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WPI > SEC Filings for WPI > Form 10-Q on 1-May-2009All Recent SEC Filings

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Form 10-Q for WATSON PHARMACEUTICALS INC


1-May-2009

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, 2008 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 pharmaceutical products that are therapeutically equivalent to proprietary products. The Brand segment includes the Company's Specialty Products and Nephrology/Medical 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 March 31, 2009 Compared to Three Months Ended March 31, 2008

                                  Three Months Ended March 31, 2009                            Three Months Ended March 31, 2008
($ in millions):        Generic         Brand       Distribution        Total        Generic         Brand       Distribution        Total

Product sales          $   395.2       $  98.2      $       153.7      $ 647.1      $   342.4       $  99.0      $       144.9      $ 586.3
Other                        6.5          13.8                  -         20.3           24.3          16.3                  -         40.6

Net revenues               401.7         112.0              153.7        667.4          366.7         115.3              144.9        626.9
Cost of sales(1)           238.5          24.2              126.0        388.7          229.7          27.5              122.9        380.1

Gross profit(1)            163.2          87.8               27.7        278.7          137.0          87.8               22.0        246.8
Gross margin(1)             40.6 %        78.4 %             18.0 %       41.8 %         37.4 %        76.1 %             15.2 %       39.4 %
Research and
development                 30.1          12.2                  -         42.3           22.6          15.4                  -         38.0
Selling and
marketing                   12.7          36.9               16.1         65.7           14.1          28.0               14.0         56.1

Contribution           $   120.4       $  38.7      $        11.6        170.7      $   100.3       $  44.4      $         8.0        152.7

Contibution margin          30.0 %        34.6 %              7.5 %       25.6 %         27.4 %        38.5 %              5.5 %       24.4 %

General and
administrative                                                            68.9                                                         50.5
Amortization                                                              21.8                                                         20.2
Gain on asset sales                                                       (1.5 )                                                          -

Operating income                                                       $  81.5                                                      $  82.0

Operating margin                                                          12.2 %                                                       13.1 %

(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 revenues consist primarily of royalties and commission revenue. Net revenues from our Generic segment for the three months ended March 31, 2009 increased 9.5% or $35.0 million to $401.7 million compared to net revenues of $366.7 million from the prior year period. This increase in sales was mainly attributable to new product launches and products acquired subsequent to the first quarter of 2008 ($57.2 million) offset in part by a decrease in other revenue ($17.8 million).
The decrease in other revenues in the three months ended March 31, 2009 for the Generic segment was primarily related to reduced royalties on sales by Sandoz, Inc. of metoprolol succinate 50 mg extended release tablets and reduced royalties on sales by GlaxoSmithKline of Wellbutrin XL® 150 mg. Sales of metoprolol

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succinate 50 mg declined as Sandoz, Inc. ceased shipping the product in the fourth quarter of 2008 and it is uncertain when sales will resume. Sales of Wellbutrin XL® 150 mg declined due to increased competition. Both items combined resulted in a reduction in royalties in the quarter totaling $15.8 million. Gross Profit (Gross Margin)
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 $26.2 million to $163.2 million in the three months ended March 31, 2009 compared to $137.0 million in the prior year period. The increase in gross profit was primarily due to new product launches and recent product acquisitions ($29.5 million), a reduction in costs associated with our Global Supply Chain Initiative over the prior year period ($5.6 million), an increase in sales of oral contraceptives and an increase in gross profit due to a favorable product
mix. These increases were partially offset by a decrease in other revenue ($17.8 million). Gross margins for our Generic segment increased 3.2 percentage points to 40.6% for the three months ended March 31, 2009 from 37.4% in the prior year period. This increase in gross margin was primarily related to higher overall margins on new product launches and recent product acquisitions. Research and Development Expenses
Generic segment R&D expenses consist predominantly of personnel-related costs, active pharmaceutical ingredient ("API") costs, contract research, biostudy and facilities costs associated with the development of our products.
Generic segment R&D expenses increased 33.0% or $7.5 million to $30.1 million in the three months ended March 31, 2008 compared to $22.6 million in the prior year period due to higher biostudy and test chemical costs ($5.4 million) and Global Supply Chain Initiative severance costs in the current year period ($1.5 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 decreased 9.5% or $1.4 million to $12.7 million in the three months ended March 31, 2009 compared to $14.1 million in the prior year period.

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Brand Segment
Net Revenues
Our brand pharmaceutical business develops, manufactures, markets, sells and distributes products within two sales and marketing groups: Specialty Products and Nephrology/Medical.
Our Specialty Products product line includes urology products such as Trelstar® and Oxytrol® and a number of non-promoted products.
Our Nephrology/Medical 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/Medical group are Ferrlecit® and INFeD®, which are used to treat low iron levels in patients undergoing hemodialysis in conjunction with erythropoietin therapy.
Other revenues in the Brand segment consist 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 revenues also include revenue recognized from R&D and licensing agreements.
Net revenues from our Brand segment for the three months ended March 31, 2009 decreased 2.8% or $3.3 million to $112.0 million compared to net revenues of $115.3 million in the prior year period. The decrease was primarily attributable to lower other revenues ($2.4 million) and lower sales of INFeD® within the Nephrology/Medical group due to a supply interruption of INFeD®'s API which is available from only one source. The INFeD® API supply interruption may continue for the remainder of 2009.
Gross Profit (Gross Margin)
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 Brand segment was $87.8 million or the same as the prior year period. A decrease in other revenues ($2.4 million) was offset by improved gross profit within the Specialty Product group in the current year period.
Gross margins for our Brand segment increased to 78.4% during the three months ended March 31, 2009 from 76.1% in the prior year period primarily due to improved product mix.
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 decreased 20.5% or $3.2 million to $12.2 million in the three months ended March 31, 2008 compared to $15.4 million in the prior year period primarily due to a $5.0 million milestone payment in the prior year period related to the filing of an NDA for RapafloTM with the FDA. This decrease in R&D expenses was partially offset by increased clinical spending on recently approved new products.
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 31.7% or $8.9 million to $36.9 million in the three months ended March 31, 2009 as compared to $28.0 million in the prior year period primarily related to increased product promotion, field force and marketing costs to support pre-launch activities related to RapafloTM and GelniqueTM.

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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 generic and brand products, which are included in their respective segment results.
Net revenues from our Distribution segment for the three months ended March 31, 2009 increased 6.1% or $8.8 million to $153.7 million compared to net revenues of $144.9 million in the prior year period primarily due to an increase in net revenues from new products launched since the first quarter of 2008 ($33.0 million) which was partially offset by lower levels of sales in the current period from price erosion and volume decreases ($24.8 million). Gross Profit (Gross Margin)
Gross profit for our Distribution segment increased $5.7 million to $27.7 million in the three months ended March 31, 2009 compared to $22.0 million in the prior year period. Gross margins also improved for our Distribution segment increasing to 18.0% during the three months ended March 31, 2009 from 15.2% in the prior year period. Distribution segment gross profit improved in the current quarter due to increased sales levels and higher gross margins. Distribution segment gross margin improved in the current quarter due to lower product acquisition costs and higher pricing on certain products. 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 14.6% or $2.1 million to $16.1 million in the three months ended March 31, 2009 as compared to $14.0 million in the prior year period primarily related to higher freight costs ($1.0 million) and higher payroll costs ($1.0 million).

Segment Contribution

                              Three Months Ended March 31,               Change
       ($ in millions):         2009                2008           Dollars         %

     Segment contribution
     Generic                $       120.4       $       100.3     $    20.1        20.0 %
     Brand                           38.7                44.4          (5.7 )     (12.8 )%
     Distribution                    11.6                 8.0           3.6        45.0 %

                            $       170.7       $       152.7     $    18.0        11.8 %

     as % of net revenues            25.6 %              24.4 %

For more information on segment contribution, refer to above Management's Discussion and Analysis of Financial Condition and Results of Operations and "NOTE 3 - OPERATING SEGMENTS" in the accompanying "Notes to Condensed Consolidated Financial Statements" in this Quarterly Report.

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Corporate General and Administrative Expenses

                                                        Three Months Ended March 31,                      Change
              ($ in millions):                           2009                   2008             Dollars            %

Corporate general and administrative expenses        $      68.9            $      50.5          $ 18.4            36.4 %
as a % of net revenues                                      10.3 %                  8.1 %

Corporate general and administrative expenses consists mainly of the cost of personnel, facilities, insurance, professional services and litigation, which is general in nature and not directly related to specific segment operations.
Corporate general and administrative expenses increased during the three months ended March 31, 2009 primarily due to an $18.0 million legal settlement of a patent dispute with Elan Corporation, Plc during the current year period.

Amortization

                                  Three Months Ended March 31,               Change
        ($ in millions):            2009                 2008          Dollars        %

     Amortization               $      21.8           $      20.2      $   1.6       7.9 %
     as a % of net revenues             3.3 %                 3.2 %

The Company's amortizable assets consist primarily of acquired product rights. For the three months ended March 31, 2009 amortization expense increased $1.6 million primarily as a result of the amortization of product rights the Company acquired in the fourth quarter of 2008 as a result of the merger between Teva Pharmaceutical Industries, Ltd. and Barr Pharmaceuticals, Inc.

Gain on Asset Sales

                                  Three Months Ended March 31,               Change
        ($ in millions):             2009                 2008         Dollars        %

     Gain on asset sales        $      (1.5 )           $       -      $ (1.5 )     100.0 %
     as a % of net revenues            (0.2 )%                0.0 %

In January 2009, we recognized a $1.5 million gain on the sale of certain property and equipment in Dombivli, India for cash consideration of $3.0 million.

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Loss on Early Extinguishment of Debt

                                                   Three Months Ended March 31,                      Change
            ($ in millions):                         2009                 2008             Dollars             %

Loss on early extinguishment of debt             $        -            $      1.1          $ (1.1 )          (100.0 )%
as a % of net revenues                                  0.0 %                 0.2 %

In November 2006, we entered into a Senior Credit Facility with Canadian Imperial Bank of Commerce, acting through its New York agency, as Administrative Agent, Wachovia Capital Markets, LLC, as Syndication Agent, and a syndicate of banks (the "2006 Credit Facility") in connection with the acquisition of the Andrx Corporation.
During the quarter ended March 31, 2008, the Company prepaid $75.0 million of outstanding debt on the 2006 Credit Facility. As a result of this prepayment, our results for the quarter ended March 31, 2008 reflect debt repurchase charges of $1.1 million which consist of unamortized debt issue costs associated with the repurchased amount.

Interest Income

                                 Three Months Ended March 31,               Change
        ($ in millions):            2009                2008         Dollars        %

     Interest income            $      2.0           $      2.3      $ (0.3 )     (13.0 )%
     as a % of net revenues            0.3 %                0.4 %

Interest income decreased for the three months ended March 31, 2009 due to a decrease in interest rates over the prior year period.

Interest Expense

                                                  Three Months Ended March 31,                      Change
            ($ in millions):                      2009                   2008               Dollars            %

Interest expense - 2006 Credit Facility       $        1.5          $           3.9        $    (2.4 )
Interest expense - convertible
contingent senior debentures due 2023
("CODES")                                              3.2                      3.2                -
Interest expense - other                                 -                     (0.3 )            0.3

Interest expense                              $        4.7          $           6.8        $    (2.1 )        (30.9 )%

as a % of net revenues                                 0.7 %                    1.1 %

Interest expense decreased for the three months ended March 31, 2009 due to reduced LIBOR rates of interest on the 2006 Credit Facility during the current year period.

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Other Income

                                                  Three Months Ended March 31,                      Change
            ($ in millions):                       2009                    2008             Dollars            %

Earnings on equity method investments         $           2.2          $        4.0        $    (1.8 )
(Loss) gain on securities                                (1.1 )                 1.4             (2.5 )
Other income                                              0.1                     -              0.1

                                              $           1.2          $        5.4        $    (4.2 )        (77.8 )%

as a % of net revenues                                    0.2 %                 0.9 %

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 primarily represent our share of equity earnings in Scinopharm Taiwan Ltd. ("Scinopharm").
Scinopharm results for the three months ended March 31, 2008 were higher than the current year period due to product launches during that period.
(Loss) Gain on Securities For the quarters ended March 31, 2009 and 2008, the Company received contingent proceeds related to the sale of our investment in Adheris, Inc. in 2006. In the quarter ended March 31, 2009 the Company received cash proceeds of $1.1 million as additional consideration on our sale of our investment in Adheris, Inc. which was recorded as a gain on securities in the quarter. This gain was offset by an other-than-temporary impairment charge of $2.2 million related to our investment in common shares of inVentiv Health, Inc. ("inVentiv") as the fair value of our investment fell below our carrying value for a six-month period. In the quarter ended March 31, 2008 the Company received common shares of inVentiv and cash as additional proceeds on our sale of our investment in Adheris, Inc. which was recorded as a gain on securities in the quarter.

Provision for Income Taxes

                                    Three Months Ended March 31,               Change
        ($ in millions):              2009                 2008          Dollars        %

   Provision for income taxes     $      30.9           $      31.2      $ (0.3 )     (1.0 )%
   Effective tax rate                    38.6 %                38.1 %

The provision for income taxes differs from the amount computed by applying the statutory U.S. federal income tax rate primarily due to state taxes and other factors which, combined, increases the effective tax rate.
The higher effective tax rate for the three months ended March 31, 2009, as compared to the same period of the prior year, primarily reflects the impact of a California state legislative change in the current quarter which was partially offset by a reduction in the effective tax rate for the R&D tax credit and certain permanent differences.

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Liquidity and Capital Resources
Working Capital Position
   Working capital at March 31, 2009 and December 31, 2008 is summarized as
follows:

                                                           March 31,          December 31,           Increase
($ in millions):                                              2009                2008              (Decrease)

Current Assets:
Cash and cash equivalents                                  $    559.0        $        507.6        $       51.4
Marketable securities                                            11.8                  13.2                (1.4 )
. . .
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