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Warner Chilcott 10-K 2008
Form 10-K
Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 10-K

 

 

(Mark One)

þ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the year ended December 31, 2007

or

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from              to             

Commission File Number 1-33039

 

 

WARNER CHILCOTT LIMITED

(Exact name of Registrant as specified in its charter)

 

 

 

Bermuda   98-0496358

(State or Other Jurisdiction of

Incorporation or Organization)

 

(I.R.S. — Employer

Identification Nos.)

Channel House

Suite 3-105

Longfield Road

Southside, St. David’s

Bermuda

(Address of principal executive offices)

Registrant’s telephone number, including area code: (441) 292-0068

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

 

Title of each class

 

Name of each exchange on which registered

Common Stock, $0.01 par value   The NASDAQ Global Market

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

 

 

Indicate by check mark whether the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.    Yes  þ    No  ¨

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.    Yes  ¨    No  þ

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

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

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definition of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer  þ   Accelerated filer  ¨    Non-accelerated filer  ¨   Smaller reporting company  ¨
     (Do not check if a smaller
reporting company)
 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act.)    Yes  ¨    No  þ

The aggregate market value of common stock held by non-affiliates as of June 30, 2007 was approximately $1,988.3 million, using the closing price per share of $18.09, as reported on The NASDAQ Global Market as of such date. Shares of common stock held by the executive officers and directors and our controlling shareholders have been excluded from this calculation because such persons may be deemed to be affiliates. This determination of affiliate status is not necessarily a conclusive determination for other purposes.

As of February 15, 2008, the number of shares of the Registrant’s common stock, par value $0.01 per share, outstanding was 250,587,497.

DOCUMENTS INCORPORATED BY REFERENCE

Certain information required by Part III of this Annual Report on Form 10-K (“Annual Report”) is incorporated by reference from the Registrant’s proxy statement to be filed pursuant to Regulation 14A with respect to the Registrant’s Annual Meeting of Shareholders to be held on May 8, 2008.

 

 

 


Table of Contents

WARNER CHILCOTT LIMITED

INDEX

 

   PART I.   

Item 1.

   Business      1

Item 1A.

   Risk Factors    18

Item 1B.

   Unresolved Staff Comments    32

Item 2.

   Properties    32

Item 3.

   Legal Proceedings    32

Item 4.

   Submission of Matters to a Vote of Security Holders    32
   PART II.   

Item 5.

   Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities    33

Item 6.

   Selected Financial Data    35

Item 7.

   Management’s Discussion and Analysis of Financial Condition and Results of Operations    38

Item 7A.

   Quantitative and Qualitative Disclosures About Market Risk    65

Item 8.

   Financial Statements and Supplementary Data    65

Item 9.

   Changes in and Disagreements with Accountants on Accounting and Financial Disclosure    65

Item 9A.

   Controls and Procedures    66

Item 9B.

   Other Information    66
   PART III.   

Item 10.

   Directors, Executive Officers and Corporate Governance    67

Item 11.

   Executive Compensation    67

Item 12.

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

67

Item 13.

   Certain Relationships and Related Transactions, and Director Independence    67

Item 14.

   Principal Accounting Fees and Services    67
   PART IV.   

Item 15.

   Exhibits, Financial Statement Schedules    68

Signatures

   69

 

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PART I.

Item 1. Business

Business Overview

We are a leading specialty pharmaceutical company currently focused on the women’s healthcare and dermatology segments of the U.S. pharmaceutical market. We are a fully integrated company with internal resources dedicated to the development, manufacturing and promotion of our products. We have established strong franchises in women’s healthcare and dermatology through our marketing techniques and specialty sales forces, which now comprise approximately 500 representatives. We believe that our proven product development capabilities, coupled with our ability to execute acquisitions and in-licensing transactions and develop partnerships, such as our relationship with LEO Pharma A/S (“LEO Pharma”), will enable us to sustain and grow these franchises. Our primary manufacturing facility is located in Fajardo, Puerto Rico.

Our franchises are comprised of complementary portfolios of established branded and development-stage products. Our women’s healthcare franchise is anchored by our strong presence in the hormonal contraceptive and hormone therapy (“HT”) categories and our dermatology franchise is built on our established positions in the markets for psoriasis and acne therapies. In women’s healthcare, we currently promote two oral contraceptives: LOESTRIN 24 FE and FEMCON FE. LOESTRIN 24 FE features a novel patented 24-day dosing regimen, which delivers an important patient benefit – shorter, lighter periods. FEMCON FE is the only oral contraceptive containing 35 mcg of ethinyl estradiol currently being actively promoted to Obstetrician/Gynecologists (“OB/GYNs”). We also have a significant presence in the HT market, primarily through our products FEMHRT, ESTRACE Cream and FEMRING. In dermatology, our psoriasis product DOVONEX Cream enjoys the leading position in the United States for the non-steroidal topical treatment of psoriasis. In addition, our product TACLONEX is the first and only once-a-day topical psoriasis treatment that combines a corticosteroid (betamethasone dipropionate) and calcipotriene, the active ingredient in DOVONEX Cream. We believe that TACLONEX is a superior topical therapy and promote it as the first line topical therapy for mild to moderate psoriasis. Our product, DORYX is one of the leading branded oral tetracyclines in the United States for the treatment of acne.

Our strategy is to grow our specialty pharmaceutical products business by focusing on therapeutic areas dominated by specialist physicians. We believe that we will continue to drive organic growth by employing our marketing techniques. Furthermore, we intend to supplement our growth and broaden our market position in our existing franchises through ongoing product development. Our internal product development is focused on new products, proprietary product improvements and new and enhanced dosage forms. In addition, we selectively review potential product in-licensing, acquisition and partnership opportunities, such as our relationship with LEO Pharma and our recent in-licensing arrangements with NexMed, Inc. (“NexMed”) and Paratek Pharmaceuticals, Inc. (“Paratek”).

The U.S. pharmaceutical market generated sales of approximately $298.9 billion in 2007 and has grown at a compound annual growth rate of approximately 7.2% since 2001, according to IMS Health, Inc. Large pharmaceutical companies have been focusing on developing and marketing “blockbuster” drugs that have the potential of generating more than $1 billion in annual revenues. The focus by large pharmaceutical companies on “blockbuster” products creates opportunities for specialty pharmaceutical companies, like us, to compete effectively in smaller therapeutic markets.

For the year ended December 31, 2007, we recorded net income of $28.9 million on revenues of $899.6 million. For the year ended December 31, 2006, we recorded a net loss of $153.5 million on revenues of $754.5 million. For the year ended December 31, 2005, we recorded a net loss of $556.6 million on revenues of $515.3 million. As of December 31, 2007, 2006 and 2005, we had total assets of $2,885.0 million, $3,162.5 million and $3,041.9 million, respectively.

 

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Strategy

We intend to continue to develop our specialty pharmaceutical products business by focusing on therapeutic markets, such as women’s healthcare and dermatology, dominated by specialist physicians. Our goal is to drive organic growth by employing our marketing techniques, developing and marketing new products and selectively reviewing potential product in-licensing, acquisition and partnership opportunities, such as our relationship with LEO Pharma and our recent in-licensing arrangements with NexMed and Paratek. We believe that our streamlined corporate organization and resulting ability to react rapidly to changing market dynamics enhances our ability to execute our strategy.

Focus on Smaller Therapeutic Markets. While large pharmaceutical companies are focusing on developing and marketing “blockbuster” drugs that have the potential of generating more than $1 billion in annual revenues, we concentrate our efforts on branded products that are prescribed by physician specialists or where a high concentration of prescriptions for the products are written by a relatively small number of physicians. In either case, we have the ability to effectively and efficiently reach the target prescribers through our sales forces. We currently market a range of established specialty pharmaceutical products in several therapeutic categories within our women’s healthcare and dermatology franchises. In our women’s healthcare franchise, we are focusing on the oral contraceptive market, although we also have a significant presence in the hormone therapy market. In our dermatology franchise, we are focusing on the psoriasis and acne therapeutic categories. The relatively small number of physicians that comprise our target markets allow us to focus our sales representatives on the physicians with the most potential to write prescriptions for our products.

Drive Organic Growth. We seek to drive organic growth of our women’s healthcare and dermatology product franchises by employing our marketing techniques. We identify the OB/GYNs and dermatologists who are frequent prescribers of products in our categories and then target our sales forces’ activities to reach these physicians. Our sales forces promote our products to these high prescribing physicians with frequent face-to-face product presentations and by providing a consistent supply of product samples. Our sales representatives also strive to build strong professional relationships with their target physicians to maximize the impact of our selling efforts. We measure the performance of our sales representatives based on increases in market share of our promoted products.

Develop and Market New Products, Proprietary Product Improvements and New and Enhanced Dosage Forms. Our product development is focused on new products with established regulatory guidance, extending proprietary protection of our products through proprietary product improvements and new and enhanced dosage forms, rather than on undertaking the costly, high-risk new drug discovery approach usually undertaken by large pharmaceutical and biotechnology companies. We have an experienced development team of scientists and technicians with proven expertise in the development of such products and have consistently demonstrated our ability to commercialize our products. By targeting our research and development efforts on our existing therapeutic categories, we believe we will be able to leverage the professional relationships our sales forces have built with high-prescribing specialist physicians.

Since March 2003, we have received approval from the U.S. Food and Drug Administration (“FDA”) for the following products:

 

   

FEMRING

 

   

FEMCON FE

 

   

FEMTRACE

 

   

DORYX delayed-release tablets

 

   

low dose FEMHRT

 

   

LOESTRIN 24 FE

 

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Selectively Review Potential Product In-Licensing, Acquisition and Partnership Opportunities. We intend to continue to evaluate opportunities to expand our pharmaceutical product portfolio by selectively reviewing potential product in-licensing, acquisition and partnership opportunities, such as our relationships with LEO Pharma, NexMed and Paratek. We focus on market segments that have characteristics similar to our current markets, which complement our strategic focus on women’s healthcare and dermatology and can benefit from promotion by our sales forces. We have acquired a number of products through license or purchase, including the following:

 

   

OVCON

 

   

LOESTRIN franchise

 

   

ESTROSTEP FE

 

   

FEMHRT

 

   

DOVONEX

 

   

TACLONEX

 

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Our Products

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

Our Principal Products

 

     

Product

(Active Ingredient)

  

Indication

  

Patent Expiry(1)

   2007 Revenue
($mm)
Women’s Healthcare    Hormonal Contraception         
  

LOESTRIN 24 FE

(Norethindrone acetate and ethinyl estradiol)

   Prevention of pregnancy    July 2014(2)    $148.9
  

FEMCON FE

(Norethindrone and ethinyl estradiol)

   Prevention of pregnancy    April 2019(3)    $32.4
  

 

Hormone Therapy

        
  

FEMHRT 1/5

and .5/2.5

(Norethindrone acetate and ethinyl estradiol)

   Oral treatment of moderate to severe vasomotor symptoms and urogenital symptoms associated with menopause    May 2010(4)    $63.7
  

ESTRACE Cream

(17-beta estradiol)

   Vaginal cream for treatment of vaginal and vulvar atrophy    Patent expired March 2001    $73.1
Dermatology    Psoriasis         
  

TACLONEX

(Calcipotriene and betamethasone dipropionate)

   Topical treatment of psoriasis    January 2020(5)    $127.2
  

DOVONEX

(Calcipotriene)

   Topical treatment of psoriasis   

Cream and Topical Solution -June 2015(6)

 

Ointment-Patent expired December 2007

   $145.3
   Acne         
  

DORYX

(Doxycycline hyclate)

   Oral adjunctive therapy for severe acne    December 2022(7)    $115.8

 

(1) See Item 1A. “Risk Factors—Risks Relating to Our Business—If generic products that compete with any of our branded pharmaceutical products are approved, sales of our products may be adversely affected.”
(2) We have received a notice of Paragraph IV certification in respect of our patent on LOESTRIN 24 FE, which may result in a generic equivalent entering the market as early as February 2009. See “Note 18” to the Notes to the Consolidated Financial Statements included elsewhere in this Annual Report.
(3) We have received notices of Paragraph IV certifications in respect of our patent on FEMCON FE. In response, our subsidiary Warner Chilcott Company, Inc., filed lawsuits against Barr Laboratories, Inc. (“Barr”) and Watson Laboratories, Inc. for infringement of our patent on FEMCON FE. Our lawsuits result in a stay of the FDA’s approval of the two related Abbreviated New Drug Applications (“ANDA”) for up to 30 months from our receipt of the notices to allow the court to resolve the suits. As a result, a generic equivalent of FEMCON FE may enter the market as early as February 2010. See “Note 18” to the Notes to the Consolidated Financial Statements included elsewhere in this Annual Report.

 

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(4) Pursuant to an agreement to settle patent litigation against Barr, we granted Barr a non-exclusive license to launch a generic version of FEMHRT six months prior to expiration of our patent.
(5) In September 2006, LEO Pharma informed us that the United States Patent and Trademark Office (the “USPTO”) ordered a reexamination of LEO Pharma’s patent on TACLONEX and certain of LEO Pharma’s products in development. In September 2007, in a non-final Action Closing Prosecution the patent examiner allowed the specific formulation claim for TACLONEX, but rejected the remaining pending claims in the reexamination of LEO Pharma’s patent. See “Note 18” to the Notes to the Consolidated Financial Statements included elsewhere in this Annual Report.
(6) LEO Pharma has received notices of Paragraph IV certifications in respect of its patent on DOVONEX Solution and elected not to bring infringement actions with respect to the related ANDA. Accordingly, a generic equivalent may enter the market as early as the first quarter of 2008. See “Note 18” to the Notes to the Consolidated Financial Statements included elsewhere in this Annual Report.
(7) Because we do not have Orange Book protection for DORYX, we are not entitled to the benefits of the automatic stay or the market exclusivity provisions of the Hatch-Waxman Act, which could result in generic competition for DORYX earlier than would be the case if we did have such protection.

Revenues by Product Class/Percentage of Total Revenues

During the periods presented, the following product classes accounted for a significant percentage of consolidated revenues:

 

(dollars in millions)    Year Ended
December 31,
2007
    Year Ended
December 31,
2006
    Year Ended
December 31,
2005
 

Dermatology

   $ 388.3    43 %   $ 309.4    41 %   $ 95.8    19 %

Oral Contraception

     267.0    30 %     228.5    30 %     171.5    33 %

Hormone Therapy

     165.8    18 %     146.7    19 %     137.4    27 %

For a discussion of product revenues and other results of our operations, see Part II. Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” For a discussion of our revenues and fixed assets by country of origin, see “Note 16” to the Notes to the Consolidated Financial Statements for the year ended December 31, 2007 included elsewhere in this Annual Report.

History and Development of the Company

Our company was formed principally through a series of acquisitions and divestitures. We began commercial operations on January 5, 2005 when we acquired Warner Chilcott PLC (the “Predecessor”). The Predecessor was incorporated in 1968 as a sales and marketing organization focused on branded pharmaceutical products in Northern Ireland, but in September 2000 expanded into the U.S. pharmaceuticals market through the acquisition of a U.S. pharmaceutical business that marketed a portfolio of products including OVCON and ESTRACE Cream. Between 2001 and 2004, the Predecessor disposed of its pharmaceutical services businesses and its U.K. pharmaceutical products businesses and focused its strategy on strengthening its pharmaceutical products business in the United States, specifically in the areas of women’s healthcare and dermatology.

In November 2004, affiliates of Bain Capital, LLC, DLJ Merchant Banking, J.P. Morgan Partners, LLC and Thomas H. Lee Partners, who we refer to collectively in this Annual Report as the “Sponsors,” reached an agreement to acquire the Predecessor. The acquisition became effective on January 5, 2005, and thereafter, following a series of transactions, we acquired 100% of the share capital of the Predecessor. We refer to this transaction in this Annual Report as the “Acquisition.” To complete the Acquisition, the Sponsors, certain of their limited partners and certain members of our management, indirectly funded equity contributions to us and certain of our subsidiaries, the proceeds of which were used to purchase 100% of the Predecessor’s share capital. On January 18, 2005, certain of our subsidiaries borrowed an aggregate of $2,020.0 million, consisting of an initial drawdown of $1,420.0 million under our $1,790.0 million senior secured credit facility and the issuance of

 

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8.75% Senior Subordinated Notes (the “Notes”) by one of our U.S. subsidiaries, Warner Chilcott Corporation. The proceeds from the acquisition financings, together with cash on hand at the Predecessor, were used to pay the selling stockholders $3,014.4 million, to retire all of the Predecessor’s outstanding share options for $70.4 million, to retire all of the Predecessor’s previously outstanding funded indebtedness totaling $195.0 million and to pay related fees and expenses. In this Annual Report, we refer to the Acquisition, together with the related financings, as the “Transactions.”

In September 2006, the Company sold 70,600,000 shares of its Class A common stock (“Class A common shares”) in an initial public offering (the “IPO”) at a price to the public of $15.00 per share for an aggregate offering price of $1,059.0 million (before direct issuance fees). Prior to the IPO we had outstanding Class A common shares and Class L common stock (the “Class L common shares”) of the Company and Preferred Stock of Warner Chilcott Holdings Company II, Limited (the “Preferred Shares”), all of which were held by the Sponsors, certain institutional investors and members of the Company’s management. In connection with the IPO, the Class L common shares of the Company and a portion of the Preferred Shares were converted into Class A common shares pursuant to the Company’s bye-laws. All of the remaining Preferred Shares were redeemed for cash.

In connection with the IPO, the Company also issued Class A common shares and non-qualified options to purchase Class A common shares to its employees. Prior to the IPO, the Sponsors collectively owned 87% of the Company’s outstanding Class A common shares (including their ownership of the Class L common shares on an as-converted basis). Immediately following the IPO, the Sponsors owned approximately 61% of the outstanding Class A common shares.

Strategic Relationship with LEO Pharma

Our product licenses with LEO Pharma relating to DOVONEX and TACLONEX include exclusive U.S. sales and marketing rights to all of LEO Pharma’s product improvements, new and enhanced dosage forms and new products that contain calcipotriene or a combination of calcipotriene and a steroid until 2020. LEO Pharma has also granted us a right of first refusal and last offer for the U.S. sales and marketing rights to all products developed by LEO Pharma principally for the treatment or prevention of dermatological diseases through 2010. In September 2007, we made a $10.0 million payment under our agreement as a result of the FDA’s acceptance of LEO Pharma’s New Drug Application (“NDA”) submission for a TACLONEX scalp product, which is included in R&D expenses in the year ended December 31, 2007. Upon FDA approval of the TACLONEX scalp product, we would be required to pay LEO Pharma $40.0 million. We expect to receive this approval in mid-2008. The $40.0 million payment will be recorded as an intangible asset in our consolidated balance sheet. Under the product development agreement, we may be required to make additional payments to LEO Pharma upon the achievement of various developmental milestones that could aggregate up to $100.0 million in addition to the aforementioned $40.0 million, if any. Further, we agreed to pay a supply fee and royalties to LEO Pharma on the net sales of those products. We may also agree to make additional payments for products that have not been identified or that are covered under the right of first refusal and last offer.

Product Acquisitions

In addition to our strategic relationship with LEO Pharma and our more recent in-licensing arrangements with companies such as NexMed and Paratek, we have built our pharmaceutical products business through a number of product acquisitions. These transactions include our acquisition of the OVCON oral contraceptive franchise and ESTRACE Cream from Bristol-Myers Squibb Company (“Bristol-Myers”) in 2000, our acquisition of ESTRACE Tablets from Bristol-Myers in 2001, our acquisition of the U.S. sales and marketing rights for SARAFEM from Eli Lilly and Company in 2003 and our acquisition of LOESTRIN, ESTROSTEP FE and FEMHRT from Pfizer Inc. (“Pfizer”) in 2003. We became the exclusive licensee of TACLONEX in the United States (subject to the terms of our supply agreement with LEO Pharma) in 2005 and acquired the exclusive U.S. sales and marketing rights to DOVONEX from Bristol-Myers in 2006.

 

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Research and Development (“R&D”)

Our R&D team has significant experience and proven capabilities in pharmaceutical development and clinical development. We focus our R&D efforts primarily on developing new products that target therapeutic areas with established regulatory guidance, making proprietary improvements to our existing products and developing new and enhanced dosage forms. When compared to the development of new products in therapeutic areas lacking established regulatory guidance, our approach to R&D generally involves less development and regulatory risk and shorter time lines from concept to market. Through this focused approach to R&D, we seek to enhance the value of our franchises by investing in relatively low-risk projects. Our investment in R&D, funded primarily by our Puerto Rican subsidiary, consists of our internal development costs, fees paid to contracted development groups and license fees paid to license rights to products in development by third parties. License fees and milestone payments are recognized as R&D expense unless or until they relate to products approved by the FDA, at which time they are capitalized as part of intangible assets.

In July 2007, we entered into an agreement with Paratek under which we acquired certain rights to novel tetracyclines under development for the treatment of acne and rosacea. We paid an upfront fee of $4.0 million and will reimburse Paratek for R&D expenses incurred during the term of the agreement. We may make additional payments to Paratek upon the achievement of certain developmental milestones that could aggregate up to $24.5 million. In addition, we agreed to pay royalties to Paratek based on the net sales of the products covered under the agreement.

In November 2007, we entered into an agreement with NexMed under which we acquired the exclusive U.S. rights to NexMed’s topically applied alprostadil cream for the treatment of erectile dysfunction. NexMed’s NDA for the product was accepted for review by the FDA in November 2007. We paid a license fee of $0.5 million and may make additional payments to NexMed upon the achievement of various developmental milestones that could aggregate up to $12.5 million. In addition, we agreed to pay royalties to NexMed based on the net sales of the products covered under the agreement.

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 Pharma, which was triggered by the FDA’s acceptance of the NDA submission for LEO Pharma’s 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 Pharma. Excluding the payments to LEO Pharma 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.

Investment in R&D totaled $26.8 million in the year ended December 31, 2006 compared with $58.6 million in the year ended December 31, 2005. R&D expense for the year ended December 31, 2006 included $3.0 million representing our cost to acquire an option to purchase certain rights with respect to a topical dermatology product currently in development by LEO Pharma. R&D expense in the year ended December 31, 2005 included $37.0 million representing our costs to acquire the rights to a line extension of TACLONEX and other product rights from LEO Pharma. Excluding product rights costs from both the 2006 and 2005 periods, R&D expense increased $2.2 million in the year ended December 31, 2006 compared to the prior year period.

As of December 31, 2007, our R&D team consisted of approximately 80 professionals. Our in-house expertise in product development and regulatory affairs allows us to prepare and submit NDAs with the FDA.

 

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Product Pipeline

The following shows certain products in our R&D pipeline and their respective stage of development. We note that the information below should be viewed with caution since there are a number of risks and uncertainties associated with the development and marketing of new products, including changes in market conditions, uncertainty as to whether any of our current product candidates will prove effective and safe in humans and whether we will be successful in obtaining required regulatory approvals. Specifically, the FDA approval process can be time-consuming and expensive without assurance that approval will be forthcoming. Generally, without FDA approval, products cannot be commercialized in the United States. Furthermore, even if we 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. Finally, our ability to market certain of the preclinical development stage products listed below is subject to the successful negotiation of acceptable licensing and supply terms with LEO Pharma and other third parties.

Women’s Healthcare

WC3016. In July 2007, we completed enrollment of the Phase III clinical study for a low-dose oral contraceptive. We currently plan to submit an NDA for this product in the first half of 2009.

WC3026. In December 2007, we completed enrollment of the Phase III clinical study for another low-dose oral contraceptive. We currently plan to submit an NDA for this product in the second half of 2009.

Dermatology

WC2055. We commenced clinical development of an oral antibiotic for the treatment of acne in the second half of 2007.

WC3018. We are in the pre-clinical phase of development for a topical antibiotic for the treatment of acne and other inflammatory skin conditions. We expect to begin clinical development in the first half of 2008.

LEO 80-185. LEO Pharma has completed Phase III development of a TACLONEX line extension for psoriasis of the scalp. LEO Pharma submitted an NDA with respect to the product, which was accepted for review by the FDA in August 2007.

LEO 80-190. LEO Pharma expects to commence Phase III development of a topical treatment for psoriasis in the second quarter of 2008.

TD1414. LEO Pharma expects to begin Phase II development of a topical antibiotic for skin infections in the first half of 2008.

WC3027. We are in the pre-clinical phase of development for a selective glucocorticoid receptor agonist (“SEGRA”) compound for treatment of inflammatory skin conditions. The SEGRA compound is licensed from Bayer AG.

WC3035. In July 2007, we entered into an agreement with Paratek under which we acquired certain rights to novel tetracyclines under development for the treatment of acne and rosacea. Currently, we are working with Paratek to select a lead compound for development.

Other

WC3036. In November 2007, we entered into an agreement with NexMed. Under the terms of the agreement, we have the exclusive U.S. rights to NexMed’s topically applied alprostadil cream for the treatment of erectile dysfunction. NexMed’s NDA for the product was accepted for review by the FDA in November 2007.

 

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Sales and Marketing

We employ marketing techniques to identify and target physicians with the highest potential to prescribe our products. Our marketing team, together with their sales colleagues, perform comprehensive analyses of market share information to develop strategies and tactics to maximize the market share and sales growth of our products. In connection with our marketing initiatives, we seek to efficiently size, deploy, direct and compensate our sales forces in order to grow our market share, sustain product sales growth, revitalize acquired products and successfully launch new products.

We regularly review the effectiveness of our sales forces as they execute our sales growth strategies. Over the course of 2007, we made adjustments to our sales forces to expand our Chilcott sales force promoting FEMCON FE to OB/GYNs to approximately 180 sales representatives. Our Women’s Healthcare sales force continues to promote LOESTRIN 24 FE and we have modestly increased the number of sales representatives to expand promotion of LOESTRIN 24 FE to approximately 220 sales representatives. In addition, our portfolio sales force of approximately 30 sales representatives promote LOESTRIN 24 FE, TACLONEX and DORYX in geographic territories lacking the density to support specialty promotional efforts. Our Dermatology sales force of approximately 70 sales representatives promotes our dermatology products to dermatologists. As of December 31, 2007, we employed approximately 500 sales representatives.

Customers

While the ultimate end-users of our products are the individual patients to whom our products are prescribed by physicians, our direct customers include certain of the nation’s leading wholesale pharmaceutical distributors, such as McKesson Corporation (“McKesson”), AmerisourceBergen Corporation (“ABC”) and Cardinal Health, Inc. (“Cardinal”), and major retail drug and grocery store chains. In June 2007, CVS Caremark Corporation (“CVS”), a national retail drug store chain that previously accounted for over 10% of our net sales and accounts receivable, began purchasing through one of our existing wholesale customers, Cardinal. As a result of this change, our customer concentration was increased as the number of customers was reduced from four to three. During the periods presented, the following customers accounted for 10% or more of our revenues:

 

     Year Ended
December 31,
2007
    Year Ended
December 31,
2006
    Year Ended
December 31,
2005
 

Cardinal

   36 %   30 %   14 %

McKesson

   35 %   36 %   28 %

AmerisourceBergen

   10 %   11 %   19 %

CVS

   4 %   10 %   10 %

Competition

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

Our principal competitors include:

 

 

 

Hormonal Contraceptives—Bayer AG (Yasmin®, Yaz®), Johnson & Johnson, (Ortho Tri-Cyclen® Lo, Ortho Evra®), Schering-Plough Corporation (Nuvaring®) and Barr Pharmaceuticals, Inc. (Seasonique®);

 

 

 

Hormone Therapy—Wyeth (Premarin®, Premarin® Vaginal Cream, Prempro™), Novo Nordisk Pharmaceuticals, Inc. (Activella®), Bayer AG (Climara®) and Barr Pharmaceuticals, Inc. (Cenestin®);

 

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Acne—Medicis Pharmaceutical Corporation (Solodyn®), Bradley Pharmaceutical (Adoxa®) and CollaGenex Pharmaceuticals Inc. (Oracea™); and

 

 

 

Psoriasis—Galderma Pharma S.A. (Clobex® Spray) and Stiefel Laboratories, Inc. (Olux® Foam, Luxíq® Foam).

Our branded pharmaceutical products are or may become subject to competition from generic equivalents, and potential generic entrants may also challenge our patents. OVCON 50, OVCON 35, ESTRACE Tablets, ESTRACE Cream and DOVONEX Ointment are currently not protected by patents. See Item 1A. “Risk Factors—Risks Relating to Our Business—If generic products that compete with any of our branded pharmaceutical products are approved, sales of our products may be adversely affected.” Generic equivalents for some of our branded pharmaceutical products are sold by other pharmaceutical companies at lower prices. As a result, drug retailers have economic incentives to fill prescriptions for branded products with generic equivalents when available. After the introduction of a generic competitor, a significant percentage of the prescriptions written for the branded product may be filled with the generic version at the pharmacy, resulting in a commensurate loss in sales of the branded product. In addition, legislation enacted in the United States allows or, in a few instances, in the absence of specific instructions from the prescribing physician, mandates the use of generic products rather than brand name products where a generic equivalent is available. The availability of generic equivalent products may cause a material decrease in revenue from our branded pharmaceutical products.

Manufacturing, Supply and Raw Materials

In May 2004, we purchased an approximately 194,000 sq. ft. pharmaceutical manufacturing facility located in Fajardo, Puerto Rico from Pfizer. Adjacent to the facility is an approximately 24,000 sq. ft. warehouse and 102,000 sq. ft. parking lot, both of which we lease from third parties. The Fajardo facility currently manufactures most of our women’s healthcare oral dose products, including LOESTRIN 24 FE, FEMCON FE, ESTROSTEP FE and OVCON 50 oral contraceptives, and packages delayed-release DORYX tablets, FEMHRT, FEMTRACE, OVCON 35 and DOVONEX and TACLONEX samples. We also utilize our facility in Larne, Northern Ireland to manufacture our FEMRING vaginal rings. We currently contract with third parties to manufacture and supply certain of our other products. We will continue to rely on our third-party development partners, Hospira, Inc., formerly FH Faulding Limited, (“Hospira”) for DORYX, and LEO Pharma for DOVONEX and TACLONEX.

We conduct quality assurance audits of our manufacturing and other property sites, our contract manufacturers’ sites, and our raw material suppliers’ sites and all related records to confirm compliance with the relevant regulatory requirements.

 

Product

  

Third-Party Manufacturer

  

Expiration

DORYX

   Hospira    December 2009, renewable thereafter by mutual agreement

DOVONEX

   LEO Pharma    January 2020

ESTRACE Cream

   Contract Pharmaceuticals Limited    February 2010

FEMHRT

   Barr    June 2009

FEMTRACE

   Pharmaceutics International, Inc.    June 2010

OVCON 35

   Barr    May 2009

TACLONEX

   LEO Pharma    January 2020

The products listed above accounted for a significant percentage of our product sales during the year ended December 31, 2007. If a supplier suffers an event that causes it to be unable to manufacture our product requirements for an extended period, the resulting shortages of inventory could have a material adverse effect on our business. See “Note 19” to the Notes to the Consolidated Financial Statements for the year ended December 31, 2007 included elsewhere in this Annual Report for information concerning supplier concentration. Also see Item 1A. “Risk Factors—Risks Relating to Our Business—Delays in production could have a material adverse impact on our business.”

 

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Patents, Proprietary Rights and Trademarks

Protecting our intellectual property, such as trademarks and patents, is a key part of our strategy.

Patents, Trade Secrets and Proprietary Knowledge

We rely on patents, trade secrets and proprietary knowledge to protect our products. We take steps to enforce our legal rights against third parties when we believe that our intellectual property or other proprietary rights have been infringed. We filed a complaint against Berlex Inc. (“Berlex”) and Bayer Schering Pharma A.G. (“Schering”) in the U.S. District Court for the District of New Jersey alleging that Berlex and Schering were willfully infringing the patent covering our LOESTRIN 24 FE oral contraceptive in connection with the marketing and sale of Yaz®. In November 2006, we reached a settlement with Berlex and Schering in connection with the patent complaint. Under the terms of the settlement, Schering will make certain payments and will license to us its proprietary SEGRA compound for the oral or topical treatment of inflammatory skin diseases. We will pay a royalty to Schering on sales of any product containing the SEGRA compound under the license. We also filed a complaint against Watson Pharmaceuticals, Inc. and one of its subsidiaries (collectively, “Watson”) alleging that Watson’s submission of an ANDA for a generic version of LOESTRIN 24 FE infringes the patent covering our LOESTRIN 24 FE oral contraceptive. More recently, each of Barr and Watson Laboratories, Inc. submitted an ANDA to the FDA in August 2007 seeking approval to market a generic version of FEMCON FE prior to the expiration of our patent. We filed infringement lawsuits against each of Watson Laboratories, Inc. and Barr in response to these submissions. See “Note 18” to the Notes to the Consolidated Financial Statements for the year ended December 31, 2007 included elsewhere in this Annual Report for a description of our litigation. We also seek to protect our proprietary rights by filing applications for patents on certain inventions, and entering into confidentiality, non-disclosure and assignment of invention agreements with our employees, consultants, licensees and other companies. However, 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 reexaminations 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. In addition, some of our key products are not protected by patents and proprietary rights and therefore are or may become subject to competition from generic equivalents. For a further discussion of our competition, see “—Competition” and Item 1A. “Risk Factors—Risks Relating to Our Business—If generic products that compete with any of our branded pharmaceutical products are approved, sales of our products may be adversely affected.”

Trademarks

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

 

DORYX

   FEMTRACE

ESTRACE

   LOESTRIN 24 FE

ESTROSTEP FE

   OVCON

FEMCON FE

   SARAFEM

FEMHRT

   Warner Chilcott

FEMRING

  

We also police our trademark portfolio against infringement. However, our efforts to protect 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 are exclusive licensee of the trademarks for TACLONEX and DOVONEX in the United States.

 

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Government Regulation

The pharmaceutical industry is subject to regulation by national, regional, state and local agencies, including the FDA, the Drug Enforcement Administration, the Department of Justice, the Federal Trade Commission (the “FTC”), the Office of Inspector General of the U.S. Department of Health and Human Services, the Consumer Product Safety Commission, the U.S. Department of Agriculture, the Occupational Safety and Health Administration and the U.S. Environmental Protection Agency (“EPA”), as well as by governmental authorities in those foreign countries in which we distribute some of our products. The Federal Food, Drug and Cosmetic Act (the “FDCA”), the Public Health Service Act and other federal and state statutes and regulations govern to varying degrees the research, development and manufacturing of, 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. The manufacture and disposal of pharmaceutical products in the United States is also regulated by the EPA.

The process of testing, data analysis, manufacturing development and regulatory review necessary to obtain and maintain required governmental approvals is costly. Non-compliance with applicable legal and regulatory requirements can result in civil fines, criminal fines and prosecution, 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 otherwise be used productively on other aspects of our business.

FDA Approval Requirements

FDA approval is required before a prescription drug can be marketed, except, in some cases, for a very small category of grandfathered drugs that have been on the market unchanged since prior to 1938 or that are otherwise considered generally recognized as safe and effective. For innovative, or non-generic, new drugs, an FDA-approved 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. In order to demonstrate safety and effectiveness, an NDA generally must include or reference pre-clinical studies and clinical data from controlled trials in humans. For a new chemical entity, this generally means that lengthy, uncertain and rigorous pre-clinical and clinical testing must be conducted. For compounds that have a record of prior or current use, it may be possible to utilize existing data or medical literature and limited new testing to support an NDA. Any pre-clinical testing must comply with the FDA’s good laboratory practice and other requirements. Clinical testing in human subjects must be conducted in accordance with the FDA’s good clinical practice and other requirements.

In order to initiate a clinical trial, the sponsor must submit an investigational new drug application, or IND, to the FDA or meet one of the narrow exemptions that exist from the IND requirement. Clinical research must also be reviewed and approved by independent institutional review boards, or IRBs, at the sites where the research will take place, and the study subjects must provide informed consent. The FDA or an IRB can prevent a clinical trial from being started or require that a clinical trial be terminated or suspended. Some clinical trials are also monitored by data safety monitoring boards, which review available data from the studies and determine whether the studies may continue or should be terminated or modified based on ethical considerations and the best interest of the study subjects. There are also legal requirements to register clinical trials on public databases when they are initiated, and to disclose the results of the trials on public databases upon completion.

The FDA can, and does, reject NDAs, require additional clinical trials, or grant approvals on only a restricted basis even when product candidates performed well in clinical trials. In addition, the FDA may approve an NDA subject to burdensome post-approval study or monitoring requirements, or require that other risk management measures be utilized. There are also requirements to conduct pediatric trials for all new NDAs and supplements to NDAs, unless a waiver or deferral applies.

 

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The FDA regulates and often inspects manufacturing facilities, equipment and processes used in the manufacturing of pharmaceutical products before granting approval to market any drug. Each NDA submission requires a substantial user fee payment unless a waiver or exemption applies. The FDA has committed generally to review and make a decision concerning approval on an NDA within 10 months, and on a new priority drug within six months. However, final FDA action on the NDA can take substantially longer, and where novel issues are presented there may be review and recommendation by an independent FDA advisory committee. The FDA can also refuse to file and review an NDA it deems incomplete or not properly reviewable.

The FDA continues to review marketed products even after approval. If previously unknown problems are discovered or if there is a failure to comply with applicable regulatory requirements, the FDA may restrict the marketing of an approved product, cause the withdrawal of the product from the market, or under certain circumstances seek recalls, seizures, injunctions or criminal sanctions. For example, the FDA may require withdrawal of an approved marketing application, labeling changes, additional studies, or other risk management measures for any marketed drug product if new information reveals questions about a drug’s safety or effectiveness. In addition, changes to the product, the manufacturing methods or locations, or labeling are subject to additional FDA approval, which may or may not be received, and which may be subject to a lengthy FDA review process.

Additional FDA Regulatory Requirements

All drugs must be manufactured, packaged and labeled in conformity with current Good Manufacturing Practices (“cGMP”) requirements, and drug products subject to an approved application must be manufactured, packaged, labeled and promoted in accordance with the approved application. Certain of our products must also be packaged with child-resistant and senior-friendly packaging under the Poison Prevention Packaging Act and Consumer Product Safety Commission regulations. Our third-party manufacturers must also comply with cGMP requirements. In complying with cGMP requirements, manufacturers must continually expend time, money and effort in production, record keeping and quality assurance and control to ensure that the product meets applicable specifications and other requirements for product safety, efficacy and quality. The FDA and other regulatory agencies periodically inspect drug manufacturing facilities to ensure compliance with applicable cGMP requirements. Failure to comply with the statutory and regulatory requirements, including, in the case of our own manufacturing facility, certain obligations that we assumed in our purchase of the facility arising out of a consent decree entered into by the previous owner before a U.S. District Court, subjects the manufacturer to possible legal or regulatory action.

The distribution of pharmaceutical products is subject to the Prescription Drug Marketing Act, or PDMA, which regulates the distribution of drugs and drug samples at the federal level and sets minimum standards for the registration and regulation of drug distributors at the state level. Under the PDMA and state law, states require the registration of manufacturers and distributors who provide pharmaceuticals in that state, including in certain states manufacturers and distributors who ship pharmaceuticals into the state even if such manufacturers or distributors have no place of business within the state. States also impose requirements on manufacturers and distributors to establish the pedigree of product in the chain of distribution, including some states that are requiring manufacturers and others to adopt new technology capable of tracking and tracing product as it moves through the distribution chain. Both the PDMA and state laws impose requirements and limitations upon drug sampling to ensure accountability in the distribution of samples. The PDMA sets forth civil and criminal penalties for violations of these and other provisions.

Other reporting and recordkeeping requirements also apply for marketed drugs, including, for prescription products, requirements to review and report cases of adverse events. Product advertising and promotion are subject to FDA and state regulation, including requirements that promotional claims conform to any applicable FDA approval and be appropriately balanced and substantiated. Adverse experiences with the use of products can result in the imposition of market restrictions through labeling changes or in product removal.

 

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Other U.S. Regulation

Our sales, marketing and scientific/educational programs must comply with applicable requirements of the anti-kickback provisions of the Social Security Act, the False Claims Act, the Veterans Healthcare Act, and the implementing regulations and policies of the U.S. Health and Human Services Office of Inspector General and U.S. Department of Justice, as well as similar state laws. Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, the exemptions and regulatory safe harbors are often limited, and promotional practices may be subject to scrutiny if they do not qualify for an exemption or safe harbor. In addition, all of our activities are potentially subject to federal and state consumer protection and unfair competition laws. We are subject to possible administrative and legal proceedings and actions under these laws. Such actions may result in the imposition of civil and criminal sanctions, which may include fines, penalties and injunctive or administrative remedies. See “Note 18” to the Notes to the Consolidated Financial Statements for the year ended December 31, 2007 included elsewhere in this Annual Report.

In recent years, Congress and some state legislatures have considered a number of proposals and have enacted laws that could effect major changes in the health care system, either nationally or at the state level. On December 8, 2003, new Medicare legislation was enacted that provides out-patient prescription drug reimbursement beginning in 2006 for all Medicare beneficiaries. The federal government and the private plans contracting with the government to deliver this new benefit, through their purchasing power under these programs, are demanding discounts from pharmaceutical companies, and these pressures may implicitly create price controls on prescription drugs.

We also participate in the Federal Medicaid rebate program established by the U.S. Omnibus Budget Reconciliation Act of 1990, as well as several state supplemental rebate programs. Under the Medicaid rebate program, we pay a rebate to each state Medicaid program for our products that are reimbursed by those programs. The Medicaid rebate amount is computed each quarter based on our submission to the Centers for Medicare and Medicaid Services at the U.S. Department of Health and Human Services of our current average manufacturing price and best price for each of our products. The terms of our participation in the program impose an obligation to correct the prices reported in previous quarters, as may be necessary. Any such corrections could result in an overage or underage in our rebate liability for past quarters, depending on the direction of the correction. In addition to retroactive rebates (and interest, if any), if we are found to have knowingly submitted false information to the government, the statute provides for civil monetary penalties in the amount of $100,000 per item of false information. Governmental agencies may also make changes in program interpretations, requirements or conditions of participation, some of which may have implications for amounts previously estimated or paid. Based upon our past practice and experience, to the extent that we were required to correct prices reported in previous quarters, we would not expect such corrections to have a material adverse effect on us.

U.S. Manufacturing for Export

Products marketed outside of the United States that are manufactured in the United States are subject to certain FDA regulations, including rules governing export, as well as regulation by the country in which the products are sold. We currently supply LOESTRIN and MINESTRIN to Barr in Canada. While we do not currently have plans to market any of our other U.S. products in other countries, except FEMHRT in Canada, we may do so from time to time.

Regulation in the United Kingdom

Though we have divested our pharmaceutical businesses in the United Kingdom, we are still subject to regulation in certain areas by the U.K. Medicines and Healthcare Products Regulatory Agency (the “MHRA”). For example, our facility in Larne, Northern Ireland is approved and regularly inspected by the MHRA and the FDA. The United Kingdom Medicines Act of 1968 and the regulations promulgated thereunder govern manufacturers of pharmaceuticals sold in the United Kingdom.

 

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Seasonality

Our results of operations are minimally affected by seasonality.

Employees

As of December 31, 2007, we had approximately 1,125 employees. The employees of our production, warehousing and manufacturing departments located at our facility in Larne, Northern Ireland are covered by a labor agreement that may be terminated at any time. This labor agreement currently remains in effect. We believe that our employee relations are satisfactory.

Environmental Matters

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

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

Executive Officers

The executive officers of Warner Chilcott Limited, their positions and their ages as of December 31, 2007, are as listed.

 

Name

  

Age

  

Position

Roger M. Boissonneault

   59    Chief Executive Officer, President and Director

W. Carl Reichel

   49    President, Pharmaceuticals

Anthony D. Bruno

   51    Executive Vice President, Corporate Development

Paul Herendeen

   52    Executive Vice President, Chief Financial Officer

Leland H. Cross

   51    Senior Vice President, Technical Operations

Herman Ellman, M.D.

   60    Senior Vice President, Clinical Development

Izumi Hara

   48    Senior Vice President, General Counsel and Corporate Secretary

Alvin D. Howard

   53    Senior Vice President, Regulatory Affairs

Roger M. Boissonneault, Chief Executive Officer, President and Director, was appointed Chief Executive Officer, President and Director of the Company as of the Acquisition Date. Mr. Boissonneault was appointed Chief Executive Officer and Director for the Predecessor in September 2000. He previously served as President and Chief Operating Officer of Warner Chilcott PLC (acquired by the Predecessor in September 2000) from 1996 to 2000, serving as a director from 1998 through 2000. From 1976 to 1996, Mr. Boissonneault served in various capacities with Warner-Lambert (now a part of Pfizer), including Vice President, Female Healthcare, Director of Corporate Strategic Planning and Director of Obstetrics/Gynecology Marketing.

 

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W. Carl Reichel, President, Pharmaceuticals, joined the Predecessor as President in October 2000 after nearly 20 years of experience at Parke-Davis, a division of Warner-Lambert (now a part of Pfizer), where he, together with Mr. Boissonneault, were pioneers in the pharmaceutical marketing methods currently employed by us. Most recently, he held the position of President, U.K./British Isles at Warner-Lambert.

Anthony D. Bruno, Executive Vice President, Corporate Development, joined the Predecessor in March 2001 as Senior Vice President, Corporate Development and General Counsel. Mr. Bruno was promoted to Executive Vice President in April 2003 and continued to serve as General Counsel of the Company until August 1, 2005. Prior to joining the Company, Mr. Bruno spent 17 years with Warner-Lambert (now part of Pfizer) where his most recent position was Vice President and Associate General Counsel, Pharmaceuticals, and he was responsible for all legal matters relating to Warner-Lambert’s pharmaceutical business worldwide.

Paul Herendeen, Executive Vice President and Chief Financial Officer, joined the Company in this position on April 1, 2005 and is responsible for our finance, accounting, treasury and management information system functions. Prior to joining the Company, Mr. Herendeen was Executive Vice President and Chief Financial Officer of MedPointe Inc. From 1998 through March 2001, Mr. Herendeen served as Executive Vice President and Chief Financial Officer of Warner Chilcott PLC (acquired by the Predecessor in September 2000). Mr. Herendeen also served as a director of the Predecessor from October 2000 through March 2001.

Leland H. Cross, Senior Vice President, Technical Operations, joined the Predecessor in this position on September 1, 2001 and is responsible for our technical operations worldwide. From 1994 to 2001, Mr. Cross was part of the Global Manufacturing group at Warner-Lambert (now part of Pfizer), where most recently he was General Manager of Pfizer Ireland Pharmaceuticals, responsible for Pfizer’s dosage manufacturing operations in Ireland. Prior to joining Warner-Lambert, Mr. Cross managed a manufacturing operation for Merck & Co. Inc.

Herman Ellman, M.D., Senior Vice President, Clinical Development, joined the Predecessor in this position in June 2000. Dr. Ellman is responsible for clinical development and medical affairs activities. Prior to joining the Predecessor, Dr. Ellman held the position of Medical Director for Women’s Healthcare of Berlex Laboratories.

Izumi Hara, Senior Vice President, General Counsel and Corporate Secretary, joined the Predecessor as Senior Vice President and Deputy General Counsel in June 2001 and is responsible for the legal matters of the Company. She was promoted to General Counsel as of August 1, 2005. Prior to joining the Predecessor, Ms. Hara held positions of increasing responsibility at Warner-Lambert (now part of Pfizer) where her most recent position was Vice President and Associate General Counsel, Corporate Affairs, where she was responsible for all corporate legal matters, including acquisitions, divestitures, alliances and other transactions in all of Warner-Lambert’s lines of business worldwide.

Alvin D. Howard, Senior Vice President, Regulatory Affairs, joined the Predecessor as Vice President, Regulatory Affairs in February 2001. He was promoted to Senior Vice President as of August 1, 2005 and is responsible for the registration of all of our products and for managing our relationships with the FDA, Health Canada and other agencies regulating the sale of pharmaceutical products. Prior to joining the Company, Mr. Howard was Vice President, Worldwide Regulatory Affairs at Roberts Pharmaceuticals.

 

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WHERE YOU CAN FIND MORE INFORMATION

We are required to file annual, quarterly and current reports, proxy statements and other information with the Securities and Exchange Commission. Unless specifically noted otherwise, these filings are not deemed to be incorporated by reference in this Annual Report. Statements contained in this Annual Report as to the contents of any contract or other document referred to are not necessarily complete and in each instance, if such contract or document is filed or incorporated by reference as an exhibit, reference is made to the copy of such contract or other document filed or incorporated by reference as an exhibit to this Annual Report, each statement being qualified in all respects by such reference. A copy of this Annual Report, including the exhibits and schedules thereto, may be read and copied at the SEC’s Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549. Information on the operation of the Public Reference Room may be obtained by calling the SEC at 1-800-SEC-0330. In addition, the SEC maintains an Internet website that contains reports, proxy statements and other information about issuers, like us, that file electronically with the SEC. The address of that site is http://www.sec.gov. We also maintain an Internet site at www.warnerchilcott.com. We make available on our internet website free of charge our Annual Reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K as soon as practicable after we electronically file such reports with the SEC. Our website and the information contained therein or connected thereto shall not be deemed to be incorporated into this Annual Report.

 

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Item 1A. Risk Factors

Special Note Regarding Forward-Looking Statements

This Annual Report contains certain forward-looking statements, including, without limitation, statements concerning the conditions in our industry, expected cost savings, our operations, our economic performance and financial condition, including, in particular, statements relating to our business and growth strategy and product development efforts. 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 and information. You 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. These risks and uncertainties include, without limitation, those identified under the captions “Business,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” below and elsewhere in this Annual Report.

You should carefully consider the risk factors set forth below as well as the other information contained in this Annual Report before making an investment decision. Additional risks and uncertainties not currently known to us or those we currently deem to be immaterial may also materially and adversely affect our business operations. Any of the following risks could materially adversely affect our business, financial condition, results of operations or cash flows. We undertake no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as otherwise required by law.

Risks Relating to Our Business

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

Our branded pharmaceutical products are or may become subject to competition from generic equivalents because there is no proprietary protection for some of the branded pharmaceutical products we sell or because our patent protection expires or is not sufficiently broad. OVCON 50, OVCON 35, ESTRACE Tablets, ESTRACE Cream and DOVONEX Ointment are currently not protected by patents. Generic equivalents are currently available for OVCON 35, ESTROSTEP FE and ESTRACE Tablets.

During the next five years, the patents protecting three of our products will expire. They are ESTROSTEP FE in April 2008, SARAFEM in May 2008 and FEMHRT in May 2010. Although our patents covering ESTROSTEP FE and FEMHRT technically expire in April 2008 and May 2010, respectively, under a 2004 settlement of patent litigation with Barr, we granted Barr a non-exclusive license to launch generic versions of these products six months prior to expiration of our patents. In October 2007, Barr launched a generic version of ESTROSTEP FE.

Although part of our strategy includes the ongoing development of proprietary product improvements to our existing products and new and enhanced dosage forms, other companies may attempt to compete with our original products losing patent protection, we may not be successful in obtaining FDA approval of our new and enhanced dosage products and doctors may not prescribe these products. For example, following our termination of the exclusivity provision of our license agreement with Barr relating to OVCON 35 on September 25, 2006, Barr launched a generic version of OVCON 35 in October 2006. Our sales of OVCON 35 decreased as a result of the launch of the generic product.

Generic equivalents for some of our branded pharmaceutical products are sold by other pharmaceutical companies at a lower cost. After the introduction of a generic competitor, a significant percentage of the prescriptions written for the branded product may be filled with the generic version at the pharmacy, resulting in a commensurate loss in sales of the branded product. In addition, legislation enacted in the United States allows or, in a few instances, in the absence of specific instructions from the prescribing physician, mandates the use of

 

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generic products rather than branded products where a generic equivalent is available. Competition from generic equivalents could have a material adverse impact on our revenues, financial condition, results of operations and cash flows.

Potential generic competitors may also challenge our patents. For example, Watson submitted an ANDA in April 2006 seeking approval to market a generic version of LOESTRIN 24 FE prior to the expiration of our patent. In addition, Barr and Watson Laboratories, Inc. submitted ANDAs in August 2007 seeking approval to market a generic version of FEMCON FE prior to the expiration of our patent. We have filed infringement lawsuits against Watson Laboratories, Inc. and Barr in response to each of these submissions. In addition, in 2006, LEO Pharma received notices of Paragraph IV certifications in respect of its patent on DOVONEX Solution and elected not to bring infringement actions with respect to the related ANDAs. Accordingly, a generic equivalent of DOVONEX Solution may enter the market as early as the first quarter of 2008.

On September 21, 2006, LEO Pharma informed us that the USPTO ordered a reexamination of LEO Pharma’s U.S. Patent No. 6,753,013 in response to a request made by Galderma R&D based on alleged prior art. The patent covers TACLONEX and certain of LEO Pharma’s products in development. We market and sell TACLONEX in the United States under a license agreement with LEO Pharma and have license rights to the products in development. LEO Pharma filed a response with the USPTO on November 13, 2006. In September 2007, LEO Pharma received a non-final Action Closing Prosecution from the USPTO, pursuant to which the patent examiner allowed the specific formulation claim for TACLONEX but rejected the remaining pending claims in the reexamination of LEO Pharma’s patent. LEO Pharma intends to vigorously defend the patent and filed a response with the USPTO on December 5, 2007. While we can offer no assurance as to the ultimate outcome of the reexamination proceedings, including any related appeals, we continue to believe that LEO Pharma will succeed in maintaining the important elements of the patent protection for TACLONEX, particularly based on the timing, extent and quality of the development work conducted by LEO Pharma with vitamin D analogues in combination with corticosteroids. If the claims included in the patent are substantially narrowed, TACLONEX could face direct or indirect competition prior to the expiration of the patent in 2020. See “Note 18” to the Consolidated Financial Statements for the year ended December 31, 2007 included elsewhere in this Annual Report.

Because the active ingredients of DORYX include antibiotics that were approved by the FDA prior to 1997, the U.S. patents covering DORYX are not permitted to be listed in the FDA’s Orange Book and are not eligible to benefit from the automatic stay or market exclusivity provisions of the Hatch-Waxman Act. When a drug is listed in the Orange Book and a potential competitor seeks to develop a generic version of such drug, an ANDA may be filed in lieu of filing a full NDA. The ANDA applicant is required to certify to the FDA as to certain matters concerning each patent for the listed drug. If the applicant certifies that the new drug will not infringe the already approved drug’s listed patents or that such patents are invalid or unenforceable, it must also send notice to the NDA and patent holders once the ANDA has been accepted for filing by the FDA. If the holders initiate a patent infringement suit within 45 days of the receipt of such notice, the FDA is automatically prevented from approving the ANDA until the earlier of 30 months from the receipt of such notice, expiration of the patent or a decision or settlement that the patent is invalid, unenforceable or not infringed. Because we do not have Orange Book protection for DORYX, we may face generic competition earlier than would be the case if we did have such protection.

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.

 

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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.

In the past we have been involved in litigation with respect to the validity and infringement of patents, and 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 principal pharmaceutical manufacturing facility located in Fajardo, Puerto Rico currently manufactures most of our women’s healthcare oral dose products, including LOESTRIN 24 FE, FEMCON FE, ESTROSTEP FE and OVCON 50 oral contraceptives, and packages our delayed-release DORYX tablets, FEMHRT, FEMTRACE, OVCON 35 and DOVONEX and TACLONEX samples. 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 facility 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 impact 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 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 the 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. In addition, adverse experiences with the use of products must be reported to the FDA and could result in the imposition of market restrictions through labeling changes or product removal.

The FDA 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

 

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materials and finished products from FDA-approved sources. FDA 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 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 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 and adversely affect our revenues, financial condition, results of operations and cash flows.

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 revenues.

Our commercial success in producing, marketing and selling products 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 treatment. 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 reimbursement levels 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. The federal government and 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 DOVONEX and TACLONEX that are covered by the Medicare drug benefit. Further, a number of other legislative and regulatory proposals aimed at changing the healthcare system have been proposed. 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, thereby adversely affecting our results of operations and cash flows.

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

 

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Taxing authorities could reallocate our taxable income among our subsidiaries, which could increase our consolidated tax liability.

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 and, following 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.

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, 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.

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. As a result, 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, approximately 564 product liability

 

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suits have been filed against us in connection with the HT products, FEMHRT, ESTRACE, 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 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 Wyeth. See “Note 18” to the Notes to the Consolidated Financial Statements for the year ended December 31, 2007 included elsewhere in this Annual Report.

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. Partly as a result of product liability lawsuits related to pharmaceuticals, product liability and other types of insurance have become more difficult and costly to obtain. 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.

A successful claim or claims brought against us 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.

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 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 sales and accounts receivable, began purchasing through one of our existing wholesale customers. As a result of

 

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this change, our customer concentration was increased. Three large wholesale distributors accounted for an aggregate of 81% of our net revenues during the year ended December 31, 2007. 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 the FDA, the Drug Enforcement Administration, the Department of Justice, the FTC, the Office of the Inspector General of the U.S. Department of Health and Human Services and other regulatory bodies, as well as governmental authorities in those foreign countries in which we manufacture or distribute some of our products. The FDCA, the Public Health Service Act and other federal and state statutes and regulations 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.

Non-compliance with these and other government regulations and other legal requirements can 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.

New 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 new regulatory requirements affecting pharmaceutical manufacturers. With respect to the manufacturing of drugs, the legislation grants the FDA extensive new 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 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.

 

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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 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. For innovative, or non-generic, new drugs, an FDA-approved 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. 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 may determine that a product does not present an acceptable risk benefit profile, and may not approve an NDA or may only approve an NDA 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 governmental approval for our NDAs, we will not be able to commercialize our products and recoup our R&D costs. Furthermore, even if we 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 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 which 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

 

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acquisitions would likely 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. In addition, in December 2003, the United States enacted the import provisions of the Medicare Prescription Drug, Improvement, and Modernization Act, which may in the future permit pharmacists and wholesalers to import prescription drugs into the United States from Canada under specified circumstances. These additional import provisions will not take effect until the Secretary of Health and Human Services makes a required certification regarding the safety and cost savings of imported drugs and the FDA has promulgated regulations setting forth parameters for importation. These conditions have not been met to date, and the law has thus not taken effect. However, legislative proposals have been introduced to remove these conditions and implement the changes to the current import laws, or to create other changes that would allow foreign versions of our products priced at lower levels than in the United States to be imported or reimported to the United States from Canada, Europe and other countries. If these provisions take effect, the volume of prescription drug imports from Canada and elsewhere could increase significantly, and our products would face competition from lower priced imports.

Even if these provisions do not take effect and alter current law, 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.

We currently sell FEMHRT in Canada. In addition, ESTRACE Tablets, DOVONEX and TACLONEX (sold as “DOVOBET” in Canada) are sold in Canada by third parties. For the year ended December 31, 2007, DOVONEX, TACLONEX, FEMHRT and ESTRACE Tablets accounted for approximately 38% of our total revenues. Due to government price regulation in Canada, these products are generally sold in Canada for lower prices than in the United States. As a result, if these drugs are imported into the United States from Canada, we may experience reduced revenue or profit margins.

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 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 outcome 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.

 

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

The Acquisition resulted in significant increases in identifiable intangible assets and goodwill. Identifiable intangible assets, which include trademarks and trade names, license agreements and patents acquired in acquisitions, were $1,329.4 million at December 31, 2007, representing approximately 46% of our total assets. Goodwill, which relates to the excess of cost over the fair value of the net assets of the businesses acquired, was $1,250.3 million at December 31, 2007, representing approximately 43% of our total assets. The majority of our intangible assets are owned by our Puerto Rican subsidiary.

Goodwill and identifiable intangible assets are recorded at fair value on the date of acquisition. Under Financial Accounting Standards Board (“FASB”) Statement No. 142, 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, 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 future determination requiring the write-off of a significant portion of intangible assets would have an adverse effect on our financial condition and results of operations. See Item 7. “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 currently of single source, innovator multiple source and non-innovator multiple source products, rebate 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. The Medicaid rebate amount is computed each quarter based on our submission to Centers for Medicare and Medicaid Services at the U.S. Department of Health and Human Services of our current AMP and best price for each of our products. The terms of our participation in the program impose an obligation to correct the prices reported in previous quarters, as may be necessary. Any such corrections could result in an overage or underage in our rebate liability for past quarters, depending on the direction of the correction. In addition to retroactive rebates (and interest, if any), if we are found to have knowingly submitted false information to the government, the statute provides for civil monetary penalties in the amount of $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.

 

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

Our financial condition could be negatively impacted by unfavorable results in our outstanding litigation matters, including those described in “Note 18” to the Notes to the Consolidated Financial Statements for the year ended December 31, 2007 included elsewhere in this Annual Report, or in lawsuits that may be initiated in the future. These matters include intellectual property litigation, product liability litigation and securities litigation, any of which, if adversely decided, could negatively impact our business, results of operations, financial condition and cash flows.

Risks Related to our Indebtedness

We have a substantial amount of indebtedness, 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 December 31, 2007, we had total indebtedness of $1,200.2 million.

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:

 

   

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;

 

   

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

 

   

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;

 

   

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

 

   

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

 

   

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.

 

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To service our indebtedness, we will require a significant amount of cash. Our ability to generate cash depends on many factors beyond our control, and any failure to meet our debt service obligations could harm our business, financial condition and results of operations.

Our ability to pay interest and principal in respect of our indebtedness principally will depend upon our future operating performance. As a result, prevailing economic conditions and financial, business and other factors, many of which are beyond our control, will affect our ability to make these payments.

If we do not generate sufficient cash flow from operations to satisfy our debt service obligations, we may have to undertake alternative financing plans, such as refinancing or restructuring our indebtedness, selling assets, reducing or delaying capital investments or seeking to raise additional capital. Our ability to restructure or refinance our indebtedness will depend on the condition of the capital markets and our financial condition at such time. Any refinancing of our indebtedness could be at higher interest rates and may require us to comply with more onerous covenants, which could further restrict our business operations. In addition, the terms of existing or future debt instruments, including the senior secured credit facility, and the indenture governing our outstanding Notes, may restrict us from adopting some of these alternatives. Our inability to generate sufficient cash flow to satisfy our debt service obligations, or to refinance our obligations at all or on commercially reasonable terms, would have an adverse effect, which could be material, on our business, financial condition and results of operations, as well as on our ability to satisfy our obligations in respect of our indebtedness.

The terms of our senior secured credit facility and the indenture governing our outstanding Notes restrict our current and future operations, particularly our ability to respond to changes in our business or to take certain actions.

The senior secured credit facility and the indenture governing our outstanding Notes contain, and any future indebtedness of ours or our subsidiaries would likely contain, a number of restrictive covenants that impose significant operating and financial restrictions on certain of our direct and indirect subsidiaries, which may result in restrictions on their ability to engage in acts that may be in our best long-term interests. The senior secured credit facility includes financial covenants, including requirements that certain of our subsidiaries:

 

   

maintain minimum interest coverage ratios; and

 

   

not exceed maximum total leverage ratios.

The senior secured credit facility limits the ability of certain of our direct and indirect subsidiaries to make capital expenditures and requires that they use a portion of excess cash flow and proceeds of certain asset sales that are not reinvested in their business and other dispositions to repay indebtedness under the senior secured credit facility.

The senior secured credit facility also includes covenants restricting, among other things, the ability of certain of our direct and indirect subsidiaries to:

 

   

incur liens;

 

   

incur or assume additional debt or guarantees or issue preferred stock;

 

   

pay dividends, or make redemptions and repurchases, with respect to capital stock;

 

   

prepay, or make redemptions and repurchases of, subordinated debt;

 

   

make loans and investments;

 

   

make capital expenditures;

 

   

engage in mergers, acquisitions, asset sales, sale/leaseback transactions and transactions with affiliates;

 

   

change business; and

 

   

amend the terms of subordinated debt.

 

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The indenture relating to our Notes also contains numerous covenants including, among other things, restrictions on certain of our direct and indirect subsidiaries’ ability to:

 

   

incur or guarantee additional indebtedness or issue disqualified or preferred stock;

 

   

create liens;

 

   

pay dividends or make other equity distributions;

 

   

repurchase or redeem capital stock;

 

   

make investments or other restricted payments;

 

   

sell assets or consolidate or merge with or into other companies;

 

   

create limitations on the ability of our restricted subsidiaries to make dividends or distributions; and

 

   

engage in transactions with affiliates.

The operating and financial restrictions and covenants in these debt agreements and any future financing agreements may adversely affect our ability to finance future operations or capital needs or to engage in other business activities. A breach of any of the restrictive covenants in the senior secured credit facility would result in a default under the senior secured credit facility. If any such default occurs, the lenders under the senior secured credit facility may elect to declare all outstanding borrowings, together with accrued interest and other fees, to be immediately due and payable, or enforce their security interest, any of which would result in an event of default under the indenture relating to our Notes. The lenders will also have the right in these circumstances to terminate any commitments they have to provide further borrowings.

Risks Relating to Our Common Stock

Future sales of our shares could depress the market price of our common stock.

Sales of a substantial number of shares of our common stock, in the public market or otherwise, or the perception that such sales could occur, could adversely affect the market price of our common stock. As of December 31, 2007, we had approximately 250.6 million shares of our common stock outstanding. In September of 2006, we completed our IPO selling 70.6 million shares of common stock that are freely tradable without restriction or further registration under the Securities Act. Approximately 179.2 million of the remaining shares were granted to members of management or sold by us in private transactions to members of management, the Sponsors and certain institutional investors, and are eligible for public sale if registered under the Securities Act or sold in accordance with Rule 144 thereunder. The Sponsors have the right, subject to certain conditions, to cause us to register approximately 152.2 million of these shares.

We filed a registration statement on Form S-8 under the Securities Act to register up to approximately 9.3 million shares of our common stock for issuance under our 2005 Equity Incentive Plan (the “Equity Incentive Plan”). As awards under this plan are granted, vest and are exercised, subject to certain limitations under the management shareholders agreement, the shares issued on exercise generally will be available for sale in the open market by holders who are not our affiliates and, subject to the volume and other applicable limitations of Rule 144, by holders who are our affiliates. As of December 31, 2007, options to purchase approximately 3.1 million shares of our common stock were outstanding (of which options to acquire approximately 1.2 million shares of common stock were vested). In addition, as of December 31, 2007, approximately 3.5 million restricted shares were granted under the Equity Incentive Plan (of which approximately 2.3 million restricted shares were vested).

 

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The market price of our common stock 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 common stock to decline significantly and without regard to our operating performance. In addition, the market price of our common stock 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 common stock market price include:

 

   

actual or expected fluctuations in our operating results;

 

   

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

 

   

conditions in our industry generally;

 

   

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

 

   

our inability to raise additional capital;

 

   

changes in market prices for our products; and

 

   

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

Provisions of our bye-laws could delay or prevent a takeover of us by a third party.

Our bye-laws could delay, defer or prevent a third party from acquiring us, despite the possible benefit to our stockholders, or otherwise adversely affect the price of our common stock. For example, our bye-laws:

 

   

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

 

   

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

 

   

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

 

   

limit the ability of stockholders to remove directors;

 

   

prohibit stockholders from filling vacancies on our board of directors for so long as a quorum of directors exists; and

 

   

require the approval of at least a majority of the voting power of the shares of our capital stock entitled to vote generally in the election of directors for stockholders to amend or repeal our bye-laws.

These provisions may discourage potential takeover attempts, discourage bids for our common stock 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 common stock. These provisions could also discourage proxy contests and make it more difficult for you and other stockholders to elect directors other than the candidates nominated by our board.

Because our Sponsors own a majority of our outstanding common stock, if they act collectively, 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.

Our Sponsors collectively beneficially own approximately 61% of our outstanding common stock. As a result, if our Sponsors act collectively, they could exercise control over the composition of our board of directors and could control the vote of our common stock. If this were to occur, our Sponsors could have effective control over our decisions to enter into any corporate transaction and could have the ability to prevent any transaction that requires the

 

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approval of our stockholders 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.

Item 1B. Unresolved Staff Comments.

None.

Item 2. Properties

In May 2004, we purchased an approximately 194,000 sq. ft. pharmaceutical manufacturing facility located in Fajardo, Puerto Rico from Pfizer. The Fajardo facility has become our primary site for the manufacture of our women’s healthcare oral dose products. The Fajardo facility currently manufactures most of our women’s healthcare oral dose products, including our LOESTRIN 24 FE, FEMCON FE, ESTROSTEP FE and OVCON 50 oral contraceptives, and packages delayed-release DORYX tablets, FEMHRT, FEMTRACE, OVCON 35 and DOVONEX and TACLONEX samples. For a discussion of our Fajardo facility, see Item 1. “Business—Manufacturing, Supply and Raw Materials.”

We also own a 118,000 sq. ft. facility in Larne, Northern Ireland, 48,000 sq. ft. of which is leased to a third party. The remainder is dedicated to the manufacture of our vaginal rings, research and product development as well as development of analytical methods.

We lease approximately 58,000 sq. ft. of office space in Rockaway, New Jersey, where our U.S. operations are headquartered.

Item 3. Legal Proceedings

See “Note 18” to the Notes to the Consolidated Financial Statements for the year ended December 31, 2007 included elsewhere in this Annual Report.

Item 4. Submission of Matters to a Vote of Security Holders.

No matter was submitted to a vote of security holders of the Company during the fourth quarter of 2007.

 

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Part II

 

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.

Our common stock was listed on The NASDAQ Global Market under the symbol “WCRX” on September 21, 2006. Prior to that date, there was no public market for our common stock. The following table presents the high and low prices for our common stock on The NASDAQ Global Market during the periods indicated:

 

     High    Low

2007:

     

First Quarter (ending March 31, 2007)

   $ 15.38    $ 13.32

Second Quarter (ending June 30, 2007)

   $ 18.95    $ 14.73

Third Quarter (ending September 30, 2007)

   $ 20.02    $ 16.50

Fourth Quarter (ending December 31, 2007)

   $ 19.55    $ 16.50

2006:

     

Third Quarter (commencing September 21, 2006 and ending September 30, 2006)

   $ 15.32    $ 12.10

Fourth Quarter (ending December 31, 2006)

   $ 14.03    $ 11.77

As of February 15, 2008, there were approximately 292 registered holders of record for our common stock and 250,587,497 shares outstanding. Because many of our shares of common stock are held by brokers and other institutions on behalf of stockholders, we are unable to estimate the total number of stockholders represented by these record holders. The closing price of our common stock on The NASDAQ Global Market on February 15, 2008, was $16.92.

During the years ended December 31, 2007 and 2006, respectively, we did not pay any cash dividends to our stockholders. We currently intend to retain future earnings to fund the development and growth of our business and, therefore, do not anticipate paying cash dividends within the foreseeable future. Any future payment of dividends will be determined by our Board and will depend on our consolidated financial position and results of operations and other factors deemed relevant by our Board.

 

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Performance Graph

The following graph shows the value as of December 31, 2007 of a $100 investment in our common stock as if made on September 21, 2006, as compared with similar investments based on the value of (i) the NASDAQ Composite Index and (ii) the NASDAQ Pharmaceuticals Index in each case on a “total return” basis assuming reinvestment of dividends. The index values were calculated assuming an initial investment of $100 in such indexes on September 21, 2006. The stock performance shown below is not necessarily indicative of future performance.

LOGO

Comparative values:

 

     Warner
Chilcott
Stock
   NASDAQ
Composite
Index
   NASDAQ
Pharmaceuticals
Index

On September 21, 2006

   $ 100.00    $ 100.00    $ 100.00

On December 31, 2006

   $ 92.44    $ 107.19    $ 102.91

On March 31, 2007

   $ 99.06    $ 107.55    $ 99.27

On June 30, 2007

   $ 121.00    $ 115.65    $ 101.62

On September 30, 2007

   $ 118.86    $ 119.94    $ 108.31

On December 31, 2007

   $ 118.60    $ 117.85    $ 102.89

Unregistered Sales of Securities

None.

Repurchases of Equity Securities During the Quarter Ended December 31, 2007

None.

 

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Item 6. Selected Financial Data.

The following table sets forth our selected historical consolidated financial data. Except for the data relating to the years ended December 31, 2007, 2006 and 2005, all data below reflects the consolidated financial data of the Predecessor. The years ended December 31, 2007, 2006 and 2005 are our first three years following the Acquisition. The financial statements relating to the year ended December 31, 2005 reflect the Acquisition as if the closing took place on January 1, 2005 and the operating results for the period January 1 through January 4, 2005 were ours. The four day period included only two business days and the impact on the results of operations for the year ended December 31, 2005 was not material. Our year ends on December 31 versus the Predecessor’s fiscal year-end of September 30.

The selected consolidated financial data as of December 31, 2007 and 2006, and for the years ended December 31, 2007, 2006 and 2005 presented in this table have been derived from our audited consolidated financial statements and related Notes included elsewhere in this Annual Report. The selected consolidated financial data as of December 31, 2005 and 2004, as of September 30, 2004 and 2003, for the quarter ended December 31, 2004 and for the fiscal years ended September 30, 2004, and 2003 presented in this table are derived from our audited consolidated financial statements and related notes which are not included in this Annual Report. The selected consolidated financial data as of and for the quarter ended December 31, 2003 is unaudited.

 

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The selected consolidated financial data set forth below should be read in conjunction with, and is qualified by reference to, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the consolidated financial statements and related Notes thereto included elsewhere in this Annual Report.

 

    Fiscal Year Ended
September 30,
  Transition Period
Quarter Ended

December 31,
         Year Ended
December 31,
 
    Predecessor          Successor  

(dollars and share amounts in

thousands, except per share amounts)

  2003   2004   2003   2004          2005     2006     2007  
    (Unaudited)  

Statement of Operations Data:

                 

Total revenue(1)(2)

  $ 365,164   $ 490,248   $ 124,789   $ 136,893         $ 515,253     $ 754,457     $ 899,561  

Costs and expenses:

                 

Cost of sales (excluding amortization and impairments)(3)

    42,042     53,488     11,408     34,529           95,224       151,750       185,990  

Selling, general and administrative(3)(4)

    124,786     146,205     37,745     41,463           162,670       253,937       265,822  

Impairment of intangible assets

    —       —       —       —             38,876       —         —    

Research and development

    24,874     26,558     6,692     4,608           58,636       26,818       54,510  

Amortization of intangible assets(3)

    38,106     52,374     13,185     21,636           233,473       253,425       228,330  

Acquired in-process research and development(3)

    —       —       —       —             280,700       —         —    

Transaction costs(3)

    —       —       —       50,973           35,975       —         —    

Net interest expense(3)(4)

    7,686     9,256     3,152     1,214           147,934       206,994       117,618  

Accretion on preferred stock of subsidiary(4)(5)

    —       —       —       —             31,533       26,190       —    
                                                     

Income / (loss) before taxes

    127,670     202,367     52,607     (17,530 )         (569,768 )     (164,657 )     47,291  

Provision / (benefit) for income taxes

    41,380     59,390     12,312     11,558           (13,122 )     (11,147 )     18,416  
                                                     

Income / (loss) from continuing operations

    86,290     142,977     40,295     (29,088 )         (556,646 )     (153,510 )     28,875  
                                                     

Discontinued operations, net of tax(6)

    9,865     8,711     2,405     —             —         —         —    
                                                     

Net income / (loss)

  $ 96,155   $ 151,688   $ 42,700   $ (29,088 )       $ (556,646 )   $ (153,510 )   $ 28,875  
                                                     

Per Share Data(7):

                 

Earnings (loss) per share—basic

                 

Class A

    N/A     N/A     N/A     N/A         $ (7.19 )   $ (1.63 )   $ 0.12  

Class L

    N/A     N/A     N/A     N/A         $ 7.35     $ 6.33       (7 )

Earnings (loss) per share—diluted

                 

Class A

    N/A     N/A     N/A     N/A         $ (7.19 )   $ (1.63 )   $ 0.12  

Class L

    N/A     N/A     N/A     N/A         $ 7.34     $ 6.33       (7 )

Weighted average shares outstanding—basic

                 

Class A

    N/A     N/A     N/A     N/A           88,311       133,897       248,916  

Class L

    N/A     N/A     N/A     N/A           10,642       10,280       (7 )

Weighted average shares outstanding—diluted

                 

Class A

    N/A     N/A     N/A     N/A           88,311       133,897       250,454  

Class L

    N/A     N/A     N/A     N/A           10,668       10,282       (7 )

Balance Sheet Data (at period end):

                 

Cash and cash equivalents

  $ 88,571   $ 186,251   $ 167,500   $ 229,565         $ 11,502     $ 84,464     $ 30,776  

Total assets(3)(8)

    1,456,419     1,419,295     1,614,403     1,454,243           3,041,877       3,162,545       2,884,974  

Total long-term debt(3)(4)(8)

    341,078     191,701     341,582     192,199           1,989,500       1,550,750       1,200,239  

Preferred stock in subsidiary(4)(5)

    —       —       —       —             435,925       —         —    

Shareholders’ equity(4)(5)

    997,125     1,126,640     1,051,701     1,104,087           332,510       1,328,232       1,354,420  

 

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(1) The increase in product revenues is, in part, attributable to product acquisitions.
(2) In March 2004, we sold the U.S. and Canadian rights to our then-marketed LOESTRIN products to a unit of Barr. Following this sale, we continued to earn revenue from supplying LOESTRIN under a supply agreement. Our total revenue for fiscal years 2004 and 2003, excluding revenue attributable to LOESTRIN product sales, was $464.0 million and $326.6 million, respectively.
(3) Completing the Acquisition affected our financial condition, results of operations and cash flows in the following ways:
  a. In the quarter ended December 31, 2004, we incurred $51.0 million of transaction costs and $3.7 million of incremental selling, general and administrative (“SG&A”) expenses directly related to the closing of the Acquisition; and
 

b.

During the year ended December 31, 2005 we completed the Acquisition for total consideration of $3,152.1 million, which was funded by approximately $1,282.8 million of equity contributions, $1,420.0 million of senior secured debt (including $20.0 million borrowed under the revolving credit facility at the time of acquisition), $600.0 million of 8.75 % Notes due 2015 and cash on hand. We recorded adjustments to the fair value of our assets and liabilities as of the date of the Acquisition including a significant increase to intangible assets and goodwill. During 2005, the following items were included in our operating results:

 

   

a charge of $22.4 million in cost of sales representing the write-off of the purchase price allocated to the fair value of our opening inventory,

 

   

$7.8 million of incremental SG&A expenses directly related to the closing of the Acquisition,

 

   

$4.9 million in SG&A expenses for the management fee to our Sponsors,

 

   

increased amortization expense resulting from the write-up of our identified intangible assets,

 

   

a $280.7 million write-off of acquired in-process research and development,

 

   

$36.0 million of transaction costs, and

 

   

increased interest expense from the indebtedness we incurred to complete the Acquisition

(4) Our IPO affected our results of operations, financial condition and cash flows as follows:

 

   

for the year ended December 31, 2006, SG&A expenses included $42.1 million of costs directly related to the IPO,

 

   

interest expense decreased due to the reduction of our outstanding debt using a portion of the proceeds from the IPO,

 

   

all of the Preferred Shares were either converted to Class A common shares or redeemed for cash at the time of the IPO,

 

   

all Class L common shares were converted into Class A common shares at the time of the IPO, and

 

   

shareholders’ equity increased $1,070.0 million.

(5) Our wholly-owned subsidiary, Warner Chilcott Holdings Company II, Limited, issued 404,439 Preferred Shares in connection with the Transactions. The Preferred Shares were entitled to cumulative preferential dividends at an accretion rate of 8% per annum, compounded quarterly.
(6) In December 2003, we sold our Pharmaceutical Development and Manufacturing Services business. In April 2004, we sold our U.K. Pharmaceutical Sales and Marketing business. In May 2004, we sold our U.K.-based sterile solutions business. No business was divested in fiscal year 2003. The discontinued operations for fiscal year 2004 included a gain on disposal of $5.4 million, net of a tax charge of $11.8 million on the sale of our Pharmaceutical Development and Manufacturing Services business, our U.K. Pharmaceutical Sales and Marketing business and our U.K.-based sterile solutions business.
(7) The Company purchased all outstanding shares of the Predecessor as part of the Acquisition, making the Predecessor’s earnings per share not comparable to the Company’s earnings per share. The Company was in a net loss position in both 2005 and 2006. The effect from the exercise of outstanding stock options and the vesting of restricted shares during the periods would have been anti-dilutive. Accordingly, the effect of the shares issuable upon exercise of such stock options and the restricted shares have not been included in the calculation of diluted earnings per share for the years ended December 31, 2006 and 2005. The December 31, 2006 earnings per share of the Class L common shares is calculated through September 30, 2006, as there were no Class L common shares outstanding during the fourth quarter of 2006. There were no outstanding Class L common shares outstanding during the year ended December 31, 2007.
(8) During the year ended December 31, 2006 we completed the acquisition of the U.S. sales and marketing rights to DOVONEX for $205.2 million and paid the final milestone payment for TACLONEX ointment of $40.0 million. We borrowed $240.0 million in connection with these transactions and recorded $238.5 million in intangible assets.

 

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Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion together with Part II, Item 6. “Selected Financial Data” and our Consolidated Financial Statements and the related Notes included elsewhere in this Annual Report. 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 Item 1A. “Risk Factors” and elsewhere in this Annual Report.

Unless otherwise noted or the context otherwise requires, references in this prospectus to “Warner Chilcott,” “the Company,” “our company,” “we,” “us” or “our” for periods after the Acquisition Date refer to the operations of Warner Chilcott Limited and for periods prior to the Acquisition Date refer to the historical operations of the Predecessor.

Overview

We are a leading specialty pharmaceutical company currently focused on the women’s healthcare and dermatology segments of the U.S. pharmaceutical market. We are a fully integrated company with internal resources dedicated to the development, manufacturing and promotion of our products. We have established strong franchises in women’s healthcare and dermatology through our marketing techniques and specialty sales forces, which now comprise approximately 500 representatives. We believe that our proven product development capabilities, coupled with our ability to execute acquisitions and in-licensing transactions and develop partnerships, such as our relationship with LEO Pharma, will enable us to sustain and grow these franchises. Our primary manufacturing facility is located in Fajardo, Puerto Rico.

We began commercial operations on January 5, 2005 when we acquired the Predecessor. The financial statements included in this Annual Report and this discussion and analysis reflect the Acquisition as if the closing took place on January 1, 2005 and the operating results for the period January 1 through January 4, 2005 were ours. The four day period included only two business days and the impact on the results of operations during the year ended December 31, 2005 was not material.

To complete the Acquisition, the Sponsors, certain of their limited partners and certain members of our management, funded equity contributions of approximately $1,282.8 million. The contributions were made in respect of approximately $880.0 million of Class A and Class L common shares issued by us and $402.8 million of Preferred Shares issued by the Company’s wholly-owned subsidiary Holdings II. On January 18, 2005, certain of the Company’s subsidiaries borrowed an aggregate $2,020.0 million consisting of an initial drawdown of $1,420.0 million under a $1,790.0 million senior secured credit facility and $600.0 million of 8.75 % Notes due 2015.

In September 2006, we completed our IPO and sold 70,600,000 of our Class A common shares. Also see discussion in “Operating results for the years ended December 31, 2006 and 2005”.

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.

Net Sales

We promote a portfolio of branded prescription pharmaceutical products primarily in the women’s healthcare and dermatology segments of the U.S. pharmaceutical market. To generate demand for our products, our sales representatives make face-to-face promotional and educational presentations to physicians who are

 

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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 directly from us (for example, major retail drug store chains) or through wholesale pharmaceutical distributors. We recognize revenue when title passes to our customers, generally free on board (“FOB”), destination, net of related revenue deductions.

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 amount of inventory held by our 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.

We generate our revenue primarily from the sale of branded pharmaceutical products in the United States (“U.S.”), including our oral contraceptives (LOESTRIN 24 FE, FEMCON FE, OVCON, and ESTROSTEP FE), our HT products (FEMHRT, ESTRACE Cream, FEMTRACE, ESTRACE Tablets and FEMRING), our oral antibiotic for the adjunctive treatment of severe acne (DORYX), our psoriasis products (DOVONEX and TACLONEX) and our treatment for premenstrual dysphoric disorder (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, the Company earns 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 Pharma, Inc. The revenue we earn under these agreements is included with the revenue from 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 from a subsidiary of Pfizer and the March 2004 sale of rights to two LOESTRIN products to a unit of Barr. In connection with these transactions, we agreed to manufacture certain products for Pfizer and Barr 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). We continue to manufacture the old LOESTRIN products for Barr.

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

 

   

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;

 

   

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

 

   

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

 

   

changes in the regulatory environment;

 

   

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

 

   

changes in the level of demand for our products;

 

   

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

 

   

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.

 

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Other Revenue

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

During the year ended December 31, 2005, we generated revenue from a co-promotion agreement with Bristol-Myers for DOVONEX. Under this agreement, we earned revenue based on Bristol-Myers’ net sales of the product. Under the co-promotion agreement, we did not recognize cost of goods sold and the selling and marketing expenses related to co-promotion revenue are included in our SG&A expenses for the year ended December 31, 2005. Our co-promotion revenue under this contract was replaced by DOVONEX sales beginning on January 1, 2006 when we acquired the exclusive U.S. sales and marketing rights to DOVONEX.

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 woman’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 Pharma (DOVONEX and TACLONEX) and Hospira (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 inflation, increased fixed costs or other factors.

For products that we manufacture (as of December 31, 2007, LOESTRIN 24 FE, FEMCON FE, ESTROSTEP FE, OVCON 50 and FEMRING) and package (as of December 31, 2007, DORYX, FEMHRT, FEMTRACE, OVCON 35 and DOVONEX and TACLONEX samples), our direct material costs include the costs of purchasing raw materials and 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 laboratory costs. We do not include amortization of intangible assets 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 14, 2005 and January 1, 2006, we became the exclusive licensee of the U.S. sales and marketing rights to TACLONEX and DOVONEX, respectively, under agreements with LEO Pharma. We are obligated to pay LEO Pharma specified supply fees and royalties as a percentage of net sales (as calculated under the terms of the agreements). In addition, with respect to DOVONEX, we were obligated to pay Bristol-Myers a royalty of 5% of net sales through December 31, 2007. Our cost of sales, as a percentage of total revenue, increased beginning in 2006 as compared with prior periods as a result of the supply fees and royalties that we paid to LEO Pharma and Bristol-Myers for DOVONEX and to LEO Pharma for TACLONEX.

SG&A Expenses

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

 

   

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

 

   

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

 

   

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.

 

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

 

   

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

 

   

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

 

   

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 our sales forces.

General and administrative (“G&A”) expenses consist of management salaries, benefits, incentive compensation, rent, legal and professional fees and miscellaneous administration and overhead costs.

Research and Development

Since we conduct very little early stage exploratory research, our research and development expenses are comprised mainly of development costs. These development costs are typically associated with:

 

   

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

 

   

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

 

   

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

Research and development 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 research and development 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.

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 general and administrative 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.

Interest Income and 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 related to the early prepayment of debt.

 

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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 FIN48 reserves are included as a component of our provision / (benefit) for income taxes. We are a Bermudian holding company with operating subsidiaries in the U.S., 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 beginning in 2004.

Currently, the Internal Revenue Service (“IRS”) is auditing the Company’s U.S. tax returns for the fiscal years ended September 30, 2003 and 2004 and the partial period of October 1, 2004 through January 17, 2005. The IRS has finished its field work related to these periods and we expect the IRS to issue a Final Revenue Agents Report in the second quarter of 2008, which would formally close the audit for these periods. We believe that we have reached a tentative agreement with the IRS on all tax matters under audit. We have recorded the related liabilities as part of our accounting under FASB Interpretation No. 48, “Accounting for Uncertainty in Income Taxes” (“FIN48”). See “Note 10” to the Notes to the Consolidated Financial Statements included elsewhere in this Annual Report for the current portion of our FIN48 liabilities. We do not expect the impact of the final settlement to be material to our consolidated financial position or results of operations, but it will adversely affect our cash flows in the quarter in which the final settlement is paid. The partial year ended December 31, 2005 remains under audit. The year ended December 31, 2006 is open for U.S. audit, but is not currently under audit. While all periods beginning with the partial year ended December 31, 2004 remains open for Puerto Rico, no tax periods are currently under audit in such jurisdiction. In addition, certain state and other foreign jurisdictions for various periods are under audit.

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

2007 Operating Summary

The following are certain significant events that occurred during the year ended December 31, 2007:

 

   

On January 29, 2007, we entered into an amendment to our senior secured credit facility whereby the interest rates on all term borrowings under our senior secured credit facility were reduced by 0.25% to LIBOR plus 2.00% or ABR plus 1.00%;

 

   

In January 2007, we entered into a profit-sharing supply and distribution agreement with Watson Pharma, Inc. pursuant to which we agreed to supply, and they agreed to market, sell and distribute in the U.S., ZENCHENT, an authorized generic version of OVCON 35;

 

   

In July 2007, we paid an upfront fee of $4.0 million pursuant to an agreement with Paratek under which we acquired certain rights to novel tetracyclines under development for the treatment of acne and rosacea, which is included in R&D expense for the year ended December 31, 2007;

 

   

In September 2007, we made a milestone payment of $10.0 million to LEO Pharma upon FDA acceptance of LEO Pharma’s NDA submission for a TACLONEX scalp product, which is included in R&D expense for the year ended December 31, 2007;

 

   

In October 2007, we announced a profit-sharing supply and distribution agreement with Watson Pharma, Inc. pursuant to which we agreed to supply, and they agreed to market, sell and distribute in the U.S., TILIA™ FE, an authorized generic version of ESTROSTEP FE;

 

   

In November 2007, we paid a license fee of $0.5 million pursuant to an agreement with NexMed under which we acquired the exclusive U.S. rights to NexMed’s topically applied alprostadil cream for the treatment of erectile dysfunction, which is included in R&D expense for the year ended December 31, 2007;

 

   

During 2007, we recorded expenses aggregating $26.5 million in connection with our settlement of the remaining anti-trust actions relating to the OVCON 35 litigation, which is included in G&A expense for the year ended December 31, 2007;

 

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During 2007, we made optional prepayments aggregating $340.0 million of our indebtedness under our senior secured credit facility; and

 

   

Our revenue for the year ended December 31, 2007 was $899.6 million and our net income was $28.9 million.

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)
 
(dollars in millions)        2007            2006        Dollars     Percent  

Oral Contraception

          

LOESTRIN 24 FE

   $ 148.9    $ 44.2    $ 104.7     237.2 %

FEMCON FE

     32.4      7.5      24.9     330.2 %

ESTROSTEP FE

     70.2      103.0      (32.8 )   (31.9 )%

OVCON 35/50 (“OVCON”)

     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 %

ESTRACE Tablets

     9.7      7.6      2.1     28.0 %

FEMTRACE

     3.8      3.3      0.5     16.4 %
                            

Total

   $ 165.8    $ 146.7    $ 19.1     13.0 %
                            

Dermatology

          

DOVONEX

   $ 145.3    $ 146.9    $ (1.6 )   (1.1 )%

TACLONEX

     127.2      60.1      67.1     111.5 %

DORYX

     115.8      102.4      13.4     13.0 %
                            

Total

   $ 388.3    $ 309.4    $ 78.9     25.4 %
                            

PMDD

          

SARAFEM

   $ 37.7    $ 37.9    $ (0.2 )   (0.6 )%

Other Product 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 %
                            

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

 

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2006, LOESTRIN 24 FE became our top promotional priority amongst our oral 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. Filled prescriptions of LOESTRIN 24 FE increased 6.5% sequentially in the quarter ended December 31, 2007 compared to the quarter ended September 30, 2007. 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 Chilcott 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. Filled prescriptions of FEMCON FE increased 15.0% sequentially in the quarter ended December 31, 2007 compared to the quarter ended September 30, 2007. 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 product by Barr, we partnered with Watson Pharma, Inc. 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. We expect generic competition to have an adverse impact on our DOVONEX Solution revenues as early as in the first quarter of 2008.

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 pre-menstrual dysphoric disorder (PMDD), decreased $0.2 million, or 0.6%, in the year ended

 

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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. We expect generic competition to have an adverse impact on our SARAFEM revenues as early as in the second quarter of 2008.

Our contract manufacturing revenues relate to certain products manufactured for Pfizer and Barr. 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:

 

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

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. Beginning in 2008, we will no longer be obligated to pay royalties to Bristol-Myers. 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:

 

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

Advertising and Promotion

   $ 81.0    $ 72.0    $ 9.0     12.5 %

Selling and Distribution

     89.5      75.8      13.7     18.1 %

General, Administrative and Other

     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. Advertising and promotion 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. General, administrative and other 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.

Research and Development (“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 Pharma, which was triggered by the FDA’s acceptance of LEO Pharma’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 Pharma. Excluding the payments to LEO Pharma 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. Our product development activities are mainly focused on improvements to our existing products, new and enhanced dosage forms and new products delivering compounds which have been previously shown to be safe and effective.

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.

Interest Income and Interest Expense (“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 period. 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. We made optional prepayments totaling $340.0 million of outstanding indebtedness under our senior secured credit facility in the year ended December 31, 2007, and $210.0 million of aggregate principal amount of our Notes and $455.0 million of outstanding indebtedness under our senior secured credit facility in the year ended December 31, 2006. The decrease in net interest expense in the year ended December 31, 2007 was primarily the result of repayments in 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 period. The cumulative reductions in debt were accomplished through the use of cash generated from our free cash flow during the past five quarters and proceeds from our IPO.

 

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Accretion on Preferred Stock in Subsidiary

Total accretion on the Preferred Shares for the years 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 FIN48 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 at 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 SFAS No. 109, 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 dealing with 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 FIN48. For any tax position, a tax benefit may be reflected in the financial statements only if it is “more likely than not” that the Company 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 forseeable 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 entities entered into an Advanced Pricing Agreement (“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. entities are compensated for services provided on behalf of our non-U.S. entities. 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.

 

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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.

Operating Results for the years ended December 31, 2006 and 2005

Impact of the IPO

Our IPO, which priced in September 2006, significantly impacted our financial position as of December 31, 2006 and our results of operations for the year ended December 31, 2006. The following information highlights the impact of our IPO on our financial position and results of operations:

Financial Position:

 

(dollars in millions)    Year Ended
December 31, 2006
 

Increase in cash and cash equivalents

   $ 12.7  

(Decrease) in other current assets

     (1.2 )

(Decrease) in other non current assets

     (18.7 )
        

Net (decrease) in total assets

   $ (7.2 )
        

(Decrease) in long-term debt

   $ (615.0 )

(Decrease) in preferred stock in subsidiary

     (462.2 )

Increase in shareholders’ equity, net

     1,070.0  
        

Net (decrease) in liabilities and shareholders’ equity

   $ (7.2 )
        

Results of operations for year ended December 31, 2006:

 

(dollars in millions)    Year Ended
December 31, 2006

Expenses for stock-based compensation in connection with the IPO (see below)

   $ 14.7

Expense for buyout of Sponsors’ advisory and monitoring agreement

     27.4
      

Total included in general and administrative expenses

   $ 42.1
      

Expense from write-off of deferred loan costs

   $ 18.7

Premium related to the prepayment of our Notes

     18.4
      

Total included in interest expense

   $ 37.1
      

Stock-based compensation in connection with the IPO

At the time of our IPO, our board of directors granted equity-based incentives to our employees and approved a change to the vesting criteria with respect to previously granted restricted shares as described below:

 

   

The equity-based incentives included: (i) grants of 892,638 shares of unrestricted Class A common shares to certain members of senior management ($13.4 million of one-time compensation expense) and (ii) grants of 237,175 shares of restricted Class A common shares and options to purchase 1,164,629 Class A common shares to employees, which vests over four years and results in expenses being recognized over the vesting period. The grants were made under our 2005 Equity Incentive Plan, as amended.

 

   

During 2005 we granted 1,642,441 restricted Class A common shares to certain employees that were to vest based on certain of our investors obtaining returns on their investment of more than 250%. The vesting terms were amended such that these shares became fully vested at the time of our IPO, which resulted in the acceleration of the unamortized compensation expense associated with such shares ($1.3 million of one-time compensation expense).

 

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DOVONEX and TACLONEX Transactions

The acquisition of the rights to DOVONEX and the FDA approval of TACLONEX ointment during year ended December 31, 2006 had a significant impact on our operating results when compared with our results for prior year periods. The launch of TACLONEX, together with the acquisition of DOVONEX, continues to impact our operating results.

During 2005, we promoted DOVONEX in the U.S. under a co-promotion agreement with Bristol-Myers and recorded amounts earned from this activity as “Other revenue.” Under the agreement, we promoted DOVONEX and earned revenue based on Bristol-Myers’ net sales (as defined in the agreement) of the product. On January 1, 2006, we acquired the exclusive U.S. sales and marketing rights to DOVONEX from Bristol-Myers and their inventories of DOVONEX products for a purchase price of $205.2 million, plus a 5% royalty on net sales of DOVONEX through December 31, 2007. The total purchase price was allocated based on the fair values of inventory ($6.7 million) and intangible assets ($198.5 million), which have a useful life of 15 years. We funded the purchase of the DOVONEX rights by borrowing $200.0 million under the delayed draw portion of our senior secured credit facility. On January 1, 2006, our license and supply agreement with LEO Pharma for DOVONEX became effective and our co-promotion agreement with Bristol-Myers was terminated. Our acquisition of the U.S. sales and marketing rights to DOVONEX did not require any significant launch costs or an increase in the size of our sales forces as we had been promoting DOVONEX since 2003. Under the LEO Pharma license and supply agreement, we agreed to pay LEO Pharma a supply fee with respect to each product within the DOVONEX product portfolio equal to 20% of net sales and a royalty equal to 10% of net sales (each as calculated under the terms of the agreement). The royalty with respect to each product within the DOVONEX product portfolio would be reduced to 5% if a generic equivalent of such DOVONEX product is introduced.

On January 9, 2006, the FDA approved LEO Pharma’s NDA for TACLONEX ointment. Under our agreements with LEO Pharma, on February 6, 2006 we paid LEO Pharma a milestone payment of $40.0 million. This amount is classified as an intangible asset (as a component of the DOVONEX / TACLONEX product family) with a useful life of 15 years. Under the terms of a license and supply agreement with LEO Pharma, we agreed to pay a supply fee for TACLONEX ranging from 20% to 25% of net sales and royalties ranging from 10% to 15% of net sales of TACLONEX (each as calculated under the terms of the agreement). Our cost of sales as a percentage of total revenue was considerably higher in 2006 as compared with 2005 as a result of the agreements related to DOVONEX and TACLONEX. In addition, we incurred significant launch costs beginning in the second quarter of 2006 when we began active promotion of TACLONEX ointment.

 

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Revenue

The following table sets forth our revenue for the years ended December 31, 2006 and 2005, with the corresponding percent change:

 

     Year Ended December 31,    Increase
(decrease)
 
(dollars in millions)        2006            2005        Dollars     Percent  

Oral Contraception

          

LOESTRIN 24 FE

   $ 44.2    $ —      $ 44.2     100 %

FEMCON FE

     7.5      —        7.5     100 %

ESTROSTEP FE

     103.0      81.3      21.7     26.7 %

OVCON 35/50 (“OVCON”)

     73.8      90.2      (16.4 )   (18.1 )%
                            

Total

   $ 228.5    $ 171.5    $ 57.0     33.3 %
                            

Hormone Therapy

          

ESTRACE Cream

   $ 65.8    $ 53.9    $ 11.9     22.1 %

FEMHRT

     58.7      61.2      (2.5 )   (4.0 )%

FEMRING

     11.3      10.7      0.6     5.4 %

ESTRACE Tablets

     7.6      9.2      (1.6 )   (17.6 )%

FEMTRACE

     3.3      2.4      0.9     36.3 %
                            

Total

   $ 146.7    $ 137.4    $ 9.3     6.8 %
                            

Dermatology

          

DOVONEX

   $ 146.9    $ —      $ 146.9     100 %

TACLONEX

     60.1      —        60.1     100 %

DORYX

     102.4      95.8      6.6     6.9 %
                            

Total

   $ 309.4    $ 95.8    $ 213.6     223.0 %
                            

PMDD

          

SARAFEM

   $ 37.9    $ 41.6    $ (3.7 )   (8.8 )%

Other Product Sales

          

Other

     8.6      23.5      (14.9 )   (64.0 )%

Contract manufacturing

     20.8      24.5      (3.7 )   (15.1 )%
                            

Total Product Net Sales

   $ 751.9    $ 494.3    $ 257.6     52.1 %
                            

Other Revenue

          

Other non product revenue

     2.6      21.0      (18.4 )   (88.0 )%
                            

Total Revenue

   $ 754.5    $ 515.3    $ 239.2     46.4 %
                            

Revenue in the year ended December 31, 2006 totaled $754.5 million, an increase of $239.2 million, or 46.4%, over 2005. The January 1, 2006 acquisition of DOVONEX was a significant factor, accounting for $125.9 million of the increase in total revenue. In 2005, we earned $21.0 million in co-promotion revenue for DOVONEX from Bristol-Myers. Also contributing to the increase in revenue were three new products introduced in 2006, TACLONEX, LOESTRIN 24 FE and FEMCON FE, which together contributed $111.8 million of growth for the year ended December 31, 2006.

In the first quarter of 2005 we entered into distribution agreements with two of our major customers. During the period from April 1 through December 31, 2005, these distributors reduced their investment in inventories of our products, which had the effect of reducing our net sales during that period. We believe the pipeline inventories of our products as of December 31, 2005 were reduced to a level such that the majority of the net sales impact from the two agreements was realized in 2005. We estimate that the contraction of these distributors’ pipeline inventory reduced our net sales by approximately $18.1 million in the year ended December 31, 2005.

 

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In February 2006, we obtained FDA approval of our oral contraceptive, LOESTRIN 24 FE, and began commercial sales of the product in March 2006. In April 2006, LOESTRIN 24 FE became our top priority amongst our oral contraceptive brands. LOESTRIN 24 FE had captured a 3% share of new prescriptions in the hormonal contraceptive market in the month of December 2006 and generated net sales in the year ended December 31, 2006 totaling $44.2 million. During the period from July 2005 through the launch of LOESTRIN 24 FE, ESTROSTEP FE was the primary focus of our promotional efforts in oral contraception, which resulted in strong growth in demand in the second half of 2005 and continuing into the first half of 2006. The 26.7% increase in ESTROSTEP FE net sales in the year ended December 31, 2006 compared with 2005 was driven by an estimated 17% growth in filled prescriptions (a proxy for unit growth) combined with the an increase in average selling price compared with 2005. OVCON net sales decreased 18.1% in the year ended December 31, 2006, primarily due to a decline in filled prescriptions of OVCON 35 of approximately 18% versus the prior year due to the launch of a generic version of OVCON 35 in the fourth quarter of 2006, offset partially by increased average selling prices compared to the prior year. We expect our sales of OVCON 35 to continue to decline due to the generic competition. Offsetting some of the decline in OVCON sales was the introduction of FEMCON FE in the fourth quarter of 2006, which is the first and only birth control pill that offers women the convenience of chewing or swallowing their daily tablet. FEMCON FE became a top sales priority for our Chilcott sales force in 2007. The Company recognized revenues of $7.5 million in 2006 for FEMCON FE, which included some initial stocking for the product.

The sales of our hormone therapy products have been affected by the general decline in the hormone therapy markets that began in July 2002 following the NIH’s early termination of a large-scale clinical trial, which was part of the Women’s Health Initiative and examined the long-term effects of combined estrogen and progestogen therapy in post-menopausal women. The decline in the hormone therapy markets slowed and we launched new products during the fourth quarter of 2005 (FEMTRACE and a lower dose of FEMHRT) to improve our position in this segment. Sales of our hormone therapy products increased $9.3 million, or 6.8%, in the year ended December 31, 2006, compared with the prior year period. Net sales of ESTRACE Cream accounted for $11.9 million of the increase. We believe that net sales of ESTRACE Cream in the year ended December 31, 2005 were reduced due to contractions in the level of pipeline inventories held by our customers during this period. Average selling prices for ESTRACE Cream during the year ended December 31, 2006 rose in comparison with 2005.

In dermatology, sales of DORYX increased $6.6 million, or 6.9%, in the year ended December 31, 2006, compared with the prior year. The increase in net sales was the result of higher pricing and a contraction of pipeline inventory levels in the prior year. DORYX prescriptions, which had been in modest decline in the first half of 2005, returned to growth in the second half of 2005 due to the impact of the specialty sales force and the introduction, in September 2005, of the new delayed-release tablet form of the product. Filled prescriptions for DORYX in the year ended December 31, 2006 were essentially flat compared with the prior year but softened during the second half of 2006 as promotional emphasis shifted to TACLONEX in the second half of 2006. Price levels in effect for DORYX during the year ended December 31, 2006 compared with the prior year contributed to the increase in net sales. On January 1, 2006, we acquired the product rights to DOVONEX from Bristol-Myers and in March 2006 we began commercial shipments of TACLONEX. The addition of these two products to our dermatology portfolio added $186.0 million to our revenue in the year ended December 31, 2006, compared with the prior year. In 2005 we promoted DOVONEX for Bristol-Myers and earned $21.0 million of co-promotion revenue in the year ended December 31, 2005.

SARAFEM, our product used to treat symptoms of pre-menstrual dysphoric disorder (PMDD), had sales of $37.9 million in the year ended December 31, 2006, compared with $41.6 million in the prior year. The decrease is attributable to sharp declines in overall prescription demand of approximately 28.7% offset slightly by price increases in the year ended December 31, 2006, compared with the prior year. We believed that SARAFEM, which is patent protected until May 2008, is facing significant indirect competition from generic fluoxetine, the active ingredient in SARAFEM.

Our contract manufacturing revenues relate to certain products manufactured for Pfizer and Barr. The decline in contract manufacturing revenue in the year ended December 31, 2006 relative to the prior year period was primarily due to the discontinuation of manufacturing of all but one product for Pfizer. Effective

 

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July 1, 2006, we signed an amendment to our supply agreement to continue producing Dilantin for Pfizer for three years with two one-year extensions at Pfizer’s option. In 2006, we generated $2.6 million of revenue consisting of royalties earned on the net sales of a product sold by a third party under a license to one of our patents. In 2005, we generated $21.0 million of revenue from a co-promotion agreement with Bristol-Myers for DOVONEX.

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

The table below shows the calculation of cost of sales, adjusted cost of sales, cost of sales percentage and adjusted cost of sales percentage for the years ended December 31, 2006 and 2005:

 

(dollars in millions)    Year Ended
December 31,
2006
    Year Ended
December 31,
2005
    $
Change
    Percent
Change
 

Product net sales

   $ 751.9     $ 494.3     $ 257.6     52.1 %
                              

Cost of sales (excluding amortization and impairment), as reported

     151.8       95.2       56.6     59.4 %
                              

Cost of sales percentage

     20.2 %     19.3 %    
                    

Cost of sales (excluding amortization and impairment), as reported

     151.8       95.2       56.6     59.4 %
                              

Less inventory step up

     1.5       22.4       (20.9 )   (93.4 )%
                              

Adjusted cost of sales (excluding amortization and impairment)

     150.3       72.8       77.5     106.3 %
                              

Adjusted cost of sales percentage

     20.0 %     14.7 %    
                    

Cost of sales increased $56.6 million in the year ended December 31, 2006 compared with the same period in 2005 primarily due to the 52.1% increase in product net sales. Net sales of DOVONEX, acquired January 1, 2006, and the launch of TACLONEX accounted for a significant portion of the increase in product net sales and an even larger portion of the increase in cost of sales in the 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, were significantly higher than the costs for our other products. Cost of sales, as a percentage of product net sales, increased to 20.2% in the year ended December 31, 2006 from 19.3% in the year ended December 31, 2005. Cost of sales in the year ended December 31, 2006 and 2005 included $1.5 million and $22.4 million, respectively, representing the increased values of inventory recorded through the allocation of acquisition purchase prices and flowing through cost of sales in the periods. Excluding the impact of these items, our adjusted cost of sales for the year ended December 31, 2006 increased $77.5 million over the prior year period. The addition of DOVONEX and TACLONEX net sales were the principal factors generating the increase in adjusted cost of sales dollars and the increase in the adjusted cost of sales percentage.

SG&A Expenses

The Company’s SG&A expenses were comprised of the following during the periods presented:

 

(dollars in millions)    Year Ended
December 31,
2006
   Year Ended
December 31,
2005
   $
Change
   Percent
Change
 

Advertising and Promotion

   $ 72.0    $ 41.0    $ 31.0    75.4 %

Selling and Distribution

     75.8      67.9      7.9    11.6 %

General, Administrative and Other

     106.1      53.8      52.3    97.6 %
                           

Total

   $ 253.9    $ 162.7    $ 91.2    56.1 %
                           

 

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SG&A expenses for the year ended December 31, 2006 increased $91.2 million, or 56.1%, from $162.7 million in 2005. The increase was mainly due to the IPO related expenses incurred during the year as well as the initiation of promotional activities in support of the launches of LOESTRIN 24 FE and TACLONEX. Included in SG&A in the year ended December 31, 2006 were $14.7 million of one-time stock compensation expenses from the impact of the unrestricted shares granted to senior management at the time of the IPO and the acceleration of the vesting of certain restricted shares granted in 2005. The year ended December 31, 2006 also included a $27.4 million buyout of our Sponsors’ advisory and monitoring agreement and an increase in legal and other consulting fees. We incurred significant advertising and promotional expenses during the year ended December 31, 2006 in support of the launches of LOESTRIN 24 FE and TACLONEX, including two waves of direct to consumer advertising for LOESTRIN 24 FE at a cost of $16.6 million. Included in SG&A in the year ended December 31, 2005 were $7.8 million of G&A costs incurred in connection with the closing of the Acquisition in January 2005, which were mainly related to employee retention compensation costs.

Research and Development

Investment in R&D totaled $26.8 million in the year ended December 31, 2006 compared with $58.6 million in the prior year period. Our product development activities focused on improvements to our existing products, new and enhanced dosage forms and new products based on compounds which have been previously shown to be safe and effective. R&D expense for the year ended December 31, 2006 included $3.0 million representing our cost to acquire an option to purchase certain rights with respect to a topical dermatology product currently in development by LEO Pharma. R&D expense in the year ended December 31, 2005 included $37.0 million representing our costs to acquire the rights to a line extension of TACLONEX and other product rights from LEO Pharma. Excluding product rights costs from both the 2006 and 2005 periods, R&D expense increased $2.2 million in the year ended December 31, 2006 compared to the prior year period.

Amortization of intangible assets

Aggregate amortization expense related to intangible assets was $253.4 million and $272.3 million (including $38.9 million related to impairment) in the years ended December 31, 2006 and 2005, respectively. During the year ended December 31, 2006 we increased the rate of amortization of our ESTROSTEP FE and FEMHRT product family intangible assets as a result of changes in our forecast of future cash flows for each product. The changes in amortization rates increased our 2006 amortization expense by $20.7 million.

Acquired In-process Research and Development

We allocated $280.7 million of the purchase price paid to complete the Acquisition to the fair value of three product development projects that, as of the Acquisition date, were not approved by the FDA for promotion and sale in the U.S. and had no alternative future use (in-process research and development or “IPR&D”). This amount was expensed in the first quarter of 2005 and is included in our consolidated statement of operations for the year ended December 31, 2005. There were no such costs recognized in the year ended December 31, 2006.

We had intended to submit an NDA for an oral contraceptive, WC 2060, in 2006, but based on discussions with the FDA have concluded that an additional clinical study would be necessary to support the application. Consequently, we decided not to proceed with this project.

TACLONEX ointment and LOESTRIN 24 FE were approved by the FDA in January and February of 2006, respectively, and began generating revenue in the first quarter of 2006. The timing of the approvals was generally in line with the assumptions made in estimating the value of the acquired IPR&D for these two product development projects.

 

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Transaction Costs

During the year ended December 31, 2005 we incurred $36.0 million of expenses representing mainly (1) fees related to bridge financing necessary to complete the Acquisition and (2) the net cost of contracts purchased to hedge movements in the U.S. dollar versus the British pound sterling during the period leading up to the closing of the Acquisition. These costs were directly related to the Acquisition but were not considered to be part of the purchase price. These costs are shown in a separate line item in our consolidated statement of operations. There were no such costs recognized in the year ended December 31, 2006.

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

Net interest expense for the year ended December 31, 2006 was $207.0 million, an increase of $59.1 million from $147.9 million in the prior year period. The increase in interest expense in 2006 was primarily due to: (1) additional borrowings on the senior secured credit facility of $240.0 million used to fund the purchase of DOVONEX and the final milestone payment for TACLONEX ointment to LEO Pharma, (2) the write-off of $19.8 million of deferred financing costs related to our optional prepayments of debt, (3) the prepayment premium of $18.4 million for the optional prepayment of $210.0 million of our Notes and (4) an increase in interest rates on our un-hedged variable rate debt.

Accretion on Preferred Stock in Subsidiary

Total accretion on the Preferred Shares for the year ended December 31, 2006 was $26.2 million as compared to $31.5 million in the prior year. The Preferred Shares were all redeemed for cash or converted to Class A common shares in conjunction with the IPO in September 2006. Therefore there will be no future accretion on the Preferred Shares.

Provision / (Benefit) for Income Taxes

Our effective tax rate for the year ended December 31, 2006 was (6.8%) versus (2.3%) in the year ended December 31, 2005. The decrease in the effective tax rate from the prior year was due primarily to the expense mix of the 2006 IPO costs amongst the various jurisdictions. Additionally, the 2005 effective tax rate was unfavorably impacted by the Acquisition. In connection with the Acquisition, the effective tax rate was unfavorably impacted by non-deductible transaction costs and non-deductible acquired in-process research and development costs.

The valuation allowance for deferred tax assets of $17.8 million and $12.1 million at December 31, 2006 and 2005, respectively, related 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 SFAS No. 109, 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 dealing with uncertainties in the application of complex tax regulations in various tax jurisdictions. Amounts related to tax contingencies that management has assessed as probable and estimable have been appropriately recorded. Potential liabilities arising from tax audit issues are recorded based on our estimate of whether, and the extent to which, additional taxes may be due. 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 forseeable 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.

 

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Net Income / (Loss)

Due to the factors described above, we reported net losses of $153.5 million and $556.6 million in the years ended December 31, 2006 and 2005, respectively.

Financial Condition, Liquidity and Capital Resources

Cash

At December 31, 2007, our cash on hand was $30.8 million, as compared to $84.5 million at December 31, 2006. As of December 31, 2007 our debt, net of cash, was $1,169.4 million and consisted of $810.2 million of borrowings under our senior secured credit facility plus $390.0 million aggregate principal amount of 8.75% Notes, less $30.8 million of cash on hand.

The following table summarizes our net (decrease) / increase in cash and cash equivalents for the periods presented:

 

(dollars in millions)    Year Ended
December 31,
2007
    Year Ended
December 31,
2006
 

Net cash provided by operating activities

   $ 339.6     $ 122.7  

Net cash (used in) investing activities

     (42.8 )     (282.7 )

Net cash (used in) / provided by financing activities

     (350.5 )     233.0  
                

Net (decrease) / increase in cash and cash equivalents

   $ (53.7 )   $ 73.0  
                

Our net cash provided by operating activities for the year ended December 31, 2007 increased $216.9 million over the prior year. We reported net income for the year ended December 31, 2007 of $28.9 million compared with a net loss of $(153.5) million for the year ended December 31, 2006. During the year ended December 31, 2007, our net income included cash expenses of $17.2 million and accruals of $9.3 million for legal expenses related to the OVCON 35 litigation. Other factors affecting the 2007 operating cash flows include a reduction of inventory of $12.3 million primarily relating to the timing of product shipments received from our suppliers. During the year ended December 31, 2007, there was a reduction in accounts receivable of $8.5 million as our days sales outstanding decreased compared to December 31, 2006. During the year ended December 31, 2006, our investment in working capital, excluding cash, increased mainly due to the acquisition of DOVONEX on January 1, 2006, and the launches of LOESTRIN 24 FE and TACLONEX, which were the most significant factors behind the $35.0 million increase in our inventories and the $20.9 million increase in our accounts receivable in the year ended December 31, 2006. Included in the year ended December 31, 2006 were one-time cash expenses related to our IPO, including a $27.4 million payment made to our Sponsors to terminate the advisory and monitoring agreement and an $18.4 million payment representing the interest premium associated with our early redemption of $210.0 million aggregate principal amount of our Notes.

Our net cash used in investing activities during the year ended December 31, 2007 totaled $42.8 million, and 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 relating to capital expenditures. Our net cash used in investing activities in the year ended December 31, 2006 consisted of $198.5 million used to purchase the rights to DOVONEX, $40.0 million paid to LEO Pharma to complete the acquisition of the rights to TACLONEX ointment, $28.8 million of contingent purchase consideration paid to Pfizer in connection with the 2003 acquisitions of ESTROSTEP FE and FEMHRT and $15.4 million of capital expenditures.

Our net cash used in financing activities in the year ended December 31, 2007 totaled $350.5 million and included our optional prepayments of $340.0 million and the scheduled repayments of $10.5 million of debt under our senior secured credit facility. We 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. Our net cash provided by

 

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financing activities in the year ended December 31, 2006 was $233.0 million. In the year ended December 31, 2006 we borrowed $240.0 million under the delayed-draw term loan portion of our senior secured credit facility, which we used to fund the DOVONEX and TACLONEX ointment transactions. Net proceeds from our IPO, net of treasury shares repurchased and the retirement of preferred stock, were $672.2 million. In the year ended December 31, 2006, we used a portion of the net proceeds from the IPO and free cash flows in the fourth quarter of 2006 to make optional prepayments under our senior secured credit facility of $455.0 million and to redeem $210.0 million aggregate principal amount of our Notes. In addition, we made $13.8 million of scheduled debt repayments in the year ended December 31, 2006 under our senior secured credit facility.

Senior Secured Credit Facility

On January 18, 2005, Warner Chilcott Holdings Company III, Limited (“Holdings III”) and its subsidiaries, Warner Chilcott Corporation (“WCC”) and Warner Chilcott Company, Inc. (“WCCI”), entered into a $1,790.0 million senior secured credit facility, with Credit Suisse as administrative agent and lender, and other lenders. The senior secured credit facility consisted of a $1,640.0 million term loan facility and a $150.0 million revolving credit facility, of which $30.0 million and $15.0 million are available for letters of credit and swing line loans, respectively, to WCC and WCCI. The senior secured credit facility also contemplates up to three uncommitted tranches of term loans up to an aggregate of $250.0 million. However, the lenders are not committed to provide these additional tranches.

Holdings III, WCC and WCCI are each borrowers and cross-guarantors under the senior secured credit facility; Holdings III’s significant subsidiaries are also guarantors and cross-guarantors of this obligation. Borrowings under the senior secured credit facility are secured by a first priority security interest in substantially all of the borrowers’ and guarantors’ assets, including a pledge of all of the outstanding capital stock of Holdings III.

The $1,400.0 million single-draw term loan was drawn in a single drawing on January 18, 2005 to (i) finance, in part, the purchase of Warner Chilcott PLC shares, (ii) refinance certain existing debt of the Predecessor and its subsidiaries and (iii) pay the fees and expenses related to the Acquisition and related financings. Amounts borrowed under the single-draw term loan that are repaid or prepaid may not be re-borrowed. In 2006, the $240.0 million delayed-draw facility was utilized to finance the acquisition of the U.S. rights to the prescription pharmaceutical product DOVONEX from Bristol-Myers for $200.0 million and a $40.0 million milestone payment to LEO Pharma following FDA approval of TACLONEX ointment. Loans may be made and letters of credit may be issued under the revolving credit facility any time prior to the final maturity of the revolving credit facility, in specified minimum principal amounts. Amounts repaid under the revolving credit facility may be re-borrowed. As of December 31, 2007, there were no borrowings outstanding under the $150.0 million revolving credit facility. The revolving credit facility matures on January 18, 2011. Based on our leverage ratio, the interest rates under the revolving credit facility are LIBOR plus 1.50% or ABR plus 0.50%.

The term loan and delayed-draw term loan facilities mature on January 18, 2012. As a result of making an optional prepayment of $90.0 million in December 2007, and aggregate optional prepayments of $340.0 million during the year ended December 31, 2007, scheduled quarterly payments under the term loan and delayed-draw term loan facilities were reduced to $8.3 million annually beginning in the first quarter of 2008. The borrowers under the senior secured credit facility are also required to make mandatory prepayments of term loans in amounts equal to 100% of net asset sale proceeds, 100% of net proceeds from issuance of debt, other than permitted debt under the senior secured credit facility, and up to 50% (with reductions based on leverage) of excess cash flow (as defined in the senior secured credit facility). Additional optional prepayments may be made at any time without premium or penalty. On January 29, 2007, the Company entered into an amendment to the senior secured credit facility whereby the interest rates on all term borrowings under the senior secured credit facility were reduced by 0.25% to LIBOR plus 2.00% or ABR plus 1.00%.

The senior secured credit facility contains a financial covenant that requires that Holdings III’s ratio of total indebtedness to earnings before interest, taxes, depreciation and amortization (“EBITDA”) (both as defined in the

 

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senior secured credit facility) not exceed certain levels. The senior secured credit facility also contains a financial covenant that requires Holdings III to maintain a minimum ratio of EBITDA to interest expense (as defined in the senior secured credit facility) and other covenants that, among other things, limit Holdings III’s ability to incur additional indebtedness, incur liens, prepay subordinated debt, make loans and investments, merge or consolidate, sell assets, change business or amend the terms of subordinated debt and restrict the payment of dividends. As of December 31, 2007, Holdings III was in compliance with all covenants and the most restrictive financial covenant was the interest coverage ratio.

The senior secured credit facility specifies certain customary events of default including, without limitation, non-payment of principal or interest, violation of covenants, inaccuracy of representations and warranties in any material respect, cross default or cross acceleration of certain other material indebtedness, bankruptcy and insolvency events, material judgments and liabilities, certain ERISA events, invalidity of guarantees and security documents under the senior secured credit facility and change of control.

The Company has entered into interest rate swap contracts covering a portion of its variable rate debt. These swaps fix the interest rates on the covered portion of the Company’s variable rate debt. The Company entered into the interest rate swaps specifically to hedge a portion of its exposure to potentially adverse movements in variable interest rates. The swaps are accounted for in accordance with SFAS Nos. 133, 138, and 149.

The terms of the swaps which were in effect as of December 31, 2007 are shown in the following table:

 

Notional
Principal Amount

(in millions)

  

Start Date

  

Maturity Date

  

Receive Variable Rate

   Pay Fixed Rate
$200.0    May-03-05    May-03-08    90 day LIBOR    4.132%
$200.0    Sept-29-06    Dec-31-09    90 day LIBOR    5.544%
$175.0    May-03-07    Dec-31-08    90 day LIBOR    5.556%
$175.0    Sept-28-07    Sept-30-08    90 day LIBOR    4.950%

8.75% Notes

On January 18, 2005, WCC, our wholly-owned U.S. subsidiary, issued $600.0 million aggregate principal amount of 8.75% Notes due 2015. The Notes are guaranteed on a senior subordinated basis by the Company, Holdings III, Warner Chilcott Intermediate (Luxembourg) S.à.r.l., the U.S. operating subsidiary (Warner Chilcott (US), LLC) and WCCI (collectively, the “Guarantors”). Interest payments on the Notes are due semi-annually in arrears on each February 1 and August 1. The issuance costs related to the Notes are being amortized to interest expense over the ten-year term of the Notes using the effective interest method. The Notes are unsecured senior subordinated obligations of WCC, are guaranteed on an unsecured senior subordinated basis by the Guarantors and rank junior to all existing and future senior indebtedness, including indebtedness under our senior secured credit facility.

All or some of the 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 Notes at redemption prices declining from 104.38% of the principal amount to 100.00% on or after February 1, 2013. In addition, WCC was permitted, at its option, at any time prior to February 1, 2008 to redeem up to 35.00% of the aggregate principal amount of the Notes with the net cash proceeds of one or more equity offerings at a redemption price of 108.75% of the principal amount. In connection with the IPO, WCC exercised this option and redeemed $210.0 million aggregate principal amount of the Notes on October 31, 2006 for a total price of $228.4 million (108.75% of the principal amount), plus accrued interest.

If Holdings III or WCC were to undergo a change of control (as defined in the indenture), each Note holder would have the right to require WCC to repurchase the Notes at a purchase price equal to 101.00% of the principal amount, plus accrued and unpaid interest. The Notes indenture contains restrictive covenants that,

 

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among other things, limit the ability of Holdings III and its subsidiaries to incur or guarantee additional debt or redeem or repurchase capital stock and restrict the payment of dividends or distributions on such capital stock. As of December 31, 2007, we were in compliance with all covenants.

The indenture governing the Notes required that Holdings III provide to holders of the Notes the information required to be contained on Form 10-K, Form 10-Q and Form 8-K under the Securities Exchange Act of 1934 (the “Exchange Act”). Since we have no material assets, liabilities or operations other than our ownership of Holdings III, the information that is included in the Exchange Act reports filed with the SEC by us following the IPO is identical in all material respects to the information included in the reports required to be filed by Holdings III under the indenture. In light of the foregoing, we deemed it advisable not to have two companies within the same consolidated group file reports with the SEC containing materially identical information. Accordingly, on October 19, 2006, we entered into a supplement to the indenture (the “Supplemental Indenture”), without the consent of the holders of the Notes, relating to the indenture in order to:

 

   

add us as a guarantor of the Notes under the indenture; and

 

   

amend the “Reports” covenant in the indenture to provide that for so long as we are a guarantor of the Notes, have no material assets, liabilities or operations other than our ownership of Holdings III and have a reporting obligation under Section 13 or Section 15(d) of the Exchange Act, if we file with the SEC the reports required under the indenture to be filed by Holdings III and include in a note to our financial statements included in such reports the condensed consolidating financial information specified by Rule 3-10 of Regulation S-X, Holdings III’s obligations under such covenant shall be deemed satisfied.

We may, at any time, request the release of our guarantee of the Notes.

Components of Indebtedness

As of December 31, 2007, the Company’s outstanding debt included the following (dollars in millions):

 

     Current
Portion as of
December 31, 2007
   Long-Term
Portion as of
December 31, 2007
   Total
Outstanding as of
December 31, 2007

Revolving credit loan

   $ —      $ —      $ —  

Term loans

     8.3      801.9      810.2

Notes

     —        390.0      390.0
                    

Total

   $ 8.3    $ 1,191.9    $ 1,200.2
                    

As of December 31, 2007, mandatory principal repayments of long-term debt in each of the five years ending December 31, 2008 through 2012 and thereafter were as follows:

 

Year Ending December 31,

   Aggregate
Maturities
(in millions)

2008

   $ 8.3

2009

     8.3

2010

     8.3

2011

     6.2

2012

     779.1

Thereafter

     390.0
      

Total long-term debt

   $ 1,200.2
      

 

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Our ability to make scheduled payments of principal, or to pay the interest or additional interest, on, or to refinance our indebtedness, or to fund planned capital expenditures will depend on our future performance, which, to a certain extent, is subject to general economic, financial, competitive, legislative, regulatory and other factors that are beyond our control. Based on the current level of operations, we believe that cash flow from operations for each of our significant subsidiaries, available cash and short-term investments, together with borrowings available under the senior secured credit facility, will be adequate to meet our future liquidity needs throughout 2008. The Company notes that future cash flows from operating activities can be adversely impacted by the settlement of contingent liabilities and could fluctuate significantly from quarter-to-quarter based on the timing of payments for certain working capital components, including income taxes. To the extent we generate excess cash flow from operations, net of cash flows from investing activities, we expect to prepay debt under our senior secured credit facility at which time we may recognize non-cash expenses for the write-off of applicable deferred loan costs which is a component of interest expense. Our assumptions with respect to future costs may not be correct, and funds available to us from the sources discussed above may not be sufficient to enable us to service our indebtedness, including the Notes, or cover any shortfall in funding for any unanticipated expenses. In addition, to the extent we make future acquisitions, we may require new sources of funding including additional debt, or equity financing or some combination thereof. We may not be able to secure additional sources of funding on favorable terms or at all.

The carrying amount reported for long-term debt, other than the Notes, approximates fair value because the underlying debt not covered by an interest rate swap (fair value of $(9.4) and $(0.1) million for all swaps as of December 31, 2007 and 2006, respectively) is at variable rates and reprices frequently. The fair value of the Notes of $401.7 and $399.8 million represents the market value of the Notes as of December 31, 2007 and 2006, respectively.

Contractual Commitments

The following table summarizes our financial commitments as of December 31, 2007:

 

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

Long-term debt:

              

Senior secured credit facility

   $ 810.2    $ 8.3    $ 16.6    $ 785.3    $ —  

8.75% Notes due 2015

     390.0      —        —        —        390.0

Interest payments on long-term debt(1)

     475.8      84.8      178.7      135.5      76.8

Supply agreement obligations(2)

     74.0      66.4      7.6      —        —  

Lease obligations

     10.4      3.5      3.4      3.2      0.3
                                  

Total Contractual Obligations

   $ 1,760.4    $ 163.0    $ 206.3    $ 924.0    $ 467.1
                                  

 

(1) Interest rates reflect borrowing rates for our outstanding long-term debt as of December 31, 2007 (including debt which is subject to our interest rate swaps) and the mandatory future reductions of long-term debt. Based on our variable rate debt levels of $60.2 million as of December 31, 2007, after taking into account the impact of our applicable interest rate swaps, a 1% change in interest rates would impact our annual interest payments by approximately $0.6 million.
(2) Supply agreement obligations consist of outstanding commitments for raw materials and commitments under non-cancelable minimum purchase requirements.

The table above does not include payments related to any of the items mentioned below.

We may owe additional future purchase consideration to Pfizer in connection with our 2003 acquisition of FEMHRT. These payments are contingent on FEMHRT maintaining market exclusivity through the first quarter

 

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of 2010. Assuming market exclusivity is maintained during this period, we would pay Pfizer additional amounts of up to $26.1 million in aggregate for FEMHRT in quarterly installments. These payments are expected to be made as follows: $11.6 million in less than one year, and $14.5 million in one to three years.

Our liability for unrecognized tax benefits under FIN48 is not included in the table above. The amounts which are expected to settle within the next twelve months are $46.7 million and amounts expected to be settled after twelve months are $9.9 million, including interest.

In September 2005, we entered into agreements with LEO Pharma under which we acquired the rights to certain products under development. LEO Pharma also granted us a right of first refusal and last offer for U.S. sales and marketing rights to dermatology products developed by LEO Pharma through 2010. In September 2007, we made a $10.0 million payment under this agreement as a result of the FDA’s acceptance of LEO Pharma’s NDA submission for a TACLONEX scalp product, which is included in R&D expenses in the year ended December 31, 2007. Upon FDA approval of the TACLONEX scalp product, we would be required to pay LEO Pharma $40.0 million. We expect to receive this approval in mid-2008. The $40.0 million payment will be recorded as an intangible asset in our consolidated balance sheet. Under the product development agreement, we may be required to make additional payments to LEO Pharma upon the achievement of various developmental milestones that could aggregate up to $100.0 million in addition to the aforementioned $40.0 million, if any. Further, we agreed to pay a supply fee and royalties to LEO Pharma on the net sales of those products. We may also agree to make additional payments for products that have not been identified or that are covered under the right of first refusal and last offer.

On January 21, 2006, we entered into an agreement with LEO Pharma to acquire an option to purchase certain rights with respect to a topical dermatology product in development. We paid $3.0 million (which is included in R&D expense in the year ended December 31, 2006) for the option upon signing and agreed to pay an additional $3.0 million upon completion of developmental milestones. The purchase price for the product remains subject to negotiation by LEO Pharma and us if the option is exercised.

In July 2007, we entered into an agreement with Paratek under which we acquired the rights to certain products under development used to treat acne and rosacea. We paid an upfront fee of $4.0 million, which is included in R&D expense in the year ended December 31, 2007, and agreed to reimburse Paratek for R&D expenses incurred during the term of the agreement. We may make additional payments to Paratek upon the achievement of various developmental milestones that could aggregate up to $24.5 million. In addition, we agreed to pay royalties to Paratek based on the net sales, if any, of the products covered under the agreement.

In November 2007, we entered into an agreement with NexMed. Under the terms of the agreement, we have exclusive U.S. rights to NexMed’s topically applied alprostadil cream for the treatment of erectile dysfunction. NexMed’s NDA was accepted for review by the FDA in November 2007. We paid a license fee of $0.5 million which was recognized in R&D expense in the year ended December 31, 2007. We may make additional payments to NexMed upon the achievement of various developmental milestones that could aggregate up to $12.5 million. In addition, we agreed to pay royalties to NexMed based on the net sales, if any, of the products covered under the agreement.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements.

New Accounting Pronouncements

See “Note 2” to the Notes to the Consolidated Financial Statements for the year ended December 31, 2007 included elsewhere in this Annual Report for a discussion of recent accounting pronouncements.

 

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Critical Accounting Policies and Estimates

We make a number of estimates and assumptions in the preparation of our financial statements in accordance with accounting principles generally accepted in the U.S. Actual results could differ significantly from those estimates and assumptions. The following discussion addresses our most critical accounting policies, which we believe are important to the portrayal of our financial condition and results of operations and require management’s judgment regarding the effect of uncertain matters.

On an ongoing basis, management evaluates its estimates and assumptions, including those related to revenue recognition, recoverability of long-lived assets and the continued value of goodwill and intangible assets. Management bases its estimates and assumptions on historical experience and on various other factors that are believed to be reasonable at the time the estimates and assumptions are made. Actual results may differ from these estimates and assumptions under different circumstances or conditions.

Revenue Recognition

We recognize revenue in accordance with SAB No. 101, Revenue Recognition in Financial Statements, as amended by SAB No. 104, Revenue Recognition. Our accounting policy for revenue recognition has a substantial impact on our reported results and relies on certain estimates that require difficult, subjective and complex judgments on the part of management. Changes in the conditions used to make these judgments could have a material impact on our results of operations. Management does not believe that the assumptions which underlie its estimates are reasonably likely to change in the future. Revenue from product sales is recognized when title to the product transfers to our customers, generally FOB destination. Recognition of revenue also requires reasonable assurance of collection of sales proceeds and completion of all performance obligations. We warrant products against defects and for specific quality standards, permitting the return of products under certain circumstances. Product sales are recorded net of trade cash discounts, sales returns, rebates, coupons and fee for service arrangements with certain distributors. Revenues associated with royalty revenues are recognized based on a percentage of sales reported by third parties.

As part of our revenue recognition policies, we estimate the items that reduce our gross sales to net sales. We establish accruals for rebates, coupons, trade cash discounts, returns and fee for service arrangements with distributors in the same period that we recognize the related sales. Of these, two significant sales deductions are sales returns and Medicaid rebate reserves.

We account for sales returns in accordance with SFAS No. 48, Revenue Recognition When Right of Return Exists, by establishing an accrual in an amount equal to our estimate of the portion of sales that are expected to be returned for credit in a future period. For established products, we estimate the sales return accrual primarily based on historical experience regarding actual sales returns but we also consider other factors that could cause future sales returns to deviate from historical levels. These factors include levels of inventory in the distribution channel, estimated remaining shelf life of products sold or in the distribution channel, product recalls, product discontinuances, price changes of competitive products, introductions of generic products and introductions of new competitive products. We consider all of these factors and adjust the accrual periodically throughout each quarter to reflect actual experience and changes in expectations. The accruals needed for future returns of new products are estimated based on the historical sales returns experience of similar products, such as those within the same line of product or those within the same or similar therapeutic category.

We participate in state government-managed Medicaid programs as well as certain other qualifying federal and state government programs whereby discounts and rebates are provided to participating state and local government entities. Discounts and rebates provided through these programs are included in our Medicaid rebate accrual. We account for Medicaid rebates by establishing an accrual in an amount equal to our estimate of Medicaid rebate claims attributable to products at the time of sale. For established products, our estimate of the required accrual for Medicaid rebates is primarily based on our actual historical experience regarding Medicaid rebates on each of our products. We also consider any new information regarding changes in the Medicaid

 

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programs’ regulations and guidelines that could impact the amount of future rebates. We consider outstanding Medicaid claims, Medicaid payments and estimated levels of inventory in the distribution channel and adjust the accrual periodically to reflect actual experience and changes in expectations.

These sales deductions reduce revenue and are included as a reduction of accounts receivable or as a component of accrued expenses. Our estimates of returns, Medicaid rebates, cash discounts, wholesaler rebates and other sales deductions have not materially differed from actual experience. The movement in the reserve accounts for the balance sheet periods presented is as follows:

 

     Returns     Medicaid     Cash
Discounts
    Wholesaler
Rebates
    Other     Total  

December 31, 2005 Balance

   $ 23.7     $ 8.6     $ 1.0     $ 2.2     $ 1.7     $ 37.2  
                                                

Current provision related to sales*

     41.3       14.9       16.7       16.2       14.6       103.7  

Current processed returns/rebates

     (29.5 )     (17.4 )     (16.1 )     (14.0 )     (13.3 )     (90.3 )
                                                

December 31, 2006 Balance

   $ 35.5     $ 6.1     $ 1.6     $ 4.4     $ 3.0     $ 50.6  
                                                

Current provision related to sales*

     56.4       16.8       19.8       19.8       25.9       138.7  

Current processed returns/rebates

     (42.7 )     (16.4 )     (20.0 )     (18.9 )     (25.1 )     (123.1 )
                                                

December 31, 2007 Balance

   $ 49.2     $ 6.5     $ 1.4     $ 5.3     $ 3.8     $ 66.2  
                                                

 

* Adjustments of estimates to actual results approximate 1.0% of net sales for each of the periods presented.

We consider information from external sources in developing our estimates of gross to net sales adjustments. We purchase prescription data for our key products, which we use to estimate the market demand. We have access to the actual levels of inventory held by three of our major customers (which aggregate approximately 81% of our sales for the year ended December 31, 2007). We also informally gather information from other sources to attempt to monitor the movement of our products through the wholesale and retail channels. We combine this external data with our own internal reports to estimate the levels of inventories of our products held in the wholesale and retail channels as this is a significant factor in determining the adequacy of our sales-related reserves. Our estimates are subject to inherent limitations that rely on third-party information, as certain third-party information is provided in the form of estimates, and reflects other limitations including lags between the date which third-party information is generated and the date on which we receive third-party information.

Inventories and Inventory Reserves

Inventories are stated at the lower of cost or market and consist of finished goods purchased from third party manufacturers and held for distribution, as well as raw materials, work-in-process and finished goods manufactured by us. We determine cost on a first-in, first-out basis.

We establish reserves for our inventory to reflect situations in which the cost of the inventory is not expected to be recovered. We review our inventory for products that are close to or have reached their expiration date and therefore are not expected to be sold, for products where market conditions have changed or are expected to change, and for products that are not expected to be saleable based on our quality assurance and control standards. The reserves we establish in these situations are equal to all or a portion of the cost of the inventory based on the specific facts and circumstances. In evaluating whether inventory is properly stated at the lower of cost or market, we consider such factors as the amount of product inventory on hand, estimated time required to sell such inventory, remaining shelf life and current and expected market conditions, including levels of competition. We record provisions for inventory obsolescence as part of cost of sales.

 

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Valuation of Goodwill and Intangible Assets

Goodwill and intangible assets constitute a substantial portion of our total assets. As of December 31, 2007, goodwill represented approximately 43.3% of our total assets and intangible assets represented approximately 46.1% of our total assets. Both our goodwill and intangible assets are associated with our one reporting unit.

Goodwill

Goodwill represents the excess of the purchase price over the fair value of assets acquired net of liabilities assumed in a purchase business combination. We periodically evaluate acquired businesses for potential impairment indicators. Our judgments regarding the existence of impairment indicators are based on legal factors, market conditions and the operational performance of our business. We carry out an annual impairment review of goodwill unless an event occurs which triggers the need for an earlier review. Future events could cause us to conclude that impairment indicators exist and that goodwill associated with our business is impaired. Goodwill is tested for impairment at the reporting unit level in accordance with SFAS No. 142, Goodwill and Other Intangible Assets, which, for us, is one reporting unit. In order to perform the impairment analysis, management makes key assumptions regarding future cash flows used to measure the fair value of the entity. These assumptions include discount rates, our future earnings and, if needed, the fair value of our assets and liabilities. In estimating the value of our intangible assets, as well as goodwill, management has applied a discount rate of 12.0%, our estimated weighted average cost-of-capital, to the estimated cash flows. Our cash flow model used a 5-year forecast with a terminal value. The factors used in evaluating goodwill for impairment are subject to change and are tracked against historical results by management. Changes in the key assumptions by management can change the results of testing. Any resulting impairment could affect our financial condition and results of operations. We completed our annual test during the quarter ended December 31, 2007 and no impairment charge resulted.

Definite-Lived Intangible Assets

We assess the impairment of definite-lived intangible assets, on a product family basis, whenever events or changes in circumstances indicate that the carrying value of such assets may not be recoverable. Our analysis includes, but is not limited to, the following key assumptions:

 

   

review of period-to-period actual sales and profitability by product;

 

   

preparation of sales forecasts by product;

 

   

analysis of industry and economic trends and projected product growth rates;

 

   

internal factors, such as the current focus of our sales forces’ promotional efforts;

 

   

projections of product viability over the estimated useful life of the intangible asset (including consideration of relevant patents); and

 

   

consideration of regulatory and legal environments.

When we determine that there is an indicator that the carrying value of definite-lived intangible assets may not be recoverable based on undiscounted future cash flows we test the asset for impairment. We measure impairment, if any, based on estimates of discounted future cash flow. These estimates include the assumptions described above about future conditions within the Company and the industry. The assumptions used in evaluating intangible assets for impairment are subject to change and are tracked against historical results by management. If actual cash flows differ from those projected by management, or if there is a change in any of these key assumptions, additional write-offs may be required. Management does not believe that its key assumptions are reasonably likely to change in the future. In 2005, we wrote down the value of certain definite-lived intangible assets and recorded an impairment expense of $38.9 million in our statement of operations.

As a result of changing assumptions in evaluating intangible assets for impairment, certain unimpaired assets may be subject to a change in amortization recognized in future periods to approximate expected future cash flows.

 

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Indefinite-Lived Intangible Assets

We also have a trademark with an indefinite life, which is not amortized. However, the carrying value would be adjusted if it were determined that the fair value has declined. The impairment test is performed on an annual basis, or more frequently if necessary, and utilizes the same key assumptions as those described above for our definite-lived assets. In addition, if future events occur that warrant a change to a definite life, the carrying value would then be amortized prospectively over the estimated remaining useful life. We completed our annual test during the quarter ended December 31, 2007 and no impairment charge resulted.

Stock-based compensation

We adopted the provisions of SFAS No. 123R effective with the commencement of our operations on the date of the Acquisition. All share-based payments to employees, including non-qualified options to purchase Class A common shares and grants of restricted Class A common shares, are measured at fair value on the date of grant and are recognized in the statement of operations as compensation expense over their vesting periods. For purposes of computing the amounts of share-based compensation expensed in any period, we treat option or share grants that time-vest as serial grants with separate vesting dates. This treatment results in accelerated recognition of share-based compensation expense. Total compensation expense recognized for the year ended December 31, 2007 was $6.1 million and the related tax benefit was $1.9 million. Total compensation expense recognized for the year ended December 31, 2006 was $17.8 million and the related tax benefit was $6.7 million. Of the 2006 expense, $14.7 million related to one-time compensation costs associated with the Company’s IPO. Total compensation expense recognized for the year ended December 31, 2005 was $6.5 million and the related tax benefit was $2.5 million. Unrecognized future compensation expense was $6.1 million at December 31, 2007 which will be recognized as an expense over a remaining weighted average period of 1.08 years.

Income Taxes

The Company must make certain estimates and judgments in determining its net income for financial statement purposes. This process affects the calculation of certain of its tax liabilities and the determination of the recoverability of certain of its deferred tax assets, which arise from temporary differences between the tax and financial statement recognition of revenue and expense. Deferred tax assets and liabilities could also be affected by changes in tax laws and rates in the future.

A valuation allowance is established to reduce deferred tax assets if, based on available evidence, it is more likely than not that some portion or all of the recorded deferred tax assets will not be realized in future periods. All available positive and negative evidence is considered in evaluating the ability to recover deferred tax assets, including past operating results, the existence of cumulative losses in recent years and the forecast of future taxable income. Assumptions used to estimate future taxable income include the amount of future state, federal and international pretax operating income and the reversal of temporary differences. These assumptions are consistent with the Company’s plans and estimates used to manage its business, however, such assumptions require significant judgment about the forecasts of future taxable income.

Any recorded valuation allowances will be maintained until it is more likely than not that the deferred tax assets will be realized. Income tax expense recorded in the future will be reduced to the extent of decreases in these valuation allowances. The realization of remaining deferred tax assets is principally dependent on future taxable income. Any reduction in future taxable income may require an additional valuation allowance to be recorded against the Company’s deferred tax assets. An increase in the valuation allowance would result in additional income tax expense and could have a significant impact on future earnings.

In addition, the calculation of our tax liabilities involves dealing with uncertainties in the application of complex tax rules in various jurisdictions. Amounts related to tax contingencies that management has assessed as unrecognized tax benefits have been appropriately recorded under the provisions of FIN48. For any tax position,

 

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a tax benefit may be reflected in the financial statements only if it is “more likely than not” that the Company 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. If the estimate of tax liabilities was less than the ultimate assessment, then an additional charge to expense would result. If payment of these amounts is ultimately less than the recorded amounts, then the reversal of the liabilities would result in tax benefits being recognized in the period when it is determined the liabilities are no longer necessary. Any adjustment to tax liabilities that relate to tax uncertainties existing at the date of the Acquisition will result in an adjustment to the goodwill recorded at the date of the Acquisition.

Litigation

We are involved in various legal proceedings in the normal course of our business, including product liability and other litigation and contingencies. We record reserves related to these legal matters when losses related to such litigation or contingencies are both probable and reasonably estimable. See “Note 18” to the Notes to the Consolidated Financial Statements for the year ended December 31, 2007 included elsewhere in this report for a description of our significant current legal proceedings.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

The principal market risk (i.e., the risk of loss arising from adverse changes in market rates and prices) to which we are exposed is interest rates on debt. We had no foreign currency option contracts at December 31, 2007.

The following risk management discussion and the estimated amounts generated from analytical techniques are forward-looking statements of market risk assuming certain market conditions occur. Actual results in the future may differ materially from these projected results due to actual developments in the global financial markets.

Interest Rate Risk

We manage debt and overall financing strategies centrally using a combination of short- and long-term loans with either fixed or variable rates. We have entered into interest rate swap contracts which fix the interest rates on a portion of our variable rate debt. We entered into the interest rate swaps specifically to hedge a portion of our exposure to potentially adverse movements in variable interest rates. Based on variable rate debt levels of $60.2 million as of December 31, 2007, after taking into account the impact of the applicable interest rate swaps, a 1.0% change in interest rates would impact net interest expense by approximately $0.2 million per quarter.

Inflation

Inflation did not have a material impact on our operations during the years ended December 31, 2007, 2006 and 2005.

Item 8. Financial Statements and Supplementary Data.

The information required by this Item is incorporated by reference to the Consolidated Financial Statements beginning on page F-1.

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.

None.

 

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Item 9A. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures.

The Company maintains disclosure controls and procedures (as defined in Rule 13a-15(e) of the Securities Exchange Act) designed to provide reasonable assurance that the information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms. These include controls and procedures designed to ensure that this information is accumulated and communicated to the Company’s management, including its Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure. Management, with the participation of the Chief Executive and Chief Financial Officers, evaluated the effectiveness of the Company’s disclosure controls and procedures as of December 31, 2007. Based on this evaluation, the Company’s Chief Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and procedures were effective as of December 31, 2007 at the reasonable assurance level.

Management’s Annual Report on Internal Control over Financial Reporting.

Management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act). The Company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes of accounting principles generally accepted in the United States. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance of achieving their control objectives.

Management, with the participation of the Chief Executive and Chief Financial Officers, evaluated the effectiveness of the Company’s internal control over financial reporting as of December 31, 2007. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control—Integrated Framework. Based on this evaluation, management, with the participation of the Chief Executive and Chief Financial Officers, concluded that, as of December 31, 2007, the Company’s internal control over financial reporting was effective.

PricewaterhouseCoopers LLP, the independent registered public accounting firm who audited the Company’s consolidated financial statements included in this Annual Report on Form 10-K, has issued a report on the effectiveness of the Company’s internal control over financial reporting as of December 31, 2007, which is included herein.

Changes in Internal Control over Financial Reporting.

There were no changes in the Company’s internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) during the quarter ended December 31, 2007, that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

Item 9B. Other Information.

None.

 

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Part III

Item 10. Directors, Executive Officers and Corporate Governance.

In addition to the information set forth under the caption “Executive Officers” in Part I of this Annual Report, the information required by this Item is incorporated by reference to our Proxy Statement with respect to our Annual Meeting of Stockholders to be held on May 8, 2008.

Item 11. Executive Compensation.

The information called for by this item is hereby incorporated by reference to our Proxy Statement with respect to our Annual Meeting of Stockholders to be held on May 8, 2008.

 

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

The information called for by this item is hereby incorporated by reference to our Proxy Statement with respect to our Annual Meeting of Shareholders to be held on May 8, 2008.

Item 13. Certain Relationships and Related Transactions, and Director Independence.

The information called for by this item is hereby incorporated by reference to our Proxy Statement with respect to our Annual Meeting of Shareholders to be held on May 8, 2008.

Item 14. Principal Accounting Fees and Services.

The information called for by this item is hereby incorporated by reference to our Proxy Statement with respect to our Annual Meeting of Shareholders to be held on May 8, 2008.

 

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PART IV.

Item 15. Exhibits, Financial Statement Schedules.

(a)(1) Financial Statements

The Financial Statements listed in the Index to the Consolidated Financial Statements, filed as part of this Annual Report.

(a)(2) Financial Statement Schedules

None.

(a)(3) Exhibits

The exhibits listed at the end of this Annual Report are filed as part of this Annual Report.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Annual Report to be signed on its behalf by the undersigned, thereunto duly authorized, on February 28, 2008.

 

WARNER CHILCOTT LIMITED

By:  

/s/    ROGER M. BOISSONNEAULT        

Name:   Roger M. Boissonneault
Title:  

Chief Executive Officer, President and Director

(Principal Executive Officer)

By:  

/s/    PAUL HERENDEEN        

Name:   Paul Herendeen
Title:  

Executive Vice President and Chief Financial Officer

(Principal Financial Officer and

Principal Accounting Officer)

Pursuant to the requirements of the Securities Exchange Act of 1934, this Annual Report has been signed by the following persons on behalf of the Registrant and in the capacities indicated on February 28, 2008.

 

Signature

  

Title

/s/    ROGER M. BOISSONNEAULT        

Roger M. Boissonneault

   Chief Executive Officer, President and Director (Principal Executive Officer)

/s/    PAUL HERENDEEN        

Paul Herendeen

   Executive Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)

/s/    TODD M. ABBRECHT        

Todd M. Abbrecht

   Director

 

James G. Andress

   Director

/s/    JAMES H. BLOEM        

James H. Bloem

   Director

/s/    DAVID F. BURGSTAHLER        

David F. Burgstahler

   Director

/s/    JOHN P. CONNAUGHTON        

John P. Connaughton

   Director

/s/    JOHN A. KING        

John A. King

   Director

/s/    STEPHEN P. MURRAY        

Stephen P. Murray

   Director

/s/    STEPHEN PAGLIUCA        

Stephen Pagliuca

   Director

/s/    STEVE RATTNER        

Steve Rattner

   Director

 

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EXHIBITS

 

Exhibit
No.

  

Description

2.1    Implementation Agreement, dated October 27, 2004, among the Consortium Members (as defined therein), Waren Acquisition Limited and Warner Chilcott PLC and Second Supplemental Agreement thereto, dated November 16, 2004 (incorporated herein by reference to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)
3.1    Memorandum of Association of Warner Chilcott Limited (incorporated herein by reference to the Registration Statement on Form S-1 filed on September 15, 2006, Registration No. 333-134893)
3.2    Bye-Laws of Warner Chilcott Limited (incorporated herein by reference to the Registration Statement on Form S-1 filed on September 5, 2006, Registration No. 333-134893)
4.1    Form of Common Stock Certificate (incorporated herein by reference to the Registration Statement on Form S-1 filed on September 5, 2006, Registration No. 333-134893)
4.2    Indenture, dated January 18, 2005, among Warner Chilcott Corporation, Warner Chilcott Holdings Company III, Limited, Warner Chilcott Intermediate (Luxembourg) S.à r.l., Warner Chilcott Company, Inc., Warner Chilcott (US), Inc. and Wells Fargo Bank, National Association (incorporated herein by reference to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)
4.3    Registration Rights Agreement dated January 18, 2005 among Warner Chilcott Corporation, Credit Suisse First Boston LLC, Deutsche Bank Securities Inc. and J.P. Morgan Securities Inc. as Representatives of the Several Purchasers (incorporated herein by reference to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)
4.4    Amended and Restated Shareholders Agreement, dated as of March 31, 2005, among Warner Chilcott Holdings Company, Limited, Warner Chilcott Holdings Company II, Limited, Warner Chilcott Holdings Company III, Limited and the Shareholders party thereto (the “Amended and Restated Shareholders Agreement”) (incorporated herein by reference to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)
4.5    First Amendment to the Amended and Restated Shareholders Agreement, dated April 19, 2005, among Warner Chilcott Holdings Company, Limited, Warner Chilcott Holdings Company II, Limited, Warner Chilcott Holdings Company III, Limited and the Shareholders party thereto (incorporated herein by reference to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)
4.6    Management Shareholders Agreement, dated as of March 28, 2005, among Warner Chilcott Holdings Company, Limited, Warner Chilcott Holdings Company II, Limited, Warner Chilcott Holdings Company III, Limited, the Management Shareholders party thereto and the Shareholders party thereto (incorporated herein by reference to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)
4.7    Joinder Agreement, dated as of April 1, 2005, among Warner Chilcott Holdings Company, Limited, Warner Chilcott Holdings Company II, Limited, Warner Chilcott Holdings Company III, Limited and Paul S. Herendeen (incorporated herein by reference to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)

 

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Exhibit
No.

  

Description

10.1    Credit Agreement, dated as of January 18, 2005, among Warner Chilcott Holdings Company III, Limited, Warner Chilcott Corporation, Warner Chilcott Company, Inc., Credit Suisse First Boston as Administrative Agent, Swing Line Lender and L/C Issuer, Deutsche Bank Securities Inc. and Credit Suisse First Boston as Joint Lead Arrangers, Deutsche Bank Securities Inc., Credit Suisse First Boston and J.P. Morgan Securities Inc. as Joint Bookrunners, Deutsche Bank Securities Inc. as Syndication Agent and JPMorgan Chase Bank, N.A. and Morgan Stanley Senior Funding, Inc. as Co-Documentation Agents (incorporated herein by reference to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)
10.2    Securities Purchase Agreement, dated January 18, 2005 by and among Warner Chilcott Holdings Company, Limited, Warner Chilcott Holdings Company II, Limited, Bain Capital Integral Investors II, L.P., BCIP Trust Associates III, and BCIP Trust Associates III-B, DLJMB Overseas Partners III, C.V., DLJ Offshore Partners III, C.V., DLJ Offshore Partners III-1, C.V., DLJ Offshore Partners III-2, C.V., DLJ MB Partners III GmbH & Co. KG, Millennium Partners II, L.P. and MBP III Plan Investors, L.P., J.P. Morgan Partners (BHCA), L.P., J.P. Morgan Partners Global Investors, L.P., J.P. Morgan Partners Global Investors (Cayman), L.P., J.P. Morgan Partners Global Investors (Cayman II), L.P., J.P. Morgan Partners Global Investors A, L.P., Thomas H. Lee (Alternative) Fund V, L.P., Thomas H. Lee Parallel (Alternative) Fund V, L.P., Thomas H. Lee (Alternative) Cayman Fund V, L.P., Putnam Investments Employees’ Securities Company I LLC, Putnam Investments Employees Securities Company II LLC, Putnam Investments Holdings, LLC, Thomas H. Lee Investors Limited Partnership, OMERS Administration Corporation (formerly known as Ontario Municipal Employees Retirement Board), AlpInvest Partners CS Investments 2003 C.V., AlpInvest Partners Later Stage Co-Investments Custodian II B.V., AlpInvest Partners Later Stage Co-Investments Custodian IIA B.V., Filbert Investment Pte Ltd and The Northwestern Mutual Life Insurance Company (incorporated herein by reference to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)
10.3    Purchase and Sale Agreement, dated as of May 3, 2004, among Pfizer Inc., Pfizer Pharmaceuticals LLC, Galen Holdings Public Limited Company and Warner Chilcott Company, Inc. (incorporated herein by reference to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)
10.4    Option and License Agreement, dated as of March 24, 2004, by and between Barr Laboratories, Inc. and Galen (Chemicals) Limited (incorporated herein by reference to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)
10.5    Finished Product Supply Agreement, dated as of March 24, 2004, by and between Barr Laboratories, Inc. and Galen (Chemicals) Limited (incorporated herein by reference to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)
10.6    Transaction Agreement by and between Galen Holdings PLC and Warner Chilcott PLC, dated May 4, 2000 (incorporated by reference to Warner Chilcott PLC’s Current Report on Form 8-K filed on May 15, 2000 (File No. 000-29364))
10.7    Estrace Transitional Support and Supply Agreement between Westwood-Squibb Pharmaceuticals, Inc. and Warner Chilcott, Inc., dated as of January 26, 2000 (incorporated by reference to Warner Chilcott PLC’s Current Report on Form 8-K filed on February 29, 2000 (File No. 000-29364) (the “Warner Chilcott PLC February 29, 2000 8-K”))
10.8      Ovcon Transitional Support and Supply Agreement between Bristol-Myers Squibb Laboratories Company and Warner Chilcott, Inc., dated as of January 26, 2000 (incorporated by reference to Warner Chilcott PLC’s February 29, 2000 8-K)

 

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Exhibit
No.

  

Description

10.9  

   License and Distribution Agreement, dated as of December 31, 1997, between F H Faulding & Co Limited, A.C.N. 007 870 984, and Warner Chilcott PLC (incorporated by reference to Warner Chilcott PLC’s report on Form 10-K filed on March 30, 1999 for the year ended December 31, 1998 (File No. 000-29364))

10.10

   Asset Purchase Agreement between Bristol-Myers Squibb Company and Galen (Chemicals) Limited, dated as of June 29, 2001 (incorporated by reference to Galen Holdings PLC’s Form F-1 filed on July 2, 2001 (File No. 333-64324) (the “Galen Holdings July 2, 2001 F-1”))

10.11

   Supply Agreement between Bristol-Myers Squibb Laboratories Company and Galen (Chemicals) Limited, dated as of June 29, 2001 (incorporated by reference to Galen Holdings July 2, 2001 F-1)

10.12

   Assignment, Transfer and Assumption Agreement, dated as of December 7, 2002, by and between Galen (Chemicals) Limited and Eli Lilly and Company (incorporated by reference to Galen Holdings PLC’s Annual Report on Form 20-F filed on January 2, 2003 for the year ended September 30, 2002 (File No. 333-12634))

10.13

   Manufacturing Agreement, dated as of December 7, 2002, by and between Galen (Chemicals) Limited and Eli Lilly and Company (incorporated by reference to Galen Holdings PLC’s Annual Report on Form 20-F filed on December 31, 2003 for the year ended September 30, 2003 (File No. 333-12634) (the “Galen Holdings’ 2002-2003 20-F”))

10.14

   Purchase and Sale Agreement (OCS) among Pfizer Inc., Galen (Chemicals) Limited and Galen Holdings PLC, dated as of March 5, 2003 (incorporated by reference to Galen Holdings’ 2002-2003 20-F)

10.15

   Purchase and Sale Agreement (Femhrt) among Pfizer Inc., Galen (Chemicals) Limited and Galen Holdings PLC, dated as of March 5, 2003 (incorporated by reference to Galen Holdings’ 2002-2003 20-F)

10.16

   Transitional Supply Agreement, dated March 27, 2003, between Galen (Chemicals) Limited and Pfizer Inc. (incorporated herein by reference to Galen Holdings’ 2002-2003 20-F)

10.17

   Co-promotion Agreement, effective May 1, 2003, by and between Bristol-Myers Squibb Company and Galen (Chemicals) Limited (incorporated herein by reference to Galen Holdings’ 2002-2003 20-F)

10.18

   Option Agreement, dated as of April 1, 2003, by and between Bristol-Myers Squibb Company and Galen (Chemicals) Limited (incorporated herein by reference to the Galen Holdings’ 2002-2003 20-F)

10.19

   Development Agreement between LEO Pharma A/S and Galen (Chemicals) Limited, dated April 2, 2003 (incorporated herein by reference to Galen Holdings’ 2002-2003 20-F)

10.20

   Manufacturing Agreement, dated as of September 24, 1997, by and between Duramed Pharmaceuticals, Inc. and Warner-Lambert Company (assigned to Galen (Chemicals) Limited pursuant to the Purchase and Sale Agreement (Femhrt), among Pfizer Inc., Galen (Chemicals) Limited and Galen Holdings PLC, dated as of March 5, 2003) (incorporated herein by reference to Galen Holdings’ 2002-2003 20-F)

10.21

   Master Agreement between Galen (Chemicals) Limited and LEO Pharma A/S, dated April 1, 2003 (incorporated herein by reference to Amendment No. 1 to the Annual Report on Form 20-F of Galen Holdings PLC, filed on January 5, 2004 for the year ended September 30, 2003 (File No. 333-12634))

10.22

   Business Purchase Agreement for the Sale and Purchase of the Business and Assets of Ivex Pharmaceuticals Limited, among Ivex Pharmaceuticals Limited, Galen Holdings, PLC, Gambro Northern Ireland Limited and Gambro BCT, Inc, dated April 28, 2004 (incorporated herein by reference to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)

 

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Exhibit
No.

  

Description

10.23

   Purchase and Sale Agreement among Galen Holdings PLC, Nelag Limited, Galen Limited and Galen (Chemicals) Limited, dated April 28, 2004 (incorporated herein by reference to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)

10.24

   Purchase and Sale Agreement among Galen Limited, Galen Holdings PLC, Galen (Chemicals) Limited and Nelag Limited, dated April 27, 2004 (incorporated herein by reference to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)

10.25

   Second Amended and Restated Employment Agreement, dated as of March 28, 2005, between Warner Chilcott (US), Inc. and Roger M. Boissonneault (incorporated herein by reference to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)

10.26

   Amended and Restated Employment Agreement, dated as of March 28, 2005, between Warner Chilcott (US), Inc. and Carl Reichel (incorporated herein by reference to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)

10.27

   Amended and Restated Employment Agreement, dated as of March 28, 2005, between Warner Chilcott (US), Inc. and Anthony Bruno (incorporated herein by reference to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)

10.28

   Severance Agreement, dated as of March 28, 2005, between Warner Chilcott (US), Inc. and Izumi Hara (incorporated herein by reference to the Annual Report on Form 10-K filed by Warner Chilcott Limited on March 26, 2007, Commission File No. 1-33039)

10.29

   Employment Agreement, dated as of April 1, 2005, between Warner Chilcott (US), Inc. and Paul Herendeen (incorporated herein by reference to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)

10.30

   License, Supply and Development Agreement (“DC Agreement”), dated as of September 14, 2005, between Warner Chilcott Company, Inc. and LEO Pharma A/S (incorporated herein by reference to Amendment No. 1 to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)

10.31

   Addendum I, dated September 14, 2005, to Master Agreement between Galen (Chemicals) Limited and LEO Pharma A/S, dated April 1, 2003 (incorporated herein by reference to Amendment No. 1 to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)

10.32

   Amended and Restated License and Supply Agreement (“Dovonex Agreement”) between Warner Chilcott Company, Inc. and LEO Pharma A/S, dated as of September 14, 2005 (incorporated herein by reference to Amendment No. 1 to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)

10.33

   Right of First Refusal Agreement between Warner Chilcott Company, Inc. and LEO Pharma A/S, dated as of September 14, 2005 (incorporated herein by reference to Amendment No. 1 to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)

 

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Exhibit
No.

  

Description

10.34

   Asset Purchase Agreement between Bristol-Myers Squibb Company and Warner Chilcott Company, Inc., dated as of September 30, 2005 (incorporated herein by reference to Amendment No. 1 to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)

10.35

   First Amendment to Asset Purchase Agreement, effective as of January 1, 2006, to the Asset Purchase Agreement between Bristol-Myers Squibb Company and Warner Chilcott Company, Inc., dated September 30, 2005 (incorporated herein by reference to Amendment No. 1 to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)

10.36

   Trademark Assignment, dated as of January 1, 2006, by and among Westwood-Squibb Pharmaceuticals, Inc., Warner Chilcott Company, Inc. and LEO Pharma A/S (incorporated herein by reference to Amendment No. 1 to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)

10.37

   Amendment, dated as of March 29, 2005, to the Credit Agreement, dated as of January 18, 2005 among Warner Chilcott Holdings Company III, Limited, Warner Chilcott Corporation, Warner Chilcott Company, Inc. and the various lenders party thereto (incorporated herein by reference to Amendment No. 1 to the Registration Statement on Form S-4 filed by Warner Chilcott Holdings Company III, Limited and Warner Chilcott Corporation, Registration Number 333-12666)

10.38

   First Amendment to Transitional Supply Agreement, effective as of July 1, 2006, between Warner Chilcott Company Inc. and Pfizer Inc. (incorporated herein by reference to the Quarterly Report on Form 10-Q filed by Warner Chilcott Holdings Company III, Limited on August 11, 2006, Commission File No. 333-126660)

10.39

   Warner Chilcott Holdings Company, Limited 2005 Equity Incentive Plan, amended and restated as of August 31, 2006 (incorporated herein by reference to the Registration Statement on Form S-1 filed on September 5, 2006, Registration No. 333-134893)

10.40

   Amendment No. 2, dated as of April 25, 2006, to the Credit Agreement dated as of January 18, 2005 (as amended by the Amendment dated as of March 29, 2005, the “Credit Agreement”), among Warner Chilcott Holdings Company III, Limited, Warner Chilcott Corporation, Warner Chilcott Company, Inc., the Lenders (as defined in the introductory paragraph to the Credit Agreement), and Credit Suisse (formerly known as Credit Suisse First Boston, acting through its Cayman Islands Branch), as administrative agent (incorporated herein by reference to the Report on Form 10-Q filed by Warner Chilcott Holdings Company III, Limited on May 12, 2006, Commission File No. 333-126660)

10.41

   Waiver, dated September 25, 2006, to Section 3.1, Section 3.3 and Section 3.5(b) of the Option and License Agreement between Barr Laboratories, Inc. (“Barr”) and Galen (Chemicals) Limited dated March 24, 2004 and to Section 2.1 of the Finished Product Supply Agreement between Barr and Galen (Chemicals) Limited dated March 24, 2004 (incorporated herein by reference to the Registration Statement on Form S-1 filed on September 5, 2006, Registration No. 333-134893)

10.42

   First Supplemental Indenture, dated October 19, 2006, among Warner Chilcott Corporation, Warner Chilcott Limited, Warner Chilcott Holdings Company III, Limited, Warner Chilcott Intermediate (Luxembourg) S.à r.l., Warner Chilcott Company, Inc., Warner Chilcott (US), Inc. and Wells Fargo Bank, National Association (incorporated herein by reference to the Current Report on Form 8-K filed by Warner Chilcott Limited, Commission File No. 001-33039)

 

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Exhibit
No.

  

Description

10.43

   Amendment No. 3, dated as of January 29, 2007, to the Credit Agreement dated as of January 18, 2005 (as amended by the Amendment dated as of March 29, 2005 and Amendment No. 2 dated as of April 25, 2006, the “Credit Agreement”), among Warner Chilcott Holdings Company III, Limited, Warner Chilcott Corporation, Warner Chilcott Company, Inc., the Lenders (as defined in the introductory paragraph to the Credit Agreement), and Credit Suisse (formerly known as Credit Suisse First Boston, acting through its Cayman Islands Branch), as administrative agent (incorporated herein by reference to the Annual Report on Form 10-K filed by Warner Chilcott Limited on March 26, 2007, Commission File No. 1-33039)

10.44

   Form of Restricted Share Award Agreement (incorporated herein by reference to the Annual Report on Form 10-K filed by Warner Chilcott Limited on March 26, 2007, Commission File No. 1-33039)

10.45

   Form of Share Option Award Agreement (incorporated herein by reference to the Annual Report on Form 10-K filed by Warner Chilcott Limited on March 26, 2007, Commission File No. 1-33039)

10.46

   Form of Bonus Share Award Agreement (incorporated herein by reference to the Annual Report on Form 10-K filed by Warner Chilcott Limited on March 26, 2007, Commission File No. 1-33039)

10.47

   Form of Management Securities Purchase Agreement (incorporated herein by reference to the Annual Report on Form 10-K filed by Warner Chilcott Limited on March 26, 2007, Commission File No. 1-33039)

10.48

   Form of Strip Grant Agreement (incorporated herein by reference to the Annual Report on Form 10-K filed by Warner Chilcott Limited on March 26, 2007, Commission File No. 1-33039)

10.49

   Form of 2005 Restricted Share Award Agreement (incorporated herein by reference to the Annual Report on Form 10-K filed by Warner Chilcott Limited on March 26, 2007, Commission File No. 1-33039)

21.1*

   Subsidiaries of the Registrant

23.1*

   Consent of PricewaterhouseCoopers LLP

31.1*

   Certification of Chief Executive Officer under Rule 13a-14(a) of the Securities Exchange Act, as amended, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

31.2*

   Certification of Chief Financial Officer under Rule 13a-14(a) of the Securities Exchange Act, as amended, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

32.1*

   Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

* Filed herewith.

 

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INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

 

     Page

Audited Consolidated Financial Statements:

  

Report of Independent Registered Public Accounting Firm

   F-2

Consolidated Balance Sheets as of December 31, 2007 and 2006

   F-3

Consolidated Statements of Operations for the years ended December 31, 2007, 2006 and 2005

   F-4

Consolidated Statements of Shareholders’ Equity for the years ended December 31, 2007, 2006 and 2005

   F-5

Consolidated Statements of Comprehensive Income for the years ended December 31, 2007, 2006 and 2005

   F-6

Consolidated Statements of Cash Flows for the years ended December 31, 2007, 2006 and 2005

   F-7

Notes to Consolidated Financial Statements

  

Note 1: The Company

   F-8

Note 2: Summary of Significant Accounting Policies

   F-8

Note 3: Initial Public Offering

   F-14

Note 4: Earnings Per Share

   F-14

Note 5: Acquisitions

   F-16

Note 6: Derivatives and Fair Value of Financial Instruments

   F-19

Note 7: Inventories

   F-20

Note 8: Property, Plant and Equipment, net

   F-20

Note 9: Goodwill and Intangible Assets

   F-20

Note 10: Accrued Expenses

   F-22

Note 11: Indebtedness

   F-22

Note 12: Stock-Based Compensation Plans

   F-25

Note 13: Shareholders’ Equity and Preferred Stock in Subsidiary

   F-27

Note 14: Commitments and Contingencies

   F-28

Note 15: Income Taxes

   F-30

Note 16: Segment Information

   F-34

Note 17: Leases

   F-35

Note 18: Legal Proceedings

   F-35

Note 19: Concentration of Credit Risk, Reliance on Significant Suppliers and Reliance on Major Products

   F-40

Note 20: Defined Contribution Plans

   F-41

Note 21: Related Parties

   F-41

Note 22: Guarantor and Non-Guarantor Condensed Consolidated Financial Information

   F-41

Note 23: Valuation and Qualifying Accounts

   F-50

Note 24: Quarterly Data (unaudited)

   F-50

 

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Shareholders and the Board of Directors of Warner Chilcott Limited:

In our opinion, the accompanying consolidated balance sheets and the related consolidated statements of operations, of shareholder’s equity, of comprehensive income and of cash flows present fairly, in all material respects, the financial position of Warner Chilcott Limited and its subsidiaries (the “Company”) at December 31, 2007 and December 31, 2006, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2007 in conformity with accounting principles generally accepted in the United States of America. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2007, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). The Company’s management is responsible for these financial statements, for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal Control over Financial Reporting. Our responsibility is to express opinions on these financial statements and on the Company’s internal control over financial reporting based on our audits (which was an integrated audit in 2007). We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement and whether effective internal control over financial reporting was maintained in all material respects. Our audits of the financial statements included examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.

As discussed in Note 15 to the consolidated financial statements, the Company changed the manner in which it accounts for uncertain income taxes in 2007.

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

/s/    PRICEWATERHOUSECOOPERS LLP

PricewaterhouseCoopers LLP

Florham Park, NJ

February 28, 2008

 

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WARNER CHILCOTT LIMITED

CONSOLIDATED BALANCE SHEETS

(All amounts in thousands except share amounts)

 

     As of December 31,
2007
    As of December 31,
2006
 

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 30,776     $ 84,464  

Accounts receivable, net

     65,774       74,287  

Inventories, net

     54,031       66,376  

Deferred income taxes

     39,530       31,778  

Prepaid income taxes

     —         20,055  

Prepaid expenses and other current assets

     26,205       18,845  
                

Total current assets

     216,316       295,805  
                

Other assets:

    

Property, plant and equipment, net

     57,453       46,035  

Intangible assets, net

     1,329,427       1,533,757  

Goodwill

     1,250,324       1,241,452  

Other non-current assets

     31,454       45,496  
                

Total assets

   $ 2,884,974     $ 3,162,545  
                

LIABILITIES

    

Current liabilities:

    

Accounts payable

   $ 17,883     $ 23,094  

Accrued expenses and other current liabilities

     186,895       136,101  

Income taxes payable

     9,467       —    

Current portion of long-term debt

     8,284       11,790  
                

Total current liabilities

     222,529       170,985  
                

Other liabilities:

    

Long-term debt, excluding current portion

     1,191,955       1,538,960  

Deferred income taxes

     88,289       113,417  

Other non-current liabilities

     27,781       10,951  
                

Total liabilities

     1,530,554       1,834,313  
                

Commitments and contingencies (see Note 14)

    

SHAREHOLDERS’ EQUITY

    

Class A Common Stock, par value $0.01 per share; 500,000,000 shares authorized; 251,073,721 and 251,047,875 shares issued and 250,583,711 and 250,557,866 shares outstanding

     2,506       2,506  

Additional paid-in capital

     2,047,164       2,040,877  

Accumulated deficit

     (681,479 )     (710,156 )

Treasury stock, at cost (490,010 Class A shares)

     (6,330 )     (6,330 )

Accumulated other comprehensive (loss) / income

     (7,441 )     1,335  
                

Total shareholders’ equity

     1,354,420       1,328,232  
                

Total liabilities and shareholders’ equity

   $ 2,884,974     $ 3,162,545  
                

 

See accompanying notes to consolidated financial statements.

 

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WARNER CHILCOTT LIMITED

CONSOLIDATED STATEMENTS OF OPERATIONS

(All amounts in thousands except per share amounts)

 

     Year Ended December 31,  
     2007     2006     2005  

REVENUE:

      

Net sales

   $ 888,192     $ 751,943     $ 494,329  

Other revenue

     11,369       2,514       20,924  
                        

Total revenue

     899,561       754,457       515,253  

COSTS, EXPENSES AND OTHER:

      

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

     185,990       151,750       95,224  

Selling, general and administrative

     265,822       253,937       162,670  

Research and development

     54,510       26,818       58,636  

Amortization of intangible assets

     228,330       253,425       233,473  

Impairment of intangible assets

     —         —         38,876  

Acquired in-process research and development

     —         —         280,700  

Transaction costs

     —         —         35,975  

Interest (income)

     (4,806 )     (4,681 )     (1,459 )

Interest expense

     122,424       211,675       149,393  

Accretion on preferred stock of subsidiary

     —         26,190       31,533  
                        

INCOME / (LOSS) BEFORE TAXES

     47,291       (164,657 )     (569,768 )

Provision / (benefit) for income taxes

     18,416       (11,147 )     (13,122 )
                        

NET INCOME / (LOSS)

     28,875       (153,510 )     (556,646 )

Preferential distribution to Class L common shareholders

     (a )     65,112       78,257  
                        

Net income / (loss) attributable to Class A common shareholders

   $ 28,875     $ (218,622 )   $ (634,903 )
                        

Earnings / (Loss) Per Share:

      

Class A—Basic

   $ 0.12     $ (1.63 )   $ (7.19 )

Class A—Diluted

   $ 0.12     $ (1.63 )   $ (7.19 )

Class L—Basic (b)

     (a )   $ 6.33     $ 7.35  

Class L—Diluted (b)

     (a )   $ 6.33     $ 7.34  

 

(a) All outstanding Class L common stock of the Company (the “Class L common shares”) was converted into Class A common stock of the Company (the “Class A common shares”) in connection with the Company’s initial public offering (“IPO”) in September 2006.
(b) Earnings per share (“EPS”) for 2006 is calculated through September 30, 2006 as there were no Class L common shares outstanding during the fourth quarter of 2006.

 

See accompanying notes to consolidated financial statements.

 

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WARNER CHILCOTT LIMITED

CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

(All amounts in thousands except share amounts)

 

     Number of
Class A
common
shares
    Number of
Class L
common
shares
    Class A
Common
Stock
    Class L
Common
Stock
    Additional
Paid-in
Capital
    Accumulated
deficit
    Accumulated
Other
Comprehensive
Income
    Treasury
Stock
    Total  

Initial funding from shareholders

   88,002,920     10,628,372     $ 880     $ 107     $ 879,042     $ —       $ —       $ —       $ 880,029  

Net (loss)

   —       —         —         —         —         (556,646 )     —         —         (556,646 )

Other comprehensive income

   —       —         —         —         —         —         4,165       —         4,165  

Stock compensation

   5,284,435     43,130       53       —         4,909       —         —         —         4,962  
                                                                    

Balance as of December 31, 2005

   93,287,355     10,671,502     $ 933     $ 107     $ 883,951     $ (556,646 )   $ 4,165     $ —       $ 332,510  
                                                                    

Proceeds from IPO

   70,600,000     —         706       —         1,004,976       —         —         —         1,005,682  

Conversion of Class L common stock

   76,549,828     (10,669,441 )     765       (107 )     (658 )     —         —         —         —    

Conversion of Preferred Stock in Warner Chilcott Holdings Company II, Limited

   9,480,302     —         95       —         134,905       —         —         —         135,000  

Net (loss)

   —       —         —         —         —         (153,510 )     —         —         (153,510 )

Stock compensation

   1,130,391     —         11       —         17,776       —         —         —         17,787  

Other

   (83,859 )   (2,061 )     (4 )     —         (73 )     —         —         (238 )     (315 )

Purchase of treasury shares

   (406,151 )   —         —         —         —         —         —         (6,092 )     (6,092 )

Other comprehensive (loss)

   —       —         —         —         —         —         (2,830 )     —         (2,830 )
                                                                    

Balance as of December 31, 2006

   250,557,866     —       $ 2,506     $ —       $ 2,040,877     $ (710,156 )   $ 1,335     $ (6,330 )   $ 1,328,232  
                                                                    

Net income

   —       —         —         —         —         28,875       —         —         28,875  

Stock compensation

   17,155     —         —         —         6,115       —         —         —         6,115  

Adoption of FIN48 (see Note 15)

     —         —         —         —         (198 )     —         —         (198 )

Exercise of non-qualified options to purchase Class A Common Shares

   8,690     —         —         —         172       —         —         —         172  

Other comprehensive (loss)

   —       —         —         —         —         —         (8,776 )     —         (8,776 )
                                                                    

Balance as of December 31, 2007

   250,583,711     —       $ 2,506     $ —       $ 2,047,164     $ (681,479 )   $ (7,441 )   $ (6,330 )   $ 1,354,420  
                                                                    

See accompanying notes to consolidated financial statements.

 

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WARNER CHILCOTT LIMITED

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(in thousands)

 

     Year Ended December 31,  
     2007     2006     2005  

Net Income / (Loss)

   $ 28,875     $ (153,510 )   $ (556,646 )

Other comprehensive income / (loss):

      

Cumulative translation adjustment