424B3 1 d424b3.htm PRELIMINARY PROSPECTUS SUPPLEMENT Preliminary Prospectus Supplement
Table of Contents

Filed pursuant to Rule 424(b)(3)
Registration No. 333-163079

The information in this prospectus supplement is not complete and may be changed. This prospectus supplement and the accompanying prospectus are not an offer to sell these securities and we are not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

 

SUBJECT TO COMPLETION, DATED NOVEMBER 13, 2009

PROSPECTUS SUPPLEMENT

(To Prospectus Dated November 13, 2009)

 

LOGO

    

Warner Chilcott plc

20,000,000 Ordinary Shares

 

 

We are offering 20,000,000 of our ordinary shares.

Our ordinary shares are listed on The NASDAQ Stock Exchange under the symbol “WCRX.” On November 12, 2009, the last reported sale price of our ordinary shares on The NASDAQ Stock Exchange was $22.92 per share.

All of the ordinary shares in this offering are being sold by the selling shareholders, which include members of our senior management, identified in this prospectus supplement. Warner Chilcott plc will not receive any of the proceeds from the sale of the shares being sold by the selling shareholders.

 

 

 

     Per Share    Total

Public offering price

   $                 $             

Underwriting discounts and commissions

   $                 $             

Proceeds, before expenses, to the selling shareholders

   $                 $             

To the extent that the underwriters sell more than 20,000,000 ordinary shares, the underwriters have the option to purchase up to an additional 3,000,000 shares from the selling shareholders at the initial price to the public less the underwriting discount.

 

 

Investing in our ordinary shares involves risks. See “Risk Factors” beginning on page S-14 of this prospectus supplement for more information.

 

 

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus supplement or the accompanying prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

 

 

The underwriters expect to deliver the shares on or about                  , 2009.

 

 

Joint Book-Running Managers

 

Goldman, Sachs & Co.    Morgan Stanley
Credit Suisse    J.P.Morgan

Co-Managers

 

BofA Merrill Lynch         Barclays Capital
Citi       Deutsche Bank Securities
   UBS Investment Bank   

 

 

The date of this prospectus supplement is                  , 2009.


Table of Contents

TABLE OF CONTENTS

 

 

Prospectus Supplement

 

     Page

Market and Industry Data

   S-ii

Prospectus Supplement Summary

   S-1

Risk Factors

   S-14

Cautionary Statement Regarding Forward-Looking Statements

   S-32

Use of Proceeds

   S-34

Capitalization

   S-35

Price Range of Ordinary Shares

   S-36

Dividend Policy

   S-37

Unaudited Pro Forma Condensed Combined Financial Information

   S-38

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

   S-49

Business

   S-87

Management

   S-116

Principal and Selling Shareholders

   S-119

Material Tax Considerations

   S-124

Underwriting

   S-132

Conflicts of Interest

   S-136

Legal Matters

   S-136

Experts

   S-136

Where You Can Find More Information

   S-137

Prospectus

 

     Page

About this Prospectus

   1

Warner Chilcott plc

   1

Use of Proceeds

   2

Ratio of Earnings to Fixed Charges

   2

Description of Securities

   3

Description of Warner Chilcott plc Share Capital

   3

Description of Debt Securities

   20

Description of Warrants

   21

Description of Purchase Contracts

   21

Description of Units

   22

Forms of Securities

   22

Plan of Distribution

   24

Where You Can Find More Information

   25

Information Concerning Forward-Looking Statements

   26

Legal Matters

   28

Experts

   28

 

 

You should rely on the information contained or incorporated by reference in this prospectus supplement and the accompanying prospectus and any free writing prospectus we provide to you. We have not, and the underwriters have not, authorized any other person to provide you with different information. If anyone provides you with different or inconsistent information, you should not rely on it. We are not, and the underwriters are not, making an offer to sell these securities in any jurisdiction where the offer or sale is not permitted. You should assume that the information appearing in this prospectus supplement is accurate only as of the date on the front cover of this prospectus supplement. Our business, financial condition, results of operations and prospects may have changed since that date.

 

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ABOUT THIS PROSPECTUS SUPPLEMENT

This document contains two parts. The first part consists of this prospectus supplement, which describes the specific terms of this offering and the securities offered. The second part, the accompanying prospectus, provides more general information, some of which may not apply to this offering. If the description of the offering varies between this prospectus supplement and the accompanying prospectus, you should rely on the information in this prospectus supplement.

Before purchasing any securities, you should carefully read both this prospectus supplement and the accompanying prospectus, together with the additional information described under the heading “Where You Can Find More Information.”

Unless otherwise noted, the information in this prospectus supplement assumes that the underwriters’ option to purchase up to an additional 3,000,000 ordinary shares will not be exercised.

MARKET AND INDUSTRY DATA

This prospectus supplement includes market share and industry data that we obtained from industry publications and surveys and internal company sources. IMS Health, Inc. (“IMS”) was the primary source for third-party industry data and forecasts. Unless otherwise stated, all market information reflects IMS data for the last twelve month (“LTM”) period ended August 31, 2009 (the latest period for which such information is available) for constructed markets on a filled prescription basis in the United States. Industry publications and surveys generally state that the information contained therein has been obtained from sources believed to be reliable, but we have not independently verified any of the data from third-party sources nor have we ascertained the underlying economic assumptions relied upon therein. Statements as to our market position are based on market data currently available to us. While we are not aware of any misstatements regarding our industry data presented herein, our estimates involve risks and uncertainties and are subject to change based on various factors, including those discussed under the heading “Risk Factors” in this prospectus supplement.

 

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PROSPECTUS SUPPLEMENT SUMMARY

This summary highlights certain information contained elsewhere or incorporated by reference in this prospectus supplement. Because this is only a summary, it does not contain all the information that may be important to you. For a more complete understanding of our business and this offering, you should read the entire prospectus supplement and the accompanying prospectus and the documents incorporated herein and therein by reference, including the annual financial statements included elsewhere or incorporated by reference in this prospectus supplement. You should also carefully consider the matters discussed under “Risk Factors.”

Unless otherwise noted or the context otherwise requires, references in this prospectus supplement to “Warner Chilcott,” “the Company,” “our company,” “we,” “us” or “our” refer to Warner Chilcott plc and its direct and indirect subsidiaries. The company that we acquired in 2005, Warner Chilcott PLC, is referred to as the “Predecessor” for all 2004 periods.

References in this prospectus supplement to “pro forma” financial information mean that such financial information has been adjusted on a pro forma basis to give effect to the PGP Acquisition and related financing thereof and the LEO Transaction. See “Unaudited Pro Forma Condensed Combined Financial Information.”

Our Business

We are a leading global specialty pharmaceutical company currently focused on the gastroenterology, women’s healthcare, dermatology and urology segments of the U.S. and Western European pharmaceuticals markets. We are a fully integrated company with internal resources dedicated to the development, manufacture and promotion of our products. Prior to the PGP Acquisition (as defined below), our broad portfolio of established branded products included oral contraceptives (LOESTRIN 24 FE and FEMCON FE), hormone therapies (ESTRACE Cream, FEMHRT and others) and an oral anti-infective for acne (DORYX). On October 30, 2009, we acquired the global branded pharmaceuticals business of The Procter & Gamble Company (“PGP”) for approximately $2.9 billion in cash and the assumption of certain liabilities (the “PGP Acquisition”). The purchase price remains subject to certain post-closing purchase price adjustments. Under the terms of the purchase agreement, we acquired PGP’s portfolio of branded pharmaceutical products, PGP’s prescription drug pipeline and its manufacturing facilities in Puerto Rico and Germany. PGP has two primary products: ASACOL and ACTONEL. ASACOL is the leading treatment for ulcerative colitis in the U.S. market for orally administered 5-aminosalicylic acid (“5-ASA”) products. ACTONEL is the leading branded product in the U.S. non-injectable osteoporosis market for the prevention and treatment of osteoporosis in women. ACTONEL is marketed under a global collaboration agreement with Sanofi-Aventis US LLC (“Sanofi”). In addition to ASACOL and ACTONEL, PGP markets several other products, including ENABLEX, which serves the overactive bladder market.

The PGP Acquisition has transformed us into a global pharmaceuticals company with significant scale and geographic reach. The PGP Acquisition adds a highly attractive specialty segment in gastroenterology (ASACOL), expands our presence in women’s healthcare (ACTONEL) and establishes us in the urology market (ENABLEX) as our development work continues on two new erectile dysfunction (“ED”) products. The combined company has an expanded sales force and infrastructure to better promote products in the United States, major Western European and other markets, increased diversity of revenue sources, enhanced product development capabilities and a deeper pipeline. Moreover, the PGP Acquisition provides an opportunity for us to apply our demonstrated expertise in the management of pharmaceutical product life cycles to PGP’s market-leading products.

 

 

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On September 23, 2009, we agreed to terminate our exclusive product licensing rights from LEO Pharma A/S (“LEO”) in the United States to TACLONEX, TACLONEX SCALP, DOVONEX and all other products in LEO’s development pipeline, and sold the related assets to LEO, for $1.0 billion in cash (the “LEO Transaction”). In connection with the LEO Transaction, we entered into a distribution agreement with LEO under which we agreed to continue to distribute DOVONEX and TACLONEX on behalf of LEO, in exchange for a distribution fee, through December 31, 2009. The LEO Transaction resulted in a gain for us for the quarter ended September 30, 2009 of $380.1 million, net of tax. The aggregate gain from the LEO Transaction is expected to be $447.6 million, net of tax. However, approximately $68.9 million of the pre-tax gain relating to certain inventories is expected to be recognized as part of income during the distribution agreement period. These gains, or the relevant portion thereof, are not included in the pro forma figures presented in the following paragraph. We believe the LEO Transaction will allow us to concentrate on the acquisition and integration of PGP.

For the year ended December 31, 2008 and the nine-month period ended September 30, 2009, on a pro forma basis giving effect to the PGP Acquisition and related financing and the LEO Transaction, we would have generated revenues of $3,076.3 million and $2,222.1 million and a net (loss) / income of $(93.1 million) and $239.6 million, respectively.

We market and sell the following principal products:

 

   

Our Principal Products

 
   

Product

(Active Ingredient)

 

Indication

 

U.S. Patent
Expiry(1)

  Twelve Months
Ended June 30,
2009 Revenue
($mm)(2)
 

Gastroenterology

  Ulcerative Colitis      
  ASACOL 400 mg (Mesalamine)   Treatment of mild to moderate ulcerative colitis and maintenance of remission   July 2013   $ 679 (3) 
  ASACOL 800 mg (Mesalamine)   Treatment of moderately active ulcerative colitis   November 2021  

Women’s Healthcare

  Osteoporosis      
 

ACTONEL

(Risedronate sodium)

  Prevention and treatment of postmenopausal osteoporosis   June 2014 and November 2023 with notices of allowance received on additional patents pending   $ 1,366 (4) 
  Oral Contraceptives      
  LOESTRIN 24 FE (Norethindrone acetate and ethinyl estradiol)   Prevention of pregnancy   July 2014   $ 210   
  FEMCON FE (Norethindrone and ethinyl estradiol)   Prevention of pregnancy   April 2019   $ 50   
  Hormone Therapy      
  ESTRACE Cream (17-beta estradiol)   Vaginal cream for treatment of vaginal and vulvar atrophy   Patent expired March 2001   $ 95   

Dermatology

  Acne      
  DORYX (Doxycycline hyclate)   Oral adjunctive therapy for severe acne in 75, 100 and 150 mg strength delayed-release tablets   December 2022   $ 187   

Urology

  Overactive bladder      
 

ENABLEX

(darifenacin)

  Treatment of overactive bladder   March 2015   $ 80   

 

 

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(1) See “Risk Factors—Risks Relating to Our Business—If generic products that compete with any of our branded pharmaceutical products are approved and sold, sales of our products may be adversely affected,” “Business—Our Principal Products” and “Business—Competition” and “Business—Legal Proceedings.” In particular, we have received Paragraph IV certification notice letters in respect of several of our products, and certain of our products are no longer protected by patent or entitled to exclusivity.
(2) We are presenting June 30, 2009 information because we do not have precise product-by-product information for PGP for the three months ended September 30, 2009. We do not believe, however, that the PGP product revenues for the three months ended September 30, 2009 were materially different than for prior periods.
(3) Represents total ASACOL revenues (400 mg and 800 mg). ASACOL 800 mg (known as ASACOL HD in the United States) was launched in the United States in June 2009.
(4) Calculated on a pro forma basis, and therefore excludes PGP revenues related to product rights divested to Ajinomoto Company (“Ajinomoto”).

Our Competitive Strengths

Diversified portfolio of branded products.    We have an established and diversified portfolio of products. The addition of the PGP products creates depth in our women’s healthcare platform and further diversifies us into the gastroenterology and urology specialty segments. The following chart presents a percentage share breakdown of pro forma revenues by product for the twelve-month period ended June 30, 2009.

Pro Forma Revenue by Product—

Twelve Months Ended June 30, 2009

LOGO

Total pro forma revenue: $2,974.8 million

 

(1) For the twelve-month period ended June 30, 2009, PGP made payments to Sanofi under a collaboration agreement totaling $472.5 million related to ACTONEL product sales. As a result, the profit contribution of ACTONEL relative to other products is less than it may appear based on product revenues alone.
(2) Warner Chilcott Dermatology revenues based on sales of DORYX.

 

 

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Well-positioned in attractive markets.    We have a portfolio of leading branded products in each of our target segments. We believe that through product differentiation, effective marketing and utilization of our experience in brand life cycle management, we are well-positioned to further enhance our product leadership positions. Most of our principal products are leading brands in their respective segments including ASACOL, the leading branded product in the U.S. market for orally administered 5-ASA class drugs, and ACTONEL, the leading branded and second most prescribed non-injectable osteoporosis treatment in the United States.

Leading sales and marketing expertise.    Our sales force is comprised of approximately 1,300 representatives (including the PGP sales force), primarily in the United States and Western Europe, that promote our products to physicians. We believe the success of our sales team is driven by our precision marketing strategies. We identify the high-prescribing physicians in our therapeutic categories and then target our sales force’s activities to reach those specific physicians. We believe this strategy results in an efficient and effective return on our marketing efforts. The acquisition of PGP expands the scope of our sales force’s reach, and we believe that the success of our sales efforts and our precision marketing strategies can be applied not only to our legacy products but also to the PGP portfolio.

Strong intellectual property portfolio with successful management of product patent risk.    Many of our products are protected by patents. We have successfully developed improvements to our existing patent-protected products, including new and enhanced dosage forms, which provide benefits to patients and, in some cases, result in new patent protection and/or extended regulatory exclusivity. Recent examples of successful improvements include approvals by the U.S. Food and Drug Administration (the “FDA”) for our patent-protected products LOESTRIN 24 FE and DORYX 150 mg tablets. PGP also has a history of successful development of product improvements, including an 800 mg dosage of ASACOL launched in June 2009. Additionally, product improvements are under development for the patent-protected ACTONEL franchise, including a new ACTONEL once-a-week product for which PGP submitted a New Drug Application (“NDA”) in the United States in September 2009 and in Canada in October 2009 and other next-generation ACTONEL products, which, if approved, are expected to provide the opportunity to regain market share in the segment and to extend the ACTONEL franchise.

Substantial development pipeline from modest investment.    Our product development efforts are focused primarily on new products with established regulatory guidance and extending proprietary protection of our existing products through product improvements that may include new and enhanced dosage forms. These development efforts tend to be lower-cost endeavors with a higher probability of success than typical development programs run by other pharmaceutical and biotechnology companies. The success of our approach to R&D is reflected in our third quarter 2009 performance, when more than half of our revenues were generated by products developed in-house, approved by the FDA and launched within the last five years (i.e. LOESTRIN 24 FE, FEMCON FE, DORYX and FEMRING). Our R&D efforts benefit from an experienced team of scientists, clinicians and regulatory professionals with proven product development expertise. We currently have an NDA on file with the FDA for our next generation “low dose” oral contraceptive, as well as several other projects in various stages of development for products that treat various indications including acne and erectile dysfunction. Through the PGP Acquisition, we have supplemented our existing pipeline and strengthened our team of experienced R&D professionals. Current PGP development projects include a new ACTONEL once-a-week product for which an NDA was submitted in the United States in September 2009 and in Canada in October 2009, other next generation versions of ACTONEL and ASACOL, as well as a nonfluorinated quinolone (class of antibiotics) and an oral anti-arrhythmic agent.

 

 

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Strong free cash flow generation.    Our business has historically generated strong free cash flow, as it benefits from modest capital expenditure requirements, favorable tax rates and relatively modest working capital requirements. While our capital expenditures as a percentage of sales are slightly higher in the nine months ended September 30, 2009 due to investments in our Fajardo, Puerto Rico manufacturing facility, our historical capital expenditures have averaged approximately 2% of sales between 2005 and 2008. Our favorable tax structure primarily stems from an agreement with the Puerto Rican tax authorities under which we enjoy a 2% tax rate on income in Puerto Rico through 2019. Additionally, we recently completed the redomestication of our parent holding company to Ireland from Bermuda, a move intended to ensure that we are headquartered in a stable long-term legal and regulatory environment. We expect that our favorable tax structure will apply to many of the PGP assets acquired in the PGP Acquisition. We believe that following the PGP Acquisition our strong free cash flow will provide us with the financial flexibility to continue to invest in our business and prepay our debt.

Proven and 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. Our management has demonstrated the ability to select and successfully bring to market products in different stages of development through a number of partnerships and collaborations. Our senior management team, led by Roger Boissonneault, Chief Executive Officer, averages over 25 years of experience in the pharmaceutical industry and has been responsible for growing our revenues (not giving effect to the LEO Transaction described below) by a compound annual growth rate (“CAGR”) of 11.5% between 2006 and 2008.

Our Strategy

Our primary strategy is to continue to develop our specialty pharmaceutical products business by focusing on therapeutic areas dominated by specialist and other high-prescribing physicians. We remain committed to driving long-term revenue and profit growth by continuing to improve upon our portfolio of products and market those products through our precision marketing techniques. Furthermore, we intend to supplement this growth and broaden our market position in our existing franchises through ongoing product development and selectively reviewing potential product in-licensing, acquisition and partnership opportunities.

Focus on selected therapeutic markets.    While large pharmaceutical companies have focused on developing “blockbuster” drugs, we concentrate our efforts on branded products that are prescribed by high-prescribing physicians, as well as developing products that complement those products and therapeutic segments.

Drive long-term growth.    We seek to drive organic growth in product franchises by employing precision marketing techniques and focus our promotional efforts on those products that are most sensitive to promotion. The LEO Transaction presents an opportunity for us to redeploy our sales force to promote our key products and focus our resources on an efficient and successful integration of PGP. The PGP Acquisition has expanded our therapeutic and geographic reach and provides a platform from which our combined sales forces will seek to drive market share by promoting complementary products.

Execute focused, efficient R&D effort.    Our product development efforts are focused primarily on developing new products that target therapeutic areas with established regulatory guidance. Substantial time and attention is devoted to making proprietary improvements to our existing products and developing new and enhanced dosage forms. This strategy will continue with the PGP products by leveraging each R&D team’s expertise to bring new products to market.

 

 

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Selectively acquire products that enhance our existing product portfolio.    To supplement our organic growth, we continually evaluate opportunities to expand our pharmaceutical product portfolio by reviewing potential product in-licensing, acquisition and partnership opportunities, such as our transactions with PGP, Paratek Pharmaceuticals, Inc. (“Paratek”), Dong-A PharmTech Co. Ltd (“Dong-A”) and NexMed, Inc. (“NexMed”). We focus on acquisitions and partnerships in therapeutic categories that we believe will complement our strategic focus. The PGP Acquisition has continued this strategy by broadening our product breadth in women’s healthcare, and by expanding our reach into gastroenterology and urology. Gastroenterology is a specialty segment that we believe is well suited to our marketing strategies as it is characterized by a small concentrated base of physicians. The expansion into the urology market complements our existing product development efforts in the ED category.

Industry

The U.S. pharmaceutical market generated sales of approximately $300 billion in 2008 and has grown at a CAGR of approximately 4.1% since 2004, according to IMS. This market accounted for approximately 75% of our pro forma revenues in the nine months ended September 30, 2009. Large pharmaceutical companies have been consolidating and are focusing on developing and marketing “blockbuster” drugs. The focus by large pharmaceutical companies on blockbuster products creates opportunities for specialty pharmaceutical companies like us to compete effectively in smaller but lucrative therapeutic markets such as gastroenterology, women’s healthcare, dermatology and urology, described below.

Gastroenterology

Ulcerative colitis (“UC”) is a form of inflammatory bowel disease that involves inflammation of the inner lining of the colon and rectum. There are an estimated 500,000 people with UC in the United States, according to the Crohn’s and Colitis Foundation of America. Typically, people are diagnosed with UC in their mid-30’s, (although the disease can occur at any age) and UC typically has a long-term impact on sufferers. Treatment varies, depending on whether the patient is trying to control a flare-up and induce remission or maintain remission. UC is generally treated with orally administered 5-ASA class drugs, such as ASACOL. 5-ASAs are typically preferred over other treatments (corticosteroids, biologics and surgery) due to lower cost and fewer side effects. ASACOL is the leading treatment for ulcerative colitis in the U.S. market for 5-ASAs with approximately 42% of the market share, based on filled prescriptions, and approximately 49% of the market share, based on revenues, in the $1.3 billion market, in each case according to IMS.

Women’s healthcare

Osteoporosis

Osteoporosis is a disease of the bone that leads to an increased risk of fracture and is most common in women after menopause. Osteoporosis can be prevented and treated with lifestyle changes and medications. The leading prescription therapies for the treatment of osteoporosis are a class of drugs called bisphosphonates, such as ACTONEL. ACTONEL is the leading branded and second most prescribed non-injectable osteoporosis treatment in the United States for the prevention and treatment of osteoporosis in postmenopausal women, with a 20% market share, based on filled prescriptions, in the $2.8 billion market, according to IMS.

Hormonal contraception

Hormonal contraception in the United States is a $4.0 billion promotionally sensitive market, according to IMS, where we are able to apply our promotional expertise and enjoy favorable

 

 

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competitive dynamics. Our total market share is approximately 6% based on filled prescriptions, according to IMS. Most prescriptions in this market are written by obstetrician/gynecologists (“OB/GYNs”). Hormonal contraception is a highly brand-dependent market, with share of new customer starts being led by promoted branded products.

Hormone therapy

Hormone therapy is a $1.9 billion market in the United States, according to IMS, which has been declining over the last several years due, in large part, to the negative impact of the discontinuation of two Women’s Health Initiative (“WHI”) studies in 2002 and 2004. The discontinuation of the WHI studies called into question the risks of systemic hormone therapy relative to the benefits. While the systemic portion of the market has been in decline, local acting therapies, such as topical creams, have proven more resilient and, in fact, have shown some growth over the last several years. Our ESTRACE Cream is a topical estrogen product for the treatment of urogenital symptoms of menopause and accounted for a 22% share of filled prescriptions in the $430 million topical cream segment of the U.S. hormone therapy market, according to IMS.

Dermatology

The United States market for dermatology products includes treatment for acne, psoriasis, infectious diseases of the skin, dermatitis, rosacea and other diseases. We target acne, one of the larger segments of the dermatology market. DORYX, a tetracycline-class oral antibiotic, is indicated for adjunctive treatment of severe acne and accounts for approximately 4% of U.S. filled prescriptions of the $1.1 billion market for antibiotics associated with the treatment of acne, according to IMS. Branded antibiotics for acne are particularly sensitive to promotion, and dermatologists are favorably disposed to prescribing differentiated branded products.

Recent Developments

PGP Acquisition

On October 30, 2009, we acquired the global branded pharmaceuticals business of The Procter & Gamble Company for approximately $2.9 billion in cash and the assumption of certain liabilities. The purchase price remains subject to certain post-closing purchase price adjustments. Under the terms of the purchase agreement, we acquired PGP’s portfolio of branded pharmaceutical products, PGP’s prescription drug pipeline and its manufacturing facilities in Puerto Rico and Germany.

In order to fund the PGP Acquisition, certain of our subsidiaries entered into new senior secured credit facilities, comprised of $2.95 billion in aggregate term loan facilities (which includes a $350.0 million delayed draw term loan facility) and a $250.0 million revolving credit facility. At closing, $2.6 billion was borrowed under the term loan facilities and no borrowings were made under the delayed draw term loan facility or the revolving credit facility. The PGP Acquisition and the entry into the new senior secured credit facilities are referred to herein as the “Transactions.”

 

LEO Transaction

On September 23, 2009, we entered into a definitive asset purchase agreement with LEO Transaction pursuant to which LEO paid us $1.0 billion in cash in order to terminate our exclusive license to distribute LEO’s DOVONEX and TACLONEX products (including all products in LEO’s development pipeline) in the United States and to acquire certain assets related to our distribution of DOVONEX and TACLONEX products in the United States. In connection with the LEO Transaction, we entered into a distribution agreement with LEO pursuant to which we agreed to, among other things,

 

 

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(1) continue to distribute DOVONEX and TACLONEX on behalf of LEO, for a distribution fee, through December 31, 2009 and (2) purchase inventories of DOVONEX and TACLONEX from LEO. In addition, we agreed to provide certain transition services to LEO for a period of up to one year after the closing.

The LEO Transaction resulted in a gain of $380.1 million, net of tax, in the quarter ended September 30, 2009. The aggregate gain from the LEO Transaction is expected to be $447.6 million, net of tax. However, approximately $68.9 million of the pre-tax gain relating to certain inventories is expected to be recognized as part of income during the distribution agreement period. We used approximately $481.8 million of the proceeds from the LEO Transaction to repay the entire remaining principal balance of the loans outstanding under our prior senior secured credit facilities of $479.8 million, as well as accrued and unpaid interest and fees of $2.0 million. This repayment resulted in the termination of the prior senior secured credit facilities, including the write-off of $6.6 million related to deferred loan costs.

Redomestication to Ireland

In August 2009, we completed a redomestication from Bermuda to Ireland, whereby each Class A common share of Warner Chilcott Limited was exchanged on a one-for-one basis for an ordinary share of Warner Chilcott plc, a newly formed public limited company organized in, and tax resident of, Ireland, and Warner Chilcott Limited became a wholly owned subsidiary of Warner Chilcott plc.

Our Sponsors

Our sponsors, Bain Capital Partners, DLJ Merchant Banking, J.P. Morgan Partners (advised by CCMP Capital) and Thomas H. Lee Partners, L.P. (the “Sponsors”) are each leading global private equity firms with established track records of successful investments and extensive experience managing investments in the healthcare industry.

 

 

We are a public limited company incorporated under the laws of Ireland. Our principal executive offices are located at Unit 19 Ardee Business Park, Hale Street, Ardee, Co. Louth, Ireland, and our telephone number at that address is +353 41 685 6983. We maintain a website at www.wcrx.com, where general information about us is available. We are not incorporating the contents of our website into this prospectus supplement.

 

 

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The Offering

 

Ordinary shares offered by the selling shareholders

20,000,000 ordinary shares (or 23,000,000 ordinary shares if the underwriters exercise their option to purchase additional shares in full).

 

Option to purchase additional shares

The selling shareholders have granted the underwriters an option to purchase up to 3,000,000 additional ordinary shares.

 

Ordinary shares to be outstanding after this offering

251,450,079 ordinary shares.

 

Use of proceeds

We will not receive any proceeds from the ordinary shares being sold by the selling shareholders.

 

Dividends

We do not intend to pay dividends on our ordinary shares in the foreseeable future. We plan to retain any earnings for use in the operation of our business and to fund future growth.

 

The NASDAQ Stock Exchange symbol

“WCRX”

 

Risk factors

Investing in our ordinary shares involves substantial risks. You should carefully consider all the information in this prospectus supplement prior to investing in our ordinary shares. In particular, we urge you to carefully consider the factors set forth under “Risk Factors.”

 

Conflicts of interest

Affiliates of J.P. Morgan Securities Inc. and Credit Suisse Securities (USA) LLC each beneficially own more than 10% of our ordinary shares. For more information, see “Conflicts of Interest.”

The number of our ordinary shares to be outstanding immediately after the closing of this offering is based on 251,450,079 ordinary shares outstanding as of October 30, 2009, but excludes 6,479,625 shares issuable upon exercise of outstanding options and 10,667,230 shares reserved for issuance under our Equity Incentive Plan.

 

 

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Summary Historical Financial Data

The following table presents summary historical financial data for Warner Chilcott and PGP for the periods presented. The historical financial data for Warner Chilcott as of and for the years ended December 31, 2006, 2007 and 2008 has been derived from the audited consolidated financial statements of Warner Chilcott. The historical financial data as of and for the nine months ended September 30, 2009 was derived from the unaudited consolidated financial statements of Warner Chilcott. All historical financial data for December 31, 2008 and prior periods is presented with Warner Chilcott Limited, now a wholly owned subsidiary of Warner Chilcott plc, as the parent of the group. Warner Chilcott plc was not formed as of or during the 2008 periods.

The historical financial data for PGP as of June 30, 2008 and 2009 and for the years ended June 30, 2007, 2008 and 2009 has been derived from the audited combined financial statements of PGP. The historical financial data for PGP as of and for the three months ended September 30, 2009 was derived from the unaudited combined financial statements of PGP.

The summary unaudited pro forma condensed combined financial data for the year ended December 31, 2008 and as of and for the nine months ended September 30, 2009 are based on the audited and unaudited historical consolidated financial statements described above, as adjusted to illustrate the estimated pro forma effect of the LEO Transaction and the Transactions as if they had occurred on January 1, 2008. The pro forma adjustments are based upon available information and certain assumptions that we believe are reasonable. The summary unaudited pro forma condensed combined financial data are for informational purposes only and do not purport to represent what our results of operations or financial position actually would have been if the LEO Transaction and the Transactions had occurred at any other date, and such data do not purport to project the results of operations for any future period. The audited and unaudited financial statements of Warner Chilcott and of PGP are incorporated into this prospectus supplement by reference. See “Unaudited Pro Forma Condensed Combined Financial Information” and “Where You Can Find More Information.”

 

    Warner Chilcott     PGP(4)          Unaudited
Pro Forma Combined
 
    Fiscal Year
Ended
December 31
    Nine Months
Ended
September 30

2009
    Fiscal Year Ended June 30   Three Months
Ended
September 30
         Fiscal Year
Ended
December 31
    Nine Months
Ended
September 30
 
    2006     2007     2008       2007(3)   2008(3)   2009(3)   2009          2008     2009  
    ($ in millions except per share amounts)  

Income statement data:

                       

Revenues

  $ 754.5      $ 899.6      $ 938.1      $ 749.6      $ 2,444.9   $ 2,531.7   $ 2,317.5   $  577.7          $   3,076.3      $ 2,222.1   

Gross profit(1)(4)

    602.7        713.5        739.3        609.5        2,162.0     2,257.9     2,069.7     526.4            2,715.1        1,984.0   

Selling, general and administrative expenses(2)(4)

    253.9        265.8        192.7        158.9        1,274.7     1,283.6     1,044.5     254.6            1,372.1        869.4   

Research and development(4)

    26.8        54.5        50.0        47.4        301.9     266.2     180.5     30.3            281.5        168.9   

Amortization of intangibles(4)

    253.4        228.3        223.9        171.0        24.0     25.1     24.4     6.1            697.2        471.7   

(Gain) on sale of assets

    —          —          —          (393.1     —       —       —       (193.5         —          —     

Accretion on preferred stock of subsidiary

    26.2        —          —          —          —       —       —       —              —          —     

Impairment of intangible assets

    —          —          163.3        —          8.3     2.8     1.8     —              166.1        1.8   

Interest (income)

    (4.7     (4.8     (1.3     (0.1     —       —       —       —              (1.3     (0.1

Interest expense

    211.7        122.4        94.4        57.3        —       —       —       —              216.2        154.1   
                                                                             

Income/(loss) before income taxes

    (164.6     47.3        16.3        568.1        553.1     680.2     818.5     428.9            (16.7     318.1   

Provision/(benefit) for income taxes

    (11.1     18.4        24.7        44.5        163.8     210.8     279.2     144.9            76.4        78.5   
                                                                             

Net income/(loss)

  $ (153.5   $ 28.9      $ (8.4   $ 523.6      $ 389.3   $ 469.4   $ 539.3   $ 284.0          $ (93.1   $ 239.6   
                                                                             

Earnings per share

                       

Basic

  $ (1.63   $ 0.12      $ (0.03   $ 2.09                  $ (0.37   $ 0.96   

Diluted

    (1.63     0.12        (0.03     2.09                    (0.37     0.96   

 

 

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    Warner Chilcott     PGP(4)          Unaudited
Pro Forma Combined
    Fiscal Year
Ended
December 31
    Nine Months
Ended
September 30

2009
    Fiscal Year Ended June 30     Three Months
Ended
September 30

2009
         Fiscal Year
Ended
December 31

2008
  Nine Months
Ended
September 30

2009
    2006     2007     2008       2007(3)     2008(3)     2009(3)          
                            ($ in millions)                     

Balance sheet data:

                       

Cash and cash equivalents

  $ 84.5      $ 30.8      $ 35.9      $ 753.7        $ 2.7      $ 2.7      $ 4.4            $ 217.1

Total assets

    3,162.5        2,885.0        2,582.9        2,726.3          1,157.2        989.4        949.1              5,805.8

Long term debt

    1,550.8        1,200.2        962.6        380.0          —          —          —                2,980.0

Total liabilities

    1,834.3        1,530.6        1,233.0        832.5          700.7        627.9        629.0              3,921.5

Total shareholders’ equity

    1,328.2        1,354.4        1,349.9        1,893.6          456.5        361.5        320.1              1,884.3
 

Other data:

                       

Adjusted EBITDA(5)

    382.6        450.6        517.9        451.5                  $ 1,094.4     1,019.0

Cash flows from operations

    122.7        339.6        313.3        340.9      470.2        443.2        514.2        120.9           

Cash flows from investing activities

    (282.8     (42.8     (71.9     958.5      (8.4     22.1        72.1        209.2           

Cash flows from financing activities

    233.0        (350.4     (236.2     (581.6   (461.9     (470.3     (586.0     (328.6        

 

(1) With respect to Warner Chilcott, gross profit excludes amortization and impairments of intangible assets.
(2) With respect to PGP, includes expenses for payments to Sanofi under a collaboration agreement in the amount of $554.8 million, $546.8 million, $472.5 million and $110.8 million for the fiscal years ended June 30, 2007, 2008 and 2009 and the three-month period ended September 30, 2009, respectively. With respect to PGP for periods presented, SG&A represents SG&A plus other operating expense less research and development.
(3) Revenues for fiscal years ended June 30, 2007, 2008 and 2009 and for the three-month period ended September 30, 2009 include $32.9 million, $36.3 million, $44.5 million and $4.2 million, respectively, related to the divestiture of rights to market ACTONEL in Japan to Ajinomoto.
(4) Certain reclassifications have been made between the audited combined financial statements of PGP and the summary historical financial data presented in this table. These reclassifications are outlined as follows:

Gross profit per the audited combined financial statements of PGP amounted to $2,100.2 million, $2,283.6 million and $2,183.0 million for the fiscal years ended June 30, 2009, 2008 and 2007, respectively, and $532.8 million for the unaudited condensed combined financial statements for the three months ended September 30, 2009. A reclassification of royalty expense related to ASACOL has been made from Other operating expense as per the audited and unaudited combined financial statements of PGP to cost of sales for the summary historical financial data in the amount of $30.5 million, $25.7 million and $21.0 million, for the fiscal years ended June 30, 2009, 2008 and 2007, respectively, and $6.4 million for the three months ended September 30, 2009.

Other operating expense per the audited combined financial statements of PGP amounted to $456 million, $603.9 million and $595.9 million for the fiscal years ended June 30, 2009, 2008 and 2007, respectively, and $131.3 million for the unaudited condensed combined financial statements for the three months ended September 30, 2009. These costs have been reclassified in their entirety into Selling, general and administrative expenses for the summary historical financial data.

Selling, general and administrative expenses per the audited combined financial statements of PGP amounted to $825.7 million, $999.5 million and $1,034.0 million for the fiscal years ended June 30, 2009, 2008 and 2007, respectively, and $166.1 million for the unaudited condensed combined financial statements for the three months ended September 30, 2009. Research and development costs in the amount of $180.5 million, $266.2 million and $301.9 million for the fiscal years ended June 30, 2009, 2008 and 2007, respectively, and $30.3 million for the three months ended September 30, 2009 have been reclassified from Selling, general and administrative expenses and included as a separate line. Amortization of intangibles in the amount of $24.4 million, $25.1 million and $24.0 million for the fiscal years ended June 30, 2009, 2008 and 2007, respectively, and $6.1 million for the three months ended September 30, 2009 have been reclassified from Selling, general and administrative expenses and included as a separate line. Impairment of intangibles in the amount of $1.8 million, $2.8 million and $8.3 million for the fiscal years ended June 30, 2009, 2008 and 2007, respectively, and $0 million for the three months ended September 30, 2009 have been reclassified from Selling, general and administrative expenses and included as a separate line.

(5)

EBITDA is defined as net income before depreciation and amortization, interest (income)/expense, and income taxes. Adjusted EBITDA is calculated by adjusting EBITDA by the items described below. We believe EBITDA and Adjusted EBITDA are useful as supplemental measures in evaluating the performance of our operating businesses and provide greater transparency into our consolidated and combined results of operations. EBITDA and Adjusted EBITDA are measures used by our management and are factors in measuring compliance with debt covenants relating to certain of our borrowing arrangements. EBITDA and Adjusted EBITDA

 

 

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should not be considered in isolation or as a substitute for net income or other income statement data prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). Our presentation of EBITDA and Adjusted EBITDA may not be comparable to similarly titled measures used by other companies. A reconciliation of EBITDA and Adjusted EBITDA to net income is included in the table below.

We believe EBITDA and Adjusted EBITDA facilitate company to company operating performance comparisons by backing out potential differences caused by variations in capital structures (affecting net interest expense), taxation and the age and book depreciation of facilities (affecting relative depreciation expense), which may vary for different companies for reasons unrelated to operating performance. We further believe that EBITDA and Adjusted EBITDA are frequently used by securities analysts, investors and other interested parties in their evaluation of companies, many of which present an EBITDA measure when reporting their results. EBITDA and Adjusted EBITDA are not necessarily comparable to other similarly titled financial measures of other companies due to the potential inconsistencies in the method of calculation. In addition, Adjusted EBITDA, as presented in this table, corresponds to the definition of EBITDA used in the indenture for our existing notes.

EBITDA and Adjusted EBITDA have limitations as analytical tools, and you should not consider them either in isolation or as substitutes for analyzing our results as reported under GAAP. Some of these limitations are:

 

  Ÿ  

EBITDA and Adjusted EBITDA do not reflect changes in, or cash requirements for, our working capital needs;

 

  Ÿ  

EBITDA and Adjusted EBITDA do not reflect our interest expense, or the cash requirements necessary to service interest or principal payments, on our debt;

 

  Ÿ  

EBITDA and Adjusted EBITDA do not reflect our income tax expense or the cash requirements to pay our taxes;

 

  Ÿ  

EBITDA and Adjusted EBITDA do not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments;

 

  Ÿ  

Although depreciation and amortization are non-cash charges, the assets being depreciated and amortized will often have to be replaced in the future, and EBITDA and Adjusted EBITDA do not reflect any cash requirements for such replacements; and

 

  Ÿ  

Other companies in our industry may calculate EBITDA and Adjusted EBITDA differently so they may not be comparable.

A reconciliation of net income to EBITDA and Adjusted EBITDA for each of the periods presented above is set forth in the following tables:

Warner Chilcott Historical

 

     Year Ended December 31,     Nine Months
Ended
September 30,
 
     2006     2007    2008     2009  
    

($ in millions)

 

Net income / (loss)

   $ (153.5   $ 28.9    $ (8.4   $ 523.6   

Interest expense, net

     207.0        117.6      93.1        57.2   

Provision for income taxes

     (11.1     18.4      24.7        44.5   

Depreciation and amortization of intangible assets

     260.5        238.6      235.3        180.7   

Impairment of intangible assets

     —          —        163.3        —     
                               

EBITDA

     302.9        403.5      508.0        806.0   
                               

Adjustments to historical EBITDA:

         

Non-cash share-based compensation

     17.8        6.1      7.9        9.4   

R&D milestone payments

     3.0        14.5      2.0        11.5   

Litigation settlements

     —          26.5      —          —     

PGP Acquisition-related expenses

     —          —        —          17.7   

Accretion on preferred stock of subsidiaries

     26.2        —        —          —     

Sponsors' management fees recorded in selling, general and administrative expenses

     31.2        —        —          —     

Stepped up inventory recorded in cost of goods sold

     1.5        —        —          —     

(Gain) on sale of assets relating to the LEO Transaction

     —          —        —          (393.1
                               

Adjusted EBITDA

   $ 382.6      $ 450.6    $ 517.9      $ 451.5   
                               

 

 

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Pro Forma Combined Company

 

          Pro Forma
Year Ended
December 31,
2008
    Pro Forma
Nine Months
Ended
September 30,
2009
 
         

($ in millions)

 
   Net income / (loss)    $ (93.1   $ 239.6   
   Interest expense, net(a)      214.9        154.1   
   Provision for income taxes      76.4        78.5   
   Depreciation recorded in selling, general and administrative expenses . . . .      43.0        40.6   
   Amortization of intangible assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .      697.2        471.7   
   Impairment of intangible assets      166.1        1.8   
                   
  

EBITDA

     1,104.4        986.6   
                   
   Adjustments to historical EBITDA:     
   Employee restructuring charges(b)      30.3        7.3   
   Non-cash share-based compensation(c)      26.6        19.5   
   Operating income from divested products(d)      (10.5     (5.6
   (Gain) on sale of divested products(d)      (58.5     —     
   R&D milestone payments(e)      2.0        11.5   
                   
  

Adjusted EBITDA

   $ 1,094.4      $ 1,019.0   
                   

 

    
  

(a)       Represents (1) pro forma interest expense of $216.2 million, net of pro forma interest income of $1.3 million for the year ended December 31, 2008 and (2) pro forma interest expense of $154.1 million, net of pro forma interest income of $(0.1) million for the nine months ended September 30, 2009.

(b)       Represents employee restructuring charges within the PGP business.

(c)       Represents non-cash share-based compensation of (1) $7.9 million of our company and $18.7 million of PGP for the year ended December 31, 2008 and (2) $9.4 million of our company and $10.1 million of PGP for the nine months ended September 30, 2009.

(d)       Represents operating income and associated gains from divested product rights of PGP.

(e)       Represents milestone payments of our company to third parties related to research and development.

            

          

            

          

          

 

 

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RISK FACTORS

In addition to the other information included or incorporated by reference in this prospectus supplement, including the matters addressed in “Cautionary Statement Regarding Forward-Looking Statements,” you should carefully consider the following risk factors set forth below before making an investment in our ordinary shares. In addition, you should read and consider the risk factors associated with our business because these risk factors may also affect the operations and financial results reported by the combined company. See “Where You Can Find More Information.”

Risks Relating to Our Business

If generic products that compete with any of our branded pharmaceutical products are approved and sold, sales of our products will be adversely affected.

Generic equivalents for branded pharmaceutical products are typically sold by competing companies at a lower cost than the branded product. After the introduction of a competing generic product, a significant percentage of the prescriptions written for the branded product are often written for the generic version, resulting in a commensurate loss in revenues of the branded product. In addition, legislation enacted in most states in the United States allows or, in some instances mandates, that a pharmacist dispense an available generic equivalent when filling a prescription for a branded product, in the absence of specific instructions from the prescribing physician. 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, because our patent protection expires or because our patent protection is not sufficiently broad. In addition, we may not be successful in our efforts to extend the proprietary protection afforded our branded products through the development and commercialization of proprietary product improvements and new and enhanced dosage forms. Competition from generic equivalents could have a material adverse impact on our revenues, financial condition, results of operations and cash flows.

ESTRACE Cream, ESTRACE Tablets, ESTROSTEP FE, SARAFEM, OVCON 50 and OVCON 35 are currently not protected by patents. Generic equivalents are currently available for ESTROSTEP FE, SARAFEM capsules, ESTRACE Tablets and OVCON 35. ASACOL is not currently protected by a patent in the United Kingdom. Although our patent covering FEMHRT expires in May 2010, under a 2004 settlement of certain patent litigation, we granted Barr Pharmaceuticals, Inc. (together, with its subsidiaries, “Barr,” which is now a division of Teva Pharmaceutical Industries, Ltd., together with its subsidiaries, “Teva”) a non-exclusive license to launch a generic version of the product six months prior to the expiration of our patent.

During the next five years, additional products of ours will lose patent protection or likely become subject to generic competition. As a result of our settlements of our outstanding patent litigation relating to LOESTRIN 24 FE and FEMCON FE, we granted non-exclusive licenses to third-parties to launch generic versions of these products during the next five years. More specifically, in January 2009, we settled patent litigation related to LOESTRIN 24 FE with Watson Pharmaceuticals, Inc. (together with its subsidiaries, “Watson”). Under the agreement, Watson will be permitted to commence marketing its generic equivalent product on the earlier of January 22, 2014 or the date on which another generic version of LOESTRIN 24 FE enters the U.S. market. In July 2009, we received a Paragraph IV certification notice letter from Lupin Ltd. and its wholly owned subsidiary Lupin Pharmaceuticals, Inc. (together, “Lupin”) in relation to the patent covering LOESTRIN 24 FE, but we do not believe that Lupin will be able to enter the market with a generic equivalent product prior to Watson. In December 2008, we settled our patent litigation related to FEMCON FE with Barr (now Teva). Under the terms of the agreement, Teva may not enter the market until the earlier of July 1, 2012 or, among other circumstances, the date that is two years following the date of the filing of an Abbreviated New Drug

 

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Application (“ANDA”) with a Paragraph IV certification by a third-party. On July 31, 2009, the Company received a Paragraph IV certification notice letter from Lupin indicating that it had submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of FEMCON FE. If Lupin filed its ANDA with respect to FEMCON FE during 2009, Teva may be able to enter the market with a generic version of FEMCON FE as early as 2011. We do not believe that Lupin will be able to enter the market with a generic equivalent product prior to Teva. In January 2009, we announced that we settled our patent litigation related to FEMCON FE with Watson. Under the agreement, Watson will be permitted to commence marketing its generic equivalent product on the earlier of 180 days after Teva enters the market with a generic equivalent product, or January 1, 2013. In late 2010, ACTONEL will lose exclusivity in certain Western European markets.

Potential generic competitors may challenge the patents protecting our branded pharmaceutical products. For example, in addition to the patent challenges resulting in the settlements described above, in December 2008 and January 2009, we and Mayne Pharma International Pty. Ltd. (“Mayne”) received Paragraph IV certification notice letters from Actavis Elizabeth LLC (“Actavis”), Mutual Pharmaceutical Company, Inc. (“Mutual”), Mylan Pharmaceuticals Inc. (“Mylan”), Impax Laboratories, Inc. (“Impax”) and Sandoz Inc. (“Sandoz”) indicating that each had submitted to the FDA an ANDA seeking approval to manufacture and sell generic versions of DORYX 75 mg and 100 mg delayed-release tablets. Those notice letters contend that the DORYX patent is invalid, unenforceable or not infringed. As a result of the enactment of the QI Program Supplemental Funding Act of 2008 (the “QI Act”) on October 8, 2008, Mayne submitted to the FDA for listing in the FDA’s Orange Book the U.S. patent covering DORYX, and potential generic competitors that had filed an ANDA prior to the listing of the DORYX patent were permitted to certify to the listed patent within 120 days of the enactment of the QI Act. Under interpretations by the FDA, DORYX 75 mg and 100 mg will not benefit from the 30-month stay on potential approvals of generic versions of those products. There are two ANDA filers for DORYX 150 mg. Based on the FDA’s interpretive guidance, we believe that DORYX 150 mg is entitled to a 30-month stay on the approval of any generic versions. We believe that stay would run out in September 2011. While we and Mayne filed infringement lawsuits against each of the potential generic competitors in response to their submissions and intend to vigorously defend the DORYX patent and pursue our legal rights, we can offer no assurance that generic equivalent products to the DORYX products will not enter the market prior to the expiration of the patent covering DORYX in 2022. On November 9, 2009, pursuant to an agreement among the Company, Mayne and Mutual, the court dismissed the lawsuit against Mutual concerning generic versions of the DORYX 75 mg and 100 mg products following Mutual’s agreement to withdraw its ANDA with respect to such products. Our remaining lawsuits against Actavis, Mylan, Impax and Sandoz relating to the DORYX 75 mg and 100 mg products, as well as our lawsuits against Impax and Mylan relating to the DORYX 150 mg products, remain pending.

Certain of the products we acquired in the PGP Acquisition have also been challenged by generic competitors. For example, in July 2004, PGP received a Paragraph IV certification notice letter from Teva that it had submitted to the FDA an ANDA seeking approval to manufacture and sell generic versions of ACTONEL. PGP filed a patent infringement suit against Teva in August 2004. In that case, Teva admitted patent infringement and the U.S. District Court for the District of Delaware decided in favor of PGP, upholding the ACTONEL New Chemical Entity (“NCE”) patent as valid and enforceable. Teva appealed, and the U.S. Court of Appeals for the Federal Circuit unanimously upheld the decision of the district court in May 2009. PGP and Roche, which licenses a patent covering once-a-month ACTONEL 150 mg to PGP, filed a patent infringement suit against Teva in September 2008, against Sun Pharma Global, Inc. (“Sun”) in January 2009 and against Apotex Inc. and Apotex Corp. (together, “Apotex”) in March 2009 related to the Paragraph IV certification notice letters received indicating that each of Teva, Sun and Apotex is seeking approval from the FDA to manufacture and sell a generic version of the once-a-month ACTONEL 150 mg product. The suit against Teva triggered a 30-month stay of FDA approval with respect to the above mentioned ANDA, which will expire upon the earlier of

 

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February 2011 or the resolution of the suit. Additionally, once-a-month ACTONEL 150 mg has FDA exclusivity through April 2011, and the underlying ACTONEL NCE patent expires in June 2014. We can offer no assurance that a generic equivalent will not be approved and enter the market prior to the expiration of the once-a-month ACTONEL 150 mg patent in 2023. In addition, in September 2007, Roxane Laboratories, Inc. (“Roxane”), a division of Boehringher Ingelheim Corporation, sent PGP a Paragraph IV certification notice letter that it had submitted to the FDA an ANDA seeking approval to manufacture and sell a generic equivalent of the ASACOL 400 mg product. PGP and Medeva Pharma Suisse A.G. (“Medeva”), the owner of the patent for the ASACOL product, filed a patent infringement suit against Roxane in October 2007, which triggered a 30-month stay of FDA approval with respect to the above mentioned ANDA. The stay will expire upon the earlier of March 2010 or the resolution of the suit. The trial has not been scheduled and is not expected to begin before March 2010. While we intend to vigorously defend the ASACOL patent and pursue our legal rights, we can offer no assurance that this lawsuit will be successful or that a generic equivalent of the ASACOL 400 mg product will not be approved and enter the market prior to the expiration of the ASACOL patent in 2013.

We cannot predict what effect, if any, such matters will have on our financial condition, results of operations and cash flows.

Our trademarks, patents and other intellectual property are valuable assets, and if we are unable to protect them from infringement or challenges, our business prospects may be harmed.

Due to our focus on branded products, 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. We also police our trademark portfolio against infringement. Our efforts to defend our trademarks may be unsuccessful and we may not have adequate remedies in the event of a finding of infringement due, for example, to the fact that a violating company may be insolvent.

We also rely on patents, trade secrets and proprietary knowledge to protect our products. We take steps to protect our proprietary rights by filing applications for patents on certain inventions, by entering into confidentiality, non-disclosure and assignment of invention agreements with our employees, consultants, licensees and other companies and enforcing our legal rights against third parties that we believe may infringe our intellectual property rights. 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 patents will be subjected to inter parte reexamination by the USPTO, whether our confidentiality, non-disclosure and assignment of invention agreements will be breached and whether we will have adequate remedies in the event of any such breach, or whether our trade secrets will become known by competitors.

We are today, and have in the past been, involved in litigation with respect to the validity and infringement of our patents. In addition, we may be involved in such litigation in the future. The outcome of this type of litigation is unpredictable, and if unfavorable, may deprive us of market exclusivity or from marketing and selling a product altogether. In addition, bringing and defending these lawsuits is costly, and consequently we may decide to not bring or defend such suits and to abandon the products to which they relate. If we lose market exclusivity for or stop marketing a product, our business, financial condition, results of operations and cash flows could be adversely affected.

Delays in production could have a material adverse impact on our business.

Our pharmaceutical manufacturing facility located in Fajardo, Puerto Rico currently manufactures many of our products, including LOESTRIN 24 FE, FEMCON FE, ESTROSTEP FE and OVCON 50

 

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oral contraceptives, and packages our delayed-release DORYX tablets, FEMHRT, FEMTRACE and OVCON 35 samples. The PGP facilities we acquired in Manati, Puerto Rico and Weiterstadt, Germany currently manufacture many of the PGP products we acquired in the PGP Acquisition, including ASACOL and ACTONEL. Because the manufacture of pharmaceutical products requires precise and reliable controls, and due to significant compliance obligations imposed by laws and regulations, we may face delays in qualifying the Fajardo, Manati and Weiterstadt facilities for the manufacture of new products or for our other products that are currently manufactured for us by third parties. In addition, natural disasters such as hurricanes, floods, fires and earthquakes could adversely affect the ability of our manufacturing facilities to supply products to us. Hurricanes are relatively common in Puerto Rico and the severity of such natural disasters is unpredictable.

In addition, certain of our pharmaceutical products are currently manufactured for us under contracts with third parties. Our contract manufacturers may not be able to manufacture our products without interruption and may not comply with their obligations under our various supply arrangements, and we may not have adequate remedies for any breach. Our contract manufacturers have occasionally been unable to meet all of our orders, which has led to the depletion of our safety stock and temporary shortages of trade supply and promotional samples.

Failure by our own manufacturing facility or any third-party manufacturer (each a “product supplier”) to comply with regulatory requirements could adversely affect their ability to supply products to us. All facilities and manufacturing techniques used for the manufacture of pharmaceutical products must be operated in conformity with current Good Manufacturing Practices (“cGMPs”). In complying with cGMP requirements, product suppliers must continually expend time, money and effort in production, record-keeping and quality assurance and control to ensure that their products meet applicable specifications and other requirements for product safety, efficacy and quality. Manufacturing facilities are subject to periodic unannounced inspections by the FDA and other regulatory authorities. Failure to comply with applicable legal requirements (including, in the case of our manufacturing facility located in Fajardo, certain obligations that we assumed in our purchase of the facility arising out of a consent decree entered into by the previous owner) subjects the product suppliers to possible legal or regulatory action, including shutdown, which may adversely affect their ability to supply us with product.

The FDA and other regulatory authorities must approve suppliers of certain active and inactive pharmaceutical ingredients and certain packaging materials used in our products as well as suppliers of finished products. The development and regulatory approval of our products are dependent upon our ability to procure these ingredients, packaging materials and finished products from suppliers approved by the FDA and other regulatory authorities. Such approval of a new supplier would be required if, for example, active ingredients, packaging materials or finished products were no longer available from the initially approved supplier or if that supplier had its approval from the FDA or other regulatory authority withdrawn. The qualification of a new product supplier or a new supplier of product components could potentially delay the manufacture of the drug involved. Furthermore, we may not be able to obtain active ingredients, packaging materials or finished products from a new supplier on terms that are as favorable to us as those agreed to with the initially approved supplier or at reasonable prices.

A delay in supplying, or failure to supply, products by any product supplier could result in our inability to meet the demand for our products, the loss of all or a portion of our market share with respect to such products, and adversely affect our revenues, financial condition, results of operations and cash flows.

 

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Pricing pressures from third-party payors, including managed care organizations, government sponsored health systems and regulations relating to Medicare and Medicaid, healthcare reform, pharmaceutical reimbursement and pricing in general could decrease our U.S. revenues.

Our commercial success in producing, marketing and selling products in the United States depends, in part, on the availability of adequate reimbursement from third-party healthcare payors, such as managed care organizations and government bodies and agencies for the cost of the products and related treatments. The market for our products may be limited by actions of third-party payors.

Managed care organizations and other third-party payors try to negotiate the pricing of medical services and products to control their costs, including by developing formularies to encourage plan beneficiaries to utilize preferred products for which the plans have negotiated favorable terms. Exclusion of a product from a formulary, or placement of a product on a disfavored formulary tier, can lead to sharply reduced usage in the managed care organization patient population. If our products are not included within an adequate number of formularies or if adequate reimbursements are not provided, or if reimbursement policies increasingly favor generic products, our market share and business could be negatively affected.

Reforms in Medicare added an out-patient prescription drug reimbursement beginning in 2006 for all Medicare beneficiaries. Private plans contracting with the government to deliver the benefit, through their purchasing power under these programs, are demanding discounts from pharmaceutical companies that may implicitly create price controls on prescription drugs. These reforms may decrease our future revenues from products such as ACTONEL, that are covered by the Medicare drug benefit.

We also face pricing pressures and potential pricing pressures for our drug products reimbursed under the Medicaid program. Most states have established preferred drug lists (“PDLs”) and require that manufacturers pay supplemental rebates, in addition to the federal rebate, to the state in order to be included in the PDL or to avoid being placed in a disfavored position on the state formulary.

Further, a number of other legislative and regulatory measures aimed at changing the healthcare system have been proposed, including federal proposals to permit the U.S. government to use its purchasing power to negotiate further discounts from pharmaceutical companies under Medicare, and proposals to increase the federal rebates we must pay to the states based on the utilization of our products under Medicaid. In addition, Congress is considering various other legislative proposals that generally are intended to expand healthcare coverage to currently uninsured Americans and to limit the rate of increase in healthcare spending. While we cannot predict whether any such proposals will be adopted or the effect such proposals may have on our business, the existence of such proposals, as well as the adoption of any proposal, may increase industry-wide pricing pressures or increase the cost of doing business (for example by imposing taxes on pharmaceutical manufacturers), thereby adversely affecting our results of operations and cash flows.

Government regulation in the European Union of the price and reimbursement status of medicinal products could limit market acceptance of our products or reduce the prices we receive for our products.

Most European Union member states impose controls on the prices at which medicines are reimbursed under state-run healthcare schemes. In many countries reimbursement of a product is conditional on the agreement by the seller not to sell the product above a fixed price in that country. Often the reimbursement price is established unilaterally by the national authorities, often accompanied by the inclusion of the product on a list of reimbursable products. Some member states operate reference pricing systems in which they set national reimbursement prices by reference to those in other member states. Increased pressures to reduce government healthcare spending and increased transparency of prices following the adoption of the euro have meant that an increasing number of

 

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governments have adopted this approach. Furthermore, with increased price transparency, parallel importation of pharmaceuticals from lower price level countries to higher priced markets has grown; and these parallel imports lower our effective average selling price.

Taxing authorities could reallocate our taxable income among our subsidiaries, which could increase our consolidated tax liability, and changes in tax laws and regulations could materially adversely affect our results of operations, financial position and cash flows.

We conduct operations world-wide through subsidiaries in various tax jurisdictions. Certain aspects of the transactions between our subsidiaries, including our transfer pricing (which is the pricing we use in the transfer of products and services among our subsidiaries) and our intercompany financing arrangements, could be challenged by applicable taxing authorities. While we believe both our transfer pricing and our intercompany financing arrangements are reasonable, either or both could be challenged by the applicable taxing authorities. Following any such challenge, our taxable income could be reallocated among our subsidiaries. Such reallocation could both increase our consolidated tax liability and adversely affect our financial condition, results of operations and cash flows.

Our U.S. operating subsidiaries previously entered into an Advance Pricing Agreement (the “APA”) with the Internal Revenue Service (the “IRS”) covering the calendar years 2006 through 2010. We cannot ensure that we will be able to enter into a new APA covering calendar years after 2010 or that any new APA will contain terms comparable to those in our existing APA. If we do not enter into a new APA, while we believe that our transfer pricing arrangements comply with applicable U.S. tax rules, the IRS could challenge our transfer pricing arrangements.

In addition, our future operating results, financial position and cash flows could be materially adversely affected by changes in the application of tax principles, including tax rates, new tax laws, or revised interpretations of existing tax laws and precedents, which result in a shift of taxable earnings between tax jurisdictions.

Changes in market conditions, including lower than expected cash flows or revenues for our branded pharmaceutical products, may result in our inability to realize the value of these products, in which case we may have to record an impairment charge.

The pharmaceutical industry is characterized by rapid product development and technological change, and as a result, our pharmaceutical products could be rendered obsolete or their value may be significantly decreased by the development of new technology or new pharmaceutical products to treat the conditions currently addressed by our products, technological advances that reduce the cost of production or marketing or pricing actions by one or more of our competitors. Some of the companies we compete against have significantly greater resources than we do, and therefore, may be able to adapt more quickly to new or emerging technologies and changes in customer requirements, or devote greater resources to the promotion and sale of their products than we can. Our inability to compete successfully with respect to these or other factors may materially and adversely affect our cash flows or revenues, or may result in our inability to realize the value of our branded pharmaceutical products, including products acquired from third parties, and may require us to record an impairment charge.

Recent legal and regulatory requirements could make it more difficult for us to obtain new or expanded approvals for our products, and could limit or make more burdensome our ability to commercialize our approved products.

The Food and Drug Administration Amendments Act of 2007 contains significant additional regulatory requirements affecting pharmaceutical manufacturers. The legislation grants the FDA extensive additional authority to impose post-approval clinical study and clinical trial requirements, require safety-related changes to product labeling, review advertising aimed at consumers, and require the adoption of risk management plans, referred to in the legislation as risk evaluation and mitigation strategies (“REMS”). The REMS may include requirements for special labeling or medication guides for

 

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patients, special communication plans for healthcare professionals, and restrictions on distribution and use. For example, if the FDA were to make the requisite findings, it might require that a new product be prescribed only by physicians with certain specialized training, only in certain designated healthcare settings, or only in conjunction with special patient testing and monitoring.

The legislation also includes, among other new requirements, provisions requiring the disclosure to the public of certain information regarding ongoing clinical trials for drugs through a clinical trial registry and for disclosing clinical trial results to the public through a clinical trial database; renewed requirements for conducting trials to generate information on the use of products in pediatric patients; and new penalties, for such acts as false or misleading consumer drug advertising. Other proposals have been made to impose additional requirements on drug approvals, further expand post-approval requirements, and restrict sales and promotional activities.

New requirements have also been imposed in some states, and proposed in other states, requiring us to provide paper or electronic pedigree information for the drugs that we distribute to help establish their authenticity and to track their movement from the manufacturer through the chain of distribution. These new federal and state requirements, and additional requirements that have been proposed and might be adopted, may make it more difficult or burdensome for us to obtain new or expanded approvals for our products, may be more restrictive or come with onerous post-approval or other requirements, may hinder our ability to commercialize approved products successfully, and may harm our business.

Delays and uncertainties in clinical trials or the government approval process for new products could result in lost market opportunities and hamper our ability to recoup costs associated with product development.

FDA approval is generally required before a prescription drug can be marketed in the United States. For innovative, or non-generic, new drugs, an FDA-approved New Drug Application (“NDA”) is required before the drugs may be marketed in the United States. The NDA must contain data to demonstrate that the drug is safe and effective for its intended uses, and that it will be manufactured to appropriate quality standards. Products marketed outside the United States are also subject to government regulation, which may be equally or more demanding. The clinical trials required to obtain regulatory approvals can be complex and expensive, and their outcomes are uncertain. Positive results from pre-clinical studies and early clinical trials do not ensure positive results in later clinical trials that form the basis of an application for regulatory approval. Even where clinical trials are completed successfully, the FDA or other regulatory authorities may determine that a product does not present an acceptable risk-benefit profile, and may not approve an NDA or its foreign equivalent or may only approve an NDA or its foreign equivalent with significant restrictions or conditions. The drug development and approval process can be time-consuming and expensive without assurance that the data will be adequate to justify approval of proposed new products. If we are unable to obtain regulatory approval for our products, we will not be able to commercialize our products and recoup our R&D costs. Furthermore, even if we were to obtain regulatory approvals, the terms of any product approval, including labeling, may be more restrictive than desired and could affect the marketability of our products, and the approvals may be contingent upon burdensome post-approval study commitments. If we are unable to obtain timely product approvals on commercially viable terms, our profitability and business could suffer. We are currently conducting Phase II and Phase III clinical trials and have pending NDAs for a number of important products, including our next generation ACTONEL product. If the NDA is not approved, we may not be able to commercialize that product in the United States and may not be able to realize the full anticipated value of the PGP Acquisition.

Changes in laws and regulations could adversely affect our results of operations, financial position or cash flows.

Our future operating results, financial position or cash flows could be adversely affected by changes in laws and regulations such as (i) changes in the FDA or equivalent foreign approval

 

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processes that may cause delays in, or limit or prevent the approval of, new products, (ii) new laws, regulations and judicial decisions affecting product marketing, promotion or the healthcare field generally and (iii) new laws or judicial decisions affecting intellectual property rights.

The perceived health effects of estrogen and combined estrogen-progestogen hormone therapy products may affect the acceptability and commercial success of our HT products.

ESTRACE Tablets, ESTRACE Cream, FEMRING and FEMTRACE are estrogen therapy products, and FEMHRT is a combined estrogen-progestogen therapy product. These hormone therapy (“HT”) products are used by women to alleviate symptoms associated with menopause. Recent studies have analyzed the health effects of estrogen therapy and estrogen-progestogen therapy products and the American College of Obstetricians and Gynecologists has recommended that consumers use these products in the lowest possible dose for the shortest possible duration. We believe the publicity surrounding some of these studies resulted in a significant industry-wide decrease in the number of prescriptions being written for estrogen therapy and estrogen-progestogen therapy products, including FEMHRT. The ultimate effect of these studies, and any further changes in labeling for our products, may further affect the acceptability of our products by patients, the willingness of physicians to prescribe our products for their patients or the duration of their therapy. In any such event, our overall rate of growth may be lower.

The loss of the services of members of our senior management team or scientific staff or the inability to attract and retain other highly qualified employees could impede our ability to meet our strategic objectives and adversely affect our business.

Our success is dependent on attracting and retaining highly qualified scientific, sales and management staff, including our Chief Executive Officer, Roger Boissonneault. We face intense competition for personnel from other companies, academic institutions, government entities and other organizations. The loss of key personnel, or our failure to attract and retain other highly qualified employees, may impede our ability to meet our strategic objectives.

Pursuant to our business strategy, we intend to develop proprietary product improvements as well as new products. This strategy may require us to hire additional employees with expertise in areas that relate to product development. We cannot fully anticipate or predict the time and extent to which we will need to hire this type of specialized personnel. We may not be successful in attracting and retaining the personnel necessary to pursue our business strategy fully. In addition, if competition continues to intensify, then our cost of attracting and retaining employees may escalate.

Product liability claims and product recalls could harm our business.

The development, manufacture, testing, marketing and sale of pharmaceutical products entail significant risk of product liability claims or recalls. Our products are, in the substantial majority of cases, designed to affect important bodily functions and processes. Unforeseen side-effects caused by, or manufacturing defects inherent in, the products sold by us could result in exacerbation of a patient’s condition, further deterioration of the patient’s condition or even death. The occurrence of such an event could result in product liability claims and/or the recall of one or more of our products. Claims may be brought by individuals seeking relief for themselves or, in certain jurisdictions, by groups seeking to represent a class. For example, as of September 30, 2009, approximately 707 product liability suits, including some with multiple plaintiffs, have been filed against, or tendered pursuant to acquisition agreements to, us in connection with the HT products FEMHRT, ESTRACE Tablets, ESTRACE Cream and medroxyprogesterone acetate. The lawsuits were likely triggered by the July 2002 and March 2004 announcements by the National Institutes of Health (“NIH”) of the terminations of two large-scale randomized controlled clinical trials, which were part of the Women’s Health Initiative (“WHI”), examining the long-term effect of HT on the prevention of coronary heart

 

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disease and osteoporotic fractures, and any associated risk for breast cancer in postmenopausal women. In the case of the trial terminated in 2002, which examined combined estrogen and progestogen therapy (the “E&P Arm of the WHI Study”), the safety monitoring board determined that the risks of long-term estrogen and progestogen therapy exceeded the benefits, when compared to a placebo. WHI investigators found that combined estrogen and progestogen therapy did not prevent heart disease in the study subjects and 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, blood clots and dementia. In the trial terminated in 2004, which examined estrogen therapy, the trial was ended one year early because the NIH did not believe that the results were likely to change in the time remaining in the trial and that the increased risk of stroke could not be justified by the additional data that could be collected in the remaining time. As in the E&P Arm of the WHI Study, WHI investigators again found that estrogen only therapy did not prevent heart disease and although study subjects experienced fewer hip fractures and no increase in the incidence of breast cancer compared to subjects randomized to placebo, there was an increased incidence of stroke and blood clots in the legs. The estrogen used in the WHI Study was conjugated equine estrogen and the progestin was medroxyprogesterone acetate, the compounds found in Premarin® and Prempro™, products marketed by Pfizer, Inc. (formerly Wyeth). See “Business—Legal Proceedings—Warner Chilcott Legal Proceedings.”

Further, we may be liable for product liability, warranty or similar claims in relation to PGP products that are pending as of the closing of the PGP Acquisition. Our agreement with P&G provides that P&G will indemnify us for 50% of the losses from any such claims, subject to certain limits. One such set of claims may relate to litigation in connection with ACTONEL. Beginning in 2003, case reports in scientific literature reported a series of adverse events involving post-menopausal women who developed osteonecrosis of the jaw (“ONJ”) subsequent to alleged use of medications for osteoporosis. The majority of these reports involved multiple myeloma patients who used high doses of intravenous bisphosphonates as part of their cancer therapy. Beginning in 2006, several complaints were filed against P&G and Sanofi-Aventis US LLC (“Sanofi”) regarding ONJ. We and P&G are aware of 86 claimants, in 78 cases, against P&G and Sanofi. Generally, the plaintiffs allege that ACTONEL increases the risk of ONJ and that this risk was not included in the product’s warnings. See “Business—Legal Proceedings—PGP Legal Proceedings.”

Product liability insurance coverage is expensive, can be difficult to obtain and may not be available in the future on acceptable terms, if at all. Our product liability insurance may not cover all the future liabilities we might incur in connection with the development, manufacture or sale of our products. In addition, we may not continue to be able to obtain insurance on satisfactory terms or in adequate amounts.

We currently maintain product liability insurance coverage for claims between $25.0 million and $100.0 million, above which we are self-insured. Our insurance may not apply to damages or defense costs related to the above mentioned HT claims or the above mentioned ONJ claims, including any claim arising out of HT products with labeling that does not conform completely to FDA hormone replacement therapy communications to manufacturers of HT products. A successful claim or claims brought against us in connection with our HT product liability litigation, the ONJ litigation or other matters that is in excess of available insurance coverage could subject us to significant liabilities and have a material adverse effect on our business, financial condition, results of operations and cash flows. Such claims could also harm our reputation and the reputation of our products, thereby adversely affecting our ability to market our products successfully. In addition, irrespective of the outcome of product liability claims, defending a lawsuit with respect to such claims could be costly and significantly divert management’s attention from operating our business. Furthermore, we could be rendered insolvent if we do not have sufficient financial resources to satisfy any liability resulting from such a claim or to fund the legal defense of such a claim.

 

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Product recalls may be issued at our discretion or at the discretion of certain of our suppliers, the FDA, other government agencies and other entities that have regulatory authority for pharmaceutical sales. From time to time, we have recalled some of our products; however, to date none of these recalls have been significant. Any recall of a significant product could materially adversely affect our business and profitability by rendering us unable to sell that product for some time.

Sales of our products may be adversely affected by the consolidation among wholesale drug distributors and the growth of large retail drug store chains.

The network through which we sell our products has undergone significant consolidation marked by mergers and acquisitions among wholesale distributors and the growth of large retail drugstore chains. As a result, a small number of large wholesale distributors control a significant share of the market, and the number of independent drug stores and small drugstore chains has decreased. For example, during the year ended December 31, 2007, CVS, a national retail drug store chain that previously accounted for over 10% of our net revenues and accounts receivable, began purchasing through one of our existing wholesale customers. As a result of this change, our customer concentration was increased. Three large wholesale distributors accounted for an aggregate of 86% of our net revenues during the year ended December 31, 2008 and 67% of the combined company’s gross revenues for the three-month period ended September 30, 2009, on a pro forma basis. In addition, excess inventory levels held by large distributors may lead to periodic and unanticipated future reductions in revenues and cash flows. Consolidation of drug wholesalers and retailers, as well as any increased pricing pressure that those entities face from their customers, including the U.S. government, may increase pricing pressure and place other competitive pressures on drug manufacturers, including us.

If we fail to comply with government regulations we could be subject to fines, sanctions and penalties that could adversely affect our ability to operate our business.

We are subject to regulation by national, regional, state and local agencies, including, in the United States, the FDA, the Drug Enforcement Administration, the Department of Justice, the Federal Trade Commission, the Office of the Inspector General of the U.S. Department of Health and Human Services, the U.S. Environmental Protection Agency and other regulatory bodies. The Federal Food, Drug and Cosmetic Act, the Public Health Service Act and other federal and state statutes and regulations in the United States, and equivalent laws and regulations in the European Union, govern to varying degrees, the research, development, manufacturing and commercial activities relating to prescription pharmaceutical products, including pre-clinical and clinical testing, approval, production, labeling, sale, distribution, import, export, post-market surveillance, advertising, dissemination of information and promotion.

Our sales, marketing, research and other scientific/educational programs must also comply with the anti-kickback and fraud and abuse provisions of the Social Security Act, the False Claims Act, the privacy provisions of the Health Insurance Portability and Accountability Act, and similar state laws. Pricing and rebate programs must comply with the Medicaid drug rebate requirements of the Omnibus Budget Reconciliation Act of 1990 and the Veterans Health Care Act of 1992. If products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply.

All of these activities are also potentially subject to federal and state consumer protection and unfair competition laws. In addition, in recent years, several states in the United States, including California, Massachusetts, Maine, Minnesota, Nevada, New Hampshire, New Mexico, Texas, Vermont and West Virginia, as well as the District of Columbia, have enacted legislation requiring pharmaceutical companies to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit pharmacies and other healthcare

 

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entities from providing certain physician prescribing data to pharmaceutical companies for use in sales and marketing and prohibit certain other sales and marketing practices. Similar legislation is being considered in other states and at the federal level in the United States. Many of these requirements are new and their breadth and application are uncertain.

Noncompliance with these and other government regulations and other legal requirements may result in civil fines, criminal fines and prosecution, the recall of products, the total or partial suspension of manufacture and/or distribution, seizure of products, injunctions, whistleblower lawsuits, failure to obtain approval of pending product applications, withdrawal of existing product approvals, exclusion from participation in government healthcare programs and other sanctions. Any threatened or actual government enforcement action can also generate adverse publicity and require that we devote substantial resources that could be used productively on other aspects of our business. Any of these enforcement actions could affect our ability to commercially distribute our products and could materially and adversely affect our business, financial condition, results of operations and cash flows.

We may not be able to successfully identify, develop, acquire, license or market new products as part of growing our business.

In order to grow and achieve success in our business, we must continually identify, develop, acquire and license new products that we can ultimately market. Any future growth through new product acquisitions will be dependent upon the continued availability of suitable acquisition candidates at favorable prices and upon advantageous terms and conditions. Even if such opportunities are present, we may not be able to successfully identify products as candidates for potential acquisition, licensing, development or collaborative arrangements. Moreover, other companies, many of which may have substantially greater financial, marketing and sales resources, are competing with us for the right to acquire such products.

If an acquisition candidate is identified, the third parties with whom we seek to cooperate may not select us as a potential partner or we may not be able to enter into arrangements on commercially reasonable terms or at all. Furthermore, we do not know if we will be able to finance the acquisition or integrate an acquired product into our existing operations. The negotiation and completion of potential acquisitions could result in a significant diversion of management’s time and resources and potentially disrupt our ongoing business. Future product acquisitions may result in the incurrence of debt and contingent liabilities and an increase in interest expense and amortization expenses, as well as significant charges relating to integration costs.

At each stage between developing or sourcing new products and marketing these products, there are a number of risks and uncertainties, and failure at any stage could have a material adverse effect on our ability to achieve commercial success with a product or to maintain or increase revenues, profits and cash flow. In addition, if we are unable to manage the challenges surrounding product development, acquisitions or the successful integration of acquisitions, it could have materially adverse effects on our business, financial condition, results of operations and cash flows.

Prescription drug importation from Canada and other countries could increase pricing pressure on certain of our products and could decrease our revenues and profit margins.

Under current U.S. law, U.S. individuals may import prescription drugs that are unavailable in the United States from Canada and other countries for their personal use under specified circumstances. Other imports, although illegal under U.S. law, also enter the country as a result of the resource constraints and enforcement priorities of the FDA and the U.S. Customs Service. The volume of prescription drug imports from Canada and elsewhere could increase due to a variety of factors, including the further spread of Internet pharmacies and actions by certain state and local governments to facilitate Canadian and other imports. These imports may harm our business.

 

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We currently sell FEMHRT, ACTONEL, ASACOL, DANTRIUM, DIDRONEL, MACROBID and ZOMIG in Canada. In addition, ESTRACE Tablets are sold in Canada by third parties. Due to government price regulation in Canada and other countries, these products are generally sold in Canada and other countries for lower prices than in the United States. As a result, if these drugs are imported into the United States from Canada or elsewhere, we may experience reduced revenue or profit margins.

We have a significant amount of intangible assets, which may never generate the returns we expect.

Our identifiable intangible assets, which include trademarks and trade names, license agreements and patents acquired in acquisitions, were $3,535.2 million on a pro forma basis at September 30, 2009, representing approximately 60.9% of our pro forma total assets of $5,805.8 million. Goodwill, which relates to the excess of cost over the fair value of the net assets of the businesses acquired, was $998.7 million on a pro forma basis at September 30, 2009, representing approximately 17.2% of our pro forma total assets. The majority of our intangible assets are owned by one of our Puerto Rican subsidiaries.

Goodwill and identifiable intangible assets are recorded at fair value on the date of acquisition. Under Accounting Standards Codification (“ASC”) No. 320, goodwill is reviewed at least annually for impairment and definite-lived intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that their carrying value may not be recoverable. Future impairment may result from, among other things, deterioration in the performance of the acquired business or product line, adverse market conditions and changes in the competitive landscape, adverse changes in applicable laws or regulations, including changes that restrict the activities of the acquired business or product line, changes in accounting rules and regulations, and a variety of other circumstances. The amount of any impairment is recorded as a charge to the statement of operations. We may never realize the full value of our intangible assets. Any determination requiring the write-off of a significant portion of intangible assets may have an adverse effect on our financial condition and results of operations. For example, in connection with our annual review of intangible assets during the fourth quarter of 2008, we recorded a non-cash impairment charge of $163.3 million relating to our OVCON / FEMCON FE product family. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations” for details.

If we fail to comply with our reporting and payment obligations under the Medicaid rebate program or other governmental pricing programs, we could be subject to additional reimbursements, penalties, sanctions and fines which could have a material adverse effect on our business.

We participate in the federal Medicaid rebate program established by the 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 minimum amount of the rebate for each unit of product is set by law as 15.1% of the average manufacturer price (“AMP”) of that product, or if it is greater, the difference between AMP and the best price available from us to any customer. The rebate amount also includes an inflation adjustment, if necessary.

As a manufacturer of different types of drug products, including products the Centers for Medicare and Medicaid Services treats as innovators (usually branded products) and noninnovators (usually generic products), rebate calculations vary among products and programs. The calculations are complex and, in certain respects, subject to interpretation by us, governmental or regulatory

 

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agencies and the courts. For example, 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, if 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 $0.1 million 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.

Federal law requires that any company that participates in the Medicaid rebate program extend comparable discounts to qualified purchasers under the Public Health Services (“PHS”) pharmaceutical pricing program. The PHS pricing program extends discounts comparable to the Medicaid rebates to a variety of community health clinics and other entities that receive health services grants from the PHS, as well as hospitals that serve a disproportionate share of economically disadvantaged patients.

Under the Veterans Health Care Act (“VHCA”), manufacturers are required to offer certain drug and biologics at a discount to a number of federal agencies including Veterans’ Administration (“VA”), Department of Defense, and the Public Health Service in order to participate in other federal funding programs including Medicare and Medicaid. Through contractual agreements with VA implementing the requirements of the VHCA, we must offer certain products on the VA Federal Supply Schedule and through other contract vehicles at prices that are equal to or lower than the Federal Ceiling Price, which is a price determined through the use of a statutory formula that provides for a discount off the average price to wholesalers. In addition, recent legislative changes purport to require that similarly discounted prices be offered for certain Department of Defense purchases for its TRICARE program via a rebate system.

Rebate and pricing calculations vary among products and programs. The calculations are complex and, in certain respects, subject to interpretation by us, governmental or regulatory agencies and the courts. For example, 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, while the Federal Ceiling Price is calculated annually by VA based on quarterly and annual sales submissions The terms of our participation in the Medicaid 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 $0.1 million per item of false information. Similar risks and obligations apply to the VHCA program. Finally, 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.

Adverse outcomes in our outstanding litigation matters could negatively affect our business, results of operations, financial condition and cash flows.

Our financial condition could be negatively affected by unfavorable results in our outstanding litigation matters, including those described in “Business—Legal Proceedings,” or in lawsuits that may be initiated in the future. These matters include intellectual property litigation and product liability litigation, any of which, if adversely decided, could negatively affect our business, results of operations, financial condition and cash flows.

 

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Risks Related to the PGP Acquisition

We may not realize the anticipated opportunities from the PGP Acquisition.

The success of the PGP Acquisition will depend, in part, on our ability to realize the anticipated growth opportunities from integrating the business of PGP with our business, including utilization of its sales force to expand our reach outside the United States. Our success depends on the successful integration of our and PGP’s businesses and operations including information systems, manufacturing and R&D operations, and financial systems. We cannot assure you that we will be able to realize such opportunities or that our management will not be distracted.

We may be required to satisfy a significant contractual obligation to Sanofi.

Sanofi currently collaborates with P&G on a global basis to develop and commercialize risedronate products (including ACTONEL) pursuant to a collaboration agreement. The PGP Acquisition constituted a change-of-control of PGP under the collaboration agreement, which gives Sanofi the right to exercise an option to put its interest in marketing ACTONEL to us at a fair market value to be determined by independent third-party firms (the “Sanofi Put”). Sanofi has until December 14, 2009 (45 days following the closing of the PGP Acquisition) to exercise its put option. If the Sanofi Put is exercised, we will fund the Sanofi Put through cash on hand and/or borrowings under the $350.0 million delayed draw term loan facility (which is part of the new senior secured credit facilities we entered into at the time of the closing of the PGP Acquisition) up to a specified threshold amount previously agreed to with P&G. If the fair market value of the Sanofi Put exceeds this threshold amount, we have the option to require P&G to provide funding for any amount in excess of the threshold amount. In exchange, P&G would receive a right to future payments based on a proportionate share of the incremental operating profits that would otherwise accrue to us following the Sanofi Put closing date through December 31, 2014 (which is in line with the expiration of the Sanofi collaboration agreement if the Sanofi Put is not exercised). If P&G funds a portion of the price of the Sanofi Put, we have the right to repay P&G (with no interest) within six months of the Sanofi Put closing date, in which case P&G will not receive any profit share payments. If Sanofi exercises its put right, our business, results of operations, financial condition and cash flows could be negatively affected in a number of ways. First, our total debt will increase in order to fund the put. Second, while we will no longer be required to make payments to Sanofi, Sanofi will no longer market our products and we will need to increase our sales force and selling expense to substitute for Sanofi’s efforts and/or seek alternative arrangements to market the products in some jurisdictions. Our management may be diverted during a transitional period, and our revenues may be affected during such period. See “Business—PGP Alliance with Sanofi.”

The PGP business faces business, regulatory and other risks, some of which may be different from the risks we currently face.

We entered into the PGP Acquisition based on a number of assumptions and determinations regarding future revenues and cash flow from PGP’s products and risks relating to the PGP business that may prove to be incorrect. Although we believe the PGP business is complementary to our current business and is consistent with our strategy, operating our combined company will require managing operations and risks that are different, in some respects, from those we currently face, including the following:

 

  Ÿ  

PGP’s business is more geographically dispersed than our business. While we currently sell our products primarily in North America, 31% of PGP’s revenues for the year ended June 30, 2009, were outside North America, primarily in Western Europe.

 

  Ÿ  

Both ASACOL and ACTONEL, PGP’s principal products, will contribute significantly more to our pro forma revenue than any of our existing products, and our business could be significantly affected by any decrease in net sales from those products that is more than we have estimated or any liability relating to them.

 

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  Ÿ  

We expect net sales of PGP’s products in the aggregate to decline over the next several years for a variety of reasons. Although we have strategies in place to mitigate this decline and in certain instances, increase revenues, those strategies may prove unsuccessful:

 

   

Net sales of ACTONEL declined 11% in the year ended June 30, 2009 compared to the prior year period, mainly due to decreased demand in the United States driven by aggressive managed care initiatives implemented to favor generic versions of once-a-week FOSAMAX and market share gains by once-a-month BONIVA. Our efforts to address market share pressures through, among other things, the marketing of once-a-month ACTONEL 150 mg and the development of a next generation once-a-week ACTONEL product, may not succeed in limiting the loss of market share in non-injectable osteoporosis treatment products.

 

   

ACTONEL will lose exclusivity in major Western European markets beginning in late 2010.

 

   

PGP began to experience some erosion of its market share for ASACOL in the United States in 2007 due to introduction of competition, and the increase in net sales of ASACOL in the acquired business’s fiscal year ended June 30, 2009 compared to the prior year period was primarily due to higher net selling prices in the United States, which more than offset decreased demand in the United States. Our ability to increase selling prices to offset decreases in demand will be limited by the effect of higher selling prices on our market share. Our efforts to address market share pressures through, among other things, the marketing of ASACOL 800 mg may prove ineffective.

 

   

We may lose exclusivity in the United States for the ASACOL 400 mg product as early as March 2010, when a 30-month stay of FDA approval for a generic version of that product developed by Roxane expires. See “Risks Related to Our Business—If generic products that compete with any of our branded pharmaceutical products are approved and sold, sales of our products will be adversely affected” and “Business—Legal Proceedings.”

These and other operational factors and risks could prove more difficult to manage than we have estimated, which could cause the benefits of the PGP Acquisition to be less than we had anticipated and could materially adversely affect our revenues and results of operations.

We have a substantial amount of indebtedness following the PGP Acquisition, which may adversely affect our cash flow and our ability to operate our business, remain in compliance with debt covenants and make payments on our indebtedness.

We have a significant amount of indebtedness. As of September 30, 2009, on a pro forma basis giving effect to the PGP Acquisition and the related financing thereof, we had total indebtedness of $2.98 billion.

Our substantial level of indebtedness increases the possibility that we may be unable to generate cash sufficient to pay, when due, the principal of, interest on or other amounts due in respect of our indebtedness. Our substantial indebtedness, combined with our leases and other financial obligations and contractual commitments, could have other important consequences. For example, it could:

 

  Ÿ  

make it more difficult for us and certain of our direct and indirect subsidiaries to satisfy our obligations with respect to our indebtedness and any failure to comply with the obligations of any of our debt instruments, including financial and other restrictive covenants, could result in an event of default under the agreements governing our indebtedness;

 

  Ÿ  

make us more vulnerable to adverse changes in general economic, industry and competitive conditions and adverse changes in government regulation;

 

  Ÿ  

require us or our subsidiaries to dedicate a substantial portion of our or their cash flow from operations to payments on our indebtedness, thereby reducing the availability of cash flows to fund working capital, capital expenditures, acquisitions and other general corporate purposes;

 

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  Ÿ  

limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate;

 

  Ÿ  

place us at a competitive disadvantage compared to our competitors that have less debt; and

 

  Ÿ  

limit our ability to borrow additional amounts for working capital, capital expenditures, acquisitions, debt service requirements, execution of our business strategy or other purposes.

Any of the above listed factors could materially adversely affect our business, financial condition and results of operations. Furthermore, our interest expense could increase if interest rates increase because debt under our senior secured credit facility bears interest at our option at adjusted LIBOR plus an applicable margin or ABR plus an applicable margin. If we do not have sufficient earnings to service our debt, we may be required to refinance all or part of our existing debt, sell assets, borrow more money or sell securities, none of which we can guarantee we will be able to do.

In addition, the agreements governing our indebtedness contain financial and other restrictive covenants that limit our subsidiaries’ ability to engage in activities that may be in our long-term best interests. A failure to comply with those covenants could result in an event of default which, if not cured or waived, could result in the acceleration of all our debt.

Risks Relating to the Offering

Future sales of our shares could depress the market price of our ordinary shares.

Sales of a substantial number of shares of our ordinary shares, in the public market or otherwise, following this offering, or the perception that such sales could occur, could adversely affect the market price of our ordinary shares. We currently have and upon completion of this offering will continue to have a total of approximately 251.5 million of our ordinary shares outstanding. Upon completion of this offering, 97.6 million of our outstanding ordinary shares will be freely tradable (or 100.6 million shares if the underwriters exercise the option to purchase additional shares in full), without restriction, in the public market, unless the shares are purchased by our affiliates, as that term is defined in Rule 144 of the Securities Act. All remaining shares were issued and sold by us in private transactions and are eligible for public sale if registered under the Securities Act or sold in accordance with Rule 144 thereunder, subject to volume and manner of sale limits in certain cases contractual restrictions in some cases. Bain Capital Partners, DLJ Merchant Banking, J.P. Morgan Partners (advised by CCMP Capital) and Thomas H. Lee Partners, L.P. (the “Sponsors”) have the right, subject to certain conditions, to cause us to register their shares following the consummation of this offering, and substantially all remaining shares that were issued in prior transactions have “piggyback” registration rights in respect of such registrations. In addition, our articles of association permit the issuance of up to approximately 248.5 million additional ordinary shares after this offering. Thus, we have the ability to issue substantial amounts of ordinary shares in the future, which would dilute the percentage ownership held by the investors who purchase our shares in this offering.

Except as disclosed in this prospectus supplement, we, our directors and executive officers and the selling shareholders have agreed with the underwriters not to sell, dispose of, or hedge any of our ordinary shares or securities convertible into or exchangeable for our ordinary shares, subject to specified exceptions, during the period from the date of this prospectus supplement continuing through the date that is 90 days after the date of this prospectus supplement. However, this agreement is subject to a number of exceptions that may result in sales prior to the expiration of the 90-day period. In addition, the underwriters may consent to the release of some or all of these shares that are subject to lock-up agreements for sale prior to the expiration of the applicable lock-up agreement. Immediately after the expiration of the 90-day lock-up period, these shares will be eligible for resale under Rule 144 or Rule 701 of the Securities Act, subject to volume limitations and applicable holding period requirements, or may be registered for sale pursuant to the registration rights described above. In

 

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particular, immediately following the expiration of the 90-day lock-up period, approximately 50.1 million shares will be eligible for resale by one of our Sponsors and certain of our institutional shareholders under Rule 144 without compliance with any volume or manner of sale limitations.

The market price of our ordinary shares may be volatile, which could cause the value of your investment to decline significantly.

Securities markets worldwide experience significant price and volume fluctuations in response to general economic and market conditions and their effect on various industries. This market volatility could cause the price of our ordinary shares to decline significantly and without regard to our operating performance. In addition, the market price of our ordinary shares could decline significantly if our future operating results fail to meet or exceed the expectations of public market analysts and investors.

Some specific factors that may have a significant effect on our ordinary shares’ market price include:

 

  Ÿ  

actual or expected fluctuations in our operating results;

 

  Ÿ  

actual or expected changes in our growth rates or our competitors’ growth rates;

 

  Ÿ  

conditions in our industry generally;

 

  Ÿ  

conditions in the financial markets in general or changes in general economic conditions;

 

  Ÿ  

our inability to raise additional capital;

 

  Ÿ  

changes in market prices for our products; and

 

  Ÿ  

changes in stock market analyst recommendations regarding our ordinary shares, other comparable companies or our industry generally.

Provisions of our articles of association could delay or prevent a takeover of us by a third party.

Our articles of association could delay, defer or prevent a third party from acquiring us, despite the possible benefit to our shareholders, or otherwise adversely affect the price of our ordinary shares. For example, our articles of association:

 

  Ÿ  

permit our board of directors to issue one or more series of preferred shares with rights and preferences designated by our board;

 

  Ÿ  

impose advance notice requirements for shareholder proposals and nominations of directors to be considered at shareholder meetings;

 

  Ÿ  

stagger the terms of our board of directors into three classes; and

 

  Ÿ  

require the approval of at a supermajority of the voting power of the shares of our share capital entitled to vote generally in the election of directors for shareholders to amend or repeal our articles of association.

These provisions may discourage potential takeover attempts, discourage bids for our ordinary shares at a premium over the market price or adversely affect the market price of, and the voting and other rights of the holders of, our ordinary shares. These provisions could also discourage proxy contests and make it more difficult for you and other shareholders to elect directors other than the candidates nominated by our board.

Because our Sponsors will continue to own a significant amount of our ordinary shares and, if they act collectively, would effectively control us after this offering, the influence of our public shareholders over significant corporate actions may be limited, and conflicts of interest between our Sponsors and us or you could arise in the future.

After giving effect to this offering, assuming that the underwriters’ option to purchase additional shares is not exercised, our Sponsors will collectively beneficially own 54.4% of our outstanding ordinary shares. As a result, if our Sponsors act collectively, they could exercise significant control over

 

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the composition of our board of directors and could effectively control the vote of our ordinary shares. If this were to occur, our Sponsors could have control over our decisions to enter into any corporate transaction and could have the ability to prevent any transaction that requires the approval of equityholders regardless of whether or not other equityholders believe that any such transactions are in their own best interests. For example, if our Sponsors act collectively, they effectively could cause us to make acquisitions that increase our indebtedness or sell revenue-generating assets. Additionally, our Sponsors are in the business of making investments in companies and may from time to time acquire and hold interests in businesses that compete directly or indirectly with us. Our Sponsors may also pursue acquisition opportunities that may be complementary to our business, and as a result, those acquisition opportunities may not be available to us. So long as our Sponsors continue to own a significant amount of our equity, even if such amount is less than 50%, and they exercise their shareholder rights collectively, they would continue to be able to significantly influence or effectively control our decisions.

We are incorporated in Ireland, and Irish law differs from the laws in effect in the United States and may afford less protection to shareholders.

Our shareholders may have more difficulty protecting their interests than would shareholders of a corporation incorporated in a jurisdiction of the United States. As an Irish company, we are governed by the Irish Companies Acts (the “Companies Act”). The Companies Act differs in some material respects from laws generally applicable to U.S. corporations and shareholders, including the provisions relating to interested directors, mergers, amalgamations and acquisitions, takeovers, shareholder lawsuits and indemnification of directors.

Under Irish law, the duties of directors and officers of a company are generally owed to the company only. Shareholders of Irish companies generally do not have rights to take action against directors or officers of the company, and may only do so in limited circumstances. Officers of an Irish company must, in exercising their powers and performing their duties, act in good faith and in the interests of the company as a whole and must exercise due care, skill and diligence. Directors have a duty not to put themselves in a position in which their duties to the company and their personal interests may conflict and also are under a duty to disclose any personal interest in any contract or arrangement with the company or any of its subsidiaries. If a director or officer of an Irish company is found to have breached his or her duties to that company, he or she may be held personally liable to the company in respect of that breach of duty. A director may be liable jointly and severally with other directors implicated in the same breach of duty.

We are an Irish company and it may be difficult for you to enforce judgments against us.

We are incorporated in Ireland and a substantial portion of our assets are or may be located in jurisdictions outside the United States. It may therefore be difficult for investors to effect service of process against us or to enforce against us judgments of U.S. courts predicated upon civil liability provisions of the U.S. federal securities laws.

There is no treaty between Ireland and the United States providing for the reciprocal enforcement of foreign judgments. The following requirements must be met before the foreign judgment will be deemed to be enforceable in Ireland:

 

  Ÿ  

The judgment must be for a definite sum;

 

  Ÿ  

The judgment must be final and conclusive; and

 

  Ÿ  

The judgment must be provided by a court of competent jurisdiction.

An Irish court will also exercise its right to refuse judgment if the foreign judgment was obtained by fraud, if the judgment violated Irish public policy, if the judgment is in breach of natural justice or if it is irreconcilable with an earlier judgment.

 

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CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This prospectus supplement and the financial statements and other documents incorporated by reference in this prospectus supplement contains forward-looking statements, including statements concerning our operations, our economic performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words “may,” “might,” “will,” “should,” “estimate,” “project,” “plan,” “anticipate,” “expect,” “intend,” “outlook,” “believe” and other similar expressions are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties.

The following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statements:

 

  Ÿ  

our substantial indebtedness;

 

  Ÿ  

competitive factors in the industry in which we operate (including the approval and introduction of generic or branded products that compete with our products);

 

  Ÿ  

our ability to protect our intellectual property;

 

  Ÿ  

a delay in qualifying our manufacturing facility to produce our products or production or regulatory problems with either third-party manufacturers upon whom we may rely for some of our products or our own manufacturing facilities;

 

  Ÿ  

pricing pressures from reimbursement policies of private managed care organizations and other third-party payors, government-sponsored health systems, the continued consolidation of the distribution network through which we sell our products, including wholesale drug distributors and the growth of large retail drug store chains;

 

  Ÿ  

the loss of key senior management or scientific staff;

 

  Ÿ  

adverse outcomes in our outstanding litigation or an increase in the number of litigation matters to which we are subject;

 

  Ÿ  

government regulation affecting the development, manufacture, marketing and sale of pharmaceutical products, including our ability and the ability of companies with which we do business to obtain necessary regulatory approvals;

 

  Ÿ  

our ability to manage the growth of our business by successfully identifying, developing, acquiring or licensing new products at favorable prices and marketing such new products;

 

  Ÿ  

our ability to obtain regulatory approval and customer acceptance of new products, and continued customer acceptance of our existing products;

 

  Ÿ  

changes in tax laws or interpretations that could increase our consolidated tax liabilities;

 

  Ÿ  

our ability to realize the anticipated opportunities from the PGP Acquisition (defined herein);

 

  Ÿ  

our potential obligations to satisfy a significant contractual obligation to Sanofi-Aventis US LLC after the closing of the PGP Acquisition; and

 

  Ÿ  

the other factors that are described under “Risk Factors” and in our periodic filings including our most recent annual report, our Current Report on Form 8-K filed on November 2, 2009, and other risks detailed from time-to-time in our public filings, financial statements and other investor communications.

 

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Our actual results or performance could differ materially from those expressed in, or implied by, any forward-looking statements relating to those matters. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do so, what impact they will have on our results of operations or financial condition. Except as required by law, we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.

 

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USE OF PROCEEDS

We will not receive any proceeds from the ordinary shares being sold by the selling shareholders.

 

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CAPITALIZATION

The following table sets forth the cash and cash equivalents and capitalization as of September 30, 2009 on an actual and pro forma basis to give effect to the Transactions. The information in this table should be read in conjunction with “Unaudited Pro Forma Condensed Combined Financial Information,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and other financial information, in each case, included elsewhere in this prospectus supplement.

 

     As of September 30, 2009  
     Actual    Pro Forma for the
Transactions
 
     ($ in millions)  

Cash and cash equivalents

   $ 753.7    $ 217.1   
               

Long-term debt, including current portion:

     

Senior secured credit facilities:

     

Revolving credit facility

   $ —      $ —     

Term A loan and Term B loan facilities

     —        2,600.0   

Delayed draw term loan facility(1)

     —        —     

Existing senior subordinated notes

     380.0      380.0   
               

Total debt

     380.0      2,980.0   

Shareholders’ equity

     1,893.6      1,884.3 (2) 
               

Total capitalization

   $ 2,273.6    $ 4,864.3   
               

 

(1) If the Sanofi Put is exercised, we may borrow up to $350.0 million under the delayed draw term loan facility. If the Sanofi Put is not exercised, the delayed draw term loan facility commitment will expire. See “Business—PGP Alliance with Sanofi.”
(2) Reduction reflects recognition of fees and expenses expected to be incurred in connection with the Transactions. See “Unaudited Pro Forma Condensed Combined Financial Information.”

 

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PRICE RANGE OF ORDINARY SHARES

Our ordinary shares are listed and traded on The NASDAQ Stock Exchange (“Nasdaq”) under the symbol “WCRX.” The following table sets forth, for the periods indicated, the high and low closing prices per share of the ordinary shares on Nasdaq.

 

     High    Low

2007

     

First quarter

   $ 15.38    $ 13.32

Second quarter

     18.95      14.73

Third quarter

     20.02      16.50

Fourth quarter

     19.55      16.50

2008

     

First quarter

   $ 18.07    $ 15.30

Second quarter

     18.46      16.26

Third quarter

     18.37      14.45

Fourth quarter

     15.72      10.81

2009

     

First quarter

   $ 14.85    $ 9.24

Second quarter

     13.64      9.64

Third quarter

     22.94      12.60

Fourth quarter (through November 12, 2009)

     24.45      20.66

On November 12, 2009, the last reported sale price of our ordinary shares on Nasdaq was $22.92 per share. As of November 10, 2009, there were approximately 174 holders of record of our ordinary shares.

 

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DIVIDEND POLICY

We have never paid cash dividends on our ordinary shares, and we intend to retain our future earnings, if any, to fund the growth of our business. We therefore do not anticipate paying any cash dividends on our ordinary shares in the foreseeable future. Our future decisions concerning the payment of dividends on our ordinary shares will depend upon our results of operations, financial condition and capital expenditure plans, as well as any other factors that the board of directors, in its sole discretion, may consider relevant.

 

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UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION

The following unaudited pro forma condensed combined financial information has been prepared to reflect estimated adjustments to the financial condition and results of operations of the Company to give effect to:

(i) The September 23, 2009 definitive asset purchase agreement (the “LEO Transaction Agreement”) with LEO Pharma A/S (“LEO”) pursuant to which LEO paid to the Company $1.0 billion in cash in order to terminate the Company’s exclusive license to distribute LEO’s DOVONEX and TACLONEX products (including all products in LEO’s development pipeline) in the United States and to acquire certain assets related to the Company’s distribution of DOVONEX and TACLONEX products in the United States (the “LEO Transaction”); the transaction was approved by the respective boards of directors of the Company and LEO, and closed simultaneously with the execution of the LEO Transaction Agreement; and

(ii) The acquisition from The Procter & Gamble Company (“P&G”) of P&G’s global branded pharmaceutical business (“PGP”) consummated on October 30, 2009 (the “PGP Acquisition”). The PGP Acquisition was funded through cash on hand and borrowings under the Company’s new senior secured credit facilities. At the closing of the PGP Acquisition on October 30, 2009, the Company borrowed $1.0 billion under a five-year Term A loan facility and $1.6 billion under a five-and-a-half-year Term B loan facility. See Note 5 below for a further description of the new senior secured credit facilities.

The unaudited pro forma condensed combined financial statements as of and for the nine months ended September 30, 2009 are based on our historical unaudited consolidated financial statements and the historical audited and unaudited combined financial statements of PGP. The unaudited pro forma condensed combined statement of operations for the year ended December 31, 2008 is based on our historical audited consolidated financial statements and the historical audited and unaudited combined financial statements of PGP. Our historical audited consolidated financial statements were filed with our Annual Report on Form 10-K for the year ended December 31, 2008, and our historical unaudited financial statements as of and for the nine months ended September 30, 2009 were filed with our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2009. The historical audited and unaudited combined financial statements of PGP were filed with our Current Report on Form 8-K filed on November 13, 2009 incorporated by reference herein. PGP’s audited combined financial statements are presented with the income statement for each financial year ending on June 30. Notes 7 and 8 below describe the method of calculating the statement of operations of PGP for the year ended December 31, 2008, and for the nine months ended September 30, 2009, respectively.

The unaudited pro forma condensed combined financial information should be read in conjunction with the accompanying notes and assumptions as well as the historical consolidated financial statements and related notes of Warner Chilcott and the historical combined financial statements and related notes of PGP. Now that the PGP Acquisition has been completed, we will conduct a review of PGP’s accounting policies in an effort to determine if differences in accounting policies require restatement or reclassification of PGP’s results of operations or financial position to conform to our accounting policies and classifications. As a result of a preliminary review, we have made certain reclassifications within these pro forma financial statements. In particular, we have reclassified royalty obligations related to the global collaboration agreement with Sanofi from other operating expense in PGP’s combined financial statements to selling expense in the pro forma condensed combined financial statements in the amount of $537.9 million for the year ended December 31, 2008 and $315.4 million for the nine months ended September 30, 2009. After further review, we may identify additional differences between the accounting policies of the two companies that, when conformed, could have a material impact on these pro forma condensed combined financial statements. During the preparation of these pro forma condensed combined financial statements, we were not aware of any further

 

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material differences other than those described above between the accounting policies of the two companies, and accordingly, these pro forma condensed combined financial statements do not assume any further material differences in accounting policies between the two companies.

The unaudited pro forma condensed combined statement of operations for the year ended December 31, 2008 and the nine months ended September 30, 2009 assumes that the LEO Transaction and the PGP Acquisition (and the related financing thereof) occurred on January 1, 2008. The unaudited pro forma condensed combined balance sheet as of September 30, 2009 assumes that the PGP Acquisition (and the related financing thereof) occurred on September 30, 2009 (the LEO Transaction is included in our historical balance sheet as of September 30, 2009). The unaudited pro forma condensed combined financial information has been prepared by management for illustrative purposes only and is not necessarily indicative of the condensed consolidated financial position or results of operations that would have been realized had the LEO Transaction or the PGP Acquisition occurred as of the dates indicated, nor is it meant to be indicative of any anticipated condensed consolidated financial position or future results of operations that the combined company will experience. The historical consolidated financial information has been adjusted in the accompanying unaudited pro forma condensed combined financial statements to give effect to pro forma events that are (1) directly attributable to the LEO Transaction and the PGP Acquisition, (2) factually supportable and (3) with respect to the unaudited pro forma condensed combined statements of operations, are expected to have a continuing impact on the combined results. Accordingly, the accompanying unaudited pro forma condensed combined statements of operations do not include any synergies that may be achievable subsequent to the LEO Transaction and the PGP Acquisition, or the impact of any one-time transaction costs.

PGP’s historical condensed combined financial statements have been “carved out” from P&G’s consolidated financial statements and reflect certain assumptions and allocations made by P&G. PGP’s historical condensed combined financial statements include all revenues, costs, assets and liabilities directly attributable to the PGP business. In addition, certain expenses reflected in the condensed combined financial statements include allocations of corporate expenses from P&G. As part of the PGP Acquisition, we entered into a transition services agreement, under which P&G will provide certain services to us that were previously provided when PGP was wholly-owned by P&G. The costs of the transition services agreement, in the aggregate, are expected to be consistent with the costs that P&G has historically allocated to PGP, and no additional adjustments are required with respect to costs to be incurred under the transition services agreement.

The PGP Acquisition has been accounted for as a business purchase combination using the acquisition method of accounting under the provisions of Accounting Standard Codification (“ASC”) No. 805, “Business Combinations”, (“ASC 805”), and applying the pro forma assumptions and adjustments described in the accompanying notes to the unaudited pro forma condensed combined financial information. The acquisition method of accounting uses the fair value concepts defined in ASC 820, “Fair Value Measurements and Disclosures.” ASC 805 requires, among other things, that most assets acquired and liabilities assumed in a business purchase combination be recognized at their fair values as of the PGP Acquisition date and that the fair value of acquired in-process research and development (“IPR&D”) be recorded on the balance sheet regardless of the likelihood of success of the related product or technology as of the completion of the PGP Acquisition. The process for estimating the fair values of IPR&D, identifiable intangible assets and certain tangible assets requires the use of significant estimates and assumptions, including estimating future cash flows, developing appropriate discount rates, estimating the costs, timing and probability of success to complete in-process projects and projecting regulatory approvals. Under ASC 805, transaction costs are not included as a component of consideration transferred and will be expensed as incurred. The excess of the purchase price (consideration transferred), if any, over the estimated amounts of identifiable assets and liabilities of PGP as of the effective date of the acquisition will be allocated to goodwill in accordance with ASC 805. The purchase price allocation is subject to completion of our analysis of the

 

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fair value of the assets and liabilities of PGP as of the effective date of the PGP Acquisition. Accordingly, the purchase price allocation in the unaudited pro forma condensed combined financial statements is preliminary and will be adjusted upon completion of the final valuation. These adjustments could be material. The final valuation is expected to be completed as soon as practicable but no later than one year from the consummation of the acquisition on October 30, 2009. The establishment of the fair value of the consideration for the acquisition, and the allocation to identifiable tangible and intangible assets and liabilities requires the extensive use of accounting estimates and management judgment. We believe the fair values assigned to the assets to be acquired and liabilities to be assumed are based on reasonable estimates and assumptions based on data currently available.

If the fair value of an asset or liability that arises from a contingency can be determined, the asset or liability would be recognized in accordance with ASC 450, “Accounting for Contingencies” (“ASC 405”). If the fair value is not determinable and the ASC 450 criteria are not met, no asset or liability is recognized.

 

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Unaudited pro forma condensed combined statement of operations

for the year ended December 31, 2008

 

    Year Ended December 31, 2008  
    WC     Adjustments
for the LEO
Transaction(1)
    WC post
LEO
Transaction
    PGP(7)   Pro forma
adjustments
    Pro
forma
 
    ($ in millions)  

Revenue

           

Net sales

  $ 919.0      $ (276.7   $ 642.3      $ 2,454.0   $ (39.1 )(2)    $ 3,057.2   

Other revenue

    19.1        —          19.1        —       —          19.1   
                                             

Total revenue

    938.1        (276.7     661.4        2,454.0     (39.1     3,076.3   

Costs, Expenses and Other

           

Cost of sales (excluding amortization and impairment of intangible assets)

    198.8        (101.2     97.6        263.6     —          361.2   

Selling, general and administrative

    192.7        (11.1     181.6        1,190.5     —          1,372.1   

Research and development

    50.0        (0.3     49.7        231.8     —          281.5   

Amortization of intangible assets

    223.9        (19.6     204.3        24.8     468.1 (4)      697.2   

Impairment of intangible assets

    163.3        —          163.3        2.8     —          166.1   

Interest (income)

    (1.3     —          (1.3     —       —          (1.3

Interest expense

    94.4        (58.5     35.9        —       180.3 (5)      216.2   
                                             

Income / (loss) before taxes

    16.3        (86.0     (69.7     740.5     (687.5     (16.7

Provision / (benefit) for income taxes

    24.7        (1.0     23.7        242.4     (189.7 )(6)      76.4   
                                             

Net (loss) / income

  $ (8.4   $ (85.0   $ (93.4   $ 498.1   $ (497.8   $ (93.1
                                             

Earnings / (loss) per share:

           

Basic

  $ (0.03     $ (0.37       $ (0.37

Diluted

    (0.03       (0.37         (0.37

 

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Unaudited pro forma condensed combined statement of operations

for the nine months ended September 30, 2009

 

    Nine Months Ended September 30, 2009  
    WC     Adjustments
for the LEO
Transaction(1)
    WC post
LEO
Transaction
    PGP(8)     Pro forma
adjustments
    Pro
forma
 
    ($ in millions)  

Revenue

           

Net sales

  $ 732.6      $ (187.8   $ 544.8      $ 1,686.3      $ (26.0 )(2)    $ 2,205.1   

Other revenue

    17.0        —          17.0        —          —          17.0   
                                               

Total revenue

    749.6        (187.8     561.8        1,686.3        (26.0     2,222.1   

Costs, Expenses and Other

           

Cost of sales (excluding amortization and impairment of intangible assets)

    140.1        (69.8     70.3        167.8        —          238.1   

Selling, general and administrative

    158.9        (7.4     151.5        735.6        (17.7 )(3)      869.4   

(Gain) on sale of assets

    (393.1     393.1        —          (193.5     193.5 (2)      —     

Research and development

    47.4        (0.2     47.2        121.7        —          168.9   

Amortization of intangible assets

    171.0        (16.1     154.9        18.4        298.4 (4)      471.7   

Impairment of intangible assets

    —          —          —          1.8        —          1.8   

Interest (income)

    (0.1     —          (0.1     —          —          (0.1

Interest expense

    57.3        (31.1     26.2        —          127.9 (5)      154.1   
                                               

Income / (loss) before taxes

    568.1        (456.3     111.8        834.4        (628.1     318.1   

Provision / (benefit) for income taxes

    44.5        (16.4     28.1        283.2        (232.8 )(6)      78.5   
                                               

Net income / (loss)

  $ 523.6      $ (439.9   $ 83.7      $ 551.2      $ (395.3   $ 239.6   
                                               

Earnings per share:

           

Basic

  $ 2.09        $ 0.33          $ 0.96   

Diluted

    2.09          0.33            0.96   

 

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Notes to unaudited pro forma condensed combined statement of operations

 

(1) Reflects adjustment to give effect to the operations of the LEO Transaction. The Company used approximately $481.8 million of the proceeds from the LEO Transaction to repay the entire remaining principle balance of the loans outstanding under it prior senior secured credit facilities of $479.8 million, as well as accrued and unpaid interest and fees of $2.0 million. This repayment resulted in the termination of the prior senior secured credit facilities.
(2) Reflects the exclusion of royalty income and the gain on sale of an asset associated with the Ajinomoto license agreement that was excluded from the PGP Acquisition.
(3) Reflects the elimination of advisory, legal and regulatory costs that were directly attributable to the PGP Acquisition but that are not expected to have a continuing impact on the combined entity’s results.
(4) Reflects the adjustment to historical intangible amortization expense previously recorded by PGP to reflect the new fair value of intangible assets acquired as part of the PGP Acquisition calculated as follows:

 

                Amortization  
     Weighted Average
Useful Life
   Estimated
Fair Value
    Year Ended
December 31,
2008
    Nine Months
Ended
September 30,
2009
 
                ($ in millions)  

Brand Intellectual Property (“IP”)

   Eight years    $ 2,615.2      $ 492.9      $ 316.8   

IPR&D

   Indefinite      308.6        —          —     
                           

Total brand IP

      $ 2,923.8      $ 492.9      $ 316.8   
                           

Removal of PGP historical intangible assets amortization

      $ (208.0   $ (24.8   $ (18.4
                           

Total adjustment

      $ 2,715.8      $ 468.1      $ 298.4   
                           

 

(5) Reflects the inclusion of interest expense related to the new debt issued in connection with the PGP Acquisition. The proceeds from the LEO Transaction were used to repay the prior senior secured credit facilities, and the related interest expense was adjusted as part of the LEO Transaction adjustments within the pro forma condensed combined statement of operations. Pro forma adjusted interest expense was calculated as follows:

 

     Year Ended
December 31, 2008
   Nine Months
Ended
September 30, 2009
     ($ in millions)

New debt issued:

     

Revolver commitment fee(a)

   $ 1.9    $ 1.4

Term A loan facility(b)

     52.9      35.1

Term B loan facility(c)

     91.7      68.1

Delayed draw term loan(d)

     3.0      —  

Amortization of debt issue costs and other(e)

     30.8      23.3
             

Total adjustment

   $ 180.3    $ 127.9
             

Interest on existing notes(f)

     35.9      26.2
             

Pro forma adjusted interest expense(g)

   $ 216.2    $ 154.1
             
 
  (a) Reflects a commitment fee of 75 basis points applied to the fully undrawn revolver of $250.0 million. If drawn, interest rates would be consistent with the Term B loan.
  (b) Reflects interest expense on the variable rate senior secured Term A loan at a rate of 5.50%. Borrowings under the senior secured credit facilities generally bear interest based on a margin over, at our option, the base rate or the reserve-adjusted LIBOR (with a LIBOR floor of 2.25%). At November 12, 2009, LIBOR was below the floor set at 2.25%. As a result, 2.25% plus 325 basis points (the fixed portion of the interest rate) is used for the calculation of interest expense on this facility. Pro forma interest expense assumes scheduled principal payments as specified in the new senior secured credit facilities agreement, as if the debt were issued on January 1, 2008. See (g) below for sensitivity of a 0.125% change in the interest rate on variable rate debt.
  (c)

Reflects interest expense on the variable rate senior secured Term B loan at a rate of 5.75%. Borrowings under the senior secured credit facilities generally bear interest based on a margin over, at our option, the base rate or the reserve-adjusted LIBOR (with a LIBOR floor of 2.25%). At November 12, 2009, LIBOR was below the floor set at 2.25%. As a result, 2.25% plus 350 basis points

 

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(the fixed portion of the interest rate) is used for the calculation of interest expense on this facility. Pro forma interest expense assumes scheduled principal payments as specified in the new senior secured credit facilities agreement, as if the debt were issued on January 1, 2008. See (g) below for sensitivity of a 0.125% change in the interest rate on variable rate debt.

  (d) The Term B loan has a delayed draw term loan facility of $350 million. We did not draw down on the facility at closing. However, there is a commitment fee of 175 basis points for 180 days after the closing of the PGP Acquisition, at which point the facility terminates if the facility has not been borrowed at such time.
  (e) Reflects debt amortization expense related to the new debt structure of the combined entity, based on $147.4 million in financing fees incurred, which will be amortized over the weighted average life of the debt of 5.1 years.
  (f) Reflects interest expense and debt amortization expense related to the existing senior subordinated notes, with a fixed interest rate of 8.75%.
  (g) If the variable interest rate was to increase or decrease by 0.125% from the rates assumed, pro forma interest expense would change by approximately $3.2 million for the fiscal year ended December 31, 2008 and $2.4 million for the nine months ended September 30, 2009.
(6) For purposes of determining the estimated income tax expense for PGP and pro forma adjustments reflected in the unaudited pro forma condensed combined statement of operations, an estimated weighted average statutory tax rate has been applied, based upon the various jurisdictions of the pro forma combined company where pre-tax profits and adjustments are reasonably expected to occur. The effective tax rate of the combined company could be significantly different (either higher or lower) depending on post-acquisition activities, including repatriation decisions, cash needs and the geographical mix of income.
(7) The fiscal year for PGP, as reflected in its audited financial statements, ends on June 30, and adjustments were required to present the combined statement of operations for the year ended December 31, 2008. To this end, unaudited interim financial information of PGP was prepared for the six months ended December 31, 2007 and 2008. The table below shows the method of calculation, including pro forma reclassifications.

 

    Year Ended
June 30, 2008
  Less: Six
Months Ended
December 2007
  Plus: Six
Months Ended
December 2008
  Year
Ended
December 31, 2008

Revenue

    ($ in millions)

Total revenue

  $ 2,531.7   $ 1,286.6   $ 1,208.9   $ 2,454.0

Costs, expenses and other

       

Cost of sales (excluding amortization and impairment of intangible assets)

    273.8     141.5     131.3     263.6

Selling, general and administrative

    1,283.6     656.6     563.5     1,190.5

Research and development

    266.2     123.4     89.0     231.8

Amortization of intangible assets

    25.1     12.4     12.1     24.8

Impairment of intangible assets

    2.8     —       —       2.8

Interest (income)

    —       —       —       —  

Interest expense

    —       —       —       —  
                       

Income before taxes

    680.2     352.7     413.0     740.5

Provision for income taxes

    210.8     109.3     140.9     242.4
                       

Net income

  $ 469.4   $ 243.4   $ 272.1   $ 498.1
                       

Certain reclassifications have been made between the six months ended December 31, 2007 and 2008 financial information of PGP and the pro forma condensed combined financial statements. These reclassifications are outlined as follows:

Gross profit per the condensed combined financial statements of PGP amounted to $1,092.1 million and $1,156.3 million for the six months ended December 31, 2008 and 2007, respectively. A reclassification of royalty expense related to ASACOL has been made from Other operating expense, as per the financial information of PGP, to cost of sales for the unaudited pro forma condensed combined financial information, in the amount of $14.5 million and $11.2 million for the six months ended December 31, 2008 and 2007, respectively.

Other operating expense per the condensed combined financial statements of PGP amounted to $238.1 million and $313.6 million for the six months ended December 31, 2008 and 2007, respectively. These costs have been reclassified in their entirety to Selling, general and administrative expenses for the unaudited pro forma condensed combined financial information.

 

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Selling, general and administrative expenses per the financial information of PGP amounted to $441.0 million and $490.0 million for the six months ended December 31, 2008 and 2007, respectively. Research and development costs in the amount of $89.0 million and $123.4 million for the six months ended December 31, 2008 and 2007, respectively, have been reclassified from Selling, general and administrative expenses and included as a separate line. Amortization of intangibles in the amount of $12.1 million and $12.4 million for the six months ended December 31, 2008 and 2007, respectively, have been reclassified from Selling, general and administrative expenses and included as a separate line.

(8) The fiscal year for PGP, as reflected in its audited financial statements, ends on June 30, and adjustments were required to present the combined statement of operations for the nine months ended September 30, 2009. To this end, unaudited interim financial information of PGP was prepared for the three months ended September 30, 2008 and 2009, incorporated by reference herein, and for the six months ended December 31, 2008. The table below shows the method of calculation, including pro forma reclassifications.

 

    Year Ended
June 30, 2009
  Less: Six
Months Ended
December 2008
  Plus: Three
Months Ended
September 2009
    Nine
Months Ended
September 30, 2009
 

Revenue

    ($ in millions)   

Total revenue

  $ 2,317.5   $ 1,208.9   $ 577.7      $ 1,686.3   

Costs, expenses and other

       

Cost of sales (excluding amortization and impairment of intangible assets)

    247.8     131.3     51.3        167.8   

Selling, general and administrative

    1,044.5     563.5     254.6        735.6   

(Gain) on sale of assets

    —       —       (193.5     (193.5

Research and development

    180.5     89.0     30.3        121.7   

Amortization of intangible assets

    24.4     12.1     6.1        18.4   

Impairment of intangible assets

    1.8     —       —          1.8   

Interest (income)

    —       —       —          —     

Interest expense

    —       —       —          —     
                           

Income before taxes

    818.5     413.0     428.9        834.4   

Provision for income taxes

    279.2     140.9     144.9        283.2   
                           

Net income

  $ 539.3   $ 272.1   $ 284.0      $ 551.2   
                           

Certain reclassifications have been made between the condensed combined financial statements of PGP for the three months ended September 30, 2009 and the pro forma condensed combined financial statements. These reclassifications are outlined as follows:

Gross profit per the condensed combined financial statements of PGP amounted to $532.8 million. A reclassification of royalty expense related to ASACOL has been made from Other operating expenses as per the financial information of PGP, to cost of sales for the unaudited pro forma condensed combined financial information, in the amount of $6.4 million.

Other operating expense per the condensed combined financial statements of PGP amounted to $131.3 million. These costs have been reclassified in their entirety to Selling, general and administrative expenses for the unaudited pro forma condensed combined financial information.

Selling, general and administrative expenses per the condensed combined financial statements of PGP amounted to $166.1 million. Research and development expenses in the amount of $30.3 million have been reclassified from Selling, general and administrative expenses and included as a separate line. Amortization of intangibles in the amount of $6.1 million has been reclassified from Selling, general and administrative expenses and included as a separate line.

 

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Unaudited pro forma condensed combined balance sheet as of September 30, 2009

 

     As of September 30, 2009
    WC   Historical
PGP
  Adjustments     Pro Forma
         ($ in millions)

Assets

       

Current assets:

          

Cash and cash equivalents

  $ 753.7   $ 4.4   $ (541.0 )(9)    $ 217.1

Accounts receivable, net

    110.7     260.5     —          371.2

Inventories, net

    68.8     74.2     77.9 (10a)      220.9

Prepaid expenses and other current assets

    85.9     104.2     (59.8 )(11)      130.3
                            

Total current assets

    1,019.1     443.3     (522.9     939.5

Property, plant and equipment, net

    87.3     75.1     —          162.4

Intangible assets, net

    611.4     208.0     2,715.8 (10c)      3,535.2

Goodwill

    998.7     156.7     (156.7 )(10)      998.7

Other non-current assets

    9.7     66.0     94.3 (12)      170.0
                            

Total assets

  $ 2,726.2   $ 949.1   $ 2,130.5      $ 5,805.8
                            

Liabilities and Stockholders Equity

          

Current liabilities:

          

Accounts payable

  $ 144.6   $ 54.4   $ —        $ 199.0

Accrued expenses and other current liabilities

    204.3     429.6     (28.6 )(10d)      605.3

Income taxes payable

    7.3     —       —          7.3

Current portion of long-term debt

    —       —       116.0 (13)      116.0
                            

Total current liabilities

    356.2     484.0     87.4        927.6

Long-term debt, excluding current portion

    380.0     —       2,484.0 (13)      2,864.0

Other non-current liabilities

    96.4     145.0     (111.5 )(10e)      129.9
                            

Total liabilities

    832.6     629.0     2,459.9        3,921.5

Stockholders’ equity

    1,893.6     320.1     (329.4 )(14)      1,884.3
                            

Total liabilities and stockholders’ equity

  $ 2,726.2   $ 949.1   $ 2,130.5      $ 5,805.8
                            

 

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Notes to unaudited pro forma condensed combined balance sheet as of September 30, 2009

 

(9) Reflects the net effect to cash resulting from the following:

 

Issuance of debt:

  

Face value (see note 13)

   $ 2,600.0   

Fees and discount (see note 9a)

     (147.4
        
     2,452.8   

PGP Acquisition:

  

Purchase price (see note 10)

     (3,100.0

Adjustments (see note 9b)

     115.7   

Fees (see note 9c)

     (9.3
        
     (2,993.6
        

Net change

   $ (541.0
        

 

  (a) Reflects financing fees associated with the new debt structure.
  (b) Reflects our estimate of adjustments to the purchase price for PGP in respect of certain liabilities to be funded by PGP.
  (c) Reflects estimated fees and expenses incurred in connection with the PGP Acquisition, including the advisory fees, other transaction costs and professional fees. Total estimated fees incurred amounted to $27.0 million, $17.7 million of which was incurred and is reflected within our September 30, 2009 historical financial statements.
(10) Reflects adjustments to record assets acquired and liabilities assumed at their estimated fair values, as of September 30, 2009. Estimated values have been based on a preliminary purchase price of $2,984.3 million. Allocation of the purchase price was based on currently available information and could change materially upon receipt of more detailed information. The preliminary purchase price allocation is as follows:

 

Calculation of consideration:

  

Purchase price

   $ 3,100.0   

Adjustments

     (115.7
        

Total consideration

   $ 2,984.3   
        

Preliminary allocation of consideration:

  

Historical book value of net assets

     320.1   

Eliminate historical goodwill

     (156.7

Eliminate historical intangible assets

     (208.0

Inventory(10a)

     77.9   

Deferred tax assets(10b)

     (112.9

Intangible assets(10c)

     2,923.8   

Accrued expenses and other current liabilities(10d)

     28.6   

Other noncurrent liabilities(10e)

     111.5   
        
   $ 2,984.3   
        

 

     Total pro forma consideration in the table above differs from the actual purchase price consideration of $2,919.3 million paid on the closing date (October 30, 2009) due to the additional month between the pro forma acquisition date (September 30, 2009) and actual acquisition date, resulting in a differing amount of purchase price adjustments.

 

  (a) At the time of the acquisition, inventories are required to be measured at fair value, which we believe will approximate net realizable value. In general, the fair valuation of inventories will result in an increase over book value to market value. We have estimated the fair value adjustment to inventories using information about the inventory of major products (principally ACTONEL and ASACOL) and utilizing assumptions (including profit margins and turnover ratios) to establish a net realizable value. The impact of the adjustment is not reflected in the unaudited pro forma condensed combined statement of operations because the adjustment will not have a continuing impact. However, the inventory adjustment will result in an increase in materials and production costs in periods subsequent to the completion of the acquisition when related inventories are sold.

 

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  (b) Reflects the elimination of net deferred tax assets, valued at zero under purchase accounting, driven by Section 338(h)(10)/338(g) elections made regarding the portion of the PGP Acquisition structured as stock transactions. This estimate is preliminary and is subject to change based on our final determination of the fair value of assets acquired and liabilities assumed. See also Notes (11) and (12) below.
  (c) Of the total estimated consideration of $2,984.3 million, approximately $2,923.8 million has been allocated to identified intangible assets, of which $2,615.2 million represents currently marketed products that are expected to be amortized over a weighted average useful life on an accelerated basis of approximately 8 years, and approximately $308.6 million has been allocated to identified IPR&D intangible products. Pro forma intangible assets on the face of the balance sheet of $3,535.2 million is comprised of WC post LEO Transaction intangible assets of $611.4 million and the intangible assets on acquisition of $2,923.8 million.

The IPR&D will be capitalized and accounted for as an indefinite-lived intangible asset and will be subject to impairment testing until the completion or abandonment of the project. Upon successful completion and launch of each project, we will make a separate determination of useful life of the IPR&D intangible, and subsequent amortization will be recorded as an expense. As the IPR&D intangibles are not currently marketed, no amortization of these items is reflected in the unaudited pro forma condensed combined statements of operations.

The fair value of identifiable intangible assets is determined primarily using the “income approach,” which is a valuation technique that provides an estimate of the fair value of an asset based on market participant expectations of the cash flows an asset would generate over its remaining useful life. Some of the significant assumptions inherent in the development of the identifiable intangible asset valuations, from the perspective of a market participant, include the estimated net cash flows for each year for each project or product (including net revenues cost of sales, research and development costs, selling and marketing costs and working capital/asset contributory asset charges), the appropriate discount rate to select in order to measure the risk inherent in each future cash flow stream, the assessment of each asset’s life cycle, competitive trends impacting the asset and each cash flow stream and other factors. The major risks and uncertainties associated with the timely and successful completion of the IPR&D projects include legal risk and regulatory risk. The underlying assumptions used to prepare the discounted cash flow analysis may change or projects may not be completed to commercial success on time or at all. For these and other reasons, actual results may vary significantly from estimated results.

 

  (d) Reflects the exclusion of (i) the write-off of $8.8 million of the current portion of historical deferred revenue and (ii) $14.8 million and $5.0 million for restructuring and bonus accruals, respectively, which will not be transferred as part of the PGP Acquisition.
  (e) Reflects (i) the write-off of $45.9 million of historical non-current deferred revenue, (ii) an adjustment of $67.3 million to reduce pension and post-employment obligations to their fair value of zero, reflecting their fully funded status upon transfer in accordance with the purchase agreement governing the PGP Acquisition, and net of (iii) $1.7 million recognized by PGP for a UK pension liability, for which PGP provided an equal amount of cash.
(11) Reflects the elimination of the current portion of deferred tax assets consistent with Note (10)(b) above of $59.8 million.
(12) Reflects (i) the recognition of the of deferred financing costs on the issuance of new debt of $147.4 million, net of (ii) the elimination of $53.1 million of long term deferred tax assets, consistent with Note 10(b) above.
(13) Reflects the issuance of $2.6 billion of new debt under the new senior secured credit facilities.
(14) Reflects the elimination of PGP’s historical equity accounts upon the PGP Acquisition and the recognition of $9.3 million in additional transaction fees related to the PGP Acquisition.

 

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

The following discussion and analysis of our results of operations and financial condition covers periods prior to the consummation of the PGP Acquisition. Accordingly, the discussion and analysis of historical periods for Warner Chilcott do not reflect the significant impact that the Transactions and the LEO Transaction, each as defined herein, will have on us. This discussion and analysis contains forward-looking statements, which involve risks and uncertainties. Our actual results may differ materially from those we currently anticipate as a result of many factors, including the factors we describe under “Risk Factors” and elsewhere in this prospectus supplement.

Overview

We are a leading global specialty pharmaceutical company currently focused on the gastroenterology, women’s healthcare, dermatology and urology segments of the U.S. and Western European pharmaceuticals markets. We are a fully integrated company with internal resources dedicated to the development, manufacture and promotion of our products. Prior to the PGP Acquisition, our broad portfolio of established branded products included oral contraceptives (LOESTRIN 24 FE and FEMCON FE), hormone therapies (ESTRACE Cream, FEMHRT and others) and an oral anti-infective for acne (DORYX).

On October 30, 2009, we acquired the global branded pharmaceuticals business of The Procter & Gamble Company (“PGP”) for approximately $2.9 billion in cash and the assumption of certain liabilities (the “PGP Acquisition”). The purchase price remains subject to certain post-closing purchase price adjustments. Under the terms of the purchase agreement, we acquired PGP’s portfolio of branded pharmaceutical products, PGP’s prescription drug pipeline and its manufacturing facilities in Puerto Rico and Germany. PGP’s principal products are ACTONEL for osteoporosis and ASACOL for ulcerative colitis (“UC”). PGP also has co-promotion rights to ENABLEX for the treatment of overactive bladder.

In order to fund the PGP Acquisition, certain of our subsidiaries entered into new senior secured credit facilities, comprised of $2.95 billion in aggregate term loan facilities (which includes a $350.0 million delayed draw term loan facility) and a $250.0 million revolving credit facility. At closing, $2.6 billion was borrowed under the term loan facilities and no borrowings were made under the delayed draw term loan facility or the revolving credit facility. We refer to the PGP Acquisition and the entry into the senior secured credit facilities as the “Transactions.”

On September 23, 2009, we agreed to terminate our exclusive product licensing rights from LEO Pharma A/S (“LEO”) in the United States to TACLONEX, TACLONEX SCALP, DOVONEX and all other products in LEO’s development pipeline, and sold the related assets to LEO, for $1.0 billion in cash (the “LEO Transaction”). In connection with the LEO Transaction, we entered into a distribution agreement with LEO under which we agreed to continue to distribute DOVONEX and TACLONEX on behalf of LEO, in exchange for a distribution fee, through December 31, 2009. The LEO Transaction resulted in a gain for us for the quarter ended September 30, 2009 of $380.1 million, net of tax. The aggregate gain from the LEO Transaction is expected to be $447.6 million, net of tax. However, approximately $68.9 million of the gain relating to certain inventories is expected to be recognized as part of pre-tax income during the distribution agreement period. These gains, or the relevant portion thereof, are excluded from the pro forma figures presented in the following paragraph. We believe the LEO Transaction will allow us to concentrate on the acquisition and integration of PGP.

For the year ended December 31, 2008 and the nine-month period ended September 30, 2009, on a pro forma basis giving effect to the PGP Acquisition (and the related financing thereof) and the LEO Transaction, we would have generated revenues of $3,076.3 million and $2,222.1 million and a net (loss) / income of $(93.1 million) and $239.6 million, respectively.

 

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Factors Affecting our Results of Operations

Revenue

We generate two types of revenue: revenue from product sales (including contract manufacturing) and other revenue which currently includes royalty revenue.

As a result of the PGP Acquisition we expect to generate substantial additional revenues in the United States, Western Europe, Canada and other countries mainly from the sale of ACTONEL and ASACOL. PGP’s revenues, similar to ours, consist of revenue from product sales and royalties from third parties. Revenue from collaborative products with third parties are recognized on a gross basis as product sales in cases where PGP is the principal in the transaction. Revenue from collaborative products based on the collaborative partners’ net sales are recognized on a net basis.

Net Sales

We promote a portfolio of branded prescription pharmaceutical products currently focused on the gastroenterology, women’s healthcare, dermatology and urology segments of the U.S. and Western European pharmaceuticals markets. To generate demand for our products, our sales representatives make face-to-face promotional and educational presentations to physicians who are potential prescribers of our products to their patients. By informing these physicians of the attributes of our products, we generate demand for our products with physicians, who then write prescriptions for their patients, who in turn go to the pharmacy where the prescription is filled. Pharmacies buy our products either through wholesale pharmaceutical distributors or directly from us (for example, retail drug store chains). We recognize revenue when title passes to our customers, generally free on board (“FOB”), destination, net of sales-related deductions, although PGP recognizes revenue from the point of shipping.

When our unit sales to customers in any period exceeds consumer demand (as measured by filled prescriptions in units), our sales in excess of demand must be absorbed before our customers begin to order again. We refer to the estimated amount of inventory held by our customers and pharmacies that purchase our product from our direct customers, generally measured in the number of days of demand on hand, as “pipeline inventory.” Pipeline inventories expand and contract in the normal course of business. When comparing reported product sales between periods, it is important to consider whether estimated pipeline inventories increased or decreased during each period.

Historically, we generated our revenue primarily from the sale of branded pharmaceutical products in the United States, including our oral contraceptives (LOESTRIN 24 FE, FEMCON FE, ESTROSTEP FE, and OVCON), our HT products (primarily ESTRACE Cream, FEMHRT, and FEMRING), our oral antibiotic for the adjunctive treatment of severe acne (DORYX), our psoriasis products prior to the LEO Transaction (TACLONEX and DOVONEX) and our treatment for pre-menstrual dysphoric disorder (“PMDD”) (SARAFEM). Our revenue from sales of these products consists primarily of sales invoiced less returns and other sales-related deductions. In addition to the products listed above, we earn revenues from the sale of generic products, including TILIA™ FE (a generic version of ESTROSTEP FE) and ZENCHENT (a generic version of OVCON 35) under profit-sharing supply and distribution agreements with Watson. Prior to the LEO Transaction, we also recognized revenue on a generic version of DOVONEX Solution under a profit-sharing supply and distribution agreement with Hi-Tech. The revenue we earn under these agreements is included with our related branded product revenue for financial reporting purposes.

Included in net sales are amounts earned under contract manufacturing agreements. These activities are by-products of our May 2004 acquisition of the Fajardo, Puerto Rico manufacturing facility

 

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from a subsidiary of Pfizer Inc. (“Pfizer”) and the March 2004 sale of rights to two LOESTRIN products to a unit of Teva Pharmaceutical Industries Ltd. (“Teva”) (then Barr Pharmaceuticals, Inc. (“Barr”)). In connection with these transactions, we agreed to manufacture certain products for Pfizer and Teva for specified periods. Contract manufacturing is not an area of strategic focus for us as these contracts produce profit margins significantly below the margins realized on sales of our branded products. We have phased out the manufacturing of all but one of the Pfizer products (the supply agreement for the production of Dilantin® was extended for three years effective July 31, 2006, subject to two one-year renewals at Pfizer’s option, the first of which renewal options has been exercised). We continue to manufacture Dilantin® for Teva.

PGP generates net sales primarily from the sale of ACTONEL, which accounted for $1.4 billion of PGP’s net sales of $2.3 billion in the year ended June 30, 2009 (of which between $500 and $550 million represented sales outside of North America), and ASACOL, which accounted for $679.0 million of PGP’s net sales in the year ended June 30, 2009. For the year ended June 30, 2009, approximately 69% of PGP’s net sales were in North America, and approximately 31% of its revenues were outside of North America, primarily in Western Europe.

Changes in revenue from sales of our products from period to period are affected by factors that include the following:

 

  Ÿ  

changes in the level of competition faced by our products, including the launch of new products by competitors and the introduction of generic equivalent products;

 

  Ÿ  

changes in the level of promotional or marketing support for our products and the size of our sales force;

 

  Ÿ  

expansion or contraction of the levels of pipeline inventories of our products held by our customers;

 

  Ÿ  

changes in the regulatory environment;

 

  Ÿ  

our ability to successfully develop or acquire and launch new proprietary products;

 

  Ÿ  

changes in the level of demand for our products, including changes based on general economic conditions in the U.S. and other major Western European economies;

 

  Ÿ  

long-term growth of our core therapeutic markets, currently gastroenterology, women’s healthcare, dermatology and urology;

 

  Ÿ  

price increases, which are common in the branded pharmaceutical industry and for the purposes of our period-over-period comparisons, reflect the average gross selling price billed to our customers before any sales-related deductions; and

 

  Ÿ  

changes in the levels of sales related deductions.

Following the PGP Acquisition, changes in our revenue will also be affected by these factors as they relate to PGP, its principal products and its additional therapeutic markets of gastroenterology and urology. Changes in PGP’s revenues may differ between its North American and Western European markets, including as a result of the following factors:

 

  Ÿ  

the loss of exclusivity for ACTONEL in PGP’s major Western European markets beginning in 2010;

 

  Ÿ  

market share pressures on ACTONEL in the United States, mainly due to aggressive managed care initiatives implemented to favor generic versions of once-a-week FOSAMAX and market share gains by once-a-month Boniva, and our success in mitigating the loss of market share through the marketing of once-a-month ACTONEL 150 mg and the development of next generation once-a-week ACTONEL product;

 

  Ÿ  

the lack of patent protection for ASACOL in the United Kingdom and the effect of market share pressures from generic competitors in the Western European market; and

 

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  Ÿ  

the erosion of market share for ASACOL in the United States since 2007 due to competition, and our success in mitigating market share pressures through, among other things, the marketing of ASACOL HD (800 mg).

Other Revenue

Beginning in the fourth quarter of 2006, we began to generate revenue related to licensing rights to sell products using our patents to third parties as a component of other revenue.

Cost of Sales (excluding Amortization and Impairment of Intangible Assets)

We currently contract with third parties to manufacture certain of our products, although we now manufacture most of our women’s healthcare oral dose products in our facility in Fajardo, Puerto Rico. We also have supply contracts with our third-party development partners, such as LEO (DOVONEX and TACLONEX) (prior to the LEO Transaction), Contract Pharmaceuticals Limited (“CPL”) (ESTRACE Cream) and Mayne (DORYX). Our supply agreements with these third-party manufacturers and development partners may include minimum purchase requirements and may provide that the price we pay for the products we sell can be increased based on factors outside of our control such as inflation, increases in costs or other factors.

For products that we manufacture and package (as of September 30, 2009, LOESTRIN 24 FE, FEMCON FE, ESTROSTEP FE, OVCON 50 and FEMRING), our direct material costs include the costs of purchasing raw materials and packaging materials. For products that we only package (as of September 30, 2009, DORYX, FEMHRT, OVCON 35), our direct material costs include the costs of purchasing packaging materials. Direct labor costs for these products consist of payroll costs (including benefits) of employees engaged in production, packaging and quality control in our manufacturing plants in Fajardo, Puerto Rico and Larne, Northern Ireland. The largely fixed indirect costs of our manufacturing plants consist of production, overhead and certain laboratory costs. We do not include amortization or impairments of intangible assets as components of cost of sales.

A significant factor that influences the cost of sales, as a percentage of product net sales, is the terms of our supply agreements with our third-party manufacturers. As of September 2005 and January 2006, we became the exclusive licensee of the U.S. sales and marketing rights to TACLONEX and DOVONEX, respectively, under agreements with LEO. We were obligated to pay LEO specified supply fees and royalties based on a percentage of our net sales. We terminated these arrangements with LEO as part of the LEO Transaction. In addition, with respect to DOVONEX, we were obligated to pay Bristol-Myers Squibb Company (“Bristol-Myers”) a royalty of 5% of net sales through December 31, 2007.

As part of the PGP Acquisition, we acquired pharmaceutical manufacturing facilities in Manati, Puerto Rico and Weiterstadt, Germany. The Manati facility currently manufactures ACTONEL products. The Weiterstadt facility manufactures ASACOL products and packages ACTONEL products for sale in markets outside the United States. The application of purchase accounting adjustments to plant, property and equipment associated with the manufacture of the PGP products may result in an increase in depreciation expense included in cost of goods sold. In addition, a purchase accounting adjustment increasing the opening value of the inventories acquired in the PGP Acquisition will result in a non-recurring charge which will be recorded in our cost of goods sold as that inventory is sold to our customers. The effect of the write up of the opening value of the PGP inventory will be to reduce our gross margin on product sales with the impact expected to be reflected in our income statement during the months following the closing of the PGP Acquisition. Once the inventory write-up flows through our cost of goods sold, we expect gross margin on total revenue to be positively affected by the PGP Acquisition.

 

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SG&A Expenses

SG&A expenses consist of selling and distribution expenses, advertising and promotion expenses (“A&P”) and general and administrative expenses (“G&A”). Selling and distribution and A&P expenses consist of all expenditures incurred in connection with the sales and marketing of our products, including warehousing costs. The major items included in selling and distribution and A&P expenses are:

 

  Ÿ  

costs associated with employees in the field sales forces, sales force management and marketing departments, including salaries, benefits and incentive bonuses;

 

  Ÿ  

promotional and advertising costs, including samples, medical education programs and direct-to-consumer campaigns; and

 

  Ÿ  

distribution and warehousing costs reflecting the transportation and storage associated with transferring products from our manufacturing facilities to our distribution contractors and on to our customers.

Changes in selling and distribution and A&P expenses, as a percentage of our revenue, may be affected by a number of factors, including:

 

  Ÿ  

changes in sales volumes, as higher sales volumes enable us to spread the fixed portion of our selling and A&P expenses over higher sales;

 

  Ÿ  

changes in the mix of products we promote, as some products (such as those in launch phase, for example) require more intensive promotion than others; and

 

  Ÿ  

changes in the size and configuration of our sales forces, such as when we establish a sales force to market a new product or expand or reduce our sales forces.

G&A expenses consist of management salaries, benefits, incentive compensation, rent, legal and professional fees and miscellaneous administration and overhead costs.

The PGP Acquisition will significantly increase the size and scope of our selling, marketing and administrative functions and our overall SG&A expenses. The majority of PGP’s sales and marketing employees joined us at the closing. General and administrative costs within PGP’s historical SG&A expense are comprised of both direct administrative costs, mainly personnel, and the cost of outside services, as well as allocated indirect overhead costs for corporate functions and shared services. Over the next year our G&A costs associated with the acquired PGP business are expected to include the costs of transition services provided for us by P&G, other direct G&A costs embedded within the acquired business and incremental costs we expect to incur as we add administrative infrastructure to support the larger, global business. In the near term we expect our total G&A costs associated with the acquired business to be at levels similar to those reported by PGP on a stand-alone basis for the year ended June 30, 2009. At the same time, PGP has recently reduced its G&A spending significantly to reduce costs and maximize profitability in light of (1) the ACTONEL franchise facing the loss of exclusivity in the major Western European markets in 2010 and (2) a decision to focus more on improvements to currently marketed brands in the United States rather than more costly, higher risk, potentially higher reward projects.

Research and Development (“R&D”)

Our R&D expenses consist mainly of development costs. These development costs are typically associated with:

 

  Ÿ  

developing improvements to our existing products, including new dosage forms;

 

  Ÿ  

developing new products based on compounds which have been previously shown to be safe and effective; and

 

  Ÿ  

supporting and conducting clinical trials and subsequent registration of products we develop internally or license from third parties.

 

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In addition, we have certain projects that focus on earlier stage exploratory research. R&D costs also include payments to third-party licensors when products that we have licensed reach contractually-defined milestones. Milestone payments are recognized as expenses, unless they meet the criteria of an intangible asset, in which case they are capitalized and amortized over their useful lives.

The aggregate level of our R&D expense in any period is related to the number of products in development and the stage of their development process. Development costs for any particular product may increase progressively during the development process, with Phase III clinical trials generally accounting for a significant part of the total development costs of a product.

The PGP Acquisition will increase the scale of our R&D activities, adding both personnel and a number of ongoing product development projects. At the same time, PGP has recently reduced its R&D spending significantly to reduce costs and maximize profitability.

Other Operating Expense (Income)

The historical statements of income for the PGP business include a significant line item for other operating expenses, which includes the payments made to Sanofi-Aventis US LLC (“Sanofi”) under the global collaboration agreement for the promotion of risedronate products, including ACTONEL. For the year ended June 30, 2009 and the three-month period ended September 30, 2009, other operating expenses totaled $456 million and $(62) million and consisted of a $473 million and a $111 million obligation to Sanofi and other expenses of $62 million and $21 million, which were offset in part by a $79 million and a $194 million gain on the sale of divested assets, respectively. Going forward, we will report the Sanofi expenses and royalty costs as part of selling and distribution expenses and intend to classify the other expense amounts in expense line items consistent with our historical presentation of our operating results.

As a result of the PGP Acquisition, Sanofi will have the right to put its interest in marketing ACTONEL under the global collaboration agreement to us. If the Sanofi Put is exercised, the collaboration agreement will be terminated and we will have the right to market ACTONEL in all of the markets in which Sanofi currently markets the product and will no longer have to share any of the profits from ACTONEL in the regions where we market the product with Sanofi. We would expect to report higher revenues from the sale of ACTONEL in the markets in which Sanofi currently promotes the product (and would incur greater costs of sales and SG&A in association with sales and operations in the additional markets) and would no longer incur co-promotion expenses for sales in the regions where we market the product. We would, however, need to increase our sales force and selling expenses to substitute for Sanofi’s efforts and/or seek alternative arrangements to market the products in some jurisdictions.

If the Sanofi Put is exercised, we plan to fund it through cash on hand and proceeds from the delayed draw term loan facility under our new senior secured credit facilities. We also will have the ability to draw upon the revolving credit facility under our new senior secured credit facilities if we choose to do so. If the fair value of the Sanofi Put exceeds a previously agreed upon threshold amount, we have the option to require P&G to fund any amount in excess of the threshold, in which case P&G would be entitled to a proportionate share of profits from the sale of ACTONEL through 2014, which would reduce our margins. We also have the option to repay any amount funded by P&G within six months of the Sanofi Put closing date (with no interest), thereby terminating the P&G profit share arrangement. We do not expect funding of the Sanofi Put to materially increase our leverage ratio. See “Business—PGP Alliance with Sanofi.”

 

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Depreciation and Amortization

Depreciation costs relate to the depreciation of property, plant and equipment and are included in our statement of operations, primarily in cost of sales and G&A expenses. Depreciation is calculated on a straight-line basis over the expected useful life of each class of asset. No depreciation is charged on land.

Amortization costs relate to the amortization of identified definite-lived intangible assets, which consists primarily of intellectual property rights. Amortization is calculated on either an accelerated or a straight-line basis over the expected useful life of the asset, with identifiable assets assessed individually or by product family. Patents and other intellectual property rights are amortized over periods not exceeding 15 years. We periodically review the amortization schedules for intangible assets to ensure that the methods employed and the amortization rates being used are consistent with our then current forecasts of future product cash flows. Where appropriate, we make adjustments to the remaining amortization to better match the expected benefit of the asset.

The application of purchase accounting adjustments related to the PGP Acquisition will lead to a significant increase in our future amortization expense and may increase the level of depreciation expense relative to the level of depreciation included in PGP’s historical results of operations.

Interest Income and Interest Expense (“Net Interest Expense”)

Interest income consists primarily of interest income earned on our cash balances. Interest (expense) consists of interest on outstanding indebtedness, amortization of deferred financing costs and the write-off of deferred financing costs associated with the early prepayment of debt.

In connection with the retirement of our prior senior secured credit facilities, we wrote off the balance of the deferred financing costs of $6.6 million related to the term loans under those facilities.

Upon the closing of the PGP Acquisition, we incurred substantial incremental indebtedness. As a result, our interest expense is expected to increase and include interest on outstanding indebtedness and the amortization of deferred financing costs.

Provision / (Benefit) for Income Taxes

Provision / (benefit) for income taxes consists of current corporate tax expense, deferred tax expense and any other accrued tax expense. In addition, interest and penalties accrued on our reserves recorded under ASC No. 740, “Income Taxes,” (“ASC 740”), are included as a component of our provision / (benefit) for income taxes. We are an Irish holding company with operating subsidiaries in the United States, Puerto Rico, the UK and the Republic of Ireland. We have a tax agreement with the Puerto Rican tax authorities whereby our earnings in Puerto Rico, which are a large component of our overall earnings, are subject to a 2% income tax for a period of 15 years expiring in 2019. See Note 15 to our audited consolidated financial statements incorporated by reference into this prospectus supplement for further discussion of our income taxes, including our application of ASC 740.

Following the PGP Acquisition, we will operate in a number of tax jurisdictions in addition to those where we now operate including many Western European countries, Australia and Canada. The PGP Acquisition was structured such that most of the acquired PGP pharmaceutical intangible assets will be owned by our Puerto Rican subsidiary. As a result, a substantial portion of the pre-tax income associated with the acquired PGP business is expected to be generated in Puerto Rico, where our earnings are subject to an income tax rate of 2% (pursuant to a grant application made to the Puerto Rico tax authorities), although we expect the portion of such pre-tax income that is not attributable to Puerto Rico to be subject to income tax at higher rates.

 

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Our Results of Operations

The discussion below of our results of operations is based on our actual historical performance and is not presented on a pro forma basis giving effect to the LEO Transaction.

Operating Results for the Quarter and Nine Months ended September 30, 2009 and 2008

Revenue

The following table sets forth our revenue for the quarter and nine months ended September 30, 2009 and 2008, with the corresponding dollar and percentage change:

 

    Quarter Ended
September 30,
  Increase
(Decrease)
    Nine Months Ended
September 30,
  Increase
(Decrease)
 
    2009   2008   Dollars     Percent         2009           2008       Dollars     Percent  
    ($ in millions)  

Oral Contraception

               

LOESTRIN 24 FE

  $ 64.6   $ 50.8   $ 13.8      27.2   $ 175.0   $ 147.9   $ 27.1      18.3

FEMCON FE

    13.3     11.4     1.9      16.9     38.6     32.9     5.7      17.3

ESTROSTEP FE(1)

    1.7     4.2     (2.5   (59.4 )%      9.7     15.3     (5.6   (36.5 )% 

OVCON(1)

    3.1     3.1     —        (1.3 )%      8.0     9.9     (1.9   (19.3 )% 
                                                   

Total

    82.7     69.5     13.2      19.0     231.3     206.0     25.3      12.3

Hormone therapy

               

ESTRACE Cream

    30.7     19.9     10.8      54.1     82.1     60.3     21.8      36.1

FEMHRT

    19.5     14.6     4.9      33.7     45.3     47.0     (1.7   (3.6 )% 

FEMRING

    4.2     4.0     0.2      4.7     11.7     11.0     0.7      6.5

Other HT Products

    2.6     2.8     (0.2   (6.7 )%      7.6     8.3     (0.7   (7.8 )% 
                                                   

Total

    57.0     41.3     15.7      37.9     146.7     126.6     20.1      15.9

Dermatology

               

DORYX

    48.2     44.8     3.4      7.6     143.4     111.6     31.8      28.5

TACLONEX

    29.0     38.2     (9.2   (24.0 )%      102.1     113.9     (11.8   (10.3 )% 

DOVONEX(1)

    23.8     26.4     (2.6   (9.9 )%      85.7     92.9     (7.2   (7.8 )% 
                                                   

Total

    101.0     109.4     (8.4   (7.7 )%      331.2     318.4     12.8      4.0

PMDD

               

SARAFEM

    4.2     2.0     2.2      105.5     12.6     14.2     (1.6   (11.3 )% 

Other product sales

               

Other

    0.2     0.9     (0.7   (82.9 )%      1.6     0.0     1.6      n.m.   

Contract manufacturing

    3.0     4.5     (1.5   (33.1 )%      9.2     15.8     (6.6   (41.6 )% 
                                                   

Total product net sales

    248.1     227.6     20.5      9.0     732.6     681.0     51.6      7.6 % 

Other revenue

               

Royalty revenue

    4.7     4.3     0.4      10.5     17.0     14.6     2.4      15.7
                                                   

Total revenue

  $ 252.8   $ 231.9   $ 20.9      9.0   $ 749.6   $ 695.6   $ 54.0      7.8
                                                   

 

(1) Includes revenue from related authorized generic product sales from the date of their respective launch.

Revenue in the quarter ended September 30, 2009 was $252.8 million, an increase of $20.9 million, or 9.0%, over the same quarter in the prior year. Revenue in the nine months ended September 30, 2009 was $749.6 million, an increase of $54.0 million, or 7.8%, over the same period in

 

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the prior year. The primary drivers of the increase in revenue for the nine months ended September 30, 2009 were the net sales of our promoted products DORYX, LOESTRIN 24 FE and ESTRACE Cream, which together contributed $28.0 million and $80.7 million of revenue growth for the quarter and nine months ended September 30, 2009, respectively, compared to the prior year periods. The growth delivered by these products was partially offset by net sales declines in certain other products, primarily TACLONEX and DOVONEX. Changes in the net sales of our products are a function of a number of factors including changes in: market demand, gross selling prices, sales-related deductions from gross sales to arrive at net sales and the levels of pipeline inventories of our products held by our direct and indirect customers. We use IMS estimates of filled prescriptions for our products as a proxy for market demand.

Net sales of our oral contraceptive products increased $13.2 million, or 19.0%, in the quarter ended September 30, 2009 and $25.3 million, or 12.3%, in the nine months ended September 30, 2009, compared with the prior year periods. LOESTRIN 24 FE generated revenues of $64.6 million in the quarter ended September 30, 2009, an increase of 27.2%, compared with $50.8 million in the prior year quarter. During the nine months ended September 30, 2009, LOESTRIN 24 FE generated revenues of $175.0 million, an increase of 18.3%, compared with $147.9 million in the prior year period. The increase in LOESTRIN 24 FE net sales in both periods was primarily due to increases in filled prescriptions of 28.1% and 15.7%, respectively, as well as higher average selling prices and an expansion of pipeline inventories relative to the prior year periods, offset in part by the impact of higher sales-related deductions. Increased utilization of the customer loyalty cards for LOESTRIN 24 FE drove an increase in sales-related deductions in the quarter and nine months ended September 30, 2009. FEMCON FE generated revenues of $13.3 million and $38.6 million in the quarter and nine months ended September 30, 2009, respectively, compared to $11.4 million and $32.9 million in the prior year periods. The increase in FEMCON FE net sales in the quarter ended September 30, 2009 was primarily due to higher average selling prices and lower sales-related deductions, offset in part by a decline in filled prescriptions of 3.8% relative to the prior year period. The increase in FEMCON FE net sales in the nine months ended September 30, 2009 is due to higher average selling prices and an increase in filled prescriptions of 5.7%, offset in part by higher sales-related deductions relative to the prior year period. We believe the increased prescription demand and market share for LOESTRIN 24 FE and the modest declines for FEMCON FE are reflective of our promotional emphasis.

Net sales of our dermatology products decreased $8.4 million, or 7.7%, in the quarter ended September 30, 2009 but increased $12.8 million, or 4.0%, in the nine months ended September 30, 2009, compared with the prior year periods. Net sales of DORYX increased $3.4 million, or 7.6%, in the quarter ended September 30, 2009, compared to the prior year quarter, primarily due to a 45.2% increase in filled prescriptions and higher average selling prices, which was offset in part by higher sales-related deductions and a contraction of pipeline inventories relative to the prior year period. The increase in filled prescriptions primarily relates to DORYX 150 mg, which we launched in the third quarter of 2008 and to which we have dedicated significant promotional efforts, including our recently launched customer loyalty card program. Increased utilization of the customer loyalty card for DORYX 150 mg drove an increase in sales-related deductions in the 2009 periods. Net sales of DORYX increased $31.8 million, or 28.5%, in the nine months ended September 30, 2009, compared to the prior year period, primarily due to a 36.4% increase in filled prescriptions, as well as higher average selling prices, which were offset in part due to higher sales-related deductions. Net sales of TACLONEX decreased $9.2 million, or 24.0%, to $29.0 million in the quarter ended September 30, 2009, compared to $38.2 million in the prior year quarter. Net sales of TACLONEX decreased $11.8 million, or 10.3%, to $102.1 million in the nine months ended September 30, 2009, compared to $113.9 million in the prior year period. The decrease in net sales in the quarter and nine months ended September 30, 2009 is primarily due to a contraction of pipeline inventories relative to the prior year periods, higher sales-related deductions as well as a decline in filled prescriptions of 12.9% and 7.2%, respectively, offset in part by the impact of higher average selling prices. Net sales of DOVONEX

 

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decreased $2.6 million, or 9.9%, and $7.2 million, or 7.8%, in the quarter and nine months ended September 30, 2009 as compared to the prior year periods. The decline in DOVONEX net sales in the quarter and nine months ended September 30, 2009 was due primarily to decreases in filled prescriptions of 19.4% and 23.1%, respectively, offset in part by higher average selling prices and lower sales-related deductions relative to the prior year period. The decline in filled prescriptions was due primarily to customers switching to other therapies, as well as the introduction of generic versions of DOVONEX Solution into the market in the second quarter of 2008, including our authorized generic product. As a result of the LEO Transaction and related distribution agreement with LEO, we will continue to record revenue from the distribution of the products through December 31, 2009. This will negatively impact our gross margin percentage during the fourth quarter of 2009. Beginning in January 2010, we will no longer be the distributor for LEO and therefore will not record any revenue or cost of sales related to the LEO products.

Net sales of our hormone therapy products increased $15.7 million, or 37.9%, in the quarter ended September 30, 2009 and $20.1 million, or 15.9%, in the nine months ended September 30, 2009, compared with the prior year periods. Net sales of ESTRACE Cream increased $10.8 million, or 54.1%, and $21.8 million, or 36.1%, in the quarter and nine months ended September 30, 2009, respectively, compared to the prior year periods. We began promotional efforts for ESTRACE Cream in early 2009. As a result, the increases in net sales were primarily due to an increase in filled prescriptions of 21.9% and 19.6% in the quarter and nine months ended September 30, 2009, respectively, and higher average selling prices. Net sales of FEMHRT increased $4.9 million, or 33.7%, in the quarter ended September 30, 2009, and decreased $1.7 million, or 3.6%, in the nine months ended September 30, 2009. The increase in FEMHRT net sales in the quarter ended September 30, 2009 was due to the expansion of pipeline inventories relative to the prior year period as well as higher average selling prices, offset in part by a decline in filled prescriptions of 14.8%. The decrease in FEMHRT net sales in the nine months ended September 30, 2009 was primarily due to a decline in filled prescriptions of 13.8%, offset in part by the impact of higher average selling prices. Generic competition may negatively impact net sales of FEMHRT beginning as early as November 2009.

Cost of Sales (excluding Amortization of Intangible Assets)

The tables below show the calculation of cost of sales and cost of sales percentage for the nine months ended September 30, 2009 and 2008:

 

     Quarter Ended
September 30, 2009
    Quarter Ended
September 30, 2008
    $
Change
    Percent
Change
 
     ($ in millions)  

Product net sales

   $ 248.1      $ 227.6      $ 20.5      9.0

Cost of sales (excluding amortization)

     44.4        46.8        (2.4   (5.2 )% 

Cost of sales percentage

     17.9     20.6    
     Nine Months Ended
September 30, 2009
    Nine Months Ended
September 30, 2008
    $
Change
    Percent
Change
 
     ($ in millions)  

Product net sales

   $ 732.6      $ 681.0      $ 51.6      7.6

Cost of sales (excluding amortization)

     140.1        145.6        (5.5   (3.8 )% 

Cost of sales percentage

     19.1     21.4    

Cost of sales (excluding amortization) decreased $2.4 million, or 5.2%, and $5.5 million, or 3.8%, in the quarter and nine months ended September 30, 2009, respectively, compared with the prior year periods. Our cost of sales, as a percentage of product net sales, decreased in both the quarter and nine months ended September 30, 2009. The decrease is due to a number of factors, primarily a favorable mix of products sold as compared to the prior periods, offset in part by increases in manufacturing costs.

 

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SG&A Expenses

SG&A expenses were comprised of the following expenses for the nine months ended September 30, 2009 and 2008:

 

     Quarter Ended
September 30, 2009
   Quarter Ended
September 30, 2008
   $
Change
    Percent
Change
 
     ($ in millions)  

Advertising and Promotion (“A&P”)

   $ 7.6    $ 9.7    $ (2.1   (21.5 )% 

Selling and Distribution

     19.8      22.0      (2.2   (9.9 )% 

General, Administrative and Other (“G&A”)

     31.7      14.2      17.5      122.7
                            

Total

   $ 59.1    $ 45.9    $ 13.2      28.7
                            
     Nine Months Ended
September 30, 2009
   Nine Months Ended
September 30, 2008
   $
Change
    Percent
Change
 
     ($ in millions)  

A&P

   $ 25.8    $ 37.2    $ (11.4   (30.8 )% 

Selling and Distribution

     63.0      68.6      (5.6   (8.2 )% 

G&A

     70.1      42.4      27.7      65.4
                            

Total

   $ 158.9    $ 148.2    $ 10.7      7.2
                            

SG&A expenses for the quarter ended September 30, 2009 were $59.1 million, an increase of $13.2 million, or 28.7%, from $45.9 million in the prior year quarter. SG&A expenses for the nine months ended September 30, 2009 were $158.9 million, an increase of $10.7 million, or 7.2%, from $148.2 million in the prior year period. A&P expenses in the quarter and nine months ended September 30, 2009 decreased $2.1 million, or 21.5%, and $11.4 million, or 30.8%, compared with the prior year periods. The decrease in the quarter ended September 30, 2009 is primarily due to an overall decrease in sampling and promotional spending due to a reduction in promotional activity as a result of a lower average headcount for the field sales force relative to the prior year quarter. The decrease in the nine months ended September 30, 2009 is primarily due to an $8.7 million decrease in direct-to-consumer advertising as well as an overall decrease in other sampling and promotional spending in the 2009 period. Selling and distribution expenses decreased by $2.2 million, or 9.9%, and $5.6 million, or 8.2%, in the quarter and nine months ended September 30, 2009, respectively, as compared to the prior year periods. The decrease in both periods is primarily due to a lower average headcount relative to the prior year periods, offset in part by new promotion expenses related to FEMRING in the current year periods. G&A expenses increased $17.5 million, or 122.7%, and $27.7 million, or 65.4%, in the quarter and nine months ended September 30, 2009, respectively, as compared with the prior year periods. The increase in the quarter ended September 30, 2009 is due in large part to increases in professional and legal fees primarily relating to the PGP Acquisition of $14.5 million and, to a lesser extent, increases in compensation expenses. The increase in the nine months ended September 30, 2009 is due in large part to increases in professional and legal fees primarily relating to the PGP Acquisition of $17.7 million, fees associated with our redomestication to Ireland of $6.3 million and, to a lesser extent, increases in compensation expenses.

R&D

Our investment in R&D for the quarter ended September 30, 2009 was $11.6 million, an increase of $1.6 million, or 16.3%, compared with $10.0 million in the prior year quarter. Our R&D expense for the nine months ended September 30, 2009 was $47.4 million, an increase of $12.7 million, or 36.6% compared with $34.7 million in the prior year period. Included in the nine months ended September 30, 2009 was a $9.0 million payment to Dong-A PharmTech Co. Ltd (“Dong-A”) upon the achievement of a developmental milestone under our existing agreement for an orally-administered udenafil product for

 

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the treatment of ED. Also included in the nine months ended September 30, 2009 was a $2.5 million payment to NexMed, Inc. (“NexMed”) in connection with our acquisition of the rights to its topically applied alprostadil cream for the treatment of ED. Excluding the $11.5 million of payments to Dong-A and NexMed during the nine months ended September 30, 2009, R&D expenditures were essentially flat compared to the prior year period.

Amortization of Intangible Assets

Amortization of intangible assets in the quarters ended September 30, 2009 and 2008 was $57.0 million and $59.1 million, respectively. Amortization of intangible assets in the nine months ended September 30, 2009 and 2008 was $171.0 million and $164.8 million, respectively. The increase in the nine months ended September 30, 2009 compared to the prior year period was due to the impact of additional accelerated amortization of the OVCON/FEMCON FE product family beginning in the quarter ended December 31, 2008 partially offset by decreases in the amortization of ESTROSTEP, due to our acceleration methodology pursuant to which we recognized greater expense in the 2008 period relative to the 2009 period. In addition, the increased amortization during the nine months ended September 30, 2009 was partially offset by decreases in the amortization of SARAFEM, which was fully amortized as of the quarter ended June 30, 2008. We continuously review our products’ remaining useful lives based on each product family’s estimated future cash flows. Our amortization methodology is calculated on either an accelerated or a straight-line basis to match the expected useful life of the asset, with identifiable assets assessed individually or by product family.

Net Interest Expense

Net interest expense for the quarter ended September 30, 2009 was $24.0 million, an increase of $0.4 million, or 1.4%, from $23.6 million in the prior year quarter. Net interest expense for the nine months ended September 30, 2009 was $57.2 million, a decrease of $15.0 million, or 20.8%, from $72.2 million in the prior year period. Included in net interest expense in the quarter ended September 30, 2009 was $6.6 million relating to the write-off of deferred loan costs associated with the repayment of $479.8 million of indebtedness under our prior senior secured credit facilities, as compared to a $1.3 million expense relating to the write-off of deferred loan costs associated with the optional prepayment of $90.0 million of indebtedness under our prior senior secured credit facilities in the quarter ended September 30, 2008. Included in net interest expense in the nine months ended September 30, 2009 was $7.8 million relating to the write-off of deferred loan costs associated with the repayment of $578.6 million of indebtedness under our prior senior secured credit facilities, as compared to a $2.4 million expense relating to the write-off of deferred loan costs associated with the optional prepayment of $160.0 million of indebtedness under our prior senior secured credit facilities in the nine months ended September 30, 2008. The decrease in net interest expense in the nine months ended September 30, 2009 was primarily the result of cumulative reductions in outstanding debt during 2008 and 2009 which reduced the average debt balance outstanding from $1,174.6 million in the nine months ended September 30, 2008 to $881.8 million in the nine months ended September 30, 2009. The cumulative reduction in the average debt level is the result of prepayments and purchases made using cash flows from operations and cash on hand, net of investing activities.

Income Taxes

As of September 30, 2009, we operated primarily in five tax jurisdictions: the United Kingdom, the United States, the Republic of Ireland, Bermuda and Puerto Rico. Our effective tax rates for the quarter and nine months ended September 30, 2009 were 5.7% and 7.8%, respectively, each of which includes the tax impact of the LEO Transaction of $13.0 million. Excluding the $380.1 million of net income resulting from the LEO Transaction, the effective tax rates were 22.2% and 18.0% for the quarter and nine months ended September 30, 2009, respectively, as compared to 13.8% and 17.5%

 

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in the prior year periods, respectively. The effective income tax rate for interim reporting periods is volatile due to changes in income mix among the various tax jurisdictions in which we operate, the impact of discrete items, as well as the overall level of consolidated income before income taxes.

Net Income

Due to the factors described above, we reported net income of $424.2 million and $40.1 million in the quarters ended September 30, 2009 and 2008, respectively, and $523.6 million and $107.3 million in the nine months ended September 30, 2009 and 2008, respectively.

Operating results for the years ended December 31, 2008 and 2007

Revenue

The following table sets forth our revenue for the years ended December 31, 2008 and 2007, with the corresponding dollar and percentage change:

 

     Year Ended December 31,    Increase (Decrease)  
         2008            2007            Dollars             Percent      
     ($ in millions)  

Oral contraceptives

          

LOESTRIN 24 FE

   $ 197.2    $ 148.9    $ 48.3      32.4

FEMCON FE

     45.8      32.4      13.4      41.5

ESTROSTEP FE(1)

     20.8      70.2      (49.4   (70.3 )% 

OVCON 35/50 (“OVCON”)(1)

     12.9      15.5      (2.6   (16.7 )% 
                            

Total

   $ 276.7    $ 267.0    $ 9.7      3.7
                            

Hormone therapy (“HT”)

          

ESTRACE Cream

   $ 83.8    $ 73.1    $ 10.7      14.7

FEMHRT

     61.5      63.7      (2.2   (3.4 )% 

FEMRING

     14.2      15.5      (1.3   (8.2 )% 

Other HT products

     11.7      13.5      (1.8   (13.3 )% 
                            

Total

   $ 171.2    $ 165.8    $ 5.4      3.3
                            

Dermatology

          

DORYX

   $ 158.9    $ 115.8    $ 43.1      37.3

TACLONEX

     153.3      127.2      26.1      20.6

DOVONEX (1)

     123.3      145.3      (22.0   (15.1 )% 
                            

Total

   $ 435.5    $ 388.3    $ 47.2      12.2
                            

PMDD

          

SARAFEM

   $ 16.9    $ 37.7    $ (20.8   (55.1 )% 

Other product net sales

          

Other

     —        3.7      (3.7   (100.0 )% 

Contract manufacturing

     18.7      25.7      (7.0   (27.3 )% 
                            

Total product net sales

   $ 919.0    $ 888.2    $ 30.8      3.5

Other Revenue

          

Royalty revenue

     19.1      11.4      7.7      68.3
                            

Total Revenue

   $ 938.1    $ 899.6    $ 38.5      4.3
                            

 

(1) Includes revenue from related authorized generic product sales from the date of their respective launch.

 

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Revenue in the year ended December 31, 2008 totaled $938.1 million, an increase of $38.5 million, or 4.3%, over the year ended December 31, 2007. The primary drivers of the increase in revenue were the net sales of our promoted products LOESTRIN 24 FE, DORYX, TACLONEX and FEMCON FE, which together contributed $130.9 million of revenue growth for the year ended December 31, 2008 compared to the prior year. The growth delivered by these products was offset primarily by significant declines in ESTROSTEP FE and SARAFEM net sales due to generic competition and declines in DOVONEX net sales. Changes in the net sales of our products are a function of a number of factors including changes in: market demand, gross selling prices, sales-related deductions from gross sales to arrive at net sales and the levels of pipeline inventories of our products. We use IMS estimates of filled prescriptions for our products as a proxy for market demand.

Net sales of our oral contraceptive products increased $9.7 million, or 3.7%, in the year ended December 31, 2008, compared with the prior year. LOESTRIN 24 FE generated revenues of $197.2 million in the year ended December 31, 2008, an increase of 32.4%, compared with $148.9 million in the prior year. The increase in LOESTRIN 24 FE net sales was primarily due to an increase in filled prescriptions of 28.8% in the year ended December 31, 2008, and to a lesser extent, higher average selling prices compared to the prior year. FEMCON FE generated revenues of $45.8 million in the year ended December 31, 2008, compared to $32.4 million in the prior year. The increase in FEMCON FE net sales in the year ended December 31, 2008 was primarily due to an increase in filled prescriptions of 58.2% versus the prior year, offset partially by the impact of higher sales-related deductions in the year ending December 31, 2008. ESTROSTEP FE net sales decreased $49.4 million, or 70.3%, in the year ended December 31, 2008, as compared to the prior year. The decrease in ESTROSTEP FE net sales was primarily due to an 80.2% decline in filled prescriptions in the year ended December 31, 2008, compared to the prior year, as a result of generic versions of ESTROSTEP FE being introduced in the fourth quarter of 2007, including our authorized generic Tilia™ FE. Our revenue from net sales of Tilia™ FE, is reported in our net sales for ESTROSTEP FE.

Net sales of our dermatology products increased $47.2 million, or 12.2%, in the year ended December 31, 2008, as compared to the prior year. Net sales of DORYX increased $43.1 million, or 37.3%, in the year ended December 31, 2008, compared to the prior year, primarily due to the launch of DORYX 150 mg in the third quarter of 2008, as well as higher average selling prices and a 10.7% increase in total DORYX filled prescriptions. In addition, we believe the average value of a DORYX 150 mg prescription is roughly one-third higher than that of a DORYX 100 mg prescription. Net sales of TACLONEX increased $26.1 million, or 20.6%, to $153.3 million in the year ended December 31, 2008, compared to $127.2 million in the prior year. The increase in net sales was primarily due to increases in filled prescriptions, measured on a per-gram basis, and higher average selling prices in the year ended December 31, 2008, compared to the prior year. The introduction of our TACLONEX scalp product in June 2008 also contributed to the increase compared to the prior year. We believe the increases in filled prescriptions for TACLONEX are not fully reflective of the increases in demand for the product during these periods. In August 2007, we began offering TACLONEX in 100 gram tubes, in addition to our original 60 gram tubes, resulting in an increase in the average grams per filled TACLONEX prescription during the year ended December 31, 2008 compared with the prior year. Net sales of DOVONEX decreased $22.0 million, or 15.1%, in the year ended December 31, 2008 as compared to the prior year. The decline in DOVONEX net sales in the year ended December 31, 2008 was due primarily to a decrease in filled prescriptions of 23.3%, and, to a lesser extent, increases in sales-related deductions during the 2008 period, which were partially offset by higher average selling prices. The decline in filled prescriptions was due primarily to the introduction of generic versions of DOVONEX Solution into the market in the second quarter of 2008, including our authorized generic product, and also due to customers switching to other therapies.

Net sales of our hormone therapy products increased $5.4 million, or 3.3%, in the year ended December 31, 2008 as compared to the prior year. Net sales of ESTRACE Cream increased $10.7

 

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million, or 14.7%, in the year ended December 31, 2008, compared to the prior year, primarily due to higher average selling prices, and an increase in filled prescriptions of 2.0%, offset in part by a contraction of pipeline inventories relative to the prior year. Net sales of FEMHRT decreased $2.2 million, or 3.4%, in the year ended December 31, 2008, compared to the prior year. The decline in FEMHRT net sales was due primarily to a decrease in filled prescriptions of 14.1% as well as higher sales-related deductions for the year ended December 31, 2008, offset partially by higher average selling prices as compared with the prior year. Generic competition may negatively impact net sales of FEMHRT beginning as early as November 2009.

Net sales of SARAFEM, our product used to treat symptoms of PMDD, decreased $20.8 million, or 55.1%, in the year ended December 31, 2008, compared with the prior year. The decrease in net sales was due primarily to a decline in filled prescriptions of 51.7% in the year ended December 31, 2008 compared to the prior year. During the first half of 2008 we discontinued sales of SARAFEM Capsules and commenced sales of SARAFEM Tablets. Generic versions of SARAFEM Capsules were introduced in May 2008 and negatively impacted our SARAFEM net sales. We expect generic competition to continue to have an adverse impact on our SARAFEM net sales in the future.

Our other product net sales declined in the year ended December 31, 2008 due to a recall of certain non-core products manufactured by a third party. As a result of the recall, our other product net sales during the year ended December 31, 2008 were negatively impacted due to contra-sales related accruals for the product recalls. We do not expect this product recall to materially affect our operating results in future periods. Our contract manufacturing revenues relate to certain products which we manufacture for third parties. Additionally, in the year ended December 31, 2008, we generated $19.1 million of revenue which consisted of royalties earned on the net sales of an oral contraceptive product sold by a third party under a license relating to one of our patents, as compared to $11.4 million in the prior year.

Cost of Sales (excluding Amortization and Impairment of Intangible Assets)

The table below shows the calculation of cost of sales and cost of sales percentage for the years ended December 31, 2008 and 2007:

 

     Year Ended
December 31,
2008
    Year Ended
December 31,
2007
    $
Change
   Percent
Change
 
     ($ in millions)  

Product net sales

   $ 919.0      $ 888.2      $ 30.8    3.5

Cost of sales (excluding amortization)

     198.8        186.0        12.8    6.9

Cost of sales percentage

     21.6     20.9     

Cost of sales increased $12.8 million in the year ended December 31, 2008 compared with the prior year, due in part to the 3.5% increase in product net sales. Our cost of sales, as a percentage of product net sales, increased from 20.9% in the year ended December 31, 2007 to 21.6% in the year ended December 31, 2008. Our cost of sales increased due to higher expenses relating to inventory reserves totaling $14.7 million in the year ended December 31, 2008 as compared to $10.9 million in the year ended December 31, 2007. Also contributing to the increase in the current year were higher costs relative to the prior year, partially offset by the absence of a 5% royalty on our net sales of DOVONEX which we were required to pay in the prior year under a contract with Bristol-Myers that terminated on December 31, 2007.

 

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SG&A Expenses

Our SG&A expenses were comprised of the following for the years ended December 31, 2008 and 2007:

 

     Year Ended
December 31,
2008
   Year Ended
December 31,
2007
   $
Change
    Percent
Change
 
     ($ in millions)  

A&P

   $ 47.3    $ 81.0    $ (33.7   (41.7 )% 

Selling and distribution

     90.0      89.5      0.5      0.5

G&A

     55.4      95.3      (39.9   (41.8 )% 
                            

Total

   $ 192.7    $ 265.8    $ (73.1   (27.5 )% 
                            

SG&A expenses for the year ended December 31, 2008 were $192.7 million, a decrease of $73.1 million, or 27.5%, compared to the prior year. A&P expenses for the year ended December 31, 2008 decreased $33.7 million, or 41.7%, versus the prior year, primarily due to a $25.4 million decrease in direct-to-consumer advertising in the year ended December 31, 2008, as well as a decrease in other promotional spending. Selling and distribution expenses for the year ended December 31, 2008 increased $0.5 million, or 0.5%, over the prior year. The increase in selling and distribution expenses was primarily due to normal inflationary increases in compensation costs offset by the impact of a lower average headcount within our sales forces during the year ended December 31, 2008 as compared to the prior year. G&A expenses in the year ended December 31, 2008 decreased $39.9 million, or 41.8%, as compared to the prior year. The year ended December 31, 2007 included a $26.5 million expense, related to the settlement of a class action lawsuit in connection with our OVCON 35 litigation. Outside legal fees (excluding litigation settlements) in the year ended December 31, 2008 decreased by $11.8 million compared with the prior year, primarily as a result of the timing of our litigation settlements.

R&D

Our investment in R&D for the year ended December 31, 2008 was $50.0 million, a decrease of $4.5 million, or 8.4%, compared with the prior year. Included in the year ended December 31, 2008 was a $2.0 million upfront payment to Dong-A to acquire certain rights to its orally-administered udenafil product, a phosphodiesterase type 5 (“PDE5”) inhibitor for the treatment of ED. R&D expense for the year ended December 31, 2007 included a $4.0 million upfront payment to Paratek Pharmaceuticals, Inc. (“Paratek”) to acquire certain rights to novel tetracyclines for the treatment of acne and rosacea. Also included in the year ended December 31, 2007 was a $10.0 million milestone payment to LEO, which was triggered by the FDA’s acceptance of LEO’s NDA submission for a TACLONEX scalp product. Excluding these one time payments in both periods, R&D expense increased $7.5 million, or 18.4%, in the year ended December 31, 2008 compared to the prior year due to costs incurred for clinical studies relating to two oral contraceptives, as well as new projects which were initiated towards the end of 2007 and early 2008. We completed the treatment phase of the Phase III clinical study for a new low-dose oral contraceptive in the third quarter of 2008.

Amortization of Intangible Assets (including Impairment of Intangible Assets)

Amortization of intangible assets in the years ended December 31, 2008 and 2007 was $387.2 million (including an impairment of intangible assets of $163.3 million) and $228.3 million, respectively. Our amortization methodology is calculated on either an accelerated or a straight-line basis to match the expected useful life of the asset, with identifiable assets assessed individually or by product family. We regularly review the remaining useful lives of our identified intangible assets based on each product family’s estimated future cash flows. During the third quarter of 2008, we accelerated the

 

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amortization on certain unimpaired non-core products based on our review. As a result, the year ended December 31, 2008 included additional amortization expense of $16.0 million.

In connection with our annual review of intangible assets, in the fourth quarter of 2008 we recorded an impairment charge of $163.3 million relating to our OVCON / FEMCON FE product family. Based on changes in a number of assumptions, including those relating to the allocation of our expected future promotional emphasis between LOESTRIN 24 FE, FEMCON FE and other oral contraceptives currently in development and our product viability estimates in light of the future expected entrance of generic competition for FEMCON FE, the projected future revenue and related cash flows for the OVCON / FEMCON FE product family declined compared to previous forecasts. The undiscounted cash flows relating to this product family no longer exceeded the book value of the intangible assets. We estimated the fair value of the product family using a discounted cash flow analysis. The fair value was compared to the then current carrying value of the intangible asset for this product family and the difference was recorded as an impairment expense in the quarter ended December 31, 2008.

Net Interest Expense

Net interest expense for the year ended December 31, 2008 was $93.1 million, a decrease of $24.5 million, or 20.8%, from $117.6 million in the prior year. Included in net interest expense in the years ended December 31, 2008 and 2007 were $3.5 million and $6.6 million, respectively, relating to the write-off of deferred loan costs associated with the optional prepayments of debt. We made optional prepayments totaling $220.0 million of outstanding indebtedness under our prior senior secured credit facilities and purchased and retired $10.0 million aggregate principal amount of our existing notes, at a discount, in the year ended December 31, 2008. In the year ended December 31, 2007, we made optional prepayments totaling $340.0 million of outstanding indebtedness under our prior senior secured credit facilities. The decrease in net interest expense in the year ended December 31, 2008 was primarily the result of the above mentioned prepayments of our outstanding debt which reduced the weighted average debt outstanding in the year ended December 31, 2008 by $281.5 million as compared to the prior year. The cumulative reductions in debt were accomplished through the use of our free cash flow.

Provision / (Benefit) for Income Taxes

Our effective tax rates, as a percentage of pre-tax income / (loss), for the years ended December 31, 2008 and 2007 were 151.0% and 38.9%, respectively. Our corporate effective tax rate with respect to any period may be volatile based on the mix of income in the tax jurisdictions in which we operate and the amount of our consolidated income / (loss) before taxes. Our Puerto Rican subsidiary holds the majority of our intangible assets and records the majority of the related amortization expense. As a result, the proportion of our consolidated book income / (loss) before taxes generated in Puerto Rico, where our tax rate is 2.0%, has a significant impact on the effective tax rate. For the year ended December 31, 2008, our U.S. subsidiaries generated income before taxes while our operations in the tax jurisdictions where we are subject to a lower tax rate, mainly Puerto Rico, generated significant losses. For the year ended December 31, 2007, our U.S. subsidiaries generated over half of our consolidated book income before taxes. As a result, the effective tax rate for the years ended December 31, 2008 and 2007 was greater than the U.S. statutory rate in both periods.

The valuation allowance for deferred tax assets of $9.9 million and $11.8 million as of December 31, 2008 and 2007, respectively, relates principally to the uncertainty of the utilization of certain deferred tax assets, primarily tax loss carryforwards in various jurisdictions. We expect to generate sufficient future taxable income to realize the tax benefits related to the remaining net deferred tax assets on our consolidated balance sheets. The valuation allowance was calculated in

 

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accordance with the provisions of ASC No. 740, Income Taxes, which requires a valuation allowance to be established or maintained when it is “more likely than not” that all or a portion of deferred tax assets will not be realized.

Our calculation of tax liabilities involves uncertainties in the application of complex tax regulations in various tax jurisdictions. Amounts related to tax contingencies that management has assessed as unrecognized tax benefits have been appropriately recorded under the provisions of ASC 740. For any tax position, a tax benefit may be reflected in the financial statements only if it is “more likely than not” that we will be able to sustain the tax return position, based on its technical merits. Potential liabilities arising from tax positions taken are recorded based on our estimate of the largest amount of benefit that is cumulatively greater than 50 percent. These liabilities may be adjusted to take into consideration changing facts and circumstances. Due to the complexity of some of these uncertainties, the ultimate resolution may result in a payment that is different from the current estimate of the tax liabilities. These potential tax liabilities are recorded in accrued expenses in our consolidated balance sheets. We intend to continue to reinvest accumulated earnings of our subsidiaries for the foreseeable future; as such, no additional provision has been made for U.S. or non-U.S. income taxes on the undistributed earnings of subsidiaries or for differences related to investments in subsidiaries.

On February 25, 2008, our U.S. operating subsidiaries entered into an APA with the IRS covering the calendar years 2006 through 2010. The APA is an agreement with the IRS that specifies the agreed upon terms under which our U.S. subsidiaries are compensated for services provided on behalf of our non-U.S. subsidiaries. The APA provides us with greater certainty with respect to the mix of our pretax income in the various tax jurisdictions in which we operate.

Net Income

Due to the factors described above, we reported net (loss) / income of $(8.4) million and $28.9 million in the years ended December 31, 2008 and 2007, respectively.

 

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Operating Results for the Years ended December 31, 2007 and 2006

Revenue

The following table sets forth our revenue for the years ended December 31, 2007 and 2006, with the corresponding dollar and percentage change:

 

     Year Ended December 31,    Increase (Decrease)  
         2007            2006            Dollars             Percent      
     ($ in millions)  

Oral Contraceptives

          

LOESTRIN 24 FE

   $ 148.9    $ 44.2    $ 104.7        237.2

FEMCON FE

     32.4      7.5      24.9        330.2

ESTROSTEP FE(1)

     70.2      103.0      (32.8     (31.9 )% 

OVCON(1)

     15.5      73.8      (58.3     (79.0 )% 
                              

Total

   $ 267.0    $ 228.5    $ 38.5        16.8
                              

Hormone Therapy

          

ESTRACE Cream

   $ 73.1    $ 65.8    $ 7.3        11.2

FEMHRT

     63.7      58.7      5.0        8.4

FEMRING

     15.5      11.3      4.2        36.9

Other HT

     13.5      10.9      2.6        24.5
                              

Total

   $ 165.8    $ 146.7    $ 19.1        13.0
                              

Dermatology

          

DORYX

   $ 115.8    $ 102.4    $ 13.4        13.0

TACLONEX

     127.2      60.1      67.1        111.5

DOVONEX

     145.3      146.9      (1.6     (1.1 )% 
                              

Total

   $ 388.3    $ 309.4    $ 78.9        25.4
                              

PMDD

          

SARAFEM

   $ 37.7    $ 37.9    $ (0.2     (0.6 )% 

Other Product Net Sales

          

Other

     3.7      8.6      (4.9     (53.8 )% 

Contract manufacturing

     25.7      20.8      4.9        23.2
                              

Total Product Net Sales

   $ 888.2    $ 751.9    $ 136.3      $ 18.1

Other Revenue

          

Royalty revenue

     11.4      2.6      8.8        352.2
                              

Total Revenue

   $ 899.6    $ 754.5    $ 145.1        19.2
                              

 

(1) Includes revenue from related authorized generic product sales from the date of their respective launch.

Revenue in the year ended December 31, 2007 totaled $899.6 million, an increase of $145.1 million, or 19.2%, over 2006. The primary drivers of the increase in revenue were the net sales of two products introduced in March 2006, LOESTRIN 24 FE and TACLONEX, which together contributed $171.8 million of revenue growth for the year ended December 31, 2007, compared to the prior year.

Sales of our oral contraceptive products increased $38.5 million, or 16.8%, in the year ended December 31, 2007, compared with the prior year. In February 2006, we received FDA approval to market our oral contraceptive, LOESTRIN 24 FE, and began commercial sales of the product in March 2006. Beginning in April 2006, LOESTRIN 24 FE became our top promotional priority amongst our oral

 

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contraceptive brands. LOESTRIN 24 FE generated revenue of $148.9 million in the year ended December 31, 2007, compared to $44.2 million in the prior year, an increase of $104.7 million, or 237.2%. The increase in revenues is primarily attributable to an increase in filled prescriptions of 300.7% compared to the prior year. We introduced and began commercial sales of FEMCON FE in the second half of 2006, but did not initiate promotional efforts in support of the product until April 2007. Beginning in April 2007, FEMCON FE became a promotional priority for our newly expanded sales force. The product generated revenues of $32.4 million in the year ended December 31, 2007 compared to $7.5 million in the prior year, an increase of $24.9 million, or 330.2%. The increase in revenues is primarily attributable to an increase in filled prescriptions of 807.8% compared to the prior year. ESTROSTEP FE net sales decreased $32.8 million, or 31.9%, in the year ended December 31, 2007, compared with the prior year as filled prescriptions declined by 37.7%. This decrease was offset partially by the impact of higher selling prices in the year ended December 31, 2007. ESTROSTEP FE filled prescriptions declined due to the shift of our promotional efforts away from the product beginning in April 2006. In addition, the decline in both prescription demand and net sales accelerated in the fourth quarter of 2007 as generic versions of ESTROSTEP FE were introduced in late October 2007. At the time of the launch of a generic version of ESTROSTEP FE by Barr Pharmaceuticals, Inc., which was subsequently acquired by Teva, we partnered with Watson and launched TILIA™ FE, an authorized generic version of ESTROSTEP FE. OVCON net sales declined $58.3 million, or 79.0%, for the year ended December 31, 2007, compared with the prior year. The decline in OVCON revenue was primarily due to the introduction of generic versions of OVCON 35 beginning in late October 2006, which led to an 84.3% decline in filled prescriptions for OVCON 35 in the year ended December 31, 2007, compared to the prior year. The decline in filled prescriptions was partially offset by price increases.

Sales of our dermatology products increased $78.9 million, or 25.4%, in the year ended December 31, 2007, compared to the prior year. This increase was primarily due to the increase in TACLONEX sales of $67.1 million in the year ended December 31, 2007 compared to the prior year. Sales of TACLONEX, which was launched in April 2006, increased primarily due to an increase in filled prescriptions of 105.4% in the year ended December 31, 2007, compared to the prior year. Sales of DORYX increased $13.4 million, or 13.0%, in the year ended December 31, 2007, compared with the prior year. DORYX prescriptions, which had been growing during the period from July 1, 2005 through June 30, 2006, softened in the second half of 2006 due to decreased promotional emphasis following the April 2006 launch of TACLONEX. In January 2007, we took steps to increase our Dermatology sales force’s emphasis on DORYX. While filled prescriptions for DORYX declined 5.4% in the year ended December 31, 2007 compared to the prior year, DORYX net sales in the year increased, as higher selling prices more than offset the decline in filled prescriptions. As a result of the promotional emphasis on DORYX, filled prescriptions increased 4.8% in the quarter ended December 31, 2007, compared to the prior year quarter. Sales of DOVONEX decreased by $1.6 million, or 1.1%, in the year ended December 31, 2007 compared with the prior year. The decline was due to a decrease in filled prescriptions of 18.8%, offset partially by higher selling prices compared with the prior year. In April 2006, we began to promote TACLONEX as the first line topical therapy for mild to moderate psoriasis. We believe the decline in filled prescriptions of DOVONEX in the year ended December 31, 2007 compared with the prior year was due, in part, to our efforts to grow TACLONEX. During the year ended December 31, 2007, we implemented marketing strategies to encourage physicians to prescribe TACLONEX instead of DOVONEX as we believe that TACLONEX is a superior topical therapy.

Sales of our hormone therapy products increased $19.1 million, or 13.0%, in the year ended December 31, 2007, compared with the prior year. FEMHRT filled prescriptions declined 8.3% in the year ended December 31, 2007 compared with the prior year, the impact of which was more than offset by higher selling prices. Filled prescriptions for ESTRACE Cream declined 2.2% in the year ended December 31, 2007, compared with the prior year. This increase was more than offset by higher selling prices. Sales of SARAFEM, our product used to treat symptoms of PMDD, decreased

 

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$0.2 million, or 0.6%, in the year ended December 31, 2007, compared with the prior year. The decrease in sales was due to the decline in filled prescriptions of 23.8% in the year ended December 31, 2007, compared to the prior year. This decrease was partially offset by price increases.

Our contract manufacturing revenues relate to certain products manufactured for Pfizer and Teva. Additionally in the year ended December 31, 2007, we generated $11.4 million of revenue which consisted of royalties earned on the net sales of a product sold by a third party under a license relating to one of our patents, as compared to $2.6 million in the year ended December 31, 2006.

Cost of Sales (excluding Amortization and Impairment of Intangible Assets)

The table below shows the calculation of cost of sales and cost of sales percentage for the years ended December 31, 2007 and 2006:

 

     Year Ended
December 31,
2007
    Year Ended
December 31,
2006
    $
Change
   Percent
Change
 
     ($ in millions)  

Product net sales

   $ 888.2      $ 751.9      $ 136.3    18.1

Cost of sales (excluding amortization)

     186.0        151.8        34.2    22.6

Cost of sales percentage

     20.9     20.2     

Cost of sales increased $34.2 million in the year ended December 31, 2007, compared with the prior year, primarily due to the 18.1% increase in product net sales. Our cost of sales, as a percentage of product net sales, increased from 20.2% in the year ended December 31, 2006 to 20.9% in the year ended December 31, 2007. The increase was due to a number of factors, including the mix of products sold, with net sales of DOVONEX and TACLONEX accounting for 30.7% of our product net sales for the year ended December 31, 2007, compared with 27.5% in the prior year. The cost of sales for DOVONEX and TACLONEX (which includes royalties based on our net sales, as defined in the relevant supply agreements), expressed as a percentage of product net sales, are significantly higher than the cost of sales for our other products. Under our contract with Bristol-Myers, which expired on December 31, 2007, we were required to pay royalties of 5.0% on our product net sales of DOVONEX. Our cost of sales was also increased during the year ended December 31, 2007 as a result of a $3.6 million expense relating to inventories of certain DOVONEX products which were not sold due to a shift in our marketing strategies relating to DOVONEX.

SG&A Expenses

The Company’s SG&A expenses were comprised of the following for the years ended December 31, 2007 and 2006:

 

     Year Ended
December 31,
2007
   Year Ended
December 31,
2006
   $
Change
    Percent
Change
 
     ($ in millions)  

A&P

   $ 81.0    $ 72.0    $ 9.0      12.5

Selling and Distribution

     89.5      75.8      13.7      18.1

G&A

     95.3      106.1      (10.8   (10.2 )% 
                            

Total

   $ 265.8    $ 253.9    $ 11.9      4.7
                            

SG&A expenses for the year ended December 31, 2007 were $265.8 million, an increase of $11.9 million, or 4.7%, compared to the prior year. A&P expenses for the year ended December 31, 2007 increased $9.0 million, or 12.5%, over the prior year, primarily due to a $17.3 million increase in

 

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direct-to-consumer advertising expenses in support of LOESTRIN 24 FE and FEMCON FE. The increase in direct-to-consumer spending was partially offset by launch costs incurred in the year ended December 31, 2006 in support of LOESTRIN 24 FE and TACLONEX. Selling and distribution expenses for the year ended December 31, 2007 increased $13.7 million, or 18.1%, over the prior year primarily due to the expansion by approximately 75 territories to our field sales forces, in the first half of 2007, to support the initiation of promotional activities for FEMCON FE. G&A expenses in the year ended December 31, 2007 decreased $10.8 million, or 10.2%, as compared to the prior year primarily due to the one-time IPO costs of $42.1 million in the year ended December 31, 2006. The decrease was offset in part by an increase in legal expenses of $27.9 million in the year ended December 31, 2007, which included $26.5 million for the settlements of certain legal matters related to the OVCON 35 litigation.

R&D

Our investment in R&D for the year ended December 31, 2007 was $54.5 million, an increase of $27.7 million, or 103.3%, compared with the prior year. Included in the year ended December 31, 2007 was a $4.0 million upfront payment to Paratek to acquire certain rights to novel tetracyclines for the treatment of acne and rosacea. Also included in the year ended December 31, 2007 was a $10.0 million milestone payment to Leo, which was triggered by the FDA’s acceptance of Leo’s NDA submission for a TACLONEX scalp product. R&D expense for the year ended December 31, 2006 included a $3.0 million expense representing our cost to acquire an option to purchase certain rights with respect to a topical dermatology product currently in development by Leo. Excluding the payments to Leo in the years ending December 31, 2007 and 2006, and to Paratek in the year ended December 31, 2007, R&D expense increased $16.7 million, or 70.2%, in the year ended December 31, 2007, compared to the prior year due to the increased level of clinical study activity during the 2007 period. More specifically, we completed the enrollment of one clinical study for a low-dose oral contraceptive in July 2007 and completed the enrollment of another clinical study for an oral contraceptive in December 2007.

Amortization of Intangible Assets

Amortization of intangible assets in the years ended December 31, 2007 and 2006 was $228.3 million and $253.4 million, respectively. Our amortization methodology is calculated on either an accelerated or a straight-line basis to match the expected useful life of the asset, with identifiable assets assessed individually or by product family. As a result of changing assumptions in evaluating intangible assets for impairment, certain assets which are not impaired may be subject to a change in amortization recognized in future periods to approximate expected future cash flows.

Net Interest Expense

Net interest expense for the year ended December 31, 2007 was $117.6 million, a decrease of $89.4 million, or 43.2%, from $207.0 million in the prior year. Included in net interest expense in the years ended December 31, 2007 and 2006 were $6.6 million and $19.8 million, respectively, relating to the write-off of deferred loan costs associated with the optional prepayments of debt. In the year ended December 31, 2007, we made optional prepayments totaling $340.0 million of outstanding indebtedness under our prior senior secured credit facilities. In the year ended December 31, 2006, we made optional prepayments totaling $455.0 million of outstanding indebtedness under our senior secured credit facility and redeemed $210.0 million aggregate principal amount of our existing notes. The decrease in net interest expense in the year ended December 31, 2007 was primarily the result of the above mentioned prepayments of our outstanding debt which reduced the weighted average debt outstanding in the year ended December 31, 2007 by $642.5 million as compared to the prior year. The cumulative reductions in debt were accomplished through the use of cash generated from our free cash flow during the previous five quarters ended December 31, 2007 and proceeds from our IPO.

 

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Accretion on Preferred Stock in Subsidiary

Total accretion on the Preferred Shares for the year ended December 31, 2006 was $26.2 million. The Preferred Shares were redeemed for cash or converted to Class A common shares in conjunction with the IPO in September 2006. There was no accretion on the Preferred Shares in the year ended December 31, 2007 and there will be no future accretion on the Preferred Shares.

Provision / (Benefit) for Income Taxes

Our effective tax rate for the years ended December 31, 2007 and 2006 was 38.9% and (6.8%), respectively. The tax provision for the year ended December 31, 2007 includes a $4.7 million expense related to our ASC 740 liabilities, of which $3.9 million relates to accrued interest. In addition, we recorded a tax benefit of $3.1 million related to the release of a deferred state tax valuation allowance.

Our corporate effective tax rate with respect to any period may be volatile based on the mix of income in the tax jurisdictions in which we operate and the amount of our consolidated income before taxes. For the year ended December 31, 2007, our U.S. entities generated almost two-thirds of our consolidated book income before taxes. Our Puerto Rican subsidiary holds the majority of our intangible assets and records the majority of the related amortization expense. As a result, the proportion of our consolidated book income before taxes generated in Puerto Rico, where our tax rate is 2.0%, was low relative to the proportion of our consolidated book income generated in the other jurisdictions, where our tax rate may be higher. Our corporate effective tax rate in 2007 was also unfavorably impacted by U.S. state income taxes and U.S. permanent non-deductible tax adjustments, which resulted in our tax rate on U.S. activities being higher than the federal statutory rate of 35.0%. The effective tax rate for the year ended December 31, 2006 was favorably impacted due primarily to the expense mix of the IPO-related costs amongst the various jurisdictions.

The valuation allowance for deferred tax assets of $11.8 million and $17.8 million as of December 31, 2007 and 2006, respectively, relates principally to the uncertainty of the utilization of certain deferred tax assets, primarily tax loss carryforwards in various jurisdictions. We expect to generate sufficient future taxable income to realize the tax benefits related to the remaining net deferred tax assets on our consolidated balance sheets. The valuation allowance was calculated in accordance with the provisions of ASC 740, which requires a valuation allowance be established or maintained when it is “more likely than not” that all or a portion of deferred tax assets will not be realized.

Our calculation of tax liabilities involves uncertainties in the application of complex tax regulations in various tax jurisdictions. Amounts related to tax contingencies that management has assessed as unrecognized tax benefits have been appropriately recorded under the provisions of ASC 740. For any tax position, a tax benefit may be reflected in the financial statements only if it is “more likely than not” that we will be able to sustain the tax return position, based on its technical merits. Potential liabilities arising from tax positions taken are recorded based on our estimate of the largest amount of benefit that is cumulatively greater than 50 percent. These liabilities may be adjusted to take into consideration changing facts and circumstances. Due to the complexity of some of these uncertainties, the ultimate resolution may result in a payment that is different from the current estimate of the tax liabilities. These potential tax liabilities are recorded in accrued expenses in the consolidated balance sheets. We intend to continue to reinvest accumulated earnings of our subsidiaries for the foreseeable future; as such, no additional provision has been made for U.S. or non-U.S. income taxes on the undistributed earnings of subsidiaries or for differences related to investments in subsidiaries.

Net Income / (Loss)

Due to the factors described above, we reported net income / (loss) of $28.9 million and $(153.5) million in the years ended December 31, 2007 and 2006, respectively.

 

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PGP Results of Operations

The table below summarizes PGP’s results from operations for the three months ended September 30, 2009 and 2008 and the years ended June 30, 2009, 2008 and 2007 and the changes for 2009 compared with 2008 and for 2008 compared with 2007:

 

    Three-Month Period
Ended
September 30,
    Fiscal Year Ended
June 30,
    Increase (Decrease)  
        F2008 vs. F2007     F2009 vs. F2008  
        2008             2009         2007     2008     2009     Dollars     Percent     Dollars     Percent  
    ($ in millions)  

Net sales

  $ 602      $ 578      $ 2,445      $ 2,532      $ 2,318      $ 87      4   $ (214   (8 )% 

Cost of products sold

    60        45        262        248        217        (14   (5 )%      (31   (12 )% 
                                                                   

Gross profit

    542        533        2,183        2,284        2,100        101      5     (184   (8 )% 

Gross profit margin

    90     92     89     90     91        

SG&A and R&D expense

    220        166        1,034        1,000        826        (34   (3 )%      (174   (17 )% 

Other operating expense (income)

    99        (62     596        604        456        8      1     (148   (24 )% 
                                                                   

Operating income

    223        429        553        680        819        127      23     139      20

Income taxes

    76        145        164        211        279        47      29     68      32
                                                                   

Net income

  $ 147      $ 284      $ 389      $ 469      $ 539      $ 80      21   $ 70      15
                                                                   

PGP’s fiscal year ends June 30. Our fiscal year ends December 31, and we will continue to operate on a calendar-year basis after the PGP Acquisition. The following discussion of PGP’s results covers the three months ended September 30, 2009 and 2008 and the three years ended June 30, 2009, 2008 and 2007.

PGP Operating Results for the Three Months ended September 30, 2009 and 2008

For the three-months ended September 30, 2009 compared with the prior year, PGP’s operating income (including the impact of gains of $36 million and $194 million for the three months ended September 30, 2008 and 2009, respectively) increased $206 million, as reductions in operating and other costs more than offset a 4% decline in revenue. Net sales declines in ACTONEL were offset, in part, by an increase in ASACOL as a result of the sales of the 800 mg product which was launched in June 2009.

Net sales of ACTONEL declined as compared with the prior year mainly due to the continued decreased demand in the United States. Net sales of ASACOL increased driven by the new 800 mg product, which was launched in the United States in June 2009. Revenue from ENABLEX increased over the prior year period. The remaining decrease was due to decreases from other minor brands, most significantly the continued decline of DIDRONEL, primarily from the loss of exclusivity in Canada.

SG&A and R&D expense declined $54 million, or 25%, in 2009 compared with 2008. The decease was driven by a decline in R&D of $17 million, or 36%, selling expenses of $14 million, or 21%, marketing expenses of $10 million, or 23%, and administrative expenses of $5 million, or 17%. The reduction in operating costs was a result of steps taken by PGP to reduce costs and maximize profitability in light of the ACTONEL franchise facing the loss of exclusivity in the major Western European markets beginning in 2010. Also, restructuring expense of $10 million was included in the prior year, compared with only $2 million in the three months ended September 30, 2009.

 

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Other operating (income) / expense includes the amount paid to Sanofi under the global collaboration agreement, as well as other expenses, net of gains realized on the sale of divested assets. Other operating income was $62 million for the three months ended September 30, 2009 compared with the prior year expense of $99 million. The difference of $161 million is primarily the result of increases in net gains on sales of divestitures of $158 million (as the three months ended September 30, 2009 included the gain of $194 million from the sale of ACTONEL market rights in Japan to Ajinomoto Company) and lower Sanofi obligations of $13 million from lower ACTONEL sales, offset, partially by higher other expenses.

PGP’s effective tax rate remained relatively flat at 34% for the three-months ended September 2009 and 2008.

PGP Operating Results for the Years ended June 30, 2009 and 2008

For the year ended June 30, 2009 compared with the prior year, PGP’s operating income increased 20% as reductions in operating and other costs more than offset an 8% decline in revenue.

Net sales of ACTONEL declined $169 million, or 11% compared with the prior year mainly due to decreased demand in the United States, particularly in the first and second calendar quarters, due to the impact of aggressive managed care initiatives implemented to favor use of generic versions of once-a-week FOSAMAX. The impact of these program changes were most pronounced in the first calendar quarter of 2009 and moderated in the second quarter. Net sales of ASACOL increased $28 million, or 4%, as the impact of slightly decreased demand in the U.S. market was more than offset by higher net selling prices. ASACOL sales outside the United States, mainly in the United Kingdom, were essentially flat compared with 2008. Revenue from ENABLEX increased $7 million. Global DIDRONEL sales decreased $22 million primarily from the loss of exclusivity on DIDROCAL in Canada. The remaining basket of “all other” products includes smaller generally non-promoted products mainly outside the United States and is expected to continue to decline in the future. Sales of these products decreased $58 million compared to the prior year (from divested brands and to a lesser extent foreign currency exchange fluctuations). Net sales of PGP products in the aggregate are expected to decline over the next several years. In particular, ACTONEL will lose exclusivity in the major Western European markets beginning in 2010. See also “Factors Affecting our Results of Operations—Net Sales.”

SG&A expense and R&D expense declined $174 million in 2009 compared with 2008. More than half of the decrease was outside the United States as PGP pared its selling, marketing, R&D and administrative costs by $90 million or 28% as steps were taken to reduce costs and maximize profitability in light of the ACTONEL franchise facing the loss of exclusivity in the major Western European markets beginning in 2010. Operating costs in North America, other than R&D, decreased a more modest $14 million, or 3%, while R&D in North America decreased $69 million as PGP adjusted the portfolio of product development projects to focus more on improvements to currently marketed brands and away from more costly, higher risk, potentially higher reward projects, resulting in headcount reductions and decreased costs for outside services.

Other operating expense includes the amount paid to Sanofi under the global collaboration agreement as well as other expenses and is net of gains realized on the sale of divested assets. Other operating expense decreased $148 million in 2009 compared with 2008 due to a $74 million or 14% decrease in the 2009 Sanofi expense driven by lower global ACTONEL sales and $69 million more gains on divested assets in 2009 compared to 2008.

PGP’s effective tax rate increased in 2009 to 34% from 31% in 2008 mainly due to the change in mix of pre-tax income between the United States and the other foreign jurisdictions where PGP operates.

 

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PGP Operating Results for the Years ended June 30, 2008 and 2007

For the year ended June 30, 2008 compared with the prior year, PGP’s revenue increased 4% while operating and other costs were reduced, which resulted in a 23% increase in operating income.

Net sales of ACTONEL increased $43 million, or 3%, in 2008 compared to the prior year. ACTONEL sales in the United States accounted for most of the increase, as sales outside the United States were essentially flat. Increased net selling prices in the United States for ACTONEL more than offset decreased demand. During 2008, ACTONEL lost market share in the United States to both once-a-month BONIVA and to generic versions of FOSAMAX, which made an impact beginning in February of 2008. Net sales of ASACOL increased $38 million or 6% as the impact of modestly decreased demand in the U.S. market due to competitive pressure from LIALDA was more than offset by higher net selling prices. ASACOL sales outside the United States, mainly in the United Kingdom, were essentially flat compared with 2007. Revenue from ENABLEX increased $14 million and all other products decreased $8 million, or 3%, compared to the prior year. The basket of all “all other” products includes smaller generally non-promoted products mainly outside the United States and is expected to decline in the future.

SG&A expense and R&D expense declined $34 million, or 3%, in 2008 compared with 2007. Increased general and administrative costs were more than offset by a reduction in research and development expense and a modest decrease in selling expense.

Other operating expense includes the amounts due to Sanofi under the global collaboration agreement as well as other expenses and is net of gains realized on the sale of divested assets. Other operating expense in 2008 was essentially flat compared to 2007.

PGP’s effective tax rate increased slightly in 2008 to 31% from 30% in 2007, mainly due to a slight change in the mix of pre-tax income between the United States and the other foreign jurisdictions where PGP operates.

Financial Condition, Liquidity and Capital Resources

Our principal sources of liquidity are cash flow from operations and borrowings under our new senior secured credit facilities. Our principal uses of cash are debt service requirements, capital expenditures and, potentially, acquisitions and in-licensing arrangements. We believe that these funds will provide us with sufficient liquidity and capital resources for us to meet our current and future financial obligations, including our scheduled principal and interest payments, as well as to provide funds for working capital, capital expenditures and other needs for at least the next twelve months.

Cash Flows

Nine Months Ended September 30, 2009 and 2008

At September 30, 2009, our cash on hand was $753.7 million, as compared to $35.9 million at December 31, 2008. At September 30, 2009, our total debt was $380.0 million and consisted of the aggregate principal amount of our outstanding existing notes. At December 31, 2008, our cash on hand was $35.9 million, as compared to $30.8 million at December 31, 2007. At December 31, 2008, our debt, net of cash, was $926.7 million and consisted of $582.6 million of borrowings under our prior senior secured credit facilities plus $380.0 million aggregate principal amount of our outstanding existing notes, less $35.9 million of cash on hand.

 

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The following table summarizes our net increase / (decrease) in cash and cash equivalents for the nine months ended September 30, 2009 and 2008:

 

     Nine Months Ended
September 30, 2009
    Nine Months Ended
September 30, 2008
 
     ($ in millions)  

Net cash provided by operating activities

   $ 340.9      $ 210.2   

Net cash provided by / (used in) investing activities

     958.5        (62.0

Net cash (used in) financing activities

     (581.6     (165.7
                

Net increase / (decrease) in cash and cash equivalents

   $ 717.8      $ (17.5
                

Our net cash provided by operating activities for the nine months ended September 30, 2009 increased $130.7 million over the prior year period. We reported net income of $523.6 million in the nine months ended September 30, 2009, of which $380.1 million related to the gain on the LEO Transaction ($393.1 million before tax), as compared to $107.3 million in the nine months ended September 30, 2008. In the nine months ended September 30, 2009, we paid $34.4 million in respect of income taxes as compared to $85.4 million in the prior year period. During the nine months ended September 30, 2008, the income tax payments were made primarily based upon (1) estimates of the amounts payable in connection with the anticipated final settlement of U.S. federal tax audits related to the tax periods ended September 30, 2003, September 30, 2004, January 17, 2005 and December 31, 2005, (2) estimates of U.S. income taxes for the December 31, 2007 and 2008 tax years, and (3) amended income tax returns filed for the tax year ended December 31, 2006 resulting from the APA signed with the IRS. Our liability for unrecognized tax benefits (including interest) under ASC Topic 740, “Accounting for Income Taxes” (“ASC 740”), which is expected to settle within the next twelve months is $1.9 million. Our liability for unrecognized tax benefits (including interest) under ASC 740 which is expected to settle after twelve months is $2.2 million. Also impacting our cash flows from operating activities relative to the prior year period was a $9.0 million cash payment made in the nine months ended September 30, 2008 relating to the final settlement of our OVCON 35 litigation which was included in net income in the year ended December 31, 2007.

Our net cash provided by investing activities during the nine months ended September 30, 2009 totaled $958.5 million, consisting of $1.0 billion of proceeds from the LEO Transaction, offset by $8.7 million of contingent purchase consideration paid to Pfizer in connection with the 2003 acquisition of FEMHRT and $32.8 million relating to capital expenditures. The cash flows used in investing activities in the nine months ended September 30, 2008 totaled $62.0 million, consisting of $8.7 million of contingent purchase consideration paid to Pfizer in connection with the 2003 acquisition of FEMHRT, $40.0 million to acquire the rights to sell TACLONEX Scalp, and $13.3 million relating to capital expenditures. Our capital expenditures in 2009 have increased significantly over the 2008 levels primarily due to continued investments in our Fajardo, Puerto Rico manufacturing facility.

Our net cash used in financing activities in the nine months ended September 30, 2009 was $581.6 million. This included the prepayment in full of the remaining $582.6 million of indebtedness under our prior senior secured credit facilities. Our net cash used in financing activities in the nine months ended September 30, 2008 was primarily the result of our repayment of $166.0 million of debt under the prior senior secured credit facilities.

We currently intend to use future cash flows provided by operating activities, net of cash used in investing activities, to make optional prepayments of our long-term debt or purchases of such debt in privately negotiated or open market transactions, by tender offer or otherwise.

 

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Year Ended December 31, 2008 and 2007

The following table summarizes our net increase / (decrease) in cash and cash equivalents for the year ended December 31, 2008 and 2007:

 

     Year Ended
December 31, 2008
    Year Ended
December 31, 2007
 
     ($ in millions)  

Net cash provided by operating activities

   $ 313.3      $ 339.6   

Net cash (used in) investing activities

     (71.9     (42.8

Net cash (used in) financing activities

     (236.3     (350.5
                

Net increase / (decrease) in cash and cash equivalents

   $ 5.1      $ (53.7
                

Our net cash provided by operating activities for the year ended December 31, 2008 decreased $26.3 million compared with the prior year. We reported a net (loss) of $(8.4) million for the year ended December 31, 2008 as compared to net income of $28.9 million for the prior year. The year ended December 31, 2008 included a non-cash impairment of intangible assets of $163.3 million. In addition, during the year ended December 31, 2008, we paid amounts in respect of income taxes totaling $99.5 million as compared $9.6 million in the prior year. During the year ended December 31, 2008, the income tax payments were made primarily based upon (1) estimates of the amounts payable in connection with the settlement of U.S. federal tax audits related to the tax periods ended September 30, 2003, September 30, 2004, January 17, 2005 and December 31, 2005, (2) estimates of U.S. income taxes for the December 31, 2007 and 2008 tax years and (3) amended income tax returns filed for the tax year ended December 31, 2006 resulting from the APA signed with the IRS. Our liability for unrecognized tax benefits (including interest) under ASC 740 which is expected to settle within the next twelve months is $2.4 million. Our liability for unrecognized tax benefits (including interest) under FIN48 which is expected to settle after twelve months is $2.3 million. Also impacting our cash flows from operating activities was a $9.0 million cash payment made in the quarter ended March 31, 2008 relating to the final settlement of the Company’s OVCON 35 litigation which was included in net income in the year ended December 31, 2007.

Our net cash used in investing activities during the year ended December 31, 2008 totaled $71.9 million, consisting of $11.6 million of contingent purchase consideration paid to Pfizer in connection with the 2003 acquisition of FEMHRT, $40.0 million to acquire the rights to sell the TACLONEX scalp product and $20.3 million relating to capital expenditures. The cash flows used in investing activities in the year ended December 31, 2007 consisted of $24.0 million of contingent purchase consideration paid to Pfizer in connection with the 2003 acquisitions of ESTROSTEP FE and FEMHRT and $18.8 million of capital expenditures.

Our net cash used in financing activities in the year ended December 31, 2008 was $236.3 million and included scheduled repayments of $7.7 million and optional prepayments of $220.0 million of debt under our prior senior secured credit facilities. During the year ended December 31, 2008, we also purchased and retired $10.0 million of aggregate principal amount of existing notes, at a discount, in privately negotiated open market transactions. Our net cash used in financing activities in the year ended December 31, 2007 was primarily the result of our repayment of $350.5 million of term debt under our prior senior secured credit facilities.

Debt

On a pro forma basis, as of September 30, 2009, we had total indebtedness of approximately $2.98 billion and $250.0 million of borrowings available under the revolving facility of our new senior secured credit facilities, subject to customary conditions.

 

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Prior Senior Secured Credit Facilities

On January 18, 2005, Warner Chilcott Holdings Company III, Limited and its subsidiaries, Warner Chilcott Corporation (“WCC”) and Warner Chilcott Company, Inc. (“WCCI”), entered into $1.79 billion senior secured credit facilities, with Credit Suisse as administrative agent and lender, and other lenders and parties thereto. The prior senior secured credit facilities consisted of a $1.64 billion term loan facility and a $150.0 million revolving credit facility, of which $30.0 million and $15.0 million were available for letters of credit and swing line loans, respectively, to WCC and WCCI. The prior senior secured credit facilities also contemplated up to three uncommitted tranches of term loans up to an aggregate of $250.0 million. However, the lenders were not committed to provide these additional tranches.

All of the outstanding debt under the prior senior secured credit facilities was repaid with a portion of the proceeds of the LEO Transaction.

Existing Notes

On January 18, 2005, WCC issued $600.0 million aggregate principal amount of 8.75% notes due 2015 (the “existing notes”). In connection with the IPO, WCC exercised its option to redeem $210.0 million aggregate principal amount of the existing notes on October 31, 2006 for a total price of $228.4 million (108.75% of the principal amount), plus accrued interest. In addition, during the fourth quarter of 2008, WCC purchased and retired $10.0 million aggregate principal amount of the existing notes, at a discount, in privately negotiated open market transactions.

As of September 30, 2009, the existing notes were guaranteed on a senior subordinated basis by the Company, Holdings III, WC Luxco S.à r.l, Warner Chilcott Intermediate (Luxembourg) S.à r.l., WC Pharmaceuticals I Limited, our U.S. operating subsidiary (Warner Chilcott (US), LLC) and WCCL (collectively, the “existing notes guarantors”). Interest payments on the existing notes are due semi-annually in arrears on each February 1 and August 1. The issuance costs related to the existing notes are being amortized to interest expense over the ten-year term of the existing notes using the effective interest method. The existing notes are unsecured senior subordinated obligations of WCC, are guaranteed on an unsecured senior subordinated basis by the existing notes guarantors and rank junior to all existing and future senior indebtedness, including indebtedness under our senior secured credit facilities.

All or some of the existing notes may be redeemed at any time prior to February 1, 2010 at a redemption price equal to par plus a “make-whole” premium specified in the indenture. On or after February 1, 2010, WCC may redeem all or some of the existing notes at redemption prices declining from 104.38% of the principal amount to 100.00% on or after February 1, 2013.

New Senior Secured Credit Facilities

The new senior secured credit facilities consist of a five-year $250.0 million revolving credit facility and an aggregate of $2.95 billion in term loan facilities, primarily comprised of a $1.0 billion five-year Term A loan facility and a $1.6 billion five-and-a-half-year Term B loan facility. We borrowed $2.6 billion under the term loan facilities to fund the PGP Acquisition. At our election, up to $350.0 million under the term loan facilities will be available as a delayed draw term loan facility, which may be drawn at any time on or prior to 180 days following the closing of the PGP Acquisition to pay our obligations in connection with the Sanofi Put, subject to conditions. Borrowings under the new senior secured credit facilities will generally bear interest based on a margin over, at our option, the base rate or the reserve-adjusted LIBOR (with a LIBOR floor of 2.25%). The new senior secured credit facilities will be secured by first priority interests in substantially all of the tangible and intangible assets owned by the borrowers and guarantors under such facilities.

 

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Capital expenditures

We anticipate that our capital expenditures following the Transactions, as a percentage of revenue, will not exceed our capital expenditures for the nine months ended September 30, 2009, as a percentage of revenue.

Acquisitions

As a part of our business strategy, from time to time we consider acquisitions, in-licensing and partnership opportunities involving complimentary products. We cannot guarantee that any such transactions will be consummated.

Contractual Commitments

The following table summarizes our financial commitments as of December 31, 2008 on an actual basis without giving effect to the Transactions:

 

     Cash Payments Due by Period
     Total    Less than 1
Year
   From 1 to 3
Years
   From 4 to 5
Years
   More than 5
Years
     ($ in millions)

Long-term debt:

              

Prior senior secured credit facilities

   $ 582.6    $ 6.0    $ 10.5    $ 566.1    $ —  

Existing notes

     380.0      —        —        —        380.0

Interest payments on long-term debt(1)

     282.0      62.0      107.0      71.4      41.6

Supply agreement obligations(2)

     72.2      53.0      19.2      —        —  

Lease obligations

     9.2      3.6      3.6