3rd Qtr/9 Mths Results 1 of 2
AstraZeneca PLC
24 October 2001
PART 1
AstraZeneca PLC
Third Quarter and Nine Months Results 2001
'Good sales growth in the third quarter and excellent progress with the
development portfolio. Confidence in good outcome for the year.'
Financial Highlights (before Exceptional Items)
Group 3rd 3rd Constant Nine Nine Constant
Quarter Quarter Currency Months Months Currency
(Continuing
operations*) 2001 2000* 2001 2000*
$m $m % $m $m %
Sales 3,950 3,797 +9 12,040 11,660 +8
Operating Profit 1,015 967 +6 3,066 3,013 +4
Profit before Tax 1,038 977 +7 3,167 3,076 +6
Earnings per Share
Group $0.43 $0.39 +12 $1.30 $1.23 +8
Group (Statutory $0.41 $0.37 $1.25 $1.25
FRS3)
* 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 share of new prescriptions in US PPI market up to 13.3
percent in September; two million prescriptions written since launch; the
company's combined share of the total US antisecretory market has increased to
31.5 percent since the launch of Nexium
* GI franchise sales up 4 percent in the quarter and the nine months
* Excluding LosecTM/PrilosecTM, sales up 19 percent in the third
quarter, with strong growth in Respiratory, Oncology, and CNS product ranges
* SymbicortTM roll-out in Europe continues; launches in UK, France,
Italy, and Spain in third quarter
* ZomigTM for migraine launched in Japan
* CasodexTM 150 mg tablets receive first regulatory approvals for the
treatment of early stage prostate cancer
* IressaTM on track for first regulatory submissions at year end
Tom McKillop, Chief Executive, said: 'Successful marketing programmes have
delivered strong sales growth in the third quarter for both new and growth
products, and I am confident of a good outcome for the full year. The
development portfolio made excellent progress, with the publication of
impressive clinical data on CrestorTM, and more recently, on IressaTM.'
London, 24 October 2001
Media Enquiries: Steve Brown/Emily Denney (020)7304 5033/5034
(London)
Staffan Ternby (Sodertalje) (8) 553 26107
Rachel Bloom (Wilmington) (302) 886 7858
Analyst/Investor Mina Blair-Robinson (London) (020) 7304 5084
Enquiries: Staffan Ternby (Sodertalje) (8) 553 26107
Ed Seage (Wilmington) (302) 886 4065
Jorgen Winroth (Wayne) (609) 896 4148
Business Highlights All narrative in this section refers to growth rates at
constant exchange rates (CER) unless otherwise indicated.
For the nine months, sales increased by 8 percent, and operating profits by 4
percent. The strength of the US dollar reduced reported sales and operating
profits by 5 percent and 2 percent respectively. Earnings per share (before
exceptional items) grew by 8 percent to $1.30.
In the third quarter sales increased by 9 percent, and operating profits by 6
percent. Exchange rate effects reduced sales by 5 percent and operating
profits by 1 percent, in a quarter marked by greater currency volatility.
Earnings per share (before exceptional items) grew by 12 percent to $0.43.
The GI franchise continued its strong performance. Sales were up by 4 percent
in the quarter and in the nine months. Sales of LosecTM/PrilosecTM were down
2 percent in the nine months, chiefly on lower prescription demand for
PrilosecTM in the USA. The small decline in LosecTM/PrilosecTM was more than
offset by strong NexiumTM sales, which reached $295 million through nine
months. Total prescriptions dispensed for NexiumTM in the US since launch now
exceed 2 million.
Since the end of the quarter, the six month pediatric exclusivity period
relating to the substance patent for Prilosec in the USA expired on 5 October.
The company has received confirmation that its pending litigation to defend
its other patents, including the formulation patents, associated with Prilosec
TM in the US will go to trial in New York on 5 December. To date, the company
is not aware of the FDA having granted an ANDA approval for any generic
omeprazole products.
Outside of GI, strong sales growth in the quarter was reported in the
Respiratory (up 18 percent), Oncology (up 25 percent) and CNS (up 72 percent)
product ranges.
Developments in our new product pipeline in the quarter included further
presentations of impressive clinical data for CrestorTM. The first long-term
Phase III data were released for CrestorTM, reinforcing its record of superior
impact on lipid levels and greater ability to achieve patient's cholesterol
targets than other currently available statins. In addition, a presentation
of the safety data from the Phase II/III programme revealed a tolerability and
safety profile comparable to the currently marketed products in the class.
The first regulatory approval for the use of CasodexTM 150 mg tablets for the
treatment of early prostate cancer was achieved in the UK on 17 September.
IressaTM remains on track for its first regulatory submissions at year's end.
Product launches in the quarter include SymbicortTM in the UK, France, Italy,
and Spain, and ZomigTM in Japan.
On the assumptions made at the beginning of the year, mid single digits sales
growth was anticipated for the full year, with earnings per share growth
slightly ahead of this (in constant currency). Based on the results to date
and an improved fourth quarter outlook for sales combined with lower projected
net interest income, it is now possible that sales growth could be in high
single digits, and that earnings per share growth may reach the double digit
level.
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 third
quarter. Growth rates are at constant exchange rates (CER).
Gastrointestinal
Third Quarter CER % Nine Months CER %
2001 2000 2001 2000
LosecTM/PrilosecTM 1,421 1,565 -6 4,287 4,532 -2
NexiumTM 168 4 n/m 295 4 n/m
Total 1,598 1,581 +4 4,612 4,570 +4
* NexiumTM sales in the quarter totalled $168 million, more than treble
those in the second quarter. Sales in the USA were $138 million, as trade
shipments reflected the steadily increasing prescription demand. NexiumTM
share of new prescriptions in the US PPI market now stands at 13.3 percent for
the month of September, up over five points in the quarter; including Prilosec
TM, the company's combined share of new prescriptions in the PPI market has
increased to 45.9 percent since the launch of NexiumTM .
* The results of head-to-head clinical trials between NexiumTM and a
competitor, lansoprazole, were presented earlier this month at the United
European Gastroenterology Week in Amsterdam. NexiumTM was shown to achieve
significantly greater healing of oesophagitis than lansoprazole.
* Sales of PrilosecTM in the USA were down by 6 percent through nine
months, leading to global sales of LosecTM/PrilosecTM being 2 percent lower
than last year. Outside of the USA, LosecTM sales grew by 4 percent, fuelled
by continued strong growth in Japan (up 89 percent), France (up 21 percent)
and Italy (up 38 percent).
Cardiovascular
Third Quarter CER % Nine Months CER %
2001 2000 2001 2000
ZestrilTM 188 299 -34 832 960 -10
AtacandTM 93 72 +37 289 196 +56
SelokenTM / Toprol-XLTM 204 144 +46 554 405 +42
PlendilTM 120 120 +5 332 353 -1
Total 786 851 -3 2,621 2,635 +4
* Total prescriptions for ZestrilTM in the USA continue to grow (up 5
percent YTD September) however the quarterly trends continue to be affected by
the uneven phasing of wholesaler shipments in both 2000 and 2001. Reported
sales in the quarter were down by 55 percent. It is anticipated that this
effect will reverse next quarter, when the comparison will be against last
year's quarterly low point.
* Sales growth of SelokenTM continues to be powered by the strong growth
of Toprol-XLTM in the USA (up 76 percent); prescription growth is around 30
percent in the US market.
* AtacandTM performed well in all major markets. Sales through nine
months are up by 44 percent in the USA, and by 63 percent in the other
markets. For the quarter, US reported sales (up 4 percent) significantly
lagged prescription growth (up 44 percent) due to unwinding of high trade
inventories.
Respiratory
Third Quarter CER % Nine Months CER %
2001 2000 2001 2000
PulmicortTM 161 159 +7 570 512 +18
AccolateTM 20 17 +24 115 131 -10
RhinocortTM 64 51 +29 194 165 +22
OxisTM 29 28 +11 94 84 +22
SymbicortTM 20 - n/m 34 - n/m
Total 329 295 +18 1,123 1,024 +16
* The US performance (up 113 percent for the nine months) of PulmicortTM
and PulmicortTM RespulesTM, is driving the worldwide sales growth.
* RhinocortTM Aqua in the USA (total prescriptions up 113 percent
through September) is responsible for the growth in RhinocortTM worldwide.
* Whilst still early in the European roll out, SymbicortTM sales
momentum continues. The product has now been launched in 20 countries,
including third quarter launches in the UK, France, Italy, and Spain.
Oncology
Third Quarter CER % Nine Months CER %
2001 2000 2001 2000
CasodexTM 149 94 +68 393 314 +32
ArimidexTM 47 35 +40 139 117 +26
NolvadexTM 160 130 +27 446 405 +13
ZoladexTM 175 189 - 519 553 +1
Total 538 455 +25 1,519 1,411 +14
* CasodexTM sales in the third quarter were strong across the board.
Sales increased 45 percent in Europe, 53 percent in Japan, and 97 percent in
the USA. The US result represents a correction from the below-trend trade
shipments in the first half of the year. Sales through nine months are now
running somewhat ahead of underlying demand, suggesting some inventory build
in the distribution channels.
* The first approval for CasodexTM 150 mg tablets for the treatment of
the early stages of prostate cancer was gained in the UK in mid September.
Licenses in other European markets are anticipated, and we expect the
regulatory submission in the USA by year end.
* Third quarter sales of ArimidexTM in the USA (up 100 percent) also
reflect unwinding the below trend phasing in the first half of the year. Sales
growth in the USA through nine months (up 17 percent) is now broadly in line
with growth in demand. Sales outside of the US grew by 30 percent in the nine
months, including contribution from the launch in Japan.
* The demand trend for NolvadexTM in the US remains positive, up around
nine percent through nine months; the third quarter sales growth rate (up 44
percent) benefits from a comparison with a weak third quarter in 2000.
CNS
Third Quarter CER % Nine Months CER %
2001 2000 2001 2000
SeroquelTM 169 89 +93 526 293 +83
ZomigTM 55 46 +27 209 178 +21
Total 237 141 +72 751 495 +55
* Sales of SeroquelTM grew strongly in the US market (up 66 percent in
the nine months). Market share is steadily growing-to 15.3 percent of new
prescriptions in September. The launch in Japan and growth in Europe brought
sales outside of the US to $88 million in the nine months.
* Sales of ZomigTM in the quarter increased by 27 percent, on good
growth in Europe coupled with initial launch sales in Japan. Sales in the US
were affected by high wholesaler inventories, which were worked down in the
quarter. The 2.5 mg strength of Zomig-ZMTTM was launched in the US in April,
with the more commercially important 5 mg strength receiving FDA approval on
18 September.
Pain, Infection and Other Pharma
Third Quarter CER % Nine Months CER %
2001 2000 2001 2000
MerremTM 56 44 +34 162 122 +41
DiprivanTM 114 109 +11 329 393 -11
XylocaineTM 52 58 -3 155 175 -4
MarcaineTM 20 22 - 61 67 -2
Total 361 379 +4 1,103 1,225 -3
* The MerremTM sales performance in the nine months reflects continued
good growth in Europe (up 22 percent) and the steady recovery of sales and
market share in the US since marketing resumed last year.
* DiprivanTM sales in the US in the nine months decreased by 18 percent
as a result of generic competition; the 33 percent increase in the quarter is
a function of the uneven quarterly phasing last year.
Geographic Sales
Third Quarter CER % Nine Months CER %
2001 2000 2001 2000
USA 2,166 1,966 +10 6,425 5,976 +8
Europe 1,170 1,205 +6 3,819 3,873 +8
Japan 202 207 +15 591 581 +17
RoW 412 419 +8 1,205 1,230 +7
* In the USA, the excellent launch performance of NexiumTM is the
greatest contributor to the growth in total sales, followed by the continued
strong showings of SeroquelTM, Toprol-XLTM and PulmicortTM.
* France, Italy and Germany continue to drive the growth in nine months
sales. Leading contributors to incremental sales are NexiumTM, AtacandTM,
LosecTM and CasodexTM.
* Sales growth in Japan is benefitting from new product launches, with
the addition of ZomigTM in June. CasodexTM and LosecTM also showed strong
growth.
Operating Profit
Operating profit before exceptional items grew by 6 percent, to $1,015 million
in the quarter, and for the nine months, increased by 4 percent to $3,066
million.
The strong US dollar reduced reported operating profits by 1 percent in the
quarter, and by 2 percent for the nine months. If current exchange rates
remain constant for the rest of the year we continue to anticipate currency
will reduce the growth in reported earnings per share by 5 cents.
Operating margin for the nine months decreased slightly, from 25.8 percent in
2000 to 25.5 percent this year. Increases in Selling, General, and
Administration costs result from launch costs. Other operating income reached
$304 million for the nine months, including proceeds from the sale of the
injectable multi-vitamin product line in the third quarter. The reported rate
of growth in R&D expenditures continued to benefit from the weakness in
sterling and Swedish kronor relative to the US dollar, contributing to an
operating margin in the third quarter (25.7 percent) that is slightly higher
than the 25.5 percent level in the third quarter last year.
Synergy benefits of $700 million were realised in the nine months, which
represents an annualised rate of $1 billion. An additional exceptional charge
of $126 million was taken in the nine months bringing the total programme
charge to $1,312 million.
Interest
The Group recorded net interest income of $101 million for the nine months.
Net interest income for the quarter ($23 million) reflects the impact of
falling US interest rates.
Taxation
Excluding exceptional items, the effective tax rate for the first nine months
of this year was 27.5 percent, compared with 29.0 percent for the same period
last year (for continuing operations).
Cash Flow
Cash generated from operating activities before exceptional items amounted to
$3.3 billion for the first nine months. After the 2000 final dividend ($0.8
billion), capital expenditures of $1.0 billion, exceptional item costs of $0.3
billion, tax payments of $0.6 billion, and share issues and buybacks of $0.7
billion, net cash outflow before non-equity financing was $0.1 billion.
At 30 September 2001 the Group had net cash funds of $3.5 billion.
Share Repurchase Programme
During the third quarter, 8.5 million Ordinary Shares (nominal value $0.25
each) were repurchased for cancellation, bringing the total for the nine
months to 16.7 million shares at a total cost of $774 million.
The total number of shares re-purchased for cancellation since the start of
the programme in December 1999 now stands at 30.4 million shares at an
aggregate cost of $1,308 million. The total number of shares in issue (as at
30 September 2001) is 1,751 million.
Fourth Quarter 2001 Calendar of Events
3 December Annual Business Review meeting (London)
5 December Annual Business Review meeting (New York)
December IressaTM NDA submission
Tom McKillop
Chief Executive
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