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Medarex Announces 2009 Second Quarter Financial Results
Friday, July 31, 2009 9:51 AM


(Source: Business Wire)trackingMedarex, Inc. (NASDAQ:MEDX) announced today its financial results for the three-month period ended June 30, 2009.

Medarex's net loss for the quarter ended June 30, 2009 was $29.2 million, or ($0.23) per share, as compared to a net loss of $53.1 million, or ($0.42) per share, for the second quarter of 2008. Included in the 2009 results was a non-cash charge of $4.7 million, or ($0.04) per share, for stock based compensation recorded in accordance with FAS 123(R), a non-cash equity in net loss of affiliate charge of $2.5 million, or ($0.02) per share, related to its share of Celldex Therapeutics, Inc. ("Celldex") net loss and a gain of $14.3 million, or $0.11 per share, from Medarex's sale of 2 million shares of Celldex's stock. Excluding the impact of these items, Medarex's net loss on a non-GAAP basis for the quarter ended June 30, 2009 was $36.3 million, or ($0.28) per share.

Total revenues for the quarter ended June 30, 2009 were $19.5 million, as compared to $10.0 million for the second quarter of 2008. Research and development (R&D) expenses for the quarter ended June 30, 2009 decreased by $1.8 million, from $52.6 million in the second quarter of 2008 to $50.8 million in the second quarter of 2009. General and administrative expenses decreased by $1.9 million for the quarter ended June 30, 2009, from $12.4 million in the second quarter of 2008 to $10.5 million in the second quarter of 2009.

Medarex ended the second quarter of 2009 with approximately $340.6 million in cash, cash equivalents and marketable securities. In addition, as of June 30, 2009, the fair market value of Medarex's equity interests in Genmab A/S and Celldex Therapeutics, Inc. were approximately $78.6 million and $23.2 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.

Second Quarter Highlights and Recent Developments

Medarex and Bristol-Myers Squibb Company (NYSE:BMY) recently announced that the companies have signed a definitive merger agreement providing for the acquisition of Medarex by Bristol-Myers Squibb, for $16.00 per share in cash. The transaction, with an aggregate purchase price of approximately $2.4 billion, has been approved by the boards of directors of both companies.

Medarex received a milestone payment from licensing partner Centocor Ortho Biotech, Inc. in connection with the marketing approval of SIMPONI (golimumab) in Canada. SIMPONI was also approved in the United States as a once-monthly subcutaneous treatment for rheumatoid arthritis and other inflammatory diseases.

Medarex received a payment of $30 million, its share of the upfront payment from Merck & Co, Inc. in connection with the exclusive licensing agreement for an investigational antibody combination (MDX-066 and MDX-1388) developed for the treatment of C. difficile infection. Under the terms of the agreement, up to $165 million in development and regulatory milestones, double-digit royalties and sales-based milestones could be expected and would be divided equally between Medarex and Massachusetts Biologic Laboratories.

Medarex received a milestone payment from licensing partner Novartis Pharma AG in connection with the marketing approval of IlarisĀ® (canakinumab) in the United States for the treatment of children and adults with cryopyrin-associated periodic syndrome, or CAPS, a serious life-long auto-inflammatory disease caused by rare genetic mutations.

Medarex added approximately $14.3 million to its cash resources through the sale of Celldex common stock, reducing Medarex's ownership in Celldex to approximately 18.7 % of the total outstanding shares.

Medarex and Bristol-Myers Squibb (BMS) commenced enrollment of a randomized, double-blind Phase 3 ipilimumab in combination with radiotherapy for prostate cancer trial (study 043) in patients with prostate cancer who failed or are intolerant to taxotere. Overall survival is the primary endpoint in this trial.

Medarex and BMS reported two-year overall survival data, which ranged from 30 to 42 percent in metastatic melanoma patients treated in three Phase 2 ipilimumab trials reported at the 2009 Annual Meeting of the American Society of Clinical Oncology (ASCO). Two-year historical survival rates in metastatic melanoma patients treated with dacarbazine have been reported to be in the range of approximately 8 to 12 percent.

Medarex also reported encouraging anti-tumor activity data at ASCO from the single-dose Phase 1 trial and multi-dose Phase 1b trial of the anti-PD1 antibody, MDX-1106, including preliminary anti-tumor activity from the ongoing multi-dose Phase 1b trial that included one patient experiencing a near complete response, two patients experiencing a near or unconfirmed partial response, and one patient experiencing stable disease.

Medarex's anti-IP10 antibody, MDX-1100, achieved its clinical development objective with strong therapeutic proof-of-concept data from the randomized, double-blind, placebo-controlled Phase 2 trial in rheumatoid arthritis (RA). The reported top-line results indicated a statistically significant improvement in ACR20 scores at 12 weeks, the primary endpoint of the study. Full results are planned to be presented at a future scientific meeting in 2009.

Medarex expanded its pipeline with the investigational new drug (IND) application filing for MDX-1338, a fully human anti-CXCR4 antibody for the treatment of cancers. The Phase 1 trial (monotherapy and chemotherapy combination) is expected to enroll patients with relapsed or refractory acute myelogenous leukemia.

Medarex commenced human testing of MDX-1203, the Company's first Antibody-Drug Conjugate generated from its proprietary technology.

Medarex and Lonza signed a collaboration agreement that gives Medarex the option to work with Lonza as a partner to provide manufacturing services in support of the development and commercialization of Medarex's pipeline of antibody and antibody-drug conjugate programs. As part of the agreement, Lonza may provide process development services for certain Medarex programs and may reserve manufacturing capacity at Lonza's biopharmaceutical facilities around the world.

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 UltiMAbĀ® 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 the most advanced product candidates currently approved for commercial sale, the subject of regulatory applications for marketing authorization or in Phase 3 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 www.medarex.com.



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