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PHARMACEUTICALS
In the central nervous system therapy area, sales
of GlaxoSmithKlines leading product for depression and
anxiety disorders, Seroxat/Paxil, were up 18
per cent in the USA. Paxil CR, launched in the USA
in April, continues to gain acceptance due to its strong tolerability
profile. International sales of Paxil grew 27 per cent
led by continued strong growth in Japan, where the product
was launched only two years ago. Sales of Wellbutrin,
for depression, grew 42 per cent, reflecting increased physician
awareness of the products outstanding efficacy and favourable
side effect profile. Lamictal, for epilepsy, continued
to grow across all regions. In January 2003, the US FDA approved
the use of Lamictal for the treatment of partial seizures
in paediatric patients aged two years and above.
In respiratory, GlaxoSmithKline continues to
be the global leader with sales of its three key products
Seretide/Advair, Flixotide and Serevent
amounting to nearly £3 billion, up 25 per
cent. Sales of Seretide/Advair grew 96 per cent and
Advair is now the market leader in the US asthma market
in new prescriptions after less than two years on the market.
The Group expects European marketing authorisation within
the next few months for the use of Seretide as a new
treatment for Chronic Obstructive Pulmonary Disease.
Anti-viral sales grew across all regions and
totalled £2.3 billion, up 12 per cent. Sales of Trizivir,
GlaxoSmithKlines new triple combination therapy for
HIV, grew 95 per cent to £315 million. Valtrex
for herpes achieved strong sales growth of 26 per cent worldwide.
In September 2002, Valtrex was approved by the FDA
for the treatment of cold sores in healthy adults and in October
2002, GlaxoSmithKline filed a further application for Valtrex
seeking the first-ever indication to reduce the risk of transmission
of genital herpes.
Anti-bacterial sales declined 12 per cent worldwide
and 22 per cent in the USA as a result of generic competition
for Augmentin and Ceftin. In the USA, GlaxoSmithKlines
two new formulations, Augmentin ES for children and
Augmentin XR for adults are performing well.
In metabolic and gastro-intestinal the Avandia
franchise, Avandia and Avandamet, grew 19 per
cent for the year and Avandia is now approved in 81 countries.
Avandamet (Avandia and metformin HCI),
launched in the fourth quarter, is the first treatment for
type 2 diabetes that targets insulin resistance and decreases
glucose production in one convenient pill.
Within vaccines, the Hepatitis franchise grew
12 per cent with sales in Europe growing ten per cent. Vaccine
sales in the USA were up 16 per cent benefiting from the launch
of Twinrix and continued growth in Havrix, driven
by new state mandates requiring Hepatitis A vaccination for
school age children. In the USA, GlaxoSmithKlines new
Pediarix vaccine was launched in January 2003.
In oncology, Zofran sales grew 22 per
cent to £708 million driven by a strong US performance,
up 28 per cent to £525 million.
In July, GlaxoSmithKline received approval
from the Swedish regulatory authorities for Avodart
(dutasteride), a DHT inhibitor for the treatment of symptomatic
benign prostatic hyperplasia. GlaxoSmithKline plans to market
Avodart in all major European markets with launches
in the first half of 2003.
Levitra (vardenafil) a new agent for
the treatment of erectile dysfunction has received approval
for marketing in Europe and launches are planned for March
2003. Levitra was researched and developed by Bayer
AG and will be co-promoted with GlaxoSmithKline.
CONSUMER HEALTHCARE
Over-the-counter sales were £1.6 billion, up
four per cent, reflecting strong growth in the smoking control
franchise. Nutritional Healthcare grew three per cent due
to strong growth in Europe for Lucozade and Ribena,
partly offset by the performance of Horlicks in international
markets. Oral care sales were down two per cent to £1.1
billion as growth from Sensodyne, Polident and
Poligrip was offset by weak sales for Aquafresh.
TRADING PROFIT AND EARNINGS
PER SHARE
Business performance trading profit was £6.7
billion with a growth of 15 per cent, greater than sales growth
of seven per cent, demonstrating an improved trading margin
of 2.1 points to 31.6 per cent compared with 2001. This is
mainly due to cost savings derived from merger integration,
manufacturing restructuring and other initiatives. Statutory
trading profit was £5.7 billion with a growth of 26
per cent.
Full year business performance earnings per
share (EPS) of 78.3 pence increased 13 per cent and eight
per cent in sterling terms reflecting a weakening of the US
dollar and other currencies. Full year statutory EPS was 66.2
pence, an increase of 38 per cent.
IMPLEMENTATION OF NEW
FINANCIAL REPORTING STANDARD
The Group has implemented Financial Reporting Standard
19 Deferred tax in 2002 which requires deferred
tax to be accounted for on a full provision basis, rather
than a partial provision basis as before. Comparative information
has been restated as necessary. The effect in 2001 is to increase
the business performance tax charge by £8 million and
the overall tax charge by £6 million. The net deferred
tax asset at 31st December 2001 has been reduced by £127
million.
THE SARBANES-OXLEY ACT
2002
Following a number of corporate and accounting scandals
in the USA, Congress passed the Sarbanes-Oxley Act 2002 (Sarbanes-Oxley)
which took effect on 30th July 2002. Sarbanes-Oxley establishes
new or enhanced standards for corporate accountability in
the USA. A number of provisions of Sarbanes-Oxley apply to
GlaxoSmithKline and, although the companys corporate
governance structure is believed to be robust and in line
with best practice, a few changes are necessary to ensure
compliance. These are described under Corporate governance
in the companys Annual Report for 2002.
LEGAL PROCEEDINGS
The Group is involved in various legal and administrative
proceedings principally intellectual property cases, product
liability and government investigations. Descriptions of the
most significant of those are described under Legal
proceedings in theNotes to the financial statements
in the companys Annual Report for 2002.
CAUTIONARY STATEMENT
Under the safe harbor provisions of the
US Private Securities Litigation Reform Act of 1995, the company
cautions investors that any forward-looking statements or
projections made by the company, including those made in this
Annual Review, are subject to risks and uncertainties that
may cause actual results to differ materially from those projected.
Factors that may affect the Groups operations are described
under Risk factors in the Operating and
financial review and prospects in the companys
Annual Report on Form 20-F, filed with the US Securities and
Exchange Commission.
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