UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
20-F
(Mark
One)
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REGISTRATION
STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT
OF 1934
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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, 2009
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OR
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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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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 _____________
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 5000
Facsimile
number: +44 20 7304 5196
(Name,
Telephone, E-Mail or Facsimile number and Address of Company Contact
Person)
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)
Indicate
the number of outstanding shares of each of the issuer’s classes of capital or
common stock as of the close of the period covered by the annual
report.
The
number of outstanding shares of each class of stock of AstraZeneca PLC as of
December 31, 2009 was:
Ordinary
Shares of 25¢ each: 1,450,958,562
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.
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.
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.
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files).*
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated 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 basis of accounting the registrant has used to prepare the
financial statements included in this filing:
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U.S.
GAAP o
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International
Financial Reporting Standards as issued by the International Accounting
Standards Board x
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Other
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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.
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.
*
This requirement does not apply to the registrant until its fiscal year ending
December 31, 2011.
Pursuant
to Rule 12b-23(a) of the Securities Exchange Act of 1934, as amended, the
information for the 2009 Form 20-F of AstraZeneca PLC (“AstraZeneca” or the
“Company”) set out below is being incorporated by reference from the Company’s
“Annual Report and Form 20-F Information 2009” included as exhibit 15.1 to this
Form 20-F dated and submitted on March 25, 2010.
References
below to major headings include all information under such major headings,
including subheadings, unless such reference is 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 performance, core financial measures and constant exchange rate
growth rates”, “Statements of competitive position, growth rates and sales”,
“AstraZeneca websites”, “External/third party websites”, “Definitions”, “Use of
terms”, “Statements of dates” and “Figures” on the inside front cover, the
paragraph regarding trade marks of the AstraZeneca group on the inside back
cover, “Cross-reference to Form 20-F” on page 205 and “Glossary” on pages 206 to
207, in each case of the Company’s “Annual Report and Form 20-F Information
2009” included as exhibit 15.1 to this Form 20-F dated March 25, 2010 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
“Financial Statements—Notes to the Financial Statements—Note 20—Share capital of
the Company” on pages 153 and 154, “Group Financial Record” on page 193 and the
first table that appears under “Additional Information—Shareholder Information”
on page 199, in each case of the Company’s “Annual Report and Form 20-F
Information 2009” included as exhibit 15.1 to this Form 20-F dated March 25,
2010 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 as issued by the International Accounting Standards Board, included in
the Company’s “Annual Report and Form 20-F Information 2009” included as exhibit
15.1 to this Form 20-F dated March 25, 2010.
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—Corporate Governance—Risk—Principal risks and uncertainties” on pages 80
to 86 of the Company’s “Annual Report and Form 20-F Information 2009” included
as exhibit 15.1 to this Form 20-F dated March 25, 2010 is incorporated by
reference.
On March
23, 2010, the US healthcare reform bill was signed into law by President
Obama. For further discussion as to the proposed US healthcare reforms,
please see the information set forth under the heading “—Principal risks and
uncertainties” on the pages referenced above of the Company’s “Annual Report and
Form 20-F Information 2009”.
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 204, “Directors’ Report—Performance—Resources, Skills and Capabilities—Our
resources” on pages 25 and 32, “Directors’ Report—Reviews—Financial
Review—Financial position, including cash flow and liquidity – 2009—Property,
plant and equipment” and “—Cash flow” on pages 39 and 41, respectively,
“Directors’ Report—Reviews—Financial Review—Financial position, including cash
flow and liquidity – 2008—Property, plant and equipment”, “—Cash flow” and
“—Investments, divestments and capital expenditure” on pages 43, 44 and 44,
respectively, “Financial Statements—Notes to the Financial Statements—Note
7—Property, plant and equipment” on page 139 and “—Note 22—Acquisitions of
business operations” on pages 154 to 156, in each case of the Company’s “Annual
Report and Form 20-F Information 2009” included as exhibit 15.1 to this Form
20-F dated March 25, 2010 is incorporated by reference.
B.
Business Overview
The
information (including graphs and tabular data) set forth under the headings
“Introduction—Our year in brief” on pages 2 to 3, “Directors’
Report—Performance” on pages 12 to 35 and “—Reviews” on pages 50 to 78,
“Additional Information—Development Pipeline” on pages 196 to 198”, “Financial
Statements—Notes to the Financial Statements —Note 1—Product revenue
information” on page 133, and “—Note 6—Segment Information” on pages 137 to 138
and “Statements of competitive position, growth rates and sales” on the inside
front cover, in each case of the Company’s “Annual Report and Form 20-F
Information 2009” included as exhibit 15.1 to this Form 20-F dated March 25,
2010 is incorporated by reference.
Restructuring
Initiatives
As
disclosed in the information set forth under the headings referenced above, the
Company plans to implement certain restructuring initiatives in its Research and
Development (“R&D”) organization from 2010 as part of its ongoing
restructuring programs. These R&D initiatives are designed to
achieve material efficiency savings in R&D, which will partially mitigate
the increase in R&D investment that would be required as projects in the
current pipeline progress to the more resource intensive, later phases of
development.
Through
its previously announced restructuring programs, the Company had realized
annualized benefits of US $1.6 billion by the end of 2009, which are expected to
grow to approximately US $2.4 billion by the end of 2010. These
programs have involved job reductions of 12,600 positions and, to the end of
2009, have resulted in the incurrence of US $2.5 billion in restructuring
costs.
Through
the Company’s next phase of restructuring plans (which includes the R&D
initiatives, as well as completion of previously announced programs and some
additional initiatives in supply chain, selling, general and administration), it
expects to realize a further US $1.9 billion in estimated annual benefits by the
end of 2014. Of this, the R&D initiatives are expected to result
in approximately US $1 billion of annual savings, of which 50% is estimated to
be cost savings and the other 50% cost avoidance.
The
Company expects to incur restructuring costs of US $2.0 billion for the next
restructuring phase, of which US $1 billion is estimated to be the cost of
implementation of the R&D initiatives (approximately 60% of which is
estimated to be cash costs).
The
Company’s next phase of restructuring, when fully implemented, may involve up to
an additional 10,400 reductions in job positions. Based on
preliminary estimates, approximately 3,500 of these 10,400 positions may be
affected by the implementation of the R&D initiatives, although after taking
account of positions retained and
relocated
to other sites, investment in new skills and capabilities and further expansion
of Biologics activities, the net reduction due to these initiatives may fall to
approximately 1,800 positions.
Results of Horizon Study
Evaluating RECENTIN
On March
8, 2010, the Company announced the top-line results of a Phase II/III study
evaluating RECENTIN (cediranib) compared with Avastin (bevacizumab) in patients
with first-line metastatic colorectal cancer (mCRC). This study, HORIZON
III, assessed the efficacy of cediranib compared with bevacizumab, both in
combination with chemotherapy. Clinical activity was observed in the
cediranib arm of the study and there was no statistically significant difference
between treatment arms on the efficacy endpoints examined. However, the
efficacy did not meet the pre-specified criteria for the primary endpoint of
non-inferiority in progression-free survival.
The
spectrum of adverse events associated with cediranib was broadly consistent with
previous studies. HORIZON III continues with ongoing collection of overall
survival data.
This is
the first of two pivotal studies of cediranib in first-line mCRC. The other
study, HORIZON II, is assessing the efficacy of cediranib combined with
chemotherapy vs. chemotherapy alone, and data are expected in the coming months.
Results from both studies will determine the clinical utility, if any, for
cediranib in colorectal cancer and decisions regarding regulatory
filing. Data from both of these studies will be submitted to a
forthcoming medical meeting in the second half of 2010.
Results
of a Phase III study with cediranib in treating recurrent glioblastoma are also
expected in the first half of 2010. Exploratory evaluations of cediranib
in other tumors are also ongoing.
Update on the Company’s
Arrangements with Merck
Information
on the Company’s arrangements with Merck & Co., Inc. (“Merck”) is set forth
under the heading “Financial Statements—Notes to the Financial Statements —Note
25—Arrangements with Merck” on pages 166 to 168 of the Company’s “Annual Report
and Form 20-F Information 2009” included as exhibit 15.1 to this Form 20-F dated
March 25, 2010, which is incorporated by reference. Capitalized terms
used below and not defined have the meanings ascribed to them in Note
25.
On March
1, 2010, the Company announced that, under the provisions of the agreements
relating to the restructuring of the joint venture in the US between the Company
and Merck (the “Agreements”), the Company has notified Merck that it will
exercise the First Option related to the relinquishment of Merck’s rights over
the products not covered by the Partial Retirement (which occurred in March
2008), other than Nexium and Prilosec and the right to receive contingent
payments in respect of the authorized generic version of felodipine.
Products covered by the First Option include Entocort, Atacand and
Plendil, and certain products still in development, including Brilinta, AZD3355,
AZD6765 and AZD2327. The Company expects to consummate this option in
April 2010, which will result in the payment to Merck of the Appraised Value of
US $647 million. As previously disclosed, in accordance with the
Agreements, in 2008 a third party appraisal resulted in a calculation of the
Appraised Value, being the net present value of the future contingent payments
in respect of all agreement products not covered by the Partial Retirement,
other than Prilosec and Nexium. Upon consummation of the First Option,
contingent payments will cease on the products covered by the First Option.
The Company made contingent payments in respect of the products included
in the First Option of US $47 million in 2009. Merck’s continuing
contingent payment interest in respect of the authorized generic version of
felodipine is the result of Ranbaxy Pharmaceuticals, Inc. becoming the exclusive
US distributor of this product. Such contingent payments will continue for
the duration of this arrangement.
Under the
Agreements a Second Option exists whereby the Company has the option to
repurchase Merck’s interests in Prilosec and Nexium in the US. Now that
the Company has exercised the First Option, the Second Option is exercisable by
the Company in 2012, or in 2017, or if combined annual sales of the two products
fall below a minimum amount. The Company’s consummation of the Second
Option will end the contingent payments in respect of Prilosec and Nexium and
will effectively end the Company’s relationship with, and obligations to, Merck
(other than some residual manufacturing arrangements). The exercise price
for the Second Option is the net present value of the future annual contingent
payments on Prilosec and Nexium as determined at the time of
exercise.
The Company made contingent payments in respect of Prilosec and Nexium
amounting to US $726 million in 2009.
Consummation
of the First Option will give rise to additional amortization expense,
associated with intangible assets related to relief from contingent payments to
Merck for products covered by the First Option, in the range of US $10 million
to US $45 million per annum charged to Cost of Goods Sold, with the amount of
the charge dependent on the launch status of the covered pipeline
compounds. A further amortization expense of approximately US $60
million per annum will be charged to SG&A, related to the ability to exploit
these products and to exploit other opportunities in the Cardiovascular and
Neuroscience therapy areas that the Company was previously prevented from doing
by Merck’s interest in these products. For the purposes of calculating
Core financial measures, the Company will exclude only the amortization expense
related to therapy area intangibles (i.e., that charged to
SG&A) from the Core financial measures calculations.
AstraZeneca and Rigel
Pharmaceuticals Sign Worldwide License Agreement for Fostamatinib
Disodium
On
February 16, 2010, the Company and Rigel Pharmaceuticals, Inc. (“Rigel”)
announced an exclusive worldwide license agreement for the global development
and commercialization of fostamatinib disodium (R788), Rigel’s late-stage
investigational product for rheumatoid arthritis (“RA”) and additional
indications. Fostamatinib disodium, which has completed a
comprehensive Phase II program, is the furthest developed oral Spleen Tyrosine
Kinase (“Syk”) inhibitor being evaluated for RA. Inhibiting Syk is thought to
block the intracellular signaling of various immune cells implicated in the
destruction of bone and cartilage which is characteristic of RA.
Once the
agreement is effective, the Company will make an upfront payment to Rigel of US
$100 million with up to an additional US $345 million payable if specified
development, regulatory and first commercial sale milestones are
achieved. Rigel will also be eligible to receive up to an additional
US $800 million of specified sales-related milestone payments if the product
achieves considerable levels of commercial success, as well as significant
stepped double-digit royalties on net sales worldwide. The Company is
responsible for all development, regulatory filings, manufacturing and global
commercialization activities in all licensed indications under the contract.
Effectiveness of the agreement is contingent on expiration or termination of the
waiting period under the US Hart-Scott-Rodino Antitrust Improvements Act of
1976, as amended.
The
Company will design a global phase III program, anticipated to begin in the
second half of 2010, with the goal of filing new drug applications with the US
Food and Drug Administration (the “FDA”) and the European Medicines Agency
(EMEA) in 2013. Fostamatinib disodium is being developed as a next
generation oral RA therapy in adults who have failed to respond adequately to a
traditional disease modifying anti-rheumatic drug (DMARD), such as methotrexate,
where a TNF biologic add-on treatment would currently be considered. Under the
terms of the agreement, the Company will also receive exclusive rights to
Rigel’s portfolio of oral Syk inhibitors, as well as for additional indications
for fostamatinib disodium beyond RA.
FDA Approves New Indication
for CRESTOR
On
February 9, 2010, the Company announced the approval by the FDA of CRESTOR
(rosuvastatin calcium) to reduce the risk of stroke, myocardial infarction
(heart attack) and arterial revascularization procedures in individuals without
clinically evident coronary heart disease but with an increased risk of
cardiovascular disease (“CVD”) based on age (men ≥50 and women ≥60),
high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and the presence of at
least one additional CVD risk factor, such as hypertension, low HDL-C, smoking,
or a family history of premature coronary heart disease.
The FDA
approval was based on data from the JUPITER (Justification for the Use of
statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin)
study which evaluated the impact of CRESTOR 20 mg on reducing major
cardiovascular (CV) events in a previously unstudied population. In
JUPITER, CRESTOR significantly reduced the relative risk of heart attack by 54%,
stroke by 48%, and arterial revascularization by 46% compared with
placebo.
C.
Organizational Structure
The
information set forth under the headings “Directors’ Report—Corporate
Governance—Business Organisation and Corporate Governance—Other
matters—Subsidiaries and principal activities” on page 98 and “Financial
Statements—Principal Subsidiaries” on page 186, in each case of the Company’s
“Annual Report and Form 20-F Information 2009” included as exhibit 15.1 to this
Form 20-F dated March 25, 2010 is incorporated by reference.
D.
Property, Plants and Equipment
The
information (including tabular data) set forth under the headings “Directors’
Report—Reviews—Financial Review—Financial position, including cash flow and
liquidity – 2009—Property, plant and equipment” and “—Financial position,
including cash flow and liquidity – 2008—Property, plant and equipment”, on
pages 39 and 43, respectively, “Directors’ Report—Corporate
Governance—Risk—Principal risks and uncertainties—Legal, regulatory and
compliance risks—Environmental/occupational health and safety liabilities” on
page 85, “Financial Statements—Notes to the Financial Statements—Note
25—Commitments and contingent liabilities—Environmental costs and liabilities”
on page 168, “—Note 7—Property, plant and equipment” on page 139 and ‘Additional
Information—Corporate Information—Property” on page 204, in each case of the
Company’s “Annual Report and Form 20-F Information 2009” included as exhibit
15.1 to this Form 20-F dated March 25, 2010 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—Performance—Business Environment—World pharmaceutical
markets” on page 13, “Directors’ Report—Reviews—Financial Review” on pages 36 to
49, “—Reviews—Geographical Review” on pages 50 to 54, “—Reviews—Therapy Area
Review—Sales by Therapy Area” (comprising tabular data only) on page 55,
“—Reviews—Therapy Area Review—Our financial performance” (comprising tabular
data only) on pages 57, 61, 63, 66, 69 and 72, “—Reviews—Therapy Area
Review—Financial performance 2009/2008” on pages 59, 61, 64, 67, 70 and 74,
“Directors’ Report—Performance—Resources, Skills and Capabilities—Research and
Development” on pages 22 to 27, “Directors’ Report—Corporate
Governance—Risk—Principal risks and uncertainties—Commercialization and business
execution risks—Competition, price controls and price reductions” on page 83,
“Financial Statements—Notes to the Financial Statements—Note 14—Interest-bearing
loans and borrowings” on page 144, “—Note 15—Financial risk management
objectives and policies” on pages 144 to 146, “—Note 16—Financial instruments”
on pages 146 to 152, “—Note 19—Capital and reserves—Other reserves” on page 153
and “—Note 25—Commitments and contingent liabilities” on pages 166 to 184, in
each case of the Company’s “Annual Report and Form 20-F Information 2009”
included as exhibit 15.1 to this Form 20-F dated March 25, 2010 is incorporated
by reference.
On March
23, 2010, the US healthcare reform bill was signed into law by President
Obama. For further discussion as to the proposed US healthcare
reforms, please see the information set forth under the heading “—Competition,
price controls and price reductions” on page 83 referenced above of the
Company’s “Annual Report and Form 20-F Information 2009”.
AstraZeneca Reaches
Agreement with UK Tax Authorities over Transfer Pricing
Subsequent
to approval of the Company’s financial statements for the year ended December
31, 2009 on January 28, 2010, on February 23, 2010 AstraZeneca
entered into an agreement with HM Revenue & Customs in the UK (“HMRC”) to
settle a long-running transfer pricing dispute and certain other outstanding UK
tax matters. The material elements of the transfer pricing dispute
are set forth under the headings “Directors’ Report—Reviews—Financial
Review—Critical accounting policies and estimates—Taxation” on pages 48 and 49
and “Financial Statements—Notes to the Financial Statements —Note 25—Tax” on
page 184, in each case of the Company’s
“Annual
Report and Form 20-F Information 2009” included as exhibit 15.1 to this Form
20-F dated March 25, 2010, incorporated by reference.
The
settlement will result in the Group paying £505 million to resolve all claims
made by HMRC in relation to the transfer pricing dispute for the 15-year period
from 1996 to the end of 2010. Of this, £450 million (US $720 million at
December 31, 2009 exchange rates) is estimated for accounting purposes as being
in respect of periods prior to December 31, 2009. As a result of this
settlement, the joint referral of this issue to the UK Tax Court by the Company
and HMRC, as disclosed in Note 25 of the Financial Statements in Company’s
“Annual Report and Form 20-F Information 2009”, will be withdrawn.
The
provision for the transfer pricing dispute is included in the total net transfer
pricing provision of US $2,327 million disclosed under “Directors’
Report—Reviews—Financial Review—Critical accounting policies and
estimates—Taxation” and in Note 25 of the Financial Statements, in each case of
the Company’s “Annual Report and Form 20-F Information 2009” on the pages
referenced above. The effect of this settlement and developments in other
transfer pricing matters is a reduction in the accrual for tax contingencies of
US $194 million which has been credited to income in the first quarter of 2010
and a total net transfer pricing provision of US $2,165 million (including the
US $720 million resulting from the settlement). The potential for
reasonably possible additional losses has also reduced from US $575
million to US $450 million.
ITEM
6 - DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A.
Directors and Senior Management
The
information set forth under the headings “Directors’ Report—Corporate
Governance—Business Organisation and Corporate Governance—Board of Directors at
31 December” and “—Senior Executive Team at 31 December” on pages 88 and 89, and
pages 90 and 91, respectively, “Directors’ Report—Corporate
Governance—Directors’ Remuneration Report—Remuneration and terms of employment
for Executive Directors and other SET members—Variable performance-related
remuneration—Policy on external appointments and retention of fees” on page 110
and “—Directors’ Remuneration Report—Directors’ emoluments in 2009—Directors’
remuneration-US dollars” (last sentence only) on page 113, in each case of the
Company’s “Annual Report and Form 20-F Information 2009” included as exhibit
15.1 to this Form 20-F dated March 25, 2010 is incorporated by
reference.
B.
Compensation
The
information (including graphs and tabular data) set forth under the headings
“Directors’ Report—Corporate Governance—Directors’ Remuneration Report” on pages
101 to 119, “Financial Statements—Notes to the Financial Statements—Note
23—Post-retirement benefits” on pages 156 to 161, “—Note 24—Employee costs and
share option plans for employees” on pages 161 to 165 and “—Note 27—Statutory
and other information—Key management personnel compensation”, on page 185, in
each case of the Company’s “Annual Report and Form 20-F Information 2009”
included as exhibit 15.1 to this Form 20-F dated March 25, 2010 is incorporated
by reference.
C.
Board Practices
The
information set forth under the headings “Directors’ Report—Corporate
Governance—Business Organisation and Corporate Governance—Board of Directors at
31 December” on pages 88 and 89, “—Senior Executive Team at 31 December” on
pages 90 and 91, “—Operation of the Board” on pages 92 and 93, —Board Committee
membership” (including tabular data) and “—Directors” each on page 93,
“—Operation of Board Committees” on pages 94 to 96, “—Principal corporate
governance requirements—UK corporate governance requirements” on pages 96 to 97
and “—US corporate governance requirements” on page 97, “Directors’
Report—Corporate Governance—Directors’ Remuneration Report—Variable
performance-related remuneration—Service contracts” and “—Non-Executive
Directors”, each on page 110, and “—Directors’ Remuneration Report—Audit—Details
of Executive Directors’ service contracts at 31 December 2009” and
“—Non-Executive Directors’ terms and conditions” (consisting of tabular data),
each on page 111, in each case of the Company’s “Annual Report and Form 20-F
Information 2009” included as exhibit 15.1 to this Form 20-F dated March 25,
2010 is incorporated by reference.
Neither
John Buchanan nor Bo Angelin, both of whom are current Non-Executive Directors
of the Company, will present themselves for re-election at the Company’s Annual
General Meeting in 2010 and both will leave the Company’s Board of Directors at
the close of the Annual General Meeting.
D.
Employees
The
information set forth under the headings “Directors’
Report—Performance—Resources, Skills and Capabilities—People” (comprising the
graphical data, the first paragraph, and the information set forth under
“Engagement and dialogue” and “Managing the impact of business change” only) on
pages 33 and 34 and “Financial Statements—Notes to the Financial Statements—
Note 24—Employee costs and share option plans for employees” (including the
tabular data) on pages 161 to 165, in each case of the Company’s “Annual Report
and Form 20-F Information 2009” included as exhibit 15.1 to this Form 20-F dated
March 25, 2010 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 161 to 165, “Directors’
Report—Corporate Governance—Directors’ Remuneration Report—Directors’ interests
in shares” on pages 115 to 119, and “Additional Information—Shareholder
Information—Major shareholdings” on pages 200 and 201 and “—Options to purchase
securities from registrant or subsidiaries” on page 201, in each case of the
Company’s “Annual Report and Form 20-F Information 2009” included as exhibit
15.1 to this Form 20-F dated March 25, 2010 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 200 and 201 of the Company’s “Annual
Report and Form 20-F Information 2009” included as exhibit 15.1 to this Form
20-F dated March 25, 2010 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 185 and “Additional Information—Shareholder
Information—Related party transactions” on page 201, in each case of the
Company’s “Annual Report and Form 20-F Information 2009” included as exhibit
15.1 to this Form 20-F dated March 25, 2010 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—Reviews—Financial Review—Capitalisation and shareholder
return—Dividend and share re-purchases” on page 42, “Directors’ Report—Corporate
Governance—Business Organisation and Corporate Governance—Other
matters—Distributions to shareholders and dividends for 2009” on page 98,
“Financial Statements” on pages 124 to 185 (including the information set
forth under the subheading “Notes to the Financial Statements”), “Financial
Statements—Principal Subsidiaries” on page 186, “Group Financial Record” on page
193, and “Additional Information—Shareholder Information” on pages 199 to 203,
in each case of the Company’s “Annual Report and
Form 20-F
Information 2009” included as exhibit 15.1 to this Form 20-F dated March 25,
2010 is incorporated by reference.
Please
see the information above under Item 5 – “Operating and Financial Review and
Prospects—AstraZeneca Reaches Agreement with UK Tax Authorities over Transfer
Pricing”, for information as to the settlement between the Company and HM
Revenue & Customs in the UK, entered into subsequent to the approval of the
Company’s financial statements for the year ended December 31, 2009, in respect
of the transfer pricing dispute disclosed under the heading “Financial
Statements—Notes to the Financial Statements—Note 25—Commitments and contingent
liabilities—Tax” on page 184 of the Company’s “Annual Report and Form 20-F
Information 2009”.
On March
18, 2010, a New Jersey state court jury returned a verdict in favor of
the Company in the first Seroquel product liability case to go to
trial. For further
information as to these product liability cases, please see the information
under the
heading “Financial Statements—Note 25—Commitments and contingent liabilities—Legal
proceedings—Seroquel (quetiapine fumarate)—Product liability” on pages
177 and 178 of the Company’s “Annual Report and Form 20-F Information
2009”.
B. Significant
Changes
Please
see the information above under Item 5 – “Operating and Financial Review and
Prospects—AstraZeneca Reaches Agreement with UK Tax Authorities over Transfer
Pricing”, for information as to the settlement between the Company and HM
Revenue & Customs in the UK, entered into subsequent to the approval of the
Company’s financial statements for the year ended December 31, 2009, in respect
of the transfer pricing dispute disclosed under the heading “Financial
Statements—Notes to the Financial Statements—Note 25—Commitments and contingent
liabilities—Tax” on page 184 of the Company’s “Annual Report and Form 20-F
Information 2009”.
Other
than as disclosed herein, since the date of the annual consolidated financial
statements included in this Form 20-F dated March 25, 2010, no significant
change has occurred.
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 199 of the Company’s
“Annual Report and Form 20-F Information 2009” included as exhibit 15.1 to this
Form 20-F dated March 25, 2010 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
|
|
|
|
|
|
|
|
|
|
High
|
|
Low
|
|
High
|
|
Low
|
|
High
|
|
Low
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010
– February
|
2,936
|
|
2,732
|
|
46.87
|
|
43.05
|
|
340.0
|
|
310.1
|
|
2010
– January
|
3,103
|
|
2,875
|
|
50.40
|
|
46.08
|
|
363.8
|
|
331.0
|
|
2009
– December
|
2,930
|
|
2,753
|
|
47.00
|
|
45.35
|
|
339.5
|
|
315.0
|
|
2009
– November
|
2,778
|
|
2,691
|
|
46.38
|
|
44.34
|
|
319.0
|
|
310.1
|
|
2009
– October
|
2,830
|
|
2,742
|
|
46.19
|
|
43.64
|
|
323.1
|
|
308.0
|
|
2009
– September
|
2,856
|
|
2,691
|
|
46.02
|
|
43.91
|
|
333.0
|
|
305.0
|
|
2009
|
2,947
|
|
2,147
|
|
47.54
|
|
30.24
|
|
356.0
|
|
261.5
|
|
|
AstraZeneca
|
|
|
|
|
|
|
|
|
|
High
|
|
Low
|
|
High
|
|
Low
|
|
High
|
|
Low
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
– Quarter 4
|
2,930
|
|
2,691
|
|
47.00
|
|
43.64
|
|
339.5
|
|
308.0
|
|
2009
– Quarter 3
|
2,878
|
|
2,644
|
|
47.54
|
|
43.01
|
|
356.0
|
|
305.0
|
|
2009
– Quarter 2
|
2,728
|
|
2,276
|
|
45.01
|
|
33.40
|
|
351.0
|
|
279.5
|
|
2009
– Quarter 1
|
2,947
|
|
2,147
|
|
41.60
|
|
30.24
|
|
331.0
|
|
261.5
|
|
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
|
|
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
|
|
(1)
|
Principally
held in bearer form.
|
B.
Plan of Distribution
Not
applicable.
C.
Markets
The
information set forth under the heading “Additional Information—Shareholder
Information—AstraZeneca PLC” on page 199 of the Company’s “Annual Report and
Form 20-F Information 2009” included as exhibit 15.1 to this Form 20-F dated
March 25, 2010 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—Articles” on page 204 of the Company’s “Annual Report and Form 20-F
Information 2009” included as exhibit 15.1 to this Form 20-F dated March 25,
2010 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 203 of the Company’s “Annual Report and Form 20-F Information 2009”
included as exhibit 15.1 to this Form 20-F dated March 25, 2010 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
(PFIC) rules”, “—UK inheritance tax” and “—UK stamp duty reserve tax and stamp
duty” on pages 202 and 203 of the Company’s “Annual Report and Form 20-F
Information 2009” included as exhibit 15.1 to this Form 20-F dated March 25,
2010 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 202 of the Company’s “Annual Report
and Form 20-F Information 2009” included as exhibit 15.1 to this Form 20-F dated
March 25, 2010 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—Reviews—Financial Review—Financial risk management” on pages
44 and 45, “Financial Statements—Note 15—Financial risk management objectives
and policies” on pages 144 to 146 and “—Note 16—Financial
Instruments—Sensitivity analysis” on page 151, in each case of the Company’s
“Annual Report and Form 20-F Information 2009” included as exhibit 15.1 to this
Form 20-F dated March 25, 2010 is incorporated by reference.
ITEM
12 - DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
A.
Debt Securities
Not
applicable.
B.
Warrants and Rights
Not
applicable.
C.
Other Securities
Not
applicable.
D.
American Depositary Shares
Fees and Charges Payable by
ADR Holders
The
Company’s American Depositary Receipt (“ADR”) program is administered by
JPMorgan Chase Bank, N.A. (“J.P. Morgan”), as the depositary. The
holder of an ADR may have to pay the following fees and charges to J.P. Morgan
in connection with ownership of the ADR:
|
Category
|
|
Depositary
actions
|
|
Associated
fee or charge
|
| |
|
|
|
|
|
(a) Depositing
or substituting the underlying shares
|
|
Issuances
against deposits of shares, including deposits and issuances pursuant to a
stock dividend or stock split declared by the Company or issuances
pursuant to a merger, exchange of securities or any other transaction or
event affecting the American Depositary Shares (“ADSs”) or the deposited
securities
|
|
Up
to US $5.00 for each 100 ADSs (or portion thereof) issued or delivered (as
the case may be)
The
depositary may sell (by public or private sale) sufficient securities and
property received in respect of share distributions, rights and other
distributions prior to such deposit to pay such charge
|
| |
|
|
|
|
|
(b) Receiving
or distributing dividends(1)
|
|
Cash
distributions made pursuant to the deposit agreement
|
|
US
$0.05 or less per ADS
|
| |
|
|
|
|
|
(c) Selling
or exercising rights
|
|
Distribution
or sale of securities, the fee being in an amount equal to the fee for the
execution and delivery of ADSs which would have been charged as a result
of the deposit of such securities
|
|
Up
to US $5.00 for each 100 ADSs (or portion thereof)
|
| |
|
|
|
|
|
(d) Withdrawing,
cancelling or reducing an underlying security
|
|
Acceptance
of ADSs surrendered for withdrawal, cancellation or reduction of deposited
securities
|
|
Up
to US $5.00 for each 100 ADSs (or portion thereof) surrendered, cancelled
or reduced (as the case may be)
The
depositary may sell (by public or private sale) sufficient securities and
property received in respect of share distributions, rights and other
distributions prior to such deposit to pay such charge
|
| |
|
|
|
|
|
(e) Transferring,
combination or split-up of receipts
|
|
Transfer,
combination and split-up of ADRs
|
|
US
$1.50 per ADR
|
| |
|
|
|
|
|
(f) General
depositary services, particularly those charged on an annual basis(1)
|
|
Services
performed by the depositary in administering the ADRs
|
|
US
$0.05 or less per ADS per calendar year (or portion thereof), payable at
the sole discretion of the depositary by billing ADR holders or by
deducting such charge from one or more cash dividends or other cash
distributions
|
| |
|
|
|
|
|
(g) Fees
and expenses of the depositary
|
|
Fees
and expenses incurred by the depositary or the depositary’s agents on
behalf of holders, including in connection with:
· compliance
with foreign exchange control regulations or any law or regulation
relating to foreign investment
· stock
transfer or other taxes and governmental charges
· cable,
telex and facsimile transmission and delivery charges
· fees
for the transfer or registration of deposited securities in connection
with the deposit or withdrawal of deposited securities
·
expenses of the depositary in connection with the conversion of
foreign currency into US dollars
· any
other charge payable by the depositary or the depositary’s agents in
connection with the servicing of the shares or other deposited securities
(which charge shall be assessed against holders as of the record date or
dates set by the depositary)
|
|
Expenses
payable at the sole discretion of the depositary by billing ADR holders or
by deducting such charges from one or more cash dividends or other cash
distributions
|
|
(1)
|
J.P.
Morgan has agreed that it shall not charge ADR holders any of these fees
without the Company’s prior written consent. No such fees have
been charged for the year ended December 31, 2009 or from January 1, 2010
to the date hereof.
|
Fees and Payments Made by
the Depositary to us
J.P.
Morgan, as ADR depositary, has agreed to reimburse certain expenses related to
the Company’s ADR program and incurred by the Company in connection with the
program. For the year ended December 31, 2009, the ADR depositary
reimbursed to the Company, or paid on its behalf to third parties, a total sum
of US $1,813,762 (comprised of reimbursements of US $1,700,000 and payments to
third parties of US $113,762, in each case as detailed in the tables
below). The ADR depositary also waived certain of its fees for
standard costs associated with the administration of the ADR program in a total
amount of US $215,000.
The table below sets forth the types of
expenses that the ADR depositary has agreed to reimburse and the amounts
reimbursed within each such category for the year ended December 31,
2009:
Category
of Expenses – Direct Payments
|
|
Reimbursement
for the year ended December 31, 2009
|
|
ADR
program expenses, including investor relations costs and legal
fees
|
|
$1,700,000
|
|
|
|
|
|
|
|
|
The ADR depositary has paid certain
expenses directly to third parties on behalf of the Company and has agreed to
waive certain of its fees for standard costs associated with the administration
of the ADR program. The table below sets forth those expenses that
the ADR depositary paid directly to third parties, and those fees waived, in
each case for the year ended December 31, 2009.
Category
of Expenses – Indirect Payments
|
|
Amount
paid for the year ended December
31, 2009
|
|
Expenses
paid by depositary to third parties on behalf of the Company – NYSE
listing fees
|
|
$113,762
|
|
Fees
waived by depositary for standard ADR program costs
|
|
$215,000
|
|
|
|
|
|
Total
|
|
$328,762
|
Under
certain circumstances, including removal of the ADR depositary or termination of
the ADR program by the Company, the Company is required to repay the ADR
depositary certain amounts reimbursed and/or expenses paid to or on behalf of
the Company. No such repayments were made during the year ended
December 31, 2009.
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—Business Organisation and Corporate Governance—Operation of Board
Committees—Audit Committee” on page 95 (the last three paragraphs of the “Audit
Committee” section only), “—Business Organisation and Corporate
Governance—Principal corporate governance requirements—UK corporate governance
requirements” on page 96 (the second, third, fourth and fifth paragraphs of the
“UK corporate governance requirements” section only), “—Principal corporate
governance requirements—US corporate governance requirements” on page 97 (the
first and second paragraphs of the “US corporate governance requirements”
section only) and “Financial Statements—Directors’ Responsibilities for, and
Report on, Internal Control over Financial Reporting” on page 122, in each case
of the Company’s “Annual Report and Form 20-F Information 2009” included as
exhibit 15.1 to this Form 20-F dated March 25, 2010 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 122 of the Company’s “Annual Report and Form
20-F Information 2009” included as exhibit 15.1 to this Form 20-F dated March
25, 2010, 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 2009, 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 2009, 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 statements of financial
position of AstraZeneca as of 31 December 2009, 2008 and 2007, and the related
consolidated statements of comprehensive income, consolidated statements of
changes in equity, and consolidated cash flow statements for each of the years
in the three-year period ended 31 December 2009, and our report dated 28 January
2010 expressed an unqualified opinion on those consolidated financial
statements.
KPMG
Audit Plc
Chartered
Accountants
8
Salisbury Square
London
EC4Y
8BB
28
January 2010
ITEM
16 – RESERVED
ITEM
16A – AUDIT COMMITTEE FINANCIAL EXPERT
The
information set forth in the first paragraph under the heading “Directors’
Report—Corporate Governance—Business Organisation and Corporate
Governance—Operation of Board Committees—Audit Committee” on pages 94 and 95 and
“—Board Committee membership” (consisting of tabular data) on page 93, in each
case of the Company’s “Annual Report and Form 20-F Information 2009” included as
exhibit 15.1 to this Form 20-F dated March 25, 2010 is incorporated by
reference.
ITEM
16B – CODE OF ETHICS
The
information set forth under the heading “Directors’ Report—Corporate
Governance—Business Organisation and Corporate Governance—Principal corporate
governance requirements—Code of Conduct” on page 97 of the Company’s “Annual
Report and Form 20-F Information 2009” included as exhibit 15.1 to this Form
20-F dated March 25, 2010 is incorporated by reference.
The
Company’s 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 185 and “Directors’ Report—Corporate Governance—Business
Organisation and Corporate Governance—Operation of Board Committees—Audit
Committee” on pages 94 and 95, in each case of the Company’s “Annual Report and
Form 20-F Information 2009” included as exhibit 15.1 to this Form 20-F dated
March 25, 2010 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
Not
applicable.
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 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.
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NYSE
Standards
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AstraZeneca
Corporate Governance Practice
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1.
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Under
the NYSE Standards, the audit committee is to be directly responsible for
the appointment,
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Under
the Combined Code, a company’s external auditors are appointed by its
shareholders. As a result,
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compensation,
retention and oversight of a listed company’s external auditor, unless
there is a conflicting requirement under the home country laws of the
company. |
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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 and removal of the external auditors, and for approving the
remuneration and terms of engagement of the external auditor. |
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2.
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Under
the NYSE Standards, the nominating/corporate governance committee and
compensation committee are to be composed entirely of independent
directors.
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Under
the Combined Code, a majority of the members of a company’s nomination
committee, and all of the members of its remuneration committee, should be
independent non-executive directors.
The
Company’s Nomination and Governance Committee and Remuneration Committee
each includes four members, including the chairman of the Company’s Board
of Directors, with the remainder all being considered by the Company’s
Board of Directors to be independent in accordance with the principles and
criteria of the Combined Code. The Company’s chairman was
considered to be independent upon his appointment as chairman (under the
Combined Code, the test of independence is not appropriate in relation to
the chairman thereafter).
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3.
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Under
the NYSE Standards, the compensation committee is to make recommendations
to the listed company’s Board of Directors with respect to non-CEO
executive officer compensation and certain other compensation plans which
are subject to Board approval.
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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, Senior Executive Team (“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.
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4.
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Under
the NYSE Standards, shareholders are entitled to vote on all equity
compensation plans and material revisions thereto, with certain limited
exemptions.
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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.
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5.
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Under
the NYSE Standards, each listed company Chief Executive Officer must
certify to the NYSE each year that he or she is not aware of any violation
by the listed company of any NYSE corporate governance listing standards,
qualifying the certification to the extent necessary.
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As the Company is a foreign
private issuer, the Company’s Chief Executive Officer is not required to
make this certification. He is, however, required to promptly
notify the NYSE in writing after any executive officer of the Company
become aware of any non-compliance with any NYSE corporate governance
rules applicable to the
Company.
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The
information set forth under the heading “Directors’ Report—Corporate
Governance—Business Organisation and Corporate Governance—Principal corporate
governance requirements—UK corporate governance requirements” on pages 96 and 97
and “—US corporate governance requirements” (final two paragraphs only) on page
97, in each case of the Company’s “Annual Report and Form 20-F Information 2009”
included as exhibit 15.1 to this Form 20-F dated March 25, 2010 is incorporated
by reference.
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 124 to 185 (including the information set forth under the subheading
“Notes to the Financial Statements” on pages 133 to 185) and “Principal
Subsidiaries” on page 186, in each case of the Company’s “Annual Report and Form
20-F Information 2009” included as exhibit 15.1 to this Form 20-F dated March
25, 2010 is incorporated by reference.
Please
see the information above under Item 5 – “Operating and Financial Review and
Prospects—AstraZeneca Reaches Agreement with UK Tax Authorities over Transfer
Pricing”, for information as to the settlement between the Company and HM
Revenue & Customs in the UK, entered into subsequent to the approval of the
Company’s financial statements for the year ended December 31, 2009, in respect
of the transfer pricing dispute disclosed under the heading “Financial
Statements—Notes to the Financial Statements—Note 25—Commitments and contingent
liabilities—Tax” on page 184 of the Company’s “Annual Report and Form 20-F
Information 2009”.
The
information set out in the above-referenced financial statements does not
constitute the Company’s statutory accounts under the UK Companies Acts for the
years ended December 31, 2009, 2008 or 2007. 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 or
under section 498(2) or (3) of the Companies Act 2006. The accounts for
2008 and 2007 have been delivered to the registrar of companies and those for
2009 will be delivered in due course.
ITEM
19 – EXHIBITS
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1.1
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Memorandum
and Articles of Association.(1)
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4.1
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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)
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4.2
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Agreement
for Service between AstraZeneca PLC and Simon Lowth, dated September 27,
2007.(3)
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4.3
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Agreement
for Service between AstraZeneca PLC and John Patterson dated February 14,
2005 (effective as of January 1, 2005).(4)
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4.4
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Agreement
for Service between AstraZeneca PLC and David R. Brennan dated December
16, 2005 (effective as of January 1, 2006).(4)
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4.5
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Form
of Deed of Indemnity for Directors.(5)
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7.1
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Statement
explaining calculation of ratio of earnings to fixed
charges.
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8.1
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List
of subsidiaries.
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12.1
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Certification
of David R. Brennan filed pursuant to 17 CFR
240.13a-14(a).
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12.2
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Certification
of Simon Lowth filed pursuant to 17 CFR 240.13a-14(a).
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13.1
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Certification
of David R. Brennan and Simon Lowth furnished pursuant to 17 CFR
240.13a-14(b) and 18 U.S.C. 1350.
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15.1
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Annual
Report and 20-F Information.(6)
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15.2
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Report
of Independent Registered Public Accounting Firm to the members of
AstraZeneca PLC by KPMG Audit Plc.
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15.3
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Consent
of KPMG Audit Plc, independent registered public accounting
firm.
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15.4
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Consent
of IMS Health.
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15.5
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Consent
of Bureau Veritas HS&E Ltd.
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(1)
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Incorporated
into this Form 20-F by reference to AstraZeneca PLC’s Form 20-F filed
March 21, 2005 (File No. 001-11960).
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(2)
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Incorporated
into this Form 20-F by reference to AstraZeneca PLC’s Form 20-F filed
March 25, 2003 (File No. 001-11960).
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(3)
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Incorporated
into this Form 20-F by reference to AstraZeneca PLC’s Form 20-F filed
March 12, 2008 (File No. 001-11960).
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(4)
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Incorporated
into this Form 20-F by reference to AstraZeneca PLC’s Form 20-F filed
March 23, 2006 (File No. 001-11960).
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(5)
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Incorporated
into this Form 20-F by reference to AstraZeneca PLC’s Form 20-F filed
March 27, 2007 (File No. 001-11960).
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(6)
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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.
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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.
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AstraZeneca
PLC
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By:
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/s/
A C N Kemp
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Name:
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A C
N Kemp
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Title:
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Authorised
Signatory
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London,
England
March 25,
2010
19