Final Results part 1 of 3
AstraZeneca PLC
01 February 2007
AstraZeneca PLC
Fourth Quarter and Full Year Results 2006
'AstraZeneca reports strong financial results for 2006, with EPS up 34 percent,
and progress in strengthening the pipeline; Company continues to drive
productivity improvements.'
Financial Highlights
Group 4th Quarter 4th Quarter Actual CER Full Year Full Year Actual CER
2006 2005 % % 2006 2005 % %
$m $m $m $m
Sales 7,154 6,286 +14 +11 26,475 23,950 +11 +11
Operating Profit 2,003 1,636 +22 +24 8,216 6,502 +26 +28
Profit before Tax 2,103 1,689 +25 +26 8,543 6,667 +28 +29
Earnings per Share $0.93 $0.77 +21 +22 $3.86 $2.91 +33 +34
Adjusted to exclude
Toprol-XLTM in US**
Sales 6,878 5,940 +16 +13 25,093 22,659 +11 +11
Earnings per Share $0.83 $0.66 +26 +29 $3.36 $2.50 +35 +36
** 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
• Sales for the full year increased by 11 percent to $26,475 million.
• Strong performance of five key growth products (NexiumTM, SeroquelTM, CrestorTM, ArimidexTM and SymbicortTM)
with combined sales reaching $13,318 million, up 23 percent for the full year.
• Operating profit increased by 28 percent for the full year to $8,216 million. Operating margin improved by
3.8 percentage points to 31.0 percent of sales.
• Free cash flow of $6,788 million for the full year. Returns to shareholders totalled $5,382 million
(dividends $2,220 million; net share repurchases $3,162 million).
• Since December 2005, the Company has entered into twelve significant licensing and acquisition projects and
nine significant research collaborations.
• On 11 January 2007, AstraZeneca announced a worldwide collaboration with Bristol-Myers Squibb to develop and
commercialise two diabetes compounds, including saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor in
Phase III development.
• The Company continues to drive productivity; initiative to improve asset utilisation announced (see page 3).
• The Company anticipates earnings per share for 2007 (excluding any contribution from US sales of Toprol-XLTM
and excluding any one-off costs associated with productivity initiatives) in the range of $3.80 to $4.05
(compared with EPS in 2006 excluding Toprol-XLTM of $3.36).
• Dividend increased by 32 percent to $1.72 for the full year. Net share repurchases for 2007 set at $4
billion.
David Brennan, Chief Executive Officer, said: 'In 2006, AstraZeneca reported
another strong set of financial results and progress in strengthening the
pipeline, but more remains to be done. Our agenda is clear. We are determined
to maintain the sales momentum of our current product portfolio and to continue
to build a pipeline to sustain our growth, while driving further productivity
improvements and enhancing cash returns to shareholders.'
London, 1 February 2007
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 Mina Blair/Jonathan Hunt/Karl Hard (London) (020) 7304 5084/5087/5322
Enquiries:
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. Interviews with David Brennan, Chief
Executive Officer, Jon Symonds, Chief Financial Officer and John Patterson,
Executive Director Development are available on www.astrazeneca.com
Business Highlights All narrative in this section refers to growth rates at
constant exchange rates (CER) unless otherwise indicated
Full Year
Sales for the full year increased 11 percent at CER and on an as reported basis,
with currency movements having minimal effect. Sales in the US were up 16
percent. Sales in other markets were up 7 percent.
Operating profit for the full year was $8,216 million, up 28 percent at CER (26
percent as reported, including a 2 percent adverse impact from currency
movements). Operating margin improved by 3.8 percentage points to 31.0 percent
of sales. Improvements in gross margin, disciplined management of SG&A expense
and higher other income for the year more than offset the planned increase in R&
D investment, which was up 16 percent compared to 2005. Earnings per share for
the full year were $3.86 versus $2.91 in 2005, an increase of 34 percent. The
Board has recommended an increase in the second interim dividend to $1.23, which
will bring the dividend for the full year to $1.72, an increase of 32 percent
for the year.
The combined sales of five key growth products (NexiumTM, SeroquelTM, CrestorTM,
ArimidexTM and SymbicortTM) grew by 23 percent to $13,318 million.
NexiumTM sales were up 12 percent for the full year to $5,182 million. Sales in
the US were up 13 percent to $3,527 million, as volume growth more than offset
the lower price realisation from contract sales. Sales in other markets were up
10 percent despite difficult market conditions in Germany.
SeroquelTM sales increased 24 percent to $3,416 million, including $2,486
million in the US (up 24 percent). As was the case in 2005, SeroquelTM was the
only brand among the three leading antipsychotic products to grow its market
share of total prescriptions in the US market in 2006. SeroquelTM market share
was up a further 1.7 points to 30.2 percent market share in December 2006.
SeroquelTM sales in other markets were up 23 percent to $930 million.
CrestorTM sales reached $2,028 million for the full year, on strong growth in
the US of 57 percent and a 61 percent increase in other markets. CrestorTM
share of new prescriptions in the US statin market increased 2.7 percentage
points in 2006, to 9.6 percent in December.
ArimidexTM sales were up 29 percent to $1,508 million. Underpinned by the
clinical evidence from the landmark ATAC trial (ArimidexTM, Tamoxifen, Alone or
in Combination), ArimidexTM has emerged as a new gold standard treatment for
post-menopausal women with early breast cancer.
SymbicortTM sales increased 18 percent to $1,184 million. Following completion
of the European Union Mutual Recognition Procedure in October 2006, Sweden
launched Symbicort SMARTTM (SymbicortTM Maintenance and Reliever Therapy) in
November. Further European launches will roll out over the course of this year.
The Company continues to plan for a US launch for SymbicortTM around the
middle of the year, although achieving this launch timeline is dependent upon
successful transfer of technology and completion of the required validation
batches.
Fourth Quarter
Sales in the fourth quarter were $7,154 million, up 11 percent at CER, or 14
percent on an as reported basis (including an exchange benefit of 3 percent).
Sales in the US were up 17 percent; sales in other markets were up 6 percent.
Combined sales for five key growth products increased 23 percent to $3,702
million: NexiumTM (up 13 percent), SeroquelTM (up 19 percent), CrestorTM (up 73
percent), ArimidexTM (up 24 percent) and SymbicortTM (up 15 percent).
Operating profit increased by 24 percent in the quarter at CER (22 percent as
reported, including a 2 percent adverse impact from currency movements).
Earnings per share in the fourth quarter were $0.93 compared with $0.77 in 2005.
Externalisation update
Strengthening the pipeline, by enhancing the productivity of our internal
discovery and development and continued pursuit of external opportunities,
remains the number one priority for the Company. In the past year, the Company
has significantly expanded its business development capability, increasing its
capacity to pursue promising external opportunities to strengthen the pipeline.
Since December 2005, AstraZeneca has entered into twelve significant business
development transactions (including three company acquisitions) and nine
significant research collaborations. Including the recently announced
collaboration with Bristol-Myers Squibb to develop two compounds to treat
diabetes, these initiatives have added five Phase II and two Phase III molecules
to our late-stage development pipeline.
Enhancing Productivity
The strong financial performance delivered over the past three years has stemmed
from good top-line growth and disciplined management of costs. Going forward,
management remains committed to maintaining a competitive financial performance
during a period when the Company, as well as the industry, faces the challenges
posed by patent expirations and pricing pressures from government and private
sector payers.
Consistent with this, the Company has taken a further step in its drive to
improve productivity, announcing a programme to improve asset utilisation within
its global supply chain. Over the next three years, the Company plans to
rationalise production assets, anticipating accounting charges of approximately
$500 million (of which approximately $300 million will be cash) and the proposed
reduction of approximately 3,000 positions, subject to consultations with works
councils, trade unions and other employee representatives, and in accordance
with local labour laws.
Future Prospects
As previously indicated, the 2007 financial contribution from the US Toprol-XLTM
franchise is difficult to forecast with any degree of certainty. In addition to
its reported results, the Company has also reported its revenue and earnings
performance in 2006, and set its targets for 2007, assuming no financial
contribution from Toprol-XLTM in the US. When the sales and profit contribution
from US sales of Toprol-XLTM are excluded from 2006 reported results, adjusted
sales were $25,093 million and earnings per share were $3.36.
For 2007, the Company anticipates that continued sales momentum from its key
product franchises should result in sales growth in the high single digits.
Tight management of costs should allow for significant growth in R&D investment
while producing double-digit EPS growth, within the range of $3.80 to $4.05 per
share. This range excludes any contribution from US sales of Toprol-XLTM and
any one-off costs associated with productivity initiatives, and includes the
additional R&D costs arising from the diabetes product collaboration with
Bristol-Myers Squibb. Our determination to increase cash returns to
shareholders is evidenced by the target of $4 billion in share repurchases (net
of shares issued) for 2007.
Under current market conditions (that is, Toprol-XLTM brand maintaining market
exclusivity on the 50/100/200mg dosage strengths and Sandoz and Par distributing
generic versions of the 25mg dosage strength), profit contribution from US sales
of the Toprol-XLTM product range, which includes sales to Par, is running at
around $100 million per month. The Company will update this estimate as market
conditions change.
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 additional generic competitors to Toprol-XLTM are
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
Fourth Quarter CER % Full Year CER %
2006 2005 2006 2005
NexiumTM 1,430 1,247 +13 5,182 4,633 +12
LosecTM/ PrilosecTM 347 411 -18 1,371 1,652 -16
Total 1,801 1,677 +5 6,631 6,355 +4
• In the US, NexiumTM sales for the full year increased by 13 percent to $3,527 million. Dispensed tablet
volume for NexiumTM increased by 17 percent for the year; all other PPI class brands in aggregate declined by
4 percent.
• In the fourth quarter, US sales for NexiumTM were up 17 percent. Dispensed tablet volume in the quarter was
up 13 percent; release of the provision associated with the US Department of Defence TRICARE Retail Pharmacy
Prescription Program (DoD/TRRx) gave rise to a positive price variance for the quarter.
• Sales of NexiumTM in other markets were up 10 percent to $1,655 million for the full year, as good volume
growth in France and Italy helped mitigate the significant price erosion in Germany. Fourth quarter sales in
markets outside the US were up 5 percent.
• In December 2006, the European Patent Office (EPO) ruled that one of the European substance patents for
NexiumTM would be rejected, following an appeal from the German generic manufacturer ratiopharm. While
disappointed with the EPO decision, AstraZeneca has confidence in the intellectual property portfolio
protecting NexiumTM. This portfolio includes process, method of use and additional substance patents with
expiration dates ranging from 2009 through to 2019. The revocation of the AstraZeneca European substance
patent relating to NexiumTM should not have any substantive impact on AstraZeneca's ability to uphold and
enforce its NexiumTM patents in the United States. AstraZeneca has several US patents covering NexiumTM, all
of which can be differentiated from the European patent found to be invalid.
• For the full year, PrilosecTM sales were down 12 percent in the US and LosecTM sales in other markets were
down 17 percent.
Cardiovascular
Fourth Quarter CER % Full Year CER %
2006 2005 2006 2005
SelokenTM / Toprol-XLTM 387 455 -16 1,795 1,735 +3
CrestorTM 625 353 +73 2,028 1,268 +59
AtacandTM 301 247 +17 1,110 974 +14
PlendilTM 65 73 -15 275 360 -24
ZestrilTM 78 84 -11 307 332 -7
Total 1,609 1,378 +14 6,118 5,332 +15
• Sales of Toprol-XLTM (metoprolol succinate) in the US were up 7 percent for the full year, to $1,382 million.
Total prescriptions in the US increased by 10 percent versus last year.
• On 21 November, a 25 mg version of metoprolol succinate was launched in the US by Sandoz (formerly Eon Labs).
Also in November, AstraZeneca announced that it had entered into a supply and distribution agreement with
Par Pharmaceutical to distribute an authorised generic version of the 25 mg dosage strength of metoprolol
succinate for the US market.
• US sales of Toprol-XLTM in the fourth quarter were down 20 percent as a result of provisions taken against
pipeline inventory in the marketplace following the onset of generic competiton.
• Sales of SelokenTM in other markets were down 2 percent in the fourth quarter and were down 7 percent for the
full year.
• Annual sales for CrestorTM exceeded $2 billion for the first time in 2006. CrestorTM has now been approved
in 84 markets and launched in 74. Since launch in early 2003, more than 9 million patients have been treated
with CrestorTM and more than 70 million prescriptions have been written.
• CrestorTM sales in the US increased by 75 percent in the fourth quarter, and were up 57 percent for the full
year. New prescriptions for statins in the US were up 17 percent for the full year; CrestorTM new
prescriptions were up 58 percent. CrestorTM new prescription market share in December 2006 was 9.6 percent,
a 2.7 percentage point increase over the last year, which was the largest share gain recorded by a branded
statin in 2006. Beginning in January 2007, the new prescription market share data will be distorted by the
launches of multiple generic simvastatin products.
• In other markets, CrestorTM sales increased by 70 percent in the fourth quarter. Sales for the full year
were up 61 percent, on good growth in Europe (up 56 percent) and in Asia Pacific resulting from expanded
sales in Japan in the second half. Volume share of the statin market for CrestorTM is now 17.4 percent in
Canada; 11.5 percent in the Netherlands; 19.3 percent in Italy; and 12.9 percent in France.
• AtacandTM sales in the US were up 12 percent for the full year. New prescriptions for AtacandTM were up 7
percent in 2006.
• In other markets, AtacandTM sales were up 14 percent in the fourth quarter and were up 14 percent for the
full year.
• PlendilTM sales were down 15 percent in the quarter and were down 24 percent for the full year as a result of
generic competition in the US market, where PlendilTM sales for the full year were down 71 percent.
Respiratory
Fourth Quarter CER % Full Year CER %
2006 2005 2006 2005
PulmicortTM 400 338 +16 1,292 1,162 +11
SymbicortTM 323 264 +15 1,184 1,006 +18
RhinocortTM 90 92 -3 360 387 -7
OxisTM 23 22 - 88 91 -3
AccolateTM 22 17 +29 81 72 +13
Total 899 773 +12 3,151 2,873 +10
• Sales of SymbicortTM increased by 15 percent in the quarter and increased 18 percent to $1,184 million for
the full year on continued market growth and share gains in Europe.
• Following completion of the European Union Mutual Recognition Procedure in October 2006, Sweden launched
Symbicort SMARTTM (SymbicortTM Maintenance and Reliever Therapy) in November. Further European launches will
roll out over the course of this year.
• In the US, the Company continues to plan for a launch of SymbicortTM for the treatment of asthma in adults
around the middle of the year, although achieving this launch timeline is dependent upon successful transfer
of technology from development to manufacturing and completion of validation batches.
• Worldwide sales of PulmicortTM were up 16 percent in the fourth quarter and were up 11 percent for the full
year. Once again, the primary driver for growth was PulmicortTM RespulesTM in the US, where sales were up 31
percent in the fourth quarter and were up 24 percent for the full year. Volume growth in the US for the full
year was approximately 10 percent, with price changes, managed care rebate adjustments and inventory
movements also contributing to reported sales growth.
• RhinocortTM sales for the full year were down 7 percent, chiefly on a 9 percent decline in sales of
RhinocortTM Aqua in the US market.
Oncology
Fourth Quarter CER % Full Year CER %
2006 2005 2006 2005
ArimidexTM 412 325 +24 1,508 1,181 +29
CasodexTM 327 283 +13 1,206 1,123 +9
ZoladexTM 272 252 +5 1,008 1,004 +1
IressaTM 63 72 -14 237 273 -11
FaslodexTM 48 39 +18 186 140 +32
NolvadexTM 23 28 -22 89 114 -19
Total 1,157 1,001 +13 4,262 3,845 +12
• In the US, sales of ArimidexTM were up 29 percent for the full year, to $614 million. Total prescriptions
increased by 21 percent. ArimidexTM share of total prescriptions for hormonal treatments for breast cancer
was 37.5 percent in December, up 2.7 percentage points during the year. In the fourth quarter, US sales for
ArimidexTM were up 33 percent.
• In other markets, ArimidexTM sales increased by 18 percent in the fourth quarter and were up 29 percent for
the full year. For the full year, sales were up 30 percent in Europe and were up 27 percent in Asia Pacific.
• CasodexTM sales in the US for the full year were up 23 percent. Sales in other markets were up 5 percent for
the full year, with sales in Japan up 10 percent.
• IressaTM sales in markets outside the US increased by 5 percent in the fourth quarter and were up 10 percent
for the full year. Sales in the Asia Pacific region for the full year were up 15 percent.
• Worldwide sales of FaslodexTM were up 32 percent for the full year, largely due to the 74 percent increase in
Europe.
Neuroscience
Fourth Quarter CER % Full Year CER %
2006 2005 2006 2005
SeroquelTM 912 755 +19 3,416 2,761 +24
ZomigTM 103 94 +7 398 352 +13
Total 1,240 1,084 +12 4,704 4,059 +16
• In the US, SeroquelTM sales were up 20 percent in the fourth quarter and increased by 24 percent for the full
year to $2,486 million. Total prescriptions increased by 12 percent for the full year, well ahead of the
market. SeroquelTM share of total prescriptions in the US antipsychotic market increased to 30.2 percent in
December 2006, up 1.7 percentage points over last year.
• In other markets, SeroquelTM sales were up 17 percent in the fourth quarter. Sales for the full year were up
23 percent, on good growth in Europe, where sales were up 25 percent, and a 15 percent increase in Asia
Pacific.
• Regulatory submissions for a sustained release (SR) once daily formulation for SeroquelTM for the treatment
of schizophrenia are under review in the US and in the European Union.
• ZomigTM sales comparisons in the US versus the prior year are affected by the resumption of full
responsibility for US commercialisation on 1 April 2005. Reported sales for ZomigTM in the US were up 5
percent in the fourth quarter and were up 39 percent for the full year. Total prescriptions for ZomigTM
declined by 6 percent for the full year.
• Sales of ZomigTM in other markets were up 8 percent in the fourth quarter and were unchanged for the full
year.
Geographic Sales
Fourth Quarter CER % Full Year CER %
2006 2005 2006 2005
US 3,390 2,907 +17 12,449 10,771 +16
Europe 2,358 2,089 +6 8,903 8,463 +6
Japan 442 424 +6 1,503 1,527 +5
RoW 964 866 +9 3,620 3,189 +11
• In the US, sales were up 16 percent for the full year. Combined sales of key growth products (NexiumTM,
SeroquelTM, CrestorTM and ArimidexTM) were up 23 percent.
• In Europe, sales for the full year were up 6 percent, on strong growth for CrestorTM (up 56 percent),
ArimidexTM (up 30 percent), SymbicortTM (up 18 percent) and SeroquelTM (up 25 percent). Good volume growth
for NexiumTM was partially offset by price erosion, particularly in Germany. Sales of LosecTM in Europe
declined by 20 percent.
• Sales in Japan for the full year were up 5 percent on good volume growth from LosecTM, oncology products and
sales of CrestorTM, which was partially offset by lower prices across the product range.
Operating Review
All narrative in this section refers to growth rates at constant exchange rates
(CER) unless otherwise indicated
Fourth Quarter
Reported sales increased by 14 percent and operating profit by 22 percent. At
constant exchange rates, sales increased by 11 percent and operating profit by
24 percent.
Currency movements for the quarter increased sales by 3 percent but reduced
operating profit by 2 percent. In comparison to last year, the dollar was 8
percent weaker against the euro, increasing sales, and also against the Swedish
krona (11 percent) and sterling (9 percent), increasing costs. The net effect
of these movements was an unfavourable currency impact to earnings per share for
the quarter of 1 cent.
Underlying US sales growth is broadly in line with reported growth of 17 percent
after adjusting for managed market accruals, inventory movements and provision
movements. Following the launch of generic Toprol-XLTM 25mg by Sandoz (formerly
Eon Labs), a provision for pipeline inventories was made. Toprol-XLTM revenues
will now be recognised conservatively as prescriptions are written, rather than
on shipments, given the likelihood of further generic approvals and launches in
2007. Also during the quarter, provisions made in respect of US Department of
Defence TRICARE Retail Pharmacy Prescription Program rebates were released. The
net impact on reported sales of these two items was broadly neutral. Outside the
US, sales increased by 6 percent.
Reported operating margin increased by 2.0 percentage points from 26.0 percent
to 28.0 percent. Excluding the effects of currency, underlying margin increased
3.1 percentage points for the quarter.
Reported gross margin of 77.9 percent is unchanged from quarter four last year.
Payments to Merck, at 4.8 percent of sales, were 0.1 percentage points lower
than last year. Currency and royalty payments reduced margin by 0.1 and 0.3
percentage points respectively. Included in quarter four were provisions
totalling $108 million relating to Toprol-XLTM, NXY-059 and other asset
provisions. Asset provisions of $100 million were included in the prior year.
Taking all these factors together underlying gross margin increased by 0.2
percentage points, primarily due to a more favourable product mix as well as
continuing operational efficiencies.
R&D expenditure was $1,124 million in the fourth quarter, up 21 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.
Approximately 4 percent of the growth over quarter four last year related to the
acquisition of Cambridge Antibody Technology Group plc. In comparison to the
fourth quarter 2005, R&D as a percentage of sales increased 1.8 percentage
points to 15.7 percent, of which currency accounted for 0.6 percentage points.
At constant rates of exchange, SG&A costs of $2,511 million represented an
increase of 1 percent versus a high comparative fourth quarter in 2005, which
arose chiefly from investments in a Medicare Outreach programme. Quarter four
saw continued investment in our key products across the business, including the
launch of CrestorTM in Japan and Australia.
Higher other income increased operating margin by 0.6 percentage points,
primarily due to the divestment of 17 non-core products in Scandinavia.
Included within cost of sales is the movement in the fair value of financial
instruments used to manage our transactional currency exposures; the gain for
the quarter, net of an exchange loss on the underlying exposures, was $25
million. Other fair value movements of $5 million are charged elsewhere in the
profit and loss.
Full Year
Reported sales increased by 11 percent and operating profit by 26 percent. At
constant exchange rates, sales increased by 11 percent and operating profit by
28 percent.
Currency had minimal impact on sales and a negative impact of 2 percent on
operating profit. Cumulatively, exchange has reduced EPS by 3 cents.
Underlying US sales growth approximates to reported sales growth of 16 percent
for the full year. Outside the US, sales increased by 7 percent.
Operating margin increased by 3.8 percentage points from 27.2 percent to 31.0
percent. Excluding the effects of currency and other income, underlying margin
increased 2.9 percentage points for the full year.
Reported gross margin increased by 1.4 percentage points to 79.0 percent of
sales. Payments to Merck (4.7 percent of sales) benefited gross margin by 0.1
percentage points whilst currency and royalties reduced gross margin by 0.1
percentage points and 0.2 percentage points respectively. Excluding the costs
for the early termination of the Medpointe ZomigTM US distribution agreement and
manufacturing provisions in 2005 and the provisions made in respect of Toprol-XL
TM, NXY-059 and manufacturing efficiencies in 2006, underlying margin improved
by 1.5 percentage points.
R&D expenditure was up 16 percent to $3,902 million (14 percent excluding
Cambridge Antibody Technology Group plc investment) and increased by 0.6
percentage points to 14.7 percent of sales. SG&A increased by 5 percent over
last year to $9,096 million, adding 2.0 percentage points to operating margin.
Higher other income increased operating margin by 1.1 percentage points due
principally to higher royalties, the $109 million gain recognised in quarter two
from the divestments of the US anaesthetics and analgesic products to Abraxis
BioScience, Inc. and the divestments of non-core products in Scandinavia.
Included within cost of sales is the movement in the fair value of financial
instruments used to manage our transactional currency exposures; the loss for
the year, net of an exchange gain on the underlying exposures was $11 million.
Other fair value movements of $5 million are charged elsewhere in the profit and
loss.
Toprol-XLTM
In 2006, Toprol-XLTM contributed US sales of $1,382 million and EPS of 50 cents.
The timing of entry to the markets of other proposed generic products is
difficult to predict; as a result, 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 year,
sales growth would be 11 percent (13 percent for the quarter) and EPS growth
would be 36 percent (29 percent for the quarter) on a CER basis.
Interest and Dividend Income
Net interest and dividend income for the year was $327 million (2005 $165
million), with $100 million in the fourth quarter (2005 $53 million). The
increase over 2005 is primarily attributable to higher average investment
balances and yields. The reported amounts include $43 million (2005 $15 million)
in the year and $9 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 year was 29.0 percent (31.3 percent for the
quarter) compared with 29.1 percent (27.4 percent for the quarter) for 2005. The
decrease for the year compared to 2005 is the net effect of tax benefits arising
from a different geographical mix of profits, tax deductions relating to share
based payments and the recognition of deferred tax assets in respect of tax
credit carry forwards, offset by an increase in tax provisions principally in
relation to global transfer pricing issues. The quarter four tax charge has
increased as a result of net movements on year-end global transfer pricing and
other provisions. The full year tax rate for 2007 is anticipated to be around
29 percent.
Cash Flow
Free cash flow (net cash generated and available for acquisitions or
distribution to shareholders) for the year was $6,788 million, compared to
$6,052 million in 2005. $5,382 million was returned to shareholders (comprising
net share repurchases of $3,162 million and dividends of $2,220 million) and
$1,148 million was invested in acquisitions (Cambridge Antibody Technology Group
plc (CAT) and KuDOS Pharmaceuticals Limited); $661 million was received from the
sale of the Humira royalty stream (acquired as part of CAT), giving a net cash
inflow for 2006 of $919 million. Net funds at the end of 2006 were $6,537
million.
Cash generated from operating activites in the year was $7,693 million, $950
million higher than in 2005. This was driven by increased profit before tax (up
$1,876 million), offset by higher tax payments and working capital requirements.
Net cash outflows from investing activities were $272 million in the year,
compared to an outflow of $1,182 million in 2005. This substantially reflects
the reallocation of funds between cash equivalents and short-term deposits;
after eliminating this effect, the net outflow reflects increased expenditure on
acquisitions, and intangible assets arising from new collaboration deals.
Investments
During December, two agreements were signed: a deal with Cubist Pharmaceuticals
Inc. to develop and commercialise all intravenous forms of Daptomycin, an
anti-infective for the Asia Pacific market, with an upfront payment of $10
million which was capitalised as an intangible asset. Secondly, a three-year
research collaboration and licensing agreement with Argenta Discovery Limited to
identify improved bronchodilators to treat chronic pulminary disease with an
initial payment of $21 million which was accrued and capitalised as an
intangible asset.
In addition, the Company accrued a further milestone payment of $20 million in
relation to the collaboration agreement with Targacept Inc. following the
decision to commence Proof of Concept studies on AZD3480 during December. The
payment has been capitalised as an intangible asset.
Subsequent to year-end, on 11 January 2007, the Company announced a worldwide
collaboration agreement with Bristol-Myers Squibb to develop and commercialise
two investigational compounds being studied for the treatment of Type 2
Diabetes. The upfront payment of $100 million has been paid and will be
capitalised as an intangible asset.
Dividends and Shareholder Return
The Board has recommended a 34 percent increase in the second interim dividend
to $1.23 (63.0 pence, 8.60 SEK) to be paid on 19 March 2007. This brings the
full year dividend to $1.72 (89.6 pence, 12.20 SEK) an increase of 32 percent.
In line with the policy stated last year the Board intends to continue its
practice of growing dividends in line with earnings (maintaining dividend cover
in the two to three times range) whilst substantially distributing the balance
of cash flow via share repurchases. In 2006, $6,367 million ($5,382 million net
of share issues) was distributed from free cash flow of $6,788 million via
dividends and share repurchases. The Board intends to continue this policy, but
firmly believes that the first call on free cash flow is business need and,
having fulfilled that, will return surplus cash flow to shareholders. The
primary business need is to build the research pipeline by supporting internal
and external opportunitites. On this basis the Board has targeted share
repurchases (net of shares issued) of $4 billion for 2007.
Share Repurchase Programme
During the fourth quarter, 19.7 million shares were repurchased for cancellation
at a total cost of $1,189 million bringing the total repurchase for the full
year to 72.2 million shares at a total cost of $4,147 million. During the year,
23.6 million shares were issued, in consideration of share option exercises and
in relation to employee share plans, for a total of $985 million.
The total number of shares in issue at 31 December 2006 is 1,532 million.
The share buy back programme is calculated to have added 6 cents to EPS for the
year, after allowing for an estimate of interest income foregone.
R&D Update
An updated R&D pipeline table is appended to this press release and is also
available on the Company's website, www.astrazeneca.com, under information for
investors.
The AstraZeneca pipeline now totals 120 projects, 95 of which involve new
chemical entities (NCE's) and 25 for the lifecycle management (LCM) of products
already on the market. The corresponding figures as at the last update in June
2006 were: 103 projects; 79 NCE's; 24 LCM.
On 11 January 2007, AstraZeneca announced a worldwide collaboration with
Bristol-Myers Squibb to develop and commercialise two diabetes compounds,
including saxagliptin, a DPP-4 inhibitor in Phase III development and
dapagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor in Phase IIb
development. Since December 2005 externalisation efforts have added five Phase
II and two Phase III molecules to our development pipeline. In addition, a
further 21 new molecules entered development from our laboratories, and the
early pipeline progressed well with 12 first human exposures in the year.
In January 2007, data from three clinical trials demonstrating the effects of
CrestorTM on atherosclerosis were submitted to regulatory authorities in the US
and the European Union. The METEOR trial is considered the pivotal trial for
registration purposes, with the ASTEROID and ORION studies providing supportive
data. The METEOR study has been submitted for presentation at the American
College of Cardiology Scientific sessions in March 2007.
SeroquelTM SR data for the treatment of schizophrenia were submitted for
registration in the US in July, and in the EU in October 2006. Data for IR
(immediate release) for bipolar depression will be submitted in the EU in the
fourth quarter 2007. Positive clinical data have been generated in studies
switching patients from SeroquelTM IR to SeroquelTM SR, relapse prevention
utilising SeroquelTM SR, and bipolar maintenance for SeroquelTM IR. A large
lifecycle management programme is ongoing. The target date for the US
regulatory submission of SeroquelTM SR for generalised anxiety disorder has been
revised to the first half of 2008. There is no change to the submission target
for major depressive disorder.
For IressaTM, Study V-15-32, a Phase III NSCLC, Ministry of Health, Labour and
Welfare (the Japanese Regulator) post-approval commitment study in a Japanese
patient population, did not meet its primary objective of demonstrating
non-inferiority for IressaTM versus docetaxel (TaxotereTM) for overall survival.
However, AstraZeneca believe these data have not altered the risk:benefit
profile of IressaTM in pre-treated Japanese NSCLC patients.
As previously announced by AtheroGenics, Inc., top-line results from the pivotal
Phase III ARISE trial for AGI-1067 are likely to be available no sooner than
late in the first quarter 2007. AtheroGenics, Inc. also reported that it
continues to work towards its goal of presenting the results at the American
College of Cardiology Scientific sessions in March 2007.
In December 2006, following successful completion of a previously disclosed
Phase IIa programme of safety and product characterisation studies, AstraZeneca
decided to continue development of AZD3480 in Alzheimer's disease and cognitive
deficits in schizophrenia. This decision triggered a $20 million milestone
payment to Targacept Inc. under the parties' collaboration agreement.
Calendar
26 April 2007 Announcement of first quarter 2007 results
26 April 2007 Annual General Meeting 2007
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 ND
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