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:
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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
INTRODUCTION AND USE OF CERTAIN TERMS | 1 | |||||
FORWARD-LOOKING STATEMENTS |
1 |
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PART I |
2 |
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Item 1. |
Identity of Directors, Senior Management and Advisers |
2 |
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Item 2. |
Offer Statistics and Expected Timetable |
2 |
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Item 3. |
Key Information |
2 |
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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 |
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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 |
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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 |
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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 |
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7. | A | Major Shareholders | 125 | |||
7. | B | Related Party Transactions | 126 | |||
7. | C | Interests of Experts and Counsel | 126 | |||
Item 8. |
Financial Information |
127 |
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8. | A | Consolidated Statements and Other Financial Information | 127 | |||
8. | B | Significant Changes | 129 | |||
Item 9. |
The Offer and Listing |
129 |
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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 |
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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 |
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Item 12. |
Description of Securities other than Equity Securities |
145 |
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PART II |
145 |
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Item 13. |
Defaults, Dividend Arrearages and Delinquencies |
145 |
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Item 14. |
Material Modifications to the Rights of Security Holders and use of Proceeds |
145 |
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Item 15. |
Controls and Procedures |
145 |
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Item 16. |
[Reserved] |
145 |
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PART III |
145 |
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Item 17. |
Financial Statements |
145 |
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Item 18. |
Financial Statements |
146 |
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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 Statementsnote 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.
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 Information3.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.
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Item 1. Identity of Directors, Senior Management and Advisers
Not applicable.
Item 2. Offer Statistics and Expected Timetable
Not applicable.
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 Statementsnote 31."
For further information regarding continuing and discontinued activities (the Agribusiness Division), see "Item 4. Information on the Company4.A. History and Development of Novartis" and "Item 5. Operating and Financial Review and Prospects5.A. Operating Results."
2
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Year Ended December 31, |
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2002(1) |
2002 |
2001(2) |
2000(2) |
2000(2)(3) |
1999(2) |
1999(2)(3) |
1998 |
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($) |
(CHF) |
(CHF) |
(CHF) |
(CHF) |
(CHF) |
(CHF) |
(CHF) |
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(in millions except per share data) |
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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 |
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Year Ended December 31, |
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2002(1) |
2002 |
2001 |
2000 |
1999 |
1998 |
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($) |
(CHF) |
(CHF) |
(CHF) |
(CHF) |
(CHF) |
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(in millions, except per share data) |
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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: |
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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 |
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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 |
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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 |
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(CHF) |
($) |
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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.
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Year ended December 31, |
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Period End |
Average(1) |
High |
Low |
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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. |
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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.
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.
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.
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 Company4.B. Business OverviewGenericsIntellectual 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:
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 accrualsincluding our assumptions regarding the portion of the waste at a site for which we are responsibleprove 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 Company4.B. Business OverviewGenerics."
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 Company4.B. Business OverviewMedical 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 Company4.B. Business OverviewAnimal 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 Prospects5.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:
In 2001:
12
In 2000:
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 Healthongoing | 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 Healthongoing | 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 |
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 | |||||
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 | |||||
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 | |||||
20
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 | |||||
21
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 | |||||
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
22
Compounds in Development
23
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
Key Marketed Products
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.
Compounds in Development
25
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
Key Marketed Products
26
Compounds in Development
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
27
Compounds in Development
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
Key Marketed Products
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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
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
Key Marketed Products
Compounds in Development
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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.
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
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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.
Compounds in Development
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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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 placeand to perhaps even be strengthenedand 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:
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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.
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 businessesthe Health Food & Slimming and Sports Nutrition lineshave 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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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.
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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 "PharmaceuticalsRegulationEuropean 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:
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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 brandsincluding Triaminic, NeoCitran/Theraflu and Tavistheavily 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 "PharmaceuticalsRegulation."
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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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 patientsat 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 groupsfrom 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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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
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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/InstaCARE |
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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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 flapdelaminating (or separating) the epithelium from the basement membraneduring 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, SwitzerlandKlybeck | 283,000 square meters | Drug substances, intermediates | ||
Basel, SwitzerlandSt. Johann | 219,000 square meters | Drug substances, intermediates | ||
Basel, SwitzerlandSchweizerhalle | 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, SwitzerlandKlybeck | 283,000 square meters | General pharmaceutical products | ||
Basel, SwitzerlandSt. 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. | ||||
69
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 Statementsnote 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
71
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 Statementsnote 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:
72
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.
73
("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 Healthongoing | 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 Healthongoing | 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 | |||||
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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 Healthongoing | 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 | ||||||
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.
78
country in Europe where it has been launched, Elidel captured a 9% share of its segment within 10 weeks of launch.
Oncology
Our Oncology business unit gained further market share and posted strong sales growth of 28% in local currencies (+19% in CHF).
Ophthalmics
Ophthalmics' sales rose 7% in local currencies (1% in CHF), driven by Visudyne.
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.
79
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.
80
Top 20 Pharmaceutical Products2002
|
|
|
|
|
|
|
% 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 Healthongoing | 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 | ) | ||||
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 Products2001
|
|
|
|
|
|
|
% 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 | ||||||||||
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.
93
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%).
94
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 | ||||
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 |
23 years |
45 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 | |||||
Contingencies
In connection with our original investment in Chiron, we agreed to:
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 Company4.D Property, Plants and EquipmentEnvironmental Matters" and "Item 8 Financial Information8.A Consolidated Statements and Other Financial Information8.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 Company4.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 Prospects5.A Operating ResultsCritical 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:
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 |
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) | ||||
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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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 |
|||
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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 | |
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
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
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.
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.
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.
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.
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 Table2002 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 |
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 |
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:
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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:
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 Employees6.B CompensationSwiss Employee Benefit Plans" and "Item 6. Directors, Senior Management and Employees6.B CompensationPersonal 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 Transactions7.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 |
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 Prospects5.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 IIItem 14. Description of Securities to be RegisteredAmerican 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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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:
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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 Information3.A Selected Financial DataCash 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.
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 | < |