2q and half year results 2013 - astrazeneca · act 1995,,p g g y p we are providing the following...

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Page 1: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

2Q and Half Year Results2013

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Page 2: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Cautionary Statement Regarding F d L ki St t tForward-Looking StatementsIn order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act 1995, we are providing the following cautionary statement: This presentation contains certain forward-looking , p g g y p gstatements with respect to the operations, performance and financial condition of the Group. Although we believe our expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results tobe materially different from those predicted. The forward-looking statements reflect knowledge and information be a e a y d e e o ose p ed c ed e o a d oo g s a e e s e ec o edge a d o a oavailable at the date of preparation of this presentation and AstraZeneca undertakes no obligation to update these forward-looking statements. We identify the forward-looking statements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in such statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond our control, include,differ materially from those contained in forward looking statements, certain of which are beyond our control, include, among other things: the loss or expiration of patents, marketing exclusivity or trade marks, or the risk of failure to obtain patent protection; the risk of substantial adverse litigation/government investigation claims and insufficient insurance coverage; exchange rate fluctuations; the risk that R&D will not yield new products that achieve commercial success; the risk that strategic alliances and acquisitions will be unsuccessful; the impact of competition,commercial success; the risk that strategic alliances and acquisitions will be unsuccessful; the impact of competition, price controls and price reductions; taxation risks; the risk of substantial product liability claims; the impact of any failure by third parties to supply materials or services; the risk of failure to manage a crisis; the risk of delay to new product launches; the difficulties of obtaining and maintaining regulatory approvals for products; the risk of failureto observe ongoing regulatory oversight; the risk that new products do not perform as we expect; the risk ofto observe ongoing regulatory oversight; the risk that new products do not perform as we expect; the risk of environmental liabilities; the risks associated with conducting business in emerging markets; the risk of reputational damage; the risk of product counterfeiting; the risk of failure to successfully implement planned cost reduction measures through productivity initiatives and restructuring programmes; the risk that regulatory approval processes for biosimilars could have an adverse effect on future commercial prospects; and the impact of increasing

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for biosimilars could have an adverse effect on future commercial prospects; and the impact of increasing implementation and enforcement of more stringent anti-bribery and anti-corruption legislation. Nothing inthis presentation should be construed as a profit forecast.

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Page 3: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

2Q and Half Year Results2013

P l S i t Chi f E ti OffiPascal Soriot, Chief Executive Officer

3

Page 4: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

2Q highlights

• 2Q revenue down 4% CER: ~ $500m decline from loss of exclusivity

$• Good progression of our growth platforms: $400m (double-digit growth @ CER)

• Growing late-stage pipeline:

− 2 NDA submissions

− 1 Phase 3 start

− 3 late-stage projects added via business development

44

Page 5: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Headline results 2Q 2013

CERgrowth

2013$m

Actualgrowth

2012$m

Revenue 6,232 6,660 -6% -4%

Core Operating Profit 2,056 2,334 -12% -10%

Core EPS $1 20 $1 57 -23% -21%Restructuring ($0.18) ($0.12)Intangible amortisation ($0.27) ($0.13)

$ $

Core EPS $1.20 $1.57 23% 21%

Intangible impairments ($0.10) ($0.01)Legal provisions/other $0.01 ($0.05)

$ $Reported EPS $0.66 $1.26 -48% -44%

55

Page 6: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Revenue impact from loss of exclusivityi d tiis moderating

500

0

Rest ofPortfolio

142 152 128232

0

LOE

th ($

m)

-500 -479

CER

gro

wt

-1000

1065

-1019

C

-1500

3Q 12 4Q 12 1Q 13 2Q 13

-1065

-1388

66

3Q 12 4Q 12 1Q 13 2Q 13

Page 7: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

5 key growth platforms

1. Brilinta

2. Diabetes

3. Emerging Markets

4. Respiratory

5 Japan

7

5. Japan

7

Page 8: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Regional revenue performance 2Q 2013

CER$m

2013$m

CERgrowth

US 2 252 4% (87)

Global Revenue 6,232 -4% (247)

US 2,252 -4% (87)

Europe 1,546 -13% (231)

Ex-Seroquel IR & Toprol-XL: +4%

Seroquel IR, Seroquel XR, Atacand& Nexium LOE

Established ROW 1,059 -6% (83)Japan 657 +10% 72 Nexium, Crestor , & Symbicort

Canada 162 -42% (121)

Other Established ROW 240 -12% (34)

E i M k t 1 375 12% 154

Crestor (70)

Crestor pricing and Seroquel IR

Emerging Markets 1,375 +12% 154China 431 +21% 72

China (+21%); Other Markets (+9%)

88

Page 9: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Good performance in Emerging Markets

14%AZ Emerging Markets Quarterly Sales Growth Rates(% at CER)

12%12%

8%

9%

8%

10%

Other Markets +9%

7%

6%

2%2%

4%

China +21%

Supply chain issues

0%0%

2%

1Q 12 2Q 12 3Q 12 4Q 12 1Q 13 2Q 13

9

1Q 12 2Q 12 3Q 12 4Q 12 1Q 13 2Q 13

9Source: AZ internal data

Page 10: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Brilinta/Brilique

US2Q 2013 Sales: $65m

• US – total TRx’s increased 33% vs.prior quarter

- Gained 9 points of preferred, $m

70

unrestricted access in MedicarePart D plans, now >70%

- Delivering acceleration plan, including 50

60EST ROW$4m

EM$7m

g g200 Transition of Care nurses in field1st July

- Increase in promotional and scientific 30

40EUR$38m

pinvestment in 2013 by greater than 50%

ROW sales $49m

At l i i N b 2 i l10

20

30

- At or closing in on Number 2 in volume share of the OAP market in the UK, Germany & Italy. Steady progressin France2Q 12

US$16m

0

10

2Q 13

10

in France

10

Page 11: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Brilinta US: Steady growth

TRx Actuals

Increasing New to Brand share in OAP market TRx growth +33% 2Q vs 1Q 2013

6,500

7,000

7,500

8,000

2Q TRx: 84 109 +33%4.8%

5.7%

5.0%

6.0%

4,500

5,000

5,500

6,000

1Q TRx: 63,288

2Q TRx: 84,109 +33%

3.5%3.8%4.0%

2,500

3,000

3,500

4,000

2.1%

2.8%

2.0%

3.0%

500

1,000

1,500

2,000

0.1%0.2%

0.9%1.0%

0 0.0%

11

Source: IMS Health NPA WeeklyWeekly data through June 28, 2013TRx estimate for June 2013 used to calculate growth rates

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Page 12: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Brilinta: ROW PerformanceOAP Volume Market Share – All Channels

GermanyOAP Volume Market Share – All Channels

Italy

3.0% BRILINTA prasugrel10.0%e BRILINTA prasugrel

2.2%2.0%

2.0%

3.0%

DO

T) M

arke

t Sha

re

6.8%7.0%

4 0%

6.0%

8.0%

DO

T) M

arke

t Sha

re BRILINTA prasugrel

0.0%

1.0%

OAP

Vol

ume

(D

0.0%

2.0%

4.0%

OAP

Vol

ume

(D

OAP Volume Market Share – All ChannelsFrance

OAP Volume Market Share – All ChannelsUK FranceUK

2.2%

1 %

2.0%

2.5%

ket

Shar

e BRILINTA prasugrel

3.2%

2.5%

3.0%

3.5%

ket S

hare

BRILINTA prasugrel

1.7%

0.5%

1.0%

1.5%

olum

e (D

OT)

Mar

k

1.4%

0.5%

1.0%

1.5%

2.0%Vo

lum

e (D

OT)

Mar

k

1212

0.0%

OAP

V 0.0%

OAP

V

Page 13: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Diabetes Franchise

Onglyza franchise

2Q 2013 Revenue: $200m

$m250 • US revenue: +29%

- DPP4 Market growth: +6% TRx

- Franchise TRx share 16.0% in June; stabilisedSymlin

200 - (-10bps from March) post formulary changes in 1Q

• ROW revenue +23%• SAVOR top line resultsBydureon

Symlin

Forxiga$10m

$32m

$3m

150 Byetta/Bydureon• US revenue: $63 million

- Steady growth for Bydureon TRx but Byetta share

Byetta$53m

$32m

100- Steady growth for Bydureon TRx, but Byetta share

decline continues

• ROW revenue: $22 million

Forxiga50

Forxiga• Revenue $4 million in 1H 13• Good initial launch uptake in Germany, UK

US NDA b itt d PDUFA d t

Onglyza$102m

13

0• US NDA resubmitted; PDUFA date

11 January 2014

Source: IMS HEALTH MDART 13

2Q 12 2Q 13

Page 14: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Onglyza: US franchise market share stabilised

TRx Share NRx Share NBRx Share

24%

Shar

e)

TRx Share NRx Share NBRx Share

20%

22%

eek

Rol

ling

S

18%

Fam

ily (5

we

16.0%15.9%

16.3%

14%

16%

Ong

lyza

14%

18-M

ay25

-May

1-Ju

n8-

Jun

15-J

un22

-Jun

29-J

un6-

Jul

13-J

ul20

-Jul

27-J

ul3-

Aug

10-A

ug17

-Aug

24-A

ug31

-Au g

7-S

ep14

-Sep

21-S

ep28

-Sep

5-O

ct12

-Oct

19-O

ct26

-Oct

2-N

ov9-

Nov

16-N

ov23

-Nov

30-N

ov7-

Dec

14-D

ec21

-Dec

28-D

ec4-

Jan

11-J

an18

-Jan

25-J

an1-

Feb

8-Fe

b15

-Feb

22-F

eb1-

Mar

8-M

ar15

-Mar

22-M

ar29

-Mar

5-A

pr12

-Apr

19-A

pr26

-Apr

3-M

ay10

-May

17-M

a y24

-May

31-M

a y7-

Jun

14-J

un21

-Jun

14Source: IMS APLD (Retail+Mail Order), IMS NPA(Un-equalized)Chart shows Rolling 5 weeks share of DPP4 Market

14

Page 15: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Bydureon/Byetta: US TRx trends

GLP-1 Market TRx70%

50%

60%

70%

30%

40%

50%

20%

30%

0%

10%

Byetta Bydureon Exenatide Victoza

15Source: IMS APLD Monthly Data May‘13. June TRx estimate based on weeklies in June.Please note the Exenatide NBRx share is Exenatide Family NBRx share and eliminates switches between the Exenatide brands

15

Page 16: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Forxiga launch uptake – Germany and UKBrand PDOTs - Launch Uptake, Germany

1,400,0001,600,0001,800,000

400,000600,000800,000

1,000,0001,200,000

0200,000

OForxiga Januvia Onglyza

Brand PDOTs - Launch Uptake, UK250,000

100 000

150,000

200,000

0

50,000

100,000

16Source: IMS MIDAS May 2013, Retail + Hospital

Forxiga Januvia Onglyza

16

Page 17: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Symbicort

USS bi t TR ’ 16% k t 2%

2Q 2013 Sales: $842m +8% CER

• Symbicort TRx’s +16% vs market +2%• TRx share at 24.1% in June 2013, +1.8 pts

since December 2012800

EM

$m

• New patient share 30.7% in June; new high

ROW600

700

800

EST ROW$101m +2%

$78m +19%

• Symbicort sales in ROW were $553m, +4% • Japan still gaining share on Adoair,

reaching 42 3% (May)400

500 EUR$374m +2%

reaching 42.3% (May)- SMART and COPD approvals

200

300

US$289m +16%

0

100 $289m +16%

2Q 12 2Q 13

1717

Page 18: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Symbicort: US market share trend

31% 30 7%

29%

s

NTC Share NRx Share TRx Share30.7%

25%

27%

nthl

y Sh

ares

25.5%

24.1%

21%

23%

BIC

OR

T M

on

17%

19%SYM

B

15%

17%

18Source: TRx and NRx from IMS Monthly NPA DataNTC from IMS Monthly NPA APLD Data 18

Page 19: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Achieve scientific leadership

FOCUS on distinctive science in 3 core TAs1PRIORITISE & ACCELERATE our pipelineAchieve

TRANSFORM our innovation culture & model

scientific leadership

TRANSFORM our innovation culture & model

1919

Page 20: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Recent pipeline news

• Forxiga (dapagliflozin) NDA resubmitted in US; 11 January 2014 PDUFA

• Moxetumomab Phase III startMoxetumomab Phase III start

• Headline results for SAVOR study

• Onglyza met its primary safety objective of non-inferiority and did noth i ffi bj i f i i f i d imeet the primary efficacy objective of superiority for a composite endpoint

(CV death, non-fatal MI, non-fatal ischaemic stroke)

• Presentation at ESC in September

• Metreleptin US NDA accepted; designated for priority review (PDUFA 27 Feb 2014)

• Fostamatinib will not progress to regulatory filings

• Growing portfolio of late stage assets; Omthera and Pearl acquisitions,FibroGen collaboration

2020

Page 21: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Growing late-stage pipeline

AZD5363 moxetumomabMEDI0639Small molecule Large molecule Small molecule Large molecule Small molecule Large molecule

Phase 1 - 25 NMEs Phase 2 - 23 NMEs Phase 3 / Reg - 8 NMEs

selumetinib MEDI-551 LesinuradAZD5363AKT solid tumours

AZD2014TORK solid tumours

moxetumomabCD22, HCL

MEDI0639DLL-4 solid tumours

volitinibMET solid tumours

MEDI-565CEA BiTE GI tumours

MEDI6469mOx40 solid tumours

selumetinibMEK solid tumours

AZD4547FGFR solid tumours

MEDI 551CD19 CLL, DLBCL

tremelimumabCTLA-4 solid tumours

olaparibPARP-BRCA solid tumours

MEDI-573IGF MBC

LesinuradURAT1 gout

brodalumabIL-17R psoriasis

metreleptinlipodystrophy

Epanovahypertriglyceridaemia

PT003LABA/LAMA COPD

MEDI9929

AZD1208PIM haems

AZD9150

MEDI3617ANG-2 solid tumours

MEDI4736PD-L1 solid tumours

AZD5423iSGRM COPD

AZD5069CXCR2 asthma

AZD2115

benralizumabIL-5R asthma / COPD

MEDI8968

mavrilimumabGM-CSFR RA

naloxegolopioid induced constipation

CAZ AVIBLI/cephalosporin SBI

AZD8186PI3 solid tumours

TSLP asthma

MEDI5872B7RP1 SLE

AZD8848TLR7 asthma

STAT3 haems

sifalimumabIFNa SLE

MEDI-546IFNaR SLE

AZD1722NHE3 ESRD/CKD

AZD6765NMDA MDD

MABA COPD IL-1R COPD, HS

AZD9291EGFRm+ solid tumours

Major Mkt Reg - 5 NMEsMEDI-551CD19 MS

MEDI-559 MEDI2070

AZD7594SGRM COPD

AZD7624ip38i COPD

AZD3241MPO Parkinson’s Disease

tralokinumabIL-13 asthma, IPF, UC

MEDI7183α4β7 UC, Crohn’s

AZD5847

AZD5213H3R neuropathic pain

MEDI4893staph alpha toxin SSI

RDEA3170

MEDI6012LCAT, ACS

Brilinta

Q-LAIV FluIntranasal influenza virus

CaprelsaEGFR inhibitor MTC

Small molecule Large molecule

Major Mkt Reg 5 NMEs

CXLBLI/cephalosporin MRSA

PRVV IL-23 Crohn’s

MEDI-550Panflu library

ATM AVIBL/BLI SBI

AZD3293BSECDR Alzheimer’s

oxazolidinone TBURAT1 gout ADP receptor antagonist

ForxigaSGLT2 inhibitor

Zinforoskin infections

21

RIAOncology NeuroscienceCVMD Infection Progressed New BD

Terminated: MEDI-557, AZD1446, AZD3480, MEDI5117, AZD8330, fostamatinib, MEDI-575, MEDI7814, and MEDI4212Pipeline table as of 30th June 2013 21

Page 22: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Business development aligned with priority TAs

CV/Metabolism Respiratory/Inflammation/Autoimmune

OncologyEarly Stage

NGM

enteroendocrine cellsDiabetes/Obesity mRNA mRNA AccurinTM

nanomedicine

3 preclinical projects

ACP-501Reverse cholesterol

transportRDX5791End stage renal disease

& chronic kidney disease

Triple combinationLABA/LAMA/ICS

RDX5791End stage renal disease

& chronic kidney disease

FG-4592End stage renal disease

& chronic kidney disease

E

PearlTriple combinationLABA/LAMA/ICSLABA/LAMA

COPD

22Late Stage

EpanovaHypertriglyceridemia

22

Page 23: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Cambridge Biomedical Campus: A vibrant innovation hub

New UK R&D Centre and

innovation hub

Future site ofGlobal Corporate HeadquartersPapworth Hospital

Addenbrooke’s HospitalThe Rosie Hospital

L b t f

23

Laboratory of Molecular Biology

Cambridge InstituteSchool of Clinical Medicine

23

Page 24: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

2Q and Half Year Results2013

Si L th Chi f Fi i l OffiSimon Lowth, Chief Financial Officer

24

Page 25: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Core margin: 2Q 2013

$mCER

% % salesDelta vsPY CER

Revenue 6,232 -4% -

Core Gross Margin 5,127 -2% 82.3 +110 bpsg , p

Distribution (76) +2% 1.2 -10 bps

Core SG&A (2 173) +6% 34 9 320 bpsCore SG&A (2,173) +6% 34.9 -320 bps

Core Other Income 218 +19% 3.5 +60 bps

Core Pre-R&D Profit 3,096 -6% 49.7 -160 bps

Core R&D (1,040) +1% 16.7 -70 bps

Core Operating Profit 2,056 -10% 33.0 -230 bps

2525

Page 26: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Phase 4 restructuring programme

Total cost $m

1Q 13$m

2Q 13$m$m $m $m

R&D 1,380 291 62

SG&A 790 240 160

COGS 130 12 86

Total 2,300* 543 308

PhasingCosts: ~$1,300m in 2013; balance split broadly evenly between 2014/15; small residual in 2016

Benefits: ~$800m by end 2016, around ½ by end 2014

Phasing

26* Of which cash costs are ~$1,700m26

Page 27: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

1H 2013: Cash flow/distributions

Cash generated from operating activities $3.8 billion (1H 2012 $2.8 billion)• Lower tax and interest payments partially offset the lower operating profit in 2013

(which included higher non-cash costs)

• A lump sum pension contribution drove higher outflows in the prior yearg y

Dividends• First interim dividend: $0.90

- Consistent with Board’s aim to set first interim dividend at approximately1/3 of prior full year dividend (FY 2012: $2.80)

• Committed to progressive dividend policy• Committed to progressive dividend policy

- Board intends to maintain or grow the dividend each year

- Cover target is 2x Core earnings over the investment cycle

- Board recognises cover in any year is likely to vary from the 2x cover targetthrough the investment cycle

2727

Page 28: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

Guidance (Core basis)

Revenue (CER) Mid to High-single digit decline

Core Operating Costs (CER)(R&D + SG&A)

Revised: Now a low to mid single digit increase vs 2012(R&D + SG&A)

g g

Core other income < $600 million (Pending resolution of Pulmicort Respules appeal)

Reported tax rate Around 23 percent

Core EPS (CER) Decline significantly > than revenue declineCore EPS (CER) Decline significantly > than revenue decline

2828

Page 29: 2Q and Half Year Results 2013 - AstraZeneca · Act 1995,,p g g y p we are providing the following cautionary statement: This presentation contains certain forward-lookin g ... implementation

2Q and Half Year Results2013

29