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: womens 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
womens 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 womens 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:
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Product
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Indication
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Active Ingredient
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Expiration of Patent
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Hormonal Contraceptives
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Ovcon 35 and Ovcon 50
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Prevention of pregnancy
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Norethindrone and ethinyl estradiol
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Patent expired
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Estrostep
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Prevention of pregnancy and treatment of moderate acne in women who desire oral contraception
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Norethindrone acetate and ethinyl estradiol
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April 2008
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Oral Hormone Therapy
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femhrt
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Treatment of moderate to severe vasomotor symptoms and urogenital symptoms associated with menopause
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Norethindrone acetate and ethinyl estradiol
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May 2010
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Estrace Tablets
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Treatment of moderate to severe vasomotor symptoms and urogenital symptoms associated with menopause
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17 (beta) estradiol
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Patent expired
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Other Hormone Therapy
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Estrace Cream
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Vaginal cream for treatment of vaginal and vulval atrophy
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17 (beta) estradiol
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Patent expired
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Femring
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Treatment of moderate to severe vasomotor symptoms and urogenital symptoms associated with menopause
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Estradiol acetate
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December 2015
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Premenstrual Dysphoric Disorder (PMDD)
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Sarafem
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Treatment of premenstrual dysphoric disorder, a severe form of premenstrual syndrome
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Fluoxetine hydrochloride
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May 2008
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Dermatology
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Doryx
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Adjunct therapy for severe acne
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Doxycycline hyclate
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Patent expired
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Dovonex(1)
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Treatment of psoriasis
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Calcipotriene
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December 2007
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(1)
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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: womens healthcare and dermatology. In womens 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 womens 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 forces 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
LEOs 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 womens 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, PresidentPharmaceuticals and Anthony Bruno, Executive Vice PresidentCorporate 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 womens 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
Womens Healthcare and Dermatological Products.
Our development effort is focused on expanding our product portfolio by capitalizing on our core knowledge of womens 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.
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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 womens 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):
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 worlds 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 womens
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:
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In June 2001, we acquired Estrace Tablets, a branded estrogen therapy product, from Bristol-Myers for approximately $95 million.
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In March 2002, we acquired Duricef, a cephalosporin antibiotic, and Moisturel, a skin moisturizing cream, from Bristol-Myers for approximately $40 million.
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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.
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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.
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In March 2004, for $1.0 million, Barr granted us an option to acquire a five-year exclusive license under Barrs 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.
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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.
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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 Pharmas other
potential products in dermatology.
Our Products
Our pharmaceutical business develops, supplies and markets branded
prescription pharmaceutical products, predominantly in the United States.
Womens Healthcare
We develop and
market products for a number of segments in the womens 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, femhrts 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
Pharmas 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 Womens 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 nations 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:
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First Quarter
Fiscal Year
2005
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Fiscal
Year
2004
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Fiscal
Year
2003
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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 ContraceptivesJohnson & 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 TherapyWyeth (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
®
);
|
|
|
|
|
DoryxMedicis Pharmaceutical Corporation (Dynacin
®
), Bradley Pharmaceutical (Adoxa
®
) and CollaGenex Pharmaceuticals, Inc. (Periostat
®
);
|
|
|
|
|
DovonexAllergan, 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
91
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 Predecessors Consolidated Financial Statements for the three years ended September 30,
92
2004, Note 18 to our Predecessors 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 ProceedingsSarafem. 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.
93
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 drugs product labeling or withdraw approval of the product should new information come to light about the safety of the drug product.
94
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 FDAs 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.
95
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.
96
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 Tevas generic product would infringe the patent-in-suit. Teva contended that the patent-in-suit was invalid, unenforceable or would not be
infringed by Tevas 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.
97
Approximately 66% of the complaints filed against us do not specify the HT drug that allegedly caused the
plaintiffs 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
Barrs ANDA Referencing Ovcon 35
In March 2004,
for $1.0 million, Barr granted us an option to acquire a five-year exclusive license under Barrs 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 Companys 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.
98