Interim Results - Part 1 of 2
AstraZeneca PLC
22 July 2004
AstraZeneca PLC
Second Quarter and Half Year Results 2004
'Strong performance from growth products delivers 11 percent increase in sales
for the second quarter. Dividend increased by 15 percent.'
Financial Highlights
Group 2nd Quarter 2nd Quarter Actual CER Half Year Half Year Actual CER
2004 2003 % % 2004 2003 % %
$m $m $m $m
Sales 5,288 4,436 +19 +11 10,362 9,171 +13 +5
Operating Profit 1,111 889 +25 +15 2,190 2,161 +1 -5
Profit before Tax 1,139 921 +24 +15 2,247 2,214 +1 -5
Earnings per Share $ 0.50 $ 0.39 +28 +18 $ 0.97 $ 0.93 +4 -3
All narrative in this section refers to growth rates at constant exchange rates
(CER)
• Second quarter sales were $5,288 million, up 11 percent. Sales in the
first half were $10,362 million, up 5 percent.
• Second quarter sales in the US increased by 17 percent, resulting in 3
percent growth for the first half. In markets outside the US, first half
sales growth was 7 percent.
• Adjusted for wholesaler stock movements, sales for key growth products
in the first half increased by approximately 35 percent.
• Operating profit in the second quarter was up 15 percent. For the
first half, operating profit was down 5 percent as a result of the phasing of
investments in R&D and SG&A.
• Other income of $129 million in the second quarter includes the gain
on the sale of the Durascan generics business in Denmark.
• The Board has recommended a 15 percent increase in first interim
dividend to $0.295.
• NexiumTM sales in the first half increased by 20 percent to $1,826
million.
• Sales for CrestorTM were $336 million in the first half. In the week
ending 9 July, CrestorTM share of new prescriptions in the US statin market
was 6.8 percent.
• SeroquelTM sales were up 27 percent in the first half to $936 million.
New clinical data demonstrating efficacy in the treatment of bipolar
depression was presented at the American Psychiatric Association congress on 6
May.
• First launch for ExantaTM occurred in Germany on 21 June, for the
prevention of venous thromboembolism associated with hip and knee replacement
surgery.
• Company continues to anticipate earnings per share in the range of
$2.00 to $2.15.
Sir Tom McKillop, Chief Executive, said: 'The 35 percent increase in sales of
growth products, with strong performances from ArimidexTM, CrestorTM, IressaTM,
NexiumTM, SeroquelTM and SymbicortTM contributed to a good first half. Although
the world pharmaceutical market is becoming increasingly challenging,
AstraZeneca is well placed with its newer products to deliver good growth.'
London, 22 July 2004
Photos of Sir Tom McKillop, Chief Executive and 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.
Media Enquiries: Steve Brown/Edel McCaffrey (London) (020) 7304 5033/5034
Staffan Ternby (Sodertalje) (8) 553 26107
Rachel Bloom (Wilmington) (302) 886 7858
Analyst/Investor Mina Blair-Robinson (London) (020) 7304 5084
Enquiries:
Jonathan Hunt (London) (020) 7304 5087
Staffan Ternby (Sodertalje) (8) 553 26107
Ed Seage/Jorgen Winroth (USA) (302) 886 4065/(212) 579 0506
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 were $5,288 million, up 19 percent on a reported
basis, including a positive exchange benefit of 8 percent. Sales outside the US
were up 7 percent. In the US second quarter sales increased by 17 percent
versus 2003. Excluding inventory movements, underlying growth in the US was
estimated to be 11 percent. Further analysis of the stock movements in the
current and prior periods is found on page 6 of this press release.
Expenditures in R&D and SG&A were $3,042 million in the second quarter, broadly
in line with the level of spending in the last several quarters, but up 14
percent in CER terms versus the second quarter 2003 (up 24 percent on a reported
basis, including a 10 percent currency impact). Operating profit was up 15
percent at CER (up 25 percent as reported). Earnings per share in the second
quarter was $0.50 versus $0.39 in 2003.
In the US market, good underlying growth was seen for NexiumTM (up 14 percent),
Toprol-XLTM (up 27 percent), SeroquelTM (up 30 percent) and ArimidexTM (up 46
percent). New products also contributed to the strong quarter. IressaTM sales
were $49 million, with prescriptions up 17 percent versus the first quarter
2004. CrestorTM sales were $113 million. In a highly competitive statin
market, CrestorTM share of new prescriptions in the week ending 9 July was 6.8
percent. The unfounded challenges to CrestorTM safety have impacted somewhat
upon the excellent progress being made in the market. The Company reaffirms its
confidence in CrestorTM, with its outstanding efficacy at a comparable risk to
the currently marketed statins.
Sales outside the US reflected strong growth for SeroquelTM (up 36 percent),
NexiumTM (up 27 percent), SymbicortTM (up 42 percent) and ArimidexTM (up 45
percent). The most recently launched products also performed well. CrestorTM
sales outside the US were $94 million; IressaTM sales were $54 million, up 65
percent.
The successful completion of the European Union Mutual Recognition Procedure for
the first indication for ExantaTM-prevention of venous thromboembolic events in
elective hip and knee replacement surgery-was announced on 5 May. Germany was
the first country to launch, on 21 June. Regulatory submissions for the first
chronic indications, including the prevention of stroke in patients with atrial
fibrillation, remain under review in the EU and the US.
First Half
First half sales were $10,362 million, up 13 percent on a reported basis,
including a positive exchange benefit of 8 percent. Sales outside the US
increased by 7 percent. In the US, the second quarter sales performance lifted
the reported growth rate in the first half to 3 percent over last year. This
remains below the estimated underlying growth of 11 percent as a result of a net
destocking versus the first half of last year, together with a recalibration of
excess inventory as further experience has been gained in the implementation of
inventory management agreements.
Operating profit in the first half was up 1 percent on a reported basis, but was
down 5 percent in CER terms. Earnings per share was $0.97 for the first half
versus $0.93 in 2003. The Board has recommended a 15 percent increase in first
interim dividend to $0.295 (16.0 pence; SEK 2.20) to be paid on 20 September
2004.
Future Prospects
The Company continues to anticipate full year earnings per share in the range of
$2.00 to $2.15. As previously indicated, strong earnings growth is expected in
the second half, fuelled by continuing strong performance from the key growth
products and a slowing in the rate of cost growth. Factors which may mitigate
include overall US prescription volumes, net realised prices and the reversal of
some of the year to date currency benefits.
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 IressaTM), the successful
registration and launch of ExantaTM, 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 Annual Report and
Form 20-F Information 2003.
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 %
2004 2003 2004 2003
LosecTM/PrilosecTM 531 714 -33 1,071 1,406 -32
NexiumTM 891 631 +36 1,826 1,466 +20
Total 1,439 1,362 - 2,935 2,907 -6
• Second quarter sales for NexiumTM in the US were up 39 percent. Though
trade inventories were reduced during the quarter, the destocking was less
than the second quarter last year. Total prescriptions in the US for NexiumTM
were up 10.6 percent in the second quarter versus last year, with total
tablets dispensed up 18 percent. New prescription volume in the US PPI market
has softened as a result of competition from PrilosecTM OTC, however, NexiumTM
new prescription market share in June is up 0.4 points from March.
• NexiumTM sales in the US for the first half increased by 16 percent,
which remains somewhat below estimated underlying growth of 22 percent.
• NexiumTM sales outside the US were up 27 percent in the second quarter
and up 32 percent in the first half, with good growth in France (up 38
percent) and Germany (up 26 percent).
• PrilosecTM sales in the US were down 60 percent in the second quarter
and 64 percent in the first half, in line with a 69 percent decline in
prescriptions through June year to date.
• Outside the US, sales of LosecTM were down 13 percent in the quarter and
10 percent year to date, although sales in Japan were up 23 percent in the
first half.
Cardiovascular
Second Quarter CER % Half Year CER %
2004 2003 2004 2003
SelokenTM /Toprol-XLTM 320 380 -19 653 748 -16
AtacandTM 216 152 +30 425 358 +8
PlendilTM 148 129 +10 259 239 +2
ZestrilTM 117 118 -10 222 226 -13
CrestorTM 207 9 n/m 336 12 n/m
Total 1,193 967 +15 2,248 1,936 +8
• Toprol-XLTM trade inventories in the US continued to unwind during the
second quarter. As a result, reported sales in the US were down 26 percent
versus last year. For the first half, sales growth in the US (down 21
percent) remains significantly below the 19 percent increase in total
prescriptions through June. SelokenTM sales outside the US were up 6 percent
in the quarter and 4 percent in the first half.
• AtacandTM prescriptions in the US were slightly lower in the first half
(down 2 percent). Reported sales growth in the first half (down 9 percent)
represents partial recovery from the 33 percent decline in the first quarter
due to inventory movements. AtacandTM sales outside the US were up 18 percent
in the first half.
• Regulatory applications have been submitted in the EU and the US seeking
approval for a new indication for AtacandTM, for the treatment of chronic
heart failure.
• Second quarter sales for CrestorTM were $113 million in the US and $94
million in other markets.
• Launch rollouts continue, as CrestorTM has now been approved in 61
markets and launched in 48.
• Uptake has been excellent during the recent launches in France and
Italy. CrestorTM value share of the statin market in France after just 17
weeks is 2.8 percent, and in Italy CrestorTM has 6.1 percent share in its
thirteenth week on the market. Further progress has been made in the earlier
launch markets. CrestorTM market share of the total statin prescriptions in
the Netherlands is 9.3 percent, 10.9 percent in Canada, and 3.7 percent in the
UK in the latest months.
• In the US, a 16.3 percent share of the dynamic market segment (new and
switch patients) has been achieved. CrestorTM market share of new statin
prescriptions in the week ending 9 July was 6.8 percent, affected by the July
4 holiday as well as recent unfounded challenges to the safety profile of
Crestor TM. With an extensive clinical trials database and more than 6
million prescriptions dispensed, CrestorTM has a safety profile comparable to
other marketed statins.
Respiratory
Second Quarter CER % Half Year CER %
2004 2003 2004 2003
SymbicortTM 205 127 +42 393 249 +37
PulmicortTM 244 239 -3 526 490 +1
RhinocortTM 100 96 +1 181 186 -6
AccolateTM 23 25 -12 53 56 -9
OxisTM 26 29 -20 51 60 -27
Total 639 552 +7 1,287 1,115 +5
• Share gains in an expanding market for fixed combination products resulted
in continued strong growth for SymbicortTM sales in the quarter (up 42
percent) and the first half (up 37 percent). Sales in the last four
consecutive quarters were $693 million. A regulatory application seeking
approval for a pressurised Metered Dose Inhaler was submitted in Europe on 9
July.
• Sales of PulmicortTM in the first half broadly followed recent trends,
as the sales decline in markets outside the US (down 6 percent) was more than
offset by growth of PulmicortTM RespulesTM in the US (up 20 percent). The
rate of growth for PulmicortTM RespulesTM in the US was dampened by an earlier
peak in the incidence of colds, flu and respiratory illness this season
compared with last year, exacerbated by net destocking of inventories compared
with the first half 2003.
• Sales for RhinocortTM Aqua in the US were down 8 percent in the first
half on inventory movements. Total prescriptions were up 1 percent.
Oncology
Second Quarter CER % Half Year CER %
2004 2003 2004 2003
CasodexTM 249 228 -1 478 417 +4
ZoladexTM 226 213 -4 439 406 -3
ArimidexTM 191 143 +24 357 236 +39
IressaTM 103 47 +106 196 66 +182
FaslodexTM 23 15 +46 49 37 +29
NolvadexTM 38 39 -13 69 100 -39
Total 834 690 +11 1,596 1,271 +15
• CasodexTM sales outside the US in the first half increased by 14 percent
on growth in Japan (up 30 percent) and in Europe (up 9 percent). Underlying
growth in the US was estimated at 5 percent; reported first half sales were
down 19 percent compared with first half 2003 which included wholesaler
stocking, particularly in the second quarter (reported sales down 29 percent
versus last year).
• ArimidexTM sales outside the US increased by 47 percent in the first
half, as usage increases in the treatment of early breast cancer. Sales in
Europe were up 53 percent and Japan posted a 37 percent increase. Total
prescriptions for ArimidexTM in the US are up 44 percent through June on
further gains in market share. Sales growth rates in the quarter (unchanged)
and in the first half (up 29 percent) are chiefly a function of wholesaler
stocking in the first half of last year.
• IressaTM sales in the US were $49 million in the second quarter, bringing
the total for the first half to $100 million. Retail prescriptions in
the US were up 17 percent versus the first quarter 2004, to nearly 26,000.
Sales in Japan were $63 million in the first half, up 40 percent. To date
more than 160,000 patients have been treated with IressaTM in either a
commercial, expanded access or clinical trial setting.
• Sales of FaslodexTM in the first half include $4 million from the early
launch markets in Europe, following marketing approval in March of this year.
Neuroscience
Second Quarter CER % Half Year CER %
2004 2003 2004 2003
SeroquelTM 488 270 +75 936 714 +27
ZomigTM 91 54 +56 186 162 +6
Total 866 563 +46 1,678 1,370 +16
• Total prescriptions for SeroquelTM in the US continue to grow strongly, up
33 percent through June. SeroquelTM share of new prescriptions in the US in
June was 25.3 percent, up 2.4 points since December, further solidifying its
number two ranking in the market. Second quarter sales in the US were up 93
percent against the destocking that occurred in the second quarter last year.
This brings the first half growth rate (up 27 percent) back closer in line
with underlying growth.
• SeroquelTM experienced good growth outside the US as well, with sales up 36
percent in the second quarter and 25 percent year to date. Sales in Europe
were up 38 percent in the first half, where market share gains have
accelerated since the launch of the bipolar mania indication.
• ZomigTM sales outside the US grew by 4 percent in the second quarter and
6 percent for the first half. The large increase in US sales in the second
quarter 2004 reflect sales to Medpointe, our US distributor, compared to the
second quarter 2003 when sales were made by AstraZeneca to the market, which
experienced significant destocking in the quarter.
Geographic Sales
Second Quarter CER % Half Year CER %
2004 2003 2004 2003
USA 2,288 1,962 +17 4,567 4,432 +3
Europe 1,928 1,646 +3 3,803 3,201 +3
Japan 376 293 +13 666 536 +10
RoW 696 535 +18 1,326 1,002 +19
• US sales trends have been affected by inventory movements in the current
and prior year periods. Estimated underlying growth was 11 percent in the
quarter and for the first half.
• Sales for the key growth products were up 32 percent in Europe in the
first half, including strong growth for NexiumTM (up 25 percent), SymbicortTM
(up 35 percent), ArimidexTM (up 53 percent) as well as the sales from the
launch of CrestorTM.
• Strong growth in oncology products (up 24 percent) and LosecTM (up 23
percent) drove the first half performance in Japan.
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 19 percent and operating profit by 25 percent. At
constant exchange rates sales increased by 11 percent and operating profit by 15
percent.
The Company has entered into inventory management agreements with some US
customers, including the three largest wholesalers. Transition to the new
arrangements began in the second quarter, and at the end of June, inventory
levels at wholesalers are estimated to be around $75 million higher than target
levels. Our analysis suggests this represents a reduction of $175 million from
the end of the first quarter.
Currency differences have continued to benefit our results. Compared with
quarter two last year the euro was 6 percent stronger than the US dollar,
benefiting sales, although the Swedish krona and sterling were also stronger,
increasing costs. Overall, currency benefited EPS by around 3 cents in
comparison with quarter two last year, as a result of the beneficial exchange
rate profile together with hedging gains in the current quarter compared to
losses in the prior year.
Gross margin improved by 1.7 percentage points to 76.9 percent of sales for the
quarter. Approximately half of this was due to proportionately lower Merck
payments (reduced to 5.2 percent of sales in the quarter) as the sales mix
continues to improve. The remainder is due to underlying productivity and
currency, including the exchange gains noted above.
In aggregate, R&D and SG&A expenses were $3,042 million, an increase of 14
percent in CER terms (24 percent on a reported basis) versus second quarter last
year. R&D expenditure was at broadly the same level as quarter one, while SG&A
increased as a result of product launches in the quarter and the start up of new
consumer campaigns.
Operating margin for the quarter was 21.0 percent, an increase of 1.0 point over
the same period last year. Higher other income benefited margin by 1.3 points,
explained principally by the gain on the disposal of the Durascan business, and
this was offset by 1.0 point from the increase in SG&A and R&D. Currency
benefited margin by around 0.5 points.
First Half
Reported sales increased by 13 percent and operating profit by 1 percent. At
constant exchange rates sales increased by 5 percent and operating profit fell
by 5 percent. Cumulatively, exchange benefited EPS by around 6 cents. Based on
current exchange rates we expect to see minimal benefits going forward. Around
half of the year to date benefit to EPS is likely to be reversed as a result of
hedging benefits seen in the second half of last year not being repeated.
Gross margin increased by 1.6 points to 77.2 percent. The reduction in Merck
payments (to 5.4 percent of sales) contributed about 1 point of this, with the
rest coming from operating improvements and currency.
Cumulatively, R&D and SG&A grew by 13 percent (24 percent actual growth) over
the same period last year although the expenditure was broadly in line with the
levels seen since the second half of last year. Operating margin for the half
year was 21.1 percent, 2.5 points below the same point last year. This is a
result of the relative growth of R&D and SG&A compared to sales growth in the
period.
Interest and Dividend Income
Net interest and dividend income for the first half was $57 million (2003 $53
million), $28 million in the second quarter (2003 $32 million). Included in net
interest is a gain arising from the close out of an interest rate swap which has
offset a decline in the core net interest income as US dollar yields have been
lower than last year whilst interest payments have increased.
Taxation
The effective tax rate for the half year was 27.0 percent compared with 27.5
percent for the comparative period in 2003. The effective tax rate for the
second quarter 2004 was 26.4 percent.
Cash Flow
Cash generated from operating activities before exceptional items in the first
half of the year fell slightly to $2,392 million from $2,473 million in 2003.
Cash expenditure on exceptional items was $7 million compared with $381million
in the first half of 2003, which included the settlement of the US Department of
Justice investigation into ZoladexTM.
Tax paid and capital expenditures were both slightly lower than last year, as
were the cash proceeds from divestments. Despite the higher dividend payment,
the net cash inflow before financing was $262 million higher than in the first
half of 2003. During quarter two a $750 million bond was issued.
Dividends
The Board has recommended a 15 percent increase in the first interim dividend to
$0.295 (16.0 pence, SEK 2.20) to be paid on 20 September 2004 to all
shareholders on the register on 13 August 2004.
Share Repurchase Programme
During the second quarter 7.7 million shares were repurchased for cancellation
at a total cost of $360 million, bringing the total repurchases for the first
half of the year to 20.2 million shares at a total cost of $968 million.
The total number of shares that remain in issue at 30 June 2004 is 1,675
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.
Upcoming Milestones and Key Events
6 October 2004 Annual Business Review meeting
21 October 2004 Announcement of third quarter results
October/November 2004 Communication of 2003 IFRS restatements
Sir Tom McKillop
Chief Executive
This information is provided by RNS
The company news service from the London Stock Exchange