Final Results (part 1 of 2)
AstraZeneca PLC
30 January 2003
AstraZeneca PLC
Fourth Quarter and Full Year Results 2002
'Earnings per Share ahead of target, benefiting from strong sales growth of
NexiumTM, SeroquelTM, and SymbicortTM.'
Financial Highlights (before Exceptional Items)
Group 4th Quarter 4th Quarter Constant Full Year Full Year Constant
(Continuing operations*) 2002 2001* Currency 2002 2001* Currency
$m $m % $m $m %
Sales** 4,901 4,366 +10 17,841 16,222 +9
Operating Profit 1,074 1,090 -2 4,356 4,156 +5
Profit before Tax 1,081 1,102 -2 4,387 4,269 +3
Earnings per Share
Before Exceptional Items $0.45 $0.45 0 $1.84 $1.73 +7
Statutory (FRS3) $0.25 $0.42 $1.64 $1.65
* Restated to be on a consistent basis under FRS19. See note 1 on page 13 for
further information.
**Sales in the fourth quarter and full year reflect an adjustment for prompt
payment discounts that have been reclassified from cost of sales to sales.
Please see note 1 on page 13 for more information.
All narrative in this section refers to growth rates at constant exchange rates
(CER)
• Earnings per Share (before exceptional items) were up 7 percent to $1.84
for the full year; Statutory Earnings per Share were $1.64.
• Sales for the full year increased by 9 percent. Sales growth excluding
LosecTM/PrilosecTM was 23 percent.
• Operating profits were up by 5 percent for the full year. Operating
profit in the fourth quarter declined by 2 percent on the expected phasing of R&
D expenditures and lower other operating income.
• NexiumTM sales were nearly $2 billion for the full year. Share of total
prescriptions in the US exceeded 20 percent in December. NexiumTM is now the
number 2 PPI in new prescription market share in the US.
• Sales of SeroquelTM exceeded $1 billion for the year, up 67 percent. An
sNDA in the US has been submitted for the use of SeroquelTM in the treatment of
acute mania associated with bipolar disorder.
• Sales of IressaTM reached $67 million for the year following launch in
Japan in the third quarter. The FDA has extended its regulatory review period
for IressaTM to May 5.
• Investment in Research and Development in 2002 was over $3 billion, as
planned.
• An exceptional charge of $350 million has been accrued to cover
potential settlement costs related to the previously disclosed investigations
into the sales and marketing of ZoladexTM in the US.
Sir Tom McKillop, Chief Executive, said: 'Sales excluding LosecTM/PrilosecTM
grew by 23 percent, showing the strength of our portfolio of growth products.
Maintaining this momentum should allow us to absorb most of the sales impact of
generic competition in 2003. Following the planned launches of CrestorTM and
ExantaTM later this year, all the elements should be in place to drive strong
sales and earnings growth from 2004.'
London, 30 January 2003
Business Highlights All narrative in this section refers to growth rates at
constant exchange rates (CER) unless otherwise indicated.
Sales for the year increased by 9 percent. The weaker US dollar increased the
reported sales growth by 1 percent. Operating profits increased by 5 percent on
both an 'as reported' and CER basis. Earnings per share (before exceptional
items) rose by 7 percent to $1.84. The Board has recommended a second interim
dividend of $0.47 (28.5 pence, 3.99 SEK) to be paid on 7 April 2003, bringing
the dividend for the full year to $0.70 (43.2 pence, 6.20 SEK).
In the fourth quarter, sales increased by 10 percent whilst operating profits
declined by 2 percent in CER terms. The decline in operating profits in the
quarter is chiefly due to the anticipated phasing of R&D expenditures and a
reduction in other operating income. Currency movements increased the reported
growth rates for sales and operating profits by 2 percent and 1 percent
respectively. Earnings per Share (before exceptional items) in the fourth
quarter was unchanged at $0.45.
In the fourth quarter, sales in the US increased by 16 percent, which the
company believes is higher than underlying demand because of wholesaler stock
movements in the current quarter compared to the fourth quarter of 2001. The
company believes the full year growth rate of 10 percent is more indicative of
the underlying performance of the business in the quarter and the full year.
GI sales grew by 7 percent for the full year, as the strong growth of NexiumTM
more than offset declines in LosecTM/PrilosecTM. NexiumTM sales more than
trebled to $1,978 million, including $453 million from markets outside the US.
In the US, NexiumTM share of total prescriptions for PPI products reached 20.5
percent in December.
Sales of LosecTM/PrilosecTM were down by 18 percent for the full year, with the
US down 21 percent. A generic omeprazole product became available in the US
market on 8 December, and thus had little effect on reported sales of PrilosecTM
for the year.
The underlying momentum in the business is evidenced by the sales growth rate of
23 percent (33 percent in the US) when sales of LosecTM/PrilosecTM are excluded.
Strong sales growth for the year was reported in CNS (up 53 percent),
Respiratory (up 16 percent) and the Oncology (up 12 percent) product ranges.
Despite good growth in AtacandTM (up 36 percent) and SelokenTM/Toprol-XLTM (up
27 percent), generic competition for ZestrilTM resulted in sales growth for
Cardiovascular products of just 1 percent.
The recently launched products-NexiumTM, SymbicortTM, FaslodexTM (in the US) and
IressaTM (in Japan)- generated nearly $2.4 billion in sales in 2002 (up from
$651 million in 2001). Five other growth products-CasodexTM, ArimidexTM,
AtacandTM, SeroquelTM, and ZomigTM - grew by another $900 million to just over
$3 billion in aggregate.
Future Prospects All narrative in this section refers to growth rates at
constant exchange rates (CER) unless otherwise indicated.
The excellent sales performance from the growth products in 2002 is expected to
continue in 2003, enabling the company to absorb most of the impact of generic
competition to PrilosecTM, NolvadexTM, and ZestrilTM and resulting in an overall
low single digit sales decline in constant currency terms. However, sales
should benefit significantly from current trends in exchange rates, but this
would largely be offset by the adverse effect on the cost base. The company
remains committed to fully supporting the launches of CrestorTM and ExantaTM.
Bearing these factors in mind and based on current exchange rates, the company
anticipates Earnings per Share in 2003 (before exceptional items) in the range
of $1.50 to $1.65 per share.
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 USA, the
successful registration and launch of new products (in particular CrestorTM,
IressaTM, and ExantaTM), continued growth of currently marketed products, the
growth in costs and expenses, interest rate movements, 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 2001 Annual Report on Form 20-F.
Media Enquiries: Steve Brown/Emily Denney (London) (020) 7304 5033/5034
Staffan Ternby (Sodertalje) (8) 553 26107
Rachel Bloom (Wilmington) (302) 886 7858
Analyst/Investor Enquiries: Mina Blair-Robinson (London) (020) 7304 5084
Jonathan Hunt (London) (020) 7304 5087
Staffan Ternby (Sodertalje) (8) 553 26107
Ed Seage/Jorgen Winroth (USA) (302) 886 4065/(212) 581 8720
Photographs of the AstraZeneca annual results conference are available from
newscast at www.newscast.co.uk from 1pm (UK time) today.
Sales
All narrative in this section refers to growth rates at constant exchange rates
(CER).
Gastrointestinal
Fourth Quarter CER % Full Year CER %
2002 2001 2002 2001
LosecTM/PrilosecTM 1,115 1,372 -20 4,623 5,578 -18
NexiumTM 686 278 n/m 1,978 568 n/m
Total 1,819 1,664 +7 6,664 6,190 +7
• NexiumTM sales for the full year were just under $2 billion. There were
a further 38 launches in 2002, bringing the total to 76 countries. The global
PPI market continues to grow strongly (around 20 percent). NexiumTM share of
the PPI market across major markets was 16 percent in October 2002.
• NexiumTM sales in the US were $1,525 million for the year, including
$521 million in the fourth quarter. NexiumTM share of total prescriptions in
the US PPI market increased to 20.5 percent in December, and its share amongst
GI specialist physicians is even higher (27 percent).
• Sales for LosecTM/PrilosecTM were down by 18 percent for the year. The
21 percent decline in the US was broadly in line with the prescription trend.
Sales performance outside the US (down 12 percent) was aided by strong growth in
Japan and Australia.
• A generic omeprazole product became available in the US market on 8
December. In the week ending 17 January, PrilosecTM brand share of total
omeprazole prescriptions was 47 percent; a rate that is consistent with reports
of constrained supply of generic product.
Cardiovascular
Fourth Quarter CER % Full Year CER %
2002 2001 2002 2001
ZestrilTM 144 256 -44 877 1,067 -18
AtacandTM 160 124 +24 569 410 +36
SelokenTM / Toprol-XLTM 263 165 +60 901 711 +27
PlendilTM 139 136 - 489 463 +5
Total 894 900 -3 3,569 3,483 +1
• Prescriptions for ZestrilTM in the US have rapidly declined since the
introduction of generics in July. Sales in the US in the fourth quarter fell to
$46 million.
• Sales of AtacandTM products grew by 36 percent on a worldwide basis in
2002, slightly ahead of the Angiotensin Receptor Blocker class. Sales in the
US increased by 37 percent for the year, although sales growth in the quarter
was only 15 percent versus a strong fourth quarter last year; total
prescriptions in the US grew by 24 percent in the quarter.
• Prescriptions continue to grow strongly for Toprol-XLTM in the US (up 38
percent for the year), consistent with the 43 percent increase in reported US
sales. US sales in the fourth quarter of $182 million were broadly in line with
prescription demand; the high growth rate (up 107 percent) reflects wholesaler
destocking in the fourth quarter last year.
Respiratory
Fourth Quarter CER % Full Year CER %
2002 2001 2002 2001
PulmicortTM 237 203 +14 812 766 +5
AccolateTM 52 30 +73 144 143 +2
RhinocortTM 76 74 +3 299 265 +13
OxisTM 29 33 -18 120 127 -9
SymbicortTM 105 49 n/m 299 83 n/m
Total 537 429 +21 1,818 1,539 +16
• SymbicortTM sales in the fourth quarter were $105 million, bringing the
total for the year to $299 million. The product has now been launched in more
than 40 countries. Value share of the fixed combination asthma products across
Europe was over 22 percent in November, with notably higher shares achieved in
Sweden (48 percent) and Germany (30 percent). The regulatory submission for
COPD treatment is being reviewed in the EU.
• PulmicortTM TurbuhalerTM sales globally reflect the declining inhaled
bronchial steroid market in the face of growing acceptance of combination
products. This was more than offset by the strong growth of PulmicortTM
RespulesTM in the US (up 75 percent), enabling PulmicortTM to achieve a 5
percent sales increase for the full year.
• RhinocortTM Aqua sales in the US increased by 39 percent for the year,
fuelled by a more than 3 point share gain in the aqueous intranasal steroid
market. It is the chief reason behind the 13 percent increase in RhinocortTM
franchise sales on a global basis in 2002.
• The sharp increase in US sales for AccolateTM in the fourth quarter is a
result of significant wholesaler stock building. Prescriptions for AccolateTM
in the US declined by 21 percent for the year.
Oncology
Fourth Quarter CER % Full Year CER %
2002 2001 2002 2001
CasodexTM 184 173 +5 644 561 +15
ArimidexTM 92 51 +78 331 188 +75
NolvadexTM 138 181 -24 480 618 -21
ZoladexTM 206 205 - 794 718 +12
FaslodexTM 16 - n/m 35 - n/m
IressaTM 41 - n/m 67 - n/m
Total 681 614 +11 2,369 2,111 +12
• ArimidexTM has enhanced its position as the leading product in the
aromatase inhibitor market for breast cancer treatment. Market share has grown
as the positive results of the ATAC trial in early breast cancer have been
incorporated into product labels and are being adopted in clinical practice.
Monthly prescriptions in the US have doubled since December 2001, driving the
127 percent increase in US sales for the year. Sales outside the US increased
by 51 percent.
• Sales of CasodexTM outside of the US increased by 42 percent to $464
million in 2002 as the use of CasodexTM 150 mg tablets in the treatment of early
prostate cancer has now been approved in 41 countries. In December, the
Oncology Drugs Advisory Committee to the US FDA did not recommend approval of
this indication in the US. Even without the benefit of this new indication,
prescriptions for CasodexTM grew by some 5 percent in the US market last year.
The reported sales decline in the US in the fourth quarter (down 35 percent) is
therefore not indicative of underlying demand, but rather an adverse comparison
against wholesaler stockbuilding in the fourth quarter of 2001.
• US sales for NolvadexTM in the fourth quarter were $99 million, as sales
of AstraZeneca's tamoxifen products recovered somewhat from the disruptions felt
as a result of the expiration of the company's distribution agreement with Barr
Laboratories. Sales were still off by 24 percent in the quarter and by 21
percent for the full year. A sharp decline in NolvadexTM sales in the US is
expected following the expiration of exclusivity in February.
• Sales of FaslodexTM in the treatment of advanced breast cancer reached
$35 million after 8 months in the US market. A European submission for second
line treatment of advanced breast cancer is planned for later this quarter.
• Sales of IressaTM for the treatment of inoperable or recurrent non-small
cell lung cancer reached $67 million in just over 4 months on the market in
Japan, indicating a high level of acceptance in this area of significant unmet
medical need. In the US, FDA has indicated that it will require an additional 3
months (to 5 May 2003) to complete its review of the pending NDA. A regulatory
submission in Europe is planned for later in the first quarter.
CNS
Fourth Quarter CER % Full Year CER %
2002 2001 2002 2001
SeroquelTM 357 170 +109 1,145 685 +67
ZomigTM 94 67 +39 328 273 +19
Total 460 243 +87 1,505 980 +53
• SeroquelTM sales exceeded the $1 billion megabrand milestone in 2002,
with strong growth of 67 percent. Share of new prescriptions in the US market
was 19.2 percent in December, up 3.7 points in the year. SeroquelTM value share
of the market in Japan is now 25 percent in just over one year on the market.
An sNDA submission in the US for use of SeroquelTM in the treatment of acute
mania associated with bipolar disorder (manic depressive illness) was announced
on 2 January. A filing in Europe is planned for later this quarter.
• In the fourth quarter, sales of SeroquelTM in the US increased by 130
percent. Whilst there was some indication of modest wholesaler stockbuilding in
the quarter, the high growth rate is largely a function of tight supply in the
fourth quarter last year.
• ZomigTM sales for the full year grew by 19 percent, with the bulk of the
increase arising in Japan (up 67 percent), France (up 29 percent) as well as
from the US (up 20 percent). RapimeltTM tablets and nasal spray formulations
have been valuable additions to the product range in countries where they have
been introduced. ZomigTM sales in the fourth quarter in the US appear to
reflect some wholesaler stockbuilding. ZomigTM prescriptions in the US
increased by 11 percent for the year, slightly ahead of the triptan market
overall.
Pain, Infection and Other Pharma
Fourth Quarter CER % Full Year CER %
2002 2001 2002 2001
MerremTM 69 65 +8 285 227 +26
DiprivanTM 117 133 -13 443 456 -3
XylocaineTM 51 57 -9 179 212 -14
MarcaineTM 23 26 -12 77 87 -11
Total 375 404 -7 1,418 1,496 -5
• Sales of MerremTM grew by 26 percent for the full year, chiefly on the
31 percent increase in sales outside the US.
• The small sales increase for DiprivanTM in the US was the result of
growth in the underlying demand for propofol offsetting small market share
losses to generic products.
Geographic Sales
Fourth Quarter CER % Full Year CER %
2002 2001 2002 2001
USA 2,564 2,219 +16 9,351 8,483 +10
Europe 1,528 1,439 -1 5,695 5,238 +5
Japan 314 260 +27 977 851 +21
RoW 495 448 +14 1,818 1,650 +13
• In the US, sales increased by 10 percent for the full year. Excluding
PrilosecTM, sales growth was 33 percent, with excellent performances in Nexium
TM, SeroquelTM, Toprol-XLTM, PulmicortTM RespulesTM, and ArimidexTM.
• Strong sales performances in France (up 13 percent) and Italy (up 16
percent) more than offset declining sales in Germany and UK, resulting in a 5
percent sales increase in Europe for the full year. Sales growth was driven by
NexiumTM, SymbicortTM, CasodexTM and SeroquelTM.
• A strongly performing product range in Oncology (including excellent
uptake for IressaTM) and continued strong growth in LosecTM (up 40 percent)
fuelled the 21 percent sales growth in Japan for the full year.
Operating Review
Full Year
Sales increased by 9 percent to $17,841 million and operating profit (before
exceptional items) increased by 5 percent to $4,356 million. Operating margin
of 24.4 percent of sales was 1.2 points below prior year. Currency impacts
reduced the margin by 0.3 points, whilst the other 0.9 point reduction was
largely due to lower other operating income. Elsewhere, improved product mix
and lower Merck payments reduced cost of sales by 0.6 points to 25.3 percent of
sales, whilst SG&A growth was broadly in-line with sales growth. R&D increased
by 0.6 points to 17.2 percent of sales, principally due to the growth in
clinical trial costs. In aggregate, R&D and SG&A grew by around 10 percent at
constant exchange rates.
Currency was 1 percent favourable on sales due to the weaker dollar. This was
offset by an adverse impact on costs leading to a slight negative currency
variance on profits versus last year.
Fourth Quarter
Sales increased by 10 percent to $4,901 million and operating profit (before
exceptional items) declined by 2 percent to $1,074 million, which led to
operating margins declining by 3.1 points to 21.9 percent of sales. Cost of
sales at 25.6 percent of sales was 0.3 points lower than 2001, principally due
to improved mix and a lower proportion of Merck payments. R&D expenditure was
$892 million or 18.2 percent of sales. The increase was largely due to
increased spend on clinical trials following a high level of patient recruitment
to key trials in the quarter. In dollar terms, R&D spend was inflated by around
5 percent due to adverse currency movements. SG&A expenditure was $1,661million
or 33.9 percent of sales, the increase due primarily to G&A costs and an adverse
currency effect. G&A costs in the fourth quarter included a number of small
reorganisation provisions aimed at improving productivity. Other operating
income at 0.4 percent of sales was 1.1 points below 2001 due to the absence of
one-off items in the quarter and a decrease in income from royalty agreements
that expired last year.
Currency increased sales in the fourth quarter by 2 percent, primarily
attributable to the weaker dollar against the euro. This benefit was partially
offset by higher costs due to the weaker dollar versus sterling and Swedish
krona, leading to a 1 percent favourable effect on operating profit.
Exceptional Item
As previously disclosed, the U.S. Department of Justice has been conducting an
investigation into the sale and marketing of ZoladexTM (goserelin acetate
implant). This investigation was prompted by the filing of a qui tam complaint
by a private party in 1997 and involves allegations of improper submissions of
claims to the Medicare and Medicaid programs. The Company and federal and state
authorities are in the process of negotiating a potential settlement of the
civil and criminal claims at issue in the investigation. As a result, although
no final agreement has been concluded, the Company believes it appropriate to
accrue $350 million to cover estimated settlement costs.
Interest
Interest income was $7 million in the quarter leading to $31 million for the
full year. Interest income in the quarter incorporates some small exchange and
revaluation losses.
Taxation
Excluding exceptional items, the effective tax rate for both the fourth quarter
and full year 2002 was 26.8 percent compared with 28.4 percent for 2001. The
2001 tax rate has been restated under FRS19. See note 1 to the preliminary
announcement for more details. No tax relief has been provided on the
exceptional item charge.
Cash Flow
Cash generated from operating activities after exceptional items amounted to
almost $5.6 billion for the year; $1.8 billion ahead of last year. This was
applied to capital expenditures of $1.5 billion, taxation paid of $0.8 billion,
dividends of $1.2 billion and share repurchases of $1.2 billion to give an
increase in net cash funds of just under $1 billion. Net cash funds at the end
of the year amounted to $3.8 billion (2001 $2.9 billion).
Share Repurchase Programme
During the quarter, 7.8 million shares were repurchased (nominal value $0.25
each) for cancellation at a total cost of $295 million bringing the total for
the year to 28.4 million at a cost of $1,190 million.
Since the commencement of the programme, 65.6 million shares have been
repurchased for cancellation at a total cost of $2,805 million.
The total number of shares in issue as at 31 December 2002 is 1,719 million.
Approximately $1.2 billion remains available under the previously announced
share repurchase programme, and it is anticipated that this will be used to
complete the programme by the end of 2003.
Upcoming Milestones and Key Events
30 April Announcement of first quarter results
30 April Annual General Meeting 2003
24 July Announcement of second quarter results
2 October Annual Business Review
23 October Announcement of third quarter results
Sir Tom McKillop
Chief Executive
This information is provided by RNS
The company news service from the London Stock Exchange