throbber
US SecUritieS & exchange commiSSion form 20-f 2008
`
`US SecUritieS & exchange commiSSion form 20-f 2008
`
`WWW.noVartiS.com
`
`0001
`
`MYLAN - EXHIBIT 1044
`Mylan et al. v. AstraZeneca
`IPR2015-01340
`
`

`
`0002
`
`0002
`
`

`
`As filed with the Securities and Exchange Commission on January 28, 2009
`
`UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`Washington D.C. 20549
`FORM 20-F
`
`REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934
`OR
`ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the fiscal
`year ended December 31, 2008
`
`អ
`
`፤
`
`អ
`
`អ
`
`OR
`TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`OR
`SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`Commission file number 1-15024
`NOVARTIS AG
`(Exact name of Registrant as specified in its charter)
`NOVARTIS Inc.
`(Translation of Registrant’s name into English)
`Switzerland
`(Jurisdiction of incorporation or organization)
`Lichtstrasse 35
`4056 Basel, Switzerland
`(Address of principal executive offices)
`Thomas Werlen
`Group General Counsel
`Novartis AG
`CH-4056 Basel
`Switzerland
`011-41-61-324-2745
`thomas.werlen@novartis.com
`(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
`Securities registered pursuant to Section 12(b) of the Act:
`Title of class
`Name of each exchange on which registered
`American Depositary Shares
`New York Stock Exchange, Inc.
`each representing 1 share,
`nominal value CHF 0.50 per share,
`and shares
`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
`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:
`2,264,852,842 shares
`Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
`Yes ፤ No អ
`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.
`
`Yes អ No ፤
`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.
`
`Yes ፤ No អ
`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):
`Large accelerated filer ፤
`Accelerated filer អ
`Non-accelerated filer អ
`Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
`អ U.S. GAAP ፤ International Financial Reporting Standards as issued by the International Accounting Standards Board អ Other
`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.
`
`Item 17 អ Item 18 អ
`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).
`Yes អ No ፤
`
`0003
`
`

`
`(This page has been left blank intentionally.)
`
`0004
`
`

`
`TABLE OF CONTENTS
`
`INTRODUCTION AND USE OF CERTAIN TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`FORWARD-LOOKING STATEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`PART I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Item 1.
`Identity of Directors, Senior Management and Advisers . . . . . . . . . . . . . . . .
`Item 2.
`Offer Statistics and Expected Timetable . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Item 3.
`Key Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`3.A Selected Financial Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`3.B
`Capitalization and Indebtedness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`3.C Reasons for the offer and use of proceeds . . . . . . . . . . . . . . . . . . . . . . . . .
`3.D Risk Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Item 4.
`Information on the Company . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`4.A History and Development of Novartis . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`4.B
`Business Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Pharmaceuticals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Vaccines and Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Sandoz . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Consumer Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`4.C Organizational Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`4.D Property, Plants and Equipment
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Item 4A. Unresolved Staff Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Item 5.
`Operating and Financial Review and Prospects . . . . . . . . . . . . . . . . . . . . . .
`5.A Operating Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`5.B
`Liquidity and Capital Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`5.C Research & Development, Patents and Licenses . . . . . . . . . . . . . . . . . . . . .
`5.D Trend Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`5.E Off-Balance Sheet Arrangements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`5.F
`Aggregate Contractual Obligations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Item 6.
`Directors, Senior Management and Employees . . . . . . . . . . . . . . . . . . . . . .
`6.A Directors and Senior Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`6.B
`Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`6.C
`Board Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`6.D Employees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`6.E
`Share Ownership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Item 7.
`Major Shareholders and Related Party Transactions . . . . . . . . . . . . . . . . . . .
`7.A Major Shareholders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`7.B Related Party Transactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`7.C
`Interests of Experts and Counsel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Item 8.
`Financial Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`8.A Consolidated Statements and Other Financial Information . . . . . . . . . . . . . .
`8.B
`Significant Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Item 9.
`The Offer and Listing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`9.A Listing Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`9.B
`Plan of Distribution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`9.C Market . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`9.D Selling Shareholders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`9.E Dilution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`9.F
`Expenses of the Issue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`
`1
`1
`3
`3
`3
`3
`3
`6
`6
`6
`18
`18
`20
`22
`51
`59
`66
`70
`71
`78
`78
`78
`136
`140
`140
`140
`141
`142
`142
`150
`168
`182
`183
`184
`184
`185
`186
`186
`186
`186
`187
`187
`188
`189
`189
`189
`189
`
`0005
`
`

`
`Additional Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Item 10.
`10.A Share capital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`10.B Memorandum and Articles of Association . . . . . . . . . . . . . . . . . . . . . . . . . .
`10.C Material contracts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`10.D Exchange controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`10.E Taxation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`10.F Dividends and paying agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`10.G Statement by experts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`10.H Documents on display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`10.I
`Subsidiary Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Item 11.
`Quantitative and Qualitative Disclosures about Non-Product-Related Market
`Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Description of Securities other than Equity Securities . . . . . . . . . . . . . . . . .
`Item 12.
`PART II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Item 13.
`Defaults, Dividend Arrearages and Delinquencies . . . . . . . . . . . . . . . . . . . .
`Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds .
`Item 15.
`Controls and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Item 16A. Audit Committee Financial Expert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Item 16B. Code of Ethics
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Item 16C. Principal Accountant Fees and Services . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Item 16D. Exemptions from the Listing Standards for Audit Committees . . . . . . . . . . . .
`Item 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers . . . . . .
`Item 16G. Corporate Governance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`PART III . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Item 17.
`Financial Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Item 18.
`Financial Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Item 19.
`Exhibits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`
`189
`189
`189
`193
`194
`194
`198
`199
`199
`199
`
`199
`205
`206
`206
`206
`206
`206
`207
`207
`208
`209
`209
`210
`210
`210
`211
`
`0006
`
`

`
`INTRODUCTION AND USE OF CERTAIN TERMS
`Novartis AG and our consolidated affiliates (Novartis or the Group) publish consolidated financial
`statements expressed in US dollars. Our consolidated financial statements found in Item 18 of this annual
`report on Form 20-F (Form 20-F) are those for the year ended December 31, 2008 and are prepared in
`accordance with International Financial Reporting Standards (IFRS) as issued by the International
`Accounting Standards Board (IASB). In this Form 20-F, references to ‘‘US dollars’’, ‘‘USD’’ or ‘‘$’’ are to
`the lawful currency of the United States of America; and references to ‘‘CHF’’ are to Swiss francs.
`
`In this Form 20-F, references to the ‘‘United States’’ or to ‘‘US’’ are to the United States of America,
`references to the European Union (EU) are to the European Union and its 27 member states and
`references to ‘‘Americas’’ are to North, Central (including the Caribbean) and South America, unless the
`context otherwise requires; references to ‘‘ADS’’ or ‘‘ADSs’’ are to Novartis American Depositary Shares;
`references to ‘‘associates’’ are to employees of our affiliates; references to the ‘‘FDA’’ are to the US Food
`and Drug Administration. All product names appearing in italics are trademarks licensed to or owned by
`Group companies. Product names identified by a ‘‘↧’’ or a ‘‘↩’’ are trademarks that are not licensed to or
`owned by the Group. You will find the words ‘‘we,’’ ‘‘our,’’ ‘‘us’’ and similar words or phrases in this
`Form 20-F. We use those words to comply with the requirement of the US Securities and Exchange
`Commission to use ‘‘plain English’’ in public documents like this Form 20-F. For the sake of clarification,
`each operating company in the Group is legally separate from all other companies in the Group and
`manages its business independently through its respective board of directors or other top local
`management body. No Group company operates the business of another Group company nor is any
`Group company the agent of any other Group company. Each executive identified in this Form 20-F
`reports directly to other executives of the company by whom the executive is employed, or to that
`company’s board of directors.
`
`FORWARD LOOKING STATEMENTS
`This Form 20-F contains certain ‘‘forward looking statements’’ within the meaning of Section 27A of
`the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as
`amended, which can be identified by the use of forward-looking terminology such as ‘‘will’’ or ‘‘expected’’,
`or similar expressions, or by express or implied discussions regarding potential new products, potential
`new indications for existing products, or regarding potential future revenues from any such products, or
`potential future sales or earnings of the Novartis Group or any of its divisions or business units; or by
`discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these
`statements. Such forward-looking statements reflect the current views of the Company regarding future
`events, and involve known and unknown risks, uncertainties and other factors that may cause actual
`results to be materially different from any future results, performance or achievements expressed or
`implied by such statements. There can be no guarantee that any new products will be approved for sale in
`any market, or that any new indications will be approved for existing products in any market, or that such
`products will achieve any particular revenue levels. Nor can there be any guarantee that the Novartis
`Group, or any of its divisions or business units, will achieve any particular financial results. In particular,
`management’s expectations could be affected by, among other things, uncertainties involved in the
`development of new pharmaceutical products; unexpected clinical trial results, including additional
`analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays
`or government regulation generally; the Group’s ability to obtain or maintain patent or other proprietary
`intellectual property protection, including the uncertainties involved in the US litigation process;
`competition in general; government, industry, and general public pricing and other political pressures; and
`the impact that the foregoing factors could have on the values attributed to the Novartis Group’s assets
`and liabilities as recorded in the Group’s consolidated balance sheet. Some of these factors are discussed
`
`1
`
`0007
`
`

`
`in more detail herein, including under ‘‘Item 3. Key Information—3.D. Risk factors,’’ ‘‘Item 4.
`Information on the Company,’’ and ‘‘Item 5. Operating and Financial Review and Prospects.’’ Should one
`or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect,
`actual results may vary materially from those described in this Form 20-F as anticipated, believed,
`estimated or expected. We provide the information in this 20-F as of the date of its filing. We do not
`intend, and do not assume any obligation, to update any information or forward looking statements set
`out in this Form 20-F.
`
`2
`
`0008
`
`

`
`Identity of Directors, Senior Management and Advisers
`Item 1.
`Not applicable.
`
`PART I
`
`Item 2. Offer Statistics and Expected Timetable
`Not applicable.
`
`Item 3. Key Information
`
`3.A Selected Financial Data
`The selected financial information set out below has been extracted from our consolidated financial
`statements prepared in accordance with IFRS as issued by the IASB. Our consolidated financial
`statements for the years ended December 31, 2008, 2007 and 2006 are included in ‘‘Item 18. Financial
`Statements’’ in this Form 20-F.
`The results of our Medical Nutrition and Gerber Business Units are shown as discontinued
`operations for all periods presented, following their divestment in 2007. See ‘‘Item 5. Operating and
`Financial Review and Prospects—5.A Operating Results—Factors Affecting Comparability of
`Year-on-Year Results of Operations’’ and ‘‘Item 18. Financial Statements—note 2’’ for more detailed
`discussion.
`All financial data should be read in conjunction with ‘‘Item 5. Operating and Financial Review and
`Prospects’’. All financial data presented in this Form 20-F are qualified in their entirety by reference to the
`consolidated financial statements and their notes.
`
`3
`
`0009
`
`

`
`INCOME STATEMENT DATA
`Net sales from continuing operations . . . . . . . . . . . .
`Operating income from continuing operations . . . . . .
`Income from associated companies . . . . . . . . . . . . . .
`Financial income . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Interest expense . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Income before taxes from continuing operations . . . . .
`Taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Net income from continuing operations . . . . . . . . . . .
`Net income from discontinued operations . . . . . . . . .
`Group net income . . . . . . . . . . . . . . . . . . . . . . . . . .
`Attributable to:
`Shareholders of Novartis AG . . . . . . . . . . . . . . . . .
`Minority interests . . . . . . . . . . . . . . . . . . . . . . . . .
`Operating income from discontinued operations
`(including divestment gains) . . . . . . . . . . . . . . . . .
`
`Basic earnings per share ($):
`—Continuing operations . . . . . . . . . . . . . . . . . . . . .
`—Discontinued operations . . . . . . . . . . . . . . . . . . . .
`—Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`
`Diluted earnings per share ($):
`—Continuing operations . . . . . . . . . . . . . . . . . . . . .
`—Discontinued operations . . . . . . . . . . . . . . . . . . . .
`—Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Cash dividends(2) . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Cash dividends per share in CHF(3) . . . . . . . . . . . . . .
`
`Operating income from continuing operations
`earnings per share ($):
`—Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`—Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`
`Year Ended December 31,
`2004(1)
`2007
`2006
`2005
`2008
`($ millions, except per share information)
`
`41,459
`8,964
`441
`384
`(290)
`9,499
`(1,336)
`8,163
`70
`8,233
`
`38,072
`6,781
`412
`531
`(237)
`7,487
`(947)
`6,540
`5,428
`11,968
`
`34,393
`7,642
`264
`354
`(266)
`7,994
`(1,169)
`6,825
`377
`7,202
`
`29,446
`6,507
`193
`461
`(294)
`6,867
`(986)
`5,881
`260
`6,141
`
`25,685
`5,835
`68
`486
`(261)
`6,128
`(962)
`5,166
`214
`5,380
`
`8,195
`38
`
`11,946
`22
`
`7,175
`27
`
`6,130
`11
`
`5,365
`15
`
`70
`
`6,152
`
`532
`
`3.59
`0.03
`3.62
`
`3.56
`0.03
`3.59
`3,345
`2.00
`
`2.81
`2.34
`5.15
`
`2.80
`2.33
`5.13
`2,598
`1.60
`
`2.90
`0.16
`3.06
`
`2.88
`0.16
`3.04
`2,049
`1.35
`
`398
`
`2.52
`0.11
`2.63
`
`2.51
`0.11
`2.62
`2,107
`1.15
`
`317
`
`2.19
`0.09
`2.28
`
`2.18
`0.09
`2.27
`1,896
`1.05
`
`3.96
`3.92
`
`2.93
`2.91
`
`3.26
`3.24
`
`2.79
`2.78
`
`2.48
`2.46
`
`(1) We adopted a number of new International Financial Reporting Standards from January 1, 2005, not all of which required
`retrospective application. Data for 2004 is therefore not comparable with 2008, 2007, 2006 and 2005.
`
`(2)
`
`(3)
`
`Cash dividends represent cash payments in the applicable year that generally relate to earnings of the previous year.
`
`Cash dividends per share represent dividends proposed that relate to earnings of the current year. Dividends for 2008 will be
`proposed to the Annual General Meeting on February 24, 2009 for approval.
`
`4
`
`0010
`
`

`
`BALANCE SHEET DATA
`Cash, cash equivalents and marketable securities &
`derivative financial instruments . . . . . . . . . . . . . . . . .
`Inventories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Other current assets . . . . . . . . . . . . . . . . . . . . . . . . . .
`Non-current assets . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Assets held for sale related to discontinued operations . .
`Total assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Trade accounts payable . . . . . . . . . . . . . . . . . . . . . . . .
`Other current liabilities . . . . . . . . . . . . . . . . . . . . . . . .
`Non-current liabilities . . . . . . . . . . . . . . . . . . . . . . . . .
`Liabilities related to discontinued operations . . . . . . . . .
`Total liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Issued share capital and reserves attributable to
`shareholders of Novartis AG . . . . . . . . . . . . . . . . . .
`Minority interests . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Total equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Total liabilities and equity . . . . . . . . . . . . . . . . . . . . . .
`Net assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Outstanding share capital
`. . . . . . . . . . . . . . . . . . . . . .
`Total outstanding shares (millions) . . . . . . . . . . . . . . . .
`
`Year Ended December 31,
`2007
`2006
`2005
`($ millions)
`
`2004
`
`13,892
`3,558
`6,470
`28,568
`
`52,488
`2,020
`9,829
`9,324
`
`10,933
`3,725
`6,785
`36,289
`
`57,732
`1,961
`13,367
`9,240
`
`24,568
`
`21,173
`
`32,990
`174
`33,164
`57,732
`33,164
`848
`2,336
`
`31,177
`138
`31,315
`52,488
`31,315
`849
`2,338
`
`2008
`
`6,117
`5,792
`8,972
`57,418
`
`78,299
`3,395
`13,109
`11,358
`
`13,201
`5,455
`8,774
`48,022
`
`75,452
`3,018
`13,623
`9,415
`
`27,862
`
`26,056
`
`50,288
`149
`50,437
`78,299
`50,437
`820
`2,265
`
`49,223
`173
`49,396
`75,452
`49,396
`815
`2,264
`
`7,955
`4,498
`8,215
`46,604
`736
`68,008
`2,487
`13,540
`10,480
`207
`26,714
`
`41,111
`183
`41,294
`68,008
`41,294
`850
`2,348
`
`Cash Dividends per Share
`Cash dividends are translated into US dollars at the Reuters Market System Rate on the payment
`date. Because we pay dividends in Swiss francs, exchange rate fluctuations will affect the US dollar
`amounts received by holders of ADSs.
`
`Year Earned
`
`Month and
`Year Paid
`
`2004 . . . . . . . . . . . . . . . . . . . .
`2005 . . . . . . . . . . . . . . . . . . . .
`2006 . . . . . . . . . . . . . . . . . . . .
`2007 . . . . . . . . . . . . . . . . . . . .
`2008(1)
`. . . . . . . . . . . . . . . . . .
`
`March 2005
`February 2006
`March 2007
`February 2008
`February 2009
`
`Total Dividend
`per share
`(CHF)
`1.05
`1.15
`1.35
`1.60
`2.00
`
`Total Dividend
`per ADS
`($)
`0.93
`0.87
`1.11
`1.41
`1.88(2)
`
`(1)
`
`(2)
`
`Dividend to be proposed at the Annual General Meeting on February 24, 2009 and to be distributed February 27,
`2009.
`
`Translated into US dollars at the 2008 period end rate of $0.94 to the Swiss franc. This translation is an example
`only, and should not be construed as a representation that the Swiss franc amount represents, or has been or could
`be converted into US dollars at that or any other rate.
`
`5
`
`0011
`
`

`
`Exchange Rates
`The following table shows, for the years and dates indicated, certain information concerning the rate
`of exchange of US dollar per Swiss franc based on exchange rate information found on Reuters Market
`System. The exchange rate in effect on January 21, 2009, as found on Reuters Market System, was
`CHF 1.00 = $0.87.
`
`Year ended December 31,
`($ per CHF)
`2004 . . . . . . . . . . . . . . . . . . . . . . . . . .
`2005 . . . . . . . . . . . . . . . . . . . . . . . . . .
`2006 . . . . . . . . . . . . . . . . . . . . . . . . . .
`2007 . . . . . . . . . . . . . . . . . . . . . . . . . .
`2008 . . . . . . . . . . . . . . . . . . . . . . . . . .
`
`Month end,
`August 2008 . . . . . . . . . . . . . . . . . . . .
`September 2008 . . . . . . . . . . . . . . . . . .
`October 2008 . . . . . . . . . . . . . . . . . . .
`November 2008 . . . . . . . . . . . . . . . . . .
`December 2008 . . . . . . . . . . . . . . . . . .
`January 2009(2)
`. . . . . . . . . . . . . . . . . .
`
`Period End
`0.88
`0.76
`0.82
`0.88
`0.94
`
`Average(1)
`0.81
`0.80
`0.80
`0.83
`0.93
`
`Low
`0.76
`0.75
`0.76
`0.80
`0.82
`
`0.90
`0.88
`0.86
`0.82
`0.82
`0.87
`
`High
`0.88
`0.88
`0.84
`0.91
`1.02
`
`0.95
`0.92
`0.89
`0.87
`0.96
`0.94
`
`(1)
`
`(2)
`
`Represents the average of the exchange rates on the last day of each full month during the year.
`
`Through January 21, 2009.
`
`3.B Capitalization and Indebtedness
`Not applicable.
`
`3.C Reasons for the offer and use of proceeds
`Not applicable.
`
`3.D Risk Factors
`Our businesses face significant risks and uncertainties. You should carefully consider all of the
`information set forth in this annual report on Form 20-F and in other documents we file with or furnish to
`the SEC, including the following risk factors, before deciding to invest in any Novartis securities. Our
`business as well as our financial condition or results of operations could be materially adversely affected
`by any of these risks, as well as other risks and uncertainties not currently known to us or not currently
`deemed to be material.
`
`Risks Facing Our Business
`
`Our Pharmaceuticals Division faces and will continue to face important patent expirations and aggressive generic
`competition.
`Our Pharmaceuticals Division’s products are generally protected by patent rights, which are intended
`to provide us with exclusive rights to market the patented products. However, those patent rights are of
`varying strengths and durations. Loss of market exclusivity for one or more important products—whether
`due to patent expiration, generic challenges or other reasons—could have a material adverse effect on our
`
`6
`
`0012
`
`

`
`results of operations. The introduction of a generic version of a branded medicine typically results in a
`significant and rapid reduction in net sales for the branded product because generic manufacturers
`typically offer their unbranded versions at sharply lower prices. The pharmaceuticals industry is
`confronted by a continuing high level of patent expirations, with products representing approximately
`$24 billion in combined annual sales facing patent expiry in 2009, similar to levels seen in 2007 and 2008,
`according to IMS Health. In addition, generic manufacturers are increasingly conducting so-called
`‘‘launches at risk’’ of products that are still under legal challenge for patent infringement, before final
`resolution of legal proceedings.
`In 2008, sales of four Novartis Pharmaceuticals Division products—Lotrel (high blood pressure),
`Lamisil (fungal infections), Trileptal (epilepsy) and Famvir (viral infections)—continued to lose sales
`following the start of generic competition in the US in 2007. As a result of generic competition, combined
`net sales for these products declined from $2.6 billion in 2006 to $1.6 billion in 2007 and $536 million in
`2008. The sharp reduction in net sales of these products had an adverse effect on the results of operations
`of our Pharmaceuticals Division in 2007 and 2008.
`Four of our five best-selling products, Diovan (high blood pressure), Zometa, Femara (both for
`cancers), and Sandostatin (acromegaly) potentially could face generic competition in the near future in
`various markets, either in the US or Europe, or both, whether due to patent challenges or the scheduled
`expiration of patents. In particular, the patent on our top-selling drug, Diovan, expires in the major
`countries of the EU in 2011 and in the US in 2012. In addition, sales of Diovan may begin to erode in 2009
`in certain countries in the EU and in 2010 in the US when a competitor product, Cozaar↧, goes off-patent.
`Similarly, zoledronic acid, the active ingredient in Zometa, as well as in Reclast/Aclasta (osteoporosis), is
`currently the subject of US patent litigation, with the possibility of an ‘‘at risk launch’’ by one or more
`generic competitors as early as the end of 2010. Femara’s patent will expire in 2011 in the US and in major
`European markets. Patent litigation against a generic manufacturer who challenged the Femara patent has
`been settled. Finally, patents protecting the Sandostatin LAR formulation, the long-acting version of
`Sandostatin which represents a majority of our sales, expires in 2010 in major markets outside the US (and
`in 2014 and beyond in the US). Clearly, the loss of exclusivity of any one of these four products could have
`a material adverse effect on our business, financial condition and results of operations.
`In addition to Zometa and Reclast/Aclasta, key products of our Pharmaceuticals Division that are the
`subject of ongoing US patent litigation include Lescol (high cholesterol), Focalin/Ritalin LA (ADHD) and
`Comtan/Stalevo (Parkinson’s disease). The loss of exclusivity of some of these products could have a
`significant adverse effect on the results of operations of our Pharmaceuticals Division. In addition, Neoral
`(transplantation) and Voltaren (pain), which are still among our top ten-selling products with combined
`net sales of $1.8 billion in 2008, have already encountered generic competition in many markets. As a
`result, sales from these products may decline significantly in the future, which could have a material
`adverse effect on our business, financial condition and results of operations.
`For more information on the patent status of our Pharmaceuticals Division’s products see ‘‘Item 4.
`Information on the Company—Item 4.B Business Overview—Pharmaceuticals—Intellectual Property.’’
`We also rely in all aspects of our businesses on unpatented proprietary technology, know-how, trade
`secrets and other confidential information, which we seek to protect through various measures including
`confidentiality agreements with licensees, employees, third party collaborators, or consultants who may
`have access to such information. If these agreements are breached, our contractual remedies may
`inadequately cover any losses.
`
`Our business is increasingly affected by pressures on drug pricing.
`The growth of overall healthcare costs as a percentage of gross domestic product in many countries
`means that governments and payors are under intense pressure to control spending even more tightly. As
`a result, our businesses and the healthcare industry in general are operating in an ever more challenging
`
`7
`
`0013
`
`

`
`environment with very significant pricing pressures. These ongoing pressures include government-imposed
`industry-wide price reductions, mandatory pricing systems, an increase in imports of drugs from lower cost
`countries to higher cost countries, shifting of the payment burden to patients through higher co-payments,
`limiting physicians’ ability to choose among competing medicines, mandatory substitution of generic drugs
`and growing pressure on physicians to reduce the prescribing of patented prescription medicines. We
`expect these efforts to continue as healthcare payors around the globe—in particular government-
`controlled health authorities, insurance companies and managed care organizations—step up initiatives to
`reduce the overall cost of healthcare, restrict access to higher-priced new medicines, increase the use of
`generics and impose overall price cuts.
`These initiatives not only affect the results of our Pharmaceuticals Division, but also have an
`increasing impact on the prices we can charge for the generic drugs marketed by our Sandoz Division.
`This is particularly true in Europe and especially Germany, our second-largest market for generic
`products, where various measures have been introduced to require generic manufacturers to lower their
`prices. In addition, in the US, a combination of aggressive efforts by distributors to increase their profit
`margins on generic products that are considered commodities, intense

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket