Interim Results - Part 1 of 2
AstraZeneca PLC
26 July 2001
AstraZeneca PLC
First Half Results 2001
'Successful US launch of Nexiuma ; AstraZeneca to 'Go it alone' with
CrestorTM'
Financial Highlights (before Exceptional Items)
Group 1st Half 1st Half Constant
(Continuing operations*) 2001 2000* Currency
$m $m %
Sales 8,090 7,863 +8
Operating Profit 2,051 2,046 +4
Profit before Tax 2,129 2,099 +5
Earnings per Share
Group $0.87 $0.84 +7
Group (Statutory FRS3) $0.84 $0.87
* Excluding Agrochemicals from prior period except for statutory FRS3 EPS
All narrative in this section refers to growth rates at constant exchange
rates (CER)
* NexiumTM achieves 10.7% share of new prescriptions in US PPI market;
including PrilosecTM, US combined share of PPI new prescriptions is over 3
points higher since NexiumTM launch.
* IressaTM trials in lung cancer fully recruited. First regulatory
submissions on track for year end.
* CrestorTM submitted for regulatory approval in US and Europe in June.
Tom McKillop, Chief Executive, said: 'The successful launches of NexiumTM and
SymbicortTM, and the good progress with our strong pipeline, mark a promising
start to the transformation of our portfolio and provide the platform for
future growth. I am confident that our decision to 'Go it alone' with Crestor
TM will deliver excellent value to shareholders.'
AstraZeneca PLC
Second Quarter Results 2001
Financial Highlights (before Exceptional Items)
Group 2nd Quarter 2nd Quarter Constant
(Continuing operations*) 2001 2000* Currency
$m $m %
Sales 4,099 3,971 +8
Operating Profit 996 1,070 -4
Profit before Tax 1,019 1,082 -2
Earnings per Share
Group $0.42 $0.43 +2
Group (Statutory FRS3) $0.40 $0.46
* Excluding Agrochemicals from prior period except for statutory FRS3 EPS.
All narrative in this section refers to growth rates at constant exchange
rates (CER)
* SymbicortTM launched in Germany and the UK
* ZomigTM approved in Japan
London, 26 July 2001
Media Enquiries: Steve Brown/Anna Isaacs (London) (020) 7304 5033/5034
Staffan Ternby (Sodertalje) (8) 553 26107
Rachel Bloom (Wilmington) (302) 886 7858
Analyst/Investor Michael Olsson/Mina Blair-Robinson (020) 7304 5087/5084
Enquiries: (London)
Staffan Ternby (Sodertalje) (8) 553 26107
Ed Seage (Wilmington) (302) 886 4065
Jorgen Winroth (Wayne) (609) 896 4148
Photographs of the AstraZeneca half year results conference are available from
newscast at www.newscast.co.uk from 2 pm (UK time) today.
Business Highlights All narrative in this section refers to growth rates at
constant exchange rates (CER) unless otherwise indicated.
For the half year, sales increased by 8 per cent, and operating profits
increased by 4 per cent. The strength of the US dollar reduced reported sales
and operating profits by 5 per cent and 4 per cent respectively. Earnings per
share (before exceptional items) grew by 7 per cent to $0.87. The Board has
recommended a first interim dividend of $0.23 (16.1 pence, SEK2.44) to be paid
on 5 October.
In the second quarter, sales increased by 8 per cent and operating profits
declined by 4 per cent, consistent with previous guidance on anticipated
quarterly phasing. Currency effects on sales and profits reduced reported
sales by 5 per cent and operating profits by 3 per cent. Earnings per share
(before exceptional items) increased in constant currency by 2 per cent to
$0.42.
Sales for the GI franchise were up by 7 per cent in the quarter. Sales of
PrilosecTM/LosecTM were up 3 per cent in the quarter. Excellent progress is
being made with NexiumTM in the USA since its launch on 19 March, with its
share of new prescriptions in the US PPI market having reached 10.7 per cent
in the week ending 13 July. NexiumTM now ranks third in the market for new
prescriptions in the class, surpassing both rabeprazole and pantoprazole after
just 17 weeks on the market. Good progress also continues in the European
roll out.
Outside of GI, strong sales growth in the quarter was reported in the CNS (up
32 per cent), Respiratory (up 14 per cent), and Oncology (up 12 per cent)
product ranges.
The US and European regulatory submissions for CrestorTM in June marked an
important milestone in the progress of our new product pipeline. In addition,
enthusiasm continues to build among the thrombosis treatment community for
ExantaTM, which is the recently announced trademark for the Oral Direct
Thrombin Inhibitor. Recruitment for all pivotal trials for IressaTM in the
treatment of non-small cell lung cancer are complete; regulatory submission
for the first indication (for monotherapy treatment in refractory patients) is
on track for year end in the USA. The phase III trial results for ViozanTM in
COPD failed to meet the target criteria for sustained efficacy, so development
was terminated and resources reallocated to other priority projects within the
portfolio.
CrestorTM is a very exciting, high priority opportunity, and resources will
be focused on realising its full potential by marketing this product
ourselves. Confidence in the profile of the product and our growing sales and
marketing strength make this preferred over a co-promotion deal. Good
proposals were made by several major companies and, while these would have
helped to absorb some near-term costs, they did not offer the best longer term
value creation. Local arrangements may be reached to co-market or co-promote
in selected countries where there is a clear tactical advantage.
The results reported for the first half of the year are in line with delivery
of the year end targets of mid single digit sales growth and earnings per
share growth slightly ahead of this (in constant currency), whilst continuing
to invest for future growth.
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 timing of the launch of generic
omeprazole in the USA, the successful registration and launch of new products
(in particular NexiumTM and CrestorTM), continued growth of currently marketed
products, the growth in costs and expenses, the amount of net interest income
earned on the group's cash balances, exchange rate fluctuations, and further
improvements in the tax rate. For further details on these and other risks
and uncertainties, see AstraZeneca PLC's Securities and Exchange Commission
filings, including the 2000 annual report on Form 20-F.
Sales
Except where stated, all narrative in this section refers to the second
quarter. Growth rates are at constant exchange rates (CER).
Gastrointestinal
Second Quarter CER % Half Year CER %
2001 2000 2001 2000
LosecTM/PrilosecTM 1,371 1,379 +3 2,866 2,967 0
NexiumTM 46 - n/m 127 - n/m
Total 1,426 1,390 +7 3,014 2,989 +4
* NexiumTM has now been launched in 20 markets to date, including the
USA on 19 March. NexiumTM share of new prescriptions in the US PPI market
reached 10.7 per cent in the week ending 13 July. After just 17 weeks on the
market, NexiumTM now ranks third among PPI products in the number of weekly
new prescriptions. Reported sales in the US for the half year total $80
million, with $17 million recorded in the second quarter combined with the $63
million recorded in the first quarter ahead of the launch in late March.
* NexiumTM sales outside of the US continue to make good progress.
Reported sales were $29 million, a 61 per cent increase from the first
quarter. Market shares now exceed 10 per cent in Germany, Norway, and
Finland. In markets outside the US, NexiumTM accounts for 6 per cent of the
PPI market in countries where it has been launched, overtaking rabeprazole.
* PrilosecTM sales in the USA were unchanged in the quarter. As
expected, PrilosecTM share of the PPI market declined, but overall
AstraZeneca's combined share of new prescriptions in the PPI market is up over
3 share points since the NexiumTM launch.
* LosecTM sales were up 4 per cent in Europe, with good growth in the
UK, France, and Italy. Sales in Japan doubled in the quarter as a result of
the launches of the long-term maintenance indication and the 10mg. tablet.
Cardiovascular
Second Quarter CER % Half Year CER %
2001 2000 2001 2000
ZestrilTM 350 385 -6 644 661 0
AtacandTM 113 68 +73 196 124 +67
SelokenTM / Toprol-XLTM 199 155 +32 350 261 +39
PlendilTM 106 118 -4 212 233 -3
Total 1,000 990 +6 1,835 1,784 +8
* As expected, ZestrilTM sales in the quarter were down, reflecting the
unfavourable comparison against last year's record trade shipments in the USA,
and further performance rebates in managed care. ZestrilTM prescriptions in
the US are up 6 per cent and its market-leading share of total prescriptions
is holding steady at around 24 per cent of the Ace Inhibitor market.
* AtacandTM, and the diuretic combination products AtacandTM Plus/
AtacandTM HCT, continued strong growth across all major markets, and this
growth is well above that of the ARB class.
* Sales of SelokenTM/Toprol-XLTM reflect continued strong growth of
Toprol-XLTM in the US market (up 52 per cent in the quarter, and 73 per cent
in the first half). Toprol-XLTM prescriptions have grown by 30 per cent year
to date.
Respiratory
Second Quarter CER % Half Year CER %
2001 2000 2001 2000
PulmicortTM 209 179 +24 409 353 +23
AccolateTM 46 59 -20 95 114 -15
RhinocortTM 74 73 +4 130 114 +18
OxisTM 33 29 +24 65 56 +27
SymbicortTM 11 - n/m 14 - n/m
Total 413 384 +14 794 729 +15
* The outstanding market acceptance of PulmicortTM RespulesTM in the US
market is the chief factor behind the 24 per cent growth in the PulmicortTM
franchise in the second quarter. PulmicortTM sales in Europe were up 3 per
cent in the quarter.
* RhinocortTM Aqua continues to fuel good growth in the rhinitis
franchise in the USA, with sales up 28 per cent in the first half. Rhinocort
TM Aqua market share of new prescriptions for aqueous nasal steroids in the US
is 12.1 per cent in June, up 5 points over last year.
* SymbicortTM is off to an excellent start in Europe. When launched in
Sweden last August, its rate of uptake rivalled that of the leading
combination product during its launch. We are seeing a similar pattern in
Germany since its introduction in April. The UK launched in June, and by
year-end launches will have occurred in most of the European Union.
Oncology
Second Quarter CER % Half Year CER %
2001 2000 2001 2000
CasodexTM 129 105 +32 244 220 +18
ArimidexTM 49 45 +16 92 82 +19
NolvadexTM 147 136 +12 286 275 +7
ZoladexTM 184 197 0 344 364 +2
Total 517 491 +12 981 956 +9
* Sales of CasodexTM in the first half were driven by the strong growth
in Europe (up 40 per cent) and Japan (up 71 per cent). In the US, CasodexTM
is approaching 75 per cent market share among anti-androgens. Total
prescriptions were broadly unchanged, whilst the 11 per cent decline in
reported sales is a function of wholesaler movements last year.
* Results from the CasodexTM Early Prostate Cancer trials were presented
at major medical congresses this spring. The combined analyses of trials in
over 8,000 patients demonstrate that CasodexTM reduces the risk of disease
progression by 42 per cent regardless of background treatment. The UK
regulatory filing occurred in March, and the US submission is anticipated by
year-end.
* ArimidexTM remains the leader in the competitive aromatase inhibitor
market. At the half year, sales growth came from Europe (up 19 per cent) as
well as from the strong launch uptake in Japan. Reported sales in the US were
down slightly and in contrast to the 16 per cent growth in prescriptions;
inventory building in the first half of last year distorts the comparisons.
CNS
Second Quarter CER % Half Year CER %
2001 2000 2001 2000
SeroquelTM 168 122 +40 357 204 +77
ZomigTM 88 67 +35 154 132 +21
Total 257 199 +32 514 354 +48
* Reported sales for SeroquelTM in the USA for the half year grew by 61
per cent, in line with the growth in prescriptions. The slower growth in the
second quarter (up 23 per cent) reflects a stocking correction following the
117 per cent growth rate reported in the first quarter. SeroquelTM market
share continues to grow-to 14.2 per cent of new prescriptions in June.
* SeroquelTM sales outside of the US more than trebled to $56 million at
the half year, on continued growth in Europe and encouraging uptake in Japan
since the launch earlier this year.
* ZomigTM RapimeltTM continues to fuel growth of ZomigTM. Sales in
Europe were up 34 per cent in the first half. ZomigTM is now the most
prescribed triptan in France, Germany, and Spain. In the USA, sales were up
15 per cent in the first half. This is somewhat ahead of prescription growth
of around 8 per cent, and reflects some inventory building of ZomigTM tablets
as well as the sales of launch stocks of the Zomig-ZMTTM formulation, which
was introduced in April.
* ZomigTM received regulatory approval in Japan on 20 June, and launch
is anticipated in September.
Pain, Infection and Other Pharma
Second Quarter CER % Half Year CER %
2001 2000 2001 2000
MerremTM 57 42 +46 106 78 +45
DiprivanTM 108 120 -5 215 284 -19
XylocaineTM 56 63 -3 103 117 -5
MarcaineTM 22 24 0 41 45 -2
Total 378 416 -1 742 846 -6
* The 45 per cent increase in MerremTM in the first half reflects steady
growth in the US since marketing resumed last April and 30 per cent growth in
Europe.
* Sales for DiprivanTM in the quarter reflect the effects of generic
competition in the US, UK and Germany, mitigated in part by good growth in
France and Japan.
Geographic Sales
Second Quarter CER % Half Year CER %
2001 2000 2001 2000
USA 2,120 1,989 +7 4,259 4,010 +6
Europe 1,358 1,340 +10 2,649 2,668 +9
Japan 211 218 +12 389 374 +18
RoW 410 424 +8 793 811 +6
* In the USA, in addition to the strong launch of NexiumTM, good growth
in SeroquelTM, Toprol-XLTM, PulmicortTM and AtacandTM drove performance in the
first half.
* Strong performances in France, Germany, and Italy featured in the 9
per cent growth reported in Europe in the first half. Key product
contributions came from NexiumTM, AtacandTM, CasodexTM and SeroquelTM.
* In Japan, growth in LosecTM and CasodexTM, combined with the launches
of AccolateTM, ArimidexTM and SeroquelTM, led to a strong first half result.
Operating Profit
Group operating profit before exceptional items grew by 4 per cent to $2,051
million in the first half, and declined by 4 per cent to $996 million in the
second quarter.
The operating margin decreased from 26.0 per cent in the first half of 2000 to
25.4 per cent as a result of launch costs and a more even phasing of R&D
costs, partially offset by other income from the disposal of non-core
products. For the second quarter, operating margins declined by 2.6 per cent
against a strong comparator quarter in 2000, principally as a result of
investment in sales and marketing and the phasing of R&D expenditure. For the
full year, margins are expected to be broadly similar to those achieved in
2000.
Synergy benefits of $450 million were realised in the half year which
represents an annualised rate of $900 million. An additional exceptional
charge of $81 million was taken in the half year bringing the total charge to
date to $1,267 million.
The stronger US dollar reduced reported sales and operating profits in the
first half by 5 per cent and 4 per cent respectively. If exchange rates remain
at current rates through the second half of the year, we continue to
anticipate a reduction of 5 cents per share from operating activities compared
with constant currency results.
Interest
The Group recorded net interest income of $78 million for the first half; the
lower realisation in the second quarter ($23 million) is chiefly a result of
falling US interest rates.
Taxation
Excluding exceptional items, the effective tax rate for the first half was
27.5 per cent, compared with 28.9 per cent in the first half of 2000 (for
continuing operations).
Cash Flow
Cash generated from operating activities before exceptional items amounted to
$2.2 billion in the first half. After the 2000 final dividend ($0.8 billion),
capital expenditure of $0.6 billion, exceptional item costs of $0.2 billion,
tax payments of $0.5 billion, and share buy-backs of $0.3 billion, net cash
outflow before non-equity financing transactions was $0.2 billion.
At 30 June 2001 the group had net cash funds of $3.3 billion.
Dividends
A first interim dividend of $0.23 (16.1 pence, SEK2.44) will be paid on 5
October 2001 to all shareholders on the register on 24 August 2001.
Share Repurchase Programme
During the second quarter 4.3 million Ordinary Shares (nominal value $0.25
each) were re-purchased for cancellation, bringing the total for 2001 to 8.2
million shares at a cost of $374 million. This represents 0.47 per cent of
the total issued share capital of AstraZeneca.
The total number of shares re-purchased for cancellation since the start of
the programme in December 1999 now stands at 21.9 million at an aggregate cost
of $910 million. The total number of shares in issue (as at 30 June 2001) is
1,760 million.
Second Half 2001 Calendar of Events
September ZomigTM launch in Japan
24 October Nine Months and Third Quarter Results
3 December Annual Business Review meeting (London)
5 December Annual Business Review meeting (New York)
December IressaTM NDA submission
Development Pipeline Update
An update of the development portfolio is being published today and is
available on AstraZeneca's website (www.astrazeneca.com).
Tom McKillop
Chief Executive