3rd Quarter Results

RNS Number : 4165G
GlaxoSmithKline PLC
22 October 2008
 



Issued: Wednesday, 22nd October 2008LondonU.K. 


Results announcement for the third quarter 2008


GSK delivers Q3 business performance*
EPS of 25.2p and increased dividend of 14p




Business performance results*



Q3 2008


Growth

9 months
2008


Growth


£m

CER%

£%

£m

CER%

£%

Turnover

5,882

(3)

7

17,442

(2)

4

Earnings per share

25.2p

(9)

6

78.0p

(5)

4



Statutory results (including restructuring charges)



Q3 2008


Growth

9 months 2008


Growth


£m

CER%

£%

£m

CER%

£%

Turnover

5,882

(3)

7 

17,442

(2)

4 

Earnings per share

20.1p

(30)

(15)

69.2p

(16)

(7)

The full results are presented under 'Income Statement' on pages 8 and 16.


Q3 business performance summary

EPS down 9% at constant exchange rates, up 6% in sterling terms benefiting from currency movements

Continued sales growth in vaccines, emerging markets and consumer healthcare helped offset impact of generic competition to US pharmaceuticals

Portfolio renewal continues with 10 product launches so far in 2008, including Rotarix (USA), Treximet (USA) and Tyverb (EU) 

Strong R&D productivity evident with a sustained level of around 30 assets in late-stage development

Early progress in strategy to globalise and diversify business with 'bolt-on' acquisitions in emerging markets and consumer healthcare 

Q3 dividend increased 8% to 14p.




*

Business performance, which is a supplemental measure, is the primary performance measure used by management and is presented after excluding restructuring charges relating to the current operational excellence programme, which commenced in October 2007, and significant acquisitions. Management believes that exclusion of these items provides a better reflection of the way in which the business is managed and gives a more useful indication of the underlying performance of the Group.


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 growth and compare 2008 business performance results with 2007 statutory results, unless otherwise stated.

  


Chief Executive Officer's Review


We are managing a considerable transition to our product portfolio this year as several mature pharmaceutical brands encounter generic competition in the USA. In the short-term, this is having a significant impact on pharmaceutical sales, although we continue to see good growth from other areas of the pharmaceuticals portfolio, including a recent improvement in prescription volumes for Advair in the United States. Also helping offset the generic impact has been growth in other parts of our business, such as vaccines, emerging markets and consumer healthcare.


This diversification in sales is an inherent strength for GSK and one we are actively nurturing, through delivery and investment in our new strategic priorities. Ultimately, we are aiming to create a more balanced healthcare business with a lower overall risk profile.



Grow a diversified global business

In Pharmaceuticals, we are making good progress to renew our product line, with 10 product launches so far this year in critical growth areas, such as oncology, and in existing franchises. 


In the future, we want our portfolio to be more balanced with a lower concentration of sales in any one or two products. Clearly, our agenda must then be to maximise the value of this broader portfolio and we are therefore deliberately taking a more global approach to commercialisation than ever before. 


The success of Advair in Japan is a good example of driving growth outside our more traditional markets.  Advair is at the vanguard of multiple future product opportunities in Japan, with the next product launch expected to be Lamictal, following its approval last week. Overall, we have the potential for more than 40 launches over the next 5 years in this market. 


In emerging markets, we are starting to make some early progress in building a more tailored portfolio for patients and consumers. We have now formalised our trading agreement with Aspen Pharmaceuticals and have so far identified around 60 assets for prospective commercialisation. 


We also recently acquired a broad range of pharmaceutical brands from BMS in Egypt. This is a fast growing market and we are now the market leader. Importantly, this acquisition also provides us with the opportunity to grow incremental sales in other markets in the Middle East and North Africa, through export of these products.


The dynamics of emerging markets are wholly different to traditional western pharmaceutical markets as there is less distinction between pharmaceutical, over-the-counter and retail market structures. Our capability to supply products and operate across this spectrum is, I believe, a competitive advantage for GSK. 


On this basis, we are determined to globalise further our Consumer Healthcare business. In September, for example, we introduced Sensodyne - the fastest growing global toothpaste brand - into the Chinese market, our first major consumer product to launch there for a decade. 


We also see multiple opportunities to build our consumer business through the switch of prescription products and the acquisition of new brands, which can complement and drive the growth of our key franchises. Our recent acquisition of Biotene, a dynamic oral healthcare brandis evidence of this.



Moving forward, it is clear that we will need to monitor closely the impact that changes in the global economy will have on consumer demand for products. To date, we have seen only modest impact on GSK's consumer products in certain territories. The strength of our diversified business model is that it helps to mitigate any potential impact on GSK as our multiple franchises operate in very different economic cycles.


In Vaccines, our sales continue to be dynamic with growth powered by a broad range of brands. We continue to expand this business and this quarter launched two new vaccines in the USARotarix and Kinrix.  


The potential of this business is significant, given our pipeline; the opportunity for global expansion, and payer needs that are increasingly directed towards preventative healthcare. At the same time, we must compete effectively for what are often binary tender orders and supply agreements. This may produce some volatility in the vaccines sales line as this business grows. Regarding recent tenders we have made good progress, in particular with Cervarix, which has been successful in approximately 60% of competitive tenders, notably in the UK for the largest vaccination programme against HPV in Europe.



Deliver more products of value

In R&D, we are continuing to make the changes necessary to deliver our pipeline going forward.


We have seen a step-change in the number of launches for GSK, and importantly we are replenishing these with new phase III entries. At present, we are maintaining a level of around 30 assets in late-stage development and our strategies in R&D are focused on sustaining this type of productivity. 


Moreover, GSK continues to deliver innovative products with 6 novel medicines and vaccines either launched or filed in 2008. In fact, around 75% of assets in our pipeline are entirely new compounds or vaccines. By any standard, this is a strong bias towards innovation and demonstrates the value GSK can bring to patients and to payers. 


We have seen good progress in our late-stage biopharmaceutical portfolio this quarter. New data for ofatumumab, a treatment for patients with chronic lymphocytic leukaemia, will be used to support a licence application planned for the end of the year. Our first in-house developed biopharmaceutical product, Bosatria, was filed for approval in Europe this quarter. We hope this will be a valuable new treatment for patients with the rare, but potentially fatal disease, hypereosinophilic syndrome. Finally, otelixizumab, a new potential treatment for Type I diabetes, entered phase III development in August.


Data on several other important assets this quarter further highlighted the potential of GSK's pipeline. New data for cancer treatments, Armala and Tykerb, demonstrated positive effects against several tumour types with high, unmet medical need. In addition, we presented results from a clinical imaging study of darapladib. These data support our belief that Lp-PLA2 inhibition may be an important therapeutic target and we plan to begin phase III clinical studies shortly.


When I outlined our new strategic priorities last quarter, I said that GSK has a very clear ambition to realise value in R&D through better allocation of capital. Here, we have made progress through reshaping our R&D organisation and the introduction of new initiatives such as our Drug Discovery Investment Board. This Board has now reviewed 75% of our 3-year investment plans for drug discovery, with the remainder expected by year-end.



We are also seeking to improve productivity and value through externalisation of R&D. This enables us to capture scientific diversity and balance expenditure with risk. We believe new alliances formed this quarter with Cellzome and the Harvard Stem Cell Institute will provide competitive advantage in researching areas such as inflammatory disease, neuroscience and oncology.


With all its option-based collaborations, GSK now has access to products and pipelines of 16 companies, bringing further significant breadth and scale to our R&D activities. Combining this capacity with our own organic efforts provides us opportunities for complementary and synergistic research.


Staying with this theme, Sirtris, our recent R&D acquisition is now effectively integrated into our discovery organisation. Like Domantis, it will continue to operate as an independent unit, but we have also established numerous research collaborations in the field of sirtuins across GSK, including in our new R&D China organisation.



Simplify GSK's operating model

Activities to improve our overall efficiency and create a new operating model for our business are well underway. Our current operational excellence programme is progressing well and we are on track to realise annual savings of at least £350 million in 2008 and £700 million by 2010. We have also commenced a series of reviews to simplify further our business, in particular, with attention to our above-country support infrastructure. 



Financial strategy

We continue to benefit from strong cash generation with net cash inflow from operating activities of over £5 billion, up 6% in sterling terms in the first nine months of this year.


Our financial strategy is focused on maintaining an efficient balance sheet, retaining flexibility to invest in our strategic priorities and increasing returns to our shareholders through our progressive dividend policy. This quarter's dividend increased by 8% to 14 pence and we have completed share repurchases of £3.3 billion in the 9 months to 30th September 2008. We expect to have completed around £4 billion of repurchases by the year-end, subject to market conditions.


With the recent changes in financial markets we now expect more investment opportunities to arise that will allow us to invest in support of our strategic priorities. To ensure we have sufficient flexibility to take advantage of these opportunities we do not currently expect to make significant share repurchases in 2009. Investment opportunities will continue to be assessed against strict financial criteria.



Outlook

In summary then, our performance is in line with our expectations and I am pleased with how we have so far responded to what is undoubtedly a challenging year for GSK. Nevertheless, we remain focused on improving our short-term performance. We have also, I believe, started to take some initial steps in the right direction to deliver our strategic agenda to improve long-term sales growth and reduce risk for the company.




Andrew Witty 

Chief Executive Officer


  


Trading Update 


Turnover and key product movements impacting turnover growth for the quarter

Total pharmaceutical turnover for the quarter declined 4% to £4.9 billion, with US turnover down 13% to £2.1 billion, impacted by generic competition to mature brands. In Europe, sales grew 6% to £1.6 billion, emerging markets sales grew 9% to £581 million and Asia Pacific/Japan sales grew 5% to £464 million.


Seretide/Advair sales were up 7% to £982 million for the quarter, with sales up 5% in the USA to £515 million and in Japan sales more than doubled to £25 million. Sales growth was also driven by Valtrex, up 21% to £303 million and Lovaza, with US sales of £75 million.


Sales of Avandia products were £191 million, a decline of 23% compared with 2007. There continues to be controversy surrounding the appropriate use of Avandia and consequently the sales outlook for the product remains negative.  Lamictal sales declined 59% to £136 million following introduction of generic competition in the US market in July. Sales of Wellbutrin (down 67% to £53 million) and Coreg IR (down 93% to £9 million) also declined due to generic competition in the US market.


Vaccines sales grew 12% to £730 million, with hepatitis vaccines up 11% to £174 million, Infanrix/Pediarix up 9% to £168 million and Fluarix/FluLaval up 11% to £144 million. In the USA, this quarter's performance reflected a difficult comparison to particularly strong sales growth in Q3 2007.  Cervarix generated £43 million of sales for the quarter.


Consumer Healthcare sales grew 3% to £994 million during the quarter, compared with 16% growth in Q3 2007, which benefited from launch-stocking of alli. Excluding sales of alli, Consumer Healthcare sales grew 5% this quarter.


Sales of oral care brands, Aquafresh and Sensodyne, grew 5% and 8% respectively during the quarter, contributing sales of £206 million. Sales of Panadol grew 9% to £82 million, whilst sales of Tums declined 17% to £21 million. Sales of Horlicks grew 10% to £53 million and sales of Lucozade grew 2% to £100 million, principally due to a poor summer in the UK.



Operating profit and earnings per share commentary


Business performance

Business performance operating profit for Q3 2008 was £1,979 million, a 10% decline in CER terms. This was greater than the turnover decline of 3% in CER terms, primarily due to higher cost of sales as a percentage of turnover.


Cost of sales increased to 24.8% of turnover (Q3 2007: 22.5%), principally reflecting the anticipated generic competition to higher margin products in the USA. SG&A costs as a percentage of turnover fell 1.2 percentage points to 28.3% compared with Q3 2007, reflecting the benefits of the current operational excellence programme and other ongoing cost control. R&D expenditure at 14.2% of turnover was broadly unchanged from last year. Pharmaceuticals R&D expenditure in the quarter was 16.4% (Q3 2007: 16.1%) of pharmaceutical turnover.


In the quarter, gains from assets disposals were £21 million (Q3 2007: £22 million), costs for legal matters were £58 million (Q3 2007: £64 million), fair value movements on financial instruments, principally the Quest collar which was closed out in the quarter, resulted in a charge of £37 million (Q3 2007: £32 million) and charges related to previous restructuring programmes were £7 million (Q3 2007: £13 million). The impact of these items on business performance operating profit was broadly neutral, compared with Q3 2007.



Business performance EPS of 25.2p decreased 9% in CER terms (a 6% increase in sterling terms) compared with Q3 2007. The favourable currency impact of 15 percentage points reflected a weakening of sterling against most major currencies.


Statutory performance

Statutory operating profit for Q3 2008 was £1,657 million, down 13% in sterling terms and down 26% CER compared with Q3 2007. This included £322 million of restructuring charges related to the current operational excellence programme; £130 million was charged to cost of sales, £157 million to SG&A and £35 million to R&D. There were no such charges in Q3 2007. Statutory performance EPS of 20.1p decreased 30% in CER terms (15% in sterling terms) compared with Q3 2007.



Cash flow

Net cash inflow from operating activities in Q3 2008 was £1,893 million, up 3% in sterling terms. For the nine months net cash inflow from operating activities was £5,067 million, a 6% increase in sterling terms over the previous year. This was used to fund net interest payable of £55 million, capital expenditure on property, plant and equipment and intangible assets of £1,284 million, and acquisitions of £324 million.


In addition, dividends paid to shareholders totalled £2,250 million (up 6% compared with 2007) and share repurchases amounted to £3,324 million.



Net debt

Net debt increased by £2.6 billion during the nine month period to £8.6 billion at 30th September 2008, comprising gross debt of £14.2 billion and cash and liquid investments of £5.6 billion.


The Group is well placed financially having completed its debt financing programme earlier in the year. At 30th September 2008, GSK had short-term borrowings (including overdrafts) repayable within 12 months of only £1.4 billion with a further £0.6 billion repayable in the subsequent 12-month period. 



Dividends

The Board has declared a third interim dividend of 14 pence per share (Q3 2007: 13p). The equivalent interim dividend receivable by ADR holders is 47.4796 cents per ADS based on an exchange rate of £1/$1.6957. The ex-dividend date will be 29th October 2008, with a record date of 31st October 2008 and a payment date of 8th January 2009.



Currency impact

If exchange rates were to hold at the average Q3 2008 levels for the rest of the year, the positive currency impact on business performance EPS growth for the full year would be around 10 percentage points.



2008 earnings guidance

GSK continues to expect a mid-single digit percentage decline in business performance EPS at constant exchange rates.


  



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

Claire Brough

Alice Hunt

Gwenan White


(020) 8047 5502

(020) 8047 5502

(020) 8047 5502

(020) 8047 5502






US Media

Nancy Pekarek 

Sarah Alspach

Mary Anne Rhyne

(919) 483 2839

(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

Tom Curry

(215) 751 5419



Brand names

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, a trademark of 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 on Form 20-F for 2007.


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

Registered in England and Wales.  Registered number: 3888792


Income statement


Three months ended 30th September 2008



Business
performance

Q3 2008

Growth

Restructuring
Q3 2008


Statutory
Q
3 2008


Q
3 2007
(restated)


£m

CER%

£m

£m

£m


------

------

------

------

------

Turnover:






Pharmaceuticals

4,888 

(4)


4,888 

4,591 

Consumer Healthcare

994 

3 


994 

885 


------ 



------ 

------ 

TURNOVER

5,882 

(3)


5,882 

5,476 







Cost of sales

(1,460)

10 

(130)

(1,590)

(1,232)


------ 


------ 

------ 

------ 

Gross profit

4,422 

(6)

(130)

4,292 

4,244 







Selling, general and administration 

(1,662)

(5)

(157)

(1,819)

(1,617)

Research and development

(834)

2 

(35)

(869)

(769)

Other operating income

53 



53 

52 


------ 


------ 

------ 

------ 







Operating profit:






Pharmaceuticals

1,755 

(12)

(311)

1,444 

1,719 

Consumer Healthcare

224 

3 

(11)

213 

191 


------ 


------ 

------ 

------ 

OPERATING PROFIT

1,979 

(10)

(322)

1,657 

1,910 







Finance income

98 



98 

75 

Finance expense

(218)



(218)

(117)

Share of after tax profits of associates 
   
and joint ventures

16 



16 

14 


------ 


------ 

------ 

------ 







PROFIT BEFORE TAXATION

1,875 

(14)

(322)

1,553 

1,882 







Taxation

(559)


62 

(497)

(536)

Tax rate %

29.8%



32.0%

28.5%


------ 


------ 

------ 

------ 

PROFIT AFTER TAXATION FOR THE PERIOD

1,316 

(16)

(260)

1,056 

1,346 


------ 


------ 

------ 

------ 







Profit attributable to minority interests

29 



29 

36 

Profit attributable to shareholders

1,287 


(260)

1,027 

1,310 


------ 


------ 

------ 

------ 


1,316 


(260)

1,056 

1,346 


------ 


------ 

--- 

------ 







EARNINGS PER SHARE

25.2p

(9)


20.1p

23.7p


------ 



------ 

------ 







Diluted earnings per share

25.0p



20.0p

23.5p


------ 



------ 

------ 



  

Turnover


Pharmaceuticals including vaccines

Three months ended 30th September 2008



Total

USA

Europe

Rest of World


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

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

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

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


£m

CER%

£m

CER%

£m

CER%

£m

CER%


------

-----

------

-----

-----

-----

----

-----

Respiratory

1,348

636

449

263 

11 

Seretide/Advair

982

7 

515

5 

324

1 

143 

35 

Flixotide/Flovent

149

(4)

71

(1)

38

(3)

40 

(10)

Serevent

60

(14)

17

(11)

32

(13)

11 

(23)

Veramyst

17

>100 

12

>100 

3

- 

2 

- 

Flixonase/Flonase

33

(39)

7

(67)

11

11 

15 

(32)










Anti-virals

792

398

199

(12)

195 

HIV

377

(5)

153

(11)

150

(6)

74 

11 

Epzicom/Kivexa

110

24 

44

21 

50

19 

16 

56 

Combivir

110

(13)

41

(26)

38

(19)

31 

26 

Trizivir

49

(20)

24

(21)

22

(17)

3 

(25)

Agenerase, Lexiva

40

(3)

21

(5)

15

(8)

4 

25 

Epivir

35

(16)

11

(29)

13

(27)

11 

22 

Ziagen

27

(11)

10

(17)

8

(22)

9 

14 










Valtrex

303

21 

223

28 

35

7 

45 

3 










Zeffix

42

(10)

4

(25)

7

31 

(9)

Relenza

12

(57)

5

(58)

-

 - 

7 

>100 










Central nervous system

585

(38)

321

(52)

142

122 

(5)

Lamictal

136

(59)

84

(71)

37

(9)

15 

- 

Imigran/Imitrex

188

5 

154

8 

24

(5)

10 

- 

Seroxat/Paxil

112

(23)

13

(67)

27

(8)

72 

(9)

Wellbutrin

53

(67)

44

(72)

6

100 

3 

100 

Requip

56

(43)

13

(81)

35

35 

8 

60 

    Requip XL

15

4

11

Treximet

4

4

- 

-

- 

- 










Cardiovascular and urogenital

466

12 

280

130

17 

56 

13 

Avodart

102

29 

63

29 

29

19 

10 

67 

Lovaza

75

- 

75

-

- 

- 

- 

Coreg

50

(69)

49

(69)

-

- 

1 

(100)

    Coreg CR

41

19 

41

19 

-

- 

- 

- 

    Coreg IR

9

(93)

8

(93)

-

- 

1 

(100)

Fraxiparine

59

22 

-

- 

47

18 

12 

38 

Arixtra

44

56 

22

43 

19

78 

3 

50 

Vesicare

18

31 

18

31 

-

- 

- 

- 

Levitra

16

15 

15

17 

1

- 

- 

 - 










Metabolic

289

(11)

136

(22)

72

(2)

81 

Avandia products

191

(23)

99

(28)

48

(16)

44 

(16)

    Avandia

118

(29)

67

(33)

20

(31)

31 

(20)

    Avandamet

63

(7)

26

(14)

26

- 

11 

- 

Bonviva/Boniva

56

24 

36

18 

18

60 

2 

(33)










Anti-bacterials

340

40

(10)

141

(1)

159 

10 

Augmentin

143

10 

9

(36)

62

6 

72 

24 

Altabax

5

>100 

4

100 

1

- 

- 

- 










Oncology and emesis

128

12 

64

13 

41

23 

16 

Hycamtin

34

20

- 

12

10 

2 

- 

Zofran

33

(9)

6

50 

15

(24)

12 

(9)

Tykerb

26

44 

12

- 

10

80 

4 

- 










Vaccines

730

12 

218

(13)

323

40 

189 

12 

Hepatitis

174

11 

82

17 

61

2 

31 

19 

Infanrix/Pediarix

168

9 

56

(10)

89

23 

23 

28 

Fluarix, FluLaval

144

11 

63

(19)

58

55 

23 

100 

Flu-prepandemic

10

(52)

-

-  

10

>100 

- 

- 

Cervarix

43

>100 

-

- 

38

- 

5 

>100 

Rotarix

39

57 

4

- 

11

67 

24 

29 

Boostrix

22

(19)

13

(40)

7

40 

2 

100 










Other

210

(3)

8

>100 

66

(6)

136 

(12)


------

---- 

------

---- 

------

---- 

----- 

---- 


4,888

(4)

2,101

(13)

1,563

1,224 


------

---- 

------

---- 

------

---- 

----- 

---- 

Pharmaceutical turnover includes co-promotion income.

  


Regional pharmaceuticals including vaccines



Q3 2008


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


£m

CER%


------

-----

USA

2,101

(13)

Europe

1,563

6 

Rest of World

1,224

5 


Asia Pacific/Japan

464

5 


Emerging markets

581

9 



------

---- 



4,888

(4)



------

---- 




Turnover


Consumer Healthcare
Three months ended 
30th September 2008



Total

USA

Europe

Rest of World


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

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

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

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


£m

CER%

£m

CER%

£m

CER%

£m

CER%


------

-----

------

-----

------

-----

------

-----










Over-the-counter medicines

476

(1)

155

(16)

142

179

13 

Panadol franchise

82

9 

-

- 

20

(6)

62

14 

Smoking cessation products

83

3 

60

2 

13

(8)

10

33 

Tums

21

(17)

18

(16)

-

-  

3

- 

Cold sore franchise

22

- 

10

(9)

8

- 

4

50 

Breathe Right

19

(5)

13

(8)

4

100 

2

(50)

Alli

18

(50)

18

(50)

-

-  

-

- 










Oral healthcare

310

54

174

82

Aquafresh franchise

116

5 

20

6 

72

2 

24

15 

Sensodyne franchise

90

8 

17

14 

43

9 

30

4 

Dental healthcare

68

9 

15

- 

27

15 

26

9 










Nutritional healthcare

208

-

-  

127

81

13 

Lucozade

100

2 

-

-  

89

- 

11

25 

Horlicks

53

10 

-

-  

5

(17)

48

14 

Ribena

44

2 

-

-  

33

(3)

11

25 


------

---- 

------

---- 

------

---- 

------

---- 


994

3 

209

(11)

443

4 

342

12 


------

---- 

------

---- 

------

---- 

------

---- 


  


GSK's late-stage pharmaceuticals and vaccines pipeline 


The following table 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. 

    

 


 

Biopharmaceuticals
USA
EU
News update in the quarter
Bosatria
HES
Ph III
Filed
Sept 2008
Filed in EU on 5th September.
belimumab
Lupus
Ph III
Ph III
 
ofatumumab
CLL / NHL
Ph III
Ph III
Announced positive interim results of CLL study (406) on 31st July.
RA
Ph III
Ph III
 
otelixizumab
Type 1 diabetes
Ph III
Ph III
Ph III study started in August.
 
 
 
 
 
Cardiovascular & Metabolic
USA
EU
News update in the quarter
Arixtra
Acute Coronary Syndromes
Filed
Approved
Aug 2007
 
Volibris
PAH Class II/III
n/a
Approved
April 2008
 
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.
Coreg CR  + ACEi
Hypertension
Ph III
n/a
Filing strategy under review.
 
 
 
 
 
Neurosciences
 
USA
EU
News update in the quarter
Requip XL
Parkinson's disease
Approved
June 2008
Approved
Mar 2007
 
Treximet
Migraine
Approved
April 2008
n/a
Filed sNDA for ‘probable migraine’ 23rd September.
Lamictal XR
Epilepsy
Filed
n/a
 
Lunivia
Sleep disorders
n/a
Filed
 
Solzira
RLS
Filed
Ph III
Filed with FDA on 16th September.
almorexant
Primary insomnia
Ph III
Ph III
Collaboration with Actelion announced 14th July
retigabine
Epilepsy
Ph III
Ph III
Collaboration with Valeant announced on 28th August.
rosiglitazone XR
Alzheimer's disease
Ph III
Ph III
 
 
 
 
 
 
Oncology
 
USA
EU
News update in the quarter
Tykerb/Tyverb
Refractory breast cancer
Approved
Mar 2007
Approved
June 2008
 
First-line / Adjuvant breast cancer
Ph III
Ph III
 
Head & neck cancer
Ph III
Ph III
 
Gastric Cancer
Ph III
Ph III
Ph III study started in September.
Avodart
Co-Rx with tamsulosin
Approved
June 2008
Approved
April 2008
 
Prostate cancer prevention
Ph III
Ph III
 
Fixed dose combination with tamsulosin
Ph III
Ph III
 
Rezonic/Zunrisa
CINV/PONV
Filed
May 2008
Filed
July 2008
 
 
 
 
 
 
Oncology / contd.
USA
EU
News update in the quarter
Promacta/Revolade
Short term ITP
Filed
Ph III
FDA PDUFA extended beyond 19th September.
Long term ITP
Ph III
Ph III
 
Hepatitis C / CLD
Ph III
Ph III
 
Armala
Renal cell cancer
Ph III
Ph III
Ph II data presented at ESMO in September.
Sarcoma
Ph III
Ph III
Ph II data presented at ESMO in September.
Ph III study started in October.
Armala + Tykerb
Inflammatory breast cancer
Ph III
Ph III
 
elesclomol
Metastatic melanoma
Ph III
Ph III
Ph II data presented at ESMO in September.
 
 
 
 
 
Respiratory & Immuno-inflammation
USA
EU
News update in the quarter
Seretide/Advair
COPD exacerbation claim
Approved
April 2008
Already in label
 
Entereg
Post operative ileus
Approved
May 2008
n/a
Returned OBD rights to Adolor 2nd September.
 
 
 
 
 
Vaccines
 
USA
EU
News update in the quarter
Rotarix
Rotavirus prophylaxis
Approved
April 2008
Approved
Feb 2006
US vaccines for Children (VFC) funding commenced on 4th August.
Kinrix
DTaP-IPV prophylaxis
Approved
June 2008
n/a
US VFC funding commenced on 4th August.
Cervarix
HPV prophylaxis
Filed
Approved
Sep 2007
 
Prepandrix
H5N1 pandemic influenza prophylaxis
Ph III
Approved
May 2008
 
Synflorix
S pneumoniae and NTHi prophylaxis
Ph III
Filed
US filing strategy under review.
MAGE-A3
NSCLC
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
Large multi-centre international efficacy study in 43,000 subjects began in September.
Simplirix
Genital herpes prophylaxis
Ph III
Ph III
 

 

Balance sheet



30th September
2008
£m

30th September
2007

£m

31st December
2007

£m

ASSETS

----

----

----

Non-current assets




Property, plant and equipment

8,395 

7,464 

7,821 

Goodwill

1,747 

985 

1,370 

Other intangible assets

4,944 

3,721 

4,456 

Investments in associates and joint ventures

445 

313 

329 

Other investments

454 

533 

517 

Deferred tax assets

2,439 

2,278 

2,196 

Derivative financial instruments

17 

132 

1 

Other non-current assets

465 

862 

687 


---- 

---- 

---- 

Total non-current assets

18,906 

16,288 

17,377 


---- 

---- 

---- 

Current assets




Inventories

3,515 

2,965 

3,062 

Current tax recoverable

50 

159 

58 

Trade and other receivables

5,483 

5,030 

5,495 

Derivative financial instruments

349 

89 

475 

Liquid investments

401 

1,084 

1,153 

Cash and cash equivalents

5,148 

2,050 

3,379 

Assets held for sale

8 

4 

4 


---- 

---- 

---- 

Total current assets

14,954 

11,381 

13,626 


---- 

---- 

---- 

TOTAL ASSETS

33,860 

27,669 

31,003 


---- 

---- 

---- 

LIABILITIES




Current liabilities




Short-term borrowings

(1,387)

(1,994)

(3,504)

Trade and other payables

(5,143)

(5,142)

(4,861)

Derivative financial instruments

(195)

(75)

(262)

Current tax payable

(1,058)

(1,217)

(826)

Short-term provisions

(1,015)

(601)

(892)


---- 

---- 

---- 

Total current liabilities

(8,798)

(9,029)

(10,345)


---- 

---- 

---- 

Non-current liabilities




Long-term borrowings

(12,801)

(4,885)

(7,067)

Deferred tax liabilities

(652)

(831)

(887)

Pensions and other post-employment benefits

(2,312)

(1,331)

(1,383)

Other provisions

(1,129)

(1,002)

(1,035)

Derivative financial instruments

- 

(72)

(8)

Other non-current liabilities

(371)

(357)

(368)


---- 

---- 

---- 

Total non-current liabilities

(17,265)

(8,478)

(10,748)


---- 

---- 

---- 

TOTAL LIABILITIES

(26,063)

(17,507)

(21,093)


---- 

---- 

---- 

NET ASSETS

7,797 

10,162 

9,910 


---- 

---- 

---- 





EQUITY




Share capital

1,423 

1,506 

1,503 

Share premium account

1,322 

1,218 

1,266 

Retained earnings

4,099 

6,818 

6,475 

Other reserves

642 

337 

359 


---- 

---- 

---- 

Shareholders' equity

7,486 

9,879 

9,603 





Minority interests

311 

283 

307 


---- 

---- 

---- 

TOTAL EQUITY

7,797 

10,162 

9,910 


---- 

---- 

---- 

  


Net assets

The book value of net assets decreased by £2,113 million from £9,910 million at 31st December 2007 to £7,797 million at 30th September 2008. This reflects an increase in net debt arising from the funding of the share buy-back programme and dividend payments, together with 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 5.75% to 6.50%. At 30th September 2008, the net deficit on the Group's pension plans was £1,192 million compared with a net deficit at 31st December 2007 of £156 million.


The carrying value of investments in associates and joint ventures at 30th September 2008 was £445 million, with a market value of £1,146 million.


In Q3 2008, GSK repurchased and cancelled £865 million of shares. The number of shares in issue at 30th September 2008, excluding those held by the ESOP Trusts and those held as Treasury shares, was 5,089 million (30th September 2007: 5,465 million).


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 2007.


At 30th September 2008, the Group's aggregate provision for legal and other disputes (not including tax matters described under 'Taxation' on page 15) was £1.2 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 2007 (as previously updated by the legal matters section of the Results Announcements for Q1 and Q2 2008) are as follows: 


With respect to the Group's action against Teva Pharmaceuticals relating to the Group's combination patent regarding Combivir, the Group received an additional certification in October 2008 related to Teva's ANDA for Combivir alleging that the Group's patent covering the crystal form of lamivudine, one of the active ingredients in Combivir, is invalid or not infringed. The patent expires in 2016. The Group is evaluating the certification. Teva has not challenged the Group patent relating to Combivir that expires in 2010.


In October 2008, the Group received a letter from Par Pharmaceuticals confirming that the FDA has accepted its ANDA for Treximet, which included a certification of invalidity, unenforceability and/or non-infringement of several patents covering Treximet that are owned by Pozen and licensed to the Group. Pozen has the right to bring actions for infringement of these patents.  Treximet has data exclusivity until April 2011.


With respect to the private indirect purchaser opt-out lawsuit brought in the Minnesota state courts relating to Paxil, such lawsuit has been settled. The terms of the settlement are confidential.


With respect to the complaint filed against Biovail and GSK by a purported class of direct purchasers alleging anti-trust violations relating to the enforcement of Biovail's Wellbutrin XL patents, a separate complaint has also been filed against the Group and Biovail by a purported class of indirect purchasers. Each of the Group and Biovail has filed motions to dismiss both of the complaints. 


With respect to the Avandia securities litigation, the Group's motion to dismiss the complaint was granted and the trial court subsequently denied the plaintiffs' motion for reconsideration. The plaintiffs have filed a notice of appeal with the US Court of Appeals for the Second Circuit. The Group plans to respond to the appeal.


Developments with respect to tax matters are described in 'Taxation' on page15.


  


Taxation

Transfer pricing and other issues are as previously described in the 'Taxation' note to the Financial Statements included in the Annual Report 2007. In relation to the dispute with the IRS regarding deductions arising from inter-company financing arrangements, GSK received a Notice of Deficiency against which it filed a petition in the US Tax Court on 4th August. There have been no material changes to other tax matters since the publication of the Results Announcement for Q2 2008.


As expected, the tax rate on business performance profit for Q3 2008 rose to 29.8% reflecting the cumulative effect of changes in the recently enacted UK Finance Act relating to restrictions on tax allowances. The year-to-date business performance rate of 29% is more indicative of the expected full-year tax charge.


GSK uses the best advice in determining its transfer pricing methodology and in seeking to manage all of its tax affairs to a satisfactory conclusion and, based on external professional advice, 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.



Accounting presentation and policies 

This unaudited Results Announcement containing condensed financial information for the three and nine months ended 30th September 2008 is prepared in accordance with the Disclosure and Transparency Rules of the United Kingdom's Financial Services Authority and the accounting policies set out in the Annual Report 2007.


This Results Announcement does not constitute statutory accounts of the Group within the meaning of section 240 of the Companies Act 1985. The balance sheet at 31st December 2007 has been derived from the full Group accounts published in the Annual Report 2007, 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.



Comparative information restatement 

As reported in the Results Announcement for Q2 2008 the regional reporting structure within the Pharmaceuticals business has been realigned together with the allocation of entities and expenses between the Pharmaceuticals and Consumer Healthcare businesses. As a result, comparative information has been restated onto a consistent basis and the effect of the restatements on each quarter in 2007 and on Q1 2008 is available on the company's website. These reallocations have no impact on Group turnover or Group operating profit.



Dividends

Paid/
payable

Pence per
share


£m



----

----

----

2008




First interim

10th July 2008

13

683

Second interim

9th October 2008

13

679

Third interim

8th January 2009

14

712





2007




First interim

12th July 2007

12

670

Second interim

11th October 2007

12

667

Third interim

10th January 2008

13

708

Fourth interim

10th April 2008

16

859




----

----




53

2,904




----

----

  

Income statement


Nine months ended 30th September 2008



Business
performance

9 months

2008

Growth

Restructuring
9 months 2008


Statutory
9 months
2008


9 months

2007
(restated)


£m

CER%

£m

£m

£m


---

---

---

---

---

Turnover:






Pharmaceuticals

14,578 

(3)


14,578 

14,136 

Consumer Healthcare

2,864 

3 


2,864 

2,606 


--- 



--- 

--- 

TURNOVER

17,442 

(2)


17,442 

16,742 







Cost of sales

(4,134)

6 

(328)

(4,462)

(3,678)


--- 


--- 

--- 

--- 

Gross profit

13,308 

(5)

(328)

12,980 

13,064 







Selling, general and administration 

(5,147)

(5)

(213)

(5,360)

(5,131)

Research and development

(2,416)

2 

(53)

(2,469)

(2,284)

Other operating income

408 



408 

356 


--- 


--- 

--- 

--- 







Operating profit:






Pharmaceuticals

5,609 

(6)

(581)

5,028 

5,504 

Consumer Healthcare

544 

(4)

(13)

531 

501 


--- 


--- 

--- 

--- 

OPERATING PROFIT

6,153 

(6)

(594)

5,559 

6,005 







Finance income

276 



276 

210 

Finance expense

(600)


(2)

(602)

(334)

Share of after tax profits of associates 
   
and joint ventures

30 



30 

40 


--- 


--- 

--- 

--- 







PROFIT BEFORE TAXATION

5,859 

(10)

(596)

5,263 

5,921 







Taxation

(1,699)


131 

(1,568)

(1,687)

Tax rate %

29.0%



29.8%

28.5%


--- 


--- 

--- 

--- 

PROFIT AFTER TAXATION FOR THE PERIOD

4,160 

(10)

(465)

3,695 

4,234 


--- 


--- 

--- 

--- 







Profit attributable to minority interests

75 



75 

77 

Profit attributable to shareholders

4,085 


(465)

3,620 

4,157 


--- 


--- 

--- 

--- 


4,160 


(465)

3,695 

4,234 


--- 


--- 

--- 

--- 







EARNINGS PER SHARE

78.0p

(5)


69.2p

74.7p


--- 



--- 

--- 







Diluted earnings per share

77.5p



68.7p

73.9p


--- 



--- 

--- 


  

Turnover


Pharmaceuticals including vaccines

Nine months ended 30th September 2008



Total

USA

Europe

Rest of World


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

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

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

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


£m

CER%

£m

CER%

£m

CER%

£m

CER%


------

-----

------

-----

-----

-----

----

-----

Respiratory

4,086

1,868

1,432

786 

10 

Seretide/Advair

2,900

8 

1,487

6 

1,024

4 

389 

29 

Flixotide/Flovent

469

(2)

214

3 

125

(6)

130 

(9)

Serevent

193

(10)

50

(11)

103

(6)

40 

(18)

Veramyst

47

>100 

38

>100 

5

- 

4 

>100 

Flixonase/Flonase

144

(20)

44

(38)

40

(3)

60 

(8)










Anti-virals

2,282

(4)

1,100

(2)

626

(14)

556 

HIV

1,096

(6)

447

(9)

471

(5)

178 

Epzicom/Kivexa

313

24 

123

14 

152

28 

38 

52 

Combivir

319

(14)

127

(17)

124

(20)

68 

8 

Trizivir

153

(20)

74

(21)

70

(16)

9 

(33)

Agenerase, Lexiva

113

1 

57

(5)

46

3 

10 

43 

Epivir

103

(19)

33

(20)

43

(22)

27 

(13)

Ziagen

78

(9)

31

(9)

27

(11)

20 

(5)










Valtrex

829

16 

591

19 

106

11 

132 

9 


 


 


 


 


Zeffix

135

(1)

11

- 

20

6 

104 

(2)

Relenza

44

(78)

15

(83)

1

(99)

28 

- 










Central nervous system

2,232

(13)

1,462

(18)

414

(1)

356 

(4)

Lamictal

749

(9)

592

(10)

108

(9)

49 

2 

Imigran/Imitrex

526

2 

427

3 

71

(3)

28 

(4)

Seroxat/Paxil

360

(19)

60

(42)

86

(15)

214 

(8)

Wellbutrin

276

(33)

254

(36)

12

>100 

10 

11 

Requip

208

(22)

91

(48)

95

29 

22 

82 

    Requip XL

23

- 

4

- 

19

- 

- 

- 

Treximet

12

- 

12

- 

-

- 

- 

- 










Cardiovascular and urogenital

1,299

(3)

763

(10)

375

12 

161 

15 

Avodart

279

31 

167

29 

85

25 

27 

63 

Lovaza

192

- 

191

- 

-

- 

1 

- 

Coreg

142

(76)

140

(75)

-

- 

2 

(83)

    Coreg CR

115

>100 

114

>100 

-

- 

1 

- 

    Coreg IR

27

(95)

26

(95)

-

- 

1 

(100)

Fraxiparine

168

10 

-

- 

134

4 

34 

39 

Arixtra

115

51 

57

44 

50

54 

8 

100 

Vesicare

48

31 

48

31 

-

- 

- 

- 

Levitra

43

11 

41

11 

2

100 

- 

- 










Metabolic

846

(33)

408

(45)

218

(9)

220 

(17)

Avandia products

576

(45)

302

(54)

151

(21)

123 

(33)

    Avandia

365

(51)

210

(58)

62

(36)

93 

(36)

    Avandamet

186

(25)

75

(39)

85

(6)

26 

(15)

Bonviva/Boniva

161

39 

105

34 

51

55 

5 

33 










Anti-bacterials

1,032

124

(15)

456

(4)

452 

Augmentin

428

2 

34

(37)

198

2 

196 

16 

Altabax

11

57 

10

43 

1

- 

- 

- 










Oncology and emesis

358

(11)

179

(23)

119

60 

10 

Hycamtin

99

6 

56

4 

35

7 

8 

17 

Zofran

93

(52)

13

(85)

47

(23)

33 

(17)

Tykerb

67

94 

33

38 

25

>100 

9 

- 










Vaccines

1,743

18 

451

799

30 

493 

16 

Hepatitis

480

17 

201

36 

189

1 

90 

16 

Infanrix/Pediarix

488

10 

156

1 

264

15 

68 

14 

Fluarix, FluLaval

149

10 

63

(18)

57

56 

29 

53 

Flu-prepandemic

49

>100 

-

-  

49

>100 

- 

- 

Cervarix

70

>100 

-

- 

59

- 

11 

>100 

Rotarix

101

81 

4

- 

30

63 

67 

78 

Boostrix

53

(6)

27

(24)

19

21 

7 

40 










Other

700

13

(63)

218

11 

469 


------

---- 

------

---- 

------

---- 

----- 

---- 


14,578

(3)

6,368

(11)

4,657

3 

3,553 

5 


------

---- 

------

---- 

------

---- 

----- 

---- 

Pharmaceutical turnover includes co-promotion income.

  


Regional pharmaceuticals including vaccines



9 months 2008


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


£m

CER%


------

-----

USA

6,368

(11)

Europe

4,657

3 

Rest of World

3,553

5 


Asia Pacific/Japan

1,348

1 


Emerging markets

1,613

10 



------

---- 



14,578

(3)



------

---- 




Turnover


Consumer Healthcare

Nine months ended 30th September 2008



Total

USA

Europe

Rest of World


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

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

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

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


£m

CER%

£m

CER%

£m

CER%

£m

CER%


------

-----

------

-----

-----

-----

------

------










Over-the-counter medicines

1,356

(2)

423

(19)

420

4 

513

14

Panadol franchise

240

13 

-

56

184

15

Smoking cessation products

206

(13)

145

(10)

42

(28)

19

6

Tums

64

(6)

55

(7)

-

(100)

9

14

Cold sore franchise

61

26

27

8

17

Breathe Right

54

13 

32

(11)

14

>100 

8

40

Alli

45

(60)

43

(61)

-

2

100










Oral healthcare

897

6 

154

- 

502

6 

241

10

Aquafresh franchise

330

58

(3)

202

70

10

Sensodyne franchise

263

12 

47

12 

127

13 

89

11

Dental healthcare

194

44

(2)

78

11 

72

10










Nutritional healthcare

611

10 

-

- 

371

5 

240

19

Lucozade

293

10 

-

260

33

29

Horlicks

157

14 

-

16

(11)

141

18

Ribena

124

-

94

(2)

30

12


------

---- 

------

---- 

------

---- 

------

-----


2,864

3 

577

(15)

1,293

5 

994

14


------

---- 

------

---- 

------

---- 

------

-----



  

Cash flow statement


Nine months ended 30th September 2008



9 Months 2008
£m

9 Months 2007
£m

2007
£m


----

----

----

Profit after tax

3,695 

4,234 

5,310 

Tax on profits

1,568 

1,687 

2,142 

Share of after tax profits of associates and joint ventures

(30)

(40)

(50)

Net finance expense

326 

124 

191 

Depreciation and other non-cash items

993 

920 

1,333 

Increase in working capital

(207)

(373)

(538)

Increase/(decrease) in other net liabilities

133 

(400)

(308)


---- 

---- 

---- 

Cash generated from operations

6,478 

6,152 

8,080 





Taxation paid

(1,411)

(1,375)

(1,919)


---- 

---- 

---- 

Net cash inflow from operating activities

5,067 

4,777 

6,161 


---- 

---- 

---- 

Cash flow from investing activities




Purchase of property, plant and equipment

(938)

(1,042)

(1,516)

Proceeds from sale of property, plant and equipment

14 

23 

35 

Purchase of intangible assets

(346)

(491)

(627)

Proceeds from sale of intangible assets

170 

7 

9 

Purchase of equity investments

(53)

(158)

(186)

Proceeds from sale of equity investments

32 

45 

45 

Purchase of businesses, net of cash acquired

(324)

(233)

(1,027)

Investment in associates and joint ventures

(7)

(1)

(1)

Interest received

269 

208 

247 

Dividends from associates and joint ventures

9 

11 

12 


---- 

---- 

---- 

Net cash outflow from investing activities

(1,174)

(1,631)

(3,009)


---- 

---- 

---- 

Cash flow from financing activities




Decrease/(increase) in liquid investments

802 

(19)

(39)

Proceeds from own shares for employee share options

- 

104 

116 

Shares acquired by ESOP Trusts

(9)

- 

(26)

Issue of share capital

58 

368 

417 

Purchase of own shares for cancellation

(3,324)

- 

(213)

Purchase of Treasury shares

- 

(2,330)

(3,538)

Increase in long-term loans

5,248 

983 

3,483 

Repayment of long-term loans

- 

(207)

(207)

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

(2,648)

451 

1,632 

Net repayment of obligations under finance leases

(34)

(29)

(39)

Interest paid

(324)

(279)

(378)

Dividends paid to shareholders

(2,250)

(2,126)

(2,793)

Dividends paid to minority interests

(69)

(69)

(77)

Other financing cash flows

(32)

(77)

(79)


---- 

---- 

---- 

Net cash outflow from financing activities

(2,582)

(3,230)

(1,741)


---- 

---- 

---- 





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

1,311 

(84)

1,411 





Exchange adjustments

354 

(1)

48 

Cash and bank overdrafts at beginning of period

3,221 

1,762 

1,762 


---- 

---- 

---- 

Cash and bank overdrafts at end of period

4,886 

1,677 

3,221 


---- 

---- 

---- 





Cash and bank overdrafts at end of period comprise:





Cash and cash equivalents 

5,148 

2,050 

3,379 


Overdrafts

(262)

(373)

(158)


---- 

---- 

---- 


4,886 

1,677 

3,221 


---- 

---- 

---- 

  


Statement of recognised income and expense



9 months 2008
£m

9 months 2007
£m


----

----

Exchange movements on overseas net assets

362 

89 

Tax on exchange movements

(5)

(4)

Fair value movements on available-for-sale investments

(48)

(59)

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

11 

7 

Exchange movements on goodwill in reserves

(41)

(1)

Actuarial (losses)/gains on defined benefit plans

(960)

1,172 

Deferred tax on actuarial movements in defined benefit plans

296 

(352)

Fair value movements on cash flow hedges

1 

(7)

Deferred tax on fair value movements on cash flow hedges

(1)

3 


---- 

---- 

Net (losses)/gains recognised directly in equity

(385)

848 




Profit for the period

3,695 

4,234 


---- 

---- 

Total recognised income and expense for the period

3,310 

5,082 


---- 

---- 




Total recognised income and expense for the period attributable to:



Shareholders

3,237 

4,992 

Minority interests

73 

90 


---- 

---- 


3,310 

5,082 


---- 

---- 


  

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 third quarter 2008 (the 'Interim Management Statement') for the three and nine months ended 30th September 2008 which comprises the income statements, balance sheet, statement of recognised income and expense, 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 set of financial statements.


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 condensed financial information in the Interim Management Statement for the three months and nine months ended 30th September 2008 has been prepared in accordance with the basis of preparation set out in the Accounting Presentation and Policies note and the Disclosure and Transparency Rules of the United Kingdom's Financial Services Authority.


Our responsibility

Our responsibility is to express to the company a conclusion on the condensed financial information in the Interim Management Statement 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 and nine months ended 30th September 2008 is not prepared, in all material respects, in accordance with the basis of preparation set out in the Accounting Presentation and Policies note and the Disclosure and Transparency Rules of the United Kingdom's Financial Services Authority.


PricewaterhouseCoopers LLP

Chartered Accountants

London

22nd October 2008



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.





This information is provided by RNS
The company news service from the London Stock Exchange
 
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