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The following is an excerpt from a 20-F SEC Filing, filed by TEVA PHARMACEUTICAL INDUSTRIES LTD on 3/17/2005.
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TEVA PHARMACEUTICAL INDUSTRIES LTD - 20-F - 20050317 - KEY_INFORMATION

ITEM 3: KEY INFORMATION

 

SELECTED FINANCIAL DATA

 

The Israeli Securities Law allows Israeli companies, such as Teva, whose securities are listed both on the Tel Aviv Stock Exchange and on certain stock exchanges in the United States (including NASDAQ), to report exclusively under SEC rules and accounting principles generally accepted in the United States (“US GAAP”). All financial statements included in this report and all financial information released in Israel are presented solely under US GAAP.

 

The following selected financial data for each of the years in the three-year period ended December 31, 2004 and at December 31, 2004 and 2003 are derived from Teva’s audited consolidated financial statements set forth elsewhere in this report, which have been prepared in accordance with US GAAP. The selected financial data for each of the years in the two-year period ended December 31, 2001 and at December 31, 2002, 2001 and 2000 are derived from other audited financial statements not appearing in this report, which have been prepared in accordance with US GAAP.

 

The selected financial data should be read in conjunction with the financial statements, related notes and other financial information included in this report.

 

The currency of the primary economic environment in which the operations of Teva and its subsidiaries in Israel and in the United States are conducted is the U.S. dollar. The functional currency of Teva’s other subsidiaries (principally operating in Europe and Canada) is their respective local currency.

 

 

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Operating Data

 

     For the year ended December 31

 
     2004

    2003

    2002

    2001

    2000

 
     U.S. dollars in millions (except per ADR amounts)  

Net sales

   4,798.9     3,276.4     2,518.6     2,077.4     1,749.9  

Cost of sales

   2,559.6     1,757.5     1,423.2     1,230.1     1,058.0  
    

 

 

 

 

Gross profit

   2,239.3     1,518.9     1,095.4     847.3     691.9  

Research and development expenses:

                              

Total expenses

   356.1     243.4     192.6     168.6     132.3  

Less participations and grants

   17.7     29.9     27.6     61.4     27.7  
    

 

 

 

 

Research and development – net

   338.4     213.5     165.0     107.2     104.6  

Selling, general and administrative expenses

   696.5     520.6     406.4     358.1     301.0  

Acquisition of in-process research and development

   596.6                       35.7  

Income from GSK litigation settlement

         100.0                    

Impairment of product rights

   30.0                          

Restructuring expenses

         7.4           15.7        
    

 

 

 

 

Operating income

   577.8     877.4     524.0     366.3     250.6  

Financial income (expenses) – net

   25.9     (5.0 )   (24.6 )   (26.0 )   (42.2 )
    

 

 

 

 

Income before income taxes

   603.7     872.4     499.4     340.3     208.4  

Income taxes

   267.2     181.5     84.8     63.6     59.6  
    

 

 

 

 

     336.5     690.9     414.6     276.7     148.8  

Share in profits (losses) of associated companies - net

   (1.2 )   1.5     (2.7 )   0.8     0.4  

Minority interests in (profits) losses of subsidiaries – net

   (3.5 )   (1.4 )   (1.6 )   0.7     (0.8 )
    

 

 

 

 

Net income

   331.8     691.0     410.3     278.2     148.4  
    

 

 

 

 

Earnings per ADR (1) (2) - Basic ($)

   0.54     1.29     0.78     0.53     0.29  
    

 

 

 

 

                                     - Diluted ($)

   0.50     1.16     0.74     0.51     0.29  
    

 

 

 

 

Weighted average number of ADRs (in millions) - Basic

   612.7     536.8     529.0     528.9     515.8  
    

 

 

 

 

                                                                                 - Diluted

   688.0     608.8     580.9     567.8     527.4  
    

 

 

 

 

Before one-time items (3)

                              

Operating income

   1,204.4     784.8     524.0     382.0     286.3  

Net income

   964.6     617.8     410.3     287.9     184.1  

Earnings per ADR (1) - Basic ($)

   1.57     1.15     0.78     0.55     0.36  

Earnings per ADR (1) (2) - Diluted ($)

   1.42     1.04     0.74     0.53     0.36  

(1) Historical figures have been adjusted to reflect the two for one stock splits effected in June 2004, December 2002 and February 2000. Each ADR represents one ordinary share.
(2) Diluted EPS for the years 2003, 2002 and 2001 has been restated to reflect the potential dilution of convertible senior debentures, pursuant to the adoption of EITF No. 04-8, which requires that the shares issuable upon conversion of such debentures be included in the computation of diluted EPS, regardless of the contingent features included in the instrument.
(3) See the reconciliation on the following page.

 

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Teva believes that excluding the following one-time items, which primarily relate to purchase accounting adjustments in connection with the Sicor acquisition (mainly in-process R&D) and to certain product rights acquired as part of a litigation settlement, from its results of operations represents a better indicator of the underlying trends in its business. The results, after these exclusions and inclusions, are the primary results used by management and Teva’s board of directors to evaluate the operational performance of the Company, to compare against the Company’s annual work plans and budgets, and ultimately to evaluate the performance of management.

 

     For the year ended December 31

     2004

   2003

   2002

   2001

   2000

     (U.S. dollars in millions)

Total income before taxes as reported *

   599.0    872.5    495.1    341.8    208.0

Deduct gain:

                        

Income from GSK litigation settlement

        100.0               

Add back charges:

                        

Sicor purchase accounting adjustments:

                        

In-process R&D

   583.6                    

Acquired inventory step up

   13.9                    

Acquisition of in-process R&D

   13.0                   35.7

Impairment of product rights

   30.0                    

Restructuring expenses

        7.4         15.7     

Total normalized income before taxes

   1,239.5    779.9    495.1    357.5    243.7

Taxes on normalized income

   274.9    162.1    84.8    69.6    59.6

Net normalized income

   964.6    617.8    410.3    287.9    184.1

Net income as reported

   331.8    691.0    410.3    278.2    148.4

* Includes share of profits (losses) of associated companies-net and minority interest in losses (profits) of subsidiaries-net.

 

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Balance Sheet Data

 

     As at December 31

     2004

   2003

   2002

   2001

   2000

     U.S. dollars in millions

Working capital

   1,997.6    2,021.5    1,377.2    1,439.8    825.1

Total assets

   9,632.0    5,915.9    4,626.8    3,460.2    2,855.6

Short-term credit, including current maturities:

                        

Convertible senior debentures (short-term)

   —      352.5    562.4    —      —  

Other

   560.4    291.7    176.1    206.5    341.5

Total short-term debt

   560.4    644.2    738.5    206.5    341.5

Long-term debt, net of current maturities:

                        

Convertible senior debentures

   1,513.4    449.9    810.0    912.0    550.0

Other

   215.0    365.5    351.4    334.9    263.9

Total long-term debt

   1,728.4    815.4    1,161.4    1,246.9    813.9

Minority interests

   10.9    6.7    4.9    2.2    1.6

Shareholders’ equity

   5,388.9    3,289.4    1,829.4    1,380.7    1,151.3

 

 

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Dividends

 

For over 30 years Teva has paid dividends, with dividends paid on a regular quarterly basis since 1987. Future dividend policy will be reviewed by the board of directors based upon conditions then existing, including Teva’s earnings, financial condition, capital requirements and other factors. Dividends are declared and paid in New Israeli Shekels. Dividends are converted into dollars and paid by the depositary of the ADRs for the benefit of owners of ADRs.

 

Dividends paid by an Israeli company to shareholders residing outside Israel are currently subject to withholding of Israeli income tax at a rate of up to 25%. In Teva’s case, the applicable withholding tax rate will depend on the particular Israeli production facilities that have generated the earnings that are the source of the dividend and, accordingly, the applicable rate will change from time to time. The rate of tax withheld on the dividend declared for the fourth quarter of 2004 was 18.5%.

 

The following table sets forth the amounts of the dividends paid in respect of each period indicated prior to deductions for applicable Israeli withholding taxes (in cents per ADR). All the figures have been adjusted to reflect the 2:1 stock splits effected in June 2004, December 2002 and February 2000. Actual dividends paid in U.S. dollars are subject to some deviation reflecting exchange rate fluctuations between the NIS (the currency in which dividends are declared) and the U.S. dollar between the declaration date and the date of actual payment.

 

     2004

   2003

   2002

   2001

   2000

1st interim

   5.0    3.7    2.2    1.7    1.4

2nd interim

   5.0    3.7    2.3    1.6    1.4

3rd interim

   5.0    3.7    2.3    1.6    1.4

4th interim

   6.9    5.0    3.5    2.4    1.7

 

 

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RISK FACTORS

 

Our business faces significant risks. You should carefully consider all of the information set forth in this Form 20-F and in our other filings with the SEC, including the following risk factors which we face and which are faced by our industry. 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 due to the risks described below and elsewhere in this Form 20-F. See “Forward-Looking Statements” on page 3.

 

Our success depends on our ability to successfully develop and commercialize pharmaceutical products.

 

Our future results of operations depend, to a significant degree, upon our ability to successfully commercialize additional generic and innovative branded pharmaceutical products. We must develop, test and manufacture generic products as well as prove that our generic products are the bio-equivalent of their branded counterparts. All of our products must meet and continue to comply with regulatory and safety standards and receive regulatory approvals; we may be forced to withdraw a product from the market if health or safety concerns arise with respect to such product. The development and commercialization process, particularly with respect to innovative products, is both time consuming and costly and involves a high degree of business risk. Our products currently under development, if and when fully developed and tested, may not perform as we expect, necessary regulatory approvals may not be obtained in a timely manner, if at all, and we may not be able to successfully and profitably produce and market such products. Delays in any part of the process or our inability to obtain regulatory approval of our products (including the products filed by Andrx Corporation, IMPAX Laboratories Inc. and Biovail Corporation, for which we have exclusive marketing rights) could adversely affect our operating results by restricting or delaying our introduction of new products. The continuous introduction of new generic products is critical to our business.

 

Our revenues and profits from any particular generic pharmaceutical products decline as our competitors introduce their own generic equivalents.

 

Selling prices of generic drugs typically decline, sometimes dramatically, as additional companies receive approvals for a given product and competition intensifies. To the extent that we succeed in being the first to market a generic version of a significant product, and particularly if we obtain the 180-day period of market exclusivity provided under the Hatch-Waxman Act, our sales, profit and profitability can be substantially increased in the period following the introduction of such product and prior to a competitor’s introduction of the equivalent product or the launch of an authorized generic. Our ability to sustain our sales and profitability on any product over time is dependent on both the number of new competitors for such product and the timing of their approvals. Our overall profitability depends, among other things, on our ability to continuously and timely introduce new products.

 

Our generic pharmaceutical products face intense competition from brand-name companies that sell or license their own generic products or seek to delay the introduction of generic products.

 

Brand-name pharmaceutical companies have taken aggressive steps to thwart competition from generic companies. In particular, brand-name companies continue to sell or license their products directly or through licensing arrangements or strategic alliances with generic pharmaceutical companies (so-called “authorized generics”). No significant regulatory approvals are required for a brand-name

 

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manufacturer to sell directly or through a third party to the generic market. Brand-name manufacturers do not face any other significant barriers to entry into such market. In addition, such companies continually seek new ways to delay generic introduction and decrease the impact of generic competition, such as

 

    filing new patents on drugs whose original patent protection is about to expire;

 

    filing an increasing number of patents that are more complex and costly to challenge;

 

    filing suits for patent infringement that automatically delay FDA approval;

 

    developing patented controlled-release or other “next-generation” products, which often reduces demand for the generic version of the existing product for which we are seeking approval;

 

    changing product claims and product labeling; or

 

    developing and marketing as over-the-counter products those branded products which are about to face generic competition.

 

These strategies may increase the costs and risks associated with our efforts to introduce generic products and may delay or prevent such introduction altogether.

 

Changes in the regulatory environment may prevent us from utilizing the exclusivity periods that are important to the success of our generic products.

 

The FDA’s policy regarding the award of 180-days market exclusivity to generic manufacturers who challenge patents relating to specific products continues to be the subject of extensive litigation in the United States. The FDA’s current interpretation of the Hatch-Waxman Act is to award 180 days of exclusivity to the first generic manufacturer who files a Paragraph IV certification under the Act challenging the patent of the branded product, regardless of whether the manufacturer was sued for patent infringement. Although the FDA’s interpretation may benefit some of the products in our pipeline, it may adversely affect others.

 

The Medicare Prescription Drug Act provides that the 180-day market exclusivity period provided under the Hatch-Waxman Act is only triggered by the commercial marketing of the product. However, the Medicare Act also contains forfeiture provisions which, if met, will deprive the first Paragraph IV filer of exclusivity. As a result, under certain circumstances, we may not be able to exploit our 180-day exclusivity period since it may be forfeited prior to our being able to market the product.

 

In addition, legal and administrative battles over triggering dates and shared exclusivities may also prevent us from fully utilizing the exclusivity periods.

 

If we elect to sell a generic product prior to any court decision or prior to the completion of all appellate level patent litigation, we could be subject to liabilities for damages.

 

At times we or our partners seek approval to market generic products before the expiration of patents for those products, based upon our belief that such patents are invalid, unenforceable, or would not be infringed by our products. As a result, we face significant patent litigation. Depending upon a complex analysis of a variety of legal and commercial factors, we may, in certain circumstances, elect to market a generic product even though litigation is still pending. This could be before any court decision is rendered or while an appeal of a lower court decision is pending. To the extent we elect to proceed in this manner, we could face substantial liability for patent infringement if the final court decision is adverse to us. For example, in 2004 we launched oxycodone and generic versions of Neurontin ® tablets and capsules despite the fact that litigation with the branded companies was still pending. Our ability to introduce new products may depend on our ability to successfully challenge patent rights held by branded companies.

 

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Our sales of Copaxone ® could be adversely affected by competition.

 

Copaxone ® is our leading innovative product, from which we derive substantial revenues and profits. To date, we and our marketing partners have been successful in our efforts to establish Copaxone ® as a leading therapy for multiple sclerosis and have increased our global market share among the currently available major therapies for multiple sclerosis. However, Copaxone ® faces intense competition from existing products, such as Avonex ® , Betaseron ® and Rebif ® . We may also face competition from additional products in development. In addition, the exclusivity protections afforded us in the United States through orphan drug status for Copaxone ® expired on December 20, 2003. If our patents on Copaxone ® are successfully challenged, we may also face generic competition for this product.

 

We are subject to government regulation that increases our costs and could prevent us from marketing or selling our products.

 

We are subject to extensive pharmaceutical industry regulations in the United States, Canada, the European Union, and its member states including England, Hungary, The Netherlands, France and Italy, in Israel and in other jurisdictions. We cannot predict the extent to which we may be affected by legislative and other regulatory developments concerning our products. We are also subject to various environmental laws and regulations in the jurisdictions where we have operations.

 

We are dependent on obtaining timely approvals before marketing most of our products. In the United States, any manufacturer failing to comply with FDA or other applicable regulatory agency requirements may be unable to obtain approvals for the introduction of new products and, even after approval, initial product shipments may be delayed. The FDA also has the authority to revoke drug approvals previously granted and remove from the market previously approved drug products containing ingredients no longer approved by the FDA. Our major facilities, both in the United States and outside the United States, and our products are periodically inspected by the FDA, which has extensive enforcement powers over the activities of pharmaceutical manufacturers, including the power to seize, force to recall and prohibit the sale or import of non-complying products, and halt operations of and criminally prosecute non-complying manufacturers.

 

In Europe and Israel, the manufacture and sale of pharmaceutical products is regulated in a manner similar in many respects to that in the United States. Legal requirements generally prohibit the handling, manufacture, marketing and importation of any pharmaceutical product unless it is properly registered in accordance with applicable law. The registration file relating to any particular product must contain medical data related to product efficacy and safety, including results of clinical testing and references to medical publications, as well as detailed information regarding production methods and quality control. Health ministries are authorized to cancel the registration of a product if it is found to be harmful or ineffective or manufactured and marketed other than in accordance with registration conditions.

 

Data exclusivity provisions exist in many countries worldwide, including in the European Union, where they were recently extended, although their application is not uniform. Similar provisions may be adopted by additional countries, including Israel, where legislation has been proposed. In general, these exclusivity provisions prevent the approval and/or submission of generic drug applications to the health authorities for a fixed period of time following the first approval of the brand name product in that country. As these exclusivity provisions operate independently of patent exclusivity, they may prevent the submission of generic drug applications for some products even after the patent protection has expired.

 

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We may not be able to successfully identify, consummate and integrate future acquisitions.

 

In the past, we have grown, in part, through a number of significant acquisitions, including our recent acquisition of Sicor Inc. We continue to be engaged in various stages of evaluating or pursuing potential acquisitions and may in the future acquire other pharmaceutical and active pharmaceutical ingredients businesses and seek to integrate them into our own operations. Future acquisitions involve known and unknown risks that could adversely affect our future revenues and operating results. For example:

 

    We compete with others to acquire companies. We believe that this competition has intensified and may result in decreased availability or increased prices for suitable acquisition candidates.

 

    We may not be able to obtain the necessary regulatory approvals, including the approval of anti-competition regulatory bodies, in any countries in which we may seek to consummate potential acquisitions.

 

    We may ultimately fail to consummate an acquisition even if we announce that we plan to acquire a company.

 

    We may fail to successfully integrate our acquisitions in accordance with our business strategy.

 

    Potential acquisitions may divert management’s attention away from our primary product offerings, resulting in the loss of key customers and/or personnel and expose us to unanticipated liabilities.

 

    We may not be able to retain the skilled employees and experienced management that may be necessary to operate the businesses we may acquire and, if we cannot retain such personnel, we may not be able to locate or hire new skilled employees and experienced management to replace them.

 

    We may purchase a company that has contingent liabilities that include, among others, known or unknown patent or product liability claims.

 

As a pharmaceutical company, we are susceptible to product liability claims that may not be covered by insurance, including potential claims relating to products that we previously sold or currently sell and that are not covered by insurance.

 

Our business inherently exposes us to claims relating to the use of our products. We sell, and will continue to sell, pharmaceutical products for which product liability insurance coverage is not available, and accordingly, we may be subject to claims that are not covered by insurance as well as claims that exceed our policy limits. Additional products for which we currently have coverage may be excluded in the future. In addition, product liability coverage for pharmaceutical companies is becoming more expensive and increasingly difficult to obtain. As a result, we may not be able to obtain the type and amount of coverage we desire. Because of the nature of these claims, we are generally not permitted under US GAAP to establish reserves in our accounts for such contingencies.

 

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Reforms in the health care industry and the uncertainty associated with pharmaceutical pricing, reimbursement and related matters could adversely affect the marketing, pricing and demand for our products.

 

Increasing expenditures for health care have been the subject of considerable public attention in Israel, North America and many European countries. Both private and governmental entities are seeking ways to reduce or contain health care costs. In many countries in which we currently operate, including Israel, pharmaceutical prices are subject to regulation. In the United States, numerous proposals that would effect changes in the United States health care system have been introduced or proposed in Congress and in some state legislatures, including the enactment in December 2003 of expanded Medicare coverage for drugs. Similar activities are taking place throughout Europe and Israel. We cannot predict the nature of the measures that may be adopted or their impact on the marketing, pricing and demand for our products.

 

The success of our innovative products depends on the effectiveness of our patents and other measures we take to protect our intellectual property rights.

 

Our success with our innovative products depends, in part, on our ability to protect our current and future innovative products and to defend our intellectual property rights. If we fail to adequately protect our intellectual property, competitors may manufacture and market products similar to ours. We have been issued patents covering our innovative products, and have filed, and expect to continue to file, patent applications seeking to protect newly developed technologies and products in various countries, including the United States. Any existing or future patents issued to or licensed by us may not provide us with any competitive advantages for our products or may even be challenged, invalidated or circumvented by competitors. In addition, such patent rights may not prevent our competitors from developing, using or commercializing products that are similar or functionally equivalent to our products.

 

We also rely on trade secrets, unpatented proprietary know-how and continuing technological innovation that we seek to protect, in part by confidentiality agreements with licensees, suppliers, employees and consultants. It is possible that these agreements will be breached and we will not have adequate remedies for any such breach. Disputes may arise concerning the ownership of intellectual property or the applicability of confidentiality agreements. Furthermore, our trade secrets and proprietary technology may otherwise become known or be independently developed by our competitors or, if patents are not issued with respect to products arising from research, we may not be able to maintain the confidentiality of information relating to such products.

 

We have significant international operations, including in Israel, which may be adversely affected by acts of terrorism, major hostilities or adverse legislation or litigation.

 

Significant portions of our operations are conducted outside of the United States, and we import a substantial number of products into the United States. We may, therefore, be directly affected and denied access to our customers by a closure of the borders of the United States for any reason or other economic, political and military conditions in the countries in which our businesses are located. We may also be affected by currency exchange rate fluctuations and the exchange control regulations of such countries or other political crisis or disturbances, which impede access to our suppliers.

 

Our executive offices and a substantial number of our manufacturing facilities are located in Israel. Teva’s Israeli operations are dependent upon materials imported from outside of Israel. We also export significant amounts of products from Israel. Accordingly, our operations could be materially and

 

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adversely affected by acts of terrorism or if major hostilities should occur in the Middle East or trade between Israel and its present trading partners should be curtailed, including as a result of acts of terrorism in the United States. Any such effects may not be covered by insurance.

 

We may be subject to legislation in Israel, primarily relating to the protection of patents and data exclusivity provisions, that would prevent us from exporting Israeli-manufactured products in a timely fashion. Additionally, the existence of third party patents in Israel, with the attendant risk of litigation, may cause Teva to move production outside of Israel or otherwise adversely affect our ability to export certain products from Israel. Although legislation addressing these problems has been proposed, we can not assure you that it will be enacted.

 

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