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42% Increase in Total Revenue For 2005 Versus Prior Year SUMMIT, N.J., Jan. 26 /PRNewswire-FirstCall/ -- Celgene Corporation (NASDAQ:CELG) announced adjusted net income of $68.1 million, or adjusted earnings per diluted share of $0.38, for the full-year. On a reported basis, under U.S. Generally Accepted Accounting Principles (GAAP), Celgene reported net income of $63.7 million, or diluted earnings per share of $0.35, compared to net income of $52.8 million, or diluted earnings per share of $0.31 in the comparable 2004 period. Total revenue was a record $536.9 million, an increase of 42% over the same period in 2004. THALOMID(R) net sales for the full-year were $387.8 million, compared to $308.6 million in 2004, an increase of 25% year-over-year. Revenue from the Ritalin(R) family of drugs totaled $72.8 million for the year, including a milestone payment of $20 million, an increase of 89% versus prior year. Total revenue for the fourth quarter increased 42% to $149.3 million from $105.4 million for the prior-year quarter. THALOMID net sales in the fourth quarter of 2005 increased 23% to $105.8 million from $86.1 million in the fourth quarter of 2004. Celgene posted fourth quarter adjusted net income of $8.0 million, or adjusted earnings per diluted share of $0.04 compared to adjusted net income of $17.4 million or adjusted earnings per diluted share of $0.10 in the fourth quarter of 2004. Sequentially, total revenue increased approximately 15% to $149.3 million in the fourth quarter from $129.5 million in the third quarter of 2005, with THALOMID sales rising approximately 7% quarter-over-quarter to $105.8 million from $99.1 million. On a reported basis, under U.S. GAAP, Celgene reported earnings per diluted share of $0.02 in the fourth quarter of 2005 versus $0.13 in the same quarter of 2004. Adjusted net income and per share amounts for the three and twelve-month periods ended December 31, 2005, eliminate the effects of charges for accelerated depreciation expense related to the Company's corporate headquarters relocation, charges to record our share of equity losses in EntreMed, Inc. and to adjust the income tax provision to reflect cash taxes. Adjusted net income and per share amounts for the twelve-month period ended December 31, 2005 also excludes a charge recorded for changes in the estimated value of our investment in EntreMed, Inc. warrants prior to our March 31, 2005 exercise. Adjusted net income and per share amounts for the three and twelve- month periods ended December 31, 2004 excludes charges recorded for changes in the estimated value of our investment in EntreMed, Inc. warrants and to adjust the income tax provision to reflect cash taxes. To further accelerate the progress of key late-stage regulatory programs, Celgene increased R&D expenditures in REVLIMID(R) Phase II and Phase III regulatory programs in myelodysplastic syndromes and multiple myeloma, including the ongoing pivotal Phase III MDS deletion 5q trial to support the Company's MAA seeking approval to market REVLIMID in Europe. Celgene incurred R&D expenses of $52.4 million in the fourth quarter of 2005, representing an increase of 19% compared to the year ago quarter. These R&D expenditures continue to support ongoing clinical progress in multiple proprietary development programs for THALOMID(R), REVLIMID, and for other immunomodulatory drugs such as CC-4047, CC-11006 and CC-10050, as well as in the TNF alpha, kinase and ligase inhibitor programs and stem cell program. Celgene reported $724.3 million in cash and marketable securities as of December 31, 2005. "In 2005, we made great strides across all areas of Celgene, and in 2006, we will continue to prepare for an incredibly promising future," said Celgene Chairman and Chief Executive Officer John W. Jackson. " We believe that the REVLIMID transformation is well on its way." 2005 COMPANY HIGHLIGHTS: Clinical, Regulatory and Drug Discovery Achievements: * The U.S. Food and Drug Administration (FDA) granted approval of REVLIMID for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID is now available through an Education and Prescribing Safety Program, called RevAssist(SM) via specialty pharmacies. * The FDA granted approval for FOCALIN XR (dexmethylphenidate HCl) extended-release capsules for the treatment of Attention- Deficit/Hyperactivity Disorder (ADHD) in adults, adolescents and children. The approval of FOCALIN XR for the treatment of ADHD was based on efficacy and safety data from clinical trials involving approximately 320 adults, adolescents and children diagnosed with ADHD. * The European Medicines Agency (EMEA) accepted for review the Company's Marketing Authorization Application (MAA) for REVLIMID(R). The application is based on the same clinical data, from an open-label Phase II trial, evaluated by the FDA to support its decision to approve REVLIMID as a treatment for transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. * Celgene submitted its Supplemental New Drug Application (sNDA) for REVLIMID to the Division of Oncology Drug Products at the FDA seeking approval to market REVLIMID as a treatment for relapsed or refractory multiple myeloma. * Celgene submitted its MAA for REVLIMID to the Swiss Intercantonal Medicines Control Office seeking approval to market REVLIMID as a treatment for transfusion-dependent anemia due to low- or intermediate- 1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. * The FDA issued an approvable letter in response to the Company's sNDA seeking approval to market THALOMID as a treatment for multiple myeloma (MM). The FDA requested revised product labeling with the specific indication of newly diagnosed multiple myeloma and updated safety information, as well as some additional patient information to finalize its review. The Company has completed its response, and anticipates an action by the FDA in the first half of 2006. * The Company announced that an external Independent Data Monitoring Committee analysis of the multi-centered, randomized, placebo-controlled phase III study (MM-003) evaluating combination thalidomide plus dexamethasone versus dexamethasone alone as induction therapy for previously untreated multiple myeloma met the pre-specified p