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WPI > SEC Filings for WPI > Form 10-Q on 31-Oct-2008All Recent SEC Filings

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Form 10-Q for WATSON PHARMACEUTICALS INC


31-Oct-2008

Quarterly Report


ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion of our financial condition and the results of operations should be read in conjunction with the "Condensed Consolidated Financial Statements" and notes thereto included elsewhere in this Quarterly Report on Form 10-Q ("Quarterly Report"). This discussion contains forward-looking statements that are subject to known and unknown risks, uncertainties and other factors that may cause our actual results to differ materially from those expressed or implied by such forward-looking statements. These risks, uncertainties and other factors include, among others, those identified under "Cautionary Note Regarding Forward-Looking Statements" under "Risks Related to our Business" in our Annual Report on Form 10-K for the year ended December 31, 2007 and elsewhere in this Quarterly Report and our Annual Report on Form 10-K.
Overview
Watson Pharmaceuticals, Inc. ("Watson", the "Company" "we", "us" or "our") was incorporated in 1985 and is engaged in the development, manufacturing, marketing, sale and distribution of brand and off-patent (generic) pharmaceutical products. Watson operates manufacturing, distribution, research and development ("R&D") and administrative facilities predominantly in the United States ("U.S.") and India with our key commercial market being the U.S.
Results of Operations
Prescription pharmaceutical products in the U.S. are generally marketed as either generic or brand pharmaceuticals. Generic pharmaceutical products are bioequivalents of their respective brand products and provide a cost-efficient alternative to brand products. Brand pharmaceutical products are marketed under brand names through programs that are designed to generate physician and consumer loyalty.
Watson has three reportable operating segments: Generic, Brand and Distribution. The Generic segment includes off-patent pharmaceutical products that are therapeutically equivalent to proprietary products. The Brand segment includes the Company's Specialty Products and Nephrology product lines. Watson has aggregated its brand product lines in a single segment because of similarities in regulatory environment, methods of distribution and types of customer. This segment includes patent-protected products and certain trademarked off-patent products that Watson sells and markets as brand pharmaceutical products. The Company sells its brand and generic products primarily to pharmaceutical wholesalers, drug distributors and chain drug stores. The Distribution segment mainly distributes generic pharmaceutical products manufactured by third parties, as well as by Watson, primarily to independent pharmacies, pharmacy chains, pharmacy buying groups and physicians' offices under the "Anda" trade name. Sales are principally generated through an in-house telemarketing staff and through internally developed ordering systems. The Distribution segment operating results exclude sales of Watson products, which are included in their respective Generic and Brand segment results.
The Company evaluates segment performance based on segment net revenues, gross profit and contribution. Segment contribution represents segment gross profit less direct R&D expenses and selling and marketing expenses. The Company has not allocated corporate general and administrative expenses or amortization as such information has not been used by management, or has not been accounted for at the segment level.

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Three Months Ended September 30, 2008 Compared to Three Months Ended

September 30, 2007

                                     Three Months Ended September 30, 2008                                Three Months Ended September 30, 2007
                          Generic          Brand          Distribution          Total          Generic          Brand          Distribution          Total
Product sales            $ 352,190       $  94,298       $      170,933       $ 617,421       $ 326,231       $  93,534       $      129,875       $ 549,640
Other                       11,593          11,677                    -          23,270          31,489          13,577                    -          45,066

Net revenues               363,783         105,975              170,933         640,691         357,720         107,111              129,875         594,706
Cost of sales(1)           212,367          30,224              144,064         386,655         210,931          22,089              113,400         346,420

Gross profit(1)            151,416          75,751               26,869         254,036         146,789          85,022               16,475         248,286
Gross margin(1)               41.6 %          71.5 %               15.7 %          39.7 %          41.0 %          79.4 %               12.7 %          41.7 %
Research and
development                 31,736          13,586                    -          45,322          26,555           9,102                    -          35,657
Selling and
marketing                   13,990          29,024               15,558          58,572          14,018          26,613               12,716          53,347

Contribution             $ 105,690       $  33,141       $       11,311         150,142       $ 106,216       $  49,307       $        3,759         159,282

Contibution margin            29.1 %          31.3 %                6.6 %          23.4 %          29.7 %          46.0 %                2.9 %          26.8 %
General and
administrative                                                                   42,697                                                               59,144
Amortization                                                                     20,200                                                               44,159
Loss (gain) on asset
sales and
impairments                                                                         303                                                               (6,118 )

Operating income                                                              $  86,942                                                            $  62,097

Operating margin                                                                   13.6 %                                                               10.4 %

(1) Excludes amortization of acquired intangibles including product rights.

Generic Segment
Net Revenues
Our Generic segment develops, manufactures, markets, sells and distributes generic products that are the therapeutic equivalent to their brand name counterparts and are generally sold at prices significantly less than the brand product. As such, generic products provide an effective and cost-efficient alternative to brand products. When patents or other regulatory exclusivity no longer protect a brand product, opportunities exist to introduce off-patent or generic counterparts to the brand product. Additionally, we distribute generic versions of third parties' brand products (sometimes known as "Authorized Generics") to the extent such arrangements are complementary to our core business. Our portfolio of generic products includes products we have internally developed, products we have licensed from third parties, and products we distribute for third parties.
Net revenues in our Generic segment include product sales and other revenue. Our Generic segment product line includes a variety of products and dosage forms. Indications for this line include pregnancy prevention, pain management, depression, hypertension and smoking cessation. Dosage forms include oral solids, transdermals, injectables and transmucosals.
Other revenue consists primarily of royalties and commission revenue. Net revenues from our Generic segment for the three months ended September 30, 2008 increased 1.7% or $6.1 million to $363.8 million compared to net revenues of $357.7 million from the prior year period. This increase in net revenues was mainly attributable to new product launches ($42.0 million), including fentanyl transdermal patch (launched at the end of the third quarter of 2007), omeprazole delayed-release capsules 40 mg (launched in the third quarter of 2008) and clarithromycin extended-release tablets (launched in the first quarter of 2008) as well as net revenues from recently launched Authorized Generics ($19.0 million) in the three months ended September 30, 2008, including TiliaTM Fe and balsalazide disodium (both launched in the fourth quarter of 2007), alendronate sodium tablets (launched in the first quarter of 2008) and dronabinol (launched in the second quarter of 2008). Increases in net revenues from new product launches were partially offset by a decrease in other revenue ($19.9 million), a decrease in net revenues from the sale of oral contraceptives and price erosion within our base business.

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The decrease in other revenue in the three months ended September 30, 2008 compared to the prior year period for the Generic segment was primarily related to reduced royalties on sales by Sandoz, Inc. of metoprolol succinate 50 mg extended release tablets (which commenced during the third quarter of 2007) and reduced royalties on sales by GlaxoSmithkline of Wellbutrin XL® 150 mg due to increased competition. Both items combined resulted in a reduction in royalties in the quarter totaling $18.9 million.
Gross Profit
Gross profit represents net revenues less cost of sales. Cost of sales includes production and packaging costs for the products we manufacture, third party acquisition costs for products manufactured by others, profit-sharing or royalty payments for products sold pursuant to licensing agreements, inventory reserve charges and excess capacity utilization charges, where applicable. Cost of sales does not include amortization costs for acquired product rights or other acquired intangibles.
Gross profit for our Generic segment increased $4.6 million to $151.4 million in the three months ended September 30, 2008 compared to $146.8 million in the prior year period. The increase in gross profit was primarily due to gross profit contribution from new product launches and recently launched Authorized Generics ($35.9 million) partially offset by a decrease in other revenue ($19.9 million), a decrease in gross profit from the sale of oral contraceptives and costs associated with our Global Supply Chain Initiative ($4.4 million). Research and Development Expenses
Generic segment R&D expenses consist predominantly of personnel-related costs, active pharmaceutical ingredient costs, contract research, biostudy and facilities costs associated with the development of our products.
Generic segment R&D expenses increased 19.5% or $5.2 million to $31.7 million in the three months ended September 30, 2008 compared to $26.6 million in the prior year period primarily due to higher biostudy and test chemical costs ($2.0 million) and increased R&D expenditures in India ($2.0 million). Selling and Marketing Expenses
Selling and marketing expenses consist mainly of personnel costs, facilities costs, insurance and professional services costs.
Generic segment selling and marketing expenses were $14.0 million in the three months ended September 30, 2008 compared to $14.0 million in the prior year period.
Brand Segment
Net Revenues
Our Brand segment develops, manufactures, markets, sells and distributes products within two sales and marketing groups: Specialty Products and Nephrology.
Our Specialty Products product line includes urology products such as Trelstar® and Oxytrol®and a number of non-promoted products.
Our Nephrology product line consists of products for the treatment of iron deficiency anemia and is generally marketed to nephrologists and dialysis centers. The major products of the Nephrology group are Ferrlecit® and INFeD®, which are used to treat low iron levels in patients undergoing hemodialysis in conjunction with erythropoietin therapy.

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Other revenue in the Brand segment consists primarily of co-promotion revenue, royalties and the recognition of deferred revenue relating to our obligation to manufacture and supply brand products to third parties. Other revenue also includes revenue recognized from R&D and licensing agreements.
Net revenues from our Brand segment for the three months ended September 30, 2008 decreased 1.1% or $1.1 million to $106.0 million compared to net revenues of $107.1 million in the prior year period. The decrease was primarily attributable to a decrease in product revenue, royalties and deferred revenue relating to our obligation to manufacture and supply certain brand products to third parties ($3.8 million) which was partially offset by higher sales within the Specialty Products group.
Gross Profit (Gross Margin)
Gross profit for our Brand segment decreased $9.3 million to $75.8 million in the three months ended September 30, 2008 compared to $85.0 million in the prior year period. Gross margin decreased to 71.5% during the three months ended September 30, 2008 compared to 79.4% in the prior year period. The decrease in gross profit and gross margin was primarily due to the recording of a $7.7 million reserve against inventory for INFeD® pending the resolution of potential quality issues with certain batches of active pharmaceutical ingredient received from a supplier.
Research and Development Expenses
Brand segment R&D expenses consist predominantly of personnel-related costs, contract research, clinical costs and facilities costs associated with the development of our products.
Brand segment R&D expenses increased 49.3% or $4.5 million to $13.6 million in the three months ended September 30, 2008 compared to $9.1 million in the prior year period primarily due to higher license and filing fees ($2.3 million) and increased clinical study costs ($0.7 million) related to the development of RAPAFLOTM (silodosin) and oxybutynin topical gel and higher labor costs. Selling and Marketing Expenses
Brand segment selling and marketing expenses consist mainly of personnel-related costs, product promotion costs, distribution costs, professional services costs, insurance and depreciation.
Brand segment selling and marketing expenses increased 9.1% or $2.4 million to $29.0 million in the three months ended September 30, 2008 as compared to $26.6 million in the prior year period primarily related to expenditures to support pre-launch activities related to RAPAFLOTMand oxybutynin topical gel. Distribution Segment
Net Revenues
Our Distribution segment mainly distributes generic pharmaceutical products manufactured by third parties, as well as by Watson, primarily to independent pharmacies, pharmacy chains, pharmacy buying groups and physicians' offices. Sales are principally generated through an in-house telemarketing staff and through internally developed ordering systems. The Distribution segment operating results exclude Watson products, which are included in their respective Generic and Brand segment results.
Net revenues from our Distribution segment for the three months ended September 30, 2008 increased 31.6% or $41.1 million to $170.9 million compared to net revenues of $129.9 million in the prior year period primarily due to an increase in net revenues from new products launched since the third quarter of 2007 ($56.4 million) which was partially offset by lower levels of sales in the current period from 2007 product launches ($5.8 million) and reduced net revenues due to price erosion.

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Gross Profit (Gross Margin)
Gross profit for our Distribution segment increased $10.4 million to $26.9 million in the three months ended September 30, 2008 compared to $16.5 million in the prior year period primarily due to higher product sales. Gross margin increased to 15.7% during the three months ended September 30, 2008 compared to 12.7% in the prior year period primarily due to lower product acquisition costs.
Selling and Marketing Expenses
Selling and marketing expenses consist mainly of personnel costs, facilities costs, insurance and freight costs, which support the Distribution segment sales and marketing functions.
Distribution segment selling and marketing expenses increased 22.3% or $2.8 million to $15.6 million in the three months ended September 30, 2008 as compared to $12.7 million in the prior year period primarily due to higher freight costs related to the increased level of net revenues and higher fuel surcharges ($1.6 million) and higher commissions ($0.6 million) on the increased level of net revenues.

Segment Contribution

                             Three Months Ended September 30,                Change
 ($ in thousands):              2008                   2007            Dollars         %
 Segment contribution
 Generic                  $        105,690       $        106,216     $    (526 )      (0.5 )%
 Brand                              33,141                 49,307       (16,166 )     (32.8 )%
 Distribution                       11,311                  3,759         7,552       200.9 %

                          $        150,142       $        159,282     $  (9,140 )      (5.7 )%

 as a % of net revenues               23.4 %                 26.8 %

For more information on segment contribution, refer to above "Management's Discussion and Analysis of Financial Condition and Results of Operations."

Corporate General and Administrative Expenses

                                                        Three Months Ended September 30,                       Change
($ in thousands):                                         2008                    2007                Dollars              %
Corporate general and administrative expenses       $       42,697          $       59,144          $ (16,447 )          (27.8 )%
as a % of net revenues                                         6.7 %                   9.9 %

Corporate general and administrative expenses consist mainly of personnel costs, facilities costs, insurance and professional services costs, which are general in nature and not directly related to specific segment operations.
Corporate general and administrative expenses decreased during the three months ended September 30, 2008 as compared to the same period of the prior year as a result of a favorable settlement of a tax-related liability due to the resolution of the Internal Revenue Service ("IRS") audit for the Company's 2000 to 2003 tax years ($5.9 million) in the current year period. In addition, the prior year period was negatively impacted by higher levels of legal accruals ($8.5 million) and severance accruals ($4.5 million).

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Amortization

                              Three Months Ended September 30,                Change
  ($ in thousands):               2008                 2007            Dollars         %
  Amortization              $       20,200        $       44,159     $ (23,959 )     (54.3 )%
  as a % of net revenues               3.2 %                 7.4 %

The Company's amortizable assets consist primarily of acquired product rights. For the three months ended September 30, 2008 amortization expense decreased 54.3% or $24.0 million as our Ferrlecit® product rights were fully amortized as of December 2007.

Loss (Gain) on Asset Sales and Impairments

                                                    Three Months Ended September 30,                      Change
($ in thousands):                                    2008                    2007                Dollars             %
Loss (gain) on asset sales and impairments        $     303            $        (6,118 )        $ 6,421            (105.0 )%
as a % of net revenues                                  0.0 %                     (1.0 )%

For the three months ended September 30, 2007, we recorded a gain on sale of our Phoenix facility in the amount of $10.6 million and also recorded an additional impairment of our Puerto Rico facility in the amount of $4.5 million. For the three months ended September 30, 2008, we recorded a loss on disposal of idle property, plant and equipment related to our current and former manufacturing facilities in Florida and Puerto Rico.

Interest Income

                                Three Months Ended September 30,               Change
   ($ in thousands):               2008                   2007           Dollars        %
   Interest income            $       2,157           $       1,964      $   193       9.8 %
   as a % of net revenues               0.3 %                   0.3 %

Interest income increased for the three months ended September 30, 2008 due to an increase in invested cash balances over the prior year period.

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Interest Expense

                                                   Three Months Ended September 30,                     Change
($ in thousands):                                  2008                      2007               Dollars            %
Interest expense - 2006 Credit Facility       $         3,709          $           6,889        $ (3,180 )
Interest expense - convertible
contingent senior debentures due 2023
("CODES")                                               3,151                      3,151               -
Change in derivative value                                  -                       (103 )           103
Interest expense - other                                  145                        188             (43 )

                                              $         7,005          $          10,125        $ (3,120 )        (30.8 )%

as a % of net revenues                                    1.1 %                      1.7 %

Interest expense decreased for the three months ended September 30, 2008 primarily due to reduced levels of debt on the 2006 Credit Facility from prepayments made during the fourth quarter of 2007 and the first quarter of 2008.

Other Income

                                                   Three Months Ended September 30,                     Change
($ in thousands):                                   2008                      2007              Dollars            %
Earnings on equity method investments         $           3,733          $         1,686        $  2,047          121.4 %
Gain on sale of securities                                8,250                        -           8,250            N/A
Other expense                                               (41 )                   (237 )           196          (82.7 )%

                                              $          11,942          $         1,449        $ 10,493          724.2 %

as a % of net revenues                                      1.9 %                    0.2 %

Earnings on Equity Method Investments
The Company's equity investments are accounted for under the equity method when the Company's ownership does not exceed 50% and when the Company can exert significant influence over the management of the investee.
Earnings on equity method investments during the three months ended September 30, 2008 primarily represents our share of equity earnings in Scinopharm Taiwan, Ltd. ("Scinopharm"). Earnings on equity method investments for the three months ended September 30, 2007 primarily represented our share of earnings in Somerset Pharmaceuticals, Inc. ("Somerset"), our joint venture with Mylan Inc. ("Mylan").
Gain on Sale of Securities
On July 28, 2008 the Company sold its fifty percent interest in Somerset to Mylan.

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Provision for Income Taxes

                                  Three Months Ended September 30,              Change
  ($ in thousands):                   2008                 2007           Dollars       %
  Provision for income taxes   $        22,975       $        20,779     $ 2,196       10.6 %
  Effective tax rate                      24.4 %                37.5 %

The lower effective tax rate for the three months ended September 30, 2008, as compared to the same period of the prior year, is primarily due to the resolution of the Company's federal income tax return examination (the"Exam") with the IRS for the years ended December 31, 2000 to 2003 (8.8%) and a tax benefit related to the sale of Somerset (4.3%).
Nine Months Ended September 30, 2008 Compared to Nine Months Ended September 30,

2007

                                          Nine Months Ended September 30, 2008                                     Nine Months Ended September 30, 2007
                             Generic           Brand          Distribution           Total            Generic           Brand          Distribution           Total
Product sales              $ 1,038,938       $ 294,756       $      443,822       $ 1,777,516       $ 1,065,152       $ 281,096       $      421,946       $ 1,768,194
Other                           68,249          44,511                    -           112,760            62,834          38,288                    -           101,122

Net revenues                 1,107,187         339,267              443,822         1,890,276         1,127,986         319,384              421,946         1,869,316
Cost of sales(1)               669,676          82,167              374,812         1,126,655           693,896          74,099              363,583         1,131,578

Gross profit(1)                437,511         257,100               69,010           763,621           434,090         245,285               58,363           737,738
Gross margin(1)                   39.5 %          75.8 %               15.5 %            40.4 %            38.5 %          76.8 %               13.8 %            39.5 %
Research and
development                     83,458          39,095                    -           122,553            77,036          31,932                    -           108,968
Selling and marketing           41,868          86,593               43,695           172,156            41,764          79,397               39,246           160,407

Contribution               $   312,185       $ 131,412       $       25,315           468,912       $   315,290       $ 133,956       $       19,117           468,363

Contibution margin                28.2 %          38.7 %                5.7 %            24.8 %            28.0 %          41.9 %                4.5 %            25.1 %
General and
. . .
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