Final Results

AstraZeneca PLC 31 January 2002 PART 1 AstraZeneca PLC Fourth Quarter and Full Year Results 2001 'Earnings per share up 11 percent. Strong portfolio to drive transformation at AstraZeneca.' Financial Highlights (before Exceptional Items) Group 4th Quarter 4th Quarter Constant Full Year Full Year Constant (Continuing operations*) 2001 2000* Currency 2001 2000* Currency $m $m % $m $m % Sales 4,440 4,144 +8 16,480 15,804 +8 Operating Profit 1,090 971 +12 4,156 3,984 +6 Profit before Tax 1,102 1,034 +12 4,269 4,110 +7 Earnings per Share Group $0.47 $0.42 +18 $1.77 $1.64 +11 Group (Statutory FRS3) $0.43 $0.19 $1.69 $1.44 * Excluding Agrochemicals from prior period except for statutory FRS3 EPS All narrative in this section refers to growth rates at constant exchange rates (CER) - NexiumTM achieves full year sales of $580 million. NexiumTM share of new prescriptions in US PPI market up to 16.3 percent in December. - Outside of GI, sales for the full year up 12 percent, and up 16 percent in the fourth quarter. Strong growth in Respiratory, Oncology, and CNS product ranges. - SymbicortTM achieves rapid market penetration, with sales in fourth quarter reaching $49 million; rollout in Europe continues. - CasodexTM sNDA for the treatment of Early Prostate Cancer was submitted to US FDA on 20 December. - IressaTM clinical data package submitted to US FDA on 28 December, supporting IressaTM as monotherapy treatment of advanced non-small cell lung cancer in patients who have failed previous chemotherapy regimens. - Positive trial results for ArimidexTM as adjuvant treatment of early breast cancer presented in December. US FDA grants Fast Track status to the planned sNDA for this indication. - Board extends share buyback programme by an additional $2 billion. Tom McKillop, Chief Executive, said: 'Investments in R&D and strengthening of our sales and marketing capabilities have positioned AstraZeneca to realise the full value of our promising pipeline. Sales momentum from existing growth products, recent launches of NexiumTM and SymbicortTM, and the launches of FaslodexTM, IressaTM, and CrestorTM planned for this year will drive the transformation of our portfolio over the next two years.' London, 31 January 2002 Media Enquiries: Steve Brown/Emily Denney (London) (020) 7304 5033/5034 Staffan Ternby (Sodertalje) (8) 553 26107 Rachel Bloom (Wilmington) (302) 886 7858 Analyst/Investor Enquiries: Mina Blair-Robinson (London) (020) 7304 5084 Staffan Ternby (Sodertalje) (8) 553 26107 Ed Seage (Wilmington) (302) 886 4065 Jorgen Winroth (Wayne) (609) 896 4148 Photographs of the AstraZeneca annual results conference are available from newscast at www.newscast.co.uk from 1pm (UK time) today. Business Highlights All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated. For the full year, sales increased by 8 percent, and operating profits by 6 percent. The strength of the US dollar reduced reported sales and profits by 4 percent and 2 percent respectively. Earnings per share (before exceptional items) grew by 11 percent to $1.77. The Board has recommended a second interim dividend of $0.47 (33.2 pence, SEK 5.01) which will be paid on 8 April 2002. In the fourth quarter sales increased by 8 percent, and operating profits by 12 percent. Exchange rates reduced reported sales by 1 percent, but had no impact on operating profits. Earnings per share (before exceptional items) grew by 18 percent to $0.47. GI franchise sales were up 2 percent for the year. LosecTM sales outside the US grew by 4 percent. In the US, total prescriptions for PrilosecTM trended lower (down around 6 percent), and with reduced trade inventories US PrilosecTM sales were down by 13 percent for the full year. NexiumTM continued its strong performance, with sales for the year reaching $580 million, including $456 million in the US. Over four million prescriptions were written for NexiumTM in the US alone in 2001. Sales outside of the US progressed well in the fourth quarter, to $47 million, bringing the full year total to $124 million. Outside of GI, sales growth for the full year was 12 percent. Growth in the Respiratory product range (up 17 percent) was fuelled by the continued growth of PulmicortTM RespulesTM in the US and the excellent launch performance of SymbicortTM in its European roll out. Oncology products were up by 16 percent on the year. SeroquelTM (up 67 percent) and ZomigTM (up 20 percent) led the CNS product range to a 48 percent increase. Other developments in the fourth quarter included the submission of the sNDA for CasodexTM in the treatment of early prostate cancer to the US FDA on 20 December, followed on 28 December by the submission of the clinical data package for IressaTM in the treatment of advanced non-small cell lung cancer refractory to previous therapy. Also in December, new data were presented demonstrating that ArimidexTM is significantly more effective, and has important tolerability benefits, compared with tamoxifen as adjuvant treatment in post menopausal women with early breast cancer. Regulatory submissions for this new indication will be made in the US and Europe in the first quarter of 2002, and the US FDA has granted the application fast track status. Future Prospects All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated. Investment in Research and Development over the past few years and more recent strengthening of our sales and marketing capability have positioned the company to realise the full potential of its promising pipeline. Over the next two years, continued execution of our transformation strategy could result in offsetting the sales potentially lost to generic competition with incremental sales from three groups of products: the established growth products, the recently launched NexiumTM and SymbicortTM, as well as from the anticipated launches of FaslodexTM in the first half of this year, IressaTM and CrestorTM in the second half, and ExantaTM in 2003. The short-term outlook for sales and profits is clearly sensitive to product approvals and launch timings, as well as assumptions regarding the timing of generic competition for some mature products. Forecasting with so many variables is challenging, and a wide range of outcomes is possible. The company believes in the strength of the intellectual property relating to PrilosecTM, however we cannot preclude the possibility that generic omeprazole could enter the US market as early as the second quarter. Even on this timing, and also assuming a rate of sales erosion comparable to fluoxetine, financial modelling suggests sales for 2002 could be broadly flat. On flat sales, earnings could be around the middle of the range of current market expectations, which lie between $1.51 and $1.66 per share. When the transformation of the portfolio is complete AstraZeneca will be well positioned for a period of accelerating sales and earnings growth, which should result in top tier financial performance in the pharmaceutical sector. 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. These include, but are not limited to: the timing of the launch of generic omeprazole in the US, the successful registration and launch of new products (in particular NexiumTM and CrestorTM), continued growth of currently marketed products, the growth in costs and expenses, the amount of net interest income earned on the Group's cash balances, exchange rate fluctuations, and further improvements in the tax rate. For further details on these and other risks and uncertainties, see AstraZeneca PLC's Securities and Exchange Commission filings, including the 2000 annual report on Form 20-F. Sales All narrative in this section refers to growth rates at constant exchange rates (CER). Gastrointestinal Fourth Quarter CER % Full Year CER % 2001 2000 2001 2000 LosecTM/PrilosecTM 1,397 1,728 -19 5,684 6,260 -7 NexiumTM 285 13 n/m 580 17 n/m Total 1,696 1,752 -3 6,308 6,322 +2 - NexiumTM sales for the quarter totalled $285 million, including $238 million in the US. NexiumTM share of new prescriptions in the US PPI market now stands at 16.3 percent for the month of December, up another 3 points in the quarter. Over 4 million prescriptions have been written for NexiumTM in the US since its introduction in March 2001, leading to an increase of over 2 million total prescriptions for AstraZeneca's PPI franchise (including PrilosecTM) compared to 2000. - NexiumTM sales outside of the US reached $124 million for the full year. The product has now been launched in 38 countries, with another 49 planned for 2002, including France, Italy, and Belgium. NexiumTM share of the PPI segment in all major launch markets (including the US) was 10 percent by value in November, exceeding both pantoprazole and rabeprazole to become the third largest PPI by value. - Sales of LosecTM in markets outside of the US were up by 4 percent for the year. Performance was notably strong in France (up 17 percent) and Italy (up 45 percent), two large European markets which have yet to launch NexiumTM. In Japan, the long-term treatment indication and the launch of the 10 mg tablet resulted in an 85 percent increase in sales for the year. - In the US, PrilosecTM sales were down 13 percent for the full year, more than the modest 6 percent decline in total prescriptions. This difference is largely attributable to reduced inventory levels at the end of the year compared to the fourth quarter last year when wholesalers increased stocks ahead of an anticipated price increase. - The PrilosecTM patent infringement cases against four generic companies continue to be heard in the US District Court in New York. - EntocortTM EC was launched in the US on 19 November for the treatment of active mild to moderate Crohn's disease. Cardiovascular Fourth Quarter CER % Full Year CER % 2001 2000 2001 2000 ZestrilTM 265 228 +15 1,097 1,188 -6 AtacandTM 125 97 +27 414 293 +46 SelokenTM / Toprol-XLTM 168 172 -3 722 577 +28 PlendilTM 139 127 +10 471 480 +2 Total 916 842 +9 3,537 3,477 +6 - The underlying prescription demand for ZestrilTM in the US (up 5 percent) remained steady throughout 2001. The uneven phasing of wholesaler shipments, as well as higher rebates on performance-based contracts contributed to the reported 6 percent decline in worldwide sales for the year. - SelokenTM sales growth was driven by the continued strong performance of Toprol-XLTM in the US. Prescriptions for Toprol-XLTM were up 32 percent, aided by the new indication for congestive heart failure launched earlier in the year. Reported sales had been running well above prescription demand throughout 2001, so the unfavourable fourth quarter comparison brought reported sales in the US for the full year (up 47 percent) more in line with the prescription trend. - AtacandTM continues to perform well across all major markets. Sales outside of the US grew by 58 percent. Reported sales in the US for the year (up 29 percent) were below the strong 47 percent growth in total prescriptions. Respiratory Fourth Quarter CER % Full Year CER % 2001 2000 2001 2000 PulmicortTM 205 193 +4 775 705 +14 AccolateTM 31 21 +48 146 152 -2 RhinocortTM 75 56 +34 269 221 +25 OxisTM 33 32 - 127 116 +15 SymbicortTM 49 - n/m 83 - n/m Total 433 348 +23 1,556 1,372 +17 - As a result of the strong performance of PulmicortTM RespulesTM, total PulmicortTM sales were up 80 percent in the US market, more than offsetting the 4 percent decline outside the US. - RhinocortTM Aqua increased its share of the aqueous intranasal steroid segment of the rhinitis market in the US to 11.6 percent in December, up from 6.8 percent a year ago; it is the driver behind the growth of RhinocortTM worldwide. - SymbicortTM has now been launched in the major markets in Europe, and 23 countries in total. Rapid market penetration has been achieved in many of these markets in a matter of weeks after launch; prospects for further growth will be enhanced by regulatory submissions for COPD in the European Union in the first quarter of 2002. Oncology Fourth Quarter CER % Full Year CER % 2001 2000 2001 2000 CasodexTM 176 119 +50 569 433 +37 ArimidexTM 52 39 +33 191 156 +27 NolvadexTM 184 171 +9 630 576 +12 ZoladexTM 209 181 +17 728 734 +5 Total 627 518 +23 2,146 1,929 +16 - CasodexTM is the world's leading anti-androgen for the treatment of prostate cancer. Strong growth was reported in all major markets. Sales for the full year increased 27 percent in the US, 43 percent in Europe, and 56 percent in Japan. Approvals for the use of CasodexTM 150 mg tablets for the treatment of early stage prostate cancer have been granted in 11 markets to date; the sNDA for this important new indication was submitted to the FDA on 20 December. - ArimidexTM remains the leading product in the aromatase inhibitor market for breast cancer treatment. Sales in the US for the full year were up 15 percent, broadly in line with the trend in total prescriptions. Sales outside the US grew by 34 percent, on good growth in Europe (up 17 percent) and excellent performance in Japan since its launch in February. - The positive results of the ATAC (ArimidexTM, Tamoxifen, Alone or in Combination) study were first presented in December, which showed that Arimidex TM is significantly more effective and has important tolerability benefits compared with the current gold standard, tamoxifen, as an adjuvant treatment in postmenopausal women with early breast cancer. The US FDA has granted 'fast track' status for the supplementary license application for this new indication. Regulatory submissions will also be made in Europe in the first quarter 2002. CNS Fourth Quarter CER % Full Year CER % 2001 2000 2001 2000 SeroquelTM 174 131 +34 700 424 +67 ZomigTM 68 59 +15 277 237 +20 Total 248 190 +32 999 685 +48 - SeroquelTM sales for the quarter (up 34 percent) were up against a strong prior year comparison in the US. For the full year, sales in the US were up 51 percent, in line with the strong growth in prescriptions. Market share in the US is now 16 percent of new prescriptions. With the successful launch in Japan, and continued growth in Europe, sales outside the US grew to $132 million for the year. - Sales of ZomigTM increased by 20 percent. The August launch in Japan and good growth in Europe, particularly for ZomigTM RapimeltTM, were the key contributors. In the US, ZomigTM share of new prescriptions increased to 15.6 percent, aided somewhat by the launch of ZomigTM ZMT 2.5 mg. The 5 mg tablet of ZomigTM is the lead strength in the US market, and the ZomigTM ZMT 5mg tablet was launched there in October. Pain, Infection and Other Pharma Fourth Quarter CER % Full Year CER % 2001 2000 2001 2000 MerremTM 65 48 +37 227 170 +40 DiprivanTM 136 114 +20 465 507 -4 XylocaineTM 57 63 -7 212 238 -5 MarcaineTM 26 25 +4 87 92 - Total 408 398 +8 1,511 1,623 - - For MerremTM, good growth in Europe (up 21 percent for the year) and continued market share gains in the US led to strong growth for the quarter and the full year. Geographic Sales Fourth Quarter CER % Full Year CER % 2001 2000 2001 2000 USA 2,275 2,177 +5 8,700 8,153 +7 Europe 1,451 1,293 +8 5,270 5,166 +8 Japan 260 244 +16 851 825 +16 RoW 454 430 +18 1,659 1,660 +9 - Sales growth in the US featured the very successful launch of NexiumTM, which generated $456 million in just nine months on the market. Excluding sales of PrilosecTM, sales growth was a robust 28 percent for the full year, with strong showings for SeroquelTM, Toprol-XLTM, and PulmicortTM. - Good double digit growth in France and Italy drove performance in Europe. Product highlights in the region include the launches of NexiumTM and Symbicort TM, as well as good growth in AtacandTM, CasodexTM and SeroquelTM. - Strong growth in LosecTM (up 85 percent) and CasodexTM (up 56 percent) and the launches of SeroquelTM, ArimidexTM, and ZomigTM fuelled the excellent results in Japan. Operating Profit Operating profit before exceptional items grew by 12 percent to $1,090 million in the quarter and by 6 percent to $4,156 million for the year. There was no currency impact on profits in the fourth quarter due to the Euro being at similar levels to the dollar as in the fourth quarter 2000. For the full year, currency reduced operating profits by 2%. The adverse effect of the Euro was partially offset by a favourable impact from our Pounds Sterling and Swedish Krona cost base. For 2002, if current spot rates stay constant for the remainder of the year, we would estimate a 2-3% adverse impact on sales with a lower impact on earnings per share. Operating margin for the year of 25.2% was unchanged from 2000. Cost of Sales as a percent of sales was broadly similar to that of 2000 (excluding the effect of a reclassification of distribution costs). Research & Development costs at $2.7 billion were 16.3 percent of sales. Increases in R&D expenditure to support the megabrand launches were offset by currency benefits, particularly from the Swedish R&D sites. Selling costs increased as a result of the new product launches and field force expansion in the US whilst G&A costs continue to be tightly controlled. Other operating income increased to $368 million for the full year (2.2% of sales); including $64 million in the fourth quarter. Synergy benefits of $1 billion were realised in 2001. A final exceptional charge of $202 million was taken in 2001 bringing the total programme charge to $1,388 million. Whilst the integration and synergy programme from the merger is now largely complete, AstraZeneca continues to identify areas for further significant improvement to enable the business to function fast and effectively. Interest The Group recorded net interest and dividend income of $113 million for the full year. Net interest income for the fourth quarter of $12 million reflects the impact of lower US interest rates as well as $14 million of exchange losses. The drop from the fourth quarter of 2000 was due to exchange gains in 2000 of $46 million. Taxation Excluding exceptional items, the effective tax rate for 2001 was 27% compared with 29% for 2000. Cash Flow In 2001 cash generated from operating activities before exceptional items amounted to $4.1 billion, and cash from net interest income amounted to $0.2 billion. This was applied to exceptional outflows of $0.4 billion, net capital expenditure and financial investment of $1.6 billion, tax payments of $0.8 billion, and dividends of $1.2 billion. Net cash inflow before management of liquid resources was $0.3 billion. After share buy-backs less issues of $1.0 billion, the outflow in net cash funds was $0.7 billion. At 31 December 2001 the Group had net cash funds of $2.9 billion. Share Repurchase Programme During the quarter, 6.75 million Ordinary Shares were re-purchased (nominal value $0.25 each) for cancellation, bringing the total for the year to 23.5 million at a total cost of $1,080 million. The total number of shares re-purchased for cancellation since the start of the programme in December 1999 now stands at 37.2 million at an aggregate cost of $1,616 million. The total number of shares in issue (as at 31 December 2001) is 1,745 million. The share buy-back programme will continue to form an integral part of the Company's financial management programme and the Board has decided to extend the buy-back programme by an additional $2 billion to be completed by the end of 2003. Upcoming Milestones and Key Events First Quarter ArimidexTM adjuvant treatment regulatory submissions First Quarter SymbicortTM COPD regulatory submissions in Europe 25 April First Quarter Results and Annual General Meeting Tom McKillop Chief Executive This information is provided by RNS The company news service from the London Stock Exchange MORE TO FOLLOW

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