PRINCETON, N.J., May 1 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq:
MEDX) announced today its financial results for the three-month period
ended March 31, 2007.
Including $152.1 million, or $1.22 per share representing Medarex's
gain from the February 2007 sale of approximately 2.5 million shares of
Genmab A/S stock, Medarex's net income for the quarter ended March 31, 2007
was $110.3 million, or $0.88 per share as compared to a net loss of $36.6
million, or ($0.33) per share for the first quarter of 2006. Also included
in the 2007 results was $2.5 million, or ($0.02) per share of the net loss
of Celldex Therapeutics, Inc. (a 60% owned subsidiary of Medarex) and a
non-cash charge of $3.5 million, or ($0.03) per share for stock based
compensation recorded in accordance with FAS 123(R). Excluding the impact
of these items, Medarex's net loss on a non-GAAP basis for the quarter
ended March 31,2007 was $35.9 million, or ($0.29) per share.
Total revenues for the quarter ended March 31, 2007 were $11.5 million
as compared to $13.1 million for the first quarter of 2006. Research and
development (R&D) expenses for the quarter ended March 31, 2007 increased
by $1.1 million, from $45.9 million in the first quarter of 2006 to $47.0
million in 2007. General and administrative expenses increased by $1.8
million for the quarter ended March 31, 2007, from $9.5 million in the
first quarter of 2006 to $11.3 million in 2007.
Medarex ended March 2007 with approximately $458.5 million in cash,
cash equivalents, marketable securities and segregated cash. Approximately
$11.6 million of this balance relates to Celldex. In addition, the fair
market value of Medarex's equity interest in Genmab was approximately
$290.6 million.
Non-GAAP Financial Measurements
This press release and the accompanying tables include non-GAAP
financial measures. For a description of these non-GAAP financial measures,
including the reasons management uses 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, please see the section of the accompanying tables
titled "Non-GAAP Financial Measures".
Medarex's product development and business accomplishments during the
first quarter of 2007 include the following:
-- Adding approximately $152 million to our cash resources through the
sale of approximately 2.5 million shares of Genmab A/S common stock,
bringing Medarex's equity ownership in Genmab to approximately 11%;
-- Filing the IND for MDX-1401, a fully human anti-CD30 antibody enhanced
for greater potency for the treatment of Hodgkin's disease;
-- Announcing the IND filing by Medarex's licensing partner, ImClone
Systems, for IMC-3G3, a fully human antibody for the treatment of
cancer;
-- Announcing the initiation of a Phase I clinical trial of MEDI-545, a
fully human antibody targeting interferon-alpha for the treatment of
psoriasis by Medarex's partner, MedImmune, Inc.;
-- Announcing encouraging follow-up data from the ongoing Phase I clinical
trial in patients with prostate cancer treated with Medarex's
ipilimumab (also known as MDX-010) in combination with Cell Genesys'
GVAX immunotherapy for prostate cancer;
-- Announcing therapeutic efficacy data in a new primate model of
established inhalation anthrax infection with ValortimTM, a fully human
monoclonal antibody product candidate being developed with PharmAthene,
Inc. for the prevention and treatment of anthrax infection; and
-- Collaborating with Compugen Ltd. to develop antibodies for the
treatment of cancer and autoimmune diseases.
Upcoming clinical response and safety data of ipilimumab in melanoma
and ipilimumab in combination with other treatment modalities for prostate
cancer scheduled for presentation at the Annual Meeting of the American
Society of Clinical Oncology (ASCO), being held in Chicago, IL on June 1-5,
2007, include:
-- A poster discussion presentation on "The efficacy and safety of
ipilimumab (MDX-010) in patients with unresectable stage III or stage
IV malignant melanoma" (Abstract #8523) during the conference's
Melanoma session on Tuesday, June 5th in location S103a/S504;
-- A poster discussion presentation on the "Kinetics of response to
ipilimumab (MDX-010) in patients with stage III/IV melanoma" (Abstract
#8525) during the conference's Melanoma session on Tuesday, June 5th
in location S103a/S504
-- An oral presentation on "Combination immunotherapy with GM-CSF and
CTLA-4 blockade for hormone refractory prostate cancer: balancing the
expansion of activated effector and regulatory T cells" (Abstract
#3001) during the conference's Combinatorial Immunotherapies for Cancer
session on Sunday, June 3rd in location E354b; and
-- A poster presentation on the "Biochemical and immunologic correlates of
clinical response in a combination trial of the GM-CSF-gene transduced
allogeneic prostate cancer immunotherapy and ipilimumab in patients
with metastatic hormone-refractory prostate cancer (HRPC)" (Abstract
#5120) during the conference's Genitourinary Cancer session on Sunday,
June 3rd in location S Hall A2.
"We moved into this year under real momentum, and we are pleased with
the advancement of new antibody programs into clinical development, as well
as encouraging data from existing programs and the additional increase to
our cash resources," said Irwin Lerner, Chairman of the Board of Directors
and Interim President and CEO of Medarex. "With a strong start for 2007, we
expect this year to be a busy year for Medarex as the company makes solid
strides towards commercialization."
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 thirty of these therapeutic product candidates derived from
Medarex technology are in human clinical testing or have had INDs submitted
for such trials, with six of the most advanced product candidatescurrently
in Phase III clinical trials. 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 http://www.medarex.com.
Statement on Cautionary Factors
Except for the historical information presented herein, matters
discussed herein may constitute forward-looking statements 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"; "believe"; "anticipate"; "intend"; "plan"; "expect";
"estimate"; "could"; "may"; or similar statements are forward-looking
statements. Medarex disclaims, however, 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, risks associated with the use of hazardous substances 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, 2006.
There can be no assurance that such development efforts will succeed or
that other 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 share data)
Three Months Ended
March 31,
(unaudited)
2007 2006
Contract and license revenues $6,998 $8,622
Reimbursement of development costs 4,541 4,455
Total revenues 11,539 13,077
Costs and expenses:
Research and development 47,022 45,939
General and administrative 11,302 9,518
Operating loss (46,785) (42,380)
Equity in net loss of affilate - (1,037)
Investment and interest income, net 155,401 2,196
Minority interest - Celldex 1,651 1,607
Non-cash gain on loss of significant
influence in Genmab - 3,202
Income (loss) before provision
for income taxes 110,267 (36,412)
Provision for income taxes 2 222
Net income (loss) $110,265 $(36,634)
Basic net income (loss) per share $0.88 $(0.33)
Diluted net income (loss) per share $0.80 $(0.33)
Weighted average number of common
shares outstanding during the
year - basic 124,690 112,213
- diluted 140,144 112,213
Condensed Consolidated Balance
Sheets
(In thousands)
March 31, December 31,
2007 2006
(unaudited) (1)
Cash, cash equivalents and
marketable securities - Medarex $445,628 $475,494
Cash and cash equivalents - Celldex 11,394 14,000
Other current assets 23,152 22,271
Property, buildings and equipment,
net 82,079 84,341
Marketable securities - Genmab 290,566 344,382
Investments in, and advances to
affiliate and partners 8,239 8,141
Segregated cash - non current 1,477 1,477
Other assets 4,162 4,587
$866,697 $954,693
Current liabilities $69,466 $70,436
Other liabilities 94,833 97,804
Convertible notes 142,062 141,581
Minority interest 3,048 4,699
Shareholders' equity 557,288 640,173
$866,697 $954,693
(1) Derived from the December 31, 2006 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, 2006.
Non-GAAP Financial Measures
MEDAREX, INC.
Condensed Statements of Operations
(non-GAAP Basis)
(In thousands, except share data)
Three Months Ended
March 31,
(unaudited)
2007 2006
Contract and license revenues $6,854 $8,494
Reimbursement of development costs 4,541 4,455
Total revenues 11,395 12,949
Costs and expenses:
Research and development 41,940 41,391
General and administrative 8,513 5,827
Operating loss (39,058) (34,269)
Equity in net loss of affiliate - (1,037)
Investment and interest income, net 3,157 1,951
Loss before provision for income
taxes (35,901) (33,355)
Provision for income taxes 2 222
Net loss $(35,903) $(33,577)
Basic and diluted net loss per share $(0.29) $(0.30)
Weighted average number of common
shares outstanding during the
year, basic and diluted 124,690 112,213
MEDAREX, INC.
Reconciliation of GAAP Net Loss to Non-GAAP Net Loss (1)
(In thousands, except per share data)
(unaudited)
March 31, March 31,
2007 2006
GAAP net income (loss) $110,265 $(36,634)
Celldex net loss (2) 4,128 4,018
Minority interest - Celldex (2) (1,651) (1,607)
Stock-based compensation expense (3) 3,498 3,848
Non-cash gain on loss of significant
influence in Genmab (4) - (3,202)
Gain on sale of Genmab stock (5) (152,143) -
Non-GAAP Net loss $(35,903) $(33,577)
GAAP Net income (loss) per share,
basic $0.88 $(0.33)
diluted $0.80 $(0.33)
Non-GAAP Net loss
per share, basic and diluted $(0.29) $(0.30)
Shares used in computing basic and
diluted
Non-GAAP net loss per share 124,690 112,213
(1) Non-GAAP amounts are intended to illustrate Medarex's results of
operations for the three months ended March 31, 2007 and 2006,
excluding the items discussed below. Management of Medarex believes
that the non-GAAP results provide insight into Medarex's performance
by focusing on results generated by its ongoing operations.
(2) In management's view, the operations of Celldex are not necessarily
indicative of, or directly attributable to, Medarex's continuing
operations.
(3) For the three months ended March 31, 2007, Medarex incurred $3.5
million in stock compensation expense, of which $2.3 million is
included in research and development expenses, and $1.2 million is
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. Medarex adopted
FAS 123(R) on a modified prospective basis beginning on January 1,
2006.
(4) In connection with a reduction in Medarex's ownership percentage in
Genmab below 20%, accumulated other comprehensive income associated
with the investment was first offset against the remaining carrying
value of the investment ($2.2 million), reducing the balance to zero,
with the remaining balance ($3.2 million) recorded as a non-cash gain
in accordance with FASB Staff Position APB 18-1, Accounting by an
Investor for Its Proportionate Share of Accumulated Other
Comprehensive Income of an Investee Accounted for in Accordance with
ABP Opinion No. 18 upon a Loss of Significant Influence.
(5) On February 17, 2007, Medarex completed the sale of 2,578,500 shares
of Genmab through a block trade. Medarex received net proceeds of
approximately $152.1 million from this sale.
SOURCE Medarex, Inc.
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Related links:
http://www.medarex.com/
http://www.prnewswire.com/comp/108265.html/
CONTACT:
Christian S. Schade, Senior VP and CFO,
+1-609-430-2880, or Laura S. Choi Investor Relations,
+1-609-430-2880, x2216, or Media, Jean Mantuano, Corporate
Communications, +1-609-430-2880, x2221, all of Medarex, Inc.
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