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AstraZeneca PLC (AZN)

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Thursday 26 July, 2012

AstraZeneca PLC

Second Quarter & Half Year Results (1 of 2)

RNS Number : 5547I
AstraZeneca PLC
26 July 2012
 



AstraZeneca PLC

Second Quarter AND Half Year Results 2012

London, 26 July 2012

As expected, generic competition and challenging market conditions reflected in lower second quarter revenues.  Progress made on execution of long-term priorities, with the on-market portfolio and the pipeline strengthened through recent business development initiatives. Financial targets for full year unchanged.

Revenue for the second quarter was $6,660 million, down 18 percent at constant exchange rates (CER).

-Loss of exclusivity on several key brands accounted for 15 percentage points of the revenue decline. Resilient performance for Crestor.  Strong growth continued for ONGLYZATM, Iressa and Faslodex.

 

-As expected, further limitations in the supply chain at our plant in Sweden continued into the second quarter; the estimated impact on second quarter revenue was around 2 percent. The Company estimates the impact for the full year will be around 1 percent of revenue.

-Emerging Markets revenue increased by 1 percent at CER.  Supply chain issues impacted Emerging Markets revenue; adjusted for this, revenue growth would have been around 8 percent. 

Core EPS was $1.53 in the second quarter, a 6 percent decline at CER.

-Core EPS benefited by $240 million ($0.19 per share) due to the tax settlement of a cross border transfer pricing issue.  The effective tax rate for the full year is now estimated to be around 20 percent.

Reported EPS in the second quarter was down 11 percent at CER to $1.27.

Diabetes alliance will expand through Bristol-Myers Squibb's acquisition of Amylin Pharmaceuticals.

The Board has recommended a first interim dividend of $0.90.  Net share repurchases were $1.6 billion in the first half; target for full year remains $4.5 billion, subject to market conditions and business needs.

Core EPS target range for the full year maintained at $5.85 to $6.15.

 

Financial Summary

  Group

 

2nd Quarter

2012

$m

2nd Quarter

2011

$m

Actual

%

CER

%


Half Year

2012

$m

Half Year

2011

$m

Actual

%

CER

%

  Revenue

6,660

8,430

-21

-18


14,009

16,722

-16

-15

  Reported










      Operating Profit

1,868

2,965

-37

-32


4,028

6,366

-37

-35

      Profit before Tax

1,763

2,858

-38

-33


3,816

6,146

-38

-36

      Earnings per Share

$1.27

$1.53

-17

-11


$2.55

$3.61

-29

-27

  Core*










      Operating Profit

2,269

3,322

-32

-27


5,266

7,000

-25

-23

      Profit before Tax

2,164

3,215

-33

-28


5,054

6,780

-25

-23

      Earnings per Share

$1.53

$1.73

-12

-6


$3.34

$3.96

-16

-13

 

*

Core financial measures are supplemental non-GAAP measures which management believe enhance understanding of the Company's performance; it is upon these measures that financial guidance for 2012 is based.  See operating and financial review below for a definition of Core financial measures and a reconciliation of Core to Reported financial measures.

 

Simon Lowth, Interim Chief Executive Officer, commenting on the results, said: "As we expected, the loss of exclusivity on some key brands and tough market conditions have resulted in a decline in revenue and earnings in the second quarter. Despite these challenges, we are on track to achieve our financial targets for the full year.

 

"The results in the first half of the year reflect the resilience of several of our brands and the benefits of disciplined cost management. Building on the collaboration with Amgen and the acquisition of Ardea, we continued to bolster our pipeline and portfolio through an exciting opportunity to expand our diabetes alliance with Bristol-Myers Squibb.

 

"Our long-term priorities remain unchanged. We are driving the performance of brands that retain exclusivity, investing in markets with long-term potential, reshaping the cost base for sustainable competitiveness and continuing to drive for productivity on our investments in innovation, whether internally or externally sourced."

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.  Core financial measures are adjusted to exclude certain significant items, such as charges and provisions related to our global restructuring programmes, amortisation and impairment of the significant intangibles relating to our acquisition of MedImmune Inc. in 2007 and our exit arrangements with Merck in the US, and other specified items.  More detail on the nature of these measures is given on page 84 of our Annual Report and Form 20-F Information 2011.

Second Quarter

 

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

 

 

Reported
2012

Restructuring

Merck &

MedImmune

Amortisation

Intangible

Impairments

Legal

Provisions

& Other

Core
2012

Core
2011

Actual

%

CER
%

Revenue

6,660 

6,660 

8,430 

(21)

(18)

Cost of Sales

(1,346)

(1,340)

(1,462)



Gross Profit

5,314 

5,320 

6,968 

(24)

(20)

% sales

79.8%





79.9%

82.7%

-2.8 

-1.9 

Distribution

(75)

(75)

(88)

(15)

(10)

% sales

1.1%





1.1%

1.0%

-0.1 

-0.1 

R&D

(1,189)

136 

(1,053)

(1,119)

(6)

(4)

% sales

17.9%





15.8%

13.3%

-2.5 

-2.4 

SG&A

(2,350)

63 

116 

66 

(2,105)

(2,627)

(20)

(18)

% sales

35.3%





31.6%

31.2%

-0.4 

-0.4 

Other Income

168 

14 

182 

188 

(3)

% sales

2.5%





2.7%

2.2%

+0.5 

+0.5 

Operating Profit

1,868 

205 

130*

66**

2,269 

3,322 

(32)

(27)

% sales

28.0%





34.1%

39.4%

-5.3 

-4.3 

Net Finance Expense

(105)

(105)

(107)



Profit before Tax

1,763 

205 

130 

66 

2,164 

3,215 

(33)

(28)

Taxation

(145)

(48)

(20)*

(3)

(216)

(815)



Profit after Tax

1,618 

157 

110 

63 

1,948 

2,400 

(19)

(14)

Non-controlling Interests

(7)

(7)

(10)



Net Profit

1,611 

157 

110 

63 

1,941 

2,390 

(19)

(14)

Weighted Average Shares

1,267 

1,267 

1,267 

1,267 

1,267 

1,267 

1,381 



Earnings per Share

1.27 

0.12 

0.09 

0.05 

1.53 

1.73 

(12)

(6)

 

*

Of the $130 million amortisation adjustment, $91 million is related to MedImmune, with a corresponding tax adjustment of $20 million; Merck related amortisation was $39 million, which carries no tax adjustment.

**

Includes $50 million of acquisition related expenses which carry no tax adjustment.

 

Revenue in the second quarter was down 18 percent at CER and declined by 21 percent on an actual basis as a result of the negative impact of exchange rate movements.  Loss of exclusivity on several key brands (including Seroquel IR from the end of March) accounted for 15 percentage points of the revenue decline; disposals of Astra Tech and Aptium accounted for 2.4 percentage points.  Continued disruptions to our supply chain from the implementation of an enterprise resource planning IT system in our plant in Sweden negatively impacted revenue by around 2 percent. The underlying problems have now been largely resolved, and production is now responding to ongoing demand, including filling back orders and restoring normal inventories in the distribution channels.  The Company estimates the impact for the full year will be around 1 percent of revenue.

 

US revenues were down 29 percent in the second quarter, with the loss of exclusivity for Seroquel IR accounting for 80 percent of the revenue decline.  Growth for Symbicort, ONGLYZATM and Faslodex was offset by the disposals of Astra Tech and Aptium.  The negative impact of US healthcare reform on second quarter revenue and costs was approximately $150 million.

 

Revenue in the Rest of World (ROW) was down 12 percent in the second quarter.  Revenue in Western Europe was down 20 percent.  In addition to the loss of exclusivity for Seroquel IR, generic competition also reduced revenues for Nexium, Atacand and Merrem in Western Europe.  Revenue in Established ROW was down 12 percent, largely due to a 30 percent decline in Canada as a result of generic competition for Crestor and Atacand.  Revenue in Emerging Markets was up 1 percent, reflecting loss of exclusivity for Seroquel IR and Crestor in Brazil and difficult market conditions in Mexico.  Revenue growth was also impacted by the supply chain issues; adjusted for this impact, Emerging Market revenues would have increased by around 8 percent.  An improvement in the growth rate in Emerging Markets is still anticipated in the second half, but double-digit growth for the full year is unlikely.

 

Core gross profit in the second quarter declined by 20 percent.  Core gross margin as a percentage of revenue was 79.9 percent, 1.9 percentage points lower than last year, largely due to a change in product mix following the loss of exclusivity on key brands, partially offset by the uplift provided by the absence of Astra Tech costs.

 

Expenditures in Core SG&A were 18 percent lower than the second quarter last year, on continued discipline in managing costs, benefits from restructuring and the absence of Astra Tech costs.  The excise fee imposed by the enactment of US healthcare reform measures amounted to 2.8 percent of Core SG&A expense in the quarter.

 

Core other income of $182 million was unchanged at CER compared with the second quarter last year.  Lower royalty income for Entocort in the US was largely offset by income from the Zomig agreement with Impax Laboratories in the US.

 

Core Pre-R&D operating profit was down 21 percent to $3,322 million in the second quarter.  Core Pre-R&D operating margin was 49.9 percent of revenue, 1.9 percentage points lower than last year.  In addition to the decline in revenue and Core gross margin, Core SG&A expense, although 18 percent lower than last year, was still higher as a percentage of revenue.

 

Core R&D expense was down 4 percent in the second quarter, as the benefits from restructuring have more than offset increased spend on projects, including the addition of the Amgen collaboration.

 

Core operating profit in the second quarter was down 27 percent to $2,269 million.  Core operating margin was 4.3 percentage points lower as a percentage of revenue than last year.  In addition to the decline in revenue and Core Pre-R&D margin, Core R&D expense, although 4 percent lower in dollar terms, was 2.4 percentage points higher as a percentage of revenue.

 

Core earnings per share in the second quarter were down 6 percent to $1.53.  Core EPS in the quarter benefited by $0.19 due to the tax settlement of a cross border transfer pricing issue.  Core EPS also benefited from a lower number of shares outstanding as a result of net share repurchases.

 

Reported operating profit in the second quarter was down 32 percent to $1,868 million; Reported EPS was down 11 percent to $1.27.  The larger declines compared with the respective Core profit measures are largely the result of higher restructuring costs in the second quarter of 2012 ($205 million) compared with the second quarter of last year ($138 million).

 

First Half

 

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

 

 

Reported
2012

Restructuring

Merck &

MedImmune

Amortisation

Intangible

Impairments

Legal

Provisions

& Other

Core
2012

Core
2011

Actual

%

CER
%

Revenue

14,009 

14,009 

16,722 

(16)

(15)

Cost of Sales

(2,721)

61 

(2,660)

(2,789)



Gross Profit

11,288 

61 

11,349 

13,933 

(19)

(17)

% sales

80.6%





81.0%

83.3%

-2.3 

-1.9 

Distribution

(151)

(151)

(168)

(10)

(7)

% sales

1.1%





1.1%

1.0%

-0.1 

-0.1 

R&D

(2,719)

581 

(2,138)

(2,191)

(2)

(1)

% sales

19.4%





15.2%

13.1%

-2.1 

-2.1 

SG&A

(4,811)

265 

233 

70 

(4,243)

(4,977)

(15)

(13)

% sales

34.3%





30.3%

29.7%

-0.6 

-0.5 

Other Income

421 

28 

449 

403 

11 

14 

% sales

3.0%





3.2%

2.4%

+0.8 

+0.8 

Operating Profit

4,028 

907 

261*

70**

5,266 

7,000 

(25)

(23)

% sales

28.8%





37.6%

41.9%

-4.3 

-3.8 

Net Finance Expense

(212)

(212)

(220)



Profit before Tax

3,816 

907 

261 

70 

5,054 

6,780 

(25)

(23)

Taxation

(556)

(189)

(38)*

(4)

(787)

(1,254)



Profit after Tax

3,260 

718 

223 

66 

4,267 

5,526 

(23)

(20)

Non-controlling Interests

(9)

(9)

(18)



Net Profit

3,251 

718 

223 

66 

4,258 

5,508 

(23)

(20)

Weighted Average Shares

1,274 

1,274 

1,274 

1,274 

1,274 

1,274 

1,389 



Earnings per Share

2.55 

0.56 

0.18 

0.05 

3.34 

3.96 

(16)

(13)

 

*

Of the $261 million amortisation adjustment, $181 million is related to MedImmune, with a corresponding tax adjustment of $38 million; Merck related amortisation was $80 million, which carries no tax adjustment. 

**

Includes $50 million of acquisition related expenses which carry no tax adjustment.

 

Revenue in the first half was down 15 percent at CER and declined by 16 percent on an actual basis as a result of the negative impact of exchange rate movements.  Loss of exclusivity on several key brands accounted for 11 percentage points of the revenue decline, which included a $187 million returns reserve against US trade inventories of Seroquel IR.  US revenue was down 20 percent; revenue in the Rest of World was down 11 percent.

 

Core gross margin was 81.0 percent of revenue, 1.9 percentage points lower than last year.

 

Expenditures in Core SG&A were 13 percent lower than the first half last year on continued spending discipline, restructuring benefits and the absence of Astra Tech costs, partially offset by selective investment in Emerging Markets.

 

Core other income in the first half was up 14 percent.  With the agreement with Impax Laboratories, beginning in the first quarter 2012, commercial contribution from Zomig in the US is now recorded as other income rather than revenue.

 

Core Pre-R&D operating profit was down 17 percent to $7,404 million.  Core Pre-R&D operating margin was 52.8 percent of revenue, down 1.7 percentage points, on lower Core gross margin and higher Core SG&A expense as a percent of revenue, partially offset by higher Core other income.

 

Core R&D expense in the first half was down 1 percent, as the 4 percent decline in the second quarter was largely offset by the 2 percent increase in the first quarter, which included the intangible impairment related to TC-5214.

 

Core operating profit in the first half was down 23 percent to $5,266 million.  Core operating margin was 37.6 percent of revenue, down 3.8 percentage points.

 

Core earnings per share were $3.34, down 13 percent compared with the first half last year.  Core EPS in the first half 2012 included a $0.19 benefit from tax settlements.  The first half 2011 included a $0.39 per share benefit from tax settlements.  Core EPS in the first half 2012 benefited from the lower number of shares outstanding compared with last year as a result of net share repurchases.

 

Reported operating profit in the first half was down 35 percent to $4,028 million; reported EPS was down 27 percent.  The larger declines compared with the respective Core financial measures are largely the result of higher restructuring costs in the first half 2012 ($907 million) compared with the first half last year ($281 million).

 

Enhancing Productivity

 

The Company is making good progress in implementing the third phase of restructuring announced in February 2012.  Restructuring charges of $205 million were taken in the second quarter, bringing the year to date total to $907 million.  It is anticipated that most of the estimated $2.1 billion programme cost will be taken in 2012.

 

The programme is on track to deliver the $1.6 billion in annual benefits by the end of 2014.

 

Finance Income and Expense

 

Net finance expense was $105 million for the quarter, versus $107 million in 2011. There was an $11 million reduction in interest payable on defined benefit pension scheme liabilities which was partially offset by a reduction in the expected return of the plan. Interest payable on debt balances and fair value losses recorded on long term bonds were broadly unchanged versus the second quarter 2011.

 

Taxation

 

The effective tax rate on a reported basis for the second quarter was 8.2 percent (2011: 25.7 percent) and 14.6 percent for the first half (2011: 18.0 percent). The effective tax rate for the quarter includes an adjustment of $240 million in respect of prior periods following the settlement of a transfer pricing matter previously provided within the amount of $649 million relating to transfer pricing disclosed in Note 25 of the 2011 Group Financial Statements. Excluding this benefit, the effective tax rate for the first half was 20.9 percent. The 20.9 percent tax rate is applied to the taxable Core adjustments to operating profit, resulting in an effective Core tax rate in the first half of 15.6 percent.

 

As a result of this provision release, the Group's effective tax rate for 2012 is now expected to be around 20 percent, 2 percentage points lower than previous guidance of around 22 percent.

 

The effective tax rate for the first half of last year benefited from a favourable adjustment to tax provisions of $520 million following the announcement in March 2011 that HM Revenue & Customs in the UK and the US Internal Revenue Service agreed the terms of an Advance Pricing Agreement regarding transfer pricing arrangements for AstraZeneca's US business for the period from 2002 to the end of 2014 and a related valuation matter. Excluding this benefit, the effective tax rate for the first half of last year was 26.5 percent on a reported basis.

 

Cash Flow

 

Cash generated from operating activities was $2,791 million in the six months to 30 June 2012, compared with $2,829 million in the same period of 2011. Improvements in working capital and lower tax payments more than offset the lower operating profit, while increased pension fund contributions drove higher outflows in non-cash and other movements.

 

Net cash inflows from investing activities were $1,353 million in the six months compared with $286 million in the first half of 2011. The difference of $1,067 million is due primarily to the net movement between cash and short-term investments and fixed deposits, only partially offset by the net cash paid on the acquisition of Ardea.

 

Cash distributions to shareholders were $4,107 million through net share repurchases of $1,602 million and $2,505 million from the payment of the second interim dividend from 2011.

 

Debt and Capital Structure

 

At 30 June 2012, outstanding gross debt (interest-bearing loans and borrowings) was $9,318 million (31 December 2011: $9,328 million). Of the gross debt outstanding at 30 June 2012, $2,008 million is due within one year (31 December 2011: $1,990 million).

 

Net funds of $210 million have decreased by $2,639 million during the first half as a result of the net cash outflow as described in the cash flow section above.

 

Dividends and Share Repurchases

 

The Board has recommended a first interim dividend of $0.90 (58.1 pence, 6.26 SEK).  The amount of the first interim dividend is a reflection of the Board's intent to rebalance the first and second interim dividends, with the aim of setting the first interim dividend at around a third of the prior year dividend, which last year was $2.80.

 

The Board has adopted a progressive dividend policy, by which the Board intends to maintain or grow the dividend each year.  In adopting this policy, the Board recognised that some earnings fluctuations are to be expected as the Company's revenue base transitions through this period of exclusivity losses and new product launches.  The Board's view is that the annual dividend will not just reflect the financial performance of a single year taken in isolation, but reflect its view of the earnings prospects for the Group over the entirety of the investment cycle.  As a result, dividend cover may vary during the period, but with the target of an average dividend cover of 2 times (ie, a payout ratio of 50 percent), based on reported earnings (before restructuring costs).

 

In setting the distribution policy and the overall financial strategy, the Board's aim is to continue to strike a balance between the interests of the business, our financial creditors and our shareholders. After providing for business investment, funding the progressive dividend policy and meeting our debt service obligations, the Board will keep under review the opportunity to return cash in excess of these requirements to shareholders through periodic share repurchases.

 

Subject to market conditions and business needs, the Board has announced that the Company intends to complete net share repurchases in the amount of $4.5 billion during 2012.  In the first half of 2012 the Group repurchased 41.0 million shares for a total of $1,854 million.  In the six months, 7.4 million shares were issued in consideration of share option exercises for a total of $252 million.

 

The total number of shares in issue at 30 June 2012 was 1,259 million.

 

Future Prospects 

 

The financial performance in the first half has been largely defined by the expected impact of the loss of exclusivity on several products, particularly Seroquel IR, as well as the disposals of Astra Tech and Aptium. These factors, together with the challenging market conditions, continue to inform our estimate of a full year decline in revenue in the range of the low to mid-teens in constant currency terms, including any residual impact from supply issues.  We continue to realise the benefits from our restructuring programmes, and will continue to exert discipline in operating expenses.  Whilst Core EPS in the second quarter saw a large benefit from the release of a tax provision, a probability weighted view of the likely realisation of this benefit was incorporated in our first quarter guidance revision, and taken together with absorbing the dilutive impact to Core EPS in 2012 from expansion of our diabetes collaboration with Bristol-Myers Squibb following their acquisition of Amylin, our Core EPS target for the full year remains in the range of $5.85 to $6.15.

 

This Core EPS guidance has been based on January 2012 average exchange rates for our principal currencies, and actual results in the first half were broadly in line with this currency assumption.  The target takes no account of the likelihood that average exchange rates for the remainder of 2012 may differ materially from the 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 2011 results announcement, and can be found on the AstraZeneca website, www.astrazeneca.com/investors.

 

Definition of Core Financial Measures

With effect from first quarter results 2013, AstraZeneca will update its definition of Core financial measures to exclude all amortisation charges and intangible asset impairments.  The new definition will provide better clarity of the impact from amortisation and impairment charges included in Core results under our current definition and, in addition, will aid comparability of our results versus our peers.  We will publish an update on this with our third quarter and nine months results.

 

Related Party Transactions

 

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

Principal Risks and Uncertainties

It is not anticipated that the nature of the principal risks and uncertainties that affect the business, and which are set out on pages 130 to 138 of the Annual Report and Form 20-F Information 2011, 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 2011 are:

 

Product pipeline risks

 

Failure to meet development targets; difficulties of obtaining and maintaining regulatory approvals for new products; failure to obtain and enforce effective intellectual property protection; delay to new product launches; strategic alliances and acquisitions may be unsuccessful.

 

Commercialisation and business execution risks

 

Challenges to achieving commercial success of new products; illegal trade in our products; developing our business in Emerging Markets; expiry or loss of, or limitations on, intellectual property rights; pressures resulting from generic competition; effects of patent litigation in respect of intellectual property rights; price controls and price reductions; economic, regulatory and political pressures; biosimilars; increasing implementation and enforcement of more stringent anti-bribery and anti-corruption legislation; expected gains from productivity initiatives are uncertain; failure of information technology; failure of outsourcing.

 

Supply chain and delivery risks

 

Manufacturing biologics; reliance on third parties for goods.

 

Legal, regulatory and compliance risks

 

Adverse outcome of litigation and/or governmental investigations; substantial product liability claims; failure to adhere to applicable laws, rules and regulations; environmental/occupational health and safety liabilities.

 

Economic and financial risks

 

Adverse impact of a sustained economic downturn; impact of fluctuations in exchange rates; limited third party insurance coverage; taxation; pensions.

 

Research and Development Update

 

A comprehensive update of the AstraZeneca R&D pipeline is presented in conjunction with this Half Year 2012 results announcement, and is available on the Company's website, www.astrazeneca.com, under information for investors.

 

The AstraZeneca pipeline now includes 90 projects, of which 83 projects are in the clinical phase of development and a further 7 are either approved or launched.  There are 9 new molecular entity (NME) projects currently in late stage development, either in Phase III or under regulatory review.  In the first half of 2012, across the clinical portfolio, 22 projects have successfully progressed to their next phase (including 7 projects entering first human testing); 10 projects have been withdrawn.

 

Developments since the first quarter update include:

 

AstraZeneca diabetes collaboration with Bristol-Myers Squibb

 

On 30 June 2012, AstraZeneca and Bristol-Myers Squibb announced an expansion of their diabetes alliance through Bristol-Myers Squibb's acquisition of Amylin Pharmaceuticals.  Bristol-Myers Squibb will acquire Amylin for $31.00 per share in cash, pursuant to a cash tender offer and second step merger, for an aggregate purchase price of approximately $5.3 billion.  The total value of the transaction, including Amylin's net debt and a contractual obligation to Eli Lilly and Company, together totalling about $1.7 billion, is approximately $7 billion.

 

Following the completion of Bristol-Myers Squibb's acquisition of Amylin, the companies will enter into collaboration arrangements, based on the framework of the existing diabetes alliance, regarding the development and commercialisation of Amylin's portfolio of products.  Following Bristol-Myers Squibb's acquisition of Amylin, AstraZeneca will make a payment to Amylin, as a wholly owned subsidiary of Bristol-Myers Squibb, in the amount of approximately $3.4 billion in cash, subject to a final true-up.  Profits and losses arising from the collaboration will be shared equally.  In addition, AstraZeneca has the option, exercisable at its sole discretion, to establish equal governance rights over key strategic and financial decisions regarding the collaboration, upon the payment to Bristol-Myers Squibb of an additional $135 million.

 

Amylin's portfolio includes a GLP-1 franchise, including two treatments for type 2 diabetes, BYETTA® (exenatide) injection and BYDUREON® (exenatide extended-release for injectable suspension/exenatide 2 mg powder and solvent for prolonged release suspension for injection) that are approved for use in both the US and Europe, and SYMLIN® (pramlinitide acetate) injection.  There is also a life-cycle management pipeline, including delivery devices and formulation improvements (including a once-monthly formulation of exenatide) under development.  The pipeline also includes metreleptin, a leptin analogue currently under review at the US Food and Drug Administration (FDA) for the treatment of diabetes and/or hypertriglyceridaemia in patients with rare forms of inherited or acquired lipodystrophy.

 

Zinforo

 

On 22 June 2012, AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Zinforo (ceftaroline fosamil), a new intravenous cephalosporin antibiotic for the treatment of adult patients with complicated Skin and Soft Tissue Infections (cSSTI) or Community Acquired Pneumonia (CAP). The CHMP's positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.

 

Ceftaroline fosamil is the first monotherapy antibiotic to combine the established tolerability of the cephalosporin class, with effective coverage of a range of bacteria responsible for serious skin infections and pneumonia, including difficult to treat strains such as methicillin-resistant Staphylococcus aureus (MRSA) in cSSTI and Streptococcus pneumoniae in CAP.

 

In 2009, Forest Laboratories granted AstraZeneca exclusive worldwide commercial rights and co-exclusive development rights for ceftaroline fosamil, excluding US, Canada and Japan. Forest launched ceftaroline fosamil with similar indications under the trade name TEFLARO® in the US in March 2011.

 

AstraZeneca has made regulatory submissions in a number of countries where it has commercialisation rights and further submissions are planned in 2012.

 

Ardea Biosciences

 

On 19 June 2012, AstraZeneca announced that it had completed the acquisition of Ardea Biosciences Inc., a biotechnology company in San Diego, California.

 

Ardea's clinically most advanced product candidate, lesinurad (formerly known as RDEA594), is currently in Phase III development as a potential treatment for the chronic management of hyperuricaemia in patients with gout.

Revenue

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

A full analysis of the Group's revenue by product and geographic area is shown in Notes 7 and 8.

 

 

Second Quarter


First Half




 

2012

2011

CER

2012

2011

CER





$m

$m

%

$m

$m

%




Gastrointestinal










   Nexium 

949

1,112

-13

1,902

2,273

-15




   Losec/Prilosec

195

239

-16

365

474

-22














Cardiovascular










   Crestor

1,587

1,714

-5

3,087

3,192

-2




   Atacand

269

385

-25

586

740

-18




   Seloken /Toprol-XL

208

232

-7

432

477

-7




   ONGLYZATM

79

46

+72

151

81

+86




   Brilinta/Brilique

18

2

n/m

27

3

n/m














Respiratory & Inflammation










   Symbicort

795

802

+3

1,518

1,554

+1




   Pulmicort

206

236

-10

433

484

-9














Oncology










   Zoladex

275

302

-6

548

577

-3




   Arimidex

147

181

-16

291

414

-29




   Casodex

118

138

-13

231

271

-15




   Iressa

154

139

+13

297

260

+15




   Faslodex

161

135

+24

312

258

+24




   Caprelsa

7

2

n/m

12

2

n/m














Neuroscience










   Seroquel

647

1,537

-57

1,785

2,882

-37




     Seroquel IR

277

1,150

-75

1,031

2,156

-52




     Seroquel XR

370

387

-1

754

726

+6




   Zomig

48

103

-50

102

204

-49




   Vimovo

17

6

+200

33

10

+240














Infection and other










   Synagis

55

48

+15

439

456

-4




   Merrem

100

158

-33

200

330

-37




   FluMist

2

-

n/m

4

3

+33




 

Gastrointestinal

·   

In the US, Nexium sales in the second quarter were $554 million, down 10 percent compared with the second quarter last year.  Dispensed retail tablet volume declined by around 10 percent.  A significant decline in low margin Medicaid prescriptions is resulting in a small increase in average selling prices due to this change in mix.  Nexium sales in the US in the first half were also down 10 percent to $1,089 million.

 

·   

Nexium sales in other markets in the second quarter were down 16 percent to $395 million.  Sales in Western Europe were down 37 percent, largely the result of generic competition.  Sales in Established Rest of World were down 15 percent due to the impact of generic competition in Canada.  Sales in Emerging Markets increased by 3 percent.  Nexium sales in other markets were down 21 percent in the first half to $813 million.

 

·   

Losec sales in markets outside the US were down 17 percent in the second quarter to $186 million.  Sales in the first half were down 23 percent to $348 million.

 

Cardiovascular

·   

In the US, Crestor sales in the second quarter were $787 million, down 1 percent.  Total prescriptions for statin products in the US increased by 1.3 percent in the second quarter.  Crestor total prescriptions increased by 1.5 percent, largely unaffected by the initial launch of generic atorvastatin in November of last year and the introduction of a larger number of generics upon the expiration of the 180-day exclusivity period at the end of May 2012.  Crestor sales in the first half in the US were down 1 percent to $1,469 million.

 

·   

Crestor sales in the Rest of World in the second quarter were down 8 percent to $800 million reflecting the expected loss of exclusivity in Canada in April 2012 arising from settlements of patent litigation.  As a result, sales in Canada were down 48 percent in the second quarter.  Excluding Canada, Rest of World sales increased by 1 percent, on growth in Emerging Markets (chiefly China) and in Japan.  Crestor sales in the Rest of World in the first half were down 3 percent to $1,618 million.

 

·   

US sales of the Toprol-XL product range, which includes sales of the authorised generic, declined by 21 percent in the second quarter to $72 million, largely the result of lower selling prices following the launch of a third generic product late last year.  Sales in the first half in the US were down 24 percent to $145 million.

 

·   

Sales of Seloken in other markets in the second quarter were up 2 percent to $136 million on 5 percent growth in Emerging Markets. Sales in the first half were up 4 percent to $287 million.

 

·   

US sales of Atacand were down 27 percent in the second quarter, to $36 million.  Sales in the first half were down 20 percent to $76 million.

 

·   

Atacand sales in other markets were down 25 percent to $233 million in the second quarter, largely due to the loss of exclusivity in Western Europe, where sales were down 30 percent, and also in Canada, where sales were down 60 percent.  Sales in the Rest of World in the first half were $510 million, down 17 percent.

 

·   

Alliance revenue from the ONGLYZATM collaboration with Bristol-Myers Squibb was up 72 percent in the second quarter to $79 million, of which $58 million was in the US and $21 million in other markets.  ONGLYZATM share of total prescriptions for DPP4 products in the US was 11.5 percent in June 2012.  KOMBIGLYZE XRTM added a further 5.4 percent total prescription share to the franchise in the US in June.  Worldwide alliance revenue in the first half was $151 million.

 

·   

Sales of Brilinta/Brilique were $18 million in the second quarter, of which $12 million was in Western Europe.  Pricing negotiations have now been successfully concluded in Germany and also in France, supporting a launch in July 2012. In Germany, in the 85 percent of target hospitals where Brilique is on protocol, Brilique continues to be the leading oral antiplatelet for incident ACS patients, ahead of prasugrel and clopidogrel.  Brilique is now the number two product in retail dynamic market share, accounting for 8.5 percent of oral antiplatelet therapy.  Sales in the US in the second quarter were $3 million, as dispensed demand has begun to stimulate reorders now that launch stocks have been largely worked down in the trade channels.  We continue to make steady progress in terms of formulary access, protocol adoption and product trial rates by interventional cardiologists.

 

·   

Sales of Brilinta/Brilique were $27 million in the first half.

 

Respiratory and Inflammation

·   

Symbicort sales in the US were $249 million, a 21 percent increase over the second quarter last year.  Total prescriptions for Symbicort were up 12 percent compared to a 1 percent increase in the market for fixed combination products.  Symbicort share of new prescriptions for fixed combination products reached 22.5 percent in June 2012, up 1 percentage point since December 2011.  Market share of patients newly starting combination therapy is 27.2 percent.  Symbicort sales in the US in the first half were up 16 percent to $466 million.

 

·   

Symbicort sales in other markets in the second quarter were $546 million, down 3 percent.  Sales in Western Europe were down 5 percent.  Sales in Established Rest of World were up 6 percent; sales in Japan were down 2 percent as shipments to our marketing partner lag underlying demand in the market.  Sales in Emerging Markets were down 3 percent.  Symbicort sales in the Rest of World in the first half were down 5 percent to $1,052 million.

 

·   

US sales of Pulmicort were down 32 percent in the second quarter to $60 million.  Sales in the first half were down 30 percent to $116 million.

 

·   

Pulmicort sales in the Rest of World were up 3 percent in the second quarter to $146 million, driven by a 42 percent increase in China.  Rest of World sales for Pulmicort in the first half were $317 million, 2 percent higher than the first half of 2011.

 

Oncology

·   

Arimidex sales in the US were $6 million in the second quarter, and were $13 million in the first half.

 

·   

Arimidex sales in the second quarter in the Rest of World were down 15 percent to $141 million.  Sales in Western Europe were down 29 percent to $36 million, reflecting the loss of exclusivity.  Sales in Japan were unchanged compared to last year.  Sales in Emerging Markets were down 15 percent. Arimidex sales in the first half in the Rest of World were down 27 percent to $278 million.

 

·   

Outside of the US, sales for Casodex in the second quarter were down 13 percent to $120 million.  More than 60 percent of revenue is in Japan, where sales were down 15 percent in the second quarter.  Sales were down 27 percent in Western Europe.  Sales in Emerging Markets were up 4 percent.  Casodex sales in the Rest of World in the first half were $233 million, down 15 percent.

 

·   

Iressa sales in the second quarter were up 13 percent to $154 million.  Sales in Emerging Markets were up 16 percent.  Sales in Western Europe were up 12 percent.  Sales in Japan were up 10 percent.  Worldwide sales of Iressa in the first half increased 15 percent to $297 million.

 

·   

Faslodex sales in the US in the second quarter were up 15 percent, reaching $75 million.  The new 500mg dosage regimen has now been widely adopted; some of the volume growth in the quarter also reflects an increase in the number of patients treated with Faslodex.  US sales in the first half were up 16 percent to $147 million.

 

·   

Faslodex sales in the Rest of World were up 31 percent to $86 million in the second quarter, with Japan accounting for nearly 60 percent of the increase.  Sales in Western Europe were up 4 percent in the quarter; sales in Emerging Markets were up 35 percent.  Sales in the Rest of World in the first half increased 32 percent to $165 million.

 

Neuroscience

 

·   

In the US, Seroquel franchise sales in the second quarter were down 70 percent to $323 million, reflecting the loss of exclusivity for Seroquel IR at the end of March 2012.  Sales of Seroquel IR were down 86 percent to $126 million in the quarter.  In the week ending 13 July, Seroquel IR share of total prescriptions for the quetiapine molecule had fallen to 6.2 percent.  US sales for Seroquel IR in the first half were down 59 percent to $668 million.

 

·   

Sales of Seroquel XR in the US were down 4 percent to $197 million in the second quarter.  Total prescriptions for Seroquel XR were down 3 percent, compared with 1 percent for the US antipsychotic market.  There was some inventory de-stocking compared to the prior year, but this was largely offset by a positive price variance in the quarter.  US sales for Seroquel XR in the first half were up 4 percent to $396 million.

 

·   

Seroquel franchise sales in the Rest of World were down 22 percent to $324 million in the second quarter, reflecting the loss of exclusivity for Seroquel IR in many markets. Sales of Seroquel IR were down 39 percent to $151 million, chiefly on a 61 percent decline in Western Europe.  Sales in Rest of World for Seroquel IR in the first half were down 28 percent to $363 million.

 

·   

Sales of Seroquel XR in the Rest of World were up 3 percent to $173 million in the second quarter.  Sales in Western Europe were down 6 percent, chiefly the result of an "at risk" launch of generics in Germany, partially offset by good launch progress in France.  Seroquel XR sales were up 4 percent in Established ROW and were up 40 percent in Emerging Markets.  Seroquel XR sales in the Rest of World for the first half were $358 million, an increase of 9 percent over last year.

 

·   

Zomig sales in the US were $2 million in the second quarter.  US commercial rights for Zomig have been licensed to Impax Laboratories; AstraZeneca's commercial contribution from Zomig in the US is now realised in other income, rather than in revenue.  Zomig sales in the Rest of World were down 25 percent to $46 million in the quarter.

 

·   

Sales of Vimovo in the second quarter were $17 million, comprised of $6 million in the US and $11 million in the Rest of World.

 

Infection and Other

 

·   

Synagis sales in the US were $1 million in the second quarter, which is out of season.  Outside the US, sales in the second quarter were $54 million, up 26 percent, which reflects the quarterly phasing of shipments to Abbott, our international distributor.

 

·   

In line with the usual seasonality, there were negligible sales of FluMist in the first half.

 

·   

Sales of Merrem in the first half were down 37 percent to $200 million as a result of generic competition in many markets.

 

Regional Revenue


Second Quarter


First Half

 

% Change


2012

2011

% Change

2012

2011


$m

$m

Actual

CER

$m

$m

Actual

CER

US

2,339

3,292

-29

-29

5,259

6,596

-20

-20

Western Europe1

1,626

2,194

-26

-20

3,401

4,429

-23

-20

Established ROW2

1,284

1,476

-13

-12

2,522

2,797

-10

-11

Canada

286

423

-32

-30

663

840

-21

-19

Japan

723

736

-2

-2

1,321

1,367

-3

-6

Other Established ROW

275

317

-13

-11

538

590

-9

-10

Emerging ROW3

1,411

1,468

-4

+1

2,827

2,900

-3

+1

Emerging Europe

283

316

-10

+1

577

636

-9

-

China

349

303

+15

+12

729

625

+17

+12

Emerging Asia Pacific

229

242

-5

-2

462

484

-5

-2

Other Emerging ROW

550

607

-9

-2

1,059

1,155

-8

-3










Total

6,660

8,430

-21

-18

14,009

16,722

-16

-15


1Western Europe comprises France, Germany, Italy, Sweden, Spain, UK and others.

2Established ROW comprises Canada, Japan, Australia and New Zealand.

3Emerging ROW comprises Brazil, China, India, Mexico, Russia, Turkey and all other ROW countries.

 

·   

In the US, revenue was down 29 percent in the second quarter, with the loss of exclusivity for Seroquel IR accounting for 80 percent of the decline.  The total impact of US healthcare reform measures on revenues and costs was around $150 million in the quarter.  There was good growth for Symbicort, ONGLYZATM and Faslodex, but this was offset by the disposals of Astra Tech and the Aptium businesses.

 

·   

Revenue in Western Europe was down 20 percent in the second quarter.  In addition to the loss of exclusivity for Seroquel IR, generic competition for Nexium, Atacand and Merrem also reduced revenue; these four products accounted for more than half the revenue decline in the quarter.

 

·   

Revenue in Established ROW was down 12 percent in the second quarter.  Revenue in Canada was down 30 percent.  In addition to the loss of exclusivity for Atacand, generic competition for Crestor entered the Canadian market in April pursuant to previously disclosed settlement of patent litigation.  Revenue in Japan was down 2 percent, as volume growth was more than offset by lower prices.

 

·   

Revenue in Emerging Markets was up 1 percent in the second quarter, reflecting loss of exclusivity for Seroquel IR and Crestor in Brazil and challenging market conditions in Mexico.  Revenue growth in Emerging Markets was also affected by the supply chain issues; adjusted for this, revenue growth would have been around 8 percent.  Revenue was up 12 percent in China on good growth for Crestor, Pulmicort and Seloken.  An improvement in Emerging Markets growth rates is anticipated in the second half of the year; however double-digit growth for the full year is now unlikely.

 

 

Condensed Consolidated Statement of Comprehensive Income        

 

 

For the six months ended 30 June


2012 

$m 


2011 

$m 

Revenue


14,009 


16,722 

Cost of sales


(2,721)


(2,821)

Gross profit


11,288 


13,901 

Distribution costs


(151)


(168)

Research and development


(2,719)


(2,360)

Selling, general and administrative costs


(4,811)


(5,376)

Other operating income and expense


421 


369 

Operating profit


4,028 


6,366 

Finance income


261 


273 

Finance expense


(473)


(493)

Profit before tax


3,816 


6,146 

Taxation


(556)


(1,108)

Profit for the period


3,260 


5,038 

Other comprehensive income:





Foreign exchange arising on consolidation


22 


246 

Foreign exchange differences on borrowings forming net investment hedges


18 


(113)

Amortisation of loss on cash flow hedge



 1 

Net available for sale gains taken to equity



18 

Actuarial (loss)/gain for the period


(349)


156 

Income tax relating to components of other comprehensive income


40 


(6)

Other comprehensive income for the period, net of tax


(261)


302 

Total comprehensive income for the period


2,999 


5,340 

 





Profit attributable to:





Owners of the parent


3,251 


5,020 

Non-controlling interests



18 

 


3,260 


5,038 

 





Total comprehensive income attributable to:





Owners of the parent


2,995 


5,318 

Non-controlling interests



22 

 


2,999 


5,340 

 





Basic earnings per $0.25 Ordinary Share


$2.55 


$3.61 

Diluted earnings per $0.25 Ordinary Share


$2.55 


$3.60 

Weighted average number of Ordinary Shares in issue (millions)


1,274 


1,389 

Diluted weighted average number of Ordinary Shares in issue (millions)


1,277 


1,395 

 

 

Condensed Consolidated Statement of Comprehensive Income        

 

 

For the quarter ended 30 June


2012 

$m 


2011 

$m 

Revenue


6,660 


8,430 

Cost of sales


(1,346)


(1,482)

Gross profit


5,314 


6,948 

Distribution costs


(75)


(88)

Research and development


(1,189)


(1,198)

Selling, general and administrative costs


(2,350)


(2,868)

Other operating income and expense


168 


171 

Operating profit


1,868 


2,965 

Finance income


129 


136 

Finance expense


(234)


(243)

Profit before tax


1,763 


2,858 

Taxation


(145)


(735)

Profit for the period


1,618 


2,123 

Other comprehensive income:





Foreign exchange arising on consolidation


(99)


38 

Foreign exchange differences on borrowings forming net investment hedges


68 


(21)

Amortisation of loss on cash flow hedge



 1 

Net available for sale (losses)/gains taken to equity


(11)


Actuarial (loss)/gain for the period


(423)


174 

Income tax relating to components of other comprehensive income


86 


(33)

Other comprehensive income for the period, net of tax


(378)


166 

Total comprehensive income for the period


1,240 


2,289 

 





Profit attributable to:





Owners of the parent


1,611 


2,113 

Non-controlling interests



10 

 


1,618 


2,123 

 





Total comprehensive income attributable to:





Owners of the parent


1,228 


2,273 

Non-controlling interests


12 


16 

 


1,240 


2,289 

 





Basic earnings per $0.25 Ordinary Share


$1.27 


$1.53 

Diluted earnings per $0.25 Ordinary Share


$1.27 


$1.53 

Weighted average number of Ordinary Shares in issue (millions)


1,267 


1,381 

Diluted weighted average number of Ordinary Shares in issue (millions)


1,269 


1,387 

 

 

Condensed Consolidated Statement of Financial Position

 


At 30 Jun 2012

$m


At 31 Dec 2011

$m


At 30 Jun 2011

$m

ASSETS

Non-current assets







Property, plant and equipment


6,047 


6,425 


6,832 

Goodwill


9,887 


9,862 


9,877 

Intangible assets


13,609 


10,980 


12,072 

Derivative financial instruments


324 


342 


319 

Other investments


167 


201 


218 

Deferred tax assets


1,579 


1,514 


1,397 

 


31,613 


29,324 


30,715 

Current assets







Inventories


2,039 


1,852 


2,021 

Trade and other receivables


7,462 


8,754 


8,320 

Other investments


1,555 


4,248 


679 

Derivative financial instruments



25 


Income tax receivable


1,072 


1,056 


1,538 

Cash and cash equivalents


7,641 


7,571 


9,613 

Assets classified as held for sale*




517 



19,777 


23,506 


22,691 

Total assets


51,390 


52,830 


53,406 

LIABILITIES

Current liabilities







Interest-bearing loans and borrowings


(2,008)


(1,990)


(372)

Trade and other payables


(8,972)


(8,975)


(8,513)

Derivative financial instruments



(9)


Provisions


(1,083)


(1,388)


(1,097)

Income tax payable


(2,738)


(3,390)


(3,660)

Liabilities classified as held for sale*




(196)



(14,801)


(15,752)


(13,838)

Non-current liabilities







Interest-bearing loans and borrowings


(7,310)


(7,338)


(9,210)

Deferred tax liabilities


(2,836)


(2,735)


(3,034)

Retirement benefit obligations


(2,523)


(2,674)


(2,354)

Provisions


(432)


(474)


(685)

Other payables


(1,248)


(385)


(470)



(14,349)


(13,606)


(15,753)

Total liabilities


(29,150)


(29,358)


(29,591)

Net assets


22,240 


23,472 


23,815 

EQUITY







Capital and reserves attributable to equity holders of the Company







Share capital


315 


323 


341 

Share premium account


3,328 


3,078 


3,010 

Other reserves


1,971 


1,951 


1,915 

Retained earnings


16,412 


17,894 


18,340 

 


22,026 


23,246 


23,606 

Non-controlling interests


214 


226 


209 

Total equity


22,240 


23,472 


23,815 

* Assets and liabilities held for sale at 30 June 2011 represent the assets and liabilities of Astra Tech

 

 

Condensed Consolidated Statement of Cash Flows

 

 

For the six months ended 30 June


2012 

$m 


 

2011 

$m 

Cash flows from operating activities





Profit before taxation


3,816 


6,146 

Finance income and expense


212 


220 

Depreciation, amortisation and impairment


1,009 


1,037 

Decrease/(increase) in working capital and short-term provisions


98 


(1,053)

Non-cash and other movements


(516)


(236)

Cash generated from operations


4,619 


6,114 

Interest paid


(285)


(282)

Tax paid


(1,543)


(3,003)

Net cash inflow from operating activities


2,791 


2,829 

Cash flows from investing activities





Movement in short-term investments and fixed deposits


2,805 


852 

Purchase of property, plant and equipment


(259)


(381)

Disposal of property, plant and equipment


148 


46 

Purchase of intangible assets


(224)


(294)

Purchase of non-current asset investments


(5)


(6)

Disposal of non-current asset investments


25 


Acquisitions of business operations


(1,187)


Interest received


71 


85 

Payments made by subsidiaries to non-controlling interests


(21)


(16)

Net cash inflow from investing activities


1,353 


286 

Net cash inflow before financing activities


4,144 


3,115 

Cash flows from financing activities





Proceeds from issue of share capital


252 


340 

Repurchase of shares for cancellation


(1,854)


(2,544)

Dividends paid


(2,505)


(2,646)

Hedge contracts relating to dividend payments


13 


41 

Movement in short-term borrowings


(62)


19 

Net cash outflow from financing activities


(4,156)


(4,790)

Net decrease in cash and cash equivalents in the period


(12)


(1,675)

Cash and cash equivalents at the beginning of the period


7,434 


10,981 

Amounts reclassified as held for sale



(47)

Exchange rate effects


(8)


40 

Cash and cash equivalents at the end of the period


7,414 


9,299 

Cash and cash equivalents consists of:





Cash and cash equivalents


7,641 


9,613 

Overdrafts


(227)


(314)



7,414 


9,299 

 

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 2011


352 


2,672


1,917 


18,272 


23,213 


197 


23,410 

Profit for the period





5,020 


5,020 


18 


5,038 

Other comprehensive income

 





298 


298 



302 

Transfer to other reserve




(15)


15 




Transactions with owners:















Dividends





(2,594)


(2,594)



(2,594)

Issue of Ordinary shares



338 




340 



340 

Repurchase of Ordinary shares


(13)



13 


(2,544)


(2,544)



(2,544)

Share-based payments





(127)


(127)



(127)

Transfer from non-controlling interests to payables







(6)


(6)

Dividend paid to non-controlling interests







(4)


(4)

Net movement


(11)


338


(2)


68 


393 


12 


405 

At 30 June 2011


341 


3,010


1,915 


18,340 


23,606 


209 


23,815 


















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 2012


323 


3,078


1,951


17,894 


23,246 


226 


23,472 

Profit for the period



-


-


3,251 


3,251 



3,260 

Other comprehensive income



-


-


(256)


(256)


(5)


(261)

Transfer to other reserve



-


10


(10)




Transactions with owners:















Dividends



-


-


(2,495)


(2,495)



(2,495)

Issue of Ordinary shares



250


-



252 



252 

Repurchase of Ordinary shares


(10)


-


10


(1,854)


(1,854)



(1,854)

Share-based payments



-


-


(118)


(118)



(118)

Transfer from non-controlling interests to payables



-


-




(5)


(5)

Dividend paid to non-controlling interests



-


-




(11)


(11)

Net movement


(8)


250


20


(1,482)


(1,220)


(12)


(1,232)

At 30 June 2012


315 


3,328


1,971


16,412 


22,026 


214 


22,240 

* Other reserves includes the capital redemption reserve and the merger reserve.

 

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 2012 and their respective responsibilities can be found on pages 100 and 101 of the AstraZeneca Annual Report and Form 20-F Information 2011 with the exceptions of Leif Johansson, Graham Chipchase and Geneviève Berger, who were appointed on 26 April 2012.  Michele Hooper retired from the Board on 26 April 2012.  David Brennan and Louis Schweitzer retired from the Board on 1 June 2012.  Leif Johansson was appointed as Non-Executive Chairman and Simon Lowth was appointed as Interim Chief Executive Officer on 1 June 2012.

 

Approved by the Board and signed on its behalf by

Simon Lowth

Interim Chief Executive Officer

26 July 2012

 

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 2012 (but not for the quarter ended 30 June 2012) 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 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") and as issued by the International Accounting Standards Board ("IASB"). 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 2012 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
 
15 Canada Square

London E14 5GL

 

26 July 2012

 

 

 

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 2012 have been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the European Union.  The annual financial statements of the Group are prepared in accordance with International Financial Reporting Standards (IFRSs) as adopted by the European Union and as issued by the International Accounting Standards Board. 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 2011, except where new or revised accounting standards have been applied. There has been no significant impact on the Group profit or net assets on adoption of new or revised accounting standards in the period.

 

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 and as such, the interim financial statements have been prepared on a Going Concern basis.

 

The information contained in Note 6 updates the disclosures concerning legal proceedings and contingent liabilities in the Group's Annual Report and Form 20-F Information 2011.

 

The comparative figures for the financial year ended 31 December 2011 are not the Company's statutory accounts for that financial year. Those accounts have been reported on by the Company'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 498(2) or (3) of the Companies Act 2006.

 

 

2      Net FUNDS

The table below provides an analysis of net funds and a reconciliation of net cash flow to the movement in net funds.



At 1 Jan 

2012 

$m 


Cash 

flow 

$m 


 

 

Acquisitions

$m


Non-cash 

mvmts 

$m 


Exchange 

mvmts 

$m 


At 30 Jun 2012

$m 

Loans due after one year


(7,338)



-



19 


(7,310)

Current instalments of loan


(1,769)



-


13 



(1,756)

Total loans


(9,107)



-


22 


19 


(9,066)

Other investments - current


4,248 


(2,805)


102


14 


(4)


1,555 

Net derivative financial instruments


358 


(13)


-


(13)



332 

Cash and cash equivalents


7,571 


78 


-



(8)


7,641 

Overdrafts


(137)


(90)


-




(227)

Short-term borrowings


(84)


62 


-



(3)


(25)



11,956 


(2,768)


102



(15)


9,276 

Net funds


2,849 


(2,768)


102


23 



210 

 

Non-cash movements in the period include fair value adjustments under IAS 39.

 

 

3      restructuring costs

Profit before tax for the six months ended 30 June 2012 is stated after charging restructuring costs of $907 million ($205 million for the second quarter 2012).  These have been charged to profit as follows:

 



2nd Quarter

2012
$m


2nd Quarter

2011
$m


Half Year

2012
$m


Half Year

2011
$m

Cost of sales


6



61


32

Research and development


136


79


581


169

Selling, general and administrative costs


63


39


265


80

Total


205


138


907


281

 

 

4      ARDEA ACQUISITION

 

On 19 June 2012, AstraZeneca completed the acquisition of Ardea Biosciences Inc. Ardea is a US (San Diego, California) based biotechnology company focused on the development of small molecule therapeutics for the treatment of serious diseases.  AstraZeneca acquired 100 percent of Ardea's shares for consideration of $1,268 million.

 

In most business acquisitions, there is a part of the cost that is not capable of being attributed in accounting terms to identifiable assets and liabilities acquired and is therefore recognised as goodwill. In the case of the acquisition of Ardea, this goodwill is underpinned by a number of elements, which individually cannot be quantified. Most significant amongst these is the premium attributable to a highly skilled workforce and established experience in the field of gout.

 

Ardea's results have been consolidated into the Company's results from 20 June 2012. For the period from acquisition to 30 June 2012, Ardea's revenues and net loss were immaterial. For the six months ended 30 June 2012, Ardea had revenues of $10 million and a net loss of $70 million.

 



Book value

$m


Fair value

adjustment

$m


 

Fair value

$m

Non-current assets







Intangible assets



1,464 


1,464 

Other







1,464 


1,468 

Current assets


199 



199 

Current liabilities


(31)


(1)


(32)

Non-current liabilities







Deferred tax liabilities



(397)


(397)




(397)


(397)

Total assets acquired


172 


1,066 


1,238 

Goodwill






30 

Fair value of total consideration






1,268 

Less: cash acquired






(81)

Cash outflow






1,187 

 

 

5      accounting impact from merck arrangements

 

In 1982, Astra AB set up a joint venture with Merck & Co., Inc. (now Merck Sharp & Dohme Corp., a subsidiary of the new Merck & Co., Inc. that resulted from the merger with Schering-Plough) ("Merck") for the purposes of selling, marketing and distributing certain Astra products in the US. In 1998, this joint venture was restructured (the "Restructuring"). Under the agreements relating to the Restructuring (the "Agreements"), a US limited partnership (the "Partnership") was formed, in which Merck is the limited partner and AstraZeneca is the general partner, and AstraZeneca obtained control of the joint venture's business subject to certain limited partner and other rights held by Merck and its affiliates. These rights provide Merck with safeguards over the activities of the Partnership and place limitations on AstraZeneca's commercial freedom to operate. The Agreements provide, in part, for:

 

·     Annual contingent payments; and

·     Termination arrangements which cause Merck to relinquish its interests in AstraZeneca's products and activities, some of which are mandatory and others optional.

 

Further details are set out in the Annual Report and Form 20-F Information 2011.

 

2008 Net Payment to Merck

As previously disclosed, on 17 March 2008 AstraZeneca made a net cash payment to Merck of approximately $2.6 billion in connection with the Partial Retirement, the True-Up and the Loan Note Receivable. This payment resulted in AstraZeneca acquiring Merck's interests in certain AstraZeneca products (including Pulmicort, Rhinocort, Symbicort and Toprol-XL), AstraZeneca ceasing contingent payments on these products and AstraZeneca obtaining the ability to exploit these products and other opportunities in the Respiratory therapy area. Intangible assets of $994 million were recognised at the time with the balance of the net payment ($1,656 million) representing payments on account for future product rights associated with the First Option and the Second Option (see below). These 'non-refundable deposits' were classified as intangible assets. 

 

First Option

As previously disclosed, on 26 February 2010 AstraZeneca exercised the First Option. Payment of $647 million to Merck was made on 30 April 2010. This payment resulted in AstraZeneca acquiring Merck's interests in products covered by the First Option including Entocort, Atacand, Plendil and the authorised generic version of felodipine, and certain products in development at the time (principally Brilinta and lesogaberan). On 30 April 2010, contingent payments on these products (except for the authorised generic version of felodipine) ceased with respect to periods after this date and AstraZeneca obtained the ability to exploit these products and other opportunities in the Cardiovascular and Neuroscience therapy areas. These rights were valued at $1,829 million and were recognised as intangible assets from 26 February 2010 ($1,182 million having been transferred from non-refundable deposits to supplement the payment of $647 million to Merck). The remaining non-refundable deposits of $474 million relate to benefits that would be secured upon AstraZeneca exercising the Second Option. (Contingent payments on the authorised generic version of felodipine will continue until the end of AstraZeneca's third party distribution arrangement. While this arrangement terminated in June 2012, the distributor is permitted to sell off its remaining stock over the next several months.)

 

Second Option

On 26 June 2012, AstraZeneca and Merck agreed to amend certain provisions of the Agreements with respect to the Second Option. AstraZeneca believes that the amendments provide a greater degree of certainty to the valuation of the Second Option that is preferable to the previous arrangements and, barring unforeseen circumstances, AstraZeneca now intends to exercise the Second Option in 2014.

 

The principal areas covered by the amendments are a change in the timing for AstraZeneca to exercise the Second Option, and agreement on the valuation methodology for setting certain aspects of the option exercise price. Under the amended Agreements, Merck has granted to AstraZeneca a new Second Option exercisable by AstraZeneca between 1 March 2014 and 30 April 2014, with closing on 30 June 2014. The options exercisable in 2017 or if combined annual sales fall below a minimum amount also remain available to AstraZeneca.

 

In addition to this revised timing for the Second Option, AstraZeneca and Merck have also reached agreement on the valuation methodology for setting certain components of the option exercise price for a 2014 exercise. In lieu of third-party appraisals, the valuation for a 2014 exercise is now a fixed sum of $327 million, based on a shared view by AstraZeneca and Merck of the forecasts for sales of Nexium and Prilosec in the US market.  The agreed amount that would be payable on 30 June 2014 is subject to a true-up in 2018 that replaces a shared forecast with actual sales for the period from closing in 2014 to June 2018.

 

In addition, the exercise price for the Second Option also includes a multiple of ten times Merck's average 1% annual profit allocation in the Partnership for the three years prior to exercise. AstraZeneca currently expects this amount to be around $80 million.

 

The component of the exercise price of the Second Option that includes the net present value of up to 5% of future US sales of Vimovo, with the precise amount dependent on an annual sales threshold that has not yet been achieved and the timing of the option exercise, will continue.

 

Under the amendments, if AstraZeneca exercises in 2014, Merck's existing rights to manufacture Nexium and Prilosec would cease upon closing.

 

In connection with the amendments, Merck also granted AstraZeneca flexibility to exploit certain commercial opportunities with respect to Nexium.

 

For accounting purposes, AstraZeneca now considers that exercise of the Second Option is virtually certain and is, in effect, no longer an option. This critical accounting judgement is supported by management's view that: AstraZeneca is fully committed to exercising the Second Option in 2014, barring unforeseen circumstances; external announcements of that intention constructively oblige AstraZeneca to exercise in 2014, barring unforeseen circumstances; and the Second Option price is highly favourable, giving economic compulsion for AstraZeneca to exercise in 2014. As such, AstraZeneca has applied an accounting treatment to reflect the Second Option as if the date of exercise were 26 June 2012 (the date of amendment of the Agreements), resulting in liabilities to Merck of approximately $1.4 billion ($1.0 billion of which will be paid by way of monthly contingent payments between 1 July 2012 and 30 June 2014 and the balance as a lump sum on 30 June 2014), and a corresponding increase to intangible assets, from that date.

 

These intangible assets are added to the $474 million carried over from the First Option and, in aggregate, reflect the value of the ability to exploit opportunities in the Gastrointestinal therapy area and relief from contingent payments.

 

Amortisation of these intangible assets commenced from 26 June 2012 and gives rise to an additional expense of approximately $140 million per annum charged to SG&A and an amortisation charge to Cost of Sales that is broadly equivalent to the contingent payment charges it replaces. AstraZeneca only excludes the amortisation expense charged to SG&A from the Core financial measures calculation and therefore there is only a negligible impact to Core financial measures from these developments.

 

The intangible assets relating to purchased product rights are subject to impairment testing and would be partially or wholly impaired if a product is withdrawn or if activity in any of the affected therapy areas is significantly curtailed.

 

 

6      LEGAL PROCEEDINGS AND CONTINGENT LIABILITIES

 

AstraZeneca is involved in various legal proceedings considered typical to its business, including litigation and investigations relating to product liability, commercial disputes, infringement of intellectual property rights, the validity of certain patents, anti-trust law and sales and marketing practices. 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 2011 (the "2011 Disclosures"). Unless noted otherwise below or in the 2011 Disclosures, no provisions have been established in respect of the claims discussed below.

 

As discussed in the 2011 Disclosures, 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.

 

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 2011 Disclosures and herein.

 

AstraZeneca has full confidence in, and will vigorously defend and enforce, its intellectual property.

 

Matters disclosed in respect of the first quarter of 2012 and April 2012

 

Patent/regulatory litigation

 

Arimidex  (anastrozole)

Patent proceedings outside the US

In March 2012, the Canadian Federal Court of Appeal dismissed Mylan Pharmaceuticals ULC's appeal against a decision prohibiting the Canadian Minister of Health from issuing it with a marketing authorisation.

 

Atacand Plus (candesartan cilexetil/hydrochlorothiazide)

Patent proceedings outside the US

In Canada, in February 2012, AstraZeneca settled notice of compliance proceedings with Cobalt Pharmaceuticals Inc., allowing that company to enter the Canadian market on 23 September 2012, or earlier, in certain circumstances.

 

Crestor (rosuvastatin calcium)

Patent proceedings in the US

In February 2012, the Federal Circuit affirmed the District Court's dismissal of AstraZeneca's patent infringement actions regarding two method-of-use patents for Crestor on pleading and ripeness grounds. AstraZeneca reserves the right to re-file the lawsuits at a later time.

 

Patent proceedings outside the US

In Canada, in February 2012, AstraZeneca reached settlement with Pharmascience Inc. (PMS) resolving the litigation regarding AstraZeneca's Crestor substance patent and, as part of the agreement, PMS may enter the Canadian market on 2 April 2012, or earlier, in certain circumstances.

 

In February 2012, the Federal Court of Australia dismissed Apotex Pty Ltd's (Apotex) motion to vacate a preliminary injunction preventing it from launching rosuvastatin in Australia. A further motion to vacate by Apotex was heard and denied in March 2012. A decision upholding the preliminary injunction was granted in favour of AstraZeneca on 23 March 2012. AstraZeneca's previously reported motions for preliminary injunctions against Watson Pharma Pty Ltd and Ascent Pharma Pty Ltd were granted in March 2012.

 

Entocort EC (budesonide)

Patent proceedings in the US

In April 2012, the US Court of Appeals for the Federal Circuit affirmed the US District Court decision that Mylan Pharmaceuticals Inc's generic budesonide product does not infringe AstraZeneca's patent protecting Entocort EC.

 

In February 2012, AstraZeneca received a notice letter from Santarus, Inc. (Santarus) stating that it had submitted a new drug application under §505(b)(2) for FDA approval to market a budesonide product. Santarus alleges non-infringement of a patent listed in the Orange Book in reference to Entocort EC. AstraZeneca is reviewing Santarus' notice.

 

Nexium  (esomeprazole magnesium)

Patent proceedings in the US

In April 2012, AstraZeneca entered into an agreement with Hetero Drugs Ltd, Unit III and Hetero USA Inc. (together, Hetero) settling AstraZeneca's patent infringement action against those entities. As part of the settlement, Hetero was granted a licence to enter the US market with generic esomeprazole magnesium on 27 May 2014, subject to regulatory approval, or earlier, in certain circumstances.

 

In January 2012, AstraZeneca received a Paragraph IV notice letter from Mylan Laboratories Ltd. (Mylan). In March 2012, AstraZeneca commenced a patent infringement action against Mylan in the US District Court for the District of New Jersey.

 

Patent proceedings outside the US

In March 2012, AstraZeneca discontinued its previously disclosed notice of compliance proceeding pending with Mylan Pharmaceuticals ULC (Mylan) with respect to Canadian Nexium substance patent number 2.290.963 after Mylan withdrew its notice of allegation.

 

Seroquel (quetiapine fumarate) and Seroquel XR (quetiapine fumarate)

US regulatory proceedings

On 12 March 2012, AstraZeneca filed a lawsuit against the FDA in the US District Court for the District of Columbia to overturn the FDA's 7 March 2012 denial of Citizen Petitions that asked the FDA to withhold final approval of any generic quetiapine that omits from its labelling certain hyperglycemia and suicidality warning language that the FDA required AstraZeneca to include in the Seroquel and Seroquel XR labelling. In the lawsuit, AstraZeneca sought to enjoin the FDA from finally approving any generic quetiapine until December 2012 when regulatory exclusivity expires for certain clinical trial data associated with the hyperglycemia warning language, or, alternatively, at least until a federal court had reviewed any FDA decision to finally approve generic quetiapine. On 23 March 2012, the District Court denied the preliminary injunction and dismissed the lawsuit without prejudice, and without reaching a decision on the merits, on the basis that filing the lawsuit prior to final FDA approval was premature. On 28 March 2012, in response to being notified by the FDA that generic versions of quetiapine had been finally approved, AstraZeneca filed a new lawsuit in the US District Court for the District of Columbia seeking a temporary restraining order (TRO) to vacate these approvals, and to enjoin any further approvals of generic quetiapine. The Court denied the request for a TRO and ordered expedited briefing on the merits to proceed.

 

Seroquel XR (quetiapine fumarate)

Patent proceedings in the US

In February 2012, the US District Court for the District of New Jersey dismissed the patent infringement action against Intellipharmaceutics Corp. and Intellipharmaceutics International Inc. (together, Intellipharmaceutics) for lack of personal jurisdiction. The patent infringement action against Intellipharmaceutics is now pending in the United States District Court for the Southern District of New York.

 

As previously reported, in October 2011, the US District Court for the District of New Jersey conducted a trial in the patent infringement actions involving the Seroquel XR formulation patent against certain generic drug manufacturers. In March 2012, the Court found the Seroquel XR formulation patent to be valid. The Court also found that Anchen Pharmaceuticals, Inc., Osmotica Pharmaceutical Corporation, Torrent Pharmaceuticals Limited, Torrent Pharma Inc., Mylan Pharmaceuticals Inc. and Mylan Inc. have infringed the Seroquel XR formulation patent. The decision has been appealed.

 

Patent proceedings outside the US

In the Netherlands, in March 2012, the District Court in the Hague upheld the validity of the formulation patent protecting Seroquel XR.

 

In the UK, in March 2012, the UK High Court found the Seroquel XR formulation patent invalid.

 

A hearing regarding the validity of the Seroquel XR formulation patent has been held in Spain and a decision is pending.

 

Generic versions of Seroquel XR have been launched in Germany, Austria and Denmark. AstraZeneca has confidence in the patent protecting Seroquel XR and will continue to take appropriate legal action. While AstraZeneca continues to have confidence in the intellectual property protecting Seroquel XR, additional generic launches and adverse Court rulings are possible.

 

Product liability litigation

 

Crestor (rosuvastatin calcium)

AstraZeneca is defending five lawsuits involving a total of 115 plaintiffs claiming injury from treatment with Crestor. The lawsuits were filed in March 2012 in California state courts. The lawsuits allege multiple types of injuries including diabetes mellitus, various cardiac injuries, rhabdomyolsis, and various liver and kidney injuries. AstraZeneca intends to defend the claims vigorously. Six plaintiffs previously filed suit in San Francisco County in 2011 for similar injuries allegedly caused by Crestor, but these cases have been stayed or dismissed.

 

Commercial litigation

 

Synagis  (palivizumab)

In September 2011, AstraZeneca's biologics arm, MedImmune, filed an action against Abbott International, LLC (Abbott) in the Circuit Court for Montgomery County, Maryland, seeking a declaratory judgment in a contract dispute. Abbott's motion to dismiss was granted. In September 2011, Abbott filed a parallel action against MedImmune in the Illinois State Court. Abbott's motion to hold the disputed funds in escrow was rejected. In February 2012, the Court denied MedImmune's motion to dismiss and is expected to set a trial date for 2013.

 

Co-payment subsidy litigation

In March 2012, the New England Carpenters Health and Welfare Fund, on behalf of a proposed class of payers that reimbursed consumers for Nexium and Crestor prescriptions as to which AstraZeneca subsidised the consumer's co-payment obligation, brought an action against AstraZeneca in the US District Court for the Eastern District of Pennsylvania. The complaint seeks unspecified treble damages and costs (including attorneys' fees), as well as an injunction prohibiting AstraZeneca from offering its co-payment subsidy programmes. Similar claims have been filed in other federal courts against seven other manufacturers with respect to their respective co-payment subsidy programmes.

 

Government investigations/proceedings

 

Nexium  (esomeprazole magnesium)

The European Commission has closed its investigation into alleged practices regarding Nexium and alleged breaches of EU competition laws.

 

Seroquel (quetiapine fumarate)

In March 2012, AstraZeneca reached an agreement in principle to settle the claims of the Montana State Attorney General regarding allegedly false and/or misleading statements made by AstraZeneca in the marketing and promotion of Seroquel, and a provision has been taken.

 

Indian Central Bureau of Investigation

In India, in February 2012, a criminal First Information Request (FIR) was filed by the Indian Central Bureau of Investigation against AstraZeneca and public officials of the Central Procurement Agency of the Delhi Directorate of Health Services (DHS). The FIR alleges that AstraZeneca submitted a false affidavit in connection with a tender for meropenem with the DHS in which AstraZeneca stated that the prices quoted were not higher than the rates quoted to other governmental, semi-governmental, autonomous or public sector hospitals, institutions or organisations, while, the FIR alleges, AstraZeneca sold the same medicine at a lower rate to another hospital, resulting in a loss to the DHS. It is further alleged in the FIR that unspecified officers of the DHS and AstraZeneca collectively sought to cancel the DHS recovery proceedings to recover any overpayment through the issuance of a "Show Cause Notice". AstraZeneca is evaluating the allegations

 

Matters disclosed in respect of the second quarter of 2012 and July 2012

 

Patent/regulatory litigation

 

Atacand Plus (candesartan cilexetil/hydrochlorothiazide)

Patent proceedings outside the US

In Canada, in May 2012, AstraZeneca settled notice of compliance proceedings with Apotex Inc. allowing that company to enter the Canadian market on 23 September 2012, or earlier, in certain circumstances.

 

Losec  (omeprazole)

Patent proceedings outside the US

In May 2012, in Canada, the Federal Court found AstraZeneca liable to Apotex Inc. for section 8 damages arising from notice of compliance proceedings that were finally dismissed in December 2003. The actual amount of damages owing, if any, will be determined at a future date by a court reference procedure.

 

Nexium (esomeprazole magnesium)

Patent proceedings in the US

In May 2012, AstraZeneca entered into an agreement with Torrent Pharmaceuticals Ltd. (Torrent) settling AstraZeneca's patent infringement action against Torrent. As part of the settlement, Torrent was granted a licence to enter the US market with generic esomeprazole magnesium on 27 May 2014, subject to regulatory approval, or earlier, in certain circumstances.

 

As previously disclosed, in 2011, AstraZeneca commenced patent litigation in the US District Court for the District of New Jersey against Hanmi USA Inc. et al. (Hanmi) in response to Hanmi's Paragraph IV notice letter that Hanmi had filed an NDA under section 505(b)(2) for FDA approval to market 20mg and 40mg esomeprazole strontium capsules. In 2011, Hanmi filed five summary judgment motions. In June 2012, the Court dismissed two of these five motions. The Court has not issued decisions regarding the remaining three motions. The Court has indicated that a trial may occur in April 2013.

 

Seroquel (quetiapine fumarate) and Seroquel XR (quetiapine fumarate)

US regulatory proceedings

On 28 June 2012, the US District Court for the District of Columbia denied AstraZeneca's and granted the FDA's cross motions for summary judgment on the issue of exclusivity for Seroquel IR.  AstraZeneca is evaluating its options.

 

Patent proceedings in the US

In July 2012, AstraZeneca received a Paragraph IV notice letter from Amneal Pharmaceuticals, LLC. AstraZeneca is evaluating the notice.

 

Patent proceedings outside the US

AstraZeneca is engaged in numerous proceedings throughout the world regarding Seroquel XR related patents and/or regulatory exclusivity for Seroquel XR.

 

In July 2012, the District Court in Barcelona found the Seroquel XR formulation patent valid.

 

Generic versions of Seroquel XR have been launched in several countries. AstraZeneca has confidence in the patent protecting Seroquel XR and will continue to take appropriate legal action. While AstraZeneca continues to have confidence in the intellectual property protecting Seroquel XR, additional generic launches and adverse court rulings are possible.

 

Product liability litigation

 

Nexium  (esomeprazole magnesium)

As previously disclosed, AstraZeneca has been named as a defendant in product liability lawsuits brought by plaintiffs alleging bone deterioration, loss of bone density and/or bone fractures caused by Nexium and/or Prilosec in the US.  Currently, there are 19 served cases involving approximately 1,400 plaintiffs, the majority of which were filed in the second quarter of 2012.

 

Seroquel (quetiapine fumarate)

In 2006, a statement of claim was filed in an Ontario court alleging, among other claims, that AstraZeneca was aware of certain health risks allegedly associated with Seroquel and that it failed to adequately warn patients of them. A motion seeking to certify the claim as a class action was heard in November 2011. In May 2012, the Ontario Superior Court of Justice dismissed the certification motion. The plaintiffs have appealed.

 

Iressa  (gefitinib)

AstraZeneca and the Japanese Ministry of Health, Labour and Welfare (MHLW) had previously appealed the February 2011 decision of the Osaka District Court which ordered AstraZeneca to pay approximately $670,000, plus interest.  On 25 May 2012, the Osaka High Court reversed the Osaka District Court decision and ruled that neither AstraZeneca, nor the MHLW, had any liability for any of the claims.  On 5 June 2012, the plaintiffs appealed the Osaka High Court decision to the Japanese Supreme Court.

 

Commercial litigation

 

Average Manufacturer's Price qui tam litigation (Streck)

On 3 July 2012, the Federal Court in Philadelphia entered an order granting in part and denying in part the Defendants' motion to dismiss. As to AstraZeneca, the Court dismissed Plaintiffs' claims, both state and federal, for all Average Manufacturer Price submissions made before 1 January 2007 but denied the motion to dismiss all claims regarding submissions made after 1 January 2007.

 

Average Wholesale Pricing litigation

In April 2012, AstraZeneca and AstraZeneca's biologics arm, MedImmune, reached a settlement with the Attorney General of Louisiana to settle claims in the average wholesale pricing litigation brought by the State.  A provision has been taken.  The Louisiana court dismissed the case on 29 June 2012.

 

Shionogi Arbitration - Crestor Royalty Calculation

On 20 July 2012, Shionogi & Co. Ltd initiated arbitration proceedings to resolve issues relating to the treatment of certain excise taxes and other specific items in the calculation of royalties on Crestor sales.

 

Toprol-XL (metoprolol succinate)

As previously disclosed, AstraZeneca is defending anti-trust claims in the US regarding the listing and enforcement of patents protecting Toprol-XL. AstraZeneca has entered into an agreement in principle to settle the remaining claims alleged by end-payers. A provision has been taken.

 

Government investigations/proceedings

 

Nexium  (esomeprazole magnesium)

In the Dutch Competition Authority (NMa) investigation into alleged abuse of a dominant position, the investigation team issued a report alleging foreclosure of generic versions of certain proton pump inhibitors other than esomeprazole. The file has now been passed to the Legal Department of the NMa. AstraZeneca completed its defence in April 2012 and awaits a decision by the Board of the NMa later in 2012.

 

Seroquel (quetiapine fumarate)

In July 2012, AstraZeneca received a civil investigative demand from the Office of the Attorney General for the State of Texas in connection with an investigation related to sales and marketing activities potentially involving Seroquel.

 

In June 2012, AstraZeneca executed an agreement to settle and dismiss the claims brought by the New Mexico State Attorney General regarding allegedly false and/or misleading statements made by AstraZeneca in the marketing and promotion of Seroquel and reached an agreement in principle to settle and dismiss similar claims brought by the Utah State Attorney General, pending documentation. Provisions have been taken in the second quarter.  In July 2012, AstraZeneca also reached an agreement in principle to settle and dismiss similar claims brought by the South Carolina State Attorney General, pending documentation. A provision will be taken in July.

 

Synagis  (palivizumab)

As previously disclosed, on 30 June 2011, AstraZeneca's biologics arm, MedImmune, received a demand from the US Attorney's Office for the Southern District of New York requesting certain documents related to the sales and marketing activities of Synagis. On 1 July 2011, MedImmune received a similar court order to produce documents from the Office of the Attorney General for the State of New York Medicaid and Fraud Control Unit pursuant to what the government attorneys advised was a joint investigation. MedImmune has accepted receipt of these requests and is coordinating with the Government offices to provide the appropriate responses and cooperate with any related investigation. The precise scope of these investigations is unknown and AstraZeneca is not in a position, at this time, to predict the scope, duration or outcome of these matters, including whether they will result in any liability to AstraZeneca.

 

On 10 May 2012, AstraZeneca's biologics arm, MedImmune, received a subpoena duces tecum from the Office of Attorney General for the State of Florida Medicaid and Fraud Control Unit requesting certain documents related to the sales and marketing activities of Synagis. MedImmune has accepted receipt of the request and is coordinating with the Florida Government to provide the appropriate responses and cooperate with any related investigation. AstraZeneca is unaware of the nature or focus of the investigation, however, based on the nature of the requests it appears to be similar to the inquiries from the State of New York and Department of Justice (which is mentioned above).

 

Serbia

As previously disclosed, after the Serbian court dismissed an indictment against AstraZeneca and other pharmaceutical companies which alleged that local employees of the defendants made improper payments to physicians, the Serbian prosecutor amended and re-served the indictment. In December 2011, AstraZeneca again requested dismissal from the Serbian court.  In May 2012, the Court denied AstraZeneca's request to dismiss the amended indictment and joined the proceedings against AstraZeneca and the other named pharmaceutical companies with the pending proceedings against the allegedly involved individual defendants.  AstraZeneca has filed an appeal with the Serbian Constitutional Court.

 


7      FIRST HALF product REVENUE analysis       



World


US


Western Europe


Established ROW


Emerging ROW

 



1st Half

2012

$m


Actual
Growth
%


Constant
 Currency
Growth

%


1st Half

2012

$m


Actual
Growth
%


1st Half

2012

$m


Actual
Growth
%


Constant
 Currency
Growth

%


1st Half

2012

$m


Actual
Growth
%


Constant
 Currency
Growth

%


1st Half

2012

$m


Actual
Growth
%


Constant
 Currency
Growth

%

Gastrointestinal:





























Nexium


1,902


(16)


(15)


1,089 


(10)


233


(49)


(46)


219


(8)


(8)


361


(2)


Losec/Prilosec


365


(23)


(22)


17 


(19)


104


(18)


(13)


159


(25)


(27)


85


(25)


(26)

Other


94


25 


27 


68 


45 


18


(18)


(14)


4




4


100 


100 

Total Gastrointestinal


2,361


(16)


(15)


1,174 


(8)


355


(41)


(38)


382


(16)


(17)


450


(7)


(4)

Cardiovascular:





























Crestor


3,087


(3)


(2)


1,469 


(1)


592


(3)



694


(9)


(10)


332


(1)


Atacand


586


(21)


(18)


76 


(20)


289


(20)


(16)


76


(38)


(37)


145


(11)


(6)

Seloken/Toprol-XL


432


(9)


(7)


145 


(24)


34


(17)


(12)


16


(16)


(16)


237



Tenormin


117


(13)


(11)




26


(13)


(7)


53


(12)


(13)


32


(16)


(13)

Plendil


133





(25)


10


(17)


(17)


7


17 


17 


113



ONGLYZATM


151


86 


86 


112 


90 


22


47 


47 


6


200 


200 


11


120 


120 

Brilinta/Brilique


27


n/m 


n/m 



n/m 


18


n/m 


n/m 


-




6


n/m 


n/m 

Others


167


(17)


(13)



(20)


81


(18)


(13)


17


(19)


(19)


65


(14)


(12)

Total Cardiovascular


4,700


(5)


(3)


1,818 


(1)


1,072


(9)


(4)


869


(13)


(13)


941


(1)


Respiratory:





























Symbicort


1,518


(2)



466 


16 


660


(9)


(5)


180


(9)


(9)


212


(7)


(2)

Pulmicort


433


(11)


(9)


116 


(30)


84


(18)


(15)


60




173


11 


13 

Rhinocort


87


(21)


(19)


31 


(28)


16


(24)


(19)


6


(33)


(33)


34


(8)


(5)

Others


91


(17)


(15)



25 


48


(14)


(11)


12




26


(32)


(29)

Total Respiratory


2,129


(6)


(3)


618 



808


(11)


(6)


258


(7)


(8)


445


(3)


Oncology:





























Zoladex


548


(5)


(3)


12 


(45)


115


(13)


(10)


218


(7)


(8)


203



12 

Arimidex


291


(30)


(29)


13 


(55)


73


(55)


(52)


141


(4)


(5)


64


(17)


(14)

Iressa


297


14 


15 



(100)


70


19 


25 


102




125


18 


17 

Casodex


231


(15)


(15)


(2)


n/m 


28


(38)


(33)


151


(12)


(15)


54


(2)


Faslodex


312


21 


24 


147 


16 


92




25


n/m 


n/m 


48


23 


33 

Others


64


14 


14 


12 


140 


7




29


(3)


(7)


16


14 


21 

Total Oncology


1,743


(5)


(4)


182 


(1)


385


(22)


(18)


666


(2)


(4)


510



10 

Neuroscience:





























Seroquel IR


1,031


(52)


(52)


668 


(59)


165


(41)


(39)


110



(2)


88


(29)


(26)

Seroquel XR


754




396 



236


(1)



46




76


21 


29 

Local Anaesthetics


272


(11)


(8)



(100)


108


(14)


(10)


99




65


(12)


(8)

Zomig


102


(50)


(49)



(91)


63


(26)


(22)


26


(26)


(26)


6


(14)


(14)

Diprivan


145


(7)


(6)



(100)


18


(22)


(17)


39


(7)


(10)


88


11 


14 

Vimovo


33


230 


240 


15 


88 


9


n/m 


n/m 


6


n/m 


n/m 


3


 n/m 


n/m 

Others


18


(5)




400 


6


(40)


(40)


1


(50)


(50)


6



17 

Total Neuroscience


2,355


(34)


(33)


1,091 


(49)


605


(21)


(17)


327


(1)


(2)


332


(6)


(1)

Infection & Other:





























Synagis


439


(4)


(4)


303 



136


(12)


(12)


-




-



Merrem


200


(39)


(37)


10 


(64)


37


(67)


(65)


14


(58)


(58)


139


(11)


(7)

FluMist


4


33 


33 



100 


-




-




-


(100)


(100)

Others


35


(51)


(51)


16 


(64)


3


(40)


(40)


6


(14)


(14)


10


(38)


(38)

Total Infection & Other


678


(21)


(20)


333 


(11)


176


(35)


(35)


20


(50)


(50)


149


(14)


(10)

Aptium Oncology


43


(62)


(62)


43 


(62)


-




-




-


-


Astra Tech


-


(100)


(100)



(100)


-


(100)


(100)


-


(100)


(100)


-


(100)


(100)

Total


14,009


(16)


(15)


5,259 


(20)


3,401


(23)


(20)


2,522


(10)


(11)


2,827


(3)


 

8              SECOND QUARTER product REVENUE analysis



World


US


Western Europe


Established ROW


Emerging ROW

 



2nd Quarter

2012

$m


Actual
Growth
%


Constant
 Currency
Growth

%


2nd Quarter

2012

$m


Actual
Growth
%


2nd Quarter

2012

$m


Actual
Growth
%


Constant
 Currency
Growth

%


2nd Quarter

2012

$m


Actual
Growth
%


Constant
 Currency
Growth

%


2nd Quarter

2012

$m


Actual
Growth
%


Constant
 Currency
Growth

%

Gastrointestinal:





























Nexium


949


(15)


(13)


554 


(10)


112


(41)


(37)


98


(16)


(15)


185


(3)


Losec/Prilosec


195


(18)


(16)



13 


60


(6)



87


(26)


(26)


39


(22)


(22)

Other


42


17 


19 


30 


36 


8


(27)


(18)


3




1



Total Gastrointestinal


1,186


(14)


(12)


593 


(8)


180


(32)


(26)


188


(21)


(20)


225


(7)


(2)

Cardiovascular:





























Crestor


1,587


(7)


(5)


787 


(1)


295


(9)


(1)


331


(21)


(20)


174



Atacand


269


(30)


(25)


36 


(27)


120


(36)


(30)


37


(39)


(36)


76


(13)


(7)

Seloken/Toprol-XL


208


(10)


(7)


72 


(21)


18


(14)


(5)


8


(20)


(20)


110



Tenormin


60


(15)


(13)




13


(13)



28


(7)


(7)


16


(30)


(30)

Plendil


60


(3)


(5)



(33)


5


(17)


(17)


4


33 


33 


49


(2)


(4)

ONGLYZATM


79


72 


72 


58 


76 


11


22 


22 


4


300 


300 


6


100 


100 

Brilinta/Brilique


18


n/m 


n/m 



n/m 


12


n/m 


n/m 


-




3


n/m 


n/m 

Others


83


(22)


(17)




40


(25)


(15)


9


(18)


(18)


32


(22)


(20)

Total Cardiovascular


2,364


(10)


(7)


963 


(1)


514


(17)


(9)


421


(21)


(20)


466


(5)


Respiratory:





























Symbicort


795


(1)



249 


21 


334


(12)


(5)


108




104


(10)


(3)

Pulmicort


206


(13)


(10)


60 


(32)


39


(20)


(14)


31




76


10 


14 

Rhinocort


43


(22)


(18)


15 


(21)


8


(33)


(25)


3


(40)


(40)


17


(11)


(5)

Others


43


(22)


(18)




24


(20)


(13)


8


33 


33 


9


(47)


(47)

Total Respiratory


1,087


(5)


(1)


326 



405


(14)


(7)


150




206


(6)


(1)

Oncology:





























Zoladex


275


(9)


(6)



(40)


57


(17)


(13)


113


(8)


(7)


99


(1)


Arimidex


147


(19)


(16)



(40)


36


(35)


(29)


73


(4)


(4)


32


(20)


(15)

Iressa


154


11 


13 




34



12 


56


10 


10 


64


16 


16 

Casodex


118


(14)


(13)


(2)


n/m 


14


(36)


(27)


78


(14)


(15)


28



Faslodex


161


19 


24 


75 


15 


47


(4)



15


n/m 


n/m 


24


20 


35 

Others


35


21 


21 



100 


4


(20)


(20)


16




9


80 


80 

Total Oncology


890


(4)


(1)


91 



192


(18)


(11)


351


(2)


(2)


256



Neuroscience:





























Seroquel IR


277


(76)


(75)


126 


(86)


52


(64)


(61)


54


(2)


(2)


45


(27)


(23)

Seroquel XR


370


(4)


(1)


197 


(4)


112


(13)


(6)


23




38


27 


40 

Local Anaesthetics


140


(10)


(5)



(100)


53


(16)


(8)


52




35


(8)


(3)

Zomig


48


(53)


(50)



(95)


29


(34)


(30)


13


(28)


(28)


4


33 


67 

Diprivan


79


(8)


(6)



(100)


8


(27)


(18)


21




50



Vimovo


17


183 


200 



20 


5


n/m 


n/m 


3


n/m 


n/m 


3


n/m 


n/m 

Others


12


33 


44 



400 


3


(25)


(25)


1




3



33 

Total Neuroscience


943


(50)


(48)


336 


(71)


262


(34)


(29)


167


(2)


(1)


178


(2)


Infection & Other:





























Synagis


55


15 


15 



(100)


54


26 


26 


-




-



Merrem


100


(37)


(33)



(92)


18


(65)


(62)


6


(68)


(68)


75



FluMist


2


n/m 


n/m 



n/m 


-




-




-



Others


19


(41)


(41)


12 


(19)


1


(50)


(150)


1



100 


5


(69)


(62)

Total Infection & Other


176


(26)


(24)


16 


(53)


73


(25)


(25)


7


(65)


(60)


80


(8)


(2)

Aptium Oncology


14


(77)


(77)


14 


(77)


-




-




-



Astra Tech


-


(100)


(100)



(100)


-


(100)


(100)


-


(100)


(100)


-


(100)


(100)

Total


6,660


(21)


(18)


2,339 


(29)


1,626


(26)


(20)


1,284


(13)


(12)


1,411


(4)


       


Shareholder Information

ANNOUNCEMENTS AND MEETINGS

_____________________________________________________________________________________________________________________________________________________________________

 

Announcement of third quarter and nine months 2012 results                 25 October 2012

Announcement of fourth quarter and full year 2012 results                        31 January 2013

 

DIVIDENDS

_____________________________________________________________________________________________________________________________________________________________________

 

The record date for the first interim dividend payable on 10 September 2012 is 10 August 2012. Shares will trade ex-dividend from 8 August 2012.

 

Future dividends will normally be paid as follows:

First interim

Announced in July and paid in September

Second interim

Announced in January and paid in March

 

TRADEMARKS

_____________________________________________________________________________________________________________________________________________________________________

 

Trademarks of the AstraZeneca group of companies appear throughout this document in italics. AstraZeneca, the AstraZeneca logotype and the AstraZeneca symbol are all trademarks of the AstraZeneca group of companies. Trademarks of companies other than AstraZeneca appear with a ® or ™ sign and include: ONGLYZA™ and KOMBIGLYZE XR™, trademarks of Bristol-Myers Squibb Company; BYETTA®, BYDUREON® and SYMLIN®, trademarks of Amylin Pharmaceuticals, Inc.; TEFLARO®, a trademark of Forest Laboratories, Inc.

 

ADDRESSES FOR CORRESPONDENCE

_____________________________________________________________________________________________________________________________________________________________________

 

Registrar and

Transfer Office

Equiniti Limited

Aspect House

Spencer Road

Lancing

West Sussex

BN99 6DA

UK

 

US Depositary

JP Morgan Chase & Co

PO Box 64504

St Paul

MN 55164-0504

US

 

 

 

Registered Office

2 Kingdom Street

London

W2 6BD

UK

 

 

Swedish Central Securities Depository

Euroclear Sweden AB

PO Box 191

SE-101 23 Stockholm

Sweden

 

 

Tel (freephone in UK):
0800 389 1580

Tel (outside UK):
+44 (0)121 415 7033

Tel (toll free in US):

888 697 8018

Tel (outside US):

+1 (651) 453 2128

Tel: +44 (0)20 7604 8000

Tel: +46 (0)8 402 9000

 

CONTACT INFORMATION

_____________________________________________________________________________________________________________________________________________________________________

 

 

Media Enquiries:                                                      Esra Erkal-Paler (London)                                       +44 20 7604 8030

Sarah Lindgreen  (London)                                     +44 20 7604 8033

Tony Jewell (Wilmington)                                        +1 302 885 4594

Ann-Leena Mikiver (Södertälje)                              +46 8 553 260 20/+46 707 428836

 

Analyst/Investor Enquiries:                                     James Ward-Lilley (London)                                   +44 20 7604 8122

Karl Hård (London)                                                 +44 20 7604 8123

Nicklas Westerholm (London)                                 +44 20 7604 8124

Ed Seage/Jörgen Winroth (US)                               +1 302 886 4065/+1 212 579 0506

 

 

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

_____________________________________________________________________________________________________________________________________________________________________

 

In 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: The interim financial statements contain certain forward-looking statements 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 to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of preparation of the interim financial statements 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, among other things: the loss or expiration of patents, marketing exclusivity or trademarks, 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, 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 failure to 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 implementation and enforcement of more stringent anti-bribery and anti-corruption legislation.


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