20-F 1 a2103086z20-f.htm 20-F
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As filed with the Securities and Exchange Commission on February 24, 2003



UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington D.C. 20549


FORM 20-F

o REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
ý ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the fiscal year ended December 31, 2002
OR
o TRANSITION 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)

Securities registered pursuant to Section 12(b) of the Act:

 
   
Title of class
American Depositary Shares
each representing 1 ordinary share,
nominal value CHF 0.50 per ordinary share,
and ordinary shares
  Name of each exchange on which registered
New York Stock Exchange, Inc.

Securities 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:

2,474,970,619 ordinary shares

        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, as amended, 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 ý No o Not Applicable

Indicate by check mark which financial statement item the Registrant has elected to follow:

Item 17 o Item 18 ý





TABLE OF CONTENTS

INTRODUCTION AND USE OF CERTAIN TERMS   1

FORWARD-LOOKING STATEMENTS

 

1

PART I

 

2

 

Item 1.

 

 

Identity of Directors, Senior Management and Advisers

 

2

 

Item 2.

 

 

Offer Statistics and Expected Timetable

 

2

 

Item 3.

 

 

Key Information

 

2
  3. A   Selected Financial Data   2
  3. B   Capitalization and Indebtedness   6
  3. C   Reasons for the offer and use of proceeds   6
  3. D   Risk factors   6

 

Item 4.

 

 

Information on the Company

 

11
  4. A   History and Development of Novartis   11
  4. B   Business Overview   13
  4. C   Organizational Structure   66
  4. D   Property, Plants and Equipment   66

 

Item 5.

 

 

Operating and Financial Review and Prospects

 

71
  5. A   Operating Results   71
  5. B   Liquidity and Capital Resources   99
  5. C   Research and Development, Patents and Licenses   104
  5. D   Trend Information   104

 

Item 6.

 

 

Directors, Senior Management and Employees

 

104
  6. A   Directors and Senior Management   104
  6. B   Compensation   112
  6. C   Board Practices   120
  6. D   Employees   123
  6. E   Share Ownership   123

 

Item 7.

 

 

Major Shareholders and Related Party Transactions

 

125
  7. A   Major Shareholders   125
  7. B   Related Party Transactions   126
  7. C   Interests of Experts and Counsel   126

 

Item 8.

 

 

Financial Information

 

127
  8. A   Consolidated Statements and Other Financial Information   127
  8. B   Significant Changes   129

 

Item 9.

 

 

The Offer and Listing

 

129
  9. A   Listing Details   129
  9. B   Plan of Distribution   131
  9. C   Market   131
  9. D   Selling Shareholders   131
  9. E   Dilution   131
  9. F   Expenses of the Issue   131

 

Item 10.

 

 

Additional Information

 

131
  10. A   Share capital   131
  10. B   Memorandum and articles of association   131
  10. C   Material contracts   135
  10. D   Exchange controls   135

  10. E   Taxation   135
  10. F   Dividends and paying agents   139
  10. G   Statement by experts   139
  10. H   Documents on display   139
  10. I   Subsidiary Information   140

 

Item 11.

 

 

Quantitative and Qualitative Disclosures about Non-Product-Related Market Risk

 

141

 

Item 12.

 

 

Description of Securities other than Equity Securities

 

145

PART II

 

145

 

Item 13.

 

 

Defaults, Dividend Arrearages and Delinquencies

 

145

 

Item 14.

 

 

Material Modifications to the Rights of Security Holders and use of Proceeds

 

145

 

Item 15.

 

 

Controls and Procedures

 

145

 

Item 16.

 

 

[Reserved]

 

145

PART III

 

145

 

Item 17.

 

 

Financial Statements

 

145

 

Item 18.

 

 

Financial Statements

 

146

 

Item 19.

 

 

Exhibits

 

147


INTRODUCTION AND USE OF CERTAIN TERMS

        Novartis AG and our consolidated subsidiaries ("Novartis" or the "Group") publish consolidated financial statements expressed in Swiss francs ("CHF"). 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, 2002. In this Form 20-F, references to "CHF" are to Swiss francs; references to "US dollars", "US$" or "$" are to the lawful currency of the United States of America; and references to "m" are to million. Solely for the convenience of the reader, this Form 20-F contains translations of certain Swiss franc amounts into US dollar amounts at specified rates. These translations should not be construed as representations that the Swiss franc amounts actually represent such US dollar amounts or could be converted into US dollars at the rate indicated or at any other rate. Unless otherwise indicated, the translations from Swiss francs into US dollars have been made at the market rate as quoted by the Reuters Market System in effect on December 31, 2002, which was $1.00 = CHF 1.40.


        In this Form 20-F, references to the "United States" or to "US" are to the United States of America, references to "Europe" are to all European countries (including Turkey, Russia and the Ukraine), references to the European Union ("EU") are to each of the 15 member-states of the EU and references to "Americas" are to North, Central (including the Caribbean) and South America, unless the context otherwise requires; references to "Novartis" or the "Group" are to Novartis AG and its consolidated subsidiaries; references to "associates" are to employees of our affiliates; references to the "FDA" are to the United States Food and Drug Administration. All product names appearing in italics are trademarks of Group companies. Product names identified by a "®" are registered trademarks of other companies. 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 United States 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.


        We furnish to holders of our ordinary shares ("shares") annual reports that include a description of operations and annual audited consolidated financial statements prepared in accordance with International Accounting Standards ("IAS"). IAS differs in certain significant respects from Generally Accepted Accounting Principles in the United States ("US GAAP"). See "Item 18. Financial Statements—note 31" for a description of the significant differences between IAS and US GAAP. The financial statements included in the annual reports are examined and reported upon by our independent accountants. We make available to our shareholders, on our web page, quarterly interim press releases that include unaudited interim consolidated financial information prepared in conformity with IAS with a reconciliation to US GAAP.


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, relating to our business and the industries in which we operate. Certain such forward-looking statements can be identified by the use of forward-looking terminology such as "believe," "expect," "may," "are expected to," "will," "will continue," "should," "would be," "seek" or "anticipate" or similar expressions or the negative thereof or other variations thereof or comparable terminology, or by discussions of strategy, plans or intentions. Such statements include descriptions of our investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products we expect to introduce and anticipated customer demand for such products. Such statements reflect our current views with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Some of these factors are discussed 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 do not intend, and do not assume any obligation, to update any information or forward-looking statements set out in this Form 20-F.

1



PART I

Item 1.    Identity of Directors, Senior Management and Advisers

        Not applicable.


Item 2.    Offer Statistics and Expected Timetable

        Not applicable.


Item 3.    Key Information

3.A  Selected Financial Data

        The financial data at December 31, 2002, 2001, 2000, 1999 and 1998 shown in the chart below are taken from audited financial statements. Our consolidated financial statements ("consolidated financial statements") for the years ended December 31, 2002, 2001 and 2000 are included elsewhere in this Form 20-F. All financial data should be read in conjunction with "Item 5. Operating and Financial Review and Prospects" and our consolidated financial statements and accompanying notes which are included elsewhere in this Form 20-F. All financial data presented in this Form 20-F are qualified in their entirety by reference to the consolidated financial statements and such notes.

        The audited financial statements used to create the selected consolidated financial data set forth below were prepared in accordance with IAS. IAS differs in certain respects from US GAAP. For a discussion of the significant differences between IAS and US GAAP, see "Item 18. Financial Statements—note 31."

        For further information regarding continuing and discontinued activities (the Agribusiness Division), see "Item 4. Information on the Company—4.A. History and Development of Novartis" and "Item 5. Operating and Financial Review and Prospects—5.A. Operating Results."

2


 
  Year Ended December 31,
 
 
  2002(1)
  2002
  2001(2)
  2000(2)
  2000(2)(3)
  1999(2)
  1999(2)(3)
  1998
 
 
  ($)

  (CHF)

  (CHF)

  (CHF)

  (CHF)

  (CHF)

  (CHF)

  (CHF)

 
 
  (in millions except per share data)

   
 
INCOME STATEMENT DATA                                  
Amounts in accordance with IAS:                              
Net sales   23,151   32,412   31,643   35,395   28,702   32,282   25,226   31,702  
   
 
 
 
 
 
 
 
 
Operating income   5,634   7,887   7,277   7,883   6,727   7,343   6,696   6,920  
Income from associated companies   (7 ) (10 ) 139   98   97   383   376   239  
Net financial income   678   949   1,067   1,091   1,216   793   990   759  
   
 
 
 
 
 
 
 
 
Income before taxes and minority interests   6,305   8,826   8,483   9,072   8,040   8,519   8,062   7,918  
Taxes   (1,064 ) (1,490 ) (1,440 ) (1,820 ) (1,504 ) (1,833 ) (1,683 ) (1,882 )
Minority interests   (16 ) (23 ) (19 ) (42 ) (25 ) (27 ) (20 ) (26 )
   
 
 
 
 
 
 
 
 
Net income   5,225   7,313   7,024   7,210   6,511   6,659   6,359   6,010  
   
 
 
 
 
 
 
 
 
Basic earnings per share(4)   2.08   2.91   2.73   2.75   2.50   2.50   2.40   2.28  
Diluted earnings per share(4)   2.03   2.84   2.72   2.75   2.50   2.50   2.40   2.28  
Cash dividends(5)   1,639   2,294   2,194   2,064       1,935       1,663  
Cash dividends per share(4),(5)   0.68   0.95   0.90   0.85       0.80       0.73  
Operating income from continuing operations per share:                                  
  basic earnings per share(4)   2.24   3.14   2.83   2.58   2.58   2.53   2.53   2.20  
  diluted earnings per share(4)   2.19   3.07   2.82   2.58   2.58   2.53   2.53   2.20  

(1)
The Swiss franc amounts have been translated into US dollars at the rate of CHF 1.40 to the dollar. Such translations should not be construed as representations that the Swiss franc amounts represent, or have been or could be converted into, US dollars at that or any other rate.

(2)
Restated to reflect a change in classification of certain sales incentives and discounts to retailers. Sales and marketing & distribution expenses have both been reduced by CHF 395 million for 2001, CHF 410 million for 2000 and CHF 183 million for 1999.

(3)
Financial data is presented on a continuing basis, excluding the results of the Agribusiness Division, which was spun-off in 2000. See "Item 4. Information on the Group—4.A. History and Development of the Group".

(4)
Basic and Diluted earnings and cash dividends per share have been adjusted to reflect a forty-for-one share split effective May 7, 2001. The years 2000, 1999 and 1998 have been adjusted to take this split into account, in order to provide per share information on a consistent basis.

(5)
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.

3


 
  Year Ended December 31,
 
  2002(1)
  2002
  2001
  2000
  1999
  1998
 
  ($)

  (CHF)

  (CHF)

  (CHF)

  (CHF)

  (CHF)

 
  (in millions, except per share data)

BALANCE SHEET DATA                        
Amounts in accordance with IAS:                        
Cash, cash equivalents and current marketable securities   12,575   17,605   22,152(2)   20,748(2)   16,328   14,170
Inventories   2,971   4,159   4,112   4,122   6,887   6,695
Other current assets   5,324   7,454   7,912(2)   8,069(2)   11,464   9,088
Long-term assets   24,274   33,984   32,585   25,257   30,848   26,272
   
 
 
 
 
 
Total assets   45,144   63,202   66,761   58,196   65,527   56,225
   
 
 
 
 
 
Trade accounts payable   1,270   1,778   1,809   1,591   1,971   1,537
Other current liabilities   7,024   9,834   12,388(2)   10,049   15,442   13,453
Long-term liabilities and minority interests   8,506   11,908   10,319(2)   9,694   10,898   9,839
Total equity   28,344   39,682   42,245   36,862   37,216   31,396
   
 
 
 
 
 
Total liabilities and equity   45,144   63,202   66,761   58,196   65,527   56,225
   
 
 
 
 
 
Net assets   28,410   39,774   42,349   36,940   37,437   31,590
Outstanding share capital   884   1,237   1,274   1,304   1,313   1,328

Amounts in accordance with US GAAP:

 

 

 

 

 

 

 

 

 

 
Income statement data                        
Net income   4,218   5,905   4,703   6,913   5,419   4,955
Basic earnings per share(3)(4)   1.74   2.44   1.90   2.74   2.10   1.92
Diluted earnings per share(3)(4)   1.71   2.39   1.90   2.74   2.10   1.92

Balance sheet data

 

 

 

 

 

 

 

 

 

 

 

 
Total equity   33,319   46,646   50,747   48,802   50,575   47,823
Total assets   50,501   70,701   75,732   72,077   79,756   73,014

(1)
The Swiss franc amounts have been translated into US dollars at the rate of CHF 1.40 to the dollar. Such translations should not be construed as representations that the Swiss franc amounts represent, or have been or could be converted into, US dollars at that or any other rate.

(2)
Restated due to reclassification of the fair value of derivative financial instruments from other current assets to cash, cash equivalents and current marketable securities and from other current liabilities to long term liabilities and minority interests.

(3)
Earnings per share has been adjusted to reflect a forty-for-one share split effective May 7, 2001. 2000, 1999 and 1998 figures have been adjusted to take this split into account, in order to provide earnings per share information on a consistent basis.

(4)
Effective January 1, 2002, goodwill and other indefinite life intangibles are no longer amortized in accordance with US GAAP. For an analysis of reported earnings per share for 2002, 2001 and 2000, see "Item 18. Financial Statements—note 31(xi)".

4


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

  Total Dividend(2)
per share

  Total Dividend(4)
per ADS

 
   
  (CHF)

  ($)

1998   April 1999   0.73   0.40
1999   April 2000   0.80   0.41
2000   April 2001   0.85   0.43
2001   March 2002   0.90   0.54
2002(1)(3)   March 2003   0.95   0.68

(1) If the Swiss franc amount for 2002 is translated into US dollars at the rate of CHF 1.40 to the dollar, the Total Dividend per share and Total dividend per ADS in US dollars would be $0.68. Such translation should not be construed as representations that the Swiss franc amount represent, or have been or could be converted into, US dollars at that or any other rate.
(2) 1998, 1999 and 2000 figures have been adjusted for a forty-for-one share split and share-to-ADS ratio change on May 7, 2001.
(3) Dividend to be proposed at the Annual General Meeting on March 4, 2003.
(4) 1998 and 1999 figures have been adjusted for a two-for-one split for the ADSs on May 11, 2000.

Exchange Rates

        The following table shows, for the years and dates indicated, certain information concerning the rate of exchange of Swiss francs per US dollar based on exchange rate information found on Reuters Market System. The exchange rate in effect on February 18, 2003, as found on Reuters Market System, was CHF 1.37 = $1.00.

 
  Year ended December 31,
 
  Period End
  Average(1)
  High
  Low
1998   1.37   1.45   1.54   1.29
1999   1.59   1.51   1.60   1.36
2000   1.64   1.69   1.83   1.55
2001   1.68   1.69   1.82   1.58
2002   1.40   1.55   1.72   1.39
September 2002   1.52   1.47
October 2002   1.51   1.47
November 2002   1.49   1.44
December 2002   1.49   1.39
January 2003   1.40   1.35
February 2003(2)   1.37   1.34

(1) Represents the average of the exchange rates on the last day of each full month during the year.
(2) The high and low US dollar/Swiss Franc exchange rate is current as of February 18, 2003.

5


3.B  Capitalization and Indebtedness

        Not applicable.

3.C  Reasons for the offer and use of proceeds

        Not applicable.

3.D  Risk factors

        You should carefully consider all of the information set forth in this Form 20-F and the following risk factors which we face and which are faced by our industry. The risks below are not the only ones we face. Additional risks not currently known to us or that we presently deem immaterial may also impair our business operations. Our business, financial condition or results of operations could be materially adversely affected by any of these risks. This Form 20-F also contains forward-looking statements that involve risks and uncertainties. Our results could materially differ from those anticipated in these forward-looking statements as a result of certain factors, including the risks we face as described below and elsewhere. See "Forward-Looking Statements."

We face intense competition from new products.

        Our products face intense competition from competitors' products. This competition may increase as new products enter the market. In such an event, our competitors' products may be safer or more effective or more effectively marketed and sold than our products. If we fail to maintain our competitive position, this could have a material adverse effect on our business and results of operations.

Our research and development efforts may not succeed.

        In order to remain competitive, we must continue to launch new and better products each year. To accomplish this, we commit substantial effort, funds and other resources to research and development, both through our own dedicated resources, and on various collaborations with third parties. Our ongoing investments in new product launches and research and development for future products could produce higher costs without a proportional increase in revenues.

        In the pharmaceutical business, the research and development process can take up to 12 years, or even longer, from discovery to commercial product launch. This process is conducted in various stages. During each stage there is a substantial risk that we will not achieve our goals and accordingly we may abandon a product in which we have invested substantial amounts. If we fail to continue developing commercially successful products, this could have a material adverse effect on our business and results of operations.

        Our dependence on research and development makes it highly important that we recruit and retain high quality researchers and development specialists. We commit substantial efforts and funds to this purpose. Should we fail in our efforts, this could have a material adverse effect on our business and results of operations.

We face intense competition from lower-cost generic products.

        We also face increasing competition from lower-cost generic products after patents on our products expire. Loss of patent protection typically leads to a rapid loss of sales for that product and could affect future results. Patent protection is no longer available in major markets for the active ingredients used in a number of our Pharmaceuticals Division's leading products.

    Neoral.    Patent protection exists for the Neoral micro-emulsion formulation and other cyclosporin formulations through 2009 and beyond in major markets. Despite this protection, generic cyclosporin products competing with Neoral have entered the transplantation market segment in

6


      the US, Germany and elsewhere. We have filed patent infringement actions against manufacturers of these generic products. However, despite a finding of infringement and an award of damages against one of these manufacturers in the US, we have so far not succeeded in obtaining an injunction, or a final judgment of damages against any of the manufacturers we have sued.

    Aredia.    Our patent protection for Aredia is limited. Generic versions of Aredia were launched in the United States in 2001 and 2002. Generic products in competition with Aredia are on sale in Canada and elsewhere. However, in 2002, we launched Zometa, our more potent successor product to Aredia.

    Sandostatin.    Basic patent protection for Sandostatin has expired in the US and Japan and will expire April 2003 in Germany and the UK, 2006 in France, and 2007 in Italy. However, protection extending to 2010 (2013 and beyond in the United States) continues in major markets for Sandostatin LAR, which represents a substantial and growing proportion of our octreotide sales.

    Cibacen/Lotensin/Cibadrex.    The basic benazepril substance patent for Cibacen/Lotensin/Cibadrex expired in Japan in 2002 and will expire in the US in August 2003 (or expected to expire in February 2004 with any six-month pediatric exclusivity) and in 2004-08 in major markets in the EU. However, Lotrel, which is a combination of benazepril with amlodipine, is patented in the US until 2017.

    Lamisil.    Lamisil is covered generically by a patent family which will expire in 2004 in the US, March 2003 in Japan and has expired in other major countries. Another patent family covers the product specifically and expires in 2006 in the US, 2004-05 in Japan and 2005-07 in major EU countries. The specific US patent is being challenged by Dr. Reddy Laboratories in the US.

    Voltaren.    Voltaren is off-patent. As a result, revenue from Voltaren may decline significantly over the next few years.

Government regulation may adversely affect our business.

        We and our competitors are subject to strict government controls on the development, manufacture, marketing, labeling, distribution and pricing of products. We must obtain and maintain regulatory approval for our pharmaceutical and other products from regulatory agencies in order to sell our products in a particular jurisdiction.

        Risks regarding the development of new products.    Our research and development activities are heavily regulated. If we fail to comply fully with applicable regulations, then there could be a delay in the submission or approval of potential new products for marketing approval. In addition, the submission of an application to a regulatory authority does not guarantee that a license to market the product will be granted. Each authority may impose its own requirements and delay or refuse to grant approval, even when a product has already been approved in another country. In our principal markets, the approval process for a new product is complex, lengthy and expensive. The time taken to obtain approval varies by country but generally takes from six months to several years from the date of application. This registration process increases the cost to us of developing new products and increases the risk that we will not succeed in selling them successfully.

        Risks regarding the manufacture of our products.    The manufacture of our products is heavily regulated by governmental authorities around the world, including the US FDA. If we or our third party suppliers fail to comply fully with such regulations then there could be a government-enforced shutdown of production facilities, which in turn could lead to product shortages. A failure to comply fully with such regulations could also lead to a delay in the approval of new products.

        Risks regarding the marketing of our products.    The marketing of our products is also heavily regulated by governments throughout the world. In many countries, particularly those in Europe, we are prohibited from marketing our products directly to consumers. In the United States, some direct-to-consumer

7



marketing practices are permitted, but the scope of allowable marketing practices is still significantly limited. Most countries also place restrictions on the manner and scope of permissible marketing to physicians and other health professionals. The effect of such regulations may be to limit the amount of revenue which we may be able to derive from a particular product. In addition, if we fail to comply fully with such regulations then civil or criminal actions could be brought against us.

        Risks regarding the pricing of our products.    In addition to normal price competition in the marketplace, the prices of our pharmaceutical products are restricted by price controls imposed by governments and health care providers in most countries. Price controls operate differently in different countries and can cause wide variations in prices between markets. Currency fluctuations can aggravate these differences. The existence of price controls can limit the revenues we earn from our products and may have an adverse effect on our business and results of operations.

    United States.    In the United States, ongoing political debates over prescription drug pricing and Medicare reform could increase pricing pressures. In particular, if Medicare reform results in the provision of outpatient pharmaceutical coverage for beneficiaries, the United States government could use its enormous purchasing power to demand discounts from pharmaceutical companies. This could effectively create price controls on prescription drugs.

    Europe.    In Europe, our operations are also subject to price and market regulations. Many governments are introducing healthcare reforms in an attempt to curb increasing healthcare costs.

    Japan.    In Japan, where we also operate, the government generally introduces price cut rounds every other year, during which the government mandates price decreases for specific products.

    Regulations favoring generics.    In response to rising healthcare costs, many governments and private medical care providers, such as Health Maintenance Organizations (HMOs), have instituted reimbursement schemes that favor the substitution of generic pharmaceuticals for more expensive brand-name pharmaceuticals. In the United States, generic substitution statutes have been enacted by virtually all states and permit or require the dispensing pharmacist to substitute a less expensive generic drug instead of an original branded drug.

        As a result, we expect that pressures on pricing and operating results will continue and may increase.

        Risks regarding the safety and efficacy of our products.    Regulatory agencies may at any time reassess the safety and efficacy of our products based on new scientific knowledge or other factors. Such reassessments could result in the amendment or withdrawal of existing approvals to market our product, which in turn would result in a loss of revenue, and could serve as an inducement to bring lawsuits against us.

        Other regulatory risks.    Changes in worldwide intellectual property protections and remedies, trade regulations and procedures, as well as unstable governments and legal systems, intergovernmental disputes and possible nationalization could also materially adversely affect our business or results of operations.

We operate in highly competitive and rapidly consolidating industries.

        We operate in highly competitive and rapidly consolidating industries. Our principal competitors are major international corporations with substantial resources for research and development, production and marketing. Our competitors are consolidating, and the strength of combined companies could affect our competitive position in all of our business areas.

Product liability claims could adversely affect our business and results of operations.

        Potentially, product liability is a significant commercial risk for us. Substantial damage awards have been made in some jurisdictions against pharmaceutical companies based upon claims for injuries allegedly caused by the use of their products. We are involved in a number of product liability cases

8



claiming damages as a result of the use of our products. While we hold insurance for product liability in reasonable and prudent amounts, it is possible that not all risks may be covered by such insurance. Such insurance is becoming more difficult to obtain and more expensive when it is available. We believe, but do not know with certainty, that any reasonably foreseeable unaccrued costs and liabilities associated with the risks of product liability claims will not have a material adverse effect on our consolidated financial position, results of operations or liquidity.

Patent claims could adversely affect our Generics Business Unit and results of its operations.

        We take all reasonable steps to ensure that our products, including the products manufactured and sold by our Generics Business Unit, do not infringe valid third-party intellectual property rights. Nevertheless, originating companies commonly assert patent and other intellectual property rights, in order to delay or prevent generic competition. As a result, we can become involved in extensive litigation regarding our generic products. If we are unsuccessful in defending against these suits, we could be subject to injunctions preventing us from selling our generic products, or to damages, which may be substantial. Either event could have a material adverse effect on our consolidated financial position, results of operations or liquidity. See "Item 4. Information on the Company—4.B. Business Overview—Generics—Intellectual Property."

Our business will continue to expose us to risks of environmental liabilities.

        In our product development programs and manufacturing processes, it is sometimes necessary for us to use hazardous materials, chemicals, viruses and toxic compounds. These programs and processes expose us to risks of accidental contamination, events of noncompliance with environmental laws and regulatory enforcement, personal injury, property damage and claims resulting from these events. If an accident occurred, or if we discover contamination caused by prior operations, we could be liable for cleanup obligations, damages or fines, which could have an adverse effect on our business and results of operations.

        The environmental laws of many jurisdictions impose actual and potential obligations on us to remediate contaminated sites. These obligations may relate to sites:

    that we currently own or operate;

    that we formerly owned or operated; or

    where waste from our operations was disposed.

        These environmental remediation obligations could significantly reduce our operating results. In particular, our accruals for these obligations may be insufficient if the assumptions underlying the accruals—including our assumptions regarding the portion of the waste at a site for which we are responsible—prove incorrect, or if we are held responsible for additional contamination.

        Stricter environmental, safety and health laws and enforcement policies could result in substantial costs and liabilities to us, and could subject our handling, manufacture, use, reuse or disposal of substances or pollutants to more rigorous scrutiny than is currently the case. Consequently, compliance with these laws could result in significant capital expenditures as well as other costs and liabilities, thereby harming our business and operating results.

The manufacture of our products is technically highly complex, and a supply interruption or delay could adversely affect our business and results of operation.

        The products we market, distribute and sell are either manufactured at our own dedicated manufacturing facilities, or through toll manufacturing arrangements or supply agreements with third parties. Since many of our products are the result of technically complex manufacturing processes, and are sometimes dependent on highly specialized raw materials, we can provide no assurances that supply sources will not be interrupted from time to time. In addition, for these same reasons, the volume of

9



production of any product cannot be rapidly altered. As a result, if we should fail to accurately predict market demand for any of our products then we may not be able to produce enough of the product to meet that demand, or may produce too much of the product, either of which could affect our business and operating results.

Foreign exchange fluctuations may adversely affect our earnings and the value of some of our assets.

        Through December 31, 2002, we prepared our consolidated financial statements in Swiss francs. Beginning on January 1, 2003, we will prepare our consolidated financial statements in US dollars. In either case, a significant portion of our earnings and expenditures are in currencies other than our reporting currency. In 2002, 43% of our sales were made in US dollars, 25% in Euro, 8% in Japanese yen, 5% in Swiss francs and 19% in other currencies. In 2002, 32% of our costs were generated in US dollars, 25% in Euro, 21% in Swiss francs, 6% in Japanese yen and 16% in other currencies. Changes in exchange rates between the Swiss franc, the US dollar and these other currencies can result in increases or decreases in our costs and earnings. Fluctuations in exchange rates between the Swiss franc, the US dollar and other currencies may also affect the book value of our assets outside Switzerland and the amount of shareholders' equity. We seek to minimize our currency exposure by engaging in hedging transactions where we deem it appropriate. To mitigate some of these risks, we have hedged certain US dollar and Japanese yen positions for 2003. We cannot predict, however, all changes in currency and interest rates, inflation or other factors, which could affect our international businesses.

Decreases in financial income could affect our earnings.

        In recent years, we have earned an attractive level of financial income, net, in a difficult investment environment, due to good currency management and investment strategies. Given the volatile nature of investment markets, there can be no guarantee that such gains will be repeated in the future, or that we can avoid suffering losses from this trading activity.

Changes in accounting rules could affect our reported results.

        The International Accounting Standards Board is entering a period of critically examining current International Accounting Standards with a view to increasing international harmonization of accounting rules. This process of amendment and convergence of worldwide accounting rules could result in significant amendments to the existing rules within the next two years in such areas as the timing of recognition of sales and other revenues arising from collaborative agreements with marketing and distribution partners, accounting for share-based compensation, goodwill and intangibles, employee benefit plans, marketable securities and derivative financial instruments and classification of balance sheet positions as debt or equity. It is not possible to predict the impact on our reported results of any such rule changes which may be made in the future, or whether such rule changes would be retrospective, potentially requiring us to restate past reported results.

Changes in tax laws could adversely affect our earnings.

        Changes in the tax laws of Switzerland, the United States, or other countries in which we do significant business, as well as changes in our effective tax rate for the fiscal year caused by other factors, could affect our net income. During 2002, no major tax legislation was enacted that would materially impact our net income. It is not possible to predict the impact on our results of any tax legislation which may be enacted in the future.

Changes in global economic conditions could affect our business and results of operations.

        Our future results could be effected by changes in the global economy, including the changes in economic conditions which have resulted, and could continue to result from recent terrorist attacks, and any additional terrorist attacks which may occur in the future, as well as from any related military activity around the world.

10




Item 4. Information on the Company

4.A  History and Development of Novartis

        Novartis AG, headquartered in Basel, Switzerland, is a public company incorporated under the laws of Switzerland with an indefinite duration. We were created as a result of the merger of Sandoz AG and CIBA-Geigy AG in December 1996. Prior to the merger, Sandoz AG and CIBA-Geigy AG were each global participants in the pharmaceutical and agrochemical industries. We are domiciled in and are governed by the laws of Switzerland.

        Our Group companies employ approximately 73,000 associates worldwide and operate in over 140 countries. Our registered shares are listed in Switzerland on the SWX Swiss Exchange ("SWX") and traded on the European trading platform virt-x, and our American Depositary Shares are listed on the New York Stock Exchange ("NYSE"). Our shares are also traded on the SEAQ International exchange in London. Our registered office is located at Lichtstrasse 35, 4056 Basel and our telephone number is 011-41-61-324-1111. We maintain an Internet website at http://www.novartis.com. In the US, Corporation Service Company (2711 Centerville Road, Suite 400, Wilmington, Delaware 19808, telephone: 1-800-927-9800) acts as our agent solely for the purpose of accepting service of process in respect of registration statements on Forms F-3 under the US Securities Act of 1933, as amended.

Major transactions in 2002, 2001 and 2000

        On November 29, 2002, our Generics Business Unit acquired 99% of Lek Pharmaceuticals d.d., the Slovenian generics company, for CHF 1.3 billion (approximately US$929 million) in cash. See "Item 4. Information on the Company—4.B. Business Overview—Generics."

        On November 29, 2002, our Consumer Health Division divested its Food & Beverage business to Associated British Foods plc, of the United Kingdom, for CHF 402 million (approximately US$287 million) in cash. See "Item 4. Information on the Company—4.B. Business Overview—Medical Nutrition." After the sale of the Food & Beverages business to Associated British Foods plc., the remaining Health Food & Slimming and Sports Nutrition businesses were reorganized as a stand-alone unit, Nutrition & Santé, which for external reporting purposes will be consolidated into our Medical Nutrition Business Unit.

        In January 2002, our Animal Health Business Unit acquired two US farm animal vaccine companies, Grand Laboratories Inc., of Iowa, and ImmTech Biologies Inc., of Kansas, for a combined minimum purchase price of CHF 168 million (approximately US$120 million), of which CHF 133 million (approximately US$95 million) was settled in Novartis American Depositary Shares. The final price may increase depending on whether certain future sales and other targets are met. See "Item 4. Information on the Company—4.B. Business Overview—Animal Health."

        On May 5, 2001 we announced the acquisition of 32 million bearer shares of Roche Holding AG, representing 20% of the voting shares of that company for approximately CHF 4.8 billion (approximately US$2.8 billion). These shares were purchased as a package from BZ Gruppe Holding AG and are intended as a financial investment of a potentially strategic nature. At December 31, 2001 we held 21.3% of the voting shares of Roche Holding AG, which represented an approximate 4% interest in the total Roche equity. During 2002, we increased our investment in Roche by CHF 2.9 billion (approximately US$2.1 billion) by acquiring a further 11.4% of the company's voting shares. At December 31, 2002, we owned 32.7% of Roche's voting shares, which represents approximately 6.2% of Roche Holding AG's total shares and equity securities.

        On December 21, 2000, Novartis Pharmaceuticals completed the acquisition of the antiviral products Famvir (famciclovir) and Vectavir/Denavir (penciclovir) from SmithKline Beecham, for a total price of CHF 2.7 billion approximately (US$1.6 billion).

11



        In November 2000, we spun-off and merged our Crop Protection and Seeds businesses with AstraZeneca's Zeneca Agrochemicals to create Syngenta AG ("Syngenta"), which is headquartered in Basel, Switzerland, and is listed on the Swiss, London, New York and Stockholm stock exchanges.

        On October 2, 2000, CIBA Vision acquired the stock of Wesley Jessen VisionCare Inc., a US corporation, for CHF 1.3 billion (approximately US$800 million) in cash.

        For a description of our principal capital expenditures and divestitures, see "Item 5. Operating and Financial Review and Prospects—5.B. Liquidity and Capital Resources."

General Corporate Initiatives

        We have undertaken a number of initiatives designed to make our management of the Group more transparent to investors and advance our corporate citizenship ideals.

        In 2002:

    We became the first major pharmaceuticals company to create internal ethical guidelines regarding the use of human stem cells in research, and we established a six-member Ethics Committee, chaired by a Professor of Ethics from the Swiss Federal Institute of Technology, to monitor global compliance with these guidelines;

    We introduced three changes to our Articles of Incorporation intended to enhance shareholders' rights: The deadline for submitting agenda items prior to a General Meeting of the shareholders was reduced from 60 to 45 days; shareholders were given the option of conducting electronic voting during the General Meeting; and Directors' terms of office were reduced from four to three years;

    We issued Guidelines to our associates to assist them in integrating our Corporate Citizenship Policy into their daily activities.

    In the US, together with other leading pharmaceutical companies, we issued the Together Rx Card which provides discounts on a broad range of pharmaceuticals from many manufacturers. The total volume of discounts provided by us under the Together Rx Card program amounted to about CHF 40 million in 2002.

        In 2001:

    We created a Board-level committee to develop and implement sound corporate governance principles;

    We gave the Board's Audit and Compliance Committee additional responsibility to monitor our compliance with law and policy;

    We instituted a new Policy of Corporate Citizenship which sets the framework for our commitment to making corporate citizenship an integral aspect of our business;

    We created a patient assistance program to help persons with limited financial means to afford Gleevec/Glivec, our innovative oncology medication;

    In collaboration with the World Health Organization ("WHO"), we announced a plan to stem the spread of malaria in Africa and other endemic regions in the developing world. As part of a world-wide initiative entitled "Roll Back Malaria," we will provide specially designed packs of Coartem, our novel malaria treatment, for distribution through WHO at cost;

    We established the Novartis Institute for Tropical Diseases in Singapore to target tropical diseases, including Dengue fever, and infections like tuberculosis;

    In the US, we instituted the Novartis CareCard program to assist low income elderly to obtain the Novartis medications they need at significant discounts;

12


    We split our shares 40 for 1 so that there is now a 1:1 share-to-ADS ratio.

        In 2000:

    We rolled out the Novartis Code of Conduct to our employees throughout the world;

    We were among the first companies to join the Global Compact, a multilateral initiative of United Nations Secretary General Kofi Annan that is consistent with our own approach to business ethics. The Global Compact formulates nine principles in the areas of environmental protection, respect for the workforce, and human rights.

        As part of our commitment to focus not just on our business, but on the business of being a responsible member of the global community, we have continued initiatives like the Novartis Community Partnership Day where all our employees around the world are encouraged, for one day each year, to give time back to the communities in which we operate.

4.B  Business Overview

General

        We are a world leader both in sales and in innovation in our continuing core businesses: pharmaceuticals and consumer health, which includes generics, OTC self-medication, animal health, medical nutrition, infant and baby foods and products, and eyecare products. We aim to hold a leadership position in all of these businesses. We are committed to improving health and well-being through innovative products and services. The name "Novartis" is derived from the Latin novae artes, meaning "new skills," which reflects our focus on research and development.

Product Areas and Geographic Markets

        We are organized into two Divisions: Pharmaceuticals and Consumer Health. In 2002, the Consumer Health Division was reorganized to include our Generics, OTC self-medication, Animal Health, Medical Nutrition (including our Nutrition & Santé unit), Infant & Baby and CIBA Vision Business Units. All references to Group figures, unless otherwise indicated, including associates and sales, include the Agribusiness Division up until the November 6, 2000 spin-off. The following tables set forth the Group's sales and operating income by Division or Business Unit for the financial years ended December 31, 2002, 2001 and 2000. Because the Pharmaceuticals Business Units have common long-term economic perspectives, common customers, common research, development, production and distribution practices, and a common regulatory environment, their financial data are not required to be separately disclosed.

13


 
  Year Ended December 31,
 
 
  2002
  2001(1)
  2000(1)
 
 
  (in CHF millions)

 
Sales to third parties              
Pharmaceuticals   21,002   20,181   18,150  
   
 
 
 
  Generics   2,809   2,433   1,973  
  OTC(3)   2,359   2,538   2,483  
  Animal Health   971   962   1,083  
  Medical Nutrition (including Nutrition & Santé)(3)   1,109   1,115   1,136  
  Infant & Baby(3)   2,075   2,227   2,108  
  CIBA Vision   1,762   1,787   1,392  
   
 
 
 
Consumer Health—ongoing   11,085   11,062   10,175  
Divested Health & Functional Food activities   325   400   377  
   
 
 
 
Consumer Health   11,410   11,462   10,552  
   
 
 
 
Sales from continuing activities   32,412   31,643   28,702  
Sales from discontinued Agribusiness activities(2)           6,693  
   
 
 
 
Group sales   32,412   31,643   35,395  
   
 
 
 

Operating income

 

 

 

 

 

 

 
Pharmaceuticals   6,022   5,677   5,401  
   
 
 
 
  Generics   406   281   242  
  OTC(3)   374   452   424  
  Animal Health   144   138   179  
  Medical Nutrition (including Nutrition & Santé)(3)   6   87   66  
  Infant & Baby(3)   355   388   371  
  CIBA Vision   183   174   100  
   
 
 
 
Consumer Health—ongoing   1,468   1,520   1,382  
Divested Health & Functional Food activities   216   (7 ) 8  
   
 
 
 
Consumer Health   1,684   1,513   1,390  
   
 
 
 
Corporate and other income/expense   181   87   (64 )
   
 
 
 
Operating income from continuing activities   7,887   7,277   6,727  
Operating income from discontinued Agribusiness activities(2)           1,156  
   
 
 
 
Group operating income   7,887   7,277   7,883  
   
 
 
 

(1)   Restated to reflect a change in classification of certain sales incentives and discounts to retailers. Sales and marketing & distribution expenses have both been reduced by CHF 395 million in 2001 and CHF 410 million in 2000.

(2)

 

Agribusiness: Crop Protection and Seeds businesses through November 6, 2000, the date of spin-off.

(3)

 

2001 and 2000 figures were previously reported as a single Business Unit under Consumer Health. They are now separated into OTC, Medical Nutrition (including Nutrition & Santé) and Infant & Baby Business Units.

14


        The table below sets forth a regional breakdown of certain data for the years ended December 31, 2002, 2001 and 2000.

 
  Americas
  Europe
  Asia/Africa/Australia
 
 
  2002
  2001
  2000
  2002
  2001
  2000
  2002
  2001
  2000
 
Sales (CHF m)(1)   16,407   16,303   17,400   10,602   10,107   11,686   5,403   5,233   6,309  
Operating income (CHF m)   1,483   2,240   2,570   5,927   4,473   4,377   477   564   936  
Number of employees (at December 31)   28,328   27,303   27,063   32,595   31,386   28,815   11,954   12,427   11,775  
Investment in tangible fixed assets (CHF m)   836   723   475   774   560   790   51   68   88  
Depreciation of tangible fixed assets (CHF m)   (308 ) (311 ) (388 ) (553 ) (561 ) (715 ) (60 ) (67 ) (86 )
Net operating assets (CHF m)(2)   8,858   10,216   9,400   19,776   17,071   11,574   1,354   1,587   1,372  

(1)
2001 and 2000 figures have been restated to reflect a change in classification of certain sales incentives and discounts to retailers. Sales and marketing & distribution expenses have both been reduced by CHF 395 million in 2001 and CHF 410 million in 2000.

(2)
2001 and 2000 figures have been restated due to reclassification of the fair value of derivative financial instruments from other current assets to cash, cash equivalents and current marketable securities and from other current liabilities to long term liabilities and minority interests.

PHARMACEUTICALS

        The business of our Pharmaceuticals Division is conducted by a number of affiliated companies throughout the world. We are a world leader in the discovery, development, manufacture and marketing of prescription medicines. Our goal is to provide a broad portfolio of effective and safe products to patients through healthcare professionals around the world. This goal is supported by approximately 80 affiliates marketing our products in more than 140 countries. In 2002, the affiliated companies of our Pharmaceuticals Division employed 44,110 associates and had CHF 21.0 billion in sales, which represented 65% of the Group's sales.

        Our product portfolio includes a wide range of products in seven major disease areas: (i) cardiovascular/metabolism/endocrinology; (ii) oncology/hematology; (iii) central nervous system; (iv) transplantation/immunology; (v) respiratory/dermatology; (vi) rheumatology/bone/hormone replacement therapy/gastrointestinal and (vii) ophthalmics. Effective January 1, 2001, Novartis Pharmaceuticals took over responsibility for operating the ophthalmic pharmaceutical business previously managed by CIBA Vision. Our Pharmaceuticals Division is organized into five Business Units: Primary Care, Oncology, Transplantation, Ophthalmics and Mature Products. The Business Units coordinate the worldwide research, distribution, marketing and sales of the products assigned to each. Because the Business Units of the Pharmaceuticals Division have common long-term economic perspectives, common customers, common research, development, production and distribution practices, and a common regulatory environment, their financial data are not required to be separately disclosed.

        The current product portfolio includes more than 30 key marketed products, of which four were launched in 2002. In addition, the portfolio includes more than 60 potential products or potential additional indications for existing products in various stages of development. See "—Research and Development."

15


Key Marketed Products

        The following table describes the key marketed products of our Pharmaceuticals Division, in alphabetical order, by therapeutic area.


Therapeutic
area

  Project/
Compound

  Generic name

  Indication

  Formulation

Cardiovascular,
metabolism and
  Cibacen/
Lotensin
  benazepril   Hypertension   Coated tablet
endocrinology  
    Cibadrex/   benazepril + HCT   Hypertension   Coated tablet
    Lotensin HCT            
   
    Co-Diovan/
Diovan HCT
  valsartan + HCT   Hypertension   Film-coated tablet
   
    Diovan   valsartan   Hypertension
Congestive Heart Failure
  Capsule, film-
coated tablet
   
    Lescol/
Lescol XL
  fluvastatin   Primary and mixed
hypercholesterolemia
Slowing the progression of
artherosclerosis
Increase of high-density
lipoprotein cholesterol (HDL-C)
  Capsule
   
    Lotrel   benazepril & amlodipine   Hypertension   Capsule
   
    Starlix   nateglinide   Type-II diabetes   Tablet

Oncology and
hematology
  Aredia   pamidronate   Hypercalcemia of malignancy
Bone metastases (breast and
myeloma)
Paget's disease of bone
  Vial
   
    Femara   letrozole   Advanced breast cancer   Coated tablet
   
    Gleevec/Glivec   imatinib
mesylate/imatinib
  Chronic Myeloid Leukemia
Gastrointestinal Stromal Tumors
  Capsule
   
    Sandostatin LAR/
Sandostatin SC
  octreotide   Acromegaly
Symptoms associated with
functional gastroenteropancreatic
endocrine tumors
  Vial, ampoule
   
    Zometa   zoledronic acid   Hypercalcaemia of malignancy
Bone metastases (broad range of tumors)
Prevention of skeletal-related events in patients with bone malignancies
  Vial

16


Central nervous   Comtan   entacapone   Parkinson's disease   Coated tablet
system  
    Exelon   rivastigmine   Alzheimer's disease   Capsule, oral
                solution
   
    Focalin   dexmethylphenidate   Attention-deficit hyperactivity
disorder
  Tablet
   
    Leponex/Clozaril   clozapine   Treatment-resistant schizophrenia
Treatment of recurrent suicidal
behavior in patients with
schizophrenia and schizoaffective
disorder
  Tablet
   
    Ritalin/
Ritalin LA
  methylphenidate   Attention-deficit hyperactivity
disorder
  Tablet, capsule
   
    Tegretol   carbamazepine   Epilepsy, acute and bipolar
affective disorders
  Tablet, chewable tablet, syrup,
suppository
   
    Trileptal   oxcarbazepine   Epilepsy   Tablet, oral
suspension

Transplantation   Neoral/
Sandimmun
  cyclosporine   Prevention of graft rejection following organ and bone marrow transplantation
Severe Psoriasis
Rheumatoid arthritis
  Capsule, oral solution, concentrate for intravenous infusion
   
    Simulect   basiliximab   Acute organ rejection in de novo renal transplantation   Vial

Respiratory   Elidel   pimecrolimus cream   Atopic dermatitis (eczema)   Cream
and  
dermatology   Famvir   famciclovir   Acute herpes zoster
Genital herpes
Herpes simplex infections in
immunocompromised patients
  Tablet
   
    Foradil(1)   formoterol   Asthma
Chronic obstuctive pulmonary disease
  Inhalation capsule (aerosol)
   
    Lamisil   terbinafine   Fungal infections of the skin and nails   Tablet, cream, DermGel, solution, spray

(1)
During the fourth quarter of 2002, we licensed the exclusive US distribution and marketing rights of Foradil to Schering-Plough Corporation. We continue to market and distribute Foradil outside of the US, where the brand has achieved broad acceptance amongst specialists and general practitioners. Our commitment to developing a global respiratory business through research, development and marketing remains a strategic priority.

17



Therapeutic
area

  Project/
Compound

  Generic name

  Indication

  Formulation

Rheumatology,
bone, hormone
replacement
  Estalis   estradiol norethisterone acetate   Symptoms of estrogen deficiency
in post-menopausal women
Post-menopausal osteoporosis
  Patch
therapy and  
gastrointestinal   Estraderm   estradiol   Symptoms of estrogen deficiency   Patch
    TTS/
Estraderm MX
      in post-menopausal women
Post-menopausal osteoporosis
   
   
    Estradot   estradiol   Symptoms of estrogen deficiency
in post-menopausal women
Post-menopausal osteoporosis
  Patch
   
    Estragest
TTS
  estradiol norethisterone acetate   Symptoms of estrogen deficiency
in post-menopausal women
Post-menopausal osteoporosis
  Patch
   
    Miacalcic   salmon calcitonin   Osteoporosis
Paget's disease
Hypercalcemia
  Nasal spray, ampoule, vial
   
    Voltaren   diclofenac   Inflammatory forms of rheumatism
Pain management
  Coated tablet,
drop, ampoule, suppository, gel
   
    Zelnorm/Zelmac   tegaserod maleate/ tegaserod   Irritable Bowel Syndrome with constipation   Tablet

Ophthalmics   Rescula   unoprostone isopropyl 0.15%   Glaucoma   Eye drop
   
    Visudyne   verteporfin   Wet form of age-related macular degeneration   Vial, activated by laser light
   
    Zaditen/Zaditor   ketotifen   Allergic conjunctivitis   Eye drop

        Not all products are registered in all markets for the treatment areas described above.

18


Compounds in Development

        The following table describes our most important compounds presently under development. "Filed" means that product registration documents have been filed with the US Food and Drug Administration ("FDA"), with regulatory authorities in the European Union (by either the centralized or mutual recognition procedure), and/or with national health authorities in Europe, but not necessarily in all jurisdictions.


Therapeutic
area

  Project/
Compound

  Generic name

  Indication

  Estimated Filing
Date/Current Phase(1)

Cardiovascular,
metabolism and
  Co-Diovan
(high doses)
  valsartan/
hydrochlorthiazide
  Hypertension   US Approved,
EU Filed
endocrinology  
    Lescol   fluvastatin sodium   Secondary prevention of   US/EU Filed
            cardiovascular events    
   
    Lotrel 5-40 and 10-40   amlodipine + benazepril   Hypertension   US Filed
   
    Starlix/
thiazolidinedione
  nateglinide +
thiazolidinedione
  Type-II diabetes   US Filed
   
    Diovan   valsartan   Congestive heart failure   US Approved,
EU 2003/III
            Post-myocardial infarction
(VALIANT)
  2004/III
            Pre-myocardial infarction
(VALUE)
  2005/III
   
    Sandostatin LAR   octreotide acetate   High-risk HTN Diabetic
retinopathy, other indications
  2004/III
   
    Starlix/Diovan   nateglinide + valsartan   Prevention of onset of Type-II diabetes/cardiovascular morbidity & mortality   >2005/III
   
    LAF237   To be determined
("TBD")
  Type-II diabetes   2005/II
   
    NKS104   pitavastatin   Dyslipidemia   2005/II
   
    SPP100(2)   TBD   Hypertension   2005/II

(1)
Phase I: Clinical trials in healthy volunteers to determine safety and tolerability. Phase II: Clinical trials in patients to determine dose ranging, safety and efficacy. Phase III: Large clinical trials to determine definitive safety and efficacy in patients.

(2)
This compound was out-licensed to Speedel for development with a callback option, which we exercised in June 2002.

19



Therapeutic
area

  Project/
Compound

  Generic name

  Indication

  Estimated Filing
Date/Current Phase(1)

Oncology and hematology   Gleevec/Glivec   imatinib mesylate/
imatinib
  Tablet dosage form
GIST tumors
Solid tumors
  US/EU Filed
Japan Filed
Filing date TBD/II
   
    Zometa   zoledronate   Hypercalcemia of malignancy   Japan Filed
            Bone metastases prevention   2005/III
   
    ICL670   TBD   Chronic iron overload   2004/III
   
    Femara   letrozole   Breast cancer (adjuvant therapy)   2005/III
   
    PTK787   vatalanib   Solid tumors   2005/III
   
    EPO906   epothillone B   Solid tumors   2004/II
   
    OctreoTher   edotreotide   Somatostatin receptor positive tumors   2004/II
   
    PKC412   midostaurin   Acute Myeloid Leukemia   >2005/II
   
    RAD001   everolimus   Solid tumors   >2005/II
   
    SOM230   TBD   Acromegaly/GEP neuroendocrine tumors   >2005/II
   
    LAQ824   TBD   Solid tumors   >2005/I
   
    XAA296   TBD   Solid tumors   >2005/I

Central nervous system   Clozaril   clozapine   Prevention of suicidal behavior   US Approved,
EU Filed
   
    Entacapone triple combination (ECL200)   levodopa/carbidopa/entacapone   Parkinson's disease   US/EU Filed
   
    Ritalin LA   methylphenidate   Attention deficit disorders   US Approved/
EU Filed
   
    Trileptal NP   oxcarbazepine   Neuropathic pain   2004/III
   
    Exelon   rivestigmine   Non-Alzheimer's dementia   >2005/III
   
    ILO522   iloperidone   Schizophrenia   TBD/III
   
    Exelon TDS   rivestigmine   Alzheimer's disease   >2005/II
   
    AMP397   TBD   Epilepsy   >2005/II
   
    TCH346   TBD   Parkinson's disease,
amyotrophic lateral sclerosis
  2005/II
   
    AAG561   TBD   Anxiety/depression   >2005/I

(1)
Phase I: Clinical trials in healthy volunteers to determine safety and tolerability. Phase II: Clinical trials in patients to determine dose ranging, safety and efficacy. Phase III: Large clinical trials to determine definitive safety and efficacy in patients.

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Therapeutic
area

  Project/
Compound

  Generic name

  Indication

  Estimated Filing
Date/Current Phase(1)

Transplantation,   Certican   everolimus   Transplantation   US/EU Filed
immunology  
    Myfortic   mycophenolate soldium   Transplantation   US 2003/III,
                EU Filed
   
    FTY720   TBD   Transplantation   2005/II

Respiratory and dermatology   Foradil   formoterol   Multi dose dry powder inhaler in asthma   US/EU Filed
            "On demand" use   >2005/III
   
    Xolair   omalizumab   Asthma/prevention of seasonal allergic rhinitis   US Filed,
EU 2003/III
   
    Lamisil   terbinafine   Tinea capitis   2004/III
   
    Elidel Ointment   pimecrolimus   Inflammatory skin diseases   2004/II
   
    Elidel oral   pimecrolimus oral   Inflammatory skin diseases   2005/II
   
    QAB149   TBD   Asthma, chronic obstructive pulmonary disease   >2005/II
   
    Elidel   pimecrolimus   Asthma   >2005/II

Rheumatology, bone, hormone replacement therapy, and gastrointestinal   Prexige   lumiracoxib   Osteoarthritis, pain

New Formulations (oral suspension; parenteral)
  US/EU Filed

2005/I
   
    Zelnorm/Zelmac   tegaserod maleate/tegaserod   Chronic constipation   2003/III
            Irritable bowel syndrome   US Approved,
EU 2004/III
            Functional dyspepsia   2004/III
            Gastroesophagal reflux disease   2005/II
   
    Zoledronic acid
(ZOL446)
  zoledronate acid   Paget's disease

Post-menopausal osteoporosis

Rheumatoid arthritis
  2005/III

>2005/III


>2005/II
   
    AAE581   TBD   Osteoporosis   >2005/II
   
    RAD001   everolimus   Rheumatoid arthritis   >2005/II
   
    SMC021   calcitonin   Osteoporosis   >2005/II
   
    SAB378   TBD   Chronic pain   >2005/I

(1)
Phase I: Clinical trials in healthy volunteers to determine safety and tolerability. Phase II: Clinical trials in patients to determine dose ranging, safety and efficacy. Phase III: Large clinical trials to determine definitive safety and efficacy in patients.

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Therapeutic
area

  Project/
Compound

  Generic name

  Indication

  Estimated Filing
Date/Phase(1)

Ophthalmics   Rescula   unoprostone isopropyl   Glaucoma   EU Filed
   
    Visudyne   verteporfin   Age-related macular degeneration (classic)   Japan Filed
            Age-related macular degeneration (occult)   2005/III
            Age-related macular degeneration (minimally classic)   >2005/II
   
    AFU057A   TBD   Glaucoma   >2005/II
   
    ABJ409A   TBD   Glaucoma   >2005/II
   
    Elidel   pimecrolimus   Dry Eye   >2005/II

(1)
Phase I: Clinical trials in healthy volunteers to determine safety and tolerability. Phase II: Clinical trials in patients to determine dose ranging, safety and efficacy. Phase III: Large clinical trials to determine definitive safety and efficacy in patients.

        The tables shown above and the summary that follows describe each of our Pharmaceuticals Division's seven key therapeutic areas. Unless otherwise indicated, and subject to required regulatory approvals and, in certain instances, contractual limitations, our intention is to sell the key marketed products throughout the world. These same compounds are in various stages of development throughout the world. For some compounds, the development process is ahead in the United States, for other compounds, development is behind in the United States. Due to the uncertainties associated with the development process, and due to regulatory restrictions in some countries, including the United States, it may not be possible to obtain registration of compounds in development for any or all of the indications referred to in this Form 20-F.

Cardiovascular/Metabolism/Endocrinology

        Our Pharmaceuticals Division markets a wide range of products for the treatment of cardiovascular disease, including products for the treatment of hypertension, hyperlipidemia, angina pectoris and heart failure. Ongoing research is focused on the development of innovative new agents to treat metabolic disorders, such as Type-II diabetes, which are associated with serious cardiovascular events, including peripheral vascular disease, diabetic retinopathy, nephropathy, stroke and myocardial infarction.

    Key Marketed Products

    Cibacen/Lotensin (benazepril) and Cibadrex/Lotensin HCT (benazepril+HCTZ) are ACE-inhibitors indicated for the first-line treatment of hypertension and as adjunct therapy in heart failure.

    Diovan (valsartan) and Co-Diovan/Diovan HCT (valsartan+HCTZ) are pioneering entrants in the angiotensin II receptor blockers (ARBs) class of antihypertensive agents. The ARBs have proven to be a key growth class of drugs within the antihypertensive market. The fixed combination product, Co-Diovan, provides additional antihypertensive efficacy for patients who require a greater reduction in blood pressure than can be achieved with monotherapy. In the US, Diovan is approved to treat congestive heart failure in patients who are intolerant of angiotensin-converting-enzyme (ACE) inhibitors. Diovan is the first ARB to obtain an indication beyond hypertension.

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    Lescol (fluvastatin) is a lipid-lowering agent for the treatment of primary and mixed hyperlipidemia and reduction of atherosclerosis. Lescol XL 80 mg is a novel extended-release line extension of the Lescol 20 and 40 mg immediate-release capsules. Lescol XL effectively treats the entire lipid profile, i.e., LDL, HDL and triglycerides. Lescol XL has been successfully introduced in major markets during the years 2000-02.

    Lotrel (benazepril-amlodipine) is a fixed combination of the ACE-inhibitor benazepril and a leading calcium antagonist (amlodipine). It is marketed only in the United States.

    Starlix (nateglinide) is a pioneering member of a class of drugs for the treatment of patients with Type-II diabetes, also known as adult-onset diabetes. The drug aims to restore the early phase of insulin release which helps control blood glucose levels at mealtime. We licensed the compound from Ajinomoto Co., Ltd. and own marketing rights for the drug worldwide, except for Japan and several other Asian markets.

    Compounds in Development

    Co-Diovan is a combination product of valsartan and hydrochlorthiazide and is in development for hypertension. Co-Diovan has been approved by the FDA and a product registration file has been submitted to regulatory authorities in the EU.

    Diovan (valsartan) has been approved for congestive heart failure in the US and is in Phase III development for this indication in the EU. Diovan is the only ARB to have demonstrated clinical benefits in heart failure in a large scale trial. The product is also in development for post and pre-myocardial infarction (Phase III), and high-risk hypertension (Phase III).

    Lescol (fluvastatin sodium) is in development for the secondary prevention of cardiovascular events, based on the LIPS trial (Lescol Intervention Prevention Study). Product registration files for this additional indication have been filed in the US and the EU.

    Lotrel (benazepril & amlodipine) has two new dosages under development for hypertension (Lotrel 5-40 and Lotrel 10-40). A product registration file for these additional dosages has been submitted to the FDA in the US and will be submitted to regulatory authorities in the EU in 2003.

    Starlix (nateglinide) is currently under development in fixed combination with thiazolidinedione for patients with Type-II diabetes mellitus inadequately controlled with nateglinide monotherapy and diet. A product registration file for this combination has been submitted to the FDA in the US.

    Sandostatin LAR (octreotide acetate) is in development for diabetic retinopathy (Phase III). This condition affects approximately 15% of patients with diabetes and is one of the leading causes of blindness in people of working age. Currently there are no effective drugs available to treat diabetic retinopathy.

    Starlix (nateglinide) is currently being investigated in combination with Diovan. In the NAVIGATOR (Nateglinide and Valsartan in Impaired Glucose Tolerance and Outcomes Research) trial, initiated in November 2001, 9,150 patients aged 50 years or older are being treated with Diovan and/or Starlix to examine the effect on progression from Impaired Glucose Tolerance to Type-II diabetes after 3 years, as well as on cardiovascular morbidity and mortality in this high-risk patient population. Results on the cardiovascular endpoint are expected to be available in 2007.

    LAF237 is a DPP-IV inhibitor in Phase II development for the treatment of Type-II diabetes. Blocking the action of the enzyme DPP-IV has been shown to improve glycemic control by increasing GLP-1 levels (a peptide that augments glucose-induced insulin secretion and also affects other aspects of glycemic control). Phase I studies have shown that once-a-day dosing maintains DPP-IV activity below the levels believed to be needed to increase GLP-1 activity sufficiently for a therapeutic effect.

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    NKS104 (pitavastatin) is a lipid-lowering agent, in development for the treatment of dyslipidemia. We acquired European marketing rights to pitavastatin in 2001. Clinical trials to date have shown that NKS104 lowers LDL cholesterol and triglycerides while increasing HDL cholesterol levels. The compound is in Phase II.

    SPP100 is an orally effective renin inhibitor being developed for the treatment of hypertension and other cardiovascular indications. Blood pressure lowering effects have been demonstrated in Phase II trials, with no significant adverse events observed. The compound was out-licensed to Speedel, but we exercised a call-back option in June 2002. As a result, we have global rights to develop and commercialize this compound.

    Starlix (nateglinide)/metformin has been terminated.

Oncology and Hematology

        The Oncology and Hematology disease area is a rapidly growing and increasingly important specialty segment. We market products for the treatment of a number of different cancers and for cancer complications, including advanced malignancies involving bone. Research and development in this disease area is aimed at the discovery and development of innovative approaches to the treatment of cancer, focusing in particular on the major forms of solid tumors (breast, prostate, lung, colorectal and ovarian cancer), which account for approximately 50% of all deaths from cancer. In addition, compounds are being developed for the treatment of other forms of oncologic and hematologic conditions.

    Recently Launched Products

    Zometa (zoledronate) is a more potent bisphosphonate than Aredia, with efficacy across a broad range of tumor types. It is administered as a 4 mg infusion over 15 minutes. In 2002, Zometa received approval in most key markets for prevention of skeletal related events in patients with advanced malignancies involving bone. These tumor types include prostate cancer, breast cancer, lung cancer, and multiple myeloma.

    Key Marketed Products

    Aredia (pamidronate) is a therapy for tumor-induced hypercalcemia, osteolysis from multiple myeloma and bone metastases from breast cancer. Our patent protection for Aredia is limited. Generic versions of Aredia were launched in the United States in 2001 and 2002. Generic products in competition with Aredia are also on sale in Canada and elsewhere.

    Femara (letrozole) is an oral aromatase inhibitor for the treatment of advanced breast cancer in women with natural or artificially induced post-menopausal status. It recently received approval for first-line therapy in major markets, based upon superior efficacy over the most widely used previous standard therapy, tamoxifen. It also is being developed for adjuvant therapy of breast cancer.

    Gleevec/Glivec (imatinib mesylate/imatinib) is a signal transduction inhibitor, which in 2002 gained approval in the US and EU for the treatment of certain forms of gastrointestinal stromal tumors (GIST). This is the second form of cancer which this drug has been approved to treat. Gleevec/Glivec was originally approved in 2001 for the treatment of patients with chronic myeloid leukemia (CML) in the blast crisis, accelerated phase or in chronic phase after failure of interferon-alpha therapy. The CML indication was expanded by the FDA (in December 2002) and the EU (in January 2003) to permit Gleevec/Glivec to be used to treat newly diagnosed patients with CML. Gleevec/Glivec is being studied as a potential treatment of solid tumors in other forms of cancer, primarily as part of a combination therapy.

    Sandostatin (octreotide) is a synthetic octapeptide derivative of the hormone somatostatin indicated for the treatment of pancreatic and gastrointestinal endocrine tumors, acromegaly, and acute variceal bleeding. Patent protection or regulatory exclusivity will expire in the next five years

24


      in major markets for this product. The basic octreotide substance patents expired in 2002 in the United States and Japan, and will expire in April 2003 in the UK and Germany, in 2006 in France, and in 2007 in Italy. However, protection extending to 2010 (and 2013 and beyond in the United States) continues in major markets for Sandostatin LAR, which represents a significant and growing proportion of our octreotide sales.

    Sandostatin LAR/Sandostatin SC (octreotide) is a long-acting release formulation (once every 28 days) approved for the control of symptoms such as the severe diarrhea and flushing associated with metastatic carcinoid tumors, and the severe diarrhea associated with vasoactive intestinal polypeptide secreting tumors. It also is indicated for the treatment of acromegaly.

    Compounds in Development

    Gleevec/Glivec (imatinib mesylate/imatinib) is being studied as part of potential combination therapies against several solid tumors as a basis for widening the range of indications to include other types of cancers. Phase II trials are in progress. In January 2003, a product registration file was submitted to regulatory authorities in Japan for the treatment of GIST tumors, an indication which was approved in the US and EU in 2002. A product registration file has been submitted to regulatory authorities in the US and EU to manufacture this product in a tablet form, rather than in its current capsule form.

    Zometa (zoledronate) is in Phase II development for the prevention of bone metasteses. A product registration file has been submitted to regulatory authorities in Japan for the treatment of hypercalcemia of malignancy, an indication which was approved in the US and EU in 2001.

    ICL670 is an iron chelator currently in Phase III clinical development. It was designed to enhance patient acceptance of such treatment. Iron accumulation resulting from red blood cell lysis can lead to organ damage and, ultimately, death. ICL670 has been shown preclinically to efficiently induce iron excretion. Bioavailability has been demonstrated orally. Recently published clinical data (American Society of Hematology 2001) demonstrate clinical effectiveness of ICL670 in achieving negative iron balance. The goal is to make iron chelation therapy more practical for patients with chronic iron overload.

    Femara (letrozole) is in Phase III development for adjuvant therapy in the treatment of breast cancer.

    PTK787 (vatalanib) is a new chemical entity with a novel mechanism of action, which inhibits tumor growth and the development of metastases through inhibition of tumor vascularization. It is expected to be biologically effective as an oral anti-angiogenic agent, in particular in combination with standard therapies against a broad range of tumor types. No significant toxicities are expected at efficacious doses that would preclude chronic administration. PTK787 is in Phase III development, and has shown no significant toxicity to date. The compound is being developed in collaboration with Schering AG of Germany.

    EPO906 (epothilone B), a novel tubulin polymerizing compound, is a cytotoxic with a similar mechanism of action as Taxol® (paclitaxel). The taxane segment is the largest cytotoxic market segment in oncology. Preclinically, epothilone B has shown more potency than paclitaxel and more activity in paclitaxel resistant tumors. Responses have been observed in Phase I in several solid tumors and it is now in Phase II clinical development. Dose limiting toxicity is diarrhea. Significant myelosuppression has not been reported to date.

    OctreoTher is a peptide hormone analog that carries a radioactive element specifically to somatostatin receptor positive malignant cells and is in Phase II trials for the treatment of solid tumors.

    PKC412 (midostaurin) is a protein kinase inhibitor and is in development for the treatment of acute myeloid leukemia. PKC412 is currently in Phase II.

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    RAD001 is an mTOR pathway inhibitor and is in Phase II development for the treatment of solid tumors. RAD001 is an orally available rapamycin derivative. Experiments have shown it to possess antiproliferative properties in a wide range of tumor models through its inhibition of the mTOR protein kinase. This makes it an attractive candidate for a broad range of cancer indications both as a single agent, and as part of combination therapies.

    SOM230 is a somastatin analog with a higher receptor affinity to sst 1, 2, 3 and 5 than currently marketed products. In addition, compared to currently available somastatin analogs, the SOM230 in vitro and in vivo data indicates a more effective and selective inhibition of GH secretion, and thus a unique hormone inhibitory profile. It provides longer lasting IGF-1 suppression across species and a longer half life of (t1/2) 23 hours. SOM230 Phase II trials in acromegaly and GEP tumors were initiated in 2002.

    LAQ824 is a histone deacetylase inhibitor in Phase I development for the treatment of solid tumors.

    XAA296 is a microtubule stabilizer in Phase I development for the treatment of solid tumors.

    PKI166 was terminated.

Central Nervous System

        Novartis Pharmaceuticals markets a broad range of central nervous system products, including agents to treat patients with schizophrenia, epilepsy, Parkinson's disease, Alzheimer's disease, and attention deficit hyperactivity disorder. Ongoing research to extend the current product portfolio in this disease area includes projects in psychiatric disease (psychoses, depression, and anxiety), neurological disorders (epilepsy, Parkinson's disease, and Alzheimer's disease), learning disorders and chronic pain.

    Recently Launched Products

    Ritalin LA (methylphenidate) has been approved in the United States for the treatment of attention-deficit hyperactivity disorder (ADHD). Ritalin LA is a once-daily formulation of Ritalin (methylphenidate HCl) which eliminates the need for a mid-day dose during school. Ritalin LA uses SODAS™ technology, a proprietary drug delivery technology of Elan Corporation, plc. We have also submitted a product registration file for this product to regulatory authorities in the EU for this condition.

    Key Marketed Products

    Comtan (entacapone) treats Parkinson's disease by enhancing the action of levodopa, the standard therapy for Parkinson's disease. The compound is licensed from Orion Pharma of Finland.

    Exelon (rivastigmine) is a therapy for the treatment of patients with mild to moderate Alzheimer's disease. Exelon has been approved in all major markets, including the 15 member-states of the EU and the United States.

    Focalin (dexmethylphenidate) is the single isomer version of methylphendiate and is approved in the United States for the treatment of ADHD. This compound is licensed from Celgene Corporation.

    Leponex/Clozaril (clozapine) is a neuroleptic agent used in treatment-resistant schizophrenia and is experiencing competition from generic competitors in many markets, including the United States.

    Tegretol (carbamazepine) was launched in 1963 for the treatment of epileptic seizures and remains a mainstay in the treatment of that disorder.

    Trileptal (oxcarbazepine) is an anti-epileptic drug for the treatment of partial seizures as adjunctive or monotherapy in adults, or as adjunctive therapy in children.

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    Compounds in Development

    Clozaril (clozapine) has been approved by the FDA for the additional indication of the prevention of suicide behavior in patients suffering from schizophrenia and schizoaffective disorder. A product registration file has also been submitted to regulatory authorities in the EU for this indication.

    Entacapone Triple Combination (ECL200—Entacapone/Levodopa/Carbidopa) product registration files have been submitted to regulatory authorities in the US and EU for the treatment of Parkinson's Disease.

    Trileptal NP (oxcarbazepine) is in Phase III development for the treatment of diabetic neuropathic pain.

    Exelon (rivastigmine) is in development for additional indications and formulations. Exelon is being investigated in Phase III trials for the treatment of non-Alzheimer's dementia. A transdermal formulation, Exelon TDS, is in Phase II development for Alzheimer's disease.

    ILO522 (iloperidone) is a mixed serotonin/dopamine antagonist for the treatment of schizophrenia and other related psychotic disorders. Iloperidone is licensed from Titan Pharmaceuticals, Inc. and is currently in Phase III clinical trials.

    AMP397 is an AMPA receptor antagonist and is in Phase II development for the treatment of epilepsy.

    TCH346 is in Phase II development and is targeted as first line intervention for neurodegenerative diseases such as Parkinson's disease, and amyotrophic lateral sclerosis, where it functions to provide neuroprotection and thereby delays further progression of these diseases.

    AAG561 is in Phase I development, and could be the first in class among the corticotrophin-releasing factor 1 antagonists, a novel concept in the treatment of depression and anxiety which encompasses huge patient populations. Phase II trials are expected to start during 2003.

Transplantation/Immunology

        We are a leader in the development of transplantation medicine, producing widely used products that help to prevent the rejection of organs following transplantation. A wide-ranging research and development program is aimed at developing new compounds and interventions in the area of chronic rejection, tolerance induction, Beta-cell inhibition, ischemia/reperfusion injury to reduce delayed graft function, inhaled therapies for lung transplantation and pancreatic islet transplantation.

    Key Marketed Products

    Neoral (cyclosporin) builds on the established clinical utility of Sandimmun to provide improved primary immunosuppression in organ transplant patients. Neoral is formulated as a microemulsion, thereby providing improved absorption and less variability in dosing. Despite our patent protection, generic companies have launched competing products in the United States and will continue to compete vigorously. Marketing authorizations have also been granted for generic products in Europe and elsewhere. Neoral was launched in Japan in 2000, and these sales have partially offset the reduction of sales in the United States and elsewhere.

    Sandimmun (cyclosporin) was introduced in 1982 for the prevention of organ rejection among patients with solid organ (kidney, heart, lung and liver) transplants and bone marrow transplantation.

    Simulect (basiliximab) is a chimeric monoclonal antibody that suppresses interleukin-driven proliferation of T-cells. Simulect is designed to complement Neoral in preventing acute rejection episodes in organ transplantation.

27


    Compounds in Development

    Certican (everolimus) is a new immunosuppressant being developed for transplantation, and is intended for use in combination with Neoral to prevent rejection episodes in patients with kidney, lung, heart and liver transplants. Product registration files for Certican have been submitted to regulatory authorities in the US and EU.
    Myfortic (mycophenolate sodium) is a new immunosuppressant in development for transplantation. Product registration files have been submitted to regulatory authorities in the EU regarding this compound. Switzerland has granted marketing authorization for the product. Myfortic is intended for use in combination with Neoral and corticosteroids to prevent rejection episodes in patients with kidney transplants. Myfortic is being developed as an advanced enteric coated tablet formulation of mycophenolate.
    FTY720 is a novel immunosuppressant being developed for transplantation. The compound currently is at the end of Phase II clinical trials and is planned to be used in combination with Neoral or Certican to prevent rejection episodes or to enhance graft survival in patients with kidney transplants. FTY720 has a new mechanism of action altering lymphocyte homing. FTY720 is being developed in capsule, oral liquid and injectable formulations. This product has been licensed from Yoshitomi Co., Ltd. of Japan.

Respiratory/Dermatology

        Our Dermatology portfolio covers a broad range of indications, with marketed products for the treatment of atopic dermatitis (eczema), fungal infections, psoriasis and wound healing. In addition, ongoing research and development is aimed at developing new compounds and extending the clinical utility of existing compounds in the areas of allergic and inflammatory skin disease, such as contact eczema and psoriasis. There is considerable demand for new dermatology treatments in these areas where current therapies are handicapped by limited efficacy or unacceptable side effects. We are committed to expanding our product range in the important Respiratory disease area. A discovery and development program is aimed at providing improved therapeutic options in the treatment of asthma and chronic obstructive pulmonary disease ("COPD"), which includes chronic bronchitis and emphysema. In addition, we market an oral antiviral agent for the treatment of herpes infections.

    Recently Launched Products

    Elidel (pimecrolimus cream) is a selective inflammatory cytokine inhibitor used in the treatment of atopic dermatitis (eczema). The compound is a member of a new class of agents—the ascomycin macrolactams. Elidel is the only non-steroid treatment for atopic dermatitis clinically proven to prevent flare progression and improve disease control versus conventional practice with topical steroids. The non-steroid safety profile makes Elidel suitable for all body areas for both children and adults. Elidel is now approved in 43 countries globally including the US and 12 EU countries. It has so far been launched in 19 countries, including the US and 8 EU countries.

    Key Marketed Products

    Lamisil (terbinafine) is used in the treatment of fungal infections of the skin, nails and scalp. Lamisil kills the fungus (fungicidal in vitro), rather than simply preventing further fungal growth. An "over-the-counter" formulation is marketed by Novartis Consumer Health in many markets, including the United States.
    Foradil (formoterol) is a long-acting bronchodialator indicated for the treatment of asthma and COPD, approved and launched in the United States in 2001. During the fourth quarter of 2002, we licensed the exclusive US distribution and marketing rights of Foradil to Schering-Plough Corporation. We continue to market and distribute Foradil outside the US, where the brand has achieved broad acceptance amongst specialists and general practitioners. The long-acting bronchodilator is a relatively new addition to the range of treatments for asthma, and is

28


      distinguished by its rapid onset of action (one to three minutes) and long-lasting effect from a single dose (12 hours). Foradil is currently marketed principally in Europe in a single-dose dry powder inhaler (the Aerolizer), and in certain markets as a pressurized metered dose inhaler. Our commitment to developing a global respiratory business through research, development and marketing, remains a strategic priority.

    Compounds in Development

    Foradil (formoterol) product registration files have been submitted to the FDA seeking marketing authorization for the Foradil Certihaler, a novel, breath-activated multi-dose dry powder inhaler technology which was developed by, and will be manufactured by affiliates of SkyePharma Plc, and which will give patients confirmation that the full dose of Foradil medication has been taken. Product registration files for the Foradil Certihaler are also in the process of being filed with regulatory authorities in Europe. We have also signed an agreement with Ivax Corporation for the EU and certain other countries (excluding the US and Japan) to market Foradil in the Airmax device, a new multi-dose dry powder inhaler developed by Ivax. This device containing Foradil is approved in Denmark and we intend to register it through the Mutual Recognition Procedure in other EU countries. (See "—Regulation—European Union.") In addition, Foradil is in Phase III development aimed at extending the clinical utility of Foradil by registering the product for use as asthma rescue medication on an as-needed ("prn") basis.
    Xolair (omalizumab) is an anti-IgE monoclonal antibody developed to treat allergic disease, irrespective of allergen, by normalizing serum IgE. The drug is being developed in collaboration with Genentech and Tanox for the treatment of allergic asthma and seasonal allergic rhinitis. We have filed product registration files for Xolair with the FDA and EMEA. Both have requested that we submit additional information regarding the drug. In response, in December 2002, we made a complete resubmission of our product registration files to FDA, including the additional pre-clinical and clinical data analyses which FDA had requested. In response to the EMEA's request, we are conducting an additional study in patients with severe asthma, and plan to submit the results of that study to EMEA by the end of 2003.
    Lamisil (terbinafine) is in Phase III development for tinea capitis.
    Elidel (pimecrolimus cream) oral and ointment formulations are also in Phase II development for inflammatory skin diseases. In addition, Elidel is in Phase II development for the treatment of asthma.
    QAB149 is in Phase II development for the treatment of asthma and COPD. QAB149 is a selective agonist of B2 adreno-receptors. QAB149 is an inhaled long-acting b2-adrenoceptor agonist, with the potential to be the first truly once-daily administered compound from this class. The molecule is a single enantiomer, and is anticipated to have an improved side-effect profile compared to currently prescribed b2-adrenoceptor agonists. Phase II clinical trial results are expected in the second half of 2003.
    DNK333 was terminated.

Rheumatology/Bone/Hormone Replacement Therapy/Gastrointestinal

        We are a leader in the rheumatology/bone/hormone replacement therapy/gastrointestinal therapeutic area with products intended to treat arthritis, osteoporosis and early menopausal symptoms, such as hot flashes, and prevent the long-term complications of these conditions, which include cardiovascular disease and osteoporosis resulting from menopausal change. The bone and rheumatology research and development pipeline includes new compounds for the treatment of rheumatoid arthritis, osteoarthritis and bone metabolism disorders, such as osteoporosis. Research and development in hormone replacement therapy is primarily focused on improving the delivery of therapy via transdermal patch technology.

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        Novartis Pharmaceuticals has recently entered the gastroenterology market with the launch of Zelnorm/Zelmac for irritable bowel syndrome with constipation, and with further development efforts regarding the use of Zelnorm/Zelmac to treat chronic constipation, functional dyspepsia, gastroesophagal reflux disease (GERD) and other conditions. The gastrointestinal disease area is an increasingly important segment due to the high level of as-yet unmet patient needs with regard to disorders with no identified cause. Research and development in this disease area is aimed at the discovery and development of innovative approaches to the treatment of upper and lower gastrointestinal disorders.

    Recently Launched Products

    Zelnorm/Zelmac (tegaserod maleate/tegaserod) is a 5-HT4 partial agonist developed to address the need for a safe and effective treatment of irritable bowel syndrome with constipation, relieving such symptoms as abdominal pain, discomfort, constipation and bloating. The FDA has approved this product for sale in the US, as have the authorities in Switzerland, Mexico, Australia, Venezuela, Argentina, Colombia, the Czech Republic and approximately 35 other nations. In certain countries, including the US, Zelnorm/Zelmac is approved for the treatment of women only.

    Key Marketed Products

    Estalis (estradiol, norethisterone acetate) transdermal patch is a treatment for symptoms of estrogen deficiency in post-menopausal women, and prevention of post-menopausal osteoporosis. The product is sub-licensed from Aventis, and offers a convenient treatment in a single patch for patients with an intact uterus.
    Estraderm TTS and Estraderm MX (estradiol) transdermal patches are treatments for symptoms of estrogen deficiency in post-menopausal women, and prevention of post-menopausal osteoporosis. These are earlier generations of transdermal patches.
    Estradot (estradiol) transdermal patch, licensed from Noven Pharmaceuticals, Inc., is a treatment for symptoms of estrogen deficiency in post-menopausal women, and prevention of post-menopausal osteoporosis. Estradot is the smallest estrogen patch available and offers a thin, flexible and discreet hormone therapy.
    Estragest TTS (estradiol, norethisterone acetate) transdermal patch is a low-dose treatment for symptoms of estrogen deficiency in post-menopausal women, and prevention of post-menopausal osteoporosis. Estragest TTS offers a high amenorrhea rate in a single patch which is changed twice a week.
    Famvir (famciclovir) is used in the treatment of acute herpes zoster and genital herpes, and was acquired in 2000 from SmithKline Beecham. The acquisition included global marketing rights, production rights and all intellectual property rights.
    Miacalcic (salmon calcitonin) is a treatment for the prevention of progressive loss of bone mass, mainly in post-menopausal women and in elderly patients, Paget's disease and hypercalcemia. Miacalcic is available both in an injectable form and as a nasal spray.
    Voltaren (diclofenac) is a non-steroidal anti-inflammatory drug (NSAID) for the treatment of inflammatory and degenerative forms of rheumatism (articular and non-articular), post-operative and post-traumatic pain and acute attacks of gout and migraines. This product faces generic competition. An "over-the-counter" formulation of the topical form of this product is marketed by Novartis Consumer Health in several markets under the name Voltaren Emulgel, for the treatment of inflammation of tendons, ligaments, muscles and joints, and for localized forms of soft-tissue and degenerative rheumatism.

    Compounds in Development

    Prexige (lumiracoxib) is an NSAID that selectively inhibits the COX-2 enzyme. We have submitted Product Registration Files for this product to the FDA and to European regulatory authorities.

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      The Prexige Product Registration Files were accepted for review by the FDA for the indications of osteoarthritis and acute pain, including primary dysmenorrhea. For rheumatoid arthritis, an additional pivotal trial has been started. An additional study, TARGET, is ongoing to investigate long-term gastrointestinal benefits and cardiovascular safety with and without low dose aspirin. Interim study results from TARGET are expected in the second quarter of 2003. New formulations (an oral suspension and a parenteral) of Prexige are also in Phase I development. These additional formulations will provide dosing options for those people who can not swallow tablets.

    Zelnorm/Zelmac (tegaserod maleate/tegaserod) was approved by the FDA for irritable bowel syndrome with constipation in July 2002. In Europe, the product registration file was withdrawn, and discussions are ongoing with the European Medical Evaluations Agency. During these discussions, the EMEA requested an additional Phase III trial, which is currently ongoing. Zelnorm/Zelmac is also in development for chronic constipation (Phase III), functional dyspepsia (Phase II) and gastroesophagal reflux disease (Phase II). A strategic alliance with Bristol-Myers Squibb Company for the co-development and co-promotion of Zelnorm/Zelmac was terminated during 2001.
    Zoledronic acid (ZOL446—zoledronate acid) is being developed for postmenopausal osteoporosis and Paget's disease. Phase II trials in osteoporosis have shown that zoledronic acid, administered as a once per year 5 mg injection, causes significant increases in bone mineral density. Phase III trials in postmenopausal osteoporosis and Paget's disease are currently in progress.
    AAE581 is being developed for the treatment of osteoporosis and is in Phase II. AAE581 is a specific inhibitor of osteoclast-derived cathepsin K, leading to reduced collagen breakdown and osteoclast-mediated bone resorption. The compound represents a novel mode of action and has been shown to effectively suppress biological markers of bone turnover up to 28 days in healthy volunteers, compared to placebo.
    RAD001 is being developed for the treatment of rheumatoid arthritis and is in Phase II. RAD001 is an inhibitor of T-cell proliferation. See "—Oncology and Hemotology—Compounds in Development."
    SMC021 is a regulator of calcium homeostasis and is in Phase II development for the treatment of osteoporosis. SMC021 is an oral formulation of salmon calcitonin. Calcitonin, a peptide, inhibits bone resorption by acting on specific receptors on osteoclasts. In addition, salmon calcitonin has been shown to have analgesic properties. Injectable and nasal spray calcitonins are currently on the market. SMC021 is a novel concept in oral peptide delivery.
    SAB378 is a cannabinoid (CB1) agonist which is in Phase I development. This compound represents a novel concept in treating pain which, on the basis of preclinical results, could be more potent than major current treatments. Results of proof of efficacy studies are expected during 2003.

Ophthalmics

        We develop and market products for the treatment of a number of different ophthalmic diseases. Research and development in this disease area is aimed at the discovery and development of innovative approaches to the treatment of glaucoma, age-related macular degeneration, eye inflammation, ocular allergies and other diseases and disorders of the eye.

    Key Marketed Products

    Visudyne (verteporfin) is a light activated drug (photosensitizer) and is used as a two-step procedure that can be performed in a doctor's office. First, the drug is injected intravenously into the patient's arm. A non-thermal laser light is then shone into the patient's eye to activate the drug. Visudyne is commercially available in 68 countries for the treatment of predominantly classic subfoveal choroidal neovascularization (CNV) caused by age-related macular degeneration. It is approved in 24 countries for the treatment of occult subfoveal CNV secondary to AMD (including

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      the EU which gained approval this year). It is also approved in over 45 countries, including the EU, US and Canada, for the treatment of subfoveal CNV due to pathologic myopia (severe near-sightedness). Further geographic expansion is planned for regions including Japan and China.

    Zaditen (ketotifen) is an eye drop which provides fast relief of symptoms in patients suffering from ocular allergy. Zaditen works through multiple mechanisms of action to provide relief within minutes and a duration of action of up to 12 hours. Zaditen provides rapid relief and long lasting control of allergy symptoms with a twice daily dosing regimen. Zaditen is approved in more than 30 countries, including the United States (where it is marketed as Zaditor) and the EU.
    Rescula (unoprostone isopropyl 0.15%) is an intraocular pressure lowering medication indicated for the treatment of primary open angle glaucoma and/or ocular hypertension. It acts by increasing the outflow of aqueous humor from the anterior chamber of the eye which leads to a reduction of the pressure. It is administered as eye drops twice daily. Rescula is approved in more than 40 countries around the world, including the US, and is currently undergoing the Mutual Recognition Procedure for approval in the EU.

    Compounds in Development

    Visudyne (verteporfin) is in development for additional indications. A Phase III trial is ongoing in occult AMD in the US and Phase II trials are in progress for minimally classic AMD and different regimens for optimizing treatment outcomes.
    AFU057A is a 1A-adrenoreceptor antagonist, currently in development for the treatment of glaucoma (Phase II).
    ABJ409A is a dopaminergic, currently in development for the treatment of glaucoma (Phase II).
    Elidel (pimecrolimus), our Dermatology product, is also currently in development for the treatment of dry eye (Phase II).
    PKC412 was terminated.

Principal Markets

        The world market for our Pharmaceuticals Division is concentrated in the United States, Europe and Japan. The following table sets forth certain data relating to our principal markets.

Pharmaceuticals

  Sales 2002
 
  (CHF millions)

  (%)

United States   8,914   42
Americas (except the United States)   1,543   7
Europe   6,667   32
Japan   2,259   11
Rest of the World   1,619   8
   
 
Total   21,002   100
   
 

        Many of our Pharmaceuticals Division's products are used for chronic conditions that require patients to consume the product over long periods of time, from months to years. Sales of the vast majority of our products are not subject to material changes in seasonal demand.

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Production

        The key goal in our manufacturing and supply chain management program is to ensure the uninterrupted, timely and cost-effective supply of products that meet all product specifications. In order to achieve this objective, we manufacture our prescription medicines at 8 bulk chemical and 18 secondary production facilities. Major bulk chemical sites are located in Basel, Switzerland; Grimsby, United Kingdom; and Ringaskiddy, Ireland. Bulk chemical production involves the manufacture of therapeutically active compounds, mainly by chemical synthesis or by a biological process such as fermentation. Secondary production involves the manufacture of "galenical" forms of drug products such as tablets, capsules, liquids, ampoules, vials and creams. Significant secondary production facilities are located in Stein, Switzerland; Wehr, Germany; Torre, Italy; Barbera, Spain; Suffern, New York, United States; in Sasayama, Japan and in various locations in Europe, including Italy, Spain, Germany, France, the United Kingdom, and Turkey.

        During clinical trials, which can last several years, the manufacturing process is rationalized and refined. By the time clinical trials are completed and products are launched, the manufacturing processes have been extensively tested and are considered stable. However, improvements to these manufacturing processes may continue throughout a product's life cycle.

        While we have not experienced material supply interruptions in the past, there can be no assurance that supply will not be interrupted in the future as a result of unforeseen circumstances. The manufacture of our products is heavily regulated, making supply never an absolute certainty. If we or our third party suppliers fail to comply fully with such regulations then there could be a government-enforced shutdown of production facilities, which in turn could lead to product shortages.

        Raw materials for the manufacturing process are purchased from a number of third party suppliers. Where possible, our policy is to maintain multiple supply sources so that the business is not dependent on a single or limited number of suppliers. However, our ability to do so may at times be limited by regulatory requirements. We monitor market developments that could have an adverse effect on the supply of essential materials. All raw materials we purchase must comply with our quality standards. Overall, prices are not volatile for materially significant raw materials.

Marketing and Distribution

        We have invested significant resources in our sales and marketing organizations to achieve a competitive presence in all of the main pharmaceutical markets worldwide. In particular, Pharmaceuticals Division affiliates have a strong presence in the US and the EU.

        Products are sold to wholesale and retail drug distributors, hospitals, clinics, government agencies and managed care providers. In each market, to the extent permitted by law, we deploy sales representatives to market our products and supporting medical staff to provide medical information to prescribers and healthcare purchasers. As of December 31, 2002 Pharmaceuticals Division affiliates had more than 6,000 medical representatives in the US field forces (including contract field forces), and more than 17,000 medical representatives worldwide. Our sales and marketing reach is further extended through various agreements with promotion and marketing partners, licensees, associates and distributors.

Competition

        Other companies selling branded prescription pharmaceutical products include Abbott Laboratories, Alcon, Allergan, AstraZeneca, Aventis, Bausch & Lomb, Bayer, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, Pharmacia, Roche, Santen, Schering-Plough and Wyeth. Competition within the pharmaceutical industry is intense and extends across a wide range of commercial activities, including pricing, product characteristics, customer service, sales and marketing, and research and development.

        In addition to the other pharmaceutical companies selling patented pharmaceuticals under trademarked brand names, our Pharmaceuticals Division faces an increasing challenge from companies

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selling generic forms of our products following the expiry of patent protection. In response to generic challenges that infringe upon our patents and trademarks, we vigorously defend our intellectual property rights. Where we have made meaningful improvements to existing products, we seek to extend the product range with patent-protected value-added line extensions. We also seek to use marketing efforts to increase brand awareness and loyalty toward our products. Ultimately, there is no guarantee that any product, even with patent protection, will remain successful if another company develops a new product offering significant improvements over existing therapies.

Research and Development

        We are among the leaders in the pharmaceuticals industry in terms of research and development investment. In 2002, we invested approximately CHF 3.6 billion in Pharmaceuticals Division research and development, which represents 17% of total pharmaceuticals sales. Our Pharmaceuticals Division invested CHF 3.4 billion and CHF 3.3 billion on research and development in 2001 and 2000 respectively. There are currently more than 60 projects in clinical development. Products expected to be launched in 2003 from our efforts include new indications or formulations for Gleevec/Glivec, Xolair, Clozaril, Comtan (Entacapone Triple Combination), Certican, Lescol, and Myfortic.

        Development of a new drug is a lengthy process, usually requiring 10 to 12 years from the initial research to bringing a drug to market, including six to eight years from Phase I clinical trials to market. At each of these steps, there is a substantial risk that we will not achieve our goals and accordingly we may be required to abandon a product in which we have made a substantial investment.

Research program

        The discovery of new drugs is a complex and challenging process which is split into different phases. These phases provide tools that allow our Research team to manage and benchmark their activities. Milestones are established for each phase of the evaluation process. Candidates only advance to the next stage if defined sets of criteria are met. One of the most important major milestones to occur is when a compound meets our early selection criteria, at which time it is declared an Early Selection Compound (ESC). Once a compound has been declared an ESC, significant resources are spent in preclinical activities to satisfy safety requirements, including toxicology studies. Only those compounds that pass this more comprehensive series of preclinical testing (on average, about one in ten candidates) advance to the development stage of a drug's life-cycle. See "—Clinical development program."

        The completion of the human genome sequence and advances in technologies and computing are changing the way we are discovering new drugs. Functional genomics at Novartis aims at focusing our discovery efforts on drug targets which are disease-relevant and offer potential for new medicines which prevent or slow the progression of a disease, rather than just treat its symptoms. Genomics research groups are located in Basel, Switzerland, and New Jersey (United States) with further support from the Genomics Institute of the Novartis Research Foundation in San Diego California (United States). In total, these activities are staffed by more than 350 scientific and technical experts. This strong in-house capability is complemented by external collaborations with numerous highly regarded biotech companies and academic groups world-wide. Advances made at Novartis and in the alliances we have with other organizations in combinatorial chemistry, ultra high throughput screening technologies, miniaturization, computational approaches, and robotics and engineering are being incorporated into our new discovery processes in order to maximize their effectiveness. To further optimize research capabilities, Novartis established the Novartis Institutes for BioMedical Research, Inc. (NIBRI) in Cambridge, Massachusetts. This new research facility will initially provide lab and office space for 400 scientists and technology experts. Novartis plans to expand this site, and to create one of the most important research campuses in the world focusing on discovery of new drugs.

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Clinical development program

        Usually in Phase I clinical trials, a drug is tested with about 20 to 80 normal, healthy volunteers. The tests study the drug's safety profile, including the safe dosage range. The studies also determine how a drug is absorbed, distributed, metabolized and excreted, and the duration of its action. In Phase II clinical trials, the drug is tested in controlled studies of approximately 100 to 300 volunteer patients (i.e., persons with the targeted disease) to assess the drug's effectiveness and safety, and to establish a proper dose. In Phase III clinical trials, the drug is further tested on larger numbers of volunteer patients (in some cases more than 15,000 patients in total) in clinics and hospitals. Physicians monitor volunteer patients closely to determine the drug's efficacy and to identify possible adverse reactions. The vast amount of data that must be collected and evaluated makes clinical testing the most time-consuming and expensive part of new drug development. The next stage in the drug development process is to seek registration for the new drug. See "—Regulation."

Initiatives to optimize the discovery and development process

        We are working to be more efficient in selecting candidate drugs for development. For example, we are now better able to select the best compounds for development by having senior management focus on development projects at an early stage. Under another initiative, special teams work to develop late stage products more quickly. The goal is to improve the likelihood of therapeutic and commercial success, which should reduce development costs and decrease time to market. In several other initiatives we are improving electronic management of the clinical trial processes, including data capture and transfer, reviewing site management as well as electronic storage and archiving of study data and documents. Overall, these initiatives have reduced clinical trial outsourcing, and have improved data quality and speed of clinical trial reporting, substantially reducing the time between initial research and the introduction of the drug to market.

Alliances and acquisitions

        Our Pharmaceuticals Division forms strategic alliances and alliance arrangements with other industry players or academic institutions in order to develop new products, acquire platform technologies and to access new markets. We license in products which complement our current product line and that are appropriate to our business strategy. Disease area strategies have been established to focus on alliances and acquisition activities for key disease areas/indications that are expected to be growth drivers in the future. Products and compounds we review for in-licensing are selected and evaluated using the same criteria as the ones used for our own internally discovered drugs.

        We have long term research undertakings totaling CHF 893 million in the aggregate as of December 31, 2002, including CHF 330 million in milestone payments. We intend to fund these expenditures from internally generated resources.

Regulation

        The international pharmaceutical industry is highly regulated. Regulatory authorities around the world administer numerous laws and regulations regarding the testing, approval, manufacturing, importing, labeling and marketing of drugs, and also review the safety and efficacy of pharmaceutical products. Further controls exist on the non-clinical and clinical development of pharmaceutical products in particular. These regulatory requirements are a major factor in determining whether a substance can be developed into a marketable product and the amount of time and expense associated with that development.

        World regulatory authorities, especially those in the US, Switzerland, the EU and Japan, have high standards of technical evaluation. The introduction of new pharmaceutical products generally entails a lengthy approval process. Of particular importance is the requirement in all major countries that products be authorized or registered prior to marketing, and that such authorization or registration be subsequently

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maintained. In recent years, the registration process has required increased testing and documentation for clearance of new drugs, with a corresponding increase in the expense of product introduction.

        To register a pharmaceutical product, a registration dossier containing evidence establishing the quality, safety and efficacy of the product must be submitted to regulatory authorities. Generally, a therapeutic product must be registered in each country in which it will be sold. In every country, the submission of an application to a regulatory authority does not guarantee that approval to market the product will be granted. Although the criteria for the registration of therapeutic drugs are similar in most countries, the formal structure of the necessary registration documents varies significantly from country to country. It is possible that a drug can be registered and marketed in one country while the registration authority in a neighboring country may, prior to registration, request additional information from the pharmaceutical company or even reject the product. It is also possible that a drug may be approved for different indications in different countries.

        The registration process generally takes between six months and several years, depending on the country, the quality of the data submitted, the efficiency of the registration authority's procedures and the nature of the product. Many countries provide for accelerated processing of registration applications for innovative products of particular therapeutic interest. In recent years, intensive efforts have been made among the United States, the EU and Japan to harmonize registration requirements in order to achieve shorter development and registration times for medical products. However, the requirement in many countries to negotiate selling prices or reimbursement levels with government regulators can substantially extend the time until final marketing approval is granted.

        The following provides a summary of the regulatory process in the principal markets served by Pharmaceuticals Division affiliates:

United States

        In the US, applications for drug registration are submitted to and reviewed by the FDA. The FDA regulates the testing, approval, manufacturing, importing, labeling and marketing of pharmaceutical products intended for commercialization in the US. The FDA also monitors all pharmaceutical products currently on the US market. The pharmaceutical development and registration process is typically intensive, lengthy and rigorous. When a pharmaceutical company has gathered data which it believes sufficiently demonstrates a drug's quality, safety and efficacy, then the company may file a New Drug Application ("NDA") for the drug. The NDA must contain all the scientific information that has been gathered about the drug and typically includes information regarding the clinical experiences of all patients tested in the drug's clinical trials. A supplemental new drug application ("sNDA") must be filed for a line extension of, or new indications for, a previously registered drug.

        Once an NDA is submitted, the FDA assigns reviewers from the fields of biopharmaceuticals, chemistry, medicine, microbiology, pharmacology/toxicology, statistics and labeling. After a complete review, these experts then provide written evaluations of the NDA, including a recommendation. These recommendations are consolidated and are used by the FDA in its evaluation of the NDA. Based on that evaluation, FDA then provides to the NDA's sponsor an approval, or an approvable, or non-approvable letter. The approvable and non-approvable letters will state the specific deficiencies in the NDA which need to be addressed. The sponsor must then submit complete responses to the deficiencies in order to restart the review procedure.

        Once the FDA has approved an NDA or sNDA, the company can make the new drug available for physicians to prescribe. The drug owner must submit periodic reports to the FDA, including any cases of adverse reactions. For some medications, the FDA requires additional post-approval studies (Phase IV) to evaluate long-term effects or to gather information on the use of the product under special conditions. The FDA also requires compliance with standards relating to good laboratory, clinical and manufacturing practices.

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European Union

        In the EU, there are two main procedures for application for marketing authorization, namely the Centralized Procedure and the Mutual Recognition Procedure. National authorizations are only possible for products intended for commercialization in a single EU member-state only, or for line extensions to existing national product licenses.

        In the Centralized Procedure, applications are made to the European Medical Evaluations Agency ("EMEA") for an authorization which is valid across all EU member-states. The Centralized Procedure is mandatory for all biotechnology products and optional for other new chemical compounds or innovative medicinal products. When a pharmaceutical company has gathered data which it believes sufficiently demonstrates a drug's quality, safety and efficacy, then the company may submit an application to the EMEA. The EMEA then receives and validates the application, and appoints a Rapporteur and Co-Rapporteur to review it. The entire review cycle requires 210 days, although there is a "clock stop" at day 120, which allows for the company to respond to questions set forth in the Rapporteur/Co-Rapporteur's Assessment Report. When the company's complete response is received by the EMEA, the clock restarts on day 121. If there are further aspects of the dossier requiring clarification, the EMEA will then request an Oral Explanation on day 180, in which the sponsor must appear before the EMEA to provide the requested additional information. On day 210, the EMEA will then take a vote to approve or not approve the application. The final decision is an EU Community decision and applicable to all Member States.

        In the Mutual Recognition Procedure, a first authorization is granted by a single EU member-state. Subsequently, mutual recognition of this first authorization is sought from the remaining EU Member-States or a subset thereof. The Mutual Recognition Procedure, commonly called MRP, requires 90 days. Within this procedure, each Member State reviews the application and can issue objections or requests for additional information. On Day 90, each Member State must be assured that the product is safe, effective and that there are no risks to the public health. Once agreement has been reached, each Member State grants separate marketing authorizations for the product.

        After the Marketing Authorizations have been granted, the company must submit periodic safety reports to the EMEA (Centralized Procedure) or to the National Health Authorities (Mutual Recognition Procedure). The licenses are renewed on a 5 year basis.

Japan

        In Japan, applications for new products are made through the Pharmaceutical and Medical Devices Evaluation Center ("PMDEC"). After a data reliability survey and a Good Clinical Practice inspection are carried out by the Organization for Pharmaceutical Safety and Research, a team evaluation is passed to the Central Pharmaceuticals Affairs Council ("CPAC"), whose special members, committees and executive committees provide a report back to the PMDEC. After a further team evaluation, a report is provided to the Ministry of Health, Labor and Welfare ("MHLW"), which makes a final determination for approval and refers this to the CPAC which then advises the MHLW on final approvability. Drug manufacturing or import license approval is issued by the local prefecture government. Once the MHLW has approved the application, the company can make the new drug available for physicians to prescribe. For some medications, the MHLW requires additional post-approval studies (Phase IV) to evaluate safety, effects and/or to gather information on the use of the product under special conditions. The MHLW also requires the Sponsor to submit safety reports.

Price Controls

        In many of the markets where we operate, the prices of pharmaceutical products are subject to direct price controls (by law) and to drug reimbursement programs with varying price control mechanisms. Due to increasing political pressure and governmental budget constraints, we expect these mechanisms to

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remain in place—and to perhaps even be strengthened—and to have a negative influence on the prices we are able to charge for our products.

        In the United States, debate over the reform of the healthcare system has resulted in an increased focus on pricing. Although there are currently no government price controls over private sector purchases in the United States, federal legislation requires pharmaceutical manufacturers to pay prescribed rebates on certain drugs to enable them to be eligible for reimbursement under healthcare programs. In the absence of new government regulation, managed care has become a potent force in the US market place that increases downward pressure on the prices of pharmaceutical products. In addition, the current national debate over Medicare reform could influence prices. If Medicare reform results in the provision of outpatient pharmaceutical coverage for beneficiaries, the US government could use its enormous purchasing power to demand additional discounts from pharmaceutical companies thereby creating de facto price controls on prescription drugs. On the other hand, Medicare drug reimbursement legislation may increase the volume of pharmaceutical drug purchases and may alleviate the pressure from the uninsured, offsetting, at least in part, potential additional price discounts. With the 2002 elections now completed, it seems more likely that a Medicare Prescription Drug Benefit will be passed in 2003 or 2004.

        In the EU, governments influence the price of pharmaceutical products through their control of national healthcare systems that fund a large part of the cost of such products to consumers. The downward pressure on healthcare costs in general in the EU, particularly with regard to prescription drugs, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross-border imports from low-priced markets (parallel imports) exert commercial pressure on pricing within a country. The expected EU enlargement (with 10 countries expected to join the EU beginning in 2004) will probably complicate the environment and have some influence on prices in the region and parallel trade.

        In Japan, the MHLW reviews the prices of individual pharmaceutical products every two years. In the past, these reviews have resulted in price reductions. The Japanese government is currently undertaking a healthcare reform initiative, and the pharmaceutical pricing system is one of the issues being reviewed. In particular, the government is reviewing the pricing of older products, including the biannual reduction of reimbursement prices adjusted for actual discounts given. The government has abandoned the previously proposed reference price system. These efforts on the part of the government may well lead to substantial reforms of the Japanese healthcare system in the near future. Such reforms likely would include additional price control mechanisms, and would place additional pressure on the prices charged for pharmaceutical products.

Intellectual Property

        We attach great importance to patents, trademarks, and know-how in order to protect our investment in research and development, manufacturing and marketing. It is our policy to seek the broadest possible protection for significant product developments in all major markets. Among other things, patents may cover the products themselves, including the product's active substance and its formulation. Patents may also cover the processes for manufacturing a product, including processes for manufacturing intermediate substances used in the manufacture of the products. Patents may also cover particular uses of a product, such as its use to treat a particular disease, or its dosage regimen.

        The protection offered by such patents extends for varying periods depending on the legal life of patents in the various countries. The protection afforded, which may also vary from country to country, depends upon the type of patent and its scope of coverage. We monitor our competitors and vigorously challenge infringements of our intellectual property.

        Patent protection is no longer available in several major markets for the active substances used in a number of our Pharmaceuticals Division's leading products:

    Neoral.    Patent protection exists for the Neoral micro-emulsion formulation and other cyclosporin formulations through 2009 and beyond in major markets. Despite this protection, generic

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      cyclosporin products competing with Neoral have entered the transplantation market segment in the US, Germany and elsewhere. We have filed patent infringement actions against manufacturers of these generic products. However, despite a finding of infringement and an award of damages against one of these manufacturers in the US, we have so far not succeeded in obtaining an injunction, or a final judgment of damages against any of the manufacturers we have sued.

    Aredia.    Our patent protection for Aredia is limited. Generic versions of Aredia were launched in the US in 2001 and 2002. Generic products in competition with Aredia are on sale in Canada and elsewhere. However, in 2002, we launched Zometa,our more potent successor product to Aredia.

    Sandostatin.    Basic patent protection for Sandostatin has expired in the US and Japan and will expire April 2003 in Germany and the UK, 2006 in France, and 2007 in Italy. However, protection extending to 2010 (2013 and beyond in the US) continues in major markets for Sandostatin | LAR, which represents a substantial and growing proportion of our octreotide sales.

    Cibacen/Lotensin/Cibadrex.    The basic benazepril substance patent for Cibacen/Lotensin/Cibadrex expired in Japan in 2002 and will expire in the US in August 2003 (or expected to expire in February 2004 with any six-month pediatric exclusivity) and in 2004-08 in major markets in the EU. However, Lotrel, which is a combination of benazepril with amlodipine, is patented in the US until 2017.

    Lamisil.    Lamisil is covered generically by a patent family which will expire in 2004 in the US, March 2003 in Japan and has expired in other major countries. Another patent family covers the product specifically and expires in 2006 in the US, 2004-05 in Japan and 2005-07 in major EU countries. The specific US patent is being challenged by Dr. Reddy Laboratories in the US.

    Voltaren.    Voltaren is off-patent. As a result, revenue from Voltaren may decline significantly over the next few years.

        The loss of patent protection can have a significant impact on our Pharmaceuticals Division. We work to offset these negative effects by developing and patenting inventions that result in process and product enhancements and by positioning many of our products in specific market niches. However, there can be no assurance that this strategy will be effective in the future to extend competitive advantage, or that we will be able to avoid substantial adverse effects from future patent expirations.

CONSUMER HEALTH

        The business of our Consumer Health Division is conducted by a number of affiliated companies throughout the world. In 2002, the Consumer Health Division was reorganized to include our Generics, OTC self-medication, Animal Health, Medical Nutrition (including our Nutrition & Santé unit), Infant & Baby, and our CIBA Vision Business Units. Each Business Unit has a leading market position in its segment by producing and marketing high quality health-related products. In 2002, the affiliates of the Consumer Health Division employed 27,552 associates and had CHF 11.4 billion in sales, which represented 35% of the Group's sales.

        In February 2002, we announced our intention to divest our Health and Functional Food business before the end of 2002. This was intended to better meet customer needs and strengthen growth initiatives, furthering our strategic focus on healthcare with pharmaceuticals at the core. In November 2002, we completed the divestment of our Food & Beverage business, including Ovaltine®/Ovomaltine®, Caotina® and Lacovo®, to Associated British Foods plc for EUR 272.5 million (approximately CHF 402 million). In November 2002, we also announced that we were delaying the divestment of the remainder of the Health and Functional Food business due to a lack of attractive offers. These remaining Health and Functional Food businesses—the Health Food & Slimming and Sports Nutrition lines—have been reorganized into a stand-alone unit called Nutrition & Santé. For reporting purposes, Nutrition & Santé's results will be included in the results of the Medical Nutrition Business Unit. We have announced our intention to sell Nutrition & Santé once an attractive bid is received.

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GENERICS

        The business of our Generics Business Unit is conducted by a number of affiliated companies throughout the world. We are a world leader in the development, manufacture and marketing of pharmaceutical products and substances which are no longer protected by patents. In January 2003, we announced plans to unite 14 of our Generics company brands under a single global umbrella name, Sandoz, to strengthen recognition and leverage share of voice in the highly competitive marketplace for generics products. The initiative capitalizes on the strong reputation of the Sandoz name, which still commands a high level of awareness and trust among physicians, pharmacists and patients.

        The affiliated companies of our Generics Business Unit compete in three principal product segments: finished dosage forms (the "Generic Pharmaceuticals Business"), active pharmaceutical ingredients and their intermediates (the "Industrial Business") and biopharmaceuticals (the "Biopharmaceuticals Business"). In the Generics Pharmaceuticals Business, we develop and manufacture drugs no longer protected by patents in finished dosage forms, and sell them to pharmacies, hospitals and other healthcare outlets around the world. In the Industrial Business, we manufacture active ingredients for pharmaceutical and biotechnological substances, and their intermediates, and sell them to customers who use them to manufacture finished goods. In developing our new Biopharmaceuticals Business, we are seeking to leverage our technology and expertise in manufacturing to develop, manufacture and market high-quality biopharmaceutical products, such as interferones, growth hormones, and insulin, both on behalf of third parties and, as originating biopharmaceutical products lose patent protection, on our own behalf.

        As of December 31, 2002, the affiliates comprising our Generics Business Unit employed 7,932 associates. Our Generics products are sold in over 140 countries throughout the world. In 2002, the affiliates comprising Generics had CHF 2.8 billion in sales, which represented 9% of the Novartis Group's total sales.

        In 2002, Generics sales grew by approximately 25% in local currencies. The business year was characterized by strongly developing US sales, the acquisition of Lek Pharmaceuticals d.d., the continued integration of recently acquired companies and the successful launch of some generics blockbusters, including the US launch of the generic form of the blockbuster antibiotic Augmentin®, amoxicillin/potassium clavulanate.

        In the United States, our Generics sales increased by 50% mainly driven by the launch of amoxicillin/potassium clavulanate in July. This more than made up for the January 2002 expiration of our exclusivity period for the ten milligram capsule formulation of fluoxetine, the generic form of the blockbuster anti-depressant Prozac®.

        In Germany, the second most important market for our Generics products, the introduction of new regulations served to limit our sales and the growth in the profitability or our Generics affiliate there. In many other key European markets we achieved excellent performance with strong double digit growth. These markets included the United Kingdom, France, Italy, the Netherlands, Belgium and Austria.

        Our key Austrian affiliate, Biochemie GmbH ("Biochemie"), achieved considerable global sales growth in 2002, with good results for products in all three business segments. Biochemie's main growth drivers were amoxicillin/potassium clavulanate, and active ingredients and intermediates for penicillins and cephalosporins.

        In November 2002, Novartis Generics acquired Lek Pharmaceuticals d.d., Slovenia's largest pharmaceuticals company. Except where otherwise noted, information in this section does not include information regarding Lek. Only a provisional balance sheet for Lek has been included in our 2002 consolidated financial statements. Lek sales will be consolidated with our sales as of January 1, 2003.

        With the acquisition of Lek, Novartis Generics is now a major supplier of generic pharmaceutical products in Central and Eastern Europe and in the former Soviet Union. The Lek group employs approximately 3900 associates. In the first six months of 2002, the Lek group achieved sales of CHF 305 million, operating income of CHF 51 million, and net income of CHF 36 million. Lek manages a wide

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ranging business portfolio, with anti-infectives, cardiovascular and gastrointestinal tract products. Lek also launched a generic version of Augmentin® in the US in 2003. For the time being, Lek products will continue to be sold under that well-regarded name, as agreed between the management of Novartis and Lek.

        In 2002, our Industrial Business achieved improved performance in active ingredients (penicillins, cephalosporin and intermediates) as a result of increased penicillin productivity which led to increased sales volumes, a shift to high-value compounds for cephalosporin antibiotics and additional long-term contracts with major pharmaceutical and biotech companies.

Key Marketed Products

        Approximately 71% of our Generics sales are derived from our Generic Pharmaceuticals Business, approximately 27% of sales are derived from our Industrial Business and approximately 2% are attributable to the Biopharmaceuticals Business.

        Key marketed products include antibiotics (such as penicillins, cephalosporins, macrolides and medicines for the treatment of tuberculosis), central nervous system drugs, cardiovascular drugs, alimentary tract preparations and hormonal tract preparations.

Recently Launched Products

        The following is a summary of the most important products launched by us in 2002.

    Loratadine (a generic version of the allergy treatment Claritin®) was launched in the United Kingdom, Netherlands, Norway and Finland in December 2002. In the US, loratadine was approved in January 2003, and we launched the product immediately. For the US launch, Novartis Generics is supporting the over-the-counter launch of this product by Novartis' OTC Business Unit, through a series of supply agreements between affiliates of the two Business Units.

    Amoxicillin/potassium clavulanate (a generic version of the antibiotic Augmentin®) was launched in the US by our affiliate Geneva Pharmaceuticals, Inc. in July 2002. Our affiliate Lek launched its own generic version of Augmentin® in the US in January 2003.

    Lisinopril hydrochlorothiazide (a generic version of the hypertension, heart failure and acute myocardial infarction treatment Prinivil® and Prinizide®) was launched in the US in July 2002.

    Mefloquine (a generic version of the malaria treatment Lariam®) was launched in the US in May 2002.

    Omeprazole (a generic version of the a proton-pump inhibitor Losec®) was launched in the Netherlands in April 2002.

    Citalopram (a generic version of the antidepressant Cipramil®) was launched in the Netherlands, Sweden, Finland and Germany on various dates early in 2002.

    Metformin (a generic version of the diabetes, alimentary tract and metabolism treatment Glucophage®) was launched in the US in January 2002.

    Nabumetone (a generic version of the anti-inflammatory/anti-rheumatic Relifex®) was launched in the US in February 2002.

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Principal Markets

        The principal markets of our Generics Business Unit are the two largest generics markets in the world: the United States and Europe. The following table sets forth the aggregate 2002 sales of Generics by region:

Generics

  Sales 2002
 
  (CHF millions)

  (%)

United States   1,086   39
Americas (except the United States)   188   7
Europe   1,059   37
Rest of the World   476   17
   
 
Total   2,809   100
   
 

        In 2002, our dynamic sales growth in the United States of 50% was driven by a favorably developing base business and the launch of amoxicillin/potassium clavulanate.

        In Germany, new generic substitution regulations became effective on February 23, 2002 which required pharmacists to substitute a prescribed drug with a less expensive drug, if available. Where more than one generic product was available for the pharmacist to choose from, the pharmacist was required to choose one of the lowest priced options. As a result, our largest German affiliate, Azupharma, was forced to reduce the prices it charged for many of its products in order to remain competitive. We expect the German market to remain difficult in the near future as a result of these new regulations. We are taking steps to improve Azupharma's performance.

        Many of our Generics Business Unit's products are used for chronic conditions that require patients to consume the product over long periods of time, from months to years. Sales of the vast majority of our products are not subject to material changes in seasonal demand.

Production

        We manufacture our Generics products at more than 15 production facilities around the world. Among these, our principal production facilities are located in Kundl, Austria and Broomfield, Colorado. While we have not experienced material supply interruptions in the past, there can be no assurance that supply will not be interrupted in the future as a result of unforeseen circumstances. The manufacture of our products is heavily regulated, making supply never an absolute certainty. If we or our third party suppliers fail to comply fully with such regulations then there could be a government-enforced shutdown of production facilities, which in turn could lead to product shortages.

        We obtain agricultural raw materials such as flours and sugars from multiple suppliers based in both the US and the EU. We obtain chemicals and other raw materials from suppliers around the world, though we focus on US- and EU-based suppliers. The raw materials we purchase are generally subject to market price fluctuations. We seek to avoid these fluctuations, where possible, through the use of long-term supply contracts. In addition, several of our Generics affiliates use e-procurement systems to further strengthen their purchasing productivity.

        We produce biotech substances like enzymes for detergents, and many of the active pharmaceutical ingredients, like penicillins, using modern bio-technological methods. These methods include fermentation processes, chemical syntheses and physical production methods, such as sterile precipitation. We are constantly developing other new manufacturing processes.

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Marketing and Distribution

        In our Generics Pharmaceuticals Business, we have a broad portfolio of off-patent medicines that we sell to pharmacies, hospitals, and other healthcare outlets. Depending on the structure of the local market, customers are serviced either by the field service team of the local Generics affiliate or by well established partners or joint venture associates.

        In our Industrial Business, we sell active pharmaceutical ingredients and biotech substances to manufacturers in the pharmaceutical industry.

        In response to rising healthcare costs, many governments and private medical care providers, such as health maintenance organizations (HMOs), have instituted reimbursement schemes that favor the substitution of generic pharmaceuticals for more expensive brand-name pharmaceuticals. In the US, generic substitution statutes have been enacted by virtually all states and permit or require the dispensing pharmacist to substitute a less expensive generic drug for the brand-name version of the drug. In Europe, the use of generic drugs is growing. But in some EU countries, reimbursement practices do not create an efficient incentive for generic substitution. As a result, generic penetration rates in many European countries are still below those reached in the US.

Competition

        Other companies selling finished dosage form generic pharmaceutical products are Mylan, Teva, Watson, and Barr in the US and Hexal, Ratiopharm, Stada, Teva, Merck Generics and Alpharma in Europe.

        Other companies selling active pharmaceutical ingredients & intermediates are Antibioticos and DSM-Anti-Infectives (both headquartered in the EU) as well as certain East Asian manufacturers.

        The market for generic products is characterized by increasing demand for high-quality pharmaceuticals which can be produced at lower costs due to minimized initial research and development investments. Increasing pressure on healthcare expenditures and numerous patent expirations have created a favorable market environment for the generics industry. This positive market trend, however, brings increased competition within the generics industry, leading to ongoing price pressure on generic pharmaceuticals.

Research and Development

        Before a generic drug may be marketed, intensive development work must be performed in order to demonstrate the bioequivalency of the generic drug to the original branded drug. Nevertheless, research and development costs associated with generic drugs are much lower than those of their original counterparts. As a result, off-patent drugs can be offered for sale at prices much lower than those of patented drugs, which must recoup substantial basic research and development costs through higher prices over the life of the product's patent.

        Currently, the affiliates of our Generics Business Unit employ almost 750 researchers and developers who explore alternative routes for the manufacture of known compounds and who aim to develop innovative forms of generic drugs. Most of these associates are based at facilities in Kundl, Austria; Dayton, New Jersey; and near Mumbai, India. In 2002, our Generics Business Unit invested CHF 215 million in research and development, which amounted to 7.6% of sales.

        We have long term research undertakings totaling CHF 26 million in the aggregate as of December 31, 2002, including CHF 9 million in milestone payments. We intend to fund these expenditures from internally generated resources.

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Regulation

        The Waxman-Hatch Act in the United States (and similar legislation in the EU and in other countries) eliminated the repetition of extensive clinical trials for generic drugs so long as they could be shown to be of identical quality and purity and to be biologically equivalent to the original branded drug.

        In the US, the decision whether a generic drug is bioequivalent to the original branded drug is made by the FDA based on an Abbreviated New Drug Application (ANDA) filed by the generic drug's manufacturer. The process typically takes approximately eighteen months from the filing of the ANDA until FDA approval. However, delays can occur if issues arise regarding the interpretation of bioequivalence study data, labeling requirements for the generic product, or qualifying the supply of active ingredients. In addition, the Waxman-Hatch Act requires a generic manufacturer to certify in certain situations that the generic drug does not infringe any current applicable patents on the drug held by the innovator, or to certify that such patents are invalid. This certification usually results in a lawsuit brought by the innovator against the generic company. In the event of such a lawsuit, the Waxman-Hatch Act imposes an automatic 30-month delay in the approval of the generic drug in order to allow the parties to resolve the intellectual property issues.

        In the EU, decisions on bioequivalence can be made by the EMEA under the Centralized Procedure, or by a single member state, after which the Mutual Recognition Procedure may be followed. See "Pharmaceuticals—Regulation—European Union." Companies may submit Abridged Applications for approval of a generic pharmaceutical product, based upon its "essential similarity" to a medicinal product authorized and marketed in the EU for not less than ten years.

Intellectual Property

        Wherever possible our products are protected by patents. Among other things, patents may cover the products themselves, including the product's active substance and its formulation. Patents may also cover the processes for manufacturing a product, including processes for manufacturing intermediate substances used in the manufacture of the products. Patents may also cover particular uses of a product, such as its use to treat a particular disease, or its dosage regimen. It is our policy to seek the broadest possible protection for significant product developments in all major markets.

        We take all reasonable steps to ensure that our generic products do not infringe valid intellectual property rights held by others. Nevertheless, originating companies commonly assert patent and other intellectual property rights in an effort to delay or prevent generic competition. As a result, we can become involved in extensive litigation regarding our generic products. If we are unsuccessful in defending these suits, we could be subject to injunctions preventing us from selling our generic products, or to damages, which may be substantial.

        In one significant example, we are involved in a series of lawsuits against affiliates of GlaxoSmithKline (GSK) regarding amoxicillin/potassium clavulanate, our generic version of GSK's Augmentin®. Our US affiliate, Geneva Pharmaceuticals, Inc., launched the first generic version of this GSK product in the US in July 2002, following favorable decisions by the United States District Court for the Eastern District of Virginia invalidating seven patents alleged by GSK to cover its Augmentin® product. GSK has appealed the district court's decision invalidating its patents. Should GSK be successful in this appeal, GSK has indicated that it intends to seek to recover its lost profits for sales it would have made had Geneva's product not been on the market.

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        GSK has also initiated actions against Geneva and several of our other affiliates (Biochemie GmbH, Biochemie SpA, and Novartis AG) in state court in Colorado and before the United States International Trade Commission, alleging that the potassium clavulanate used in manufacturing the Geneva product is produced using a micro-organism strain allegedly stolen from GSK, an allegation which Geneva and the other Novartis affiliates deny. GSK has also filed a separate lawsuit in state court in North Carolina against our affiliate Lek, alleging that the potassium clavulanate used in manufacturing the Augmentin® generic product sold by Lek is produced using a micro-organism strain allegedly stolen from GSK, an allegation which Lek denies. Should GSK ultimately be successful in any of these actions, we may be subject to an injunction against further sales, and to damages claims, which may be considerable.

OTC

        Our Over-the-Counter (OTC) Business Unit manufactures and distributes products for the treatment and prevention of common medical conditions and ailments to enhance people's overall health and well being. In 2002, our OTC business posted CHF 2.4 billion in sales, representing 7% of group sales, and ranking it the sixth largest global self-medication company on the basis of sales, with strong positions in Europe (second largest) and North America (seventh largest), as well as a growing presence in Latin America and Asia. As of December 31, 2002, our OTC Business Unit employed 3,797 associates worldwide.

Key Marketed Products

        The OTC Business Unit's main product categories are cough, cold and allergy treatments, gastrointestinal treatments, dermatological treatments, analgesics, vitamins, minerals and supplements, venous disorder treatments and smoking cessation treatment. The major OTC brands are:

Key brands

  Market/segment
Nicotinell/Habitrol   Smoking cessation
Voltaren Emulgel   Topical Muscle Pain
Sandoz   Minerals
LamisilAT Cream   Athlete's foot treatment
Otrivin   Nasal decongestant
Triaminic   Pediatric cough & cold
NeoCitran/TheraFlu   Cold remedies and flu
Maalox   Antacid
Ex-Lax/Benefiber   Laxatives
Gas-X   Anti Gas
Denavir/Vectavir   Cold Sore
Fenistil   Wound healing

        In 2002, the OTC Business Unit had a number of key brand achievements:

    Lamisil, the one week treatment for athlete's foot, had strong sales results, led by Western Europe, where sales increased by 32%. This resulted in a global sales increase for Lamisil products of 10% over 2001.

    Voltaren Emulgel, a topical analgesic for muscle pain and the largest OTC brand in our portfolio, achieved the number 1 global position in sales within the topical analgesics category with a 6.7% share of the category's sales.

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    Nicotinell/Habitrol, our smoking cessation franchise, increased sales by 31% over 2001 driven by the introduction of consumer-preferred chewing gum products and by major private label gains in North America and Asia.

    We launched several innovative new products or formulations, including Otrivin nasal decongestant, which was developed based on insights from consumers. The introduction of new moisturizing and allergy formulations of Otrivin supported the brand's outstanding 11% increase in worldwide sales compared to 2001.

    We acquired the Buckley's cough and cold remedy brand in Canada, and began selling Buckley's products in March 2002.

    2002 was also the first full year of sales of the OTC Benefiber brand laxative product, with the brand quickly establishing a 7% share of its market segment in the US.

        It is important to the overall success of the Novartis Group that we maximize the revenues we obtain from our products at each stage of their existence. The OTC Business Unit contributes to this life-cycle management goal with key brands such as Voltaren Emulgel, Lamisil AT and Denavir/Vectavir generating substantial sales after their transfer from the Pharmaceuticals Division.

Principal Markets

        In 2002, OTC realized the majority of its sales in its two principal markets: the US and Europe, including Eastern Europe. In 2002, the OTC Business Unit and Kao Corporation agreed to end their joint venture to market OTC products in Japan. However, OTC remains committed to expanding its presence in the Japanese market. The following table sets out our 2002 sales by geographic region.

OTC

  Sales 2002
 
  (CHF millions)

  (%)

United States   751   32
Americas (except the United States)   223   9
Europe   1,114   48
Rest of World   271   11
   
 
Total   2,359   100
   
 

        The OTC business is marked by a high degree of seasonality, with our cough, cold and allergy brands—including Triaminic, NeoCitran/Theraflu and Tavist—heavily influenced by the timing and severity of the annual cold and flu season and allergy seasons.

Production

        Our OTC Business Unit has a manufacturing and supply infrastructure comprised of the Business Unit's own plants, strategic third parties and other Novartis Group plants (which are predominantly owned and operated by the Pharmaceuticals Division). The primary OTC plants are located in Switzerland and in the United States.

        The goal of our supply chain strategy is to produce and distribute high quality products in an efficient manner. The balance of internal, external and Group sites provides flexibility and predictable sources of supply in the event of capacity constraints or other potential disruptions to supply. The manufacture of our products is heavily regulated, making supply never an absolute certainty. If we or our third party suppliers fail to comply fully with such regulations then there could be a government-enforced shutdown of production facilities, which in turn could lead to product shortages. While we have not experienced

46



material supply interruptions in the past, there can be no assurance that supply will not be interrupted in the future as a result of unforeseen circumstances.

        Raw materials for the manufacturing process are purchased from a number of our affiliates and third party suppliers. For the most part, the products and services we procure are not proprietary and are available from a number of suppliers. We often "single-source" supplies, but we have a policy of having at least a second approved and validated supplier registered for most key materials so that substitution is possible. Where practical and beneficial, we have long-term contracts in place on key production inputs. We also proactively monitor markets and developments that could have an adverse effect on the supply of essential materials.

Marketing and Distribution

        We aim to be a leading global participant in fulfilling the needs of patients and consumers for self-medication healthcare. Strong brands, science-based products and in-house marketing and sales organizations are key strengths that allow the business to achieve this objective. We distribute our products through various channels, such as pharmacies, food, drug and mass retail outlets.

Competition

        The fundamental trends driving the growth of our OTC business are increasing pressures on government health funding, changing consumer attitudes towards personal well being, the rise of a self-care mentality among consumers and successful switches of prescription products to OTC status. Other companies selling over-the-counter pharmaceutical products include major international corporations with substantial financial and other resources, such as Aventis, Bayer, GlaxoSmithKline, Johnson & Johnson, Roche, Pfizer, Procter & Gamble and Wyeth.

Research and Development

        In OTC, the focus of research and development activities is primarily on dermatology, analgesics, cough, cold, allergy, gastrointestinal, minerals, and cardiovascular risk reduction (through smoking cessation programs). OTC also works closely with the Pharmaceuticals Division to evaluate appropriate products that can be switched from prescription to OTC status. The development of line extensions to leverage brand equities is also of high importance. These extensions can take many forms including new flavors, new galenical forms and more consumer-friendly packaging.

        The OTC business employs over 200 associates in R&D with the primary research facility located in Switzerland. Local country R&D organizations largely manage compliance, regulatory needs and medical affairs. In 2002, the OTC Business Unit spent CHF 104 million in R&D, representing approximately 4.4% of net sales.

        We have long term research undertakings totaling CHF 4 million in the aggregate as of December 31, 2002. We intend to fund these expenditures from internally generated resources.

Regulation

        For OTC products, the regulatory process for bringing a product to market consists of preparing and filing a detailed dossier with the appropriate national or international registration authority and obtaining approval in the United States or registration in the EU and the rest of the world. See "Pharmaceuticals—Regulation."

        In the US, in addition to the NDA process which is also used to approve prescription pharmaceutical products, an OTC product may be sold if the FDA has determined that the product's active ingredient is generally recognized as safe and effective. FDA makes this determination through a regulatory process known as the OTC Review. In the OTC Review, the FDA establishes, in a series of monographs, the conditions under which particular active ingredients may be recognized as safe and effective for OTC use.

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Pharmaceutical companies can market products containing these active ingredients without the necessity of filing an NDA and going through its formal approval process, so long as the company complies with the terms of the published monograph.

        Most countries also have a regulatory process for switching a particular pharmaceutical product from prescription to OTC status. The process varies from country to country.

Intellectual Property

        Our OTC business is brand-oriented and, therefore, we consider our trademarks to be of utmost value. Trademarks protect most of our brands in the majority of the markets where these brands are sold, and we vigorously protect these trademarks from infringement. Our most important trademarks are used in a number of countries. Local variations of these international trademarks are employed where legal or linguistic considerations require the use of an alternative.

        Wherever possible our products are protected by patents. Among other things, patents may cover the products themselves, including the product's active substance and its formulation. Patents may also cover the processes for manufacturing a product, including processes for manufacturing intermediate substances used in the manufacture of the products. Patents may also cover particular uses of a product, such as its use to treat a particular disease, or its dosage regimen. It is our policy to seek the broadest possible protection for significant product developments in all major markets.

ANIMAL HEALTH

        Our Animal Health Business Unit enhances and extends the life of companion animals and improves the health and productivity of farm animals. At December 31, 2002, the affiliates of Animal Health employed 2,218 associates and achieved sales of CHF 971 million, which represents 3% of the Group's sales.

        Animal Health researches, develops, manufactures and markets a wide variety of products for both companion and farm animals including farmed fish. In 2002, the companion animal segment accounted for 48% of our total Animal Health sales and the farm animal segment, including Vaccines and Aquaculture, for 52%. Products include parasiticides, antimicrobials, vaccines and veterinary pharmaceuticals. Our Animal Health business has a dedicated research and development team, which benefits from synergies with other Novartis businesses, most notably, research in the Pharmaceuticals Division.

        We acquired Grand Laboratories Inc. and ImmTech Biologics Inc. in the United States in January 2002 for a combined minimum purchase price of CHF 168 million. The final price may increase depending on whether certain future sales and other targets are met. These businesses specialize in the development, manufacture and marketing of vaccine products for cattle and pigs. Through these acquisitions we increased the share of vaccines to 8% of total sales, strengthened our position in the vaccines market and established our presence in the US farm animal segment.

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Recently Launched Products

Product

  Description
  Registration/Launch Status
Atopica   Treatment of topic dermatitis in dogs   Registered and launched 2002 in Australia/New Zealand, Switzerland and France

Agita

 

Farm fly control

 

Launched in Thailand, Philippines, Malaysia, Turkey, Slovakia, Slovenia.

Capstar

 

Fast-acting oral flea control for dogs and cats

 

Launched in the EU countries in 2002

Clik

 

All-season protection against blowflies on sheep

 

After first EU launch in the UK in 2001, it was registered and launched in France, Ireland and Netherlands

Deramaxx

 

First COX-2 inhibitor approved for pain control in dogs

 

Approval of acute pain control claim was received in the USA in September with launch in the same month

Econor

 

Therapeutic antimicrobial for pigs

 

Re-launch in EU countries following EMEA approval of additional data

Fortekor

 

Congestive Heart Failure in dogs, CRI in cats

 

Launch in South Africa

Milbemax

 

Intestinal worm control in dogs and cats

 

Product launched after first EU approval in France and in Australia


Vaccines


 


 


 


 

Digital Dermatitis Vaccine

 

Vaccine for Digital Dermatitis in dairy

 

Launched in the US

Forte Vaccine Range

 

Prevention of bacterial and viral diseases in farmed salmon

 

Launched in Norway

Pyceze

 

Control of fungal infections in fish and fish eggs

 

Pyceze is the only authorized treatment to replace previously used products now banned by the UK authorities

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Key Marketed Products

Main Products

  Description
Pets (dogs and cats)    

Fortekor

 

Treatment of congestive heart failure in dogs and chronic renal insufficiency in cats

Interceptor

 

Prevention of heartworm and intestinal worms

Program

 

Control of fleas

Sentinel

 

Prevention of heartworm and control of fleas and intestinal worms

Farm animals

 

 

Clik

 

Season-long prevention of blowfly strikes in sheep

Endex

 

Treatment and control of liver fluke and gastro-intestinal worms in cattle and sheep

Fasinex

 

Treatment and control of liver flukes in cattle and sheep

Tiamutin, Econor

 

Treatment of bacterial infections in pigs and poultry

Vetrazin

 

Treatment of blowfly in sheep

Vaccines and Aquahealth

 

 

Betamax, Excis

 

Treatment and control of salmon lice

Birnagen Forte, Furogen

 

Prevention of infectious pancreatic necrosis in farmed salmon

Bovidec

 

Prevention of bovine viral diarrhea in cattle

Fusogard

 

Prevention of foot rot and liver abscess control in cattle

Pyceze

 

Treatment and control of fungal infections in fish and fish eggs

Scourboss, Somnustar

 

Prevention of enteric disease in cattle

Virashield

 

Prevention of respiratory disease in cattle

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Principal Markets

        Products for companion animals are sold predominantly in North America, the EU, Australia and Japan. In most other countries, sales of farm animal products dominate. The following table sets out 2002 total sales of our Animal Health products by region:

Animal Health

  Sales 2002
 
  (CHF millions)

  (%)

United States   364   38
Americas (except the United States)   136   14
Europe   294   30
Rest of the World   177   18
   
 
Total   971   100
   
 

        Pharmaceutical and biological product sales in all of our main Animal Health business segments (aqua, farm and companion animals) fluctuate seasonally, and can be significantly affected by climatic and economic conditions, and by changing health or reproduction rates of animal populations.

Production

        Approximately 80% of our production volume is manufactured by third parties, including Novartis affiliates in other Business Units. Animal Health has production facilities of its own located around the world, including the US, France and China.

        The manufacture of our products is heavily regulated, making supply never an absolute certainty. If we or our third party suppliers fail to comply fully with such regulations then there could be a government-enforced shutdown of production facilities, which in turn could lead to product shortages. While we have not experienced material supply interruptions in the past, there can be no assurance that supply will not be interrupted in the future as a result of unforeseen circumstances.

        We obtain our raw materials from sources around the world. We depend to a large extent on suppliers for the raw materials, intermediates and active ingredients. We make use of long term supply agreements to limit the volatility of prices charged to us for raw materials.

Marketing and Distribution

        Our products are predominantly prescription-only treatments for animals. The major distribution channels are veterinarians and wholesalers of veterinary products. Primary marketing efforts are targeted at veterinarians using such marketing tools as printed materials, direct mail, advertisements and articles in the veterinary special press, our participation at conferences for veterinarians and the organization of special educational events, focusing primarily on new treatment areas. In addition, we engage in general public relations activities, including advertising in the general printed media and direct advertising of brands, respecting the relevant national legislation in each country. Novartis Animal Health has representatives in approximately 40 countries.

Competition

        Other companies selling veterinary pharmaceutical products for companion and farm animals are Bayer, Elanco, Fort Dodge (Wyeth), Intervet (Akzo Nobel), Merial, Pfizer, and Schering-Plough. Most of these companies offer a broad range of products for both companion and farm animals, and their marketing efforts are at a comparable level to ours.

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Research and Development

        Novartis Animal Health has dedicated research facilities in Switzerland and Australia for antiparasitics. In the United States, United Kingdom and Canada, we focus on the development of new vaccines for farm animals and farmed fish. In 2002, we devoted CHF 94 million to research and development, representing 9.7% of total sales.

        In these efforts, we use high-capacity, in-vitro micro-screening to assess a large number of natural products and synthetic chemicals for bioactivity. Our researchers also collaborate with external partners to develop veterinary treatments. Drug delivery projects, some in collaboration with external partners, concentrate on our key treatment areas and aim to improve efficacy and ease of use.

        In addition to these research activities, we exploit synergies with other Novartis businesses to develop new products. Products originally developed for human use are further developed to treat comparable diseases in companion animals. The products Atopica, Clomicalm and Fortekor are examples of effective synergies with the Pharmaceuticals Division.

        We have long term research undertakings totaling CHF 11 million in the aggregate as of December 31, 2002 including CHF 8 million in milestone payments. We intend to fund these expenditures from internally generated resources.

Regulation

        The registration procedures for animal medicines are similar to those for human medicines. In the US, animal health products are generally regulated by the FDA. Certain product categories are regulated by the Environmental Protection Agency (EPA), and vaccines are regulated by the US Department of Agriculture (USDA). Within the FDA, the Center for Veterinary Medicine is responsible for animal drugs. A New Animal Drug Application for product registration must be accompanied by extensive data on safety, environmental effects and on clinical studies, as well as information on manufacturing, quality control and labeling.

        In the EU, veterinary medicinal products need marketing authorization from the competent authority of a member-state (national authorization) or through a community procedure, which is either the Centralized Procedure or the Mutual Recognition Procedure. In the Centralized Procedure, applications are submitted to the EMEA, and the marketing authorization that is granted by the European Commission is then valid throughout the EU. In the Mutual Recognition Procedure, the marketing authorization granted by the first member-state is mutually recognized by the other member-states through a shortened approval procedure.

        In Japan, veterinary medicinal products are approved by the Ministry of Agriculture Fisheries and Food ("MAFF"). The application, including supplementary local trial data, is reviewed by the MAFF and a General Investigation Committee, a Special Investigation Committee and a Permanent Investigational Committee before authorization is granted.

Intellectual Property

        Our business is brand-oriented and, therefore, we consider our trademarks to be of utmost value. Trademarks protect most of our brands in the majority of the markets where these brands are sold, and we vigorously protect these trademarks from infringement. Our most important trademarks are used in a number of countries. Local variations of these international trademarks are employed where legal or linguistic considerations require the use of an alternative.

        Wherever possible our products are protected by patents. Among other things, patents may cover the products themselves, including the product's active substance and its formulation. Patents may also cover the processes for manufacturing a product, including processes for manufacturing intermediate substances used in the manufacture of the products. Patents may also cover particular uses of a product, such as its

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use to treat a particular disease, or its dosage regimen. It is our policy to seek the broadest possible protection for significant product developments in all major markets.

MEDICAL NUTRITION

        Our Medical Nutrition Business Unit is a leader in its field, and offers a wide range of enteral and oral nutrition products and devices tailored to the varying needs of patients and healthcare professionals. We are dedicated to maintaining and improving the health and well being of consumers and patients—at home or in health care delivery settings (hospitals, nursing homes and home health care)—by fulfilling their nutritional needs. In partnership with health care professionals, Medical Nutrition offers the highest quality medical nutrition products, devices and services ranging from standard to disease-specific products that improve health and quality of life for all age groups—from pediatrics to geriatrics. This broad range of supplements, tube feedings and food provides essential nutrients for good nutrition when illness or disabilities limit a person's ability to eat a balanced diet.

        In November 2002, we divested our Food & Beverage business, including Ovaltine®/Ovomaltine®, Caotina® and Lacovo®, to Associated British Foods plc for Euro 272.5 million (approximately CHF 402 million). The transaction is in furtherance of our strategy of focusing on healthcare and our core pharmaceuticals business. Our remaining Health Food & Slimming and Sports Nutrition businesses have been reorganized into a stand-alone unit called Nutrition & Santé. For reporting purposes, this unit's results will be included in the results of the Medical Nutrition Business Unit. We have announced our intention to sell Nutrition & Santé once an attractive bid is received.

        In 2002, Medical Nutrition (including Nutrition & Santé and the Food & Beverage business until the date of its divestment) posted CHF 1.4 billion in sales, representing 4% of Group sales. As of December 31, 2002, Medical Nutrition (including Nutrition & Santé) employed 2,701 associates worldwide.

Key Marketed Products

        Medical Nutrition.    Our Medical Nutrition Business Unit covers the full spectrum of disease and age specific nutrition. Depending on their condition, patients need specific nutritional support to protect and accelerate their recovery from a disease or surgery. From our comprehensive range of innovative and trusted products for Medical Nutrition, we have created five strong and recognizable global brands.

Key brands

  Market/segment
Resource   Range of standard and disease-specific oral nutritional supplements

Isosource

 

A complete tube and sip feed, providing for normal nutritional requirements

Novasource

 

Range of nutritional tube and sip feeds for specialty or disease specific needs

Impact

 

Range of standard and disease-specific oral nutritional supplements

Compat

 

Range of standard and specialty devices to deliver tube feeds to the gastrointestinal tract of patients

        Medical Nutrition will continue to focus on a disease-specific approach while leveraging its global brands especially in the Acute and Home Care market segments.

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        During 2002, Medical Nutrition established a major partnership in the US with the Walgreens chain of drug stores, to better capture the outpatient market. Under this partnership, Walgreens promotes our Medical Nutrition products through its promotional and advertising activities. Outpatient customers are able to purchase our Medical Nutrition products on-line through the Walgreens Medical Nutrition Center, located at the www.resource.walgreens.com website or through a toll-free telephone number, for delivery through Walgreens' order fulfillment system.

        We have made successful in-roads in Japan by licensing our Impact brand to Ajinomoto Co., Ltd.

        2002 was also the first full year of sales of the Sustagen brand in Australia and New Zealand. This brand was licensed in from Mead Johnson & Co. at the end of 2001.

        During 2002, the Medical Nutrition Business Unit ceased doing business in Argentina due to the economic situation in that country.

        Nutrition & Santé.    The stand-alone unit Nutrition & Santé has the following brands:

Key brands

  Market/segment
Health Food & Slimming brands:

Céréal

 

A broad range of natural and dietetic foods to health conscious consumers

Gerblé

 

A broad range of health food products, many made with wheat germ, which deliver functional benefits

Gerlinéa

 

An affordable slimming product range, targeting consumers who wish to remain slim whilst eating as normally as possible, rather than consumers with a medical weight issue

Modifast

 

Slimming products with added vitamins, minerals and proteins

Dietisa

 

A product portfolio range including medicinal plants, health foods, dietary supplements and cosmetics sold mostly in Spain and Portugal

Pesoforma

 

Similar product range as
Gerlinéa focusing at the Italian market

Lecinova

 

Food supplement sold in Italy

Milical

 

Meal substitutes range with very low calorie diet (VLCD) and vitamins, minerals & supplements (VMS)

Sports Nutrition brands:

 

 

Isostar

 

Marketed with a niche, scientific strategy to appeal primarily to professional and performance-driven athletes

Powerplay

 

Products targeted to bodybuilding available only in Switzerland, Germany and Austria

Mineralplus

 

A recovery powder targeted at athletes who participate in endurance sports. Available only in Germany and Austria

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Principal Markets

        In 2002, our Medical Nutrition Business Unit (including Nutrition & Santé) realized the majority of its sales in its two principal markets: the United States and the EU. The following table sets out our 2002 sales by geographic region. The figures include the sales of Nutrition & Santé and the divested Food & Beverage business through the date of its divestment.

Medical Nutrition

  Sales 2002
 
  (CHF millions)

  (%)

United States   398   28
Americas (except the United States)   43   3
Europe   799   56
Rest of World   194   13
   
 
Total   1,434   100
   
 

        Medical Nutrition's products are not subject to seasonality of demand.

Production

        Our Medical Nutrition Business Unit has a manufacturing and supply infrastructure comprised of the Business Unit's own plants as well as strategic third party suppliers and other Novartis Group plants. The most significant of the dedicated Medical Nutrition plants are located in the US and Germany.

        The goal of our supply chain strategy is to produce high quality products in an efficient manner. The balance of internal, external and Group sites provides flexibility and predictable sources of supply in the event of capacity constraints or other potential disruptions to ongoing supply.

        Raw materials for the manufacturing process are purchased from a number of our affiliates and third party suppliers. For the most part, the products and services we procure are not proprietary and are available from a number of suppliers. Where practical and beneficial, we have long-term contracts in place on key production inputs. We also proactively monitor markets and developments that could have an adverse effect on the supply of essential materials. The manufacture of many of our products is regulated, making supply never an absolute certainty. If we or our third party suppliers fail to comply fully with such regulations then there could be a government-enforced shutdown of production facilities, which in turn could lead to product shortages. While we have not experienced material supply interruptions in the past, there can be no assurance that supply will not be interrupted in the future as a result of unforeseen circumstances.

Marketing and Distribution

        The majority of the Medical Nutrition Business Unit's sales (excluding Nutrition & Santé) are to health institutions, such as hospitals, nursing homes, home healthcare providers and group purchasing organizations. In addition, in the US, outpatient consumers can purchase our products directly through our Walgreens partnership, by means of a toll-free telephone call or the internet.

Competition

        Novartis Medical Nutrition (excluding Nutrition & Santé) is the second largest medical nutrition company in the US in terms of sales, and the fourth largest in Europe. Other companies selling medical nutrition products are Abbott Ross, Fresenius, Mead Johnson, Nestlé and Nutricia.

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Research and Development

        The Medical Nutrition research and development function is responsible for generating new products and therapies based on the needs of the market. Concepts are developed into prototypes by incorporating new and existing ingredients, processes, and packaging. Prototypes are scaled from bench top to pilot plant to production scale. Product attributes are validated through clinical trials under the direction of R&D, which assures that the product is safe and well-tolerated. Label claims, label designs, and regulatory compliance issues are also addressed. The product's attributes are reviewed by management prior to product launch. On-going product quality is monitored and improved through specification development, testing, and corrective and preventative action.

        We have long term research undertakings totaling CHF 4 million in the aggregate as of December 31, 2002. We intend to fund these expenditures from internally generated resources.

Regulation

        Foodstuffs are highly regulated in order to protect the public health. The following areas are generally subject to international and national food regulations: development, manufacturing, packaging, quality (food standards, ingredients), safety, labeling and advertising of foods. In the US, Medical Nutrition's products are covered by FDA regulations covering medical foods, dietary supplements (under the DSHEA regulations) and medical devices.

Intellectual Property

        Our Medical Nutrition businesses are brand-oriented and, therefore, we consider our trademarks to be of utmost value. Trademarks protect most of our brands in the majority of the markets where these brands are sold, and we vigorously protect these trademarks from infringement. Our most important trademarks are used in a number of countries. Local variations of these international trademarks are employed where legal or linguistic considerations require the use of an alternative.

        Wherever possible our products are protected by patents. Among other things, patents may cover the products themselves, including the product's active substance and its formulation. Patents may also cover the processes for manufacturing a product, including processes for manufacturing intermediate substances used in the manufacture of the products. Patents may also cover particular uses of a product, such as its use to treat a particular disease, or its dosage regimen. It is our policy to seek the broadest possible protection for significant product developments in all major markets.

INFANT & BABY

        In 2002, our Infant & Baby Business Unit, best known for its Gerber products, posted CHF 2.1 billion in sales, which amounted to a 3% increase in local currencies over 2001, and represented 6% of the Group's sales. The major contributor to this continued solid performance is the US, spurred by innovations in the Juice, Graduates and Tender Harvest lines. An outstanding success has been Lil' Entrees, a new line of microwavable convenience meals in trays. These results are especially strong, given that 2002 baby products industry sales have been negatively impacted by a 1% decline in births in the US in 2001.

        Besides nutrition products, the company offers a wide variety of other products for infants and toddlers, including a baby accessory line (featuring nursing and feeding aids), wellness products (such as lotions and washes), and life insurance. As of December 31, 2002, our Infant & Baby Business Unit employed 4,901 associates worldwide.

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Key Marketed Products

        Globally, our Infant & Baby Business Unit offers more than 200 food products. From Gerber 1st FOODS to Graduates, the company's product line covers each phase of child development with diverse flavors and textures. Gerber baby and toddler foods include Cereals, 1st FOODS, 2nd FOODS, 3rd FOODS, Tender Harvest (organic food), Finger Foods, Fruit and Vegetable Juices and Gerber Graduates Toddler Food. Gerber's nutrition business began in 1928, in Fremont, Michigan and will mark its 75th anniversary in 2003. Gerber began its baby accessory line in 1960 and now markets more than 350 Gerber and NUK® branded products. Bottles, teethers, pacifiers, breastfeeding accessories and spill-proof cups are just a few of the products now being distributed to babies and parents around the world.

        Continuing its commitment to baby care, Gerber introduced a complete line of skincare and healthcare products in 1999, all designed to help parents raise happy, healthy babies. The skincare products include a full line of washes, lotions and tear-free shampoos with the Gerber SkinNutrients unique blend of seven vitamins and natural ingredients. The healthcare line includes Pediatric Electrolyte Solution, Tooth & Gum Cleanser, Diaper Rash Ointment, Gas Relief Drops and Vitamin Drops.

        We have licensed the Gerber trademark to an unaffiliated company, Gerber Childrenswear, Inc., which sells bibs, apparel, shoes and similar products carrying the trademark. Gerber Childrenswear, Inc. pays royalties to our affiliate, Gerber Products Company, for the use of the trademark.

        In addition, since 1967, our affiliate Gerber Life Insurance Company, has been marketing life insurance protection directly to the consumer. Currently, Gerber Life's Grow Up policy is the leading juvenile whole life insurance product distributed in the United States and Canada.

        The major brands and product groups in Infant & Baby are:

Key Brands

  Product groups
  Main markets
Gerber, Graduates, Lil' Entrees, Tender Harvest, Yukery, 1st FOODS, 2nd FOODS, 3rd FOODS   Baby food   US, Latin America, Europe, Asia

Argos, Fiona, Gerber, Lillo by Gerber, Ninet,
NUK®

 

Baby Care

 

US, Canada, Asia, Latin America

Argos, Capent, Gerber, Ninet

 

Baby Wellness

 

US, Latin America

Gerber Life

 

Insurance

 

US

Recently Launched Products

        In the US, Gerber continued to build on its position as a leader in infant feeding and care with a number of innovations in 2002. In response to consumers' need for convenience, Gerber launched single-serve plastic packages, ideal for out-of-home feeding. Gerber now offers all juices and top selling fruit purees in single-serve plastic containers. The number of different products packaged in plastic will continue to expand in 2003. In addition, 2002 saw our successful launch of a new line of Gerber multi- compartment dinners, Lil' Entrees. The Lil' Entrees line offers parents of babies and toddlers a new alternative which provides meals for their children that are both nutritious and convenient. Finally, the launch of the single-serve cereal pouch in 2002 demonstrates the growing importance of the convenient single-serve segment.

        Within the Gerber Care/Wellness business, a number of innovative new products were launched at the end of 2002. The new spill-proof Insulated Cool Cup helps beverages to retain their desired temperature longer. Also, two new cups were launched that help during key development transitions. The first helps

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babies transition from the bottle to spill-proof cups. The second will later help them transition from the spill-proof cups to adult cups. For breast feeding mothers, a line of breast therapy items was introduced in 2002, which includes soothers, warm-cool packs and moistening sticks.

Principal Markets

        In 2002, the Infant & Baby Business Unit realized the majority of its sales in its two principal markets: the United States and Latin America. The following table sets out our 2002 sales by geographic region.

Infant & Baby

  Sales 2002
 
  (CHF millions)

  (%)

North America   1,635   79
Latin America   350   17
Europe/Middle East/Africa   75   3
Asia   15   1
   
 
Total   2,075   100
   
 

        Infant & Baby retail sales are not significantly affected by seasonal variations.

Production

        Key factors in Infant & Baby's successful supply chain strategy include a high efficiency, low cost structure and the mitigation of risks through multiple production sources. Regional sites serve specific markets but are also capable of providing support as needed to other regions in the event of supply disruption. Gerber operates production facilities in North America, South America and Eastern Europe for nutrition and care products. Major production sites ranked by size are in the US, Mexico and Poland.

        The manufacture of most of our products is heavily regulated, making supply never an absolute certainty. If we or our third party suppliers fail to comply fully with such regulations then there could be a government-enforced shutdown of production facilities, which in turn could lead to product shortages. While we have not experienced material supply interruptions in the past, there can be no assurance that supply will not be interrupted in the future as a result of unforeseen circumstances. The Baby Accessory and Wellness franchises tend to utilize suppliers from a wider geographic area.

        We often "single-source" supplies, but we have a policy of having at least a second approved and validated supplier registered for most key materials so that substitution is possible. Where practical and beneficial, we have long-term contracts in place on key production inputs. We also proactively monitor markets and developments that could have an adverse effect on the supply of essential materials.

        Raw materials for the manufacturing process are purchased from a number of third party suppliers. For the most part, raw materials for our nutrition products are sourced from within the country of use. Our growers and suppliers are well versed in our strict agricultural requirements and tend to have long term relationships with us. We are subject to adverse weather and growing conditions, but mitigate this as much as possible with alternative geographic sourcing areas.

Marketing and Distribution

        The mission for the Infant and Baby Business Unit is to leverage our brand leadership of trust in helping parents nurture happy, healthy babies into the leading infant and baby brand around the world. In 2002, Gerber began converting glass jars to plastic containers for its nutrition products. This major innovation is a result of consumer data which clearly indicates the preference for plastic as a better fit for today's active parents and families. Strong brands, product development based on sound nutrition

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principles, and in-house marketing and sales organizations are some of our key strengths. Gerber products are distributed through food, drug and mass merchandiser retail outlets.

Competition

        Other companies selling infant and baby foods are Del Monte and Beechnut in the US, Nestlé in Latin America, Nutricia in Eastern Europe and other regional businesses elsewhere. Other companies selling baby accessory and wellness products are Johnson & Johnson, Playtex and Avent in the US. There are other companies selling these products located in Latin America and Asia.

Research and Development

        The Infant & Baby Business Unit has a Research and Development department which uses a multi-faceted approach to deliver consumer innovation by developing new processes, products and packaging for the nutrition, care and baby accessory franchises. Internally developed new processes include NatureLock, a patented cooking process for jarred fruits and vegetables. New products include Lil' Entrees, our nutritious, portable meals for toddlers. Packaging innovations include aseptic plastic packaging, which provide additional convenience for consumers.

        In addition, Gerber R&D oversees research regarding the needs of infants and their development. For example, Gerber's Feeding Infants and Toddlers Study (FITS) analyzed the nutrient intake of 3,000 infants and toddlers. The results of this Study will be published in 2003. In 2002, the Infant & Baby Business Unit invested approximately CHF 36 million in research and development (1.7% of Infant & Baby sales).

Regulation

        Foodstuffs are highly regulated in order to protect the public health. The following areas are generally subject to international and national food regulations: development, manufacturing, packaging, quality (food standards, ingredients), safety, labeling and advertising of foods. Infant foods are regulated by various governmental agencies on a country by country basis. There is no global harmony of requirements and regulations. Many countries do require product registrations to document safety and nutrition of imported food products. Gerber food products are specifically designed to meet the nutritional needs of infants and toddlers in the regions where they are sold and generally exceed requirements of regulatory agencies. These nutritional need standards are determined based on independent, peer-reviewed research, or by studies sanctioned by authorities such as the World Health Organization (WHO) or the US Department of Health and Human Services.

        In the US, agencies such as the FDA, the US Department of Agriculture (USDA), the Environmental Protection Agency and the Consumer Product Safety Commission are responsible for providing safety specifications and otherwise regulating our products and ingredients. The FDA and USDA have issued regulations and standards regarding the use of specific ingredients in certain types of food products, including which ingredients are allowed, and at what level, as well as ingredients that may be required in certain products. In addition, these agencies regulate food product labeling and the claims which can be made regarding food products. Globally, safety of ingredients and products are guided by the Codex Alimentarius, a section of the WHO.

Intellectual Property

        Our Infant & Baby Business Unit is brand-oriented, with the Gerber baby trademark among the most recognized in the world. Therefore, we consider this trademark, as well as others within Infant & Baby, to be of utmost value. Trademarks protect most of our brands in the majority of the markets where these brands are sold, and we vigorously protect these trademarks from infringement. Our most important trademarks are used in a number of countries. Local variations of these international trademarks are employed where legal or linguistic considerations require the use of an alternative.

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        Wherever possible our products are protected by patents. Patents may cover products, product formulations, processes, intermediate products or product uses. It is our policy to seek the broadest possible protection for significant product developments in all major markets.

CIBA VISION

        The business of our CIBA Vision Business Unit is conducted by a number of affiliated companies in more than 70 countries. CIBA Vision is a world leader in the research, development and manufacturing of eye care products, specifically soft contact lenses, lens care products, and ophthalmic surgical products. As of December 31, 2002, the affiliates of CIBA Vision employed 6,003 associates worldwide. In 2002, the affiliates of CIBA Vision had sales of CHF 1.8 billion, representing 6% of Group sales.

        CIBA Vision completed the acquisition of Wesley Jessen VisionCare, Inc., a leading provider of specialty contact lenses in the United States, in October 2000.

        On January 1, 2001, CIBA Vision's Ophthalmic Pharmaceuticals business became part of our Pharmaceuticals Division in a reorganization.

Recently Launched Products

    Focus DAILIES Toric, the world's first and only daily disposable lens for astigmatism, was introduced in a number of European countries in June through October 2002. Additional launches are planned globally for the near future.

    Focus NIGHT & DAY continuous wear lenses received the CE Mark for therapeutic use in July 2002 and are now offered throughout Europe with this indication.

    We launched a number of new product additions around the world to our leading brands of cosmetic and color contact lenses. Those products include FreshLook Radiance, new designs for WildEyes novelty lenses, GlitterEyes specialty contact lenses, and DuraSoft 2 ColorBlends, daily wear, specialty color lenses, incorporating CIBA Vision's unique ColorBlends technology.

    SOLO-care PLUS, an enhanced formulation of our one-bottle lens disinfection system, offers a one-bottle, no rub, no rinse cleaning and disinfection system and was introduced in the US in April 2002.

    AQuify, an innovative lens drop that replicates the behavior of natural tears to provide long-lasting comfort of contact lenses initially launched in Europe in February 2002 and was recently launched in Benelux, Chile and Hungary.

    CV232 SRE (Square Round Edge), the latest design of the pre-folded intraocular lens that allows a smaller incision during cataract surgery, was introduced in May in Europe and August in the US.

    Vivarte PRESBYOPIC, an anterior chamber phakic refractive lens used for the correction of presbyopia, was launched in Europe in September 2002.

    PRL Injector System, an improved convenient injector system for the PRL phakic refractive lens, was launched in Europe in September 2002.

    VisThesia, a combination viscoelastic and anesthetic, which may help shorten cataract surgeries, was introduced in Europe in September 2002.

    In February, we introduced the Tear Film Analyzer in the US. The Analyzer is a diagnostic system that helps evaluate the levels of certain proteins in tear film which can help determine the cause of dry eye symptoms.

    In August 2002, we obtained exclusive rights in the US and Canada to market the Ex-PRESS mini glaucoma shunt, an innovative and minimally invasive approach for treating glaucoma.

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Key Marketed Products

        The table below sets out the key marketed products in each of CIBA Vision's three principal product segments:

Main Products

  Description
Contact Lenses    

Focus DAILIES

 

One-day disposable

Focus DAILIES
Progressives

 

One day disposable to correct presbyopia

Focus DAILIES
Toric

 

One day disposable to correct astigmatism

Focus NIGHT&DAY

 

Extended wear for up to 30 days and nights continuous wear

Focus Progressives

 

Corrects presbyopia

Focus Toric

 

Corrects astigmatism

Focus
Monthly

 

Replaced monthly

Focus
1-2 Week

 

Replaced every one to two weeks

Focus
1-2 Week SoftColors

 

Replaced every one to two weeks; enhances the color of light eyes

DuraSoft 3 Colors

 

Conventional cosmetic tinted lenses

FreshLook
Colorblends

 

Opaque lenses that blend three colors on one lens creating a more natural looking cosmetic tinted lens for dark or light eyes

FreshLook Colors

 

Disposable lenses for eye color change

FreshLook Radiance

 

Lens for people with light or dark eyes that provides illuminating effects that vary based on a person's natural eye color, skin tone and hair color

GlitterEyes

 

Specialty contact lenses that give eyes the brilliant gleam of glitter

Precision UV

 

First Disposable lens with ultraviolet light protection

WildEyes

 

Novelty lenses

Illusions Opaque

 

Conventional lenses for changing the color of dark eyes

Cibasoft

 

Conventional lenses with handling tint

Cibasoft Softcolors

 

Conventional lenses for enhancing the color of light eyes

 

 

 

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Lens Care Products


 


 

AOSept

 

Hydrogen peroxide disinfectant system

AOSept Clear Care/AOSept
PLUS

 

An enhanced formulation of our leading hydrogen peroxide disinfectant; the first one-bottle, no rub lens care solution with no added preservatives in the United States

SOLO-care

 

One bottle lens disinfectant system

SOLO-care
Plus

 

An enhanced formulation of our one-bottle lens disinfection system; offers a one-bottle, no rub, no rinse cleaning and disinfection system

BLUE Sept/BLUE Vision

 

One-step hydrogen peroxide lens disinfection system; features blue color indicator

QuickCARE/Insta
CARE

 

Five-minute disinfectant system

Pure Eyes

 

Two-bottle hydrogen peroxide system

Focus
Lens Drops

 

For lubricating contact lenses

AQuify

 

Lens drop that replicates natural tears


Ophthalmic Surgical


 


 

MemoryLens

 

Pre-folded intraocular lens, used in a surgical procedure to restore vision in people with cataracts

CV232 SRE (Square Round Edge)

 

Latest design of the pre-folded intraocular lens that allows a smaller incision during cataract surgery

VisThesia

 

Combination of viscoelastic and anesthetic

PRL
(Phakic Refractive Lens)

 

The first and only foldable posterior chamber phakic refractive lens designed to float on a patient's natural lens and to self-center behind the iris

Vivarte

 

The first and only foldable anterior chamber phakic refractive lens

Vivarte
PRESBYOPIC

 

Anterior chamber phakic refractive lens used for the correction of presbyopia

Ex-PRESS
mini glaucoma shunt

 

Minimally invasive approach for the surgical treatment of glaucoma

Tear Film Analyzer

 

Diagnostic system that helps evaluate the levels of certain proteins in tear film which can help determine the cause of a patient's dry eye

Bioinsulated
Punctum Plus

 

Provides relief from severe dry eye symptoms

UniVisc

 

Viscoelastic solution

Ophthalin
and Ophthalin Plus

 

Viscoelastic solution offered outside the United States

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Products in Development

        CIBA Vision intends to expand its product portfolio through both its own dedicated research and development resources as well as the acquisition of new and innovative technologies. Product development is focused on contact lenses as well as ophthalmic surgical products and involves the creation and development of entirely new product offerings in these markets as well as line extensions of current products. The acquisition of Wesley Jessen VisionCare in October 2000 included several exciting technologies and CIBA Vision anticipates incorporating these technologies into other contact lens products in its pipeline.

        In the ophthalmic surgical area, CIBA Vision is working on the development of innovative products including the Sub-epithelial Separator. The Sub-epithelial Separator (SES) is an automated microkeratome-based medical device that creates an epithelial flap—delaminating (or separating) the epithelium from the basement membrane—during laser surgery. This device eliminates the need for alcohol currently used during the procedure. By eliminating the alcohol, which can be toxic to cells, the device promotes faster healing, less damage to cells and less pain for patients.

Principal Markets

        Our principal markets, in terms of 2002 sales, were North America (United States and Canada), Europe and Japan. Sales are not subject to seasonality. The following table sets forth 2002 sales for CIBA Vision by region:

CIBA Vision

  Sales 2002
 
  (CHF millions)

  (%)

United States   690   39
Americas (except the United States)   97   5
Europe   594   34
Japan   261   15
Rest of the World   120   7
   
 
Total   1,762   100
   
 

Production

        CIBA Vision has major production facilities in Indonesia, Georgia and Illinois (United States), Germany, Puerto Rico and Canada. The manufacture of our products is heavily regulated, making supply never an absolute certainty. If we or our third party suppliers fail to comply fully with such regulations then there could be a government-enforced shutdown of production facilities, which in turn could lead to product shortages. While we have not experienced material supply interruptions in the past, there can be no assurance that supply will not be interrupted in the future as a result of unforeseen circumstances.

        We purchase basic chemical commodity raw materials for our lens products from industrial vendors. These raw materials are then reformulated into the monomers and polymers required to produce contact lenses. Polymer chemistry is one of the innovative elements in our contact lens products. The technology to produce the polymers and monomers is stable and well-defined.

        We enter into long-term supply contracts (generally over one to two years) with industrial raw material vendors, which limits volatility. In addition, most raw materials are basic chemical commodities and multiple suppliers are available. Certain lens products use proprietary chemicals that are produced specifically for us and sold exclusively to us. We also use a custom-designed process to synthesize

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macromonomers, a key raw material needed in contact lens production, which are produced by a contract vendor for a negotiated price.

Marketing and Distribution

        Contact lenses are considered medical devices by regulatory authorities and, therefore, are available only with a prescription from an eye-care professional in most countries. CIBA Vision lenses can be purchased from independent eye care professionals and optical chains. CIBA Vision's lens care products can be found in major drug, food and mass merchandising retail chains in the United States, Europe, Japan and elsewhere. In addition, mail order and Internet sales are becoming increasingly important channels in major markets worldwide.

        Eye care professionals are CIBA Vision's primary marketing focus. In addition, we have direct-to-consumer initiatives including free trials and coupons.

Competition

Contact Lenses

        Growth in the contact lenses market is driven primarily by an increased demand for lenses and an increasingly varied product mix. As consumers move toward frequent replacement lenses, including one-day disposable lenses, demand for lenses is increasing. Additionally, the customer base is expanding with the development of new contact lens options, such as daily disposable, 30-night continuous wear, toric lenses for astigmatic patients and lenses to correct presbyopia, a condition prevalent among the "Baby Boom" generation. We are well-positioned in the contact lens market as the second-leading player on the basis of market share. CIBA Vision now has the broadest product portfolio of any competitor in the industry. The colored lens technology we acquired with Wesley Jessen also creates a strong combination with our CIBA Vision products that should prove attractive to women and teenagers, in particular. Other companies selling contact lenses are Bausch & Lomb and Johnson & Johnson.

Lens Care

        We expect to increase our presence in the one-bottle market segment with our SOLO-care lens care product and to maintain a leading position in the peroxide category with AOSept Clear Care lens care, which is required by wearers of frequent replacement and conventional contact lenses, is a mature market and the products will continue to face competitive pressure due to the increasing preference for daily disposable and continuous wear lenses, which require little or no lens care.

        CIBA Vision is a global leader in the peroxide lens care category with AOSept, although this is a declining segment of the market. Market segment share is increasing in the growing one-bottle market segment with our SOLO-care, BLUE Sept and AOSept Clear Care disinfection systems. Other companies selling lens care products are Alcon, Advanced Medical Optics and Bausch & Lomb.

Ophthalmic Surgical

        The Ophthalmic Surgical market includes intraocular lenses and phaco equipment for cataracts, laser vision correction, surgical devices, surgical adjuncts and vitreo-retinal products. We are present in the cataract segment with our intraocular lens, CV232 SRE, which is a pre-folded, intraocular lens. We are the only company with a position in both the anterior and posterior phakic refractive lens market where we have acquired licenses. Phakic refractive lenses are used for patients requiring a high degree of correction. The Ex-PRESS mini glaucoma shunt is an innovative and minimally invasive approach for the treatment of glaucoma. It has been shown to reduce intraocular pressure up to 35% and can be completed five times faster than conventional glaucoma surgeries. Other companies selling ophthalmic surgical products are Alcon, Advanced Medical Optics, Bausch & Lomb, Pharmacia and Staar Surgical.

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Research and Development

        The research results of other Novartis affiliates provide CIBA Vision with new chemical compounds for future products and access to developments in biotechnology. These resources are complemented by CIBA Vision's internal research and development capabilities, licensing agreements and joint research and development partnerships with third parties (companies, individuals and universities). We invested CHF 109 million in research and development of eye care products in 2002, representing 6% of the Business Unit's sales.

        We have long term research commitments totaling CHF 2 million in the aggregate as of December 31, 2002. We intend to fund these expenditures from internally generated resources.

Regulation

        Contact lenses, surgical devices and lens care products are regulated as medical devices in the United States, the EU and Japan. These jurisdictions each have risk-based classification systems that determine the type of information which must be provided to the local regulators in order to obtain the right to market a product.

        In the US, all devices must receive pre-market approval by the FDA. There are two review procedures to gain this pre-market approval: a pre-market application ("PMA") and a 510(k) submission. Under a PMA, the manufacturer must submit to the FDA supporting evidence sufficient to prove the safety and effectiveness of the device. The FDA has 180 days to review a PMA. Certain products, however, may qualify for a submission authorized by Section 510(k) of the US Food, Drug and Cosmetic Act. Under this procedure, the manufacturer gives the FDA a pre-market notification that it intends to commence marketing the product, and that it has established that the product is substantially equivalent to another product already on the market. The FDA has 90 days to review a 510(k) submission. In the US, no 30-day extended-wear lenses had previously existed on the market, so we are required to proceed under the PMA procedure. Ophthalmic surgical devices fall into both PMA or 510(k) categories depending on the availability of data from previously approved devices. Lens care products generally qualify for 510(k) submission.

        In the EU, the "CE" mark is required for all medical devices sold. CIBA Vision affiliates hold a CE mark for the classes of vision care medical devices that they sell. The CE mark allows CIBA Vision to market products upon signing a declaration of conformity with the EU's Medical Device Directive requirements, which CIBA Vision affiliates do for each product sold. In addition, medical device sales in the EU require auditing by a certified third party (a "Notified Body") to ensure that the manufacturer's quality systems are in compliance with the requirements of the ISO 9000 standards. CIBA Vision has two Notified Bodies which routinely audit the company's quality systems.

        In Japan, contact lenses are categorized as medical devices and are subject to an approval process similar to that in the United States. Although there is an improvement in the willingness to accept foreign data and a movement toward harmonization of requirements, in order to enter the Japanese market, local clinical trials often are required and local protocols must then be observed. Lens care products for soft lenses take several years to gain approval due to the extensive amount of additional data and clinical testing required. Surgical devices are also categorized by risk level and a lengthy testing, review and approval process is required. Saline solutions for hard lenses are unregulated.

Intellectual Property

        Our CIBA Vision business is brand-oriented and, therefore, we consider our trademarks to be of utmost value. Trademarks protect most of our brands in the majority of the markets where these brands are sold, and we vigorously protect these trademarks from infringement. Our most important trademarks are used in a number of countries. Local variations of these international trademarks are employed where legal or linguistic considerations require the use of an alternative.

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        Wherever possible our products are protected by patents. Among other things, patents may cover the products themselves, including the product's active substance and its formulation. Patents may also cover the processes for manufacturing a product, including processes for manufacturing intermediate substances used in the manufacture of the products. Patents may also cover particular uses of a product, such as its use to treat a particular disease, or its dosage regimen. It is our policy to seek the broadest possible protection for significant product developments in all major markets.

4.C  Organizational Structure

        The Novartis Group is a multinational group of companies specializing in research, development, manufacture, sales and distribution of innovative healthcare products. Novartis AG, our Swiss holding company, owns, directly or indirectly, 100% of all significant operating companies. For a list of our subsidiaries, see note 30 to the consolidated financial statements.

        The Group is divided operationally into two Divisions: Pharmaceuticals and Consumer Health. Our Pharmaceuticals Division is organized into five Business Units: Primary Care, Oncology, Transplantation, Ophthalmics and Mature Products. The six Business Units of the Consumer Health Division are: Generics, OTC, Animal Health, Medical Nutrition, Infant & Baby and CIBA Vision. The Business Units coordinate the worldwide research, distribution, marketing and sales of the products assigned to each. Because the Business Units of the Pharmaceuticals Division have common long-term economic perspectives, common customers, common research, development, production and distribution practices, and a common regulatory environment, their financial data are not required to be separately disclosed.

4.D  Property, Plants and Equipment

        Our principal executive offices are located in Basel, Switzerland. Our Business Units operate through a number of affiliates having offices, research facilities and production sites throughout the world.

        It is our policy to own our facilities. A few (mainly in the United States) are leased under long-term leases. Some of our principal facilities are subject to mortgages and other security interests granted to secure indebtedness to certain financial institutions. As of December 31, 2002, the total amount of indebtedness secured by these facilities was not material to the Group. We believe that our production plants and research facilities are well maintained and generally adequate to meet our needs for the foreseeable future.

        The following table sets forth our major production and research facilities. For a further description of our material facilities, see "—4.B Business Overview," and the sections entitled "—Production" and "—Research and Development" included within the discussions of each of our business segments.

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Location/Division or Business Unit

  Size of Site

  Major Activity


Major Production facilities:        

Pharmaceuticals        

Taboão da Serra, Brazil

 

539,000 square meters

 

Suppositories, capsules, tablets, syrups, suspensions, creams, drop solutions, powders

Ringaskiddy, Ireland   532,000 square meters   Drug substances, intermediates

Basel, Switzerland—Klybeck   283,000 square meters   Drug substances, intermediates

Basel, Switzerland—St. Johann   219,000 square meters   Drug substances, intermediates

Basel, Switzerland—Schweizerhalle   213,000 square meters   Drug substances, intermediates

Stein, Switzerland   460,000 square meters   Steriles, tablets, capsules, transdermals, intermediates

Grimsby, United Kingdom   929,000 square meters   Drug substances, intermediates

Suffern, NY (United States)   656,000 square meters   Tablets, capsules, transdermals

Horsham, United Kingdom   112,000 square meters   Tablets, capsules

Wehr, Germany   165,000 square meters   Tablets, creams, ointments

Torre, Italy   210,000 square meters   Tablets

Barbera, Spain   51,000 square meters   Tablets, capsules

Huningue, France   70,000 square meters (Pharmaceuticals and Animal Health facilities)   Suppositories, liquids, solutions, suspensions

Sasayama, Japan   104,000 square meters   Suppositories, capsules, tablets, syrups, suspensions, creams, drop solutions, powders

Generics        

Kundl, Austria

 

266,000 square meters total area (production and R&D facilities)

 

Biotech products, intermediates, active drug substances, final steps (finished pharmaceuticals)

Broomfield, CO (United States)   60,000 square meters   Broad range of finished dosage forms

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OTC        

Nyon, Switzerland

 

58,400 square meters (production and R&D facilities)

 

Liquids and creams

Lincoln, NE (United States)   44,870 square meters   Liquids, creams and tablets

Animal Health        

WUSI-Farm, China

 

42,000 square meters

 

Insecticides, antibacterials, acaricides, powders

Dundee, Scotland   34,000 square meters   Packaging, formulation liquids, solids, creams, sterile filling vaccines

Larchwood, IA (United States)   29,700 square meters (production and R&D facilities)   Veterinary immunologicals

Medical Nutrition        

Minneapolis, MN (United States)

 

33,500 square meters (production and R&D facilities)

 

Medical nutrition products

Osthofen, Germany   44,000 square meters (production and R&D facilities)   Medical nutrition and Nutrition & Santé products

Infant & Baby        

Fremont, MI (United States)

 

107,000 square meters (production and R&D facilities)

 

Gerber jarred baby food, fruit and vegetable juices, dry boxed cereal

Fort Smith, AR (United States)   80,451 square meters   Gerber jarred baby food, dry cereal

Querétaro, Mexico   205,000 square meters   Gerber jarred baby food, fruit and vegetable juices, dry canned and bagged cereal

Reedsburg, WI (United States)   30,000 square meters   Baby Care products; spill-proof cups, bottles, nipples, breast pads, pacifiers, overcaps

Rzeszow, Poland   45,000 square meters   Gerber baby food, fruit juice

CIBA Vision        

Pulau Batam, Indonesia

 

16,700 square meters

 

Contact lenses

Duluth, GA (United States)   16,700 square meters   Contact lenses

Des Plaines, IL (United States)   26,940 square meters   Freshlook product line

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Grosswallstadt, Germany   19,000 square meters   Contact lenses

Cidra, Puerto Rico   124,000 square meters   Contact lenses

Toronto, Canada   145,000 square meters   LCP production

Major Research and Development facilities:        

Pharmaceuticals        

East Hanover, NJ (United States)

 

135,591 square meters

 

General pharmaceutical products

Summit, NJ (United States)(1)   66,242 square meters   General pharmaceutical products

Cambridge, MA (United States)   22,500 square meters   General pharmaceutical products (as of March 1, 2003)

Basel, Switzerland—Klybeck   283,000 square meters   General pharmaceutical products

Basel, Switzerland—St. Johann   219,000 square meters   General pharmaceutical products

Vienna, Austria   39,000 square meters   Dermatology and infectious diseases

Tsukuba, Japan   20,600 square meters   General pharmaceutical products

Horsham and London, UK   37,700 square meters   Respiratory and nervous system diseases

Generics        

Kundl, Austria

 

266,000 square meters total area (production and R&D facilities)

 

Biotech processes, innovations in antibiotic technologies

Kolshet, India   5,000 square meters   Generic pharmaceuticals

Dayton, NJ (United States)   29,000 square meters   Generic pharmaceuticals

OTC        

Nyon, Switzerland

 

58,400 square meters (production and R&D facilities)

 

Over the counter medicine products

Animal Health        

St. Aubin, Switzerland

 

9,000 square meters

 

Parasiticides

(1)  The Summit, NJ site has been sold to a third party. We have leased the site back from the buyer until March 2003. All site operations will be moved to other Group sites prior to that date.

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Larchwood, IA (United States)   29,700 square meters (production and R&D facilities)   Veterinary immunologicals development

Medical Nutrition        

Minneapolis, MN (United States)

 

33,500 square meters (production and R&D facilities)

 

Medical nutrition products

Osthofen, Germany   44,000 square meters (production and R&D facilities)   Medical nutrition and Nutrition & Santé products

Infant & Baby        

Fremont, MI (United States)

 

107,000 square meters (production and R&D facilities)

 

Baby food products

CIBA Vision        

Duluth, GA (United States)

 

9,000 square meters

 

Vision-related medical devices

        On May 6, 2002, we announced the establishment of the Novartis Institutes for BioMedical Research, Inc. (NIBRI) in Cambridge, Massachusetts. This new research facility will initially provide 22,500 square meters of lab and office space for 400 scientists and technology experts, and will subsequently be expanded to provide lab and office space for 900 scientists and technology experts. Our initial investment in this new facility is approximately US$250 million (approximately CHF 350 million).

        On August 15, 2002, we announced plans to expand our UK and Swiss production facilities for manufacturing Diovan (valsartan), in order to boost Diovan production by 300 tons per year. We plan to invest approximately CHF 380 million in this project, of which approximately CHF 320 million will be used to construct a new building at our Grimsby, UK production facility, and approximately CHF 60 million will be used to expand an existing production unit at our Schweizerhalle facility outside Basel, Switzerland.

Environmental Matters

        We integrate core values of environmental protection into our business strategy to add value to the business, manage risk and enhance our reputation.

        We are subject to laws and regulations concerning the environment, safety matters, regulation of chemicals and product safety in the countries where we manufacture and sell our products or otherwise operate our business. These requirements include regulation of the handling, manufacture, transportation, use and disposal of materials, including the discharge of pollutants into the environment. In the normal course of our business, we are exposed to risks relating to possible releases of hazardous substances into the environment which could cause environmental or property damage or personal injuries, and which could require remediation of contaminated soil and groundwater. Under certain laws, we may be required to remediate contamination at certain of our properties regardless of whether the contamination was caused by us, or by previous occupants of the property.

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        We believe that we are in substantial compliance with environmental, health and safety requirements applicable to us. We are committed to providing safe and environmentally sound workplaces that will not adversely affect the health or environment of employees or the communities in which we operate. We believe that we have obtained all material environmental permits required for the operation of our facilities as well as all material authorizations required for the products produced by us. We believe that we are not currently subject to liabilities for non-compliance with applicable environmental, health and safety laws that would materially and adversely affect our business, financial condition or results of operations. However, there is a risk that legislation enacted in the future could create liabilities for past activities undertaken in compliance with then-current laws and regulations or that there is environmental or other damage of which we are not aware.

        In recent years, the operations of all companies have become subject to increasingly stringent legislation and regulation related to occupational safety and health, product registration and environmental protection. Such legislation and regulations are complex and constantly changing, and there can be no assurance that future changes in laws or regulations would not require us to install additional controls for certain of our emission sources, to undertake changes in our manufacturing processes or to remediate soil or groundwater contamination at facilities where such clean-up is not currently required. Some of our facilities are over 50 years old, and there may be soil and groundwater contamination at such facilities. However, based on current information, we do not believe that expenditures related to such possible contamination, beyond those already accrued, will be significant.

        Our expenditures, excluding Agribusiness, related to capital investments for environmental, health and safety compliance measures were approximately CHF 53 million in 2002 (CHF 11 million for environment), CHF 56 million in 2001 (CHF 12 million for environment), and CHF 55 million in 2000 (CHF 20 million for environment). While we cannot predict with certainty our aggregate capital environmental investments in 2003, based on current information and existing assets, we estimate that such aggregate expenditures will be comparable to the 2002 figure.

        It is difficult to estimate the future costs of environmental protection and remediation because of many uncertainties, including uncertainties about the state of laws, regulations and information related to individual locations and sites. However, given our experience to date regarding environmental matters and the facts currently known, we believe that compliance with existing and known national and local environmental laws and regulations will not have a material effect on our total capital expenditures, earnings or competitive position.


Item 5.    Operating and Financial Review and Prospects

5.A  Operating Results

        The following operating and financial review and prospects should be read in conjunction with our consolidated financial statements included in this Form 20-F. The consolidated financial statements and the financial information discussed below have been prepared in accordance with IAS. For a discussion of the significant differences between IAS and US GAAP, see "Item 18. Financial Statements—note 31."

Overview

        We are a world leader both in sales and in innovation in our continuing core businesses: pharmaceuticals and consumer health, which includes generics, OTC self-medication, animal health, medical nutrition, infant and baby foods and products, and eyecare products, with global sales of CHF 32.4 billion in 2002. We aim to hold a leadership position in all of our businesses.

        Novartis AG was formed in 1996 out of a merger of two global participants in the pharmaceutical and agrochemical industries, Sandoz AG and CIBA-Geigy AG. Accounting for the merger under IAS was based on a uniting of interests and therefore did not result in any goodwill nor in any goodwill

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amortization. Under US GAAP, the merger is accounted for as a purchase of CIBA-Geigy AG by Sandoz AG. For a discussion of the significant differences between IAS and US GAAP purchase accounting, see "Item 18. Financial Statements—note 31." In November 2000, we spun-off our Crop Protection and Seeds businesses and merged them with AstraZeneca's Zeneca Agrochemicals to create Syngenta. Pre-spinoff sales from these business are shown as "Sales from discontinued Agribusiness activities."

Factors affecting results

        The global healthcare market is growing rapidly due to, among other reasons, the aging population in developed countries, unmet needs in many therapeutic areas (such as cancer and cardiovascular disease), the adoption of more industrialized lifestyles in emerging economies, and increased consumer demand fuelled by broad and rapid access to information. At the same time, the healthcare industry is under increasing pressure to reduce prices as payors in the public and private sectors seek to curb rising healthcare costs.

        Our revenues are directly related to our ability to identify high potential products while they are still in development and to bring them to market quickly and effectively. Efficient and productive research and development is crucial in this environment as we, like our competitors, search for efficacious and cost-efficient pharmaceutical solutions to health problems. The need for increased resources in order to take advantage of the full range of new research and development technologies has been among the reasons for the consolidation which has taken place across the industry, and for the increase in collaborations between leading companies and niche players at the forefront of their particular technology areas. The growth in new technology, particularly genomics, will almost certainly have a fundamental impact on the pharmaceutical industry as a whole, and upon our future development.

        In addition, competitive conditions have intensified as a result of regulation, price reductions, reference prices, parallel imports, higher patient co-payments and increased pressure on physicians to limit prescribing. Pressure on our and other pharmaceutical companies to lower prices is expected to increase primarily as a result of government initiatives to reduce patient reimbursement, restrict prescribing levels, increase the use of generics and impose overall price cuts. The introduction of technologically innovative products and devices by competitors and growing parallel imports, mainly in the EU, pose additional challenges.

        Exchange rate exposure also affects our results as we have both sales and costs in many currencies other than the Swiss franc. This gives rise to both transaction exposure in subsidiary financial statements due to foreign currency denominated transactions and translation exposure from converting foreign subsidiary results and balance sheets into our Swiss franc consolidated financial statements. Our results have not been significantly affected by inflation. See "Exchange Rate Exposure and Risk Management" below.

Critical Accounting Policies

        Our principal accounting policies are set out in note 1 of our consolidated financial statements and conform with International Accounting Standards (IAS). Significant judgments and estimates are used in preparation of the consolidated financial statements which, to the extent that actual outcomes and results may differ from these assumptions and estimates, could affect the accounting in at least the following areas:

    Long-lived assets, including identifiable intangibles and goodwill, are regularly reviewed for impairment whenever events or changes in circumstance indicate that the balance sheet carrying amount of the asset may not be recoverable. In order to assess if there is any impairment, estimates are made of the future cash flows expected to result from the use of the asset and its eventual disposition. If the balance sheet carrying amount of the asset is more than the greater of its value in use to us or its net selling price, then an impairment loss for the difference is recognized. Actual outcomes could vary significantly from such estimates of discounted future cash flow. Factors such

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      as changes in the planned use of buildings, machinery or equipment, or closing of facilities or lower than anticipated sales for products with capitalized rights could result in shortened useful lives or impairment.

    We have extensive investments in marketable securities and have significant derivative financial instrument positions which are mainly, but not exclusively, held for hedging underlying positions. Under current IAS accounting rules unrealized gains and losses on marketable securities and cash flow-related derivative financial instruments that qualify for hedge accounting are recorded in separate components of equity and not in the income statement. Our management regularly reviews such positions to determine the extent to which unrealized losses are temporary. Depending on the stock market and other factors at the time of this review it may be necessary to treat certain of the unrealized losses as permanent and transfer these losses out of the equity component into our income statement. Prior to January 1, 2001, our policy on accounting for derivative instruments which were not considered to be hedges was to value them at the lower of cost on inception and fair value on a portfolio basis. A net unrealized loss was included in the current year's result. A net unrealized gain was not recorded. Prior to January 1, 2001, our policy on accounting for derivative financial instruments which were considered to be hedges was very similar to IAS 39 requirements, although the conditions for hedge effectiveness were less strict. Prior to January 1, 2001, our accounting policy was that marketable securities were carried at the lower of cost or market and unrealized losses were included as financial income, net in the income statement.

    We have investments in associated companies (generally investments of between 20% and 50% of a company's voting shares) that are accounted for by using the equity method. Due to the various estimates that have been made in applying the equity method, the amounts recorded in the consolidated financial statements in respect of Roche Holding AG and Chiron Corporation may require adjustments in the following year as more financial and other information becomes publicly available.

    We sponsor pension and other retirement plans in various forms covering employees who meet eligibility requirements. These plans cover the majority of our employees. Several statistical and other factors which attempt to anticipate future events are used in calculating the expense and liability related to the plans. These factors include assumptions about the discount rate, expected return on plan assets and rate of future compensation increases, as determined by our management within certain guidelines. In addition, our actuarial consultants also use statistical information such as withdrawal and mortality rates to estimate these factors. The actuarial assumptions used may differ materially from actual results due to changing market and economic conditions, higher or lower withdrawal rates or longer or shorter life spans of participants. These differences may result in a significant impact to the amount of pension income or expense recorded in future years.

    We have provisions for environmental remediation costs. The material components of the environmental provisions consist of a risk assessment based on investigation of the various sites. Future remediation expenses are affected by a number of uncertainties which include, but are not limited to, the method and extent of remediation, the percentage of waste material attributable to us at the remediation sites relative to that attributable to other parties, and the financial capabilities of the other potentially responsible parties. Our management believes that such costs will not materially affect our consolidated financial position, results of operations or cash flow.

    A number of our affiliates are the subject of litigation arising out of the normal conduct of their business. As a result, claims could be made against them which, in whole or in part, might not be covered by insurance. In our opinion, however, the outcome of these actions will not materially affect our financial position, results of operations or cash flow.

    In 2002, we continued to amortize goodwill under IAS even though for US GAAP purposes we ceased to amortize goodwill in accordance with Statement of Financial Accounting Standards

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      ("SFAS") No. 142 "Goodwill and Other Intangible Assets." SFAS 142 requires us to perform an annual review of our US GAAP goodwill for impairment. We intend to perform a similar review of our IAS goodwill. We currently do not expect a material future impairment charge. However, there can be no assurance that at the time the review is completed a material impairment charge will not be recorded.

        The International Accounting Standards Board is entering a period of critically examining current International Accounting Standards with a view to increasing international harmonization of accounting rules. This process of amendment and convergence of worldwide accounting rules could result in significant amendments to the existing rules within the next two years in such areas as the timing of recognition of sales and other revenues arising from collaborative agreements with marketing and distribution partners, accounting for share based compensation, goodwill and intangibles, employee benefit plans, marketable securities and derivative financial instruments and classification of balance sheet positions as debt or equity.

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Results of Operations

        The following table sets forth selected income statement data for each of the periods indicated.

 
  2002
  2001(2)
  2000(2)
 
 
  (CHF millions)

  (CHF millions)

  (CHF millions)

 
Sales to third parties              
Pharmaceuticals   21,002   20,181   18,150  
   
 
 
 
  Generics   2,809   2,433   1,973  
  OTC(3)   2,359   2,538   2,483  
  Animal Health   971   962   1,083  
  Medical Nutrition (including Nutrition & Santé)(3)   1,109   1,115   1,136  
  Infant & Baby(3)   2,075   2,227   2,108  
  CIBA Vision   1,762   1,787   1,392  
   
 
 
 
Consumer Health—ongoing   11,085   11,062   10,175  
Divested Health & Functional Food activities   325   400   377  
   
 
 
 
Consumer Health   11,410   11,462   10,552  
   
 
 
 
Sales from continuing activities   32,412   31,643   28,702  
Sales from discontinued Agribusiness activities(1)           6,693  
   
 
 
 
Group sales   32,412   31,643   35,395  
   
 
 
 
               
Sales   32,412   31,643   28,702  
Cost of goods sold   (7,618 ) (7,886 ) (7,316 )
Marketing and distribution   (10,987 ) (10,703 ) (9,146 )
Research and development   (4,339 ) (4,189 ) (4,011 )
Administration and general overheads   (1,581 ) (1,588 ) (1,502 )
   
 
 
 
Operating income from continuing activities   7,887   7,277   6,727  

Operating income from discontinued Agribusiness activities(1)

 

 

 

 

 

1,156

 
   
 
 
 
Group Operating income   7,887   7,277   7,883  
   
 
 
 
Operating income by Division/Business Unit              
Pharmaceuticals   6,022   5,677   5,401  
   
 
 
 
  Generics   406   281   242  
  OTC(3)   374   452   424  
  Animal Health   144   138   179  
  Medical Nutrition (including Nutrition & Santé)(3)   6   87   66  
  Infant & Baby(3)   355   388   371  
  CIBA Vision   183   174   100  
   
 
 
 
Consumer Health—ongoing   1,468   1,520   1,382  
Divested Health & Functional Food activities   216   (7 ) 8  
   
 
 
 
Consumer Health   1,684   1,513   1,390  
   
 
 
 
Corporate and other income/expense   181   87   (64 )
   
 
 
 
Operating income from continuing activities   7,887   7,277   6,727  
Income from associated companies   (10 ) 139   97  
Financial income, net   949   1,067   1,216  
Taxes   (1,490 ) (1,440 ) (1,504 )
Minority interests   (23 ) (19 ) (25 )
   
 
 
 
Net income from continuing activities   7,313   7,024   6,511  
Operating income, income from associated companies, financial income, taxes and minority interest of discontinued Agribusiness sector(1)           699  
   
 
 
 
Group net income   7,313   7,024   7,210  
   
 
 
 

(1)
Agribusiness: Crop Protection and Seeds businesses.

(2)
2001 and 2000 figures have been restated to reflect a change in classification of certain sales incentives and discounts to retailers. Sales and marketing & distribution expenses have both been reduced by CHF 395 million in 2001 and CHF 410 million in 2000.

(3)
2001 and 2000 figures reported the results of OTC, Medical Nutrition (including Health and Functional Foods) and Infant & Baby together under the name Consumer Health. These businesses have now been separated into the OTC, Medical Nutrition (including Nutrition & Santé) and Infant & Baby Business Units.

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2002 Compared to 2001

Overview

        The following compares our results in the year ended December 31, 2002 to those of the year ended December 31, 2001. In 2001 the results of the OTC, Medical Nutrition (including Health and Functional Foods) and Infant & Baby businesses were reported together under the name Consumer Health. These businesses have now been separated into the OTC, Medical Nutrition (including Nutrition & Santé and the Food & Beverage business through its divestment in 2002) and Infant & Baby Business Units. Due to new accounting rules, 2001 sales have been restated to reflect a change in the classification of certain sales incentives and discounts to retailers. This restatement amounted to a sales reduction of CHF 395 million in 2001, with a corresponding reduction in Marketing and Distribution expenses.

        In Swiss francs, our sales in 2002 increased by 2% over 2001 to CHF 32.4 billion (+11% in local currencies); operating income grew by 8% to CHF 7.9 billion; net income increased by 4% to CHF 7.3 billion and free cash flow (excluding acquisitions of subsidiaries and the voting shares of Roche Holding AG) rose by 10% in Swiss francs to CHF 4.5 billion.

        Pharmaceuticals accounted for 65% of the Group's total sales and Consumer Health 35%. The two Divisions generated 76% and 24% of the Group's total operating income, respectively. In 2002, the Consumer Health Division was reorganized to include our Generics, OTC self-medication, Animal Health, Medical Nutrition (including our Nutrition & Santé unit), Infant & Baby, and our CIBA Vision Business Units.

        Geographically, 47% of sales were generated in the NAFTA region (43% in the USA), 33% in Europe and 20% in the rest of the world.

        Sales growth was driven by a volume increase of 10%. All Business Units except Generics and CIBA Vision benefited from small price increases which in total amounted to 1%. The sales increase due to acquisitions was negligible. The sales performance in Swiss francs suffered from a 9% negative currency effect as the Swiss franc rose on average 8% against the US dollar, 10% against the yen and 3% against the Euro.

        Our operating margin in 2002 was 24.3% of sales, an increase of 1.3% percentage points over the 23.0% of sales of the previous year. Productivity gains and improvements in the product mix lead to a 3% reduction in the cost of goods sold, while marketing and distribution expenses increased by 3%, slightly more than sales, to support product launches and key growth drivers.

        Research and development investments were increased 4% mainly due to the new Pharmaceuticals Division research strategy and the establishment of our new facility in Cambridge, USA.

        As a result of all these factors, operating income increased overproportionally, climbing 8% in Swiss francs to CHF 7.9 billion.

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Sales

        The following table sets forth selected sales data for each of the periods indicated.

 
  Year ended December 31,

   
   
 
 
  Change in CHF
  Change in local
currencies

 
 
  2002
  2001(1)
 
 
  (CHF millions)

  (CHF millions)

  (%)

  (%)

 
Sales                  
Pharmaceuticals   21,002   20,181   4   13  
   
 
 
 
 
  Generics   2,809   2,433   15   25  
  OTC(2)   2,359   2,538   (7 ) (1 )
  Animal Health   971   962   1   10  
  Medical Nutrition (including Nutrition & Santé)(2)   1,109   1,115   (1 ) 4  
  Infant & Baby(2)   2,075   2,227   (7 ) 3  
  CIBA Vision   1,762   1,787   (1 ) 6  
   
 
 
 
 
Consumer Health—ongoing   11,085   11,062   0   6  
Divested Health & Functional Food activities   325   400          
   
 
 
 
 
Consumer Health   11,410   11,462   0   7  
   
 
 
 
 
Group sales   32,412   31,643   2   11  
   
 
 
 
 

(1)
Restated to reflect the reclassification of certain sales incentives and discounts to retailers. In 2001, sales have been reduced by a total of CHF395 million (CHF129 million for OTC, CHF50 million for Medical Nutrition and CHF216 million for Infant & Baby) with a corresponding reduction in marketing and distribution expenses.

(2)
2001 figures reported the results of OTC, Medical Nutrition (including Health and Functional Foods) and Infant & Baby together under the name Consumer Health. These businesses have now been separated into the OTC, Medical Nutrition (including Nutrition & Santé) and Infant & Baby Business Units.

Pharmaceuticals Division

        Sales increased 4% in Swiss francs or 13% in local currencies from CHF 20.2 billion in 2001 to CHF 21.0 billion in 2002, driven in particular by the cardiovascular and oncology businesses, where Diovan, Lotrel, Lescol, Gleevec/Glivec, Zometa and Sandostatin were the main growth drivers. The introduction of new products, such as Elidel, Zometa and Zelnorm/Zelmac, together with the addition of new strengths and new indications to existing brands all contributed to lifting sales.

        Double-digit sales growth in local currencies was achieved in all regions, including Japan despite government mandated price decreases. In Europe, strong performances in Spain and France offset the effects of pricing pressures in several countries, mandatory generic substitution in Germany, and the effects of parallel imports.

        Diovan (hypertension) posted sales of CHF 2.6 billion, making it our best selling product ever. Extending its leadership of the angiotensin-2 receptor blocker category in the US, it became the first and only drug of its kind to receive approval there for treatment in heart failure patients. To add further choice and flexibility, a new higher dose (160/25) formulation of Co-Diovan was launched in the US. Our second flagship anti-hypertensive, Lotrel, generated sales of CHF 1.0 billion, lifted by the July launch of a new formulation (10 mg amlodipine + 20 mg benazepril HCl).

        The third main pillar of the cardiovascular franchise, Lescol (cholesterol reduction), posted sales of CHF 896 million. The brand's strong growth in Europe and other regions has been driven by its particularly favorable risk/benefit profile and convenient XL extended-release formulation.

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        In Oncology, Gleevec/Glivec gained approval in the US, the EU and Japan for first-line use in treating certain forms of chronic myeloid leukemia (CML). It also received approval early in the year for use in gastrointestinal stromal tumors (GIST). Exceeding expectations, Gleevec/Glivec sales reached CHF 953 million, making it our fifth biggest-selling product. Another leading Oncology brand, Sandostatin continued to post substantial double-digit growth, with sales reaching CHF 943 million, despite the launch of generic competitors in Europe. Zometa (bone metastases and complications of a broad range of cancers) achieved sales of CHF 758 million. Zometa is the more potent and convenient successor to Aredia, which is facing patent expiry. The new drug gained EU and US approvals for a broader range of cancer settings, and is approaching or has exceeded the previous sales level of Aredia in many markets.

        In Transplantation, the Neoral franchise was underpinned by market share gains in Japan and yielded sales of CHF 1.6 billion. It continues to compete strongly against branded and generic competition owing to a reluctance among physicians to switch patients who are stable and doing well on Neoral.

        The Mature Products business continued to report only a modest decline in sales on a comparable basis as a result of focused investments on selected key products and markets. Of the leading brands, the anti-inflammatory Voltaren continued to compete well against generics and the COX-2 inhibitor class of drugs and achieved sales of CHF 925 million.

        Overall, the Pharmaceuticals Division's top ten products generated CHF 11.7 billion, reflecting an increase of 32% in local currencies, while the top twenty products expanded sales by 17% in local currencies to CHF 16.4 billion. Unless otherwise indicated, all percentages set forth in the following section refer to local currencies.

Primary Care

        Primary care sales grew 13% in local currencies (+5% in CHF) primarily due to strong sales growth of Diovan and the other key products discussed below.

    Diovan (+49%, US: +40%; hypertension) became our best selling product ever, further extending its category leadership in the US to more than 35% of total angiotensin II receptor blocker prescriptions. Backed by the Val-Heft study data showing improved survival, reduced hospitalization and cost effectiveness benefits, Diovan became the first and only drug of its kind to receive approval for treatment in heart failure patients. To complement the broad choice and flexibility for patients and physicians, a new higher dose (160/25) formulation of Co-Diovan was launched in the US.

    Lotrel (35% US: +35%; hypertension), also extended its share of new prescriptions. A new formulation (10 mg amlodipine +20 mg benazepril HCl) was launched in July and has been well received by physicians and patients, reflecting the fact that 90% of Lotrel patients achieve their blood pressure goal with the additional benefits of an ACE inhibitor.

    Lescol (+18%, US: +13%; cholesterol reduction) sales grew strongly in Europe and in other regions, reflecting the drug's particularly favorable risk/benefit profile and convenient XL extended-release formulation. Following the publication of data showing that Lescol reduced the risk of serious cardiac events after surgery to unblock coronary arteries, a new indication in angioplasty patients was filed in August for regulatory approval in the US.

    Lamisil (+4%, US: –3%; fungal infections) sales picked up towards the end of the year mainly in the US. While the onychomycosis market segment has been declining, Lamisil has extended its commanding share of both total and new prescriptions in the US to more than 80% in 2002.

    Elidel (eczema) was launched in 13 countries, including the US, and completed the mutual recognition procedure in Europe. Sales in 2002 reached CHF 148 million. Within just six months, this highly effective, non-steroid cream has become the number one branded topical treatment for eczema in the US, where it has captured over 8% of new prescriptions. In Denmark, the first

78


      country in Europe where it has been launched, Elidel captured a 9% share of its segment within 10 weeks of launch.

    Exelon (+26%, US: +28%; Alzheimer's disease) posted good sales growth and captured a further share both of new and total prescriptions in the US. New marketing initiatives are under way to counter increased competition in its fast-growing segment. Studies revealed that Exelon inhibits an additional enzyme (butyrylcholinesterase) that contributes to neurological dysfunction in Alzheimer's disease. As a result, an expanded labeling was approved in Europe to include the product's unique dual inhibition properties.

    Zelnorm/Zelmac (irritable bowel syndrome with constipation) has now gained approval in 28 countries including the US where it was launched in September. With progress being made on reimbursement, 2002 sales totaled CHF 70 million.

Oncology

        Our Oncology business unit gained further market share and posted strong sales growth of 28% in local currencies (+19% in CHF).

    Gleevec/Glivec, for treating certain forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), continued to bring benefits to thousands of patients in more than 80 countries. Exceeding expectations, 2002 sales reached CHF 953 million, making it our fifth biggest selling product. Gleevec/Glivec obtained approval as first-line treatment in the US, EU and Switzerland, and major progress was achieved on reimbursement, especially in the UK, Australia and New Zealand.

    Zometa (complications of a broad range of cancers), launched in 2002, achieved sales of CHF 758 million, making it the world's fastest growing bisphosphonate used for bone metastases. More potent and convenient than Aredia, Zometa has gained EU and US approvals for a broader range of cancer settings, and is approaching or has exceeded the previous sales level of Aredia in many markets.

    Aredia (bone metastases; –64%; US: –84%) sales reflect the successful launch and superiority of Zometa and the anticipated competition from multiple generic entrants in several markets.

    Sandostatin continued to post substantial double-digit growth, with sales up 23% (US: +39%) to CHF 943 million despite the launch of generic competitors in Europe. Growth was driven by sustained market penetration of the convenient, long-acting, once-a-month "LAR" formulation.

    Femara, the first-line therapy for advanced breast cancer in postmenopausal women, posted a 37% (US: +55%) rise in sales to CHF 271 million. Femara is the US leader in the first-line metastatic breast cancer setting.

Ophthalmics

        Ophthalmics' sales rose 7% in local currencies (–1% in CHF), driven by Visudyne.

    Visudyne (+27%; US: +19%; treatment in macular degeneration) posted sales of CHF 443 million, and has now been approved in more than 65 countries for its main indication and in more than 45, including the EU, US and Canada, for additional indications.

Transplantation

        Sales decreased 4% in local currencies (–11% in CHF) as a result of branded and generic competition to the Neoral franchise. Their impact however continues to be limited by the importance physicians attach to avoiding fluctuations in drug concentrations in patients who are stable and doing well on Neoral.

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    Neoral/Sandimmun, sales (–5%; US: –12%) were underpinned by market share gains in Japan, which partly offset price pressures and branded competition in other regions.

    Simulect, the induction immunosuppressant designed to complement Neoral, posted a 21% rise in sales (US: +4%) following its successful launch in Japan and continued market segment share gains from established competitor brands in most regions.

    Myfortic, a new formulation for preventing organ rejection in kidney transplantation, gained first approvals in Switzerland, Brazil, India and Australia, while Certican, a novel drug intended for use in combination with Neoral and corticosteroids to prevent rejection episodes in patients with kidney transplants, was submitted for approval in the EU and US.

Mature Products

        The mature brands reported a 10% sales rise in local currencies (no increase in CHF) due to a switch of products into this Business Unit and as a result of focused investments on selected key products and markets.

    Voltaren (–3%, US: –18%; anti-inflammatory) continued to compete well against generics and the COX-2 inhibitor class of drugs.

    Cibacen/Lotensin/Cibadrex (antihypertensive) continued to deliver positive results as sales climbed 9% (US: +14%) mainly as a result of renewed external field-force support in the US.

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Top 20 Pharmaceutical Products—2002

 
   
   
   
   
   
   
  % change
 
Brands

  Therapeutic Area
  United
States

  % change
in local
currencies

  Rest of
the World

  % change
in local
currencies

  Total
  in CHF
  in local
currencies

 
 
   
  (CHF m)

   
  (CHF m)

   
  (CHF m)

   
   
 
Diovan/Co-Diovan   Hypertension   1,212   40   1,368   58   2,580   37   49  
Neoral/Sandimmun   Transplantation   426   (12 ) 1,181   (2 ) 1,607   (12 ) (5 )
Lamisil (group)   Fungal infections   653   (3 ) 702   12   1,355   (4 ) 4  
Lotrel   Hypertension   1,011   35           1,011   24   35  
Gleevec/Glivec   Chronic Myeloid Leukemia   330   103   623   741   953   271   303  
Sandostatin (group)   Acromegaly   439   39   504   12   943   16   23  
Voltaren (group)   Inflammation/pain   18   (18 ) 907   (3 ) 925   (13 ) (3 )
Lescol   Cholesterol reduction   405   13   491   23   896   10   18  
Zometa   Cancer complications   562   NA   196   NA   758   NA   NA  
Cibacen/Lotensin/Cibadrex   Hypertension   523   14   191   (4 ) 714   1   9  

 
Top ten products   5,579   35   6,163   28   11,742   22   32  
Miacalcic   Osteoporosis   371   (9 ) 241   (4 ) 612   (13 ) (7 )
Tegretol (incl. CR/XR)   Epilepsy   189   (22 ) 376   1   565   (17 ) (8 )
Leponex/Clozaril   Schizophrenia   186   (12 ) 315   8   501   (7 ) 0  
Exelon   Alzheimer's disease   259   28   213   24   472   17   26  
Visudyne   Wet form of age-related macular degeneration   259   19   184   40   443   18   27  
HRT Range   Hormone Replacement   215   5   222   (10 ) 437   (10 ) (3 )
Trileptal   Epilepsy   331   111   102   49   433   73   91  
Aredia   Cancer complications   125   (84 ) 303   (27 ) 428   (66 ) (64 )
Foradil   Asthma   36   136   371   4   407   4   10  
Famvir   Viral Infections   244   17   99   7   343   6   14  

 
Top twenty products   7,794   15   8,589   19   16,383   9   17  
Rest of portfolio   1,120   (6 ) 3,499   0   4,619   (9 ) (1 )

 
Total   8,914   12   12,088   13   21,002   4   13  

 

NA Not applicable as no or insignificant prior year sales.

Consumer Health Division

        Sales of the Consumer Health Division increased in local currencies by 7%, however, fell slightly in Swiss franc terms from CHF 11.5 billion in 2001 to CHF 11.4 billion in 2002. The following are specific comments on the results of the Business Units within the Consumer Health Division:

Generics

        Sales rose 15% in Swiss francs or 25% in local currencies to CHF 2.8 billion, led by the US and Europe, the launch of new products, and expansion into new markets.

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        The Generic Pharmaceuticals Business with finished forms lifted sales by 35% in local currencies, driven by the US performance and new launches, in particular the US launch of amoxicillin/potassium clavulanate, Geneva's generic form of the anti-infective Augmentin®. The introduction of other products, including mefloquine (malaria), nabumetone (inflammation), metformin (diabetes), fluoxetine (depression), lisinopril and lisinopril HCTZ (hypertension) also fuelled growth.

        Sales in Europe grew dynamically, particularly in France, Italy and the Netherlands, due to several launches including the ulcer treatment omeprazole.

        The Industrial Business franchise posted an increase of 1% in Swiss francs and a 3% increase in local currencies. A new Biopharmaceuticals Business franchise was added, focused on the manufacture of active ingredients, mostly modern recombinant products.

        In November, our Business Unit successfully completed its friendly take-over bid for Lek Pharmaceuticals d.d., Slovenia's leading drug-maker. The CHF 1.3 billion acquisition opens up a leading position for our Generics business in Central and Eastern Europe, and in the countries of the former Soviet Union. No sales have been recorded from this acquisition in 2002 due to the fact that the acquisition closed late in the year (resulting in immaterial post-closing sales) and the fact that we are still in the process of integrating Lek into our reporting systems.

OTC

        Sales were 7% off their 2001 level in Swiss francs or down 1% in local currencies. Excluding terminated, acquired, in-licensed and transferred businesses, the underlying sales growth was 3% in local currencies, driven by the key brands Lamisil (antifungal), Voltaren Emulgel (analgesic), Otrivin (nasal decongestant) and Nicotinell/Habitrol (smoking cessation). These products compensated for the weak cough and cold season in the US earlier in 2002 and a drop in Calcium Sandoz sales resulting from reimbursement issues in Europe and Mexico.

Animal Health

        Sales were up 1% in Swiss francs or 10% in local currencies to CHF 971 million, driven by double-digit growth in Latin America and the US, where the vaccine businesses acquired in January were the main contributors. Overall, acquisitions contributed approximately 6 percentage points to local currency sales growth.

        The companion animal franchise was driven by strong sales of Interceptor (worm treatment) and Fortekor (cardio-renal drug), complemented by a number of new launches in key markets, including Atopica, for atopic dermatitis in dogs, and Deramaxx, the first COX-2 product for pain control in dogs, and Milbemax, for intestinal parasites in cats and dogs.

        Sales in the farm animal franchise were driven by the therapeutic anti-infectives, the strong performance in Latin America, and the recovery in the UK from the foot and mouth epidemic of 2001.

        The acquisition of Grand Laboratories and ImmTech in the US boosted the vaccines and aquahealth franchise, which delivered a strong rise in sales and now represents 8% of Animal Health's revenues.

Medical Nutrition (including Nutrition & Santé)

        Combined sales reached CHF 1.1 billion, down 1% in Swiss francs but up 4% in local currencies. Double digit growth in Europe lifted Medical Nutrition sales, which were driven by the strong performance of Enteral Nutrition (Isosource and Novasource) and additional sales impetus from the Medical Food franchise (Resource).

        In Nutrition & Santé, sales growth from the core-brands offset the impact of distributor changes in China and Italy, while Sports Nutrition sales were lifted by the introduction of Isostar "Fast Hydration".

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        Within Medical Nutrition the Health Food & Slimming and Sports Nutrition businesses are regrouped as of January 1, 2003 into the new Nutrition & Santé stand-alone unit to optimize its business potential and to prepare for future divestment.

Infant & Baby

        Although sales fell 7% in Swiss franc terms, sales grew in local currencies by 3%, which was above the industry average, to CHF 2.1 billion. The major contributor was Gerber in the US, spurred by innovations in the Juice, Graduates, and Tender Harvest lines and the outstanding success of Lil' Entrees, a new line of microwavable convenience trays targeted at the toddler segment. Gerber's revenues from this segment increased 5%.

        Despite the Baby Care business competing against private label entries it achieved a record market share in this segment and the Gerber Wellness line of skincare and healthcare products achieved a 7% rise in sales helped by the successful re-launch of its infant skin care line.

CIBA Vision

        Sales fell 1% in Swiss franc terms but rose 6% in local currencies to CHF 1.8 billion, driven by the high-volume lens franchise, which outpaced the market. Strong selling brands included Focus DAILIES, NIGHT & DAY, and FreshLook colored lenses, supported by the launch of the FreshLook Radiance line in several markets including the US, which launched in December. Focus DAILIES Toric, the world's first and only daily disposable lens for astigmatism correction, was launched in Europe and is in the process of being introduced in the US.

        The lens-care franchise continued to compete in a shrinking market mainly in the US. Sales declined, but were underpinned by increases in certain countries and the roll-out of FreshLook Care in Japan.

        The ophthalmic surgical business was lifted by several innovative products including VisThesia, a combination viscoelastic gel and anesthetic, which may help shorten cataract surgeries, Vivarte PRESBYOPIC phakic refractive lens; and an improved convenient injector system for the PRL phakic refractive lens.

Divested Health & Functional Food activities

        We divested our Food & Beverage business, including the Ovaltine®, Caotina® and Lacovo® brands, at the end of November 2002 to Associated British Foods for CHF 402 million. 2002 sales from this divested business, up until the divestment, amounted to CHF 325 million (2001: CHF 400 million).

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Operating Expenses

        The following table sets forth our operating expenses for each of the periods indicated.

 
  Year ended December 31,
   
 
 
  Change in CHF
 
 
  2002
  2001(1)
 
 
  (CHF
millions)

  (CHF millions)

  (%)

 
Sales   32,412   31,643   2  
Cost of goods sold   (7,618 ) (7,886 ) (3 )
Marketing and distribution   (10,987 ) (10,703 ) 3  
Research and development   (4,339 ) (4,189 ) 4  
Administration and general overheads   (1,581 ) (1,588 ) 0  
   
 
 
 
Operating income   7,887   7,277   8  
   
 
 
 

(1) Restated to reflect the reclassification of certain sales incentives and discounts to retailers as sales deductions instead of marketing and distribution expenses.

Cost of goods sold

        Cost of goods sold decreased as a percentage of sales from 24.9% in 2001 to 23.5% in 2002. This was mainly due to continued improvements in productivity and a favorable product mix in Pharmaceuticals.

Marketing & distribution

        Marketing & distribution expenses as a percentage of sales increased by 0.1% over 2001 to 33.9% of sales as slightly higher investments in the Pharmaceuticals Division field force and promotional activities were offset by reductions in the Consumer Health Division.

Research & development

        Research & development expenses as a percentage of sales were 13.4% in 2002, a small increase over the 2001 level of 13.2%.

Administration & general overheads

        Cost containment, especially in Pharmaceuticals, and the recording of CHF 267 million of hedging gains, resulted in a negligible increase in administration & general overheads. As a percentage of sales, administration & general overheads fell to 4.9% in 2002 from 5.0% in 2001.

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Operating Income

        The following table sets forth selected operating income data for each of the periods indicated.

 
  2002
  2001
  Change in CHF
 
 
  (CHF millions)

  (CHF millions)

  (%)

 
Pharmaceuticals   6,022   5,677   6  
   
 
 
 
  Generics   406   281   44  
  OTC(1)   374   452   (17 )
  Animal Health   144   138   4  
  Medical Nutrition (including Nutrition & Santé)(1)   6   87   (93 )
  Infant & Baby(1)   355   388   (9 )
  CIBA Vision   183   174   5  
   
 
 
 
Consumer Health—ongoing   1,468   1,520   (3 )
Divested Health & Functional Food activities   216   (7 )    
   
 
 
 
Consumer Health   1,684   1,513   11  
   
 
 
 
Corporate and other income/expense   181   87   108  
   
 
 
 
Group operating income   7,887   7,277   8  
   
 
 
 

(1) 2001 figures reported the results of OTC, Medical Nutrition (including Health and Functional Foods) and Infant & Baby together under the name Consumer Health. These businesses have now been separated into the OTC, Medical Nutrition (including Nutrition & Santé) and Infant & Baby Business Units.

        Our operating income increased by 8% from CHF 7.3 billion in 2001 to CHF 7.9 billion in 2002. Our operating margin was 24.3% of sales, an increase of 1.3 percentage points compared with 2001 (23.0%).

Pharmaceuticals Division

        The Pharmaceuticals Division's operating income rose 6% to CHF 6.0 billion in 2002 with the Division's operating margin improving by 0.6 percentage points over the year to 28.7%. As a percentage of sales, the cost of goods sold improved 1.2 percentage points due to product mix changes and productivity gains. Marketing & distribution investments increased slightly as a percentage of sales to drive the launches of Elidel and Zelnorm/Zelmac.

        Implementation of the new research strategy and the establishment of the new Cambridge research facility led to a 4% increase in research & development investments, which remained at 17% of sales.

        Included in administration and general overheads were currency hedging gains of CHF 267 million which were offset by CHF 314 million of impairment charges against the goodwill of the Division's biotechnology investments (Genetic Therapy Inc., Systemix Inc., and Imutran Ltd. acquisitions from 1995 and 1996) due to the aforementioned change in research and development strategy, and a CHF 80 million additional impairment charge against the pitavastatin marketing rights acquired in 2001. These impairment charges have been determined based on discounted cash flow models of the expected future sales arising from these activities.

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Consumer Health Division

        The Division's operating income has increased by 11% over the year from CHF 1.5 billion in 2001 to CHF 1.7 billion in 2002. The Division's ongoing operating income, excluding the impact of the divested Health & Functional Food activities, has fallen by 3% to CHF 1.47 billion. As explained below, increases in the operating income of Generics, Animal Health and CIBA Vision Business Units have been offset by falls in the Division's other Business Units.

Generics

        Operating income increased significantly by 44% over 2001, fuelled by top-line growth, productivity gains and a stronger focus on higher margin products. Although regional sales forces were expanded and new markets entered, marketing & distribution expenses were reduced as a percentage of sales.

        Research & development investments increased 27% to CHF 215 million due to product developments and the funding of the new Generics R&D center in Vienna.

        The positive trend of sales and functional costs, and the non-recurrence of acquisition-related costs last year, lifted the operating margin 3 percentage points to 14.5%. We have not recorded any contribution to operating income from the recently completed Lek acquisition.

OTC

        Operating income dropped 17% over the year to CHF 374 million, as a result of lower sales volumes and increased general & administration expenses due primarily to the Divisional reorganization announced in February and exit costs from a Japanese joint venture. These were partially offset by reduced marketing & distribution expenses. The operating margin fell 1.9 percentage points to 15.9%.

Animal Health

        2002 operating income increased 4% to CHF 144 million, leading to an operating margin of 14.8% (2001: 14.3%). Apart from acquisition-related charges, operating costs were reduced significantly as marketing & distribution investments were focused on key new launches, while research & development investments were maintained as a percentage of sales.

Medical Nutrition (including Nutrition & Santé)

        Operating income fell 93% to CHF 6 million as a result of restructuring provisions of CHF 40 million and a one-time provision for potential additional value-added tax charges in Germany. As a result, the operating margin fell to 0.5% from 7.8% in 2001. Excluding the exceptional items of CHF 66 million operating income would have been CHF 72 million and would have produced an operating margin of 6.5%.

Infant & Baby

        2002 operating income fell 9% to CHF 355 million. Operating income was affected by one-off goodwill impairment charges of CHF 39 million primarily related to the Hiborn acquisition in Brazil of 1998. As a result, the operating margin fell to 17.1% from 17.4% in 2001. Excluding this impairment of CHF 39 million, the operating margin would have been 19.0%.

CIBA Vision

        Operating income reached CHF 183 million. Investments in marketing & distribution were increased to power new launches and advertising campaigns. Research & development investments slightly increased as the Business Unit focused on the development of new products and lens production technology. Operating margin increased slightly to 10.4% in 2002 compared with 9.7% in 2001.

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Divested Health & Functional Food activities

        The operating income of CHF 216 million includes the divestment gain of CHF 205 million, after related restructuring charges arising on the divestment of the Food & Beverage business, and the normal operating income from these activities offset by CHF 28 million of goodwill impairment charges in connection with this divestment.

Corporate and Other Income/Expense

        This includes the costs of corporate management, income resulting from charging share and share option plan costs to the operating companies, and pension income. Net corporate income increased from CHF 87 million in 2001 to CHF 181 million in 2002.

Net income

        The following table sets forth selected income statement data for the periods indicated.

 
  2002
  2001
  Change in CHF
 
 
  (CHF
millions)

  (CHF millions)

  (%)

 
Operating income   7,887   7,277   8  
Income from associated companies   (10 ) 139      
Financial income, net   949   1,067   (11 )
   
 
 
 
Income before taxes and minority interests   8,826   8,483   4  
Taxes   (1,490 ) (1,440 ) 3  
   
 
 
 
Income before minority interests   7,336   7,043   4  
Minority interests   (23 ) (19 ) 21  
   
 
 
 
Net income   7,313   7,024   4  
   
 
 
 

Income from associated companies

        Associated companies are accounted for using the equity method where we own between 20% and 50% of the voting shares of such companies. Income from associated companies is mainly derived from our investments in Roche Holding AG and Chiron Corporation.

        We have a 32.7% (2001: 21.3%) interest in Roche voting shares, which represents a 6.2% (2001: 4.0%) interest in the total Roche equity. The income statement effect after taking into account the required charges due to additional depreciation and amortization arising from allocating the purchase price to tangible and intangible assets and goodwill, resulted in a pre-tax loss of CHF 180 million (2001: CHF 39 million loss). See "—5.D Trend Information."

        Our 42.0% interest in Chiron contributed pre-tax income of CHF 167 million (2001: CHF 185 million). Our share of the net income of both Roche and Chiron is based upon analysts' estimates for the full year 2002. Any differences between these estimates and actual results will be adjusted in 2003. In 2001, our income statement includes five quarters of results for Chiron, including an estimate of Chiron's fourth quarter results. Up to 2000, income from Chiron was included in our financial statements with a three month lag, with only the four quarters through to September 30 of the year being consolidated.

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Financial income, net

        A lower but still attractive level of net financial income of CHF 949 million (2001: CHF 1,067 million), was generated in a difficult environment due to good currency management and equity strategies. Gross financial income of CHF 1,144 million (including net income on options and forward contracts and after deducting other financial expense) was CHF 408 million lower than in 2001 because the average level of liquidity has been lower and interest rates were also substantially lower in the current year.

        This was partially offset by lower interest expense of CHF 301 million (2001: CHF 367 million) and by net currency gains of CHF 106 million (up CHF 224 million from last year). The net currency gain was due to currency gains of CHF 380 million, mainly from US dollar and Japanese yen positions, partially offset by losses in emerging markets.

Taxes

        Despite increased profits, the tax charge of CHF 1.5 billion increased only CHF 50 million over the year. Taxes as a percentage of income before tax were 16.9% in 2002 compared to 17.0% in 2001.

Net income

        Net income as a percentage of total sales increased, from 22.2% in 2001 to 22.6% in 2002. This was due to margin increases in the operating businesses offsetting lower financial income.

2001 Compared to 2000

Overview

        The following compares our results in the year ended December 31, 2001 to those of the year ended December 31, 2000. 2001 and 2000 information has been restated to reflect a change in classification of certain sales incentives and discounts to retailers. The restatement amounted to a sales reduction of CHF 395 million in 2001, and CHF 410 million in 2000, with a corresponding reduction in Marketing & Distribution expenses. The following figures have also been restated to separate out the results of the OTC, Infant & Baby, and Medical Nutrition (including Nutrition & Santé and the Food & Beverage business through its divestment in 2002) Business Units. We had previously reported the results of these businesses together under the name Consumer Health. In 2002, our Consumer Health Division was reorganized to include these Business Units, together with our Generics, Animal Health and CIBA Vision Business Units.

        In Swiss francs, our sales from continuing activities in 2001 increased by 10% over 2000 to CHF 31.6 billion; our operating income increased by 8% to CHF 7.3 billion; our net income increased by 8% to CHF 7.0 billion; and our free cash flow (excluding acquisitions of subsidiaries, of 21.3% of the voting shares of Roche Holding AG and of marketing and product rights) increased by 25% in Swiss francs to CHF 4.1 billion. 47% of our sales were generated in the NAFTA region (43% in the United States), 32% in Europe and 21% in the rest of the world.

        Growth from our continuing activities was driven by an 8% increase in our sales volume. All of our Business Units except for Generics benefited from price increases which in total amounted to 2%. The sales increase due to the acquisition of new products and subsidiaries was 4%. Our sales performance in Swiss francs suffered from a 4% unfavorable currency effect as the Swiss franc rose against the yen by an average of 12% and against the Euro by 3%.

        Overall, Pharmaceuticals accounted for 64% of our total sales. Of the remaining businesses, Generics contributed 8% of our total sales, OTC 8%, Animal Health 3%, Medical Nutrition (including Nutrition & Santé) 5%, Infant & Baby 6% and CIBA Vision 6%.

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        Our operating margin from continuing activities in 2001 was 23.0% of sales, a decrease of 0.4 percentage points compared with 2000 (23.4%). Although our cost of goods sold (+8%) and research and development expenses (+4%) increased at a lower rate than sales, our marketing and distribution expenses (+17%) increased at a significantly higher rate than did our sales. Overall, our marketing and distribution expenses reached 34% of sales (2000: 32% of sales). This was due to investments associated with sales force enhancements and new product launches, particularly in Pharmaceuticals. Our research and development expenses as a percentage of sales fell in 2001 to 13.2% from 14.0% in 2000, primarily because of the strong growth in our sales.

Sales

        The following table sets forth selected sales data for each of the periods indicated.

 
  Year ended December 31,
 
 
  2001(1)
  2000(1)
  Change in
CHF

  Change in local
currencies

 
 
  (CHF millions)

  (CHF millions)

  (%)

  (%)

 
Sales                  
Pharmaceuticals   20,181   18,150   11   15  
   
 
 
 
 
  Generics   2,433   1,973   23   26  
  OTC(2)   2,538   2,483   2   5  
  Animal Health   962   1,083   (11 ) (7 )
  Medical Nutrition (including Nutrition & Santé)(2)   1,515   1,513   0   3  
  Infant & Baby(2)   2,227   2,108   6   6  
  CIBA Vision   1,787   1,392   28   33  
   
 
 
 
 
Consumer Health   11,462   10,552   9   11  
   
 
 
 
 
Sales from continuing activities   31,643   28,702   10   14  
Sales from discontinued Agribusiness activities(3)       6,693          
   
 
 
 
 
Group sales   31,643   35,395   (11 ) (8 )
   
 
 
 
 

(1)
2001 and 2000 figures have been restated to reflect a change in classification of certain sales incentives and discounts to retailers. Sales and marketing & distribution expenses have both been reduced by CHF 395 million in 2001 and CHF 410 million in 2000.

(2)
2001 and 2000 figures reported the results of OTC, Medical Nutrition (including Health and Functional Foods) and Infant & Baby together under the name Consumer Health. These businesses have now been separated into the OTC, Medical Nutrition (including Nutrition & Santé) and Infant & Baby Business Units.

(3)
Agribusiness: Crop Protection and Seeds businesses spun-off on November 6, 2000.

Pharmaceuticals Division

        Sales increased by 11% in Swiss francs or by 15% in local currencies to CHF 20.2 billion in 2001 from CHF 18.2 billion in 2000. In the United States, where 43% of turnover was generated, sales increased by 24% reaching CHF 8.6 billion. This performance was driven by numerous product launches, particularly in the United States, most notably Gleevec/Glivec (chronic myeloid leukemia), which achieved sales of CHF 257 million in less than 8 months. As a result of the Gleevec/Glivec launch, oncology product sales expanded by 28% in local currencies. Acquisitions, principally Famvir (antivirals), which was acquired late in 2000, contributed 2% to the Division's sales growth. Continued marketing focus on key products such as Diovan/Co-Diovan (hypertension), Lotrel (hypertension), Lamisil (fungal infections) and Exelon (Alzheimer's) was also a major factor in the sales growth.

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        Diovan/Co-Diovan (hypertension) surpassed Sandimmun/Neoral (transplantation) as our best-selling product in 2001 with CHF 1.9 billion in sales (+58% in local currencies). Diovan, an angiotensin II receptor blocker, took the leadership position in new prescriptions from Cozaar® (the competitor product by Merck) in the United States. Diovan is the only drug of its class to have shown a clinical benefit with regard to heart failure.

        Lotrel (hypertension), another key product in the cardiovascular therapeutic area, continued to expand its share of new prescriptions in its sector to 22%, and achieved sales of CHF 813 million, which was an increase of 48% in local currencies. Lotrel sales were also the key driver behind the performance of the Cibacen group which achieved total sales of CHF 1.5 billion, an increase over last year of 22% in local currencies.

        The decline in sales due to generic erosion or new competition continued to be limited for both Neoral/Sandimmun (—7% in local currencies) and Voltaren (—8% in local currencies). Neoral/Sandimmun achieved sales of CHF 1.8 billion and Voltaren of CHF 1.1 billion.

        Aredia (bone metastases) expanded beyond last year's sales and reached CHF 1.3 billion, although the first competing generic products entered the market at the beginning of December. Our follow-on product Zometa received approval during 2001 both in Europe and in the United States for its first indication, hypercalcemia of malignancy, and received approval during 2002 in the US for bone metastases, its second indication. We expect our combined Aredia/Zometa sales to decline slightly in 2002, since Zometa is not yet likely to fully compensate for the anticipated decline in Aredia sales.

        Overall, Pharmaceuticals' top ten products reached total sales of CHF 12.0 billion reflecting an increase of 13% in local currencies. Pharmaceuticals' top twenty products expanded sales by 19% in local currencies to CHF 15.6 billion.

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Top 20 Pharmaceutical Products—2001

 
   
   
   
   
   
   
  % change
 
Brands

  Therapeutic Area
  United
States

  % change
in local
currencies

  Rest of the
World

  % change
in local
Currencies

  Total
  In CHF
  In local
currencies

 
 
   
  (CHF m)

   
  (CHF m)

   
  (CHF m)

   
   
 
Diovan/Co-Diovan   Hypertension   943   47   937   70   1,880   53   58  
Neoral/Sandimmun   Transplantation   525   (20 ) 1,304   (2 ) 1,829   (11 ) (7 )
Cibacen/Lotensin   Hypertension   1,309   28   209   (7 ) 1,518   21   22  
(of which Lotrel)       813   48           813   47   48  
Lamisil (group)   Fungal infections   730   22   675   16   1,405   (15 ) 19  
Aredia (group)   Cancer complications   835   17   435   12   1,270   13   15  
Voltaren   Inflammation/pain   24   (51 ) 1,042   (7 ) 1,066   (15 ) (8 )
Sandostatin (group)   Acromegaly   343   38   473   20   816   23   26  
Lescol   Cholesterol reduction   388   15   426   18   814   12   17  
Miacalcic   Osteoporosis   443   (6 ) 264   10   707   (2 ) 0  
Tegretol   Epilepsy   263   9   420   (4 ) 683   (3 ) 1  

 
Top ten products       5,803   17   6,185   10   11,988   9   13  
Leponex/Clozaril   Schizophrenia   229   (16 ) 310   5   539   (8 ) (5 )
Estraderm (group)   Hormone replacement   221   30   263   (7 ) 484   5   6  
Exelon   Alzheimer's disease   219   158   184   65   403   100   104  
Foradil   Asthma   17   NA   373   16   390   18   21  
Visudyne   Wet form of age-related macular degeneration   238   114   139   154   377   123   127  
Famvir (group)   Antivirals   244   NA   79   NA   323   NA   NA  
Nitroderm TTS   Heart disease   3   (55 ) 317   (3 ) 320   (11 ) (4 )
Zaditen   Asthma, allergy           265   (6 ) 265   (16 ) (6 )
Gleevec/Glivec   Chronic myeloid Leukemia   176   NA   81   NA   257   NA   NA  
Trileptal   Epilepsy   170   129   80   36   250   84   87  

 
Top twenty total       7,320   29   8,276   12   15,596   15   19  
Rest of portfolio       1,316   4   3,269   4   4,585   (1 ) 4  

 
Total       8,636   24   11,545   10   20,181   11   15  

 

NA
Not applicable as insignificant or non-existent prior year sales.

Consumer Health Division

Generics

        Sales increased by 23% in Swiss francs or by 26% in local currencies to CHF 2.4 billion from CHF 2.0 billion in 2000. Strategic acquisitions completed in early 2001 in the United States, Argentina, the UK and Germany account for 20 percentage points of this increase. In the United States (32% of sales), sales increased by 39% in local currency (4% excluding acquisitions) as a result of reorganization initiatives, the successful integration of the Apothecon acquisition, and the launch of a generic version of Eli Lilly's Prozac® (fluoxetine). Generics' US affiliate, Geneva Pharmaceuticals, holds 6-month exclusivity rights to commercialize the 10 mg capsule formulation of fluoxetine.

        Our Generics Pharmaceuticals Business (for finished pharmaceutical products) achieved a sales increase of 39% in Swiss Francs due to acquisitions, product launches and the global roll-out of the generic version of the combination of amoxicillin and clavulanic acid.

        Our Industrial Business (active pharmaceutical ingredients and biotech substances) grew by 6% in Swiss francs as a result of focused efforts in high quality intermediates and the expansion of the biotechnology business.

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OTC

        Sales increased from CHF 2.48 billion in 2000 to CHF 2.54 billion in 2001. The increase of 5% in local currencies (2% in Swiss francs) was driven by the key brands Nicotinell™/Habitrol® (smoking cessation), Voltaren Emulgel (topical pain relief) and Lamisil Cream (antifungal).

Animal Health

        Sales fell by 11% in Swiss francs, or 7% in local currencies, to CHF 962 million in 2001 from CHF 1.1 billion in 2000, as the companion animal market in the U.S suffered from inventory reductions at the veterinary clinic level and competitive pressures in the flea product market continued. The farm animal business saw a flat performance as the impact of the foot-and-mouth disease crisis in Europe was felt. The acquired vaccine and aquaculture businesses grew sales, but these businesses are at present too small to offset these events.

Medical Nutrition (including Nutrition & Santé)

        Sales recorded an increase of 3% in local currencies, but stayed constant in Swiss francs at CHF 1.5 billion in 2000 and 2001. The Home Care market drove sales growth, together with a strong performance in Europe, and a strong second half in the United States, offset by a decline in the juice business in Poland.

Infant & Baby

        Sales increased 6% in both local currencies and Swiss francs from CHF 2.1 billion in 2000 to CHF 2.2 billion in 2001. Gerber reached a new record market share with 75.9% in the US baby/toddler food segment, while Gerber Care and Gerber Wellness products continued to make progress in a competitive marketplace.

CIBA Vision

        Sales increased by 28% in Swiss francs, or 33% in local currencies, to CHF 1.8 billion in 2001 from CHF 1.4 billion in 2000. Excluding the impact of the Wesley Jessen acquisition, sales increased by 5% in local currencies. The innovative Focus range of lenses, led by FocusDailies and Focus Night & Day, and the acquired FreshLook brand of cosmetic lenses, were drivers of sales growth. Focus Night & Day also became the first high-oxygen extended wear contact lens for up to 30 nights of continuous wear to receive US FDA approval. Innovative product launches including Aosept Plus/Aosept Clear Care and SOLO-care Plus, as well as upcoming specialty lens product developments, are aimed at addressing the overall declining lens care and specialty lens markets.

Discontinued Agribusiness Division

        Agribusiness was only included in our Group figures up to its spin-off on November 6, 2000.

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Operating Expenses

        The following table sets forth our operating expenses for each of the periods indicated.

 
  Discontinued
activities

  Continuing
activities

  Group
 
 
  (CHF
millions)

  (CHF millions)

  (CHF millions)

 
2001(1)              
Cost of goods sold       (7,886 ) (7,886 )
Marketing and distribution       (10,703 ) (10,703 )
Research and development       (4,189 ) (4,189 )
Administration and general overheads       (1,588 ) (1,588 )
2000(1)              
Cost of goods sold   (2,926 ) (7,316 ) (10,242 )
Marketing and distribution   (1,389 ) (9,146 ) (10,535 )
Research and development   (646 ) (4,011 ) (4,657 )
Administration and general overheads   (576 ) (1,502 ) (2,078 )

(1) 2001 and 2000 figures have been restated to reflect a change in classification of certain sales incentives and discounts to retailers. Sales and marketing & distribution expenses have both been reduced by CHF 395 million in 2001 and CHF 410 million in 2000.

        The following table sets forth our continuing operating expenses for each of the periods indicated.

 
  Year ended December 31,
   
 
  Change in CHF
 
  2001(1)
  2000(1)
 
  (CHF
millions)

  (CHF millions)

  (%)

Sales from continuing activities   31,643   28,702   10
Cost of goods sold   (7,886 ) (7,316 ) 8
Marketing and distribution   (10,703 ) (9,146 ) 17
Research and development   (4,189 ) (4,011 ) 4
Administration and general overheads   (1,588 ) (1,502 ) 6
   
 
 
Operating income from continuing activities   7,277   6,727   8
   
 
 

(1) 2001 and 2000 figures have been restated to reflect a change in classification of certain sales incentives and discounts to retailers. Sales and marketing & distribution expenses have both been reduced by CHF 395 million in 2001 and CHF 410 million in 2000.

Cost of goods sold

        Our cost of goods sold for continuing activities decreased as a percentage of our sales from 25.5% in 2000 to 24.9% in 2001. This was mainly due to continued improvements in productivity and product mix in Pharmaceuticals.

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Marketing and distribution

        Our marketing and distribution expenses for continuing activities as a percentage of our sales increased from 31.9% in 2000 to 33.8% in 2001 as significant investments were made in the Pharmaceuticals field force and in promotional activities to support key products.

Research and development

        Our research and development expenses for continuing activities as a percentage of our sales were 13.2% in 2001 compared to 14.0% in 2000. This is primarily the result of strong growth in Pharmaceuticals' sales.

Administration and general overheads

        The costs of implementing state-of-the-art information technology systems in Pharmaceuticals and other Business Units led to an increase in our administration and general overheads by 5.7%. As a percentage of sales from continuing activities, however, there was a fall in administration and general overheads to 5.0% in 2001 from 5.2% in 2000.

Operating Income

        The following table sets forth selected operating income data for each of the periods indicated.

 
  2001
  2000
  Change in CHF
 
 
  (CHF millions)

  (CHF millions)

  (%)

 
Pharmaceuticals   5,677   5,401   5  
   
 
 
 
  Generics   281   242   16  
  OTC(1)   452   424   7  
  Animal Health   138   179   (23 )
  Medical Nutrition (including Nutrition & Santé) (1)   80   74   8  
  Infant & Baby(1)   388   371   5  
  CIBA Vision   174   100   74  
   
 
 
 
Consumer Health   1,513   1,390   9  
Corporate and other income/expense   87   (64 )    
   
 
 
 
Operating income from continuing activities   7,277   6,727   8  
Operating income from discontinued Agribusiness activities(2)       1,156      
   
 
 
 
Group operating income   7,277   7,883   (8 )
   
 
 
 

(1) 2001 and 2000 figures reported the results of OTC, Medical Nutrition (including Health and Functional Foods) and Infant & Baby together under the name Consumer Health. These businesses have now been separated into the OTC, Medical Nutrition (including Nutrition & Santé) and Infant & Baby Business Units.
(2) Agribusiness: Crop Protection and Seeds businesses.

        Our operating margin on continuing activities was 23.0% of our sales, a decrease of 0.4 percentage points compared with 2000 (23.4%).

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Pharmaceuticals Division

        Operating income increased 5% to CHF 5.7 billion in 2001 from CHF 5.4 billion in 2000. Operating margin fell by 1.7 percentage points to 28.1% in 2001, due to a 24% increase in marketing and distribution expenses, which now represent almost 36% of sales, compared to 32% in 2000 as field force and promotion activities were increased due to new product launches. The operating income also includes a charge of CHF 216 million for impairment of pitavastatin marketing rights which were written down from their initial value of CHF 722 million. Research and development expenses fell slightly as a percentage of Division sales, to 17% of sales compared to 18% in 2000, even though the actual amount increased by 4% in Swiss franc terms. Additional productivity improvements also were achieved reducing the cost of goods sold as a percentage of sales.

Consumer Health Division

Generics

        The Business Unit had an operating income of CHF 281 million in 2001, an increase of 16% compared with CHF 242 million in 2000. The operating margin declined from 12.3% in 2000 to 11.5% in 2001 due to several factors. These included integration costs associated with completing several acquisitions during the year; increased price pressure, especially in the United States; costs related to legal actions in the United States; and stepped-up investment in marketing.

OTC

        Operating income increased by 7% from CHF 424 million in 2000 to CHF 452 million in 2001, driven by the key brands Nicotinell/Habitrol (smoking cessation), Voltaren Emulgel (topical pain relief) and Lamisil Cream (antifungal). The operating margin increased 0.8% from 17% in 2000 to 17.8% in 2001.

Animal Health

        Operating income fell by 23% from CHF 179 million in 2000 to CHF 138 million principally due to the significantly reduced level of sales, particularly in the companion animal business. The Business Unit's operating margin also declined from 16.5% in 2000 to 14.3% in 2001, principally due to a decline in US sales in the higher-margin companion animal business.

Medical Nutrition (including Nutrition & Santé)

        Operating income increased by 8% from CHF 74 million in 2000 to CHF 80 million in 2001. Operating margin increased by 0.4% from 4.9% in 2000 to 5.3% in 2001.

Infant & Baby

        Operating income increased by 5% from CHF 371 million in 2000 to CHF 388 million in 2001 due to increased market share in the US Baby/Toddler food segment. Operating margin decreased slightly from 17.6% in 2000 to 17.4% in 2001.

CIBA Vision

        Operating income increased by 74% from CHF 100 million in 2000 to CHF 174 million in 2001 and operating margin increased from 7.2% in 2000 to 9.7% in 2001. The 2001 operating income includes the impact of the Wesley Jessen business on revenue and costs for the full twelve months of 2001 compared to only three months in 2000. On a comparable basis, excluding exceptional integration costs related to the acquisition of Wesley Jessen of CHF 34 million (2000: CHF 110 million), operating income decreased slightly by 1% from CHF 210 million in 2000 to CHF 208 million in 2001, and the operating margin declined from 15.1% in 2000 to 11.6% in 2001, principally due to goodwill charges.

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Corporate and Other Income/Expense

        Corporate and other income/expense include the costs of corporate and country management, offset by employee benefit, share and share option plan charges levied on the operating companies and credited to corporate other income. In 2001, Corporate and other income/expense achieved a net income of CHF 87 million, compared with a net expense of CHF 64 million in 2000, principally due to higher share and share option charges to Division companies.

Net income

        The following table sets forth selected income statement data for the periods indicated.

 
  Discontinued activities
  Continuing activities
  Group
 
 
  (CHF millions)

  (CHF millions)

  (CHF millions)

 
2001              
Operating income       7,277   7,277  
Income from associated companies       139   139  
Financial income, net       1,067   1,067  
Taxes       (1,440 ) (1,440 )
Minority interests       (19 ) (19 )
       
 
 
Net income       7,024   7,024  
       
 
 
2000              
Operating income   1,156   6,727   7,883  
Income from associated companies   1   97   98  
Financial income, net   (125 ) 1,216   1,091  
Taxes   (316 ) (1,504 ) (1,820 )
Minority interests   (17 ) (25 ) (42 )
   
 
 
 
Net income   699   6,511   7,210  
   
 
 
 

Net Income from continuing activities

        The following table sets forth selected income statement data from continuing activities for the periods indicated.

 
  2001
  2000
  Change in CHF
 
 
  (CHF millions)

  (CHF millions)

  (%)

 
Operating income from continuing activities   7,277   6,727   8  
Income from associated companies   139   97   43  
Financial income, net   1,067   1,216   (12 )
   
 
 
 
Income before taxes and minority interests   8,483   8,040   6  
Taxes   (1,440 ) (1,504 ) (4 )
   
 
 
 
Income before minority interests   7,043   6,536   8  
Minority interests   (19 ) (25 ) (24 )
   
 
 
 
Net income from continuing activities   7,024   6,511   8  
   
 
 
 

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Income from associated companies

        We account for income from our associated companies using the equity method where we own between 20% and 50% of the voting shares of such companies. In 2001, income from associated companies was mainly derived from our stakes in Roche Holding AG (Roche) and in Chiron Corporation (Chiron).

        Our ownership of 21.3% of Roche voting shares, which represents a 4% interest in the total Roche voting and non-voting equity instruments, was acquired in the first half of 2001. The income statement effect after taking into account the required charges due to additional depreciation and amortization arising from allocating the purchase price to tangible and intangible assets and goodwill, resulted in a pre-tax loss of CHF 39 million. Our ownership of 41.9% of Chiron shares resulted in pre-tax income of CHF 185 million (2000: CHF 97 million).

        Our share of the net income of both Roche and Chiron is based upon analysts' estimates of their net income for the full year 2001. Any differences between these estimates and actual results will be recorded in 2002. In 2001, our income statement includes five quarters of results for Chiron, including an estimate of Chiron's fourth quarter results. Up to 2000, income from Chiron was included in our financial statements with a three month lag, with only the four quarters through to September 30 of the year being consolidated.

Financial income/expense, net

        We realized financial income, net from continuing activities of CHF 1.1 billion in 2001 despite difficult market conditions. This result was achieved through successful management of liquid funds and a gain from the sale of US dollar denominated bonds. Our 2001 financial income was CHF 149 million lower than the CHF 1.2 billion achieved in 2000. The 2000 figure excludes CHF 125 million of interest expense which was allocated to the discontinued Agribusiness activity, because it related to the debt which was transferred to Syngenta on its spin-off.

        Interest income from our investments fell from CHF 1.0 billion in 2000 to CHF 639 million in 2001 due to lower interest rates and less liquidity. Interest expense fell slightly from CHF 385 million in 2000 (excluding CHF 125 million allocated to Agribusiness) to CHF 367 million in 2001.

        Increased capital gains realized from our sale of US dollar bonds and from other sources contributed an additional CHF 359 million to our financial results. The net result from our financial derivative transactions (mainly options and forward contracts) improved by CHF 405 million, largely as a result of our management of liquid funds. We do not write uncovered options, so a large part of our net derivative expense is compensated by gains on the underlying assets.

        The financial impact from the different currencies held by our affiliates changed from a gain of CHF 329 million in 2000 to a loss of CHF 118 million in 2001. This change was largely the result of major currency losses during 2001 from the currency devaluations in Turkey and Brazil.

Taxes

        Our 2001 tax charge on continuing activities was 4% less in 2001 than in 2000. Our 2001 tax charge totaled CHF 1.4 billion as compared to the 2000 tax charge on continuing activities of CHF 1.5 billion (excluding CHF 316 million allocated to the discontinued Agribusiness activities). Taxes on our continuing activities as a percentage of income before tax were reduced to 17.0% compared with 18.7% in 2000. This is due to a change in the geographic mix of taxable income.

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Net income

        Net income from our continuing activities as a percentage of our total sales decreased slightly from 22.7% in 2000 to 22.2% in 2001. This decrease was principally due to profit margin declines in some of our businesses and to lower financial income.

Exchange Rate Exposure and Risk Management

        We transact business in many currencies other than the Swiss franc. On average in 2002, the Swiss franc was stronger against the US dollar, Japanese yen, Euro and British pound than in 2001. The total negative currency effect on sales growth was 9% and the total negative impact on operating income growth was 2%.

        On average in 2001, the Swiss franc was stronger against the Japanese yen, Euro and British pound, yet remained almost at the same level against the US dollar as in 2000. The total negative currency effect on sales growth in 2001 as against 2000 was 4% and the total negative impact on operating income growth was 1%.

        As a result of our foreign currency exposure, exchange rate fluctuations have a significant impact in the form of both translation risk and transaction risk on our income statement. Translation risk is the risk that our consolidated financial statements for a particular period or as of a certain date may be affected by changes in the prevailing rates of the various currencies of the reporting subsidiaries against the Swiss franc. Transaction risk is the risk that the value of transactions executed in currencies other than the subsidiary's currency may vary according to currency fluctuations.

        In 2002, 43% of our sales were generated in US dollars, 25% in Euro, 5% in Swiss francs, 8% in Japanese yen and 19% in other currencies. In 2001, 45% of our sales were generated in US dollars, 23% in Euro, 5% in Swiss francs, 8% in Japanese yen and 19% in other currencies. In 2000, 44% of sales were generated in US dollars, 24% in Euro, 6% in Swiss francs, 8% in Japanese yen and 18% in other currencies.

        In 2002, 32% of our operating costs were generated in US dollars, 25% in Euro, 21% in Swiss francs, 6% in Japanese yen, and 16% in other currencies. In 2001, 31% of our operating costs were generated in US dollars, 22% in Euro, 26% in Swiss francs, 5% in Japanese yen, and 16% in other currencies. In 2000, 33% of operating costs were generated in US dollars, 23% in Euro, 26% in Swiss francs, 5% in Japanese yen, and 13% in other currencies.

New Accounting Pronouncements

        See note 31(l)(xii) and (xiii) to the consolidated financial statements for a discussion of the effect of new accounting standards.

US Dollar Reporting

        We intend to change the reporting currency of our consolidated financial statements from Swiss francs to US dollars beginning on January 1, 2003. The 2002 consolidated financial information will be restated into US dollars with this restatement being available prior to the release of the first quarter 2003 financial data.

        The move to presenting the consolidated financial data in US dollars reflects the increasing importance of our sales in US dollars and will make the financial information more easily comparable with peer companies in the pharmaceutical industry.

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5.B  Liquidity and Capital Resources

        The following table sets forth certain information about our cash flow and net liquidity for each of the periods indicated.

 
  Year ended December 31,
 
 
  2002
  2001(1)
  2000(1)
 
 
  (CHF millions)

 
Cash flow from continuing operating activities   8,162   7,342   6,175  
Cash flow used for continuing investing activities   (4,455 ) (4,675 ) (50 )
Cash flow used for financing activities   (6,617 ) (354 ) (4,755 )
Net cash flow from discontinued operating and investing Agribusiness activities           1,271  
Net effect of currency translation on cash and cash equivalents   (99 ) 31   (119 )
   
 
 
 
Change in cash and cash equivalents   (3,009 ) 2,344   2,522  
Change in short- and long-term marketable securities   (1,538 ) (940 ) (4,375 )
Change in short- and long-term financial debts   858   (2,524 ) 3,770  
   
 
 
 
Change in net liquidity   (3,689 ) (1,120 ) 1,917  
Net liquidity at January 1   13,475   14,595   12,678  
   
 
 
 
Net liquidity at December 31   9,786   13,475   14,595  
   
 
 
 

(1)
Restated due to reclassification of the fair value of derivative financial instruments from other current assets to marketable securities & financial derivatives and from other short term liabilities to short term financial debts.

Cash Flow From Continuing Operating Activities

        Our primary source of liquidity is cash generated from our operations. The cash flow from operating activities increased by CHF 0.8 billion (11%) to CHF 8.2 billion mainly as result of higher net income and increased non-cash expenses. Depreciation, amortization and impairment charges increased by CHF 0.3 billion to CHF 2.1 billion. Current tax payments were CHF 181 million lower than prior year despite an increase of the total tax charge of CHF 50 million.

        In 2001, cash flow from continuing operations increased to CHF 7.3 billion in 2001 from CHF 6.2 billion in 2000. CHF 637 million of the increase is attributed to reduced funding of working capital.

        Our free cash flow, excluding the impact of the acquisitions of the Roche stake, Lek and marketing and product rights, increased 25% from CHF 3.3 billion in 2000 to CHF 4.1 billion in 2001, and 9.6% from CHF 4.1 billion in 2001 to CHF 4.5 billion in 2002.

        Our capital expenditure on tangible fixed assets for the 2002 financial year totaled CHF 1.7 billion (5.1% of sales), compared to a comparable figure CHF 1.4 billion (4.3% of sales) in 2001 and CHF 1.4 billion in 2000 (4.0% of sales).

        This level of capital expenditure reflects the continuing investment in production and research and development facilities. We intend to maintain spending at 2002 levels in 2003 and to fund these expenditures with internally generated resources.

        Free cash flow of the Divisions and Business Units uses the same definition as that for our Group, however no dividends, tax or financial receipts or payments are included in the Division and Business Unit calculation.

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        The following table details the components of these increases.

 
  2002
  2001
  2000
 
 
  (CHF millions)

 
Cash flow from continuing operating activities   8,162   7,342   6,175  
Purchase of tangible fixed assets   (1,661 ) (1,351 ) (1,179 )
Purchase of intangibles and financial assets   (4,137 ) (7,552 ) (3,088 )
Sale of tangible, intangible and financial assets   1,525   1,825   749  
Dividends paid to third parties   (2,294 ) (2,194 ) (2,064 )
Acquisition of product and marketing rights       826   2,661  
Acquisition of 11.4% (in 2002) and 21.3% (in 2001) of the voting shares of Roche Holding AG   2,868   5,177      
   
 
 
 
Free cash flow from continuing activities              
  (excluding Roche stake, product and marketing rights acquisitions)   4,463   4,073   3,254  
   
 
 
 

Cash Flow From Continuing Investing Activities

        Our cash outflow due to investing activities was CHF 4.5 billion, only marginally below last year. CHF 4.2 billion was spent to increase the strategic investment in Roche and for the acquisition of Lek. The net investment in tangible assets accounted for CHF 1.7 billion. The net proceeds from sale of marketable securities was CHF 0.7 billion.

        Our net cash outflow from investing activities increased to CHF 4.7 billion in 2001 from CHF 50 million in 2000. The more than CHF 4.6 billion increase in 2001 over 2000 was primarily due to the CHF 5.2 billion we spent to acquire our strategic interest in Roche Holding AG.

Cash Flow From Financing Activities

        The cash flow used for financing activities was CHF 6.6 billion. CHF 5.1 billion was spent for the acquisition of treasury shares and CHF 2.3 billion for dividend payments while the issue of a EUR 1 billion bond and the conversions of the remaining two convertible bonds contributed to a net inflow of CHF 0.8 billion.

        Our net cash outflow from financing activities decreased to CHF 354 million in 2001 from CHF 4.8 billion in 2000. The CHF 4.4 billion decrease in 2001 as compared to 2000 was due mainly to proceeds we received from the issuance of equity option instruments and from a non-convertible bond issue.

        In 2002, we received CHF 0.8 billion by increasing our financial debts as compared to receipts of CHF 1.6 billion in 2001, and payment of CHF 1.5 billion in 2000 from reducing our financial debts.

Net Liquidity

        Our overall liquidity (cash, cash equivalents and marketable securities including financial derivatives) amounted to CHF 17.6 billion at December 31, 2002, a reduction of CHF 4.6 billion over the previous year-end balance. Net liquidity (liquidity less financial debt) remains high at CHF 9.8 billion despite a reduction of CHF 3.7 billion from the December 31, 2001 level due to the various financing activities explained above.

        Our overall net liquidity was CHF 13.5 billion as of December 31, 2001. This was a decrease of CHF 1.1 billion from our overall net liquidity of CHF 14.6 billion as at December 31, 2000.

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        We use marketable securities and derivative financial instruments to manage the volatility of our exposures to market risk in interest rates and liquid investments. Our objective is to reduce, where appropriate, fluctuations in earnings and cash flows. We manage these risks by selling existing assets or transactions. We therefore expect that any loss in value for those securities or derivative financial instruments generally would be offset by increases in the value of those hedged transactions.

        Until December 31, 2002 we used the Swiss franc as our reporting currency. From January 1, 2003 we use the US dollar as our reporting currency. We are exposed to foreign exchange movements in other currencies. We enter into various contracts, which are impacted by currency movements. We manage the risk associated with currency movements by entering into various contracts to preserve the value of assets, commitments and anticipated transactions. In particular, we enter into forward contracts and foreign currency option contracts in order to hedge certain anticipated foreign currency revenues and our net investments in certain foreign subsidiaries. See "Item 11. Quantitative and Qualitative Disclosures About Market Risk," for additional information.

Contractual Obligations

        We have long-term research agreements with various institutions which require us to fund various research projects in the future. As of December 31, 2002, the aggregate total amount of payments which may be required under these agreements was CHF 594 million. We expect to fund these long-term research agreements with internally generated resources.

        As of December 31, 2002, our total financial debt was CHF 7.8 billion, as compared with CHF 8.7 billion as of December 31, 2001, and CHF 6.1 billion as of December 31, 2000. The decrease of CHF 0.9 billion of debt at December 31, 2002 compared to December 31, 2001 is primarily due to the conversion of CHF 1.2 billion of convertible debt and reduction in short-term debt partially offset by the issue of a EUR 1.0 billion straight bond due 2007.

        The increase of CHF 2.6 billion of debt at December 31, 2001 compared to December 31, 2000 was primarily due to the issue of CHF 1.3 billion of straight debt. Our year-end debt/equity ratio fell slightly to 0.20:1 in 2002 from 0.21:1 in 2001 and 0.17:1 in 2000.

        We had CHF 3.6 billion in non-convertible bonds at December 31, 2002, up from CHF 2.3 billion at December 31, 2001 and CHF 961 million as of December 31, 2000. The increase from 2001 to 2002 is primarily due to the issuance on November 14, 2002 by our Bermuda affiliate, Novartis Securities Investment Ltd, of EUR 1 billion of 3.75% guaranteed notes, due 2007, guaranteed by Novartis AG. The increase from 2000 to 2001 was primarily due to the issuance on October 17, 2001 by our Bermuda affiliate, Novartis Securities Investment Ltd, of EUR 900 million of 4% guaranteed notes, due 2006, guaranteed by Novartis AG.

        For details on the maturity profile of debt, currency and interest rate structure, see note 18 to the consolidated financial statements.

        As of December 31, 2002, we had short-term debt (excluding the current portion of long-term debt) of CHF 3.8 billion as compared with CHF 4.9 billion as of December 31, 2001, and CHF 3.9 billion as of December 31, 2000. This short-term debt consisted mainly of CHF 1.3 billion (2001: CHF 1.0 billion; 2000: CHF 408 million) in commercial paper; and other bank and financial debt, including interest-bearing employee accounts, of CHF 2.0 billion (2001: CHF 2.8 billion; 2000: CHF 3.1 billion).

        We are in compliance with all covenants or other requirements set forth in our financing agreements. We do not have any rating downgrade triggers that would accelerate maturity of our debt. For details of the maturity profile of debt, currency and interest rate structure, see note 18 to the consolidated financial statements. Our debt continues to be rated by Standard & Poor's and Moody's respectively as AAA and Aaa for long-term maturities and A1+ and P1 for short-term debt. We consider our working capital to be sufficient for our present requirements.

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        The following summarizes our contractual obligations and other commercial commitments, and the effect such obligations and commitments are expected to have on our liquidity and cash flow in future periods.

 
  Payments Due by Period
Contractual Obligations

  Total
  Less than
1 year

  2–3 years
  4–5 years
  After
5 years

 
  (CHF millions)

Long-Term Debt   3,784   29   836   2,874   45
Operating Leases   1,313   259   355   207   492
Finance Leases   203   127   76        
Research & Development Commitments (excluding potential milestone payments)(1)   594   279   245   68   2
   
 
 
 
 
Total Contractual Cash Obligations   5,894   694   1,512   3,149   539
   
 
 
 
 

(1)
The possible impact of potential milestone payments are explained in the following section, "Contingencies".

Contingencies

        In connection with our original investment in Chiron, we agreed to:

    purchase up to $500 million of new Chiron equity, at Chiron's request (a "Put"). To date, Chiron has made no such request.

    guarantee up to $703 million of Chiron debt. We are not obligated to make any payments under this guarantee unless Chiron defaults on the debt. If Chiron uses this guarantee in excess of $403 million, then our Put obligation is reduced by the excess amount.

        The outstanding equity put and guarantee expire no later than 2011.

        We have entered into long-term research agreements with various institutions. These agreements may require us to make up to CHF 347 million in potential milestone and other contingent payments. Of this amount, we may be required to pay up to CHF 269 million within the next 5 years.

        For other contingencies, see "Item 4 Information on the Company—4.D Property, Plants and Equipment—Environmental Matters" and "Item 8 Financial Information—8.A Consolidated Statements and Other Financial Information—8.A.7 Legal Proceedings."

Share repurchase program

        On July 22, 2002, we initiated our third share buy-back program to repurchase shares on the SWX Swiss Exchange for up to a total of CHF 4 billion. During 2002, 24.6 million shares were repurchased via a second trading line on the SWX for a total amount of CHF 1.5 billion. As with our past share buy-back programs, our Board will propose reducing the Group's share capital by 22.7 million shares, corresponding to the shares repurchased but not yet cancelled, at the forthcoming Annual General Meeting to be held on March 4, 2003.

        During 2002, an additional 55.4 million shares, net were also repurchased on the first trading line for a total of CHF 3.6 billion.

        In February 2001, our Board of Directors approved a second share repurchase program for an amount of up to CHF 4 billion by means of a second trading line established on the SWX Swiss Exchange. As of December 31, 2001, we had repurchased 59 million shares for a total of CHF 3.9 billion. An additional 1.9 million shares were then purchased during January 2002 to complete this program. The

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average price for the shares we acquired under this program was CHF 66. On March 21, 2002 the Annual General Meeting cancelled 61.1 million shares with a nominal value of CHF 31 million.

        On August 27, 1999, we announced our intention to repurchase shares in the open market for an amount of up to CHF 4 billion. That repurchase program was completed in January 2001. The program was wholly financed with our surplus liquidity. The acquired shares are kept as treasury shares.

        At December 31, 2002, our holding of treasury shares (excluding the amount that we will propose to be cancelled at the March 2003 Annual General Meeting and treasury shares reserved for call options) amounted to 272 million shares or 9.6% of the total number of issued shares.

Other equity instruments

        During December 2001, through indirectly held affiliates, we sold a total of 55 million ten-year Low Exercise Price Options ("LEPOs") on our shares in two tranches, with an exercise price of CHF 0.01, for EUR 2.2 billion in proceeds (EUR 40 per LEPO). The LEPOs will be settled using Novartis treasury shares. We have accounted for the LEPOs in our balance sheet as an increase in share premium at fair value less related issuance costs. Exercises will be recorded as a share issuance with no gains (losses) recorded in our consolidated statements of income.

        We also sold a total of 55 million ten-year Put options (the "Put options") on our shares in two tranches with an exercise price of EUR 51 for EUR 616 million in proceeds (EUR 11.22 per Put option). The Put options can be exercised at the third, fourth, fifth, sixth, seventh, and tenth anniversary of the date of sale and can, at our option, either be physically settled, or net-share settled, using our treasury shares. We hold the right to accelerate the exercise date and expiration date for any outstanding options at any time on or after December 6, 2006 at the accreted exercise price of the Put options. We have accounted for the option premium associated with the Put options as an increase in share premium less related issuance costs. Exercises will be recorded as treasury share transactions with no gains (losses) recorded in our consolidated statements of income.

        The contractual terms of the Put options place a limit on the number of shares to be delivered in a net share settlement. We cannot under any circumstances be forced into a net cash settlement by the counterparty. If we choose to physically settle the Put options, however, this could result in a cash payment to the counterparty. The total possible cash payment measured at the earliest possible exercise date for the two tranches of Put options (2004 and 2005) would amount to EUR 3.1 billion increasing to EUR 3.8 billion at the expiry dates (2010 and 2011) of the two tranches.

Convertible Bonds

        A 2% Convertible Bond was issued on October 6, 1995 by our affiliate, Sandoz Capital BVI Ltd. (now Novartis Capital Ltd., "Novartis Capital"). This Bond was guaranteed by Sandoz AG and due in 2002 in the amount of $750 million. The bonds were convertible into Novartis shares up to and including September 30, 2002. As of December 31, 2001, bonds with an aggregate principal amount of $717.4 million were outstanding, entitling their holders to a maximum of 27,560,117 of our shares (taking into account the forty-for-one share split). In 2002, except for Bonds with a value of US$120,000, all of these Bonds were converted into 27,555,462 Novartis shares. The remaining US$120,000 in Bonds were repaid.

        A 11/4% Convertible Bond was issued on October 23, 1995 by Novartis Capital. This Bond was guaranteed by Sandoz AG and due in 2002 in the amount of CHF 750 million. As of December 31, 2001, bonds with an aggregate principal amount of CHF 19.2 million were outstanding, entitling their holders to a maximum of 766,200 of our shares (taking into account the forty-for-one share split) and 19,155 shares of Syngenta AG. In 2002, all of these Bonds were converted into 766,200 Novartis shares and 19,155 shares of Syngenta AG.

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Straight Bond

        On November 14, 2002, our affiliate, Novartis Securities Investment Ltd, Bermuda, issued a 3.75% bond, guaranteed by Novartis AG and due in 2007, in the amount of EUR 1 billion.

        On October 17, 2001, our affiliate, Novartis Securities Investment Ltd., Bermuda, issued a 4% bond, guaranteed by Novartis AG and due in 2006, in the amount of EUR 900 million.

ADS Direct Purchase Plan and Dividend Reinvestment Plan

        The Direct Purchase and Dividend Reinvestment Plan for our ADSs, which are listed on the New York Stock Exchange, is a no-fee plan open to new investors as well as existing ADS shareholders in the US. This plan features no enrollment, purchase or dividend reinvestment fees. An initial investment of $500 is required, or the deposit of a minimum of 10 Novartis ADSs into a plan account. Transaction fees are applied when ADSs are sold. To date, there have been no new issuances of Novartis shares or ADSs under this plan and no effect on our share capital or balance sheet.

5.C  Research and Development, Patents and Licenses

        Our research and development spending totaled CHF 4.3 billion, CHF 4.2 billion and CHF 4.0 billion for the years 2002, 2001 and 2000, respectively. The amounts for 2000 have been restated to exclude research and development spending by the discontinued Agribusiness Division. Each of our Divisions and Business Units has its own research and development and patents policies. For a description of those research and development and patents policies, see "Item 4. Information on the Company—4.B Business Overview."

5.D  Trend Information

        As of December 31, 2002, we owned 32.7% of the voting shares of Roche Holdings AG. We accounted for this investment using the equity method, which in turn depends on various estimates of Roche's financial results. See "Item 5. Operating and Financial Review and Prospects—5.A Operating Results—Critical Accounting Policies." On February 10, 2003, Roche announced the sale of its Vitamins and Fine Chemicals Business, and related asset impairment charges of CHF 1.65 billion and incremental legal provisions of CHF 0.6 billion. Our preliminary estimate of our pre-tax share of these charges and provisions is approximately CHF 140 million. In accordance with the Group's policy, the impact of this charge as well as other changes to our estimate of Roche's 2002 results of operations will be reflected in the Group's 2003 first quarter results.

        Please see "—5.A Operating Results" for additional trend information.


Item 6. Directors, Senior Management and Employees

6.A  Directors and Senior Management

        We are fully committed to good corporate governance. Our principles and rules on corporate governance are laid down in our Articles of Incorporation, the Regulations of the Board and the Charters of the Board Committees. The Board's Corporate Governance Committee reviews these principles and rules regularly in the light of prevailing best practices and forwards suggestions for improvement to the full Board approval.

        In 2002, our shareholders' rights were reinforced by three changes to the Articles of Incorporation: Reduction of the deadline for submitting agenda items prior to a General Meeting from 60 to 45 days, introduction of the option of conducting electronic voting during the General Meeting, and reduction in the Directors' terms of office from four to three years.

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        Our Board of Directors is elected by our shareholders and holds the ultimate decision-making authority for Novartis AG, except for those matters reserved by law or by our Articles of Incorporation to the shareholders. The Board is comprised of 12 persons. An additional two directors will be proposed for election at the Annual General Meeting of Shareholders on March 4, 2003. They are Srikant Datar, Professor of Accounting and Senior Associate Dean of the Harvard Business School, and Wendelin Wiedeking, Chief Executive Officer of Dr. Ing. h.c. F. Porsche AG. The average age of our Directors is 62 and their average tenure is 5 years. Our Chairman and Chief Executive Officer, Daniel Vasella, is our only executive Director. Messrs. Lippuner and Jetzer were members of the Executive Committee until 1996 and 1999, respectively. The primary functions of the Board, as defined in the Swiss Code of Obligations and in our Articles of Incorporation, are:

    strategic direction and management;

    accounting matters, financial control and financial planning;

    appointing and dismissing of members of the Executive Committee and other key executives;

    overall supervision of business operations; and

    setting out the motions to be presented to the General Meeting, including approval of financial statements.

        The agenda for Board meetings is set by the Chairman and Chief Executive Officer. Any member of the Board (the "Directors") may request in writing that an item be included on the agenda.

        The Directors receive materials in advance of Board meetings allowing them to prepare for the handling of the items on the agenda.

        The Board recognizes the importance of being fully informed on material matters involving the Group and our business. Therefore, the Directors are required to hold discussions with our management, to review materials provided to them, to visit offices and plants and to participate in no less than a majority of the meetings of the Board and its Committees.

        The Chairman and Chief Executive Officer recommends members of senior management who at the invitation of the Board, attend Board meetings to report on areas of the business within their responsibility, thereby ensuring that the Board has sufficient information to make appropriate decisions.

        The Board reviews the performance of the Chairman and Chief Executive Officer once a year. The Board also meets in Executive Session from time to time to consider other matters of importance to our business.

        Daniel Vasella has been elected by the Board as our Chairman and also to serve Novartis AG as Chief Executive Officer. The Board has appointed Prof. Helmut Sihler as Vice Chairman and Lead Director. Hans-Jörg Rudloff has been elected Vice Chairman.

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        During 2002, the Board met 7 times. Detailed information on each Director's attendance at full Board and Board Committee meetings is provided in the table below:

 
  Full
Board

  Chairman's
Committee

  Compensation
Committee

  Audit and
Compliance
Committee

  Corporate
Governance
Committee

Number of meetings in 2002   7   9   3   4   2
Daniel Vasella, MD       7(1)       9(1)            
Prof. Helmut Sihler, JD, PhD   6   8       3(1)       4(1)   2
Hans-Jörg Rudloff   6   8   3       1
Dr. h.c. Birgit Breuel   7           4    
Prof. Peter Burckhardt, MD   7                
H.-U. Doerig, PhD(2)   1           1    
Walter G. Frehner   7           4    
William W. George   7   9   3           2(1)
Alexandre F. Jetzer   7                
Pierre Landolt   7                
Prof. Ulrich Lehner, PhD(3)   5               3(4)    
Heini Lippuner   7   9            
Prof. Rolf M. Zinkernagel, MD   7               2

(1)
Chair.

(2)
Until March 21, 2002.

(3)
Since March 21, 2002.

(4)
Since August 20, 2002.

Directors

        Dr. h.c. Daniel Vasella, MD (Age 49).    Chairman of the Board of Directors and Chairman of the Chairman's Committee (since 1999), Chief Executive Officer and Head of the Group Executive Committee (since 1996). His current term as Chairman expires in 2004. Daniel Vasella graduated with an MD in medicine from the University of Berne in 1979. After holding a number of medical positions in Switzerland, he joined Sandoz Pharmaceuticals Corporation in the USA in 1988. From 1993 to 1995, Daniel Vasella advanced from Head of Corporate Marketing and Senior Vice President and Head of Worldwide Development to Chief Operating Officer of Sandoz Pharma Ltd. In 1995 and 1996, Daniel Vasella was a member of the Sandoz Group Executive Committee and the Chief Executive Officer of Sandoz Pharma Ltd. Daniel Vasella is also a member of the Board of Directors of Pepsico, Inc., United States, the Board of Directors of Credit Suisse Group, Switzerland and the Supervisory Board of Siemens AG, Germany. In addition, he is a member of the International Board of Governors of the Peres Center for Peace in Israel and a member of several industry associations and educational institutions, including the International Business Leaders Advisory Council for the Mayor of Shanghai, where he serves as Chairman. In 2002, Daniel Vasella was awarded an honorary doctorate by the University of Basel.

        Prof. Helmut Sihler, JD, PhD (Age 72).    Vice Chairman of our Board (since 1996), Lead Director and a member of the Chairman's Committee and Compensation Committee (since 1999), and Chairman of the Audit and Compliance Committee and a member of the Corporate Governance Committee (since 2001). His current term expires in 2004. Helmut Sihler studied philology and law. in Graz, Austria and Burlington, Vermont (USA) and graduated with a doctorate in philology and a JD. In 1957, he joined Henkel KGaA, Germany, initially holding several positions in the marketing department for consumer goods. From 1980 to 1992, Helmut Sihler was Chairman of the Central Board of Management of Henkel KGaA. In the years 1988 and 1989, Helmut Sihler was President of the Association of the German Chemical Industry. In 1983, Helmut Sihler was elected to the Board of Ciba-Geigy AG. Helmut Sihler was ad interim CEO of Deutsche Telekom AG, Germany, from July to November 2002 and he is Chairman of the Supervisory Board of Porsche AG, Germany.

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        Hans-Jörg Rudloff (Age 62).    Vice Chairman of our Board of Directors (since 1996), a member of the Chairman's Committee and Compensation Committee (since 1999), and a member of the Corporate Governance Committee (since 2001). His current term expires in 2004. Hans-Jörg Rudloff studied economics at the Universities of Bern and Grenoble and graduated in 1965. He joined Credit Suisse in Geneva, Switzerland, and moved to New York in 1968 to join the investment banking firm of Kidder Peabody International. He was in charge of the Swiss operation and was elected Chairman and a member of the Board of Kidder Peabody International in 1978. In 1980 he joined Credit Suisse First Boston and was elected Vice-Chairman in 1983 and Chairman and CEO in 1989. From 1986 to 1990 Hans-Jörg Rudloff was also a member of the Executive Board of Credit Suisse in Zurich, Switzerland, in charge of all securities and capital market departments. In 1990 he became a member of the Executive Board of CS First Boston and a member of the CS Holding Board. From 1994 to 1998, Hans-Jörg Rudloff was Chairman of MC-BBL in Luxembourg and joined Barclays Capital in 1998 where he is presently Chairman of the Executive Committee. In 1994, Hans-Jörg Rudloff was elected to the Board of Directors of Sandoz AG and served as its Vice-Chairman from 1995 to 1996. Hans-Jörg Rudloff also serves on a number of boards of other companies, including the Boards of Directors of the TBG Group (Thyssen-Bornemisza Group), Monaco, Marcuard S.A., Geneva, and RBC, Russia, the Advisory Board of Landeskreditbank, Baden-Württemberg, Germany, and the Beirat of EnBW (Energie Baden- Württemberg), Germany. He is also on the Advisory Board of the MBA program of the University of Bern, Switzerland.

        Dr. h.c. Birgit Breuel (Age 65).    Director (since 1996), and a member of the Audit and Compliance Committee (since 1999). Her current term expires in 2005. Birgit Breuel studied politics at the Universities of Hamburg, Oxford and Geneva. She was Minister of Economy and Transport (1978-86) and Minister of Finance (1986-90) of the Land Niedersachsen (Lower Saxony), the second largest state of Germany. In 1990, Birgit Breuel was elected to the Executive Board of the Treuhandanstalt, which was responsible for the privatization of the former East Germany's economy; in 1991, she also became the President of the Treuhandanstalt. From 1995 to 2000, she acted as the General Commissioner and CEO of the world exhibition EXPO 2000 in Hannover, Germany. In 1994, Birgit Breuel was elected to the Board of Directors of Ciba-Geigy AG. Birgit Breuel is also a member of the Supervisory Board of Gruner+Jahr AG, Hamburg, Germany.

        Prof. Peter Burckhardt, MD (Age 64).    Director (since 1996). His current term expires in 2005. After studying in Basel and Hamburg, Germany, Peter Burckhardt graduated with an MD from the University of Basel in 1965. He trained from 1966 to 1978 in internal medicine and endocrinology, mainly at the University Hospital of Lausanne, Switzerland, and the Massachusetts General Hospital, Boston, USA, and was nominated Chief of Clinical Endocrinology in 1978, and full Professor of Internal Medicine and Chairman of the Department of Internal Medicine at the University Hospital of Lausanne in 1982. Since 1992, he has been the Head of the Medical Service at the same University. Since 1982 Peter Burckhardt has been the Chairman of the Novartis- (formerly Sandoz-) Foundation for Biomedical Research in Switzerland. Next to his activities as a clinician and academic teacher, Peter Burckhardt is conducting clinical research, mainly in bone diseases and calcium metabolism. He has authored more than 300 scientific publications and is an editorial board member of several international scientific journals. He is Chairman of National Societies at the International Foundation of Osteoporosis, and is a former president of the Swiss Internist's Society and member of the Appeal Committee of the Swiss Office for Drug Control. Peter Burckhardt is a board member of numerous scientific societies including the Swiss Societies of Nutrition, Clinical Chemistry, Endocrinology, Bone and Mineral Research, the Committee for Endocrinology of the European Community, and since 1990, the organization of the International Symposia on Nutrition and Osteoporosis.

        Walter G. Frehner (Age 69).    Director (since 1996), and a member of the Audit and Compliance Committee (since 2001). His current term expires in 2004. After completing commercial school and an apprenticeship at the Bernese Cantonal Bank in Interlaken, Switzerland, Walter Frehner broadened his experience both in Switzerland and abroad. In 1958 he joined Swiss Bank Corporation (now UBS) where he held a number of increasingly senior positions. He was appointed General Manager and member of the

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Executive Board in 1978, President of the Executive Board (CEO) in 1987 and Chairman of the Board of Directors in 1993 from which position he retired in 1996. Walter Frehner has been a member of the Board of Directors of Ciba-Geigy AG since 1994. He is also a member of the Board of Directors of Schindler Holding AG, Ebikon, Switzerland, and of Bâloise Holding AG, Basel, Switzerland, where he is also the Vice Chairman.

        William W. George (Age 60).    Director (since May 1999), and a member of the Chairman's Committee and Chairman of the Corporate Governance Committee (since 2001). His current term expires in 2003. William W. George received his BSIE from Georgia Institute of Technology in 1964 and his MBA from Harvard University in 1996. From 1966 to 1969, he worked in the US Department of Defense as special assistant to the Secretary of the Navy and as assistant to the Comptroller. After having served as President of Litton Microwave Cooking Products, William W. George held a series of executive positions with Honeywell from 1978 to 1989. Thereafter he served as President and Chief Operating Officer of Medtronic, Inc. in Minneapolis, USA, and, from 1991 to 2001, as its Chief Executive Officer. From 1996 to 2002, he was Medtronic's Chairman. William W. George is a member of the Boards of Directors of Goldman Sachs and Target Corporation (formerly Dayton Hudson). He is also a Visiting Professor of Management at Ecole Polytechnic Fédérale Lausanne and at the International Institute of Management Development. In addition, he is a member of the Board of Directors of Harvard Business School, American Red Cross, Carnegie Endowment for International Peace and Minneapolis Institute of Arts.

        Alexandre F. Jetzer (Age 61).    Director (since 1996). His current term expires in 2005. Alexandre Jetzer studied law and economics at the University of Neuchatel, Switzerland and is a licensed attorney. After more than ten years as General Secretary of the Swiss Federation of Commerce and Industry (Vorort), Alexandre Jetzer joined Sandoz in 1980. In 1981 he became Member of its Group Executive Committee in capacity of Chief Financial Officer (CFO) and, as of 1990, as Head of Management Resources and International Coordination. From 1995 to 1996, he was Vice Chairman and Chief Executive Officer of Sandoz Pharmaceuticals Corporation in East Hanover, New Jersey, USA. From the time of the Novartis merger in 1996 until 1999, he was a member of the Novartis Executive Committee and Head of International Coordination, Legal & Taxes. He is also a member of the Board of Directors of Clariden Bank, Zurich, Switzerland.

        Pierre Landolt (Age 55).    Director (since 1996). His current term expires in 2005. Pierre Landolt graduated with a Bachelor of Law degree from the University of Sorbonne in Paris. From 1974 to 1976, he worked for Sandoz Brazil. In 1977, he acquired an agricultural estate in Brazil, cultivating organic tropical fruit as well as producing dairy products. In 1989, he founded a firm for irrigation systems. In the same year, he became the main associate and director of a bank in São Paulo. Since 1997 Pierre Landolt has been Associate and Chairman of Axial Par Ltda, São Paulo, a company investing in sustainability. In 2000, he was co-founder of Eco Carbone LLC, Delaware, USA, a company focused on the development of carbon sequestration processes in Europe, Africa and South America. In 1986, Pierre Landolt was elected as a member of the Board of Directors of Sandoz AG. Pierre Landolt is the President of the Sandoz family foundation, Glaris, Switzerland, and the Chairman of the Board of Directors of Emasan AG, Basel, Switzerland. He is also a member of the Board of Directors of Syngenta AG, and of the Syngenta Foundation for Sustainable Agriculture, both in Basel, Switzerland. In addition, he serves as chairman of the Board of Directors of Curacao International Trust Company, Curacao, Netherlands Antilles, and as vice-chairman of the Boards of Directors of Sandoz FF Holding Bancaire et Financière S.A., Pully, Switzerland, Parmigiani, Mesure et Art du Temps S.A., Fleurier, Switzerland, and the Fondation du Montreux Jazz Festival, Montreux, Switzerland.

        Prof. Ulrich Lehner, PhD (Age 56).    Director and member of the Audit and Compliance Committee (since 2002). His current term expires in 2005. Ulrich Lehner studied business administration and mechanical engineering in Darmstadt, Germany. After completing his studies in 1972, he was a teaching and research assistant at the Institute for Business Administration at the Darmstadt Technical University. He earned a doctorate in economics in 1975. From 1975 to 1981, Ulrich Lehner was an auditor with Deutsche Treuhand-Gesellschaft AG in Düsseldorf, Germany. In 1981, he joined Henkel KGaA as Head of Domestic Affairs in the Central Accounting/Tax Department. After heading the Controlling

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Department of Fried. Krupp GmbH in Essen, Germany, from 1983 to 1986, he returned to Henkel as Finance Director. From 1991 to 1993, Ulrich Lehner headed the then-formed Management Holding, Henkel Asia-Pacific Ltd., in Hong Kong. From 1994 to 1995, he served Henkel KGaA, as Corporate Vice President of the Finance and Controlling Department, and, from 1995 to 2000, as Executive Vice President, Finance/Logistics. He was appointed Deputy President in 1999 and President and CEO of Henkel KGaA in 2000. Ulrich Lehner also serves as a member of the Board of Directors of Dresdner Bank, Luxembourg, Luxembourg, and of Ecolab Inc., St. Paul, USA. In addition, he is a member of the Advisory Board of Dr. August Oetker KG, Bielefeld, Germany, and of Krombacher Brauerei, Krombach, Germany. He is an Honorary Professor at the University of Münster, Germany.

        Heini Lippuner (Age 69).    Director (since 1996) and member of the Chairman's Committee (since 1999). His current term expires in 2005. After completing his commercial studies in St. Gallen, Switzerland, Heini Lippuner began his career with Geigy Ltd in the Dyestuffs Division. Following a number of foreign assignments, he headed the Dyestuffs and Chemicals Division in Germany from 1968 to 1972. He served as a member of the world-wide Dyestuffs and Chemicals Division's management committee of Ciba-Geigy Ltd from 1973 to 1982, and became the Head of this Division in 1982. In 1986, Heini Lippuner became a member of the Executive Committee of the Ciba-Geigy Group and took over as its Chairman and Chief Operating Officer in 1988. Heini Lippuner is also a member of the Board of Directors of Bühler AG, Uzwil, Switzerland, and of Asset Link AG, Reinach BL, Switzerland. In addition he is the Chairman of the Foundation Board of the International Institute for Management Development (IMD) in Lausanne, Switzerland, and serves on the advisory boards of Credit Suisse Group, Zurich, Switzerland.

        Prof. Rolf M. Zinkernagel, MD (Age 58).    Director (since 1999) and member of the Corporate Governance Committee (since 2001). His current term expires in 2003. Rolf Zinkernagel graduated from the University of Basel with an MD in 1970. Since 1992 he has been Professor and Director of the Institute of Experimental Immunology at the University of Zurich, Switzerland. Rolf Zinkernagel has received many awards and prizes for his work and contribution to science, the most prestigious being the Nobel Prize for Medicine which he was awarded in 1996. He is a member of the Swiss Society of Allergy and Immunology, the American Associations of Immunologists and of Pathologists, the ENI European Network of Immunological Institutions, and the International Society for Antiviral Research and a member of the Executive Board of the International Union of Immunological Societies (IUIS). Rolf Zinkernagel is a member of the Boards of Directors of Cytos Biotechnology AG, Schlieren/Zurich, Switzerland. He is also a member of the Scientific Advisory Boards of: The Lombard Odier Darier Hentsch & Cie Bank, Geneva, Switzerland; BT & T, Jersey; Bio-Alliance Capital, Frankfurt, Germany; Aravis General Partner Ltd., Cayman Islands; Cytos Biotechnology AG, Schlieren/Zurich, Switzerland; Bioxell, Milano, Italy; Esbatech, Zurich, Switzerland; Novimmune, Geneva, Switzerland; and MannKind, Sylmar CA, USA. Rolf Zinkernagel is also a Science Consultant to: GenPat 77, Berlin/Munich, Germany; Aponetics AG, Witterswil, Switzerland; Solis Therapeutics, Palo Alto, USA and Ganymed, Mainz, Germany.

Executive Officers and Senior Management

        Dr. h.c. Daniel Vasella, MD (Age 49).    Chairman of the Board of Directors and Chairman of the Chairman's Committee (since 1999), Chief Executive Officer and Head of the Group Executive Committee (since 1996). See "—Directors."

        Urs Bärlocher, JD (Age 60).    Head of Legal and General Affairs and a member of the Group Executive Committee (since 1999). Urs Bärlocher earned his JD at the University of Basel and was admitted to the bar in 1970. After having worked as a tax lawyer, he joined Sandoz in 1973, and held a number of key positions including Head of Strategic Planning and Head of Group Reporting. In 1987, he was made a member of the Sandoz Executive Board responsible, among other things, for Strategic Planning, HR, Legal, Taxes, Patents and Trademarks. In 1990, he became CEO of the Sandoz Nutrition Division and then, in 1993, CEO of Sandoz Pharma. In 1995, Urs Bärlocher assumed the position of Chairman of the

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Board of Sandoz Deutschland GmbH (Germany) and Biochemie GmbH (Austria). After the formation of Novartis in 1996, he served as Head of International Coordination, Legal, Tax, Insurance, before his responsibilities were widened to include in addition, among other things, Corporate Intellectual Property, Corporate Health, Safety & Environment, Corporate Affairs and Corporate Security.

        Raymund Breu, PhD (Age 57).    Chief Financial Officer and a member of the Group Executive Committee (since 1996). Raymund Breu graduated from the Swiss Federal Institute of Technology (ETH) in Zurich, Switzerland, with a PhD in mathematics. In 1975, he joined the Treasury Department of the Sandoz Group, and, in 1982, became the Head of Finance for the Sandoz affiliates in the UK. In 1985, he was appointed Chief Financial Officer of Sandoz Corporation in New York, where he was responsible for all Sandoz Finance activities in the US. In 1990, he became Group Treasurer of Sandoz Ltd., Basel, Switzerland, and, in 1993, Head of Group Finance and Member of the Sandoz Executive Board. Raymund Breu is also a member of the Board of Directors of Chiron Corporation (in which we hold an equity position), and of the SWX Swiss Exchange and of its admission panel and its takeover commission.

        Paul Choffat, JD (Age 53).    Head of Novartis Consumer Health and member of the Group Executive Committee (since 2002). Paul Choffat holds a JD from the University of Lausanne, Switzerland, and an MBA from the International Institute for Management Development in Lausanne. He started his professional career with Nestlé in Zurich, Switzerland, and London, UK. From 1981 to 1985, he was a project manager at McKinsey & Company in Zurich. Between 1987 and 1994, he held a number of leading positions at Landis & Gyr in Zug, Switzerland, where he became a member of the Executive Board and Head of the Communications Division. In 1994, he moved to Von Roll in Gerlafingen, Switzerland, as CEO. Paul Choffat joined Sandoz in 1995 as Head of Management Resources and International Coordination. He subsequently became a member of the Executive Board and was responsible for Group Planning and Organization. During the Novartis merger he headed the integration office. In 1996, he returned to line management as CEO of Fotolabo SA, Montpreveyres-sur-Lausanne, Switzerland, where he remained for three years before becoming an entrepreneur and private investor in 1999.

        Thomas Ebeling (Age 44).    Head of Novartis Pharma (since 2000) and member of the Group Executive Committee (since 1998). Thomas Ebeling graduated from the University of Hamburg with a degree in psychology. From 1987 to 1991, he held several positions of increasing responsibility at Reemstma, Germany. In 1991, he joined Pepsi-Cola Germany as Marketing Director. He became Marketing Director for Germany and Austria in 1993 and was National Sales and Franchise Director for Pepsi's retail and on-premise sales from 1994. He then served as General Manager of Pepsi-Cola Germany. In 1997, Thomas Ebeling joined Novartis as General Manager of Novartis Nutrition for Germany and Austria. After having served as CEO of Novartis' global nutrition operations, he became Head of Novartis Nutrition worldwide, then Head of Novartis Consumer Health worldwide, and then Chief Operating Officer of Novartis Pharmaceuticals, before attaining his present position.

        Prof. Mark C. Fishman, MD (Age 52).    Head of Pharmaceuticals Research and a member of the Group Executive Committee (since 2002). Mark Fishman is a graduate of Yale College and Harvard Medical School. He completed his internal Medicine Residency, Chief Residency, and Cardiology training at the Massachusetts General Hospital. He serves on several editorial boards and has worked with national policy and scientific committees including those of the NIH and Welcome Trust. He has been honored with many awards and distinguished lectureships and is a Fellow of the American Academy of Arts and Sciences. Before joining Novartis, Mark Fishman was Professor of Medicine at Harvard Medical School and Chief of Cardiology and Director of the Cardiovascular Research Center at the Massachusetts General Hospital.

        Norman C. Walker (Age 50).    Head of Human Resources (since 1998) and a member of the Group Executive Committee (since 1999). Norman Walker earned a degree in Business Studies at the University of Brighton, UK, in 1975 and attended the Harvard International Senior Management Program in 1994. He started his professional career with Ford Motor Company in London in 1975. Over a period of 9 years he held a number of posts in human resources (HR) management before he joined GrandMet in London in 1984 where he assumed HR positions in various of their business units. Norman Walker subsequently

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joined Kraft Foods in 1991 and held a number of leading HR positions in Germany, the United States and Switzerland. More specifically, he headed HR activities for commercial and manufacturing operations in 26 countries and maintained a dynamic HR effort there during a period of significant change, as the company acquired, merged and refocused its business portfolio.

        Gilbert Wenzel (Age 46).    Resigned as Head of Strategic Planning and a member of the Group Executive Committee during 2002, a position he had held since 2000.

Business Unit(1) Heads

Name, nationality and age

  Head of
Business Unit

  Active for Novartis since
  Significant positions previously held
  Education
David Epstein American, 41   Oncology
(since 2000)
  1989   Chief Operating Officer and member of the Executive Committee of Novartis Pharmaceuticals Corporation (US)   Bachelor of Science, Pharmacy (Rutgers University) and MBA (Columbia University)

Anthony Rosenberg British, 49   Transplantation and Immunology (since 2001)   1980   Various leading positions with Sandoz UK and Novartis Group   Bachelor of Science (University of Leicester) and Master of Science (University of London)

Flemming Ørnskov Danish, 45   Ophthalmics
(since 2003)
  2001   Vice President and Head of Cardiovascular Metabolic Business Franchise at Novartis Pharmaceuticals Corporation (US)   Doctor of Medicine (University of Copenhagen, Denmark), MBA (INSEAD) and Master of Public Health (Harvard University)

Peter Hewes British, 55   Mature Products
(since 2000)
  1976   Regional European Head of Novartis Pharma; Country Head of Sandoz Portugal   Bachelor of Arts, Economics (University of Reading, UK)

Christian Seiwald Austrian, 47   Generics
(since 2001)
  1982   Country Head of Novartis Austria; Head of Novartis Austria Pharma Operations   MBA (Innsbruck University, Austria)

Michel Orsinger Swiss, 45   OTC
(since 2002)
  1993   Senior Vice-President Europe, Middle East and Africa for Novartis' Nutrition and OTC Business Unit; General Manager Sandoz Nutrition Unit Switzerland   MBA (St. Gallen, Switzerland)

Kurt T. Schmidt American, 45   Animal Health
(since 2002)
  2002   General Manager Food for Kraft Foods Germany; Marketing Director Wrigley Company for German-speaking Europe, Eastern Europe and the Middle East   Bachelor of Science (United States Naval Academy, Annapolis) and MBA (University of Chicago)

Frank Palantoni American, 45   Infant & Baby
(since 2002)
  1998   President and CEO of Gerber US Marketing; management positions with Procter & Gamble, Nabisco and Groupe Danone   Bachelor of Science (Tufts University) and MBA (Columbia University)

Michel Gardet French, 45   Medical Nutrition
(since 2002)
  1991   General Manager of Novartis Consumer Health Iberia; Head of Health and Functional Nutrition Novartis   MA (Ecole Supérieure de Commerce de Paris)

Joseph T. Mallof American, 51   CIBA Vision
(since 2002)
  2002   Regional President of S.C. Johnson & Son for the Americas Asia Pacific; General Manager of Procter & Gamble in Japan and the Philippines   Bachelor of Science (Purdue University) and MBA (University of Chicago)

(1)
In 2002, the following Executives retired from or terminated their employment with the Novartis Group: Gilbert Wenzel (Executive Committee Member), Glen Bradley (Business Unit Head), Hans-Beat Guertler (Business Unit Head) and Luzi von Bidder (Business Unit Head).

        None of the above directors or senior management have any family relationship with any other director or member of our senior management. Executive officers are elected by the Board of the affiliate which employs them, typically for an indefinite term of office. They may be removed by the Board at any time. None of the above directors or senior management were appointed pursuant to an arrangement or understanding between such officer or director and any third party.

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6.B  Compensation

Non-Executive Directors Compensation

        The Compensation Committee of our Board of Directors advises the Board on the compensation of our non-executive Directors. Non-executive Directors receive an annual retainer in an amount that varies with the Board and Committee responsibilities of the Director. Directors are eligible to participate in certain of the equity programs which we offer to senior management and selected employees. Directors receive no additional fees for attending meetings or acting as committee chairs. Directors can choose to receive the annual retainer in cash, shares or share options or a combination thereof. In addition, subject to the business performance of the Group, the Directors may receive a share grant. In 2002, 3,000 shares were granted to each Director in acknowledgement of 2001 business performance. Directors are reimbursed for travel and other necessary business expenses incurred in the performance of their services.

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2002 Non-Executive Directors' Compensation

 
  Annual Cash
Compensation
(CHF)

  Shares (number)
  Share Options (number)
Daniel Vasella, MD
Chairman and CEO
Chairman's Committee (Chair)
  (please refer to the table on page 118)

Prof. Helmut Sihler, JD, PhD
Vice Chairman, Lead Director
Chairman's Committee (Member)
Compensation Committee (Chair)
Audit and Compliance Committee (Chair)
Corporate Governance Committee (Member)

 

230,179

 

7,544

 

17,276

Hans-Jörg Rudloff
Vice Chairman
Chairman's Committee (Member)
Compensation Committee (Member)
Corporate Governance Committee (Member)

 

24,686

 

3,000

 

24,570

Dr. h.c. Birgit Breuel
Audit and Compliance Committee (Member)

 

219,940

 

3,000

 

 

Prof. Peter Burckhardt, MD

 

95,656

 

4,212

 

 

Hans-Ulrich Doerig, PhD(1)
Audit and Compliance Committee (Member)

 

11,832

 

3,000

 

 

Walter G. Frehner
Audit and Compliance Committee (Member)

 

78,546

 

3,000

 

10,750

William W. George
Chairman's Committee (Member) Corporate Compensation Committee (Member)
Corporate Governance Committee (Chair)

 

87,500

 

3,000

 

23,035

Alexandre F. Jetzer

 

12,312

 

3,000

 

9,214

Pierre Landolt

 

55,550

 

3,000

 

6,911

Prof. Ulrich Lehner, PhD(2)
Audit and Compliance Committee (Member)

 

391,371

 

 

 

 

Heini Lippuner
Chairman's Committee (Member)

 

18,310

 

3,000

 

18,428

Prof. Rolf M. Zinkernagel, MD(3)
Corporate Governance Committee (Member)

 

267,832

(3)

3,000

 

15,357

 

 



 



 



Total

 

1,493,714

 

38,756

 

125,541

 

 



 



 



(1)
Hans-Ulrich Doerig, PhD, who is Vice Chairman of the Executive Board and Group Chief Risk Officer of Credit Suisse Group, stepped down from the Board of Novartis AG at the 2002 Annual General Meeting in line with our commitment to good corporate governance principles and to avoid any question of possible conflicts of interest. (Daniel Vasella, MD, is a Member of the Board of Directors of Credit Suisse Group.)

(2)
Prof. Ulrich Lehner, PhD, CEO of Henkel AG, was elected as a new Board Member at the 2002 Annual General Meeting.

(3)
Includes CHF 250,000 for acting as the Board's delegate in the scientific advisory boards of the Genomics Institute of the Novartis Research Foundation (GNF) and the Novartis Institute for Tropical Diseases (NITD).

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Ownership of Novartis Shares and Share Options by the Non-Executive Directors

        The total number of Novartis shares owned as of December 31, 2002 by the non-executive Directors and persons closely linked to them was 252,016. The phrase "persons closely linked to them" means (i) their spouse, (ii) their children below age 18, (iii) any legal entities that they own or otherwise control, or (iv) any legal or natural person who is acting as their fiduciary. No non-executive Director owned 1% or more of our outstanding shares.

        As of December 31, 2002, the individual ownership of Novartis shares and options by the non-executive Directors (including persons closely linked to them) was as follows:

Beneficial Owner

  Number of shares
owned directly
or indirectly

Daniel Vasella, MD (please refer to the table on page 119)
Prof. Helmut Sihler, JD, PhD   34,304
Hans-Jörg Rudloff   86,080
Dr. h.c. Birgit Breuel   4,160
Prof. Peter Burckhardt, MD   16,732
Walter G. Frehner   13,220
William W. George   19,720
Alexandre F. Jetzer   46,120
Pierre Landolt(1)   100
Prof. Ulrich Lehner, PhD   120
Heini Lippuner   26,060
Prof. Rolf M. Zinkernagel, MD   5,400
   
Total   252,016
   

(1)
Mr. Landolt is also the Chairman of the Board of Directors of Emasan AG. See "Item 7. Major Shareholders and Related Party Transactions—7.A Major Shareholders."

        As of the same date, the non-executive Directors held a total of 331,901 Novartis share options. The number of share options, and exercise price have been adjusted to reflect the share split of 1:40 in 2001. Broken down by grant year the number of options held are:

Grant Year

  Options held
(number)

  Exercise
Price
(CHF)

  Term
life
(years)

2002   125,541   62.0   9
2001   90,480   70.0   9
2000   78,680   51.3   9
1999   17,200   68.4   9
1998   20,000   42.8   9

Compensation for former Directors and Executives

        In 2002, a total amount of CHF 180,000 was paid to three former members of the Board and CHF 2,186,507 to two former members of senior management, who were not employed by us during 2002.

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Report of the Compensation Committee

Executive Compensation Policy

        Our compensation programs are designed to attract, retain and motivate the high caliber of executives, managers and associates who are critical to the success of the corporation. Globalization of labor markets for specialists and executives has led to a rapid convergence between US and European principles of compensation and a stronger focus on long-term, equity based forms of programs.

        Overall, the intention of our programs is to provide compensation opportunities that

    are comparable to those provided by a selected group of industry specific competitors;

    support a performance oriented culture that allows high performers to achieve superior rewards; and

    align executive, management and associates to create sustainable shareholder value.

        Total individual compensation at target performance level is aimed at the median of comparable companies of our industries. Annual cash and equity incentive awards are based on both overall Group or affiliate company and individual performance. Long-term incentive awards include share options and other forms of equity participation.

        Executive compensation programs strongly encourage significant levels of share ownership and put a high portion of total compensation at risk, subject to individual and company performance and the appreciation of Novartis shareholder value.

        The Compensation Committee believes that the existing compensation programs have achieved the desired effects.

Compensation Programs Descriptions

Total Compensation

        The total compensation package for each executive consists of the three basic components discussed in more detail below. Target salary and bonus levels are set at the median of the peer group, based on available public data and the analysis of external compensation advisors. Actual compensation levels of individuals may in some instances surpass the median of the market, reflecting superior results. The Compensation Committee believes that this position is consistent with the performance of the Group and its evaluation of the external market.

Salaries

        The 2002 salaries of the Swiss-based Executive Committee members are shown in the "Salary" column of the Summary Table -2002 Compensation.

Annual Incentive Awards

        Under the terms of the Novartis Annual Incentive Plan, awards are made each year based on the achievement of predetermined Group and individual performance objectives. Below a threshold level of performance, no awards may be granted under the plan.

Long-Term Incentive Compensation

        Long-term incentive compensation, in the form of share options, performance-contingent shares, and restricted shares, comprises a major portion of the total compensation package for executives. In any given year, an executive may be offered share options, performance-contingent shares, and/or restricted shares. Long-term incentives are targeted at the median of the competitive market, with above-average and superior performance resulting in long-term compensation above the targeted amounts. Below a

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threshold level of performance, no awards may be granted under the Plan. Share options are also granted to selected employees.

Share Options

    (a)
    Novartis Share Option Plan

        Under the Novartis Share Option Plan, Directors, executives and other selected employees of Group companies (collectively, the "Participants") may be granted options to purchase Novartis shares. These options are granted both in recognition of past performance and as an incentive for future contributions by the Participants. They allow the Participants to benefit as the price of the shares increases over time, and so provide a long-term incentive for improvements in our profitability and success. If a Participant voluntarily leaves Novartis, options not yet vested will generally be forfeited. The options under the Novartis Share Option Plan have an exercise period of seven years, which begins after the lapse of a two-year vesting period.

    (b)
    Novartis US ADS Incentive Plan for US-based employees

        Introduced in 2001, the Novartis US ADS Incentive Plan grants options to US-based Directors, officers and other selected employees replacing a Share Appreciation Right Plan. Its terms and conditions are substantially equivalent to the Novartis Share Option Plan.

Share Plans

        We offer to certain Directors and executives a Long-Term Performance Plan, a Leveraged Share Savings Plan and a Restricted Share Plan. These plans are designed to foster long-term commitment of eligible employees by aligning their incentives to our performance.

    (a)
    Long-Term Performance Plan

        Under the Long-Term Performance Plan, participants are awarded the right to earn Novartis shares. Actual payouts, if any, are determined with the help of a formula which measures, among other things, our performance using economic value added relative to pre-determined strategic plan targets over a three-year period. Additional functional objectives may be considered in the evaluation of performance. If performance is below the threshold level of the pre-determined targets, then no shares will be earned. To the extent the Group's performance exceeds the threshold performance level, an increasing amount of Novartis shares, up to the maximum cap, will be earned.

    (b)
    Leveraged Share Savings Plan

        There are two separate Leveraged Share Savings Plans:

        Participants can choose to receive part or all of their Annual Incentive Award in shares. Shares awarded under this Plan are blocked for five years after the grant date. After expiration of the blocking period, the respective shares are matched with an equal number of shares.

        In 2001 the Board approved a new employee share ownership plan under which Swiss based employees receive part of their income up to a specified amount in Novartis shares. After the expiration of a blocking period of three years the award is matched with half a share for each share held.

    (c)
    Restricted Share Plan

        Under the Restricted Share Plan employees may be granted restricted share awards either as a result of a general grant or as a result of an award based on having met certain performance criteria. Shares granted under this Plan generally have a five-year vesting period. Restricted shares carry a high risk of ownership for Swiss based employees as the tax liability in Switzerland is based on the initial price of the share instead of a later, potentially lower price at vesting date.

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Employee Benefits

        Employee benefits offered to executives are designed to be competitive and to provide a "safety-net" of protection against the financial catastrophes that can result from disability or death, and to provide a reasonable level of retirement income based on years of service with Novartis.

Evaluation of the Executive Committee Members' Performance

        The Compensation Committee meets without the Chairman and CEO to evaluate his performance, and with the Chairman and CEO to evaluate the performance of other Swiss-based Executive Committee members. The bonuses and long-term incentives for 2001 and the base salaries for 2002 were discussed and approved at the meetings of the Compensation Committee held in January and February 2002.

        The decisions on compensation of Swiss-based Executive Committee members were mainly based on individual performance evaluations taking into account current market conditions. In 2002, the Compensation Committee considered management's achievement of short and long-term goals, including revenue growth, economic value creation (operating and net income, earnings per share and economic value added) and ongoing efforts to optimize organizational effectiveness and productivity. The Compensation Committee also takes into consideration management's responses to the changes in the global marketplace and the strategic position of the Group. The performance measures were weighted subjectively by each member of the Compensation Committee.

The Compensation Committee of the Board of Directors:

Prof. Helmut Sihler, JD, PhD (Chairman)
Hans-Jörg Rudloff
William W. George

Executive Compensation

        In 2002, there were a total of 20 Executive Committee members and Business Unit Heads ("Executives"), including those who retired or terminated their employment in 2002. In total, the Executives received CHF 13,293,000 in salaries and CHF 5,063,000 in cash bonuses. The number of share options granted were 2,255,723 and the number of shares granted 317,736. An additional CHF 2,896,000 was set aside for their pension, retirement and similar benefits. Compensation represents all payments made in 2002; however, cash bonuses and long-term compensation are based on 2001 business performance. The following summary compensation table provides details on the 2002 compensation of the Swiss-based Executive Committee members.

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Summary Table—2002 Compensation

 
  Annual Compensation
  Long-Term Compensation
   
   
Name and Principal Position

  Salary
(CHF)

  Cash
Bonus
(CHF)

  Restricted
Share
Awards
(number)(1)

  Unrestricted
Share
Awards
(number)(2)

  Share
Options
(number)(3)

  All Other
Compensation
(CHF)(4)

  Total
(CHF)(5)

Daniel Vasella, MD Chairman & CEO   2,916,667       121,164   71,753   921,376   156,000   20,158,777
Urs Bärlocher, JD
Head, Legal & General Affairs
  660,000       13,328   6,625   101,352   156,000   2,437,088
Raymund Breu, PhD Chief Financial Officer   900,000       18,175   8,973   276,413   156,000   4,534,588
Paul Choffat, JD
Head, Consumer Health
  750,000                   156,000   906,000
Thomas Ebeling,
Head, Pharmaceuticals
  1,000,000   1,100,000   6,452   10,313   270,271   556,000   6,077,087
Norman Walker,
Head, Corporate Human Resources
  600,000       8,240   5,858   43,858   153,759   1,804,234

(1)
The Restricted Share Awards include the shares granted under the Leveraged Share Savings Plan.

(2)
The Unrestricted Share Awards include the shares granted under the Long-Term Performance Plan.

(3)
The share options granted provide the right to purchase one share per option. The closing price at grant was CHF 61.90 per share, the exercise price was CHF 62.00 per share. The options have a cliff-vesting period of two years after the date of grant and will expire on March 7, 2011. These tradable share options have a tax value of CHF 9.19 per option, calculated based on the Black-Scholes Method.

(4)
Amounts include among others, payments made to the Management Pension Fund, a defined contribution plan.

(5)
The total compensation amounts have been calculated using the taxable value of the shares and share options granted.

        Under the Novartis Share Option Plan and the Novartis US ADS Incentive Plan described above, a total number of 20,967,700 share options were granted to 6,741 Participants. 11% of the overall number of share options were granted to Executives.

Ownership of Novartis Shares and Share Options by the Executives

        The total number of Novartis shares owned as of December 31, 2002 by the Executives and persons closely linked to them was 836,106. The phrase "persons closely linked to them" means (i) their spouse, (ii) their children below age 18, (iii) any legal entities that they own or otherwise control, or (iv) any legal or natural person who is acting as their fiduciary. No Executive owned 1% or more of our outstanding shares.

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        As of December 31, 2002, the Executives held a total of 3,646,543 Novartis share options. The number of share options, and exercise price were adjusted to reflect the share split of 1:40 in 2001. Broken down by grant year the number of options held are:

Grant Year

  Options
held
(number)(1)

  Exercise
Price
(CHF)

  Term
life
(years)

2002   2,255,723   62.0   9
2001   703,340   70.0   9
2000   461,040   51.3   9
1999   115,400   68.4   9
1998   111,040   42.8   9

(1)
The number of share options held includes share options granted under the Novartis Share Option Plan and the US ADS Incentive Plan.

        As of December 31, 2002, the individual ownership of Novartis shares by the Swiss-based Executive Committee members (including persons closely linked to them) were as follows:

Beneficial Owner

  Number of
shares owned
directly or
indirectly

Daniel Vasella, MD   316,997
Urs Bärlocher, JD   135,373
Raymund Breu, PhD   174,048
Paul Choffat, JD   750
Thomas Ebeling   44,522
Norman Walker   30,178
   
Total   701,868
   

Swiss Employee Benefit Plans

(a)  Swiss Pension Fund

        The Swiss Pension Fund is a defined benefit fund that provides retirement benefits and risk insurance (covering death or disability). The Swiss Pension Fund is funded by contributions from Group companies and the insured employees. The Swiss Pension Fund insures remuneration up to a maximum of CHF 220,000 per year. The maximum retirement pension is 60% of the insured remuneration after 40 years of contribution. The table below shows the annual pension benefit by Base Salary and Years of

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Service. In 2002 Novartis contributed CHF 9,316 for each of the Swiss-based Executive Committee members.

 
  Years of Service
Base Salary (CHF)

  15
  20
  25
  30
  35
  40
100,000   16,938   22,584   28,230   33,876   39,522   45,168
140,000   25,938   34,584   43,230   51,876   60,522   69,168
180,000   34,938   46,584   58,230   69,876   81,522   93,168
220,000   43,938   58,584   73,230   87,876   102,522   117,168
over 220,000   43,938   58,584   73,230   87,876   102,522   117,168

(b)  Swiss Management Pension Fund

        The Swiss Management Pension Fund is a defined contribution plan and provides retirement benefits and risk insurance (covering death or disability) for components of remuneration not covered by the Swiss Pension Fund. Employees exceeding the maximum insurable remuneration of the Swiss Pension Fund are eligible for the Swiss Management Pension Fund. The benefits under the Swiss Management Pension Fund are granted in addition to those of the Swiss Pension Fund. The Swiss Management Pension Fund is funded through contributions by Novartis and the employee.

Personal Loans, Consulting, Change of Control and Severance Agreements

        Under the provisions of the US Sarbanes-Oxley Act, enacted in July 2002, no new loans may be given to executives. Prior to the Act, loans were granted to two executives totaling CHF 2,060,000. The loans are interest bearing at market rates and are repayable by October 2005.

        Four Executives, including Daniel Vasella, have contracts with us granting them 36 months severance pay in the event they are terminated. In addition, if any of these Executives is terminated during the 12 months following a change of control of Novartis, then their 36-month severance rights are extended for an additional 24 months.

        Between January 1, 2002 and December 31, 2002, 3 Executives left the company. Under the terms of the agreements with those Executives, CHF 1,287,500 have been paid as severance.

6.C  Board Practices

        The table below shows the terms of office of our Board of Directors:

Name

  Start of Term
  End of Term
Daniel Vasella, MD (Chairman)   1996   2004
Prof. Helmut Sihler, JD, PhD (Vice Chairman and Lead Director)   1996   2004
Hans-Jörg Rudloff (Vice Chairman)   1996   2004
Dr. h.c. Birgit Breuel   1996   2005
Prof. Peter Burckhardt, MD   1996   2005
Prof. Ulrich Lehner, PhD   2002   2005
Walter G. Frehner   1996   2004
William W. George   1999   2003
Alexandre F. Jetzer   1996   2005
Pierre Landolt   1996   2005
Heini Lippuner   1996   2004
Prof. Rolf M. Zinkernagel, MD   1999   2003

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Board Committees

        Decisions are made by the Board of Directors as a whole. To assist the Board in carrying out its duties four committees have been created: the Chairman's Committee, the Compensation Committee, the Audit and Compliance Committee and the Corporate Governance Committee (the "Board Committees"). Each Board Committee has a written Charter outlining its duties and responsibilities and a chair elected by the Board. The Board Committees meet regularly and are charged with making full reports and recommendations to the Board at its regular meetings. The meeting agendas of the Board Committees are determined by their chairs. The Board Committee members receive in advance of Committee meetings materials allowing them to prepare for the handling of the items on the agenda.

The Chairman's Committee

        The Chairman's Committee consists of the Chairman and Chief Executive Officer, the two Vice Chairmen, one of whom is the Lead Director, and such other members as are elected by the Board from time to time. The Chairman's Committee deals with all matters delegated to it according to its Charter. It prepares the agenda for meetings of the Board and can take any preliminary and required action on behalf of the Board. The Chairman's Committee also interfaces with the Executive Committee of Novartis, specifically approving personnel appointments and financial measures which exceed the authority of the Executive Committee but which do not require approval by the full Board.

        Current members of the Chairman's Committee are Dr. Daniel Vasella (Chairman), Prof. Dr. Helmut Sihler, Hans-Jörg Rudloff, Heini Lippuner and William W. George.

The Compensation Committee

        The Compensation Committee is composed of three to five independent Directors.

        The Compensation Committee reviews and approves our compensation policies and programs, including share option programs and other incentive-based compensation. It is responsible for reviewing and approving the compensation paid to members of the Executive Committee and other selected key executives, and for reviewing the performance of the Chairman and Chief Executive Officer. The Compensation Committee from time to time seeks outside expert advice to support recommendations and decisions.

        Current members of the Compensation Committee are Prof. Dr. Helmut Sihler (Chairman), Hans-Jörg Rudloff and William W. George.

The Audit and Compliance Committee

        The Audit and Compliance Committee consists of three to five members. The Board of Directors has determined that all of the members of the Committee are independent, as defined by the rules of the New York Stock Exchange. Members of the Committee shall have sufficient financial and compliance experience and ability to enable them to discharge their responsibilities as members. The Committee's main duties are:

    To select, evaluate and propose to the Board the external auditors to be nominated for approval by the annual Shareholders' Meeting.

    To review annually the external audit scope, audit plans and relevant processes, the results of the external audit, and whether recommendations made have been implemented by our management.

    To discuss with the external auditors the results of the audit, any unusual items or disclosures contained in the audit, and the matters required by Statement on Auditing Standards No. 61, as amended.

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    To review annually the internal audit scope, audit plans and relevant processes, the results of the internal audit, and whether recommendations made have been implemented by our management.

    To review with external and internal auditors, and with our financial and accounting personnel, our accounting policies and financial controls.

    To review with management, internal auditors and external auditors any significant risks or exposures we may face, and to assess the steps management has taken to minimize such risks.

    To review the annual financial statements and annual report to consider whether they conform to accepted accounting principles and with the standards we have set.

    To review the processes and procedures for management's monitoring of our compliance with laws, regulations and with our Code of Conduct, as well as major legislative and regulatory developments that may have a significant impact on us.

    To review compliance by our management with those of our policies designated by the Board from time to time, including the Insider Trading Policy.

    To oversee our participation in the Global Compact.

        Current members of the Audit and Compliance Committee are Prof. Dr. Helmut Sihler (Chairman), Dr. h.c. Birgit Breuel, Dr. Ulrich Lehner and Walter G. Frehner.

The Corporate Governance Committee

        The Corporate Governance Committee consists of three to five independent Directors. The Committee's main duties are:

    To develop principles of corporate governance and recommend them to the Board for its approval.

    To review periodically the principles of corporate governance approved by the Board to ensure that they remain relevant and are being complied with.

    To review the composition and size of the Board in order to ensure the Board has the proper expertise and its membership consists of persons with sufficiently diverse backgrounds.

    To determine the criteria for selection of the Chairman and Chief Executive Officer, Directors and Board Committee members.

    To plan for continuity on the Board as existing Board members retire or rotate off the Board.

    To prepare and annually review succession plans for the Chairman and Chief Executive Officer in case of his resignation, retirement or death.

    To evaluate the performance of current Directors proposed for re-election, and recommend to the Board as to whether Directors should stand for re-election.

    To conduct an annual evaluation of the Board as a whole.

    With the Chairman and Chief Executive Officer, to periodically review the Charter and composition of each Board Committee and make recommendations to the Board for the creation of additional Board Committees or the change in mandate or dissolution of Board Committees.

    To ensure that each Board Committee is comprised of Directors suitable for the tasks of the Committee and that each Committee conducts the required number of meetings and makes sufficient reports to the Board on its activities and findings.

        Current members of the Corporate Governance Committee are William W. George (Chairman), Prof. Dr. Helmut Sihler, Hans-Jörg Rudloff and Prof. Dr. Rolf Zinkernagel.

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Directors Service Contracts

        We have no contracts with any of our non-Executive Directors which would provide for benefits upon termination of employment. Daniel Vasella, in his capacity as CEO, is entitled to receive benefits upon termination. See "Item 6. Directors, Senior Management and Employees—6.B Compensation—Swiss Employee Benefit Plans" and "Item 6. Directors, Senior Management and Employees—6.B Compensation—Personal Loans, Consulting, Change of Control and Severance Agreements."

6.D  Employees

        The table below sets forth the breakdown of the total average number of our full time equivalent employees by main category of activity and geographic area for the past three years. The totals set forth for 2000 have been adjusted to exclude employees of the divested Agribusiness Division.

For the year ended December 31, 2002
(full time equivalents)

  Research &
Development

  Production &
Supply

  Marketing &
Distribution

  General &
Administration

  Total
Europe   6,320   10,467   11,487   4,306   32,580
The Americas   3,512   8,764   13,733   2,689   28,698
Asia/Africa/Australia   821   2,906   7,873   1,144   12,744
   
 
 
 
 
Total   10,653   22,137   33,093   8,139   74,022
   
 
 
 
 
For the year ended December 31, 2001
(full time equivalents)

  Research &
Development

  Production &
Supply

  Marketing &
Distribution

  General &
Administration

  Total
Europe   5,804   9,875   10,531   4,734   30,944
The Americas   3,043   9,081   11,750   3,083   26,957
Asia/Africa/Australia   741   3,502   7,146   1,030   12,419
   
 
 
 
 
Total   9,588   22,458   29,427   8,847   70,320
   
 
 
 
 
For the year ended December 31, 2000
(full time equivalents)

  Research &
Development

  Production &
Supply

  Marketing &
Distribution

  General &
Administration

  Total
Europe   5,627   9,961   9,461   5,662   30,711
The Americas   2,957   9,656   10,941   2,905   26,459
Asia/Africa/Australia   674   3,691   6,537   996   11,898
   
 
 
 
 
Total   9,258   23,308   26,939   9,563   69,068
   
 
 
 
 

        A relatively small number of our employees are represented by unions. We have not experienced any material work stoppages in recent years, and we consider our employee relations to be good.

6.E  Share Ownership

        The aggregate amount of our shares personally owned by current non-executive Directors and Executives as of December 31, 2002 was 953,884 shares, which amount is less than 1% of our outstanding shares. No individual non-executive Director or Executive owned 1% or more of our outstanding shares. However, our Director Pierre Landolt is also the Chairman of the Board of Directors of Emasan AG. See "Item 7. Major Shareholders and Related Party Transactions—7.A Major Shareholders."

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        The aggregate amount of Novartis share and ADS options, including other information regarding the options, held by current Directors and the Executives as of December 31st, 2002 is set forth below:

Title of Options

  Amount of
shares called for
by the options

  Exercise
Price(1)
(CHF)

  Purchase
Price
(if any)

  Expiration Date
  Total number
of options
held

Novas07 Options   1   42.80   0   January 15, 2007   131,040
Novas08 Options   1   68.40   0   January 16, 2008   132,600
Novas09 Options   1   51.30   0   March 10, 2009   539,720
Novas10 Options   1   70.00   0   March 7, 2010   626,760
Novas11 Options   1   62.00   0   March 7, 2011   1,822,069
Total Novartis Share Options                   3,252,189
Novartis ADS Options Cycle V   1   $41.97   0   March 7, 2011   167,060
Novartis ADS Options Cycle VI   1   $37.28   0   March 7, 2012   559,195
Total Novartis ADS Options                   726,255

(1)
Exercise price indicated is per share.

Novartis Employee Ownership Plans

        Pursuant to the Novartis Employee Ownership Plan, which was approved by the Board of Directors in 1998, all employees of our Swiss affiliates are entitled to purchase 120 shares, at a predetermined discount price, after each full year of service. In 2001, the price was set at CHF 12.50 per share. 80 of the shares were freely disposable, and 40 of the shares must be deposited with us until the person concerned leaves the employment, or retires from, the relevant Swiss affiliate. These employees were then required to immediately buy the shares to which they became entitled. During 2002, 2001 and 2000, an aggregate of 406,448, 862,720 and 1,429,520 shares, respectively, were acquired by these employees under this plan.

        A new Novartis Employee Ownership Plan was introduced in January 2002 for all employees of our Swiss affiliates, replacing the existing plan. These employees will receive an annual incentive bonus delivered in Novartis shares at a fixed date at the then valid fair market value of the shares (to be delivered in the beginning of March 2003). The new plan will allow these employees to choose to immediately sell either all or half of the shares received, or to keep all the shares for a three year vesting period, at which time we will give the employee one additional free share for every two shares retained and deposited by the employee under this plan.

        Beginning January 2002, two share ownership plans were introduced for employees of our UK affiliates. The first is the Novartis UK Share Ownership Plan, a UK Inland Revenue-approved plan set up under a Trust. For every two shares purchased, employees will receive one share free. However, the employee would forfeit the matching share and any tax relief received if the employee were to leave the employ of his or her UK employer within 3 years of the award. If the shares are held in the plan for 5 years or more then the employee will not be liable for any form of tax on either the shares they purchased or the free matching shares. The employee's maximum annual investment under this plan is GBP 1,500.

        Under the second UK plan, the Novartis UK Incentive Conversion Plan, employees can invest their net incentive bonus, which is the maximum allowable payment to the Novartis UK Share Ownership Plan. For every two shares purchased the employee will receive one free share. But the employee would forfeit the free share if the employee leaves the employ of his or her UK employer within 3 years of the award.

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Item 7. Major Shareholders and Related Party Transactions

7.A  Major Shareholders

        Based on our share register, we believe that we are not directly or indirectly owned or controlled by another corporation or government, and that there are no arrangements that may result in a change of control.

        As of December 31, 2002, our registered share capital was CHF 1,412,075,000, divided into 2,824,150,000 shares with a nominal value of CHF 0.50 each. Based on our share register, it appears that approximately 77% of our registered shares are held in Switzerland, and approximately 12% of our shares are held in the United States. However, since certain of our shares are held by brokers or other nominees, the above numbers are not representative of the actual number of US and Swiss persons who are beneficial owners of our shares.

        As of December 31, 2002 no person or entity was the owner of more than 5% of our shares, whether or not the voting rights of such shares were exercisable. Our largest registered shareholders are Emasan AG (3.1%) and the Novartis Foundation for Employee Participation (3.3%). In 2001, these shareholders held 3.8% and 3.5%, respectively. Both shareholders are entered in the share register with voting rights for their entire shareholdings.

        The largest registered nominee shareholder with voting rights is the Depositary for our ADSs, JPMorgan Chase (7.4%), which entered into a nominee agreement with us and disclosed the names, addresses and number of shares of the beneficial owners for whose account it holds the shares. No other nominee shareholders nor any beneficial owner known to us holds more than 2% of our shares.

Shares

        We have one class of registered shares. As of December 31, 2002, a total of 2,824,150,000 shares were registered, with a nominal value of CHF 0.50 each. The shares are fully paid-in and non-assessable.

        We may issue certificates representing several shares. Shareholders may exchange these certificates at any time for certificates representing smaller numbers of shares, or for individual share certificates. If the owner of the shares consents, we may renounce the printing and delivery of share certificates.

Capital Structure

        As of December 31, 2002, our share capital was CHF 1,412,075,000, made up of 2,824,150,000 fully paid-in registered shares, each with the nominal value of CHF 0.50. On March 21, 2002, our shareholders approved a reduction of our share capital by CHF 30,527,340. We have submitted a new proposal to our shareholders, to be voted upon at their next Shareholders Meeting on March 4, 2003, for a further reduction of our share capital by CHF 11,340,000.

        As of December 31, 2002, we held 444,251,543 shares in our treasury, calculated in accordance with US GAAP. When calculated in accordance with IAS, the number of treasury shares was 349,179,381. These numbers differ because of varying rules regarding whether shares held by certain foundations, which are independent from Novartis under Swiss company law, must be consolidated with shares held by the Group as treasury shares. US GAAP requires that we consolidate shares held by the employee share participation foundation. This is not required under IAS.

        In May 2001 we made available to US investors a direct share purchase and dividend reinvestment program for ADRs through our depositary bank, JPMorgan Chase. See "Item 5. Operating and Financial Review and Prospects—5.B. Liquidity and Capital Resources."

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American Depositary Shares

        We incorporate by reference the disclosure regarding our ADS program included in the registration statement on Form 20-F/A (File No. I-15024), as filed with the Commission on May 9, 2000, in the section entitled "Part II—Item 14. Description of Securities to be Registered—American Depositary Receipts."

        On May 3, 2001, we filed an Amendment No. 2 to the Amended and Restated Deposit Agreement, dated as of May 7, 2001, pursuant to the Registration Statement on Form F-6 (File No. 333-13446). The Amendment No. 2 changed the ADS-to-share ratio from 40-to-1 to 1-to-1.

        On January 31, 2002, we filed a Restricted Issuance Agreement dated as of January 11, 2002, supplementing Amendment No. 2 to the Amended and Restated Deposit Agreement dated as of May 3, 2001, as an exhibit to the Registration Statement on Form F-3 (File No. 333-81862). The Restricted Issuance Agreement supplemented the Deposit Agreement to permit the deposit of restricted ADSs into a parallel facility to the ADR facility established in the Deposit Agreement.

7.B  Related Party Transactions

        We have formed certain foundations for the purpose of advancing employee welfare, employee share participation, research and charitable contributions. The charitable foundations foster health care and social development in rural countries. The foundations are autonomous, and their boards are responsible for administering the foundations in accordance with the foundations' purpose and applicable law.

        The employee share participation foundation has not been included in our consolidated financial statements prepared under IAS, as the International Accounting Standards Committee, Standing Interpretations Committee No. 12, exempts post-employment and equity compensation plans from its scope. The total assets of this foundation, as of December 31, 2002, included 95.1 million of our shares with a market value of approximately CHF 4.8 billion. As of December 31, 2001, the assets included 101.3 million of our shares with a fair market value of CHF 6.1 billion. This foundation has been consolidated with our financial statements under US GAAP, and is included as a reconciling item in the US GAAP reconciliation.

        In 2002 we granted short-term loans totaling CHF 875 million to the employee welfare and other foundations and received short-term loans totaling CHF 3 million from them. In 2001, we granted short-term loans totaling CHF 1.2 billion to these foundations and received short-term loans totaling CHF 10 million from them. In 2000 we granted short-term loans totaling CHF 936 million to these foundations, received short-term loans totaling CHF 6 million from them and sold 1.4 million of our shares to them at market rates.

7.C  Interests of Experts and Counsel

        Not applicable.

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Item 8. Financial Information

8.A  Consolidated Statements and Other Financial Information

8.A.1 See Item 18.

8.A.2 See Item 18.

8.A.3 See Report of Independent Accountants, page F-2.

8.A.4 We have complied with this requirement.

8.A.5 Not applicable.

8.A.6 Not applicable.

8.A.7 Legal proceedings.

        A number of our affiliates are the subject of litigation arising out of the normal conduct of their business. As a result, claims could be made against them which, in whole or in part, might not be covered by insurance. In our opinion, however, the outcome of these actions will not materially affect our financial position, results of operations or cash flow. In the interest of transparency we are providing information on the following cases:

    Augmentin® (amoxicillin/potassium clavulanate):    we are involved in a series of lawsuits against affiliates of GlaxoSmithKline (GSK) regarding amoxicillin/potassium clavulanate, our generic version of GSK's Augmentin®. Our US affiliate, Geneva Pharmaceuticals, Inc., launched the first generic version of this GSK product in the US in July 2002, following favorable decisions by the United States District Court for the Eastern District of Virginia invalidating seven patents alleged by GSK to cover its Augmentin® product. GSK has appealed the district court's decision invalidating its patents. GSK has also initiated actions against Geneva and several of our other affiliates (Biochemie GmbH, Biochemie SpA, and Novartis AG) in state court in Colorado and before the United States International Trade Commission, alleging that the potassium clavulanate used in manufacturing the Geneva product is produced using a micro-organism strain allegedly stolen from GSK, an allegation which Geneva and the other Novartis affiliates deny. GSK has also filed a separate lawsuit in state court in North Carolina against our affiliate Lek Pharmaceuticals d.d., alleging that the potassium clavulanate used in manufacturing the Augmentin® generic product sold by Lek is produced using a micro-organism strain allegedly stolen from GSK, an allegation which Lek denies.

    Borison and Diamond:    Dr. Borison and Dr. Diamond were clinical investigators who had conducted clinical trials for many pharmaceutical companies, including Ciba-Geigy and Sandoz. Borison and Diamond were indicted by the State of Georgia for diverting payments from pharmaceutical companies from their employer, the Medical College of Georgia, to themselves. The investigation also brought to light allegations relating to informed consent and faulty patient care practices. Borison and Diamond pleaded guilty to a variety of felonies. Several lawsuits, known as Hodges, Huckeba, Lewis and Thomas, were filed against one of our affiliates on behalf of patients who participated in the clinical trials. Of these cases, only three remain. Of these, one, Huckeba, is a purported class action brought on behalf of 185 individuals. The cases are all in the early stages of discovery.

    Enteral Pump Investigation:    The Department of Justice in the United States is investigating marketing and pricing practices of the enteral pump industry in the US, including whether certain federal criminal statutes have been violated. One of our Medical Nutrition affiliates is a subject of the investigation.

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    Parlodel:    Since November 1986, Novartis affiliates have been defendants in lawsuits alleging personal injuries resulting from the administration of Parlodel for, among other indications, inhibition of post partum lactation. Currently, there are 24 cases pending. They are in various stages of discovery and/or motion practice. Four cases currently have trial dates in 2003.

    Pharmaceutical Antitrust Litigation:    Novartis affiliates, along with numerous other prescription drug manufacturers, are defendants in various actions brought by certain US retail pharmacies, alleging antitrust and pricing violations.

    PPA:    Novartis affiliates are parties to over 300 lawsuits in the US brought by people in 2001 and 2002 who claim to have been injured by products containing phenylpropanolamine (PPA) sold by certain of those affiliates. These cases are in various stages of litigation with the first trials set for 2003.

    Ritalin:    In 2000, one of our affiliates was named as defendant in five class action lawsuits and several personal injury claims involving Ritalin. The plaintiffs were consumers and third party payors who alleged that Novartis and others have been involved in "fraud and conspiracy" in the over-promotion of ADHD (attention deficit hyperactive disorder) and Ritalin. All of the class actions were dismissed. However, one of these dismissals was reversed on appeal. Only two personal injury claims remain.

    SMON: (Subacute Myelo Optico Neuropathy):    In 1996 an affiliate of Ciba-Geigy Ltd., one of our predecessor companies, together with two other pharmaceutical companies, settled certain product liability issues related to sales of its product Clioquinol in Japan. Under the settlement, one of our affiliates is required to pay certain future health care costs of the claimants.

    Terazosin:    One of our Generics affiliates is a defendant in a number of lawsuits in the US claiming injuries and damages allegedly arising out of violation of antitrust laws in the settlement, by the affiliate and Abbott Pharmaceuticals, of a contentious patent litigation involving Abbott's Hytrin® and our generic equivalent product.

        We believe that our affiliates have meritorious defenses in these cases, and they are vigorously defending each of them.

        We maintain general liability insurance, including product liability insurance, covering claims on a worldwide basis. While claims could be made against our affiliates which, in whole or in part, might not be covered by insurance, we believe that our insurance coverage limits and retention amounts are reasonable and prudent in light of our businesses and the risks to which we are subject.

8.A.8 Dividend policy.

        Subject to the dividend policy described below, our Board of Directors expects to recommend the payment of a dividend in respect of each financial year. If approved by our shareholders at the relevant annual Shareholders' Meeting, which is normally held in March, the dividends will be payable immediately following such approval. Any shareholder who purchased our shares on or before the second trading day after the shareholders' meeting shall be deemed to be entitled to receive the dividends and, in bonus issues, new shares, and to exercise shareholders' preemption rights to participate in issues of securities. Dividends are reflected in our financial statements in the year in which they are approved by our shareholders.

        Our Board's stated policy is that, over the long term, the size of the dividend should be geared to growth in our after-tax earnings. All future dividends paid by us will depend upon our financial condition at the time, the results of our operations and other factors.

        The Board will propose a dividend of CHF 0.95 per share to the shareholders for approval at the Annual General Meeting to be held on March 4, 2003. Because we pay dividends in Swiss francs, exchange rate fluctuations will affect the US dollar amounts received by holders of ADSs. For a summary of

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dividends we paid in the past five years, see "Item 3. Key Information—3.A Selected Financial Data—Cash Dividends per Share."

8.B  Significant Changes

        On March 21, 2002, our shareholders approved a reduction of our share capital by CHF 30,527,340. Our share capital is now CHF 1,412,075,000 and is divided into 2,824,150,000 shares with a nominal value of CHF 0.50 each.

        We will submit a new proposal to our shareholders, to be voted upon at their next annual Shareholders Meeting on March 4, 2003, for a further reduction of our share capital by CHF 11,340,000, as a means of fully retiring those shares acquired as a result of the share repurchase program announced in July 2002.


Item 9. The Offer and Listing

9.A  Listing Details

        Our shares are listed in Switzerland on the SWX Swiss Exchange ("SWX"). The principal trading market for our shares is the virt-x, a virtual exchange created by, among others, the SWX. Prior to the creation of virt-x in June 2001, our shares were traded on the SWX. Since 1996, our shares have also been quoted on London's SEAQ International.

        American Depositary Shares (ADSs), each representing one share, have been available in the US through an American Depositary Receipts (ADR) program since December 1996. This program was established pursuant to a Deposit Agreement which we entered into with J.P. Morgan Chase & Co. as Depositary (the "Deposit Agreement"). Our ADSs have been listed on the NYSE since May 2000, and are traded under the symbol "NVS."

        The table below sets forth, for the periods indicated, the high and low closing sales prices for our shares traded in Switzerland and for ADSs traded in US. The data below regarding our shares reflects price and volume information for trades completed by members of the virt-x (or the SWX, as applicable) during the day as well as for inter-dealer trades completed off the virt-x (or the SWX, as applicable) and certain inter-dealer trades completed during trading on the previous business day. The data below has been adjusted to reflect the 40-for-1 share split and diminution in nominal share value from CHF 20 to CHF 0.50 and the ADS-share ratio change from 40-for-1 to 1-for-1 effective May 7, 2001. Each ADS now represents one share.

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        The following share data was taken from virt-x and SWX; the ADS data was taken from Bloomberg:

 
  Shares
  ADSs
 
  High
  Low
  High
  Low
 
  (CHF per share)

  ($ per ADS)

Annual information for the past five years                
2002   69.10   49.20   43.83   34.10
2001   74.15   54.95   45.00   32.98
2000(1)   73.90   49.72   44.94   34.63
1999(1)   72.95   42.68   53.13   34.63
1998(1)   69.35   48.30   53.25   35.50
Quarterly information for the past two years                
2002                
First Quarter   66.55   56.60   39.65   34.30
Second Quarter   69.10   58.50   43.83   38.13
Third Quarter   65.30   50.50   43.56   34.10
Fourth Quarter   60.50   50.00   40.62   35.53
2001                
First Quarter   74.15   62.88   44.28   38.14
Second Quarter   72.10   61.30   41.04   35.21
Third Quarter   65.25   54.95   37.58   33.61
Fourth Quarter   65.29   55.80   39.74   34.15
Monthly information for most recent six months                
September 2002   61.45   55.75   41.01   37.67
October 2002   60.50   55.10   40.62