Navigation Links
Endo Pharmaceuticals Reports Fourth Quarter and Full-Year Financial Results
Date:2/27/2009

- 16% Growth in Annual Net Sales Driven by Demand for Branded Products

- Adjusted Diluted EPS of $2.40 from Operations, up 25% from 2007

- Provides 2009 Adjusted EPS Guidance Range of $2.59 - $2.67

CHADDS FORD, Pa., Feb. 27 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) today reported double-digit percentage growth in net sales and adjusted diluted earnings per share for the fourth quarter and full year ended December 31, 2008.

Net sales for the three months ended December 31, 2008 increased 14% to $347.3 million compared with $304.6 million in the fourth quarter of 2007. Net income for the three months ended December 31, 2008 was $74.9 million compared with $50.6 million in the comparable 2007 period.

Diluted earnings per share for the three months ended December 31, 2008 were $0.64 compared with $0.38 in the comparable 2007 period. As detailed in the Supplemental Financial Information below, adjusted diluted earnings per share for the three months ended December 31, 2008 increased 37% to $0.71 compared with $0.52 in the same period in 2007.

Full-Year Results

Net sales for the year ended December 31, 2008 were $1.261 billion compared with $1.086 billion for the year ended December 31, 2007, an increase of 16%. Net income for the year ended December 31, 2008 was $261.7 million versus $227.4 million in the comparable 2007 period.

Diluted earnings per share for the year ended December 31, 2008 were $2.12 compared with $1.69 in the comparable 2007 period. As detailed in the Supplemental Financial Information below, adjusted diluted earnings per share for the full year 2008 increased 25% to $2.40 compared with $1.92 in 2007.

Selected Product Review

LIDODERM(R): For the quarter ended December 31, 2008, net sales of LIDODERM decreased 2% to $205.4 million compared with $208.7 million in the same period a year ago. Prescription volume for LIDODERM increased 1% in the fourth quarter of 2008 versus the comparable 2007 period. For the year ended December 31, 2008, net sales of LIDODERM increased 8% to $765.1 million compared with $705.6 million in the same period a year ago. Prescription volume for LIDODERM increased 6% in the twelve months of 2008 versus the comparable 2007 period.

OPANA(R) ER and OPANA(R): Combined net sales for the OPANA franchise increased 81% to $52.3 million for the fourth quarter 2008 compared with $28.9 million in the same period a year ago. Prescription volume for OPANA ER and OPANA increased 64% in the fourth quarter 2008 versus the comparable 2007 period. For the year ended December 31, 2008, net sales for the OPANA franchise increased 68% to $180.4 million compared with $107.1 million in the same period a year ago. The 2007 annual results include the recognition of $13.8 million in deferred revenue for commercial shipments of OPANA ER and OPANA made to customers in 2006.

PERCOCET(R): Net sales of PERCOCET were $33.4 million for the three months ended December 31, 2008 compared with $30.6 million in the same period in 2007. Net sales of PERCOCET were $130.0 million for the year ended December 31, 2008 compared with $121.7 million in the same period in 2007.

FROVA(R): Net sales of FROVA were $16.8 million for the three months ended December 31, 2008 compared with $14.1 million for the same period in 2007. Prescription volume increased 9% for the twelve months of 2008 versus the comparable 2007 period. For the year ended December 31, 2008, net sales of FROVA were $58.0 million compared with $52.4 million in the same period in 2007.

VOLTAREN(R) GEL: Net sales of VOLTAREN GEL were $23.8 million for the year ended December 31, 2008.

Generic Products: For the fourth quarter of 2008, net sales from the company's generic products were $24.1 million compared with $19.2 million in the same period in 2007. For the twelve months ended December 31, 2008, net sales of the company's generic products were $92.3 million compared with $87.6 million in the same period in 2007.

R&D Update

Endo recently announced three new research collaborations to develop novel treatments for pain and discover potential cancer treatments. The first collaboration, with Harvard University, is focused on a new pain-drug delivery technique which targets pain-sensing neurons without affecting motor neurons. Under the terms of this agreement, Endo has received exclusive world-wide rights to the technology and will be responsible for development and commercialization of any drug candidates discovered under this agreement.

The second agreement, with Aurigene Discovery Technologies Limited, is a three-year collaboration to discover novel drug candidates to treat cancer. Aurigene will be responsible for all discovery and preclinical research activities, while Endo will be responsible for all clinical development and commercialization of drug candidates that advance into human testing. Endo will also provide research funding and milestone payments and receive worldwide rights to all intellectual property that results from this collaboration.

The third agreement, announced today, is with Grunenthal GMBH for the exclusive rights to develop and market the investigational drug axomadol in the United States and Canada. Axomadol is a patented new chemical entity discovered by Grunenthal and currently in Phase II development for the treatment of moderate to moderately severe chronic pain and diabetic peripheral neuropathic pain. Under the license agreement, Endo will pay Grunenthal an upfront cash payment as well as additional potential payments that are linked to the achievement of future clinical, regulatory and commercial milestones. In addition, Grunenthal will receive payments based on a percentage of annual net sales of the product in the US and Canada. The product will be manufactured by Grunenthal. Endo will participate with Grunenthal in joint product development and commercialization committees and be responsible for all clinical development, product registration, marketing and sales activities in the Endo territories, while Grunenthal will be responsible outside the US and Canada.

As part of its continuing strategic review of projects and programs, Endo has decided to discontinue development of EN 3285 (NAC oral rinse) and EN 3270 (transdermal sufentanil patch). EN 3285, being studied for the treatment of oral mucositis, was on clinical hold, while EN 3270 was licensed from Durect Corporation and in Phase II development for the treatment of moderate-to-severe chronic pain. Endo will return to Durect all development rights to its transdermal sufentanil patch.

2009 Financial Guidance

Endo estimates 2009 net sales to be between $1.390 billion and $1.440 billion, GAAP earnings per share to be between $1.73 and $1.81 and adjusted diluted earnings per share to be between $2.59 and $2.67. A full reconciliation of the projected 2009 adjusted earnings per share is detailed below and is subject to certain assumptions as set forth below. As it has done in the past, in 2009, Endo will present both GAAP results and adjusted results. However, starting with the results of the first quarter of 2009, Endo's adjusted results (including the above guidance) will exclude the impact of amortization of commercial intangible assets ($30.8 million for the year ended December 31, 2008 and included in cost of sales) in addition to the following items that Endo has excluded in prior periods, as applicable, the impact of any of the non-recurring costs of future business combinations, estimated upfront and milestone payments to partners, certain contract termination costs, the payment of certain separation benefits, asset impairment charges, changes in the fair value of certain of our financial instruments and changes in the fair value of certain business combination contingent liabilities.

Note to Investors

Endo will conduct a conference call with financial analysts to discuss this news release today at 10:30 a.m. ET. Investors and other interested parties may access the conference call by dialing (866) 543-6405 (domestic) or (617) 213-8897 (international). Please dial in 10 minutes prior to the scheduled start time and reference passcode 10990222.

A replay of the call will be available from February 27 at 1:30 p.m. ET by dialing (888) 286-8010 (domestic) or (617) 801-6888 (international), passcode 15067182, and will run until 12:00 a.m. ET on March 6, 2009. A simultaneous webcast of the call for interested investors and others 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 March 6, 2009. 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 GAAP statements of operations to our adjusted statements of operations for each of the three months ended December 31, 2008 and December 31, 2007 (Certain prior period amounts have been reclassified to conform to the current period presentation) (in thousands, except per share data):

    Three Months Ended December 31,    Actual
     2008 (unaudited)                  (GAAP)       Adjustments    Adjusted

    Net sales                         $347,336           $-        $347,336
    Costs and expenses:
      Cost of sales                     76,681            -          76,681
      Selling, general and
       administrative                  130,288       (2,850) (1)    127,438
      Research and development          27,967       (7,281) (2)     20,686
      Purchased in-process research
       and development                    (530)         530  (3)          -

    Operating income                   112,930        9,601         122,531

      Interest expense                   2,805            -           2,805
      Interest and other income, net    (1,785)      (3,320) (4)     (5,105)

    Income before income taxes         111,910       12,921         124,831
      Income taxes                      36,968        5,185  (5)     42,153

    Net income                         $74,942       $7,736         $82,678

    Diluted earnings per share           $0.64                        $0.71
    Diluted weighted average shares    116,894                      116,799


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

    (1) To exclude stock-based compensation.
    (2) To exclude stock-based compensation ($371) and upfront and milestone
        payments to partners ($6,910).
    (3) To exclude purchased in-process research and development.
    (4) To exclude changes in fair value of financial instruments, net.
    (5) To reflect the tax effect of the pre-tax adjustments above at the
        applicable tax rates.

    Three Months Ended December 31,    Actual
     2007 (unaudited)                  (GAAP)       Adjustments    Adjusted

    Net sales                         $304,582           $-        $304,582
    Costs and expenses:
      Cost of sales                     62,045            -          62,045
      Selling, general and
       administrative                  119,450       (2,703) (1)    116,747
      Research and development          54,592      (27,075) (2)     27,517
      Impairment of other
        intangible assets                  889         (889) (3)          -

    Operating income                    67,606       30,667          98,273

      Interest expense                      27            -              27
      Interest and other income, net   (11,036)           -         (11,036)

    Income before income taxes          78,615       30,667         109,282
      Income taxes                      28,017       11,640  (4)     39,657

    Net income                         $50,598      $19,027         $69,625

    Diluted earnings per share           $0.38                        $0.52
    Diluted weighted average shares    134,632                      134,558


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

    (1) To exclude stock-based compensation.
    (2) To exclude stock-based compensation ($285) and upfront and
        milestone payments to partners ($26,790).
    (3) To exclude impairment of other intangible assets.
    (4) To reflect the tax effect of the pre-tax adjustments above at the
        applicable tax rates.

The following tables provide a reconciliation of our GAAP statements of operations to our adjusted statements of operations for each of the twelve months ended December 31, 2008 and December 31, 2007 (Certain prior period amounts have been reclassified to conform to the current period presentation) (in thousands, except per share data):

    Year Ended December 31, 2008
      (unaudited)                       Actual
                                         (GAAP)     Adjustments     Adjusted

    Net sales                       $1,260,536           $-      $1,260,536
    Costs and expenses:
      Cost of sales                    267,235            -         267,235
      Selling, general and
       administrative                  488,063      (27,973) (1)    460,090
      Research and development         110,211      (18,843) (2)     91,368
      Impairment of other
       intangible assets                 8,083       (8,083) (3)          -
      Purchased in-process
       research and development           (530)         530  (4)          -

    Operating income                   387,474       54,369         441,843

      Interest expense                   8,354            -           8,354
      Interest and other income, net   (23,080)      (3,320) (5)    (26,400)

    Income before income taxes         402,200       57,689         459,889
      Income taxes                     140,459       22,265  (6)    162,724

    Net income                        $261,741      $35,424        $297,165

    Diluted earnings per share           $2.12                        $2.40
    Diluted weighted average shares    123,720                      123,602


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

    (1) To exclude stock-based compensation ($15,492), separation benefits
        ($10,459), contract termination costs ($540) and asset impairment
        charges ($1,482).
    (2) To exclude stock-based compensation ($1,442), upfront and milestone
        payments to partners ($8,910), separation benefits ($825), contract
        termination costs ($4,551) and asset impairment charges ($3,115).
    (3) To exclude impairment of other intangible assets.
    (4) To exclude purchased in-process research and development.
    (5) To exclude changes in fair value of financial instruments, net.
    (6) To reflect the tax effect of the pre-tax adjustments above at the
        applicable tax rates.


    Year Ended December 31, 2007
     (unaudited)                       Actual
                                       (GAAP)   Adjustments    Adjusted

    Net sales                       $1,085,608        -      $1,085,608
    Costs and expenses:
      Cost of sales                    217,369        -         217,369
      Selling, general and
       administrative                  411,869  (12,397) (1)    399,472

      Research and development         138,255  (36,391) (2)    101,864
      Impairment of other
       intangible assets                   889     (889) (3)          -

    Operating income                   317,226   49,677         366,903

      Interest expense                     117        -             117
      Interest and other income, net   (36,141)       -         (36,141)

    Income before income taxes         353,250   49,677         402,927
      Income taxes                     125,810   19,001  (4)    144,811

    Net income                        $227,440  $30,676        $258,116

    Diluted earnings per share           $1.69                    $1.92
    Diluted weighted average shares    134,525                  134,548


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

    (1) To exclude stock-based compensation.
    (2) To exclude stock-based compensation ($1,531) and upfront and
        milestone payments to partners ($34,860).
    (3) To exclude impairment of other intangible assets.
    (4) To reflect the tax effect of the pre-tax adjustments above at the
        applicable tax rates.


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

    2009 Outlook (unaudited)

                                                            Year Ended
                                                        December 31, 2009

    Projected GAAP diluted
     income per common share                           $1.73    to     $1.81
    Upfront and milestone
     payments to partners                              $0.26           $0.26
    Amortization of commercial
     intangible assets                                 $0.48           $0.48
    Indevus transaction and
     separation costs                                  $0.23           $0.23
    Interest expense adjustment
     for APB 14-1                                      $0.12           $0.12
    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
                                                      ($0.23)         ($0.23)
    Diluted adjusted income per
     common share guidance                             $2.59    to     $2.67

The company's guidance is being issued based on certain assumptions including:

  • Adjusted effective tax rate of approximately 33.6% in 2009;
  • Weighted average number of common shares outstanding of 117.1 million shares for the year ended December 31, 2009;
  • The February 23, 2009 acquisition date of Indevus Pharmaceuticals, Inc.; and
  • Certain of the above amounts are based on preliminary estimates and there can be no assurance that Endo will achieve these results.

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.

About Endo

Endo Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development, sale and marketing of branded and generic prescription pharmaceuticals used primarily to treat and manage pain. Its products include LIDODERM(R), a topical patch to relieve the pain of postherpetic neuralgia; PERCOCET(R) and PERCODAN(R) tablets for the relief of moderate-to-moderately severe pain; FROVA(R) tablets for the acute treatment of migraine attacks with or without aura in adults; OPANA(R) tablets for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate; OPANA(R) 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; and VOLTAREN(R) gel, a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment. The company markets its branded pharmaceutical products to physicians in pain management, neurology, surgery, oncology, and primary care. More information, including this and past press releases of Endo Pharmaceuticals, is available at www.endo.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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. Risks and uncertainties include the satisfaction of closing conditions for the acquisition, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act; the tender of a majority of the outstanding shares of common stock of Indevus; the possibility that the transaction will not be completed, or if completed, not completed on a timely basis; the possibility that the acquisition of Indevus is not complementary to Endo; the potential that market segment growth will not follow historical patterns; general industry conditions and competition; business and economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment; 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/A for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on April 29, 2008. 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.

(Tables Attached)

The following tables present Endo's unaudited net sales for the three months and year ended December 31, 2008 and December 31, 2007:

                     Endo Pharmaceuticals Holdings Inc.
                           Net Sales (unaudited)
                              (in thousands)

                                                  Three Months Ended
                                                        December 31,

                                                     2008             2007
          LIDODERM( R )                           $205,385         $208,661
          OPANA( R ) ER AND OPANA( R )              52,258           28,869
          PERCOCET( R )                             33,413           30,559
          FROVA( R )                                16,770           14,072
          VOLTAREN( R ) GEL                         12,495                -
          Other Brands                               2,873            3,228

                Total Brands                      $323,194         $285,389

                Total Generics                     $24,142          $19,193

                      Total Net Sales             $347,336         $304,582



     

                      Endo Pharmaceuticals Holdings Inc.
                           Net Sales (unaudited)
                              (in thousands)

                                                         Year Ended
                                                        December 31,
                                                    2008             2007
          LIDODERM( R )                          $765,097         $705,587
          OPANA( R ) ER AND OPANA( R )            180,429          107,143
          PERCOCET( R )                           129,966          121,742
          FROVA( R )                               58,017           52,437
          VOLTAREN( R ) GEL                        23,791                -
          Other Brands                             10,904           11,065

                Total Brands                   $1,168,204         $997,974

                Total Generics                    $92,332          $87,634

                      Total Net Sales          $1,260,536       $1,085,608



The following table presents condensed consolidated cash flow data for the year ended December 31, 2008 and December 31, 2007:

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

                                                           Year Ended
                                                           December 31,
                                                      2008             2007

    Net cash provided by operating activities      $356,602         $365,742
    Net cash provided by (used in) investing
     activities                                     178,832         (614,528)
    Net cash used in financing activities          (110,066)         (28,974)

    Net increase (decrease) in cash and cash
     equivalents                                   $425,368        $(277,760)

    Cash and cash equivalents, beginning of
     period                                        $350,325         $628,085

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


'/>"/>
SOURCE Endo Pharmaceuticals
Copyright©2009 PR Newswire.
All rights reserved


Related medicine news :

1. Endo Pharmaceuticals Returns Product Rights to TRANSDUR(TM)-Sufentanil to DURECT
2. Anadys Pharmaceuticals Reports Fourth Quarter and Year-End 2008 Financial Results and Highlights
3. Arbor Pharmaceuticals Announces the Launch of XYLAREX(TM) - A New Nonantibiotic Product for the Dietary Management of Recurrent Ear Infections in Children
4. Endo Pharmaceuticals Appoints William Montague to Board of Directors
5. Access Pharmaceuticals Closes Acquisition of MacroChem Corp.
6. Savient Pharmaceuticals Reports Fourth Quarter and Year-End 2008 Financial Results
7. Valeant Pharmaceuticals Reports Fourth Quarter and Full Year Financial Results
8. Transdel Pharmaceuticals, Inc. Featured on National Broadcast Television
9. Update: Onyx Pharmaceuticals Reports Record Full Year and Fourth Quarter 2008 Financial Results
10. Vanda Pharmaceuticals Responds to Announcement and Filing by a Group Led by Tang Capital Partners, LP
11. Onyx Pharmaceuticals Reports Record Full Year and Fourth Quarter 2008 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... ... February 09, 2016 , ... A new leadership team for Mid-South Youth Camp, ... Wiley made the announcement Monday night, Feb. 8, prior to the evening session of ... and the creator of GO! Camp, has been named director. Gayle McDonald, currently the ...
(Date:2/10/2016)... ... February 09, 2016 , ... Ross A. Clevens, ... delighted to welcome a new addition to their growing practice. Beginning this month, ... a nurse practitioner performing cosmetic procedures including injectables, fillers and laser ...
(Date:2/10/2016)... , ... February 09, 2016 , ... ... concussion, yet the cause of injury may be one of many possible sources: ... PT Continuing Education Course , Mastering Rehab Solutions for the Complexities ...
(Date:2/9/2016)... ... February 09, 2016 , ... Steven Douglas Associates is a sponsor ... Event, an upscale fundraiser held in South Florida. The Inaugural What’s Your Taste event ... year the event will be held in a new, more causal format at the ...
(Date:2/9/2016)... Fort Worth, Texas (PRWEB) , ... February 09, ... ... restoration and reconstruction firm helping businesses recover after a disaster, announced today the ... restoration service companies in Hawaii. , “Investing in like-minded companies who ...
Breaking Medicine News(10 mins):
(Date:2/10/2016)... --> --> ... Packaging Equipment Market by Package Type (Blister, Strip, Bottle, ... Type (Tablet, Powder, Cream, Syrup, Aseptic Liquid, Aerosol) - ... market during the forecast period of 2015 to 2020. ... of 6.9% during the forecast period to reach USD ...
(Date:2/10/2016)... 10, 2016 The campaign aims to ... 5 years reach the milestone of their 5 th birthday ... ensure 2,50,532 children between the ages of 2 - 5 years ... --> The campaign aims to ensure ... reach the milestone of their 5 th birthday   ...
(Date:2/9/2016)... , Feb. 9, 2016  Insulet Corporation (NASDAQ: PODD ... insulin pump technology with its OmniPod ® ... Lemoine has been appointed to Insulet,s Board of Directors. ... directors, eight of whom are independent. --> ... of audit and finance experience and a deep knowledge of ...
Breaking Medicine Technology: