1st Quarter Results (1 of 2)
AstraZeneca PLC
24 April 2008
AstraZeneca PLC
First Quarter Results 2008
- Core EPS increased by 9 percent at CER to $1.28.
- First quarter sales increased by 4 percent at CER to $7,677 million.
- Inclusion of MedImmune sales more than offset the decline in
Toprol-XL((TM)) sales in the US.
- Strong growth in Emerging Markets, with sales up 11 percent at CER.
- Underlying business performance on track. Core EPS target increased to
reflect year to date currency impact.
- Revised target range for Core EPS is $4.45 to $4.75.
- First of 3 planned regulatory filings for the year achieved.
- US Biologics Licence Application for motavizumab submitted in January.
- Settlement agreement with Ranbaxy in Nexium(TM) patent infringement
announced 15 April.
- Agreement gives increased clarity and stability to allow continued
inves(TM)ent in our growing pipeline.
- Company will vigorously defend its intellectual property.
Financial Summary
Group 1st Quarter 1st Quarter Actual CER
2008 2007 % %
$m $m
Sales 7,677 6,966 +10 +4
Reported
Operating Profit 2,257 2,170 +4 -5
Profit before Tax 2,143 2,267 -5 -15
Earnings per Share $1.03** $1.02 +1 -9
Core
Operating Profit 2,765 2,274 +21 +12
Profit before Tax 2,651 2,371 +12 +2
Earnings per Share* $1.28 $1.07 +19 +9
*Core financial measures are supplemental non-IFRS measures which management
believe useful to understanding the Company's performance; it is upon these
measures that financial guidance for 2008 is based. See Operating and Financial
Review for a reconciliation of Core to Reported financial measures.
**Included in Reported EPS for Q1 2008 is a ($0.12) charge for impairment of
intangible assets related to Ethyol(TM), a product acquired with MedImmune,
arising from an 'at risk' launch of a generic product by Sun Pharmaceutical
Industries Ltd., prior to the conclusion of ongoing patent litigation.
David Brennan, Chief Executive Officer, said: 'The first quarter performance
puts us on track to achieve our full year financial targets. We have also
announced the motavizumab BLA submission in January - the first of three
regulatory filings planned for 2008 - and the agreement to settle the Nexium(TM)
patent infringement litigation against Ranbaxy, which has provided increased
clarity and stability to allow us to continue the substantial inves(TM)ent in
our growing pipeline of new medicines.'
London, 24 April 2008
Media Enquiries: Steve Brown/Chris Sampson
(London) (020) 7304 5033/5130
Earl Whipple (Wilmington) (302) 885 8197
Per Lorentz (Sodertaje) (8) 553 26020
Analyst/
Investor Enquiries: Mina Blair/Karl Hard (London) (020) 7304 5084/5322
Jonathan Hunt (London) (020) 7304 5087
Staffan Ternby (Sodertaje) (8) 553 26107
Ed Seage/Jorgen Winroth (US) (302) 886 4065/(212) 579 0506
Peter Vozzo (MedImmune) (301) 398 4358
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 at CER, or 10 percent on an as
reported basis. Sales in the US were up 5 percent; the inclusion of MedImmune
sales in the quarter more than offset the decline in Toprol-XL(TM) sales in the
US market. Sales in the Rest of World were up 4 percent. Sales in Established
Markets were up 1 percent despite a 1 percent decline in Western Europe. Sales
in Emerging Markets were up 11 percent, driven by strong growth in China and
other Asian markets.
Core operating profit in the first quarter was up 12 percent to $2,765 million,
as a result of improvement in Core gross margin and continued efficiencies in SG
&A and R&D. Reported operating profit, which included restructuring and synergy
costs ($117 million), Merck and MedImmune related amortisation ($134 million)
and an intangible asset impairment charge as a result of the 'at risk' launch of
a generic competitor to MedImmune's oncology product Ethyol(TM) ($257 million)
was $2,257 million, 5 percent lower than last year.
Core earnings per share in the first quarter were $1.28 compared with $1.07 in
the first quarter 2007, a 9 percent increase at CER. The increase is the result
of the growth in Core operating profit and the benefit of a lower number of
shares outstanding, partially offset by increased net interest expense.
Research and Development Update
In the first quarter, the first of three planned regulatory submissions for 2008
was achieved, with the submission of the Biologics Licence Application in the US
for motavizumab in January. The filing for saxagliptin is on track for mid-year,
with Phase III clinical data to be presented at the upcoming American Diabetes
Association meeting. The regulatory submission for Zactima(TM) is planned for
the fourth quarter.
The large lifecycle management programme in support of Seroquel XR(TM) is
nearing completion, culminating in a large number of regulatory submissions in
2008. Regulatory filings in the US and Europe for Seroquel XR(TM) for the
trea(TM)ent of Bipolar Mania and Bipolar Depression were announced early in the
first quarter. The US submission for Seroquel XR(TM) for the trea(TM)ent of
major depressive disorder (MDD) was made on 29 February. Submissions for MDD in
Europe and filings for generalised anxiety disorder (GAD) in the US and Europe
will follow later this year. Much of the clinical data supporting the MDD and
GAD filings will be presented at the American Psychiatric Association meeting
early next month.
On 31 March, AstraZeneca announced its decision to stop the Crestor(TM) JUPITER
clinical study early based on a recommendation from an Independent Data
Monitoring Board and the JUPITER Steering Committee, which met on 29 March. The
study will be stopped early because there is unequivocal evidence of a reduction
in cardiovascular morbidity and mortality amongst patients who received Crestor
(TM) when compared to placebo.
The JUPITER study team has initiated activities to close this large multi-centre
study. Over 15,000 trial participants will be scheduled by their investigator
for final assessments at over 1,200 sites in 26 countries. Data from these
visits will generate 80,000 pages of case report forms. We plan to complete the
analysis in the fourth quarter of this year.
Enhancing Productivity
The Company remains on track to deliver two-thirds of the total programme
benefits of $1.4 billion per annum by the end of this year, with the full amount
to be delivered by 2010.
As part of this programme, AstraZeneca undertook major restructuring in many of
its European sales and marketing organisations in 2007. As a result, the Company
is now delivering about the same level of sales with smaller sales forces in its
largest marketing companies in Western Europe.
The R&D organisation is now actively involved in the implementation of our
agreement with Cognizant to provide centralised Data Management services for the
whole of AstraZeneca Clinical Development. This agreement is the largest such
contract within the pharmaceutical industry and will deliver economies of scale
and cost savings that will help R&D deliver its commi(TM)ent to improving
productivity and efficiency.
A further $117 million in costs associated with the Company-wide restructuring
and synergy programmes were charged to the first quarter accounts, bringing
cumulative charges since the inception of the programmes to $1,083 million.
Future Prospects
Based on an assessment of the underlying business performance in the first
quarter and the outlook for the remainder of the year, the Company believes it
is on track to achieve the full year targets. The target range for Core earnings
per share has been increased to $4.45 to $4.75 to reflect the currency benefits
realised in the first quarter relative to the currency assumptions upon which
the targets were based.
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 rate of growth in sales of generic competitors to Toprol-XL(TM)
in the US market, the rate of growth in sales of generic products in the PPI
market in the US, continued growth in currently marketed products (in particular
Crestor(TM), Nexium(TM), Seroquel(TM), Symbicort(TM) and Arimidex(TM)), 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 2007 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
First Quarter CER %
2008 2007
Nexium(TM) 1,238 1,308 -9
Losec(TM)/ Prilosec(TM) 252 279 -16
Total 1,510 1,607 -10
• In the US, Nexium(TM) sales in the first quarter were $736 million, a 15
percent decline compared with last year. Volume was broadly unchanged
compared with the first quarter last year; dispensed retail unit demand was
essentially flat, whilst an increase in non-retail volume was offset by
trade destocking during the quarter. Net prices during the first quarter
are slightly lower than those realised in the fourth quarter 2007; the
price variance versus the first quarter 2007 reflects the back-loaded
phasing of the lower prices realised over the course of last year.
• Nexium(TM) sales in other markets were up 1 percent, as sales growth in
Canada and in Emerging Markets exceeded the declines in Nexium(TM) sales in
Western Europe.
• The Company expects a mid-single digit sales decline for worldwide sales of
Nexium(TM) for the full year.
• Prilosec(TM) sales in the US were down 13 percent in the first quarter.
Losec(TM) sales in other markets were down 17 percent despite modest
increases in Japan and China.
Cardiovascular
First Quarter CER %
2008 2007
Crestor(TM) 772 628 +16
Seloken(TM) / Toprol-XL(TM) 190 444 -60
Atacand(TM) 346 296 +7
Plendil(TM) 66 65 -6
Zestril(TM) 59 80 -33
Total 1,571 1,653 -11
• In the US, Crestor(TM) sales in the first quarter were $353 million, a 3
percent increase over last year. Crestor (TM) share of total prescriptions
in the US statin market increased to 8.75 percent in March; Crestor(TM) is
the only branded statin to gain market share during the first quarter.
Since the launch of the atherosclerosis indication in November 2007,
Crestor(TM) share of new patient starts, as well as net switches to
Crestor(TM) from other statin products, has increased.
• Crestor(TM) sales in Rest of World now exceed those in the US. Crestor(TM)
sales in other markets were up 32 percent to $419 million. Sales in Western
Europe were up 11 percent. Crestor(TM) sales increased by 180 percent in
Japan, where Crestor(TM) volume share of the statin market has reached 13.2
percent.
• US sales of the Toprol-XL(TM) product range, which includes sales of the
authorised generic to Par, were $64 million in the first quarter, down 81
percent. Generic products accounted for 87 percent of dispensed
prescriptions in the first quarter.
• Sales of Seloken(TM) in other markets were unchanged, as the growth in
Emerging Markets offset the decline in Established Markets.
• Atacand(TM) sales in the first quarter were down 5 percent in the US. Sales
in other markets increased 10 percent, chiefly in Western Europe.
Respiratory and Inflammation
First Quarter CER %
2008 2007
Symbicort(TM) 471 354 +21
Pulmicort(TM) 411 401 -1
Rhinocort(TM) 80 92 -16
Oxis(TM) 17 23 -35
Accolate(TM) 18 19 -5
Total 1,040 931 +5
• Symbicort(TM) sales in the US were $44 million in the first quarter.
Specialist adoption of Symbicort(TM) is steadily increasing; since launch
more than 80 percent of allergists and 70 percent of pulmonary specialists
in our target audience have prescribed Symbicort(TM). The product trial
rate among primary care physicians has increased to more than 29 percent.
Overall, Symbicort(TM) share of new prescriptions for fixed combinations
reached 7.8 percent in the week ending 11 April; market share among
patients newly starting combination trea(TM)ents has increased to over 15
percent.
• US regulatory filings for Symbicort(TM) for the trea(TM)ent of COPD and for
paediatric use are planned for the second quarter 2008.
• Symbicort(TM) sales in other markets were up 9 percent in the first
quarter, to $427 million, with more than half of the increase coming from
Western Europe.
• US sales for Pulmicort(TM) were up 2 percent in the first quarter. Initial
stocking of the Pulmicort(TM) Flexhaler (TM) dry powder inhaler (which
replaces Pulmicort(TM) Turbuhaler(TM) in the market) took place in the
first quarter 2007, and has adversely affected the reported sales growth
rate for the quarter. Sales of Pulmicort(TM) Respules (TM) increased 11
percent against the backdrop of a relatively mild season for respiratory
illness.
• Pulmicort(TM) sales in other markets were down 6 percent in the first quarter.
Oncology
First Quarter CER %
2008 2007
Arimidex(TM) 430 401 +2
Casodex(TM) 316 310 -5
Zoladex(TM) 255 249 -6
Iressa(TM) 58 52 +4
Faslodex(TM) 56 49 +8
Nolvadex(TM) 18 19 -16
Ethyol(TM) * 14 - n/m
Total 1,165 1,096 -1
* Sales of this MedImmune product are consolidated in AstraZeneca accounts from
1 June 2007. As a result, there are no prior period sales included. • In the US,
sales of Arimidex(TM) were up 13 percent in the first quarter, to $183 million.
Total prescriptions for Arimidex(TM) increased by 2 percent in the quarter.
• Arimidex(TM) sales in other markets were down 6 percent to $247 million as
sales in Western Europe reflect a slowing in the aromatase inhibitor market
and a small decline in market share.
• Casodex(TM) sales in the first quarter were down 10 percent in the US and
declined 4 percent in other markets.
• Iressa(TM) sales increased by 4 percent in the first quarter, chiefly as a
result of growth in Asian Emerging Markets, including China. Sales in Japan
were down 4 percent.
• Faslodex(TM) sales in the US were $25 million in the first quarter,
unchanged from the first quarter 2007. Sales in other markets were $31
million, an increase of 17 percent.
• In the US, sales of Ethyol(TM) were $14 million in the first quarter. On 31
March, Sun Pharmaceutical Industries Ltd. commenced an 'at risk' launch of
its generic amifostine product prior to the conclusion of ongoing patent
litigation. MedImmune has subsequently entered into a supply and
distribution agreement with Bedford Pharmaceuticals to distribute an
authorised generic version of amifostine. The generic launch gave rise to
an intangible asset impairment charge in the first quarter accounts.
Neuroscience
First Quarter CER %
2008 2007
Seroquel(TM) 1,050 923 +10
Zomig(TM) 107 107 -7
Total 1,378 1,227 +7
• In the US, Seroquel(TM) sales were up 7 percent to $702 million. Total
prescriptions for Seroquel(TM) increased 8 percent in the first quarter,
with 25 percent of the growth attributable to Seroquel XR(TM). The increase
in Seroquel(TM) prescriptions accounted for more than half the prescription
growth for the antipsychotic market in the US in the first quarter.
• Seroquel(TM) sales in other markets increased 17 percent in the first
quarter to $348 million. Sales were up 17 percent in Western Europe,
fuelled by a 43 percent increase in Germany, which included launch stocking
for Seroquel XR(TM).
• Zomig(TM) sales in the first quarter were down 6 percent in the US and were
down 7 percent in other markets.
Infection and Other
First Quarter CER %
2008 2007
Synagis(TM)* 519 - n/m
Merrem(TM) 213 178 +12
FluMist(TM)* - - n/m
Total 787 252 +206
* Sales of these MedImmune products are consolidated in AstraZeneca accounts
from 1 June 2007. As a result, there are no prior period sales included.
• Sales of Synagis(TM) totalled $519 million in the first quarter. US sales
were $456 million; sales outside the US were $63 million. There are no
corresponding sales recorded in the AstraZeneca accounts in the prior year;
on a pro-forma basis Synagis(TM) sales are 2 percent above the first
quarter last year.
Geographic Sales
First Quarter CER %
2008 2007
North America 3,723 3,488 +5
US 3,401 3,234 +5
Established ROW* 2,973 2,664 +1
Emerging ROW 981 814 +11
*Established ROW comprises Western Europe (including France, UK, Germany, Italy,
Sweden, and others), Japan, Australia and New Zealand.
• In the US, sales were up 5 percent in the first quarter. The addition of
MedImmune sales more than offset the decline in Toprol-XL(TM). Underlying
demand growth was ahead of reported sales growth as a result of some
destocking in the quarter. Among the key brands, the growth in
Symbicort(TM), Crestor(TM), Arimidex(TM) and Seroquel (TM) was offset by
the decline in Nexium(TM).
• Sales in the Established Rest of World segment were up 1 percent. Sales in
Western Europe were down 1 percent, with sales growth for Seroquel(TM),
Symbicort(TM) and Crestor(TM) offset by the declines in Losec(TM) and
Nexium(TM). Sales in Japan were up 4 percent, as wholesalers constrained
purchases ahead of the biennial price decreases taking effect in April.
Sales in Australia increased 29 percent, fuelled by the launch performance
of Crestor (TM).
• Sales in Emerging Markets increased 11 percent, accounting for two-thirds
of total Company sales growth outside the US. Sales in Emerging Asia
markets (including China) were up 22 percent. Sales in Latin America were
up 11 percent.
Operating and Financial Review
All narrative in this section refers to growth rates at constant exchange rates
(CER) unless otherwise indicated
First Quarter
Restructuring
Reported and synergy MedImmune Ethyol(TM) Merck Core Core Actual CER
2008 costs Amortisation Impairment Amortisation 2008 2007 % %
Sales 7,677 - - - - 7,677 6,966 10 4
Cost of Sales (1,502) 32 - - - (1,470) (1,404)
Gross Margin 6,175 32 - - - 6,207 5,562 12 5
% sales 80.4% 80.9% 79.8% +1.1 +0.6
Distribution (66) - - - - (66) (61) 8 2
% sales 0.9% 0.9% 0.9% - -
R&D (1,236) 54 - - - (1,182) (1,170) 1 -2
% sales 16.1% 15.4% 16.8% +1.4 +1.1
SG&A (2,737) 31 79 257 25 (2,345) (2,195) 7 2
% sales 35.7% 30.6% 31.5% +0.9 +0.7
Other income 121 - 30 - - 151 138 9 8
% sales 1.6% 2.0% 2.0% - +0.1
Operating Profit 2,257 117 109 257 25 2,765 2,274 21 12
% sales 29.4% 36.0% 32.6% +3.4 +2.5
Net finance (114) - - - - (114) 97
(expense)/income
Profit before Tax 2,143 117 109 257 25 2,651 2,371 12 2
Taxation (638) (35) (32) (77) - (782) (728)
Profit after Tax 1,505 82 77 180 25 1,869 1,643 14 4
Minority Interests (2) - - - - (2) (4)
Net Profit 1,503 82 77 180 25 1,867 1,639 14 4
Weighted Average 1,457 1,457 1,457 1,457 1,457 1,457 1,527
Shares
Earnings per Share 1.03 0.06 0.05 0.12 0.02 1.28 1.07 19 9
A reconciliation by quarter of Reported to Core financial measures for 2007 is
given in note 3.
Sales increased by 10 percent on a reported basis and by 4 percent on a constant
currency basis. Currency movements increased sales by 6 percent.
Core gross margin of 80.9 percent in the first quarter is 0.6 percentage points
higher than last year. Principal contributors were lower payments to Merck (1.2
percentage points), and continued efficiency gains and favourable product mix
(0.8 percentage points), partially offset by higher royalty payments (1.4
percentage points), chiefly due to the inclusion of Synagis(TM) sales in the
first quarter of 2008.
Core R&D expenditure was $1,182 million in the first quarter, down 2 percent
over last year. In the first quarter 2007, there were intangible asset
impairment charges relating to the collaborations with AtheroGenics and Avanir;
excluding these impairments, Core R&D expenditure was up 4 percent in the
quarter, due to the inclusion of MedImmune R&D expense offset by ongoing
efficiencies. The Company continues to make good progress on the delivery of R&
D projects and productivity initiatives.
Core SG&A costs of $2,345 million were 2 percent higher than the first quarter
of 2007, where the inclusion of MedImmune has more than offset operational
efficiencies and benefits from the Company's productivity initiatives. Excluding
MedImmune, Core SG&A expense was 2 percent lower than last year.
Core other income of $151 million was $13 million higher than the first quarter
in 2007 with the inclusion of MedImmune being partially counterbalanced by lower
one-time gains and royalty income. The amortisation expense relating to the
intangible assets arising from MedImmune's licensing and royalty income streams
has been reclassified from SG&A to other income. As a result of this change, the
Company still expects Core other income to be similar to last year, but with
this amortisation expense, other income on a reported basis will be lower than
2007.
Core operating profit was $2,765 million, an increase of 12 percent at CER or up
21 percent on an as reported basis. Currency movements increased operating
profit by 9 percent. In comparison to last year, the dollar was 13 percent
weaker against the euro, increasing sales, and also against the Swedish krona
(11 percent) and sterling (1 percent), increasing costs. On a constant currency
basis, Core operating margin increased by 2.5 percentage points to 36.0 percent
of sales, as a result of improvements in gross margin and efficiencies in SG&A
and R&D.
Core earnings per share in the first quarter were $1.28, a CER increase of 9
percent, as the increase in Core operating profit and the benefit of a lower
number of shares in issue was partially offset by increased net interest
expense. Core earnings per share on an as reported basis increased 19 percent.
Reported operating profit was down 5 percent to $2,257 million, reflecting the
impact of restructuring and synergy costs ($117 million), MedImmune related
amortisation ($109 million) and the impairment of intangible assets arising from
the 'at risk' launch of a generic competitor to Ethyol(TM) ($257 million)
compared with the first quarter last year. Reported earnings per share were
$1.03.
Finance Income and Expense
Net finance expense was $114 million for the first quarter, versus income of $97
million in the first quarter of 2007. This decrease is primarily attributable to
the interest payable on the borrowings to acquire MedImmune, Inc.
Taxation
The effective tax rate for the quarter was 29.8 percent compared with 31.0
percent for the same period last year. For the full year the tax rate is
anticipated to be around 29.5 percent, the same as for 2007.
Cash Flow
Cash generated from operating activities was $2,391 million in the first
quarter, in comparison with $2,187 million in 2007. The increase of $204 million
was mainly driven by an increase in operating profit before depreciation,
amortisation and impairment of $419 million, partially offset by an increase in
interest payments of $256 million.
Net cash outflows from investing activities were $2,937 million in the first
quarter, versus $616 million in 2007. This was due primarily to the payment of
$2,630 million to Merck (see note 6), which was partially offset by reductions
in expenditure on new externalisation deals and in the purchase of short term
inves(TM)ents and fixed deposits.
Cash distributions to shareholders were $2,007 million, through the payment of
the second interim dividend from 2007.
Inves(TM)ents
As described in note 6, on 17 March, the Company made payments under the
provisions of the Merck agreements of approximately $2.6 billion. These have
been recorded as intangible assets to reflect the benefits accruing in respect
of relief from future contingent payments and the ability to fully exploit our
resources and products within certain therapy areas. There were no other
significant inves(TM)ents in the quarter.
Debt and Capital Structure
As at 31 March 2008, outstanding gross debt (including loans, short-term
borrowings and overdrafts) was $15,002 million (31 December: $15,156 million),
of which $11,116 million is due after one year (31 December: $10,876 million).
Outstanding net debt of $11,752 million increased by $2,640 million from 31
December, principally as a result of the significant cash outflows as described
above.
Share Repurchases
During the first quarter, there were no share repurchases.
The total number of shares in issue at 31 March 2008 was 1,457 million.
The Board's distribution policy and its overall financial strategy is to strike
a balance between the interests of the business, our shareholders and our
financial creditors, whilst maintaining a strong inves(TM)ent grade credit
rating. The Board expects to undertake share repurchases in the region of $1
billion in 2008, subject to business needs.
Calendar
31 July 2008 Announcement of second quarter and half year 2008 results
30 October 2008 Announcement of third quarter and nine months 2008 results
David Brennan
Chief Executive Officer
This information is provided by RNS
The company news service from the London Stock Exchange