Q1 Results - Part 1 of 2
AstraZeneca PLC
26 April 2001
AstraZeneca PLC
First Quarter Results 2001
'First Quarter Results in Line with Expectations'
Financial Highlights (before Exceptional Items)
Group 1st Quarter 1st Quarter Constant
(Continuing operations*) 2001 2000 Currency
$m $m %
Sales 3,991 3,892 +7
Operating Profit 1,055 976 +12
Profit before Tax 1,110 1,017 +12
Earnings per Share
Group $0.45 $0.41 +12
Group (Statutory FRS3) $0.44 $0.41
* Excluding Agrochemicals from prior period
All narrative in this section refers to growth rates at constant exchange
rates (CER)
* Nexium(R) launch continues to fully meet expectations. Excellent
progress has been made in Europe, and the early response to the US launch
on 19 March is very promising.
* Strong growth in Japan (up 26 per cent) fuelled by new product launches.
* US regulatory approvals were received for Toprol-XL(R) in congestive
heart failure, and for Zomig-ZMTTM fast melt tablet for migraine.
* First regulatory filings made for Casodex(R) in the treatment of early
prostate cancer and for Faslodex(R) for second line treatment of advanced
breast cancer.
* A further three important new chemical entities to be filed this year:
CrestorTM for the treatment of elevated cholesterol, ViozanTM for chronic
obstructive pulmonary disease, and IressaTM for the treatment of non-small
cell lung cancer.
Tom McKillop, Chief Executive Officer, said: ' First quarter results are in
line with our expectations and with targets for the full year. Products in
their growth phase continue to do well and good progress is being made towards
realising the full potential of our exciting development portfolio.'
London, 26 April 2001
Media Enquiries: Steve Brown (London) +44 20 7304 5033
Staffan Ternby (Sodertalje) +46 8 553 26107
Rachel Bloom (Wilmington) +1 302 886 7858
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Staffan Ternby (Sodertalje) +46 8 553 26107
Ed Seage (Wilmington) +1 302 886 4065
Jorgen Winroth (Wayne) +1 609 896 4148
Business Highlights All narrative in this section refers to growth rates at
constant exchange rates (CER) unless otherwise indicated.
Sales increased by 7 per cent and operating profits were up by 12 per cent in
the first quarter. The strength of the US dollar reduced reported sales and
operating profits by 4 per cent each. Earnings per share (before exceptional
items) rose by 12 per cent to $0.45.
Excluding the GI franchise, sales grew by 10 per cent, with good performances
in Cardiovascular, Respiratory and CNS products, particularly Seroquel(R),
more than offsetting the anticipated generic erosion of Diprivan(R). Total GI
sales were up 2 per cent, with sales of Nexium(R), benefiting from trade
stocking for the USA launch, more than offsetting a slight decline in Losec(R)
/Prilosec(R). The Nexium(R) launch programme continues to go well. Good
progress is being made in Europe and the initial uptake in the USA is very
encouraging. Whilst early prescription data should be viewed with caution,
Nexium(R) has achieved a 3.0% share of new prescriptions in the US PPI market
in the week ending 13 April with momentum building. This is in line with our
high aspirations for the product.
Progress continues both on the new product pipeline and on important life
cycle initiatives for our current growth products. The USA submission of the
Faslodex(R) NDA on 29 March for second line treatment of advanced breast
cancer was the first of four planned filings for important new chemical
entities this year, to be followed by CrestorTM, ViozanTM, and IressaTM. The
presentation of Phase III data for CrestorTM generated great interest at the
American College of Cardiology meeting in March. In the USA the FDA approved
Toprol-XL(R) for use in congestive heart failure and the fast-melt formulation
of Zomig(R) for migraine. In Oncology, the first data from the Casodex(R)
Early Prostate Cancer programme were presented and formed the basis of the
first registration package submitted on 28 March in the UK.
Performance for the first quarter is consistent with delivery of the targets
for the year announced in February, that is mid single digit sales growth with
earnings slightly ahead of this. The quarterly pattern, however, will be
uneven. In particular the comparison with a strong second quarter in 2000 and
heavy R&D and launch costs will mean a decline in the second quarter
compensated by a stronger second half.
Disclosure Notice: The preceding forward looking statements relating to
expectations for earnings and business prospects for the Company 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 Nexium(R)
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 the
Company's Securities and Exchange Commission filings, including the 2000
annual report on Form 20-F.
Sales
All narrative in this section refers to the first quarter unless otherwise
indicated. Growth rates are at constant currency
Gastrointestinal
First Quarter CER %
2001 2000
Losec(R)/Prilosec(R) 1,495 1,588 -3
Nexium(R) 81 - -
Total 1,588 1,599 +2
* Nexium(R) has now been launched in 12 markets to date. Good progress
continues in the early launch markets in Europe. The USA launched Nexium
(R) on March 19, and the initial uptake is very encouraging and well in
line with our high aspirations.
* As Nexium(R) has only been in the US market for two weeks in the
quarter, the Prilosec(R) ex-factory sales trend is independent of any
Nexium(R) launch effect. Prilosec(R) sales in the quarter were down 7 per
cent (in contrast to total prescriptions, which were up 3 per cent). March
signalled the beginning of wholesaler destocking of inventories which were
built late last year in response to a competitor's price increase and
continued into the first quarter. Thus, a weaker second quarter is
expected as this inventory continues to be worked through.
* Pre-trial proceedings are essentially complete for the first four
defendants in the US patent litigation for Prilosec(R). The first trial
date has been set for 29 May in New York.
* Outside of the USA, sales of Losec(R) were up 3 per cent in Europe;
whilst in Japan, sales were doubled (off a small base) on encouraging
response to the launch of the long term maintenance indication and the 10
mg tablet.
Cardiovascular
First Quarter CER %
2001 2000
Zestril(R) 294 276 +11
Atacand(R) 83 56 +59
Seloken(R)/Toprol-XL(R) 151 106 +49
Plendil(R) 106 115 -3
Total 835 794 +11
* The continued roll out of Atacand(R) Plus/ Atacand(R) HCT fuelled good
growth in Atacand(R) across all major markets.
* Worldwide sales of Zestril(R) increased by 11 per cent, as sales in the
USA rebounded from the artificially low fourth quarter of 2000. In the
USA, Zestril(R) market share continues to hold steady at 24 per cent
despite the launch of generic enalapril and sales are expected to continue
to grow in line with prescription demand. The ex-factory growth rate in
the USA next quarter is expected to show a decline against the record
trade shipments reported in Q2 2000.
* Seloken(R)/Toprol-XL(R) sales were up on strong US sales growth (up 118
per cent). Prescription growth in the USA remains robust at over 30 per
cent, but the exceptional ex-factory growth rate is against an unusually
low Q1 2000. The launch of the indication for congestive heart failure on
2 April should drive continued growth for the product.
Respiratory
First Quarter CER %
2001 2000
Pulmicort(R) 200 174 +22
Accolate(R) 49 55 -9
Rhinocort(R) 56 41 +42
Oxis(R) 32 27 +30
Symbicort(R) 3 - -
Total 381 345 +18
* Pulmicort(R) sales continue to be driven by the performance in the USA,
particularly Pulmicort(R) Respules(R). Competitive pressures continue to
erode sales outside of the US.
* Rhinocort(R) Aqua performance in the USA was the main contributor to the
worldwide growth of the Rhinocort(R) franchise.
* Symbicort(R) continues to challenge Seretide(R) in Sweden, its first
launch market, gaining a 30 per cent share of the combination market in
the first quarter. The broader roll out has begun; the German launch
occurred on 2 April, with some twenty markets in total expected by year
end.
Oncology
First Quarter CER %
2001 2000
Casodex(R) 115 115 +5
Arimidex(R) 43 37 +24
Nolvadex(R) 139 139 +3
Zoladex(R) 160 167 +3
Total 464 465 +5
* For Casodex(R), continued strong growth was achieved in Japan and in
Europe. In the USA, where Casodex(R) market share is now over 70 per cent,
prescription growth for Casodex(R) continues in an otherwise maturing
market for combination therapy for advanced prostate cancer. The 26 per
cent decline in reported sales in the USA is a function of the strong
first quarter of 2000 where 35 per cent of the full year's sales were
realised.
* The first filing for Casodex(R) in the treatment of early prostate
cancer occurred in the UK at the end of March, with further submissions,
including the USA, expected later this year. This new indication will
drive growth in the future.
* Arimidex(R) grew by 24 per cent and remains the market leading aromatase
inhibitor. The product continues to respond to the new indication for the
first line treatment of advanced breast cancer.
* Reported sales of Nolvadex(R) this quarter in the USA (up 3 per cent)
lag the prescription growth of nearly 10 per cent, indicating some further
destocking.
CNS
First Quarter CER %
2001 2000
Seroquel(R) 189 82 +132
Zomig(R) 66 65 +5
Total 257 155 +69
* The attractive product profile of Seroquel(R) continues to be reflected
in excellent growth in prescription demand in the USA (total prescriptions
up 64 per cent). Reported US sales (up 117 per cent) are well ahead of
this underlying demand and therefore include some trade inventory build.
Encouraging sales development following last year's launches in Italy and
Germany continues. The launch in Japan by our licensee Fujisawa took place
in February of this year.
* In the US migraine market, the triptan class prescription growth has
eased to low double digits; Zomig(R) prescription growth was in line with
this. Reported US sales declined by 9 per cent against the year ago
quarter which was characterised by wholesaler stock building. Outside the
USA sales were up 33 per cent.
* Now launched in eighteen markets, Zomig(R) Rapimelt(R) continues to
perform well; it was launched last week in the USA as Zomig-ZMT TM.
Pain, Infection and other pharma
First Quarter CER %
2001 2000
Merrem(R) 49 36 +44
Diprivan(R) 107 164 -31
Xylocaine(R) 47 54 -7
Marcaine(R) 19 21 -5
Total 364 430 -10
* Diprivan(R) sales are down; the decline in the USA is a result of
generic competition but also against an unusually strong prior year
quarter.
* Good growth in Europe and continued recovery of sales in the USA drove
Merrem(R) performance.
Geographic
First Quarter CER %
2001 2000
USA 2,139 2,021 +6
Europe 1,291 1,328 +7
Japan 178 156 +26
RoW 383 387 +4
* In the USA sales grew by 15 per cent excluding the GI franchise, with
strong growth in Cardiovascular (up 20 per cent), Respiratory (up 53 per
cent) and CNS (up 68 per cent).
* In Europe, strong performances in France, Italy, and improved
performance in Germany more than offset weakness in Spain and Sweden.
* The strong growth in Japan was a result of continued growth in Casodex
(R), the new maintenance indication for Losec(R), and by the launches of
Seroquel(R), Arimidex(R) and Accolate(R) in February.
Operating Profit
Group operating profit before exceptional items grew by 12 per cent to $1,055
million for the quarter.
The operating margin increased from 25.1 per cent in the first quarter of 2000
to 26.4 per cent, partly due to higher other income, which included a gain of
$64 million on the disposal of the dental anaesthetics product range, offset
by increased R&D and selling costs.
Synergy benefits of $210 million were recorded in the first quarter.
Exchange effects reduced sales and profits by 4 per cent each in the quarter
as a result of the strength of the US dollar against the Euro and yen, which
more than offset the benefits against Sterling and the Swedish krona.
The continued strength of the dollar will reduce reported profits for the full
year. If current exchange rates remain constant through the balance of the
year, we project that reported EPS will be reduced by around five cents per
share, which is an additional three cents per share from the projection made
in February.
Interest
The Group recorded net interest income of $55 million (2000: $19 million). The
net interest position has continued to improve as a result of the Group's
strong positive cash flows.
Taxation
The effective tax rate for the first quarter, before exceptional items, was
28.5 per cent compared to 29.0 per cent for continuing operations for the
first quarter 2000.
Cash Flow
Cash generated from operating activities before exceptional items amounted to
$1.4 billion for the quarter. This was used to fund capital expenditures of
$0.3 billion, exceptional items costs of $0.1 billion and to pay taxes of
$0.08 billion. Net cash inflow before financing transactions and the share
repurchase programme was $0.9 billion. At 31 March 2001 the Group had net
funds of $4.3 billion.
Share Repurchase Programme
During the first quarter 3.9 million Ordinary Shares (nominal value $0.25
each) were purchased for cancellation for an aggregate sum of $174 million,
giving an average cost of $44.71 per share. We expect the programme of share
buybacks to continue as part of a structured process of balance sheet
management and shareholder return.
The total number of shares repurchased for cancellation since the start of the
programme in December 1999 stands at 17.6 million at an aggregate cost of $710
million. The total number of shares in issue (as at 31 March 2001) was 1,764
million.
Upcoming Milestones and Key Dates
Second Quarter CrestorTM NDA/MAA submissions
26 July Half Year Results
24 October Nine Months and Third Quarter Results
Tom McKillop
Chief Executive Officer