Celgene Reports Record Third Quarter 2009 Operating and Financial Results

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.”

Product Sales Performance

Non-GAAP total revenue was a record $692.2 million for the quarter ended September 30, 2009, an increase of 18 percent from 2008. GAAP total revenue was $695.1 million for the quarter ended September 30, 2009. The increase in total revenue was driven by global market share gains, reimbursement approvals, increased duration of therapy of REVLIMID^® and the global growth of VIDAZA^®. REVLIMID net sales were $449.6 million, an increase of 31 percent over the same period in 2008. THALOMID^® net sales (inclusive of Thalidomide Pharmion™ and Thalidomide Celgene™) were $110.0 million. VIDAZA net sales were $103.1 million, an increase of 62 percent over sales in the third quarter of 2008. Revenue from Focalin^® and the Ritalin^® family of drugs totaled $25.8 million for the third quarter of 2009 compared to $23.8 million over the same period last year.

For the first nine months of 2009, non-GAAP total revenue was a record $1.919 billion, an increase of 19 percent year-over-year. GAAP total revenue was $1.929 billion for the nine months ended September 30, 2009. REVLIMID net sales for the first nine months of 2009 reached $1.209 billion, an increase of 27 percent over $955.2 million for the same period in 2008. THALOMID net sales for the first nine months of 2009 were $329.2 million. Vidaza net sales for the first nine months of 2009 reached $270.5 million, an increase of 97 percent over the same period in 2008, which excludes 2008 Vidaza sales prior to the March 7 acquisition of Pharmion.

Research and Development

To support clinical development and to advance global regulatory filings, the company increased R&D investments in multiple international clinical programs. For the third quarter of 2009, non-GAAP R&D expenses, which exclude share-based employee compensation expense, were $178.2 million compared to $149.9 million for the third quarter of 2008. These R&D expenditures continue to support ongoing clinical progress in multiple proprietary development programs for REVLIMID^®, pomalidomide and other IMiDs^® compounds; VIDAZA^®; amrubicin, our lead compound for small cell lung cancer; apremilast and our other oral anti-inflammatory compounds; our kinase inhibitor programs; our Activin inhibitor program with ACE-011 and placenta-derived stem cell programs. On a GAAP basis, R&D expenses were $193.4 million for the third quarter of 2009 and $160.9 million for the same period in 2008.

Selling, General, and Administrative

Non-GAAP selling, general and administrative expenses, which exclude share-based employee compensation expense, were $172.3 million for the third quarter of 2009 compared to $152.0 million for the third quarter of 2008. The increase in expenses was due primarily to unrestricted donations to non-profit organizations for co-pay assistance. On a GAAP basis, selling, general and administrative expenses were $192.5 million for the third quarter of 2009 compared to $168.6 million for the third quarter of 2008.

Interest and Other Income, Net

For the quarter ended September 30, 2009, interest and other income, net, was $34.9 million compared to $21.6 million in the same period in 2008.

Cash, Cash Equivalents, and Marketable Securities

Celgene reported $2.764 billion in cash, cash equivalents, and marketable securities as of September 30, 2009.

Non-GAAP Financial Information

See the attached Reconciliation of GAAP to Non-GAAP Net Income (Loss) for an explanation of the amounts excluded and included to arrive at non-GAAP net income and non-GAAP earnings per share amounts for the three- and nine-month periods ended September 30, 2009 and 2008. Non-GAAP financial measures provide investors and management with supplemental measures of operating performance and trends that facilitate comparisons between periods before and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the company’s basic operations do not meet the GAAP definition of unusual or non-recurring items. Non-GAAP net income and non-GAAP earnings per share are not, and should not be viewed as a substitute for similar GAAP items. We define non-GAAP diluted earnings per share amounts as non-GAAP net income divided by the weighted average number of diluted shares outstanding. Our definition of non-GAAP net income and non-GAAP diluted earnings per share may differ from similarly named measures used by others.

Conference Call and Webcast Information

Celgene will host a conference call to discuss the results and achievements of its third quarter 2009 and its operating and financial performance on October 22, 2009, at 9 a.m. EDT. The conference call will be available by webcast at www.celgene.com. An audio replay of the call will be available from noon October 22, 2009, until midnight EDT October 29, 2009. To access the replay, in the U.S. dial 888-203-1112; outside the U.S. dial 719-457-0820; and enter reservation number 9504107. The Company’s fourth quarter 2009 financial and operational results will be reported on January 28, 2010.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the company’s Web site at www.celgene.com.

This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company’s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company’s filings with the Securities and Exchange Commission such as Form 10-K, 10-Q and 8-K reports.