1st Quarter Results

RNS Number : 9731Q
GlaxoSmithKline PLC
22 April 2009
 





Issued: Wednesday, 22nd April 2009LondonU.K. 


Results announcement for the first quarter 2009


GSK delivers Q1 EPS of 26.3p before major restructuring*

and increased dividend of 14p



Results before major restructuring*


Q1 2009


Growth



£m

CER%

£%


Turnover

6,769 

(5)

19 


Earnings per share

26.3p

(28)

3 



Total results


Q1 2009


Growth



£m

CER%

£%


Turnover

6,769 

(5)

19 


Restructuring charges

264 




Earnings per share

22.3p

(39)

(9)



The full results are presented under 'Income Statement' on page 7.

*  For explanations of the measures 'results before major restructuring' and 'CER growth', see page 6.



Summary


EPS before major restructuring 26.3p, down 28% CER, up 3% in sterling terms



Q1 profit performance adversely impacted by gross margin decline due to US generic competition, one-off R&D intangible write-offs and phasing of SG&A costs



£5.6 billion pharmaceutical sales (-6%); US sales were £2.3 billion (-22%) primarily due to continued generic competition. Strong growth in Emerging Markets (+18%) Asia Pacific/Japan (+12%) and Europe (+7%) 




£1.1 billion Consumer Healthcare sales (+4%) with 12 new product launches in Q1 and pan-European launch of alli now underway




Vaccine sales of £625 million (+18%); portfolio further strengthened with recent approval of Synflorix in Europe and Cervarix data filed in the USA 




Announced acquisition of specialist dermatology company Stiefel to increase GSK's growth and diversification with significant revenue and synergy opportunities - completion expected Q3 2009



Definitive step taken to re-energise HIV business with creation of new specialist company with industry-leading pipeline - completion expected Q4 2009



targeted 'bolt-on' transactions to strengthen and diversify Emerging Markets and Consumer Healthcare businesses in last 6 months




4 new pharmaceutical product filings in 2009; GSK has over 10 new products filed with regulators in the USAEurope and Japan




Progressive dividend policy continues with Q1 dividend of 14p (+8%)




  

GSK's strategic priorities


GSK has focused its business around the delivery of three strategic priorities, which aim to increase growth, reduce risk and improve GSK's long-term financial performance:



Grow a diversified global business

Deliver more products of value

Simplify GSK's operating model


Chief Executive Officer's Review


This quarter has shown divergent performances in our pharmaceutical business with US sales declining 22% to £2.3 billion, but strong sales performances reported in other regions. Europe, Emerging Markets, Asia Pacific/Japan and our Consumer Healthcare business all delivered good growth this quarter and contributed £4.billion in sales, representing approximately 66% of overall turnover. 


In the USA, we are experiencing some of our toughest performance challenges as our product portfolio transitions and we re-shape our business. Generic competition to our heritage CNS portfolio reduced sales by close to £450 million compared to the same quarter last year. 


As I have said before, our US business is a vital part of GSK's future and we are aggressively re-engineering our US operations to make sure we have the right resource in the right areas and an overall lower level of infrastructure costs.


With 10 new products launched in the last 2 years and 6 more in review with regulators, including Cervarix, I believe we now have the right structure in place to fully capitalise on our new product opportunities in this market.


I am confident that we are making progress to adapt our US business model, and that we will deliver long-term success in this marketplace. I am equally confident that, in the short-term, with generic exposure reducing significantly and several new product launches to come, we can expect a significant improvement to the performance of this business during the second half of 2009.


The significant impact to higher margin US sales this quarter resulted, as expected, in a decline to our gross profit margin, and this together with one-off intangible asset write-offs in R&D, primarily explains the reported difference we see between sales and earnings performance for the first quarter.


In the quarter, we also reported a higher SG&A margin, as a percentage of sales, than we expect for the full year. This is essentially a reflection of phasing of costs versus sales during the year and looking forward, we are making no change to our previously communicated expectations for the SG&A margin in 2009.


In 2009, we have already seen some significant changes in our industry. For GSK, I am pleased with the progress we have made against our strategic priorities to improve long-term growth and reduce risk.


The acquisition of Stiefel Laboratories will provide us with the opportunity to create a new product and development platform in dermatology, with the formation of a new world-leading, specialist dermatology business.


It will provide immediate new revenue flows to GSK and we see substantive revenue and synergy opportunities through combining GSK's geographic reach with Stiefel's expertise in dermatology; and leveraging our existing commercial infrastructure and manufacturing capability. 


The innovative transaction, we announced last week with Pfizer, to create a new specialist HIV company, also provides GSK with new options to leverage our existing capabilities, in a critical therapeutic area, and deliver future growth and shareholder value.




We have now completed five transactions to advance our commercial positions in Consumer Healthcare and Emerging Markets in the last six monthsincluding three this year.


These transactions complement the organic programme of investment we have accelerated to strengthen and diversify GSK's business. For example, in Emerging Markets, we have added a further 670 representatives to our salesforces this year, this is in addition to the 850 new people recruited in 2008.


The strong start to the year of our Japanese business was particularly encouraging, with sales growth driven by Advair and Relenza. The opportunity for GSK, in the Japanese market is significant with a substantial schedule of new product launches to come, including newly received approvals for Allermist and Tykerb


In Europe, we are in the midst of launching two significant new productsSynflorix, a competitive new vaccine that provides increased protection for infants against pneumococcal diseases; and alli, our new weight-loss treatment - the first time GSK has launched an OTC brand simultaneously across the region. 


Our Consumer Healthcare business delivered 12 new product launches in the first quarter. This launch schedule is exactly in line with our strategy to drive market share growth through focused brand innovation, delivery of strong value propositions and by maintaining levels of A&P investment. 


For the quarter, we have seen year-on-year market share gains in our OTC and oral healthcare businesses; and 7 of our top 10 brands grew market share. This resilient performance has been particularly impressive given the current economic downturn. So far, we have only seen a limited impact on our business mainly resulting from lower consumer demand for nutritionals in the UK and some customer de-stocking of consumer healthcare products in Europe.


We are continuing to maintain a level of around 30 assets in our late-stage pipeline; and pipeline output for the quarter remained positive with 6 filings completed with regulatory authorities. 


Nevertheless, we are not complacent about R&D productivity. Whilst we have recently successfully transitioned the novel diabetes treatment Syncria and the MAGE-A3 cancer immunotherapeutic for melanoma to phase III development, disappointing phase III results for elesclomol and rosiglitazone XR in Alzheimer's disease are evidence that research and development remains challenging.


In summary, this first quarter performance was indicative of what we always expected to be a year of two halves for GSK. 


In this first half of the year, our performance will be heavily impacted by the year-on-year comparative effect of generic entries in the USA. However, in the second half of 2009, this impact is projected to reduce and we expect to see increased sales contributions from new products. 


Finally, I am pleased to confirm that our progressive dividend policy continues and this quarter GSK's dividend increased 8% to 14 pence.



Andrew Witty 

Chief Executive Officer

  


Trading Update 


Turnover and key product movements impacting growth for the quarter

Total pharmaceutical turnover declined 6% to £5.6 billion, as US performance (-22% to £2.3 billion) continued to be significantly impacted by generic competition to several mature brands. Outside the USA, pharmaceuticals sales grew 7% to £3.3 billion with strong growth in other regions: Sales were up 7% to £1.8 billion in Europe, up 12% to £639 million in Asia Pacific/ Japan and up 18% to £661 million in Emerging Markets.


Seretide/Advair sales were level at £1.2 billion. Reported US sales growth (down 5% to £653 million) was primarily impacted by variations in wholesaler stocking patterns; estimated underlying sales growth for Advair in the USA was in the mid-single digit percentage range. In Europe, sales were level at £394 million. Seretide/Advair performed very strongly in Emerging Markets (+27% to £65 million) and in Japan (sales more than doubled to £36 million) where the product was approved in January 2009 for the treatment of COPD. 


Sales of antiviral treatment Relenza were £222 million in the quarter, reflecting significant orders for pandemic stockpiling from the UK and Japanese Governments. Total vaccine sales grew 18% to £625 million with strong growth in Europe (+23%) and in the Rest of the World (+46%) partially offset by a 21% decline in US sales reflecting increased competition in the hepatitis and DTPa segments. Overall vaccines performance included significant contributions from Rotarix (+74% to £57 million) following its US launch in mid-2008 and Cervarix (more than doubling to £48 million) which continues to win the majority of competitive tenders in markets where it is launched. Other strong pharmaceutical sales performances in the quarter included Lovaza (+54% to £106 million) and respiratory treatment Ventolin (+23% to £116 million).


Lamictal sales fell 61% to £144 million, following the introduction of generic competition to the product in the USA in July 2008 (US sales fell 74% to £86 million in the quarter). Sales of Imitrex/Imigran (-68% to £64 million) and Wellbutrin XL (-66% to £52 million) also fell due to generic competition in the US market. Total Avandia product sales declined 19% to £197 million, with US sales falling 18% to £112 million and European sales down 30% to £43 million.


Total Consumer Healthcare sales grew 4% in the quarter to £1.1 billion. Sales of Oral healthcare products rose 5% to £368 million, reflecting continued growth from Sensodyne (+7% to £112 million). Sales of Aquafresh were flat at £128 million and sales of £6 million were contributed by newly acquired dry-mouth treatment Biotene. Within Nutritionals, strong growth from Horlicks (+20% to £75 million) offset decline in sales of Lucozade (-12% to £80 million) resulting from a reduction in 'impulse sector' demand in the UK. OTC product sales rose 5% to £567 million, including sales of £32 million from anti-obesity treatment alli, which was launched in European markets at the end of March. Other strong OTC performances included smoking cessation products (+12% to £82 million) and the Panadol franchise (+6% to £99 million).


Operating profit and earnings per share commentary


Results before major restructuring

Operating profit before major restructuring for Q1 2009 was £1,976 million, a 31% decline in CER terms.


Cost of sales increased to 24.3% of turnover (Q1 2008: 22.8%), principally reflecting the anticipated generic competition to higher margin products in the USA. SG&A costs as a percentage of turnover increased by 1.1 percentage points to 31.4% compared with Q1 2008, reflecting investment in growth markets and increased pension costs partially offset by the benefits of the current restructuring programme. Excluding legal charges, SG&A costs were 30.6% of turnover. We continue to expect SG&A costs (excluding legal charges) as a percentage of sales for this year to be slightly higher than in 2008 (27.7%).


R&D expenditure at 15.9% (Q1 2008: 13.7%) of total turnover was impacted by £115 million of intangible asset write-offs, including £90 million with respect to elesclomol. Excluding these write-offs, R&D expenditure would have been 14.2% of turnover. We now expect R&D expenditure for the current year to be slightly higher as a percentage of sales than in 2008 (14.4%).


In the quarter, gains from asset disposals were £1 million (Q1 2008: £56 million), costs for legal matters were £51 million (Q1 2008: £39 million), there was a charge of £5 million for the fair value movements on financial instruments (Q1 2008: £66 million income) and charges related to previous restructuring programmes were £3 million (Q1 2008: £6 million).


Other Operating Income in the quarter was £54 million including royalty income of £67 million (Q1 2008: £62 million), partially offset by equity investment impairment and fair value movements on financial instruments. In addition, profit on disposal of interest in associates was £115 million as 5.7 million Quest shares were sold. We continue to expect to deliver slightly higher combined total of Other Operating Income and profit on disposal of interests in associates this year than in 2008 (£541 million).


EPS before major restructuring of 26.3p decreased 28% in CER terms (a 3% increase in sterling terms) compared with Q1 2008. The favourable currency impact of 31 percentage points reflected the weakness of Sterling against most major currencies.


The current restructuring programme remains on track to deliver cumulative annual savings of £1 billion by the end of this year, and £1.7 billion by the end of 2011.


Total results after restructuring

Operating profit after restructuring for Q1 2009 was £1,712 million, down 13% in sterling terms and down 40% CER compared with Q1 2008. This included £264 million of restructuring charges related to the current operational excellence programme (Q1 2008: £85 million); £143 million was charged to cost of sales (Q1 2008: £60 million), £71 million to SG&A (Q1 2008: £25 million) and £50 million to R&D (Q1 2008: nil). EPS after restructuring of 22.3p decreased 39% in CER terms (9% in sterling terms) compared with Q1 2008.


Cash flow and net debt

Net cash inflow from operating activities for Q1 2009 was £1,736 million, down 4% in sterling terms. This was used to fund net interest of £15 million, capital expenditure on property, plant and equipment and intangible assets of £388 million, acquisitions of £501 million and the dividend paid to shareholders of £730 million


Net debt decreased by £0.4 billion during the period to £9.8 billion at 31st March 2009, comprising gross debt of £16.4 billion and cash and liquid investments of £6.6 billion.


The Group is well placed financially having completed its debt financing programme during 2008. At 31st March 2009, GSK had short-term borrowings (including overdrafts) repayable within 12 months of only £1.3 billion with a further £0.7 billion repayable in the subsequent year.


Dividends

The Board has declared a first interim dividend of 14 pence per share (Q1 2008: 13 pence). The equivalent interim dividend receivable by ADR holders is 40.9304 cents per ADS based on an exchange rate of £1/$1.4618. The ex-dividend date will be 29th April 2009, with a record date of 1st May 2009 and a payment date of 9th July 2009.


Currency impact

The Q1 results are based on average exchange rates, principally £1/$1.44, £1/€1.09 and £1/Yen 136. The period end exchange rates were £1/$1.43, £1/€1.08 and £1/Yen 142. If exchange rates were to hold at these period end levels for the rest of 2009, the estimated positive impact on 2009 sterling EPS growth before major restructuring would be approximately 23 percentage points.


  



GlaxoSmithKline (GSK) together with its subsidiary undertakings, the 'Group' - 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. GlaxoSmithKline's website www.gsk.com gives additional information on the Group. Information made available on the website does not constitute part of this document.



Enquiries:



UK Media


Philip Thomson

David Outhwaite

Stephen Rea


(020) 8047 5502

(020) 8047 5502

(020) 8047 5502






US Media

Nancy Pekarek

Mary Anne Rhyne

Kevin Colgan

Sarah Alspach

(919483 2839

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(215) 751 7709






European Analyst / Investor

David Mawdsley

Sally Ferguson

Gary Davies

(020) 8047 5564

(020) 8047 5543

(020) 8047 5503






US Analyst / Investor

Tom Curry

Jen Baxter

(215) 751 5419

(215) 751 7002




Results before major restructuring

Results before major restructuring is a measure used by management to assess the Group's financial performance and is presented after excluding restructuring charges relating to the new Operational Excellence programme, which commenced in October 2007 and the acquisition of Reliant Pharmaceuticals in December 2007. Management believes that this presentation assists shareholders in gaining a clearer understanding of the Group's financial performance and in making projections of future financial performance, as results that include such costs, by virtue of their size and nature, have limited comparative value.


CER growth

In order to illustrate underlying performance, it is the Group's practice to discuss its results in terms of constant exchange rate (CER) growth.  This represents growth calculated as if the exchange rates used to determine the results of overseas companies in Sterling had remained unchanged from those used in the comparative period.  All commentaries are presented in terms of CER growth, unless otherwise stated.


Brand names and partner acknowledgements

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 on Form 20-F for 2008.


GlaxoSmithKline plc, 980 Great West Road, Brentford, Middlesex TW8 9GSUnited Kingdom

Registered in England and Wales.  Registered number: 3888792



Income statement


Three months ended 31st March  2009



Results
before
 major
restructuring
Q1 2009

Growth

Major
restructuring
Q1 2009


Total
Q1 2009

Results
before
 major
restructuring
Q1 2008

Major
restructuring
Q1 2008



Total
Q1 2008


£m

CER%

£m

£m

£m

£m

£m


------

------

------

------

------

------

------









TURNOVER

6,769 

(5)


6,769 

5,686 


5,686 









Cost of sales

(1,644)

13 

(143)

(1,787)

(1,299)

(60)

(1,359)


------ 


------ 

------ 

------ 

------ 

------ 

Gross profit

5,125 

(10)

(143)

4,982 

4,387 

(60)

4,327 









Selling, general and
  administration 

(2,129)

(1)

(71)

(2,200)

(1,720)

(25)

(1,745)

Research and development

(1,074)

14 

(50)

(1,124)

(780)


(780)

Other operating income

54 



54 

161 


161 


------ 


------ 

------ 

------ 

------ 

------ 

OPERATING PROFIT

1,976 

(31)

(264)

1,712 

2,048 

(85)

1,963 









Finance income

28 



28 

82 


82 

Finance expense

(202)


(1)

(203)

(168)

(2)

(170)

Profit on disposal of interest
   
in associate

115 



115 




Share of after tax profits  
  of associates and joint

  ventures

14 



14 

(1)


(1)


------ 


------ 

------ 

------ 

------ 

------ 









PROFIT BEFORE TAXATION

1,931 

(31)

(265)

1,666 

1,961 

(87)

1,874 









Taxation

(560)


63 

(497)

(563)

21 

(542)

Tax rate %

29.0%



29.8%

28.7%


28.9%


------ 


------ 

------ 

------ 

------ 

------ 

PROFIT AFTER TAXATION FOR THE PERIOD

1,371 

(31)

(202)

1,169 

1,398 

(66)

1,332 


------ 


------ 

------ 

------ 

------ 

------ 









Profit attributable to minority
  interests

38 



38 

25 


25 

Profit attributable to 
  shareholders

1,333 


(202)

1,131 

1,373 

(66)

1,307 


------ 


------ 

------ 

------ 

------ 

------ 


1,371 


(202)

1,169 

1,398 

(66)

1,332 


------ 


------ 

------ 

------ 

------ 

------ 









EARNINGS PER SHARE

26.3p

(28)


22.3p

25.6p


24.4p


------ 



------ 

------ 


------ 









Diluted earnings per share

26.2p



22.2p

25.5p


24.2p


------ 



------ 

------ 


------ 


  

Pharmaceuticals turnover 


Three months ended 31st March 2009



Total 

USA 

Europe 

Rest of World 


-----------------

-----------------

-----------------

----------------


£m 

CER%

£m 

CER%

£m 

CER%

£m 

CER%


------

-----

------

-----

------

-----

------

-----

Respiratory

1,735

1 

844

(1)

546

(1)

345

9 

Avamys/Veramyst

31

85 

20

17 

9

>100 

2

- 

Flixonase/Flonase

69

11 

10

100 

12

(23)

47

14 

Flixotide/Flovent

195

(6)

99

(4)

48

(2)

48

(12)

Seretide/Advair

1,214

- 

653

(5)

394

- 

167

26 

Serevent

62

(24)

19

(18)

31

(22)

12

(38)

Ventolin

116

23 

38

>100 

37

(3)

41

(5)

Zyrtec

18

9 

-

- 

-

- 

18

9 










Anti-virals

1,116

18 

488

2 

340

45 

288

16 

HIV

419

(8)

195

(8)

169

(9)

55

(6)

Agenerase, Lexiva

48

6 

27

6 

17

(7)

4

100 

Combivir

112

(16)

53

(16)

41

(17)

18

(17)

Epivir

34

(21)

13

(18)

14

(20)

7

(25)

Epzicom/Kivexa

137

10 

58

5 

62

10 

17

27 

Trizivir

56

(20)

30

(22)

24

(17)

2

(33)

Ziagen

27

(16)

14

- 

9

(11)

4

(50)


 


 


 


 


Valtrex

344

2 

257

8 

42

- 

45

(17)


 


 


 


 


Relenza

222

>100 

11

- 

110

- 

101

>100 

Zeffix

53

(13)

4

- 

7

(14)

42

(14)


 


 


 


 


Central Nervous System

499

(53)

216

(73)

145

(2)

138

(3)

Imigran/Imitrex

64

(68)

28

(83)

25

(4)

11

- 

Lamictal

144

(61)

86

(74)

39

3 

19

- 

Requip

50

(56)

8

(90)

32

(3)

10

40 

     Requip XL

22

>100 

5

- 

17

>100 

-

- 

Seroxat/Paxil

126

(21)

14

(61)

28

(14)

84

(3)

Treximet

14

- 

14

- 

-

- 

-

- 

WellbutrinWellbutrin XL

64

(63)

54

(68)

6

67 

4

50 


 


 


 


 


Cardiovascular and urogenital

551

6 

344

7 

141

2 

66

10 

Arixtra

59

29 

33

26 

22

29 

4

50 

Avodart

122

12 

73

8 

36

7 

13

50 

Coreg, Coreg CR

51

(23)

51

(23)

-

- 

-

- 

Fraxiparine

55

(8)

-

- 

43

(10)

12

- 

Levitra

20

7 

19

8 

1

- 

-

- 

Lovaza

106

54 

105

52 

-

- 

1

- 

Vesicare

24

21 

24

21 

-

- 

-

- 

Volibris

2

- 

-

- 

2

- 

-

- 


 


 


 


 


Metabolic

294

(16)

150

(18)

68

(21)

76

(8)

Avandia products

197

(19)

112

(18)

43

(30)

42

(8)

    Avandia

121

(23)

74

(25)

18

(27)

29

(14)

    Avandamet

66

(16)

31

(4)

24

(32)

11

14 

Bonviva/Boniva

62

(4)

38

(15)

21

20 

3

- 


 


 


 


 


Anti-bacterials

426

(1)

47

(24)

189

(7)

190

13 

Augmentin

186

- 

16

(29)

84

(9)

86

20 


 


 


 


 


Oncology and emesis

144

1 

70

(12)

51

16 

23

11 

Hycamtin

43

10 

26

6 

15

9 

2

50 

Promacta

2

- 

2

- 

-

- 

-

- 

Tyverb/Tykerb

34

42 

11

(20)

17

>100 

6

100 

Zofran

32

(7)

7

67

14

(25)

11

- 


 


 


 


 


Vaccines

625

18 

119

(21)

286

23 

220

46 

Boostrix

26

62 

11

60 

8

40 

7

100 

Cervarix

48

>100 

-

- 

39

>100 

9

>100 

Fluarix, FluLaval

6

- 

-

- 

-

- 

6

- 

Flu Pre-Pandemic

6

20 

-

- 

5

25 

1

- 

Hepatitis

149

(12)

52

(28)

61

(5)

36

3 

Infanrix, Pediarix

175

(5)

39

(41)

109

14 

27

14 

Rotarix

57

74 

15

- 

13

22 

29

39 


 


 


 


 


Other

233

(25)

5

- 

74

(7)

154

(32)


------

---- 

------

---- 

------

---- 

-----

---- 


5,623

(6)

2,283

(22)

1,840

7 

1,500

6 


------

---- 

------

---- 

------

---- 

-----

---- 

Pharmaceutical turnover includes co-promotion income.


  


Consumer Healthcare turnover


Three months ended 31st March 2009



Total 

USA 

Europe 

Rest of World 


--------------

--------------

--------------

--------------


£m

CER%

£m

CER%

£m

CER%

£m

CER%


------

-----

------

-----

------

-----

------

-----










Over-the-counter medicines

567

5 

180

4 

156

(2)

231

13 

alli

32

>100 

29

>100 

3

- 

-

- 

Breathe Right

27

24 

14

11 

7

20 

6

67 

Cold sore franchise

23

(5)

9

- 

11

(10)

3

- 

Nicotene replacement therapy

82

12 

58

11 

17

6 

7

50 

Panadol

99

6 

-

- 

20

(11)

79

11 

Tums

30

5 

27

6 

-

- 

3

- 










Oral healthcare

368

5 

78

14 

184

1 

106

8 

Aquafresh franchise

128

- 

27

(5)

73

(2)

28

9 

Biotene

6

- 

5

- 

-

- 

1

- 

Denture care

80

5 

19

- 

28

- 

33

14 

Sensodyne franchise

112

7 

26

27 

47

2 

39

3 










Nutritional healthcare

211

1 

-

- 

95

(15)

116

22 

Horlicks

75

20 

-

- 

5

(17)

70

24 

Lucozade

80

(12)

-

- 

65

(16)

15

20 

Ribena

38

(5)

-

- 

25

(7)

13

- 


------

---- 

------

---- 

------

---- 

------

----


1,146

4 

258

7 

435

(4)

453

14 


------

---- 

------

---- 

------

---- 

------

----


  

GSK's late-stage pharmaceuticals and vaccines pipeline 


The table below is provided as part of GSK's quarterly update to show events and changes to the late stage pipeline during the quarter and up to the date of announcement.


The following asset was listed as terminated in the last quarterly update and is no longer included in the table: Coreg CR+ACEi


Biopharmaceuticals

USA

EU

News update in the quarter 

mepolizumab

HES

Ph III

Filed

US filing strategy under review.

ofatumumab

CLL

Filed

Jan 2009

Filed

Feb 2009

Filed in EU for refractory CLL on 5th Feb 2009.

Priority Review granted in USA. Phase III relapsed CLL study started March 2009.


NHL

Ph III

Ph III



RA

Ph III

Ph III


belimumab

Lupus

Ph III

Ph III


otelixizumab

Type 1 diabetes

Ph III

Ph III


Syncria

Type 2 diabetes

Ph III

Ph III

Phase III started Feb 2009.






Cardiovascular & Metabolic

USA

EU

News update in the quarter 

Arixtra

Acute Coronary Syndromes

Filed

Approved


Avandamet XR

Type II diabetes 

Ph III

Ph III

Filing strategy under review.

Avandia + statin

Type II diabetes 

Ph III

Ph III

Filing strategy under review.

darapladib

Atherosclerosis

Ph III

Ph III







Neurosciences


USA

EU

News update in the quarter

Lamictal XR

Epilepsy

Filed

n/a

US PDUFA date extended to 28th May 2009

Lunivia

Sleep disorders

n/a

Filed

EMEA has not approved 'new active substance' status. GSK and Sepracor considering next steps.

Solzira

RLS

Filed

Jan 2009

Ph III


almorexant

Primary insomnia

Ph III

Ph III


retigabine

Epilepsy

Ph III

Ph III

Target filing in 2009.

rosiglitazone XR

Alzheimer's disease

Ph III

Ph III

Programme terminated due to lack of efficacy.






Oncology


USA

EU

News update in the quarter

Promacta/Revolade

Chronic  ITP

Approved

Filed

RAISE sNDA submitted 19th March 2009.

Hepatitis C / CLD

Ph III

Ph III



Prostate cancer prevention

Ph III

Ph III

REDUCE study data to be presented at AUA 27th April 2009.

Avodart

Duodart (fixed dose combination with tamsulosin)

Filed

Mar 2009

Filed

Filed in USA 20th March 2009.

Rezonic/Zunrisa

CINV/PONV

Filed

Filed

FDA AdCom scheduled for 20th May 2009. PDUFA date extended to 23rd June 2009.

pazopanib

Renal cell cancer

Filed 

Filed

Mar 2009

Filed in EU 4th March 2009.


Sarcoma

Ph III

Ph III


  

Oncology / contd.

USA

EU

News update in the quarter


First-line metastatic

Filed

Mar 2009

Filed

Mar 2009

Filed hormone receptor positive first line metastatic indication in EU on 30th March 2009 and in USA on 31st March 2009.

Tykerb

Adjuvant breast cancer

Ph III

Ph III



Head & neck cancer

Ph III

Ph III



Gastric cancer

Ph III

Ph III


elesclomol

Metastatic melanoma

Ph III

Ph III

Synta announced 27th February 2009 that the Phase III SYMMETRY trial was suspended due to a safety signal.

pazopanib + Tykerb

Inflammatory breast cancer

Ph III

Ph III







Vaccines


USA

EU

News update in the quarter

Cervarix

HPV prophylaxis

Filed

Approved

Final data from 008 study filed in USA on 30th March 2009

Prepandrix

H5N1 pandemic influenza prophylaxis

Ph III

Approved


Synflorix

S pneumoniae and NTHi prophylaxis

n/a

Approved Mar 2009

Approved in EU 31st March 2009. No current plan to file in the USA.

MAGE-A3

NSCLC

Ph III

Ph III



Melanoma

Ph III

Ph III


HibMenCY-TT

MenCY and Hib prophylaxis

Ph III

n/a


MenACWY

MenACWY prophylaxis

Ph III

Ph III


New generation flu

Influenza prophylaxis

Ph III

Ph III


Simplirix

Genital herpes prophylaxis

Ph III

Ph III




  


Balance sheet



31st March
2009
£m

31st March
2008
£m

31st December
2008
£m

ASSETS

----

----

----

Non-current assets




Property, plant and equipment

9,441 

8,026 

9,678 

Goodwill

2,147 

1,372 

2,101 

Other intangible assets

6,157 

4,492 

5,869 

Investments in associates and joint ventures

499 

328 

552 

Other investments

512 

424 

478 

Deferred tax assets

2,772 

2,262 

2,760 

Derivative financial instruments

112 

113 

107 

Other non-current assets

560 

806 

579 


---- 

---- 

---- 

Total non-current assets

22,200 

17,823 

22,124 


---- 

---- 

---- 

Current assets




Inventories

4,107 

3,314 

4,056 

Current tax recoverable

95 

45 

76 

Trade and other receivables

5,920 

5,316 

6,265 

Derivative financial instruments

258 

483 

856 

Liquid investments

364 

1,225 

391 

Cash and cash equivalents

6,221 

2,147 

5,623 

Assets held for sale

2 

3 

2 


---- 

---- 

---- 

Total current assets

16,967 

12,533 

17,269 


---- 

---- 

---- 

TOTAL ASSETS

39,167 

30,356 

39,393 


---- 

---- 

---- 

LIABILITIES




Current liabilities




Short-term borrowings

(1,276)

(1,799)

(956)

Trade and other payables

(5,752)

(5,329)

(6,075)

Derivative financial instruments

(254)

(244)

(752)

Current tax payable

(948)

(1,056)

(780)

Short-term provisions

(1,516)

(851)

(1,454)


---- 

---- 

---- 

Total current liabilities

(9,746)

(9,279)

(10,017)


---- 

---- 

---- 

Non-current liabilities




Long-term borrowings

(15,106)

(8,114)

(15,231)

Deferred tax liabilities

(717)

(989)

(714)

Pensions and other post-employment benefits

(3,227)

(1,326)

(3,039)

Other provisions

(1,529)

(1,084)

(1,645)

Derivative financial instruments

(2)

- 

(2)

Other non-current liabilities

(406)

(354)

(427)


---- 

---- 

---- 

Total non-current liabilities

(20,987)

(11,867)

(21,058)


---- 

---- 

---- 

TOTAL LIABILITIES

(30,733)

(21,146)

(31,075)


---- 

---- 

---- 

NET ASSETS

8,434 

9,210 

8,318 


---- 

---- 

---- 





EQUITY




Share capital

1,416 

1,476 

1,415 

Share premium account

1,340 

1,295 

1,326 

Retained earnings

4,619 

5,717 

4,622 

Other reserves

687 

428 

568 


---- 

---- 

---- 

Shareholders' equity

8,062 

8,916 

7,931 





Minority interests

372 

294 

387 


---- 

---- 

---- 

TOTAL EQUITY

8,434 

9,210 

8,318 


---- 

---- 

---- 

  

Cash flow statement


Three months ended 31sMarch 2009



Q1 2009
£m

Q1 2008
£m

2008
£m


----

----

----

Profit after tax

1,169 

1,332 

4,712 

Tax on profits

497 

542 

1,947 

Share of after tax (profits)/losses of associates and joint ventures

(14)

1 

(48)

Profit on disposal of interest in associates

(115)

- 

- 

Net finance expense

175 

88 

530 

Depreciation and other non-cash items

603 

310 

1,437 

Decrease in working capital

22 

39 

69 

(Decrease)/increase in other net liabilities

(271)

(204)

408 


---- 

---- 

---- 

Cash generated from operations

2,066 

2,108 

9,055 





Taxation paid

(330)

(307)

(1,850)


---- 

---- 

---- 

Net cash inflow from operating activities

1,736 

1,801 

7,205 


---- 

---- 

---- 

Cash flow from investing activities




Purchase of property, plant and equipment

(268)

(254)

(1,437)

Proceeds from sale of property, plant and equipment

7 

2 

20 

Purchase of intangible assets

(120)

(61)

(632)

Proceeds from sale of intangible assets

- 

- 

171 

Purchase of equity investments

(23)

(12)

(87)

Proceeds from sale of equity investments

1 

2 

42 

Purchase of businesses, net of cash acquired

(501)

- 

(454)

Investment in associates and joint ventures

(7)

(2)

(9)

Decrease/(increase) in liquid investments

23 

(14)

905 

Proceeds from disposal of interest in associates

178 

- 

- 

Interest received

41 

87 

320 

Dividends from associates and joint ventures

3 

2 

12 


---- 

---- 

---- 

Net cash outflow from investing activities

(666)

(250)

(1,149)


---- 

---- 

---- 

Cash flow from financing activities




Proceeds from own shares for employee share options

3 

6 

9 

Shares acquired by ESOP Trusts

(50)

(1)

(19)

Issue of share capital

15 

30 

62 

Purchase of own shares for cancellation

- 

(986)

(3,706)

Increase in long-term loans

- 

693 

5,523 

Net increase in/(repayment of) short-term loans

166 

(1,811)

(3,059)

Net repayment of obligations under finance leases

(11)

(12)

(48)

Interest paid

(56)

(42)

(730)

Dividends paid to shareholders

(730)

(708)

(2,929)

Dividends paid to minority interests

(41)

(34)

(79)

Other financing cash flows

50 

54 

68 


---- 

---- 

---- 

Net cash outflow from financing activities

(654)

(2,811)

(4,908)


---- 

---- 

---- 





Increase/(decrease) in cash and bank overdrafts in the period

416 

(1,260)

1,148 





Exchange adjustments

(11)

(5)

1,103 

Cash and bank overdrafts at beginning of period

5,472 

3,221 

3,221 


---- 

---- 

---- 

Cash and bank overdrafts at end of period

5,877 

1,956 

5,472 


---- 

---- 

---- 





Cash and bank overdrafts at end of period comprise:





Cash and cash equivalents 

6,221 

2,147 

5,623 


Overdrafts

(344)

(191)

(151)


---- 

---- 

---- 


5,877 

1,956 

5,472 


---- 

---- 

---- 

  

Statement of comprehensive income


Q1 2009
£m

Q1 2008
£m


----

----

Profit for the period

1,169 

1,332 




Exchange movements on overseas net assets

(214)

129 

Tax on exchange movements

- 

(6)

Fair value movements on available-for-sale investments

17 

(87)

Deferred tax on fair value movements on available-for-sale investments

(1)

15 

Actuarial (losses)/gains on defined benefit plans

(135)

219 

Deferred tax on actuarial movements in defined benefit plans

37 

(54)

Fair value movements on cash flow hedges

(3)

- 


---- 

---- 

Other comprehensive income for the period

(299)

216 





---- 

---- 

Total comprehensive income for the period

870 

1,548 


---- 

---- 




Total comprehensive income for the period attributable to:



Shareholders

844 

1,527 

Minority interests

26 

21 


---- 

---- 


870 

1,548 


---- 

---- 


Statement of changes in equity


Share
capital

£m

Share
premium

£m

Retained
earnings

£m

Other
reserves

£m

Minority
interests

£m

Total
equity

£m


---

---

---

---

---

---

At 1st January 2009

1,415 

1,326

4,622 

568 

387 

8,318 








Total comprehensive income for the period



828 

16 

26 

870 

Distributions to minority shareholders





(41)

(41)

Dividends to shareholders



(730)



(730)

Shares issued

1 

14




15 

Consideration received for shares 
 
  transferred by ESOP Trusts





Shares acquired by ESOP Trusts




(50)


(50)

Write-down on shares held by ESOP Trusts



(150)

150 


Share-based incentive plans



49 



49 


---

---

---

---

---

---

At 31st March 2009

1,416 

1,340

4,619 

687 

372 

8,434 


---

---

---

---

---

---


At 1st January 2008

1,503 

1,266

6,475 

359 

307 

9,910 








Total comprehensive income for the period



1,596 

(69)

21 

1,548 

Distributions to minority shareholders





(34)

(34)

Dividends to shareholders



(708)



(708)

Shares issued

1 

29




30 

Shares purchased for cancellation

(28)


(1,591)

28 


(1,591)

Consideration received for shares 
  transferred by ESOP Trusts





Shares acquired by ESOP Trusts




(1)


(1)

Write-down on shares held by ESOP Trusts



(105)

105 


Share-based incentive plans



52 



52 

Tax on share-based incentive plans



(2)



(2)


---

---

---

---

---

---

At 31st March 2008

1,476 

1,295

5,717 

428 

294 

9,210 


---

---

---

---

---

---

  


Segmental information


GSK has implemented IFRS 8 'Operating segments' with effect from 1st January 2009 and this has resulted in a change to the segmental information reported by GSK. Comparative information has been presented on a consistent basis.


GSK's operating segments are being reported based on the financial information provided to the Chief Executive Officer and the responsibilities of the Corporate Executive Team (CET). Individual members of the CET are responsible for geographic regions of the Pharmaceuticals business and for the Consumer Healthcare business as a whole, respectively.


R&D investment is essential for the sustainability of the pharmaceutical businesses. However, for segment reporting, the US, Europe, Emerging Markets and Asia Pacific/Japan regional pharmaceutical operating profits exclude allocations of globally funded R&D as well as central costs, principally corporate functions and unallocated manufacturing costs. GSK's management reporting process allocates intra-Group profit on a product sale to the market in which that sale is recorded, and the profit analyses below have been presented on that basis.


The Other trading pharmaceuticals segment includes Canada, Puerto Rico, central vaccine tender sales and contract manufacturing sales.


The Pharmaceuticals R&D segment is the responsibility of the Chairman, Research & Development and is therefore being reported as a separate segment.


Unallocated pharmaceuticals costs include costs such as vaccines R&D and central manufacturing costs not attributed to other segments.


Corporate and other unallocated costs and disposal profits include corporate functions, costs for legal matters, fair value movements on financial instruments and investments and profits on global asset disposals.



Turnover by segment

Q1 2009
£m

Q1 2008
(restated)

£m


Growth

CER%


----

----

----

US pharmaceuticals

2,283 

2,138 

(22)

Europe pharmaceuticals

1,840 

1,496 

Emerging Markets pharmaceuticals

661 

469 

18 

Asia Pacific/Japan pharmaceuticals

639 

420 

12 

Other trading pharmaceuticals

200 

244 

(29)


----

----


Pharmaceuticals turnover

5,623 

4,767 

(6)

Consumer Healthcare turnover

1,146 

919 


----

----



6,769 

5,686 

(5)


----

----




  


Operating profit by segment

Q1 2009
£m

Q1 2008
(restated)

£m


Growth

CER%


----

----

----

US pharmaceuticals

1,494 

1,458 

(27)

Europe pharmaceuticals

1,057 

831 

9 

Emerging Markets pharmaceuticals

228 

163 

9 

Asia Pacific/Japan pharmaceuticals

346 

212 

11 

Other trading pharmaceuticals

113 

161 

(40)

Pharmaceuticals R&D

(901)

(636)

18 

Other unallocated pharmaceuticals costs

(292)

(184)

41 


----

----


Pharmaceuticals operating profit

2,045 

2,005 

(27)

Consumer Healthcare operating profit

189 

159 

(1)


----

----


Segment operating profit

2,234 

2,164 

(25)

Corporate and other unallocated costs and disposal profits

(258)

(116)



----

----


Operating profit before major restructuring

1,976 

2,048 

(31)

Major restructuring

(264)

(85)



----

----


Total operating profit

1,712 

1,963 






Finance income

28 

82 


Finance costs

(203)

(170)


Profit on disposal of interest in associate

115 

- 


Share of after tax profits of associates and joint ventures

14 

(1)



----

----


Profit before taxation

1,666 

1,874 



----

----




Segmental commentary


US pharmaceuticals turnover declined 22% and operating profit declined by 27% as the related decline in gross profit was only partially mitigated by a 16% reduction in SG&A costs.


In Emerging Markets and Asia Pacific/Japan pharmaceuticals operating profit grew at a slower rate than turnover growth reflecting SG&A investment in support of our strategic priorities. Other trading pharmaceuticals turnover declined, reflecting lower contract manufacturing income. 


Pharmaceuticals R&D costs increased primarily due to higher intangible asset write-offs and adverse currency movements. Costs excluding intangible asset write-offs of £115 million (Q1 2008: £6 million) increased by 5% CER.


Other unallocated pharmaceuticals costs increased in 2009 due to higher centrally held manufacturing costs.


Consumer Healthcare turnover increased 4% but operating profits declined 1% reflecting regional mix, higher commodity prices and SG&A investment in support of our strategic priorities.  


Central unallocated costs increased quarter-on-quarter due to higher pension charges in Q1 2009 and a beneficial fair value movement in Q1 2008 on the Quest collar, which was terminated during 2008.

  

Legal matters

The Group is involved in various legal and administrative proceedings principally product liability, intellectual property, tax, anti-trust and governmental investigations and related private litigation concerning sales, marketing and pricing which are more fully described in the 'Legal proceeding' note in the Annual Report 2008.


At 31st March 2009, the Group's aggregate provision for legal and other disputes (not including tax matters described under 'Taxation') was £1.9 billion. The ultimate liability for legal claims may vary from the amounts provided and is dependent upon the outcome of litigation proceedings, investigations and possible settlement negotiations.


Significant developments since the date of the Annual Report 2008 are as follows:


In March 2009, the Group received para iv certifications from ANDA applicants, Teva Pharmaceuticals USA, Par Pharmaceutical, Inc., and Apotex Inc., alleging that two patents covering Lovaza are invalid, unenforceable, or not infringed. The patents expire in 2013 and 2017. The Group is the licensee under these patents. Pronova is the owner of the patents and has the first right to sue under these patents. At this time Pronova has not sued the ANDA applicants. If Pronova sues the ANDA applicants, a stay against FDA approval will be effected until the earlier of an adverse decision in the case or May 2012.


In the Wellbutrin XL action filed in the US District Court for the Eastern District of Pennsylvania against Biovail and GSK alleging unlawful monopolisation and other antitrust violations related to the enforcement of Biovail's Wellbutrin XL patents and the filing, by Biovail, of citizen petitions, GSK's motion to dismiss the complaint of the purported class of direct purchasers was denied. Accordingly, the case will proceed to discovery. In the same matter, the purported class of indirect purchasers has filed an amended complaint, thus mooting GSK's pending motion to dismiss their complaint.


With respect to the purported direct and indirect purchaser class actions relating to Flonase, the Group's motion to dismiss the complaints was granted without prejudice on 15th April 2009 by the US District Court for the Eastern District of Pennsylvania. On 17th April 2009, Roxane Laboratories, Inc. filed suit against the Group in the US District Court for the Eastern District of Pennsylvania, alleging anticompetitive conduct by the Group in filing certain citizen petitions which are alleged to have delayed Roxane's entry into the market for Flonase. The Group is currently collecting information about the allegations included in this complaint.


Developments with respect to tax matters are described in 'Taxation' below.


Taxation

Transfer pricing and other issues are as previously described in the 'Taxation' note to the Financial Statements included in the Annual Report 2008. There have been no material changes to tax matters since the publication of the Annual Report.


GSK continues to believe that it has made adequate provision for the liabilities likely to arise from open assessments. The ultimate liability for such matters may vary from the amounts provided and is dependent upon the outcome of litigation proceedings and negotiations with the relevant tax authorities.



Dividends

Paid/
payable

Pence per
share


£m



----

----

----

2009




First interim

9th July 2009

14

710



----

----

2008




First interim

10th July 2008

13

683

Second interim

9th October 2008

13

679

Third interim

8th January 2009

14

730

Fourth interim

9th April 2009

17

859




----

----




57

2,951




----

----






The weighted average number of shares was 5,064 million (Q1 2008: 5,355 million).

  


Net assets

The book value of net assets increased by £116 million from £8,318 million at 31st December 2008 to £8,434 million at 31st March 2009. This reflects a decrease in net debt arising from the operating activities in the period partially offset by the dividend payment and an increase in the pension deficit. The increase in the pension deficit arose predominantly from a reduction in asset values and an increase in the estimated long-term UK inflation rate, partially offset by an increase in the rate used to discount UK pension liabilities from 6.20% to 6.60% and the rate used to discount US pension liabilities from 6.00% to 6.50%. At 31st March 2009, the net deficit on the Group's pension plans was £1,954 million compared with £1,697 million at 31st December 2008.


The carrying value of investments in associates and joint ventures at 31st March 2009 was £499 million, with a market value of £1,118 million.


At 31st March 2009, the ESOP Trusts held 120.4 million GSK shares against the future exercise of share options and share awards. The carrying value of £1,342 million has been deducted from other reserves. The market value of these shares was £1,310 million.


GSK did not purchase any shares for cancellation in the period. At 31st March, the company held 474.2 million Treasury shares at a cost of £6,286 million, which has been deducted from retained earnings.



Reconciliation of cash flow to movements in net debt

Q1 2009
£m

Q1 2008
£m

2008
£m


----

----

----

Net debt at beginning of the period

(10,173)

(6,039)

(6,039)





Increase/(decrease) in cash and bank overdrafts

416 

(1,260)

1,148 

Cash (inflow)/outflow from liquid investments

(23)

14 

(905)

Net increase in long-term loans

- 

(693)

(5,523)

Net (increase in)/repayment of short-term loans

(166)

1,811 

3,059 

Net repayment of obligations under finance leases

11 

12 

48 

Exchange adjustments

167 

(340)

(1,918)

Other non-cash movements

(29)

(46)

(43)


---- 

---- 

---- 

Decrease/(increase) in net debt

376 

(502)

(4,134)


---- 

---- 

---- 

Net debt at end of the period

(9,797)

(6,541)

(10,173)


---- 

---- 

---- 



Business acquisitions and disposals

On 7th January 2009, the Group acquired all of the share capital of Genelabs Technologies Inc., a California biotechnology company with a strong and focused portfolio in hepatitis C vaccines. The purchase price of £41 million included £12 million of cash and cash equivalents, with the remainder represented by preliminary net asset valuations of £29 million.


On 30th January 2009, the Group acquired all of the share capital of Bristol Myers Squibb Pakistan (Private) Limited and certain associated trademarks for a cash consideration of £23 million. As a result, the Group has acquired a portfolio of over 30 well-established pharmaceutical brands, many of which occupy leading market positions in key therapeutic disease areas in Pakistan. The purchase price of £23 million was represented by preliminary valuations of intangible assets of £7 million, goodwill of £8 million and other net assets of £8 million.


On 31st March 2009, the Group acquired from UCB S.A. its marketed product portfolio across certain territories in Africa, the Middle East, Asia Pacific and Latin America which includes several leading pharmaceutical brands in a number of disease areas. The purchase price of £451 million included £2 million of net cash, £428 million of intangible assets, £75 million of goodwill and £54 million of other liabilities. These are provisional valuations and may change in the future.


Subsequent to the quarter-end, GSK announced agreements to create a new specialist HIV business with Pfizer and to acquire the dermatology company, Stiefel Laboratories, Inc. for consideration of up to $3.6 billion.


  


Related party transactions

The Group's significant related parties are its joint ventures and associates as disclosed in the company's Annual Report 2008. In March 2009, 5,749,157 shares in the Group's associate, Quest Diagnostics Inc. were sold for a cash consideration of £178 million, the majority of the shares being sold direct to Quest Diagnostics Inc. with the remainder being sold in the market.


Apart from the above share sale, there were no material transactions with any of the Group's joint ventures and associates in the period. There were no material transactions with directors.



Contingent liabilities

There were contingent liabilities at 31st March 2009 in respect of guarantees and indemnities entered into as part of the ordinary course of the Group's business. No material losses are expected to arise from such contingent liabilities.



Exchange rates

The Group operates in many countries and earns revenues and incurs costs in many currencies. The results of the Group, as reported in Sterling, are affected by movements in exchange rates between Sterling and other currencies. Average exchange rates, as modified by specific transaction rates for large transactions, prevailing during the period are used to translate the results and cash flows of overseas subsidiaries, associates and joint ventures into Sterling. Period-end rates are used to translate the net assets of those entities. The currencies which most influenced these translations and the relevant exchange rates were: 





Q1 2009

Q1 2008




----

----

Average rates:






£/US$



1.44

1.99


£/Euro



1.09

1.32


£/Yen



136

210







Period end rates:






£/US$



1.43

1.99


£/Euro



1.08

1.26


£/Yen



142

198


During Q1, average and period end Sterling exchange rates were weaker against the US Dollar, the Euro and the Yen compared with the same period in 2008.



Accounting presentation and policies 

This unaudited Results Announcement containing condensed financial information for the three months ended 31st March 2009 is prepared in accordance with the Disclosure and Transparency Rules of the United Kingdom's Financial Services Authority, IAS 34 'Interim Financial Reporting' and the accounting policies set out in the Annual Report 2008, except that GSK has implemented IAS 1 (Revised) 'Presentation of financial statements', IAS 23 (Revised) 'Borrowing costs' and IFRS 8 'Operating segments' with effect from 1st January 2009The implementation of IFRS 8 has resulted in a change to the segmental information reported by GSK, as described in 'Segmental information' on page 15. Comparative information has been presented on a consistent basis.


This Results Announcement does not constitute statutory accounts of the Group within the meaning of sections 434(3) and 435(3) of the Companies Act 2006. The balance sheet at 31st December 2008 has been derived from the full Group accounts published in the Annual Report 2008, which has been delivered to the Registrar of Companies and on which the report of the independent auditors was unqualified and did not contain a statement under either section 237(2) or section 237(3) of the Companies Act 1985.



  

Independent review report to GlaxoSmithKline plc


Introduction

We have been engaged by the company to review the condensed financial information in the results announcement for the first quarter 2009 (the 'Interim Management Statement') for the three months ended 31st March 2009 which comprises the income statement, balance sheet, statement of comprehensive income, statement of changes in equity, cash flow statement and related notes (excluding the pharmaceuticals and vaccines pipeline table). We have read the other information contained in the Interim Management Statement and considered whether it contains any apparent misstatements or material inconsistencies with the information in the condensed financial information.


Directors' responsibilities

The Interim Management Statement is the responsibility of, and has been approved by, the directors. The directors are responsible for preparing the Interim Management Statement in accordance with the Disclosure and Transparency Rules of the United Kingdom's Financial Services Authority.


The annual financial statements of the group are prepared in accordance with IFRSs as adopted by the European Union. The condensed financial information included in the Interim Management Statement has been prepared in accordance with International Accounting Standard 34, 'Interim Financial Reporting', as adopted by the European Union.


Our responsibility

Our responsibility is to express to the company a conclusion on the condensed financial information in the interim financial report based on our review. This report, including the conclusion, has been prepared for and only for the company for the purpose of the Disclosure and Transparency Rules of the Financial Services Authority and for no other purpose. We do not, in producing this report, accept or assume responsibility for any other purpose or to any other person to whom this report is shown or into whose hands it may come save where expressly agreed by our prior consent in writing.


Scope of review

We conducted our review in accordance with International Standard on Review Engagements (UK and Ireland) 2410, 'Review of Interim Financial Information Performed by the Independent Auditor of the Entity' issued by the Auditing Practices Board for use in the United Kingdom. A review of interim financial information consists of making enquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing (UK and Ireland) and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.


Conclusion

Based on our review, nothing has come to our attention that causes us to believe that the condensed financial information in the Interim Management Statement for the three months ended 31st March 2009 is not prepared, in all material respects, in accordance with International Accounting Standard 34 as adopted by the European Union and the Disclosure and Transparency Rules of the United Kingdom's Financial Services Authority.


PricewaterhouseCoopers LLP

Chartered Accountants

22nd April 2009

London



Notes:


(a)

The maintenance and integrity of the GlaxoSmithKline plc website is the responsibility of the directors; the work carried out by the auditors does not involve consideration of these matters and, accordingly, the auditors accept no responsibility for any changes that may have occurred to the interim report since it was initially presented on the website.



(b)

Legislation in the United Kingdom governing the preparation and dissemination of financial information may differ from legislation in other jurisdictions.









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