Celgene announces fiscal 2009 third-quarter results

Celgene CorporationOct 22 2009

Celgene Corporation (NASDAQ:CELG):

2009 Third Quarter Financial Results Year-Over-Year:

• Non-GAAP Total Revenue Increased 18 Percent to $692 Million; GAAP Total Revenue $695 Million
• REVLIMID Net Product Sales Increased 31 Percent to $450 Million
• VIDAZA Net Product Sales Increased 62 Percent to $103 Million
• THALOMID^® Net Product Sales Totaled $110 Million
• Non-GAAP Operating Income Increased 30 Percent to $292 Million; GAAP Operating Income $236 Million
• Non-GAAP Net Income Increased 40 Percent to $260 Million; GAAP Net Income $217 Million
• Non-GAAP Earnings Per Share Increased 40 Percent to $0.56 Per Diluted Share; GAAP Earnings $0.46 Per Diluted Share

Recent Developments And Highlights:

• REVLIMID^® Reimbursement Approvals In United Kingdom And Canada
• Additional REVLIMID Regulatory Approvals in the Middle East and Latin America
• Lancet Oncology Published Results From ECOG EA403 Phase III Trial, Demonstrating REVLIMID Plus Low-Dose Dexamethasone Is An Active Regimen For Patients With Newly Diagnosed Multiple Myeloma (MM)
• NHL-001 Study Published In Journal Of Clinical Oncology Reported REVLIMID Demonstrated Single Agent Activity With Durable Responses In A Heavily Pretreated Patient Population
• Advancing REVLIMID Solid Tumor Program In Prostate Cancer, Renal Cell Carcinoma, Pancreatic Cancer, and Colorectal Cancer
• Journal Of Clinical Oncology Published Two Articles Highlighting Clinical Potential Of Pomalidomide As Treatment For MM and Myelofibrosis
• VIDAZA^® Upgraded By National Comprehensive Cancer Network (NCCN) To Preferred Therapy Based On Unprecedented Survival For Intermediate-2 And High-Risk Myelodysplastic Syndromes (MDS)
• VIDAZA Now Listed By NCCN As Low Intensity Treatment Option For Patients With Acute Myeloid Leukemia
• Initiated Phase II Trial Of ACE-011 For Treatment Of Chemotherapy Induced Anemia In Metastatic Breast Cancer
• Completed Enrollment Of Phase I Proof-Of-Principle Study For Proprietary PDA-001 Placenta-Derived Stem Cells In Crohn’s Disease
• Celgene Cellular Therapeutics Patent Estate Highlighted In Nature Biotechnology

2009 Selected Corporate Objectives:

• Maximize Global Clinical, Regulatory And Commercial Potential Of REVLIMID, VIDAZA, Pomalidomide, Apremilast, Amrubicin, ACE-011, PDA-001 And THALOMID^®
• Meet With EMEA, FDA and International Regulatory Agencies Regarding MM-015 Filing Strategy
• Commercial Launch of REVLIMID In Australia
• Gain Health Canada Regulatory Approval For VIDAZA In High-Risk MDS
• Submit REVLIMID Regulatory Filing For Del 5q MDS In Japan
• Advance REVLIMID Lymphoma Initiative Through More Than 60 Clinical Trials Worldwide, Including Novel Combinations In Multiple Patient Segments
• Advance REVLIMID Chronic Lymphocytic Leukemia (CLL) Initiative Through More Than 40 Clinical Trials Worldwide
• Complete Apremilast Phase II Study In Recalcitrant Psoriasis And Phase IIb Study In Moderate-To-Severe Psoriasis
• Complete Enrollment of Amrubicin Phase III Trial In Patients With Small Cell Lung Cancer

Celgene Corporation (NASDAQ:CELG) announced non-GAAP (Generally Accepted Accounting Principles) net income of $259.8 million, or non-GAAP earnings per diluted share of $0.56 for the quarter ended September 30, 2009. Non-GAAP net income for the third quarter of 2008 was $185.9 million, or non-GAAP earnings per diluted share of $0.40. Based on U.S. GAAP, Celgene reported net income of $216.8 million, or earnings per diluted share of $0.46 for the quarter ended September 30, 2009. GAAP net income for the third quarter of 2008 was $136.8 million, or earnings per diluted share of $0.29.

Celgene posted non-GAAP net income of $681.0 million or non-GAAP earnings per diluted share of $1.46 during the first nine months of 2009 as compared to non-GAAP net income of $517.9 million and non-GAAP earnings per diluted share of $1.13 in 2008. On a GAAP basis, Celgene reported net income of $522.5 million or earnings per diluted share of $1.12 for the first nine months of 2009, compared to GAAP net loss of $1.384 billion or a loss per diluted share of $3.17 in 2008, which was primarily due to an in-process research and development charge associated with the acquisition of Pharmion Corporation in March 2008.

“All key functional areas – commercial, clinical, regulatory, and operations – executed as planned globally and delivered an exceptional quarter,” said Chairman and Chief Executive Officer Sol J. Barer, Ph.D. “We are looking forward to sharing significant clinical data with you across a broad range of Celgene compounds in the fourth quarter that will demonstrate the extraordinary global potential of our deep and diverse clinical pipeline.”