3rd Quarter Results (1 of 2)

AstraZeneca PLC 21 October 2004 AstraZeneca PLC Third Quarter and Nine Months Results 2004 'A strong third quarter with sales up 7 percent and Earnings per Share up 19 percent.' Financial Highlights (before Exceptional Items) Group 3rd 3rd Actual CER Nine Nine Actual CER Quarter Quarter Months Months % % % % 2004 2003 2004 2003 $m $m $m $m Sales 5,265 4,803 +10 +7 15,627 13,974 +12 +6 Operating Profit 1,261 1,101 +15 +16 3,451 3,262 +6 +2 Profit before Tax 1,274 1,119 +14 +15 3,521 3,333 +6 +2 Earnings per Share Before Exceptional $0.55 $0.47 +17 +19 $1.52 $1.40 +9 +5 Items Statutory (FRS3) $0.72 $0.47 +53 +56 $1.69 $1.40 +21 +16 All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated • Third quarter sales increased by 7 percent to $5,265 million and operating profit increased by 16 percent to $1,261 million. • Sales outside the US increased 8 percent whilst US sales increased by 6 percent. Growth in total sales is estimated to be 11 percent after adjustment for US wholesaler de-stocking. Stock levels are now normal. • Sales for the nine months increased by 6 percent and operating profit by 2 percent. • Sales of the key growth products were $8,018 million for the nine months, estimated to be up 35 percent after adjusting for wholesaler stock movements in the US. • Third quarter earnings per share of $0.72 includes a benefit of $0.17 from exceptional items. • Provisions of $80 million have been charged against operating profit following the non-approval of Exanta(TM) in the US. • Nexium(TM) third quarter sales decreased 6 percent; a 34 percent increase outside the US was more than offset by a 17 percent decline in the US, principally as a result of wholesaler stock building in 2003. • Crestor(TM) sales were $260 million in the quarter, bringing year to date sales to $596 million. Since launch more than 11 million prescriptions have been dispensed worldwide. • Seroquel(TM) sales were $529 million in the third quarter, and have reached $1.9 billion over the last twelve months. In September, Seroquel(TM) became the market leader in new prescriptions in the US atypical antipsychotic market. • The Group now anticipates earnings per share (before exceptional items) of around $2.10 for the full year, inclusive of the Exanta(TM) provisions. Sir Tom McKillop, Chief Executive, said: 'Despite the recent disappointment with Exanta(TM), the business is performing well in the second half. A continuing strong performance in the fourth quarter should yield full year pre-exceptional earnings of around $2.10 per share, and will provide an effective platform for growth in 2005.' London, 21 October 2004 Media Enquiries: Steve Brown/Edel McCaffrey (London) (020) 7304 5033/5034 Staffan Ternby (Sodertalje) (8) 553 26107 Rachel Bloom-Baglin (Wilmington) (302) 886 7858 Analyst/Investor Enquiries: Mina Blair (London) (020) 7304 5084 Jonathan Hunt (London) (020) 7304 5087 Staffan Ternby (Sodertalje) (8) 553 26107 Ed Seage/Jorgen Winroth (US) (302) 886 4065/(212) 579 0506 Photos of Sir Tom McKillop, Chief Executive and Jonathan Symonds, Chief Financial Officer are available on www.newscast.co.uk. Broadcast footage of AstraZeneca products and activities is available on www.thenewsmarket.com/ astrazeneca. Business Highlights All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated Third Quarter Sales in the third quarter were $5,265 million, up 10 percent on a reported basis, including a positive exchange benefit of 3 percent. Sales outside the US were up 8 percent at CER. In the US, third quarter sales were up 6 percent versus a strong third quarter 2003 which included wholesaler stock building. Inventories in the US are now at target levels in aggregate. Adjusting for inventory movements, US sales were up an estimated 15 percent, bringing the growth rate for Group sales to 11 percent in the quarter. On this same basis, global sales of key growth products were up 35 percent over last year, indicating continued momentum in the business. Expenditures in R&D and SG&A were $2,760 million in the third quarter, up 4 percent at CER versus the third quarter 2003. As expected, this rate of growth is significantly lower than the 13 percent increase at CER reported at the half year. Operating profit increased by 16 percent in the third quarter. Earnings per share (before exceptional items) in the third quarter was $0.55 versus $0.47 in 2003. Exceptional gains of $0.17 per share were recorded in the third quarter arising from the disposal of the Advanta joint venture and an exceptional tax credit. Nexium(TM) sales were up 34 percent outside the US. In the US, sales were down 17 percent due to wholesaler destocking in the current quarter set against significant wholesaler stock building in the third quarter 2003 ahead of a September price change. Dispensed tablet volume in the US increased by 17 percent over 2003. Crestor(TM) sales were $260 million in the third quarter, including $162 million in the US. Since launch 11 million prescriptions have been dispensed worldwide. Crestor(TM) share of new prescriptions in the US statin market was 7.6 percent in the week ending 8 October. Sales of oncology products were up 18 percent in the quarter. Arimidex(TM) sales increased 58 percent. Iressa(TM) sales were $113 million versus $70 million (up 57 percent) in the third quarter 2003. Seroquel(TM) sales were up 51 percent to $529 million in the quarter. Sales outside the US were up 33 percent. The 59 percent increase in the US was flattered by a weak third quarter 2003. US prescription growth remains strong, up 31 percent year to date. Sales in the last twelve months are now just under $1.9 billion. A comprehensive review of the performance of key brands, as well as an update of the Group's expanding Research and Development pipeline was presented at the Annual Business Review meeting held on 6 October. Nine Months For the nine months, sales increased 12 percent on a reported basis, including a positive exchange benefit of 6 percent. Sales outside the US were up 7 percent at CER. US sales were up 4 percent, which is considerably below the estimated underlying growth rate of 12 percent. Strong third quarter operating profit growth lifted year to date operating profits to a 6 percent increase on a reported basis, including a positive exchange benefit of 4 percent. Earnings per share (before exceptional items) was $1.52 compared with $1.40 last year. Future Prospects The pattern of good sales growth, combined with the slowing rate of growth in R& D and SG&A expenses evidenced in the third quarter results, should continue in the fourth quarter and should give rise to strong earnings growth versus a comparatively weak fourth quarter last year. For the full year the Company now anticipates earnings per share (before exceptional items) of around $2.10. Disclosure Notice: The preceding forward-looking statements relating to expectations for earnings and business prospects for AstraZeneca PLC are subject to risks and uncertainties, which may cause results to differ materially from those set forth in the forward-looking statements. These include, but are not limited to: the rate of growth in sales of generic omeprazole in the US, continued growth in currently marketed products (in particular Crestor(TM), Nexium(TM), Seroquel(TM), Symbicort(TM), Arimidex(TM) and Iressa(TM)), the growth in costs and expenses, interest rate movements, exchange rate fluctuations and the tax rate. For further details on these and other risks and uncertainties, see AstraZeneca PLC's Securities and Exchange Commission filings, including the Annual Report and Form 20-F Information 2003. Sales All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated Gastrointestinal Third Quarter CER % Nine Months CER % 2004 2003 2004 2003 Losec(TM)/ Prilosec(TM) 430 631 -34 1,501 2,037 -32 Nexium(TM) 951 1,000 -6 2,777 2,466 +10 Total 1,407 1,649 -17 4,342 4,556 -10 • Third quarter sales for Nexium(TM) in the US were down 17 percent, as the excess stocks at the end of the second quarter were normalised during this quarter, as compared with the significant wholesaler stocking that occurred in the third quarter 2003 ahead of a September price change. Thus nine months reported sales in the US (up 2 percent) do not correlate with the estimated underlying growth of 22 percent. • Sales of Nexium(TM) outside the US were up 34 percent for the quarter and 32 percent for the nine months on strong performance in all major markets. • The intravenous formulation for Nexium(TM) is now being launched in Europe, and US approval is expected in early 2005. On 16 September, the Group announced successful completion of the Mutual Recognition Procedure (MRP) in the European Union for new indications for Nexium(TM), including the healing of gastric ulcers and, for patients at risk, the prevention of gastric and duodenal ulcers associated with NSAID therapy. Approvals in the US and other markets are anticipated in the coming months. • Prilosec(TM) sales in the US were down 62 percent in the third quarter and 63 percent year to date, in line with the decline in prescriptions. • Outside the US, sales of Losec(TM) were down 20 percent in the quarter and 13 percent for the nine months, although year to date sales increased in Japan (up 21 percent) and China (up 25 percent). Cardiovascular Third Quarter CER % Nine Months CER % 2004 2003 2004 2003 Seloken(TM) / Toprol-XL(TM) 353 286 +22 1,006 1,034 -5 Atacand(TM) 214 185 +13 639 543 +10 Plendil(TM) 102 144 -30 361 383 -10 Zestril(TM) 105 116 -12 327 342 -12 Crestor(TM) 260 76 n/m 596 88 n/m Total 1,208 984 +20 3,456 2,920 +12 • Sales of Toprol-XL(TM) in the US were up 35 percent in the third quarter, as sales in the quarter were broadly in line with the underlying demand. Year to date prescription growth is 19 percent. Year to date sales (down 7 percent) still compare unfavourably with the wholesaler stock building which occurred in the first nine months of 2003. Patent litigation is progressing in the US against three companies seeking FDA approval to sell generic metoprolol succinate. Further information about this litigation is set out in Note 4 to these interim financial statements. • Sales of Seloken(TM) outside the US were down 2 percent in the quarter and up 2 percent for the nine months. • Atacand(TM) sales outside the US were up 15 percent in the third quarter and 17 percent for the nine months. • Atacand(TM) sales in the US were up 7 percent in the quarter and down 4 percent for the nine months. Total prescriptions through August declined by 3 percent. • Review of regulatory applications in the EU and the US seeking approval for Atacand(TM) in the treatment of chronic heart failure are ongoing. • Crestor(TM) sales in the third quarter were $260 million, including $162 million in the US, an increase over the corresponding figures in the second quarter of $207 million and $113 million respectively. • Crestor(TM) has now been approved in 64 countries and launched in 51. Since launch more than 11 million prescriptions have been dispensed. • Following a positive recommendation from an advisory committee to the Ministry of Health in Japan, Crestor(TM) is on track for approval before the end of 2004. • Growth in the US statin market has accelerated through 2004 as a result of increased promotional efforts and the publication of new guidelines calling for more intensive treatment of elevated cholesterol. New prescriptions for statins in the third quarter grew 18 percent, as compared with just 6 percent growth for the full year 2003. Crestor(TM) share of new prescriptions in this expanding market for the week ending 8 October was 7.6 percent, a 0.9 point recovery from early July. Market share in the dynamic segment (new and switch patients) was 14.7 percent in the latest week. • Crestor(TM) sales in Europe ($157 million year to date) reflect good progress in the launches in France (3.4 percent value share at 30 weeks) and in Italy (8.0 percent value share at week 26). In the latest month, Crestor(TM) share of total statin prescriptions in the Netherlands is 9.9 percent, 11.4 percent in Canada and 3.5 percent in the UK. Respiratory Third Quarter CER % Nine Months CER % 2004 2003 2004 2003 Symbicort(TM) 185 128 +39 578 377 +37 Pulmicort(TM) 211 184 +12 737 674 +4 Rhinocort(TM) 87 86 - 268 272 -4 Accolate(TM) 31 20 +55 84 76 +8 Oxis(TM) 25 31 -22 76 91 -25 Total 574 485 +15 1,861 1,600 +8 • Sales of Symbicort(TM) increased 39 percent in the third quarter and 37 percent for the nine months. Sales in the last twelve months reached $750 million. • In the US, sales of Pulmicort(TM) Respules(TM) in the quarter (up 17 percent) and for the nine months (up 14 percent) are below the estimated underlying growth of 20 percent as a result of wholesaler destocking compared with the same period in 2003. • Total prescriptions in the US market for intranasal steroids to treat allergies are flat year to date, as are prescriptions for Rhinocort(TM) Aqua. Sales for the nine months are down 7 percent due to wholesaler inventory movements. Oncology Third Quarter CER % Nine Months CER % 2004 2003 2004 2003 Casodex(TM) 258 230 +7 736 647 +5 Zoladex(TM) 236 224 +1 675 630 -1 Arimidex(TM) 221 136 +58 578 372 +45 Iressa(TM) 113 70 +57 309 136 +117 Faslodex(TM) 24 19 +26 73 56 +28 Nolvadex(TM) 30 38 -26 99 138 -35 Total 885 722 +18 2,481 1,993 +15 • Casodex(TM) sales outside the US were up 6 percent in the quarter and 11 percent for the nine months. Japan continues to be the main driver for growth, with sales up 27 percent for the nine months. • Casodex(TM) sales in the US for the nine months remain below last year's level (down 10 percent) compared with estimated sales growth of 7 percent as a result of stocking differences between the periods. • Arimidex(TM) sales continue to benefit from increased usage in the treatment of early breast cancer. Total prescriptions for Arimidex(TM) in the US increased 43 percent through September. US sales growth for the nine months was 42 percent (up from the 29 percent reported at the half year) as a result of strong third quarter growth (up 67 percent). • Arimidex(TM) sales for the nine months also grew strongly in Europe (up 55 percent) and in Japan (up 36 percent). • Sales of Iressa(TM) in the US were $59 million in the quarter and $159 million for the nine months. Retail prescriptions in the third quarter were 63 percent higher than last year and 8 percent ahead of the second quarter 2004. Sales in Japan were up 15 percent in the quarter and 30 percent for the nine months. Sales in other markets reached $53 million for the nine months. • Sales for Faslodex(TM) for the nine months were up 28 percent on launches following European marketing approval in March of this year. US sales were up 13 percent. Neuroscience Third Quarter CER % Nine Months CER % 2004 2003 2004 2003 Seroquel(TM) 529 345 +51 1,465 1,059 +35 Zomig(TM) 81 83 -4 267 245 +2 Diprivan(TM) 126 105 +18 374 339 +5 Local anaesthetics 128 121 +4 398 344 +7 Others 16 17 -12 54 54 -9 Total 880 671 +29 2,558 2,041 +20 • Seroquel(TM) sales outside the US increased 33 percent in the third quarter on strong growth in Europe (up 44 percent) fuelled by the launches for the bipolar mania indication. Nine month sales were up 28 percent. • Prescriptions for atypical antipsychotics in the US increased 9 percent through September; Seroquel(TM) prescriptions were up 31 percent. In September, Seroquel(TM) share of new prescriptions reached 26.4 percent, overtaking risperidone to become the leading product in new prescriptions. • Third quarter sales of Seroquel(TM) in the US were in line with underlying demand. The 59 percent growth rate reflects wholesaler destocking in the third quarter 2003. Sales for the nine months were up 37 percent. • Zomig(TM) sales in the US were down 9 percent in the third quarter, and up 2 percent for the nine months. Outside the US, third quarter sales were down 2 percent and up 3 percent for the nine months. Geographic Sales Third Quarter CER % Nine Months CER % 2004 2003 2004 2003 US 2,407 2,271 +6 6,974 6,703 +4 Europe 1,858 1,662 +7 5,661 4,863 +3 Japan 352 297 +9 1,018 833 +9 RoW 648 573 +12 1,974 1,575 +16 • The reported growth rates for sales in the US, influenced by wholesaler stock movements, understate the strong underlying growth. Adjusted for stock movements, nine month sales were up 12 percent (28 percent excluding the three patent expired products) • For the nine months, sales growth in Europe reflects, in addition to the launch roll-out for Crestor(TM), strong performances for Nexium(TM) (up 30 percent), Symbicort(TM) (up 35 percent), Arimidex(TM) (up 55 percent), and Seroquel(TM) (up 40 percent). This strong volume growth was able to offset the sales decline in Losec(TM) and price erosion in most markets. • Oncology products (up 20 percent) and Losec(TM) (up 21 percent) drove sales performance in Japan for the nine months. Operating Review All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated Third Quarter Reported sales increased by 10 percent and operating profit by 15 percent. At constant exchange rates sales increased by 7 percent and operating profit by 16 percent. In quarter three, the net effect of exchange on operating profit was marginally negative and reduced EPS by less than 1 cent. Compared with quarter three last year the euro was 8 percent stronger than the US dollar, benefiting sales, whilst the Swedish krona and sterling were respectively 8 percent and 11 percent stronger, increasing costs. Hedging gains were broadly similar to quarter three last year. The US inventory management agreements (IMAs) have now been extended to 16 wholesalers and are providing more predictability to shipments in the US. Excess inventories have been largely worked off and at the end of the third quarter target inventories of less than one month had been achieved for most products. During the third quarter, wholesaler inventories over and above normal levels fell by around $75 million compared with an increase of $100 million during quarter three last year. Adjusting for these movements, total Group sales increased by approximately 11 percent. Gross margins improved by 0.6 percentage points to 76.1 percent for the quarter. Sales mix continues to improve with payments to Merck declining to 4.9 percent of sales in the quarter from 6.7 percent in the third quarter last year. Following non-approval of Exanta(TM) in the US by the FDA, provisions of $80 million have been made against inventories and assets associated with Exanta(TM). In aggregate, R&D and SG&A expenses were $2,760 million, an increase of 4 percent versus the third quarter last year as launch costs have peaked. R&D expenditure grew by 8 percent against a relatively low quarter in 2003 whilst SG &A growth was restricted to 2 percent, mainly through relatively low promotional expenses in the US compared to the third quarter last year. Before the adverse impact of currency, R&D and SG&A together declined by 1.5 points in the quarter as a percentage of sales. Operating margin for the quarter was 24.0 percent, an increase of 1.1 points over the same period last year. Gross margin, SG&A and R&D (as noted above) benefited operating margin, with the adverse currency impact on costs reducing margin by around 0.8 points. Nine Months Reported sales increased by 12 percent and operating profit by 6 percent. At constant exchange rates sales increased by 6 percent and operating profit by 2 percent. Cumulatively, exchange benefited EPS by around 5 cents. We expect to see a 2 cent to 3 cents negative effect in quarter four, based on current exchange rates and the hedging benefits seen in quarter four 2003 which are not expected to be repeated. As mentioned above, US wholesaler inventories have come down to target levels. The first nine months of 2003 saw a substantial buy-in of $300 million of wholesaler inventories over and above normal. Adjusting for these movements, total Group sales grew by approximately 10 percent. Gross margin increased by 1.2 points to 76.8 percent. Payments to Merck at 5.2 percent of sales are 1.4 points lower than last year but this benefit, and that from ongoing operating improvements, were partially offset by the provisions in respect of Exanta(TM). The rate of growth in R&D and SG&A expenses for the nine months was 10 percent at CER (18 percent as reported), which is down from the 13 percent CER growth reported at the half year, mainly as a result of launch costs having peaked. Individually, R&D recruitment in Discovery and Development in the latter half of last year continued to drive cost growth over the first nine months of 2004, whilst SG&A growth was driven by product launches and new consumer campaigns. Operating margin for the nine months was 22.1 percent, 1.2 points below the same period last year. The improvement in gross margin percentage has been more than offset by the growth in investment in R&D and SG&A, particularly in the first half of the year. Interest and Dividend Income Net interest and dividend income for the first nine months was $70 million ($71 million in 2003), including $13 million in the third quarter ($18 million in 2003). As previously reported, net interest includes a gain arising from the close out of an interest rate swap that has offset a decline in core net interest income, as US dollar yields have been lower than last year whilst interest payments have increased. Taxation The effective tax rate for the third quarter and nine months was 27.0 percent compared with 27.5 percent for the comparative periods in 2003. The movements in the Statement of Total Recognised Gains and Losses include a credit of $357 million in respect of agreed tax relief on exchange losses in the UK. Exceptional Items The disposal of the Advanta joint venture was completed on 1 September 2004 for $287 million, including $48 million due on final agreement of the net assets at disposal. The profit on disposal, after transaction costs and warranty and indemnity provisions, was $219 million. There is no tax charge arising on the disposal. An agreement has been reached with US tax authorities that a portion of the $355 million Zoladex(TM) settlement, recorded as an exceptional item in 2002, is deductible for tax purposes. Consequently, an exceptional tax credit has been recorded in quarter three of $58 million in relation to this. Cash Flow Cash generated from operating activities before exceptional items in the nine months increased to $3,805 million from $3,532 million in the comparative period. This was due to increased trading profits for the nine months against the same period last year which, together with a reduced net outflow relating to working capital requirements and a reduction in the cash paid in respect of exceptional items, has meant that net cash from operating activities increased by $652 million to $3,797 million. Tax paid ($1,011 million) and capital expenditure ($927 million) were broadly similar to the comparative period in 2003. There was a $308 million inflow from the disposals of Durascan and Advanta compared to $80 million in respect of the disposal of Marlow Foods in the prior year. The 2004 interim dividend payment was made in September as opposed to October in 2003, resulting in accelerated dividend payments of $1,378 million compared to $770 million. $1,550 million has been paid under the share repurchase scheme in the nine months to date compared with $532 million in the comparative period in 2003. Net cash funds have decreased by $607 million from the beginning of the year to stand at $2,889 million at 30 September 2004. Share Repurchase Programme During the third quarter, 13.3 million shares were repurchased for cancellation at a total cost of $582 million bringing the total repurchases for the first nine months to 33.5 million shares at a total cost of $1,550 million. The total number of shares that remain in issue at 30 September 2004 is 1,661 million. Upcoming Milestones and Key Events 25 October 2004 Communication of 2003 and H1 2004 IFRS restatements 27 January 2005 Announcement of fourth quarter and full year 2004 results Sir Tom McKillop Chief Executive This information is provided by RNS The company news service from the London Stock Exchange

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