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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
20-F
(Mark
One)
o
REGISTRATION
STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT
OF 1934
OR
x
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For
the fiscal year ended December 31, 2008
OR
o
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
OR
o
SHELL
COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
Date of
event requiring this shell company report _____________
For the transition period
from _____________ to
_____________
Commission
file number 001-11960
ASTRAZENECA
PLC
(Exact
name of Registrant as specified in its charter)
England
(Jurisdiction
of incorporation or organization)
15
Stanhope Gate, London W1K 1LN
(Address
of principal executive offices)
Adrian
Kemp
AstraZeneca
PLC
15 Stanhope Gate, London W1K 1LN
Telephone:
+44 20 7304 5103
(Name,
Telephone and Address of Company Contact Person)
Securities
registered or to be registered pursuant to Section 12(b) of the
Act:
Title
of each class
Name
of each exchange on which registered
American
Depositary Shares, each representing one Ordinary Share of 25¢
each
The
New York Stock Exchange
Ordinary
Shares of 25¢
each
The
New York Stock Exchange*
*
Not
for trading, but only in connection with the registration of American
Depositary Shares representing such Ordinary Shares pursuant to the
requirements of the Securities and Exchange
Commission.
Securities
registered or to be registered pursuant to Section 12(g) of the
Act:
None
(Title of
Class)
Securities
for which there is a reporting obligation pursuant to Section 15(d) of the
Act:
None
(Title of
Class)
The
number of issued shares of each class of stock of AstraZeneca PLC as of March
17, 2009 was:
Ordinary
Shares of 25¢ each: 1,447,644,517
Redeemable
Preference Shares of £1 each: 50,000
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act
x Yes o No
If this
report is an annual or transition report, indicate by check mark if the
registrant is not required to file reports pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934.
o Yes x No
Note —
checking the box above will not relieve any registrant required to file reports
pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from
their obligations under those Sections.
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days.
x Yes o No
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accredited filer. See definition of
“accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange
Act. (Check one):
Large
accelerated filer x
Accelerated
filer o
Non-accelerated
filer o
Indicate
by check mark which basis of accounting the registrant has used to prepare the
financial statements included in this filing:
U.S.
GAAP o
International
Financial Reporting Standards as issued by the International Accounting
Standards Board x
Other
o
If
“Other” has been checked in response to the previous question, indicate by check
mark which financial statement item the registrant has elected to
follow.
o Item
17 o Item
18
If this
is an annual report, indicate by check mark whether the registrant is a shell
company (as defined in Rule 12b-2 of the Exchange Act).
o Yes x No
(APPLICABLE
ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PAST FIVE
YEARS)
Indicate
by check mark whether the registrant has filed all documents and reports
required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act
of 1934 subsequent to the distribution of securities under a plan confirmed by a
court.
o Yes o No
Pursuant
to Rule 12b-23(a) of the Securities Exchange Act of 1934, as amended, the
information for the 2008 Form 20-F of AstraZeneca PLC (the “Company”) set out
below is being incorporated by reference from the Company’s “Annual Report and
Form 20-F Information 2008” included as exhibit 15.1 to this Form 20-F dated and
submitted on March 17, 2009.
References
below to major headings include all information under such major headings,
including subheadings, unless such reference is part of a reference to a
subheading, in which case such reference includes only the information contained
under such subheading. Graphs and tabular data are not included
unless specifically identified below. Photographs are also not
included.
In
addition to the information set out below, the information set forth under the
headings “Cautionary statement regarding forward-looking statements”, “Inclusion
of reported, constant exchange rate and core financial measures”, “Statements of
competitive position, growth rates and sales”, “AstraZeneca websites” and
“External/third party websites” on page 1, “Trade marks”, “Use of terms” and
“Statements of dates” on the inside back cover, “Definitions and Interpretation”
on page 196, “Cross-Reference to Form 20-F” on page 198 and “Glossary” on pages
199 to 200, in each case of the Company’s “Annual Report and Form 20-F
Information 2008” included as exhibit 15.1 to this Form 20-F dated March 17,
2009 is incorporated by reference.
PART
1
ITEM
1 - IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Not
applicable.
ITEM
2 - OFFER STATISTICS AND EXPECTED TIMETABLE
Not
applicable.
ITEM
3 - KEY INFORMATION
A.
Selected Financial Data
The
information (including graphs and tabular data) set forth under the headings
“AstraZeneca and our Year in Brief—Financial Highlights” on page 2, “Directors’
Report—Reporting our Performance – Financial” on page 15, “Financial
Statements—Notes to the Financial Statements—Note 20—Share Capital of Parent
Company” on page 129, “Group Financial Record” on page 172 and the first table
that appears under “Additional Information—Shareholder Information” on page 190,
in each case of the Company’s “Annual Report and Form 20-F Information 2008”
included as exhibit 15.1 to this Form 20-F dated March 17, 2009 is incorporated
by reference. The selected financial data incorporated by reference
herein is derived from audited financial statements of the Company and its
consolidated entities, prepared in accordance with International Financial
Reporting Standards (“IFRS”) as adopted by the European Union and IFRS as issued
by the International Accounting Standards Board, included in the Company’s
“Annual Report and Form 20-F Information 2008” included as exhibit 15.1 to this
Form 20-F dated March 17, 2009.
The
following tables show certain information regarding the exchange rate for pounds
sterling, for the periods and dates indicated through February 28, 2009, based
on the Noon Buying Rate certified by the New York Federal Reserve Bank (the
“Noon Buying Rate”) for customs purposes for pounds sterling expressed in US
dollars per £1.00, and, for the periods and dates indicated from March 1, 2009
to March 6, 2009 and for the yearly average data for 2009, based on the
Bloomberg Foreign Exchange Fixings Rate (the “BFIX Rate”) at noon expressed in
US dollars per £1.00, unless otherwise specified.
The noon
exchange rate, based on the BFIX Rate, as at March 6, 2009, the latest
practicable date for which exchange rate data was available, was £1.00 =
$1.41.
1
March
2009 (to March 6)
February
2009
January
2009
December
2008
November
2008
October
2008
September
2008
High
1.42
1.49
1.53
1.55
1.62
1.78
1.86
Low
1.41
1.42
1.37
1.44
1.48
1.55
1.75
Monthly
Average (through March 6, 2009)(1)
1.41
1.44
1.45
1.49
1.53
1.69
1.80
2009
(to
March
6)
2008
2007
2006
2005
2004
Yearly
Average(2)
1.44
1.84
2.01
1.86
1.81
1.84
(1) Average of the Noon Buying Rate (or the
BFIX Rate, in the case of March, 2009), on the last available date of
publication within the relevant month.
(2) Average of the Noon Buying Rate on the
last day of each full month during the period (or, in the case of 2009, the BFIX
Rate on the last available date of publication within the relevant
month).
B.
Capitalization and Indebtedness
Not
applicable.
C.
Reason for the Offer and Use of Proceeds
Not
applicable.
D.
Risk Factors
The
information set forth or referenced under the heading “Directors’
Report—Risk—Principal Risks and Uncertainties” on pages 76 to 82 of the
Company’s “Annual Report and Form 20-F Information 2008” included as exhibit
15.1 to this Form 20-F dated March 17, 2009 is incorporated by
reference.
ITEM
4 - INFORMATION ON THE COMPANY
A.
History and Development of the Company
The
information (including tabular data) set forth under the headings “Additional
Information—Corporate Information—History and Development of the Company” on
page 197, “Directors’ Report—Resources, Skills and Capabilities—Our Resources”
and “—Supply and Manufacturing” on pages 18 (third paragraph only) and 27
respectively, “Directors’ Report—Financial Position, including Cash Flow and
Liquidity – 2008—Property, plant and equipment” and “—Cash flow”, on pages 35
and 36, respectively, “Directors’ Report— Financial Position, including Cash
Flow and Liquidity – 2007—Investments, divestments and capital expenditure” on
page 41, “Financial Statements—Notes to the Financial Statements—Note
7—Property, Plant and Equipment” on pages 114 and 115 and “Financial
Statements—Notes to the Financial Statements—Note 22—Acquisitions of Business
Operations” on pages 130 to 133, in each case of the Company’s “Annual Report
and Form 20-F Information 2008” included as exhibit 15.1 to this Form 20-F dated
March 17, 2009 is incorporated by reference.
B.
Business Overview
The
information (including graphs and tabular data) set forth under the headings
“AstraZeneca and our Year in Brief” on pages 2 to 3, “Directors’ Report” on
pages 8 to 30 (excluding the “Expanding Patient Populations” graphic and the
first and third paragraphs under the heading “Expanding Patient Population, on
page 10) and pages 48 to 73, “Financial Statements—Notes to the Financial
Statements—Note 5—Segment Information” and “—Note 6—Product Revenue Information”
on pages 111 to 113, and “Statements of competitive position, growth rates and
sales” on page 1, in each case of the Company’s “Annual Report and Form 20-F
Information 2008” included as exhibit 15.1 to this Form 20-F dated March 17,
2009 is incorporated by reference.
2
FDA Approves Symbicort for
COPD
On March
2, 2009, the Company announced that the U.S. Food and Drug Administration (FDA)
has approved SYMBICORT (budesonide/formoterol fumarate dihydrate) 160/4.5 mcg
for the twice daily maintenance treatment of airflow obstruction in patients
with chronic obstructive pulmonary disease (COPD), including chronic bronchitis
and emphysema.
The FDA
approval is based on results from two pivotal clinical trials, SHINE (6-month)
and SUN (12-month), which found SYMBICORT improved lung function within five
minutes of the first dose and sustained that lung function improvement for the
duration of the studies. SYMBICORT pMDI (pressurized metered-dose inhaler) has
been available in the U.S. since June, 2007 for the long-term maintenance
treatment of asthma in patients 12 years of age and older.
Seroquel XR – FDA Complete
Response Letter and Psychopharmacologic Drugs Advisory
Committee
On
February 27, 2009, the Company announced that it had received a Complete
Response Letter (CRL) from the FDA asking for additional information for the
supplemental New Drug Application (sNDA) for SEROQUEL XR (quetiapine fumarate)
Extended Release Tablets for the treatment of Generalised Anxiety Disorder (GAD)
in adult patients. AstraZeneca is evaluating the contents of the CRL
and the proposed labelling revisions.
On
February 25, 2009, the Company announced that it had been advised by the FDA
that the FDA Psychopharmacologic Drugs Advisory Committee (PDAC) is tentatively
scheduled to meet on April 8, 2009, to discuss the safety and efficacy of sNDAs
for SEROQUEL XR proposed for the treatment of major depressive disorder (MDD)
and GAD.
Partnership with MAP
Pharmaceuticals – Unit Dose Budesonide
On
February 23, 2009, MAP Pharmaceuticals, Inc. announced that its initial Phase
III clinical trial of Unit Dose Budesonide (UDB) for the potential treatment of
children with asthma did not meet its co-primary endpoints: asthma control as
assessed by changes from baseline in night-time and daytime composite symptom
scores, in either of the doses evaluated when compared with
placebo.
The
Company and MAP Pharmaceuticals announced, in December, 2008, an exclusive
worldwide agreement to develop and commercialise UDB, MAP Pharmaceuticals’
proprietary nebulised formulation of budesonide. This agreement is subject to
review in the United States under the U.S. Hart-Scott-Rodino Act and becomes
effective after the waiting period has ended. The Company intends to work
with MAP Pharmaceuticals to conduct further analyses of these data to determine
appropriate next steps for the programme.
Primary Endpoint for PN 400
Phase III Clinical Programmes
On
January 29, 2009, the Company announced that its co-development partner for the
investigational compound PN 400, POZEN Inc., has been informed that the FDA has
completed its internal discussions and that there is no change to the previous
agreements that gastric ulcer incidence is an acceptable primary endpoint for
the PN 400 Phase III clinical programmes. In October, the FDA had
announced that they were conducting an internal review on the acceptability of
gastric ulcers as a primary endpoint in clinical studies.
C.
Organizational Structure
The
information set forth under the headings “Directors’ Report—Other Matters—Other
Company Disclosures and Information—Subsidiaries and principal activities” on
page 94 and “Financial Statements—Principal Subsidiaries” on page 164, in each
case of the Company’s “Annual Report and Form 20-F Information 2008” included as
exhibit 15.1 to this Form 20-F dated March 17, 2009 is incorporated by
reference.
D.
Property, Plants and Equipment
The
information (including tabular data) set forth under the headings “Directors’
Report—Research and Development—Our Resources” on pages 17 and 18, “Directors’
Report—Financial Review—Financial Position,
3
including
Cash Flow and Liquidity – 2008 —Property, plant and equipment” and “—Financial
Position, including Cash Flow and Liquidity – 2007—Property, plant and
equipment”, on pages 35 and 40, respectively, “Directors’ Report—Risk—Principal
Risks and Uncertainties—Industry/Economic Environment
Risks—Environmental/occupational/health and safety liabilities” on page 79,
“Financial Statements—Notes to the Financial Statements—Note 25—Commitments and
contingent liabilities—Environmental costs and liabilities” on pages 146 to 147
and “Financial Statements—Notes to the Financial Statements—Note 7—Property,
Plant and Equipment” on pages 114 to 115, in each case of the Company’s “Annual
Report and Form 20-F Information 2008” included as exhibit 15.1 to this Form
20-F dated March 17, 2009 is incorporated by reference.
ITEM
4A - UNRESOLVED STAFF COMMENTS
Not
applicable.
ITEM
5 - OPERATING AND FINANCIAL REVIEW AND PROSPECTS
The
information (including graphs and tabular data) set forth under the headings
“Directors’ Report—World Pharmaceutical Markets” (comprising first table only)
on page 9, “Directors’ Report—Financial Review” on pages 31 to 47, “Directors
Report—Geographical Review” on pages 48 to 52, “Directors’ Report—Therapy Area
Review—Sales by Therapy Area” (comprising final tabular data only) on page 53,
“Directors’ Report—Therapy Area Review—Our Financial Performance” (comprising
tabular data only) on pages 55, 58, 60, 62, 65 and 68, “Directors’
Report—Therapy Area Review—Financial Performance 2008/2007” on pages 56, 58, 60,
63, 66 and 69, “Directors’ Report—Resources, Skills and Capabilities—Research
and Development” on pages 17-21, “Financial Statements—Notes to the Financial
Statements—Note 14—Interest Bearing Loans and Borrowings” on page 119,
“Financial Statements—Notes to the Financial Statements—Note 16—Financial
Instruments” on pages 122 to 126, “Financial Statements—Notes to the Financial
Statements—Note 19—Capital and Reserves—Other reserves” on page 128 and
“Financial Statements—Notes to the Financial Statements—Note 25—Commitments and
Contingent Liabilities” on pages 144 to 162, in each case of the Company’s
“Annual Report and Form 20-F Information 2008” included as exhibit 15.1 to this
Form 20-F dated March 17, 2009 is incorporated by reference.
ITEM
6 - DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A.
Directors and Senior Management
The
information set forth under the headings “Directors’ Report—Business
Organisation and Corporate Governance—Board of Directors at 31 December 2008” on
pages 84 and 85, “—Chief Executive Officer, Delegation of Authority and Senior
Executive Team—Senior Executive Team” on page 86 and “Remuneration
Report—Directors’ Remuneration Report—Variable Remuneration—Policy on external
appointments and retention of fees” on page 181, in each case of the Company’s
“Annual Report and Form 20-F Information 2008” included as exhibit 15.1 to this
Form 20-F dated March 17, 2009 is incorporated by reference.
On
February 27, 2009, the Company announced that Håkan Mogren, Non-Executive Deputy
Chairman, will retire from the Company’s Board of Directors at the close of the
Company’s AGM on April 30, 2009.
B.
Compensation
The
information (including graphs and tabular data) set forth under the headings
“Remuneration Report—Directors’ Remuneration Report” on pages 174 to 188,
“Financial Statements—Notes to the Financial Statements—Note 23—Post-Retirement
Benefits”, “—Note 24—Employee Costs and Share Option Plans for Employees” and
“—Note 27—Statutory and Other Information—Key management personnel
compensation”, on pages 133 to 138, 138 to 143, and 163, respectively, in each
case of the Company’s “Annual Report and Form 20-F Information 2008” included as
exhibit 15.1 to this Form 20-F dated March 17, 2009 is incorporated by
reference.
C.
Board Practices
The
information set forth under the headings “Directors’ Report—Business
Organisation and Corporate Governance—Board of Directors at 31 December 2008”
and “—Chief Executive Officer, Delegation of Authority
4
and
Senior Executive Team—Senior Executive Team”, on pages 84 to 86, “—Operation of
the Board of Directors” and “—Operation of Board Committees” on pages 87 to 91,
“—Principal UK and US Governance Requirements—UK Corporate Governance
Requirements” and “—US Corporate Governance Requirements” on pages 91 to 93, and
“Directors’ Remuneration Report—Executive Directors’ and Senior Executive Team’s
Remuneration and Terms of Employment—Details of Executive Directors’ Service
Contracts at 31 December 2008” (consisting of tabular data), “—Service
contracts” and “—Non-Executive Directors”, each on page 181, in each case of the
Company’s “Annual Report and Form 20-F Information 2008” included as exhibit
15.1 to this Form 20-F dated March 17, 2009 is incorporated by
reference.
D.
Employees
The
information set forth under the headings “Directors’ Report—Resources, Skills
and Capabilities—People” (comprising the graphical data and first paragraph
only) on page 28, “—Communication and Dialogue” on pages 28 to 29 and “Financial
Statements—Notes to the Financial Statements— Note 24—Employee Costs and Share
Option Plans for Employees” (including the tabular data) on pages 138 to 143, in
each case of the Company’s “Annual Report and Form 20-F Information 2008”
included as exhibit 15.1 to this Form 20-F dated March 17, 2009 is incorporated
by reference.
E.
Share Ownership
The
information (including graphs and tabular data) set forth under the headings
“Financial Statements—Notes to the Financial Statements— Note 24—Employee Costs
and Share Option Plans for Employees” on pages 138 to 143, “Remuneration Report—
Directors’ Remuneration Report —Directors’ Interests in Shares” on pages 185 to
188, and “Additional Information—Shareholder Information—Major
Shareholdings—Title of class” and “—Shareholder Information—Options to Purchase
Securities from Registrant or Subsidiaries” (consisting of tabular data and
related text), both on page 192, in each case of the Company’s “Annual Report
and Form 20-F Information 2008” included as exhibit 15.1 to this Form 20-F dated
March 17, 2009 is incorporated by reference.
ITEM
7 - MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A.
Major Shareholders
The
information set forth under the heading “Additional Information—Shareholder
Information—Major Shareholdings” on pages 191 to 192 of the Company’s “Annual
Report and Form 20-F Information 2008” included as exhibit 15.1 to this Form
20-F dated March 17, 2009 is incorporated by reference.
B.
Related Party Transactions
The
information set forth under the headings “Financial Statements—Notes to the
Financial Statements—Note 27—Statutory and Other Information—Related Party
Transactions” on page 163 and “Additional Information—Shareholder
Information—Related Party Transactions” on page 192, in each case of the
Company’s “Annual Report and Form 20-F Information 2008” included as exhibit
15.1 to this Form 20-F dated March 17, 2009 is incorporated by
reference.
C.
Interests of Experts and Counsel
Not
applicable.
ITEM
8 - FINANCIAL INFORMATION
A.
Consolidated Statements and Other Financial Information
The
information (including graphs and tabular data) set forth under the headings
“Directors’ Report—Financial Review—Capitalisation and Shareholder
Return—Dividend and Share Re-Purchases” on page 37, “Directors’ Report—Business
Organisation and Corporate Governance—Other Matters—Distributions to
shareholders” on page 95, “Financial Statements” on pages 100 to 163
(including the information set forth under the subheading “Notes to
5
the
Financial Statements”), “Financial Statements—Principal Subsidiaries” on page
164, “Group Financial Record” on page 172, and “Additional
Information—Shareholder Information” on pages 190 to 195, in each case of the
Company’s “Annual Report and Form 20-F Information 2008” included as exhibit
15.1 to this Form 20-F dated March 17, 2009 is incorporated by
reference.
B. Significant
Changes
Since the
date of the annual consolidated financial statements included in this Form 20-F
dated March 17, 2009, no significant change has occurred, except as otherwise
disclosed herein.
ITEM
9 - THE OFFER AND LISTING
A.
Offer and Listing Details
The
information (including graphs and tabular data) set forth under the heading
“Additional Information—Shareholder Information” on page 190 of the Company’s
“Annual Report and Form 20-F Information 2008” included as exhibit 15.1 to this
Form 20-F dated March 17, 2009 is incorporated by reference.
In
addition, the table below sets forth, for the periods indicated, the reported
high and low share prices of AstraZeneca PLC, on the following
bases:
·
for
shares listed on the London Stock Exchange (LSE) the reported high and low
middle market closing quotations are derived from The Daily Official
List;
·
for
shares listed on the Stockholm Stock Exchange (SSE) the high and low
closing sales prices are as stated in the Official
List;
·
for
American Depositary Shares (ADS) listed on the New York Stock Exchange the
reported high and low sales are as reported by Dow Jones (ADR
quotations).
AstraZeneca
Ordinary
LSE
ADS
Ordinary
SSE(1)
High
Low
High
Low
High
Low
(GB
pence)
(GB
pence)
(US$)
(US$)
(SEK)
(SEK)
2009
– February
2,767
2,238
40.16
31.33
330.0
287.5
2009
– January
2,947
2,671
41.60
38.36
331.0
309.5
2008
– December
2,807
2,420
41.12
35.24
326.0
300.0
2008
– November
2,888
2,245
44.38
34.10
340.5
280.5
2008
– October
2,630
2,075
44.76
36.50
320.0
253.5
2008
– September
2,766
2,415
48.95
43.53
321.5
292.5
2008
2,888
1,748
49.85
34.10
340.5
211.5
2008
– Quarter 4
2,888
2,075
44.76
34.10
340.5
253.5
2008
– Quarter 3
2,766
2,130
49.85
43.42
321.5
255.5
2008
– Quarter 2
2,289
1,981
44.57
39.36
268.0
235.5
2008
– Quarter 1
2,345
1,748
45.70
35.50
296.5
211.5
2007
2,984
2,093
59.04
42.82
414.0
272.0
2007
– Quarter 4
2,589
2,093
52.47
42.82
343.5
272.0
2007
– Quarter 3
2,770
2,278
56.16
45.56
374.5
315.0
2007
– Quarter 2
2,953
2,567
59.04
51.00
401.0
354.5
2007
– Quarter 1
2,984
2,734
58.78
53.53
414.0
367.5
2006
3,529
2,574
66.37
45.12
484.0
352.5
2005
2,837
1,861
49.50
34.72
392.0
243.0
2004
2,749
1,863
50.85
35.88
374.0
237.5
(1)
Principally
held in bearer form.
6
B.
Plan of Distribution
Not
applicable.
C.
Markets
The
information set forth under the heading “Additional Information—Shareholder
Information” on page 190 of the Company’s “Annual Report and Form 20-F
Information 2008” included as exhibit 15.1 to this Form 20-F dated March 17,
2009 is incorporated by reference.
D.
Selling Shareholders
Not
applicable.
E.
Dilution
Not
applicable.
F.
Expenses of the Issue
Not
applicable.
ITEM
10 - ADDITIONAL INFORMATION
A.
Share Capital
Not
applicable.
B.
Memorandum and Articles of Association
The
information set forth under the heading “Additional Information—Corporate
Information—Memorandum and Articles of Association” on page 197 of the Company’s
“Annual Report and Form 20-F Information 2008” included as exhibit 15.1 to this
Form 20-F dated March 17, 2009 is incorporated by reference.
C.
Material Contracts
Not
applicable.
D.
Exchange Controls
The
information set forth under the headings “Additional Information—Shareholder
Information—Exchange Controls and Other Limitations Affecting Security Holders”
on page 194 of the Company’s “Annual Report and Form 20-F Information 2008”
included as exhibit 15.1 to this Form 20-F dated March 17, 2009 is incorporated
by reference.
E.
Taxation
The
information set forth under the headings “Additional Information—Shareholder
Information—Taxation for US Residents”, “—UK and US Income Taxation of
Dividends”, “—Taxation on Capital Gains”, “—Passive Foreign Investment Company
Rules”, “—UK Inheritance Tax” and “—UK Stamp Duty Reserve Tax and Stamp Duty” on
pages 193 to 194 of the Company’s “Annual Report and Form 20-F Information 2008”
included as exhibit 15.1 to this Form 20-F dated March 17, 2009 is incorporated
by reference.
F.
Dividends and Paying Agents
Not
applicable.
7
G.
Statement by Experts
Not
applicable.
H.
Documents on Display
The
information set forth under the heading “Additional Information—Shareholder
Information—Documents on Display” on page 193 of the Company’s “Annual Report
and Form 20-F Information 2008” included as exhibit 15.1 to this Form 20-F dated
March 17, 2009 is incorporated by reference.
In
addition, we file reports and other information with the United States
Securities and Exchange Commission (the “SEC”). You can read and copy
these reports and other information at the SEC’s Public Reference Room at 100 F
Street, N.E., Washington, D.C. 20549. You can call the SEC at
1-800-SEC-0330 for further information on the Public Reference
Room. The SEC also maintains a website at www.sec.gov which contains
in electronic form each of the reports and other information that we have filed
electronically with the SEC.
I.
Subsidiary Information
Not
applicable.
ITEM
11 - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The
information (including graphs and tabular data) set forth under the headings
“Directors’ Report—Financial Review—Financial Risk Management” on pages 41 to
42, and “Financial Statements—Note 15—Financial Risk Management Objectives and
Policies” and “—Note 16—Financial Instruments—Sensitivity Analysis” on pages 120
to 126, in each case of the Company’s “Annual Report and Form 20-F Information
2008” included as exhibit 15.1 to this Form 20-F dated March 17, 2009 is
incorporated by reference.
ITEM
12 - DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
Not
applicable.
PART
II
ITEM
13 - DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
(a) There
has been no material default in payment of principal, interest, a sinking or
purchase fund installment, or any other material default with respect to any
indebtedness of the Company or any of its significant subsidiaries.
(b) There
have been no arrears in the payment of dividends on, and no material delinquency
with respect to, any class of preferred stock of any significant subsidiary of
the Company.
ITEM
14 - MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF
PROCEEDS
Not
applicable.
ITEM
15 - CONTROLS AND PROCEDURES
The
information set forth under the heading “Directors’ Report—Business Organisation
and Corporate Governance—Operation of Board Committees—Audit Committee” on page
90 (the last three paragraphs of the “Audit Committee” section only), “—Business
Organisation and Corporate Governance—Principal UK and US Governance
Requirements” on pages 91 to 92 (the third, fourth, fifth and sixth paragraphs
of the “Principal UK and US Governance Requirements” section only) and
“Financial Statements—Directors’ Responsibilities for, and Report on, Internal
Control over Financial Reporting” on page 98, in each case of the Company’s
“Annual Report and Form 20-F Information 2008” included as exhibit 15.1 to this
Form 20-F dated March 17, 2009 is incorporated by reference.
8
Management’s Annual Report
on Internal Control over Financial Reporting
As
required by US regulations, management is responsible for establishing and
maintaining adequate internal control over financial reporting for the company,
and is required to identify the framework used to evaluate the effectiveness of
the Company’s internal control over financial reporting and to assess the
effectiveness of such internal control. In this regard, management
has made the same assessment and reached the same conclusion as that set forth
in the section entitled “Financial Statements—Director’s Responsibilities for,
and Report on, Internal Control over Financial Reporting” on page 98 of the
Company’s “Annual Report and Form 20-F Information 2008” included as exhibit
15.1 to this Form 20-F dated March 17, 2009, which is incorporated herein by
reference.
Report of Independent
Registered Public Accounting Firm
The Board
of Directors and Members
AstraZeneca
PLC:
We have
audited AstraZeneca PLC’s (“AstraZeneca”) internal control over financial
reporting as of 31 December 2008, based on criteria established in Internal Control — Integrated
Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission (COSO). AstraZeneca’s management is responsible
for maintaining effective internal control over financial reporting and for its
assessment of the effectiveness of internal control over financial reporting.
Our responsibility is to express an opinion on the Company’s internal control
over financial reporting based on our audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether effective
internal control over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of internal control over
financial reporting, assessing the risk that a material weakness exists, and
testing and evaluating the design and operating effectiveness of internal
control based on the assessed risk. Our audit also included performing such
other procedures as we considered necessary in the circumstances. We believe
that our audit provides a reasonable basis for our opinion.
A
company's internal control over financial reporting is a process designed to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles. A company's internal
control over financial reporting includes those policies and procedures that (1)
pertain to the maintenance of records that, in reasonable detail, accurately and
fairly reflect the transactions and dispositions of the assets of the company;
(2) provide reasonable assurance that transactions are recorded as necessary to
permit preparation of financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the company are
being made only in accordance with authorizations of management and directors of
the company; and (3) provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use, or disposition of the company’s
assets that could have a material effect on the financial
statements.
Because
of its inherent limitations, internal control over financial reporting may not
prevent or detect misstatements. Also, projections of any evaluation
of effectiveness to future periods are subject to the risk that controls may
become inadequate because of changes in conditions, or that the degree of
compliance with the policies or procedures may deteriorate.
In our
opinion, AstraZeneca maintained, in all material respects, effective internal
control over financial reporting as of 31 December 2008, based on criteria
established in Internal
Control — Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission.
We also
have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the consolidated balance sheets of AstraZeneca
as of 31 December 2008, 2007 and 2006, and the related consolidated income
statements, consolidated statements of recognized income and expense, and
consolidated cash flow statements for each of the years in the three-year period
ended 31 December 2008, and our report dated 29 January 2009 expressed an
unqualified opinion on those consolidated financial statements.
9
KPMG
Audit Plc
Chartered
Accountants
8
Salisbury Square
London
EC4Y
8BB
29
January 2009
ITEM
16 – RESERVED
ITEM
16A – AUDIT COMMITTEE FINANCIAL EXPERT
The
information set forth in the first paragraph under the heading “Directors’
Report—Business Organisation and Corporate Governance—Operation of Board
Committees—Audit Committee” on pages 89 and 90 and “—Board Committee Membership”
(consisting of tabular data) on page 88, in each case of the Company’s “Annual
Report and Form 20-F Information 2008” included as exhibit 15.1 to this Form
20-F dated March 17, 2009 is incorporated by reference.
ITEM
16B – CODE OF ETHICS
The
information set forth under the heading “Directors’ Report—Business Organisation
and Corporate Governance—Principal UK and US Governance Requirements—Code of
Conduct” on page 93 of the Company’s “Annual Report and Form 20-F Information
2008” included as exhibit 15.1 to this Form 20-F dated March 17, 2009 is
incorporated by reference.
The
AstraZeneca Code of Conduct is available at www.astrazeneca.com.
ITEM
16C – PRINCIPAL ACCOUNTANT FEES AND SERVICES
The
information (including tabular data) set forth under the heading “Financial
Statements—Notes to the Financial Statements—Note 27—Statutory and Other
Information” on page 163 and “Directors’ Report—Business Organisation and
Corporate Governance—Operation of Board Committees—Audit Committee” on pages 89
and 90, in each case of the Company’s “Annual Report and Form 20-F Information
2008” included as exhibit 15.1 to this Form 20-F dated March 17, 2009 is
incorporated by reference.
ITEM
16D – EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES
Not
applicable.
ITEM
16E – PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED
PURCHASERS
Period
(a)
Total number of Shares (or units) purchased(1)
(b)
Average Price Paid per Share (or Units)
(c)
Total Number of Shares (or Units) Purchased as Part of Publicly Announced
Plans or Programs
(d)
Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May
Yet Be Purchased Under the Plans or Programs
Month
#1
Jan
1 - Jan 31
0
-
0
$1.00bn
Month
#2
Feb
1 - Feb 28
0
-
0
$1.00bn
Month
#3
Mar
1 - Mar 31
0
-
0
$1.00bn
10
Period
(a)
Total number of Shares (or units) purchased(1)
(b)
Average Price Paid per Share (or Units)
(c)
Total Number of Shares (or Units) Purchased as Part of Publicly Announced
Plans or Programs
(d)
Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May
Yet Be Purchased Under the Plans or Programs
Month
# 4
Apr
1 - Apr 30
0
-
0
$1.00bn
Month
#5
May
1 - May 31
1,000,000
£20.95
1,000,000
$0.96bn
Month
#6
Jun
1 - Jun 30
3,980,000
£21.21
3,980,000
$0.79bn
Month
#7
Jul
1 - Jul 31
0
-
0
$0.79bn
Month
#8
Aug
1 - Aug 31
3,265,640
£26.02
3,265,640
$0.63bn
Month
#9
Sep
1 - Sep 30
5,153,042
£25.35
5,153,042
$0.40bn
Month
#10
Oct
1 - Oct 31
199,258
£25.08
199,258
$0.39bn
Month
#11
Nov
1 - Nov 30
0
-
0
$0.39bn
Month
#12
Dec
1 - Dec 31
0
-
0
$0.39bn
Total
13,597,940
£23.97
13,597,940
$0.39bn
(1) On 31 January 2008, the Company
announced that it expected to undertake share repurchases in the region of $1
billion in 2008, subject to business needs. On 30 October 2008, the
Company announced that no further share repurchases would take place in 2008 in
order to maintain the flexibility to invest in the business. The Company has
announced that it does not plan to make any share repurchases in 2009.
ITEM
16F – CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT
Not
applicable.
ITEM
16G – CORPORATE GOVERNANCE
AstraZeneca
PLC is a public limited company incorporated in England and Wales, listed on the
London Stock Exchange and is subject to the authority of the Financial Services
Authority in the UK. As a result, it follows the UK Combined Code on
Corporate Governance (the “Combined Code”) in respect of its corporate
governance practices. The Company has ADRs listed on the New York
Stock Exchange (“NYSE”) and, under the NYSE Corporate Governance Standards (the
“NYSE Standards”) applicable to listed companies, as a foreign private issuer,
the Company is permitted to follow the corporate governance practice of its home
country in lieu of certain provisions of the NYSE Standards.
A summary
of the significant ways in which the Company’s corporate governance practices
differ from those followed by US domestic companies under the NYSE Standards is
set forth below.
NYSE
Standards
AstraZeneca
Corporate Governance Practice
1.
Under
the NYSE Standards, the audit committee is to be directly responsible for
the appointment, compensation, retention and oversight of a company’s
external auditor, unless there is a conflicting requirement under the home
country laws of the company.
Under
the Combined Code, a company’s external auditors are appointed by its
shareholders. As a result, the Company’s audit committee is
responsible for making recommendations to the Board of Directors, for the
Board of Directors to propose to the Company’s shareholders in general
meeting, in relation to the appointment, re-appointment, terms of
compensation and removal of the external
auditors.
11
2.
Under
the NYSE Standards, the nominating/corporate governance committee and
compensation committee are to be composed entirely of independent
directors.
Under
the Combined Code, a majority of the members of these committees should be
independent directors. Accordingly, a majority of the members
of the Company’s Nomination and Governance Committee are independent
directors.
The
Company’s Remuneration Committee includes at least four members, including
the chairman of the Company’s Board of Directors, with the remainder all
being independent directors (under the Combined Code, a determination as
to the independence of the chairman of the Company’s Board of Directors
may be made only upon appointment as chairman).
3.
Under
the NYSE Standards, the Compensation Committee is to make recommendations
to the Company’s Board of Directors with respect to non-CEO executive
officer compensation and certain other compensation plans which are
subject to Board approval.
In
compliance with the Combined Code, the Company’s Remuneration Committee
determines the Company’s global remuneration frameworks and principles,
approves individual salary decisions and related matters for members of
the Company’s Board of Directors, SET and the Company Secretary, and
reviews annual bonus payments for all executives reporting directly to SET
members. While the Remuneration Committee does not make initial
recommendations to the Board of Directors in this respect, it does report
to the Board of Directors on these matters.
4.
Under
the NYSE Standards, shareholders are entitled to vote on all equity
compensation plans and material revisions thereto, with certain limited
exemptions.
Under
the listing rules of the UK Listing Authority (the “UKLA Rules”), with
which the Company complies, shareholder approval is required to be
obtained by the Company for the adoption of equity compensation plans
which are either long-term incentive schemes in which directors of the
Company can participate or schemes which may involve the issue of new
shares. Under the UKLA Rules, these plans may not be changed to
the benefit of the plan participants unless shareholder approval is
obtained (with certain minor exceptions, for example, to benefit the
administration of the plan or to take account of tax
benefits). The UKLA Rules in respect of shareholder approval
regarding equity compensation plans, or any material revision thereto, may
differ from the NYSE Standards.
The
information set forth in the final paragraph under the heading “Directors’
Report—Business Organisation and Corporate Governance—Principal UK and US
Governance Requirements—US Corporate Governance Requirements” on page 93 and
“—UK Corporate Governance Requirements” on pages 91 and 92, in each case of the
Company’s “Annual Report and Form 20-F Information 2008” included as exhibit
15.1 to this Form 20-F dated March 17, 2009 is incorporated by
reference.
12
PART
III
ITEM
17 - FINANCIAL STATEMENTS
The
Company has responded to Item 18 in lieu of this item.
ITEM
18 - FINANCIAL STATEMENTS
The
information set forth in Exhibit 15.2 hereto “Report of Independent Registered
Public Accounting Firm to the members of AstraZeneca PLC by KPMG Audit Plc” is
incorporated in this section by reference. The information (including
graphs and tabular data) set forth under the headings “Financial Statements” on
pages 100 to 163 (including the information set forth under the subheading
“Notes to the Financial Statements” on pages 108 to 163) and “Principal
Subsidiaries” on page 164, in each case of the Company’s “Annual Report and Form
20-F Information 2008” included as exhibit 15.1 to this Form 20-F dated March
17, 2009 is incorporated by reference.
The
information set out in the above-referenced financial statements does not
constitute the company’s statutory accounts under the U.K. Companies Acts for
the years ended December 31, 2008, 2007 or 2006. Those accounts have been
reported on by the company’s auditors; their reports were unqualified and did
not contain a statement under section 237(2) or (3) of the Companies Act
1985. The accounts for 2007 and 2006 have been delivered to the registrar
of companies and those for 2008 will be delivered in due course.
13
ITEM
19 – EXHIBITS
1.1
Memorandum
and Articles of Association.(1)
4.1
Master
Restructuring Agreement dated as of June 19, 1998 between Astra AB, Merck
& Co., Inc., Astra Merck Inc., Astra USA, Inc., KB USA, L.P., Astra
Merck Enterprises, Inc., KBI Sub Inc., Merck Holdings, Inc. and Astra
Pharmaceuticals, L.P.(2)
4.2
Agreement
for Service between AstraZeneca PLC and Simon Lowth, dated September 27,
2007.(3)
4.3
Agreement
for Service between AstraZeneca PLC and John Patterson dated February 14,
2005 (effective as of January 1, 2005).(4)
4.4
Agreement
for Service between AstraZeneca PLC and David R. Brennan dated December
16, 2005 (effective as of January 1, 2006).(4)
4.5
Form
of Deed of Indemnity for Directors.(5)
7.1
Statement
explaining calculation of ratio of earnings to fixed
charges.
8.1
List
of subsidiaries.
12.1
Certification
of David R. Brennan filed pursuant to 17 CFR
240.13a-14(a).
12.2
Certification
of Simon Lowth filed pursuant to 17 CFR 240.13a-14(a).
13.1
Certification
of David R. Brennan and Simon Lowth furnished pursuant to 17 CFR
240.13a-14(b) and 18 U.S.C. 1350.
15.1
Annual
Report and 20-F Information.(6)
15.2
Report
of Independent Registered Public Accounting Firm to the members of
AstraZeneca PLC by KPMG Audit Plc.
15.3
Consent
of KPMG Audit Plc, independent registered public accounting
firm.
15.4
Consent
of IMS Health.
15.5
Consent
of Bureau Veritas HS&E Ltd.
(1)
Incorporated
into this Form 20-F by reference to AstraZeneca PLC’s Form 20-F filed
March 21, 2005 (File
No.
001-11960).
(2)
Incorporated
into this Form 20-F by reference to AstraZeneca PLC’s Form 20-F filed
March 25, 2003 (File
No.
001-11960).
(3)
Incorporated
into this Form 20-F by reference to AstraZeneca PLC’s Form 20-F filed
March 12, 2008 (File
No.
001-11960).
(4)
Incorporated
into this Form 20-F by reference to AstraZeneca PLC’s Form 20-F filed
March 23, 2006 (File
No.
001-11960).
(5)
Incorporated
into this Form 20-F by reference to AstraZeneca PLC’s Form 20-F filed
March 27, 2007 (File
No.
001-11960).
(6)
Certain
of the information included within exhibit 15.1, which
is provided pursuant to Rule 12b-
23(a) (3) of the Securities Exchange Act of 1934, as
amended, is incorporated by reference in this Form 20-F,
as specified elsewhere in this Form 20-F. With the exception of the
items and pages so specified, the Annual Report and Form 20-F
Information is not deemed to be filed as part of this Annual Report
on form 20-F.
14
SIGNATURE
The
registrant hereby certifies that it meets all of the requirements for filing on
Form 20-F and that it has duly caused and authorized the undersigned to sign
this annual report on its behalf.
AstraZeneca
PLC
By:
/s/
A C N Kemp
Name:
A C
N Kemp
Title:
Authorised
Signatory
London,
England
March 17,
2009
15
Exhibit
7.1
RATIO
OF EARNINGS TO FIXED CHARGES
Our
consolidated ratios of earnings to fixed charges calculated in accordance with
IFRS for the twelve month periods ended December 31, 2008, 2007, 2006, 2005 and
2004 are as follows:-
2008
2007
2006
2005
2004
IFRS
13.5
15.6
92.7
85.6
93.6
For the
purpose of computing these ratios, earnings consist of the income from
continuing ordinary activities before taxation of Group companies and income
received from companies owned 50% or less, plus fixed charges (excluding
capitalized interest). Fixed charges consist of interest (including capitalized
interest) on all indebtedness, amortization of debt discount and expense and
that portion of rental expense representative of the interest
factor.
At
December 31, 2008
Country
Percentage
of
voting
share
capital
held
Principal
activity
UK
AstraZeneca
UK Limited
England
100
(1)
Research
and development, manufacturing, marketing
AstraZeneca
Reinsurance Limited
England
100
Insurance
and reinsurance underwriting
AstraZeneca
Treasury Limited
England
100
Treasury
Continental
Europe
NV
AstraZeneca SA
Belgium
100
Manufacturing,
marketing
AstraZeneca
Dunkerque Production SCS
France
100
Manufacturing
AstraZeneca
SAS
France
100
Research,
manufacturing, marketing
AstraZeneca
GmbH
Germany
100
Development,
manufacturing, marketing
AstraZeneca
Holding GmbH
Germany
100
Manufacturing,
marketing
AstraZeneca
SpA
Italy
100
Manufacturing,
marketing
AstraZeneca
Farmaceutica Spain SA
Spain
100
Manufacturing,
marketing
AstraZeneca
AB
Sweden
100
Research
and development, manufacturing, marketing
AstraZeneca
BV
The
Netherlands
100
Marketing
The
Americas
AstraZeneca
Canada Inc.
Canada
100
Research,
manufacturing, marketing
IPR
Pharmaceuticals Inc.
Puerto
Rico
100
Development,
manufacturing, marketing
AstraZeneca
LP
US
99
Research
and development, manufacturing, marketing
AstraZeneca
Pharmaceuticals LP
US
100
Research
and development, manufacturing, marketing
Zeneca
Holdings Inc.
US
100
Manufacturing,
marketing
MedImmune,
Inc.
US
100
Research
and development, manufacturing, marketing
Asia,
Africa & Australasia
AstraZeneca
Pty Limited
Australia
100
Development,
manufacturing, marketing
AstraZeneca
KK
Japan
80
Manufacturing,
marketing
1) Shares held
directly.
The
companies and other entities listed above are those whose results or
financial position principally affected the figures shown in the Group
Financial Statements. A full list of subsidiaries, joint ventures and
associates will be annexed to the Company’s next annual return filed with
the Registrar of Companies. The country of registration or incorporation
is stated alongside each company. The accounting year ends of subsidiaries
and associates are 31 December, except for Aptium Oncology, Inc. which,
owing to local conditions and to avoid undue delay in the preparation of
the Financial Statements, is 30 November. AstraZeneca operates through 290
subsidiaries worldwide. The Group Financial Statements consolidate the
Financial Statements of the Company and its subsidiaries at 31 December
2007. Products are manufactured in 20 countries worldwide and are sold in
over 100 countries.
CERTIFICATION
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT 2002
I, David
R. Brennan, certify that:
1.
I
have reviewed this annual report on Form 20-F of AstraZeneca
PLC;
2.
Based
on my knowledge, this report does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
3.
Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the company
as of, and for, the periods presented in this
report;
4.
The
company’s other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and
have:
(a)
Designed
such disclosure controls and procedures, or caused such disclosure
controls
and procedures to be designed under our supervision, to ensure
that material information relating to the company, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being
prepared;
(b)
Designed
such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting
principles;
(c)
Evaluated
the effectiveness of the company’s disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by
this report based on such evaluation;
and
(d)
Disclosed
in this report any change in the company’s internal control over financial
reporting that occurred during the period covered by the annual report
that has materially affected, or is reasonably likely to materially
affect, the company’s internal control over financial reporting;
and
5.
The
company’s other certifying officer(s) and I have disclosed, based on our
most recent evaluation of internal control over financial reporting, to
the company’s auditors and the audit committee of the company’s board of
directors (or persons performing the equivalent
functions):
(a)
All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the company’s ability to record,
process, summarize and report financial information;
and
(b)
Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the company’s internal control
over financial reporting.
March
17, 2009
/s/
David R. Brennan
David
R. Brennan
Chief
Executive Officer, AstraZeneca PLC
CERTIFICATION
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT 2002
I, Simon
Lowth, certify that:
1.
I
have reviewed this annual report on Form 20-F of AstraZeneca
PLC;
2.
Based
on my knowledge, this report does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
3.
Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the company
as of, and for, the periods presented in this
report;
4.
The
company’s other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and
have:
(a)
Designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures
to be designed under our supervision, to ensure
that material information relating to the company, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being
prepared;
(b)
Designed
such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting
principles;
(c)
Evaluated
the effectiveness of the company’s disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by
this report based on such evaluation;
and
(d)
Disclosed
in this report any change in the company’s internal control over financial
reporting that occurred during the period covered by the annual report
that has materially affected, or is reasonably likely to materially
affect, the company’s internal control over financial reporting;
and
5.
The
company’s other certifying officer(s) and I have disclosed, based on our
most recent evaluation of internal control over financial reporting, to
the company’s auditors and the audit committee of the company’s board of
directors (or persons performing the equivalent
functions):
(a)
All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the company’s ability to record,
process, summarize and report financial information;
and
(b)
Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the company’s internal control
over financial reporting.
March
17, 2009
/s/
S. Lowth
S.
Lowth,
Chief
Financial Officer, AstraZeneca PLC
1.
the
Report fully complies with the requirements of Section 13(a) or 15(d) of
the Exchange Act; and
2.
the
information contained in the Report fairly presents, in all material
respects, the financial condition and results of operations of AstraZeneca
PLC.
March
17, 2009
/s/
David R. Brennan
David
R. Brennan
Chief
Executive Officer, AstraZeneca PLC
/s/
S. Lowth
S.
Lowth,
Chief
Financial Officer, AstraZeneca PLC
Exhibit
15.1
INTRODUCTION
2
AstraZeneca and our year in brief
2
Financial highlights
2
Chairman’s statement
4
Chief Executive Officer’s review
5
DIRECTORS’ REPORT
8
Introduction
8
Business environment
9
Strategy, goals and
performance measurement
12
> Measuring our performance
14
>
Reporting our performance –
Financial and Non-financial
15
Resources, skills and capabilities
16
> Medicines
16
> Research and development
17
> Development pipeline
at 29 January 2009
22
> Sales and marketing
25
> Intellectual property
26
> Supply and manufacturing
27
> People
28
Financial review
31
> Measuring performance
31
> Business background and
major events affecting 2008
32
>
Results of operations –
summary analysis of year
to 31 December 2008
33
> Financial position, including
cash flow and liquidity – 2008
34
> Restructuring and synergy costs
36
> Capitalisation and shareholder return
37
> Future prospects
37
> Results of operations –
summary analysis of year to
31 December 2007
38
> Financial position, including
cash flow and liquidity – 2007
40
> Financial risk management
41
> Critical accounting policies
and estimates
43
> Other accounting information
47
IMPORTANT INFORMATION
FOR READERS OF THIS REPORT
Cautionary statement regarding
forward-looking statements
The purpose of this Annual Report
and Form 20-F Information is to
provide information to the members
of the Company. In order, among
other things, to utilise the ‘safe
harbour’ provisions of the US
Private Securities Litigation
Reform Act 1995 and the UK
Companies Act 2006, we are
providing the following cautionary
statement: This Annual Report and
Form 20-F Information contains
certain forward-looking statements
with respect to the operations,
performance and financial
condition of the Group. Although
we
believe our expectations are based
on reasonable assumptions, any
forward-looking statements, by
their nature, involve risks and
uncertainties and may be
influenced by factors that could
cause actual outcomes
and results
to be materially different from those
predicted. The forward-looking
statements reflect knowledge and
information available at the date
of the preparation of this Annual
Report and Form 20-F Information
and the Company undertakes no
obligation to update these
forward-looking statements. We
identify the forward-looking
statements by using the words
‘anticipates’, ‘believes’,
‘expects’, ‘intends’ and similar
expressions in such statements.
Important factors that could cause
actual results to differ
materially from those contained in
forward-looking statements,
certain of which are beyond our
control, include, among other
things, those factors identified
in the Principal Risks and
Uncertainties section on pages 74
to 82 of this document. Nothing in
this Annual Report and Form 20-F
Information should be construed as
a profit forecast.
Inclusion of reported, constant
exchange rate and core financial
measures
Throughout the Directors’ Report
and in the Financial Highlights
section on page 2 and 3 the
following measures are referred to:
>
Reported performance. Reported
performance takes into account
all the factors (including
those which we cannot
influence, principally currency
exchange rates) that have
affected the results of our
business as reflected in our
Group Financial Statements
prepared in accordance with
International Financial
Reporting Standards as adopted
by the European Union and as
issued by the International
Accounting Standards Board.
>
Core financial measures. This
is a non-GAAP measure because
unlike reported performance it
cannot be derived directly from
the information in the Group’s
Financial Statements. This
measure is adjusted to exclude
certain significant items, such
as charges
INTRODUCTION
DIRECTORS’ REPORT
FINANCIAL STATEMENTS
REMUNERATION REPORT
ADDITIONAL
INFORMATION
1
Geographical review
48
> North America
48
> Rest of World
50
Therapy area review
53
> Cardiovascular
54
> Gastrointestinal
57
> Infection
59
> Neuroscience
61
> Oncology
64
> Respiratory and Inflammation
67
Other businesses
70
Environmental sustainability
71
In the global community
72
Risk
74
> Managing risk, principal risks
and uncertainties
74
> Principal risks and uncertainties
76
Business organisation and
Corporate governance
83
> Business organisation
83
> Board of Directors at
31 December 2008
84
> Chief Executive Officer,
delegation of authority
and Senior Executive Team
86
FINANCIAL STATEMENTS
98
Preparation of the
Financial Statements and Directors’ responsibilities
98
> Directors’ responsibility
statement pursuant to DTR 4
98
Directors’ responsibilities for,
and report on, internal control
over financial reporting
98
Auditor’s reports on the
Financial Statements and on internal
control over financial reporting
(Sarbanes-Oxley Act section 404)
99
Independent auditor’s
report to the members of AstraZeneca PLC (Group)
99
Consolidated income statement
for the year ended 31 December
100
Consolidated statement of
recognised income and expense
for the year ended 31 December
100
Consolidated balance sheet
at 31 December
101
Consolidated cash flow statement
for the year ended 31 December
102
Accounting policies
103
>Basis of accounting and preparation
of financial information
103
Notes to the Financial Statements
(Group)
108
1 Operating profit
108
2 Finance income and expense
108
3 Taxation
109
4 Earnings per $0.25
Ordinary Share
111
5 Segment information
111
6 Product revenue information
113
7 Property, plant and equipment