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The following is an excerpt from a S-4 SEC Filing, filed by WARNER CHILCOTT HOLDINGS CO III, LTD on 7/18/2005.
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WARNER CHILCOTT HOLDINGS CO III, LTD - S-4 - 20050718 - BUSINESS

BUSINESS

 

Business Overview

 

We are a U.S. specialty pharmaceutical company focused on marketing, developing and manufacturing branded prescription pharmaceutical products in two core therapeutic categories: women’s healthcare and dermatology. We develop, manufacture, supply and market branded prescription pharmaceutical products, predominantly in the United States. Our strategy comprises four elements: focus on niche markets, continue organic growth of our pharmaceutical business, develop new proprietary products and acquire products that complement and strengthen our existing product portfolio. We have established strong franchises in our core therapeutic categories through our precision marketing techniques and specialty sales forces of approximately 400 representatives.

 

The U.S. pharmaceutical market generated sales of approximately $250.0 billion in 2004 and has grown at a compound annual growth rate of 12.3% since 1992, according to IMS. Large pharmaceutical companies have been consolidating and are increasingly focusing their research and development and sales and marketing capabilities on developing and marketing “blockbuster” drugs. This market dynamic creates opportunities for specialty pharmaceutical companies like us to profitably market products.

 

We believe that our focused promotion in the therapeutic categories of women’s healthcare and dermatology positions us well to grow revenues of our products in these areas. We believe that our sales forces represent one of the largest contingents of sales representatives dedicated to promoting and marketing branded women’s healthcare and dermatology products to OB/GYNs and dermatologists in the United States. These sales representatives specifically target physicians who are high prescribers of products in our therapeutic categories. Our experienced management team possesses significant expertise in this type of precision marketing of prescription pharmaceutical products and has an established track record of acquiring branded pharmaceuticals and developing line extensions. By engaging in focused R&D aimed at generating improvements and line extensions in our existing therapeutic categories, we are able to make modest investments in relatively low-risk projects that extend product life cycles.

 

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Our principal products include:

 

Product


 

Indication


 

Active Ingredient


 

Expiration of Patent


Hormonal Contraceptives

           

Ovcon 35 and Ovcon 50

  Prevention of pregnancy   Norethindrone and ethinyl estradiol   Patent expired

Estrostep

  Prevention of pregnancy and treatment of moderate acne in women who desire oral contraception   Norethindrone acetate and ethinyl estradiol   April 2008

Oral Hormone Therapy

           

femhrt

  Treatment of moderate to severe vasomotor symptoms and urogenital symptoms associated with menopause   Norethindrone acetate and ethinyl estradiol   May 2010

Estrace Tablets

  Treatment of moderate to severe vasomotor symptoms and urogenital symptoms associated with menopause   17 (beta) estradiol   Patent expired

Other Hormone Therapy

           

Estrace Cream

  Vaginal cream for treatment of vaginal and vulval atrophy   17 (beta) estradiol   Patent expired

Femring

  Treatment of moderate to severe vasomotor symptoms and urogenital symptoms associated with menopause   Estradiol acetate   December 2015

Premenstrual Dysphoric Disorder (PMDD)

   

Sarafem

  Treatment of premenstrual dysphoric disorder, a severe form of premenstrual syndrome   Fluoxetine hydrochloride   May 2008

Dermatology

           

Doryx

  Adjunct therapy for severe acne   Doxycycline hyclate   Patent expired

Dovonex(1)

  Treatment of psoriasis   Calcipotriene   December 2007

(1) We do not currently own Dovonex. We currently co-promote Dovonex under an agreement with Bristol-Myers. Bristol-Myers has informed us that Dovonex generated net sales and gross profits in the U.S. market of approximately $136.5 million and $93.6 million, respectively, for Bristol-Myers for the twelve months ended December 31, 2004. We have the right, and intend, to acquire the exclusive U.S. sales and marketing rights to Dovonex from Bristol-Myers in January 2006 for $200.0 million plus a 5% royalty on net sales through 2007.

 

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Strategy

 

We intend to continue to develop our specialty pharmaceutical products business through focusing on niche markets, driving organic growth through precision marketing, developing and marketing product line extensions and selectively acquiring complementary products that enhance our existing product portfolio.

 

Focus on Niche Markets. While large pharmaceutical companies are primarily focusing on developing “blockbuster” drugs, we concentrate our efforts on branded products in niche markets (or high concentration of prescribing by few physicians) which can be more effectively targeted by our sales force of approximately 400 representatives. We currently market a range of established specialty pharmaceutical products in two core therapeutic categories: women’s healthcare and dermatology. In women’s healthcare, our primary areas of concentration are hormonal contraceptives and hormone therapy. In the dermatology category, we promote treatments for acne and psoriasis. Given the niche nature of our markets, our sales representatives are able to target the primary prescription writers of these products, OB/GYNs and dermatologists. The OB/GYNs and dermatologists to whom we promote our products account for a large percentage of the total prescriptions written in those markets.

 

Drive Organic Growth. We will continue to drive organic growth of our core women’s healthcare and dermatology product franchises through precision marketing (targeting high-prescribing OB/GYNs and dermatologists), sales force monitoring and compensation, and product pricing.

 

By analyzing prescription data, we are able to identify and track high-volume prescribing OB/GYNs and dermatologists in our two core therapeutic categories. These high-prescribing physicians are covered by our sales force with high frequency product promotion and sampling. Our sales representatives also seek to build strong professional relationships with their target physicians to maximize the impact of our selling efforts and promote loyalty to our brands. Our sales force’s compensation is tied to market share (prescription) growth.

 

Our product pricing growth is in-line with pricing growth of competing branded products and reviewed regularly by management. We believe that prices for branded products in our sectors are likely to continue to rise over time on a steady and sustainable basis, in line with historical trends.

 

Develop and Market Product Line Extensions. Our development efforts focus primarily on extending proprietary protection of our products through product line extensions, rather than undertaking the costly, high-risk new drug discovery usually associated with large pharmaceutical and biotechnology companies. We have an experienced development team of scientists and technicians with proven expertise in the development of line extensions and formulations and have consistently demonstrated our ability to commercialize our development efforts. Since March 2003, we have received approval from the FDA for five of our products. In addition to Femring, which was approved in March 2003, we received FDA approval for Ovcon 35 Chewable, a line extension with patent protection through June 2021, Femtrace, a new estrogen only hormone therapy available in three dosages, a new dosage form of our Doryx line of acne treatment that was approved on May 6, 2005 and femhrt Lo, a low dose combination hormone therapy approved on January 14, 2005. In addition, we expect to receive FDA approval in 2006 for Estrostep Chewable, a chewable form of our Estrostep product and Loestrin 24, an oral contraceptive with a 24-day regimen. By targeting our R&D efforts on our existing therapeutic categories, we believe we will be able to leverage the professional relationships our sales force has built with high-prescribing specialist physicians. We have also recently signed letters of intent with LEO Pharma regarding potential Dovonex and Dovobet line extensions and a right of first refusal for LEO’s other potential products in dermatology.

 

Selectively Acquire Complementary Products that Enhance Our Existing Product Portfolio. We intend to continue to evaluate opportunities to expand our pharmaceutical product portfolio by selectively purchasing and licensing established branded products which complement our strategic focus on women’s healthcare and dermatology and can benefit from our sales force of approximately 400 representatives. During the past five years, we have acquired a number of products, including Ovcon and Estrostep, and increased market share and revenue for these products. We intend to acquire the exclusive U.S. sales and marketing rights to Dovonex, a leading psoriasis treatment, from Bristol-Myers in January 2006 for $200.0 million plus a 5% royalty on net sales

 

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through 2007. Our sales force currently promotes Dovonex for Bristol-Myers, and therefore the 2006 acquisition of the Dovonex rights will not require any significant launch costs or any significant increase in the size of our sales force. In addition, we have licensed from LEO Pharma, subject to FDA approval, the exclusive U.S. sales and marketing rights to Dovobet, a combination-therapy psoriasis treatment that combines calcipotriene, the active ingredient in Dovonex, with a corticosteroid into a single topical treatment. The NDA for Dovobet was accepted for filing on May 9, 2005 and we expect to launch this product in the first half of 2006. A final milestone payment of $40.0 million will be payable to LEO Pharma upon FDA approval.

 

Our Competitive Strengths

 

Experienced Management Team. We have an experienced management team with extensive pharmaceutical industry expertise and a track record of identifying, developing and promoting specialty pharmaceutical products. Roger Boissonneault, Chief Executive Officer, Carl Reichel, President—Pharmaceuticals and Anthony Bruno, Executive Vice President—Corporate Development and General Counsel, have over 75 years of combined experience in the pharmaceutical industry, including tenures at the Parke-Davis division of Warner-Lambert. While at Warner-Lambert, Mr. Boissonneault led its successful women’s healthcare division from 1991 to 1995. In addition, our new Executive Vice President and Chief Financial Officer, Paul Herendeen, has extensive experience as a chief financial officer in the pharmaceutical industry.

 

Leading Sales and Marketing Expertise. We believe we have one of the largest contingents of sales representatives dedicated to calling on OB/GYNs and dermatologists in the United States. We employ precision marketing strategies to target specific physicians who are high prescribers of products in our therapeutic categories. Our marketing success is enhanced by the professional relationships our sales force has built with these prescribers. With compensation tied to new prescription growth, our sales force is highly motivated to increase our market share.

 

Strong Intellectual Property Portfolio. Many of our products are protected by patents. Our strategy is to extend exclusivity by developing improvements to our products with strong intellectual property protection. Such launches are currently planned for several of our product franchises, including Ovcon, Doryx and Estrostep. Additionally, several of our products that are not currently protected by current patents continue to enjoy exclusivity due to proprietary manufacturing technology and, for topical products that act locally, the challenges associated with conducting bioequivalence studies.

 

Substantial Development Pipeline of Branded Women’s Healthcare and Dermatological Products. Our development effort is focused on expanding our product portfolio by capitalizing on our core knowledge of women’s healthcare and dermatological products. We have an experienced development team of scientists and technicians with proven expertise in the development of line extensions and formulations. We have consistently demonstrated our ability to obtain FDA approvals for our products. Recently, we received FDA approval for five of our products, Femring, Ovcon 35 Chewable, Femtrace, a new dosage form of our Doryx line of products, and femhrt Lo.

 

Well-Positioned in Attractive Markets. We believe that our core therapeutic categories feature attractive long-term growth characteristics and that our products are well-positioned to capitalize on those growth trends. For example, the market for hormonal contraceptives, which are being increasingly prescribed for their benefits beyond contraception, has experienced a compound annual growth rate of 4.9% in new prescriptions from calendar year 2002 through calendar year 2004. In the HT market, treatment regimens are increasingly focused on lower dose products, and we expect to launch femhrt Lo in late 2005 to fulfill growing market demand for lower dose therapies. Due to new therapy options and price increases, sales in the psoriasis and the oral antibiotic acne medication markets have increased by approximately 135%* and 29%, respectively, from calendar year 2002 through calendar year 2004. In the psoriasis market, we plan to capitalize on the leading market position of Dovonex with the introduction of Dovobet, contingent on FDA approval.

 


* IMS Health, Retail and Hospital Provider Audit, NDTI and Data View, December 2004.

 

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Branded Diversified Product Offering. We have an established portfolio of branded pharmaceutical products in the areas of women’s healthcare and dermatology. The following chart presents a breakdown of our products by percentage share of our total revenues for fiscal year 2004 (and does not include anticipated contributions from our planned acquisitions of the exclusive U.S. sales and marketing rights to Dovonex and Dovobet and revenues attributable to Loestrin product sales):

 

LOGO

 

Strong Free Cash Flow Generation. Our business generates strong free cash flow, as it benefits from modest capital expenditures, a low tax rate and minimal working capital requirements. Over the three years ended September 30, 2004, capital expenditures (including the $4.0 million acquisition of our manufacturing facility in Fajardo, Puerto Rico) averaged $6.1 million and 3.4% of EBITDA from continuing operations. We have requested and expect to enter into a tax agreement with the tax authorities in Puerto Rico, whereby our earnings in Puerto Rico, which are a large component of our overall earnings, will be subject to a 2.0% income tax for a period of 15 years, thereby reducing our overall tax rate. We believe our strong free cash flow will enable us to adequately service debt and will provide us with financial flexibility to invest in our business.

 

Principal Shareholders With Proven Healthcare Sector Expertise. Our principal shareholders are investment funds affiliated with Bain Capital Partners LLC, DLJ Merchant Banking III, Inc., J.P. Morgan Partners, LLC and Thomas H. Lee Partners, L.P., who are among the world’s largest private equity firms. Each invests across a broad range of industries and has significant experience in the healthcare sector. Their prior healthcare investments include Barrier Therapeutics, Inc., Charles River Laboratories, Inc., Eyetech Pharmaceuticals, Inc., Fisher Scientific International Inc., Myogen, Inc., Nyco Holdings ApS, Physio-Control International Corporation, Pri-Med Healthcare, Inc., Seattle Genetics, Inc., Stericycle, Inc., Wesley Jessen Visioncare, Inc. and Wilson Greatbatch Technologies, Inc.

 

History and Development of the Company

 

We began commercial operations on January 5, 2005 when we acquired the Predecessor. On October 27, 2004, the Sponsors reached an agreement on the terms of a recommended acquisition of the Predecessor. The Acquisition became effective on January 5, 2005 and thereafter, following a series of transactions, we acquired 100% of the share capital of the Predecessor. See “The Transactions.”

 

Our company has been built through acquisition and divestitures. The Predecessor was founded in 1968 as a sales and marketing organization focused on branded pharmaceutical products in Northern Ireland, but in October 2000 expanded into the U.S. pharmaceuticals market through the acquisition, for $325.5 million, of a U.S. pharmaceutical business that marketed Ovcon and Estrace Cream.

 

Between 2000 and 2004, the Predecessor disposed of its pharmaceutical services businesses and focused its strategy on strengthening its pharmaceutical products business, specifically in the areas of women’s healthcare and dermatology. In fiscal year 2002, the Predecessor sold CSS, CTS and ICTI for aggregate consideration of approximately $235 million. In December 2003, the Predecessor sold the PDMS business for $34.0 million. In March 2004, the Predecessor granted Duramed an exclusive license in the United States and Canada to market,

 

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distribute and sell its then-marketed Loestrin and Minestrin hormonal contraceptive products for a cash consideration of $45.0 million. In April 2004, it sold its U.K. pharmaceutical products business for $72.0 million, and in May 2004, it sold its U.K.-based sterile solutions business for $4.5 million.

 

Product and Related Acquisitions

 

We have strengthened our pharmaceutical products business since expanding into the U.S. market in September 2000 through the following product acquisitions:

 

    In June 2001, we acquired Estrace Tablets, a branded estrogen therapy product, from Bristol-Myers for approximately $95 million.

 

    In March 2002, we acquired Duricef, a cephalosporin antibiotic, and Moisturel, a skin moisturizing cream, from Bristol-Myers for approximately $40 million.

 

    In January 2003, we acquired the U.S. sales and marketing rights for Sarafem from Lilly for approximately $295 million and paid an additional $10.0 million in 2004 to exercise our option to make the license of those rights exclusive. Sarafem is a prescription treatment for PMDD, a severe form of premenstrual syndrome.

 

    In March and April 2003, we acquired the hormonal contraceptives Loestrin and Estrostep and an oral continuous combined estrogen-progestogen hormone therapy, femhrt, from Pfizer for approximately $359 million, with up to an additional cash consideration of approximately $125 million payable, depending on how long market exclusivity for Estrostep and femhrt is maintained. In March 2004, we granted Duramed an exclusive license in the United States and Canada to market, distribute and sell our then-marketed Loestrin and Minestrin hormonal contraceptive products for a cash consideration of $45.0 million.

 

    In March 2004, for $1.0 million, Barr granted us an option to acquire a five-year exclusive license under Barr’s ANDA for which Ovcon 35 oral contraceptive is the reference drug. In May 2004, we exercised this option for an additional payment of $19.0 million. Once Barr is able to validate the manufacturing process for the ANDA product, the related supply arrangement will provide us with an alternative source for the supply of this key product.

 

    In May 2004, we purchased a pharmaceutical manufacturing facility in Fajardo, Puerto Rico from Pfizer for approximately $4.0 million. This will enable us over time to reduce our near total dependence on third-party manufacturing, although we anticipate that we will continue to outsource the manufacturing of some products to third parties. The facility has the capacity to accommodate the development and manufacture of additional products.

 

Dovonex and Dovobet Transactions

 

Beginning in April 2003, the Predecessor entered into a major strategic alliance in dermatology with LEO Pharma, the owner of the patents covering Dovonex and Dovobet, and Bristol-Myers, the exclusive licensee of Dovonex in the United States.

 

Dovonex is a leading non-steroidal topical treatment for psoriasis. Under our co-promotion agreement with Bristol-Myers, we have agreed to promote Dovonex until December 31, 2007. Under the agreement, we are compensated by Bristol-Myers for achieving sales of Dovonex above agreed levels. We also entered into an agreement giving us the option to purchase Bristol-Myers’ rights to Dovonex under pre-negotiated terms in January 2006, which we intend to exercise, for a purchase price of $200.0 million plus a 5% royalty on net sales of Dovonex through 2007. Once we have acquired Bristol-Myers’ rights to Dovonex, our license and supply agreement with LEO Pharma will become effective. Under this license and supply agreement, we will pay LEO Pharma a supply fee for Dovonex equal to 20% of net sales and a royalty equal to 10% of net sales (which will be reduced to 5% if a generic equivalent is introduced).

 

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Dovobet is a combination of the topical steroid betamethasone dipropionate and calcipotriene (the active ingredient found in Dovonex). Under our agreements with LEO Pharma for Dovonex and Dovobet, we paid LEO Pharma $2.0 million in December 2001, an additional $10.0 million in April 2003 and are obligated to make a final milestone payment of $40.0 million at the time Dovobet receives final FDA approval. Upon final FDA approval and the satisfaction of other conditions (including the completion of our acquisition of Bristol-Myers’ rights to Dovonex) we will become the exclusive licensee of Dovobet in the United States, subject to the terms of a pre-negotiated license and supply agreement with LEO Pharma. Under the terms of this license and supply agreement, we will pay LEO Pharma a supply fee for Dovobet ranging from 20% to 25% of net sales and royalties ranging from 10% to 15% of net sales. We have also recently signed letters of intent with LEO Pharma regarding potential Dovonex and Dovobet line extensions and a right of first refusal for LEO Pharma’s other potential products in dermatology.

 

Our Products

 

Our pharmaceutical business develops, supplies and markets branded prescription pharmaceutical products, predominantly in the United States.

 

Women’s Healthcare

 

We develop and market products for a number of segments in the women’s healthcare therapeutic category, including hormonal contraceptives, hormone therapy and therapy for premenstrual dysphoric disorder.

 

Principal Products.

 

Hormonal Contraceptives

 

Ovcon 35 and Ovcon 50. Ovcon, an oral contraceptive, was introduced in the late 1970s. We acquired the rights to the Ovcon products from Bristol-Myers in February 2000. Ovcon is the only branded 35 mcg. oral contraceptive without a generic equivalent in the market. Ovcon revenue for the quarter ended March 31, 2005 increased 30.8% over the prior year quarter.

 

We received final approval from the FDA in November 2003 for the Ovcon 35 Chewable tablet. Ovcon 35 Chewable is protected by a newly-issued U.S. patent covering chewable hormonal contraceptives running through June 2021. We intend to launch Ovcon 35 Chewable in early 2006.

 

Estrostep. Estrostep was introduced by Warner-Lambert in 2000 and was acquired by us in March 2003. We believe that hormonal contraceptives are increasingly being prescribed to older reproductive women and are increasingly prescribed for their benefits in addition to contraception. To take advantage of these market trends, our sales force commenced active promotion of Estrostep in the second quarter of fiscal year 2004. This product experienced a 20.2% increase in revenue in the quarter ended March 31, 2005 over the prior year quarter.

 

Oral Hormone Therapy

 

femhrt. We acquired femhrt, a continuous estrogen-progestogen therapy that was introduced in 2000, from Pfizer in April 2003. During calendar year 2004, femhrt enjoyed the #3 market share in terms of revenues and new prescriptions in the oral estrogen-progestogen therapy segment. Despite the overall decrease in the market and a decrease in femhrt prescription volume, femhrt’s share of total prescriptions in the oral estrogen-progestogen therapy segment increased over the three years following the early termination of the E&P Arm of the WHI Study.

 

We believe that following the early termination of the E&P Arm of the WHI Study, lower dose oral hormone therapies have experienced increased demand. We received FDA approval of our sNDA for femhrt Lo in January 2005 and expect to launch this product in late 2005. We believe that femhrt Lo will position us well to fulfill growing market demand for lower dose therapies in the HT market.

 

Estrace Tablets; Femtrace. Estrace Tablets are available in three dosages and were introduced in 1975. We acquired this product from Bristol-Myers in June 2001. In August 2004, we received FDA approval for Femtrace, a proprietary second generation tablet which contains estradiol acetate, and we plan to launch this product in the second half of 2005.

 

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Other Hormone Therapy

 

Estrace Cream. Estrace Cream, an estrogen therapy for the treatment of local symptoms of menopause, was introduced in 1984. We acquired the rights to this product from Bristol-Myers in February 2000. The local hormone therapy segment, unlike oral hormone therapies, was not adversely affected by the early termination of the E&P Arm of the WHI Study.

 

Femring. We received final approval from the FDA in March 2003 and launched Femring in June 2003. Femring is a vaginal ring containing a core of estradiol acetate.

 

Premenstrual Dysphoric Disorder

 

Sarafem. Sarafem, which contains the active ingredient fluoxetine, was introduced in 2000 and is available in two dosages: 10 mg. and 20 mg. Sarafem is a treatment for PMDD, a severe form of premenstrual syndrome. We purchased the U.S. sales and marketing rights to Sarafem from Lilly in January 2003. Sarafem is the only brand of SSRI that is exclusively indicated for treatment of PMDD and is indicated for intermittent, rather than continuous, dosing. We believe that this allows Sarafem to be a preferred treatment option for patients who wish to avoid any stigma associated with being treated with an antidepressant. We believe revenues from Sarafem have been adversely affected by increased therapeutic substitution and the discontinuation of promotion to primary care physicians after we acquired the product from Lilly. As a result of this increasingly competitive environment, Sarafem has experienced lower prescription volumes over the last two fiscal years.

 

Dermatology

 

Principal Products.

 

Acne

 

Doryx. Doryx is the leading branded oral antibiotic prescribed by dermatologists for the treatment of acne in terms of prescription volume. We acquired the rights to distribute Doryx in the United States from Warner-Lambert in June 1997 and in September 1999 repositioned the product for the dermatology market. We believe that the success of this product has been attributable in part to its dosage form of unique enterically coated doxycycline hyclate pellets in a capsule which reduces stomach upset, a common side effect of products containing doxycycline hyclate. We received FDA approval for delayed-release Doryx tablets on May 6, 2005.

 

Psoriasis

 

Dovonex. Dovonex is the leading non-steroidal topical treatment for psoriasis. For each quarter over the last four fiscal years, Dovonex has had the #1 share of both revenues and prescriptions in the non-steroidal topical treatment segment. Often prescribed as a combination therapy with a topical corticosteroid, we believe that Dovonex enjoys wide brand recognition and acceptance among dermatologists as a leading treatment for mild to moderate psoriasis. In April 2003, we entered a co-promotion agreement with Bristol-Myers for Dovonex in the United States. Under the co-promotion agreement, we agreed to promote Dovonex for Bristol-Myers, the exclusive licensee of Dovonex, until December 31, 2007. Under the agreement, we are compensated by Bristol-Myers for achieving sales of Dovonex above agreed levels. We have an option to acquire the exclusive U.S. sales and marketing rights to Dovonex from Bristol-Myers under pre-negotiated terms in January 2006, which we intend to exercise, for a purchase price of $200.0 million plus a 5% royalty on net sales of Dovonex through 2007.

 

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Research and Development

 

Our research and development activity is focused on the development of proprietary products that are complementary to our product lines, particularly line extensions of our existing branded products and new products in our core therapeutic categories. Our strategy is to pursue products that represent improvements to existing pharmaceuticals rather than create new chemical entities. Improvements to existing products generally involve less development and regulatory risk and shorter time lines from concept to market.

 

During fiscal year 2004, we invested $26.6 million in R&D activities, a 7% increase over our prior fiscal year investment of $24.9 million, reflecting the activities associated with our efforts to obtain regulatory approval for Loestrin 24, femhrt Lo, delayed-release Doryx tablets and Femtrace as well as advancing our research and development portfolio. We received FDA approval for Femtrace in August 2004 and plan to launch this product in the second half of 2005. Our research and development investment in fiscal year 2002 totaled $16.0 million. As of March 31, 2005, our research and development team consisted of 45 professionals. Our in-house expertise in product development and regulatory affairs allows us to prepare and submit NDAs with the FDA and other regulatory authorities for our own products.

 

Research and Development Portfolio

 

New Therapy

 

Dovobet. In April 2003, we entered into agreements with LEO Pharma relating to the development and U.S. commercialization of Dovobet. LEO Pharma’s NDA for Dovobet was accepted for filing by the FDA on May 9, 2005. Dovobet (also known in some countries as Daivobet) has been approved and is currently marketed by or behalf of LEO Pharma in 57 countries, including the United Kingdom, Canada and France. Under the terms of our agreements with LEO Pharma (and in addition to other payments we have made under these agreements), we paid $5.0 million in relation to R&D associated with Dovobet. We are obligated to make a final milestone payment of $40.0 million due at the time Dovobet receives final FDA approval. Thereafter, under the terms of a license and supply agreement, we will pay LEO Pharma certain supply fees and royalty payments. See “—Dovonex and Dovobet Transactions.” We expect to launch Dovobet in the first half of 2006.

 

Line Extensions and New Products

 

Ovcon 35 Chewable. In November 2003, we received approval from the FDA for our oral contraceptive product Ovcon 35 Chewable. Ovcon 35 Chewable is protected by a newly-issued U.S. patent covering chewable oral contraceptives through June 2021. We plan to launch Ovcon 35 Chewable in early 2006.

 

Estrostep 24. We initiated Phase III development of a 24-day oral contraceptive, Estrostep 24, in May 2004 and amended our IND for Estrostep in connection with the product during development. We plan to submit an NDA for this product in the second half of 2006.

 

Estrostep Chewable. Estrostep Chewable will be a chewable version of our Estrostep product. We plan to submit an NDA for this product in the second half of 2005.

 

Loestrin 24. Loestrin 24 is a 24-day regimen oral contraceptive. A NDA for this product was submitted to the FDA on April 15, 2005 and was accepted by the FDA for filing on June 17, 2005.

 

femhrt Lo. We plan to introduce a lower dose version of femhrt (femhrt 0.5/2.5 mcg. tablets) in late 2005. The NDA for femhrt Lo was approved by the FDA on January 14, 2005.

 

Femtrace. In August 2004, we received approval from the FDA for Femtrace tablets, our proprietary follow-on product for Estrace Tablets. We plan to introduce 0.45 mg., 0.9 mg. and 1.8 mg. doses of Femtrace in the second half of 2005.

 

Doryx. We submitted an NDA with the FDA for delayed-release Doryx tablets in April 2004. We received FDA approval on May 6, 2005.

 

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Sales and Marketing

 

In fiscal year 2005, we reorganized our three U.S. sales forces to permit our sales forces to focus promotional efforts by therapeutic category. We now have a Women’s Healthcare sales force that promotes oral contraceptives to OB/GYNs, a Specialty sales force that promotes dermatology products to dermatologists and the Chilcott sales force that promotes hormone therapy products and Sarafem to OB/GYNs. We believe we have one of the largest contingents of sales representatives dedicated to calling on OB/GYNs and dermatologists in the United States. As of March 31, 2005, we employed 406 sales representatives.

 

We employ precision marketing strategies to target specific physicians who are high prescribers of products in our categories. The execution of these strategies require comprehensive internal analysis of actual prescription data to determine the most effective allocation of our sales and marketing resources and enable us to expand market share in targeted markets. Our precision marketing team, together with their sales and marketing colleagues, analyze prescription data and develop strategies and tactics to maximize growth in our sales and market share. By employing these marketing techniques, we have been able to sustain product growth, revitalize acquired products and successfully launch new products.

 

Customers

 

While the ultimate end-users of our products are the individual patients to whom our products are prescribed by physicians, our direct customers include certain of the nation’s leading wholesale pharmaceutical distributors, such as McKesson Corporation, Cardinal Health, Inc., AmerisourceBergen Corporation and other major drug retailers. During the last three fiscal years, the following distributors each accounted for more than 10% of our net revenues:

 

Customer


   First Quarter
Fiscal Year
2005


    Fiscal
Year
2004


    Fiscal
Year
2003


    Fiscal
Year
2002


 

McKesson

   26 %   31 %   32 %   24 %

Cardinal

   20 %   17 %   20 %   16 %

AmerisourceBergen

   16 %   14 %   14 %   13 %

 

Competition

 

The pharmaceutical industry is highly competitive. Our branded products compete with brands marketed by other pharmaceutical companies including large, fully integrated concerns with financial, marketing, legal and product development resources substantially greater than ours.

 

Our principal competitors are in the United States and include:

 

    Hormonal Contraceptives—Johnson & Johnson (Ortho Tri-Cyclen ® Lo, Ortho Evra ® ), Schering A.G./Berlex Laboratories, Inc. (Yasmin ® ), Akzo Nobel N.V./Organon (Nuvaring ® ) and Barr Pharmaceuticals, Inc. (Seasonale ® );

 

    Hormone Therapy—Wyeth (Premarin ® , Premarin ® Low Dose, Premarin ® Vaginal Cream, Prempro , Prempro ® Low Dose, Premphase ® ), Pfizer Inc. (Estring ® ), Schering A.G./Berlex Laboratories, Inc. (Climara ® , Menostar ® ) and Barr Pharmaceuticals, Inc. (Cenestin ® );

 

    Doryx—Medicis Pharmaceutical Corporation (Dynacin ® ), Bradley Pharmaceutical (Adoxa ® ) and CollaGenex Pharmaceuticals, Inc. (Periostat ® );

 

    Dovonex—Allergan, Inc. (Tazorac ® ) and Connetics Corporation (Olux Foam ® and Soriatane ® ).

 

Our branded pharmaceutical products are or may become subject to competition from generic equivalents because there is no proprietary protection for some of the branded pharmaceutical products we sell or because we lose proprietary protection due to the expiration of a patent. Ovcon, Estrace Tablets, Estrace Cream and Doryx are currently not protected by patents. Generic equivalents for some of our branded pharmaceutical products are

 

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sold by other pharmaceutical companies which claim that their products provide equivalent therapeutic benefits at a lower cost. For instance, Estrace Tablets currently face generic competition and, although the product accounts for about 14% of oral estrogen therapy products prescribed in the United States according to IMS, currently experiences a substitution rate of approximately 89%. Generic equivalents generally generate higher margins for drug retailers. Therefore, drug retailers have an incentive to substitute a generic equivalent when one is available. Typically, after the introduction of a generic equivalents, up to 90% of the prescriptions written by authorized prescribers for the branded product may be filled with a generic at the pharmacy, resulting in a commensurate loss in sales of the branded product (substitution rates are generally significantly lower for hormonal contraceptives). In addition, under an agreement to settle patent claims against Barr relating to our Estrostep oral contraceptive and our femhrt hormone therapy, we granted Barr a non-exclusive license to launch generic versions of Estrostep and femhrt six months prior to patent expiration in 2008 and 2010, respectively. We cannot assure you what effect, if any, these activities will have on our results of operations. In addition, legislation enacted in the United States allows, or, in a few instances, in the absence of specific instructions from the prescribing physician, mandates the use of generic products rather than brand name products where a generic equivalent is available. The availability of generic equivalent products may cause a material decrease in revenue from our branded pharmaceutical products.

 

As the pharmaceutical industry is characterized by rapid product development and technological change, our pharmaceutical products could be rendered obsolete or made uneconomical by the development of new pharmaceuticals to treat the conditions addressed by our products, technological advances affecting the cost of production, or marketing or pricing actions by one or more of our competitors. Our business, results of operations and financial condition could be materially adversely affected by any one or more of these developments. Our competitors may also be able to complete the regulatory process for new products before we are able to do so and, therefore, may begin to market their products in advance of our products. We believe that competition among both branded and generic pharmaceuticals aimed at the markets identified by us will be based on, among other things, product efficacy, safety, reliability, availability and price.

 

Manufacturing, Supply and Raw Materials

 

In May 2004, we purchased an approximately 194,000 sq. ft. pharmaceutical manufacturing facility located in Fajardo, Puerto Rico from Pfizer. Adjacent to the facility is an approximately 24,000 sq. ft. warehouse and 102,000 sq. ft. parking lot, both of which we lease from third parties. The Fajardo facility currently manufactures our Estrostep oral contraceptive, packages femhrt and Ovcon 35 and is being qualified to package delayed-release Doryx tablets. We anticipate that the Fajardo facility will become our primary site for the manufacture and packaging of our oral dose products. However, while we transfer these manufacturing activities to the Fajardo facility, we will continue to be dependent upon third-party contract manufacturers for the manufacture of many of our products. To ensure their compliance, we conduct quality assurance audits of our contract manufacturers’ sites and records to determine compliance with the relevant regulatory requirements.

 

In May 2004, we entered into a supply agreement with Barr for Ovcon 35 oral contraceptive under which Barr agreed to provide us with our requirements for finished product through 2009. Bristol-Myers no longer manufactures Ovcon 35 but will be supplying Ovcon 35 Chewable product for us, Bristol-Myers manufactures Estrace Cream under a long-term supply agreement that runs through February 2009. Estrace Tablets are also manufactured for us by Bristol-Myers under a supply agreement that runs through July 2006. Duricef is manufactured for us by Bristol-Myers under a supply agreement that runs through March 2007. Doryx is supplied to us by FH Faulding & Co Limited under a license and distribution arrangement that runs through 2009 and is renewable thereafter. Sarafem is manufactured by Lilly pursuant to a three-year manufacturing agreement which may, under certain circumstances, be extended for one additional year. femhrt is manufactured under an agreement between Warner-Lambert and Duramed which has been assigned to us by Warner-Lambert. These products accounted for a significant percentage of our product sales in fiscal year 2004. In the event that a supplier suffers an event that caused it to be unable to manufacture our product requirements for a sustained period the resulting shortages of inventory could have a material adverse effect on our business. See Note 19 to our Predecessor’s Consolidated Financial Statements for the three years ended September 30,

 

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2004, Note 18 to our Predecessor’s Consolidated Financial Statements for the quarter ended December 31, 2004 and Note 15 to our Consolidated Financial Statements for the quarter ended March 31, 2005 appearing elsewhere in this prospectus for information concerning supplier concentration.

 

In the United States, the FDA must approve suppliers of certain ingredients for our products and of finished product. The development and regulatory approval of our products is dependent on our ability to procure active ingredients, packaging materials and finished product from FDA-approved sources. If pharmaceutical ingredients, packaging materials or finished products were no longer available from an FDA-approved source, we would be required to obtain FDA approval to change the supplier of that material or product. The qualification of a new supplier could potentially disrupt the manufacture, and therefore our supply of products for sale. Although we consider our sources of supply to be adequate, there can be no assurance that we will continue to be able to obtain materials and finished products as required.

 

Trademarks, Patents and Proprietary Rights

 

Protection of intellectual property, such as trademarks and patents, is a key part of our strategy through which we seek the freedom to continue to manufacture and sell our products and operate in our strategic areas without interferences by third parties, and to prevent others from obtaining patent protection limiting our freedom to operate within our strategic areas.

 

Patents, Trade Secrets and Proprietary Knowledge

 

We rely on patents, trade secrets and proprietary knowledge to protect our products. We seek to protect our proprietary rights by enforcing our legal rights against third parties that we believe may infringe our intellectual property rights. For example, we have been involved in legal proceedings against Teva for alleged infringement of our patent on our Sarafem product, in which we have received a favorable judgment which has been affirmed on appeal. See “—Legal Proceedings—Sarafem.” We also generally seek to protect our proprietary rights by filing applications for patents on certain inventions, and entering into confidentiality, non-disclosure and assignment of invention agreements with our employees, consultants, licensees and other companies. We do not ultimately control whether we will be successful in enforcing our legal rights against third party infringers, whether our patent applications will result in issued patents, whether our confidentiality, non-disclosure and assignment of invention agreements will not be breached and whether we will have adequate remedies for any such breach, or that our trade secrets will not otherwise become known by competitors. In addition, some of our key products are not protected by patents and proprietary rights and therefore are or may become subject to competition from generic equivalents. However, for some of these products, we have maintained market exclusivity because it is difficult to produce a generic equivalent for them. For example, because of the difficulty in demonstrating bio-equivalence in topical products, Estrace Cream currently has no generic competition despite the expiration of our patent in 2002. For a further discussion of our competition, see “ —Competition.”

 

Patents covering the following products will expire prior to maturity of the notes:

 

Product


 

Patent Expires


Dovonex

  December 2007

Sarafem

  May 2008

Estrostep

  April 2008

femhrt

  May 2010

 

Patent expiration provides competitors with the first opportunity to introduce a generic equivalent. Although part of our strategy includes introducing line extensions that will extend our proprietary protection, other companies may attempt to compete with our original products losing patent protection, and we may not be successful in having our line extensions approved by the FDA and prescribed by doctors. In addition, under an agreement to settle patent claims against Barr relating to our Estrostep oral contraceptive and our femhrt hormone therapy, we granted Barr a non-exclusive license to launch generic versions of Estrostep and femhrt six months prior to patent expiration in 2008 and 2010, respectively.

 

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Trademarks

 

Due to our branded product focus, we consider our trademarks to be valuable assets. Therefore, we actively manage our trademark portfolio, maintain long-standing trademarks and obtain trademark registrations for new brands in all jurisdictions in which we operate. The names indicated below are certain of our key registered trademarks, some of which may not be registered in all jurisdictions:

 

Doryx

  Loestrin

Estrace

  Ovcon

Estrostep

  Sarafem

femhrt

  Warner Chilcott

Femring

   

 

We also police our trademark portfolio against infringement. However, our efforts may be unsuccessful against competitors or other violating entities and we may not have adequate remedies for any breach because, for example, a violating company may be insolvent.

 

Government Regulation

 

FDA and other Regulatory Requirements

 

The pharmaceutical industry is subject to regulation by regional, country, state and local agencies. The research, development and commercial activities relating to prescription pharmaceutical products are subject to extensive regulation by the FDA. The Federal Food, Drug, and Cosmetic Act (“FDCA”), the Public Health Services Act, other federal and state statutes and regulations govern to varying degrees the testing, approval, production, labeling, distribution, post-market surveillance, advertising, dissemination of information, and promotion of pharmaceutical products. In addition, manufacturers of approved drugs must comply with current Good Manufacturing Practices, or cGMP. Manufacture and disposal of pharmaceutical products in the United States is also regulated by the Environmental Protection Agency.

 

All pharmaceutical marketers are directly or indirectly (through third parties) subject to regulations that cover the manufacture, testing, storage, labeling, documentation/record keeping, approval, advertising, promotion, sale, warehousing, and distribution of pharmaceutical drug products. We are required to obtain, as are other drug companies manufacturing or marketing drugs, approval from the FDA and other regulatory bodies based upon pre-clinical testing, manufacturing chemistry and control data, bioequivalence and other clinical data which we are required to generate prior to gaining regulatory approval necessary to begin marketing most new drug products. The generation of this required data is regulated by the FDA and other regulatory bodies. The process of clinical testing, data analysis, manufacturing development, and regulatory review necessary for required governmental approvals can be costly. Non-compliance can result in fines and judicially imposed sanctions. In addition, administrative or judicial actions can result in the recall of products and the total or partial suspension of manufacture and/or distribution. The government can also refuse to approve pending applications or supplements to approved applications.

 

FDA approval is required before any drug, including a generic equivalent of a previously approved drug, can be marketed. Certain drugs are not considered by the FDA to be “new” drugs and fall outside of the typical FDA pre-marketing approval process. These drugs, referred to as “grandfathered” products, generally were in use prior to the enactment of the FDCA. Several of the products sold by us are grandfathered products. The FDA has expressed the view that all prescription drugs should ultimately be subject to pre-market clearance requirements. If the FDA adopts this stance it could potentially affect products currently, or proposed to be, marketed as grandfathered drugs.

 

The FDA regulations require post-marketing reporting of adverse drug events of the drug product. The FDA may, at any time, take action to modify and restrict the drug’s product labeling or withdraw approval of the product should new information come to light about the safety of the drug product.

 

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The FDA also regulates post-approval advertising and promotional activities to assure that these activities are being conducted in conformity with statutory and regulatory requirements. Failure to adhere to these requirements could result in regulatory actions.

 

The FDA’s Quality Systems Regulations mandate that drugs be manufactured, packaged and labeled in conformity with cGMP. In complying with cGMP regulations, manufacturers must continue to expend time, money and effort in production, record keeping and quality control to ensure that the product meets applicable specifications and other requirements to ensure product safety and efficacy. The FDA periodically inspects drug manufacturing facilities to ensure compliance with applicable cGMP requirements. Failure to comply with the statutory and regulatory requirements subjects the manufacturer to possible legal or regulatory action. Adverse experiences with the use of products must be reported to the FDA and could result in the imposition of market restrictions through labeling changes or in product removal. Product approvals may be withdrawn if compliance with regulatory requirements is not maintained or if problems concerning safety or efficacy of the product occur following approval. Such legal or regulatory action could materially adversely affect our business, financial condition and results of operations.

 

Other Regulation

 

The distribution of pharmaceutical products is subject to the Prescription Drug Marketing Act, or (“PDMA”), which regulates such activities at both the federal and state level. Under the PDMA and its implementing regulations, states are permitted to require registration of manufacturers and distributors who provide pharmaceuticals even if such manufacturers or distributors have no place of business within the state. PDMA imposes requirements and limitations upon drug sampling and prohibits states from licensing wholesale distributors of prescription drugs unless the state licensing program meets certain federal guidelines that include, among other things, minimum standards for storage, handling and record keeping. The PDMA also sets forth civil and criminal penalties for violations of these and other provisions. The FDA and the states are still implementing various sections of the PDMA.

 

We are also subject to the jurisdiction of various other federal and state regulatory and enforcement departments and agencies, such as the Federal Trade Commission (“FTC”), the Department of Justice and the Department of Health and Human Services. We are, therefore, subject to possible administrative and legal proceedings and actions by those organizations. Such actions may result in the imposition of civil and criminal sanctions, which may include fines, penalties and injunctive or administrative remedies.

 

In recent years, Congress and some state legislatures have considered a number of proposals and have enacted laws that could effect major changes in the health care system, either nationally or at the state level. On December 8, 2003, new Medicare legislation was enacted that provides prescription drug reimbursement beginning in 2006 for all Medicare beneficiaries. In the meantime a temporary drug discount card program is being established for Medicare beneficiaries. The federal government, through its purchasing power under these programs, is likely to demand discounts from pharmaceutical companies that may implicitly create price controls on prescription drugs.

 

We also participate in the Federal Medicaid rebate program established by the U.S. Omnibus Budget Reconciliation Act of 1990, as well as several state supplemental rebate programs. Under the Medicaid rebate program, we pay a rebate to each state Medicaid program for our products that are reimbursed by those programs. The Medicaid rebate amount is computed each quarter based on our submission to the Centers for Medicare and Medicaid Services at the U.S. Department of Health and Human Services of our current AMP and best price for each of our products. The terms of our participation in the program impose an obligation to correct the prices reported in previous quarters, as may be necessary. Any such corrections could result in an overage or underage in our rebate liability for past quarters, depending on the direction of the correction. In addition to retroactive rebates (and interest, if any), if we are found to have knowingly submitted false information to the government, the statute provides for civil monetary penalties in the amount of $100,000 per item of false information. Governmental agencies may also make changes in program interpretations, requirements or conditions of participation, some of which may have implications for amounts previously estimated or paid.

 

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Based upon our past practice and experience, to the extent that we were required to correct prices reported in previous quarters, we would not expect such corrections to have a material adverse effect on us.

 

In addition, the Medicare Prescription Drug, Improvement, and Modernization Act allows for the importation of less expensive prescription drugs from Canada under specified circumstances. These additional import provisions will not take effect until the Secretary of Health and Human Services makes a required certification regarding the safety and cost savings of imported drugs and the FDA has promulgated regulations setting forth parameters for importation. In the absence of such regulations, importation of prescription drugs from Canada generally remains illegal. We currently sell femhrt in Canada. In addition, Estrace Tablets, Dovonex and Dovobet are sold in Canada by third parties. For fiscal year 2004, femhrt and Estrace Tablets accounted for 17.4% of our sales. For the first quarter of fiscal year 2005, femhrt and Estrace Tablets accounted for 14.5% of our sales. Due to government price regulation in Canada, these products are generally sold in Canada for lower prices than in the United States.

 

Products marketed outside of the United States that are manufactured in the United States are subject to certain FDA regulations, as well as regulation by the country in which the products are sold. While we do not currently have plans to market any of our U.S. products in other countries, except the sale of femhrt in Canada, we may do so from time to time.

 

Regulation in the United Kingdom

 

Though we have divested our businesses in the United Kingdom, we are still subject to regulation in certain areas by the U.K. Medicines and Healthcare products Regulatory Agency (the “MHRA”). For example, our facility in Larne, Northern Ireland is approved and regularly inspected by the MHRA. The United Kingdom Medicines Act 1968, which governs applications for marketing authorizations for human use in the United Kingdom, imposes additional burdens on manufacturers and promoters of pharmaceuticals sold in the United Kingdom. We contract manufacture Menoring (known as Femring in the United States) for Nelag Limited in the United Kingdom.

 

Seasonality

 

The results of operations of our pharmaceutical products business are minimally affected by seasonality.

 

Property, Plant and Equipment

 

In May 2004, we purchased an approximately 194,000 sq. ft. pharmaceutical manufacturing facility located in Fajardo, Puerto Rico from Pfizer. The Fajardo facility currently manufactures our Estrostep oral contraceptive, packages femhrt and Ovcon 35 and is being qualified to package delayed-release Doryx tablets. The Fajardo facility will become our primary site for the manufacture of our oral dose products. For a discussion of our Fajardo facility, see “Manufacturing, Supply and Raw Materials.”

 

We also have a 106,000 sq. ft. FDA approved facility in Larne, Northern Ireland, 43,000 sq. ft. of which is leased to the purchaser of our sterile products business. The remainder is dedicated to the manufacture of our vaginal rings, research and product development as well as development of analytical methods. We lease approximately 42,000 sq. ft. of office space in Rockaway, New Jersey, where our U.S. operations are headquartered.

 

Employees

 

As of March 31, 2005, we had approximately 986 employees, an increase of 33 from September 30, 2004, which reflects the addition of sales representatives and the expansion of our workforce at the Fajardo manufacturing facility. The employees of our production, stores and engineering departments, located at our facility in Larne, Northern Ireland are covered by a labor agreement that may be terminated any time after January 2006. We believe that our employee relations are satisfactory.

 

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Environmental Matters

 

Our operations and facilities are subject to U.S. and foreign environmental laws and regulations, including those governing air emissions, water discharges, the management and disposal of hazardous substances and wastes, and the cleanup of contaminated sites. We could incur substantial costs, including cleanup costs, fines and civil or criminal sanctions, or third party property damage or personal injury claims, in the event of violations or liabilities under these laws and regulations, or non-compliance with the environmental permits required at our facilities. Potentially significant expenditures could be required in order to comply with environmental laws that may be adopted or imposed in the future.

 

We acquired our Fajardo, Puerto Rico facility from Pfizer in 2004. Under the purchase agreement, Pfizer retained certain liabilities relating to preexisting contamination and indemnified us, subject to certain limitations, for other potential environmental liabilities. While we are not aware of any material claims or obligations relating to this site, other current or former manufacturing sites, or any off-site location where we sent hazardous wastes for disposal, the discovery of additional contaminants or the imposition of additional cleanup obligations at Fajardo or at other sites, or the failure of any other party to meet its financial obligations to us, could result in significant liability.

 

Legal Proceedings

 

Sarafem

 

Lilly initiated legal proceedings in 2002 against Teva for patent infringement in response to an abbreviated new drug application filed by Teva to market a generic version of Sarafem. Since acquiring the U.S. sales and marketing rights to Sarafem from Lilly in January 2003, we have continued to pursue these claims vigorously. The suit asserted that the commercial manufacture, use, sale or offer to sell in the United States, or importation into the United States of Teva’s generic product would infringe the patent-in-suit. Teva contended that the patent-in-suit was invalid, unenforceable or would not be infringed by Teva’s commercial manufacture, use, sale or offer to sell in the United States, or importation into the United States of Teva generic products. In July 2004, the U.S. District Court for the District of Indiana ruled in our favor upholding the validity of our Sarafem patent and holding that the patent-in-suit was both valid and infringed by Teva. On July 13, 2005, the United States Court of Appeals for the Federal Circuit affirmed the decision of the district court. The patent expires in May 2008.

 

Hormone Therapy Product Liability Litigation

 

Approximately 360 product liability suits have been filed against us in connection with the HT products, femhrt and Estrace. The cases pending against us are in the very early stages of litigation and we are still analyzing and conducting investigations of the individual complaints.

 

The lawsuits appear to have been triggered by the July 2002 announcement by the NIH of the early termination of one of two large-scale randomized controlled clinical trials, which were part of the WHI, examining the long-term effect (up to 8½ years) of hormone therapy on the prevention of heart disease and osteoporosis, and any associated risk for breast cancer in postmenopausal women. In the E&P Arm of the WHI Study, the safety monitoring board determined that the risks exceeded the benefits, when comparing combined estrogen and progestogen therapy to a placebo. The estrogen used in this trial was CEE and the progestin was MPA, the compounds found in Prempro ® , a Wyeth product used by more than six million women (at the inception of the trial) in the United States each day. According to the article summarizing the principal results from the E&P Arm of the WHI Study in the July 17, 2002 issue of the Journal of the American Medical Association , despite a decrease in the incidence of hip fracture and colorectal cancer, there was an increased risk of invasive breast cancer, coronary heart disease, stroke and blood clots in patients randomized to the estrogen and progestogen therapy. Numerous lawsuits were filed against Wyeth, as well as against other manufacturers of HT products, after the publication of the summary of the principal results of the E&P Arm of the WHI Study.

 

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Approximately 66% of the complaints filed against us do not specify the HT drug that allegedly caused the plaintiff’s injuries. These complaints broadly allege that the plaintiff suffered injury as a result of an HT product. We have sought and continue to seek dismissal of lawsuits that, after further investigation, do not actually involve any of our products. We have successfully reduced the number of HT suits we will have to defend. Of the approximately 360 suits that were filed, approximately 23 have been dismissed and approximately 37 involving Estrace have been successfully tendered to Bristol-Myers’ defense counsel pursuant to an indemnification provision in the asset purchase agreement pursuant to which we acquired Estrace. The purchase agreement included an indemnification agreement whereby Bristol-Myers indemnified us for product liability exposure associated with Estrace products that were shipped prior to June 2001. We have forwarded agreed upon dismissal motions in another 126 cases to plaintiffs’ counsel.

 

We have product liability insurance that covers liability in excess of $10 million and up to $30 million. We self-insure for liability in excess of $30 million and up to $40 million, and have additional insurance coverage for liability from $40 million to $50 million and co-insurance from $50 million to up to $100 million, above which we are again self-insured. This insurance may not apply to damages or defense costs related to any claim arising out of HT products with labeling that does not conform completely with FDA hormone replacement therapy communications to manufacturers of HT products. Currently, labeling changes for Estrace Tablets that conform to such communication are pending before the FDA. Although we cannot assure you when the cases will be decided or what the potential scope of our liability will be, based upon our experience with these cases to date, which as noted above, are still in the preliminary stages, we believe that the likelihood of any material liability arising is remote.

 

FTC Investigation Regarding Exercise of Option for a Five-Year Exclusive License to Barr’s ANDA Referencing Ovcon 35

 

In March 2004, for $1.0 million, Barr granted us an option to acquire a five-year exclusive license under Barr’s ANDA for which our Ovcon 35 oral contraceptive is the reference drug. In May 2004, we exercised this option for an additional payment of $19.0 million. At the same time, we entered into a finished product supply agreement with Barr under which Barr agreed to provide us with our requirements for finished Ovcon products throughout the term of the license. Barr has begun supplying Ovcon and will be the Company’s sole source of supply for this product.

 

We have received civil investigative demands and subpoenas from the FTC that, although not alleging any wrongdoing, seek documents and testimony relating to this transaction. We cannot assure you that the FTC will not bring an administrative proceeding against us or seek injunctive relief from the federal courts, or if brought, that we will prevail in such proceedings, or that the remedy sought and imposed by the FTC will allow us to proceed with the terms of the option and related supply agreement. An unfavorable outcome of the FTC investigations could adversely affect our profits and cash flows by making future supply of Ovcon and the nature of future competition more uncertain.

 

General Matters

 

In addition to the matters discussed above, we are involved in various legal proceedings of a nature considered normal to our business including product liability and other matters. In the event of adverse outcomes of these proceedings (except as discussed above), we believe that resulting liabilities are either covered by insurance, established reserves, or would not have a material adverse effect on our financial condition or our results of operations.

 

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