FORM 6-K


SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549


Report of Foreign Issuer


Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934

For July 2009 – 3rd August 2009

Commission File Number:  001-11960

AstraZeneca PLC

15 Stanhope Gate, London W1K 1LN, England


Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F X            Form 40-F  __

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):            

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes  __                 No X

If “Yes” is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b):   82-_____________
 

 
AstraZeneca PLC

INDEX TO EXHIBITS

 
1. Press release entitled, “Transaction by Persons Discharging ManagerialResponsibilities”, dated 1 July 2009.
   
2. Press release entitled, “IRESSA (GEFITINIB) receives marketingauthorisation for the treatment of non-small cell lung cancer in Europe”,dated 1 July 2009.
   
3.
Press release entitled, “AstraZeneca terminates License Agreement with MAP Pharmaceuticals regarding Unit Dose Budesonide “dated 9 July 2009.
   
4.
Press release entitled, “AstraZeneca second quarter and half year results 2009”, dated 29 July 2009.
   
5.
Press release entitled, “AstraZeneca second quarter and half year results 2009 (front half)”, dated 30 July 2009.
   
6.
Press release entitled, “AstraZeneca second quarter and half year results 2009 - Responsibility Statement of the Directors in Respect of the Half-Yearly Financial Report” (back half), dated 30 July 2009.
   
7. Press release entitled, “Transaction by Person Discharging Managerial Responsibilities Disclosure Rules DTR.3.1.4R”, dated 31 July 2009.
   
8.
Press release entitled, “Transparency Directive Voting Rights and Capital”, dated 31 July 2009.
   
9.
Press release entitled, “FDA approves ONGLYZA for the treatment of type 2 diabetes in the US”, dated 3 August 2009.
 


SIGNATURES



Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 

  AstraZeneca PLC  
       
       
Date: 10 August 2009
 By:
/s/ Justin Hoskins
  
  Name:
Justin Hoskins
  
  Title:
Deputy Company Secretary
  
 

Item 1

 
Transaction by Persons Discharging Managerial Responsibilities
Disclosure Rule DTR 3.1.4

We hereby inform you that on 30 June 2009, the interest of Anders Ekblom, a person discharging managerial responsibilities, in AstraZeneca PLC Ordinary Share of $0.25 each has changed as detailed below.

The change in interest relates to an award made in March 2008 under the AstraZeneca Restricted Share Plan, whereby, in accordance with the terms of the award, Mr Ekblom has now become beneficially entitled to 8,306 of the 16,612 shares originally awarded.  After certain mandatory tax deductions, Mr Ekblom has received 3,731 shares into a personal brokerage account.

The market price of AstraZeneca Ordinary Shares on 30 June 2009 was £27.12.

A C N Kemp
Company Secretary
1 July 2009
 
 

Item 2
 

IRESSA (GEFITINIB) RECEIVES MARKETING AUTHORISATION FOR THE TREATMENT OF NON-SMALL CELL LUNG CANCER IN EUROPE

AstraZeneca announced today that the European Commission has granted marketing authorisation for the oral anti-cancer drug, IRESSA for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (epidermal growth factor receptor-tyrosine kinase) across all lines of therapy. The authorisation is based on a submission package including two pivotal Phase III studies comparing IRESSA with chemotherapy, IPASS and INTEREST.

IRESSA acts by inhibiting the tyrosine kinase enzyme in the EGFR, thus blocking the transmission of signals involved in the growth and spread of tumours. A mutation in the EGFR is a characteristic occurring in 10-15% of lung cancers in non-Asians, and studies have shown that these types of tumours are particularly sensitive to IRESSA.

Anders Ekblom, Executive Vice President for Development at AstraZeneca, said: "IRESSA is the first truly targeted treatment for lung cancer, and the EU marketing authorisation today represents an important step forward in the treatment of this devastating disease. For the first time, patients with EGFR mutation positive tumours will have a more effective and better tolerated alternative to chemotherapy as a first-line treatment.”

AstraZeneca will work closely with clinicians and pathology groups on a country-by-country basis to facilitate appropriate access to EGFR mutation diagnostic testing.

AstraZeneca has agreed to conduct a Follow-up Measure Study to generate further data in a Caucasian NSCLC patient population and is currently in discussion with the EMEA to finalise the study design and endpoints.


About IRESSA
In 2005, AstraZeneca withdrew its EU marketing authorisation application for IRESSA following data from the Phase III international ISEL study in pre-treated patients not eligible for further chemotherapy. ISEL did not meet its primary objective of a statistically significant improvement in OS for IRESSA compared to placebo, but did confirm a number of important clinical benefits for IRESSA including tumour shrinkage and a significant improvement in time to treatment failure. The refractory (patients whose tumours had grown during or soon after receiving prior chemotherapy) nature of the ISEL population is the most likely explanation for the magnitude of the survival improvement with IRESSA compared to placebo not reaching statistical significance.

Following delivery of the INTEREST data, AstraZeneca submitted a new regulatory package to the EMEA in May 2008; the IPASS data were added to the submission package when they became available in Q3 2008.

There is a rolling programme of approvals and licence updates for IRESSA around the world in a broad second-line population based on data from the INTEREST study.
 

 
IRESSA is already an established therapy for pre-treated NSCLC in the Asia-Pacific region, where AstraZeneca is in consultation with regulatory authorities to discuss the potential use of IRESSA in first-line therapy.

About the INTEREST and IPASS studies
The INTEREST (IRESSA Non-small-cell lung cancer Trial Evaluating REsponse and Survival against Taxotere) study was a randomised, open-label, parallel-group, Phase III trial evaluating survival with IRESSA versus docetaxel in 1,466 patients with locally advanced or metastatic recurrent NSCLC who had previously received platinum-based chemotherapy. The primary endpoint of INTEREST was OS, with the objective of demonstrating that IRESSA was non-inferior to docetaxel chemotherapy.

IPASS (IRESSA Pan-ASia Study) was an open label, randomised, parallel-group study that assessed the efficacy, safety and tolerability of IRESSA versus carboplatin/paclitaxel as first-line treatment in a clinically selected population of patients from Asia.    The primary endpoint of IPASS was PFS (the length of time a patient lives without their tumour progressing), with the objective of demonstrating that IRESSA was non-inferior to carboplatin/paclitaxel doublet chemotherapy.

The study enrolled 1,217 patients in Asia with advanced NSCLC who had not received prior chemotherapy for advanced disease, whose tumours were of adenocarcinoma histology and who had either never smoked, or were former light smokers (ceased smoking at least 15 years ago and <= 10 pack-years exposure).

About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines.  For more information about AstraZeneca, please visit: www.astrazeneca.com


CONTACTS:

Media Enquiries UK:
    
Chris Sampson
+44 20 7304 5130  (24 hours)
  
Neil McCrae
+44 207 304 5045  (24 hours)
  
Sarah Lindgreen
+44 20 7304 5033  (24 hours)
  
     
Investor Enquiries UK:
    
Jonathan Hunt
+44 207 304 5087
mob: +44 7775 704032
Karl Hard
+44 207 304 5322
mob: +44 7789 654364
     
Investor Enquiries US:
    
Ed Seage
+1 302 886 4065
mob: +1 302 373 1361
Jorgen Winroth
+1 212 579 0506
mob: +1 917 612 4043


1 July 2009

- ENDS -


Item 3

ASTRAZENECA TERMINATES LICENSE AGREEMENT WITH MAP PHARMACEUTICALS REGARDING UNIT DOSE BUDESONIDE

AstraZeneca announced today that it has terminated the license agreement with MAP Pharmaceuticals, Inc., regarding Unit Dose Budesonide (UDB).

UDB, an investigational treatment for paediatric asthma, was the subject of an initial Phase III clinical trial conducted by MAP Pharmaceuticals.  On 23 February 2009, MAP announced that the trial failed to meet its primary endpoints.

In light of the clinical trial results, AstraZeneca exercised its right to terminate the license agreement and expects to record an impairment charge of $44m in the second quarter results.


About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines.  For more information about AstraZeneca, please visit: www.astrazeneca.com

CONTACTS:

Media Enquiries UK:
    
Chris Sampson
+44 20 7304 5130  (24 hours)
  
Neil McCrae
+44 207 304 5045  (24 hours)
  
Sarah Lindgreen
+44 20 7304 5033  (24 hours)
  
 
Media Enquiries US:
    
David Albaugh
+1 302 886 7098
  
Emily Denney   
 
+1 302 885 3451 
  
Investor Enquiries UK:
    
Jonathan Hunt
+44 207 304 5087
mob: +44 7775 704032
Karl Hard
+44 207 304 5322
mob: +44 7789 654364
James Mead
+44 20 7304 5084 
mob: +44 7825 530018
     
Investor Enquiries US:
    
Ed Seage
+1 302 886 4065
mob: +1 302 373 1361
Jorgen Winroth
+1 212 579 0506
mob: +1 917 612 4043

09 July 2009
- ENDS -
 

Item 4


AstraZeneca second quarter and half year results 2009

Tomorrow, Thursday, 30 July 2009 AstraZeneca will be releasing its second quarter and half year results for 2009 at 11:00BST.

An analysts presentation of the second quarter and half year results will take place at 13:00bst and will be accessible by a choice of two routes:

1) Audio webcast (available at http://www.astrazeneca.com/).  You will be able to email questions to the presenters during the Q&A session.

2) Teleconference with Q&A. Dial in numbers:
UK: 0800 077 8491
Sweden: 0200 110 487
International: +44 (0)844 800 0810
US: 1 866 804 8688
Emergency back-up: +44 (0)1296 311 600

Passcode: AstraZeneca Half Year analyst call.

Printable pdf versions of slides will be available to download on the AstraZeneca Investor Relations website (http://www.astrazeneca.com/investors/ ) 15 minutes before the analysts presentation begins.

Details of the teleconference and webcast replay facilities are available on the Investor Relations part of the AstraZeneca website at http://www.astrazeneca.com/.


 
Item 5
 
 
AstraZeneca PLC
SECOND QUARTER AND HALF YEAR RESULTS 2009
London, 30 July 2009

 
Second quarter sales increased by 9 percent at constant exchange rates (CER) to $7,958 million.
 
-Crestor sales increased by 33 percent at CER.  Quarterly sales exceed $1 billion for the first time.
 
-US sales of Toprol-XL, benefiting from withdrawal of generic products, accounted for 3 percent of global sales growth at CER.
 
-Emerging Markets sales increased by 8 percent at CER; on track for double-digit growth for the full year.
 
Core operating profit in the second quarter increased by 37 percent at CER to $3,606 million on sales growth, higher other income and operational efficiencies.
 
Core EPS in the second quarter increased by 37 percent at CER to $1.64.
 
Reported EPS in the second quarter increased by 10 percent at CER to $1.18.
 
-Provisions totalling $430 million have been taken in the second quarter with respect to various federal and state investigations and civil litigation matters relating to drug marketing and pricing practices (see Note 4).
 
Strong cash flows have reduced net debt by $3 billion since 31 December 2008.
 
The Board has recommended a first interim dividend of $0.59, an increase of 7 percent.
 
Continued progress on the pipeline, including three regulatory submissions since the first quarter.
 
-Applications for regulatory approval submitted in the US for Certriad (lipid abnormalities) and Vimovo (pain relief for arthritis); Zactima (lung cancer) submitted in the US and the European Union.
 
-Iressa approved in Europe for lung cancer treatment.
 
-New diabetes treatment ONGLYZATM recommended for approval by European CHMP.
 
Core EPS target for the full year increased to range of $5.70 to $6.00.
 
Financial Summary
 
Group
 
2nd Quarter
2009
$m
2nd Quarter
2008
$m
Actual
%
CER
%
  
Half Year
2009
$m
Half Year
2008
$m
Actual
%
CER
%
    Sales
7,958
7,956
-
+9
  
15,659
15,633
-
+8
Reported
                  
    Operating Profit
2,851
2,473
+15
+19
  
6,014
4,730
+27
+28
    Profit before Tax
2,608
2,279
+14
+18
  
5,611
4,422
+27
+27
    Earnings per Share
$1.18
$1.11
+6
+10
  
$2.66
$2.14
+24
+24
Core*
                  
    Operating Profit
3,606
2,737
+32
+37
  
6,968
5,502
+27
+28
    Profit before Tax
3,363
2,543
+32
+38
  
6,565
5,194
+26
+28
    Earnings per Share
$1.64
$1.25
+31
+37
  
$3.22
$2.53
+27
+28
                   

*
Core financial measures are supplemental non-GAAP measures which management believe enhances understanding of the Company’s performance; it is upon these measures that financial guidance for 2009 is based.  See page 10 for a definition of Core financial measures and pages 10 and 11 for a reconciliation of Core to Reported financial measures.

David Brennan, Chief Executive Officer, said:  “Our business performance, in the context of tough global economic conditions, has been better than we anticipated.  Good operating execution as well as the Toprol-XL benefit has led to a strong first half performance, which is reflected in our increased Core EPS target for the full year.  Continued progress on the pipeline is evidenced by significant regulatory submissions and approvals since our first quarter report.”

 
 
Interim Management Report

Business Highlights All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated
 

Second Quarter

Sales in the second quarter increased by 9 percent at CER, but were flat on an actual basis as a result of the negative impact of exchange rate movements.  Sales benefited from strong growth of the Toprol-XL franchise in the US as a result of the market withdrawal by two generic competitors; adjusting for this, global sales increased by 6 percent.  US sales were up 13 percent (6 percent excluding Toprol-XL).  Group sales in the Rest of World were also up 6 percent.  Sales in Established Markets were up 5 percent.  Emerging Markets sales growth was 8 percent, lower than recent quarters but broadly in line with the Company’s expectations.  Double-digit sales growth in Emerging Markets is anticipated for the full year.

Core operating profit in the second quarter was up 37 percent to $3,606 million.  Approximately 60 percent of the Core operating profit increase was driven by higher sales; the balance from operational efficiencies and higher other income related to proceeds from the disposal of certain Nordic OTC products. Reported operating profit increased by 19 percent to $2,851 million; this growth rate was 18 percentage points lower than the growth in Core operating profit, reflecting provisions totalling $430 million with respect to various federal and state investigations and civil litigation matters relating to drug marketing and pricing practices taken in the second quarter 2009.

Core earnings per share in the second quarter were $1.64 compared with $1.25 in the second quarter 2008, a 37 percent increase at CER and in line with the growth in Core operating profit in the quarter. Reported earnings per share in the second quarter were up 10 percent to $1.18, after charging the legal provisions as well as higher restructuring and synergy costs.

First Half

Sales in the first half increased by 8 percent at CER, but were flat on an actual basis as a result of the negative impact of exchange rate movements.  Sales in the US were up 10 percent (5 percent excluding the impact of Toprol-XL).  Sales in the Rest of World were up 6 percent.  Sales in Established Markets were up 4 percent.  Sales in Emerging Markets increased by 11 percent.

Core operating profit increased by 28 percent to $6,968 million as a result of sales growth, operating efficiencies and higher other income compared with the first half of 2008.  Reported operating profit was $6,014 million, an increase of 28 percent, the same as the growth in Core operating profit, as the negative impact of the legal provisions in the second quarter 2009 was somewhat offset by the Ethyol impairment that was charged in the first quarter 2008.

Core earnings per share for the first half were $3.22, an increase of 28 percent, in line with the growth in Core operating profit.  Reported EPS increased by 24 percent to $2.66, reflecting the effects of the legal provisions and the Ethyol impairment noted above as well as higher restructuring and synergy costs.

Research and Development Update

A comprehensive update of the AstraZeneca R&D pipeline is presented in conjunction with this Half Year 2009 results announcement, and is available on the Company’s website, www.astrazeneca.com, under information for investors.

The AstraZeneca pipeline now includes 142 projects, including 98 projects in the clinical phase of development.  There are 10 NME projects currently in late stage development, either in Phase III or under regulatory review.  Across the portfolio, since the last update on 29 January, 24 projects have successfully progressed to their next phase (including 11 molecules entering first human testing); 14 compounds have been added from Discovery research; 14 compounds have been withdrawn.

Continued progress has been made on the pipeline since the first quarter update, including three new regulatory submissions:



Certriad

On 4 June 2009, AstraZeneca and Abbott announced that the companies have submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for an investigational compound for the treatment of mixed dyslipidaemia, a combination of two or more lipid abnormalities including high LDL-cholesterol (the “bad” cholesterol), high triglycerides and low HDL-cholesterol (the “good” cholesterol). The NDA is for a fixed-dose combination product containing the active ingredients of Crestor (rosuvastatin calcium) and TRILIPIX™ (fenofibric acid).  Pending approval of the NDA, the treatment will be marketed as Certriad.

Vimovo

On 30 June 2009, AstraZeneca announced that its development partner, Pozen, Inc., has submitted an NDA to the US FDA for Vimovo (PN400), a product under investigation for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) in patients who are at risk of developing NSAID-associated gastric ulcers. PN400 is a fixed-dose combination of enteric-coated naproxen and immediate release esomeprazole. The proposed trade name is Vimovo, pending regulatory approval.

Zactima

In June 2009, AstraZeneca submitted regulatory applications in the US and European Union for Zactima, seeking approval for use of a dose of 100mg daily in the second-line treatment of advanced non-small cell lung cancer (NSCLC) in combination with chemotherapy.

Results for the ZEPHYR study, a Phase III trial of 300mg of Zactima used as monotherapy in patients who have failed treatment with an EGFR inhibitor in advanced NSCLC, and the ZETA study (300mg Zactima monotherapy in advanced medullary thyroid cancer) will be presented in the first half of 2010.

Other significant pipeline developments include:

ONGLYZATM

AstraZeneca and Bristol-Myers Squibb Company have announced that their marketing authorisation application for ONGLYZATM (saxagliptin) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of type 2 diabetes in adults as add-on therapy with metformin, a thiazolidinedione or a sulphonylurea.

The CHMP’s positive opinion on ONGLYZATM will now be reviewed by the European Commission which has the authority to approve medicines for the European Union. AstraZeneca and Bristol-Myers Squibb expect the European Commission to issue its decision on a Marketing Authorisation for this type 2 diabetes investigational drug in the European Union in the coming months.

The Prescription Drug User Fee Act (PDUFA) date for the FDA review of the ONGLYZA™ NDA is 30 July 2009.

Iressa

On 1 July 2009, AstraZeneca announced that the European Commission has granted marketing authorisation for the oral anti-cancer drug Iressa for the treatment of adults with locally advanced or metastatic NSCLC with activating mutations of EGFR-TK (epidermal growth factor receptor-tyrosine kinase) across all lines of therapy. The authorisation is based on a submission package including two pivotal Phase III studies comparing Iressa with chemotherapy, IPASS and INTEREST.

Brilinta

On 11 May 2009, AstraZeneca announced top line results from the Phase III trial, PLATO (A Study of Platelet Inhibition and Patient Outcomes), which demonstrate that Brilinta (ticagrelor), the investigational oral antiplatelet treatment for acute coronary syndromes (ACS), has achieved a statistically significant primary efficacy endpoint versus clopidogrel, in the prevention of cardiovascular (CV) events in patients with ACS. The primary efficacy measure was time to first occurrence of any event from the composite of myocardial infarction, stroke, and CV death.

In PLATO, the overall safety profile for Brilinta was in line with the safety data observed in the Phase II studies. Given the size of the PLATO trial, further analysis of the entire database, secondary variables, and subgroups is ongoing. The results of PLATO will be presented at the European Society of Cardiology annual meeting on 30 August 2009.
 
 
 
The submission of Brilinta to regulatory authorities remains on schedule for the fourth quarter of 2009.

Crestor

Regulatory applications to amend the Crestor label to reflect the significant reductions in cardiovascular events demonstrated in the landmark JUPITER clinical trial are now under review by regulatory authorities in the US and in Europe, as the April 2009 submission in the US was followed, as planned, by the submission in Europe during the second quarter 2009.

In July 2009, the US FDA granted an additional six-month period of market exclusivity to Crestor based on studies the Company conducted in paediatric patients.  The allowed six-month paediatric exclusivity period, which takes effect upon expiration of the patent, will extend the exclusivity of Crestor to 8 July 2016.

Symbicort

Based on the Complete Response Letter (CRL) AstraZeneca received in April 2009 from the FDA regarding the Symbicort sNDA for use in paediatric asthma patients 6-11 years of age, additional clinical work will be needed to support the approval of Symbicort in this patient population.
 
This additional clinical work will result in a significant delay of an FDA approval. AstraZeneca is meeting with the FDA to discuss the necessary programme of additional work, and will be able to provide more details after that discussion.

Seroquel XR

In June 2009, the Company submitted a response to the CRL received from the US FDA in December 2008 regarding the sNDA for Seroquel XR for the treatment of Major Depressive Disorder (MDD) in adult patients.  This submission should trigger a six-month review period by the FDA.

On 29 May 2009, AstraZeneca announced that the Company has referred its application for Seroquel XR for the treatment of recurrent depressive episodes in adult patients with Major Depressive Disorder (MDD) to the CHMP.  This follows notification to AstraZeneca by the Netherlands Health Authority (MEB), acting as the Reference Member State for the Mutual Recognition Process (MRP), that the Seroquel XR application for MDD has been refused.

To date, Seroquel XR has been approved for use in MDD in Canada and Australia.

Novel Influenza A (H1N1) Vaccine

MedImmune’s technology and capability is evidenced by the solid progress being made to deliver a live attenuated intranasal vaccine (LAIV) against the Novel Influenza A (H1N1) influenza virus.  To date, MedImmune has successfully produced a master virus seed candidate, using a proprietary and unique process known as reverse genetics, which appears to be growing well.

On 24 July, during a presentation to the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC), MedImmune reported that based on vaccine yields of the first manufactured lots, MedImmune estimates it may be able to produce a total of 200 million doses of bulk vaccine, of which approximately 40 million doses can be filled and finished into nasal sprayers by March 2010.  The number of finished, filled doses is currently limited by the availability of sprayers, however, MedImmune is taking steps to increase the supply of sprayers, as well as working with the US government to define a path for an alternative delivery device.

A robust clinical trial programme will begin shortly for the Novel Influenza A (H1N1) vaccine, with patient enrollment expected to begin in mid-August.  If public health authorities determine the need for emergency use of H1N1 vaccine prior to completion of these clinical studies, MedImmune’s vaccine for the Novel Influenza A (H1N1) virus could be available as early as September.

AZD0837

The programme of work aimed at resolving the previously identified issue concerning the stability of tablets of the investigational oral anticoagulant AZD0837 intended for use in the Phase III clinical trial programme is largely complete, so the project is now deemed to be “Phase III ready”.  We have not, as yet, finalised the scope of the Phase III development programme, but the soonest we could commence Phase III work would be the second half of 2009.  The Company is exploring a number of options, including the consideration of working with an external partner.

 

Enhancing Productivity

Good progress continues on the previously announced business reshaping programmes.  In the second quarter, $190 million in restructuring costs were charged, bringing the total charges in the first half to $262 million.

All programmes remain on track to deliver the expected benefits of $2.1 billion per annum by 2010, with a further $0.4 billion by 2013.

Future Prospects

Business performance in the context of tough global economic conditions has been better than we anticipated.  Good operating execution and some one-off benefits, such as the favourable Toprol-XL impact and delayed generic entry for Casodex in the US, has led to a strong first half performance.  All of these factors, together with the outlook for the remainder of year (including some impact from the Novel Influenza A (H1N1) vaccine, up to the 40 million dose fill and finish capacity), are reflected in our increased financial guidance for the full year.

For the full year, the Company now estimates sales growth will be around mid-single digits at CER, with roughly half the benefit from one-off items.  Core EPS is now anticipated to be in the range of $5.70 to $6.00. This increased Core EPS guidance is due solely to operational performance; there is no impact from currency.

This target takes no account of the likelihood that average exchange rates for the remainder of 2009 may differ materially from the January 2009 average rates upon which our earnings guidance is based.  An estimate of the sales and earnings sensitivity to movements of our major currencies versus the US dollar was provided in conjunction with the Full Year 2008 results announcement, and can be found on the AstraZeneca web site.

It is not anticipated that the nature of the principal risks and uncertainties that affect the business, and which are set out on pages 76-82 of the Annual Report and Form 20-F Information 2008, will change in respect of the second six months of the financial year.

In summary, the principal risks and uncertainties listed in the Annual Report and 20-F Information 2008 are:

Industry/Economic Risks

Expiration of patents or marketing exclusivity, patent litigation and early loss of patents, marketing exclusivity or trademarks, expiration or earlier loss of patents covering competing products, failure to obtain patent protection, impact of fluctuations in exchange rates, debt-funding arrangements, bad debts, adverse impact of a sustained economic downturn, owning and operating a biologics and vaccines business, competition, price controls and price reductions, taxation, substantial product liability claims, performance of new products, environmental/occupational/health and safety liabilities, developing our business in Emerging Markets and product counterfeiting.

Legal/Compliance/Regulatory Risks

Adverse outcome of litigation and/or government investigations and insufficient insurance coverage, difficulties of obtaining and maintaining regulatory approvals for new products and failure to observe continuing regulatory oversight.

Business Execution Risks

Challenges to achieving commercial success of new products, acquisitions and strategic alliances formed as part of our externalisation strategy may be unsuccessful, reliance on third parties for supplies of materials and services, failure to manage a crisis, delay to new product launches, failure of information technology and outsourcing and productivity initiatives.

 
 
Sales

All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated
 
Gastrointestinal
 
Second Quarter
CER %
Half Year
CER %
 
2009
$m
2008
$m
  
2009
$m
2008
$m
  
Nexium
1,246
1,323
+1
2,438
2,561
+2
Losec/Prilosec
245
290
-10
456
542
-12
Total
1,514
1,634
-
2,941
3,144
-

·
In the US, Nexium sales in the second quarter were $724 million, down 4 percent compared with the second quarter last year.  Dispensed retail tablet volume increased by 0.5 percent.  Nexium was the only major PPI brand to grow volume in the quarter.  Average realised selling prices for Nexium were around 3 percent lower.
 
·
Nexium sales in the US in the first half were down 4 percent to $1,429 million.
 
·
Nexium sales in other markets in the second quarter were up 8 percent to $522 million.  Sales in Western Europe were up 6 percent.  There was double-digit sales growth in Canada and in Australia. Sales in Emerging Markets were up 8 percent, including 31 percent growth in China.
 
·
Nexium sales in other markets were up 10 percent in the first half to $1,009 million.
 
·
Prilosec sales in the US were down 75 percent in the second quarter and were down 69 percent in the first half, as a result of the entry of generic competition to the 40mg dosage form in the second half of 2008.
 
·
Sales of Losec in the Rest of World were up 5 percent in the second quarter, on double-digit growth in Japan and China.  Losec sales in the Rest of World were up 1 percent in the first half.
 


Cardiovascular
 
Second Quarter
CER %
Half Year
CER %
 
2009
$m
2008
$m
  
2009
$m
2008
$m
  
Crestor
1,129
916
+33
2,098
1,688
+34
Seloken /Toprol-XL
417
206
+112
705
396
+87
Atacand
356
388
+6
679
734
+6
Plendil
60
70
-7
121
136
-6
Zestril
47
65
-17
94
124
-15
Total
2,148
1,807
+30
3,958
3,378
+27

·
In the US, Crestor sales in the second quarter were up 32 percent to $547 million.  Crestor total prescriptions increased by 25 percent, nearly 4 times the statin market growth and keeping pace with the 26 percent growth for generic simvastatin.  Crestor share of total prescriptions continued to increase, reaching 10.8 percent in June 2009.  Crestor dynamic share (new and switch patients) is now more than 15 percent, second only to simvastatin.
 
·
US sales for Crestor for the first half increased by 33 percent to $1,025 million.
 
·
Crestor sales in the Rest of World were up 35 percent to $582 million in the second quarter.  Crestor volume growth in recent months is 3 to 4 times higher than the statin market growth in both Established and Emerging Markets.  There was strong growth in Western Europe (up 23 percent), Canada (up 32 percent), Japan (up 68 percent) and Australia (up 76 percent).  Sales in Emerging Markets were up 33 percent.
 
·
Crestor sales in the Rest of World were up 34 percent to $1,073 million in the first half.
 
·
US sales of the Toprol-XL product range, which includes sales of the authorised generic, increased by 320 percent in the second quarter to $298 million.  Total prescriptions for the franchise more than doubled.  Pipeline filling of the authorised generic product following a return to full supply and price changes accounted for the balance of the sales growth.  The two generic competitor products remain off the US market, and it remains difficult to ascertain when or if these products will return to the market or when potential new entrants may be approved.
 
·
Toprol-XL franchise sales in the US in the first half were up 251 percent to $474 million.
 
 
 
·
Sales of Seloken in other markets were up 2 percent in both the second quarter and the first half.
 
·
US sales for Atacand were down 4 percent in the second quarter and 3 percent in the first half.  Atacand sales in Rest of World were up 9 percent in the second quarter and 8 percent for the year to date.


Respiratory and Inflammation

 
Second Quarter
CER %
Half Year
CER %
 
2009
$m
2008
$m
  
2009
$m
2008
$m
  
Symbicort
551
518
+24
1,066
989
+24
Pulmicort
311
383
-14
603
794
-20
Rhinocort
72
92
-15
136
172
-15
Oxis
16
21
-5
28
38
-8
Accolate
16
19
-16
32
37
-11
Total
997
1,078
+4
1,932
2,118
+2

·
Symbicort sales in the US were $111 million in the second quarter, a 95 percent increase over last year.  Growth is being fuelled by continued penetration of the asthma market as well as the contribution from the launch of the COPD indication.  Symbicort share of new prescriptions for fixed combination products increased to 13.9 percent in June 2009, up more than a full percentage point in the quarter; market share of patients new to combination therapy is now 22.9 percent.
 
·
US sales of Symbicort in the first half were $210 million, an increase of 108 percent.
 
·
Symbicort sales in other markets in the second quarter were $440 million, 15 percent ahead of the second quarter last year, with sales growth being fuelled by Symbicort SMART, which has now been approved in 96 markets.  Sales in Western Europe were up 15 percent.  Emerging Markets sales were up 19 percent in the quarter.
 
·
Symbicort sales in the Rest of World in the first half were up 14 percent to $856 million.
 
·
US sales for Pulmicort in the second quarter were down 23 percent to $194 million.  The generic budesonide for inhalation suspension (BIS) product shipped by Teva at the end of 2008 continues to be drawn down in the market.  Pulmicort Respules share of dispensed BIS prescriptions increased to 62 percent in the second quarter, up from 48 percent in quarter one. We anticipate that the remaining stock of the Teva generic should be depleted from dispensing outlets during the third quarter 2009.
 
·
US sales of Pulmicort in the first half were down 30 percent to $367 million.
 
·
Sales of Pulmicort in the Rest of World in the first half were unchanged at $236 million.


Oncology
 
Second Quarter
CER %
Half Year
CER %
 
2009
$m
2008
$m
  
2009
$m
2008
$m
  
Arimidex
483
490
+7
946
920
+10
Casodex
245
358
-29
481
674
-28
Zoladex
272
310
-1
504
565
-1
Iressa
75
67
+10
143
125
+10
Faslodex
64
65
+9
123
121
+12
Nolvadex
22
24
-4
42
42
-
Ethyol
5
6
-17
9
20
-55
Total
1,167
1,338
-6
2,250
2,503
-5


·
In the US, sales of Arimidex were up 11 percent in the second quarter to $224 million.  Total prescriptions for Arimidex were down 4 percent, slightly greater than the 2 percent decline in the market for hormonal treatments for breast cancer.
 
·
US sales for Arimidex in the first half were up 15 percent to $443 million.
 
·
Arimidex sales in other markets were up 3 percent in the second quarter and 7 percent in the first half.
 
 
 
·
Casodex sales in the US in the second quarter were down 21 percent to $62 million.  Total prescriptions declined by 6 percent and there was some destocking in anticipation of generic launches following loss of exclusivity in April.  On 7 July 2009, the FDA approved 8 generic bicalutamide products.  Casodex sales in the US in the first half were down 19 percent to $116 million.
 
·
Casodex sales in the Rest of World in the second quarter were down 31 percent to $183 million as a result of generic competition in Western Europe, where sales were down 60 percent.  Sales in the first half in Rest of World were down 30 percent to $365 million.
 
·
Iressa sales increased by 10 percent to $143 million in the first half, with the sales performance in Japan (up 14 percent) and China (up 36 percent) accounting for the increase.
 
·
Faslodex sales in the first half increased by 6 percent in the US and grew by 16 percent in the Rest of World.


Neuroscience
 
Second Quarter
CER %
Half Year
CER %
 
2009
$m
2008
$m
  
2009
$m
2008
$m
  
Seroquel
1,249
1,112
+18
2,374
2,162
+15
Zomig
107
114
+3
208
221
+2
Total
1,591
1,488
+14
3,023
2,866
+12

·
In the US, Seroquel sales were up 22 percent to $893 million in the second quarter.  Total prescriptions for the Seroquel franchise increased by 3.5 percent in the second quarter, with all of the growth attributable to the Seroquel XR formulation.  Market share for the Seroquel franchise was a market-leading 31.2 percent in June 2009 (down 30 basis points in the quarter), of which 2.3 percentage points were for Seroquel XR, which was up 80 basis points.
 
·
US sales for Seroquel in the first half were $1,693 million, 18 percent ahead of last year.
 
·
Seroquel sales in the Rest of World were $356 million in the second quarter, an 11 percent increase despite the 70 percent decline in Canada due to generic competition.  Sales in Western Europe were up 22 percent.  Sales in Emerging Markets were up 28 percent.
 
·
For the first half, Seroquel sales in the Rest of World increased by 9 percent to $681 million.



Infection and Other
 
Second Quarter
CER %
Half Year
CER %
 
2009
$m
2008
$m
  
2009
$m
2008
$m
  
Synagis
54
81
-33
599
600
-
Merrem
213
226
+9
415
439
+8
FluMist
-
-
-
2
-
n/m
Total
302
365
-7
1,094
1,152
+1


·
In the US, sales of Synagis in the first half were up 3 percent to $502 million, the majority of which were recorded during the RSV season in the first quarter.  Outside the US, Synagis sales were down 13 percent to $97 million.
 
·
In line with the usual seasonality, there were no sales of FluMist recorded in the second quarter.
 
·
The US government has placed 2 orders totalling $151 million for MedImmune’s LAIV against Novel Influenza A (H1N1) which are scheduled for shipment beginning in the second half of 2009.  This project has been funded in whole or in part with Federal funds from HHS/ASPR/BARDA, under Contract No. HHS01002009000021.


 
Geographic Sales
 
Second Quarter
CER %
Half Year
CER %
 
2009
$m
2008
$m
  
2009
$m
2008
$m
  
North America
3,843
3,463
+13
7,734
7,186
+9
  US
3,548
3,126
+13
7,172
6,527
+10
Established ROW*
3,051
3,340
+5
5,885
6,313
+4
Emerging ROW
1,064
1,153
+8
2,040
2,134
+11

*
Established ROW comprises Western Europe (including France, UK, Germany, Italy, Sweden, and others), Japan, Australia and New Zealand.

· 
In the US, sales were up 13 percent in the second quarter.  Excluding Toprol-XL, sales increased by 6 percent.  Seroquel, Crestor and Symbicort were the key drivers of sales growth in the quarter, more than offsetting the declines in Prilosec, Nexium and Pulmicort Respules.
 
· 
Sales in the Established Rest of World segment were up 5 percent in the second quarter.  Sales in Western Europe were up 2 percent, as growth for Crestor, Symbicort and Seroquel more than offset generic erosion on Casodex.  Sales in Japan were up 11 percent, chiefly on sales growth for Crestor, the Oncology franchise and Losec.  Crestor accounted for more than two-thirds of the 17 percent sales increase in Australia.
 
· 
Sales in Emerging Markets were up 8 percent in the second quarter.  This is lower than the trend in recent quarters but is broadly in line with our expectations, although sales in Mexico were impacted by H1N1 influenza as well as a change in local distribution.  Sales in China were up 25 percent in the quarter.  The Company anticipates double-digit sales growth in Emerging Markets for the full year.
 
 
 
Operating and Financial Review

All narrative in this section refers to growth rates at constant exchange rates (CER) and on a Core basis unless otherwise indicated.  These measures, which are presented in addition to our Reported financial information, are non-GAAP measures which management believe useful to enhance understanding of the Group’s underlying financial performance of our ongoing businesses and the key business drivers thereto.  The Core financial measure is adjusted to exclude certain items, such as charges and provisions related to restructuring and synergy programmes, amortisation and the impairment of the significant intangibles arising from corporate acquisitions and those related to our current and future exit arrangements with Merck in the US, and other specified items.  More detail on the nature of each of these adjustments is given in our Annual Report and Form 20-F Information 2008.  During the second quarter, the Group enhanced its methodology for calculating growth rates in constant currency terms.  The constant exchange growth rates (CER) disclosed for the second quarter and the first half have been calculated using the updated methodology.
 
Second Quarter

All financial figures, except earnings per share, are in $ millions.  Weighted average shares in millions.

 
 
Reported
2009
Restructuring
and Synergy Costs
Merck &
MedImmune
Amortisation
Intangible
Impairments
Legal
Provisions
 
Core
2009
 
Core
2008
 
Actual
%
 
CER
%
Sales
7,958 
- 
- 
-
-
7,958 
7,956 
- 
9 
Cost of Sales
(1,464)
84 
- 
-
-
(1,380)
(1,431)
    
Gross Profit
6,494 
84 
- 
-
-
6,578 
6,525 
1 
10 
% sales
81.6%
        
82.7%
82.0% 
+0.7 
+0.7 
Distribution
(70)
- 
- 
-
-
(70)
(75)
(8)
11 
% sales
0.9%
        
0.9%
0.9% 
- 
-0.1 
R&D
(1,059)
24 
- 
-
-
(1,035)
(1,265)
(18)
(3)
% sales
13.3%
        
13.0%
15.9% 
+2.9 
+1.8 
SG&A
(2,828)
82 
100 
-
430
(2,216)
(2,656)
(17)
(8)
% sales
35.5%
        
27.9%
33.4% 
+5.5 
+5.0 
Other Income
314 
- 
35 
-
-
349 
208 
68 
70 
% sales
3.9%
        
4.4%
2.6% 
+1.8 
+1.5 
Operating Profit
2,851 
190 
135 
-
430
3,606 
2,737 
32 
37 
% sales
35.8%
        
45.3%
34.4% 
+10.9 
+8.9 
Net Finance Expense
(243)
- 
- 
-
-
(243)
(194)
    
Profit before Tax
2,608 
190 
135 
-
430
3,363 
2,543 
32 
38 
Taxation
(891)
(61)
(37)
-
-
(989)
(719)
    
Profit after Tax
1,717 
129 
98 
-
430
2,374 
1,824 
30 
36 
Minority Interests
(10)
- 
- 
-
-
(10)
(8)
    
Net Profit
1,707 
129 
98 
-
430
2,364 
1,816 
30 
36 
Weighted Average Shares
1,448 
1,448 
1,448 
1,448
1,448
1,448 
1,456 
    
Earnings per Share
1.18 
0.10 
0.06 
-
0.30
1.64 
1.25 
31 
37 

Sales were unchanged on an actual basis but grew by 9 percent at constant currency.

Core gross margin of 82.7 percent in the second quarter was 0.7 percentage points higher than last year.  Lower payments to Merck (0.4 percentage points) and continued efficiency gains and mix factors (1.4 percentage points) were partially offset by higher royalty payments (1.1 percentage points).

Core R&D expenditure was $1,035 million in the second quarter, 3 percent lower than last year, as increased investment in biologics and the MAP intangible write off of $44 million were more than offset by continued R&D productivity initiatives and lower costs associated with Crestor JUPITER and Brilinta PLATO trials compared with last year.

Core SG&A costs of $2,216 million were 8 percent lower than the second quarter of 2008, as continued investment in Emerging Markets was more than offset by the operational efficiencies across the US and Established Markets and a reduction in certain legal expenses from last year.

Core other income of $349 million was $141 million higher than the second quarter of 2008, chiefly as a result of the Nordic over-the-counter (OTC) product portfolio disposal.

Core operating profit was $3,606 million, an increase of 37 percent at CER, up 32 percent on an actual basis. In comparison with last year against the dollar, the euro was 13 percent weaker (reducing sales and costs), the Swedish krona was 24 percent weaker (reducing costs) and sterling was 22 percent weaker (reducing costs). Core operating margin increased by 8.9 percent to 45.3 percent of sales, as a result of sales growth, efficiencies in gross margin, SG&A and R&D as well as the Nordic OTC disposal within other income.
 

 
Core earnings per share in the second quarter were $1.64, up 37 percent, as the increase in Core operating profit was partially offset by a higher tax rate and higher net finance expense. Core earnings per share on an actual basis, including an adverse currency impact of 6 percent, increased by 31 percent.

Reported operating profit was up 19 percent to $2,851 million. Reported earnings per share were $1.18.


First Half

All financial figures in table, except earnings per share, are in $ millions.  Weighted average shares in millions.

 
 
Reported
2009
Restructuring
and Synergy Costs
Merck &
MedImmune
Amortisation
Intangible
Impairments
Legal
Provisions
 
Core
2009
 
Core
2008
 
Actual
%
 
CER
%
Sales
15,659 
- 
- 
-
-
15,659 
15,633 
- 
8 
Cost of Sales
(2,847)
115 
- 
-
-
(2,732)
(2,901)
    
Gross Profit
12,812 
115 
- 
-
-
12,927 
12,732 
2 
9 
% sales
81.8%
        
82.6%
81.5% 
+1.1 
+0.8 
Distribution
(134)
- 
- 
-
-
(134)
(141)
(5)
13 
% sales
0.9%
        
0.9%
0.9% 
- 
-0.1 
R&D
(2,039)
24 
- 
-
-
(2,015)
(2,447)
(18)
(2)
% sales
13.0%
        
12.9%
15.7% 
+2.8 
+1.4 
SG&A
(5,204)
123 
199 
-
430
(4,452)
(5,001)
(11)
(2)
% sales
33.2%
        
28.4%
32.0% 
+3.6 
+2.9 
Other Income
579 
- 
63 
-
-
642 
359 
79 
87 
% sales
3.7%
        
4.1%
2.3% 
+1.8 
+1.7 
Operating Profit
6,014 
262 
262 
-
430
6,968 
5,502 
27 
28 
% sales
38.4%
        
44.5%
35.2% 
+9.3 
+6.7 
Net Finance Expense
(403)
- 
- 
-
-
(403)
(308)
    
Profit before Tax
5,611 
262 
262 
-
430
6,565 
5,194 
26 
28 
Taxation
(1,750)
(82)
(67)
-
-
(1,899)
(1,501)
    
Profit after Tax
3,861 
180 
195 
-
430
4,666 
3,693 
26 
28 
Minority Interests
(8)
- 
- 
-
-
(8)
(10)
    
Net Profit
3,853 
180 
195 
-
430
4,658 
3,683 
26 
28 
Weighted Average Shares
1,447 
1,447 
1,447 
1,447
1,447
1,447 
1,456 
    
Earnings per Share
2.66 
0.13 
0.13 
-
0.30
3.22 
2.53 
27 
28 

Sales were unchanged on a reported basis but grew by 8 percent at constant currency.

Core gross margin of 82.6 percent in the first half was 0.8 percentage points higher than last year. Lower payments to Merck (0.6 percentage points) and continued efficiency gains and mix factors (1.2 percentage points) were partially offset by higher royalty payments (1.0 percentage points).

Core R&D expenditure was $2,015 million in the first half, 2 percent lower than last year due to similar drivers as described in the second quarter.

Core SG&A costs of $4,452 million were 2 percent lower than the first half of 2008, where continued investment in Emerging Markets was more than offset by the operational efficiencies across the US and Established Markets.

Core other income of $642 million was $283 million higher than the first half of 2008, chiefly as a result of the Abraxaneâ and Nordic OTC disposals.

Core operating profit was $6,968 million, an increase of 28 percent at CER, up 27 percent on an actual basis. Core operating margin increased by 6.7 percent to 44.5 percent of sales, as a result of sales growth, efficiencies in gross margin, SG&A and R&D as well as the disposals within other income.

Core earnings per share in the first half were $3.22, up 28 percent, as the increase in Core operating profit and a lower number of shares in issue were partially offset by higher net finance expense. Core earnings per share on an actual basis, including an adverse currency impact of 1 percent, increased by 27 percent.

Reported operating profit was up 28 percent to $6,014 million. Reported earnings per share were $2.66.
 

 
Finance Income and Expense

Net finance expense was $403 million for the first half ($243 million for the quarter), versus $308 million ($194 million for the quarter) in 2008. The key drivers were the continued reversal of the fair value gain as described below, reduced interest received due to lower interest rates, a higher net interest expense on pension obligations, partially offset by reduced interest payable on lower debt balances.

Net finance expense included a net fair value loss of $79 million for the quarter ($36 million loss in Q2 2008) and $100 million for the first half ($8 million gain in H1 2008) as credit spreads have reduced since the year end.  As outlined in the full year 2008 results, a net fair value gain of $130 million was recorded in 2008 mainly relating to two long-term bonds. These bonds are swapped to floating interest rates and accounted for using the fair value option under IFRS. Under this accounting treatment both the bonds and the related interest rate swaps are measured at fair value, with changes in fair value reported in the income statement. The fair value of each instrument reflects changes in market interest rates, which broadly offset, but the fair value of these bonds also reflects changes in credit spreads.  If credit spreads continue to reduce, the 2008 gain will reverse further in 2009.

Taxation

The effective tax rate for the second quarter is 34.2 percent (2008 28.6 percent) and 31.2 percent for the first half (2008 29.1 percent). Excluding the impact of the $430 million legal provisions in the second quarter, the effective tax rate for the second quarter would be 29.3 percent, and 29.0 percent for the first half.  For the full year, the tax rate, excluding the impact of the $430 million legal provisions, is currently anticipated to be around 29.5 percent.

Cash Flow

Cash generated from operating activities was $5,334 million in the six months to 30 June 2009, compared with $4,292 million in the corresponding six month period in 2008.  The improvement of $1,042 million is primarily driven by the increase in cash generated from operations of $1,224 million, reflecting the strong underlying performance and improved working capital management, partially offset by higher tax payments of $186 million.

Net cash outflows from investing activities were $162 million in the six months compared with $3,199 million in the corresponding period in 2008. The movement of $3,037 million is due primarily to the payment of $2,630 million to Merck in 2008 as part of the partial retirement, and the proceeds from the disposal of the Abraxane® co-promotion rights of $269 million received in H1 2009.

Cash distributions to shareholders were $2,103 million through payment of the second interim dividend from 2008.

Debt and Capital Structure

As at 30 June 2009, outstanding gross debt (including loans, short-term borrowings and overdrafts) was $11,661 million (31 December 2008: $11,848 million).  Of this debt, $1,498 million is due within one year (31 December 2008: $993 million), which we currently anticipate repaying from current cash balances of $7,195 million, without the need to refinance.  Strong business cash flows have reduced net debt by $3,008 million since 31 December 2008 to $4,166 million.

Dividends and Share Repurchases

The Board has recommended a first interim dividend for 2009 of $0.59 per share (36.0 pence, 4.41 SEK), an increase of 7 percent, to be paid on 14 September 2009.

As announced in 2008, the Group’s share repurchase programme has been suspended.  As a result, during the first six months, no shares were re-purchased. In the half year, 0.6 million shares were issued in consideration of share option exercises for a total of $19 million.

The total number of shares in issue at 30 June 2009 was 1,448 million.

Related Party Transactions

There have been no significant related party transactions in the period.


 
Calendar

29 October 2009
Announcement of third quarter and nine months 2009 results
28 January 2010
Announcement of fourth quarter and full year 2009 results

David Brennan
Chief Executive Officer

 


Media Enquiries:
Neil McCrae (London)
(020) 7304 5045
 
Chris Sampson/Sarah Lindgreen (London)
(020) 7304 5130/5033
 
Tony Jewell (Wilmington)
(302) 885 4594
 
Ann-Leena Mikiver (Södertälje)
(8) 553 260 20
     
Analyst/Investor Enquiries
Karl Hård (London)
(020) 7304 5322
 
Jonathan Hunt (London)
(020) 7304 5087
 
Ed Seage/Jörgen Winroth (US)
(302) 886 4065/(212) 579 0506
     


 
Item 6
 
Responsibility Statement of the Directors in Respect of the Half-Yearly Financial Report
 
We confirm that to the best of our knowledge:
 
●     the condensed set of financial statements has been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the European Union;
 
● the half-yearly management report includes a fair review of the information required by:
 
 
(a)
DTR 4.2.7R of the Disclosure and Transparency Rules, being an indication of important events that have occurred during the first six months of the financial year and their impact on the condensed set of financial statements; and a description of the principal risks and uncertainties for the remaining six months of the year; and
 
 
(b)
DTR 4.2.8R of the Disclosure and Transparency Rules, being related party transactions that have taken place in the first six months of the current financial year and that have materially affected the financial position or performance of the entity during that period; and any changes in the related party transactions described in the last annual report that could do so.
 
The Board
 
The Board of Directors that served during all or part of the six-month period to 30 June 2009 and their respective responsibilities can be found on pages 84 and 85 of the AstraZeneca Annual Report and Form 20-F Information 2008.  John Patterson retired from the Board on 31 March 2009. Håkan Mogren retired from the Board on 30 April 2009.
 

Approved by the Board and signed on its behalf by
David Brennan
Chief Executive Officer
30 July 2009
 

 
Independent Review Report To AstraZeneca PLC
 
Introduction
 
We have been engaged by the Company to review the condensed set of financial statements in the half-yearly financial report for the six months ended 30 June 2009 (but not for the quarter ended 30 June 2009) which comprises condensed consolidated statement of comprehensive income, condensed consolidated statement of financial position, condensed consolidated statement of cash flows, condensed consolidated statement of changes in equity and Notes 1 to 4, 5 and 7. We have read the other information contained in the half-yearly financial report and considered whether it contains any apparent misstatements or material inconsistencies with the information in the condensed set of financial statements.

This report is made solely to the Company in accordance with the terms of our engagement to assist the Company in meeting the requirements of the Disclosure and Transparency Rules ("the DTR") of the UK's Financial Services Authority ("the UK FSA"). Our review has been undertaken so that we might state to the Company those matters we are required to state to it in this report and for no other purpose. To the fullest extent permitted by law, we do not accept or assume responsibility to anyone other than the Company for our review work, for this report, or for the conclusions we have reached.

Directors' responsibilities

The half-yearly financial report is the responsibility of, and has been approved by, the Directors. The Directors are responsible for preparing the half-yearly financial report in accordance with the DTR of the UK FSA.

As disclosed in Note 1, the annual financial statements of the group are prepared in accordance with International Financial Reporting Standards (“IFRSs”) as adopted by the European Union (“EU”). The condensed set of financial statements included in this half-yearly financial report has been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the EU.

Our responsibility

Our responsibility is to express to the Company a conclusion on the condensed set of financial statements in the half-yearly financial report based on our review.

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 UK. 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 set of financial statements in the half-yearly financial report for the six months ended 30 June 2009 is not prepared, in all material respects, in accordance with IAS 34 as adopted by the EU and the DTR of the UK FSA.




Jimmy Daboo

For and on behalf of KPMG Audit Plc

Chartered Accountants

8 Salisbury Square
London EC4Y 8BB
 
30 July 2009
 
 
 
Condensed Consolidated Statement of Comprehensive Income
 

For the six months ended 30 June
    
2009
$m
      
2008
$m
  
Revenue
     15,659       15,633  
Cost of sales
     (2,847 )     (2,957 )
Gross profit
     12,812       12,676  
Distribution costs
     (134 )     (141 )
Research and development
     (2,039 )     (2,533 )
Selling, general and administrative costs*
     (5,204 )     (5,571 )
Other operating income and expense
     579       299  
Operating profit
     6,014       4,730  
Finance income
     207       402  
Finance expense
     (610 )     (710 )
Profit before tax
     5,611       4,422  
Taxation
     (1,750 )     (1,289 )
Profit for the period
     3,861       3,133  
Other comprehensive income:
                
Foreign exchange arising on consolidation
     230       254  
Foreign exchange differences on borrowings forming net investment hedges
     (75 )     (162 )
Net available for sale losses taken to equity
     (3 )     (4 )
Actuarial loss for the period
     (115 )     (37 )
Income tax relating to components of other comprehensive income
     52       80  
Other comprehensive income for the period, net of tax
     89       131  
Total comprehensive income for the period
     3,950       3,264  
                 
Profit attributable to:
                
Owners of the parent
     3,853       3,123  
Non-controlling interests
     8       10  
      3,861       3,133  
                 
Total comprehensive income attributable to:
                
Owners of the parent
     3,948       3,249  
Non-controlling interests
     2       15  
      3,950       3,264  
                 
Basic earnings per $0.25 Ordinary Share
     $2.66       $2.14  
Diluted earnings per $0.25 Ordinary Share
     $2.66       $2.14  
Weighted average number of Ordinary Shares in issue (millions)
     1,447       1,456  
Diluted average number of Ordinary Shares in issue (millions)
     1,448       1,457  
 
* 2009 includes provisions totalling $430 million with respect to various federal and state investigations and civil litigation matters relating to drug marketing and pricing practices (see Note 4).
 
 
 
Condensed Consolidated Statement of Comprehensive Income
 

For the quarter ended 30 June
    
2009
$m
      
2008
$m
  
Revenue
     7,958       7,956  
Cost of sales
     (1,464 )     (1,455 )
Gross profit
     6,494       6,501  
Distribution costs
     (70 )     (75 )
Research and development
     (1,059 )     (1,297 )
Selling, general and administrative costs*
     (2,828 )     (2,834 )
Other operating income and expense
     314       178  
Operating profit
     2,851       2,473  
Finance income
     94       144  
Finance expense
     (337 )     (338 )
Profit before tax
     2,608       2,279  
Taxation
     (891 )     (651 )
Profit for the period
     1,717       1,628  
Other comprehensive income:
                
Foreign exchange arising on consolidation
     468       (26 )
Foreign exchange differences on borrowings forming net investment hedges
     (211 )     (2 )
Net available for sale gains taken to equity
     8       10  
Actuarial gain/(loss) for the period
     455       (327 )
Income tax relating to components of other comprehensive income
     (73 )     106  
Other comprehensive income for the period, net of tax
     647       (239 )
Total comprehensive income for the period
     2,364       1,389  
                 
Profit attributable to:
                
Owners of the parent
     1,707       1,620  
Non-controlling interests
     10       8  
      1,717       1,628  
                 
Total comprehensive income attributable to:
                
Owners of the parent
     2,360       1,384  
Non-controlling interests
     4       5  
      2,364       1,389  
                 
Basic earnings per $0.25 Ordinary Share
   $ 1.18     $ 1.11  
Diluted earnings per $0.25 Ordinary Share
   $ 1.18     $ 1.11  
Weighted average number of Ordinary Shares in issue (millions)
     1,448       1,456  
Diluted average number of Ordinary Shares in issue (millions)
     1,448       1,457  
 
* 2009 includes provisions totalling $430 million with respect to various federal and state investigations and civil litigation matters relating to drug marketing and pricing practices (see Note 4).
 
 
 
Condensed Consolidated Statement of Financial Position
 
   
As at 30 Jun
2009
$m
    
As at 31 Dec
2008
$m
    
As at 30 Jun
2008
$m
  
ASSETS
Non-current assets
                  
Property, plant and equipment
     7,262       7,043       8,479  
Goodwill
     9,887       9,874       9,903  
Intangible assets
     12,098       12,323       13,638  
Derivative financial instruments
     285       449       116  
Other investments
     171       156       199  
Deferred tax assets
     1,371       1,236       1,391  
      31,074       31,081       33,726  
Current assets
                        
Inventories
     1,866       1,636       2,269  
Trade and other receivables
     7,361       7,261       7,335  
Derivative financial instruments
     38       -       11  
Other investments
     42       105       47  
Income tax receivable
     2,624       2,581       2,474  
Cash and cash equivalents
     7,195       4,286       4,340  
      19,126       15,869       16,476  
Total assets
     50,200       46,950       50,202  
LIABILITIES
Current liabilities
                        
Interest bearing loans and borrowings
     (1,498 )     (993 )     (3,841 )
Trade and other payables
     (7,366 )     (7,178 )     (7,409 )
Derivative financial instruments
     (65 )     (95 )     -  
Provisions
     (957 )     (600 )     (484 )
Income tax payable
     (5,257 )     (4,549 )     (4,257 )
      (15,143 )     (13,415 )     (15,991 )
Non-current liabilities
                        
Interest bearing loans and borrowings
     (10,163 )     (10,855 )     (11,032 )
Derivative financial instruments
     -       (71 )     -  
Deferred tax liabilities
     (3,170 )     (3,126 )     (4,172 )
Retirement benefit obligations
     (3,103 )     (2,732 )     (2,117 )
Provisions
     (520 )     (542 )     (579 )
Other payables
     (159 )     (149 )     (216 )
      (17,115 )     (17,475 )     (18,116 )
Total liabilities
     (32,258 )     (30,890 )     (34,107 )
Net assets
     17,942       16,060       16,095  
EQUITY
                        
Capital and reserves attributable to equity holders of the Company
                        
Share capital
     362       362       363  
Share premium account
     2,065       2,046       1,923  
Other reserves
     1,932       1,932       1,887  
Retained earnings
     13,437       11,572       11,801  
      17,796       15,912       15,974  
Non-controlling interests
     146       148       121  
Total equity
     17,942       16,060       16,095  
 
 
 
Condensed Consolidated Statement of Cash Flows
 

For the six months ended 30 June
    
2009
$m
      
2008
$m
  
Cash flows from operating activities
                
Profit before taxation
     5,611       4,422  
Finance income and expense
     403       308  
Depreciation, amortisation and impairment
     849       1,163  
Decrease/(increase) in working capital
     258       (445 )
Other non-cash movements
     (173 )     276  
Cash generated from operations
     6,948       5,724  
Interest paid
     (320 )     (324 )
Tax paid
     (1,294 )     (1,108 )
Net cash inflow from operating activities
     5,334       4,292  
Cash flows from investing activities
                
Movement in short term investments and fixed deposits
     68       2  
Purchase of property, plant and equipment
     (404 )     (504 )
Disposal of property, plant and equipment
     37       22  
Purchase of intangible assets
     (140 )     (2,741 )
Disposal of intangible assets
     269       -  
Purchase of non-current asset investments
     (19 )     (32 )
Disposal of non-current asset investments
     1       -  
Interest received
     36       91  
Dividends paid by subsidiaries to minority interest
     (10 )     (37 )
Net cash outflow from investing activities
     (162 )     (3,199 )
Net cash inflow before financing activities
     5,172       1,093  
Cash flows from financing activities
                
Proceeds from issue of share capital
     19       35  
Repurchase of shares
     -       (208 )
Dividends paid
     (2,103 )     (2,007 )
Movement in short term borrowings
     (139 )     (374 )
Net cash outflow from financing activities
     (2,223 )     (2,554 )
Net increase/(decrease) in cash and cash equivalents in the period
     2,949       (1,461 )
Cash and cash equivalents at the beginning of the period
     4,123       5,727  
Exchange rate effects
     20       1  
Cash and cash equivalents at the end of the period
     7,092       4,267  
Cash and cash equivalents consists of:
                
Cash and cash equivalents
     7,195       4,340  
Overdrafts
     (103 )     (73 )
      7,092       4,267  
 
 
 
Condensed Consolidated Statement of Changes in Equity
 

   
Share
capital
$m
    
Share
premium
account
$m
    
Other*
reserves
$m
    
Retained
earnings
$m
    
Total
$m
    
Non-
controlling
interests
$m
    
Total
equity
$m
  
At 1 January 2008
     364       1,888       1,902       10,624       14,778       137       14,915  
Profit for the period
     -       -       -       3,123       3,123       10       3,133  
Other comprehensive income
     -       -       -       126       126       5       131  
Transfer to other reserve
     -       -       (16 )     16       -       -       -  
Transactions with owners:
                                                        
Dividends
     -       -       -       (1,967 )     (1,967 )     -       (1,967 )
Issue/(repurchase) of AstraZeneca PLC Ordinary shares
     (1 )     35       1       (207 )     (172 )     -       (172 )
Share-based payments
     -       -       -       86       86       -       86  
Transfer from non-controlling interests to payables
     -       -       -       -       -       (5 )     (5 )
Dividend paid to non-controlling interest
     -       -       -       -       -       (26 )     (26 )
At 30 June 2008
     363       1,923       1,887       11,801       15,974       121       16,095  
                                                         
   
Share
capital
$m
    
Share
premium
account
$m
    
Other*
reserves
$m
    
Retained
earnings
$m
    
Total
$m
    
Non-
controlling
interests
$m
    
Total
equity
$m
  
At 1 January 2009
     362       2,046       1,932       11,572       15,912       148       16,060  
Profit for the period
     -       -       -       3,853       3,853       8       3,861  
Other comprehensive income
     -       -       -       95       95       (6 )     89  
Transfer to other reserve
     -       -       -       -       -       -       -  
Transactions with owners:
                                                        
Dividends
     -       -       -       (2,171 )     (2,171 )     -       (2,171 )
Issue of AstraZeneca PLC Ordinary shares
     -       19       -       -       19       -       19  
Share-based payments
     -       -       -       88       88       -       88  
Transfer from non-controlling interests to payables
     -       -       -       -       -       (3 )     (3 )
Dividend paid to non-controlling interest
     -       -       -       -       -       (1 )     (1 )
At 30 June 2009
     362       2,065       1,932       13,437       17,796       146       17,942  
 
* Other reserves includes the capital redemption reserve and the merger reserve.
 

Notes to the Interim Financial Statements

 
1    BASIS OF PREPARATION AND ACCOUNTING POLICIES
 
These condensed consolidated interim financial statements (“interim financial statements”) for the six months ended 30 June 2009 have been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the European Union.  As required by the Disclosure and Transparency Rules of the Financial Services Authority, the interim financial statements have been prepared applying the accounting policies and presentation that were applied in the preparation of the Company’s published consolidated financial statements for the year ended 31 December 2008, except where new or revised accounting standards have been applied.

During the year, the Group has applied IAS 1 Presentation of Financial Statements (revised 2007) which has introduced a number of terminology changes (including titles for the condensed financial statements) and has resulted in a number of changes in presentation and disclosure. The revised standard has had no impact on the reported results or financial position of the Group. In addition, the Group has adopted IFRS 2 Amendment regarding Vesting Conditions and Cancellations, IAS 23 Borrowing Costs (revised 2007) and Amendments to IAS 32 Financial Instruments: Presentation and IAS 1 Presentation of Financial Statements, none of which have had a significant effect on the reported results or financial position of the Group.

In addition, the Group has adopted IFRS 8 Operating Segments. AstraZeneca's pharmaceutical business is one operating segment because it is managed as a fully-integrated business whereby manufacturing and research and development are essential upstream activities without which there could be no sales and marketing.  The manufacturing and research and development functions are managed and operate on a global basis and are not dedicated to individual marketing or therapy areas.  Major decisions are taken through cross-functional committees recognising the integrated nature of the business. In assessing performance and making resource allocation decisions, the Senior Executive team (SET) (which is AstraZeneca's chief operating decision making body) reviews financial information on an integrated basis for the Group as a whole substantially in the form of, and on the same basis as, the Group’s IFRS financial statements. The SET also reviews sales performance on both a geographical and product/therapy area basis.

The Group has considerable financial resources available.  The Group’s revenues are largely derived from sales of products which are covered by patents and for which, historically at least, demand has been relatively unaffected by changes in the general economy.  As a consequence, the Directors believe that the Group is well placed to manage its business risks successfully despite the current uncertain economic outlook and as such, the interim financial statements have been prepared on a Going Concern basis.

The information contained in Note 4 updates the disclosures concerning legal proceedings and contingent liabilities in the Group’s Annual Report and Form 20-F Information 2008.

The comparative figures for the financial year ended 31 December 2008 are not the Company's statutory accounts for that financial year. Those accounts have been reported on by the Group's auditors and delivered to the registrar of companies. The report of the auditors was (i) unqualified, (ii) did not include a reference to any matters to which the auditors drew attention by way of emphasis without qualifying their report, and (iii) did not contain a statement under section 237(2) or (3) of the Companies Act 1985.

 
 
2    NET DEBT
 
The table below provides an analysis of net debt and a reconciliation of net cash flow to the movement in net debt.
 
   
At 1 Jan
2009
$m
    
Cash
flow
$m
    
Non-cash
movements
$m
    
Exchange
movements
$m
    
At 30 Jun
2009
$m
  
Loans due after one year
     (10,855 )     -       766       (74 )     (10,163 )
Current instalments of loans
     (650 )     -       (703 )     -       (1,353 )
Total loans
     (11,505 )     -       63       (74 )     (11,516 )
Other investments - current
     105       (78 )     12       3       42  
Net derivative financial instruments
     283       10       (35 )     -       258  
Cash and cash equivalents
     4,286       2,887       -       22       7,195  
Overdrafts
     (163 )     62       -       (2 )     (103 )
Short term borrowings
     (180 )     139       -       (1 )     (42 )
      4,331       3,020       (23 )     22       7,350  
Net debt
     (7,174 )     3,020       40       (52 )     (4,166 )

 
Non-cash movements in the period include fair value adjustments under IAS 39.
 
3    RESTRUCTURING AND SYNERGY COSTS
 
Profit before tax for the six months ended 30 June 2009 is stated after charging restructuring and synergy costs of $262 million ($248 million in the first half of 2008).  These have been charged to the income statement as follows:
 
   
2nd Quarter
2009
$m
    
2nd Quarter
2008
$m
    
Half Year
2009
$m
    
Half Year
2008
$m
  
Cost of sales
     84       24       115       56  
Research and development
     24       32       24       86  
Selling, general and administrative costs
     82       75       123       106  
Total
     190       131       262       248  
 
 
4    LEGAL PROCEEDINGS AND CONTINGENT LIABILITIES
 
AstraZeneca is involved in various legal proceedings considered typical to its business, including litigation relating to product liability, commercial disputes, infringement of intellectual property rights, the validity of certain patents and anti-trust law. The matters discussed below constitute the more significant developments since publication of the disclosures concerning legal proceedings in the Company's Annual Report and Form 20-F Information 2008.

As discussed in the Company's Annual Report and Form 20-F Information 2008, for the majority of claims in which AstraZeneca is involved it is not possible to make a reasonable estimate of the expected financial effect, if any, that will result from ultimate resolution of the proceedings. In these cases, AstraZeneca discloses information with respect only to the nature and facts of the cases but no provision is made.

In cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed and which are not subject to appeal, or where a loss is probable and we are able to make a reasonable estimate of the loss, we record the loss absorbed or make a provision for our best estimate of the expected loss.

As previously and herein disclosed, AstraZeneca is defending its interests in various federal and state investigations and civil litigation matters relating to drug marketing and pricing practices. In view of the current status of these matters, the Company now believes that it is possible to make a reasonable estimate of the losses expected and accordingly has recorded provisions in the aggregate amount of $430 million, being our best estimate of the loss expected for all matters relating to drug marketing and pricing practices where we can now make a reasonable estimate. No further details can be provided at this time because to do so could seriously prejudice the Company. These provisions are in addition to the amounts disclosed in the Annual Report and Form 20-F Information 2008.

The position could change over time and the estimates that we have made and upon which we have relied in calculating these provisions are inherently imprecise. There can, therefore, be no assurance that any losses that result from the outcome of any legal proceedings will not exceed the amount of the provisions that have been booked in the accounts.  The major factors causing this uncertainty are described more fully in the Annual Report and Form 20-F Information 2008 and herein.


 
Matters previously disclosed in respect of the first quarter of 2009 and April 2009

Crestor (rosuvastatin) 
Patent litigation - US
As previously disclosed, in January 2008 abbreviated new drug application-filers sued by AstraZeneca in the District of Delaware for infringement of the Patent No. RE37,314 (the '314 patent), responded to AstraZeneca's pleadings, some submitting jurisdictional motions seeking dismissals of parties and claims. In November 2008, the Court issued a magistrate's Report and Recommendation Regarding Motions to Dismiss deciding the defendants' various jurisdictional motions. In January 2009, the Court adopted the magistrate's recommendations. 

In March 2009, Magistrate Judge Leonard Stark heard argument and reserved judgment in the Court's Markman Hearing in respect of claim construction of the '314 patent claims. Discovery proceeds under an amended schedule. 
 
As previously disclosed, in October 2008, Teva Pharmaceuticals Industries Ltd. (Teva), filed a patent infringement lawsuit against AstraZeneca Pharmaceuticals LP, AstraZeneca PLC, AstraZeneca UK Limited and IPR Pharmaceuticals, Inc. in the Eastern District of Pennsylvania. In January 2009, AstraZeneca PLC and AstraZeneca UK Limited moved for dismissal on jurisdictional grounds. The Court administratively dismissed the motions without prejudice to allow time for discovery. In April 2009, AstraZeneca PLC and AstraZeneca UK Limited renewed those motions, which will proceed. In March 2009, AstraZeneca moved to transfe