3rd Quarter Results - part 1
AstraZeneca PLC
26 October 2006
AstraZeneca PLC
Third Quarter and Nine Months Results 2006
'A strong third quarter with sales up 11 percent and Earnings per Share up 34
percent.'
Financial Highlights
Group 3rd Quarter 3rd Quarter Actual CER 9 Months 9 Months Actual CER
2006 2005 % % 2006 2005 % %
$m $m $m $m
Sales 6,516 5,789 +13 +11 19,321 17,664 +9 +11
Operating Profit 2,106 1,695 +24 +24 6,213 4,866 +28 +29
Profit before Tax 2,187 1,743 +25 +25 6,440 4,978 +29 +30
Earnings per Share $1.01 $0.76 +33 +34 $2.93 $2.14 +37 +38
Adjusted to exclude
Toprol-XLTM in US*
Sales 6,143 5,455 +13 +11 18,216 16,719 +9 +11
Earnings per Share $0.87 $0.65 +34 +34 $2.53 $1.84 +38 +39
* This Non-GAAP presentation excludes US sales and earnings contribution from
Toprol-XLTM from both current year and prior year periods.
All narrative in this section refers to growth rates at constant exchange rates
(CER) unless otherwise indicated
• Third quarter sales increased by 11 percent to $6,516 million and operating profit increased by 24 percent to
$2,106 million.
• Sales increase in the third quarter was driven by the strong performance of five key growth products whose
combined sales increased by 21 percent to $3,322 million.
• Sales for the nine months were $19,321 million, up 11 percent. Operating profit for the nine months
increased by 29 percent (including the $109 million divestment gain recognised in the second quarter of this
year). Operating margin for the nine months was 32.2 percent of sales.
• Free cash flow of $4,793 million for the nine months. Share repurchases (net of shares issued) totalled
$2,024 million year to date.
• CrestorTM share of new prescriptions in the US statin market reached 9.6 percent in the week ending 13
October.
• Regulatory submission for sustained release (SR) formulation of SeroquelTM in the European Union announced 19
October. US regulatory approval for the treatment of bipolar depression received on 20 October. SeroquelTM
is now the first and only single medication approved to treat both depressive and manic episodes associated
with bipolar disorder.
• Investigational drug NXY-059 does not meet efficacy endpoints in a pivotal Phase III trial in Acute Ischemic
Stroke (the SAINT II study). The Company plans no further development.
• Successful completion of the European Union Mutual Recognition Procedure for SymbicortTM Maintenance And
Reliever Therapy (Symbicort SMARTTM ) announced 9 October; launches for this new asthma treatment concept
will take place over the coming months.
• The Company now anticipates earnings per share between $3.85 and $3.95 for the full year.
David Brennan, Chief Executive Officer, said: 'For the Third Quarter we have
produced another strong set of results, and have increased our financial targets
for the full year. While today's announcement of the clinical trial results for
NXY-059 is disappointing, I remain committed to maintaining this operating and
financial momentum and to strengthening the pipeline.'
London, 26 October 2006
Media Enquiries: Steve Brown/Edel McCaffrey (London) (020) 7304 5033/5034
Staffan Ternby (Sodertalje) (8) 553 26107
Emily Denney (Wilmington) (302) 886 3451
Analyst/Investor Enquiries: Mina Blair/Jonathan Hunt (London) (020) 7304 5084/ 5087
Staffan Ternby (Sodertalje) (8) 553 26107
Ed Seage/Jorgen Winroth (US) (302) 886 4065/(212) 579 0506
Pictures of senior executives 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 increased by 11 percent at CER, or 13 percent on an
as reported basis (including an exchange benefit of 2 percent). Sales in the US
were up 18 percent. Outside the US, sales were up 5 percent resulting from
weakness in Europe (up 1 percent); sales in other markets grew by 12 percent.
R&D expense, including the consolidation of Cambridge Antibody Technology R&D
spend, increased by 19 percent at CER compared with the third quarter last year
(which was the lowest quarterly spend in 2005). SG&A expenses were up 4 percent
at CER. Operating profit in the third quarter was up 24 percent to $2,106
million; operating margin was 32.3 percent. Earnings per share in the third
quarter were $1.01 versus $0.76 in 2005, an increase of 34 percent.
The combined sales of five key growth products (NexiumTM, SeroquelTM, CrestorTM,
ArimidexTM and SymbicortTM) grew by 21 percent in the third quarter to $3,322
million.
NexiumTM sales in the third quarter were up 13 percent to $1,280 million. Sales
in the US were up 15 percent as continued strong volume growth was partially
offset by lower realised prices.
SeroquelTM sales were up 19 percent to $848 million. On 19 October, the Company
announced the regulatory submission for a sustained release (SR) once-daily
formulation of SeroquelTM in the European Union. The US Food and Drug
Administration (FDA) approved SeroquelTM for the treatment of patients with
depressive episodes associated with bipolar disorder on 20 October.
CrestorTM sales in the quarter were $536 million, up 62 percent. CrestorTM
share of new prescriptions in the US statin market in the week ending 13 October
was 9.6 percent. CrestorTM sales in other markets were up 66 percent.
ArimidexTM sales in the third quarter were $382 million, up 24 percent. In
August, ArimidexTM became the market leader in total prescriptions for hormonal
treatments for breast cancer in the US market, surpassing tamoxifen for the
first time.
SymbicortTM sales in the quarter were $276 million, up 11 percent. On 9
October, the successful completion of the European Union Mutual Recognition
Procedure for SymbicortTM Maintenance And Reliever Therapy (Symbicort SMARTTM)
was announced. This new treatment approach enables patients to take control of
their asthma and use just one inhaler for both maintenance and relief of asthma
symptoms.
Nine Months
For the nine months, sales increased 11 percent at CER, or 9 percent on an as
reported basis (including a 2 percent adverse impact from currency movements).
Sales in the US were up 15 percent, with sales in other markets up 7 percent.
Combined sales for five key growth products were $9,616 million (up 23 percent):
NexiumTM (up 12 percent), SeroquelTM (up 26 percent), CrestorTM (up 53 percent),
ArimidexTM (up 30 percent) and SymbicortTM (up 19 percent).
At CER, the rate of SG&A expense growth (up 6 percent) was 5 percentage points
less than the rate of sales growth, resulting in an improved operating margin
(32.2 percent of sales), despite the 14 percent increase in R&D expenditure for
the nine months. Operating profit increased by 29 percent to $6,213 million
(including the $109 million divestment gain recognised in the second quarter
this year). Earnings per share were $2.93 compared with $2.14 last year, an
increase of 38 percent.
Future Prospects
For the full year, the Company now anticipates earnings per share in the range
of $3.85 to $3.95.
Included in this target is around 10 cents of earnings related to Toprol-XLTM in
the US for the remaining 2 months of the year. This 10 cents of earnings
exposure excludes any one-time asset or inventory adjustments that may be
required should generic companies receive final regulatory approval and seek to
launch 'at risk'.
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: when and if a generic competitor to Toprol-XLTM were introduced in
the US market prior to completion of Appellate Court process, the rate of growth
in sales of generic omeprazole in the US, continued growth in currently marketed
products (in particular CrestorTM, NexiumTM, SeroquelTM, SymbicortTM and
ArimidexTM), 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 2005 Annual Report on Form 20-F.
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 %
2006 2005 2006 2005
NexiumTM 1,280 1,127 +13 3,752 3,386 +12
LosecTM/ PrilosecTM 324 376 -15 1,024 1,241 -15
Total 1,625 1,518 +6 4,830 4,678 +4
• Third quarter sales for NexiumTM in the US were up 15 percent versus the third quarter 2005 on continued
strong volume growth partially offset by lower realised prices. Dispensed tablet volume for NexiumTM
increased by 19 percent in the quarter, although growth in September (up 15 percent) was affected by the loss
of a managed healthcare plan contract. PPI market growth was 13 percent in the quarter. Volume for generic
omeprazole was up 68 percent; all other brands in aggregate declined by 5 percent in the quarter.
• US sales for NexiumTM for the nine months were up 11 percent.
• Sales of NexiumTM in other markets were up 6 percent in the quarter and 12 percent year to date, affected by
the significant reduction in the reference price for PPI's in Germany. Excluding Germany, RoW sales for the
quarter increased by 11 percent, and by 18 percent for the nine months.
• For the nine months, PrilosecTM sales were down 18 percent in the US and LosecTM sales in other markets were
down 15 percent.
Cardiovascular
Third Quarter CER % Nine Months CER %
2006 2005 2006 2005
SelokenTM / Toprol-XLTM 473 437 +7 1,407 1,280 +10
CrestorTM 536 325 +62 1,403 915 +53
AtacandTM 279 238 +13 809 727 +12
PlendilTM 68 82 -18 210 287 -26
ZestrilTM 76 83 -10 229 248 -6
Total 1,579 1,327 +17 4,509 3,954 +15
• Sales of Toprol-XLTM in the US were up 12 percent for the quarter and 17 percent for the nine months. Total
prescriptions for Toprol-XLTM increased by 12 percent for the nine months; the beta blocker market growth was
8 percent. To date, the only Abbreviated New Drug Application filed by a generic company to receive FDA
approval has been that filed by Eon Labs Manufacturing, Inc.
• Sales of SelokenTM in other markets were down 6 percent in the third quarter and 8 percent for the nine
months.
• In the US, CrestorTM sales increased 59 percent in the third quarter to $301 million. CrestorTM share of new
prescriptions in the US statin market was 9.6 percent in the week ending 13 October. Market share in the
dynamic segment (new and switch patients) was 14.0 percent in the latest week. US sales for the nine months
were up 50 percent.
• In other markets, CrestorTM sales increased 66 percent in the third quarter to $235 million, on a strong
performance in Europe (up 57 percent) and some initial stocking sales in Japan, as the product becomes more
widely available following the successful completion of the interim report of the post-marketing surveillance
programme. Volume share of the statin market for CrestorTM is now 15.9 percent in Canada; 11.2 percent in
the Netherlands; 18.0 percent in Italy; and 10.9 percent in France.
• CrestorTM sales in other markets were up 57 percent for the nine months.
• AtacandTM sales in the US were up 23 percent in the third quarter, on 4 percent growth in prescriptions,
price changes and some inventory movements. Sales were up 7 percent for the nine months.
• In other markets, AtacandTM sales increased 10 percent in the third quarter and increased 15 percent year to
date.
• PlendilTM sales were down 18 percent in the quarter and down 26 percent year to date as a result of generic
competition in the US market, where sales for the nine months were down 74 percent.
Respiratory
Third Quarter CER % Nine Months CER %
2006 2005 2006 2005
PulmicortTM 263 234 +11 892 824 +9
SymbicortTM 276 240 +11 861 742 +19
RhinocortTM 83 91 -9 270 295 -8
OxisTM 21 23 -13 65 69 -5
AccolateTM 20 14 +43 59 55 +7
Total 696 636 +7 2,252 2,100 +9
• Sales of SymbicortTM increased 11 percent to $276 million in the third quarter. Sales for the nine months
were up 19 percent.
• Successful completion of the European Union Mutual Recognition Procedure for SymbicortTM Maintenance And
Reliever Therapy (Symbicort SMARTTM) was announced on 9 October. Symbicort SMARTTM is licensed for use in
adults who need an inhaled corticosteroid and a long acting bronchodilator combination treatment. With this
new treatment approach, patients take a maintenance dose of SymbicortTM to keep control of their asthma and,
if further symptoms occur, can take additional inhalations 'as needed' to provide symptom relief.
• Worldwide sales of PulmicortTM continue to be driven by the growth of PulmicortTM RespulesTM in the US, where
sales were up 28 percent in the quarter and 21 percent for the nine months. Estimated volume growth for
PulmicortTM RespulesTM for the nine months is around 7 percent; the variance with reported sales growth is a
combination of inventory movements, managed care rebate adjustments and price changes.
• RhinocortTM sales year to date were down 8 percent, chiefly on sales of RhinocortTM Aqua in the US market
(down 12 percent). RhinocortTM Aqua prescriptions in the US were down 15 percent for the nine months.
Oncology
Third Quarter CER % Nine Months CER %
2006 2005 2006 2005
ArimidexTM 382 303 +24 1,096 856 +30
CasodexTM 299 276 +7 879 840 +8
ZoladexTM 255 258 -2 736 752 +1
IressaTM 62 61 +5 174 201 -10
FaslodexTM 47 37 +24 138 101 +38
NolvadexTM 21 26 -15 66 86 -18
Total 1,076 963 +11 3,105 2,844 +12
• In the US, sales of ArimidexTM were up 28 percent in the third quarter and for the nine months. Total
prescriptions in the US were up 23 percent year to date. ArimidexTM market share of total prescriptions for
hormonal treatments for breast cancer in the US increased to 37.2 percent in September. In August,
ArimidexTM achieved market leadership as prescriptions exceeded those for tamoxifen for the first time.
• ArimidexTM sales in other markets were up 22 percent in the third quarter, and up 32 percent for the nine
months, on strong year to date sales growth in Europe (up 34 percent) and Asia Pacific (up 27 percent).
• In August 2006, the consensus findings of the International Aromatase Inhibitor Panel were published, in
which the panel agreed that aromatase inhibitors, such as ArimidexTM, surpass tamoxifen as the most effective
treatment option for post-menopausal women with early, hormone-sensitive breast cancer.
• CasodexTM sales for the nine months were up 19 percent in the US, on estimated volume growth of 7 percent.
Sales in other markets were up 5 percent year to date.
• IressaTM sales in the third quarter increased by 5 percent as a result of a 17 percent increase in sales in
Asia Pacific. For the nine months, IressaTM sales were down 10 percent, but increased by 12 percent outside
of the US.
• FaslodexTM sales increased by 38 percent for the nine months, to $138 million, as sales were up 93 percent in
Europe and were up 12 percent in the US.
Neuroscience
Third Quarter CER % Nine Months CER %
2006 2005 2006 2005
SeroquelTM 848 706 +19 2,504 2,006 +26
ZomigTM 99 86 +13 295 258 +16
Total 1,150 1,001 +14 3,464 2,975 +17
• In the US, SeroquelTM sales in the third quarter were up 19 percent to $613 million. Total prescriptions
increased by 12 percent year to date, well ahead of the market growth rate. Sales in the US for the nine
months were up 26 percent.
• In other markets, SeroquelTM sales were up 20 percent in the third quarter and 24 percent for the nine
months.
• Regulatory filing in the European Union for a sustained release (SR) once-daily formulation for SeroquelTM
was announced on 19 October.
• SeroquelTM was approved in the US for the treatment of patients with depressive episodes associated with
bipolar disorder on 20 October.
• ZomigTM sales comparisons in the US versus the prior year continue to be affected by the resumption of full
responsibility for US commercialisation on 1 April 2005. ZomigTM sales in the US were up 52 percent in the
quarter and 55 percent for the nine months.
• Sales of ZomigTM in other markets were down 5 percent in the third quarter and 3 percent year to date.
Geographic Sales
Third Quarter CER % Nine Months CER %
2006 2005 2006 2005
US 3,100 2,621 +18 9,059 7,864 +15
Europe 2,118 2,012 +1 6,545 6,374 +7
Japan 370 367 +7 1,061 1,103 +4
RoW 928 789 +15 2,656 2,323 +12
• Sales growth in the US in the third quarter was fuelled by the sales of key growth products (NexiumTM,
SeroquelTM, CrestorTM and ArimidexTM) whose combined sales increased by 23 percent.
• In Europe, third quarter growth for CrestorTM (up 57 percent), SeroquelTM (up 25 percent), ArimidexTM (up 17
percent) and SymbicortTM (up 11 percent) were the highlights for what was otherwise a difficult quarter.
• Third quarter sales in Japan were up 7 percent on growth in oncology products and initial stocking sales for
CrestorTM.
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 13 percent and operating profit by 24 percent. At
constant exchange rates, sales increased by 11 percent and operating profit by
24 percent.
Currency movements for the quarter had a positive impact on sales of 2 percent
and were neutral to operating profit. In comparison to quarter three last
year, the dollar was weaker against the euro (4 percent), increasing sales, and
also against the Swedish krona (6 percent) and sterling (5 percent), increasing
costs. As a result of this currency profile there was minimal currency impact
to earnings per share for the quarter.
Underlying US sales growth is broadly in line with reported growth of 18 percent
after adjusting for managed market accruals, inventory movements and other
factors. Outside the US, sales increased by 5 percent.
Reported operating margin increased by 3.0 percentage points from 29.3 percent
to 32.3 percent. Excluding the effects of currency and other income, underlying
margin improved 2.3 percentage points for the quarter.
Gross margin increased by 1.0 percentage points to 79.5 percent of sales.
Payments to Merck at 4.8 percent of sales were level with the third quarter last
year. Currency reduced gross margin by 0.1 percentage points over quarter three
last year and royalty payments decreased margin by 0.3 percentage points. Taken
together this implies an underlying margin increase of 1.4 percentage points,
primarily due to a more favourable product and market mix as well as increased
operational efficiencies.
R&D expenditure was $962 million in the third quarter, up 19 percent over last
year due to increased activity levels related to the progression of the in-house
portfolio and the effect of the externalisation strategy. Included in R&D is $31
million of investment related to Cambridge Antibody Technology Group plc, which
accounted for approximately 4 percent of the growth over quarter three last
year. In comparison to the low third quarter 2005, R&D investment reduced
operating margin by 1.0 percentage points.
SG&A increased by 4 percent to $2,180 million for the quarter resulting from
increased investment in emerging markets and the continued investment in our key
products across the business. Our ability to hold the rate of SG&A growth below
the rate of growth of sales led to SG&A adding 2.2 percentage points to
operating margin in the quarter.
Higher other income increased operating margin by 1.2 percentage points, due
primarily to an increase in royalties.
The fair value adjustments relating to financial instruments amounted to a $17
million charge in the quarter; $16 million charge to cost of sales and $1
million charge to interest.
Nine Months
Reported sales increased by 9 percent and operating profit by 28 percent. At
constant exchange rates, sales increased by 11 percent and operating profit by
29 percent.
Currency had an adverse impact on sales of 2 percent and 1 percent on operating
profit. Cumulatively, exchange has decreased EPS by 2 cents. Assuming current
exchange rates remain unchanged for the remainder of the year, we would expect
to see a further adverse impact to EPS in quarter four of around 2 cents.
Underlying US sales growth approximates to reported sales growth of 15 percent
for the nine months. Outside the US, sales increased by 7 percent.
Operating margin increased by 4.7 percentage points from 27.5 percent to 32.2
percent. Excluding the effects of currency and other income, underlying margin
improved 3.1 percentage points for the nine months.
Gross margin increased by 1.9 percentage points to 79.4 percent of sales.
Payments to Merck (4.7 percent of sales) had a neutral effect on gross margin
with currency and royalties reducing gross margin by 0.1 percentage points and
0.2 percentage points respectively. Excluding prior year costs for the early
termination of the Medpointe ZomigTM US distribution agreement, underlying
margin improved by 2.0 percentage points.
R&D expenditure was up 14 percent to $2,778 million (13 percent excluding
Cambridge Antibody Technology Group plc investment) reducing operating margin by
0.4 percentage points. SG&A increased by 6 percent over last year to $6,585
million, adding 1.5 percentage points to operating margin.
Higher other income increased operating margin by 1.4 percentage points due
principally to higher royalties and the $109 million gain recognised in quarter
two from the divestment of the US anaesthetics and analgesic products to Abraxis
Biosciences, Inc.
The fair value adjustments relating to financial instruments amounted to a $21
million charge for the nine months to cost of sales.
Toprol-XLTM
In the nine months, Toprol-XLTM contributed US sales of $1,105 million and EPS
of 40 cents. While uncertainties remain as to whether, when and with which
strengths generic companies will launch, the Company believes that future
performance can be best judged by excluding Toprol-XLTM from current
performance. Consequently, if Toprol-XLTM were excluded from the current and
prior period for the nine months, sales growth would be 11 percent (11 percent
for the quarter) and EPS growth would be 39 percent (34 percent for the
quarter).
Based on current forecasts, the contribution of Toprol-XLTM to EPS for the
remaining two months of the year is estimated at 10 cents, assuming no generic
launches 'at risk'.
Interest and Dividend Income
Net interest and dividend income for the nine months was $227 million (2005 $112
million), with $81 million in the third quarter (2005 $48 million). The increase
over 2005 is primarily attributable to higher average investment balances and
yields. The reported amounts include $35 million (2005 $13 million) in the nine
months, and $11 million (2005 $2 million) in the quarter, arising from employee
benefit fund assets and liabilities reported under IAS 19, 'Employee Benefits'.
Taxation
The effective tax rate for the nine months was 28.3 percent (27.2 percent for
quarter) compared with 29.8 percent (29.4 percent for quarter) for the same
period last year. The decrease over 2005 is primarily due to tax benefits on
share based payments and a different geographical mix of profits. The tax
benefit in relation to share based payments had the effect of reducing the tax
rate by 0.7 percentage points for the nine months, driven by a higher tax credit
recognised as a result of the increase in the share price applied to all
outstanding options. The 2005 rate included a one-off adverse impact of no tax
relief in respect of the LosecTM fine. It is anticipated that the full year tax
rate for 2006 will be in the range of 28 to 29 percent.
Cash Flow
Free cash flow* for the nine months was $4,793 million compared to $4,294
million in the same period of 2005.
Shareholder returns of $4,244 million comprising net share repurchases of $2,024
million and $2,220 million dividend payments and a net $1,170 million cash
outflow from the acquisitions (net of cash acquired), resulted in an overall
decrease in net funds of $435 million.
Cash generated from operating activities in the period was $5,533 million, $719
million higher than in the first nine months of 2005. An increase in profit
before tax of $1,462 million was offset by a $236 million increase in working
capital requirements and a $422 million increase in tax paid.
Net cash outflows from investing activities of $557 million for the nine months
compared to $621 million in 2005. Net cash from investing activities was
affected by the management of group funds, with funds being transferred between
long-term deposits and liquid cash; inflows for the nine months of $1,353
million contrast with outflows of $101 million in 2005. During the nine months,
cash of $1,170 million was paid for the acquisition of Cambridge Antibody
Technology Group plc and KuDOS Pharmaceuticals Limited. There was a $352
million increase in expenditure on intangible assets, mainly as a result of new
collaboration deals.
* - Cash flows before share issues and returns to shareholders; movements in
short term investments, fixed deposits and short term borrowings; and
acquisitions.
Investments
The Company announced in July a collaboration with Abbott Laboratories to
co-develop and market a combination product using CrestorTM and Abbott's
proprietary, next generation TriCor(R) (ABT-335).
In August, the Company completed the acquisition of Cambridge Antibody
Technology Group plc (CAT). The Company has consolidated total net assets of
approximately $1,200 million on the acquisition, including intangible assets and
goodwill of approximately $1,300 million (representing products in development,
royalty income from launched products and the technologies utilised in
developing monoclonal antibodies together with the resultant libraries),
deferred tax liabilities of $355 million and other net assets of $295 million.
On 25 October, the Company disposed of the Humira royalty stream, an asset
acquired as part of the acquisition of CAT, to Royalty Pharma for $700 million,
settled in cash (subject to adjustment for all royalty amounts accrued for and
received by CAT since 1 January 2006). There was no gain or loss on disposal.
The disposal has the effect of reducing the intangible assets and goodwill
recognised to approximately $600 million. Consequently the associated annual
amortisation will be reduced from approximately $80 million to $20 million,
offsetting the effect of the disposal of the royalty income stream.
The Company also announced in August a research and commercialisation agreement
with Pozen Inc. to co-develop and market a fixed dose combination product of
esomeprazole and coated naproxen. The upfront payment of $40 million, which was
settled in cash, has been capitalised as an intangible asset.
During September, the Company has announced collaboration and commercialisation
agreements with Dynavax Technologies Corporation and Schering AG. The initial
payments totalling $23 million have been capitalised as intangible assets.
Share Repurchase Programme
During the third quarter, 21.4 million shares were repurchased for cancellation
at a total cost of $1,331 million, bringing the total repurchases for the first
nine months of the year to 52.5 million shares at a total cost of $2,958
million. During the first nine months, 22.5 million shares were issued, in
consideration of share option exercises and in relation to employee share plans,
for a total of $934 million. It is anticipated that share repurchases (net of
new issues) for the full year will be around $3 billion.
The total number of shares in issue at 30 September 2006 was 1,551 million.
The share buy back programme is calculated to have added 5 cents to EPS for the
nine months after allowing for an estimate of interest income foregone.
R&D Update
The regulatory filing for a sustained release (SR) formulation for SeroquelTM in
the European Union was submitted on 19 October. The US FDA approved SeroquelTM
for the treatment of patients with depressive episodes associated with bipolar
disorder on 20 October.
The successful completion of the European Union Mutual Recognition Procedure for
SymbicortTM Maintenance And Reliever Therapy (Symbicort SMARTTM) was announced
on 9 October.
The METEOR clinical trial for CrestorTM has been completed and the study has
been submitted for presentation at the American College of Cardiology meeting in
March 2007. The findings from the METEOR study, together with data from the
ASTEROID and ORION studies, will form the basis of the planned regulatory
submission for atherosclerosis in the first half of 2007.
As announced on 26 October, results from the SAINT II trial showed that the
investigational drug NXY-059 did not meet its primary outcome of a statistically
significant reduction in stroke related disability, as assessed by the modified
Rankin Scale (mRS) (p=0.33, odds ratio 0.94). AstraZeneca plans no further
development of NXY-059 in acute ischemic stroke.
The Phase III study of IressaTM (gefitinib) in patients with highly refractory
squamous cell head and neck cancer (the IMEX study) did not achieve its primary
objective of demonstrating improved overall survival compared with methotrexate
chemotherapy. Although IressaTM showed some evidence of anti-tumour activity in
the trial, the Company has decided not to make a regulatory marketing
application based upon this data. Data from the IMEX study will be presented at
a suitable medical meeting in due course.
PLATO, the phase III clinical trial for AZD6140, has commenced patient
enrolment. PLATO is a head to head outcomes study of AZD6140 versus
clopidogrel. The trial will be conducted in over 40 countries with 1,000
investigational centres and will include 18,000 Acute Coronary Syndrome (ACS)
patients. PLATO is designed to reflect the 'real world' by including a broad
patient population in the study.
Calendar
1 February 2007 Announcement of fourth quarter and full year 2006 results
26 April 2007 Announcement of first quarter 2007 results
26 April 2007 Annual General Meeting
26 July 2007 Announcement of second quarter and half year 2007 results
1 November 2007 Announcement of third quarter and nine months 2007 results
David Brennan
Chief Executive Officer
This information is provided by RNS
The company news service from the London Stock Exchange