Interim Results - Part 1 of 2
AstraZeneca PLC
28 July 2005
AstraZeneca PLC
Second Quarter and Half Year Results 2005
'Record sales and operating profit in the first half year: year end targets
increased.'
Financial Highlights
Group 2nd Quarter 2nd Quarter Actual CER Half Year Half Year Actual CER
2005 2004 % % 2005 2004 % %
$m $m $m $m
Sales 6,132 5,288 +16 +13 11,875 10,362 +15 +12
Operating Profit 1,718 1,052 +63 +53 3,171 2,104 +51 +44
Profit before Tax 1,749 1,046 +67 +55 3,235 2,130 +52 +45
Earnings per Share $0.75 $0.48 +55 +40 $1.38 $0.95 +45 +37
All narrative in this section refers to growth rates at constant exchange rates
(CER)
• Excellent second quarter, with sales up 13 percent and operating profit up 53 percent.
• Record first half sales of $11,875 million (up 12 percent) driven by sales of key growth products (up 25
percent).
• First half operating profit up 44 percent and operating margin increased to 26.7 percent, benefiting from good
cost management and productivity improvements.
• Free cash flow of $2,855 million in the first half. Share repurchases totalled $1,182 million year to date;
target for the year increased to around $3 billion.
• The Board has recommended a 29 percent increase in first interim dividend to $0.38.
• NexiumTM sales in the first half increased by 22 percent to $2,259 million.
• Sales for CrestorTM were $590 million in the first half, up 72 percent. In the week ending 15 July, CrestorTM
share of new prescriptions in the US statin market was 6.2 percent.
• SeroquelTM sales were up 37 percent in the first half to $1,300 million.
• SymbicortTM sales were up 21 percent in the first half to $502 million. US regulatory submission confirmed
for the end of September.
• ArimidexTM sales in the first half were $553 million, up 50 percent. Sales in the last twelve months have
reached $1,007 million.
• Company now anticipates earnings per share above $2.75 for the full year.
Sir Tom McKillop, Chief Executive, said: 'Strong sales growth and productivity
gains have delivered an outstanding first half performance leading to higher
shareholder returns and an increase in financial targets for the full year.'
London, 28 July 2005
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Enquiries:
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Business Highlights All narrative in this section refers to growth rates at
constant exchange rates (CER) unless otherwise indicated
Second Quarter
Sales in the second quarter increased 13 percent at CER, or 16 percent on an as
reported basis (including a positive exchange benefit of 3 percent). Sales in
the US were up 20 percent. Good sales growth was also achieved in other markets
(up 8 percent); sales in Europe were up 8 percent and sales increased 10 percent
in Asia Pacific. Global sales of key growth products increased 28 percent.
Combined expenditures in R&D and SG&A were 3 percent lower than the second
quarter 2004 (up 1 percent as reported). This spending discipline combined with
the strong sales performance resulted in a 53 percent increase in operating
profit. Earnings per share in the second quarter were $0.75 versus $0.48 in
2004, an increase of 40 percent.
NexiumTM sales were $1,204 million in the second quarter, up 33 percent. Sales
in the US were up 35 percent versus the second quarter 2004, as a result of good
growth in dispensed tablet volume (up 17 percent) as well as destocking in the
second quarter last year. Sales in other markets were up 28 percent.
CrestorTM sales were $317 million in the second quarter. Sales in the US were
$184 million, up 63 percent. CrestorTM share of new prescriptions in the US
statin market was 6.2 percent in the week ending 15 July. In other markets
sales were up 34 percent, with good growth in France and Italy.
Sales of IressaTM were $59 million in the second quarter, with $47 million
accounted for by sales in Asia Pacific. Sales in the US were down 86 percent.
ArimidexTM continues to build upon its market leading position among aromatase
inhibitors for the treatment of breast cancer. ArimidexTM sales in the quarter
were up 51 percent, and reached $1,007 million in the last 12 months.
SymbicortTM sales were up 17 percent in the second quarter to $255 million.
SeroquelTM sales were $667 million, on strong growth in the US (up 34 percent)
and in other markets (up 37 percent).
First Half
For the first half, sales increased 12 percent at CER, or 15 percent on an as
reported basis (including a positive exchange benefit of 3 percent). Sales in
the US were up 15 percent and sales in other markets were up 8 percent. Sales
for key growth products were up 25 percent in the first half, on strong
performances for NexiumTM (up 22 percent), SeroquelTM (up 37 percent), CrestorTM
(up 72 percent), ArimidexTM (up 50 percent) and SymbicortTM (up 21 percent).
Good sales growth combined with lower expenditures in R&D and SG&A (down 3
percent at CER, in aggregate) resulted in a 44 percent increase in operating
profit for the first half. Earnings per share were $1.38 compared with $0.95
last year.
Future Prospects
Following two quarters of robust sales and excellent productivity gains, the
Company now expects to exceed the earnings guidance set at the beginning of the
year. Sales growth is now expected to approach double digits in constant
currency, and earnings per share is now anticipated to be above $2.75, implying
an operating margin around 27 percent for the full year. This performance
creates a platform for good earnings growth in the following two years.
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: the rate of growth in sales of generic omeprazole in the US,
continued growth in currently marketed products (in particular CrestorTM, Nexium
TM, 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
Gastrointestinal
Second Quarter CER % Half Year CER %
2005 2004 2005 2004
LosecTM/PrilosecTM 438 531 -21 865 1,071 -22
NexiumTM 1,204 891 +33 2,259 1,826 +22
Total 1,661 1,439 +13 3,160 2,935 +5
• NexiumTM sales in the US in the second quarter were up 35 percent versus the second quarter of 2004. Dispensed
tablet volume increased by 17 percent, well ahead of the US PPI market. The effect of price was neutral. The
reported sales growth rate was affected by wholesaler destocking last year and favourable managed care
adjustments. NexiumTM share of total prescriptions in the US PPI market was 28.5 percent in June, up 1.6
percentage points since December 2004. NexiumTM is the only leading PPI to increase market share from year-end
levels.
• First half sales of NexiumTM in the US were up 18 percent, with volume growth of 16 percent.
• NexiumTM sales in other markets were up 28 percent for the quarter and the first half.
• PrilosecTM sales in the US were down 38 percent in the second quarter and declined 37 percent in the first
half.
• In other markets, sales of LosecTM were down 16 percent in the second quarter. Sales in Japan were up 23
percent and sales in China were up 28 percent.
Cardiovascular
Second Quarter CER % Half Year CER %
2005 2004 2005 2004
SelokenTM /Toprol-XLTM 435 320 +34 843 653 +27
AtacandTM 254 216 +13 489 425 +10
PlendilTM 112 148 -26 205 259 -23
ZestrilTM 78 117 -36 165 222 -30
CrestorTM 317 207 +50 590 336 +72
Total 1,370 1,193 +12 2,627 2,248 +14
• Sales of Toprol-XLTM in the US were up 47 percent in the second quarter and 35 percent for the first half.
Reported growth rates in both periods are ahead of estimated demand growth of 30 percent as a result of
wholesaler destocking in 2004.
• Sales of SelokenTM in other markets were up 7 percent in the second quarter and 10 percent in the first half.
• AtacandTM sales in the US were up 16 percent in the second quarter and down 2 percent in the first half.
Total prescriptions in the US in the first half were down 8 percent. On 19 May the Company announced that the
US FDA has approved a new use for AtacandTM for the treatment of heart failure in patients with left
ventricular dysfunction to reduce cardiovascular death and to reduce heart failure hospitalisations. Atacand
TM is the first angiotensin receptor blocker (ARB) to provide these benefits with or without an ACE inhibitor
and is the only ARB with proven benefit when used with conventional therapy that includes both an ACE
inhibitor and a beta blocker.
• Sales of AtacandTM in other markets were up 11 percent in the second quarter and 15 percent year to date.
• CrestorTM sales in the first half were $590 million, bringing sales for the last 12 months to $1,162 million.
Since launch more than 27 million prescriptions have been dispensed to 5 million patients worldwide.
• In the US, sales of CrestorTM in the second quarter were up 63 percent to $184 million. Sales in the first
half were $338 million, an increase of 83 percent. In the week ending 15 July, CrestorTM share of new
prescriptions in the US statin market was 6.2 percent. Market share in the dynamic segment (new and switch
patients) was 7.6 percent.
• In other markets, CrestorTM sales were $133 million in the second quarter (up 34 percent) on continued strong
growth in Europe. Volume share in the statin market is now in double digits in Canada (12.3 percent), the
Netherlands (10.5 percent) and most recently, Italy (10.9 percent). Market share in France is 5.4 percent, up
another percentage point since the first quarter report.
• Sales of PlendilTM in the first half were down 23 percent as a result of the introduction of generic
felodipine into the US market in November 2004. First half sales of PlendilTM in the US declined 42 percent.
Respiratory
Second Quarter CER % Half Year CER %
2005 2004 2005 2004
SymbicortTM 255 205 +17 502 393 +21
PulmicortTM 276 244 +11 590 526 +9
RhinocortTM 112 100 +10 204 181 +11
AccolateTM 13 23 -47 41 53 -25
OxisTM 23 26 -16 46 51 -16
Total 718 639 +8 1,464 1,287 +10
• SymbicortTM sales in the first half were up 21 percent to $502 million, as the product continues to grow share
in the nearly $3 billion per annum market outside the US for fixed combination products for asthma and chronic
obstructive pulmonary disease (COPD).
• The regulatory filing for SymbicortTM in the US is on track for submission by the end of September 2005.
• In May results from the COSMOS trial were presented at the 101st International Conference of the American
Thoracic Society, which demonstrated that SymbicortTM Maintenance and Reliever Therapy (formerly Single
Inhaler Therapy) reduces the risk of severe asthma attacks by 25 percent (primary endpoint) and the total
number of severe asthma attacks by 22 percent, when compared to fluticasone/salmeterol. Results from the
COSMOS study will be added to the European regulatory file for SymbicortTM Maintenance and Reliever Therapy,
with re-submission planned before the end of 2005.
• PulmicortTM sales growth in the first half is a result of strong growth for PulmicortTM RespulesTM in the US
(up 31 percent) more than offsetting declines in sales of PulmicortTM TurbuhalerTM worldwide.
• Sales for RhinocortTM Aqua in the US were up 26 percent in the first half, as positive variances on stock
movements and managed care adjustments more than offset a small decline in total prescriptions.
Oncology
Second Quarter CER % Half Year CER %
2005 2004 2005 2004
CasodexTM 287 249 +12 564 478 +14
ZoladexTM 263 226 +12 494 439 +8
ArimidexTM 297 191 +51 553 357 +50
IressaTM 59 103 -44 140 196 -31
FaslodexTM 35 23 +52 64 49 +29
NolvadexTM 32 38 -19 60 69 -16
Total 976 834 +14 1,881 1,596 +14
• CasodexTM sales in the US were up 10 percent in the second quarter and the first half on inventory movements
and pricing. Total prescription volume was down 2 percent year to date.
• CasodexTM sales in other markets were up 13 percent in the second quarter and 15 percent year to date, chiefly
on sales growth in Japan (up 19 percent in the first half).
• In the US, sales of ArimidexTM were up 79 percent in the second quarter and 72 percent in the first half, as
inventory movements and pricing added to the 42 percent increase in total prescriptions for the first half.
In the US, ArimidexTM new prescription share for hormonal treatments for breast cancer reached 32 percent in
June, up nearly 3 percentage points since the end of last year.
• ArimidexTM sales in other markets were up 38 percent in the first half, on good growth in Europe (up 38
percent) and Japan (up 36 percent).
• On 28 June the Company announced that ArimidexTM has been granted a new indication-adjuvant treatment of
post-menopausal women with hormone receptor positive early invasive breast cancer-from the Medicines and
Healthcare Products Regulatory Agency in the UK, leading to further approvals in five other European countries
(Austria, Germany, Italy, Portugal and Spain) under the European Mutual Recognition Variation Procedure.
• IressaTM sales in the second quarter were $59 million, including $47 million of sales in Asia Pacific (up 5
percent). Sales in Japan were 17 percent lower than second quarter last year.
• IressaTM sales in the US were $7 million in the second quarter, 86 percent lower than last year. On 17 June
the Company announced a revised label for the US that indicates IressaTM is only to be used in patients who
have previously taken IressaTM and who are benefiting or have benefited from IressaTM. To implement the new
label as of 15 September 2005 AstraZeneca will initiate the IressaTM Access Program to fill renewal
prescriptions for IressaTM through a single mail order pharmacy for patients meeting the criteria set forth by
the label.
• Sales of FaslodexTM in the first half reached $64 million (up 29 percent) on strong growth in Europe since
marketing approval in March of last year. Sales in the US were up 2 percent.
Neuroscience
Second Quarter CER % Half Year CER %
2005 2004 2005 2004
SeroquelTM 667 488 +35 1,300 936 +37
ZomigTM 104 91 +12 172 186 -11
Total 1,022 866 +16 1,974 1,678 +15
• SeroquelTM sales in the second quarter were $667 million (up 35 percent) on good growth in the US (up 34
percent) and in Europe (up 62 percent), particularly Germany.
• In the US, SeroquelTM sales in the second quarter and the first half increased 34 percent, broadly in line
with estimated underlying sales growth of around 30 percent for the year to date. In June, new prescription
market share in the US was 28.7 percent, 3.8 percentage points clear of its closest competitor.
• In other markets, SeroquelTM sales in the first half were up 44 percent, on sales growth in Europe (up 59
percent) and Canada (up 27 percent).
• ZomigTM sales in the US in the second quarter were $46 million (up from $9 million in the first quarter 2005)
upon resumption of full responsibility for US commercialisation on 1 April.
• Sales of ZomigTM in other markets were up 3 percent in the second quarter and 8 percent in the first half.
Geographic Sales
Second Quarter CER % Half Year CER %
2005 2004 2005 2004
USA 2,743 2,288 +20 5,243 4,567 +15
Europe 2,197 1,928 +8 4,362 3,803 +8
Japan 399 376 +6 736 666 +9
RoW 793 696 +9 1,534 1,326 +10
• Sales in the US in the second quarter were fuelled by strong growth for NexiumTM, SeroquelTM, Toprol-XLTM,
CrestorTM, and ArimidexTM, which more than offset declines in sales of patent-expired products and of Iressa
TM.
• Sales growth in Europe in the second quarter was driven by NexiumTM (up 27 percent), Oncology products (up 22
percent), SeroquelTM (up 62 percent), SymbicortTM (up 12 percent) and CrestorTM (up 32 percent).
• Second quarter sales in Japan reflect good growth in LosecTM (up 23 percent), ZoladexTM (up 17 percent),
CasodexTM (up 18 percent) and ArimidexTM (up 33 percent).
• Sales in China increased 38 percent in the first half to $135 million, on good growth in LosecTM and the
anaesthetic products combined with the launch of IressaTM.
Operating Review
All narrative in this section refers to growth rates at constant exchange rates
(CER) unless otherwise indicated
Second Quarter
Reported sales increased by 16 percent and operating profit by 63 percent. At
constant exchange rates sales increased by 13 percent and operating profit by 53
percent.
Reported US sales growth in the second quarter of 20 percent compares to
underlying growth of 17 percent after adjusting for inventory movements and
quarterly managed care accruals. For the six months underlying US growth rates
approximate to reported rates although variances arise at the individual product
levels. Fee for service contracts are now in place with the majority of US
wholesalers.
Currency benefited reported sales by 3 percent and operating profit by 10
percent. In comparison to the second quarter last year, the dollar was weaker
against the euro (4 percent), benefiting sales, and also against the Swedish
krona (4 percent) and sterling (3 percent), increasing costs. These currency
movements, together with hedging benefits, increased earnings per share by 6
cents for the quarter.
Reported operating margin increased by 8.1 percentage points from 19.9 percent
to 28.0 percent. Currency benefited margin by 1.0 percentage points, implying
an underlying margin improvement of 7.1 percentage points.
Gross margin increased by 2.3 percentage points to 78.6 percent of sales.
Currency benefited gross margin by 1.3 percentage points. Payments to Merck at
5.0 percent of sales were 0.2 percentage points higher than the second quarter
last year, implying an underlying increase to margin of 1.2 percentage points
resulting from improved product mix and ongoing operating efficiencies.
In aggregate, R&D and SG&A expenses of $3,089 million declined 3 percent
compared to last year as disciplined expenditure management and productivity
improvements continue throughout the organization. In comparison to second
quarter last year R&D and SG&A combined added 7.9 percentage points to operating
margin. R&D expenditures decreased by 9 percent against a high comparative
quarter and through a reduction in the level of external spend on manpower and
contract research organization costs. SG&A cost growth was held flat mostly due
to lower promotional spend as product launch costs have peaked. SG&A includes a
charge of $75 million in respect of the fine levied by the European Commission
for alleged LosecTM abuse of dominant position (which will be appealed).
Lower other income reduced margin by 1.8 percentage points due principally to
the gain on disposal of the Durascan business last year.
The fair value adjustments relating to financial instruments were $2 million in
quarter two, comprising a $6 million benefit in cost of sales, a $7 million
charge to interest and a $3 million benefit to R&D.
First Half
Reported sales increased by 15 percent and operating profit by 51 percent. At
constant exchange rates sales increased by 12 percent and operating profit by 44
percent.
Currency benefited reported sales by 3 percent and operating profit by 7
percent. As a result of the recent strengthening of the dollar, current
exchange rates would suggest approximately half of the 7 cent EPS benefit
realized to date will reverse in the second half of the year.
Operating margin increased by 6.4 percent from 20.3 percent to 26.7 percent.
Underlying margin improvement was 6.0 percentage points for the half year with
currency benefiting margin by 0.4 percentage points.
Gross margin increased by 0.3 percentage points to 77.1 percent of sales. Lower
payments to Merck (4.7 percent of sales) and currency benefited gross margin by
0.1 and 0.7 percentage points respectively. The resulting underlying decline of
0.5 percent is mostly attributable to fair value adjustments of exchange
contracts and the costs of the termination of the Medpointe ZomigTM distribution
agreement in the US in the first quarter.
Cumulatively, R&D and SG&A expenses declined by 3 percent (1 percent actual
growth) compared to the same period last year. The combined decline in R&D and
SG&A added 7.3 percentage points to operating margin, with 2.7 percentage points
from R&D and 4.6 percentage points from SG&A.
Lower other income reduced margin by 0.9 percentage points due principally to
the gain on disposal of the Durascan business in the first half of last year.
Fair value adjustments relating to financial instruments and impairments
amounted to a $43 million charge for the half year, with $17 million charged to
cost of sales, $7 million charged to interest and $19 million charged to R&D.
Interest and Dividend Income
Net interest and dividend income for the first half was $64 million (2004, $26
million), with $31 million in the second quarter (2004, $6 million expense). The
increase over second quarter last year is primarily attributable to the higher
average investment balances and yields. The reported amounts include net
interest income of $11 million in the first half and $6 million in the second
quarter arising from employee benefit fund assets and liabilities as required by
IAS 19 together with a charge to interest in the first half of $7 million and $7
million in the second quarter related to fair value adjustments on bonds and
interest rate swaps.
Taxation
The effective tax rate for the half year was 29.9 percent (2004, 24.2 percent).
The increase is due to a different geographical mix of profits and no relief in
respect of the LosecTM fine. 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. For the full year the rate is anticipated to
be around 29.0 percent.
Cash Flow
Cash generated from operating activities was $3.2 billion, $1.5 billion higher
than in the first half of 2004. Higher operating profits and a reduction in
working capital of $131 million were the main drivers of this, offset by an
increase in tax paid to $810 million.
Cash inflows from investing activities of $477 million in the half year compare
with $78 million outflows in the equivalent period in 2004. The change is
primarily as a result of short-term management of funds on deposit - inflows in
the first half of $776 million compare with inflows of $443 million in the first
half of 2004. Expenditure on property, plant and equipment fell by $172 million
to $411 million.
Free cash flow (which represents net cash flows before financing activities, as
adjusted for movements in short term deposits) for the period was $2,855
million, an increase of $1,693 million. After accounting for net share
repurchases of $1,148 million, the $1,079 million dividend payment to
shareholders and foreign exchange effects, there is a $1,386 million increase in
cash and cash equivalents.
Net cash funds at 30 June 2005 of $4,536 million were $571 million higher than
31 December 2004.
Dividends
The Board has recommended a 29 percent increase in the first interim dividend to
$0.38 (21.9 pence, SEK 2.99) to be paid on 19 September 2005 to all shareholders
on the register on 12 August 2005.
Share Repurchase Programme
During the second quarter 16.6 million shares were repurchased for cancellation
at a total cost of $701 million bringing the total repurchases for the first
half of the year to 28.5 million shares at a total cost of $1,182 million. As
previously indicated it is intended that free cash flow will be fully
distributed; it is currently anticipated that share repurchases for the full
year will now increase to around $3 billion.
The total number of shares in issue at 30 June 2005 is 1,617 million.
Updated R&D Pipeline Table
An updated R&D pipeline table is available on the Company's website,
www.astrazeneca.com, under information for investors. Summaries of results of
completed clinical trials can now be found on www.astrazenecaclinicaltrials.com
and details of new or ongoing hypothesis-testing studies will also be accessible
through this site in compliance with the global industry position on disclosure
of information.
Key pipeline news include confirmation of a September US filing for SymbicortTM
pMDI for asthma, the filing target for SeroquelTM in bipolar depression being
brought forward to around the end of this year, and the movement of ZactimaTM
(AZD6474) into Phase III for treatment of solid tumours. The unexpected
preclinical finding in RET mutation has now translated into positive clinical
data in the rare medullary cell cancer of the thyroid.
A decision has been taken to move the filing for CeroviveTM (stroke) to 2007 to
allow for an increase in the size of the pivotal SAINT II trial. AZD0865
(acid-related disorders) and AZD8129 (depression/anxiety) have been withdrawn
from development following review of Phase II data. The anti-arrhythmic AZD7009
intravenous Phase II programme continues but oral studies are on hold pending a
review of non-cardiac side effects observed in the Phase II studies.
Other changes are listed in the R&D pipeline table.
Calendar
8 September 2005 Discovery presentation by Jan Lundberg (London)
27 October 2005 Announcement of third quarter and nine months results
Q4 2005 (Date TBD) Education seminar on Merck payments
2 February 2006 Announcement of fourth quarter and full year results 2005
Sir Tom McKillop
Chief Executive
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