3rd Quarter Results (1 of 2)
AstraZeneca PLC
27 October 2005
AstraZeneca PLC
Third Quarter and Nine Months Results 2005
'A strong third quarter with sales up 9 percent and Earnings per Share up 52
percent: year end targets increased.'
Financial Highlights
Group 3rd Quarter 3rd Quarter Actual CER 9 Months 9 Months Actual CER
2005 2004 % % 2005 2004 % %
$m $m $m $m
Sales 5,789 5,265 +10 +9 17,664 15,627 +13 +10
Operating Profit 1,695 1,172 +45 +45 4,866 3,276 +49 +44
Profit before Tax 1,743 1,419* +23 +23 4,978 3,549* +40 +36
Earnings per Share:
Before non-recurring
items $0.76 $0.51 +49 +52 $2.14 $1.46 +46 +42
Statutory $0.76 $0.68* +12 +13 $2.14 $1.63* +31 +27
* There were two non-recurring 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 52 percent at CER in the third quarter and 42
percent for the nine months compared with 2004.
All narrative in this section refers to growth rates at constant exchange rates
(CER) unless otherwise indicated
• Third quarter sales increased by 9 percent to $5,789 million and
operating profit increased by 45 percent to $1,695 million.
• Sales increase was driven by the strong performance of 5 key growth
products (NexiumTM, CrestorTM, SymbicortTM, ArimidexTM and SeroquelTM) whose
combined sales increased by 25 percent.
• Sales for the nine months increased by 10 percent and operating profit
by 44 percent. Operating margin for the nine months was 27.5 percent of sales.
• Free cash flow of $4,294 million for the nine months. Share
repurchases totalled $2,182 million year to date.
• NexiumTM sales in the third quarter were $1,127 million, up 18
percent.
• CrestorTM sales in the third quarter were $325 million, up 23 percent.
In the week ending 14 October, CrestorTM share of new prescriptions in the US
statin market was 6.8 percent.
• SymbicortTM sales in the third quarter were $240 million, up 28
percent. US regulatory application for the pMDI formulation for the treatment
of asthma was submitted on 23 September.
• ArimidexTM sales in the third quarter were $303 million, up 36
percent. Share of total prescriptions in the US market is up 6.3 percentage
points since December.
• SeroquelTM sales in the third quarter were $706 million, up 32
percent.
• The Company now anticipates earnings per share between $2.85 and $2.95
for the full year.
Sir Tom McKillop, Chief Executive, said: 'A continued strong sales performance,
especially for the five key growth products, together with benefits arising from
productivity initiatives across the entire Company has produced an outstanding
result for the nine months, and is reflected in an increase in our financial
targets for the full year.'
London, 27 October 2005
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) (020) 7304 5084
Jonathan Hunt (London) (020) 7304 5087
Staffan Ternby (Sodertalje) (8) 553 26107
Ed Seage/Jorgen Winroth (US) (302) 886 4065/(212) 579 0506
Photos of Jonathan Symonds, Chief Financial Officer are available on
www.newscast.co.uk. Broadcast footage of AstraZeneca products and activities is
available on www.thenewsmarket.com/astrazeneca
Business Highlights All narrative in this section refers to growth rates at
constant exchange rates (CER) unless otherwise indicated
Third Quarter
Sales in the third quarter increased by 9 percent at CER, or 10 percent on an as
reported basis (including an exchange benefit of 1 percent), with good sales
growth in all regions (US up 9 percent; Europe up 8 percent; Japan up 6 percent;
Rest of World up 13 percent).
Combined expenditures in R&D and SG&A were up 2 percent at CER and as reported,
with currency having no impact. Operating profit in the third quarter was up 45
percent. Earnings per share were $0.76 versus $0.68 in 2004, which included
$0.17 in non-recurring benefits from a disposal gain and a tax credit.
Excluding these items from last year, third quarter earnings per share increased
52 percent.
Sales growth was driven by the strong performance of 5 key growth products
(NexiumTM, CrestorTM, SymbicortTM, ArimidexTM and SeroquelTM) whose combined
sales increased 25 percent to $2,701 million.
NexiumTM sales were up 18 percent to $1,127 million on good growth in the US (up
17 percent) and in other markets (up 19 percent).
CrestorTM sales in the quarter increased 23 percent to $325 million, including
$189 million in the US. CrestorTM share of new prescriptions in the US statin
market was 6.8 percent in the week ending 14 October, up from 5.9 percent for
the month of June.
SymbicortTM sales were $240 million, up 28 percent. The US regulatory
application for the pMDI formulation of SymbicortTM for the treatment of asthma
was submitted on 23 September.
Quarterly sales for ArimidexTM exceeded $300 million for the first time (up 36
percent to $303 million), building upon its market leading position among
aromatase inhibitors for the treatment of breast cancer.
SeroquelTM sales were $706 million, on strong growth in the US (up 30 percent)
and in other markets (up 41 percent).
Since September, the Company has received notifications containing paragraph IV
certifications alleging invalidity and non-infringement in respect of certain of
AstraZeneca's patents relating to PulmicortTM RespulesTM, SeroquelTM, and
NexiumTM. The Company continues to have full confidence in its intellectual
property protecting these products.
Nine Months
For the nine months, sales increased 10 percent at CER, or 13 percent on an as
reported basis (including an exchange benefit of 3 percent). Sales increased 13
percent in the US and were up 8 percent in other markets. Sales growth for the
nine months was fuelled by NexiumTM (up 20 percent), CrestorTM (up 51 percent),
SymbicortTM (up 22 percent), ArimidexTM (up 45 percent) and SeroquelTM (up 35
percent). Combined sales for these five products were $7,905 million, up 29
percent.
The sustained focus on productivity throughout the organization continues to
yield benefits ahead of initial expectations. The 44 percent increase in
operating profit derives from strong sales growth and the impact of ongoing
productivity gains. Activity-related costs, particularly in R&D, are lower year
to date, but will increase as larger scale clinical trials commence in support
of an emerging late stage product pipeline, including ZactimaTM and AZD2171.
Earnings per share were $2.14 compared with $1.63 last year. Excluding the
$0.17 in non-recurring gains in 2004, earnings per share increased by 42 percent
for the nine months.
Future Prospects
The Company continues to anticipate sales growth around the double digits mark
for the full year in constant currency terms. This sales growth, combined with
excellent progress in improving productivity, should result in earnings per
share for the full year between $2.85 and $2.95.
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,
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
Gastrointestinal
Third Quarter CER % Nine Months CER %
2005 2004 2005 2004
LosecTM/ PrilosecTM 376 430 -15 1,241 1,501 -20
NexiumTM 1,127 951 +18 3,386 2,777 +20
Total 1,518 1,407 +7 4,678 4,342 +6
• Third quarter sales for NexiumTM in the US were up 17 percent versus the
third quarter 2004, which was affected by some wholesaler destocking.
Dispensed tablet growth of 13 percent was partially offset by lower realised
prices. NexiumTM share of total prescriptions in the US PPI market was 29.1
percent in September, up 2.2 percentage points since December.
• US sales for NexiumTM for the nine months were up 18 percent.
• Sales of NexiumTM in other markets were up 19 percent in the quarter and
25 percent year to date, with particularly strong growth achieved in France
and Germany.
• PrilosecTM sales in the US for the nine months were down 33 percent. In
other markets, LosecTM sales declined 18 percent, although sales increased
by 27 percent in Japan and by 22 percent in China.
Cardiovascular
Third Quarter CER % Nine Months CER %
2005 2004 2005 2004
SelokenTM / Toprol-XLTM 437 353 +23 1,280 1,006 +26
AtacandTM 238 214 +9 727 639 +10
PlendilTM 82 102 -22 287 361 -22
ZestrilTM 83 105 -22 248 327 -27
CrestorTM 325 260 +23 915 596 +51
Total 1,327 1,208 +9 3,954 3,456 +11
• Sales of Toprol-XLTM in the US were up 31 percent for the quarter and 33
percent for the nine months, still running ahead of estimated underlying
growth of 24 percent year to date as a result of destocking which occurred
during 2004.
• Sales of SelokenTM in other markets were up 3 percent in the third
quarter and 7 percent for the nine months.
• AtacandTM sales in the US were down 11 percent in the third quarter and
down 5 percent for the nine months. Increased promotion following the
launch of the heart failure indication has stabilised AtacandTM prescription
market share in the US over the last several months.
• In other markets, AtacandTM sales increased 18 percent in the third
quarter and increased 16 percent year to date.
• In the US, CrestorTM sales increased 17 percent in the third quarter to
$189 million. CrestorTM share of new prescriptions in the US statin market
was 6.8 percent in the week ending 14 October. Market share in the dynamic
segment (new and switch patients) was 9.9 percent in the latest week. US
sales for the nine months were up 52 percent.
• In other markets, CrestorTM sales increased 34 percent in the third
quarter and were up 48 percent year to date, with France and Italy
contributing to a strong performance in Europe (up 51 percent year to date).
Volume share of the statin market for CrestorTM is now 12.4 percent in Canada;
10.4 percent in the Netherlands; 11.7 percent in Italy; and 5.7 percent in
France.
• PlendilTM sales are down 22 percent in the quarter and year to date as a
result of generic competition in the US market, where sales for the nine
months are down 44 percent.
Respiratory
Third Quarter CER % Nine Months CER %
2005 2004 2005 2004
SymbicortTM 240 185 +28 742 578 +22
PulmicortTM 234 211 +10 824 737 +10
RhinocortTM 91 87 +4 295 268 +9
AccolateTM 14 31 -55 55 84 -36
OxisTM 23 25 -12 69 76 -14
Total 636 574 +10 2,100 1,861 +10
• Sales of SymbicortTM increased 28 percent to $240 million in the third
quarter. Sales for the nine months were up 22 percent. The regulatory file
for the pMDI formulation of SymbicortTM for the treatment of asthma in the
US was submitted on 23 September. A European Union mutual recognition
variation procedure for a new asthma treatment concept, SymbicortTM
Maintenance and Reliever Therapy, was initiated on 26 October.
• Worldwide sales of PulmicortTM continue to be driven by the growth of
PulmicortTM RespulesTM in the US, where sales were up 43 percent in the
quarter and 34 percent for the nine months as a result of good underlying
growth and some wholesaler stock movements between the two periods.
• RhinocortTM sales year to date are up 9 percent, chiefly on sales of
RhinocortTM Aqua in the US market (up 11 percent), which has been favourably
impacted by price changes and managed care rebate adjustments. RhinocortTM
Aqua prescriptions in the US are down 8 percent through nine months.
Oncology
Third Quarter CER % Nine Months CER %
2005 2004 2005 2004
CasodexTM 276 258 +7 840 736 +11
ZoladexTM 258 236 +7 752 675 +7
ArimidexTM 303 221 +36 856 578 +45
IressaTM 61 113 -46 201 309 -36
FaslodexTM 37 24 +50 101 73 +35
NolvadexTM 26 30 -13 86 99 -15
Total 963 885 +8 2,844 2,481 +12
• CasodexTM sales in the US were down 2 percent in the third quarter,
broadly in line with the prescription trend. Sales for the nine months were
up 6 percent on inventory movements and pricing.
• CasodexTM sales in other markets were up 10 percent in the quarter and
up 14 percent for the nine months. For the nine months, CasodexTM sales were
up 10 percent in Europe and increased 18 percent in Japan.
• In the US, sales of ArimidexTM were up 40 percent in the quarter and up
59 percent for the nine months. Growth in total prescriptions was 42 percent
year to date. ArimidexTM share of total prescriptions for hormonal treatments
for breast cancer in the US increased to 33.2 percent in September, up another
1.6 percentage points in the quarter and 6.3 percentage points higher since the
beginning of the year.
• ArimidexTM sales in other markets were up 34 percent in the third
quarter and up 37 percent for the nine months, on strong year to date sales
in Europe (up 36 percent) and Japan (up 31 percent).
• Sales of IressaTM in the third quarter were $61 million, including $46
million of sales in Asia Pacific (up 7 percent in the quarter). For the nine
months, sales in Asia Pacific were up 9 percent, as sales in China and other
markets more than offset the 14 percent sales decline in Japan.
• In the US, sales of IressaTM were $12 million in the third quarter,
consistent with labelling which restricts usage to patients who have
previously taken the product and are benefiting from its use.
• Sales for FaslodexTM for the nine months reached $101 million (up 35
percent), chiefly on growth in Europe since marketing approval in March of
last year. Sales in the US for the nine months were up 8 percent to $67
million.
Neuroscience
Third Quarter CER % Nine Months CER %
2005 2004 2005 2004
SeroquelTM 706 529 +32 2,006 1,465 +35
ZomigTM 86 81 +5 258 267 -6
Total 1,001 880 +13 2,975 2,558 +14
• In the US, SeroquelTM sales were up 30 percent in the third quarter and
up 33 percent for the nine months, broadly in line with underlying sales
growth. In September, SeroquelTM new prescription market share in the US
increased to 29.7 percent, the only brand among the top three products to
grow share this year.
• In other markets, SeroquelTM sales were up 41 percent in the third
quarter and 43 percent for the nine months, on a strong year to date
performance in Europe (up 53 percent) and Canada (up 32 percent).
• ZomigTM sales in the US were down 7 percent in the third quarter. Total
prescriptions declined by 5 percent in the quarter. Year to date, sales
were down 27 percent as a result of the low first quarter sales ahead of the
transfer of distribution rights from Medpointe back to AstraZeneca on
1 April.
• Sales of ZomigTM in other markets were up 11 percent in the third
quarter and 9 percent year to date.
Geographic Sales
Third Quarter CER % Nine Months CER %
2005 2004 2005 2004
US 2,621 2,407 +9 7,864 6,974 +13
Europe 2,012 1,858 +8 6,374 5,661 +8
Japan 367 352 +6 1,103 1,018 +8
RoW 789 648 +13 2,323 1,974 +11
• Sales in the US in the third quarter represent strong performances for
the key growth products and Toprol-XLTM, which more than offset declines in
sales of patent expired products and IressaTM.
• The third quarter sales performance in Europe was led by the 5 key
growers (up 27 percent), which more than offset an 18 percent decline in
LosecTM.
• Third quarter sales in Japan reflect continued strong growth for LosecTM
(up 35 percent), CasodexTM (up 15 percent), ZoladexTM (up 11 percent) and
ArimidexTM (up 24 percent).
• Sales in China increased 25 percent to $61 million in the third quarter
on good growth in 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
Third Quarter
Reported sales increased by 10 percent and operating profit by 45 percent. At
constant exchange rates, sales increased by 9 percent and operating profit by 45
percent. Following the successful introduction of Distribution Service
Agreements in the US, reported Group and US sales reflect underlying demand.
Wholesaler buying patterns in the prior year, however, continue to affect some
individual product performances.
Currency had a 1 percent benefit to sales and was neutral to operating profit.
In comparison to quarter three last year the dollar was slightly weaker against
the euro, benefiting sales, and stronger against the Swedish krona (2 percent)
and sterling (2 percent), decreasing costs. Overall, currency depressed EPS by
1 cent as the beneficial exchange rate profile was offset by hedging benefits
from 2004 not being repeated during the quarter.
Reported operating margin increased by 7.0 percentage points from 22.3 percent
to 29.3 percent. Currency reduced margin by 0.3 percentage points and other
income increased margin by 0.2 percentage points resulting in an underlying
margin improvement of 7.1 percentage points for the quarter.
Gross margin increased by 2.9 percentage points to 78.5 percent of sales.
Currency depressed gross margin by 0.7 percentage points and payments to Merck
were level with prior year at 4.8 percent of sales. Included in the third
quarter last year are ExantaTM inventory and asset provisions of $80 million
which depressed gross margin and, when excluded, implies a 1.9 percentage point
underlying improvement for the quarter, due mostly to improved product mix and
operational efficiencies.
In aggregate, R&D and SG&A expenses of $2,837 million increased 2 percent over
last year. In comparison to third quarter last year, R&D and SG&A combined added
3.5 percentage points to operating margin. The sustained focus on productivity,
combined with the lower level of late stage clinical trials compared with 2004,
resulted in R&D expenditures decreasing by 4 percent for the quarter. SG&A
increased by 4 percent for the quarter primarily due to increased investment in
the US on NexiumTM, CrestorTM and SeroquelTM over prior year.
The fair value adjustments relating to financial instruments amounted to an $18
million benefit in quarter three; $5 million benefit in cost of sales, $3
million benefit to interest and $10 million benefit to R&D.
Nine Months
Reported sales increased by 13 percent and operating profit by 49 percent. At
constant exchange rates, sales increased by 10 percent and operating profit by
44 percent.
Currency benefited reported sales by 3 percent and operating profit by 5
percent. Cumulatively, exchange has benefited EPS by around 6 cents. We expect
to see a 2 to 3 cents reduction in the year to date benefit during quarter four
based on the current strengthening of the dollar and the hedging benefits
realized in quarter four 2004 not being repeated.
Operating margin increased by 6.5 percent from 21.0 percent to 27.5 percent.
Underlying margin improvement was 7.0 percentage points for the nine months as
the currency benefit of 0.1 percentage points was offset by a reduction in
margin of 0.6 percent from other income, due principally to the gain on the
disposal of the Durascan business last year.
Gross margin increased by 1.1 percentage points to 77.5 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 provisions and
the costs associated with the termination of the Medpointe ZomigTM distribution
agreement in the first quarter of this year, underlying margin improved by 0.4
percentage points.
Benefits from ongoing productivity initiatives, together with a low point in the
R&D and SG&A investment cycle, have resulted in a 2 percent decline (up 1
percent as reported) in combined R&D and SG&A expense year to date. In
comparison to the first nine months last year, R&D and SG&A combined added 6.0
percentage points to operating margin.
The fair value adjustments relating to financial instruments amounted to a $61
million charge for the nine months; $52 million charge in cost of sales, $4
million charge to interest and $5 million charge to R&D.
Interest and Dividend Income
Net interest and dividend income for the third quarter was $48 million (2004 $28
million) and for the nine months was $112 million (2004 $54 million). The
increase over 2004 is primarily attributable to higher average investment
balances and yields. The reported amount includes net income of $13 million in
the first nine months and $3 million in the third quarter arising from employer
benefit fund assets and liabilities as required by IAS 19.
Taxation
The effective tax rate for the third quarter was 29.4 percent (2004, rate
excluding non-recurring items 28.9 percent) and for the nine months was 29.8
percent (2004, rate excluding non-recurring items 25.9 percent). The increase
over 2004 is due to a different geographical mix of profits 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. For the full year, the
rate is anticipated to be in the 29 to 30 percent range.
Cash Flow
Cash generated from operating activities was $4,814 million; $2,015 million
higher than in the first nine months of 2004. This is as a result of a $1,590
million increase in operating profits and a net $590 million cash improvement in
working capital, primarily due to lower inventory levels and higher creditor
levels.
Cash outflows from investing activities of $621 million in the first nine months
compare with $694 million outflows in the equivalent period in 2004. Capital
expenditure fell by $247 million to $586 million. In the comparative period for
2004, $308 million disposal proceeds were received in respect of disposals of
business operations.
Free cash flow (which represents net cash flows before financing activities, as
adjusted for movements in short term deposits) for the period was $4,294
million. After accounting for net share repurchases of $2,106 million, the
$1,717 million dividend payment to shareholders and foreign exchange effects,
there is a $362 million increase in cash and cash equivalents.
Net funds at 30 September 2005 of $4,398 million were $433 million higher than
31 December 2004.
Share Repurchase Programme
During the third quarter, 21.3 million shares were repurchased for cancellation
at a total cost of $1 billion bringing the total repurchase for the first nine
months of the year to 49.8 million shares at a total cost of $2,182 million.
For the full year share repurchases are expected to exceed $3 billion.
The total number of shares in issue at 30 September 2005 is 1,597 million.
R&D Update
Development of AZD2171, a Vascular Endothelial Growth Factor (VEGF) signalling
inhibitor for the treatment of solid tumours, is being accelerated into a Phase
II/III clinical programme.
In addition to the submission of a US NDA for SymbicortTM pMDI for the treatment
of asthma, an EU mutual recognition variation procedure for a new asthma
concept, SymbicortTM Maintenance and Reliever Therapy was initiated on 26
October.
A US regulatory submission to support the use of SeroquelTM in bipolar
depression will be made around the end of 2005 based on the results of two
successful pivotal studies (BOLDER I and II) in this indication.
Regulatory submissions for CeroviveTM, a novel free-radical trapping
neuroprotective agent for the acute treatment of ischaemic stroke, are now
scheduled for H1 2007 subject to the outcome of the CHANT and SAINT II studies.
The CHANT study evaluating CeroviveTM in patients with haemorrhagic stroke is
now fully recruited and results will be available in Q1 2006.
The development of the oral extended release formulation of AZD7009 for
maintenance of sinus rhythm after conversion of atrial fibrillation has been
terminated. The intravenous programme targeted at conversion of patients from
atrial fibrillation to sinus rhythm remains in Phase II.
The Phase II project evaluating AZD7371 for the treatment of overactive bladder
has also been terminated.
A complete update of the AstraZeneca development pipeline will be provided as a
part of the 2005 Annual Results presentation.
Calendar
2 February 2006 Announcement of fourth quarter and full year 2005 results
27 April 2006 Announcement of first quarter 2006 results
27 April 2006 Annual General Meeting 2006
27 July 2006 Announcement of second quarter and half year 2006 results
26 October 2006 Announcement of third quarter and nine months 2006 results
Sir Tom McKillop
Chief Executive
This information is provided by RNS
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