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Celgene Reports Record Second Quarter Product Sales and Operating Profits

2007 Second Quarter Financial Results Year-Over-Year:

  • Total Revenue Increased 76 Percent To $348 Million
  • Product Sales Increased 81 Percent To $319 Million
  • REVLIMID(R) Net Product Sales Increased 187 Percent To $181 Million
  • THALOMID(R) Net Product Sales Totaled $118 Million
  • Adjusted Operating Income Increased 143 Percent To $130 Million
  • Adjusted Net Income Increased 160 Percent To $110 Million
  • Adjusted Earnings Per Share Increased 136 Percent To $0.26 Per Diluted Share

    2007 Financial Outlook:

  • Total Revenue Targeted To Increase To A $1.4 Billion Range
  • Adjusted Diluted Earnings Per Share Targeted To A Range of $1.00 to $1.05

    Recent Highlights:

  • REVLIMID Granted Full Marketing Authorization From European Medicines Agency for Use In Combination With Dexamethasone As A Treatment For Patients With Multiple Myeloma Who Have Received At Least One Prior Therapy
  • Positive Clinical Data On CC-10004 Confirmed Potential As Novel Oral Approach To Treating Inflammatory Diseases
  • Over 140 Abstracts On Data Highlighting REVLIMID, THALOMID And CC-4047 At Major International Medical Meetings
  • At ASCO 2007, Preliminary Data From The National Cancer Institute Sponsored ECOG (E4A03) Phase III Trial Reported Survival Advantage For Patients Newly Diagnosed With Multiple Myeloma With REVLIMID Plus Low-Dose Dexamethasone
  • REVLIMID Multiple Myeloma And MDS Clinical Programs Advanced In Japan, The Third Largest Healthcare Market In The World
  • On June 12, 2007 U.S. Patent 7,230,012 Was Issued Further Broadening The Intellectual Property Estate Around Our THALOMID Franchise

    2007 Milestones:

  • Execute REVLIMID(R) European Launches Following Price, Reimbursement And Distribution Approvals In Each Country
  • Advance International REVLIMID Regulatory Programs in Japan, Canada, Australia, Switzerland, Israel and ROW
  • Advance REVLIMID In Key NHL & CLL Trials
  • Advance CC-10004 And CC-11050 In Anti-Inflammatory Indications
  • REVLIMID Clinical Data From Newly Diagnosed Multiple Myeloma Trials To Be Reported At Major Medical Meetings and Peer-Reviewed Publications
  • Advance CC-4047 In Hematological Malignancies And Solid Tumor Cancers, Including Clinical Trial in Relapsed/Refractory Multiple Myeloma
  • Evaluate CC-11006 In MDS And Hematological Malignancies

    SUMMIT, N.J.--(BUSINESS WIRE)--July 26, 2007--Celgene Corporation (NASDAQ: CELG) announced adjusted net income of $110.4 million, or adjusted earnings per diluted share of $0.26 for the quarter ended June 30, 2007. Based on U.S. Generally Accepted Accounting Principles (GAAP), Celgene reported net income of $54.9 million, or diluted earnings per share of $0.13 for the quarter ended June 30, 2007, including after-tax share-based employee compensation expense of $12.7 million, compared to net income in the prior year period of $9.6 million or diluted earnings per share of $0.03, including after-tax share-based employee compensation expense of $20.7 million. Total revenue was a record $347.9 million for the quarter ended June 30, 2007, an increase of 76.4% over the same period in 2006. The increase in total revenue was driven by REVLIMID net sales of $180.9 million, an increase of 187.2% over the same period in 2006. THALOMID(R) net sales reached $117.7 million. ALKERAN(R) net sales for the second quarter of 2007 were $18.7 million compared to $4.5 million in the second quarter of 2006. Revenue from Focalin(TM) and the Ritalin(R) family of drugs totaled $24.8 million for the second quarter of 2007 compared to $17.7 million over the same period last year.

    For the six-month period of 2007, total revenue was a record $641.3 million, an increase of 69.2% year-over-year. Total net product sales reached a record $588.7 million, an increase of 74.9% year-over-year. REVLIMID net sales for the six-month period of 2007 reached $327.2 million compared to $95.5 million in 2006. THALOMID net sales for the six-month period of 2007 were $223.7 million compared to $214.4 million in 2006. Celgene posted adjusted net income of $196.1 million or adjusted earnings per diluted share of $0.46 during the six-month period of 2007, compared to adjusted net income of $76.2 million or adjusted earnings per diluted share of $0.20 for the six-month period of 2006. For the six-month period of 2007 on a U.S. GAAP basis, Celgene reported net income of $112.3 million or earnings per diluted share of $0.27, compared to net income of $25.6 million or earnings per diluted share of $0.07 in 2006.

    See the attached Condensed Consolidated Statements of Operations and Reconciliation of GAAP Earnings to Adjusted Earnings for an explanation of the amounts excluded and included to arrive at adjusted net income, adjusted per share amounts and adjusted pro-forma income tax rate, for the three-month and six-month periods ended June 30, 2007 and 2006. Adjusted or Non-GAAP financial measures provide investors and management with supplemental measures of operating performance and trends that facilitate comparisons between periods before, during and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the Company's basic operations do not meet the GAAP definition of unusual or non-recurring items. Adjusted net income and adjusted earnings per share are not, and should not be viewed as a substitute for similar GAAP items. We define adjusted diluted earnings per share amounts as adjusted net income divided by the GAAP weighted average number of diluted shares outstanding. Our definition of adjusted net income and adjusted diluted earnings per share may differ from similarly named measures used by others.

    To support clinical development and to advance global regulatory filings the Company increased R&D investments in multiple international clinical programs evaluating REVLIMID(R) and other IMIDs(R) compounds. For the second quarter of 2007, the Company incurred adjusted R&D expenses of $86.6 million. These R&D expenditures support ongoing clinical progress in multiple proprietary development programs for REVLIMID and other IMiDs compounds; for our lead oral anti-inflammatory compounds; our pleiotropic pathway modifier program; as well as our kinase and ligase inhibitor programs and placental-derived stem cell program. On a GAAP basis, R&D expenses were $89.9 million for the second quarter of 2007.

    Adjusted selling, general and administrative expenses increased to $103.3 million for the second quarter in 2007. SG&A include increased spending for marketing and sales expenses related to product launch activities in Europe and continued expansion of Celgene International in nearly 35 countries, including Europe, Japan, Australia and Canada. Marketing and sales expenses are expected to remain flat in the third and fourth quarters of 2007. On a reported GAAP basis, selling, general and administrative expenses were $114.0 million for the second quarter in 2007.

    For the quarter ended June 30, 2007, adjusted net interest and other net income (expense) increased to $23.6 million from $7.7 million over the same period in 2006.

    Celgene reported more than $2.3 billion in cash and marketable securities as of June 30, 2007, an increase of $207 million over the sequential quarter ended March 31, 2007.

    "This was a historic quarter by all measures underscored by extraordinary financial and operational results," said Celgene Chairman and Chief Executive Officer Sol J. Barer. "We are building a world leading hematology-oncology Company with a major presence in inflammatory diseases. As a result of the strong momentum established in the second quarter we have made significant progress towards accomplishing that mission."

    Webcast

    Celgene will host a conference call to discuss the results and achievements of its second quarter 2007 operating and financial performance on July 26, 2007 at 9:00 a.m. EDT. The conference call will be available by webcast at www.celgene.com. An audio replay of the call will be available from noon EDT July 26, 2007 until midnight EDT August 2, 2007. To access the replay, dial 1-888-203-1112 and enter reservation number 5815904. The Company's third quarter 2007 financial and operational results will be reported on Thursday, October 25, 2007.

    About Celgene

    Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at www.celgene.com.

    This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as Form 10-K, 10-Q and 8-K reports.

                     Celgene Corporation and Subsidiaries
              Condensed Consolidated Statement of Operations and
             Reconciliation of GAAP Earnings to Adjusted Earnings
                                 (Unaudited)
                    (In thousands, except per share data)
    
    
    
                                              Three Months Ended
                                                June 30, 2007
                                     -------------------------------------
                                       GAAP    Adjustments(1)  "Adjusted"
                                     -------- ---------------- -----------
    Net product sales                $318,945                    $318,945
    Collaborative agreements and
     other revenue                      5,100                       5,100
    Royalty revenue                    23,862                      23,862
                                     --------                  -----------
        Total revenue                 347,907                     347,907
    
    Cost of goods sold                 28,701    (408) (2)         28,293
    Research and development           89,934  (3,343) (2)         86,591
    Selling, general and
     administrative                   113,986 (10,674) (2) (3)    103,312
                                     -------- --------         -----------
        Total costs and expenses      232,621 (14,425)            218,196
                                     -------- --------         -----------
    
    Operating income                  115,286   14,425            129,711
    
    Equity in losses (income) of
     affiliated companies                 949  (1,060) (4)          (111)
    Interest and other income
     (expense), net                    18,757    4,803 (2) (5)     23,560
    
                                     -------- --------         -----------
    Income before taxes               133,094   20,288            153,382
    
    Income tax provision (benefit)     78,224 (35,277) (6)         42,947
    
                                     -------- --------         -----------
    Net income                        $54,870  $55,565            110,435
                                     ======== ========         ===========
    
    Per common share:
    Net income - basic                  $0.14    $0.15 (7)          $0.29
                                     ======== ========         ===========
    Net income - diluted                $0.13    $0.13 (7)          $0.26
                                     ======== ========         ===========
    
    Weighted average shares
     outstanding-basic                381,086                     381,086
                                     ========                  ===========
    Weighted average shares
     outstanding-diluted              431,377                     431,377
                                     ========                  ===========
    
    
    
                                               Three Months Ended
                                                 June 30, 2006
                                      ------------------------------------
                                        GAAP    Adjustments(1)  "Adjusted"
                                      -------- ---------------- ----------
    Net product sales                 $176,401                    $176,401
    Collaborative agreements and
     other revenue                       4,323                       4,323
    Royalty revenue                     16,515                      16,515
                                      --------                  ----------
        Total revenue                  197,239                     197,239
    
    Cost of goods sold                  26,799    (461) (2)         26,338
    Research and development            57,018  (3,401) (2)         53,617
    Selling, general and
     administrative                     83,036 (19,116) (2) (3)     63,920
                                      -------- --------         ----------
        Total costs and expenses       166,853 (22,978)            143,875
                                      -------- --------         ----------
    
    Operating income                    30,386   22,978             53,364
    
    Equity in losses (income) of
     affiliated companies                1,375  (1,375) (4)              -
    Interest and other income
     (expense), net                      7,332      378 (5)          7,710
    
                                      -------- --------         ----------
    Income before taxes                 36,343   24,731             61,074
    
    Income tax provision (benefit)      26,735  (8,211) (6)         18,524
    
                                      -------- --------         ----------
    Net income                          $9,608  $32,942            $42,550
                                      ======== ========         ==========
    
    Per common share:
    Net income - basic                   $0.03    $0.09 (7)          $0.12
                                      ======== ========         ==========
    Net income - diluted                 $0.03    $0.08 (7)          $0.11
                                      ======== ========         ==========
    
    Weighted average shares
     outstanding-basic                 347,696                     347,696
                                      ========                  ==========
    Weighted average shares
     outstanding-diluted               370,360                     403,381
                                      ========                  ==========
    
    
    
    Notes to Reconciliation of GAAP Earnings to "Adjusted" Earnings
    
    (1)Adjusted net income and adjusted per share amounts for the three-
        month periods ended June 30, 2007 and 2006 eliminate the effects
        of charges for share-based employee compensation expense
        associated with the application of the Statement of Financial
        Accounting Standards, or SFAS, No. 123 (revised 2004), "Share-
        Based Payment", or SFAS 123(R). The after tax net impact of share-
        based employee compensation expense reduced GAAP net income by
        $12.7 million, or $0.03 per diluted share, for the three-month
        period ended June 30, 2007 and $14.2 million, or $0.03 per diluted
        share, for the three-month period ended June 30, 2006. Adjusted
        net income and per share amounts for the three-month periods ended
        June 30, 2007 and 2006 also exclude amortization of acquisition
        intangibles resulting from the acquisition of Penn T Limited,
        charges to record our share of equity losses in EntreMed, Inc.,
        charges recorded for changes in the estimated value of our
        investment in EntreMed, Inc. warrants and adjustments to the
        income tax provision to reflect an estimated pro-forma income tax
        rate. Also, the three-month period ended June 30, 2006 excludes
        accelerated depreciation expense related to the Company's
        corporate headquarters relocation. See below for a description of
        line item adjustments.
    
    Line Item Adjustments:
    ----------------------------------------------------------------------
    (2)To exclude SFAS 123(R) share-based compensation expense totaling
        $16,981 and $20,717 for the three-month periods ended June 30,
        2007 and 2006, respectively.
    (3)To exclude the amortization of acquisition intangibles resulting
        from the acquisition of Penn T Limited in the amount of $2,250 in
        2007 and $2,160 in 2006 and to exclude accelerated depreciation
        expense related to the relocation of the Company's corporate
        headquarters in the amount of $101 in 2006.
    (4)To exclude the Company's share of equity losses in EntreMed, Inc.
    (5)To exclude the charge recorded for changes in the estimated value
        of the Company's investment in EntreMed, Inc. warrants.
    (6)The adjusted income tax provision reflects an annualized 28.0%
        estimated pro-forma income tax rate for 2007 and a 32.0% estimated
        pro-forma income tax rate for 2006. The tax rates for both years
        was computed by taking the Company's GAAP earnings in each taxable
        jurisdiction in which the Company operates and making adjustments
        required to arrive at taxable income ("book-tax adjustments").
        Taxable income is increased to add-back the tax deduction for the
        exercise of employee stock options. In jurisdictions where net
        operating losses are available for carry forward, taxable income
        is reduced by the amount of net operating loss carry forwards that
        the Company believes will be deductible and sustainable upon
        audit. Taxable income, after the adjustments for employee stock
        options and net operating loss carryforwards, is multiplied by the
        applicable statutory tax rate to arrive at estimated taxes due.
        Estimated taxes due are divided by the Company's adjusted income
        before taxes to arrive at the pro-forma income before taxes to
        arrive at the pro-forma income tax rates.
    (7)Adjusted per share amounts represent adjusted net income divided by
        the GAAP weighted average number of shares outstanding.
    
                     Celgene Corporation and Subsidiaries
              Condensed Consolidated Statement of Operations and
             Reconciliation of GAAP Earnings to Adjusted Earnings
                                 (Unaudited)
                    (In thousands, except per share data)
    
    
    
                                               Six Months Ended
                                                 June 30, 2007
                                     -------------------------------------
                                       GAAP    Adjustments(1)   "Adjusted"
                                     -------- ----------------- ----------
    Net product sales                $588,741                   $588,741
    Collaborative agreements and
     other revenue                      9,904                      9,904
    Royalty revenue                    42,677                     42,677
                                     -------- ---------         --------
       Total revenue                  641,322     -              641,322
    
    Cost of goods sold                 50,756     (797) (2)       49,959
    Research and development          169,509   (5,945) (2)      163,564
    Selling, general and
     administrative                   221,407  (19,471) (2) (3)  201,936
                                     -------- ---------         --------
       Total costs and expenses       441,672  (26,213)          415,459
                                     -------- ---------         --------
    
    Operating income                  199,650    26,213          225,863
    
    Equity in losses of affiliated
     companies                          2,232   (2,043) (4)          189
    Interest and other income
     (expense), net                    41,774     4,865 (2) (5)   46,639
    
                                     -------- ---------         --------
    Income before taxes               239,192    33,121          272,313
    
    Income tax provision (benefit)    126,913  (50,666) (6)       76,247
    
                                     -------- ---------         --------
    Net income                       $112,279 $  83,787          196,066
                                     ======== =========         ========
    
    Per common share:
    Net income - basic               $   0.30 $    0.22 (7)     $   0.52
                                     ======== =========         ========
    Net income - diluted             $   0.27 $    0.19 (7)     $   0.46
                                     ======== =========         ========
    
    Weighted average shares
     outstanding-basic                379,350                    379,350
                                     ========                   ========
    Weighted average shares
     outstanding-diluted              430,346                    430,346
                                     ========                   ========
    
    
    
    
                                               Six Months Ended
                                                 June 30, 2006
                                     -------------------------------------
                                       GAAP    Adjustments(1)   "Adjusted"
                                     -------- ----------------- ----------
    Net product sales                $336,644                     $336,644
    Collaborative agreements and
     other revenue                      8,216                        8,216
    Royalty revenue                    34,220                       34,220
                                     -------- ---------         ----------
       Total revenue                  379,080     -                379,080
    
    Cost of goods sold                 56,943     (919) (2)         56,024
    Research and development          111,542   (7,349) (2)        104,193
    Selling, general and
     administrative                   149,903  (31,667) (2) (3)    118,236
                                     -------- ---------         ----------
       Total costs and expenses       318,388  (39,935)            278,453
                                     -------- ---------         ----------
    
    Operating income                   60,692    39,935            100,627
    
    Equity in losses of affiliated
     companies                          4,466   (4,466) (4)           -
    Interest and other income
     (expense), net                    11,183       271 (5)         11,454
    
                                     -------- ---------         ----------
    Income before taxes                67,409    44,672            112,081
    
    Income tax provision (benefit)     41,777   (5,911) (6)         35,866
    
                                     -------- ---------         ----------
    Net income                       $ 25,632 $  50,583           $ 76,215
                                     ======== =========         ==========
    
    Per common share:
    Net income - basic               $   0.07 $    0.15 (7)       $   0.22
                                     ======== =========         ==========
    Net income - diluted             $   0.07 $    0.13 (7)       $   0.20
                                     ======== =========         ==========
    
    Weighted average shares
     outstanding-basic                345,841                      345,841
                                     ========                   ==========
    Weighted average shares
     outstanding-diluted              369,108                      402,129
                                     ========                   ==========
    
    
    
    
    Notes to Reconciliation of GAAP Earnings to "Adjusted" Earnings
    
    (1) Adjusted net income and adjusted per share amounts for the six-
         month periods ended June 30, 2007 and 2006 eliminate the effects
         of charges for share-based employee compensation expense
         associated with the application of the Statement of Financial
         Accounting Standards, or SFAS, No. 123 (revised 2004), "Share-
         Based Payment", or SFAS 123(R). The after tax net impact of
         share-based employee compensation expense reduced GAAP net income
         by $20.5 million, or $0.05 per diluted share, for the six-month
         period ended June 30, 2007 and $25.2 million, or $0.07 per
         diluted share, for the six-month period ended June 30, 2006.
         Adjusted net income and per share amounts for the six-month
         periods ended June 30, 2007 and 2006 also exclude amortization of
         acquisition intangibles resulting from the acquisition of Penn T
         Limited, charges to record our share of equity losses in
         EntreMed, Inc., charges recorded for changes in the estimated
         value of our investment in EntreMed, Inc. warrants and
         adjustments to the income tax provision to reflect an estimated
         pro-forma income tax rate. Also, the six-month period ended June
         30, 2006 excludes accelerated depreciation expense related to the
         Company's corporate headquarters relocation. See below for a
         description of line item adjustments.
    
    Line Item Adjustments:
    ----------------------------------------------------------------------
    (2) To exclude SFAS 123(R) share-based compensation expense totaling
         $26,554 and $35,500 for the six-month periods ended June 30, 2007
         and 2006, respectively.
    (3) To exclude the amortization of acquisition intangibles resulting
         from the acquisition of Penn T Limited in the amount of $4,465 in
         2007 and $4,233 in 2006 and to exclude accelerated depreciation
         expense related to the relocation of the Company's corporate
         headquarters in the amount of $202 in 2006.
    (4) To exclude the Company's share of equity losses in EntreMed, Inc.
    (5) To exclude the charge recorded for changes in the estimated value
         of the Company's investment in EntreMed, Inc. warrants.
    (6) The adjusted income tax provision reflects an annualized 28.0%
         estimated pro-forma income tax rate for 2007 and a 32.0%
         estimated pro-forma income tax rate for 2006. The tax rates for
         both years was computed by taking the Company's GAAP earnings in
         each taxable jurisdiction in which the Company operates and
         making adjustments required to arrive at taxable income ("book-
         tax adjustments"). Taxable income is increased to add-back the
         tax deduction for the exercise of employee stock options. In
         jurisdictions where net operating losses are available for carry
         forward, taxable income is reduced by the amount of net operating
         loss carry forwards that the Company believes will be deductible
         and sustainable upon audit. Taxable income, after the adjustments
         for employee stock options and net operating loss carryforwards,
         is multiplied by the applicable statutory tax rate to arrive at
         estimated taxes due. Estimated taxes due are divided by the
         Company's adjusted income before taxes to arrive at the pro-forma
         income tax rates.
    (7) Adjusted per share amounts represent adjusted net income divided
         by the GAAP weighted average number of shares outstanding.
    
                     Celgene Corporation and Subsidiaries
                       Consolidated Balance Sheet Data
                                 (Unaudited)
                    (In thousands, except per share data)
    
    
                                                    June 30,  December 31,
                                                      2007        2006
                                                   ---------- ------------
    
    
    Cash, cash equivalents & marketable securities $2,321,812   $1,982,220
    Total assets                                    3,148,610    2,735,791
    Convertible notes                                 399,880      399,889
    Stockholders' equity                            2,287,227    1,976,177
    

    CONTACT:
    Celgene Corporation
    David Gryska, 908-673-9059
    Sr. Vice President and Chief Financial Officer
    Or
    Brian P. Gill, 908-673-9530
    Vice President, Corporate Communications

    SOURCE: Celgene Corporation