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Endo Pharmaceuticals Reports Third Quarter 2009 Financial Results and Increases Full-Year Financial Guidance
Date:10/29/2009

CHADDS FORD, Pa., Oct. 29 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) today reported financial results for the third quarter of 2009.

Total revenues during the third quarter of 2009 increased 14 percent to $361 million compared with $317 million in the third quarter of 2008. Net income for the three months ended September 30, 2009 was $49 million, compared with $66 million in the comparable 2008 period. As detailed in the supplemental financial information below, adjusted net income for the three months ended September 30, 2009 was $74 million, compared with $79 million in the same period in 2008. Reported diluted earnings per share for the three months ended September 30, 2009 were $0.42 compared with $0.55 in the third quarter of 2008. Adjusted diluted earnings per share for the three months ended September 30, 2009 were $0.63, compared with $0.66 in the same period in 2008.

Total revenues for the nine months ended September 30, 2009 were $1.07 billion, compared with $913 million in the comparable 2008 period. Reported diluted earnings per share for the nine months ended September 30, 2009 were $1.01 compared with $1.45 in the comparable period of 2008. Adjusted diluted earnings per share for the nine months ended September 30, 2009 were $2.04, compared with $1.74 in the same period in 2008.

    ($in thousands,
     except per
     share amounts)
                          Third Quarter                Year-to-Date

                        2009      2008  Change        2009       2008  Change
    Total Revenues  $361,027  $316,768    14%   $1,069,435   $913,200    17%
    Reported Net
     Income           49,422    65,994   (25%)     118,488    182,650   (35%)
    Reported Diluted
     EPS                0.42      0.55   (24%)        1.01       1.45   (30%)
    Adjusted Income   74,251    78,724    (6)%     239,141    219,638     9%
    Adjusted Diluted
     EPS               $0.63     $0.66    (5)%       $2.04      $1.74    17%



"This is an exciting time for Endo Pharmaceuticals," said Dave Holveck, president and CEO of Endo. "Our core business continues to exceed our expectations; we have successfully launched Valstar(TM) for bladder cancer this quarter, and we are planning for the launch of our long-acting injectable testosterone product, which will now be called Aveed(TM). We believe our third quarter performance, in conjunction with a solid outlook for the remainder of the year, warrants an increase in our revenue and earnings guidance. And we continue to actively pursue business development opportunities that will further diversify our top line in the years ahead."

2009 Financial Guidance

The company is raising guidance for 2009 annual total revenues and adjusted diluted earnings per share. The company now estimates total revenues to be between $1.440 billion and $1.465 billion. The company also now estimates reported (GAAP) diluted earnings per share to be between $1.41 and $1.47, and this EPS increase is primarily due to changes in the fair value of contingent consideration associated with the Indevus transaction partially offset by the addition of milestone payments associated with the company's recent deal with ProStrakan to in-license FORTESTA(TM). Adjusted diluted earnings per share are now estimated to be between $2.67 and $2.73. The company's reported (GAAP) EPS guidance does not include any estimates for potential future changes in the fair value of contingent consideration or for potential new business development transactions. These items could have a significant impact on the actual reported diluted earnings per share in the future. A reconciliation of GAAP to non-GAAP calculations is attached to this press release.

Third Quarter Highlights

On September 3, VALSTAR(TM) became commercially available for the treatment of a distinct form of bladder cancer. VALSTAR represents a new treatment option for patients who may otherwise have exhausted all other FDA-approved treatment alternatives.

On September 24, Endo announced the final results of a cash tender offer by one of its wholly owned subsidiaries, for any and all outstanding Ledgemont PhaRMA(SM) Secured 16% Notes. This offer resulted in Endo's acquiring $48 million of the $105 million aggregate principal amount that was outstanding and reflects the company's ongoing efforts to manage its capital structure.

Selected Product Review

PAIN PRODUCTS

LIDODERM®: For the quarter ended September 30, 2009, net sales of LIDODERM were $193 million comparable to $194 million in the same period a year ago. For the nine months ended September 30, 2009, net sales of LIDODERM were flat at $560 million compared with $560 million in the same period a year ago.

OPANA® ER and OPANA®: Combined net sales for the OPANA franchise increased 42 percent to $59 million for the third quarter 2009 compared with $41 million in the same period a year ago. For the nine months ended September 30, 2009, combined net sales for the OPANA franchise increased 30 percent to $167 million compared with $128 million in the same period a year ago.

FROVA®: Net sales of FROVA were $15 million for the three months ended September 30, 2009 compared with $14 million for the same period in 2008. Net sales of FROVA were $42 million for the nine months ended September 30, 2009 compared with $41 million for the same period in 2008.

Voltaren® Gel: Net sales of Voltaren Gel were $20 million for the three months ended September 30, 2009 compared with $10 million for the same period in 2008. Net sales of Voltaren Gel were $57 million for the nine months ended September 30, 2009 compared with $11 million for the same period in 2008.

ONCOLOGY/ENDOCRINOLOGY PRODUCTS

SUPPRELIN® LA: Net Sales of SUPPRELIN LA for the third quarter were $8 million. For the period from the acquisition date of Indevus until September 30, 2009, net sales of SUPPRELIN LA were $18 million.

VANTAS®: Net Sales of VANTAS for the third quarter were $6 million. For the period from the acquisition date of Indevus until September 30, 2009, net sales of VANTAS were $14 million.

OTHER BRANDED PRODUCTS

For the third quarter of 2009, net sales of other branded products were $4 million compared with $3 million in the same period in 2008. For the nine months ended September 30, 2009, net sales of other branded products were $12 million compared with $8 million in the same period in 2008.

GENERIC AND NON-PROMOTED PRODUCTS

For the third quarter of 2009, net sales from the company's generic products were $23 million compared with $22 million in the same period in 2008. Net sales of Percocet® were $31 million for the three months ended September 30, 2009, which is comparable to net sales of Percocet® in the same period in 2008. For the nine months ended September 30, 2009, net sales from the company's generic products were $96 million compared with $68 million in the same period in 2008. During the first half of 2009, the company benefitted from a market dislocation in the supply for certain generic products. Market conditions have now essentially normalized for these products. Net sales of Percocet® were $96 million for the nine months ended September 30, 2009, comparable to $97 million in the same period in 2008.

Conference Call Information

Endo will conduct a conference call with financial analysts to discuss this news release today at 9:00 a.m. ET. Investors and other interested parties may call 800-798-2884 (domestic) or 617-614-6207 (international) and enter code 12555118. Please dial in 10 minutes prior to the scheduled start time.

A replay of the call will be available from October 29 at 12:00 p.m. ET until 12:00 a.m. ET on November 4 by dialing 888-286-8010 (domestic) or 617-801-6888 (international) and enter code 66458151.

A simultaneous webcast of the call may be accessed by visiting www.endo.com. In addition, a replay of the webcast will be available until 12:00 a.m. ET on November 4. The replay can be accessed by clicking on "Events" in the Investor Relations section of the website.

Supplemental Financial Information

The following tables provide a reconciliation of our reported (GAAP) statements of operations to our adjusted statements of operations for each of the three months ended September 30, 2009 and September 30, 2008 (Certain prior period amounts have been adjusted to reflect the retrospective adoption of FSP APB 14-1 and to conform to the current period presentation) (in thousands, except per share data):

    Three Months Ended         Actual
     September 30, 2009       Reported
     (unaudited)                (GAAP)  Adjustments       Adjusted

    Total Revenues            $361,027            $       $361,027
    Costs and expenses:
      Cost of revenues          97,307      (22,617)  (1)   74,690
      Selling, general and
       administrative          139,922       (2,549)  (2)  137,373
      Research and
       development              59,690      (30,718)  (3)   28,972
      Acquisition-related
       items                   (20,206)      20,206   (4)       --

    Operating income            84,314       35,678        119,992

      Interest expense, net     10,204       (3,730)  (5)    6,474
      Other income, net         (5,219)       3,727   (6)   (1,492)

    Income before income taxes  79,329       35,681        115,010
      Income taxes              29,907       10,852   (7)   40,759

    Net income                 $49,422      $24,829        $74,251

    Diluted earnings per share   $0.42           --          $0.63
    Diluted weighted
     average shares            117,643           --        117,643



Notes to reconciliation of our GAAP statements of operations to our adjusted statements of operations:

  1. To exclude amortization of commercial intangible assets related to marketed products of $16,738 and the impact of an Indevus inventory step-up recorded as part of acquisition accounting of $5,879.
  2. To exclude certain separation payments.
  3. To exclude upfront and milestone payments to partners.
  4. To exclude Indevus transaction and separation costs of $2,484 as well as the impact, under purchase accounting, of a gain recorded to reflect the change in the company's current estimate of fair value, in accordance with GAAP, of the contingent consideration associated with the Indevus acquisition of ($22,690).
  5. To exclude additional interest expense as a result of adopting FSP APB 14-1 of $3,958 and to exclude amortization of the premium on debt acquired from Indevus of ($228).
  6. To exclude changes in fair value of financial instruments, net of ($298) as well as the gain on the extinguishment of a portion of the debt acquired from Indevus of $4,025.
  7. To reflect the cash tax savings resulting from the Indevus acquisition as well as the tax effect of the pre-tax adjustments above at applicable tax rates.
    Three Months Ended        Actual
     September 30, 2008      Reported
     (unaudited)              (GAAP)   Adjustments        Adjusted

    Total Revenues           $316,768            $        $316,768
    Costs and expenses:
      Cost of revenues         71,027       (8,878)  (1)    62,149
      Selling, general and
       administrative         116,249       (3,583)  (2)   112,666
      Research and
       development             22,165       (4,551)  (3)    17,614
      Impairment of other
       intangibles                 --           --              --

    Operating income          107,327       17,012         124,339

      Interest expense
       (income), net            1,401       (3,611)  (4)    (2,210)
      Other expense, net            9           --               9

    Income before income
     taxes                    105,917       20,623         126,540
      Income taxes             39,923        7,893   (5)    47,816

    Net income                $65,994      $12,730         $78,724

    Diluted earnings per share  $0.55           --           $0.66
    Diluted weighted
     average shares           119,954           --         119,954



Notes to reconciliation of our GAAP statements of operations to our adjusted statements of operations:

  1. To exclude amortization of commercial intangible assets related to marketed products.
  2. To exclude separation costs of $1,561, impairment of long lived assets of $1,482 and contract termination costs of $540.
  3. To exclude contract termination costs.
  4. To exclude additional interest expense as a result of adopting FSP APB 14-1.
  5. To reflect the tax effect of the pre-tax adjustments above at the applicable tax rates.

The following tables provide a reconciliation of our reported (GAAP) statements of operations to our adjusted statements of operations for each of the nine months ended September 30, 2009 and September 30, 2008 (Certain prior period amounts have been adjusted to reflect the retrospective adoption of FSP APB 14-1 and to conform to the current period presentation) (in thousands, except per share data):

    Nine months Ended           Actual
     September 30, 2009        Reported
     (unaudited)                (GAAP)    Adjustments        Adjusted

    Total Revenues           $1,069,435            $       $1,069,435
    Costs and expenses:
      Cost of revenues          275,385      (54,860)  (1)    220,525
      Selling, general and
       administrative           389,520       (2,549)  (2)    386,971
      Research and
       development              136,612      (61,120)  (3)     75,492
      Acquisition-related
       items                     41,222      (41,222)  (4)

    Operating income            226,696      159,751          386,447

      Interest expense, net      28,213      (10,699)  (5)     17,514
      Other (income)
       expense, net              (5,629)       6,030   (6)        401

    Income before income
     taxes                      204,112      164,420          368,532
      Income taxes               85,624       43,767   (7)    129,391

    Net income                 $118,488     $120,653         $239,141

    Diluted earnings per share    $1.01           --            $2.04
    Diluted weighted
     average shares             117,401           --          117,401



Notes to reconciliation of our GAAP statements of operations to our adjusted statements of operations:

  1. To exclude amortization of commercial intangible assets related to marketed products of $43,714 and the impact of an Indevus inventory step-up recorded as part of acquisition accounting of $11,146.
  2. To exclude certain separation payments.
  3. To exclude upfront and milestone payments to partners.
  4. To exclude Indevus transaction and separation costs of $37,982 as well as the impact, under purchase accounting, of a loss recorded to reflect the change in the company's current estimate of fair value, in accordance with GAAP, of the contingent consideration associated with the Indevus acquisition of $3,240.
  5. To exclude additional interest expense as a result of adopting FSP APB 14-1 of $11,667 and to exclude the amortization of the premium on debt acquired from Indevus of ($968).
  6. To exclude changes in fair value of financial instruments, net of $2,005 as well as a gain on the extinguishment of a portion of the debt acquired from Indevus of $4,025.
  7. To reflect the cash tax savings resulting from the Indevus acquisition and the tax effect of the pre-tax adjustments above at applicable tax rates.
    Nine months Ended         Actual
     September 30, 2008      Reported
     (unaudited)               (GAAP)  Adjustments        Adjusted

    Total Revenues           $913,200            $        $913,200
    Costs and expenses:
      Cost of revenues        190,554      (21,944)  (1)   168,610
      Selling, general and
       administrative         357,775      (12,481)  (2)   345,294
      Research and
       development             82,244      (10,491)  (3)    71,753
      Impairment of other
       intangibles              8,083       (8,083)  (4)

    Operating income          274,544       52,999         327,543

      Interest income, net     (8,292)      (6,620)  (5)   (14,912)
      Other income, net          (835)                        (835)

    Income before income
     taxes                    283,671       59,619         343,290
      Income taxes            101,021       22,631   (6)   123,652

    Net income               $182,650      $36,988        $219,638

    Diluted earnings per share  $1.45           --           $1.74
    Diluted weighted
     average shares           126,012           --         126,012



Notes to reconciliation of our GAAP statements of operations to our adjusted statements of operations:

  1. To exclude amortization of commercial intangible assets related to marketed products.
  2. To exclude separation costs of $10,459, impairment of long-lived assets of $1,482 and contract termination costs of $540.
  3. To exclude upfront and milestone payments to partners of $2,000, separation costs of $825, impairment of long lived assets of $3,115 and contract termination costs of $4,551.
  4. To exclude impairment of other intangibles.
  5. To exclude additional interest expense as a result of adopting FSP APB 14-1.
  6. To reflect the tax effect of the pre-tax adjustments above at the applicable tax rates.

For an explanation of Endo's reasons for using non-GAAP measures, see Endo's Current Report on Form 8-K filed today with the Securities and Exchange Commission.



     Reconciliation of Projected GAAP Diluted Earnings Per Share to Adjusted
                        Diluted Earnings Per Share Guidance


                                                                Year Ended
                                                             December 31, 2009

    Projected GAAP diluted income per common share           $1.41  to  $1.47
    Upfront and milestone payments to partners               $0.62      $0.62
    Amortization of commercial intangible assets and
     Indevus inventory step-up                               $0.60      $0.60
    Separation costs                                         $0.02      $0.02
    Indevus transaction and separation costs and
     change in fair value of contingent consideration        $0.36      $0.36
    Interest expense adjustment for APB 14-1 and the
     amortization of the premium on debt acquired from
     Indevus                                                 $0.14      $0.14
    Changes in fair value of financial instruments and
     gain on the extinguishment of a portion of the debt
     acquired from Indevus                                  ($0.06)    ($0.06)
    Tax effect of pre-tax adjustments at the applicable
     tax rates and certain other expected cash tax savings
     as a result of the Indevus acquisition                 ($0.42)    ($0.42)
    Diluted adjusted income per common share guidance        $2.67  to  $2.73

    The company's guidance is being issued based on certain assumptions
     including:
    - Adjusted effective tax rate of approximately 35% in 2009.
    - Certain of the above amounts are based on estimates and there can be no
      assurance that Endo will achieve these results.
    - Includes all completed business development transactions as of September
      30, 2009.

About Endo

Endo Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development, sale and marketing of branded and generic prescription pharmaceuticals used to treat and manage pain, prostate cancer and the early onset of puberty in children, or central precocious puberty (CPP). Its products include LIDODERM®, a topical patch to relieve the pain of postherpetic neuralgia; Percocet® and Percodan® tablets for the relief of moderate-to-moderately severe pain; FROVA® tablets for the acute treatment of migraine attacks with or without aura in adults; OPANA® tablets for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate; OPANA® ER tablets for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time; Voltaren® Gel, which is owned and licensed by Novartis AG, a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as those of the hands and the knees; VANTAS® for the palliative treatment of advanced prostate cancer; SUPPRELIN® LA for the treatment of early onset puberty in children; and VALSTAR(TM) for the treatment of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable medical risks. The company markets its branded pharmaceutical products to physicians in pain management, urology, endocrinology, oncology, neurology, surgery and primary care. More information, including this and past press releases of Endo Pharmaceuticals, is available at www.endo.com.

The following tables present Endo's unaudited Total Revenues for the three months ended September 30, 2009 and September 30, 2008:


                         Endo Pharmaceuticals Holdings Inc.
                              Total Revenues (unaudited)
                                  (in thousands)

                                   Three Months Ended
                                     September 30,

                                       2009             2008     Growth

     LIDODERM(R)                   $192,738         $194,138        (1%)
     OPANA(R) ER and OPANA(R)        58,894           41,496         42%
     PERCOCET(R)                     30,690           31,371        (2%)
     Voltaren(R) Gel                 19,584           10,299         90%
     FROVA(R)                        15,000           14,306          5%
     SUPPRELIN(R) LA                  8,092               --         NM
     VANTAS(R)                        6,491               --         NM
     Other Brands                     3,927            2,748         43%

           Total Brands            $335,416         $294,358         14%

           Total Generics           $22,928          $22,410          2%

           Total Royalty and Other                                   NM
            Revenue                  $2,683              $--

                 Total Revenues    $361,027         $316,768         14%



The following tables present Endo's unaudited Total Revenues for the nine months ended September 30, 2009 and September 30, 2008:


                        Endo Pharmaceuticals Holdings Inc.
                            Total Revenues (unaudited)
                                 (in thousands)

                                     Nine months Ended
                                       September 30,

                                         2009             2008     Growth

     LIDODERM(R)                     $559,846         $559,712          0%
     OPANA(R) ER and OPANA(R)         166,878          128,171         30%
     PERCOCET(R)                       96,394           96,553        (0%)
     Voltaren(R) Gel                   57,437           11,296        408%
     FROVA(R)                          42,479           41,247          3%
     SUPPRELIN(R) LA                   18,091               --         NM
     VANTAS(R)                         14,046               --         NM
     Other Brands                      12,196            8,031         52%

           Total Brands              $967,367         $845,010         14%

           Total Generics             $95,605          $68,190         40%

           Total Royalty and Other                                     NM
            Revenue                    $6,463              $--

                 Total Revenues    $1,069,435         $913,200         17%



The following table presents condensed consolidated cash flow data for the nine months ended September 30, 2009 and September 30, 2008:


                          Endo Pharmaceuticals Holdings Inc.
                    Condensed Consolidated Cash Flow Data (unaudited)
                                 (in thousands)


                                                         Nine months Ended
                                                           September 30,


                                                           2009          2008


    Net cash provided by operating activities          $219,015      $228,109

    Net cash (used in) provided by investing
     activities                                        (425,449)      153,486

    Net cash used in financing activities              (112,506)      (98,961)
    Net (decrease) increase in cash and cash
     equivalents                                      $(318,940)     $282,634

    Cash and cash equivalents, beginning of period     $775,693      $350,325

    Cash and cash equivalents, end of period           $456,753      $632,959



Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the company's financial position, results of operations, market position, product development and business strategy, as well as estimates of future net sales, future expenses, future net income and future earnings per share. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "intend," "guidance" or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in this press release. These factors include, but are not limited to: the possibility that the acquisition of Indevus is not complementary to Endo; the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and pipeline products; competition in our industry, including for branded and generic products, and in connection with our acquisition of rights to assets, including intellectual property; government regulation of the pharmaceutical industry; our dependence on a small number of products and on outside manufacturers for the manufacture of our products; our dependence on third parties to supply raw materials and to provide services for certain core aspects of our business; new regulatory action or lawsuits relating to our use of controlled substances in many of our core products; our exposure to product liability claims and product recalls and the possibility that we may not be able to adequately insure ourselves; our ability to protect our proprietary technology; our ability to successfully implement our in-licensing and acquisition strategy; the availability of third-party reimbursement for our products; the outcome of any pending or future litigation or claims by the government; our dependence on sales to a limited number of large pharmacy chains and wholesale drug distributors for a large portion of our total net sales; a determination by a regulatory agency that we are engaging in inappropriate sales or marketing activities, including promoting the "off-label" use of our products; the loss of branded product exclusivity periods and related intellectual property; and exposure to securities that are subject to market risk including auction-rate securities the market for which is currently illiquid; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, particularly the discussion under the caption "Item 1A, RISK FACTORS" in our annual report on Form 10-K for the year ended December 31, 2008, which was filed with the Securities and Exchange Commission on March 2, 2009. The forward-looking statements in this press release and on the related conference call are qualified by these risk factors. These are factors that, individually or in the aggregate, we think could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

SOURCE Endo Pharmaceuticals


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