain
in market share. Sales in the fourth quarter were up 24 percent.
• PrilosecTM sales in the US were down 28 percent for the full year. In other markets, LosecTM sales declined
15 percent, although sales increased by 25 percent in Japan and by 16 percent in China.
Cardiovascular
Fourth Quarter CER % Full Year CER %
2005 2004 2005 2004
SelokenTM / Toprol-XLTM 455 381 +19 1,735 1,387 +24
AtacandTM 247 240 +3 974 879 +8
PlendilTM 73 94 -22 360 455 -23
ZestrilTM 84 113 -26 332 440 -27
CrestorTM 353 312 +12 1,268 908 +38
Total 1,378 1,321 +4 5,332 4,777 +10
• Sales of Toprol-XLTM in the US increased by 32 percent for the full year, which was ahead of underlying
growth of 23 percent as a result of the destocking which occurred in 2004. Fourth quarter sales in the US
were up 29 percent.
• On 17 January 2006 the Company announced it had received a decision of Judge Rodney Sippel of the US District
Court for the Eastern District of Missouri that found that the patents asserted by AstraZeneca that cover
Toprol-XLTM were invalid and unenforceable. The Company disagrees with and is disappointed by these
conclusions. The Company maintains that both patents are valid and enforceable and will appeal the Court's
decision.
• Sales of SelokenTM in other markets declined 4 percent in the fourth quarter, but were up 4 percent for the
full year.
• AtacandTM sales in the US were down 8 percent for the full year, in line with the decline in total
prescriptions. Increased promotion following the launch of the heart failure claim has stabilized AtacandTM
prescription market share over the second half of 2005.
• In other markets, AtacandTM sales were up 10 percent in the fourth quarter and were up 14 percent for the
full year.
• CrestorTM has now been approved in 75 markets and launched in 69. Since first launch in early 2003 nearly 6
million patients have been treated with CrestorTM and 40 million prescriptions have been written. CrestorTM
sales for the full year reached $1,268 million, up 38 percent.
• CrestorTM sales in the US increased by 34 percent to $730 million for the full year, but were up just 4
percent against a difficult comparison versus fourth quarter last year. CrestorTM share of new prescriptions
in the US statin market was 6.9 percent in the week ending 20 January. Market share in the dynamic segment
(new and switch patients) was 8.8 percent in the latest week.
• In other markets, CrestorTM sales increased 27 percent in the fourth quarter. Sales for the full year were
up 41 percent, on good growth in Europe (up 44 percent) and Canada (up 25 percent). Volume share of the
statin market for CrestorTM is now 13.4 percent in Canada; 11.2 percent in the Netherlands; 11.7 percent in
Italy; and 6.0 percent in France.
• PlendilTM sales for the full year were down 23 percent as a result of generic competition in the US market,
where sales declined by 49 percent.
Respiratory
Fourth Quarter CER % Full Year CER %
2005 2004 2005 2004
SymbicortTM 264 219 +22 1,006 797 +22
PulmicortTM 338 313 +8 1,162 1,050 +9
RhinocortTM 92 93 -2 387 361 +6
AccolateTM 17 32 -47 72 116 -39
OxisTM 22 25 -12 91 101 -14
Total 773 722 +7 2,873 2,583 +9
• SymbicortTM sales for the full year reached $1,006 million. Sales growth was 22 percent for both the fourth
quarter and the full year, as market share continues to increase in the fast-growing combination product
segment of the asthma and COPD markets.
• The regulatory file for the pMDI formulation of SymbicortTM for the treatment of asthma in the US was
submitted on 23 September.
• In 2005 data from the STAY and COSMOS clinical trials were published. These studies are part of a large
clinical trial programme, data from which consistently indicate that the novel treatment concept-Symbicort
Maintenance and Reliever TherapyTM-prevents patients from developing potentially life-threatening asthma
attacks better than fixed dose inhaled corticosteroids or combination therapy. An application seeking
regulatory approval for this treatment concept in the European Union was submitted in October 2005.
• Sales of PulmicortTM were up 9 percent for the full year, as the 18 percent growth in the US (fuelled by a 28
percent increase in PulmicortTM RespulesTM) more than offset a 2 percent decline in other markets.
• RhinocortTM sales were up 6 percent for the full year, chiefly on sales of RhinocortTM Aqua in the US (up 7
percent), where price changes and managed care rebate adjustments more than offset the 10 percent decline in
total prescriptions.
Oncology
Fourth Quarter CER % Full Year CER %
2005 2004 2005 2004
CasodexTM 283 276 +5 1,123 1,012 +10
ZoladexTM 252 242 +5 1,004 917 +7
ArimidexTM 325 233 +40 1,181 811 +44
IressaTM 72 80 -9 273 389 -31
FaslodexTM 39 26 +50 140 99 +39
NolvadexTM 28 35 -17 114 134 -16
Total 1,001 895 +13 3,845 3,376 +12
• CasodexTM sales in the US were down 5 percent in the fourth quarter, but increased by 3 percent for the full
year to $239 million. Total prescriptions were 3 percent lower than last year.
• CasodexTM sales in other markets were up 7 percent in the fourth quarter and 11 percent for the full year,
with Japan accounting for nearly half of this sales growth.
• ArimidexTM sales increased 44 percent to $1,181 million for the full year. ArimidexTM value share of the
market for hormonal treatments for breast cancer reached 50 percent in the latest month, a share more than
twice that of its closest competitor. ArimidexTM is the leading aromatase inhibitor as a result of its
well-established profile in primary adjuvant treatment for breast cancer, where the ATAC trial demonstrated
its superiority over tamoxifen as initial adjuvant therapy. In December, data from a new meta-analysis of
three international clinical trials demonstrated that switching patients from tamoxifen therapy to ArimidexTM
results in an overall survival benefit versus remaining on tamoxifen treatment.
• In the US, sales of ArimidexTM were up 58 percent in the fourth quarter and increased 59 percent for the full
year. Total prescriptions increased by 40 percent versus last year, on a 7.1 percentage point increase in
market share.
• ArimidexTM sales in other markets increased by 31 percent in the fourth quarter. For the full year sales
were up 35 percent on excellent growth in Europe (up 35 percent) and Japan (up 27 percent).
• IressaTM sales were down 31 percent for the full year, chiefly as a result of the 63 percent decline in the
US. IressaTM sales in Asia Pacific increased 7 percent for the full year, as sales in China and other
markets more than offset a 15 percent sales decline in Japan.
• Sales for FaslodexTM for the full year reached $140 million (up 39 percent) as a result of good growth in
Europe since marketing approval in March 2004. Sales in the US were up 11 percent for the year.
• ZoladexTM sales for the full year increased 7 percent to $1,004 million, as good sales growth in other
markets (up 13 percent) more than offset a 23 percent decline in the US.
Neuroscience
Fourth Quarter CER % Full Year CER %
2005 2004 2005 2004
SeroquelTM 755 562 +34 2,761 2,027 +35
ZomigTM 94 89 +6 352 356 -3
Total 1,084 938 +16 4,059 3,496 +15
• SeroquelTM sales reached $2,761 million for the full year (up 35 percent), including $2,003 million in the
US. SeroquelTM value share of the global atypical antipsychotic market increased 2.7 percentage points in
the twelve months ended 30 September 2005.
• In the US, SeroquelTM sales were up 34 percent in the fourth quarter and increased 33 percent for the full
year, ahead of prescription growth of 20 percent as a result of higher realized prices and favourable
contract rebate adjustments. SeroquelTM share of new prescriptions in the US antipsychotic market increased
to 29.8 percent in December 2005, up 2.2 percentage points over last year.
• In other markets, SeroquelTM sales were up 35 percent in the fourth quarter. Sales for the full year
increased by 40 percent on strong growth in Europe (up 48 percent), Asia Pacific (up 22 percent) and Canada
(up 29 percent).
• In October 2005 top-line results were released from the BOLDER II study, reinforcing the findings from the
landmark BOLDER I study which demonstrate that monotherapy with SeroquelTM results in statistically
significant reductions in levels of bipolar depression compared with placebo. On 30 December a supplemental
New Drug Application was submitted to the US FDA seeking approval for SeroquelTM for the treatment of
patients with depressive episodes associated with bipolar disorder. If approved, SeroquelTM would be the
only single agent indicated to treat both the depressive and manic episodes associated with bipolar disorder.
• ZomigTM sales for the full year declined by 3 percent, as growth in other markets (up 8 percent) was more
than offset by an 18 percent decline in the US.
• DiprivanTM sales in other markets were down 8 percent for the full year. US sales declined 44 percent,
chiefly on lower prices as a result of the introduction of another generic product.
Geographic Sales
Fourth Quarter CER % Full Year CER %
2005 2004 2005 2004
US 2,907 2,657 +9 10,771 9,631 +12
Europe 2,089 1,988 +7 8,463 7,649 +8
Japan 424 412 +8 1,527 1,430 +8
RoW 866 742 +10 3,189 2,716 +11
• In the US sales were up 12 percent for the full year. Sales growth for NexiumTM, SeroquelTM, Toprol-XLTM,
ArimidexTM and CrestorTM more than offset the declines in PrilosecTM, PlendilTM, and IressaTM.
• Sales in Europe increased by 8 percent for the full year, with good volume growth partially offset by lower
realized prices. Sales for the five key products combined grew by 30 percent, which more than compensated
for a 24 percent decline in LosecTM.
• Sales in Japan were up 8 percent for the full year as a result of good growth for LosecTM, CasodexTM,
ZoladexTM and ArimidexTM.
• Sales in China were up 33 percent to $272 million for the full year on good growth in cardiovascular products
and LosecTM and the launch of IressaTM.
Operating Review
All narrative in this section refers to growth rates at constant exchange rates
(CER) unless otherwise indicated
Fourth Quarter
Reported sales increased by 8 percent and operating profit by 29 percent. At
constant exchange rates, sales increased by 9 percent and operating profit by 26
percent.
Reported US sales growth in the fourth quarter of 9 percent compares to
underlying growth of 8 percent after adjusting for a slight increase in
inventory levels in the quarter and the phasing of managed care accruals in the
prior year. Individual product level performances continue to be affected as a
result of prior year buying patterns.
Currency movements in the quarter adversely affected sales by 1 percent and
benefited operating profit by 3 percent. Overall, currency movements in the
quarter benefited EPS by 2 cents. Currency movements in the quarter compared to
quarter four last year were stronger than anticipated with the euro 9 percent
weaker than the dollar, decreasing sales, while the Swedish krona and sterling
were 15 percent and 6 percent weaker respectively, decreasing costs. This
profile yielded a net positive currency impact compared to the negative impact
anticipated at quarter three.
Reported operating margin increased by 4.0 percentage points from 22.0 percent
to 26.0 percent. Currency benefited margin by 0.7 percentage points implying an
underlying margin improvement of 3.3 percentage points for the quarter.
Gross margin increased by 3.7 percentage points to 77.9 percent of sales. The
0.1 percent benefit to gross margin due to lower payments to Merck at 4.9
percent of sales was offset by currency. Included in quarter four this year were
provisions of around $100 million for manufacturing efficiencies, however the
prior year included the ExantaTM and IressaTM provisions totalling $156 million.
Taken together this implies an underlying margin increase of 2.7 percentage
points due mostly to favourable product mix and continued operational
efficiencies.
In aggregate, R&D and SG&A expenses of $3,276 million increased 11 percent over
last year. In comparison to quarter four last year, combined R&D and SG&A
reduced operating margin by 0.9 percentage points. Reported R&D expenditures
were down 3 percent on an as reported basis, but up 1 percent over last year in
constant currency terms. SG&A increased by 15 percent over last year largely as
the result of increased product investment in the US and Rest of World markets,
together with investments in a Medicare Outreach programme to boost patient
awareness.
The fair value adjustments relating to financial instruments amounted to a $38
million benefit in quarter four; $20 million benefit in cost of sales, $22
million benefit to R&D and $4 million charge to interest.
Full Year
Reported sales increased by 12 percent and operating profit by 43 percent. At
constant exchange rates, sales increased by 10 percent and operating profit by
39 percent. Overall, exchange benefited EPS by around 8 cents.
US sales increased by 12 percent with inventory movements neutral across the
year following the successful introduction of Distribution Service Agreements.
Adjustments to managed care accruals at the half year benefited annual US sales
growth by 2 percent resulting in an underlying demand growth of 10 percent for
the year.
Operating margin increased by 6.0 percent from 21.2 percent to 27.2 percent.
Currency benefited margin by 0.4 percentage points resulting in an underlying
margin improvement of 5.6 percentage points for the year.
Gross margin increased by 1.8 percentage points to 77.6 percent of sales. Lower
payments to Merck (4.8 percent of sales) and currency each benefited gross
margin by 0.1 percentage points. Excluding prior year ExantaTM and IressaTM
provisions totalling $236 million, the costs associated with the termination of
the Medpointe ZomigTM distribution agreement in the first quarter of this year,
and the manufacturing efficiency provisions charged in the fourth quarter of
2005, underlying margin improved by 1.2 percentage points.
R&D and SG&A combined grew by 2 percent (3 percent as reported) with R&D
declining by 4 percent and SG&A growing by 4 percent. The combined effect of
these movements added 4.1 percentage points to operating margin for the full
year. Excluding the LosecTM European Commission fine and the investments made
on the Medicare Outreach programme in the fourth quarter of this year SG&A
growth was around 2 percent.
Lower other income reduced margin by 0.3 percentage points due principally to
the gain on the disposal of the Durascan business in the prior year.
The fair value adjustments relating to financial instruments amounted to a $23
million charge for the full year; $32 million charge in cost of sales, $17
million benefit to R&D and $8 million charge to interest.
Interest and Dividend Income
Net interest and dividend income for the fourth quarter was $53 million (2004
$24 million) and for the full year was $165 million (2004 $78 million). The
increase over 2004 is primarily attributable to higher average investment
balances and yields. The reported amount includes net income of $15 million in
the full year and $2 million in the fourth quarter arising from employee benefit
fund assets and liabilities as required by IAS 19.
Taxation
The effective tax rate for the fourth quarter was 27.4 percent (2004 rate
excluding exceptional items 28.3 percent) and for the twelve months was 29.1
percent (2004 rate excluding exceptional items 26.6 percent). The charge for the
year increases mainly due to the movements in provisions relating to foreign tax
credits and transfer pricing. The increase over 2004 also reflects the release
of provisions following a settlement of prior year issues in 2004, and no relief
in respect of the LosecTM fine. Taxation in 2004 also benefited from a one-off
reduction in the deferred tax liability in relation to rolled over gains
following agreements with the relevant tax authorities.
Cash Flow
Cash generated from operating activities was $6,743 million compared with $4,817
million in 2004. This increase is principally a result of a $1,955 million
increase in operating profits and the effects of a net $399 million cash inflow
from favourable movements in working capital, particularly with inventory,
offset by a $360 million increase in tax paid.
Free cash flow (which represents net cash flows before financing activities, as
adjusted for movements in short term deposits) for the year was $6,052 million
compared with $3,932 million in 2004. After accounting for net share
repurchases of $2,858 million, the $1,717 million dividend payment to
shareholders and foreign exchange effects, there is a $968 million increase in
cash and cash equivalents.
Cash outflows from investing activities of $1,182 million in the year compared
with $970 million inflows in 2004. The inflows in 2004 were mainly a result of
a change in investment strategy that led to the bulk of group cash being
transferred to more liquid funds and which require classification as cash
equivalents under IFRS, rather than short-term investments.
Capital expenditure fell by $253 million to $810 million and expenditure on
non-current asset investments was $105 million lower in 2005 as a result of the
$110 million investment in Cambridge Antibody Technology made in the fourth
quarter 2004. In 2004, the disposal proceeds of $355 million were principally in
respect of the disposal of Advanta.
Net funds at 31 December 2005 of $5,402 million were $1,406 million higher than
at 31 December 2004.
Investments
New collaboration agreements signed during 2005 with Avanir and Astex created
intangible assets worth $20 million. Further payments were made in respect of
existing licensed in products amounting to $44 million.
In December, new collaboration agreements with Protherics PLC, Targacept Inc and
Atherogenics Inc. were announced and are recorded as post balance sheet events.
We will invest $41 million in the global development and commercialisation
agreement with Protherics, being a 4.3% investment in equity and an intangible
asset. The licensing and commercialisation agreement with Atherogenics Inc.
will initially require a $50 million payment by AstraZeneca and the licensing
and research collaboration agreement with Targacept Inc. will initially require
a $10 million payment by AstraZeneca. Both of these payments will be recorded
as intangible assets.
We have also entered into an agreement to acquire the total share capital of
KuDOS Pharmaceuticals Limited for $210 million, subject to cash and working
capital adjustment. Most of the cost of the investment reflects an intangible
representing the oncology technology platform of KuDOS.
Our recent focus on licensing in opportunities with third parties will result in
additional intangible asset investment in the balance sheet. Should any of
these products fail in development, the associated intangibles will need to be
written off.
Dividends and Shareholder Return
The Board has recommended a 43 percent increase in the second interim dividend
to $0.92 (51.8 pence, 7.02 SEK) to be paid on 20 March 2006. This brings the
full year dividend to $1.30 (73.7 pence, 10.01 SEK) an increase of 38 percent.
In line with the policy stated last year the Board intends to continue its
practice of growing dividends in line with earnings (maintaining dividend cover
in the two to three times range) whilst substantially distributing the balance
of cash flow via share repurchases. In 2005 $4.7 billion was distributed from
free cash flow of $6.1 billion via dividends and share repurchases. The Board
intends to continue this policy, but firmly believes that the first call on free
cash flow is business need and, having fulfilled that, will return surplus cash
flow to shareholders. The primary business need is to build the research
pipeline by supporting internal and external opportunities. On this basis the
Board intends to repurchase shares at around the same level as 2005.
Share Repurchase Programme
During the fourth quarter, 17.9 million shares were repurchased for cancellation
at a total cost of $819 million bringing the total repurchase for the full year
to 67.7 million shares at a total cost of $3,001 million.
The total number of shares in issue at 31 December 2005 is 1,581 million.
Based on an estimate of interest income foregone, the share buy back programme
is calculated to have added 8 cents to EPS.
Updated R&D Pipeline Table
The US submission for the pMDI formulation of SymbicortTM for the fixed dose
treatment of asthma in adults and adolescents was filed on 23rd September and
the FDA review is ongoing as are US Phase III COPD studies. In Europe, where
the Turbuhaler version of SymbicortTM has been registered for a number of years
in asthma and COPD as a maintenance therapy, our enlarged submission package for
use as Maintenance and Reliever Therapy (SMART) was filed on schedule in the
third quarter and is now going through mutual recognition with Sweden as the
reference member state. The European development programme for the pMDI version
of SymbicortTM is being expanded to include data on two extra strengths of the
product. This will allow easier switching between the existing TurbuhalerTM and
the new pMDI device. Data will be ready to supplement the registration package
in 2008.
New data on CrestorTM will be presented in the first half of 2006, including the
top line results of the ASTEROID study, looking at the effect of CrestorTM on
the regression of coronary artery atheroma. The results of recently completed
pharmacoepidemiology studies will also be presented during this time period.
The European and US submissions for the Sustained Release formulation of
SeroquelTM for the treatment of schizophrenia is now scheduled for Q3 2006.
SeroquelTM is now in Phase III development for Generalised Anxiety Disorder
(GAD) and Major Depressive Disorder (MDD) using the Sustained Release
formulation.
ExantaTM was submitted to the European regulatory authorities in December 2005
under the new centralised procedure for the indication of prevention of stroke
in atrial fibrillation. In the US, the company continues discussions with the
FDA, but the current assessment is that it is unlikely a way forward for Exanta
TM registration in the US will be identified.
ZactimaTM, a VEGF/EGF TKI inhibitor for the treatment of NSCLC and medullary
thyroid cancer, has been granted fast track and orphan status by the FDA for the
thyroid indication. In January 2006, the EU COMP (Committee for Orphan
Medicinal Products) positive opinion of December 2005 regarding orphan drug
status for ZactimaTM in the treatment of medullary thyroid cancer, was adopted.
The submission target dates for GalidaTM, a PPAR agonist for diabetes/metabolic
syndrome, currently 2H 2007 for the US and Europe, are subject to the results of
Phase III studies currently ongoing and regulatory discussions.
AZD6140, an ADP receptor antagonist being developed in the area of arterial
thrombosis, has progressed to Phase III for the treatment of acute coronary
syndrome.
Phase II data on AZD0837 has confirmed that it could be differentiated from
ExantaTM with regard to the liver signal but also showed a short half-life,
which precludes once daily dosing. It has been decided to develop this product
through an extended release formulation, and whilst early data shows that such a
formulation is feasible, AZD0837 will not enter Phase III development for launch
until data on the definitive formulation has been generated which could take up
to two years.
In December 2005 rights to a late Phase III compound (AGI-1067) for the
treatment of atherosclerosis were obtained from Atherogenics Inc. Two compounds
in Phase II development were also acquired: TC-1734, a product for the treatment
of Alzheimer's disease from Targacept Inc, and CytofabTM, Protherics's compound
in development for the treatment of severe sepsis.
Our oncology discovery capability and early pipeline has been further
strengthened by the acquisition of KuDOS Pharmaceuticals.
An updated R&D pipeline table is appended to this press release and is also
available on the Company's website, www.astrazeneca.com under information for
investors.
Calendar
14 March 2006 Education seminar on Merck payments
27 April 2006 Announcement of first quarter 2006 results
27 April 2006 Annual General Meeting 2006
8 June 2006 Business Review meeting (London)
27 July 2006 Announcement of second quarter and half year 2006 results
26 October 2006 Announcement of third quarter and nine months 2006 results
David Brennan
Chief Executive Officer
This information is provided by RNS
The company news service from the London Stock Exchange
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