3rd Quarter Results-Part 1
AstraZeneca PLC
24 October 2002
AstraZeneca PLC
Third Quarter and Nine Months Results 2002
'EPS up 10 percent for nine months. Earnings targets increased for the year. Third quarter impacted by phasing of R&D
spend and lower disposal gains.'
Financial Highlights (before Exceptional Items)
Group 3rd Quarter 3rd Quarter Constant Nine Months Nine Months Constant
(Continuing operations*) 2002 2001* Currency 2002 2001* Currency
$m $m % $m $m %
Sales 4,350 3,950 +6 13,153 12,040 +9
Operating Profit 921 1,015 -9 3,282 3,066 +8
Profit before Tax 923 1,038 -11 3,306 3,167 +5
Earnings per Share
Group $0.39 $0.42 -7 $1.39 $1.28 +10
Group (Statutory FRS3) $0.39 $0.40 $1.39 $1.23
* Restated to be on a consistent basis under FRS19. See note 1 on page 12 for
further information.
All narrative in this section refers to growth rates at constant exchange rates
(CER)
• Earnings targets increased; company anticipates earnings per share for
the year around 4 to 5 percent above the $1.73 reported last year.
• Sales for the nine months increased by 9 percent. Sales in the quarter
were impacted by US wholesaler stocking trends for SeroquelTM and Toprol-XLTM as
well as by the expiration of tamoxifen distribution agreement with Barr
Laboratories.
• Operating profits were up 8 percent in the nine months. In the third
quarter operating profits were down 9 percent, chiefly due to lower other
operating income, which in the third quarter 2001 included disposal of the
multi-vitamins products and royalty income from agreements which have now
expired.
• NexiumTM sales reached $493 million in the third quarter and over $1.3
billion for the nine months. NexiumTM new prescriptions in the US are now
exceeding those for PrilosecTM.
• On 11 October the PrilosecTM formulation patents were ruled valid in the
Southern District Court in New York. Three of the four defendants were found to
infringe these patents. AstraZeneca is reviewing the Judge's ruling finding
non-infringement by Kudco.
• IressaTM was fully launched for the treatment of non-small cell lung
cancer in Japan on 30 August. Sales reached $26 million in the third quarter.
• On 24 September the Oncology Drugs Advisory Committee to the US FDA
voted in favour of accelerated approval for IressaTM for advanced non-small cell
lung cancer.
Tom McKillop, Chief Executive, said: 'Prescriptions for our key growth products
continue to grow strongly. I am encouraged by the excellent start for IressaTM
in Japan and the Advisory Committee recommendation for approval in the US. The
court ruling upholding the validity of our formulation patents for PrilosecTM is
excellent news, allowing us to upgrade our earnings expectations for the full
year.'
London, 24 October 2002
AstraZeneca press office and investor relations contact details are on page 3.
Business Highlights All narrative in this section refers to growth rates at
constant exchange rates (CER) unless otherwise indicated.
For the nine months sales increased by 9 percent and operating profits by 8
percent. Exchange rate movements against the US dollar had no effect on
reported sales growth, but reduced reported operating profit growth rate by 1
percent. Earnings per share (before exceptional items) rose by 10 percent to
$1.39. There have been no exceptional items in the current year.
Sales in the third quarter increased by 6 percent at constant exchange rates.
The weakening of the US dollar against all major currencies had a beneficial
effect on sales, lifting reported sales growth to 10 percent. The weakening of
the US dollar against Sterling and Krona has resulted in an adverse effect on
operating costs, which offset the benefit on sales. As a result, the currency
effect on operating profits was neutral. Operating profits declined by 9
percent on both an 'as reported' and CER basis, chiefly attributed to lower
other operating income versus the third quarter 2001, which included a gain on
the disposal of the multi-vitamin product line and income from royalty
agreements that expired last year. Earnings per share (before exceptional
items) in the third quarter were 7 percent lower, to $0.39.
Sales for the nine months grew by 8 percent in the US and by 9 percent in the
rest of the world, including continued strong growth in Japan (up 19 percent).
In the third quarter, sales outside the US grew by 10 percent, and by 4 percent
in the US. Wholesaler purchasing patterns affected the reported ex-factory
sales in the US. Prescription trends in the US remain consistently strong for
Toprol-XLTM and SeroquelTM, but reported ex-factory sales growth was well below
prescription growth. In addition, NolvadexTM sales were significantly lower in
the third quarter as orders for generic tamoxifen were sharply curtailed ahead
of the August expiration of the company's distribution agreement with Barr
Laboratories.
The strong performance of NexiumTM, where sales reached $1.3 billion for the
nine months, fuelled the 7 percent increase in GI product sales. In the US,
NexiumTM share of new prescriptions for PPI products was 22 percent in the week
ending 11 October, and NexiumTM now accounts for more than 50 percent of new
prescriptions for AstraZeneca PPI products.
On 11 October, following a trial in the Southern District Court of New York,
Judge Barbara Jones ruled that two patents ('230 and '505) relating to the
formulation of omeprazole, the active ingredient in PrilosecTM, are valid until
2007. In addition, the Judge ruled that Andrx, Genpharm, and Cheminor have
infringed these patents. The court ruled that Kudco did not infringe. The
company is reviewing the ruling with respect to Kudco and continues to evaluate
its options for further action.
Sales outside the GI franchise grew by 10 percent for the nine months.
Respiratory product sales grew by 14 percent, on the launch roll-out of
SymbicortTM and the performance of PulmicortTM RespulesTM and RhinocortTM Aqua
in the US. The continued strong growth in demand for SeroquelTM fuelled the 42
percent increase in CNS product sales.
Oncology sales growth was 13 percent for the nine months. In the third quarter,
IressaTM was approved in Japan for the treatment of inoperable or recurrent
non-small cell lung cancer (NSCLC). The product was fully launched following
NHI Price listing on 30 August. The uptake has been encouraging, with sales
reaching $26 million in the quarter. On 24 September the Oncology Drugs
Advisory Committee to the US Food and Drug Administration voted in favour of
accelerated approval for IressaTM for advanced NSCLC.
As reported in August, following a constructive meeting with the US Food and
Drug Administration to discuss the company's response to the approvable letter
for CrestorTM, the company has undertaken to provide further information from
its ongoing study programme for CrestorTM to supplement that already submitted
to the agency. This response to the approvable letter will support the use of
CrestorTM over the dose range of 10-40mg in the general population of patients
with lipid disorders and is scheduled for submission during the first quarter of
2003.
Results from the EXPRESS study of ExantaTM, which supported the regulatory
submission in Europe for prevention of venous thromboembolism in orthopaedic
surgery, will be presented next week at the International Congress on
Thrombosis. Further information on ExantaTM and other products in the company's
R&D portfolio will be featured at the Annual Business Review analyst meeting on
7 November in Alderley Park, UK.
Future Prospects All narrative in this section refers to growth rates at
constant exchange rates (CER) unless otherwise indicated.
Following the rulings in the PrilosecTM patent case, the company does not expect
a generic omeprazole product in the US market in 2002. On this basis and taking
other factors into account, the company has increased its outlook for full year
earnings, and now anticipates growth in earnings per share of around 4 to 5
percent above the $1.73 reported last year (restated under FRS 19).
The company will address the 2003 outlook in conjunction with the presentation
of its 2002 annual results on 30 January.
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 timing of the launch of generic omeprazole in the USA, 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 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.
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
Sales
Except where stated, all narrative in this section refers to the third quarter.
Growth rates are at constant exchange rates (CER).
Gastrointestinal
Third Quarter CER % Nine Months CER %
2002 2001 2002 2001
LosecTM/PrilosecTM 1,223 1,421 -16 3,578 4,287 -17
NexiumTM 493 168 n/m 1,323 295 n/m
Total 1,731 1,598 +6 4,946 4,612 +7
• NexiumTM sales in the US were over $1 billion for the nine months, and
were $378 million in the third quarter. NexiumTM share of new prescriptions in
the US PPI market increased to 20.7 percent in September. In recent weeks, more
than half of all new prescriptions for AstraZeneca's PPI products are for Nexium
TM.
• NexiumTM sales outside the US were $292 million in the nine months, with
$115 million in the third quarter. As for recent launches, market share is over
7 percent after six months in France, and more than 8 percent in five months
since launch in Italy.
• LosecTM/PrilosecTM sales were down 16 percent in the quarter, chiefly on
the 18 percent decline in the US (which was broadly in line with the trend in
prescriptions) and generic competition in the UK.
• Total GI franchise sales, however, grew both in the US (up 6 percent in
the quarter and 7 percent YTD) and in the rest of the world (up 4 percent in the
quarter and by 8 percent YTD).
Cardiovascular
Third Quarter CER % Nine Months CER %
2002 2001 2002 2001
ZestrilTM 189 188 -3 748 832 -10
AtacandTM 132 93 +33 413 289 +41
SelokenTM / Toprol-XLTM 206 204 -2 652 554 +17
PlendilTM 149 120 +20 355 332 +6
Total 850 786 +3 2,713 2,621 +4
• As expected, prescriptions for ZestrilTM in the US experienced a sharp
decline in the third quarter following the launch of generics in July, but
reported sales in the US in the third quarter actually rose 2 percent against
the weak third quarter of 2001. A rapid fall-off in reported sales in the
fourth quarter is anticipated.
• Good growth in sales of AtacandTM products was reported in Europe (up 32
percent) and in the US (up 31 percent) in the third quarter. Total
prescriptions for AtacandTM and AtacandTM HCT in the US are up by 32 percent
through September.
• Prescription growth for Toprol-XLTM in the US remains strong (up 39
percent through September). Reported sales in the US in the third quarter were
down 1 percent on wholesaler destocking combined with a strong third quarter
last year.
Respiratory
Third Quarter CER % Nine Months CER %
2002 2001 2002 2001
PulmicortTM 150 161 -12 580 570 +1
AccolateTM 28 20 +40 95 115 -16
RhinocortTM 80 64 +22 226 194 +15
OxisTM 30 29 -7 91 94 -5
SymbicortTM 72 20 n/m 194 34 n/m
Total 394 329 +13 1,292 1,123 +14
• SymbicortTM sales reached $72 million in the quarter. Encouraging
results were presented last month at the European Respiratory Society congress,
showing that SymbicortTM significantly reduces the number of exacerbations and
improves lung function in patients with COPD. AstraZeneca has submitted a
regulatory package in the EU seeking approval for SymbicortTM in COPD treatment.
• PulmicortTM sales in the third quarter were down by 10 percent in the
US, and by 13 percent in the rest of the world. The strong underlying
prescription performance for PulmicortTM RespulesTM in the US continues (total
prescriptions up 75 percent through September), but fluctuations in wholesaler
purchase patterns led to a 4 percent decline in reported US sales in the
quarter.
• Steady growth in prescriptions for RhinocortTM Aqua in the US (up 43
percent through September) is the chief contributor to sales growth for the
RhinocortTM franchise globally.
Oncology
Third Quarter CER % Nine Months CER %
2002 2001 2002 2001
CasodexTM 191 149 +22 465 393 +18
ArimidexTM 96 47 +98 242 139 +73
NolvadexTM 86 160 -47 348 446 -21
ZoladexTM 208 175 +14 595 519 +16
FaslodexTM 11 - n/m 19 - n/m
IressaTM 26 - n/m 26 - n/m
Total 622 538 +12 1,710 1,519 +13
• Good growth in Europe (up 42 percent) and in Japan (up 40 percent) led
to the 22 percent increase in CasodexTM sales in the third quarter.
• Sales of CasodexTM in the US ($73 million in the third quarter)
rebounded sharply from the low levels seen in the first six months ($65 million
in the first half 2002), and were up 3 percent versus the strong third quarter
2001.
• ArimidexTM sales continue to reflect positive reception to the ATAC
trial results showing benefit in the adjuvant treatment of early breast cancer.
The US FDA approval for this new indication was announced on 6 September. Sales
outside the US were up 50 percent for the nine months, and by 119 percent in the
US. The US performance is based on strong prescription demand (up 71 percent
through September) and some building of wholesaler inventories.
• NolvadexTM sales in the US in the third quarter were $74 million lower
than last year, as orders for generic tamoxifen were sharply curtailed ahead of
the expiration of our distribution agreement with Barr Laboratories at the end
of August.
• The encouraging initial uptake continues in the US for FaslodexTM, the
new medicine for the treatment of advanced breast cancer. Sales were $11
million in the third quarter, bringing year to date sales to $19 million.
• Full launch of IressaTM in Japan occurred on 30 August following NHI
price listing. The uptake has been encouraging, with sales in the quarter
reaching $26 million.
CNS
Third Quarter CER % Nine Months CER %
2002 2001 2002 2001
SeroquelTM 200 169 +16 804 526 +53
ZomigTM 69 55 +18 237 209 +12
Total 277 237 +14 1,064 751 +42
• At the half year, reported sales for SeroquelTM in the US were running
ahead of prescription growth, an indicator of rising trade inventories.
Wholesaler destocking in the third quarter has resulted in reported growth of 5
percent. Prescription demand remains firmly on trend, up 47 percent through
September.
• SeroquelTM sales outside the US grew by 62 percent in the third quarter.
• Sales for ZomigTM outside the US increased by 18 percent in the nine
months, with strong growth reported in France (up 35 percent). The 67 percent
increase in the US in the third quarter is a function of destocking in the third
quarter of last year. Prescriptions for ZomigTM in the US are up 12 percent
through September as a result of continued growth of the ZomigTM-ZMT
formulation.
Pain, Infection and Other Pharma
Third Quarter CER % Nine Months CER %
2002 2001 2002 2001
MerremTM 76 56 +34 218 162 +35
DiprivanTM 105 114 -10 331 329 +2
XylocaineTM 43 52 -17 128 155 -15
MarcaineTM 19 20 -10 54 61 -11
Total 352 361 -4 1,065 1,103 -3
• MerremTM sales continued to grow in all major markets. Sales in the US
were up 43 percent and sales increased by 32 percent outside the US in the nine
months.
Geographic Sales
Third Quarter CER % Nine Months CER %
2002 2001 2002 2001
USA 2,244 2,166 +4 6,963 6,425 +8
Europe 1,390 1,170 +6 4,195 3,819 +7
Japan 251 202 +23 663 591 +19
RoW 465 412 +15 1,332 1,205 +13
• Sales growth of 8 percent in the US for the nine months was fuelled by
the continued strong performances of NexiumTM, SeroquelTM, and Toprol-XLTM,
although uneven wholesaler purchasing patterns in the latter two affected the
third quarter growth rate.
• In Europe, sales increased by 7 percent for the nine months. France and
Italy are driving this growth. As for products, growth in Europe is due to the
performance of NexiumTM, SymbicortTM, the oncology product range, and Seroquel
TM.
• The oncology products, including an encouraging start to IressaTM, were
responsible for much of the strong growth reported in Japan, with additional
contribution from LosecTM and SeroquelTM.
Operating Review
Nine Months
In constant currency terms, sales increased by 9 percent to $13,153 million and
operating profit before exceptional items increased by 8 percent to $3,282
million. Operating margin of 25.0 percent of sales was 0.5 points below prior
year. Currency accounted for 0.3 points of the margin reduction. The other 0.2
points reduction comprised lower other operating income partially offset by
lower cost of sales. SG&A and R&D were at similar percentages to sales as 2001.
Currency was broadly neutral on sales and slightly adverse on costs, leading to
an adverse currency variance of 1 percent on operating profit as compared to
last year.
Third Quarter
Sales increased by 6 percent in constant currency to $4,350 million and
operating profit before exceptional items declined by 9 percent to $921 million.
Operating margin declined by 4.5 percentage points, to 21.2 percent of sales.
Currency increased sales growth in the third quarter by 4 percent, primarily
attributable to the weaker dollar against the Euro. This benefit was offset by
higher costs due to the weaker dollar versus Sterling and Swedish Krona, leading
overall to a neutral effect on operating profit. Currency accounted for nearly
half of the increase in SG&A, and around a third of the increase in R&D expense
reported in the quarter.
Cost of sales at 27.1 percent was broadly similar to 2001, with higher payments
to Merck offset by lower manufacturing costs. SG&A expenditure (33.7 percent of
sales) grew in line with sales. R&D expenditure was 17.4 percent of sales in
the quarter, 1.9 points higher than 2001. This was due to a lower comparator in
2001 (where the third quarter represented only 23 percent of 2001 full year R&D
expenditure), currency, and underlying growth in clinical trials. Other
operating income at 0.3 percent of sales was 2.1 percentage points behind 2001
due to the multi-vitamins disposal in 2001 as well as income from royalty
agreements that expired last year.
Interest
Interest income in the quarter of $2 million was lower than the third quarter
2001 ($23 million) because of a combination of lower interest rate return on
cash investments and a higher charge arising from the annual revaluation of
long-term employee healthcare liabilities.
Taxation
Excluding exceptional items, the effective tax rate for the third quarter 2002
was 26.25 percent, compared with 28.4 percent for 2001. This brought the
year-to-date tax rate to 26.8 percent (28.4 percent for 2001). The 2001 tax
rate has been restated under FRS 19. See note 1 to the interim financial
statements for more detail.
Cash Flow
Cash generated from operating activities amounted to $4.1 billion for the nine
months. This was applied to capital expenditures of $1.0 billion, taxation paid
of $0.7 billion, dividends of $0.8 billion, and share repurchases of $0.9
billion to give an increase in net cash funds of $0.8 billion.
At 30 September 2002 the Group had net cash funds of $ 3.6 billion.
Share Repurchase Programme
During the quarter, 4.6 million shares (nominal value $0.25 each) were
repurchased for cancellation at a total cost of $148 million, bringing the total
for the year to 20.6 million at a cost of $896 million.
The total number of shares repurchased for cancellation since the beginning of
the programme now stands at 57.8 million at an aggregate cost of $2,510 million.
The total number of shares in issue as at 30 September 2002 is 1,725 million.
Under the extended share repurchase programme announced with the 2001 year end
results, $1,490 million remains, which it is anticipated will be completed by
the end of 2003.
Upcoming Milestones and Key Events
7 November Annual Business Review meeting
30 January 2003 Announcement of 2002 Full Year Results
Tom McKillop
Chief Executive
This information is provided by RNS
The company news service from the London Stock Exchange