Celgene Reports Record Third Quarter 2010 Operating and Financial Results

SUMMIT, N.J., Sunday, October 31st 2010 [ME NewsWire]:

Record Third Quarter Results Driven By Share Gains Across Major Markets

REVLIMID® Third Quarter Global Net Product Sales Increased 43% Y/Y

VIDAZA® Third Quarter Global Net Product Sales Increased 37% Y/Y

Non-GAAP Third Quarter Diluted Earnings Per Share Increased 34% Y/Y

(BUSINESS WIRE)-- Celgene Corporation (NASDAQ: CELG):

2010 Third Quarter Financial Results Year-Over-Year

• Non-GAAP Total Revenue Increased 31 Percent to $908 Million; GAAP Total Revenue $910 Million

• Global REVLIMID Net Product Sales Increased 43 Percent to $641 Million

• Global VIDAZA Net Product Sales Increased 37 Percent to $141 Million

• Global THALOMID® Net Product Sales of $94 Million

• Non-GAAP Operating Income Increased 40 Percent to $409 Million; GAAP Operating Income $311 Million

• Non-GAAP Net Income Increased 35 Percent to $350 Million; GAAP Net Income $281 Million

• Non-GAAP Diluted Earnings Per Share Increased 34 Percent to $0.75; GAAP Diluted Earnings Per Share $0.60

2010 Financial Outlook Update (Includes Impact of Acquisition of Abraxis BioScience)

• Total Revenue Expected to Increase Approximately 34 Percent Year-Over-Year to Approximately $3.60 Billion, Up From a Previous Range of $3.40 to $3.45 Billion

• REVLIMID Net Product Sales Anticipated to Increase Approximately 44 Percent Year-Over-Year to Approximately $2.45 Billion, Up From a Previous Range of $2.30 to $2.35 Billion

• Non-GAAP Diluted Earnings Per Share Expected to Increase Approximately 34 Percent Year-Over-Year to a Range of $2.78 to $2.80, Up From a Previous Range of $2.65 to $2.70

Recent Developments and Highlights

• Completed Acquisition of Abraxis BioScience

• Completed $1.25 Billion Debut Debt Offering

• Announced Appointment of Jacqualyn A. Fouse as Senior Vice President and Chief Financial Officer

• Initiated Launch of REVLIMID® in Japan for Treatment of Relapsed/Refractory Multiple Myeloma

• Initiated PALACE 1, PALACE 2, and PALACE 3, Phase III Trials Evaluating Apremilast in Psoriatic Arthritis, and ESTEEM 1, a Phase III Trial Evaluating Apremilast in Moderate-to-Severe Psoriasis

• Brought Infringement Action to Enforce our REVLIMID Patents Against Natco Pharma Ltd. for Filing an Abbreviated New Drug Application With a Paragraph IV Certification for Lenalidomide

• ABRAXANE® Pharmaceutical Composition and Method Claims Patent Issued on October 26, 2010, expiring in 2024

• Initiated MF-002, a Phase III Trial Evaluating Pomalidomide in Myelofibrosis
• Initiated AZA-AML-001, a Phase III Trial Evaluating VIDAZA® in Newly Diagnosed Acute Myeloid Leukemia

• Initiated Phase II Trial for PDA-001 Cellular Therapy in Crohn’s Disease

2010 Selected Corporate Objectives

• Expand Celgene Product Approvals, Reimbursements, and Global Market Share

• Submit REVLIMID Newly Diagnosed Multiple Myeloma (NDMM) Regulatory Filing with European Medicines Agency

• Complete Enrollment of MM-020, a Phase III Trial Evaluating REVLIMID and Low-Dose Dexamethasone Versus Melphalan, Prednisone, and Thalidomide in NDMM

• Submit ISTODAX® Peripheral T-cell Lymphoma Regulatory Filing with Food and Drug Administration

• Advance More Than 25 Phase III and Pivotal Clinical Trials and 17 Preclinical Programs Addressing More Than 30 Serious and Debilitating Diseases

• Initiate ESTEEM 2, a Phase III Trial Evaluating Apremilast in Moderate-to-Severe Psoriasis, and PALACE 4, a Phase III Trial Evaluating Apremilast in Psoriatic Arthritis

• Initiate Phase II Trial for Apremilast in Rheumatoid Arthritis

• Initiate Phase II Trial for PDA-001 Cellular Therapy in Ischemic Stroke; Initiate Phase I Trial in Multiple Sclerosis

• Initiate Phase II Trial for JNK CC-930 in Idiopathic Pulmonary Fibrosis and Discoid Lupus Erythematosus

Celgene Corporation (NASDAQ: CELG) announced non-GAAP (Generally Accepted Accounting Principles) net income of $349.9 million, or non-GAAP diluted earnings per share of $0.75 for the quarter ended September 30, 2010. Non-GAAP net income for the third quarter of 2009 was $259.8 million or non-GAAP diluted earnings per share of $0.56. Based on U.S. GAAP, Celgene reported net income of $281.2 million, or diluted earnings per share of $0.60 for the quarter ended September 30, 2010. GAAP net income for the third quarter of 2009 was $216.8 million, or diluted earnings per share of $0.46.

Celgene posted non-GAAP net income of $967.7 million or non-GAAP diluted earnings per share of $2.07 during the first nine months of 2010 as compared to non-GAAP net income of $681.0 million and non-GAAP diluted earnings per share of $1.46 in 2009. On a GAAP basis, Celgene reported net income of $670.9 million, or diluted earnings per share of $1.44 for the first nine months of 2010, compared to GAAP net income of $522.5 million, or diluted earnings per share of $1.12 in 2009.

“Our third quarter results reflect outstanding operational execution by our global team,” said Bob Hugin, Celgene’s Chief Executive Officer. “Our expanding portfolio of innovative therapies in oncology and immune-inflammatory diseases further positions us for sustained growth and value creation in the near and long term.”

Product Sales Performance

Non-GAAP total revenue was a record $908.1 million for the quarter ended September 30, 2010, an increase of 31 percent from 2009. GAAP total revenue was $910.1 million for the quarter ended September 30, 2010. The increase in total revenue was driven by global market share gains and increased duration of therapy of REVLIMID® and VIDAZA®. Net sales of REVLIMID were $641.3 million, an increase of 43 percent over the same period in 2009. VIDAZA® net sales were $141.4 million, an increase of 37 percent from 2009. Global THALOMID® (inclusive of Thalidomide Celgene® and Thalidomide Pharmion®) sales were $94.2 million, a 14 percent decrease from 2009. Revenue from Focalin® and the Ritalin® family of drugs totaled $22.6 million for the third quarter of 2010 compared to $25.8 million over the same period in 2009.

For the first nine months of 2010, non-GAAP total revenue was a record $2.547 billion, an increase of 33 percent year-over-year. GAAP total revenue was $2.554 billion for the nine months ended September 30, 2010. REVLIMID net sales for the first nine months of 2010 were $1.759 billion, an increase of 45 percent over $1.209 billion for the same period in 2009. VIDAZA net sales for the first nine months of 2010 were $393.6 million, an increase of 46 percent over the same period in 2009. THALOMID net sales for the first nine months of 2010 were $296.0 million, a decrease of 10 percent from the same period in 2009. Revenue from Focalin and the Ritalin family of drugs totaled $79.3 million for the first nine months of 2010, an increase of 3 percent over the same period in 2009.

Research and Development

For the third quarter of 2010, non-GAAP R&D expenses, which exclude upfront collaboration payments and share-based employee compensation expense, were $232.3 million compared to $178.2 million for the third quarter of 2009. These R&D expenditures continue to support ongoing clinical progress in multiple proprietary development programs for REVLIMID, pomalidomide, and other compounds; VIDAZA; ISTODAX®; amrubicin; apremilast and our oral anti-inflammatory compounds; our kinase inhibitor programs; our activin inhibitor program with ACE-011; and cellular therapy programs. On a GAAP basis, R&D expenses were $253.5 million for the third quarter of 2010 and $193.4 million in the same period in 2009.

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For media enquiries, please contact: Celgene Corporation Jacqualyn A. Fouse, 908-673-9956 Sr. Vice President and Chief Financial Officer Tim Smith, 908-673-9951 Director, Investor Relations