1st Quarter Results - Part 1

AstraZeneca PLC 25 April 2002 PART 1 AstraZeneca PLC First Quarter Results 2002 'Good first quarter results, EPS up 22 percent. Earnings targets raised for full year.' Financial Highlights (before Exceptional Items) Group 1st Quarter 1st Quarter Constant (Continuing operations*) 2002 2001* Currency $m $m % Sales 4,421 3,991 +13 Operating Profit 1,297 1,055 +22 Profit before Tax 1,318 1,110 +19 Earnings per Share Group $0.55 $0.45 +22 Group (Statutory FRS3) $0.55 $0.44 * Restated to be on a consistent basis under FRS19. See note on page 11 for further information. All narrative in this section refers to growth rates at constant exchange rates (CER) • NexiumTM achieved sales of $356 million in the first quarter. NexiumTM share of new prescriptions in US PPI market increased to 18.8 percent. • SymbicortTM sales were $54 million in the first quarter. Regulatory package for use in Chronic Obstructive Pulmonary Disease (COPD) submitted in European Union. • Excellent progress with ArimidexTM in adjuvant treatment of early breast cancer; promotion already started in Japan; FDA has granted six-month priority review, and the European file was submitted on 8 April. • CasodexTM sNDA for early prostate cancer granted Priority Review Status by FDA on 20 February. • SeroquelTM sales were $336 million in the quarter, an increase of 79 percent, resulting from strong underlying demand combined with some wholesaler stocking. • FDA response to CrestorTM NDA now expected by end of June. Tom McKillop, Chief Executive, said: 'This is a good set of results. The transformation of our portfolio continues, with strong performances from NexiumTM, SymbicortTM, AtacandTM, SeroquelTM and our range of cancer medicines. The regulatory reviews for CrestorTM and IressaTM are ongoing in major markets, and we will be filing for marketing approval for ExantaTM in Europe in the third quarter.' London, 25 April 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 Jonathan Hunt (London) (020) 7304 5087 Staffan Ternby (Sodertalje) (8) 553 26107 Ed Seage (Wilmington) (302) 886 4065 Jorgen Winroth (New York) (212) 581 8720 Business Highlights All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated. Sales in the first quarter increased by 13 percent, and operating profits by 22 percent. Exchange rate movements against the US dollar reduced reported sales growth by 2 percent, but had a favourable impact on operating profits by 1 percent. Earnings per share (before exceptional items) rose by 22 percent to $0.55. Sales grew by double digits in all major regions, including a 14 percent increase in the US. Sales growth in the US was broadly in line with underlying demand, as speculative buying around announced or anticipated price changes affected the first quarter 2002 and the first quarter 2001 to a similar degree. Trade inventories increased by some $200 million in both periods, although it was mostly the Cardiovascular and CNS products that were affected in 2002, whilst it was chiefly PrilosecTM in the first quarter 2001. The company expects normal unwinding of these inventories over the next two quarters, and there should be no impact on achievement of our full year targets. GI franchise sales were up by 1 percent in the quarter. The strong growth of NexiumTM continues. Sales in the quarter were $356 million, including $293 million in the US. Sales of LosecTM outside the US were broadly unchanged. In the US PrilosecTM sales were down by 26 percent, in line with the decline in prescriptions, as NexiumTM continues to represent a growing proportion of AstraZeneca's PPI franchise. Total prescriptions for AstraZeneca PPI products in the US (PrilosecTM and NexiumTM) are 15 percent ahead of last year. The PrilosecTM patent infringement cases against four generic companies continues to be heard in the US District Court in New York. To date there have been no generic omeprazole products introduced in the US market. Excluding GI products, sales growth in the first quarter was 20 percent. Other developments since the beginning of 2002 included regulatory submissions in the US and Europe for ArimidexTM in the adjuvant treatment of early breast cancer. In CNS products, February marked the launch of ZomigTM Nasal Spray in Sweden, its first market, as well as the regulatory submission in the US. ZomigTM RapimeltTM tablets received approval in Japan on 15 March. The IressaTM NDA in Japan for use as monotherapy in treatment of advanced non-small cell lung cancer (NSCLC) was submitted on 28 January. The rolling submission of data in the US to support the fast track review for this indication continues, and the company is planning for launches in both of these major markets in the second half of the year. Completion, validation, and analysis of the pivotal trials for the use in combination with cytotoxic agents in NSCLC is expected in the second half of this year; regulatory submissions for this indication, including first submissions in Europe for IressaTM, are now expected in fourth quarter 2002. The regulatory review of CrestorTM in the US is ongoing and, whilst AstraZeneca does not normally comment on the progress of regulatory reviews, the company has been informed by FDA that it will not complete its response to the CrestorTM NDA by 26 April*, but expects to do so before the end of June. Additional information and analyses are being generated to support the use of CrestorTM at higher doses. AstraZeneca is confident in the profile of CrestorTM and looks forward to a positive outcome. The precise timing of the US launch awaits completion of the review, but is unlikely to be in the third quarter. Based on the excellent results achieved in the European EXPRESS study of ExantaTM for the prevention of blood clots following orthopaedic surgery (which will not be published in detail until later this year) the company confirms its intention to submit for European marketing approval in the third quarter of this year. *April 26th marks the end of the ten-month review period by which FDA targets a response for seventy percent of filings under the PDUFA agreement. Future Prospects All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated. As stated in the year end 2001 results announcement, the short term outlook for sales and profits could vary depending on product approvals, launch timings, and entry of generic competition for PrilosecTM and other mature products. At the time of that announcement, the range of market expectations for earnings was between $1.51 and $1.66 per share, and the company anticipated earnings per share in the middle of this range. Based upon the company's current views on these variables, earnings per share are now expected to be around the top of this range. 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 2001 annual report on Form 20-F. Sales All narrative in this section refers to growth rates at constant exchange rates (CER). Gastrointestinal First Quarter CER % 2002 2001 LosecTM/PrilosecTM 1,218 1,495 -18 NexiumTM 356 81 n/m Total 1,587 1,588 +1 • NexiumTM sales continued their strong growth. Sales in the US reached $293 million in the quarter. NexiumTM share of new prescriptions in the US retail PPI market was 18.8 percent in March, up 2.5 points since year end. • NexiumTM achieved sales outside of the US of $63 million, with market share gains across the board. Market share in Europe is now over 9 percent. NexiumTM was launched in France at the end of March, and launches in Italy and Belgium, among others, will follow later this year. • Sales of LosecTM outside the US were broadly unchanged (down 1 percent) with good growth reported in France, Italy, and Japan. • In the US, PrilosecTM sales were down by 26 percent, broadly in line with the trend in prescriptions, as NexiumTM continues to represent a growing proportion of AstraZeneca's PPI franchise. • The PrilosecTM patent infringement cases against four generic companies continues to be heard in the US District Court in New York. Cardiovascular First Quarter CER % 2002 2001 ZestrilTM 283 294 -3 AtacandTM 151 83 +84 SelokenTM / Toprol-XLTM 236 151 +57 PlendilTM 108 106 +4 Total 961 835 +17 • Sales of AtacandTM Plus/AtacandTM HCT and AtacandTM grew strongly in all major markets. Sales outside the US were up 43 percent. Total prescriptions in the US were up 35 percent. Reported sales growth (up 170 percent) was well ahead of prescriptions, a result of inventory building this year versus wholesaler de-stocking in the first quarter 2001. • Sales of SelokenTM/Toprol-XLTM continue to grow on the strength of the performance of Toprol-XLTM in the US. Aided by the congestive heart failure indication launched last April, total prescriptions are up 37 percent. Wholesaler stocking lifted the reported sales increase in the US to 100 percent. • Sales of ZestrilTM declined slightly, chiefly on generic competition outside the US. Respiratory First Quarter CER % 2002 2001 PulmicortTM 229 200 +17 AccolateTM 33 49 -31 RhinocortTM 64 56 +14 OxisTM 31 32 -3 SymbicortTM 54 3 n/m Total 446 381 +19 • The SymbicortTM launch in Europe continues to make good progress, with particularly strong penetration of the combination segment in France, Germany, and the Scandinavian markets. As planned, the regulatory submission for COPD treatment was made in Europe in the quarter. • Despite competitive pressures on PulmicortTM sales outside the US, overall sales grew by 17 percent, driven by the strong US performance for PulmicortTM RespulesTM (up 128 percent) and some stock building on PulmicortTM TurbuhalerTM. • In the US, RhinocortTM Aqua continues to increase its share of the aqueous intranasal steroid segment of the rhinitis market, up over 4 points in the last twelve months to 12.7 percent in March. Total prescriptions are up over 55 percent over the first quarter 2001. Oncology First Quarter CER % 2002 2001 CasodexTM 124 115 +12 ArimidexTM 66 43 +55 NolvadexTM 143 139 +5 ZoladexTM 190 160 +23 Total 528 464 +17 • Sales of CasodexTM outside the US grew by 49 percent, reflecting strong growth in Europe (up 55 percent) and in Japan (up 39 percent). This growth was partially offset by the 37 percent decline in the US, as significant wholesaler de-stocking following the price increase in early January masked underlying prescription growth of around 7 percent. The supplemental NDA for the treatment of early prostate cancer with CasodexTM was granted Priority Review Status by FDA on 20 February. • The growth in ArimidexTM sales resulted from a balanced performance, with strong sales growth in the US (up 69 percent) and in markets outside the US (up 48 percent). The US sales increase tracked the underlying demand; new prescription share in the growing aromatase inhibitor market has shot up to 62.6 percent in March, an increase of nearly 9 points in the last three months. • Promotion of ArimidexTM for the adjuvant treatment of early breast cancer has begun in Japan. Regulatory submissions for this important new indication have been made in Europe and the US, with the US granting Priority Review Status for the application earlier this month. CNS First Quarter CER % 2002 2001 SeroquelTM 336 189 +79 ZomigTM 93 66 +43 Total 436 257 +71 • The market acceptance for SeroquelTM continues to be reflected in steady growth in demand. Sales outside the US grew by 73 percent. Prescriptions in the US were up 48 percent versus the first quarter last year. New prescription share in March was 16.7 percent, up nearly 4 points versus a year ago; this is the largest share gain among the leading atypical antipsychotics. Sales in the US were up 80 percent, indicating stock building in the distribution channels. • ZomigTM sales outside the US were up 31 percent, with good growth in France. Sales in the US were up 50 percent, well ahead of the growth in prescriptions (up 11 percent). Pain, Infection and Other Pharma First Quarter CER % 2002 2001 MerremTM 67 49 +39 DiprivanTM 113 107 +9 Local anaesthetics 96 104 -4 Total 347 364 -2 • Strong growth in the US (up 67 percent) drove MerremTM performance. Sales outside the US increased by 33 percent. Geographic Sales First Quarter CER % 2002 2001 USA 2,448 2,139 +14 Europe 1,395 1,291 +10 Japan 172 178 +10 RoW 406 383 +11 • Sales in the US were up by 14 percent in the quarter despite the decline in PrilosecTM sales as more of the PPI franchise migrates to NexiumTM. NexiumTM was the key growth driver in the quarter, and underlying demand for key growth products such as SeroquelTM, Toprol-XLTM, AtacandTM, ArimidexTM and CasodexTM was also strong. • Sales growth in Europe was fuelled by SymbicortTM and NexiumTM, as well as by important contributions from CasodexTM, ZoladexTM, AtacandTM and Seroquel TM. France, Italy, and Spain were the fastest growing of the largest markets. • Sales in Japan continue to grow in double digits, with a strong performance in oncology products and continued good growth in LosecTM leading the quarter's performance. Operating Profit Operating profit before exceptional items grew by 22 percent at constant exchange rates to $1,297 million in the quarter. This was well ahead of sales growth, partly aided by higher wholesaler inventories and favourable phasing of R&D and sales and marketing costs. As highlighted, wholesaler inventories in the US were some $200 million above normal levels, but at a level similar to the end of first quarter 2001. Currency had a 1% favourable impact on profit in the first quarter. The continuing benefits of the strong dollar against the Swedish Krona and Pounds Sterling more than offset the adverse effect on the Euro. For 2002, if current spot rates stay constant for the remainder of the year, we would estimate an adverse impact of around 1-2% on earnings per share, consistent with our guidance given in the 2001 results release. Operating margin for the quarter of 29.3% was nearly three percentage points ahead of 2001. Cost of sales was marginally lower than last year with lower contingent payments to Merck. Research and development costs were 15.8 percent of sales, down from 16.8 percent of sales in 2001, partly through a favourable currency impact, particularly from the Swedish Krona, and also from phasing of project costs. Selling, general and administrative costs were up 5% with increases in selling costs partially offset by a decline in general and administrative costs. Other operating income at $156 million was similar to 2001 levels and included a gain from the disposal of SularTM in the US. Interest The group recorded net interest and dividend income of $21 million in the quarter. The variance against 2001 was caused by lower US interest rates as well as marginally lower cash balances as a result of the share repurchase programme. Taxation Excluding exceptional items, the effective tax rate for the first quarter 2002 was 27% compared with 28.4% for 2001. The 2001 tax rate has been restated under FRS19. See Note 1 to the interim financial statements for more detail. Cash Flow Cash generated from operating activities amounted to $1.9 billion in the first quarter aided by a timing benefit in the quarterly payment to Merck. The net increase in net cash funds after capital expenditure, tax and share repurchases was $1.4 billion in the quarter. Share Repurchase Programme During the quarter, 2.8 million ordinary shares were re-purchased (nominal value $0.25 each) for cancellation at a total cost of $140.0 million. The total number of shares re-purchased for cancellation since the start of the programme in December 1999 now stands at 40.0 million at an aggregate cost of $1,756 million. The total number of shares in issue (as at 31 March 2002) is 1,743 million. Upcoming Milestones and Key Events 25 April Annual General Meeting 25 July Half Year results Third Quarter ExantaTM filing in Europe for orthopaedic surgery 24 October Third Quarter and Nine Month results Fourth Quarter IressaTM filing for combination therapy in NSCLC 7 November Annual Business Review Tom McKillop Chief Executive This information is provided by RNS The company news service from the London Stock Exchange MORE TO FOLLOW. QRFSESSAISESESL

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