SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
AstraZeneca PLC
Date: February 1, 2003 By: /s/ G H R Musker
Name: G H R Musker
Title: Company Secretary & Solicitor
Agenda Item 1
ASTRAZENECA FILES sNDA FOR SEROQUEL(R) (QUETIAPINE)
IN BIPOLAR DISEASE
AstraZeneca today announced that it has submitted a Supplemental New Drug
Application (sNDA) to the U.S. Food and Drug Administration (FDA) for
SEROQUEL(R) (quetiapine) for the treatment of acute mania associated with
bipolar disorder (manic depressive illness).
The application to the FDA follows the completion of a comprehensive bipolar
disorder clinical trial programme undertaken by AstraZeneca to examine the
efficacy and tolerability of SEROQUEL in this important disease area. The
programme has delivered consistently strong and positive results in both the
monotherapy and adjunctive therapy studies, which confirm SEROQUEL to be an
ideal first line agent.
The proposed new indication is expected to expand the market for SEROQUEL, which
is currently indicated for the treatment of schizophrenia in adults. Analysts
estimate that bipolar disorder alone constitutes a multibillion-dollar market.
The illness affects an estimated 2.3 million American adults and is ranked as
the second leading cause of disability worldwide among the neuro-psychiatric
disorders. To date, over 4 million people have been treated with Seroquel
worldwide. SEROQUEL is the fastest-growing atypical antipsychotic on the market,
with annualised sales that approached $1 billion in Q3 2002.
2 January 2003
Media Enquiries:
Emily Denney, Tel: +44 (0) 207 304 5034
Investor Relations:
Mina Blair-Robinson, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
-ENDS -
Agenda Item 2
ASTRAZENECA ANNOUNCES FDA REQUIRES MORE TIME FOR
PRIORITY REVIEW OF IRESSA(R)(ZD1839) U.S. APPLICATION-
DECISION EXPECTED BY MAY 5, 2003
The U.S. Food and Drug Administration (FDA) has notified AstraZeneca that it
requires more time to review information requested of the company during the six
month priority review of the new drug application (NDA) for IRESSA(R)
(ZD1839/gefitinib). AstraZeneca will work closely with the Agency to complete
the review in a prompt and effective manner. The extended user fee goal date is
May 5th 2003.
On September 24, 2002 the Oncologic Drugs Advisory Committee (ODAC) made a clear
recommendation to the FDA supporting the approval of IRESSA(R)
(ZD1839/gefitinib). Since that time, AstraZeneca has continued to provide
additional information to the FDA as requested by the agency, including
extensive safety information on patients involved in clinical trials, the
expanded access programme (compassionate use) and clinical use in Japan where
the drug is approved.
At the urging of patients and physicians, and with the support of the FDA,
AstraZeneca continues to provide an extensive compassionate use programme for
the drug during the review period. In the past two years, almost 20,000 patients
in the U.S. have received IRESSA(R) through this programme.
Lung cancer is the leading cause of cancer deaths in the United States, which
accounted for approximately 155,000 deaths in 2002. Non-small cell lung cancer
is the most common form of lung cancer, accounting for 80 per cent of all lung
cancer cases. IRESSA(R) is being considered for use in the most advanced of
these patients, who have progressed despite multiple other treatments. Currently
no treatment option exists for these patients.
9 January 2003
Media Enquiries:
Emily Denney, Tel: +44 (0) 20 7304 5034
Steve Brown, Tel: +44 (0) 20 7304 5033
Investor Relations:
Jonathan Hunt, Tel: +44 (0) 20 7304 5087
Mina Blair Robinson: Tel: +44 (0) 20 7304 5084
Notes to editors:
For more information on AstraZeneca please visit www.astrazeneca.com
This press release contains forward-looking statements with respect to
AstraZeneca's business. By their nature, forward-looking statements and
forecasts involve risks and uncertainties because they relate to events and
depend on circumstances that will occur in the future. There are a number of
factors that could cause actual results and developments to differ materially.
For a discussion of those risks and uncertainties, please see the company's
Annual Report/Form 20-F for 2001.
IRESSA(R) is a trademark of the AstraZeneca group of companies.
-Ends-
Agenda Item 3
COMPANIES ACT 1985 SECTION 198
DISCLOSURE OF INTEREST IN VOTING SHARES IN PUBLIC COMPANIES
ON 9 JANUARY 2003 WE WERE INFORMED BY THE CAPITAL GROUP COMPANIES, INC., A
REGISTERED INVESTMENT MANAGER IN THE U.S., THAT ON 7 JANUARY 2003 ITS INTEREST
IN THE USD0.25 ORDINARY SHARES OF ASTRAZENECA PLC HAD DECREASED TO 208,550,628
SHARES (12.13 PER CENT OF THE ISSUED ORDINARY CAPITAL) FROM THE PREVIOUSLY
NOTIFIED LEVEL OF 214,373,635 SHARES (12.42 PER CENT). THE REASON FOR THIS
ANNOUNCEMENT IS THAT, WITHIN THE SAID HOLDING OF 12.13 PER CENT OF THE ISSUED
ORDINARY CAPITAL OF ASTRAZENECA PLC, CAPITAL GUARDIAN TRUST COMPANY, AN
AFFILIATE OF THE CAPITAL GROUP COMPANIES, INC., HAS DECREASED ITS INTEREST IN
THESE SHARES TO 85,393,793 SHARES (4.97 PER CENT) FROM 86,567,127 SHARES (5.02
PER CENT).
G H R MUSKER
COMPANY SECRETARY
10 JANUARY 2003
Agenda Item 4
COMPANIES ACT 1985 SECTION 198
DISCLOSURE OF INTEREST IN VOTING SHARES IN PUBLIC COMPANIES
ON 14 JANUARY 2003 WE WERE INFORMED BY THE CAPITAL GROUP COMPANIES, INC., A
REGISTERED INVESTMENT MANAGER IN THE U.S., THAT ON 10 JANUARY 2003 ITS INTEREST
IN THE USD0.25 ORDINARY SHARES OF ASTRAZENECA PLC HAD DECREASED TO 204,812,653
SHARES (11.92 PER CENT OF THE ISSUED ORDINARY CAPITAL) FROM THE PREVIOUSLY
NOTIFIED LEVEL OF 208,550,628 SHARES (12.13 PER CENT).
G H R MUSKER
COMPANY SECRETARY
14 JANUARY 2003
Agenda Item 5
AstraZeneca PLC
Fourth Quarter and Full Year Results 2002
"Earnings per Share ahead of target, benefiting from strong sales growth
of Nexium(TM), Seroquel(TM), and Symbicort(TM)."
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)
o Earnings per Share (before exceptional items) were up 7 percent to $1.84
for the full year; Statutory Earnings per Share were $1.64.
o Sales for the full year increased by 9 percent. Sales growth excluding
Losec(TM)/Prilosec(TM)was 23 percent.
o 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.
o Nexium(TM) sales were nearly $2 billion for the full year. Share of total
prescriptions in the US exceeded 20 percent in December. Nexium(TM) is now
the number 2 PPI in new prescription market share in the US.
o Sales of Seroquel(TM) exceeded $1 billion for the year, up 67 percent. An
sNDA in the US has been submitted for the use of Seroquel(TM) in the
treatment of acute mania associated with bipolar disorder.
o Sales of Iressa(TM) reached $67 million for the year following launch in
Japan in the third quarter. The FDA has extended its regulatory review
period for Iressa(TM) to May 5.
o Investment in Research and Development in 2002 was over $3 billion, as
planned.
o 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 Zoladex(TM) in the US.
Sir Tom McKillop, Chief Executive, said: "Sales excluding Losec(TM)/Prilosec(TM)
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 Crestor(TM) and
Exanta(TM) 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 Nexium(TM)
more than offset declines in Losec(TM)/Prilosec(TM). Nexium(TM) sales more than
trebled to $1,978 million, including $453 million from markets outside the US.
In the US, Nexium(TM) share of total prescriptions for PPI products reached 20.5
percent in December.
Sales of Losec(TM)/Prilosec(TM) 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
Prilosec(TM) 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 Losec(TM)/Prilosec(TM) 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 Atacand(TM) (up 36 percent) and Seloken(TM)/Toprol-XL(TM)
(up 27 percent), generic competition for Zestril(TM) resulted in sales growth
for Cardiovascular products of just 1 percent.
The recently launched products--Nexium(TM), Symbicort(TM), Faslodex(TM) (in the
US) and Iressa(TM) (in Japan)-- generated nearly $2.4 billion in sales in 2002
(up from $651 million in 2001). Five other growth products--Casodex(TM),
Arimidex(TM), Atacand(TM), Seroquel(TM), and Zomig(TM) -- 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 Prilosec(TM), Nolvadex(TM), and Zestril(TM) 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 Crestor(TM) and
Exanta(TM). 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 Crestor(TM),
Iressa(TM), and Exanta(TM)), 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.
2
AstraZeneca PLC
Sales
All narratives in this section refers to growth rates at constant exchange rates
(CER).
Gastrointestinal
Fourth Quarter CER % Full Year CER %
2002 2001 2002 2001
Losec(TM)/Prilosec(TM) 1,115 1,372 -20 4,623 5,578 -18
Nexium(TM) 686 278 n/m 1,978 568 n/m
Total 1,819 1,664 +7 6,664 6,190 +7
o Nexium(TM) 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). Nexium(TM) share
of the PPI market across major markets was 16 percent in October 2002.
o Nexium(TM) sales in the US were $1,525 million for the year, including $521
million in the fourth quarter. Nexium(TM) 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).
o Sales for Losec(TM)/Prilosec(TM) 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.
o A generic omeprazole product became available in the US market on 8
December. In the week ending 17 January, Prilosec(TM) 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
Zestril(TM) 144 256 -44 877 1,067 -18
Atacand(TM) 160 124 +24 569 410 +36
Seloken(TM)/ Toprol-XL(TM) 263 165 +60 901 711 +27
Plendil(TM) 139 136 - 489 463 +5
Total 894 900 -3 3,569 3,483 +1
o Prescriptions for Zestril(TM) 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.
o Sales of Atacand(TM) 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.
o Prescriptions continue to grow strongly for Toprol-XL(TM) 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.
3
AstraZeneca PLC
Respiratory
Fourth Quarter CER % Full Year CER %
2002 2001 2002 2001
Pulmicort(TM) 237 203 +14 812 766 +5
Accolate(TM) 52 30 +73 144 143 +2
Rhinocort(TM) 76 74 +3 299 265 +13
Oxis(TM) 29 33 -18 120 127 -9
Symbicort(TM) 105 49 n/m 299 83 n/m
Total 537 429 +21 1,818 1,539 +16
o Symbicort(TM) 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.
o Pulmicort(TM) Turbuhaler(TM) 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 Pulmicort(TM)
Respules(TM) in the US (up 75 percent), enabling Pulmicort(TM) to achieve a
5 percent sales increase for the full year.
o Rhinocort(TM) 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
Rhinocort(TM) franchise sales on a global basis in 2002.
o The sharp increase in US sales for Accolate(TM) in the fourth quarter is a
result of significant wholesaler stock building. Prescriptions for
Accolate(TM) in the US declined by 21 percent for the year.
Oncology
Fourth Quarter CER % Full Year CER %
2002 2001 2002 2001
Casodex(TM) 184 173 +5 644 561 +15
Arimidex(TM) 92 51 +78 331 188 +75
Nolvadex(TM) 138 181 -24 480 618 -21
Zoladex(TM) 206 205 - 794 718 +12
Faslodex(TM) 16 - n/m 35 - n/m
Iressa(TM) 41 - n/m 67 - n/m
Total 681 614 +11 2,369 2,111 +12
o Arimidex(TM) 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.
o Sales of Casodex(TM) outside of the US increased by 42 percent to $464
million in 2002 as the use of Casodex(TM) 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 Casodex(TM) 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.
4
o US sales for Nolvadex(TM) 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 Nolvadex(TM) sales
in the US is expected following the expiration of exclusivity in February.
o Sales of Faslodex(TM) 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.
o Sales of Iressa(TM) 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
Seroquel(TM) 357 170 +109 1,145 685 +67
Zomig(TM) 94 67 +39 328 273 +19
Total 460 243 +87 1,505 980 +53
o Seroquel(TM) 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.
Seroquel(TM) 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
Seroquel(TM) 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.
o In the fourth quarter, sales of Seroquel(TM) 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.
o Zomig(TM) 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). Rapimelt(TM) tablets and nasal spray
formulations have been valuable additions to the product range in countries
where they have been introduced. Zomig(TM) sales in the fourth quarter in
the US appear to reflect some wholesaler stockbuilding. Zomig(TM)
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
Merrem(TM) 69 65 +8 285 227 +26
Diprivan(TM) 117 133 -13 443 456 -3
Xylocaine(TM) 51 57 -9 179 212 -14
Marcaine(TM) 23 26 -12 77 87 -11
Total 375 404 -7 1,418 1,496 -5
o Sales of Merrem(TM)grew by 26 percent for the full year, chiefly on the 31
percent increase in sales outside the US.
o The small sales increase for Diprivan(TM) in the US was the result of
growth in the underlying demand for propofol offsetting small market share
losses to generic products.
5
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
o In the US, sales increased by 10 percent for the full year. Excluding
Prilosec(TM), sales growth was 33 percent, with excellent performances in
Nexium(TM), Seroquel(TM), Toprol-XL(TM), Pulmicort(TM) Respules(TM), and
Arimidex(TM).
o 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 Nexium(TM), Symbicort(TM), Casodex(TM) and Seroquel(TM).
o A strongly performing product range in Oncology (including excellent uptake
for Iressa(TM)) and continued strong growth in Losec(TM) (up 40 percent)
fuelled the 21 percent sales growth in Japan for the full year.
6
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 $1,661 million
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 Zoladex(TM) (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.
7
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
8