1st Quarter Results

AstraZeneca PLC 30 April 2003 AstraZeneca PLC First Quarter Results 2003 'Earnings per Share $0.54. Targets for the year maintained.' Financial Highlights (before Exceptional Items) Group 1st Quarter 1st Quarter Constant (Continuing operations) 2003 2002 Reported Currency $m $m % % Sales 4,735 4,346 +9 +4 Operating Profit 1,272 1,297 -2 -3 Profit before Tax 1,293 1,318 -2 -3 Earnings per Share Group $0.54 $0.55 -2 -3 Group (Statutory FRS3) $0.54 $0.55 All narrative in this section refers to growth rates at constant exchange rates (CER) • Sales increased by 4 percent. Excluding LosecTM/PrilosecTM sales grew by 23 percent, benefiting from wholesaler stocking in the US. • Operating profits were down by 3 percent, affected by $141 million lower other operating income compared with the first quarter 2002, which included proceeds from the sale of Sular marketing rights. • Costs in R&D and SG&A combined increased by 4 percent in CER terms. • Earnings per Share of $0.54 were down 3 percent. • NexiumTM sales were $835 million. Share of total prescriptions in the US market increased to 21.4 percent in March. • Sales of CrestorTM in the quarter were $3 million, following successful launches in Canada in mid-February, and in the Netherlands and the UK in March. • IressaTM sales were $19 million in the first quarter. IressaTM submission in Europe for the treatment of non-small cell lung cancer was announced on 11 February. Target date for completion of US FDA regulatory review is 5 May. • SymbicortTM sales were $122 million in the first quarter. Successful completion of Mutual Recognition Procedure in Europe for use in chronic obstructive pulmonary disease (COPD) was announced 10 February. Tom McKillop, Chief Executive, said: 'The transformation of our product portfolio is proceeding as anticipated, with strong demand for the growth and recently launched products balancing the expected declines due to patent expiries. With this sales performance and the planned programme of product launches we are well placed to achieve the financial targets for the year we communicated in January.' London, 30 April 2003 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 4 percent. Operating profit decreased by 3 percent. Earnings per Share were down by 3 percent to $0.54. The weaker US dollar increased the reported sales growth rate by 5 percent. Nearly all the currency benefit on reported sales was offset by the adverse currency impact on operating costs, with the overall result that reported operating profits and earnings per share benefited by just 1 percent from currency movements. Other operating income for the first quarter 2003 ($15 million) was significantly lower than the first quarter 2002 ($156 million) which included proceeds from the sale of Sular marketing rights to First Horizon. Costs in R& D and SG&A combined increased by 4 percent in CER terms. Sales growth in the first quarter was 4 percent in the US and 5 percent in the rest of the world. As expected, sales in the US reflected significant generic competition for PrilosecTM, ZestrilTM, and NolvadexTM. In aggregate, sales of these three products were $669 million lower than the first quarter 2002. This was more than offset by a continued strong performance in the rest of the portfolio, with sales up 55 percent. The company estimates that underlying demand for these products grew by around 35 percent. The balance of the growth is attributable to favourable effects from wholesaler stock movements in the US market in this quarter compared to the first quarter 2002, which also benefited from stock building. At the end of the first quarter 2003, the company estimates that trade inventories are some $400 million higher than normal (and some $200 million higher than at the end of the first quarter 2002). This inventory should be worked off in the normal course of business over the next two quarters, with no adverse effect on our estimates for revenue for the year as a whole. The products chiefly affected include NexiumTM, SeroquelTM, Toprol-XLTM and AtacandTM. NexiumTM sales were up 136 percent on strong prescription demand and wholesaler stock building in the US. PrilosecTM sales in the US were $287 million in the first quarter, a decline of 60 percent, broadly in line with the trend in prescriptions. Generic omeprazole market share has been holding steady at around 60 percent of total prescriptions for the omeprazole molecule in recent weeks. Sales of Cardiovascular products were down just 3 percent, despite the significant decline in ZestrilTM, as good prescription growth in the US continues for Toprol-XLTM (up 31 percent) and AtacandTM (up 19 percent). The first sales for CrestorTM were recorded in the quarter ($3 million), with the mid-February launch in Canada followed by the first European launches in the Netherlands and in the UK. Oncology product sales grew by 6 percent, as growth in CasodexTM, ArimidexTM, FaslodexTM and IressaTM more than offset generic erosion on NolvadexTM. Iressa TM sales of $19 million in the quarter were affected by label changes and some market adjustment following the rapid up-take in the fourth quarter 2002. The regulatory submission in the EU for IressaTM in the treatment of locally advanced or metastatic non-small cell lung cancer was announced 11 February. The target date for completion of the review by the US FDA is May 5. FaslodexTM sales were $22 million in the quarter, and the file for second-line treatment of advanced breast cancer was submitted in the EU in February. Other product development highlights in the quarter included regulatory submissions in the US and Europe for the use of SeroquelTM for the treatment of manic episodes associated with bipolar disorder, and for the use of NexiumTM for the treatment of upper GI symptoms in patients taking non-steroidal anti-inflammatory drugs (NSAIDs). Future Prospects All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated. After adjusting for wholesaler buying patterns, the underlying sales revenue for the quarter was in line with the company's expectations, with expected declines due to patent expiries balanced by strong demand in the growth and recently launched products. Therefore the company has not changed its targets for the full year, and continues to anticipate earnings per share in the range of $1.50 to $1.65 per share. 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 rate of growth in sales of generic omeprazole in the US, the successful registration and launch of new products (in particular CrestorTM, IressaTM, and ExantaTM), continued growth of currently marketed products, the growth in costs and expenses, interest rate movements, exchange rate fluctuations, and the effective tax rate. For further details on these and other risks and uncertainties, see AstraZeneca PLC's Securities and Exchange Commission filings, including the 2002 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 % 2003 2002 LosecTM/PrilosecTM 692 1,192 -45 NexiumTM 835 347 +136 Total 1,545 1,552 -3 • NexiumTM sales in the US increased by 135 percent to $669 million. Total prescriptions in the first quarter were up 68 percent over last year, with wholesaler stock building responsible for much of the balance. Market share of total PPI prescriptions in the US continues to grow, reaching 21.4 percent in March. Total prescriptions for the PPI class were up 14 percent versus the first quarter 2002. • Sales of NexiumTM in markets outside the US were up 142 percent to $166 million. • Regulatory submissions for the use of NexiumTM in the treatment of upper GI symptoms in patients taking NSAIDs were announced on 1 April. • Sales of LosecTM/PrilosecTM declined by 45 percent, with PrilosecTM sales in the US down by 60 percent as a result of competition from generic omeprazole. PrilosecTM share of total omeprazole prescriptions was around 40 percent in March, consistent with restricted supply of generic product. • Sales of LosecTM outside the US declined by 22 percent as a result of generic competition as well as in response to the continued strong growth of NexiumTM. Sales of LosecTM in Japan, however, grew by 62 percent. Cardiovascular First Quarter CER % 2003 2002 ZestrilTM 108 277 -64 AtacandTM 206 149 +31 SelokenTM / Toprol-XLTM 368 231 +56 PlendilTM 110 106 -1 Total 969 946 -3 • Sales of ZestrilTM in the US were $20 million in the quarter (down 89 percent) as generic lisinopril now accounts for over 90 percent of dispensed prescriptions. • Sales of AtacandTM grew by 44 percent in the US, whereas total prescriptions in the US were up 19 percent versus the first quarter 2002. Since US sales in the first quarter 2002 also benefited from wholesaler stocking, this indicates a high level of trade inventories at the end of March. Sales of AtacandTM outside the US increased by 20 percent. • Toprol-XLTM prescriptions in the US increased by 31 percent compared to the first quarter 2002, well above the 8 percent growth for the beta blocker class as a whole. Reported sales growth of 76 percent on a strong first quarter last year also means wholesaler stocks are well above normal levels. • CrestorTM was successfully launched in Canada on 19 February, followed by the Netherlands and the UK in March. Sales were $3 million. The company is encouraged by the early launch experience in these markets. In Canada, for example, after 8 weeks Crestor has achieved an estimated new prescription market share of 23.5 percent within the private payer statin market which represents about 40 percent of the total Canadian market, the remainder requiring government sector formulary acceptances. The company strongly advises caution when interpreting such early prescription tracking data and, in particular, counsels against extrapolating to other markets. Respiratory First Quarter CER % 2003 2002 PulmicortTM 251 227 +6 AccolateTM 31 32 -3 RhinocortTM 90 63 +40 OxisTM 31 31 -10 SymbicortTM 122 54 +102 Total 563 442 +20 • SymbicortTM continues to gain market share in the fast-growing fixed combination segment of the asthma market, with market share in Europe having grown to around 24 percent. Successful completion of the Mutual Recognition Procedure in Europe for the use of SymbicortTM in COPD was announced 10 February. • Prescriptions for PulmicortTM RespulesTM in the US were up 34 percent versus the first quarter last year, whilst reported sales increased by 56 percent. • In the US, Rhinocort AquaTM share of prescriptions for intranasal steroids grew to 14 percent in March, fuelling a growth in total prescriptions of 37 percent. Reported sales increased by 113 percent, indicating above normal levels of stocking. • AccolateTM sales were up 5 percent in the US, whilst prescriptions were down by 19 percent. Wholesaler inventories were high at the beginning of the first quarter of 2003 and remain so as a result of further speculative purchases. Oncology First Quarter CER % 2003 2002 CasodexTM 189 123 +44 ArimidexTM 93 65 +35 NolvadexTM 61 140 -57 IressaTM 19 - n/m FaslodexTM 22 - n/m ZoladexTM 193 187 -2 Total 581 520 +6 • Expanded usage of CasodexTM 150 mg tablets in the treatment of early prostate cancer has contributed to the 26 percent increase in sales for markets outside the US, to $129 million in the quarter. The 100 percent increase in US sales is compared to the destocking which occurred in the first quarter of 2002; stock levels at the end of the first quarter this year are close to normal. Underlying demand for CasodexTM in the US is broadly unchanged. • Expansion of labelled claims into the adjuvant treatment for early breast cancer is driving sales growth for ArimidexTM throughout the world. Sales outside the US increased by 41 percent. In the US, total prescriptions were up 64 percent over last year's first quarter. Reported sales growth of 27 percent reflects inventory movements. • Market exclusivity for NolvadexTM in the US expired in February, followed by the launch of several generic products. US sales declined by 71 percent. • Sales of FaslodexTM in the US reached $22 million in the quarter, and reflect steady progression in utilisation since launch last May. • Sales of IressaTM were $19 million. Sales built quite rapidly in the fourth quarter 2002 following launch in Japan, and some reduction from this level was likely as pent-up demand was cleared. However, lower sales this quarter also reflect the labelling revisions implemented in response to post-marketing reports of interstitial lung disease (ILD). • The regulatory submission in Europe for the use of IressaTM for the treatment of locally advanced or metastatic non-small cell lung cancer was made in February. The target date for the US FDA to complete its review of IressaTM is 5 May, according to the Prescription Drug User Fee Act (PDUFA) guidelines. CNS First Quarter CER % 2003 2002 SeroquelTM 444 329 +33 ZomigTM 108 92 +13 Total 560 428 +28 • In markets outside the US SeroquelTM sales grew by 79 percent, including strong growth in Japan. • In the US, total prescriptions for SeroquelTM were up 36 percent versus the first quarter 2002. Market share for SeroquelTM has grown despite the launch of new entrants, reaching 18.4 percent in March. Sales for Seroquel TM in the US increased by 26 percent. Wholesaler stock building has occurred this year and in the first quarter 2002; trade inventories are above normal at quarter's end. • Regulatory files were submitted in the EU and the US for the use of SeroquelTM in the treatment of mania associated with bipolar disorder. • Sales of ZomigTM were up by 17 percent in the US and by 6 percent in the rest of the world. US sales exceeded underlying prescription demand both in this quarter and the first quarter last year. Pain, Infection and Other Pharma First Quarter CER % 2003 2002 MerremTM 74 67 +10 DiprivanTM 136 111 +19 Local anaesthetics 101 96 -1 Total 377 342 +5 • Sales of DiprivanTM in the US were 53 percent higher than the first quarter last year, as a result of a combination of market growth and significant wholesaler stock building in anticipation of price changes. Geographic Sales First Quarter CER % 2003 2002 US 2,470 2,383 +4 Europe 1,555 1,387 -2 Japan 243 172 +32 RoW 467 404 +19 • Apart from wholesaler stock movements, underlying demand in the US featured strong growth in NexiumTM, Toprol-XLTM, and SeroquelTM, which partially offset sales lost to generic competition. • Sales in Europe were off 2 percent. Good volume growth in France and Italy was offset by price reductions in Italy and generic competition in the UK. NexiumTM, SymbicortTM, SeroquelTM, CasodexTM and AtacandTM were the key growth products. • The Oncology product range (up 35 percent) as well as SeroquelTM and LosecTM paced the sales increase in Japan. Operating Review Sales grew by 4 percent. Operating profit declined by 3 percent. The operating margin decline of 2.9 percentage points is almost entirely explained by the absence of disposal gains, which in the first quarter of 2002 included a gain on the sale of Sular marketing rights for the US. Without this gain, operating margin for the first quarter of 2002 would have been 26.8 percent of sales, and operating profit would have increased by 8 percent this quarter. The other elements of operating margin showed a net improvement of 0.4 percentage points, as small increases in R&D and SG&A as a percent of sales (0.5 and 0.3 points respectively) were more than offset by improvements in gross margin. Gross margin increased by 1.2 points to 76 percent of sales through mix benefits as well as lower proportional payments to Merck. The weaker US dollar increased sales by 5 percent and operating profits by 1 percent, accounting for around 0.7 percentage points of the margin decline. Currency for the year is expected to have a broadly neutral effect on profits. In recent years the first quarter results have been marked by speculative wholesaler purchases ahead of anticipated price increases. At the end of the first quarter 2003 it was estimated that wholesaler inventories were some $400 million above normal, compared to $200 million at the end of the first quarter 2002. The products principally affected in 2003 were NexiumTM, SeroquelTM, Toprol-XLTM and AtacandTM. It is expected that these excess inventories will unwind over the next two quarters with no overall impact on sales for the year. Interest Interest income was $21 million in the quarter, with higher overall cash balances compensating for lower yield on investments. Taxation The effective tax rate for the first quarter 2003 was 27.5 percent compared with 27.0 percent for the same period in 2002. Cash Flow Cash generated from operating activities after exceptional items amounted to $1.2 billion for the first quarter, compared with $1.9 billion for the same quarter 2002. Much of this variance arises from a timing difference in payments made to Merck (the first quarter 2002 benefited from the absence of such payment) and receivables arising from the strong first quarter sales. In the first quarter 2003 capital expenditures were $0.3 billion, taxation paid was $0.2 billion, and share repurchases were $0.1 billion, resulting in an increase in net cash funds of just under $0.5 billion. Net cash funds at the end of the quarter amounted to $4.3 billion ($3.8 billion in fourth quarter 2002). Share Repurchase Programme During the quarter, 4.04 million ordinary shares were re-purchased (nominal value $0.25 each) for cancellation at a total cost of $129 million. Since the commencement of the programme, 70.6 million shares have been repurchased for cancellation at a total cost of $2,968 million. The total number of shares in issue (as at 31 March 2003) is 1,715 million. Approximately $1.0 billion remains available under the previously announced share repurchase programme. Upcoming Milestones and Key Events 24 July Announcement of second quarter and half year results 2 October Annual Business Review 23 October Announcement of third quarter and nine months results Tom McKillop Chief Executive This information is provided by RNS The company news service from the London Stock Exchange

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