For full report, see attachment.
LONDON, April 23, 2008-GlaxoSmithKline plc today announces its
unaudited results for the first quarter ended 31st March 2008.
Commenting on GSK’s performance for the quarter, JP Garnier,
Chief Executive Officer, said: “Our performance this quarter
was in line with our expectations. We continue to see sustained
growth from key areas of our business such as Seretide/Advair,
vaccines and consumer. However, sales were impacted by generic
competition and declines in Avandia sales.
We are also making good progress in strengthening our product
portfolio, with approvals and regulatory progress on 4 key products
already this year. These products are at the forefront of a
substantive pipeline of projects in clinical development - with 96
NCEs and 24 new vaccines this pipeline is testament to GSK’s
innovation and gives the company a very strong foundation for the
future.”
PHARMACEUTICAL UPDATE
Total pharmaceutical turnover for the first quarter declined 4% to
4.8 billion, with growth from key products
offset by significant generic competition to products in the USA
and declines in Avandia sales in all regions.
In the United States, turnover was 2,138 million, down 10%,
in Europe turnover was 1,526 million,
down 1%, and in International markets sales were 1,129
million, up 6%.
Seretide/Advair sales up 10% with strong performance in all
regions
Sales of Seretide/Advair, for asthma and COPD, rose 10% to
954 million, with sales in the USA also
growing 10% to 499 million. In Europe, sales grew 9% to
351 million and in International sales grew by
16% to 104 million.
GSK continues to see increased use of Seretide/Advair in the
treatment of COPD and is in ongoing
discussions with the FDA to further expand the indication for use
in this patient group. GSK expects a
decision from the FDA during the second quarter.
Vaccine sales of 436 million up 10% driven by strong US
performance
US vaccine sales grew 34% for the quarter to 109 million,
driven by continued strong performances of
hepatitis vaccines, up 66% to 53 million, and
Infanrix/Pediarix, up 21% to 51 million. In Europe,
sales
of vaccines were up 5% to 202 million. In International
markets sales rose 2% to 125 million, adversely
impacted in part by the timing of shipments. GSK expects stronger
growth in this region in the rest of this
year.
GSK expects to submit a response to the FDA’s Complete
Response letter regarding Cervarix in the
second quarter and will continue discussions with the agency
regarding the application. Cervarix has now
been approved in more than 60 countries with discussions regarding
reimbursement and tender orders ongoing.
Sales for Cervarix in the quarter were 12 million.
In April, GSK received FDA approval for Rotarix, a new two-dose
vaccine to prevent rotavirus
gastroenteritis, with launch expected in the second half of the
year. Sales of Rotarix in markets outside of
the USA grew 79% to 27 million.
In February, GSK received a positive opinion from the EMEA
regarding Prepandrix, its pre-pandemic flu
vaccine. Prepandrix will be the first vaccine approved for
pre-pandemic use in Europe. In March a supply
contract was signed by the Finnish Government for 5.2 million doses
of Prepandrix for use in advance of a
pandemic flu outbreak. Shipments will commence in the second half
of 2008.
New growth drivers
Arixtra, for deep vein thrombosis and pulmonary embolism, delivered
strong growth with sales up 70% to
35 million. Sales grew in Europe (up 33% to 14
million) following approval last year for the treatment of
specific acute coronary syndromes (ACS). In the USA, GSK is in
on-going discussions with the FDA
regarding a potential ACS indication.
Avodart, for benign prostatic hyperplasia (enlarged prostate),
continued to perform strongly with sales up
30% to 85 million for the quarter. GSK has filed for a
co-prescription indication in the USA, Europe and
International markets for use of Avodart in combination with the
alpha-blocker, tamsulosin. In April, GSK
received its first regulatory approval for this indication in
Europe under the mutual recognition procedure.
GSK expects a response from the FDA in June for this
application.
GSK’s co-promotion income for Boniva/Bonviva, the only
once-monthly oral medicine for postmenopausal
osteoporosis, was up 50% to 49 million.
Sales of GSK’s newly acquired Lovaza, an omega-3-acid product
for adult patients with very high levels of
triglycerides, contributed 50 million (72% on a proforma
basis).
Tykerb/Tyverb, for breast cancer, achieved sales of 19
million for the quarter. An extensive development
programme involving 10 phase III clinical trials is ongoing,
including metastatic, first line and adjuvant
breast cancer. Last week new data were presented at the European
Breast Cancer Conference in Berlin
which demonstrated the efficacy of Tykerb in shrinking tumours
prior to surgery and reducing the number of
chemotherapy-resistant cancer stem cells responsible for tumour
regeneration. Enrolment was completed
for TEACH in the quarter – a phase III study investigating
whether adjuvant treatment with Tykerb will
improve survival in early breast cancer by preventing the disease
from recurring.
Veramyst/Avamys, for allergic rhinitis, generated sales of
13 million across the USA and Europe for the
quarter.
Other key pharmaceutical products
Sales of Avandia products, for the treatment of type 2 diabetes,
fell 56% to 191 million. Sales in the USA
for the quarter were 99 million, down 66%, with
Avandia’s share of total prescriptions in the US oral
anti-diabetic market currently stable at around 4%. In Europe sales
were 54 million, down 14%, and in
International markets 38 million, down 44%.
Sales of Coreg products, for heart disease, fell 77% to 48
million, following the introduction of generic
competition to Coreg IR in September 2007. Sales of Coreg CR were
35 million with increasing share
gains made in the US hypertension market.
Total sales of HIV products were 358 million, down 5%.
Competition to older products, Combivir
(-13% to 105 million) and Epivir (-22% to 34
million), was partially offset by strong sales growth of
Epzicom/Kivexa (25% to 99 million).
Sales of Lamictal, for the treatment of epilepsy and bipolar
disorder, were 290 million driven by strong
performance in the USA with sales up 22% to 240
million.
Sales of Relenza, an antiviral treatment for flu, were 29
million (92 million in Q1 2007), reflecting the
variable timing of tender orders from governments stockpiling
against a possible flu pandemic.
Sales of Requip, for Parkinson’s Disease/Restless Legs
Syndrome, grew 15% to 94 million for the
quarter. Requip XL, a new once-daily formulation for
Parkinson’s Disease, has now been launched in 12
European markets. In the USA, GSK expects a response from the FDA
on its application for Requip XL
during the second quarter of 2008.
Sales of Valtrex, for herpes, rose 9% to 249 million, with
US sales up 7% to 173 million, driven by
increased use of the product for prevention of herpes transmission.
Sales in Europe grew 18% to 37
million and in International sales grew 9% to 39
million.
Product sales affected by generic competition were Wellbutrin (-3%
to 126 million), Flixonase/Flonase
(-33% to 46 million) and Zofran (-69% to 29
million).
CONSUMER HEALTHCARE UPDATE
Consumer Healthcare sales grew 8% to 893 million, driven by
innovation and geographic expansion
In Europe, sales grew 7% to 413 million with strong
performances in Central and Eastern Europe. In
International, sales grew 18% to 285 million with strong
performances from key markets, Latin America,
India and the Middle East.
Sales in North America declined 2% to 195 million due to
strong competition to smoking cessation
products from prescription medicines and retailers’ own-label
nicotine replacement products. Excluding the
smoking cessation brands, North American consumer healthcare sales
grew 6% to 157 million.
Over-the-counter medicine sales grew 4% to 411 million.
Following its successful launch in June 2007,
alli contributed sales of 9 million which were impacted by
normalisation of inventory levels after a yearend
promotion. Demand for alli continues to be strong and, based on
retail market data, underlying
demand is estimated to have been 35 million during the
quarter. Panadol sales grew 19% to 80 million.
Sales of Breathe Right, recently acquired from CNS, grew 14% to
17 million. The product will be
launched in European, Asian and Latin American markets this
year.
Oral healthcare sales were up 8% to 289 million for the
quarter. Sales of Sensodyne grew 19% to 86
million, aided by the successful launch of Sensodyne Pronamel.
Sales of Aquafresh grew 7% to 83
million, and sales of the denture care brands, Poligrip, Corega and
Polident, grew 4% to 60 million.
Nutritional healthcare sales for the quarter increased by 14% to
193 million. Lucozade continued its
excellent performance, up 18% to 86 million. Horlicks sales
grew 18% to 56 million, whilst sales of
Ribena declined 5% to 37 million.
PHARMACEUTICAL PIPELINE UPDATE
In February, the company published an update of its R&D
pipeline. GSK currently has 157 projects in
clinical development comprising 96 NCEs, 37 PLEs and 24 Vaccines.
GSK has 34 key assets currently in
phase III development or registration.
First major market approvals and filings
In April, GSK received FDA approval for Treximet, a new acute
treatment of migraine. Treximet is the first
and only migraine product designed to target multiple mechanisms of
migraine by combining a triptan, a
class of migraine-specific medicines pioneered by GSK, and an
anti-inflammatory pain reliever in a single
tablet. Treximet will be launched in the USA in May.
In March, the FDA granted priority review for Promacta, an oral
thrombopoeitin receptor agonist, for the
short-term treatment of patients with chronic idiopathic
thrombocytopenic purpura. The FDA’s decision on
Promacta is expected in the second quarter and, if approved, would
be the first treatment of its type to be
approved for this indication.
In February, the EMEA granted a positive opinion for approval of
Volibris (ambrisentan) to treat functional
class II and III pulmonary arterial hypertension.
Late-stage pipeline progress
Following analysis of the full data set for darapladib, which
includes the dose ranging study presented at
the American College of Cardiology in March and the IBIS-2 imaging
study, GSK intends to progress
darapladib into Phase III development and will shortly start
discussions with regulators regarding the
structure of the Phase III programme. GSK expects data from IBIS-2
to be presented and published in the
second half of the year.
In March, positive phase III data were published demonstrating that
Bosatria (mepolizumab) showed
disease control with reduced corticosteroid use in treatment of
hypereosinophilic syndrome. This is a group
of rare disorders leading to significant respiratory, cardiac, skin
and gastrointestinal problems and can be
life-threatening in some people with advanced disease.
Positive results from the third pivotal phase III study for
GSK1838262 (XP13512) were also received in the
quarter demonstrating its efficacy as a treatment of
moderate-to-severe symptoms of primary restless legs
syndrome. GSK expects to file ‘262 with the FDA for approval
in the third quarter of 2008.
Acquisitions
On 22nd April GSK announced an agreement to acquire Sirtris
Pharmaceuticals, a world leader in ‘sirtuin’
research and development. Sirtuins are a class of enzymes that
could be used to develop new medicines to
address diseases associated with metabolism and ageing such as
diabetes, muscle wasting and
neurodegeneration.
Collaborations
On 17th April, GSK announced a worldwide strategic alliance with
Regulus Therapeutics to discover,
develop and market novel microRNA-targeted therapeutics, a new
approach for the treatment of a wide
range of diseases, including inflammatory diseases such as
rheumatoid arthritis and inflammatory bowel
disease.
FINANCIAL REVIEW
Dividend
The Board has declared a first interim dividend of 13 pence per
share. This compares with a dividend of 12
pence per share for Q1 2007. The equivalent interim dividend
receivable by ADR holders is 51.8570 cents
per ADS based on an exchange rate of 1/$1.9945. The
ex-dividend date will be 30th April 2008, with a
record date of 2nd May 2008 and a payment date of 10th July
2008.
Share buy-back programme
GSK repurchased 986 million of shares in Q1 2008 which have
been cancelled. Repurchases of 6 billion
are expected in 2008.
Operational Excellence
In October 2007, GSK announced a significant new 1.5 billion
Operational Excellence programme to
improve the effectiveness and productivity of its operations. This
new programme is expected to deliver
annual pre-tax savings of 700 million by 2010. GSK expects
to realise the majority of annual savings
within the first two years of the programme, with approximately
350 million expected in 2008 and 550
million in 2009.
One-off charges of 87 million before tax relating to the new
Operational Excellence programme were
recorded in Q1 2008.
Operating profit and earnings per share
Business performance operating profit of 2,048 million
decreased by 9% in CER terms compared with Q1
2007. This was more than the fall in turnover of 3%, reflecting
higher R&D costs and lower other operating
income, partly offset by lower SG&A expenditure. Costs of sales
increased to 22.8% of turnover (Q1 2007:
22.1%) reflecting the impact of generic competition to higher
margin products and lower Avandia sales,
partly offset by improvements in manufacturing efficiencies.
In the quarter, gains from asset disposals and legal settlements
were 54 million (Q1 2007: 102 million),
costs for legal matters were 39 million (Q1 2007: 26
million), fair value movements on financial
instruments resulted in income of 66 million (Q1 2007:
33 million) and charges related to previous
restructuring programmes were 6 million (Q1 2007: 9
million). The business performance operating profit
impact of these items was a 75 million credit in Q1 2008 (Q1
2007: 100 million credit).
GSK’s share of the results of associates was a 1
million loss (Q1 2007: 15 million profit) as a result of
the
recognition of a legal provision made by Quest Diagnostics
Inc.
Business performance profit after taxation decreased by 13% in CER
terms, more than the decline in
operating profit, reflecting higher net interest costs (primarily
driven by increased borrowing to fund the share
repurchase programme) and a higher tax rate. Business performance
EPS of 25.6 pence decreased 9% in
CER terms (5% in sterling terms) compared with Q1 2007.
Statutory operating profit for the quarter, including restructuring
costs of 85 million for the new Operational
Excellence programme and significant acquisitions, was 1,963
million and statutory EPS was 24.4 pence.
Currencies
The Q1 2008 results are based on average exchange rates,
principally 1/$1.99, 1/Euro 1.32 and
1/Yen
210. The period-end exchange rates were 1/$1.99,
1/Euro 1.26 and 1/Yen 198. If exchange rates
were
to hold at the average Q1 2008 levels for the rest of the year, the
positive currency impact on business
performance EPS growth for the full-year would be around 4 to 5
percentage points.
2008 earnings guidance
GSK continues to expect a mid-single digit percentage decline in
business performance EPS, at constant
exchange rates.
GlaxoSmithKline – one of the world’s leading
research-based pharmaceutical and healthcare companies –
is
committed to improving the quality of human life by enabling people
to do more, feel better and live longer. For
company information including a copy of this announcement and
details of the company’s updated product
development pipeline, visit GSK at www.gsk.com.
Enquiries:
UK Media
Philip Thomson
Alice Hunt
Gwenan White
(020) 8047 5502
(020) 8047 5502
(020) 8047 5502
US Media Nancy Pekarek
Mary Anne Rhyne
(215) 751 7709
(919) 483 2839
European Analyst / Investor David Mawdsley
Sally Ferguson
Gary Davies
(020) 8047 5564
(020) 8047 5543
(020) 8047 5503
US Analyst / Investor Frank Murdolo
Tom Curry
(215) 751 7002
(215) 751 5419
Brand names appearing in italics throughout this document are
trademarks of GSK or associated companies with the exception of
Levitra, a
trademark of Bayer, Bonviva/Boniva, a trademark of Roche, and
Vesicare, a trademark of Astellas Pharmaceuticals in many countries
and of Yamanouchi Pharmaceuticals in certain countries, all
of which are used under licence by the Group.
Cautionary statement regarding forward-looking statements
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 Announcement, are subject to risks
and
uncertainties that may cause actual results to differ materially
from those projected. Factors that may affect the Group’s
operations are
described under ‘Risk Factors’ in the ‘Business
Review’ in the company’s Annual Report 2007.
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