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Celgene Reports Third Quarter 2012 Operating And Financial Results

Cash, Cash Equivalents and Marketable Securities

Operating cash flow was $1,528 million for the first nine months of 2012, an increase of 14 percent compared to 2011. Under our authorized stock repurchase program, we purchased approximately 10.8 million shares during the third quarter of 2012 at a total cost of approximately $744 million. As of September 30, 2012, we had $2,417 million remaining under the existing stock repurchase program. During the third quarter of 2012, we issued an aggregate of $1,500 million in five- and ten-year bonds. We ended the third quarter with $3,833 million in cash and marketable securities.

Products & Pipeline:

We are conducting over 25 late-stage clinical trials. REVLIMID is in several phase III trials across a range of hematological malignancies that include newly diagnosed multiple myeloma and maintenance, lymphomas, chronic lymphocytic leukemia, and non deletion 5q myelodysplastic syndromes (MDS). Phase III trials with pomalidomide in relapsed refractory multiple myeloma and myelofibrosis, in addition to VIDAZA for acute myeloid leukemia, are also underway. In solid tumors, we are evaluating ABRAXANE in phase III trials for metastatic melanoma and pancreatic cancer. Our lead product candidate in Inflammation & Immunology, apremilast, is being evaluated in a broad phase III program for psoriatic arthritis, psoriasis, and ankylosing spondylitis.

Beyond our phase III programs is a growing early-to-mid-stage pipeline of novel therapies addressing significant unmet medical needs, including CC-292 (BTK inhibitor), CC-223 (dual TORK inhibitor), CC-115 (dual TORK/DNA PK inhibitor), CC-122 (pleiotropic pathway modulator), CC-486 (oral azacitidine), CC-220 (anti-inflammatory), PDA-001 (cellular therapies), in addition to partnered molecules ACE-11 (ActR fusion protein), ACE-536 (GDF trap), and EPZ-5676 (DOT1L inhibitor).

Key Updates:


REVLIMID: We are advancing REVLIMID into new hematological malignancies. The pivotal phase II EMERGE trial in relapsed refractory mantle cell lymphoma achieved the endpoints outlined in the Special Protocol Assessment (SPA). Based upon these results, we will submit a supplemental new drug application (sNDA) to the Food and Drug Administration (FDA) by year-end. Presentation of the EMERGE data are expected at the American Society of Hematology (ASH) meeting in December.

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