3rd Quarter Results - Part 2

RNS Number : 5759B

AstraZeneca PLC

29 October 2009

 

Condensed Consolidated Statement of Comprehensive Income    

For the nine months ended 30 September		2009 $m		2008 $m
Revenue		23,859		23,408
Cost of sales		(4,110)		(4,486)
Gross profit		19,749		18,922
Distribution costs		(207)		(220)
Research and development		(3,095)		(3,824)
Selling, general and administrative costs*		(7,867)		(8,057)
Other operating income and expense		638		431
Operating profit		9,218		7,252
Finance income		332		637
Finance expense		(907)		(1,024)
Profit before tax		8,643		6,865
Taxation		(2,661)		(1,994)
Profit for the period		5,982		4,871
Other comprehensive income:
Foreign exchange arising on consolidation		430		(439)
Foreign exchange differences on borrowings forming net investment hedges		(95)		112
Net available for sale gains/(losses) taken to equity		2		(1)
Actuarial loss for the period		(65)		(150)
Income tax relating to components of other comprehensive income		56		82
Other comprehensive income for the period, net of tax		328		(396)
Total comprehensive income for the period		6,310		4,475
Profit attributable to:
Owners of the parent		5,968		4,853
Non-controlling interests		14		18
		5,982		4,871
Total comprehensive income attributable to:
Owners of the parent		6,293		4,451
Non-controlling interests		17		24
		6,310		4,475
Basic earnings per $0.25 Ordinary Share		$4.12		$3.34
Diluted earnings per $0.25 Ordinary Share		$4.12		$3.33
Weighted average number of Ordinary Shares in issue (millions)		1,448		1,455
Diluted average number of Ordinary Shares in issue (millions)		1,449		1,456

* 2009 includes provisions totalling $538 million with respect to various federal and state investigations and civil litigation matters relating to drug marketing and pricing practices (see Note 4).

  Condensed Consolidated Statement of Comprehensive Income    

For the quarter ended 30 September		2009 $m		2008 $m
Revenue		8,200		7,775
Cost of sales		(1,263)		(1,529)
Gross profit		6,937		6,246
Distribution costs		(73)		(79)
Research and development		(1,056)		(1,291)
Selling, general and administrative costs*		(2,663)		(2,486)
Other operating income and expense		59		132
Operating profit		3,204		2,522
Finance income		125		235
Finance expense		(297)		(314)
Profit before tax		3,032		2,443
Taxation		(911)		(705)
Profit for the period		2,121		1,738
Other comprehensive income:
Foreign exchange arising on consolidation		200		(693)
Foreign exchange differences on borrowings forming net investment hedges		(20)		274
Net available for sale gains taken to equity		5		3
Actuarial gain/(loss) for the period		50		(113)
Income tax relating to components of other comprehensive income		4		2
Other comprehensive income for the period, net of tax		239		(527)
Total comprehensive income for the period		2,360		1,211
Profit attributable to:
Owners of the parent		2,115		1,730
Non-controlling interests		6		8
		2,121		1,738
Total comprehensive income attributable to:
Owners of the parent		2,345		1,202
Non-controlling interests		15		9
		2,360		1,211
Basic earnings per $0.25 Ordinary Share		$1.46		$1.20
Diluted earnings per $0.25 Ordinary Share		$1.46		$1.19
Weighted average number of Ordinary Shares in issue (millions)		1,449		1,452
Diluted average number of Ordinary Shares in issue (millions)		1,453		1,455

* 2009 includes provisions totalling $108 million with respect to various federal and state investigations and civil litigation matters relating to drug marketing and pricing practices (see Note 4).  Condensed Consolidated Statement of Financial Position

		As at 30 Sep 2009 $m		As at 31 Dec 2008 $m		As at 30 Sep 2008 $m
ASSETS Non-current assets
Property, plant and equipment		7,363		7,043		7,830
Goodwill		9,893		9,874		9,870
Intangible assets		12,230		12,323		13,223
Derivative financial instruments		351		449		158
Other investments		183		156		179
Deferred tax assets		1,339		1,236		1,374
		31,359		31,081		32,634
Current assets
Inventories		1,898		1,636		2,083
Trade and other receivables		8,008		7,261		7,181
Other investments		40		105		55
Income tax receivable		2,800		2,581		2,710
Cash and cash equivalents		7,794		4,286		3,541
		20,540		15,869		15,570
Total assets		51,899		46,950		48,204
LIABILITIES Current liabilities
Interest bearing loans and borrowings		(980)		(993)		(2,546)
Trade and other payables		(7,385)		(7,178)		(6,939)
Derivative financial instruments		(108)		(95)		(76)
Provisions		(1,052)		(600)		(359)
Income tax payable		(5,591)		(4,549)		(4,536)
		(15,116)		(13,415)		(14,456)
Non-current liabilities
Interest bearing loans and borrowings		(10,290)		(10,855)		(10,826)
Derivative financial instruments		-		(71)		(55)
Deferred tax liabilities		(3,273)		(3,126)		(3,864)
Retirement benefit obligations		(2,880)		(2,732)		(2,018)
Provisions		(553)		(542)		(567)
Other payables		(234)		(149)		(186)
		(17,230)		(17,475)		(17,516)
Total liabilities		(32,346)		(30,890)		(31,972)
Net assets		19,553		16,060		16,232
EQUITY
Capital and reserves attributable to equity holders of the Company
Share capital		363		362		362
Share premium account		2,130		2,046		2,005
Other reserves		1,913		1,932		1,915
Retained earnings		14,988		11,572		11,823
		19,394		15,912		16,105
Non-controlling interests		159		148		127
Total equity		19,553		16,060		16,232

  Condensed Consolidated Statement of Cash Flows 

For the nine months ended 30 September		2009 $m		2008 $m
Cash flows from operating activities
Profit before taxation		8,643		6,865
Finance income and expense		575		387
Depreciation, amortisation and impairment		1,312		1,693
Increase in working capital		(239)		(862)
Other non-cash movements		(109)		196
Cash generated from operations		10,182		8,279
Interest paid		(512)		(536)
Tax paid		(2,013)		(1,792)
Net cash inflow from operating activities		7,657		5,951
Cash flows from investing activities
Movement in short term investments and fixed deposits		74		28
Purchase of property, plant and equipment		(638)		(750)
Disposal of property, plant and equipment		44		28
Purchase of intangible assets		(362)		(2,796)
Disposal of intangible assets		269		-
Purchase of non-current asset investments		(30)		(33)
Disposal of non-current asset investments		2		5
Interest received		79		131
Dividends paid by subsidiaries to minority interest		(10)		(37)
Net cash outflow from investing activities		(572)		(3,424)
Net cash inflow before financing activities		7,085		2,527
Cash flows from financing activities
Proceeds from issue of share capital		85		118
Repurchase of shares		-		(603)
Dividends paid		(2,977)		(2,739)
Repayment of loans		(650)		-
Issue of loans		-		787
Movement in short term borrowings		(151)		(2,425)
Net cash outflow from financing activities		(3,693)		(4,862)
Net increase/(decrease) in cash and cash equivalents in the period		3,392		(2,335)
Cash and cash equivalents at the beginning of the period		4,123		5,727
Exchange rate effects		60		(33)
Cash and cash equivalents at the end of the period		7,575		3,359
Cash and cash equivalents consists of:
Cash and cash equivalents		7,794		3,541
Overdrafts		(219)		(182)
		7,575		3,359

  Condensed Consolidated Statement of Changes in Equity 

		Share capital $m		Share premium account $m		Other* reserves $m		Retained earnings $m		Total $m		Non- controlling interests $m		Total equity $m
At 1 January 2008		364		1,888		1,902		10,624		14,778		137		14,915
Profit for the period		-		-		-		4,853		4,853		18		4,871
Other comprehensive income		-		-		-		(402)		(402)		6		(396)
Transfer to other reserve		-		-		10		(10)		-		-		-
Transactions with owners:
Dividends		-		-		-		(2,767)		(2,767)		-		(2,767)
Issue/(repurchase) of AstraZeneca PLC Ordinary shares		(2)		117		3		(602)		(484)		-		(484)
Share-based payments		-		-		-		127		127		-		127
Transfer from non-controlling interests to payables		-		-		-		-		-		(8)		(8)
Dividend paid to non-controlling interest		-		-		-		-		-		(26)		(26)
At 30 September 2008		362		2,005		1,915		11,823		16,105		127		16,232
		Share capital $m		Share premium account $m		Other* reserves $m		Retained earnings $m		Total $m		Non- controlling interests $m		Total equity $m
At 1 January 2009		362		2,046		1,932		11,572		15,912		148		16,060
Profit for the period		-		-		-		5,968		5,968		14		5,982
Other comprehensive income		-		-		-		325		325		3		328
Transfer to other reserve		-		-		(19)		19		-		-		-
Transactions with owners:
Dividends		-		-		-		(3,026)		(3,026)		-		(3,026)
Issue of AstraZeneca PLC Ordinary shares		1		84		-		-		85		-		85
Share-based payments		-		-		-		130		130		-		130
Transfer from non-controlling interests to payables		-		-		-		-		-		(5)		(5)
Dividend paid to non-controlling interest		-		-		-		-		-		(1)		(1)
At 30 September 2009		363		2,130		1,913		14,988		19,394		159		19,553

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

Notes to the Interim Financial Statements 

1    BASIS OF PREPARATION AND ACCOUNTING POLICIES

These unaudited condensed consolidated interim financial statements ("interim financial statements") for the nine months ended 30 September 2009 have been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the European Union. Details of the accounting policies applied are those set out in AstraZeneca PLC's Annual Report and Form 20-F Information 2008. 

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

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

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

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

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

2    Net debt

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

		At 1 Jan 2009 $m		Cash flow $m		Non-cash movements $m		Exchange movements $m		At 30 Sep 2009 $m
Loans due after one year		(10,855)		-		694		(129)		(10,290)
Current instalments of loans		(650)		650		(703)		(26)		(729)
Total loans		(11,505)		650		(9)		(155)		(11,019)
Other investments - current		105		(84)		16		3		40
Net derivative financial instruments		283		10		(50)		-		243
Cash and cash equivalents		4,286		3,448		-		60		7,794
Overdrafts		(163)		(56)		-		-		(219)
Short term borrowings		(180)		151		-		(3)		(32)
		4,331		3,469		(34)		60		7,826
Net debt		(7,174)		4,119		(43)		(95)		(3,193)

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

3    restructuring and synergy costs

Profit before tax for the nine months ended 30 September 2009 is stated after charging restructuring and synergy costs of $374 million ($365 million in the first nine months of 2008). These have been charged to profit as follows:

		3rd Quarter 2009 $m		3rd Quarter 2008 $m		9 months 2009 $m		9 months 2008 $m
Cost of sales		24		72		139		128
Research and development		6		30		30		116
Selling, general and administrative costs		82		15		205		121
Total		112		117		374		365

4    legal proceedings and contingent liabilities

AstraZeneca is involved in various legal proceedings considered typical to its business, including litigation relating to product liability, commercial disputes, infringement of intellectual property rights, the validity of certain patents and antitrust law. The matters discussed below constitute the more significant developments since publication of the disclosures concerning legal proceedings in the Company's Annual Report and Form 20-F Information 2008 and Interim Management Statement 2009 as part of the Company's Half-Yearly Financial Report for the six-month period to 30 June 2009.

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

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

As previously and herein disclosed, AstraZeneca is defending its interests in various federal and state investigations and civil litigation matters relating to drug marketing and pricing practices and in respect of which the Company previously disclosed that it had recorded a provision in the second quarter of 2009 for losses expected in the aggregate amount of $430 million. This provision has now been increased in the aggregate amount to $538 million. $520 million of this $538 million provision has been made in respect of the US Attorney's Office's investigation into sales and marketing practices involving Seroquel with the remainder relating to average wholesale price litigation pending in the US federal court. The current status of these matters is described herein. This provision constitutes our best estimate at this time of the losses expected for these matters and is in addition to the amount disclosed in the Annual Report and Form 20-F Information 2008.

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

Matters disclosed in respect of the third quarter of 2009

Arimidex (anastrozole)

Patent litigation - Canada

In July 2009, AstraZeneca Canada Inc. (AstraZeneca Canada) received a Notice of Allegation from Mylan Pharmaceuticals ULC (trading under the name Genpharm ULC) (Mylan) in respect of Canadian Patent No. 1,337,420 (the '420 patent) listed on the Patent Register in Canada for Arimidex. Mylan alleges, among other things, that the '420 patent is invalid and/or its product does not infringe the '420 patent.  In September 2009, AstraZeneca filed a Notice of Application in federal court seeking an order prohibiting the Minister of Health from issuing a Notice of Compliance to Mylan for its anastrozole tablets until the expiration of the '420 patent.

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

Atacand (candesartan cilexetil)

Patent litigation - Canada

As previously disclosed, in April 2009, AstraZeneca Canada Inc. (AstraZeneca Canada) received a Notice of Allegation from Sandoz Canada Inc. (Sandoz) in respect of Canadian Patent Nos. 2,040,955 (the '955 patent) and 2,083,305 (the '305 patent) listed on the Patent Register in Canada for Atacand. Sandoz has confirmed that it will await the expiry of the '955 patent, but alleges that the '305 patent is not infringed and is not properly listed on the Patent Register. In May 2009, AstraZeneca filed a Notice of Application in federal court seeking an order prohibiting the Minister of Health from issuing a Notice of Compliance to Sandoz for its 4, 8 and 16mg candesartan cilexetil tablets until the expiration of the '305 patent.

In August 2009, AstraZeneca Canada received a Notice of Allegation from Sandoz in respect of the '955 patent, the '305 patent and Canadian Patent No. 2,125,251 (the '251 patent) listed on the Patent Register for Atacand Plus (candesartan cilexetil - hydrochlorothiazide (HCT)). Sandoz has confirmed that it will await the expiry of the '955 patent, but alleges that the '305 patent is not infringed and is not properly listed on the Patent Register and that the '251 patent is not infringed, invalid and not properly listed.  In September 2009, AstraZeneca filed a Notice of Application in federal court seeking an order prohibiting the Minister of Health from issuing a Notice of Compliance to Sandoz for its 16/12.5mg candesartan cilexetil - HCT tablets until the expiration of the '305 and '251 patents.

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

Crestor (rosuvastatin)

Patent litigation - US

In September 2009, AstraZeneca filed a Motion for Summary Judgment of No Inequitable Conduct. Briefing proceeds. Defendants Apotex Inc. and Aurobindo Pharm Ltd have renewed their respective jurisdictional motions seeking separate trials in Florida and New Jersey respectively. Expert discovery otherwise proceeds under an amended schedule. In October 2009, Magistrate Judge Leonard Stark ordered oral argument on the summary judgment motion and other motions pending before the Court. The hearing has been scheduled for November 2009. In October 2009, Judge Joseph Farnan overruled the objections of Par Pharmaceuticals Inc. and Mylan Pharmaceuticals Inc. to Magistrate Stark's May 2009 Report and Recommendation Regarding Claim Construction and adopted Magistrate Stark's recommendations for claim construction of the RE37,314 patent claims.

As previously disclosed, in October 2008, Teva Pharmaceuticals Industries Ltd. (Teva), filed a patent infringement lawsuit against AstraZeneca Pharmaceuticals LP, AstraZeneca PLC, AstraZeneca UK Limited and IPR Pharmaceuticals, Inc. in the Eastern District of Pennsylvania. As previously reported, in March 2009, AstraZeneca moved to transfer the case to the US District Court, District of Delaware and in April 2009, AstraZeneca moved to strike Teva's jury demand. The Court denied AstraZeneca's motions. In September 2009, AstraZeneca filed a Motion for Summary Judgment of Invalidity Due to Prior Invention. Briefing proceeds. Fact discovery is otherwise proceeding.

Patent litigation - Canada

As previously disclosed, in April 2009, AstraZeneca Canada Inc. (AstraZeneca Canada) received a Notice of Allegation from Cobalt Pharmaceuticals, Inc. (Cobalt) in respect of Canadian Patent Nos. 2,072,945 (the '945 patent) and 2,313,783 (the '783 patent) listed on the Patent Register in Canada for Crestor. In May 2009, AstraZeneca filed a Notice of Application in federal court seeking an order prohibiting the Minister of Health from issuing a Notice of Compliance to Cobalt for its 5, 10, 20 and 40mg rosuvastatin calcium tablets until the expiration of the '945 and '783 patents.

In May 2009, AstraZeneca Canada received a Notice of Allegation from Sandoz Canada Inc. (Sandoz) with respect to the '945 and '783 patents. In July 2009, AstraZeneca filed a Notice of Application in federal court seeking an order prohibiting the Minister of Health from issuing a Notice of Compliance to Sandoz for its 5, 10, 20 and 40mg rosuvastatin calcium tablets until the expiration of the '945 and '783 patents.

In August 2009, AstraZeneca Canada received a Notice of Application from ratiopharm Inc. (ratiopharm) with respect to the '945 and '783 patents. Ratiopharm claims that the '945 patent and the '783 patent are not infringed and invalid.  In October 2009, AstraZeneca filed a Notice of Application in federal court seeking an order prohibiting the Minister of Health from issuing a Notice of Compliance to ratiopharm for its 5, 10, 20 and 40mg rosuvastatin calcium tablets until the expiration of the '945 and '783 patents.

In addition to the previously disclosed Notice of Compliance proceedings currently pending against Novopharm Limited (Novopharm) and Apotex Inc. (Apotex), separate, parallel patent infringement actions were filed on 18 September 2009 against Novopharm and Apotex in the Federal Court of Canada with respect to the '945 patent.

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

Exanta (ximelagatran)

As previously disclosed, in an opinion dated 3 June 2008, the United States District Court for the Southern District of New York dismissed in its entirety the consolidated amended complaint that had alleged claims on behalf of purchasers of AstraZeneca publicly traded securities during the period April 2003 to September 2004 under sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5. Plaintiffs appealed this decision to the US Court of Appeals for the Second Circuit, except for the ruling regarding two of the four individual defendants. In June 2009, the Second Circuit Court of Appeals summarily affirmed the trial court's dismissal of the action. Plaintiffs have not appealed the Second Circuit Court of Appeals' decision. This litigation is therefore concluded.  

Nexium (esomeprazole)

Patent litigation - US

In a notice-letter dated September 2009, Lupin Limited (Lupin) informed AstraZeneca that Lupin had submitted an ANDA to FDA for 20 and 40mg esomeprazole magnesium delayed-release capsules. Lupin's notice-letter contains Paragraph IV certifications for patents listed in the FDA Orange Book with reference to Nexium.  In October 2009, AstraZeneca commenced patent infringement litigation against Lupin in the US District Court for the District of New Jersey. The Lupin litigation is in early stages and has not been consolidated. No trial date has been set.

Patent Litigation - EU

In June 2009, AstraZeneca filed an application with the District Court of Copenhagen in Denmark seeking an interlocutory injunction proceeding to restrain Sandoz A/S from marketing products containing generic esomeprazole magnesium in Denmark. AstraZeneca considers that the products marketed by Sandoz A/S infringe intellectual property owned by AstraZeneca relating to Nexium. The case will be heard in court in Denmark and oral proceedings are scheduled to start in November 2009. 

By way of background, in April 2009 the Danish Medicines Agency granted Sandoz A/S, Hexal A/S and 1A Farma A/S (companies in the Sandoz group) approval to market a generic version of Nexium (20 and 40mg esomeprazole magnesium). Sandoz A/S launched its esomeprazole magnesium products in Denmark in June 2009. 

Information on the Heads of Medicines Agencies website confirmed that Denmark is the Reference Member State for the applications involved in this decentralised regulatory procedure. Companies in the Sandoz group have also launched its esomeprazole magnesium products in Slovenia, Hungary, Bulgaria and Austria. Other countries included in the same regulatory procedure are the Czech Republic, Estonia, Finland, Ireland, Latvia, Lithuania, Norway, Poland, Portugal, Romania and Spain.

To prevent Sandoz Farmacêutica Limitada (Sandoz Farmacêutica) from infringing patent rights of AstraZeneca in Portugal, AstraZeneca has initiated legal proceedings to suspend the effect of decisions taken by administrative bodies in Portugal. In August 2009, AstraZeneca filed the request with the Lisbon Administrative Court of First Instance seeking a preliminary injunction and initiating main action in the administrative courts in Portugal. On 27 October, the Lisbon Administrative Court of First Instance granted AstraZeneca a preliminary injunction against Sandoz Farmacêutica suspending the efficacy of the marketing and price approvals for Sandoz Farmacêutica's generic esomeprazole. Sandoz Farmacêutica may appeal against this judgement within 15 days.

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

Seroquel (quetiapine fumarate)

Sales and marketing practices

As previously disclosed, the US Attorney's Office in Philadelphia, working with a number of states as part of the National Medicaid Fraud Control Unit, has been directing an investigation relating to Seroquel involving a review of sales and marketing practices, including allegations that AstraZeneca promoted Seroquel for non-indicated (off-label) uses, and a second investigation related to selected physicians who participated in clinical trials involving Seroquel. AstraZeneca understands that these investigations are the subject of two sealed qui tam (whistleblower) lawsuits filed under the False Claims Act. In September 2009, AstraZeneca reached an agreement in principle with the US Attorney's Office to resolve the investigations, subject to the negotiation and finalisation of appropriate implementing agreements, including civil settlement agreements and a corporate integrity agreement. We have accordingly increased our provision with respect to this matter to $520 million, taken in 2009. This forms part of the $538 million provision referred to earlier. 

Product liability

As previously disclosed, AstraZeneca Pharmaceuticals LP, either alone or in conjunction with one or more affiliates, has been sued in numerous individual personal injury actions involving Seroquel.

As of 9 October 2009, AstraZeneca was defending 14,444 served or answered lawsuits involving 22,189 plaintiff groups. To date, approximately 2,603 additional cases have been dismissed by order or agreement and approximately 1,635 of those cases have been dismissed with prejudice.

The first two trials are now scheduled to begin in Delaware and New Jersey state courts in mid-January 2010.

AstraZeneca is also aware of approximately 142 additional cases (1,500 plaintiffs) that have been filed but not yet served and has not determined how many additional cases, if any, may have been filed. Some of the cases also include claims against other pharmaceutical manufacturers such as Eli Lilly & Co., Janssen Pharmaceutica, Inc. and/or Bristol-Myers Squibb Company. 

AstraZeneca intends to litigate these cases on their individual merits and will defend against the cases vigorously. 

AstraZeneca has product liability insurance dating from 2003 for Seroquel-related product liability claims. The insurers that issued the applicable policies for 2003 have reserved the right to dispute coverage for Seroquel-related product liability claims on various grounds, and AstraZeneca currently believes that there are likely to be disputes with some or all of its insurers about the availability of some or all of this coverage.

As of 30 September 2009, legal defence costs of approximately $623 million have been incurred in connection with Seroquel-related product liability claims. This amount exceeds the maximum insurance receivable that AstraZeneca will recognise under applicable accounting principles at this time with respect to the applicable insurance policies. Accordingly, ongoing defence costs and damages, if any, that may be incurred in connection with Seroquel-related product liability claims will result in a charge to profit. There can be no assurance that additional coverage under the policies will be available or that the insurance receivable we previously recognised will be realisable in full.  

In addition, given the status of the litigation currently, legal defence costs for the Seroquel claims, before damages, if any, are likely to approximate, and may exceed, the total stated upper limits of the applicable insurance policies in any event.

Patent litigation - US

As previously disclosed, in July 2008, the United District Court for the District of New Jersey granted AstraZeneca's Motion for Summary Judgment of No Inequitable Conduct in litigation involving Teva Pharmaceutical Industries Ltd. and Sandoz, Inc.  In September 2009, the Court of Appeals for the Federal Circuit affirmed the District Court's decision.

Average Wholesale Price Litigation

As previously disclosed, AstraZeneca is a defendant, along with many other pharmaceutical manufacturers, in several sets of cases involving allegations that, by causing the publication of allegedly inflated wholesale list prices, defendants caused entities to overpay for prescription drugs. 

As previously reported, in June 2009, the state court presiding over the putative class action in Arizona granted AstraZeneca's motion for summary judgment and denied plaintiffs' motion for class certification as moot. The plaintiffs did not appeal this ruling.

In September 2009, a panel of the First Circuit Court of Appeals affirmed a District of Massachusetts opinion granting class certification, finding liability, and awarding approximately $12.9 million in favour of a class of Massachusetts payors for the drug Zoladex.  Accordingly, we have taken a provision of $12.9 million with respect to this matter, which is included in the $108 million provision taken in the third quarter 2009.  In October 2009, the company filed a petition seeking reconsideration of the panel's decision by the full First Circuit Court of Appeals.   

In October 2009, a Kentucky jury found AstraZeneca liable for reporting false and misleading prices for drugs reimbursed by the Commonwealth of Kentucky Medicaid Agency, and awarded the Commonwealth $14.72 million in compensatory damages and $100 in punitive damages. The Commonwealth has indicated that it will ask the trial judge to award civil penalties of up to $2,000 per violation and attorneys' fees. AstraZeneca is considering its options for further reviews, including the possibility of appeal.

As previously disclosed, the average wholesale price litigation claims filed by the Alabama Attorney General were tried in February 2008, resulting in a jury verdict against AstraZeneca and a judgment against the company in the amount of $160 million following post-trial motions.  In October 2009, the Supreme Court of Alabama overturned the trial court's judgment against AstraZeneca and rendered judgment in AstraZeneca's favour instead.

Pain Pump Litigation

As previously disclosed, AstraZeneca LP, AstraZeneca Pharmaceuticals LP, Zeneca Holdings Inc., and/or AstraZeneca PLC have been named among other defendants in cases pending in various US jurisdictions, alleging generally that the use of Marcaine, Sensorcaine, Xylocaine and/or Naropin, with or without epinephrine, administered in pain pumps that were implanted into patients in connection with arthroscopic surgery, caused chondrolysis. As of 16 October 2009, the AstraZeneca defendants were currently defending lawsuits involving 87 active plaintiffs.   To date, 186 plaintiffs have voluntarily dismissed, or are in the process of dismissing, their cases against the AstraZeneca defendants.  Six additional cases were dismissed by the court on AstraZeneca motions. 

In October 2009, AstraZeneca Pharmaceuticals LP was served with a putative class action lawsuit brought by a single plaintiff on behalf of "several hundred" class members and against more than 20 defendants, including AstraZeneca Pharmaceuticals LP and AstraZeneca PLC, filed in Texas State District Court.  The putative class is purportedly defined as all individuals who received local anaesthetics intra-articularly for up to 72 hours or more via a pain pump and includes no geographical limitations.  The complaint seeks unspecified compensatory and exemplary damages from the AstraZeneca defendants under various product liability theories.  

AstraZeneca intends to vigorously defend against this matter.  

As previously disclosed, rights to market Sensorcaine, Xylocaine and Naropin in the US were sold to Abraxis Bioscience Inc. (Abraxis) in June 2006 but many of these lawsuits may be a retained liability under the terms of the Asset Purchase Agreement with Abraxis.

5    NINE MONTHS territorial REVENUE analysis    

						% Growth
		9 months 2009 $m		9 months 2008 $m		Actual		Constant Currency
US		10,831		9,726		11		11
Canada		862		979		(12)		2
North America		11,693		10,705		9		10
Western Europe**		6,715		7,445		(10)		3
Japan		1,674		1,355		24		10
Other Established ROW		590		653		(10)		13
Established ROW*		8,979		9,453		(5)		4
Emerging Europe		783		924		(15)		8
China		599		456		31		28
Emerging Asia Pacific		577		618		(7)		7
Other Emerging ROW		1,228		1,252		(2)		14
Emerging ROW		3,187		3,250		(2)		13
Total Revenue		23,859		23,408		2		8

*	Established ROW comprises Western Europe (including France, UK, Germany, Italy, Sweden and others), Japan, Australia and New Zealand.
**	For the nine months 2009, Western Europe revenue growth excluding Synagis would be -10 percent on an actual basis and 3 percent on a constant currency basis.

6    THIRD QUARTER territorial REVENUE analysis    

						% Growth
		3rd Quarter 2009 $m		3rd Quarter 2008 $m		Actual		Constant Currency
US		3,659		3,199		14		14
Canada		300		320		(6)		1
North America		3,959		3,519		12		13
Western Europe**		2,292		2,434		(6)		3
Japan		568		459		24		9
Other Established ROW		234		247		(5)		8
Established ROW*		3,094		3,140		(1)		4
Emerging Europe		260		315		(17)		2
China		211		168		26		26
Emerging Asia Pacific		201		204		(1)		8
Other Emerging ROW		475		429		11		24
Emerging ROW		1,147		1,116		3		15
Total Revenue		8,200		7,775		5		10

*	Established ROW comprises Western Europe (including France, UK, Germany, Italy, Sweden and others), Japan, Australia and New Zealand.
**	For the third quarter 2009, Western Europe revenue growth excluding Synagis would be -6 percent on an actual basis and 4 percent on a constant currency basis.

7    NINE MONTHS product REVENUE analysis

		World								US
		9 months 2009 $m		9 months 2008 $m		Actual Growth %		Constant Currency Growth %		9 months 2009 $m		Actual Growth %
Gastrointestinal:
Nexium		3,681		3,876		(5)		1		2,118		(7)
Losec/Prilosec		696		791		(12)		(9)		49		(64)
Others		81		66		23		32		42		83
Total Gastrointestinal		4,458		4,733		(6)		(1)		2,209		(9)
Cardiovascular:
Crestor		3,245		2,610		24		32		1,548		30
Seloken/Toprol-XL		1,119		600		87		95		767		271
Atacand		1,049		1,120		(6)		6		197		(1)
Tenormin		217		236		(8)		(5)		11		(21)
Zestril		141		184		(23)		(15)		13		(13)
Plendil		181		201		(10)		(5)		10		(33)
ONGLYZATM*		9		-		n/m		n/m		9		n/m
Others		188		209		(10)		-		11		n/m
Total Cardiovascular		6,149		5,160		19		28		2,566		57
Respiratory:
Symbicort		1,628		1,490		9		23		335		103
Pulmicort		923		1,098		(16)		(12)		574		(20)
Rhinocort		199		244		(18)		(13)		101		(27)
Oxis		44		56		(21)		(5)		-		-
Accolate		49		55		(11)		(7)		36		(8)
Others		98		126		(22)		(10)		-		-
Total Respiratory		2,941		3,069		(4)		5		1,046		(2)
Oncology:
Arimidex		1,422		1,406		1		7		658		14
Casodex		655		974		(33)		(32)		130		(40)
Zoladex		786		860		(9)		-		37		(33)
Iressa		218		192		14		9		4		(20)
Ethyol		11		23		(52)		(52)		9		(61)
Others		257		304		(15)		(10)		84		(34)
Total Oncology		3,349		3,759		(11)		(6)		922		(8)
Neuroscience:
Seroquel		3,605		3,292		10		14		2,544		16
Local anaesthetics		433		458		(5)		5		30		15
Zomig		319		336		(5)		1		136		(1)
Diprivan		211		213		(1)		4		34		17
Others		33		43		(23)		(12)		5		(29)
Total Neuroscience		4,601		4,342		6		11		2,749		15
Infection and Other:
Synagis		681		724		(6)		(6)		519		(4)
Non Seasonal Flu		152		-		n/m		n/m		152		n/m
Merrem		636		680		(6)		6		129		(15)
FluMist		94		71		32		32		94		32
Other Products		113		171		(34)		(29)		63		(28)
Total Infection and Other		1,676		1,646		2		7		957		12
Aptium Oncology		321		294		9		9		321		9
Astra Tech		364		405		(10)		1		61		2
Total		23,859		23,408		2		8		10,831		11

* ONGLYZATM is recorded as alliance revenue. This does not represent ex-factory sales, but rather AstraZeneca's share of the gross profit from its collaboration with Bristol-Myers Squibb on this product.

8    THIRD QUARTER product REVENUE analysis

		World								US
		3rd Quarter 2009 $m		3rd Quarter 2008 $m		Actual Growth %		Constant Currency Growth %		3rd Quarter 2009 $m		Actual Growth %
Gastrointestinal:
Nexium		1,243		1,315		(5)		(1)		689		(12)
Losec/Prilosec		240		249		(4)		(3)		18		(54)
Others		34		25		36		44		19		73
Total Gastrointestinal		1,517		1,589		(5)		(1)		726		(12)
Cardiovascular:
Crestor		1,147		922		24		30		523		25
Seloken/Toprol-XL		414		204		103		110		293		307
Atacand		370		386		(4)		5		70		4
Tenormin		74		79		(6)		(5)		4		(20)
Zestril		47		60		(22)		(15)		5		(29)
Plendil		60		65		(8)		(5)		4		-
ONGLYZATM*		9		-		n/m		n/m		9		n/m
Others		70		66		6		14		11		n/m
Total Cardiovascular		2,191		1,782		23		29		919		60
Respiratory:
Symbicort		562		501		12		22		125		95
Pulmicort		320		304		5		8		207		6
Rhinocort		63		72		(13)		(7)		28		(28)
Oxis		16		18		(11)		-		-		-
Accolate		17		18		(6)		-		12		(8)
Others		31		38		(18)		(8)		-		-
Total Respiratory		1,009		951		6		13		372		19
Oncology:
Arimidex		476		486		(2)		2		215		11
Casodex		174		300		(42)		(43)		14		(80)
Zoladex		282		295		(4)		1		14		(30)
Iressa		75		67		12		7		2		-
Ethyol		2		3		(33)		(33)		1		(67)
Others		90		105		(14)		(10)		29		(34)
Total Oncology		1,099		1,256		(13)		(10)		275		(17)
Neuroscience:
Seroquel		1,231		1,130		9		12		851		14
Local anaesthetics		148		149		(1)		6		11		83
Zomig		111		115		(3)		1		47		(2)
Diprivan		77		69		12		16		11		22
Others		11		13		(15)		(8)		2		100
Total Neuroscience		1,578		1,476		7		11		922		13
Infection and Other:
Synagis		82		124		(34)		(34)		17		(69)
Non Seasonal Flu		152		-		-		-		152		-
Merrem		221		241		(8)		-		40		(34)
FluMist		92		71		30		30		92		30
Other Products		35		58		(40)		(38)		19		(41)
Total Infection and Other		582		494		18		22		320		46
Aptium Oncology		104		98		6		6		104		6
Astra Tech		120		129		(7)		1		21		5
Total		8,200		7,775		5		10		3,659		14

* ONGLYZATM is recorded as alliance revenue. This does not represent ex-factory sales, but rather AstraZeneca's share of the gross profit from its collaboration with Bristol-Myers Squibb on this product.

Shareholder Information

ANNOUNCEMENTS AND MEETINGS

Announcement of fourth quarter and full year 2009 results	28 January 2010
Announcement of first quarter 2010 results	29 April 2010
Annual General Meeting	29 April 2010
Announcement of second quarter and half year 2010 results	29 July 2010
Announcement of third quarter and nine months 2010 results	28 October 2010

DIVIDENDS

The record date for the first interim dividend payable on 14 September 2009 (in the UK, Sweden and the US) was 7 August 2009. Ordinary shares traded ex-dividend on the London and Stockholm Stock Exchanges from 5 August 2009. ADRs traded ex-dividend on the New York Stock Exchange from the same date.

The record date for the second interim dividend for 2009 payable on 15 March 2010 (in the UK, Sweden and the US) will be 5 February 2010. Ordinary shares will trade ex-dividend on the London and Stockholm Stock Exchanges from 3 February 2010. ADRs will trade ex-dividend on the New York Stock Exchange from the same date.

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: Abraxane®, a registered trademark of Abraxis BioScience, LLC., ONGLYZA™, a trademark of Bristol-Myers Squibb Company, Plavix® and Iscover®, trademarks of Sanofi-Aventis SA and TRILIPIX™, a trademark of Fournier Industrie Et Sante.

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 15 Stanhope Gate London W1K 1LN UK	Swedish Central Securities Depository Euroclear Sweden AB PO Box 7822 SE-103 97 Stockholm Sweden
Tel (freephone in UK):  0800 389 1580 Tel (outside UK):  [phone]	Tel (toll free in US):  800 990 1135 Tel (outside US):  [phone]	Tel: [phone]	Tel: [phone]

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: These 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 at the date of preparation of these 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. These forward-looking statements are subject to numerous risks and uncertainties. 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 risk of expiration or early loss of patents (including patents covering competing products), marketing exclusivity or trademarks; the risk of patent litigation; failure to obtain patent protection; the impact of fluctuations in exchange rates; our debt-funding arrangements; bad debts; the adverse impact of a sustained economic downturn; risks relating to owning and operating a biologics and vaccines business; competition; price controls and price reductions; taxation; the risk of substantial product liability claims; the performance of new products; environmental/occupational health and safety liabilities; the development of our business in emerging markets; product counterfeiting; the risk of adverse outcome of litigation and/or government investigations and risk of insufficient insurance coverage; the difficulties of obtaining and maintaining regulatory approvals for new products; the risk of failure to observe continuing regulatory oversight; the risk that R&D will not yield new products that achieve commercial success; the risk that acquisitions and strategic alliances formed as part of our externalisation strategy may be unsuccessful; the risk of reliance on third parties for supplies of materials and services; the risk of failure to manage a crisis; the risk of delay to new product launches; information technology and outsourcing; risks relating to productivity initiatives and reputation.

 

END

 

 

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