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The following is an excerpt from a 20-F SEC Filing, filed by TARO PHARMACEUTICAL INDUSTRIES LTD on 6/29/2004.
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TARO PHARMACEUTICAL INDUSTRIES LTD - 20-F - 20040629 - COMPANY_INFORMATION

     In each province of Canada there is a drug benefit formulary. A formulary lists the drugs for which a provincial government will reimburse qualifying persons and the prices at which the government will reimburse such persons. There is not complete uniformity among provinces. However, provincial governments generally will reimburse the lowest available price of the generic equivalents of any drug listed on the formulary list of the province. The formularies can also provide for drug substitution, even for patients who do not qualify for government reimbursement. The effect of these provincial formulary regimes is to encourage the sale of lower-priced versions of pharmaceutical products. The potential lack of reimbursement represents a significant threat to our business. Additionally, the substitution effect may adversely affect our ability to profitably market our products.

We may be adversely affected if the rate of inflation in Canada exceeds the rate of devaluation of the Canadian dollar against the U.S. dollar.

     A substantial portion of our expenses, primarily labor and occupancy expenses in Canada, is incurred in Canadian dollars. As a result, the cost of our operations in Canada, as measured in U.S. dollars, is subject to the risk that the rate of inflation in Canada will exceed the rate of devaluation of the Canadian dollar in relation to the U.S. dollar or that the timing of any devaluation will lag behind inflation in Canada. If the U.S. dollar cost of our operations in Canada increases, our U.S. dollar-measured results of operations will be adversely affected.

ITEM 4. INFORMATION ON THE COMPANY

      A. HISTORY AND DEVELOPMENT OF THE COMPANY

     The legal and commercial name of our company is Taro Pharmaceutical Industries Ltd. We were incorporated under the laws of the State of Israel in 1959 under the name Taro-Vit Chemical Industries Ltd. In 1984, we changed our name to Taro Vit Industries Ltd. and in 1994 we changed our name to Taro Pharmaceutical Industries Ltd. In 1961, we completed the initial public offering of our ordinary shares, which are currently traded on the Nasdaq National Market under the symbol “TARO.” In that year, we also acquired 97% of the outstanding stock of an Israeli corporation, then known as Taro Pharmaceutical Industries Ltd., or TPIL. In 1981, we sold 37% of our interest in TPIL. In 1993, after acquiring all of the outstanding shares of TPIL, we merged TPIL into our company. In July 2001, we completed a split of our ordinary shares by distributing a dividend of one ordinary share for each ordinary share then outstanding and one ordinary share for every ten founders’ shares then outstanding. In October 2001, we sold 3,950,000 of our ordinary shares, and selling shareholders sold 1,800,000 of our ordinary shares, in a public offering.

     In May 2002, we purchased substantially all of the assets of Thames Pharmacal Company, Inc., or Thames, a manufacturer of prescription and OTC pharmaceuticals, through a newly-created subsidiary of Taro U.S.A. The purchase price was approximately $6.4 million, all of which was paid in cash. The assets acquired included

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the right to all of Thames’ generic prescription and OTC products, as well as Thames’ laboratories and manufacturing operations. We also added to our operations all of Thames’ approximately 60 employees and acquired the leases for its facilities, which include laboratories, manufacturing and warehousing operations, located in Ronkonkoma, New York.

     On January 14, 2003, Taro Pharmaceuticals North America Inc., or TNA, entered into a license and option agreement with Medicis Pharmaceutical Corporation, or Medicis. According to the agreement, TNA, on June 1, 2004, exercised its option and purchased from Medicis four branded prescription product lines for sale in the United States and Puerto Rico for an aggregate purchase price of $23.8 million. Approximately $11.7 million was for the licensing period and was payable over five consecutive quarters. The balance of $12.1 million was due upon the exercise of the purchase option. Two of these products are used in dermatology and the other two are used in pediatrics.

     On March 21, 2003, our Irish subsidiary, Taro Pharmaceuticals Ireland Ltd., acquired, for 5.55 million Euros paid in cash, a multi-purpose pharmaceutical manufacturing and research facility in Ireland. The facility was purchased out of liquidation proceedings under the Official Liquidator appointed by the High Court of Ireland.

     The facility consists of 124,000 square feet of manufacturing, laboratory, office and warehouse space located on a 14-acre campus in central Ireland. The facility, which was operating until the end of 2002, has been licensed and approved by the Irish Medicines Board to manufacture and distribute pharmaceutical products in Ireland and the European Union.

     In December 2003, our Canadian subsidiary expanded its distribution capacity with the purchase of a 108,797 square foot distribution facility located on 6.7 acres in Brampton, Ontario in close proximity to the existing facilities.

     In January 2004, our U.S. subsidiary expanded its distribution capacity with the purchase of a 315,000 square foot distribution center on 25 acres of land in South Brunswick, New Jersey. The U.S. subsidiary acquired the facility for approximately $18 million. In conjunction with the purchase, we expect that the U.S. subsidiary will receive some financial incentives from the New Jersey Economic Development Authority.

     Our registered office in Israel is located at 14 Hakitor Street, Haifa Bay, Israel, 26100. Our principal executive offices are located at Italy House, Euro Park, Yakum 60972, Israel, and our telephone number there is 972-9-971-1800.

Capital Expenditures

     During the past three years, our capital expenditures amounted to approximately $156.9 million. The focus of our capital expenditure program has been the expansion and upgrade of our manufacturing facilities and information technology systems in order to enable us to increase operational efficiencies, remain in compliance with current Good

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Manufacturing Practices, or cGMP, accommodate increasing demand for our products, and maintain a competitive position in the marketplace.

     The major projects undertaken during the past three years, as part of our capital expenditure program, include:

the expansion of our production and distribution facilities in Canada and Israel;

the construction of new research and development and plant operations facilities in Canada and Israel;

the acquisition of additional production and packaging equipment;

the upgrade of our information technology systems;

acquisition of additional land in Haifa Bay, Israel for expansion of our facilities;

acquisition of a facility (previously rented by us) in Canada;

acquisition of Thames;

acquisition of a 32% interest in a 123,713 square feet building adjacent to the offices of Taro U.S.A. for the construction of research laboratory and administrative offices;

acquisition of a multi-purpose pharmaceutical manufacturing and research facility in Ireland;

acquisition of a distribution center facility in New Jersey; and

acquisition of a distribution facility in Ontario, Canada.

     In addition, in anticipation of an increase in sales and the overall growth of our operations, we have purchased, leased or contracted to purchase additional properties and ordered new equipment for our construction of new multi-purpose pharmaceutical and chemical plants in Haifa Bay, Israel. (For a detailed presentation of our property, plant and equipment, please see Note 5 to our consolidated financial statements included elsewhere in this report.)

      B. BUSINESS OVERVIEW

     We are a multinational, science-based pharmaceutical company. We develop, manufacture and market prescription and OTC pharmaceutical products, as well as active pharmaceutical ingredients, or APIs, primarily in the United States, Canada and Israel. Our primary areas of focus include topical creams and ointments, liquids, capsules and tablets mainly in the dermatological, cardiovascular and central nervous system therapeutic categories. We operate principally through three entities: Taro Pharmaceutical Industries Ltd., or Taro Israel, and two of its subsidiaries, Taro Pharmaceuticals Inc., or

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Taro Canada, and Taro U.S.A. The principal activities and primary product lines of these subsidiaries may be summarized as follows:

                 
Entity
  Principal Activities
  Primary Product Lines
Taro Israel
    Manufactures more than 60 finished dosage form pharmaceutical products for sale in Israel and for export     Dermatology: Prescription and OTC semi-solid products (creams, ointments, gels and liquids)
 
               
    Produces, for its own use and for sale to third parties, APIs used in the manufacture of finished dosage form pharmaceutical products  


  Cardiology and Neurology: Prescription oral dosage products

Oral Analgesics: Prescription and OTC
 
               
    Markets both proprietary and generic products in the local Israeli market     OTC Nasal Sprays and Nutritional Supplements
 
               
    Performs research and development independently and through Taro Research Institute Ltd., a Taro subsidiary     Oral, Opthalmic and OTC preparations
 
               
Taro Canada
    Manufactures more than 45 finished dosage form pharmaceutical products for sale in Canada and for export     Dermatology: Prescription and OTC semi-solid products (creams, ointments, gels and liquids)
 
               
    Markets both proprietary and generic products in the local Canadian market     Cardiology and Neurology: Prescription oral dosage products
 
               
    Performs research and development independently and through Taro Research Institute        
 
               
Taro U.S.A.
    Manufactures more than 10 finished dosage form pharmaceutical products for sale in the United States and for export     Dermatology: Prescription and OTC semi-solid products (creams, ointments, gels and liquids)
 
               
    Markets both proprietary and generic products in the local U.S. market     Cardiology and Neurology: Prescription oral dosage products
 
               
    Performs research and development independently and through Taro Research Institute     OTC products

     In May 2001, we received approval from the FDA to market the first generic equivalent of Schering-Plough’s Lotrisone® cream, which we began to sell at the end of that month. According to industry sources, within a few weeks we had become the

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leading supplier of the generic equivalent of Lotrisone® cream in the United States, a position which we maintained throughout the remainder of 2001, 2002 and 2003. Our generic equivalent of Lotrisone® cream was our largest selling product and comprised approximately 11%, 16% and 19% of our consolidated sales in 2003, 2002 and 2001, respectively.

     As of April 29, 2004 31 of our ANDAs and one NDA are being reviewed by the FDA. In addition, there are multiple products for which either development or internal regulatory work is in process. The applications pending before the FDA are at various stages in the review process, and there can be no assurance that we will be able to successfully complete any remaining testing or that, upon completion of such testing, approvals for any of the applications currently under review at the FDA will be granted. In addition, there can be no assurance that the FDA will not grant approvals for competing products submitted by our competitors prior to granting approval to us.

The Generic Pharmaceutical Industry

     Generic pharmaceuticals are the chemical and therapeutic equivalents of brand-name drugs and are typically marketed after the patents for brand-name drugs have expired. Generic pharmaceuticals generally must undergo clinical testing that demonstrates that they are bioequivalent to their branded equivalents and are manufactured to the same standards. Proving bioequivalence generally requires data demonstrating that the generic formulation results in a product whose rate and extent of absorption are within an acceptable range of the results achieved by the brand-name reference drug. In some instances, bioequivalence can be established by demonstrating that the therapeutic effect of the generic formula falls within an acceptable range of the therapeutic effects achieved by the brand-name reference drug.

     Generic pharmaceutical products must meet the same quality standards as branded pharmaceutical products although they are sold at prices that are substantially lower than those of their branded counterparts. As a result, generic pharmaceuticals represent a much larger percentage of total drug prescriptions dispensed than their corresponding percentage of total sales. This discount tends to increase (and margins tend to decrease) as the number of generic competitors increases for a given product. Because of this pricing dynamic, companies that are among the first to develop and market a generic pharmaceutical tend to earn higher profits than companies that subsequently enter the market for that product. Furthermore, products that are difficult to develop or are intended for niche markets generally attract fewer generic competitors and therefore may offer higher profit margins than those products that attract a larger number of competitors. However, profit is influenced by many factors other than the number of competitors for a given drug or the size of the market. Depending on the actions of each of our competitors, price discounts can be just as significant for a specific product with only a few competitors or a small market, as for a product with many competitors or a large market.

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     In recent years, the market for generic pharmaceuticals has grown dramatically. We believe that this growth has been driven by the following factors, among others:

  efforts by governments, employers, third-party payors and consumers to control healthcare costs;

  increased acceptance of generic products by physicians, pharmacists and consumers; and

  the increasing number of pharmaceutical products whose patents have expired and are therefore subject to competition from, and substitution by, generic equivalents.

Products

     Currently, we market more than 180 pharmaceutical products in over 20 countries. The following table represents some of our key product groups and the major markets in which they are sold:

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        U.S. Brand   Therapeutic   Major   Rx/
Product Groups
  Dosage Form
  Name
  Category
  Markets
  OTC
Amiodarone HCI
  tablets   Cordarone®   Cardiovascular   U.S.   Rx
 
                   
Ammonium Lactate
  cream   Lac-Hydrin®   Moisturizer   U.S. Canada   Rx/
OTC
 
                   
Bethamethasone
Dipropionate
(augmented)
  cream, gel   Diprolene®   Topical
Corticosteroid
  U.S.   Rx
 
                   
Carbamazepine
  tablets, controlled release tablets, chewable tablets, oral suspension   Tegretol®   Anticonvulsant   U.S. Canada Israel   Rx
 
                   
Clobetasol
Propionate
  cream, ointment, gel, topical solution, emollient cream   Temovate®   Topical
Corticosteroid
  U.S.   Rx
 
                   
Clorazepate
Dipotassium
  tablets   Tranxene®   Antianxiety   U.S.   Rx
 
                   
Clotrimazole
  cream, topical solution,
vaginal cream
  Lotrimin®,
Gyne-Lotrimin®
  Antifungal   U.S. Canada Israel   Rx/
OTC
 
                   
Clotrimazole and Betametazone
Dipropionate
  cream   Lotrisone®   Antifungal   U.S.   Rx
 
                   
Desonide
  cream, ointment   Tridesilon®   Topical
Corticosteroid
  U.S.   Rx
 
                   
Desoximetasone
  cream, ointment, gel   Topicort®   Topical
Corticosteroid
  U.S. Canada Israel   Rx
 
                   
Diflorasone
Diacetate
  cream, ointment   Psorcon®   Topical
Corticosteroid
  U.S.   Rx
 
                   
Econazole Nitrate
  C   Spectazole®   Antifungal   U.S.   Rx
 
                   
  ream                
 
                   
Enalapril/Enalapril
Hydrochlorothiazide
  tablets   Vasotec®/Vaseretic®   Cardiovascular   U.S.   Rx
 
                   
Etodolac
  tablets, capsules   Lodine®   Analgesic   U.S. Canada Israel   Rx
 
                   
Etodolac XL
  extended release tablets,
capsules
  Lodine XL®   Analgesic   U.S. Israel   Rx
 
                   
Fluocinonide
  cream, ointment, gel,
topical solution,
emollient cream
  Lidex®   Topical
Corticosteroid
  U.S. Canada Israel   Rx
 
                   
Fluorouracil
  solution   Efuex®   Topical   U.S.   Rx

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        U.S. Brand   Therapeutic   Major   Rx/
Product Groups
  Dosage Form
  Name
  Category
  Markets
  OTC
Hydrocortisone
Valerate
  cream, ointment   Westcort®   Topical
Corticosteroid
  U.S.   Rx
 
                   
Hydrocortisone
  cream, ointment   Cortizone®   First Aid   U.S. Canada Israel   OTC
 
                   
Ketoconazole
  tablets, cream   Nizoral®   Antifungal   U.S.   Rx
 
                   
Malathion
  lotion   Ovide®   Pediculicide   U.S.   Rx
 
                   
Nystatin
  cream, ointment, oral
suspension, vaginal cream
  Mycostatin®   Antifungal   U.S. Canada Israel   Rx/
OTC
 
                   
Salicyclic Acid and Urea
  ointment   Kersal®   Exfoliating
Moisturizer
  U.S. Canada   OTC
 
                   
Triamcinolone
Acetonide
  cream, ointment, dental
paste, dental paste with
lidocane
  Kenalog®   Topical
Corticosteroid
  U.S.
Canada
Israel
  Rx
 
                   
Warfarin Sodium
  tablets   Coumadin®   Anticoagulant   U.S. Canada Israel   Rx

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     Topical corticosteroids are used in the treatment of some dermatologic conditions (including psoriasis, eczema and various types of skin rashes). Antifungals are used in the treatment of some infections (including athlete’s foot, ringworm and vaginal yeast infections). Anticonvulsants are used in the treatment of various seizure disorders (including epilepsy). Cardiovascular products are used in the treatment of heart disease. There are several categories of cardiovascular drugs, including anticoagulants, antihypertensive and antiarrhythmics. Anticoagulants are blood thinners used in the treatment of heart disease and stroke associated with heart disease.

Sales and Marketing

     In the United States, Israel and Canada, our sales are primarily generated by our own dedicated sales force. In other countries, we sell through agents and other distributors. Our sales force is supported by our customer service and marketing employees.

     The following is a breakdown of our sales by geographic region, including the percentage of our total consolidated sales for each period:

                                                 
    2003
  2002
  2001
    In   % of our   In   % of our   In   % of our
    thousands
  total sales
  thousands
  total sales
  thousands
  total sales
U.S.A.
  $ 283,197       90 %   $ 183,857       87 %   $ 123,762       83 %
Canada
    15,603       5 %     12,819       6 %     8,968       6 %
Israel
    13,468       4 %     11,809       5 %     13,690       9 %
Other
    3,190       1 %     3,096       2 %     2,810       2 %
 
   
 
     
 
     
 
     
 
     
 
     
 
 
Total
  $ 315,458       100 %   $ 211,581       100 %   $ 149,230       100 %
 
   
 
     
 
     
 
     
 
     
 
     
 
 

     In 2003, sales in the United States accounted for approximately 90% of our total consolidated sales. In addition to marketing prescription drugs, Taro U.S.A. markets its OTC products primarily as store brands under its customers’ labels to wholesalers, drug chains, food chains and mass merchandisers. During 2003, we sold to approximately 250 customers in the United States. The following table represents sales to our three largest wholesale customers as a percent of consolidated sales during the last three years:

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Customer
  2003
  2002
  2001
AmerisourceBergen Corporation
    20 %     22 %     13 %
McKesson Corporation
    17 %     12 %     15 %
Cardinal Health, Inc.
    9 %     9 %     9 %

     The following table sets forth the contributions to sales by each type of customer of Taro U.S.A. in 2003:

         
    Percentage of
Customer Type
  Consolidated Sales
Drug wholesalers
    52 %
Drug store chains
    15 %
Mass merchandisers food and retail chains
    11 %
Generic drug distributors
    8 %
Managed care organizations
    4 %

     In 2003, sales in Israel accounted for approximately 4% of our total consolidated sales. The marketing sales and distribution of prescription pharmaceuticals and OTC products in Israel is closely monitored by the Israeli government. The market for these products is dominated by institutions that are similar to health maintenance organization in the United States, as well as private pharmacies. Most of our marketing efforts in Israel focus on selling directly to these groups. In 2003, sales to other international markets accounted for approximately 1% of our consolidated sales.

     All pharmaceutical products sold in Israel are subject to price controls. Permitted price increases are enacted by the Israeli government as part of a formal review process. In addition, recently enacted parallel import regulations are expected to further increase pressure within the industry to lower prices on prescription products. There are no restrictions on the import of pharmaceuticals, provided that they comply with registration requirements of the Israeli Ministry of Health.

     In Israel, the pharmaceutical market is divided into two market segments: (i) the private market, which includes drug store chains, private pharmacies and wholesalers; and

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(ii) the institutional market, which includes Kupat Holim Klalit or Kupat Holim (the largest health fund in Israel), the Israel Ministry of Health and other health insurance groups.

     The following table sets forth the contributions to sales by each type of customer of Taro Israel and other international markets in 2003:

         
    Percentage of
Customer Type
  Consolidated Sales
Institutional market
    3 %
Private market
    1 %
Other international markets
    1 %

     In 2003, sales in Canada accounted for approximately 5% of our total consolidated sales. Taro Canada has approximately 4,000 customers, which consist primarily of independent pharmacies.

     The following table sets forth the contributions to sales by each type of customer of Taro Canada in 2003:

         
    Percentage of
Customer Type
  Consolidated Sales
Drug wholesalers
    4 %
Drug chains, independent pharmacies and others
    1 %

     As a result of our sales growth during the past five years, especially in North America, we have expanded the production capacity of our Israel, U.S. and Canadian operations. In addition, we utilize contract manufacturing for certain products to satisfy customer demand in a timely manner. In 2001, 2002 and 2003, our production capacity increased significantly as a result of our investment in facilities, capital equipment and an increase in the number of our manufacturing personnel. As a result, in each of 2001, 2002 and 2003, backorders generally represented less than one percent (1%) of our annualized consolidated sales .

Competition and Pricing

     The pharmaceutical industry is intensely competitive. We compete with the original manufacturers of the brand-name equivalents of our generic products, other generic drug manufacturers (including brand-name companies that also manufacture generic drugs), and manufacturers of new drugs that may compete with our generic drugs. Many of our competitors have greater financial, production and research and development resources, substantially larger sales and marketing organizations, and substantially greater name recognition than we have.

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     Historically, brand-name drug companies have attempted to prevent generic drug manufacturers from producing certain products and to prevent competing generic drug products from being accepted as equivalent to their brand-name products. We expect such efforts to continue in the future. Also, some brand-name competitors, in an attempt to participate in the generic drug sales of their branded products, have introduced generic equivalents of their own branded products, both prior and subsequent to the expiration of their patents or FDA exclusivity periods for such drugs. These competitors have also introduced generic equivalents of brand-name drug products other than their own.

     In the United States, we compete with such brand-name manufacturers as Novartis, Schering-Plough, Medicis Pharmaceutical, GlaxoSmithKline and Bristol-Myers Squibb, as well as with generic companies such as Alpharma, Altana, Atrix, Barr Laboratories, Clay Park Labs, Geneva Pharmaceuticals, Mylan Laboratories, Teva Pharmaceuticals U.S.A. and Warrick Pharmaceuticals. In the market for proprietary drugs, our ElixSure® products compete with products of Johnson & Johnson, Novartis and Wyeth among others. These companies have more resources, market and name recognition and better access to customers than we have. Therefore, there can be no assurance of the success of any of our products, including but not limited to our ElixSure® products.

     We compete in the Canadian market with Hoffmann-La Roche, Schering Canada, Novartis, GlaxoSmithKline, Medicis Canada, Bayer and Bristol-Myers Squibb Canada, as well as with other manufacturers of generic products, such as Apotex, Novopharm Limited (Teva), Ratiopharm, GenPharm and Pharmascience.

     Pricing in Canada is established in part by competitive factors and in part by Canadian formulary price lists published by the Canadian provinces.

     In Israel, we compete with Teva Pharmaceutical Industries Ltd., Agis Industries (1983) Ltd., Dexon and Rafa, among others. In addition, many leading multinational companies, including Bayer, Eli Lilly, Merck and Pfizer, market their products in Israel.

     In Israel, the government establishes the prices for pharmaceutical products as part of a formal review process. In addition, recently enacted parallel import regulations are expected to further increase pressure within the industry to lower prices. There are no restrictions on the import of pharmaceuticals provided that they comply with registration requirements of the Israeli Ministry of Health.

Manufacturing and Raw Materials

     We currently manufacture finished pharmaceutical products at our government approved facilities in the United States, Canada and Israel and active pharmaceutical ingredients at our facilities in Israel. Due to the continued growth of sales of our products, we have been expanding these facilities, our related research and development and warehousing facilities and we are continuing to do so.

     For the manufacture of our finished dosage form pharmaceutical products, we use pharmaceutical chemicals that we either produce ourselves or purchase from chemical

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manufacturers in the open market globally. Substantially all of such chemicals are obtainable from a number of sources, subject to regulatory approval. However, we purchase certain raw materials from single source suppliers. Obtaining the regulatory approvals required to add alternative suppliers of such raw materials for products sold in the United States or Canada may be a lengthy process. We strive to maintain adequate inventories of single source raw materials in order to ensure that any delays in receiving such regulatory approvals will not have a material adverse effect on our business. However, we may become unable to sell certain products in the United States or Canada pending approval of one or more alternate sources of raw materials.

     We synthesize the active pharmaceutical ingredient used in some of our key products, including our warfarin sodium tablets, our carbamazepine products and our clorazepate dipotassium tablets. We plan to continue the strategic selection of active pharmaceutical ingredients for synthesis in order to maximize the advantages from this scientific capability.

Industry Practices Relating to Working Capital Items

     Certain customary industry selling practices affect our supply of working capital, including, but not limited to providing favorable payment terms to customers and discounting selling prices through the issuance of free products as well as other incentives within a specified time frame if a customer purchases more than a specified threshold of a product. These incentives are provided principally with the intention of maintaining or expanding our distribution at the expense of competing products.

     Industry standards require that pharmaceutical products be made available to customers from existing stock levels rather than on a made-to-order basis. Therefore, in order to accommodate market demand adequately, we strive to maintain sufficiently high levels of inventories. The growth of our sales in the past few years has resulted in higher levels of inventory in anticipation of additional business for new products and from new customers, the exact timing of which cannot be accurately determined.

Government Regulation

     We are subject to extensive pharmaceutical industry regulation in the United States, Canada, Israel and other jurisdictions, and may be subject to future legislative and other regulatory developments concerning our products and the healthcare field generally. Any failure by us to comply with applicable policies and regulations of any of the numerous authorities that regulate our industry could have a material adverse effect on our results of operations.

     In the United States, Canada, Israel and other jurisdictions, the manufacture and sale of pharmaceutical products are regulated in a similar manner. Legal requirements generally prohibit the handling, manufacture, marketing and importation of any pharmaceutical product unless it is properly registered in accordance with applicable law. In addition, approval is required before any new drug or a generic equivalent to a previously approved drug can be marketed. Furthermore, each country requires approval of manufacturing facilities, including adherence to good manufacturing practices during the production and storage of

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pharmaceutical products. As a result, we have had periodic inspections of our facilities and records. For example, Taro Canada was inspected by the FDA in 1995, 1996, 1998 and 2001 and our facilities in Haifa Bay, Israel were inspected by the FDA in 1996, 1997, 1999 and 2002.

     Regulatory authorities in each country also have extensive enforcement powers over the activities of pharmaceutical manufacturers, including the power to seize, force the recall of and prohibit the sale or import of non-complying products and, to halt the operations of and criminally prosecute and fine non-complying manufacturers. These regulatory authorities also have the power to revoke approvals previously granted and remove from the market previously approved drug products.

     In the United States, Canada, Israel and other jurisdictions, we, as well as other manufacturers of drugs, are dependent on obtaining timely approvals for products. The approval process in each country has become more rigorous and costly in recent years. There can be no assurance that approvals will be granted in a timely manner or at all. In the United States, Canada, Israel and other jurisdictions, the procedure for drug product approvals, if such approval is ultimately granted, generally takes longer than one year. Inability or delay in obtaining approvals for our products could adversely affect our product introduction plans and our results of operations.

     In the United States, any drug that is not generally recognized as safe and effective by qualified experts for its intended use is deemed to be a “new drug” which requires FDA approval. Approval is obtained, either by the submission of an ANDA or an NDA. If the “new drug” is a new dosage form, a strength not previously approved, a new indication or an indication for which the ANDA procedure is not available, an NDA is required.

     We generally receive approval for generic products by submitting an ANDA to the FDA. When processing an ANDA, the FDA waives the requirement of conducting complete clinical studies, although it may require bioavailability and/or bioequivalence studies. “Bioavailability” is generally determined by the rate and extent of absorption and levels of concentration of a drug product in the blood stream needed to produce a therapeutic effect. “Bioequivalence” compares the bioavailability of one drug product with another and, when established, indicates that the rate of absorption and levels of concentration of a generic drug in the body or on the skin are substantially equivalent to the previously approved brand-name reference drug. An ANDA may be submitted for a drug on the basis that it is bioequivalent to a previously listed drug, contains the same active ingredient, has the same route of administration, dosage form, and strength as the listed drug, and otherwise complies with legal and regulatory requirements. There can be no assurance that approval for ANDAs can be obtained in a timely manner, or at all. ANDA approvals are granted after the review by the FDA of detailed information submitted as part of the ANDA regarding the pharmaceutical ingredients, drug production methods, quality control, labeling, and demonstration that the product is therapeutically equivalent or bioequivalent to the brand-name reference drug. Demonstrating bioequivalence generally requires data demonstrating that the generic formula results in a product whose rate and extent of absorption are within an acceptable range of the results achieved by the brand-name reference drug. In some instances, bioequivalence can be established by demonstrating that the therapeutic effect of the generic formula falls within an

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acceptable range of the therapeutic effects achieved by the brand-name reference drug. Approval of an ANDA, if granted, generally takes more than one year from the submission of the application.

     Products resulting from our proprietary drug program may require us to submit an NDA to the FDA. When processing an NDA, the FDA generally requires, in addition to the ANDA requirements (except for bioequivalence), complete pharmacological and toxicological studies in animals and humans to establish the safety and efficacy of the drug. However, the clinical studies required prior to the NDA submission are both costly and time consuming, and often take five to seven years or longer, depending, among other factors, on the nature of the chemical ingredients involved and the indication for which the approval is sought. Approval of an NDA, if granted, generally takes at least one year from the submission of the application to the FDA.

     Among the requirements for drug approval by the FDA is that manufacturing procedures and operations conform to cGMP, as defined in the U.S. Code of Federal Regulations. The cGMP regulations must be followed at all times during the manufacture of pharmaceutical products. In complying with the standards set forth in the cGMP regulations, a manufacturer must expend time, money and effort in the areas of production and quality control to ensure full compliance.

     If the FDA believes a company is not in compliance with cGMP, certain sanctions may be imposed, including: (i) withholding new drug approvals as well as approvals for supplemental changes to existing applications; (ii) preventing the receipt of necessary licenses to export products; (iii) preventing the importation of certain products into the United States; (iv) classifying the company as an “unacceptable supplier” and thereby disqualifying the company from selling products to federal agencies and (v) pursuing a consent decree or court action that limits company operations or imposes monetary fines. We believe that we are currently in substantial compliance with cGMP.

     In addition, because we market a controlled substance in the United States and other controlled substances in Canada and Israel, we must meet the requirements of the United States Controlled Substances Act and its equivalents in Israel and Canada, as well as the regulations promulgated thereunder in each country. These regulations include stringent requirements for manufacturing controls, receipt and handling procedures and security to prevent diversion of, or the unauthorized access to, the controlled substances in each stage of the production and distribution process.

     In May 1992, the Generic Drug Enforcement Act of 1992, or the Generic Act, was enacted. The Generic Act, a result of legislative hearings and investigations into the generic drug approval process, allows the FDA to impose debarment and other penalties on individuals and companies that commit certain illegal acts relating to the generic drug approval process. In some situations, the Generic Act requires the FDA not to accept or review for a period of time ANDAs from a company or an individual that has committed certain violations. It also provides for temporary denial of approval of applications during the investigation of certain violations that could lead to debarment and also, in more limited

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circumstances, provides for the suspension of the marketing of approved drugs by the affected company.

     Lastly, the Generic Act allows for civil penalties and withdrawal of previously approved applications. To our knowledge, neither we nor any of our employees has ever been subject to debarment.

     The review process in Canada and Israel is substantively similar to the review process in the United States.

Environmental Compliance

     We believe that we are currently in compliance with all applicable environmental laws and regulations in Canada,the United States and Ireland. In Israel, in light of the continued expansion of our Haifa Bay facility and an enhanced general enforcement program instituted by the Israeli Ministry of the Environment, we have taken steps to improve our waste water treatment facility and plan to further upgrade our facility in accordance with a plan submitted to the Ministry. The cost of this program is not anticipated to have a material adverse effect on our business or operations. However, environmental laws and regulations may become more stringent and therefore require us to commit substantial resources which are beyond our current plan.

      C. ORGANIZATIONAL STRUCTURE

     The legal and commercial name of our company is Taro Pharmaceutical Industries Ltd. We were incorporated under the laws of the State of Israel in 1959 under the name Taro-Vit Chemical Industries Ltd. In 1984, we changed our name to Taro Vit Industries Ltd., and in 1994, we changed our name to Taro Pharmaceutical Industries Ltd.

     The following is a list of our principal subsidiaries and countries of incorporation:

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Name of Subsidiary
  Country of Incorporation
Taro Research Institute Ltd.
  Israel
 
   
Taro International Ltd.
  Israel
 
   
Taro Pharmaceuticals U.S.A., Inc.
  United States
 
   
Taro Pharmaceuticals Inc.
  Canada
 
   
Taro Pharmaceuticals North America, Inc.
  Cayman Islands
 
   
Taro Pharmaceuticals (UK) Ltd.
  United Kingdom
 
   
Taro Pharmaceuticals Europe B.V.
  The Netherlands
 
   
Taro Hungary Kft.
  Hungary
 
   
Taro Pharmaceuticals Canada, Ltd.
  Canada
 
   
Taro Pharmaceutical Laboratories, Inc.
  United States
 
   
Taro Pharmaceuticals Ireland Ltd.
  Ireland
 
   
Taro Pharmaceuticals India Pvt. Ltd.
  India

See Note 2c to our consolidated financial statements included elsewhere in this annual report for information regarding the ownership of our subsidiaries.

      D. PROPERTY, PLANTS AND EQUIPMENT

     The following is a list of our facilities as of April 1, 2004:

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    Square        
Location
  Footage
  Main Use
  Own/Lease
Haifa Bay, Israel
    190,000     Pharmaceutical manufacturing, production laboratories, offices and warehousing   Own
 
               
Haifa Bay, Israel
    77,000     Chemical production, including tank farm and chemical finishing plant   Own
 
               
Haifa Bay, Israel
    40,000     Research facility   Own
 
               
Haifa Bay, Israel
    5,000     Warehouse   Lease
 
               
Haifa Bay, Israel
    10,000     Warehouse, maintenance   Lease
 
               
Yakum, Israel
    15,000     Administrative offices   Lease
 
               
Brampton, Canada
    68,000     Pharmaceutical manufacturing and production laboratories   Own
 
               
Brampton, Canada
    74,000     Laboratories and administration   Own
 
               
Brampton, Canada
    108,797     Distribution & Warehousing   Own
 
               
Brampton, Canada
    75,400     Administration and warehousing   Lease
 
               
Hawthorne, New York
    42,000     Administrative offices   Lease
 
               
Hawthorne, New York
    90,000     Warehousing   Lease
 
               
Hawthorne, New York
    37,000     Research laboratory and administrative offices   Own
 
               
South Brunswick, New Jersey
    315,000     Distribution facility   Own
 
               
Hertford, United Kingdom
    1,250     Administrative offices   Lease

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    Square        
Location
  Footage
  Main Use
  Own/Lease
Ronkonkoma, New York
    50,000     Pharmaceutical manufacturing, production laboratories and warehousing   Lease
 
               
Budapest, Hungary
    1,250     Administrative offices   Lease
 
               
Roscrea, Ireland
    124,000     Pharmaceutical manufacturing, research laboratories and warehousing   Own
 
               
Mumbai, India
    9,000     Pharmaceutical research laboratories and administrative offices   Lease

     Our plant, research and office facilities in Haifa Bay, Israel are located in a complex of buildings with an aggregate area of approximately 322,000 square feet. We lease much of the land underlying these facilities from the Israel Land Authority pursuant to long-term ground leases that expire between 2009 and 2049. We have the option to renew each lease for an additional 49 years. We also lease approximately 15,000 square feet of adjacent space in Haifa Bay pursuant to two separate leases. The first is for ten years, which commenced in January 2001, with an option to purchase this property at the termination of the lease. The second was for an initial term of five years, commencing in September 1997, and has subsequently been renewed for two additional one-year terms. For additional information, please refer to Note 6 to our consolidated financial statements included elsewhere in this annual report.

     Since December 2000, we have purchased approximately 570,000 square feet of land adjacent to the Haifa Bay plant for expansion of our manufacturing and warehouse facilities. We lease approximately 15,000 square feet of space in a facility located in Yakum, Israel, which is used for administrative and marketing offices.

     In February 2002, Taro Canada purchased 74,000 square feet of space that we had leased since March 1997 adjacent to the main 68,000 square foot manufacturing facility, which we own, in Brampton, Canada. In September 2000, Taro Canada leased an additional 75,400 square feet of office and warehouse space, adjacent to the other two facilities, for a period of five years, with renewal options, which can extend the lease period for an additional twenty years. In December 2003, Taro Canada purchased for $3.6 million a 108,797 square foot building in close proximity to its existing facilities. This building is used for warehousing and distribution.

     In August 2002, Taro U.S.A. purchased a 32% interest in a 123,713 square foot building in which it located its U.S. research operations for approximately $4.4 million. The U.S. subsidiary has two options exercisable at two different times to purchase the remainder of the building, approximately 86,000 square feet, for an additional amount of $9.3 million.

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     In January 2004, Taro U.S.A. purchased a 315,000 square foot distribution facility in South Brunswick, New Jersey for approximately $18 million.

     In addition, Taro U.S.A. leases approximately 130,000 square feet of office and warehouse space in Hawthorne, New York pursuant to two leases. One lease, for approximately 100,000 square feet, expires in July 2007 and the other lease, for approximately 30,000 square feet expired on April 30, 2004 and was not renewed.

ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS

      A. OPERATING RESULTS

     The following discussion should be read in conjunction with our consolidated financial statements and related notes for the three years ended December 31, 2003, which are included elsewhere in this annual report.

Overview

     We are a multinational, science-based pharmaceutical company. We develop, manufacture and market prescription and OTC pharmaceutical products, as well as active pharmaceutical ingredients, primarily in Israel, Canada and the United States. Our primary areas of focus include topical creams and ointments, liquids, capsules and tablets. We operate principally through three entities: Taro Israel and two of its subsidiaries, Taro Canada and Taro U.S.A.

     We generate most of our revenues from the sales of prescription and OTC pharmaceutical products. Portions of our OTC products are sold as private label products primarily to chain drug stores, food stores, drug wholesalers, drug distributors and mass merchandisers in the United States. During the past three years, three major drug wholesalers in the United States accounted for the following proportion of our total consolidated sales in millions:

                                                 
    2003
  2002
  2001
Customer
  Amount
  Percent
  Amount
  Percent
  Amount
  Percent
AmerisourceBergen Corporation
  $ 62.7       20 %   $ 46.5       22 %   $ 19.4       13 %
McKesson Corporation
  $ 53.0       17 %   $ 25.4       12 %   $ 22.3       15 %
Cardinal Health, Inc.
  $ 28.4       9 %   $ 19.0       9 %   $ 13.4       9 %

     We also sell active pharmaceutical ingredients to unaffiliated customers around the world. Sales of active pharmaceutical ingredients to third parties have historically represented

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