4th March 2009 |
1) | IMS Health has not been provided with a full copy of the draft Annual Report but only a very limited number of pages from the documents as indicated above; |
2) | IMS Health has not undertaken an independent review of the information disclosed in the Annual Report other than to discuss our observations as to the accuracy of the information relating to IMS Health and certain pharmaceutical industry data derived by IMS Health; |
3) | AstraZeneca acknowledges and agrees that IMS Health shall not be deemed an “Expert” in respect of AstraZeneca’s securities |
filings, and AstraZeneca agrees that it shall not characterise IMS Health as such; and |
4) | AstraZeneca accepts full responsibility for the disclosure of all information and data, including that relating to IMS Health, set forth in the Annual Report as filed with the SEC and agrees to indemnify IMS Health from any third party claims that may arise therefrom. |
ACCEPTED AND AGREED this 5th day of March 2009: AstraZeneca PLC | |||||
By: | /s/ Justin Hoskins | ||||
Name: | Justin Hoskins | ||||
Title: | Deputy Company Secretary |
INTRODUCTION | DIRECTORS’ REPORT | FINANCIAL STATEMENTS | REMUNERATION REPORT | ADDITIONAL INFORMATION |
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and provisions related to restructuring and synergy programmes, amortisation and the impairment of the significant intangibles arising from corporate acquisitions and those related to our current and future exit arrangements with Merck in the US, and other specified items. A reconciliation between reported performance and core performance is provided on page 34. |
> | Constant exchange rate (CER) growth rates. This is also a non-GAAP measure. This measure removes the effects of currency movements (by retranslating the current year’s performance at previous years’ exchange rates and adjusting for other exchange effects, including hedging). A reconciliation of reported results adjusted for the impact of currency movements is provided on page 33. |
Sales | Growth | Market value | ||||||||||
$bn | % | % | ||||||||||
Emerging ROW | ||||||||||||
2008 | 108 | 14 | 16 | |||||||||
2007 | 87 | 13 | 14 | |||||||||
2006 | 74 | 12 | 13 | |||||||||
Established ROW | ||||||||||||
2008 | 271 | 5 | 39 | |||||||||
2007 | 232 | 4 | 37 | |||||||||
2006 | 211 | 4 | 37 | |||||||||
North America | ||||||||||||
2008 | 310 | 2 | 45 | |||||||||
2007 | 304 | 7 | 49 | |||||||||
2006 | 284 | 7 | 50 | |||||||||
Growth | Growth | Market Share | Sales | |||||||||||||||||||||
Rank | Rank | MAT/Q3/08 | MAT/Q3/07 | MAT/Q3/08 | MAT/Q3/08 | |||||||||||||||||||
MAT/Q3/08 | MAT/Q3/07 | % | % | % | $bn | |||||||||||||||||||
US | 1 | 1 | 1 | 7 | 42 | 291 | ||||||||||||||||||
Japan | 2 | 2 | 4 | 2 | 9 | 65 | ||||||||||||||||||
France | 3 | 3 | 4 | 5 | 6 | 43 | ||||||||||||||||||
Germany | 4 | 4 | 6 | 3 | 6 | 42 | ||||||||||||||||||
Italy | 5 | 6 | 4 | – | 4 | 26 | ||||||||||||||||||
UK | 6 | 5 | 2 | 5 | 3 | 23 | ||||||||||||||||||
Spain | 7 | 7 | 8 | 8 | 3 | 23 | ||||||||||||||||||
Canada | 8 | 8 | 6 | 7 | 3 | 19 | ||||||||||||||||||
China1 | 9 | 9 | 27 | 21 | 3 | 18 | ||||||||||||||||||
Brazil2 | 10 | 10 | 12 | 10 | 2 | 13 | ||||||||||||||||||
Turkey2 | 11 | 13 | 9 | 18 | 2 | 10 | ||||||||||||||||||
South Korea | 12 | 11 | 11 | 10 | 1 | 10 | ||||||||||||||||||
Australia | 13 | 14 | 11 | 8 | 1 | 9 | ||||||||||||||||||
Mexico2 | 14 | 12 | 4 | 8 | 1 | 9 | ||||||||||||||||||
India2 | 15 | 15 | 13 | 13 | 1 | 7 | ||||||||||||||||||
Poland | 16 | 17 | 9 | 8 | 1 | 7 | ||||||||||||||||||
Netherlands | 17 | 16 | 5 | 8 | 1 | 7 | ||||||||||||||||||
Belgium | 18 | 18 | 8 | 4 | 1 | 6 | ||||||||||||||||||
Greece2 | 19 | 19 | 12 | 18 | 1 | 6 | ||||||||||||||||||
Sweden | 20 | 20 | 6 | 6 | 1 | 4 | ||||||||||||||||||
Data based on world retail and hospital pharmacy sales except: | |
1 | Hospital pharmacy only |
2 | Retail pharmacy only |
MAT = Moving Annual Total | |
Source: IMS Health 2008 MIDAS Quantum |
10 |
> | Increasing and ageing populations in established markets. |
> | Emergence of expanded patient populations in new markets. |
> | Continued unmet medical need. |
> | Continued scientific and technological advance. |
3 | Source: WHO statistics 2008. |
11 |
> | Continued pressure on the price of medicines. |
> | Higher regulatory hurdles for new medicines and new indications. |
> | Competition from research-based and, increasingly, generic pharmaceutical companies. |
> Despite a continually challenging environment, including generic pressure, combined sales ofArimidex,Crestor,Nexium,SeroquelandSymbicortup 5% in the US – 65% of our total US sales. > Maintained market position as the second largest brand name pharmaceutical company in Canada. > Solid sales performance in the Rest of World, up 5%. > Strong brand performance in Western Europe but intense competition and governmental controls over healthcare expenditure. > Strong volume growth from key products,Crestor,LosecandSeroquelin Japan. > Emerging Rest of World delivers strong sales growth, up 16% with Emerging Europe sales up 10% and Emerging Asia sales up 10%. > Continued expansion in China, including continued sales growth up 31%. > EU Commission of a Sectoral Inquiry into the pharmaceutical industry continues, with a final report expected in Spring 2009. 49 2008 2007 2006 2008 compared to 2007 2007 compared to 2006 Growth due Growth due CER to exchange CER to exchange CER Reported CER Reported Sales growth effect Sales growth effect Sales growth growth growth growth $m $m $m $m $m $m $m % % % % US 13,510 142 2 13,366 917 – 12,449 1 1 7 7 Canada 1,275 95 35 1,145 54 60 1,031 8 11 5 11 14,785 237 37 14,511 971 60 13,480 2 2 7 8 Western Europe 9,743 55 573 9,115 282 760 8,073 1 7 3 13 Japan 1,957 73 223 1,661 170 (12 ) 1,503 4 18 11 11 Other Established ROW 843 107 21 715 83 77 555 15 18 15 29 12,543 235 817 11,491 535 825 10,131 2 9 5 13 Emerging Europe 1,215 102 85 1,028 102 95 831 10 18 12 24 China 627 136 54 437 91 18 328 31 43 28 33 Emerging Asia Pacific 802 72 (19 ) 749 62 41 646 10 7 10 16 Other Emerging ROW 1,629 247 39 1,343 223 61 1,059 18 21 21 27 4,273 557 159 3,557 478 215 2,864 16 20 17 24 31,601 1,029 1,013 29,559 1,984 1,100 26,475 3 7 7 12 51 > Crestorsales up 26% to $3.6 billion andCrestor is now approved in every EU country. > Crestorstudy demonstrates significant reduction in major cardiovascular events (44% compared to placebo in men and women with elevated hsCRP but low/normal cholesterol levels). > Atacandsales up 10% to $1.5 billion. > Worldwide collaboration with Bristol-Myers Squibb to develop and commercialise dapagliflozin expanded to include Japan. > US submission for fixed dose combination ofCrestorand Abbott’s Trilipix™, for the treatment of mixed dyslypidaemia, anticipated for third quarter 2009. > Toprol-XLUS sales down 70% for the full year. 1 Licensed from Shionogi & Co. Ltd. 2 Licensed from Takeda Chemicals Industries Ltd. 3 Licensed from Merck & Co., Inc.
Our key marketed products
In the pipeline
Reported performance
Reported performance> Sales ofNexium$5.2 billion, down 2%. > Nexiumsubmissions in the EU for the short-term maintenance of haemostasis and prevention of re-bleeding in patients with peptic ulcer bleeding following therapeutic endoscopy and in the US for use in patients with peptic ulcer bleeding following therapeutic endoscopy. > In late 2008, a Complete Response Letter received from the FDA in connection with ourNexiumsubmission for peptic ulcer bleeding. > Losec/Prilosec sales $1.05 billion declining in the EU and US due to continuous generic pressure including the recent patent expiry in Italy. Overall sales down 14%; Japan sales still growing, up 5%. > Settlement of patent litigation in the US brought by AstraZeneca against Ranbaxy, with enforceability of disputedNexiumpatents conceded and an agreement for licensed sales of genericNexiumfrom May 2014. > Other patent litigation continuing in the US against generic manufacturers following abbreviated new drug applications relating toNexium.
REFLUX DISEASE (GERD)
Our key marketed products 2008 2007 2006 2008 compared to 2007 2007 compared to 2006 Growth due Growth due CER to exchange CER to exchange CER Reported CER Reported Sales growth effect Sales growth effect Sales growth growth growth growth $m $m $m $m $m $m $m % % % % 5,200 (121 ) 105 5,216 (104 ) 138 5,182 (2 ) – (2 ) 1 1,055 (156 ) 68 1,143 (277 ) 49 1,371 (14 ) (8 ) (20 ) (17 ) Other 89 2 3 84 2 4 78 2 6 3 8 6,344 (275 ) 176 6,443 (379 ) 191 6,631 (4 ) (2 ) (6 ) (3 )
Reported performance
Reported performance> Merremsales of $897 million, up 13%. > Strong reported growth forMerremof 16% globally; 39% in the US. > Synagissales of $1.23 billion; in the US $923 million. > Biologics Licence Application submitted for motavizumab, an improved anti-respiratory syncytial virus monoclonal antibody. A Complete Response Letter subsequently received from the FDA. > Market authorisation application submitted to European Medicines Agency for Live Attenuated Influenza Vaccine. 1 Licensed from Dainippon Sumitomo Pharma Co., Ltd.
Our key marketed products
Our key marketed products
Our key marketed products 2008 2007 2006 2008 compared to 2007 2007 compared to 2006 Growth due Growth due CER to exchange CER to exchange CER Reported CER Reported Sales growth effect Sales growth effect Sales growth growth growth growth $m $m $m $m $m $m $m % % % % 897 97 27 773 121 48 604 13 16 20 28 1,230 612 – 618 618 – – n/m n/m n/m n/m 104 51 – 53 53 – – n/m n/m n/m n/m Other 220 (54 ) 4 270 (12 ) 11 271 (20 ) (19 ) (4 ) – 2,451 706 31 1,714 780 59 875 41 43 89 96 1 Acquired in June 2007.
In the pipeline
In the pipeline
Reported performance
Reported performance> Seroquelsales up 9% to over $4.45 billion. > Seroquel XRapproved in the US for acute bipolar depression, acute bipolar mania and bipolar maintenance. > Seroquel XRapproved under the European Mutual Recognition Procedure for the treatment of acute bipolar depression and acute bipolar mania in October.Seroquelalso approved at the same time for the treatment of acute bipolar depression. > FDA Complete Response Letter received onSeroquel XRfor Major Depressive Disorder in December. > Regulatory submissions made forSeroquel XRfor the treatment of Major Depressive Disorder and for Generalised Anxiety Disorder in both the US and EU. > Summary Judgment Motion granted to AstraZeneca in the patent infringement actions commenced against two generic drug manufacturers in the US following abbreviated new drug applications relating toSeroquel. > Separate lawsuits filed in the US against third party manufacturers relating to infringement of theSeroquel XRpatents. > Personal injury actions in the US and Canada involvingSeroquelbeing defended vigorously.
SeroquelandSeroquel XRand by the successful introduction of a range of new medicines aimed at significant medical need in psychiatry, analgesia (pain control) and cognition (including Alzheimer’s disease and cognitive disorders in schizophrenia).
Our key marketed products
We have progressed AZD8529 into Phase I and AZD2624 into Phase II for the treatment of schizophrenia, with AZD2327 entering Phase Ila and AZD6765 and AZD7325 entering into Phase IIb clinical development for the treatment of anxiety and/or depression. 2008 2007 2006 2008 compared to 2007 2007 compared to 2006 Growth due Growth due CER to exchange CER to exchange CER Reported CER Reported Sales growth effect Sales growth effect Sales growth growth growth growth $m $m $m $m $m $m $m % % % % 4,452 346 79 4,027 526 85 3,416 9 11 15 18 278 (3 ) 18 263 (53 ) 12 304 (1 ) 6 (17 ) (13 ) 448 (3 ) 17 434 18 18 398 (1 ) 3 5 9 Local anaesthetics 605 13 35 557 (6 ) 34 529 2 9 (1 ) 5 Other 54 (7 ) 2 59 (1 ) 3 57 (12 ) (8 ) (2 ) 4 5,837 346 151 5,340 484 152 4,704 �� 6 9 10 14
(PAIN CONTROL)
Our key marketed products
In the pipeline 63
Reported performance
Reported performance> Arimidexsales up 4% to $1.86 billion and is the leading branded hormonal breast cancer therapy in the US, Japan and France. > Casodexsales $1.26 billion, down 12%. Expiry of EU marketing exclusivity in 2008. > Zoladexsales $1.14 billion, down 3%. > Results from three Phase IIIZactimatrials in non-small cell lung cancer (NSCLC) showed thatZactima, in combination with standard chemotherapy, brings clinical benefits to patients with previously treated NSCLC. > Results from theIressaPhase III INTEREST study underpin a marketing authorisation application in the EU and the pan-Asian IPASS study met its primary objective showing superior progression-free survival forIressacompared with two chemotherapies in clinically selected patients. > ZD4054 progressed into Phase III development for hormone-resistant prostate cancer. > Registration trials ongoing ofRecentinin first line colorectal cancer and recurrent glioblastoma multiforme.
Our key marketed products1 In November 2008, we entered into an agreement with Abraxis under which Abraxis re-acquired exclusive rights to market Abraxane® in the US.
Reported performance
Reported performance> Symbicortsales over $2 billion, up 22%. > Symbicort Rapihaler(pMDI) licensed for long-term maintenance treatment of asthma in the US. Submissions made for use in COPD and paediatric asthma. > Outside the US,Symbicort Turbuhaler SMARTnow approved for use in managing asthma in over 90 countries. > Symbicort Turbuhalernow approved in COPD in over 80 countries. > The Joint Advisory Committee of the FDA concluded that the benefits ofSymbicortoutweigh the risks in adult and adolescent asthma patients. > Continued growth forPulmicortwith sales of $1.49 billion. > Settlement of AstraZeneca’sPulmicort Respulespatent infringement litigation against Teva including an exclusive licence to Teva to sell genericPulmicort Respulesfrom 15 December 2009 with significant royalties for AstraZeneca.
Our key marketed products 69
In the pipeline
Reported performance
Reported performance Terms used in the Annual Report and Form 20-F Information US equivalent or brief description Accruals Accrued expenses Allotted Issued Bank borrowings Payable to banks Called-up share capital Issued share capital Creditors Liabilities/payables Current instalments of loans Long term debt due within one year Debtors Receivables and prepaid expenses Earnings Net income Finance lease Capital lease Fixed asset investments Non-current investments Freehold Ownership with absolute rights in perpetuity Interest receivable Interest income Interest payable Interest expense Loans Long term debt Prepayments Prepaid expenses Profit Income Profit and loss account Income statement/consolidated statement of income Reserves Retained earnings Short term investments Redeemable securities and short term deposits Share premium account Premiums paid in excess of par value of Ordinary Shares Statement of recognised income and expense Statement of comprehensive income ESTABLISHED REST OF WORLD EMERGING REST OF WORLD Canada Western Europe Japan Other Established Emerging Europe China Emerging Other Emerging Asia Pacific US Canada Austria Japan Australia Czech Republic China India Algeria Belgium New Zealand Estonia Hong Kong Malaysia Argentina Denmark Latvia Philippines Brazil Finland Poland South Korea Central America France Slovakia Taiwan Chile Germany Turkey Thailand Colombia Greece Egypt Holland Lebanon Italy Mexico Norway Morocco Portugal Peru Spain Saudi Arabia Sweden South Africa UK UAE Venezuela Iceland Albania Afghanistan Luxembourg Belarus Bangladesh Bosnia-Herzegovina Brunei Bulgaria Cambodia Croatia Indonesia Georgia Laos Hungary Myanmar Macedonia Nepal Romania Papua New Guinea Russia Serbia/Montenegro Singapore Sri Lanka Vietnam