10-K 1 a2129953z10-k.htm 10-K

 

United States
Securities and Exchange Commission

Washington, D.C. 20549

 

FORM 10-K

 

ý

Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2003 or

 

o

Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

For the transition period from             to            

 

Commission File Number 0-20045

 

Watson Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Nevada

(State or other jurisdiction of incorporation or organization)

 

311 Bonnie Circle, Corona, CA 92880-2882

(Address of principal executive offices, including ZIP code)

 

95-3872914

(I.R.S. Employer Identification No.)

 

Registrant’s telephone number, including area code: (909) 493-5300

 

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

 

Title of each class

Common Stock, $0.0033 Par Value

 

Name of each exchange on which registered

New York Stock Exchange

 

Securities registered pursuant to Section 12(g) of the Act: None

 

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days:  Yes ý  No o

 

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of Registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  o

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Act).
Yes
ý  No o

 

Aggregate market value of Common Stock held by non-affiliates of the Registrant, as of June 30, 2003:

$4,339,556,396 based on the last reported sales price on the New York Stock Exchange

 

Number of shares of Registrant’s Common Stock outstanding on March 5, 2004: 108,699,047

 

DOCUMENTS INCORPORATED BY REFERENCE

 

Part III incorporates certain information by reference from the registrant’s proxy statement for the 2004 Annual Meeting of Stockholders, to be held on May 17, 2004. Such proxy statement will be filed no later than 120 days after the close of the registrant’s fiscal year ended December 31, 2003.

 

 



 

WATSON PHARMACEUTICALS, INC.

 

TABLE OF CONTENTS
FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2003

 

PART I

 

 

 

 

 

ITEM 1.

Business

 

 

 

 

ITEM 2.

Properties

 

 

 

 

ITEM 3.

Legal Proceedings

 

 

 

 

ITEM 4.

Submission of Matters to a Vote of Security Holders

 

 

 

 

ITEM 4a.

Executive Officers of the Registrant

 

 

 

 

PART II

 

 

 

 

 

ITEM 5.

Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

 

 

 

 

ITEM 6.

Selected Financial Data

 

 

 

 

ITEM 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operation

 

 

 

 

ITEM 7A.

Quantative and Qualitative Disclosures About Market Risk

 

 

 

 

ITEM 8.

Financial Statements and Supplementary Data

 

 

 

 

ITEM 9.

Changes in and Disagreements With Accountants on Accounting and Financial Disclosure

 

 

 

 

ITEM 9A.

Controls and Procedures

 

 

 

 

PART III

 

 

 

 

 

ITEM 10.

Directors and Executive Officers of the Registrant

 

 

 

 

ITEM 11.

Executive Compensation

 

 

 

 

ITEM 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

 

 

 

 

ITEM 13.

Certain Relationships and Related Transactions

 

 

 

 

ITEM 14.

Principal Accounting Fees and Services

 

 

 

 

PART IV

 

 

 

 

 

ITEM 15.

Exhibits, Financial Statement Schedules, and Reports on Form 8-K

 

 

 

 

SIGNATURES

 

 

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PART I

 

ITEM 1.  BUSINESS

 

Business Overview

 

Watson Pharmaceuticals, Inc. (Watson, which may be referred to as we, us or our) is engaged in the development, manufacture, marketing, sale and distribution of branded and off-patent (generic) pharmaceutical products.  We also develop advanced drug delivery systems designed to enhance the therapeutic benefits of existing drug forms.  Watson operates manufacturing, distribution, research and development, and administrative facilities primarily in the United States of America (U.S.).

 

Watson was incorporated in 1985 and began operations as a manufacturer and marketer of off-patent pharmaceuticals.  In February 1993, we completed our initial public offering.  Through internal product development and acquisitions of products and businesses, we have grown into a diversified specialty pharmaceutical company.  As of December 31, 2003, we marketed more than 35 branded pharmaceutical products and more than 120 generic pharmaceutical products.

 

Our principal executive offices are located at 311 Bonnie Circle, Corona, California, 92880.  Our internet website address is www.watsonpharm.com.  Our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, and all amendments thereto, from 1998 to present, are available free of charge on our internet website.  These reports are posted on our website as soon as reasonably practicable after such reports are electronically filed with the Securities and Exchange Commission (SEC).  Our website also includes a section concerning corporate governance, including our Corporate Governance Guidelines, Board Committee Charters, Code of Conduct and other information.

 

Business Developments

 

During 2003, we continued to acquire products and businesses and invest in internal product development and other strategic alliances to grow our existing product pipeline and strengthen our resources and capabilities.

 

In February 2003, we acquired the U.S. rights to the Fioricet® and Fiorinal® product lines from Novartis Pharmaceuticals Corporation (Novartis).  These products are indicated for the treatment of tension headaches.

 

In February 2003, we received final U.S. Food and Drug Administration (FDA) approval of our New Drug Application (NDA) for Oxytrol® (oxybutynin transdermal system), the first and only transdermal therapy to treat overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.  There were numerous milestones related to Oxytrol®, during 2003, including:

 

      March 2003—Filed European Marketing Authorization Application seeking European marketing approval for Oxytrol®.

      March 2003—Entered into a service agreement with Ventiv Health providing full-time sales representatives and managers to compliment Watson’s existing sales force.

      May 2003—Acceptance for review of New Drug Submission for Oxytrol® by Health Canada, Therapeutic Products Directorate.

      September 2003—Entered into a marketing and supply agreement with UCB Pharma, whereby UCB Pharma will market Watson’s oxybutynin transdermal product in Europe.

      November 2003—Received positive opinion from the European Agency for the Evaluation of Medicinal Products (EMEA) Committee for Proprietary Medicinal Products (CPMP).  The CPMP opinion serves as the basis for a European Commission approval, which is under review.

 

In March 2003, we issued $575 million of convertible contingent senior debentures (CODES).  The CODES, which are convertible into shares of Watson common stock upon the occurrence of certain events, are due in March 2023.

 

In May 2003, we entered into an agreement with a syndicate of lenders for a five-year, $300 million senior, unsecured revolving credit facility for working capital and other general corporate purposes.

 

During 2003, we expanded our strategic alliance with Cipla Ltd. (Cipla), the second largest pharmaceutical company in India.  The original agreement to develop, manufacture and commercialize generic pharmaceutical products was entered into in December 2002.  Under the terms of the expanded agreement, the companies will work together to develop additional products.  The products included in our agreement with Cipla represent a substantial portion of the generic products we currently have in development.  Watson will be responsible for pursuing regulatory approvals and will have exclusive U.S. marketing rights for all developed products.  Cipla will be the primary manufacturer of the products.

 

In October 2003, we acquired Amarin Development AB (ADAB), a wholly-owned drug development subsidiary of Amarin Corporation plc (Amarin).  The acquisition included a number of patented, oral, controlled-release drug delivery technologies developed and under development by ADAB, together with the products it has developed using these technologies, including glipizide extended release tablets, for which Watson received FDA

 

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approval of the 10 mg and 5mg strength in September 2003.

 

In February 2004, the FDA issued an approvable letter relating to EmSam™, a selegilene transdermal patch for the treatment of depression being developed by Somerset Pharmaceuticals (Somerset), a joint venture between Watson and Mylan Laboratories, Inc.  The FDA’s letter indicates that Somerset has submitted sufficient data to support the efficacy of EmSam™ (20mg, 30mg & 40mg) in the acute and maintenance treatment of major depressive disorder.  Somerset has initiated discussions with the FDA to review and clarify its comments.  These comments include a requirement that Somerset conduct Phase IV post-marketing pharmacokinetic and safety studies, as well as additional pharmacology/toxicology studies.  In addition, Somerset will initiate discussions with the FDA regarding proposed labeling, including FDA’s request to include labeling addressing tyramine dietary restrictions while taking EmSam™.  Somerset is exploring opportunities to outlicense the EmSam™ product to a marketing partner.

 

In February 2004, we commenced a cash tender offer and consent solicitation for all of our $150 million principal amount of 7 1/8% Senior Notes due 2008.  As a result of this tender offer, we repurchased approximately $102 million of our 1998 Senior Notes for a total consideration of $115 million, or a 13% premium over the face amount of each note.

 

Business Description

 

Prescription pharmaceutical products in the U.S. are generally marketed as either brand or generic pharmaceuticals.  Branded pharmaceutical products are marketed under brand names through programs that are designed to generate physician and consumer loyalty.  Generic pharmaceutical products are bioequivalents of their respective branded products and provide a cost-efficient alternative to branded products.  As a result of the differences between the two types of products, we operate and manage our business as two segments: branded and generic pharmaceutical products.

 

Branded Pharmaceutical Products

 

Newly developed pharmaceutical products are normally patented and, as a result, generally are offered by a single provider when first introduced to the market.  We currently market a number of patented products to physicians, hospitals, and other markets that we serve.  We also market certain trademarked off-patent products directly to healthcare professionals.  We classify these patented and off-patent trademarked products as our branded pharmaceutical products.  Net revenues from our branded products accounted for approximately 53% of our total product net revenues in 2003.

 

Our branded pharmaceutical business currently develops, manufactures, markets, sells and distributes products primarily through the following sales and marketing groups:

 

      Women’s Health

      General Products

      Urology

      Nephrology

 

We market our branded products through these sales and marketing groups, represented by 768 sales professionals. Each of our specialized sales and marketing groups focuses on physicians who specialize in the diagnosis and treatment of different medical conditions and each group offers products to satisfy certain needs of these physicians.  There are several branded products such as Oxytrol®, which are applicable to multiple physician audiences and each of the sales groups promotes those products to their physician audiences.  We believe this focused sales and marketing approach enables us to foster close professional relationships with physicians and cover the primary care physicians who also prescribe in selected therapeutic areas.  We generally sell our branded products under the “Watson Pharma” and the “Oclassen® Dermatologics” labels.

 

Our sales and marketing groups have targeted selected therapeutic areas predominately because of their potential growth opportunities and the size of the physician audience.  Our expanded primary care sales force (consisting of both Watson and Ventiv employees) supports the specialty therapeutic areas by promoting products from each of these areas to primary care physicians and other specialties, who fall outside of the established therapeutic areas.  We believe that the nature of these markets and the identifiable base of physician prescribers provide us with the opportunity to achieve significant market penetration through our specialized sales forces.  Many of our branded products realize higher profit margins than our generic products.  We intend to continue to expand our branded product portfolio through internal product development, strategic alliances and acquisitions.

 

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Our portfolio of branded pharmaceutical products includes the following products, which represented 89% of total branded product net revenues in 2003:

 

WATSON BRANDED PRODUCT

 

ACTIVE INGREDIENT

 

THERAPEUTIC CLASSIFICATION

Actigall®

 

Ursodiol

 

Dissolution of gallstones

Androderm®

 

Testosterone (transdermal patch)

 

Male hormone replacement

Condylox®

 

Podofilox

 

Genital warts

Ferrlecit®

 

Sodium ferric gluconate in sucrose injection

 

Hematinic

Fioricet®

 

Butalbital, caffeine and acetaminophen

 

Barbiturate and analgesic

Fiorinal®

 

Butalbital, caffeine and aspirin

 

Barbiturate and analgesic

INFeD®

 

Iron dextran

 

Hematinic

Levora®

 

Levonorgestrel and ethinyl estradiol

 

Oral contraceptive

Low-OgestrelTM

 

Norgestrel and ethinyl estradiol

 

Oral contraceptive

Microgestin®

 

Norethindrone acetate and ethinyl estradiol

 

Oral contraceptive

Microzide®

 

Hydrochlorothiazide

 

Anti-hypertensive

MonoNessa®

 

Norgestimate ethinyl estradiol

 

Oral contraceptive

Necon®

 

Norethindrone and ethinyl estradiol

 

Oral contraceptive

Necon 7/7/7®

 

Norethindrone and ethinyl estradiol

 

Oral contraceptive

Nor-QD®

 

Norethindrone

 

Oral contraceptive

Norco 10s®

 

Hydrocodone bitartrate & acetaminophen

 

Analgesic

Oxytrol®

 

Oxybutnin (transdermal patch)

 

Overactive bladder

TriNessaTM

 

Norgestimate and ethinyl estradiol

 

Oral contraceptive

Tri-Norinyl®

 

Norethindrone and ethinyl estradiol

 

Oral contraceptive

Trivora®

 

Levonorgestrel and ethinyl estradiol

 

Oral contraceptive

Zovia®

 

Ethynodiol diacetate and ethinyl estradiol

 

Oral contraceptive

 

WOMEN’S HEALTH

 

Our Women’s Health product lines include oral contraceptives, a genital warts treatment, a hormone replacement therapy and a visual cervical screening device.  Currently, we have a total of 17 oral contraceptives in our product portfolio.  We market our Women’s Health products primarily to obstetricians and gynecologists.

 

GENERAL PRODUCTS AND UROLOGY

 

Our General Products and Urology product lines include urology, anti-hypertensive, neurology, psychiatry, pain management and dermatology products.  Currently, we have a total of 20 products being marketed through this marketing group.  We market these products to urologists and primary care physicians, as well as endocrinologists.

 

NEPHROLOGY

 

Our Nephrology product line consists of products for the treatment of iron deficiency anemia.  We generally market our Nephrology products to nephrologists and dialysis centers.  Our primary product in the Nephrology group is Ferrlecit®, which is indicated for patients undergoing hemodialysis in conjunction with erythropoietin therapy.  Ferrlecit® accounted for 9%, 11%, and 12% of our consolidated net revenues in 2003, 2002 and 2001, respectively.  Ferrlecit® (sodium ferric gluconate complex in sucrose injection), introduced in 1999, was granted a five-year exclusivity period by the FDA as a new chemical entity.  This exclusivity period ended in February 2004.  We have submitted a pediatric study to the Ferrlecit® NDA which could extend this exclusivity period for an additional six months.

 

Generic Pharmaceutical Products

 

When patents or other regulatory exclusivity no longer protect a branded product, opportunities exist to introduce off-patent or generic counterparts to the branded product.  These generic products are the therapeutic equivalent to their brand name counterparts and are generally sold at prices significantly less than the branded product.  As such, generic pharmaceuticals provide an effective and cost-efficient alternative to branded products.

 

Watson is a leader in the development, manufacture and sale of generic pharmaceutical products.  We currently market more than 120 generic pharmaceutical products.  With respect to generic products, our strategy is to continue to target generic drugs that are difficult to formulate or manufacture or that will complement or broaden our existing product lines.  Since the prices and unit volumes of our branded products will likely decrease upon the introduction of generic alternatives, we also intend to develop generic alternatives to our branded products where market conditions and the competitive environment justify such activities.  Net revenues from our generic products accounted for approximately 47% of our product net revenues in 2003.

 

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Our portfolio of generic pharmaceutical products includes the following products, which represented 62% of total generic product net revenues in 2003:

 

WATSON GENERIC PRODUCT

 

COMPARABLE
BRAND NAME

 

BRAND HOLDER

 

THERAPEUTIC CLASSIFICATION

Butalbital, aspirin, caffeine and codeine (BACC)

 

Fiorinal®
w/codeine

 

Watson Pharmaceuticals

 

Analgesic

Carisoprodol

 

Soma®

 

Medpointe

 

Muscle relaxant

Cyclobenzaprine

 

Flexeril®

 

Merck & Co., Inc.

 

Muscle relaxant

Folic acid

 

Folvite®

 

Wyeth

 

Hematinics, Others

Glipizide ER

 

Glucotrol XL®

 

Pfizer Laboratories

 

Anti-diabetic

Hydrocodone bitartrate/ acetaminophen

 

Lorcet®

 

Forest Pharmaceuticals

 

Analgesic

Hydrocodone bitartrate/ acetaminophen

 

Vicodin®

 

Abbott Laboratories

 

Analgesic

Hydroxychloroquine

 

Plaquenil®

 

Sanofi-Synthelabo

 

Anti-malarial

Hydroxyzine

 

Atarax®

 

Pfizer Laboratories

 

Anti-anxiety

Lisinopril

 

Zestril®

 

AstraZeneca

 

Anti-hypertensive

Lorazepam

 

Ativan®

 

Wyeth

 

Tranquilizer

Meprobamate

 

Miltown®, Equanil®

 

Medpointe, Wyeth

 

Anti-anxiety

Metformin

 

Glucophage®

 

Bristol-Myers Squibb

 

Anti-diabetic

Minocycline

 

Minocin®

 

Wyeth

 

Anti-infective systemic

Nicotine polacrilex gum

 

Nicorette®

 

GlaxoSmithKline

 

Aid to smoking cessation

Nicotine transdermal system

 

Habitrol®

 

Novartis

 

Aid to smoking cessation

Nifedipine ER

 

Adalat CC®

 

Bayer AG

 

Anti-hypertensive

Oxycodone/acetaminophen

 

Percocet®

 

Endo Pharmaceuticals

 

Analgesic

Promethazine

 

Phenergan®

 

Wyeth

 

Antihistamine

Propafenone hydrochloride

 

Rythmol®

 

Abbott Laboratories

 

Anti-arrhythmic

 

We predominantly market our generic products to various drug wholesalers and national retail drugstore chains utilizing 21 sales and marketing professionals.  We sell our generic products primarily under the “Watson Laboratories” label, with the exception of our over-the-counter products which we sell under our “Rugby” label or under private label.

 

Increasingly aggressive tactics employed by brand pharmaceutical companies to delay generic competition have increased the risks and uncertainties regarding the timing of approval of generic products.  Expansion of our generic product line in recent years has been attributable to alliances, internal product development and acquisitions.

 

Financial Information About Segments

 

Watson primarily evaluates the performance of its branded and generic segments based on net revenues and gross profit.  Summarized net revenues and gross profit information for each of the last three fiscal years is presented in Note 15 in the accompanying Notes to Consolidated Financial Statements.

 

Research and Development

 

We devote significant resources to the research and development of branded and generic products and proprietary drug delivery technologies.  We incurred research and development expenses of $102.1 million in 2003, $82.2 million in 2002, and $64.1 million in 2001.  Our research and development strategy focuses on the following product development areas:

 

      the development of sustained-release technologies and the application of these technologies to existing drug forms;

      the application of proprietary drug-delivery technology for new product development in specialty areas;

      the expansion of existing oral immediate-release products with respect to additional dosage strengths;

      the acquisition of mid-to-late stage branded drugs;

      off-patent drugs that are difficult to develop or manufacture, or that complement or broaden our existing product lines; and

 

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      off-patent drugs that target smaller specialized or under-served markets.

 

As of December 31, 2003, we maintained research and development facilities in Corona, California; Danbury, Connecticut; Copiague, New York; Malmo, Sweden; Salt Lake City, Utah; and Changzhou City, People's Republic of China.

 

We are presently developing a number of branded products, some of which utilize novel drug-delivery systems, through a combination of internal and collaborative programs, including joint ventures.

 

Our current branded product development efforts include:

 

Ferrlecit® Expanded Indications.  Our efforts for expanded indications for our second generation IV iron product, Ferrlecit®, include a pediatric indication, use of Ferrlecit® in combination with erythropoietin therapy in patients undergoing chemotherapy treatment, use of Ferrlecit® in peritoneal dialysis patients, and use in patients with chronic kidney disease who are not yet on dialysis.

 

      The pediatric hemodialysis study is completed and we have submitted the final report to the FDA.  As the study was conducted at the request of the FDA, we expect a pediatric extension will be granted to our current exclusivity date and will extend our NDA exclusivity to August 2004.

      The in life portion of our Phase II feasibility trial evaluating the effects of Ferrlecit® in the treatment of anemia with cancer patients on erythropoietin therapy is completed and an interim analysis demonstrated greater increases in hemogloblin for patients on Ferrlecit® relative to oral iron or no oral iron control groups.  The analysis of the complete study is currently underway and we expect to publish the results of the study in 2004.

      An End of Phase II meeting was held with the FDA in December 2003 and the design of the Phase III program for an oncology indication was reviewed.  Based upon that meeting, we plan to initiate the Phase III program in 2004.

      Finally, we have initiated two Phase IV studies related to patients with chronic kidney disease who are not yet on dialysis.

 

EmSam™.  Our joint venture, Somerset, is developing EmSam™, a selegeline patch for depression.  In August 2003, the FDA accepted Somerset’s resubmission of its NDA for EmSam™.  In February 2004, the FDA issued an approvable letter for EmSam™.  The FDA’s letter indicates that Somerset has submitted sufficient data to support the efficacy of EmSam™ (20mg, 30mg & 40mg) in the acute and maintenance treatment of major depressive disorder.  Somerset has initiated discussions with the FDA to review and clarify its comments.  These comments include a requirement that Somerset conduct Phase IV post-marketing pharmacokinetic and safety studies as well as additional pharmacology/toxicology studies.  In addition, Somerset will initiate discussions with the FDA regarding proposed labeling, including FDA’s request to include labeling addressing tyramine dietary restrictions while taking EmSam™. Somerset is exploring opportunities to outlicense the EmSam™ product to a marketing partner.

 

Prestara™.  In August 2002, the FDA issued an approvable letter to Genelabs Technologies, Inc. (Genelabs), for its NDA for Prestara™ (formerly Aslera™ or GL701).  Based upon the results of an additional bone mineral density trial, the FDA agreed to a prevention of osteoporosis indication for women with systemic lupus erythematosus (SLE or lupus) pending a final confirmatory trial.  In a prior Genelabs study, a positive effect on bone mineral density was observed in women with mild to moderate SLE on low-dose glucocorticoids.  Final approval is contingent upon the successful completion of the additional clinical trial confirming this positive effect and submission of data for the qualification of a manufacturing site.  The study is fully enrolled and, according to Genelabs, results from this trial are expected to be available in the fourth quarter of 2004.  Watson holds exclusive North American marketing rights to Prestara™.

 

Female-T Patch.  We are collaborating with Procter & Gamble on the development of a testosterone patch for the treatment of sexual dysfunction in women.  Under the terms of the development agreement, Procter & Gamble is responsible for clinical, regulatory and marketing activities and Watson is responsible for formulation, development and initial patch manufacturing.  The product is currently in Phase III clinical trials, being conducted by Proctor & Gamble.

 

Other Products in Development.  We are currently working on the development of a contraception patch, a controlled release pain product, and second generation Oxytrol® and Fioricet® line extensions, in addition to other products within our Women’s Health, Urology and General Products divisions.

 

Discontinued R&D Projects.  In December 2003, we received preliminary results from our two Phase III clinical trials related to our proprietary topical patch for the treatment of onychomycosis (fungal infection of the toe and fingernails).  Initial analysis demonstrated a statistically significant difference in the primary end point (complete cure defined as the growth of a healthy new nail plus negative mycology plus negative potassium hydroxide) relative to placebo in one trial.  The second trial failed to demonstrate a statistically significant difference versus placebo.  After careful review and analysis of all

 

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study findings, we have decided to discontinue the development of this product.

 

During 2003, we continued to expand our investment in branded and generic research and development through internal programs, collaborative arrangements, including the expansion of our Cipla agreement, and the acquisition of ADAB.  Our goal is to increase the number of ANDAs and NDAs we submit to the FDA in the future.  However, product development is inherently risky and uncertain.  See “Risks Related to Our Business—If we are unable to successfully develop or commercialize new products, our operating results could suffer.”

 

Growth Strategy

 

We intend to grow our business through a combination of internal research and development, alliances and acquisitions.  We believe that our three-pronged growth strategy will allow us to expand both our branded and generic product offerings.  Based upon business conditions, our financial strength and other factors, we regularly reexamine our growth strategies and may change them at anytime.  See “Risks Related to Our Business.”

 

Customers

 

We sell our branded and generic pharmaceutical products primarily to drug wholesalers, retailers and distributors, including large chain drug stores, hospitals, clinics, government agencies and managed healthcare providers such as health maintenance organizations and other institutions.  These customers comprise a significant part of the distribution network for pharmaceutical products in the U.S.  This distribution network is continuing to undergo significant consolidation marked by mergers and acquisitions among wholesale distributors and the growth of large retail drug store chains.  As a result, a small number of large, wholesale distributors controls a significant share of the market, and the number of independent drug stores and small drug store chains has decreased.  We expect that consolidation of drug wholesalers and retailers will impact pricing and create other competitive pressures on drug manufacturers.

 

Sales to certain of our customers accounted for 10% or more of our annual net revenues during the past three years.  The following table illustrates those customers and the respective percentage of our net revenues for which they account:

 

Customer

 

2003

 

2002

 

2001

 

AmeriSourceBergen Corp *

 

17

%

21

%

14

%

McKesson HBOC

 

15

%

16

%

15

%

Cardinal Health, Inc.

 

12

%

11

%

11

%

Walgreen Co.

 

11

%

11

%

n/a

 

 


*      In August 2001, AmeriSource Health Corporation merged with Bergen Brunswig.  Prior to the merger, Amerisource accounted for 7% of our net revenues in 2001.  These pre-merger revenues from Amerisource are not included in the amount above for AmerisourceBergen Corp.

 

The loss of any of these customers could materially and adversely affect our business, results of operations, financial condition and cash flows.

 

Competition

 

The pharmaceutical industry is highly competitive.  We compete with different companies depending upon product categories, and within each product category, upon dosage strengths and drug delivery systems.  Such competitors include the major brand name and generic manufacturers of pharmaceutical products, especially those doing business in the U.S.  In addition to product development, other competitive factors in the pharmaceutical industry include product quality and price, reputation and service and access to proprietary and technical information.  It is possible that developments by others will make our products or technologies noncompetitive or obsolete.

 

Competing in the branded product business requires us to identify and quickly bring to market new products embodying technological innovations.  Successful marketing of branded products depends primarily on the ability to communicate the effectiveness, safety and value to healthcare professionals in private practice, group practices and managed care organizations.  We anticipate that our branded product offerings will support our existing areas of therapeutic focus.  Based upon business conditions and other factors, we regularly reexamine our business strategies and may from time to time reallocate our resources from one therapeutic area to another, withdraw from a therapeutic area or add an additional therapeutic area in order to maximize our overall growth opportunities.

 

Our competitors in branded products include the major brand name manufacturers of pharmaceuticals such as Johnson & Johnson, Wyeth and Pfizer.  Based on total assets, annual revenues and market capitalization, we are considerably smaller than these and other national competitors in the branded product area.  These competitors, as well as others, have been in business for a longer period of time, have a greater

 

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number of products on the market and have greater financial and other resources than we do.  If we directly compete with them for the same markets and/or products, their financial strength could prevent us from capturing a meaningful share of those markets.

 

We actively compete in the generic pharmaceutical business.  Revenues and gross profit derived from the sales of generic pharmaceutical products tend to follow a pattern based on certain regulatory and competitive factors.  As patents and regulatory exclusivity for brand name products expire, the first off-patent manufacturer to receive regulatory approval for generic equivalents of such products is generally able to achieve significant market penetration.  As competing off-patent manufacturers receive regulatory approvals on similar products, market share, revenues and gross profit typically decline, in some cases, dramatically.  Accordingly, the level of market share, revenues and gross profit attributable to a particular generic product is normally related to the number of competitors in that product’s market and the timing of that product’s regulatory approval and launch, in relation to competing approvals and launches.  Consequently, we must continue to develop and introduce new products in a timely and cost-effective manner to maintain our revenues and gross profit.  In addition to competition from other generic drug manufacturers, we face competition from brand name companies in the generic market.  Many of these companies seek to participate in sales of generic products by, among other things, collaborating with other generic pharmaceutical companies or by marketing their own generic equivalent to their branded products.  Our major competitors in generic products include Teva Pharmaceutical Industries, Ltd., Barr Laboratories, Inc., Mylan Laboratories, Inc., Andrx Corporation, IVAX Corporation and Sandoz Pharmaceuticals, a division of Novartis.  See “Risks Related to Our Business—The pharmaceutical industry is highly competitive.”

 

Manufacturing, Suppliers and Materials

 

We manufacture many of our own finished products at our plants in Corona, California; Miami, Florida; Carmel, New York; Copiague, New York; Salt Lake City, Utah; Phoenix, Arizona; and Humacao, Puerto Rico.  Our manufacturing operations are subject to extensive regulatory oversight and could be interrupted at any time.  Our Corona, California and Phoenix, Arizona facilities are each currently subject to a consent decree of permanent injunction. In July 2003, FDA inspected our Humacao, Puerto Rico facility and issued a Form 483 at the conclusion of the inspection. See “Risks Related to Our Business—Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our product development and manufacturing capabilities.” See also “Item 3. Legal Proceedings.”

 

For certain of our products, we contract with third parties for the manufacture of the products, some of which are currently available only from sole or limited suppliers.  These third-party manufactured products include products that have historically accounted for a significant portion of our revenues, such as Ferrlecit®, and a number of our oral contraceptive products.  Third-party manufactured products accounted for approximately 41%, 47% and 48% of our product net revenues in 2003, 2002 and 2001, respectively, and 48%, 41%, and 62% of our gross profit in 2003, 2002, and 2001, respectively.

 

We are dependent on third parties for the supply of the raw materials necessary to develop and manufacture our products, including the active and inactive pharmaceutical ingredients used in our products.  We are required to identify the supplier(s) of all the raw materials for our products in the drug applications that we file with the FDA.  If raw materials for a particular product become unavailable from an approved supplier specified in a drug application, we would be required to qualify a substitute supplier with the FDA, which would likely interrupt manufacturing of the affected product.  To the extent practicable, we attempt to identify more than one supplier in each drug application.  However, some raw materials are available only from a single source and, in some of our drug applications, only one supplier of raw materials has been identified, even in instances where multiple sources exist.

 

In addition, we obtain a significant portion of our raw materials from foreign suppliers.  Arrangements with international raw material suppliers are subject to, among other things, FDA regulation, various import duties, foreign currency risk and other government clearances.  Acts of governments outside the U.S. may affect the price or availability of raw materials needed for the development or manufacture of our products.  In addition, any changes in patent laws in jurisdictions outside the U.S. may make it increasingly difficult to obtain raw materials for research and development prior to the expiration of the applicable U.S. or foreign patents.  See “Risks Related to Our Business—If we are unable to obtain sufficient supplies from key suppliers that in some cases may be the only source of finished products or raw materials, our ability to deliver our products to the market may be impeded.”

 

Patents and Proprietary Rights

 

We believe patent protection of our proprietary products is important to our business.  Our success with our branded products will depend, in part, on our ability to obtain, and successfully defend if challenged, patent or other proprietary protection for such products.  We currently have a number of U.S. and foreign patents issued or pending.  However, the issuance of a

 

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patent is not conclusive as to its validity or as to the enforceable scope of the claims of the patent.  Accordingly, our patents may not prevent other companies from developing similar or functionally equivalent products or from successfully challenging the validity of our patents.  If our patent applications are not approved or, even if approved, if such patents are circumvented or not upheld in a court of law, our ability to competitively exploit our patented products and technologies may be significantly reduced.  Also, such patents may or may not provide competitive advantages for their respective products or they may be challenged or circumvented by competitors, in which case our ability to commercially exploit these products may be diminished.  From time to time, we may need to obtain licenses to patents and other proprietary rights held by third parties to develop, manufacture and market our products.  If we are unable to timely obtain these licenses on commercially reasonable terms, our ability to commercially exploit such products may be inhibited or prevented.

 

We also rely on trade secrets and proprietary know-how that we seek to protect, in part, through confidentiality agreements with our partners, customers, employees and consultants.  It is possible that these agreements will be breached or will not be enforceable in every instance, and that we will not have adequate remedies for any such breach.  It is also possible that our trade secrets will otherwise become known or independently developed by competitors.

 

We may find it necessary to initiate litigation to enforce our patent rights, to protect our trade secrets or know-how or to determine the scope and validity of the proprietary rights of others.  Litigation concerning patents, trademarks, copyrights and proprietary technologies can often be protracted and expensive and, as with litigation generally, the outcome is inherently uncertain.

 

Pharmaceutical companies with branded products are increasingly suing companies that produce off-patent forms of their brand name products for alleged patent and/or copyright infringement or other violations of intellectual property rights which may delay or prevent the entry of such a generic product into the market.  For instance, when we file an ANDA seeking approval of a generic equivalent to a branded drug, we may certify under the Drug Price Competition and Patent Restoration Act of 1984 (the Hatch-Waxman Act) to the FDA that we do not intend to market our generic drug until any patent listed by the FDA as covering the branded drug has expired, in which case, the ANDA will not be approved by the FDA until no earlier than the expiration of such patent(s).  On the other hand, we could certify that any patent listed as covering the branded drug is invalid and/or will not be infringed by the manufacture, sale or use of our generic form of the branded drug.  In that case, we are required to notify the branded product holder or the patent holder that such patent is invalid or is not infringed.  The patent holder has 45 days from receipt of the notice in which to sue for patent infringement.  The FDA is then prevented from approving our ANDA for 30 months after receipt of the notice unless the lawsuit is resolved in our favor in less time or a shorter period is deemed appropriate by a court.  In addition, increasingly aggressive tactics employed by brand companies to delay generic competition have increased the risks and uncertainties regarding the timing of approval of generic products.

 

Because a balanced and fair legislative and regulatory arena is critical to the pharmaceutical industry, we will continue to devote management time and financial resources on government activities.  We currently maintain an office and staff a full-time government affairs function in Washington, D.C. that maintains responsibility for keeping abreast of state and federal legislative activities.

 

Litigation alleging infringement of patents, copyrights or other intellectual property rights may be costly and time consuming.  See “Risks Related to Our Business—Third parties may claim that we infringe their proprietary rights and may prevent us from manufacturing and selling some of our products.”

 

Government Regulation and Regulatory Matters

 

All pharmaceutical manufacturers, including Watson, are subject to extensive, complex and evolving regulation by the federal government, principally the FDA, and to a lesser extent, by the U.S. Drug Enforcement Administration (DEA) and state government agencies.  The Federal Food, Drug and Cosmetic Act, the Controlled Substances Act and other federal statutes and regulations govern or influence the testing, manufacturing, packing, labeling, storing, record keeping, safety, approval, advertising, promotion, sale and distribution of our products.

 

FDA approval is required before any dosage form of any new drug, including an off-patent equivalent of a previously approved drug, can be marketed.  The process for obtaining governmental approval to manufacture and market pharmaceutical products is rigorous, time-consuming and costly, and the extent to which it may be affected by legislative and regulatory developments cannot be predicted.  We are dependent on receiving FDA and other governmental approvals prior to manufacturing, marketing and shipping new products.  Consequently, there is always the risk the

 

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FDA or other applicable agency will not approve our new products, or the rate, timing and cost of such approvals will adversely affect our product introduction plans or results of operations.  See “Risks Related to Our Business—If we are unable to develop or commercialize new products, our operating results will suffer” and “—Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our product development and manufacturing capabilities.”

 

All applications for FDA approval must contain information relating to product formulation, raw material suppliers, stability, manufacturing processes, packaging, labeling and quality control.  There are generally two types of applications for FDA approval that would be applicable to our new products:

 

      New Drug Application (NDA).  We file a NDA when we seek approval for drugs with active ingredients and/or with dosage strengths, dosage forms, delivery systems or pharmacokinetic profiles that have not been previously approved by the FDA.  Generally, NDAs are filed for newly developed branded products or for a new dosage form of previously approved drugs.

      Abbreviated New Drug Application (ANDA).  We file an ANDA when we seek approval for off-patent, or generic, equivalents of a previously approved drug.

 

The process required by the FDA before a previously unapproved pharmaceutical product may be marketed in the U.S. generally involves the following:

 

      preclinical laboratory and animal tests;

      submission of an investigational new drug application (IND), which must become effective before clinical trials may begin;

      adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed product for its intended use;

      submission of a NDA containing the results of the preclinical and clinical trials establishing the safety and efficacy of the proposed product for its intended use; and

      FDA approval of a NDA.

 

Preclinical tests include laboratory evaluation of the product, its chemistry, formulation and stability, as well as animal studies to assess the potential safety and efficacy of the product.  We then submit the results of these studies to the FDA as part of an IND, which must become effective before we may begin human clinical trials.  The IND automatically becomes effective 30 days after receipt by the FDA unless the FDA, during that 30-day period, raises concerns or questions about the conduct of the trials as outlined in the IND.  In such cases, the IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can begin.  In addition, an independent Institutional Review Board at the medical center proposing to conduct the clinical trials must review and approve any clinical study.

 

Human clinical trials are typically conducted in sequential phases:

 

      Phase I.  During this phase, the drug is initially introduced into a relatively small number of healthy human subjects or patients and is tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion.

      Phase II.  This phase involves studies in a limited patient population to identify possible adverse effects and safety risks, to determine the efficacy of the product for specific targeted diseases or conditions, and to determine dosage tolerance and optimal dosage.

      Phase III.  When Phase II evaluations demonstrate that a dosage range of the product is effective and has an acceptable safety profile, Phase III trials are undertaken to further evaluate dosage, clinical efficacy and to further test for safety in an expanded patient population at geographically dispersed clinical study sites.

      Phase IV.  After a drug has been approved by the FDA, phase IV studies are conducted to explore additional patient populations, compare the drug to a competitor, or to further study the risks, benefits and optimal use of a drug.  These studies may be a requirement as a condition of the initial approval.

 

The results of product development, preclinical studies and clinical studies are then submitted to the FDA as part of a NDA, for approval of the marketing and commercial shipment of the new product.  The NDA drug development and approval process currently averages approximately five to ten years.

 

FDA approval of an ANDA is required before we may begin marketing an off-patent or generic equivalent of a drug that has been approved under a NDA, or a previously unapproved dosage form of a drug that has been approved under a NDA.  The ANDA approval process generally differs from the NDA approval process in that it does not require new preclinical and clinical studies; instead, it relies on the clinical studies establishing safety and efficacy conducted for the previously approved NDA drug.  The ANDA process, however, requires data to show that the ANDA drug is bioequivalent (i.e., therapeutically equivalent) to the previously approved drug.  “Bioequivalence” compares the bioavailability of one drug product with another and, when established, indicates whether the rate and extent of absorption of a generic drug in the

 

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body are substantially equivalent to the previously approved drug.  “Bioavailability” establishes the rate and extent of absorption, as determined by the time dependent concentrations of a drug product in the bloodstream needed to produce a therapeutic effect.  The ANDA drug development and approval process generally takes less time than the NDA drug development and approval process since the ANDA process does not require new clinical trials establishing the safety and efficacy of the drug product.

 

Supplemental NDAs or ANDAs are required for, among other things, approval to transfer products from one manufacturing site to another and may be under review for a year or more.  In addition, certain products may only be approved for transfer once new bioequivalency studies are conducted or other requirements are satisfied.

 

To obtain FDA approval of both NDAs and ANDAs, our manufacturing procedures and operations must conform to FDA quality system and control requirements generally referred to as current Good Manufacturing Practices (cGMP), as defined in  Title 21 of the U.S. Code of Federal Regulations.  These regulations encompass all aspects of the production process from receipt and qualification of components to distribution procedures for finished products.  They are evolving standards; thus, we must continue to expend substantial time, money and effort in all production and quality control areas to maintain compliance.  The evolving and complex nature of regulatory requirements, the broad authority and discretion of the FDA, and the generally high level of regulatory oversight results in the continuing possibility that we may be adversely affected by regulatory actions despite our efforts to maintain compliance with regulatory requirements.

 

We are subject to the periodic inspection of our facilities, procedures and operations and/or the testing of our products by the FDA, the DEA and other authorities, which conduct periodic inspections to assess compliance with applicable regulations.  In addition, in connection with its review of our applications for new products, the FDA conducts pre-approval and post-approval reviews and plant inspections to determine whether our systems and processes comply with cGMP and other FDA regulations.  Among other things, the FDA may withhold approval of NDAs, ANDAs or other product applications of a facility if deficiencies are found at that facility.  Vendors that supply finished products or components to us that we use to manufacture, package and label products are subject to similar regulation and periodic inspections.

 

Following such inspections, the FDA may issue notices on Form 483 and Warning Letters that could cause us to modify certain activities identified during the inspection.  A Form 483 notice is generally issued at the conclusion of an FDA inspection and lists conditions the FDA investigators believe may violate cGMP or other FDA regulations.  FDA guidelines specify that a Warning Letter be issued only for violations of “regulatory significance” for which the failure to adequately and promptly achieve correction may be expected to result in an enforcement action.

 

Our Corona, California facility and our Steris facility located in Phoenix, Arizona are each currently subject to a consent decree of permanent injunction. In July 2003, FDA inspected our Humacao, Puerto Rico facility and issued a Form 483 at the conclusion of the inspection. See “Risks Related to Our Business—Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our product development and manufacturing capabilities.” See also “Item 3. Legal Proceedings.”

 

Failure to comply with FDA and other governmental regulations can result in fines, unanticipated compliance expenditures, recall or seizure of products, total or partial suspension of production and/or distribution, suspension of the FDA’s review of NDAs, ANDAs or other product applications enforcement actions, injunctions and criminal prosecution.  Under certain circumstances, the FDA also has the authority to revoke previously granted drug approvals.  Although we have internal compliance programs, if these programs do not meet regulatory agency standards or if our compliance is deemed deficient in any significant way, it could have a material adverse effect on us.  See “Risks Related to Our Business—Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our product development and manufacturing capabilities.”

 

The Generic Drug Enforcement Act of 1992 established penalties for wrongdoing in connection with the development or submission of an ANDA.  Under this Act, the FDA has the authority to permanently or temporarily bar companies or individuals from submitting or assisting in the submission of an ANDA, and to temporarily deny approval and suspend applications to market generic drugs.  The FDA may also suspend the distribution of all drugs approved or developed in connection with certain wrongful conduct and/or withdraw approval of an ANDA and seek civil penalties.  The FDA can also significantly delay the approval of any pending NDA, ANDA or other regulatory submissions under the Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities Policy Act.

 

Reimbursement levels include Medicare, Medicaid and other federal and state medical assistance programs established according to statute and government regulations and policy.  Federal law

 

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requires that all pharmaceutical manufacturers rebate a percentage of their revenues arising from Medicaid-reimbursed prescription drug programs.  Such rebates are made to individual states, based on applicable sales in each state.  The required rebate is currently 11% of the average manufacturer price for sales of Medicaid-reimbursed products marketed under ANDAs.  For sales of Medicaid-reimbursed single source products and/or products marketed under NDAs, manufacturers are required to rebate the greater of approximately 15.1% of the average manufacturer price, or the difference between the average manufacturer price and the lowest net sales price to a non-government customer during a specified period.

 

There has been enhanced political attention, governmental scrutiny and litigation at the federal and state levels of the prices paid or reimbursed for pharmaceutical products under Medicaid, Medicare and other government programs.  See “Risks Related to Our Business—Investigations into average wholesale prices may adversely affect our business.” See also “Item 3. Legal Proceedings.”

 

In order to assist us in commercializing products, we have obtained from government authorities and private health insurers and other organizations, such as Health Maintenance Organizations (HMOs) and Managed Care Organizations (MCOs), authorization to receive reimbursement at varying levels for the cost of certain products and related treatments.  Third party payers increasingly challenge pricing of pharmaceutical products.  The trend toward managed healthcare in the U.S., the growth of organizations such as HMOs and MCOs and legislative proposals to reform healthcare and government insurance programs could significantly influence the purchase of pharmaceutical products, resulting in lower prices and a reduction in product demand.  Such cost containment measures and healthcare reform could affect our ability to sell our products and may have a material adverse effect on our business, results of operations, financial condition and cash flows.  Due to the uncertainty surrounding reimbursement of newly approved pharmaceutical products, reimbursement may not be available for some of our products.  Additionally, any reimbursement granted may not be maintained or limits on reimbursement available from third-party payers may reduce the demand for, or negatively effect the price of, those products.

 

Federal, state and local laws of general applicability, such as laws regulating working conditions, also govern us.  In addition, we are subject, as are all manufacturers generally, to various federal, state and local environmental protection laws and regulations, including those governing the discharge of material into the environment.  We do not expect the costs of complying with such environmental provisions to have a material effect on our earnings, cash requirements or competitive position in the foreseeable future.

 

As part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, companies are now required to file with the Federal Trade Commission and the Department of Justice certain types of agreements entered into between brand and generic pharmaceutical companies related to the manufacture, marketing and sale of generic versions of branded drugs.  This new requirement could affect the manner in which generic drug manufacturers resolve intellectual property litigation and other disputes with branded pharmaceutical companies, and could result generally in an increase in private-party litigation against pharmaceutical companies.  The impact of this new requirement, and the potential private-party lawsuits associated with arrangements between brand name and generic drug manufacturers, is uncertain and could adversely affect our business.

 

Continuing studies of the proper utilization, safety and efficacy of pharmaceuticals and other health care products are being conducted by industry, government agencies and others.  Such studies, which increasingly employ sophisticated methods and techniques, can call into question the utilization, safety and efficacy of previously marketed products and in some cases have resulted, and may in the future result, in the discontinuance of their marketing.

 

Seasonality

 

Our business is not materially affected by seasonal factors.

 

Backlog

 

Due to the relatively short lead-time required to fill orders for our products, backlog of orders is not material to our business.

 

Employees

 

As of December 31, 2003, we had 3,983 employees.  Of our employees, approximately 431 are engaged in research and development, 1,503 in manufacturing, 854 in quality assurance and quality control, 736 in sales and marketing, and 459 in administration.  We believe our relations with our employees are good.

 

ITEM 2.  PROPERTIES

 

We conduct our operations using a combination of owned and leased properties.  We believe that these facilities are suitable for the purposes for which we use them.

 

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Our owned properties consist of facilities used for research and development (R&D), manufacturing, warehouse, storage, distribution and administrative functions.  The following table provides a summary of locations of our owned properties:

 

LOCATION

 

PRIMARY USE

 

SEGMENT

Carmel, New York

 

Manufacturing

 

Generic

Changzhou City, Peoples Republic of China

 

Manufacturing, R&D

 

Generic

Coleraine, Northern Ireland

 

Manufacturing

 

Generic

Copiague, New York

 

Manufacturing, R&D

 

Generic

Corona, California

 

Manufacturing, R&D

 

Generic/Branded

Humacao, Puerto Rico

 

Manufacturing

 

Generic

Miami, Florida

 

Manufacturing

 

Generic

Salt Lake City, Utah

 

Manufacturing, R&D

 

Branded

Phoenix, Arizona

 

Manufacturing

 

Generic/Branded

 

In addition to the properties discussed above, we own one property at our facility in Cherry Hill, New Jersey, formerly operated by Marsam Pharmaceuticals, Inc. (Marsam).  During 2001, operations at our Cherry Hill facility were terminated.  During 2002, we sold two buildings in Cherry Hill and are continuing to attempt to sell the remaining property at that location.  This asset has been reclassified from asset held for disposition to asset held and used as of January 1, 2003.

 

Properties that we lease are primarily located throughout the U.S. and include distribution centers, research and development, manufacturing, warehouse, sales and marketing, and administrative facilities.  The following table provides a summary of locations of our significant leased properties:

 

LOCATION

 

PRIMARY USE

 

SEGMENT

Brewster, New York

 

Distribution

 

Generic/Branded

Corona, California

 

Administration

 

Generic/Branded

Glenview, Illinois

 

Distribution

 

Generic/Branded

Morristown, New Jersey

 

Sales and Marketing, Administration

 

Generic/Branded

Malmo, Sweden

 

R&D

 

Generic/Branded

 

Our leased properties are subject to various lease terms and expirations.  Included in our leased properties is a lease with His-Hsiung Hsu Hwa Chao (Chao Family) Trust I, a related-party trust, for a manufacturing facility in Corona, California.  This lease will expire in 2004. It is our intent to renew this lease prior to expiration.

 

We believe that we have sufficient facilities to conduct our operations during 2004.  However, we continue to evaluate the purchase or lease of additional properties, as our business requires.

 

ITEM 3.  LEGAL PROCEEDINGS

 

Phen-fen litigation.  Beginning in late 1997, a number of product liability suits were filed against Watson, The Rugby Group (Rugby) and certain other Watson affiliates, as well as numerous other manufacturing defendants, for personal injuries allegedly arising out of the use of phentermine hydrochloride.  The plaintiffs allege various injuries, ranging from minor injuries and anxiety to heart damage and death.  As of March 5, 2004, approximately 611 cases were pending against Watson and its affiliates in numerous state and federal courts.  Most of the cases involve multiple plaintiffs, and several were filed or certified as class actions.  The Company believes it will be fully indemnified by Rugby’s former owner, Aventis Pharmaceuticals (Aventis, formerly known as Hoechst Marion Roussel, Inc.) for the defense of all such cases and for any liability that may arise out of these cases.  Aventis is currently controlling the defense of all these matters as the indemnifying party under its agreements with us.  Additionally, Watson may have recourse against the manufacturing defendants in these cases.

 

Cipro® Litigation.  Beginning in July 2000, a number of suits have been filed against Watson, Rugby and other company affiliates in various state and federal courts alleging claims under various federal and state competition and consumer protection laws.  Several plaintiffs have filed amended complaints and motions seeking class certification.  As of March 5, 2004, approximately 42 cases had been filed against Watson, Rugby and other Watson entities.  Twenty-two of these actions have been consolidated in the U.S.  District Court for the Eastern District of New York (In re: Ciprofloxacin Hydrochloride Antitrust

 

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Litigation, MDL Docket No. 001383).  In May 2003, the court hearing the consolidated action granted Watson’s motion to dismiss and made rulings limiting the theories under which plaintiffs can seek recovery against Rugby and the other defendants.  Portions of that decision are expected to be appealed.  Other actions are pending in various state courts.  The actions generally allege that the defendants engaged in unlawful, anticompetitive conduct in connection with alleged agreements, entered into prior to Watson’s acquisition of Rugby from Aventis, related to the development, manufacture and sale of the drug substance ciprofloxacin hydrochloride, the generic version of Bayer’s brand drug, Cipro®.  The actions generally seek declaratory judgment, damages, injunctive relief, restitution and other relief on behalf of certain purported classes of individuals and other entities.  The courts hearing the cases in Wisconsin and New York have dismissed the actions.  Plaintiffs have appealed the dismissals.  The court hearing the case in California has set the trial for November 8, 2004.  In addition, Watson understands that various state and federal agencies are investigating the allegations made in these actions.  Aventis has agreed to defend and indemnify Watson and its affiliates in connection with the claims and investigations arising from the conduct and agreements allegedly undertaken by Rugby and its affiliates prior to Watson’s acquisition of Rugby, and is currently controlling the defense of these actions.  Discovery is ongoing.

 

Buspirone Litigation.  In April 2002, various class and individual plaintiffs, as well as several states, filed complaints or amended complaints against Bristol-Myers Squibb Company (BMS), Watson, and Watson’s subsidiaries Watson Pharma, Inc. (formerly known as Schein Pharmaceutical, Inc.) and Danbury Pharmacal, Inc. (collectively “Schein”).  Most of these actions were consolidated in the buspirone antitrust litigation in the United States District Court for the Southern District of New York.  (In re: Buspirone Antitrust Litigation, MDL Docket No. 1410).  The complaints allege that in 1994 Schein entered into an unlawful agreement with BMS in an attempt to block competition in the buspirone market.  The complaints alleged that BMS paid Schein in exchange for Schein’s agreement not to pursue its attempts to invalidate BMS’ U.S. Patent No. 4,182,763, claiming buspirone, and not to launch a generic version of BMS’ branded product BuSpar®.  The FTC also conducted an investigation into allegations made in these actions.  BMS agreed to defend and indemnify Watson and its affiliates (including Schein) in connection with these claims and investigations.  All of the buspirone lawsuits were settled and dismissed during 2003.  Watson and its subsidiaries obtained a full release of all claims.

 

Governmental Reimbursement Investigations and Proceedings.  In November 1999, Schein was informed by the U.S. Department of Justice that Schein, along with numerous other pharmaceutical companies, is a defendant in a qui tam action brought in 1995 under the U.S. False Claims Act currently pending in the U.S. District Court for the Southern District of Florida.  Watson has also learned that an action alleging parallel state law claims may have been filed in California Superior Court; however, Watson does not know if it or any of its affiliates have been named as a party.  Schein has not been served in either qui tam action.  A qui tam action is a civil lawsuit brought by an individual for an alleged violation of a federal statute, in which the U.S. Department of Justice has the right to intervene and take over the prosecution of the lawsuit at its option.  Pursuant to applicable federal law, the qui tam actions are under seal and, at this time, no details are available concerning, among other things, the various theories of liability against Schein or the amount of damages sought from Schein.  The Company believes that the qui tam actions relate to whether allegedly improper price reporting by pharmaceutical manufacturers led to increased payments by Medicare and/or Medicaid.  The qui tam actions may seek to recover damages from Schein based on its price reporting practices.  Schein has also received and responded to notices or subpoenas from the attorneys general of various states, including Florida, Nevada, New York, California and Texas, indicating investigations, claims and/or possible lawsuits relating to pharmaceutical pricing issues and whether allegedly improper actions by pharmaceutical manufacturers led to excessive payments by Medicare and/or Medicaid.  On June 26, 2003, Watson received a request for records and information from the U.S. House Committee on Energy and Commerce in connection with that committee’s investigation into pharmaceutical reimbursements and rebates under Medicaid.  Watson has produced documents in response to the request.  Other state and federal inquiries regarding pricing and reimbursement issues are anticipated.

 

Beginning in July 2002, Watson and certain of its subsidiaries, as well as numerous other pharmaceutical companies, were named as defendants in various state and federal court actions alleging improper or fraudulent reporting practices related to the reporting of average wholesale prices of certain products, and that the defendants committed other improper acts in order to increase prices and market shares.  The majority of these actions have been

 

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consolidated in the United States District Court for the District of Massachusetts (In re: Pharmaceutical Industry Average Wholesale Price Litigation, MDL Docket No. 1456).  The consolidated amended complaint alleges that the defendants’ acts improperly inflated the reimbursement amounts paid by various public and private plans and programs.  The amended complaint alleges claims on behalf of a purported class of plaintiffs that paid any portion of the price of certain drugs, which price was calculated based on its average wholesale price, or contracted with a pharmacy benefit manager to provide others with such drugs.  On February 24, 2004, the court in the consolidated action granted in part and denied in part the defendants’ motion to dismiss the amended complaint, and authorized the parties to proceed with discovery.  In a related case, on October 1, 2003, an action was filed in the United States District Court for the District of Massachusetts by the Commonwealth of Massachusetts.  (The Commonwealth of Massachusetts v.  Mylan Laboratories, Inc., et al., Civil Action No. 03-cv-11865 (PBS)).  This action names as defendants numerous pharmaceutical companies that are alleged to have sold generic pharmaceutical products, including Watson and Schein.  The complaint alleges, among other things, that the defendants’ improper or inaccurate pricing, marketing and rebate calculation practices for specified drug products resulted in false and inflated claims being paid by Massachusetts under its Medicaid program.  That complaint is the subject of a pending motion to dismiss.  These actions, if successful, could adversely affect Watson and may have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

 

FDA Matters.  In May 2002, Watson reached an agreement with the U.S. Food and Drug Administration (FDA) on the terms of a consent decree with respect to its Corona, California manufacturing facility.  The court approved the consent decree on May 13, 2002 (United States of America v. Watson Laboratories, Inc., and Allen Y. Chao, United States District Court for the Central District of California, EDCV-02-412-VAP).  The consent decree with the FDA does not require any fine, a facility shutdown, product recalls or any reduction in production or service at the Company’s Corona facility.  The consent decree applies only to the Corona facility and not other manufacturing sites.  The decree requires Watson to ensure that its Corona, California facility complies with the FDA’s current Good Manufacturing Practices (cGMP) regulations.  Pursuant to the agreement, Watson hired an independent expert to conduct inspections of the Corona facility at least once each year.  In February 2003, and February 2004, respectively, the first and second annual inspections were completed and the independent expert submitted its report of the inspection to the FDA.  In each instance, the independent expert reported its opinion that, based on the findings of the audit of the facility, the FDA’s applicable cGMP requirements, applicable FDA regulatory guidance, and the collective knowledge, education, qualifications and experience of the expert’s auditors and reviewers, the systems at Watson’s Corona facility audited and evaluated by the expert are in compliance with the FDA’s cGMP regulations.  However, the FDA is not required to accept or agree with the independent expert’s opinion.  If, in the future, the FDA determines that, with respect to its Corona facility, Watson has failed to comply with the consent decree or FDA regulations, including cGMPs, the consent decree allows the FDA to order Watson to take a variety of actions to remedy the deficiencies.  These actions could include ceasing manufacturing and related operations at the Corona facility, and recalling affected products.  Such actions, if taken by the FDA, could adversely affect the Company, its results of operations, financial position and/or cash flows.

 

As a result of FDA actions dating back to 1998, Steris Laboratories, Inc., Watson’s subsidiary acquired in connection with the Schein acquisition, entered into a consent decree with the FDA in October 1998.  Steris operates an injectible manufacturing and distribution facility in Phoenix, Arizona.  Under the terms of the consent decree, Steris was required, among other things, to demonstrate through independent certifications that Steris’ processes, quality assurance and quality control programs, and management controls comply with cGMP regulations.  The consent decree also provided for independent certification of Steris’ management controls, quality assurance and quality control programs and employee cGMP training.  Steris submitted to the FDA a corrective action plan provided for under the consent decree and is implementing the Steris corrective action plan.  In 1999, Steris resumed certain manufacturing and distribution operations under the expedited certification procedures provided in the consent decree.  Under the consent decree, newly manufactured products at the Steris facility were required to undergo certification by independent experts and review by the FDA prior to commercial distribution.  In August 2000, the FDA authorized Steris to monitor its commercial distribution of INFeD® without certification by independent third-party consultants.  In March 2002, the FDA completed an inspection of the Steris facility and found it to be in compliance with

 

16



 

cGMP regulations.  In November 2002, the FDA authorized Steris to manufacture and distribute commercial products without batch-by-batch review by an independent third-party consultant or the FDA.  In September 2003, Steris completed the final independent expert inspection required pursuant to the terms of the consent decree.  The inspection found the facility to be in a satisfactory state of good manufacturing practices control.  However, the FDA is not required to accept or agree with the independent expert’s opinion.  If, in the future, the FDA determines that Steris has failed to comply with the consent decree or FDA regulations, including cGMPs, the consent decree allows the FDA to order Steris to take a variety of actions to remedy the deficiencies.  These actions could include ceasing manufacturing and related operations at the Steris facility, and recalling affected products.  Watson is continuing to evaluate divestiture or other alternatives related to the Steris facility.

 

Securities Litigation.  Beginning in November 2003, several securities class action lawsuits were commenced in the United States District Court for the Central District of California against Watson and certain of its present and former officers and directors.  (City of St. Claire Shores Fire and Police Retirement System v. Watson Pharmaceuticals, Inc., et al. Case No. CV03-8236; Virginia H. Laddey, TR Laddey Living Trust U/A 10/2/85 v. Watson Pharmaceuticals, Inc., et al., Case No. SACV03-1731; Nicholas A. Melaragno v. Watson Pharmaceuticals, Inc., et al., Case No. CV03-9291; and Paul Watford v. Watson Pharmaceuticals, Inc., et al, Case No. CV03-8946).  Additionally, two shareholder derivative actions have been filed in California Superior Court for the County of Riverside. (Philip Orlando v. Allen Chao, et al., Case No. 403717; and Charles Zimmerman v. Allen Chao, et al, Case No. 403715).  These federal and state cases all relate to the drop in the price of the Company’s common stock in November 2001, and allege generally that the Company failed to timely advise investors about matters such as falling inventory valuations, increased competition and manufacturing difficulties, and therefore, that the Company’s published financial statements and public announcements during 2000 and 2001 were false and misleading. On February 9, 2004, the federal court issued an order consolidating all of the federal actions. In the shareholder derivative actions pending in state court, the parties have agreed that the lead plaintiff will have until April 9, 2004 to file an amended complaint, and that the defendants will have until May 24, 2004 to respond to the amended complaint.  The Company believes that these actions are without merit, and that it has substantial meritorious defenses, and intends to defend the matters vigorously.  However, these actions, if successful, could adversely affect the Company and may have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

 

Department of Health and Human Services Subpoena.  In December 2003, the Company’s subsidiary, Watson Pharma, Inc., received a subpoena from the Office of the Inspector General (OIG) of the Department of Health and Human Services.  The subpoena requested documents relating to physician meetings conducted during 2002 and 2003 related to Watson Pharma’s Ferrlecit® intravenous iron product. Watson Pharma is cooperating with the OIG to provide the requested documents.  However, the Company cannot predict what additional actions, if any, may be taken by the OIG, Department of Health and Human Services, or other governmental entities.

 

Watson and its affiliates are involved in various other disputes, governmental and/or regulatory inspections, inquires, investigations and proceedings, and litigation matters that arise from time to time in the ordinary course of business.  The process of resolving matters through litigation or other means is inherently uncertain and it is possible that the resolution of these matters will adversely affect the Company, its results of operations, financial condition and cash flows.

 

ITEM 4.  SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

 

No matters were submitted to a vote of security holders during the fourth quarter of the fiscal year ended December 31, 2003.

 

17



 

ITEM 4A.  EXECUTIVE OFFICERS OF THE REGISTRANT

 

Below are our executive officers as of March 12, 2004.

 

NAME

 

AGE

 

PRINCIPAL POSITION WITH REGISTRANT

Allen Chao, Ph.D.

 

58

 

Chairman and Chief Executive Officer

Joseph C. Papa

 

48

 

President and Chief Operating Officer

Charles P. Slacik

 

50

 

Executive Vice President, Chief Financial Officer

Ian McInnes, Ph.D.

 

51

 

Executive Vice President, Supply Chain

David A. Buchen

 

39

 

Senior Vice President, General Counsel, and Secretary

Maria Chow Yee

 

49

 

Senior Vice President, New Product Introduction and Operations

Charles D. Ebert, Ph.D.

 

50

 

Senior Vice President, Research and Development

David C. Hsia, Ph.D.

 

59

 

Senior Vice President, Scientific Affairs

Susan Skara

 

53

 

Senior Vice President, Human Resources

 

Allen Chao, Ph.D.

 

Allen Chao, Ph.D., age 58, a co-founder of Watson, has been our Chief Executive Officer since 1985 and Chairman since May 1996.  Dr. Chao served as our President from February 1998 to October 2002.  Dr. Chao serves on the Board of Directors of Somerset Pharmaceuticals, Inc., a research and development pharmaceutical company, which is fifty percent owned by Watson.  He also serves on the Board of Directors of Accuray, Inc., a developer of medical devices for the treatment of cancers.  Dr. Chao received a Ph.D. in Industrial and Physical Pharmacy from Purdue University in 1973.

 

Joseph C. Papa

 

Joseph C. Papa, age 48, has been our President since October 2002 and our Chief Operating Officer since November 2001.  Prior to joining Watson, Mr. Papa was President and Chief Operating Officer of DuPont Pharmaceuticals Company from February 2001 to November 2001, responsible for U.S., International and European Operations, as well as for manufacturing and the quality assurance and regulatory compliance organizations.  Prior to joining DuPont Pharmaceuticals Company, he was President, North America Global Country Operations for Pharmacia Corporation from May 2000 to February 2001.  From 1997 to 2000, Mr. Papa was President, U.S. Operations for Searle Pharmaceuticals Company.  Mr. Papa received a M.B.A. from Northwestern University in 1983 and a B.S. in Pharmacy from the University of Connecticut in 1978.

 

Charles P. Slacik, CPA

 

Charles Slacik, age 50, has served as Executive Vice President and Chief Financial Officer since May 2003.  Prior to joining Watson, Mr. Slacik was Senior Vice President and Chief Financial Officer for C.R. Bard, Inc., a medical device company, from 1999 to 2003 and held numerous positions at Wyeth (formerly American Home Products Corporation) from 1981 to 1999.  Mr. Slacik received his B.S. in Accounting and Finance from the University of Connecticut.

 

Ian McInnes, Ph.D.

 

Ian McInnes, Ph.D., age 51, has served as Executive Vice President, Supply Chain since June 2003.  Prior to joining Watson, Dr. McInnes was Senior Vice President, Global Supply and Corporate Officer, Head of Global Supply for Pharmacia Corporation from 1996 to 2003.  Additionally he held positions for various Glaxo Wellcome affiliates.  Dr. McInnes received his B.S and Ph.D. in Manufacturing Technology and Manufacturing Management from the University of Strathclyde, Scotland.

 

David A. Buchen

 

David A. Buchen, age 39, has served as Senior Vice President, General Counsel and Secretary since November 2002.  From November 2000 to November 2002, Mr. Buchen served as Vice President and Associate General Counsel.  From February 2000 to November 2000, he served as Vice President and Senior Corporate Counsel.  From November 1998 to February 2000, he served as Senior Corporate Counsel and Corporate Counsel.  He also served as Assistant Secretary from February 1999 to November 2002.  Prior to joining Watson, Mr. Buchen was Corporate Counsel at Bausch & Lomb Surgical (formerly Chiron Vision Corporation) from November 1995 until November 1998 and was an attorney with the law firm of Fulbright & Jaworski, LLP.  Mr. Buchen received a B.A. in Philosophy from the University of California, Berkley in 1985, and a Juris Doctor with honors from George Washington University Law School in 1989.

 

18



 

Maria Chow Yee

 

Maria Chow Yee, age 49, has been a Vice President of Watson Laboratories, Inc., a subsidiary of Watson, since 1992 and served as our Senior Vice President, Manufacturing Operations from March 2001 until January 2004. Since January 2004, Ms. Chow Yee has served as our Senior Vice President, New Product Introduction and Operations.  Ms. Chow received a B.S. in Business Administration from California State University, Long Beach in 1979.

 

Charles D. Ebert, Ph.D.

 

Charles D. Ebert, Ph.D., age 50, has served as our Senior Vice President, Research and Development since May 2000.  He served as our Senior Vice President, Proprietary Research and Development from June 1999 to May 2000.  Before joining Watson, Dr. Ebert served TheraTech, Inc. as its Senior Vice President, Research and Development since 1992, and as its Vice President, Research and Development from 1987 to 1992.  Dr. Ebert receiveda B.S. in Biology from the University of Utah in 1977 and a Ph.D. in Pharmaceutics from the University of Utah in 1981.

 

David C. Hsia, Ph.D.

 

David C. Hsia, Ph.D., age 59, has served as our Senior Vice President, Scientific Affairs since May 1995 and has been a Vice President of Watson since 1985.  Dr. Hsia is also co-founder of Watson.  He has been involved in the development of pharmaceutical formulations for oral contraceptives, sustained-release products and novel dosage forms for over 20 years.  Dr. Hsia received a Ph.D. in industrial and physical pharmacy from Purdue University in 1975.

 

Susan Skara

 

Susan Skara, age 53, has served as our Senior Vice President, Human Resources since November 2002.  Ms. Skara joined Watson in March 1999 as Vice President, Human Resources, a position she held until November 2002.  Prior to joining Watson, Ms. Skara worked for Apria Healthcare and last held the position of Senior Vice President of Human Resources from November 1996 to June 1998.  Ms. Skara received a B.A. in French from California State University, Fullerton.

 

Our executive officers are typically appointed annually by the Board of Directors, hold office until their successors are chosen and qualified, and may be removed at any time by the affirmative vote of a majority of the Board.  We have employment agreements with each of our executive officers.  David Hsia is the brother-in-law of Allen Chao.  There are no other family relationships between any director and executive officer of Watson.

 

PART II

 

ITEM 5.  MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

 

Our common stock is traded on the New York Stock Exchange under the symbol “WPI.” The following table sets forth the quarterly high and low share trading price information for the periods indicated:

 

 

 

High

 

Low

 

Year ended December 31, 2003:

 

 

 

 

 

First

 

$

31.75

 

$

26.90

 

Second

 

$

43.57

 

$

27.70

 

Third

 

$

45.18

 

$

37.20

 

Fourth

 

$

50.12

 

$

37.84

 

 

 

 

 

 

 

Year ended December 31, 2002:

 

 

 

 

 

First

 

$

33.25

 

$

25.65

 

Second

 

$

27.43

 

$

23.00

 

Third

 

$

26.00

 

$

17.95

 

Fourth

 

$

30.80

 

$

22.17

 

 

As of March 5, 2004, we estimate that there were approximately 3,602 holders of our common stock, including those who held in street or nominee name.

 

We have not paid any cash dividends since our initial public offering in February 1993, and do not anticipate paying any cash dividends in the foreseeable future.

19



 

PART II

 

ITEM 6.  SELECTED FINANCIAL DATA

 

WATSON PHARMACEUTICALS, INC.

FINANCIAL HIGHLIGHTS(1)

 

At December 31, (In thousands,
except per share amounts)

 

2003

 

2002

 

2001

 

2000

 

1999

 

Operating Highlights:

 

 

 

 

 

 

 

 

 

 

 

Net revenues

 

$

1,457,722

 

$

1,223,198

 

$

1,160,676

 

$

811,524

 

$

704,890

 

Gross profit(2)

 

$

833,071

 

$

651,316

 

$

648,467

 

$

439,743

 

$

470,550

 

Operating income(2),(3)

 

$

338,913

 

$

269,364

 

$

101,319

 

$

8,232

 

$

241,075

 

Net income(3)

 

$

202,864

 

$

175,796

 

$

116,361

 

$

157,495

 

$

182,661

 

Basic earnings per share

 

$

1.89

 

$

1.65

 

$

1.10

 

$

1.55

 

$

1.85

 

Diluted earnings per share

 

$

1.86

 

$

1.64

 

$

1.07

 

$

1.52

 

$

1.82

 

Weighted average shares outstanding, basic

 

107,488

 

106,675

 

106,130

 

101,430

 

98,500

 

Weighted average shares outstanding, diluted

 

108,927

 

107,367

 

108,340

 

103,575

 

100,520

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance Sheet Highlights:

 

 

 

 

 

 

 

 

 

 

 

Current assets(2)

 

$

1,323,489

 

$

913,451

 

$

878,399

 

$

705,413

 

$

459,918

 

Working capital(2)

 

$

984,804

 

$

537,986

 

$

633,274

 

$

411,926

 

$

309,137

 

Total assets

 

$

3,282,600

 

$

2,663,464

 

$

2,528,334

 

$

2,592,945

 

$

1,465,581

 

Total debt

 

$

722,535

 

$

415,237

 

$

483,805

 

$

536,154

 

$

151,194

 

Deferred tax liabilities

 

$

143,626

 

$

151,890

 

$

186,145

 

$

255,968

 

$

87,060

 

Total stockholders’ equity

 

$

2,057,346

 

$

1,798,284

 

$

1,672,050

 

$

1,547,969

 

$

1,058,908

 

 


(1)   We acquired Makoff R&D Laboratories, Inc. (Makoff) in 2000 and TheraTech, Inc. (TheraTech) in 1999.  These transactions were accounted for under the pooling of interests accounting method, and accordingly, the selected consolidated financial data in Item 6 includes the results of operations of these businesses for all periods presented (as if the companies noted had always operated as one).

(2)   As of January 1, 2003, we reclassified our Steris Laboratories, Inc. and Marsam Pharmaceuticals, Inc. facilities from assets held for disposition to assets held and used.  The Company reclassified gross profit, operating income, assets and working capital for the 2000, 2001 and 2002 periods to conform to current period presentation, which has no effect on net income, total assets or retained earnings.

(3)   For discussion on comparability of operating income and net income, please refer to financial line item discussion in our Management’s Discussion and Analysis of Financial Condition and Results of Operations in this Annual Report.

 

We did not pay any cash dividends during the years presented.  In 2000, Makoff made distributions to its stockholders, before its merger with Watson, totaling $2.4 million.

 

20



 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

Any statements made in this report that are not statements of historical fact or that refer to estimated or anticipated future events are forward-looking statements.  We have based our forward-looking statements on our management’s beliefs and assumptions based on information available to our management at the time these statements are made.  Such forward-looking statements reflect our current perspective of our business, future performance, existing trends and information as of the date of this filing.  These include, but are not limited to, our beliefs about future revenue and expense levels and growth rates, prospects related to our strategic initiatives and business strategies, express or implied assumptions about government regulatory action or inaction, anticipated product approvals and launches, business initiatives and product development activities, assessments related to clinical trial results, product performance and competitive environment, and anticipated financial performance.  Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “would,” “estimate,” “continue,” or “pursue,” or the negative other variations thereof or comparable terminology, are intended to identify forward-looking statements.  The statements are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to predict.

 

We caution the reader that certain important factors may affect our actual operating results and could cause such results to differ materially from those expressed or implied by forward-looking statements.  We believe the risks and uncertainties discussed under the Section entitled “Risks Related to Our Business,” and other risks and uncertainties detailed herein and from time to time in our Securities and Exchange Commission filings, may affect our actual results.

 

We disclaim any obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.  We also may make additional disclosures in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K that we may file from time to time with the Securities and Exchange Commission.  Other factors besides those listed here could also adversely affect us.  This discussion is provided as permitted by the Private Securities Litigation Reform Act of 1995.

 

Risks Related to Our Business

 

We operate in a rapidly changing environment that involves a number of risks, some of which are beyond our control.  The following discussion highlights some of these risks and others are discussed elsewhere in this report.  These and other risks could materially and adversely affect our business, financial condition, operating results or cash flows.

 

RISKS ASSOCIATED WITH INVESTING IN THE BUSINESS OF WATSON

 

IF WE ARE UNABLE TO SUCCESSFULLY DEVELOP OR COMMERCIALIZE NEW PRODUCTS, OUR OPERATING RESULTS WILL SUFFER.

 

Our future results of operations will depend to a significant extent upon our ability to successfully commercialize new branded and generic products in a timely manner.  There are numerous difficulties in developing and commercializing new products, including:

 

      developing, testing and manufacturing products in compliance with regulatory standards in a timely manner;

      receiving requisite regulatory approvals for such products in a timely manner;

      the availability, on commercially reasonable terms, of raw materials, including active pharmaceutical ingredients and other key ingredients;

      developing and commercializing a new product is time consuming, costly and subject to numerous factors that may delay or prevent the development and commercialization of new products, including legal actions brought by our
competitors;

      experiencing delays or unanticipated costs; and

      commercializing generic products may be substantially delayed by the listing with the FDA of patents that have the effect of potentially delaying approval of the off-patent product by up to 30 months, and in some cases, such patents have issued and been listed with the FDA after the key chemical patent on the branded drug product has expired or been litigated, causing additional delays in obtaining approval.

 

As a result of these and other difficulties, products currently in development by Watson may or may not receive the regulatory approvals necessary for marketing by Watson or other third-party partners.  This risk particularly exists with respect to the development of proprietary products because of the uncertainties, higher costs and lengthy time frames associated with research and development of such products and the inherent unproven market acceptance of such products.  If any of our products, when acquired or developed and approved, cannot be successfully or timely commercialized, our operating results could be adversely affected.  We cannot guarantee that any investment we make in developing products will be recouped, even if we are successful in commercializing those products.

 

21



 

Our branded pharmaceutical expenditures may not result in commercially successful products.

 

During 2003, we increased our planned expenditures for the development and marketing of our branded business.  During 2004 and thereafter, we may further increase the amounts we expend for our branded pharmaceutical business.  We cannot be sure these business expenditures will result in the successful discovery, development or launch of branded products that will prove to be commercially successful or will improve the long-term profitability of our business.

 

Our gross profit may fluctuate from period to period depending upon our product sales mix, our product pricing, and our costs to manufacture or purchase products.

 

Our future results of operations, financial condition and cash flows depend to a significant extent upon our branded and generic product sales mix.  Our sales of branded products tend to create higher gross margins than do our sales of generic products.  As a result, our sales mix (the proportion of total sales between branded products and generic products) will significantly impact our gross profit from period to period.  During 2003, sales of our branded products and generic products accounted for approximately 53% and 47%, respectively, of our net product sales.  During that same period, branded products and generic products contributed approximately 73% and 27%, respectively, to our gross profits.  Factors that may cause our sales mix to vary include:

 

              the amount of new product introductions;

              marketing exclusivity, if any, which may be obtained on certain new products;

              the level of competition in the marketplace for certain products;

              the availability of raw materials and finished products from our suppliers; and

              the scope and outcome of governmental regulatory action that may involve us.

 

The profitability of our product sales is also dependent upon the prices we are able to charge for our products, the costs to purchase products from third parties, and our ability to manufacture our products in a cost effective manner.

 

Loss of revenues from Ferrlecit®, a significant product, could have a material adverse effect on our results of operations, financial condition and cash flows.

 

In 2004 we will lose regulatory exclusivity on our Ferrlecit® product, which will allow generic applicants to submit ANDAs for Ferrlecit®.  In 2003, Ferrlecit® accounted for approximately 9% of our net revenues and 14% of our gross profit.  In February 2004, we submitted a Citizen’s Petition to FDA requesting that FDA not approve any ANDA for a generic version of Ferrlecit® until certain manufacturing, physiochemical and safety and efficacy criteria are satisfied.  We cannot predict whether FDA will grant or deny our Citizen’s Petition or when it may take such action.  We believe Ferrlecit® is a difficult product to manufacture and that it will be difficult for a generic competitor to demonstrate to FDA that its product is the same as Ferrlecit®.  However, if a generic version of Ferrlecit® is approved by FDA and enters the market, our net revenues could significantly decline, which could have a material adverse effect on our results of operations, financial condition and cash flows. 

 

If we are unsuccessful in our joint ventures and other collaborations, our operating results could suffer.

 

We have made substantial investments in joint ventures and other collaborations and may use these and other methods to develop or commercialize products in the future.  These arrangements typically involve other pharmaceutical companies as partners that may be competitors of ours in certain markets.  In many instances, we will not control these joint ventures or collaborations or the commercial exploitation of the licensed products, and cannot assure you that these ventures will be profitable.  Although restrictions contained in certain of these programs have not had a material adverse impact on the marketing of our own products to date, any such marketing restrictions could affect future revenues and have a material adverse effect on our operations.  Our results of operations may suffer if existing joint ventures or collaboration partners withdraw, or if these products are not timely developed, approved or successfully commercialized.

 

If we are unable to adequately protect our technology or enforce our patents, our business could suffer.

 

Our success with the branded products that we develop will depend, in part, on our ability to obtain patent protection for these products.  We currently have a number of U.S. and foreign patents issued and pending.  We cannot be sure that we will receive patents for any of our pending patent applications or any patent applications we may file in the future.  If our current and future patent applications are not approved or, if approved, if such patents are not upheld in a court of law, it may reduce our ability to competitively exploit our patented products.  Also, such patents may or may not provide competitive advantages for their respective products or they may be challenged or circumvented by our competitors, in which case our ability to commercially exploit these products may be diminished.

 

We also rely on trade secrets and proprietary know-how that we seek to protect, in part, through confidentiality agreements with our partners, customers, employees and consultants.  It is possible that these agreements will be breached or that they will not be enforceable in every instance, and that we will not have adequate remedies for any such breach.

 

22



 

It is also possible that our trade secrets will become known or independently developed by our competitors.

 

If we are unable to adequately protect our technology, trade secrets or propriety know-how, or enforce our patents, our results of operations, financial condition and cash flows could suffer.

 

If branded pharmaceutical companies are successful in limiting the use of generics through their legislative and regulatory efforts, our sales of generic products may suffer.

 

Many branded pharmaceutical companies increasingly have used state and federal legislative and regulatory means to delay generic competition.  These efforts have included:

 

      pursuing new patents for existing products which may be granted just before the expiration of one patent which could extend patent protection for additional years or otherwise delay the launch of generics;

      using the Citizen Petition process to request amendments to FDA standards;

      seeking changes to U.S. Pharmacopeia, an organization which publishes industry recognized compendia of drug standards;

      attaching patent extension amendments to non-related federal legislation; and

      engaging in state-by-state initiatives to enact legislation that restricts the substitution of some generic drugs, which could have an impact on products that we are developing.

 

If branded pharmaceutical companies are successful in limiting the use of generic products through these or other means, our sales of generic products may decline.  If we experience a material decline in generic product sales, our results of operations, financial condition and cash flows will suffer.

 

From time to time we may need to rely on licenses to proprietary technologies, which may be difficult or expensive to obtain.

 

We may need to obtain licenses to patents and other proprietary rights held by third parties to develop, manufacture and market products.  If we are unable to timely obtain these licenses on commercially reasonable terms, our ability to commercially exploit our products may be inhibited or prevented.

 

Third parties may claim that we infringe their proprietary rights and may prevent us from manufacturing and selling some of our products.

 

The manufacture, use and sale of new products that are the subject of conflicting patent rights have been the subject of substantial litigation in the pharmaceutical industry.  These lawsuits relate to the validity and infringement of patents or proprietary rights of third parties.  We may have to defend against charges that we violated patents or proprietary rights of third parties.  This is especially true in the case of generic products on which the patent covering the branded product is expiring, an area where infringement litigation is prevalent, and in the case of new branded products where a competitor has obtained patents for similar products.  Litigation may be costly and time-consuming, and could divert the attention of our management and technical personnel.  In addition, if we infringe on the rights of others, we could lose our right to develop or manufacture products or could be required to pay monetary damages or royalties to license proprietary rights from third parties.  Although the parties to patent and intellectual property disputes in the pharmaceutical industry have often settled their disputes through licensing or similar arrangements, the costs associated with these arrangements may be substantial and could include ongoing royalties.  Furthermore, we cannot be certain that the necessary licenses would be available to us on terms we believe to be acceptable.  As a result, an adverse determination in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent us from manufacturing and selling a number of our products, which could harm our business, financial condition, results of operations and cash flows.

 

As a part of our business strategy, we plan to consider and, as appropriate, make acquisitions of technologies, products and businesses, which may result in us experiencing difficulties in integrating the technologies, products and businesses that we acquire and/or experiencing significant charges to earnings that may adversely affect our stock price and financial condition.

 

We regularly review potential acquisitions of technologies, products and businesses complementary to our business.  Acquisitions typically entail many risks and could result in difficulties in integrating the operations and personnel of companies that we acquire and the technologies and products that we acquire.  If we are not able to successfully integrate our acquisitions, we may not obtain the advantages that the acquisitions were intended to create, which may adversely affect our business, results of operations, financial condition and cash flows, our ability to develop and introduce new products and the market price of our stock.  In addition, in connection with acquisitions, we could experience disruption in our business or employee base.  There is also a risk that key employees of companies that we acquire or key employees necessary to successfully commercialize technologies and products that we acquire may seek employment elsewhere, including with our competitors.  Furthermore, there

 

23



 

may be overlap between the products or customers of Watson and the companies that we acquire that may create conflicts in relationships or other commitments detrimental to the integrated businesses.

 

In addition, as a result of acquiring businesses, products or entering into other significant transactions, we have experienced, and will likely continue to experience, significant charges to earnings for merger and related expenses that may include transaction costs, closure costs or acquired in-process research and development charges.  These costs may include substantial fees for investment bankers, attorneys, accountants and financial printing costs and severance and other closure costs associated with the elimination of duplicate or discontinued products, operations and facilities.  Charges that we may incur in connection with acquisitions could adversely affect our results of operations for particular quarterly or annual periods.

 

If we are unable to obtain sufficient supplies from key suppliers that in some cases may be the only source of finished products or raw materials, our ability to deliver our products to the market may be impeded.

 

We are required to identify the supplier(s) of all the raw materials for our products in our applications with the FDA.  To the extent practicable, we attempt to identify more than one supplier in each drug application.  However, some products and raw materials are available only from a single source and, in some of our drug applications, only one supplier of products and raw materials has been identified, even in instances where multiple sources exist.  Among others, this includes products that have historically accounted for a significant portion of our revenues, such as Ferrlecit® and a significant number of our oral contraceptive products.  From time to time, certain of our outside suppliers have experienced regulatory or supply-related difficulties that have inhibited their ability to deliver products and raw materials to us, causing supply delays or interruptions.  To the extent any difficulties experienced by our suppliers cannot be resolved within a reasonable time, and at reasonable cost, or if raw materials for a particular product become unavailable from an approved supplier and we are required to qualify a new supplier with the FDA, our profit margins and market share for the affected product could decrease, as well as delay our development and sales and marketing efforts.

 

Our arrangements with foreign suppliers are subject to certain additional risks, including the availability of government clearances, export duties, political instability, war, acts of terrorism, currency fluctuations and restrictions on the transfer of funds.  For example, we obtain a significant portion of our raw materials from foreign suppliers.  Arrangements with international raw material suppliers are subject to, among other things, FDA regulation, various import duties and other government clearances.  Acts of governments outside the U.S. may affect the price or availability of raw materials needed for the development or manufacture of our products.  In addition, recent changes in patent laws in jurisdictions outside the U.S. may make it increasingly difficult to obtain raw materials for research and development prior to the expiration of the applicable U.S. or foreign patents.

 

Our policies regarding returns, allowances and chargebacks, and marketing programs adopted by wholesalers, may reduce our revenues in future fiscal periods.

 

Based on industry practice, generic product manufacturers, including us, have liberal return policies and have been willing to give customers post-sale inventory allowances.  Under these arrangements, from time to time, we give our customers credits on our generic products that our customers hold in inventory after we have decreased the market prices of the same generic products.  Therefore, if new competitors enter the marketplace and significantly lower the prices of any of their competing products, we would likely reduce the price of our product.  As a result, we would be obligated to provide significant credits to our customers who are then holding inventories of such products, which could reduce sales revenue and gross margin for the period the credit is provided.  Like our competitors, we also give credits for chargebacks to wholesale customers that have contracts with us for their sales to hospitals, group purchasing organizations, pharmacies or other retail customers.  A chargeback is the difference between the price the wholesale customer pays and the price that the wholesale customer’s end-customer pays for a product.  Although we establish reserves based on our prior experience and our best estimates of the impact that these policies may have in subsequent periods, we cannot ensure that our reserves are adequate or that actual product returns, allowances and chargebacks will not exceed our estimates.

 

Investigations of the calculation of average wholesale prices may adversely affect our business.

 

Many government and third-party payors, including Medicare, Medicaid, HMOs and MCOs, reimburse doctors and others for the purchase of certain prescription drugs based on a drug’s average wholesale price, or AWP.  In the past several years, state and federal government agencies have conducted ongoing investigations of manufacturers’ reporting practices with respect to AWP, in which they have suggested that reporting of inflated AWP’s have led to excessive payments for prescription drugs.  For example, beginning in July 2002, we and certain of our subsidiaries, as well as numerous other pharmaceutical companies,

 

24



 

were named as defendants in various state and federal court actions alleging improper or fraudulent practices related to the reporting of AWP of certain products, and other improper acts in order to increase prices and market shares.  We have also received notices or subpoenas from the attorneys general of various states, including Florida, Nevada, New York, California and Texas, indicating investigations, claims and/or possible lawsuits relating to pharmaceutical pricing issues and whether allegedly improper actions by pharmaceutical manufacturers led to excessive payments by Medicare and/or Medicaid.  These actions, if successful, could adversely affect us and may have a material adverse effect on our business, results of operations, financial condition and cash flows.

 

The design, development, manufacture and sale of our products involves the risk of product liability claims by consumers and other third parties, and insurance against such potential claims is expensive and may be difficult to obtain.

 

The design, development, manufacture and sale of our products involve an inherent risk of product liability claims and the associated adverse publicity.  Insurance coverage is expensive and may be difficult to obtain, and may not be available in the future on acceptable terms, or at all.  Although we currently maintain product liability insurance for our products in amounts we believe to be commercially reasonable, if the coverage limits of these insurance policies are not adequate, a claim brought against Watson, whether covered by insurance or not, could have a material adverse effect on our business, results of operations, financial condition and cash flows.

 

The loss of our key personnel could cause our business to suffer.

 

The success of our present and future operations will depend, to a significant extent, upon the experience, abilities and continued services of key personnel.  For example, although we have other senior management personnel, a significant loss of the services of Allen Chao, Ph.D., our Chairman and Chief Executive Officer, or other senior executive officers, could cause our business to suffer.  We cannot assure you that we will be able to attract and retain key personnel.  We have entered into employment agreements with all of our senior executive officers, including Dr. Chao.  We do not carry key-man life insurance on any of our officers.

 

Rising insurance costs could negatively impact profitability.

 

The cost of insurance, including workers compensation, product liability and general liability insurance, have risen significantly in the past year and are expected to continue to increase in 2004.  In response, we may increase deductibles and/or decrease certain coverages to mitigate these costs.  These increases, and our increased risk due to increased deductibles and reduced coverages, could have a negative impact on our results of operations, financial condition and cash flows.

 

Implementation of an enterprise resource planning system could cause business interruptions and negatively affect our profitability and cash flows.

 

We are in the process of implementing an enterprise resource planning (ERP) system to improve customer service, enhance operating efficiencies, and provide more effective management of business operations.  This implementation will enable Watson to better meet both the changing standards of industry technology and the needs of its customer base.  During 2003 and 2002, we spent $39.7 million and $17.4 million, respectively, on the implementation of our ERP system, including both capital and operating expenses. During 2004, we expect to spend approximately $28 million on our ERP implementation.  However, implementation of ERP systems and software carry risks such as cost overruns, project delays and business interruptions and delays.  If we experience a material business interruption as a result of our ERP implementation, it could adversely affect us, and could have a material adverse effect on our business, results of operations, financial condition and cash flows.

 

Issuance of debt or equity securities could materially change our operating results and financial condition.

 

We may consider issuing additional debt or equity securities in the future to fund potential acquisitions or investment, to refinance existing debt, or for general corporate purposes.  If a material acquisition or investment is completed, our operating results and financial condition could change materially in future periods.  However, no assurance can be given that additional funds will be available on satisfactory terms, or at all, to fund such activities.

 

Significant balances of intangible assets, including product rights and goodwill acquired, are subject to impairment testing and may result in impairment charges, which will adversely affect our results of operations and financial condition.

 

A significant amount of our total assets is related to acquired product rights and goodwill.  As of December 31, 2003, the carrying value of our product rights and other intangible assets was approximately $1 billion and the carrying value of our goodwill was approximately $500 million. 

 

Our product rights are stated at cost, less accumulated amortization.  We determine original fair value and amortization periods for product rights based on our assessment of various factors impacting estimated useful lives and cash flows of the acquired products.  Such factors include the product’s position in its life cycle, the existence or absence of like products in the market, various other competitive and regulatory issues and contractual terms.  Significant changes to any of these factors would require us to perform an impairment test on the affected asset and, if evidence of impairment exists, we would be required to take an impairment charge with respect to the asset.  Such a charge would adversely affect our results of operations and financial condition.

 

Goodwill is tested for impairment annually and when events occur or circumstances change that could potentially reduce the fair value of the reporting unit.  Impairment testing compares the fair value of the reporting unit to its carrying amount.  An impairment, if any, would be recorded in operating income and could have a significant adverse affect on our results of operations and financial condition.

 

RISKS RELATING TO INVESTING IN THE PHARMACEUTICAL INDUSTRY

 

Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our product development, manufacturing and distribution capabilities.

 

All pharmaceutical companies, including Watson, are subject to extensive, complex, costly and evolving regulation by the federal government, principally the FDA and to a lesser extent by the DEA and state government agencies.  The Federal Food, Drug and Cosmetic Act, the Controlled Substances Act and other federal statutes and regulations govern or influence the testing, manufacturing, packing, labeling,

 

25



 

storing, record keeping, safety, approval, advertising, promotion, sale and distribution of our products.

 

Under these regulations, we are subject to periodic inspection of our facilities, procedures and operations and/or the testing of our products by the FDA, the DEA and other authorities, which conduct periodic inspections to confirm that we are in compliance with all applicable regulations.  In addition, the FDA conducts pre-approval and post-approval reviews and plant inspections to determine whether our systems and processes are in compliance with current Good Manufacturing Practice, or cGMP, and other FDA regulations.  Following such inspections, the FDA may issue notices on Form 483 and warning letters that could cause us to modify certain activities identified during the inspection.  A Form 483 notice is generally issued at the conclusion of a FDA inspection and lists conditions the FDA inspectors believe may violate cGMP or other FDA regulations.  FDA guidelines specify that a warning letter is issued only for violations of “regulatory significance” for which the failure to adequately and promptly achieve correction may be expected to result in an enforcement action.

 

Our principal manufacturing facility in Corona, California (which manufactured products representing approximately 21% of our total net revenues for 2003) and our Steris facility located in Phoenix, Arizona are each currently subject to a consent decree of permanent injunction.  We cannot assure you that the FDA will determine that we have adequately corrected deficiencies at our manufacturing sites (including those referenced above), that subsequent FDA inspections will not result in additional inspectional observations at such sites, that approval of any of the pending or subsequently submitted NDAs, ANDAs or supplements to such applications by Watson or its subsidiaries will be granted or that the FDA will not seek to impose additional sanctions against Watson or any of its subsidiaries.  The range of possible sanctions includes, among others, FDA issuance of adverse publicity, product recalls or seizures, fines, total or partial suspension of production and/or distribution, suspension of the FDA’s review of product applications, enforcement actions, injunctions, and civil or criminal prosecution.  Any such sanctions, if imposed, could materially harm our operating results and financial condition.  Under certain circumstances, the FDA also has the authority to revoke previously granted drug approvals.  Similar sanctions as detailed above may be available to the FDA under a consent decree, depending upon the actual terms of such decree.  Although we have instituted internal compliance programs, if these programs do not meet regulatory agency standards or if compliance is deemed deficient in any significant way, it could materially harm our business.  Certain of our vendors are subject to similar regulation and periodic inspections.

 

The process for obtaining governmental approval to manufacture and market pharmaceutical products is rigorous, time-consuming and costly, and we cannot predict the extent to which we may be affected by legislative and regulatory developments.  We are dependent on receiving FDA and other governmental or third-party approvals prior to manufacturing, marketing and shipping our products.  Consequently, there is always the chance that we will not obtain FDA or other necessary approvals, or that the rate, timing and cost of such approvals, will adversely affect our product introduction plans or results of operations.  We carry inventories of certain product(s) in anticipation of launch, and if such product(s) are not subsequently launched, we may be required to write-off the related inventory.

 

Federal regulation of arrangements between manufacturers of branded and generic products could adversely affect our business.

 

As part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, companies are now required to file with the Federal Trade Commission and the Department of Justice certain types of agreements entered into between brand and generic pharmaceutical companies related to the manufacture, marketing and sale of generic versions of branded drugs.  This new requirement could affect the manner in which generic drug manufacturers resolve intellectual property litigation and other disputes with branded pharmaceutical companies and could result generally in an increase in private-party litigation against pharmaceutical companies or additional investigations or proceedings by the FTC or other governmental authorities.  The impact of this new requirement, and the potential private-party lawsuits associated with arrangements between brand name and generic drug manufacturers is uncertain, and could adversely affect our business.

 

Healthcare reform and a reduction in the reimbursement levels by governmental authorities, HMOs, MCOs or other third-party payors may adversely affect our business.

 

In order to assist us in commercializing products, we have obtained from government authorities and private health insurers and other organizations, such as HMOs and MCOs, authorization to receive reimbursement at varying levels for the cost of certain products and related treatments.  Third party payors increasingly challenge pricing of pharmaceutical products.  The trend toward managed healthcare in the U.S., the growth of organizations such as HMOs and MCOs and

 

26



 

legislative proposals to reform healthcare and government insurance programs could significantly influence the purchase of pharmaceutical products, resulting in lower prices and a reduction in product demand.  Such cost containment measures and healthcare reform could affect our ability to sell our products and may have a material adverse effect on our business, results of operations and financial condition.  Due to the uncertainty surrounding reimbursement of newly approved pharmaceutical products, reimbursement may not be available for some of Watson’s products.  Additionally, any reimbursement granted may not be maintained or limits on reimbursement available from third-party payors may reduce the demand for, or negatively affect the price of, those products and could harm significantly our business, results of operations, financial condition and cash flows.  We may also be subject to lawsuits relating to reimbursement programs that could be costly to defend, divert management’s attention and adversely affect our operating results.

 

The pharmaceutical industry is highly competitive.

 

We face strong competition in both our generic and branded product businesses.  The intensely competitive environment requires an ongoing, extensive search for technological innovations and the ability to market products effectively, including the ability to communicate the effectiveness, safety and value of branded products to healthcare professionals in private practice, group practices and managed care organizations.  Our competitors vary depending upon product categories, and within each product category, upon dosage strengths and drug-delivery systems.  Based on total assets, annual revenues, and market capitalization, we are smaller than certain of our national competitors in the branded product arena.  Most of our competitors have been in business for a longer period of time than Watson, have a greater number of products on the market and have greater financial and other resources than we do.  If we directly compete with them for the same markets and/or products, their financial strength could prevent us from capturing a profitable share of those markets.  It is possible that developments by our competitors will make our products or technologies noncompetitive or obsolete.

 

We also compete in the generic pharmaceutical business.  Revenues and gross profit derived from the sales of generic pharmaceutical products tend to follow a pattern based on certain regulatory and competitive factors.  As patents for brand name products and related exclusivity periods expire, the first generic manufacturer to receive regulatory approval for generic equivalents of such products is generally able to achieve significant market penetration.  As competing off-patent manufacturers receive regulatory approvals on similar products or as brand manufacturers launch generic versions of such products (for which no separate regulatory approval is required), market share, revenues and gross profit typically decline, in some cases dramatically.  Accordingly, the level of market share, revenue and gross profit attributable to a particular generic product is normally related to the number of competitors in that product’s market and the timing of that product’s regulatory approval and launch, in relation to competing approvals and launches.  Consequently, we must continue to develop and introduce new products in a timely and cost-effective manner to maintain our revenues and gross margins.

 

Sales of our products may continue to be adversely affected by the continuing consolidation of our distribution network and the concentration of our customer base.

 

Our principal customers are wholesale drug distributors and major retail drug store chains.  These customers comprise a significant part of the distribution network for pharmaceutical products in the U.S.  This distribution network is continuing to undergo significant consolidation marked by mergers and acquisitions among wholesale distributors and the growth of large retail drug store chains.  As a result, a small number of large wholesale distributors control a significant share of the market, and the number of independent drug stores and small drug store chains has decreased.  We expect that consolidation of drug wholesalers and retailers will increase pricing and other competitive pressures on drug manufacturers, including Watson.

 

For the year ended December 31, 2003, our four largest customers accounted for 17%, 15%, 12% and 11% respectively, of our net revenues.  The loss of any of these customers could materially adversely affect our business, results of operations and financial condition and our cash flows.  In addition, none of our customers are party to any long-term supply agreements with us which would enable them to change suppliers freely should they wish to do so.

 

27



 

ITEM 7.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

Except for the historical information contained herein, the following discussion contains forward-looking statements that are subject to known and unknown risks, uncertainties and other factors that may cause our actual results to differ materially from those expressed or implied by such forward-looking statements.  We discuss such risks, uncertainties and other factors throughout this report and specifically under the caption “Cautionary Note Regarding Forward-Looking Statements” just preceeding this Item in this Form 10-K.  In addition, the following discussion of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and notes thereto included elsewhere in this report.

 

GENERAL

 

We are primarily engaged in the development, manufacture, marketing, sale and distribution of branded and off-patent (generic) pharmaceutical products.  Watson was incorporated in 1985 and began operations as a manufacturer and marketer of off-patent pharmaceuticals.  Through internal product development and synergistic acquisitions of products and businesses, the Company has grown into a diversified specialty pharmaceutical company.  The Company also develops advanced drug delivery systems designed to enhance the therapeutic benefits of existing drug forms.  Watson operates manufacturing, distribution, research and development and administrative facilities primarily in the U.S.

 

CRITICAL ACCOUNTING POLICIES

 

Watson’s consolidated financial statements are presented on the basis of accounting principles that are generally accepted in the U.S.  We have taken into consideration all professional accounting standards that are effective for the year ended December 31, 2003 in preparing our consolidated financial statements.  Our significant accounting policies are described in Note 2 in the accompanying Notes to Consolidated Financial Statements.  Included within these policies are our “critical accounting policies.” Critical accounting policies are those policies that are most important to the preparation of our consolidated financial statements and require management’s most subjective and complex judgment due to the need to make estimates about matters that are inherently uncertain.  Although we believe that our estimates and assumptions are reasonable, actual results may differ significantly from these estimates.  Changes in estimates and assumptions based upon actual results may have a material impact on our results of operations and/or financial condition.  Our critical accounting policies are described in detail below.

 

Revenue and Provision for Sales Returns and Allowances

 

When we sell our products, we reduce the amount of revenue we recognize from such sale by an estimate of future product returns and sales allowances.  Sales allowances include cash discounts, rebates, chargebacks, and other similar expected future payments relating to product sold in the current period.  Factors that are considered in our estimates of future product returns and sales allowances include historical payment experience in relationship to revenues, estimated customer inventory levels, and current contract prices and terms with both direct and indirect customers.  If actual future payments for product returns and sales allowances exceed the estimates we made at the time of sale, our financial position, results of operations and cash flows would be negatively impacted.

 

Our provision for chargebacks is our most significant and complex estimated sales allowance.  A chargeback represents an amount payable in the future to a wholesaler for the difference between the invoice price paid to us by our wholesale customer for a particular product and the negotiated contract price that the wholesaler’s customer pays for that product.  Our chargeback estimates take into consideration the current average chargeback rates by product and estimated wholesaler inventory levels.  We continually monitor our assumptions giving consideration to current pricing trends and estimated wholesaler inventory levels and make adjustments to these estimates when we believe that the actual chargeback amounts payable in the future will differ from our original estimates.

 

Inventory Valuation

 

Inventories consist of finished goods held for distribution, raw materials and work in process.  Additionally, at December 31, 2003, we had approximately $41.7 million in inventory relating to products that are pending approval by the FDA or have not yet been launched due to contractual restrictions.  Our inventories are stated at the lower of cost (first-in, first-out method) or market (net realizable value).  We write down inventories to net realizable value based on forecasted demand and market conditions, which may differ from actual results.

 

Investments

 

All of our marketable securities are classified as available-for-sale and are reported at fair value, based on quoted market prices.  The adjustment to fair value is

 

28



 

included on the balance sheet in a separate component of stockholders’ equity as unrealized gains and losses and reported as other comprehensive income.  No gains or losses on marketable securities are realized until shares are sold or a decline in fair value is determined to be other-than-temporary.  If a decline in fair value is determined to be other-than-temporary, an impairment charge is recorded and a new cost basis in the investment is established.

 

We employ a systematic methodology that considers all available evidence in evaluating potential impairment of our investments.  In the event that the cost of an investment exceeds its fair value, we evaluate, among other factors, general market conditions, the duration and extent to which the fair value is less than cost, as well as our intent and ability to hold the investment.  We also consider specific adverse conditions related to the financial health of and business outlook for the investee, including industry and sector performance, changes in technology, operational and financing cash flow factors, and rating agency actions.  However, when the carrying value of an investment is greater than the realizable value for an extended period, unless sufficient positive, objective evidence exists to support such an extended period, the decline will be considered other-than-temporary.  Any decline in the market prices of our equity investments that are deemed to be other-than-temporary may require us to incur additional impairment charges.

 

Product Rights

 

Our product rights are stated at cost, less accumulated amortization, and are amortized using the straight-line method over their estimated useful lives ranging from eight to twenty years.  We determine amortization periods for product rights based on our assessment of various factors impacting estimated useful lives and cash flows of the acquired products.  Such factors include the product’s position in its life cycle, the existence or absence of like products in the market, various other competitive and regulatory issues, and contractual terms.  Significant changes to any of these factors may result in a reduction in the product right’s useful life and an acceleration of related amortization expense, which could cause our operating income, net income and earnings per share to decline.

 

Product rights are tested periodically for impairment when events or changes in circumstances indicate that an asset’s carrying value may not be recoverable.  The impairment testing involves comparing the carrying amount of the asset to the forecasted undiscounted future cash flows of the product(s).  In the event the carrying value of the asset exceeds the undiscounted future cash flows of the product(s) and the carrying value is considered not recoverable, an impairment exists.  An impairment loss is measured as the excess of the asset’s carrying value over its fair value, calculated using a discounted future cash flow method.  The computed impairment loss is recognized in net income in the period that the impairment occurs.

 

Goodwill and Indefinite-Lived Intangible Assets

 

We test goodwill and indefinite-lived intangible assets for impairment annually.  Additionally, we may perform tests between annual tests if an event occurs or circumstances change that could potentially reduce the fair value of a reporting unit below its carrying amount.  See Note 8 in the accompanying Notes to Consolidated Financial Statements.  An impairment, if any, would be recorded in operating income and could significantly adversely affect net income and earnings per share.

 

RESULTS OF OPERATIONS

 

We had a year of solid performance with continual growth over the last three years.  We launched over 25 products as well as improved unit sales and market growth for many of our existing products resulting in a 15% increase in net income.  We continued to build our infrastructure and foundation for future growth by increasing our investment in research and development, resulting in 14 new ANDA submissions and significant progress in our branded clinical trials.  We have strengthened our sales and marketing presence with the addition of experienced sales representatives.  We believe that the investment in research and development and key strategic alliances make us well positioned to expand our product pipeline in niche therapeutic areas and gain additional market share.

 

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YEAR ENDED DECEMBER 31, 2003 COMPARED TO 2002

 

Net Revenues

 

 

 

 

 

 

 

CHANGE

 

Years Ended December 31, ($ in thousands):

 

2003

 

2002

 

$

 

%

 

Net Revenues by Segment:

 

 

 

 

 

 

 

 

 

Branded pharmaceutical products

 

$

749,195

 

$

649,495

 

$

99,700

 

15.4

%

% of product net revenues

 

53

%

55

%

 

 

 

 

Generic pharmaceutical products

 

659,277

 

537,450

 

121,827

 

22.7

%

% of product net revenues

 

47

%

45

%

 

 

 

 

Other

 

49,250

 

36,253

 

12,997

 

35.9

%

Total net revenues

 

$

1,457,722

 

$

1,223,198

 

$

234,524

 

19.2

%

 

Net revenues increased in all segments, with our Generics division contributing over 50% of the growth.  Other net revenues increased primarily due to revenue received from Aventis Pharmaceuticals (Aventis) under a 1998 agreement entered into in connection with our acquisition of the Rugby Group, Inc.  Pursuant to the agreement, we are entitled to a portion of the proceeds received by Aventis in connection with Barr Laboratories, Inc.’s sales of ciprofloxacin tablets. Other net revenues also includes $21 million of contingent payments received from Aventis in 2003 relating to a litigation settlement. The final contingent payment relating to this settlement was received in September 2003. Other revenues will decline in 2004 since no future contingent payments will be received relating to this settlement.

 

BRANDED PHARMACEUTICAL PRODUCTS

 

The increase in net revenues from our branded pharmaceutical products was primarily attributable to revenue growth within our General Products division.  The predominant factors contributing to the increase were higher unit sales of our Androderm® testosterone patch, resulting from focused product promotions and prescription growth, the acquisition of the Fioricet® and Fiorinal® product lines from Novartis during the first quarter of 2003 and the launch of our Oxytrol® product during the second quarter of 2003.

 

Women’s Health also contributed to the increase in net revenues as a result of new product launches such as our TriNessa™, Mononessa™, and Necon® 7/7/7 products, offset by lower sales volume of existing oral contraceptive products due to additional market competition.  Net revenues from our Nephrology division declined slightly.

 

We expect our branded pharmaceutical products net revenues to increase by 8% during 2004 as a result of higher Oxytrol® sales, and an increase in Women’s Health sales due to full year sales of TriNessa™, which we launched in December 2003, and the expected launch of a new oral contraceptive product.

 

GENERIC PHARMACEUTICAL PRODUCTS

 

The increase in net revenues from our generic segment was predominantly as a result of 15 new product launches, such as oxycodone acetaminophen and glipizide extended-release, product reintroductions and certain price increases on key products with limited competition during 2003.  Our nicotine gum product also contributed to the increase as a result of increased market share and the introduction of a new packaging size.

 

We expect to increase net sales by 30% on our generic pharmaceutical products in 2004 through over 12 new product launches, including Bupropion SR 100mg strength that was launched in January 2004, and the expected launch of the 150mg strength, a full year of sales for the products launched in fourth quarter of 2003 (oxycodone acetaminophen and glipizide extended-release) and new products from our own internal development efforts and strategic alliances.

 

NET REVENUE MIX

 

Net revenue mix is an important consideration in evaluating the profitability of our business.  Our branded products generally realize higher gross profit margins than our generic products.  Any significant change in our net revenue mix could substantially impact our gross profit, gross margin and the overall profitability of our business.  During 2004, we expect slightly higher sales of our generic products compared to our branded division.

 

Gross Profit Margin on Product Net Revenues (Gross Margin)

 

Years Ended December 31, ($ in thousands):

 

2003

 

2002

 

Gross Margin by Segment:

 

 

 

 

 

Branded pharmaceutical products

 

76.4

%

76.0

%

Generic pharmaceutical products

 

32.0

%

22.6

%

Gross margin on product net revenues

 

55.7

%

51.8

%

 

30



 

The overall increase in gross margin on product net revenues is due to increases in our generic pharmaceutical products from our price increases for certain products with a competitive advantage, the launch of higher margin products, including oxycodone acetaminophen and glipizide extended-release and higher margins on existing products, such as nicotine gum.  The gross margin from our branded products remained consistent.  Higher gross margins resulting from the launch of Oxytrol® and product sales of Fiorinal® and Fioricet® were offset by a decline in Women’s Health due to an incremental increase in sales of in-licensed products, which have lower gross margins than internally developed Women's Health products.

 

We expect the gross margin on our generic pharmaceutical products in 2004 to slightly increase with the timely launch of 12 new generic products, including Bupropion SR 150mg tablets, and our ability to sustain price increases on key products.  We expect the gross margin on our branded pharmaceutical products to decline slightly due to lower margins from certain Women’s Health products due to product mix increase of in-licensed products, including TriNessa™.  Overall gross margins are expected to decline slightly in 2004 as the expected margin declines in our branded pharmaceutical products and lower other revenue will outweigh the increase in our generic pharmaceutical products.

 

Research and Development (R&D) Expenses

 

 

 

 

 

 

 

CHANGE

 

Years Ended December 31, ($ in thousands):

 

2003

 

2002

 

$

 

%

 

R&D expenses

 

$

102,083

 

$

82,178

 

$

19,905

 

24.2

%

as % of net revenues

 

7.0

%

6.7

%

 

 

 

 

 

Research and development expenses increased from the prior year due to increased spending on clinical studies and expanded generic development programs.  The clinical studies predominantly relate to our anti-fungal nail patch, which we discontinued in 2004, a transdermal contraceptive patch, continued studies with Oxytrol® and additional indications for Ferrlecit®.  Expenses also increased due to biostudies and other expenses related to various generic products under different stages of development.  As previously mentioned, during 2003 we expanded our relationship with Cipla.  This expansion results in increased spending on development of new off-patent products.

 

Research and development is expected to increase over 30% in 2004, as the result of increased clinical expenses associated with our generic and branded product pipelines.

 

Selling, General and Administrative (SG&A) Expenses

 

 

 

 

 

 

 

CHANGE

 

Years Ended December 31, ($ in thousands):

 

2003

 

2002

 

$

 

%

 

SG&A expenses

 

$

320,201

 

$

238,458

 

$

81,743

 

34.3

%

as % of net revenues

 

22.0

%

19.5

%

 

 

 

 

 

Selling, general and administrative expenses increased from the prior year primarily due to higher spending associated with our Oxytrol® product launch in April 2003 and additional costs related to expansion of our sales force through our relationship with Ventiv Health Inc., our contract sales organization.  We also experienced increases related to the ongoing implementation of our new ERP system.

 

Selling, general and administrative expenses are expected to increase slightly in 2004 due to continued Oxytrol® sales and marketing expenses and ERP costs, however, we expect a decline as a percentage of net sales.

 

Amortization Expense

 

 

 

 

 

 

 

CHANGE

 

Years Ended December 31, ($ in thousands):

 

2003

 

2002

 

$

 

%

 

Amortization

 

$

71,874

 

$

61,316

 

$

10,558

 

17.2

%

 

31



 

The increase in amortization expenses is primarily due to amortization associated with the Fiorinal® and Fioricet® product lines acquired in February 2003.  We expect amortization expense for 2004 t