Celgene reports total revenue of $758M for fourth-quarter of 2009

Jan 28 2010

Celgene Corporation (NASDAQ: CELG):

2009 Fourth Quarter Financial Results Year-Over-Year:

• Non-GAAP Total Revenue Increased 22 Percent to $758 Million; GAAP Total Revenue $761 Million
• Global REVLIMID Net Product Sales Increased 35 Percent to $497 Million
• Global VIDAZA Net Product Sales Increased 68 Percent to $117 Million
• Global THALOMID^® Net Product Sales of $108 Million
• Non-GAAP Operating Income Increased 48 Percent to $337 Million; GAAP Operating Income $283 Million
• Non-GAAP Net Income Increased to $290 Million; GAAP Net Income $254 Million
• Non-GAAP Diluted Earnings Per Share Increased to $0.62; GAAP Diluted Earnings Per Share $0.54

2009 Full Year Financial Results Year-Over-Year:

• Non-GAAP Total Revenue Increased 20 Percent to $2.68 Billion; GAAP Total Revenue $2.69 Billion
• Global REVLIMID Net Product Sales Increased 29 Percent to $1.71 Billion
• Global VIDAZA Net Product Sales Increased to $387 Million
• Global THALOMID Net Product Sales of $437 Million
• Non-GAAP Operating Income Increased 30 Percent to $1.10 Billion; GAAP Operating Income $842 Million
• Non-GAAP Net Income Increased to $971 Million; GAAP Net Income $777 Million
• Non-GAAP Diluted Earnings Per Share Increased 33 Percent to $2.08; GAAP Diluted Earnings Per Share $1.66

2010 Financial Outlook Year-Over-Year

• Total Revenue Expected to Increase Approximately 20 Percent to a Range of $3.2 to $3.3 Billion
• REVLIMID^® Net Product Sales Anticipated to Increase Approximately 25 Percent to a Range of $2.1 to $2.2 Billion
• Non-GAAP Diluted Earnings Per Share Expected to Increase Approximately 25 Percent to a Range of $2.55 to $2.60

Recent Developments and Highlights

Hematology

• More Than 200 Abstracts Evaluating Celgene Products Across a Range of Indications Presented at the 51st American Society of Hematology Meeting
• First Interim Analysis of Phase III MM-015 Study Reported 50 Percent Improvement in Progression Free Survival in Newly Diagnosed Elderly Multiple Myeloma Patients Receiving Continuous REVLIMID
• Initial Data from National Cancer Institute (NCI) and Cancer and Leukemia Group B (CALGB) Phase III Study Reported Statistically Significant Improvement in Time-to-Disease Progression with Continuous REVLIMID Therapy in Patients with Multiple Myeloma Following Autologous Stem Cell Transplant
• Initial Data from Intergroupe Francophone du Myelome (IFM) Phase III Study Reported Statistically Significant Improvement in Progression Free Survival with Continuous REVLIMID Therapy in Patients with Multiple Myeloma Following Autologous Stem Cell Transplant
• REVLIMID Regulatory and Reimbursement Approvals Granted in Multiple Regions, Including U.K., Canada, Australia, and Latin America
• New Drug Application Filed with Japanese Ministry of Health, Labor and Welfare for REVLIMID in Previously Treated Multiple Myeloma and Del 5q Myelodysplastic Syndrome
• U.S. REVLIMID Label in Multiple Myeloma and Del 5q Myelodysplastic Syndrome Updated With New Starting Dose Guidelines for Patients with Renal Impairment
• VIDAZA^® Launch Completed in Majority of Key European Regions

Oncology

• Completed Enrollment of Amrubicin Phase III Trial In Patients With Small Cell Lung Cancer; Data Expected in Second Half of 2010
• Initiated Phase II Trial of ACE-011 for Treatment of Chemotherapy Induced Anemia In Metastatic Breast Cancer
• Advanced REVLIMID Solid Tumor Program In Prostate Cancer, Renal Cell Carcinoma, Pancreatic Cancer, and Colorectal Cancer

Inflammation and Immunology

• Apremilast Phase II Study In Psoriatic Arthritis and Phase IIb Study In Moderate-To-Severe Psoriasis Met Primary Endpoints; Phase III Studies to Start in 2010
• Completed Phase I Proof-Of-Principle Study For Proprietary PDA-001 Placenta-Derived Stem Cells In Crohn’s Disease
• Completed Phase Ib Multiple Dose Study of CC-930, a First-in-Class JNK Inhibitor

Selected Corporate Developments

• Acquired Gloucester Pharmaceuticals, Providing Celgene With Novel HDAC Inhibitor, ISTODAX^® (romidepsin), for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
• R&D Day Scheduled for March 4, 2010

2010 Selected Corporate Objectives

• Expand Celgene Product Approvals, Reimbursements and Global Market Share
• Submit REVLIMID^® Newly Diagnosed Multiple Myeloma (NDMM) Regulatory Filings with European Medicines Agency and Food and Drug Administration
• Gain Marketing Approval and Launch REVLIMID in Japan for Multiple Myeloma
• Complete Enrollment of MM-020, a Phase III Trial>
• REVLIMID Data from IFM 2005-02, CALGB-100104, and MM-015 Trials to be Presented at Major Medical Meetings
• Complete Launch of VIDAZA^® in Europe and Rest-of-World
• Launch ISTODAX in CTCL in the U.S. and Complete U.S. Pivotal Study in Peripheral T-Cell Lymphoma
• Advance 20 Phase III and Pivotal Clinical Trials
• Advance 16 Preclinical Programs Addressing More Than 25 Serious and Debilitating Diseases
• Initiate Apremilast Phase III Studies in Psoriasis and Psoriatic Arthritis
• Initiate Pomalidomide Pivotal Studies in Multiple Myeloma and Myelofibrosis
• Complete Amrubicin Phase III Trial in Patients With Small Cell Lung Cancer
• Initiate Multiple Phase II Trials for PDA-001 Cellular Therapy
• Initiate Phase II Trials for JNK CC-930 in Idiopathic Pulmonary Fibrosis

Celgene Corporation (NASDAQ: CELG) announced non-GAAP (Generally Accepted Accounting Principles) net income of $290.3 million, or non-GAAP diluted earnings per share of $0.62 for the quarter ended December 31, 2009. Non-GAAP net income for the fourth quarter of 2008 was $200.9 million or non-GAAP diluted earnings per share of $0.43. Based on U.S. GAAP, Celgene reported net income of $254.2 million, or diluted earnings per share of $0.54 for the quarter ended December 31, 2009. GAAP net loss for the fourth quarter of 2008 was $149.3 million, or diluted loss per share of $0.33.

Celgene posted non-GAAP net income of $971.3 million or non-GAAP diluted earnings per share of $2.08 during 2009 as compared to non-GAAP net income of $718.8 million and non-GAAP diluted earnings per share of $1.56 in 2008. On a GAAP basis, Celgene reported net income of $776.7 million or diluted earnings per share of $1.66 for 2009, compared to GAAP net loss of $1.534 billion or a diluted loss per share of $3.46 in 2008, which was primarily due to an in-process research and development charge associated with the acquisition of Pharmion Corporation in March 2008.

Product Sales Performance

Non-GAAP total revenue was a record $757.8 million for the quarter ended December 31, 2009, an increase of 22 percent from 2008. GAAP total revenue was $761.0 million for the quarter ended December 31, 2009. The increase in total revenue was driven by global market share gains, increased duration of therapy of REVLIMID^® and reimbursement approvals. Net sales of REVLIMID were $497.1 million, an increase of 35 percent over the same period in 2008. Global THALOMID^® (inclusive of Thalidomide Celgene™ and Thalidomide Pharmion™) and VIDAZA^® net sales were $107.7 million and $116.7 million, respectively. Revenue from Focalin^® and the Ritalin^® family of drugs totaled $27.6 million for the fourth quarter of 2009 compared to $27.9 million over the same period in 2008.

For the full year of 2009, non-GAAP total revenue was a record $2.677 billion, an increase of 20 percent year-over-year. GAAP total revenue was $2.690 billion for 2009. Total non-GAAP net product sales reached a record $2.555 billion, an increase of 21 percent year-over-year. REVLIMID net sales for the full year reached $1.706 billion compared to $1.325 billion in 2008. Global 2009 THALOMID and VIDAZA net sales for the full year were $436.9 million and $387.2 million, respectively.

Research and Development

For the fourth quarter of 2009, non-GAAP R&D expenses, which exclude share-based employee compensation expense, were $181.8 million compared to $153.8 million for the fourth quarter of 2008, which also excluded the purchase of the VIDAZA royalty obligation. 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 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 $201.7 million for the fourth quarter of 2009 and $468.6 million in the same period in 2008.

Selling, General, and Administrative

Non-GAAP selling, general and administrative expenses, which exclude share-based employee compensation expense, were $193.3 million for the fourth quarter of 2009 compared to $181.7 million for the fourth quarter of 2008. The increase was primarily due to marketing and sales expenses related to product launch activities of VIDAZA in Europe. On a GAAP basis, selling, general and administrative expenses were $211.6 million for the fourth quarter of 2009 and $200.2 million in the same period in 2008.

Interest and Other Income, Net

For the quarter ended December 31, 2009, interest and other income, net, decreased to $22.0 million compared to $34.9 million in the same period in 2008.

Cash, Cash Equivalents, and Marketable Securities

Celgene reported $2.997 billion in cash, cash equivalents, and marketable securities as of December 31, 2009, an increase of $774.7 million from December 31, 2008.