Medarex Announces 2008 Second Quarter Financial Results

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Tue Aug 5, 2008 4:09pm EDT

PRINCETON, N.J., Aug. 5 /PRNewswire-FirstCall/ -- Medarex, Inc.
(Nasdaq: MEDX) announced today its financial results for the quarter ended
June 30, 2008.
    Medarex's net loss for the quarter ended June 30, 2008 was $53.1 million,
or ($0.42) per share as compared to a net loss of $41.0 million, or ($0.32)
per share for the second quarter of 2007. Included in the 2008 results was a
non-cash charge of $6.0 million, or ($0.05) per share for stock based
compensation recorded in accordance with FAS 123(R) and a non-cash equity in
net loss of affiliate charge of $3.5 million or ($0.03) per share related to
our share of the net loss of AVANT Immunotherapeutics, Inc. ("AVANT").
Excluding the impact of these items, Medarex's net loss on a non-GAAP basis
for the quarter ended June 30, 2008 was $43.6 million, or ($0.34) per share.
    Total revenues for the quarter ended June 30, 2008 were $10.0 million, as
compared to $11.8 million for the second quarter of 2007. Research and
development (R&D) expenses for the quarter ended June 30, 2008 increased by
$7.3 million, from $45.3 million in the second quarter of 2007 to $52.6
million in the second quarter of 2008. General and administrative expenses
increased by $1.8 million for the quarter ended June 30, 2008, from $10.6
million in the second quarter of 2007 to $12.4 million in the second quarter
of 2008.
    Medarex ended the second quarter of 2008 with approximately $426.7 million
in cash, cash equivalents and marketable securities. In addition, as of June
30, 2008, the fair market value of Medarex's equity interests in Genmab A/S
and AVANT were approximately $87.1 million and approximately $72.2 million,
respectively.
    Non-GAAP Financial Measurements
    This press release and the accompanying tables include non-GAAP financial
measures. Please see the section of the accompanying tables titled
"Reconciliation of GAAP Net Income (Loss) to Non-GAAP Net Loss" for a
description of these non-GAAP financial measures, including reasons for
Medarex management's decision to use each measure, and reconciliations of
these non-GAAP financial measures to the most directly comparable financial
measures prepared in accordance with Generally Accepted Accounting Principles.
    "Our clinical development achievements this quarter speak to our steadfast
commitment to execute on our business strategy, which is focused on providing
long-term value through the development and advancement of medically
meaningful products in our portfolio," said Howard H. Pien, President and CEO
of Medarex. "We are also pleased with the recent regulatory progress announced
by our licensing partner, Centocor, Inc., regarding the development of
ustekinumab and golimumab for multiple inflammatory diseases. These two
antibodies represent some of the first UltiMAbs generated from Medarex's
technology that have the potential to become significant royalty-generating
assets for Medarex."
    Medarex's 2008 Second Quarter Highlights:
    -- At the 2008 American Society of Clinical Oncology (ASCO) annual meeting
in May/June 2008, preliminary results indicating long-term survival and anti-
tumor activity of ipilimumab in advanced melanoma were presented in multiple
presentations studying ipilimumab treatment as a monotherapy and in
combination with chemotherapy. Ipilimumab is an investigational oncology
immunotherapy designed to sustain an active immune response in its attack on
cancer cells.  Interim data from a Phase 1/2 trial which demonstrated safety
and preliminary efficacy of ipilimumab in combination with radiotherapy for
metastatic castration resistant prostate cancer were also presented at ASCO.
    -- Positive preliminary anti-tumor activity data from an ongoing oncology
Phase 1 trial of MDX-1106 were also presented at the 2008 ASCO annual meeting.
MDX-1106 is a fully human antibody that targets the PD-1 signaling pathway, an
important path in activating T-cell responses and promoting an immune response
to fight cancer and infectious disease.
    -- Two separate Phase 2 trials of MDX-1100 were initiated for the
treatment of ulcerative colitis and rheumatoid arthritis. MDX-1100 is a fully
human antibody that targets IP-10, a chemokine expressed and associated with
multiple inflammatory disease conditions.
    -- Positive Phase 1 safety and preliminary efficacy data for MDX-1100 in
ulcerative colitis were presented at the 2008 Digestive Disease Week meeting
in May 2008.
    -- At the 2008 Annual Meeting of the American Association for Cancer
Research in April 2008, several investigational programs using Medarex's
antibody-drug conjugate technology presented encouraging preclinical data.
    About Medarex
    Medarex is a biopharmaceutical company focused on the discovery,
development and potential commercialization of fully human antibody-based
therapeutics to treat life-threatening and debilitating diseases, including
cancer, inflammation, autoimmune disorders and infectious diseases. Medarex
applies its UltiMAb(R) technology and product development and clinical
manufacturing experience to generate, support and potentially commercialize a
broad range of fully human antibody product candidates for itself and its
partners. Over forty of these therapeutic product candidates derived from
Medarex technology are in human clinical testing or have had INDs submitted
for such trials, with seven of the most advanced product candidates currently
in Phase 3 clinical trials or the subject of regulatory applications for
marketing authorization. Medarex is committed to building value by developing
a diverse pipeline of antibody products to address the world's unmet
healthcare needs. For more information about Medarex, visit its website at
www.medarex.com.
    Statement on Cautionary Factors
    Except for the historical information presented herein, the statements
relating to Medarex's investments and advances related to its products in this
press release may constitute forward-looking statements, as defined in the
Private Securities Litigation Reform Act of 1995, that are subject to certain
risks and uncertainties that could cause actual results to differ materially
from any future results, performance or achievements expressed or implied by
such statements.  Statements that are not historical facts, including
statements preceded by, followed by, or that include the words "potential";
"preliminary"; or similar statements are forward-looking statements. Medarex
disclaims any intent or obligation to update these forward-looking statements.
Risks and uncertainties include risks associated with product discovery and
development, uncertainties related to the outcome of clinical trials, slower
than expected rates of patient recruitment, unforeseen safety issues resulting
from the administration of antibody products in patients, uncertainties
related to product manufacturing, the need for additional capital, compliance
with regulatory requirements, risks associated with the use of hazardous
substances and risks associated with the enforceability of our patents, as
well as risks detailed from time to time in Medarex's public disclosure
filings with the U.S. Securities and Exchange Commission (SEC), including its
Annual Report on Form 10-K for the fiscal year ended December 31, 2007 and its
quarterly reports on Form 10-Q. There can be no assurance that such
development efforts will succeed or that developed products will receive
required regulatory clearance or that, even if such regulatory clearance were
received, such products would ultimately achieve commercial success. Copies of
Medarex's public disclosure filings are available from its investor relations
department.
    Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks of
Medarex, Inc. All rights are reserved.


                                MEDAREX, INC.
               Condensed Consolidated Statements of Operations

                    (In thousands, except per share data)

                               Three Months Ended      Six Months Ended
                                    June 30,                June 30,
                                2008        2007        2008        2007
                                  (unaudited)             (unaudited)
    Contract and license
     revenues                  $5,891      $6,800     $13,875     $13,798
    Reimbursement of
     development costs          4,069       4,995       8,088       9,536
      Total revenues            9,960      11,795      21,963      23,334

    Costs and expenses:
      Research and
       development             52,574      45,273     101,866      92,295
      General and
       administrative          12,435      10,569      24,844      21,871
        Operating loss        (55,049)    (44,047)   (104,747)    (90,832)

    Equity in net loss of
     affiliate                 (3,546)          -      (5,331)          -
    Interest income, net        5,496       3,945     160,314     159,346
    Impairment loss on
     investments in partners        -      (2,141)          -      (2,141)
    Minority interest
     - Celldex                      -       1,289           -       2,940

      Income (loss) before
       provision for income
       taxes                  (53,099)    (40,954)     50,236      69,313
    Provision for income
     taxes                          -           -          23           2
        Net income (loss)    $(53,099)   $(40,954)    $50,213     $69,311

    Basic net income (loss)
     per share                 $(0.42)     $(0.32)      $0.39       $0.55
    Diluted net income
     (loss) per share          $(0.42)     $(0.32)      $0.38       $0.52

    Weighted average number
     of common shares
     outstanding during
     the year - basic         127,724     126,430     127,927     125,730
              - diluted       127,724     126,430     138,864     139,684



                    Condensed Consolidated Balance Sheets
                                (In thousands)

                                                    June 30,    December 31,
                                                      2008           2007
                                                   (unaudited)       (1)

    Cash, cash equivalents and marketable
     securities - Medarex                           $426,669       $334,772
    Cash and cash equivalents - Celldex                    -         14,000
    Marketable securities - Genmab                         -        152,000
    Other current assets                              18,554         29,013
    Property, buildings and equipment, net            74,178         79,925
    Marketable securities - Genmab non-current        87,054        139,165
    Investment in AVANT Immunotherapeutics             7,809              -
    Other assets                                       9,369         10,985
                                                    $623,633       $759,860

    Current liabilities                              $71,427        $81,645
    Other liabilities                                 83,545         89,454
    Convertible notes                                144,468        143,505
    Shareholders' equity                             324,193        445,256
                                                    $623,633       $759,860


    (1) Derived from the December 31, 2007 audited financial statements. For
        further information, refer to the consolidated financial statements
        and footnotes thereto included in Medarex's Annual Report on Form 10-K
        for the year ended December 31, 2007.


    This press release dated August 5, 2008, contains non-GAAP financial
measures. The following table reconciles the non-GAAP financial measures
contained in the press release to the most directly comparable financial
measures prepared in accordance with GAAP. These non-GAAP financial measures
include non-GAAP net loss and non-GAAP net loss per share. Non-GAAP financial
measures should be considered in addition to, and not as a substitute for, or
superior to, financial measures prepared in accordance with GAAP.
    The following reconciliation of GAAP net income (loss) to non-GAAP net
loss and GAAP net income (loss) per share to non-GAAP net loss per share is
provided as a complement to results presented in accordance with GAAP because
Medarex's management believes these non-GAAP financial measures provide better
insight into Medarex's performance by focusing on results generated by its
ongoing operations and are important in comparing current results with prior
period results. Non-GAAP net loss and non-GAAP net loss per share are intended
to illustrate Medarex's results of operations for the periods presented
excluding the items discuss below. Medarex's management believes investors'
understanding of Medarex's financial performance is enhanced as a result of
our disclosing these non-GAAP financial measures. Non-GAAP net loss and non-
GAAP net loss per share should not be viewed in isolation or as a substitute
for GAAP net income (loss) or GAAP net income (loss) per share.


                                MEDAREX, INC.
        Reconciliation of GAAP Net Income (Loss) to Non-GAAP Net Loss
                    (In thousands, except per share data)
                                 (unaudited)

                                Three Months Ended      Six Months Ended
                                     June 30,               June 30,
                                    (unaudited)           (unaudited)
                                 2008        2007       2008        2007
    GAAP Net income (loss)    $(53,099)   $(40,954)   $50,213     $69,311
    Celldex net loss (1)             -       3,221      2,924       7,349
    Minority interest -
     Celldex (1)                     -      (1,289)        -       (2,940)
    Stock-Based compensation
     expense (2)                 5,968       4,322     11,259       7,821
    Impairment loss on
     investments in partners         -       2,141          -       2,141
    Equity in net loss
     of affiliate                3,546           -      5,331           -
    Gain on sale of
     Genmab stock                    -           -   (151,834)   (152,143)
    Non-GAAP Net loss         $(43,585)   $(32,559)  $(82,107)   $(68,461)

    GAAP Net income (loss)
     per share,
      basic                     $(0.42)     $(0.32)     $0.39       $0.55
      diluted                   $(0.42)     $(0.32)     $0.38       $0.52

    Non-GAAP Net loss
     per share, basic
     and diluted                $(0.34)     $(0.26)    $(0.64)     $(0.54)

    Shares used in computing
     basic and diluted GAAP
     net income (loss) per
     share and Non-GAAP net
     loss per share            127,724     126,430    127,927     125,730



    (1) In management's view, the operations of Celldex prior to its merger
        with AVANT Immunotherapeutics, Inc. (effective March 7, 2008) are not
        necessarily indicative of, or directly attributable to, Medarex's
        continuing operations. Celldex's operations relate primarily to the
        research, development and commercialization of therapeutic vaccines,
        which is outside the scope of Medarex's core business operations.

    (2) For the three and six months ended June 30, 2008, Medarex incurred
        $6.0 million and $11.3 million in non-cash stock compensation expense,
        of which $2.8 million and $4.8 million are included in research and
        development expenses and $3.2 million and $6.5 million, respectively,
        are included in general and administrative expenses. Stock
        compensation expense includes costs associated with stock awards,
        including stock options which were recorded in accordance with the
        provisions of FAS 123(R). FAS 123(R) requires companies to record
        stock-based payments in the financial statements using a fair value
        method.


    In addition to excluding the items described in footnotes 1 and 2 above,
items have been excluded based upon management's evaluation (on an individual
basis) of both quantitative and qualitative aspects of the item, including,
(i) size and nature, (ii) whether it relates to our ongoing business
operations, and (iii) whether management expects it to occur as part of our
normal business on a regular basis. Those additional items excluded for
purposes of determining non-GAAP net loss and non-GAAP net loss per share are
gain on sales of Genmab stock, equity in net loss of affiliate and impairment
loss on investments in partners.
SOURCE  Medarex, Inc.

Christian S. Schade, Senior VP and CFO, +1-609-430-2880, Laura S. Choi,
Investor Relations, +1-609-430-2880, ext. 2216, or Nichol Harber, Corporate
Communications (media), +1-609-430-2880, ext. 2214, all of Medarex, Inc.
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