GSK: Preliminary Results Announcement for the year ended 31st December 2007
- GSK reports 2007 Business Performance* EPS of 99.1p up 10% CER
- Strong fourth quarter business performance EPS growth of 17% CER
LONDON,
Feb. 7, 2008-GlaxoSmithKline plc (GSK) today announces its
unaudited results for the year ended 31st December 2007. The full
results are presented under ‘Income Statement’ on pages
9 and 10, and are summarised below.
FINANCIAL RESULTS*
| 2007 |
Growth |
Q4 2007 |
Growth |
|||
| £m | CER% | £% | £m | CER% | £% | |
| Turnover |
22,716 |
2 |
(2) |
5,974 |
- | - |
| Business performance* | ||||||
| Operating profit |
7,931 |
8 |
2 |
1,926 |
14 |
13 |
| Earnings per share |
99.1p |
10 |
4 |
24.4p |
17 |
16 |
| Total results | ||||||
| Operating profit |
7,593 |
3 |
(3) |
1,588 |
(7) |
(7) |
| Earnings per share |
94.4p |
5 |
(1) |
19.6p |
(7) |
(7) |
Total results include restructuring charges of £338 million before tax for the quarter and full year.
BUSINESS PERFORMANCE SUMMARY*
- GSK delivers 2007 business performance EPS up 10% CER – at high end of guidance
- 2007 dividend of 53p +10%; £6 billion of shares expected to be repurchased in 2008
- Industry-leading pipeline delivery in 2007, with 10 product approvals including Tykerb, Cervarix and Veramyst
- Sustained product flow expected - 13 new product opportunities currently filed with regulators, including: Promacta (USA), Rotarix (USA), Treximet (USA) and Synflorix (EU and International)
- Late stage pipeline enhancement continues with 9 new phase III programmes started in last 12 months - 34 key assets currently in phase III/registration
- Consumer Healthcare delivers strong 2007 performance, with sales up 14% to £3.5 billion
- In 2008, GSK expects that the impact of lower Avandia sales together with increased generic competition will lead to a mid-single digit percentage decline in business performance EPS, at constant exchange rates
- Currency – 2007 Sterling EPS growth adversely impacted by 6 percentage points due to currency movements
* Management reports business performance, a
supplemental non-IFRS measure which excludes significant one-off
restructuring
charges, as it believes this is useful to an understanding of the
Group’s performance. 2007 business performance results
exclude
restructuring charges of £338 million before tax relating to
the new Operational Excellence programme which commenced in
October
2007.
In order to illustrate underlying performance, it is the
Group’s practice to discuss its results in terms of constant
exchange rate (CER)
growth. All commentaries are presented in terms of CER and compare
2007 business performance results with 2006 total results,
unless otherwise stated. See ‘Accounting Presentation and
Policies’ on page 23.
Commenting on GSK’s performance for 2007 and outlook, JP
Garnier, Chief Executive Officer, said:
“Despite a significant setback on Avandia, good sales
performance from other areas of our broad portfolio
enabled GSK to deliver 10% EPS growth in 2007 – at the high
end of our guidance.
The decline in Avandia sales, together with increased generic
competition in the USA, will adversely impact our
earnings in 2008, but looking ahead we remain confident in
GSK’s future. Our fast-growing vaccines business,
the resurgence of our consumer healthcare division and the strong
performance of many key pharmaceutical
products are all providing contributions to growth. The momentum of
our late-stage pipeline continues to
enhance our business and is producing a significant renewal of our
product line – last year GSK received a
record 10 product approvals and this year expects regulatory
decisions on more than 10 new product
opportunities.”
PHARMACEUTICAL UPDATE
Total pharmaceutical turnover was level for 2007 at £19.2
billion. In the United States, turnover fell 3% to
£9.3 billion for the year, due to a substantial reduction in
Avandia sales and generic competition to Flonase,
Wellbutrin XL, Zofran and Coreg IR.
Turnover in Europe was up 2% to £5.7 billion, with good
performances from Seretide, vaccines and newer
products offsetting the impact of generic competition and continued
pricing pressure from European
governments. Turnover in International was £4.3 billion, up
6%, with good growth reported in Japan
(sales +10% to £867 million).
Seretide/Advair sales up 10% to £3.5 billion
Sales of Seretide/Advair, for asthma and COPD, rose 9% to
£1.9 billion in the USA. In Europe, sales
grew 9% to £1.2 billion and in International sales grew by
23% to £372 million, enhanced by its launch in
Japan in June.
GSK continues to see increased use of Seretide/Advair in the
treatment of COPD and is in ongoing
discussions with the FDA to expand the indication for use in this
patient group, including assessment of
data supporting a claim for reduction of exacerbations.
Vaccine sales up 20% to £2 billion driven by strong US
performance
Vaccine sales grew strongly across all regions with US sales up 44%
for the year to £628 million, sales in
Europe up 14% to £814 million and sales in International
markets up 8% to £551 million.
In the USA, sales of hepatitis vaccines grew 33% to £199
million, and sales of Infanrix/Pediarix, rose
23% to £196 million.
GSK’s pre-pandemic influenza vaccine achieved sales of
£146 million for the year and discussions
regarding further orders continue with governments.
Sales of new two-dose vaccine, Rotarix, to prevent rotavirus
gastroenteritis, doubled to £91 million in 2007
with strong growth in both Europe and International. In the USA,
the FDA accepted the Rotarix file for
review in August last year and GSK expects a response in the first
half of this year.
Cervarix, GSK’s vaccine to prevent cervical cancer, has been
approved in 51 countries around the world,
and negotiations with governments regarding reimbursement and
tender decisions are ongoing. Further
licensing applications have been submitted in 27 countries
including Japan, where the vaccine has been
granted priority review. In the USA, the FDA issued a Complete
Response letter in December, to the
company’s licence application made earlier in the year. GSK
plans to submit a response to the FDA in the
second quarter and will continue discussions with the agency
regarding the application.
Avandia product group sales declined to £1.2 billion
Sales of Avandia products, for the treatment of type 2 diabetes,
fell 29% to £780 million in the USA, with
fourth quarter sales down 55% to £130 million, following
publication in May of a meta-analysis. Outside the
USA, sales in Europe grew 4% for the year to £227 million,
and in International markets, sales declined 7%
to £212 million.
Other key pharmaceutical growth drivers delivered combined sales of
£2.9 billion, up 25%
Sales of Lamictal, for the treatment of epilepsy and bipolar
disorder, grew 18% to £1.1 billion, driven by
sales in the USA which were up 26% to £892 million. The
company expects to respond to the FDA’s
approvable letter for Lamictal XR around mid-year.
Sales of Valtrex, for herpes, rose 18% to £934 million, with
US sales up 20% to £668 million, driven by
increased use of the product for prevention of transmission. Sales
in Europe grew 9% to £120 million and
in International grew 13% to £146 million.
Sales of Requip, for Parkinson’s Disease/Restless Legs
Syndrome, grew 36% to £346 million. Requip XL,
a new once-daily formulation for Parkinson’s Disease, has now
been approved in 13 European countries
and launched in 7 markets. Further European approvals are
anticipated during 2008. In the USA, GSK
expects a response from the FDA on its application for Requip XL
during the first half of 2008.
Avodart, for benign prostatic hyperplasia (enlarged prostate),
continued to perform strongly with sales up
38% to £285 million for the year. Positive data from the
CombAT study (assessing use of Avodart and the
alpha-blocker, tamsulosin, as combination therapy) were recently
published in the Journal of Urology. GSK
has filed for a co-prescription indication in the USA, Europe and
other International markets. A response is
expected from the FDA during the second quarter of 2008.
GSK’s co-promotion income for Boniva/Bonviva, the only
once-monthly medicine for post-menopausal
osteoporosis, was up 79% to £161 million.
Arixtra, for deep vein thrombosis and pulmonary embolism, delivered
strong growth with sales up 81% to
£100 million. Sales grew strongly in Europe (up 70% to
£39 million), following approval last year for the
treatment of specific acute coronary syndromes (ACS). The ACS
approval was supported by data showing
that Arixtra had similar efficacy to Lovenox, but Arixtra patients
had a significantly lower risk of bleeding
and a significant mortality benefit compared to Lovenox. In the
USA, GSK anticipates submitting a
response to the FDA’s approvable letter for a potential ACS
indication in the first half of 2008.
Newly launched NCEs
Tykerb/Tyverb, for breast cancer, achieved sales of £51
million for the year, with US sales of £36 million
following successful launch of the product in March. In December,
the EMEA granted a positive opinion for
approval of Tyverb and a decision for approval from Japanese
regulatory authorities is expected later this
year.
Veramyst/Avamys, for allergic rhinitis, generated sales of
£21 million, following launch in the USA in June
2007. In January 2008, GSK received European approval for Avamys
nasal spray to treat allergic rhinitis
in adults and children. A licence application is currently under
review with regulatory authorities in Japan.
Altabax/Altargo, a first in class antibacterial for treatment of
skin infections, recorded initial sales of £11
million following approval in 2007. As a novel topical
antibacterial, Altabax/Altargo provides physicians with
an effective new treatment option, requiring half as many doses in
fewer days than other topical antibiotics,
and has shown a low potential for the development of
resistance.
Other products
Total sales of HIV products were over £1.4 billion, down 1%.
Competition to older products, Combivir
(-10% to £455 million) and Epivir (-20% to £156
million), was partially offset by strong sales growth of new
products Epzicom/Kivexa (+39% to £324 million) and Lexiva
(+13% to £141 million).
Sales of Relenza, an antiviral treatment for flu, were £262
million, more than double the prior year, driven
primarily by one-off government orders for stockpiling against a
possible flu pandemic.
Sales of Imitrex/Imigran, for migraine were £685 million, up
3%, with sales growth in the USA (up 9% to
£558 million) offset by the impact of generic competition in
other regions.
Sales of Coreg products, for heart disease, fell 18% to £587
million, following the introduction of generic
competition to Coreg IR in September. Sales of Coreg CR, which was
launched in March 2007, were £88
million.
Other product sales affected by generic competition were Wellbutrin
(-37% to £529 million), Flonase
(-34% to £199 million) and Zofran (-77% to £196
million).
Fourth quarter pharmaceutical turnover down 2% to £5.0
billion
Fourth quarter pharmaceutical performance was impacted by declining
US turnover, which was down 8%
to £2.3 billion adversely impacted by lower Avandia sales and
generic competition to Coreg IR, Flonase,
Wellbutrin XL and Zofran. In Europe, total pharmaceutical turnover
grew 4% to almost £1.6 billion and in
International markets rose 6% to £1.2 billion.
PHARMACEUTICAL PIPELINE UPDATE
R&D pipeline progress
In 2007, GSK maintained momentum in delivering its late-stage
pipeline, receiving 10 product approvals and
filing 10 product applications. GSK currently has 13 new product
opportunities filed with regulators. GSK also
commenced 9 new phase III clinical development programmes in 2007
and now has 34 key assets in phase
III/registration.
2007 Approvals Products currently filed 2007 progressed into Phase
III
Adoair (Japan) Avodart & alpha blocker co-Rx belimumab*
(LymphoStat B)
Altabax/Altargo* (USA & EU) Cervarix (USA & Japan)
elesclomol*
Arixtra ACS (EU) Entereg POI*+ GSK 1838262* (XP13512)
Arixtra VTE (Japan) H5N1 vaccine* (EU) MAGE-A3 therapeutic
vaccine*
Atriance (EU) Kinrix (USA) MenACWY vaccine*
Cervarix* (EU) Lamictal XR (USA) ofatumumab* (RA)
Requip XL (EU) Lunivia* (EU) Promacta* (Hep C)
Tykerb* (USA & EU) Promacta* (USA) Tykerb + Armala* (IBC)
Veramyst* (USA) Requip XL (USA) Tykerb (Head & Neck)
Wellbutrin XL (EU) Rotarix (USA)
Synflorix* (EU & Int’l)
Treximet+
Volibris* (EU)
* Bold = NCEs (first launch in major market or currently in
clinical development)
+ Additional data filed in 2007
Recent filings
In December, GSK filed Promacta, an oral platelet growth factor
therapy, with the FDA for the short-term
treatment of chronic idiopathic thrombocytopenic purpura. Also in
December, new data from the ongoing
EXTEND study were presented at the American Society of Haematology
meeting demonstrating that
Promacta sustains increased platelet counts during long-term
treatment. Following completion of an
ongoing phase III study (RAISE), GSK intends to file Promacta for
use as a long-term treatment during the
second half of 2008.
GSK filed Synflorix, for approval in Europe and International
markets in December. With a dual mode of
action against S. pneumoniae and non-typeable Haemophilus
influenzae, Synflorix has the potential to
protect children against invasive pneumococcal disease beyond that
offered by current vaccines, and
bacterial respiratory infections such as acute middle ear
infections (otitis media).
In January, additional supportive data for Treximet, a new
treatment for acute migraine, were submitted to
the FDA. Treximet is a combination of gold-standard migraine
treatment, sumatriptan, and naproxen
sodium in a single tablet designed to target multiple mechanisms of
migraine with enhanced efficacy and
duration of treatment response. A decision regarding the licence
application for Treximet is expected from
the FDA during the first half of 2008.
An FDA Advisory Committee meeting was held in January to discuss
use of Entereg for the management
of post-operative ileus (POI). A decision from the FDA is expected
in early February.
Q4 late-stage pipeline progress
GSK1838262 – results from a second positive phase III trial
demonstrating the potential of ’262 as a
treatment for Restless Legs Syndrome were announced last month.
Additional phase III data are expected
during the first quarter of 2008, with an FDA filing planned for
the third quarter.
Rezonic – positive data from two phase III trials in
chemotherapy-induced nausea and vomiting were
received in 2007 and GSK expects to file Rezonic for use in this
indication and for the treatment of postoperative
nausea and vomiting in 2008.
ofatumumab – two phase III studies to assess use of
ofatumumab totreat rheumatoid arthritis were
initiated in November. In addition, a phase II study in diffuse
large B-cell lymphoma commenced in
December.
Tykerb+Armala (pazopanib) – phase III trials commenced in
December 2007 with an initial study
evaluating use of the combination to treat women with metastatic
inflammatory breast cancer. This will be
the first trial of its kind to be conducted without the use of
chemotherapy.
elesclomol (formerly STA-4783) – progressed into phase III
development for treatment of metastatic
melanoma in November. In January 2008 elesclomol was granted US
orphan drug designation for this
indication.
Horizon – during the fourth quarter, GSK advanced its
development programme for a next-generation once
daily combination product for the treatment of asthma into
late-stage clinical trials. Large phase IIb asthma
studies for ‘698, an inhaled corticosteroid, and ‘444,
a long-acting beta agonist, were initiated with results
expected during the second half of 2008.
darapladib (LpPLA2 inhibitor for treatment of atherosclerosis)
– phase II dose-ranging data will be
presented at the American College of Cardiology meeting in March.
Data from the IBIS 2 imaging study
will shortly be submitted to a major medical journal.
Q4 acquisitions and collaborations
In December, GSK acquired Reliant Pharmaceuticals and its portfolio
of speciality medicines combating
heart disease, including US marketing rights to Lovaza
(omega-3-acid ethyl esters). Lovaza is the only
prescription omega-3 medicine approved by the FDA for the treatment
of adult patients with very high
levels of triglycerides and generated net sales of £157
million, in 2007, representing an increase of 104%
over 2006.
GSK strengthened its oncology portfolio in December by exercising
its option with Exelixis to develop
XL880, a small molecule compound currently in phase II trials in
patients with papillary renal cell
carcinoma, gastric cancer and head and neck cancer.
During the fourth quarter, GSK formed a number of worldwide
strategic alliances to discover, develop and
market candidate compounds. These include an alliance with OncoMed
to develop novel antibody
therapeutics to target cancer stem cells, Santaris to develop
compounds based on unique locked nucleic
acid technology against viral diseases and Galapagos to develop
novel antibacterials and antivirals.
CONSUMER HEALTHCARE UPDATE
Consumer Healthcare delivers strong 2007 performance with sales up
14% to nearly £3.5 billion
Consumer Healthcare maintained strong growth momentum with total
sales up 14% to nearly £3.5 billion.
In the USA, sales grew 30% to £990 million. In Europe, sales
grew 7% to £1.6 billion and, in International,
sales grew 10% to £934 million.
• Over-the-counter medicine sales grew 20% to £1.7
billion, with Panadol up 14% to £262 million and
alli sales of £150 million since launch in the USA in June.
Smoking Control products declined 6% to
£314 million. Breathe Right and FiberChoice, added to the
portfolio with the acquisition of CNS in
December 2006, achieved combined sales of £81 million.
• Oral care sales grew 8% to over £1 billion. Sales of
Aquafresh were up 12% to £308 million, helped by
the success of new Aquafresh White Trays. Sensodyne also grew
strongly, up 16% for the year to
£293 million, driven by a successful launch of Sensodyne
ProNamel.
• Nutritional healthcare products sales grew 9% to £716
million. Lucozade grew 16% to £347 million,
and Horlicks grew 12% to £174 million. Ribena sales were down
7% to £156 million.
FINANCIAL REVIEW
Dividends
The Board has declared a fourth interim dividend of 16 pence per
share resulting in a dividend for the year of
53 pence, a five pence increase over the dividend of 48 pence per
share for 2006. The equivalent interim
dividend receivable by ADR holders is 62.7264 cents per ADS based
on an exchange rate of £1/$1.9602. The
ex-dividend date will be 13th February 2008, with a record date of
15th February 2008 and a payment date of
10th April 2008.
Share buy-back programme
GSK repurchased £3,750 million of shares in 2007 of which
£3,537 million are held as Treasury shares and
£213 million have been cancelled. Share repurchases of
£2.5 billion were made as part of the new £12
billion
share buy-back programme announced in July 2007. A further £6
billion of repurchases under this programme
are expected in 2008.
Operational Excellence
GSK announced in October 2007 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 by 2008 and £550 million by 2009. These
savings will partly mitigate the expected impact to
2008 earnings from generic competition and lower Avandia sales and
the associated adverse impact on GSK’s
gross margin.
In Q4 2007, GSK has introduced a 3-column approach to the income
statement. ‘Business Performance’
shows GSK’s underlying results excluding restructuring costs
related to the new Operational Excellence
programme announced in October 2007 and significant acquisitions.
There were no significant acquisitionrelated
restructuring costs incurred in 2006 or 2007. The middle column
shows restructuring costs and the
‘Total’ column shows the full IFRS statutory
results.
One-off charges of £338 million before tax relating to the
new Operational Excellence programme were
recorded in Q4 2007.
Operating profit and earnings per share – full year
Business performance operating profit of £7,931 million
increased by 8% in CER terms compared with 2006
and was above turnover growth of 2% in CER terms, reflecting lower
SG&A and R&D costs and higher other
operating income.
In the year, gains from asset disposals were £109 million
(£169 million in 2006), costs for legal matters were
£255 million (£333 million in 2006), fair value
movements on financial instruments resulted in an income of
£41
million (income of £29 million in 2006) and charges related
to previous restructuring programmes were £92
million (£205 million in 2006). The business performance
operating profit impact of these items was a £197
million charge in 2007 (£340 million charge in 2006).
Business performance profit after taxation increased by 8% in CER
terms, in line with the increase in operating
profit as a lower tax rate for the year was offset by higher net
interest costs.
Business performance EPS of 99.1 pence increased 10% in CER terms
(4% increase in sterling terms)
compared with 2006. The adverse currency impact of 6 percentage
points on EPS growth predominantly
reflected the strength of sterling against the US dollar.
Total operating profit, including restructuring costs of £338
million, was £7,593 million and total EPS was 94.4
pence.
Operating profit and earnings per share – Q4 2007
Business performance operating profit of £1,926 million
increased by 14% in CER terms compared with Q4
2006 and was above flat turnover growth, reflecting lower SG&A
and R&D costs and higher other operating
income.
Costs of goods increased to 25.6% (2006: 24.2%) reflecting
unfavourable product and regional mix and one-off
items including stock write-offs. Excluding one-off items, cost of
goods was approximately 24.2% of turnover.
In the quarter, gains from asset disposals were £20 million
(£3 million in 2006), costs for legal matters were
£62
million (£81 million in 2006), fair value movements on
financial instruments resulted in income of £51 million
(£46 million income in 2006) and charges related to previous
restructuring programmes were £43 million (£132
million in 2006). The business performance operating profit impact
of these items was a £34 million charge in
2007 (£164 million charge in 2006).
Business performance profit after taxation increased by 12% in CER
terms, which was slightly lower than the
growth in operating profit and reflected higher net interest costs
partly offset by a lower tax rate. Business
performance EPS of 24.4 pence increased 17% in CER terms (16%
increase in sterling terms) compared with
2006, benefiting from the movements highlighted in the previous
paragraph.
Total operating profit for the quarter, including restructuring
costs, was £1,588 million and total EPS was
19.6 pence.
Currencies
The 2007 results are based on average exchange rates, principally
£1/$2.00, £1/Euro 1.46 and £1/Yen 235.
The period-end exchange rates were £1/$1.99, £1/Euro
1.36 and £1/Yen 222. If exchange rates were to hold
at the average January 2008 levels (£1/$1.99, £1/Euro
1.35 and £1/Yen 217) for the rest of the year, the
positive currency impact on business performance EPS growth for the
full-year would be around 3 percentage
points.
Earnings guidance
In 2008, GSK expects that the impact of lower Avandia sales
together with increased generic competition will
lead to 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
Claire Brough
Alice Hunt
Joss Mathieson
Gwenan White
(020) 8047 5502
(020) 8047 5502
(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, Entereg
is a trademark of the Adolor Corporation in the USA 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 2006.
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