As
filed with the Securities and Exchange Commission on March 12, 2008
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
20-F
(Mark
One)
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o
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REGISTRATION
STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT
OF 1934
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OR
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x
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ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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For
the fiscal year ended December 31,
2007
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OR
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o
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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OR
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o
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SHELL
COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
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Date
of event requiring this shell company report
_____________
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For
the transition period from _____________ to
_____________
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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)
Securities
registered or to be registered pursuant to Section 12(b) of the
Act:
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Name
of each exchange on which registered
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American
Depositary Shares, each representing one Ordinary Share of 25¢
each
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The
New York Stock Exchange
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Ordinary
Shares of 25¢
each
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The
New York Stock Exchange*
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*
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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.
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Securities
registered or to be registered pursuant to Section 12(g) of the
Act:
None
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 12, 2008
was:
Ordinary
Shares of 25¢ each: 1,457,014,156
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):
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Large
accelerated filer x
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Accelerated
filer o
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Non-accelerated
filer o
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Indicate
by check mark which financial statement item the registrant has elected to
follow.
o Item 17
x 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).
(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.
Pursuant
to Rule 12b-23(a) of the Securities Exchange Act of 1934, as amended, the
information for the 2007 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 2007” included as exhibit 15.1 to this Form 20-F dated and
submitted on March 12, 2008.
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” on the
inside front cover, the information set forth under the headings “Trade marks”,
“Use of terms”, “Statements of dates”, “Statements of competitive position”,
“Statements of growth rates, sales and market data” and “AstraZeneca websites”
on the inside back cover and the information on pages 202 to 204, in each case
of the Company’s “Annual Report and Form 20-F Information 2007” included as
exhibit 15.1 to this Form 20-F dated March 12, 2008 is incorporated by
reference.
PART
I
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 set forth under the headings “Financial Highlights” on pages 2 and
3, “Financial Statements—Notes to the Financial Statements—Note 30—Share Capital
of Parent Company” (including tabular data) on page 176, “Financial
Statements—Group Financial Record” (including tabular data) on page 184 and the
first table that appears under “Additional Information—Shareholder Information”
on page 186, in each case of the Company’s “Annual Report and Form 20-F
Information 2007” included as exhibit 15.1 to this Form 20-F dated March 12,
2008 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.
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 “Additional
Information—Risk” on pages 193 to 199 of the Company’s “Annual Report and Form
20-F Information 2007” included as exhibit 15.1 to this Form 20-F dated March
12, 2008 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 200, “Directors’ Report—Our Resources, Skills and Capabilities—Supply and
Manufacturing—Supply capability” on page 34, “Directors’ Report—Financial
Review—Financial Position, Including Cash Flow and Liquidity—Property, plant and
equipment”, “—Cash flow” and “—Investments, divestments and capital
expenditure” on pages 81 to 83, “Directors’ Report—Financial
Review—Acquisition of MedImmune”, on pages 83 and 84, “Financial
Statements—Notes to the Financial Statements—Note 8—Property, Plant and
Equipment” on pages 131 and 132 and “Financial Statements—Notes to the Financial
Statements—Note 24—Acquisitions of Business Operations” on pages 145 to 148, in
each case of the Company’s “Annual Report and Form 20-F Information 2007”
included as exhibit 15.1 to this Form 20-F dated March 12, 2008 is incorporated
by reference.
B.
Business Overview
The
information set forth under the heading “AstraZeneca and our Year in Brief” on
page 1, the information (including graphs and tabular data) set forth under the
headings “Directors’ Report” on pages 8 to 76, “Financial Statements—Notes to
the Financial Statements—Note 6—Segment Information” on pages 128 to 129,
“Financial Statements—Notes to the Financial Statements—Note 7—Product Sales
Information” on page 130 and “Statements of competitive position” on the inside
back cover, in each case of the Company’s “Annual Report and Form 20-F
Information 2007” included as exhibit 15.1 to this Form 20-F dated March 12,
2008 is incorporated by reference.
On
February 27, 2008, the Company announced that its HORIZON III Phase II/III
head-to-head study of RECENTIN (cediranib, AZD2171) with chemotherapy versus
bevacizumab (Avastin) with chemotherapy in patients with first line metastatic
colorectal cancer (CRC) will be progressing directly into Phase III at 20mg.
Patients will also continue to be recruited at 20mg into the first line CRC
HORIZON II study of RECENTIN with chemotherapy versus chemotherapy
alone.
The
HORIZON Independent Data Monitoring Committee (IDMC) conducted a planned end of
Phase II (EOP II) review of efficacy and tolerability data from HORIZON I,
HORIZON II and HORIZON III. Data from HORIZON I, in second line colorectal
cancer, would not by itself have contributed to a positive EOP II decision.
However, when combined with a review of data from HORIZON II and III by the
IDMC, the IDMC confirmed the HORIZON programme in 1st line CRC could continue
and HORIZON II and III had met pre-defined EOP II criteria.
AstraZeneca
also announced that the National Cancer Institute of Canada Clinical Trials
Group (NCIC-CTG) has informed AstraZeneca that the BR24 Phase II/III study of
RECENTIN at 30mg in first line non-small cell lung cancer (NSCLC) will not
continue into Phase III following the planned end of Phase II efficacy and
tolerability analysis by the study’s Data Safety Monitoring Committee. Although
evidence of clinical activity was seen, there appeared to be an imbalance in
toxicity and therefore the study was considered not to have met the pre-defined
criteria for automatic continuation into Phase III.
AstraZeneca
is working in close collaboration with the NCIC-CTG to understand the BR24 data
further.
In
addition to colorectal and non-small cell lung cancer, the RECENTIN development
programme includes trials in recurrent glioblastoma and a number of signal
search studies in other tumours.
C.
Organizational Structure
The
information set forth under the headings “Directors’ Report—Corporate Governance
and Managing Risk—Corporate Governance: Other Matters—Subsidiaries
and principal activities” on page 45 and “Financial Statements—Principal
Subsidiaries” on page 177, in each case of the Company’s “Annual Report and Form
20-F Information 2007” included as exhibit 15.1 to this Form 20-F dated March
12, 2008 is incorporated by reference.
D.
Property, Plants and Equipment
The
information (including tabular data) set forth under the headings “Directors’
Report—Our Resources, Skills and Capabilities—Main Facilities” on page 37,
“Directors’ Report—Financial Review—Financial Position, including Cash Flow and
Liquidity—Property, plant and equipment” on page 81, “Additional
Information—Risk—Industry/Economic Environment Risks—Environmental/occupational
health and safety liabilities” on page 196, “Financial Statements—Notes to the
Financial Statements—Note 27—Commitments and contingent
liabilities—Environmental costs and liabilities” on pages 160 to 161 and
“Financial Statements—Notes to the Financial Statements—Note 8—Property, Plant
and Equipment” on pages 131 to 132, in each case of the Company’s “Annual Report
and Form 20-F Information 2007” included as exhibit 15.1 to this Form 20-F dated
March 12, 2008 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—Geographical Review—North America—US—Medicare Part D
prescription drug benefit” on page 70, “Directors’ Report—Our Resources, Skills
and Capabilities—Sales and Marketing—Price regulation” on pages 31 to 32,
“Directors Report—Geographical Review” on pages 69 to 72, “Directors’
Report—Financial Review” on pages 77 to 96, “Directors’ Report—Our Resources,
Skills and Capabilities—Research and Development” on pages 23 to 26, “Financial
Statements—Notes to the Financial Statements—Note 15—Interest Bearing Loans and
Borrowings” on page 135, “Financial Statements—Notes to the Financial
Statements—Note 16—Financial Risk Management Objectives and Policies” on pages
136 to 137, “Financial Statements—Notes to the Financial Statements—Note
17—Financial Instruments” on pages 138 to 141, “Financial Statements—Notes to
the Financial Statements—Note 21—Reserves—Nature and purpose of other reserves”
on page 145 and “Financial Statements—Notes to the Financial Statements—Note
27—Commitments and Contingent Liabilities” on pages 158 to 174, in each case of
the Company’s “Annual Report and Form 20-F Information 2007” included as exhibit
15.1 to this Form 20-F dated March 12, 2008 is incorporated by
reference.
On
February 28, 2008, the Company announced that, under the provisions of the
agreements relating to the restructuring of the AstraZeneca and Merck & Co.
joint venture in the United States, AstraZeneca has been informed that Merck has
elected not to exercise the First Option related to the relinquishment of
Merck’s rights over the products not covered by the Partial Retirement, other
than Nexium and Prilosec. As a result of this decision, contingent payments will
continue on the products Atacand, Lexxel, Plendil and Entocort until at least
2010, at which time AstraZeneca may exercise this option at the 2008 Appraised
Value of approximately $650 million. The Appraised Value also includes rights to
certain products that are still in clinical development (AZD6140, AZD3355,
AZD0328 and AZD2327). AstraZeneca made contingent payments in respect of the
products included in the First Option of $69 million in 2007.
Other
aspects of the scheduled termination arrangements will proceed as
follows:
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·
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The
Partial Retirement of Merck’s limited partnership interest, under which
Merck’s rights in respect of certain products will end. The products
covered by the Partial Retirement include Toprol-XL, Pulmicort, Rhinocort
and Symbicort. AstraZeneca made contingent payments in respect of these
products amounting to $182 million in 2007. AstraZeneca will pay Merck
approximately $4.27 billion in respect of the Partial
Retirement.
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·
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A
true-up of the Advance Payment, which was triggered at the time of the
merger between Astra and Zeneca, under which Merck relinquished all
rights, including contingent payment on future sales, to potential Astra
products with no existing or pending US patents at the time of the merger,
amounting to a payment by Merck to AstraZeneca of approximately $0.24
billion, inclusive of interest.
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·
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Settlement
of the loan note receivable by AstraZeneca from Merck, in the amount of
$1.4 billion inclusive of accrued
interest.
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The
combined effects of these three items will be a net cash outflow from
AstraZeneca to Merck of approximately $2.63 billion upon settlement during the
first quarter 2008.
Further
details on the accounting treatment of these events from the Company’s
perspective will be provided in conjunction with the Q1 2008 earnings
announcement on April 24, 2008.
ITEM
6 - DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A.
Directors and Senior Management
The
information set forth under the headings “Directors’ Report — Board of Directors
at 31 December 2007” on pages 18 and 19 and “Remuneration Report—Directors’
Remuneration report—Executive Directors’ and Senior Executive Team’s
Remuneration and Terms of Employment—Policy on external appointments and
retention of fees” on page 105, in each case of the Company’s “Annual Report and
Form 20-F Information 2007” included as exhibit 15.1 to this Form 20-F dated
March 12, 2008 is incorporated by reference.
On
February 18, 2008, the Company announced the appointment of Jean-Philippe
Courtois to the Board of Directors as a Non-Executive Director with immediate
effect. Jean-Philippe Courtois, age 47, is President of Microsoft International
and a Senior Vice-President of Microsoft Corporation, having joined Microsoft in
1984. He has previously served as Chief Executive Officer and
President of Microsoft Europe, Middle East and Africa.
B.
Compensation
The
information set forth under the headings “Remuneration Report” on pages 98 to
114, “Financial Statements—Notes to the Financial Statements—Note
25—Post-Retirement Benefits” on pages 148 to 153, “Financial Statements—Notes to
the Financial Statements—Note 26—Employee Costs and Share Option Plans for
Employees” on pages 153 to 158 and “Financial Statements—Notes to the Financial
Statements—Note 29—Statutory and Other Information—Key management personnel
compensation” on page 175, in each case of the Company’s “Annual Report and Form
20-F Information 2007” included as exhibit 15.1 to this Form 20-F dated March
12, 2008 is incorporated by reference.
C.
Board Practices
The
information set forth under the headings “Directors’ Report—Business
Organisation—Board of Directors at 31 December 2007” on pages 18 to 19,
“Directors’ Report—Corporate Governance and Managing Risk—Corporate Governance:
Operation of the Board of Directors” and “—Corporate Governance and Managing
Risk—Corporate Governance: Operation of Board Committees” on pages 38
to 42, “—Corporate Governance and Managing Risk—Corporate Governance: Principal
UK and US Governance Requirements—The US Sarbanes-Oxley Act of 2002” and “—The
New York Stock Exchange” each on page 43, “Business Report—Business
Organisation—Chief Executive Officer and Delegation of Authority” and
“—Senior Executive Team” each on page 20, and “Directors’ Remuneration
Report—Executive Director’s and Senior Executive Team’s Remuneration and Terms
of Employment—Details of Executive Directors’ service contracts at 31 December
2007” (consisting of tabular data), “—Service contracts” and “—Non-Executive
Directors”, each on page 105, in each case of the Company’s “Annual Report and
Form 20-F Information 2007” included as exhibit 15.1 to this Form 20-F dated
March 12, 2008 is incorporated by reference.
D.
Employees
The
information set forth under the headings “Directors’ Report—Our Resources,
Skills and Capabilities—People—Communication and dialogue” and “—Employee
relations”, each on page 36 and “Financial Statements—Notes to the Financial
Statements—Note 26—Employee Costs and Share Option Plans for Employees”
(including the tabular data) on pages 153 to 158, in each case of the Company’s
“Annual Report and Form 20-F Information 2007” included as exhibit 15.1 to this
Form 20-F dated March 12, 2008 is incorporated by reference.
E.
Share Ownership
The
information set forth under the headings “Financial Statements—Notes to the
Financial Statements—Note 26—Employee Costs and Share Option Plans for
Employees” on pages 153 to 158, “Remuneration Report—Directors’ Remuneration
Report—Variable Remuneration” (including tabular data) on pages 102 to 105,
“Remuneration Report—Directors’ Remuneration Report—Directors’ Interests in
Shares” on pages 110 to 112, “Remuneration Report—Directors’ Remuneration
Report—Share Options” on page 113, “—Directors’ Remuneration Report—Gains by
Directors on Exercise of Share Options” on page 114, and “Additional
Information—Shareholder Information—Major Shareholdings—Title of class” and
“—Options to Purchase Securities from Registrant or Subsidiaries” (consisting of
tabular data and related text), both on page 188, in each case of the Company’s
“Annual Report and Form 20-F Information 2007” included as exhibit 15.1 to this
Form 20-F dated March 12, 2008 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 187 to 188 of the Company’s “Annual
Report and Form 20-F Information 2007” included as exhibit 15.1 to this Form
20-F dated March 12, 2008 is incorporated by reference.
B.
Related Party Transactions
The
information set forth under the headings “Financial Statements—Notes to the
Financial Statements—Note 29—Statutory and Other Information—Related party
transactions” on page 175 and “Additional Information—Shareholder
Information—Related Party Transactions” on page 188, in each case of the
Company’s “Annual Report and Form 20-F Information 2007” included as exhibit
15.1 to this Form 20-F dated March 12, 2008 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 84, “Directors’ Report—Corporate
Governance and Managing Risk—Corporate Governance: Other Matters—Returns to
shareholders” on pages 45 to 46, “Financial Statements” on pages 118 to 176
(including the information set forth under the subheading “Notes to the
Financial Statements”), “Financial Statements—Principal Subsidiaries” on page
177, “Financial Statements—Group Financial Record” on page 184, and “Additional
Information—Shareholder Information” on pages 186 to 192, in each case of the
Company’s “Annual Report and Form 20-F Information 2007” included as exhibit
15.1 to this Form 20-F dated March 12, 2008 is incorporated by
reference.
B. Significant
Changes
Since the
publication of the Company’s Annual Report and Form 20-F Information 2007, the
Company has become aware of certain developments with respect to currently
pending litigation involving the Company and/or its affiliates, as described in
more detail below.
Average Wholesale Price
Class Action Litigation
A verdict
was reached in February, 2008 in the Montgomery County Circuit Court awarding
$40 million in compensatory damages and $175 million in punitive damages for
alleged false and misleading reporting of prices for drugs reimbursed by the
Alabama State Medicaid Agency in the US.
The
Company was among 73 pharmaceutical manufacturers named in a lawsuit filed in
2005 by the Alabama Attorney General, alleging that misleading and false
reported prices had caused Alabama Medicaid to reimburse pharmacists too much
money on prescriptions filed for Medicaid patients.
The
Company considers the lawsuit to be legally and factually unfounded, and
believes that serious errors occurred during the proceedings and that the
verdict should not be upheld. The Company believes that it has fully
complied with the law, government guidelines and contracts that govern Medicaid
pricing.
The
Company announced on February 22, 2008 that it intends to seek reconsideration
or reversal of the verdict through appeal, in which it is confident that it will
prevail and so no provision has been made for these awards.
The
information set forth under the heading “Financial Statements—Notes to the
Financial Statements—Commitments and Contingent Liabilities—Average Wholesale
Price Class Action Litigation” at page 171 of the Company’s
“Annual Report and Form 20-F Information 2007” included as exhibit 15.1 to this
Form 20-F dated March 12, 2008 is incorporated by reference.
Patent Litigation
(Seroquel)
On March
12, 2008, the Company announced that a trial date has been set for patent
litigation in the US District Court for the District of New Jersey against Teva
Pharmaceutical Industries Ltd. (‘Teva’) and Sandoz, Inc. (‘Sandoz’) alleging
infringement of AstraZeneca’s patent as a result of Teva’s and Sandoz’s filings
of Abbreviated New Drug Applications (‘ANDAs’). The ANDAs seek approval to
market generic versions of Seroquel (quetiapine fumarate tablets) in the US
before Seroquel’s patent expires in 2011. The US District Court for
the District of New Jersey has set a date for trial beginning on 11 August
2008.
The
information set forth under the heading “Financial Statements—Notes to the Financial
Statements—Commitments and Contingent
Liabilities—Seroquel (quetiapine
fumarate)—Patent Litigation” at pages 168 and 169 of the Company’s “Annual Report and Form 20-F Information
2007” included as
exhibit 15.1 to this Form
20-F dated March 12, 2008
is incorporated by
reference.
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 186 of the Company’s
“Annual Report and Form 20-F Information 2007” included as exhibit 15.1 to this
Form 20-F dated March 12, 2008 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:
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·
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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;
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·
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for
shares listed on the Stockholm Stock Exchange (‘SSE’) the high and low
closing sales prices are as stated in the Official
List;
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·
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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).
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AstraZeneca
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High
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|
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Low
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|
|
High
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|
|
Low
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|
|
High
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Low
|
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|
|
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|
|
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|
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2007
– Quarter 4
|
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2,606
|
|
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|
2,090
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|
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|
52.97 |
|
|
|
42.21 |
|
|
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343.5 |
|
|
|
271.0 |
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2007
– Quarter 3
|
|
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2,793
|
|
|
|
2,200
|
|
|
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56.60 |
|
|
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44.62 |
|
|
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379.5 |
|
|
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310.5 |
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2007
|
|
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2,991
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|
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|
2,090
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|
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59.47 |
|
|
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42.21 |
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|
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415.5 |
|
|
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271.0 |
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2006
|
|
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3,529
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|
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2,574
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|
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66.37 |
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|
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45.12 |
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484.0 |
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352.5 |
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2005
|
|
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2,837
|
|
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1,861 |
|
|
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49.50 |
|
|
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34.72 |
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392.0 |
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|
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243.0 |
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2004
|
|
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2,749
|
|
|
|
1,863 |
|
|
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50.85 |
|
|
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35.88 |
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374.0 |
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|
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237.5 |
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2003
|
|
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2,868
|
|
|
|
1,820 |
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|
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49.47 |
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29.98 |
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382.0 |
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245.0 |
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(1)
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Principally
held in bearer form.
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B.
Plan of Distribution
Not
applicable.
C.
Markets
The
information set forth under the heading “Additional Information—Shareholder
Information” on page 186 of the Company’s “Annual Report and Form 20-F
Information 2007” included as exhibit 15.1 to this Form 20-F dated March 12,
2008 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 200 of the Company’s
“Annual Report and Form 20-F Information 2007” included as exhibit 15.1 to this
Form 20-F dated March 12, 2008 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 190 of the Company’s “Annual Report and Form 20-F Information 2007”
included as exhibit 15.1 to this Form 20-F dated March 12, 2008 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 189 to 190 of the Company’s “Annual Report and Form 20-F Information 2007”
included as exhibit 15.1 to this Form 20-F dated March 12, 2008 is incorporated
by reference.
F.
Dividends and Paying Agents
Not
applicable.
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 189 of the Company’s “Annual Report
and Form 20-F Information 2007” included as exhibit 15.1 to this Form 20-F dated
March 12, 2008 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 Policies” on pages
85 to 86, “—Financial Review—Capitalisation and Shareholder Return—Sensitivity
analysis—31 December 2007” and “—Financial Review—Capitalisation and Shareholder
Return—Sensitivity analysis—31 December 2006”, both on page 85, in each case of
the Company’s “Annual Report and Form 20-F Information 2007” included as exhibit
15.1 to this Form 20-F dated March 12, 2008 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—Corporate Governance
and Managing Risk—Corporate Governance: Operation of Board Committees—Audit
Committee” on page 41 (the last three paragraphs of the “Audit Committee”
section only), “—Corporate Governance: Principal UK and US Governance
Requirements—Internal Controls, Risk Management and Turnbull Report Guidance” on
pages 42 to 43 and “Financial Statements—Directors’ Responsibilities for, and
Report on, Internal Control over Financial Reporting” on page 116, in each case
of the Company’s “Annual Report and Form 20-F Information 2007” included as
exhibit 15.1 to this Form 20-F dated March 12, 2008 is incorporated by
reference.
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 116 of the
Company’s “Annual Report and Form 20-F Information 2007” included as exhibit
15.1 to this Form 20-F dated March 12, 2008, 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 December 31, 2007, 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 December 31, 2007, 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 December 31, 2007, 2006 and 2005, 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 December 31, 2007, and our report dated January 31, 2008 expressed an
unqualified opinion on those consolidated financial statements.
KPMG Audit
Plc
Chartered
Accountants
8
Salisbury Square
London
EC4Y
8BB
January
31, 2008
ITEM
16 – RESERVED
ITEM
16A – AUDIT COMMITTEE FINANCIAL EXPERT
The
information set forth in the first paragraph under the heading “Directors’
Report—Corporate Governance and Managing Risk—Corporate Governance: Operation of
Board Committees—Audit Committee” on pages 39 and 40 and “—Board Committee
Membership” (consisting of tabular data) at page 41, in each case of the
Company’s “Annual Report and Form 20-F Information 2007” included as exhibit
15.1 to this Form 20-F dated March 12, 2008 is incorporated by
reference.
ITEM
16B – CODE OF ETHICS
The
information set forth under the heading “Directors’ Report— Corporate Governance
and Managing Risk—Corporate Governance: Principal UK and US Governance
Requirements—Code of Conduct” on page 44 of the Company’s “Annual Report and
Form 20-F Information 2007” included as exhibit 15.1 to this Form 20-F dated
March 12, 2008 is incorporated by reference.
The
AstraZeneca Code of Conduct and the Finance Code of Conduct are 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 29—Statutory and Other
Information” on page 175 and “Directors’ Report—Corporate Governance and
Managing Risk—Corporate Governance: Operation of Board Committees—Audit
Committee” on page 40, in each case of the Company’s “Annual Report and Form
20-F Information 2007” included as exhibit 15.1 to this Form 20-F dated March
12, 2008 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
|
|
|
(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 |
|
|
|
0 |
|
|
$
|
4.17bn |
|
|
Month
#2
Feb
1 - Feb 28
|
|
|
7,058,572 |
|
|
£
|
29.19 |
|
|
|
7,058,572 |
|
|
$
|
3.76bn |
|
|
Month
#3
Mar
1 - Mar 31
|
|
|
14,058,731 |
|
|
£
|
28.28 |
|
|
|
14,058,731 |
|
|
$
|
2.99bn |
|
|
Month
# 4
Apr
1 - Apr 30
|
|
|
8,760,501 |
|
|
£
|
27.86 |
|
|
|
8,760,501 |
|
|
$
|
2.50bn |
|
|
|
|
(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
#5
May
1 - May 31
|
|
|
4,950,000 |
|
|
£
|
26.96 |
|
|
|
4,950,000 |
|
|
$
|
2.23bn |
|
|
Month
#6
Jun
1 - Jun 30
|
|
|
4,204,000 |
|
|
£
|
26.22 |
|
|
|
4,204,000 |
|
|
$
|
2.01bn |
|
|
Month
#7
Jul
1 - Jul 31
|
|
|
5,715,137 |
|
|
£
|
26.56 |
|
|
|
5,715,137 |
|
|
$
|
1.70bn |
|
|
Month
#8
Aug
1 - Aug 31
|
|
|
9,419,812 |
|
|
£
|
24.17 |
|
|
|
9,419,812 |
|
|
$
|
1.24bn |
|
|
Month
#9
Sep
1 - Sep 30
|
|
|
7,446,255 |
|
|
£
|
23.99 |
|
|
|
7,446,255 |
|
|
$
|
0.88bn |
|
|
Month
#10
Oct
1 - Oct 31
|
|
|
5,303,369 |
|
|
£
|
24.90 |
|
|
|
5,303,369 |
|
|
$
|
0.60bn |
|
|
Month
#11
Nov
1 - Nov 30
|
|
|
9,575,000 |
|
|
£
|
22.16 |
|
|
|
9,575,000 |
|
|
$
|
0.16bn |
|
|
Month
#12
Dec
1 - Dec 31
|
|
|
3,436,000 |
|
|
£
|
22.84 |
|
|
|
3,436,000 |
|
|
$
|
0.00bn |
|
|
Total
|
|
|
79,927,377 |
|
|
£
|
25.77 |
|
|
|
79,927,377 |
|
|
$
|
0.00bn |
|
(1) On
February 1, 2007, the Company announced that the Board had targeted share
repurchases (net of shares issued) of $4 billion for 2007. On January
31, 2008, the Company announced that share repurchases for the full year
amounted to $4.17 billion.
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 118 to 176 (including the information set forth under the subheading
“Notes to the Financial Statements” on pages 124 to 176) and “Principal
Subsidiaries” on page 177, in each case of the Company’s “Annual Report and Form
20-F Information 2007” included as exhibit 15.1 to this Form 20-F dated March
12, 2008 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, 2007, 2006 or 2005. 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 2006 and 2005 have been delivered to the Registrar
of Companies and those for 2007 will be delivered in due course.
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.
|
| |
|
|
4.3
|
Agreement
for Service between AstraZeneca PLC and John Patterson dated February 14,
2005 (effective as of January 1, 2005).(3)
|
| |
|
|
4.4
|
Agreement
for Service between AstraZeneca PLC and David R. Brennan dated December
16, 2005 (effective as of January 1, 2006).(3)
|
| |
|
|
4.6
|
Form
of Deed of Indemnity for Directors.(4)
|
| |
|
|
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.(5)
|
| |
|
|
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 23,
2006 (File No.
001-11960).
(4)
Incorporated
into this Form 20-F by reference to AstraZeneca PLC’s Form 20-F filed March 27,
2007 (File No.
001-11960).
(5)
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.
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/
J W Hoskins
|
|
|
|
Name:
|
J W
Hoskins
|
|
|
|
Title:
|
Authorised
Signatory
|
|
London,
England
March 12,
2008
13