Celgene's first-quarter non-GAAP total revenue up 31% to $789 million

Apr 29 2010

Celgene Corporation (NASDAQ: CELG):

“Our exceptional first quarter operating results represent the collective efforts of our Celgene team worldwide as we not only continue our global expansion, but also continue our efforts to discover and deliver new therapies”

2010 First Quarter Financial Results Year-Over-Year

• Non-GAAP Total Revenue Increased 31 Percent to $789 Million; GAAP Total Revenue $791 Million
• Global REVLIMID Net Product Sales Increased 46 Percent to $530 Million
• Global VIDAZA Net Product Sales Increased 60 Percent to $120 Million
• Global THALOMID^® Net Product Sales of $104 Million
• Non-GAAP Operating Income Increased 65 Percent to $359 Million; GAAP Operating Income $270 Million
• Non-GAAP Net Income Increased 44 Percent to $295 Million; GAAP Net Income $234 Million
• Non-GAAP Diluted Earnings Per Share Increased 43 Percent to $0.63; GAAP Diluted Earnings Per Share $0.50

2010 Financial Outlook Update

• Total Revenue Expected to Increase Approximately 25 Percent Year-Over-Year to a Range of $3.3 to $3.4 Billion, Up From a Previous Range of $3.2 to $3.3 Billion
• REVLIMID Net Product Sales Anticipated to Increase Approximately 30 Percent Year-Over-Year to a Range of $2.2 to $2.3 Billion, Up From a Previous Range of $2.1 to $2.2 Billion
• Non-GAAP Diluted Earnings Per Share Expected to Increase Approximately 25 Percent Year-Over-Year to a Range of $2.60 to $2.65, Up From a Previous Range of $2.55 to $2.60

Recent Developments and Highlights

• Senior Management Succession Plan Announced
• Approximately 50 Abstracts to be Presented at The American Society of Clinical Oncology (ASCO) Meeting Evaluating Celgene Products Including REVLIMID^®, VIDAZA^®, THALOMID^®, ISTODAX^®, Pomalidomide and Amrubicin
• Highlighted Value of Celgene's Innovative Research and Development Portfolio at Research and Development Day
• Completed Acquisition of Gloucester Pharmaceuticals and Initiated U.S. Commercial Launch of ISTODAX, a Novel HDAC Inhibitor for the Treatment of Cutaneous T-Cell Lymphoma
• Formed Strategic Research Collaboration With Agios Pharmaceuticals, Inc. Focused on Targeting Cancer Metabolism
• Primary Endpoint Met in Intergroupe Francophone du Myelome (IFM) Phase III Study (IFM 2005-02) Evaluating Treatment with Continuous REVLIMID in Patients with Multiple Myeloma Following Autologous Stem Cell Transplant
• Initiated MDS-005 Phase III Trial Evaluating REVLIMID in Low/Int-1 non-del5q Myelodysplastic Syndromes
• Phase I Study of PDA-001, Celgene Cellular Therapeutics' Immunomodulatory Therapy, Met Primary Endpoint of Safety and Demonstrated Encouraging Clinical Benefit

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 U.S. Pivotal Study of ISTODAX in Peripheral T-Cell Lymphoma and Advance Regulatory Strategies
• Advance More Than 20 Phase III and Pivotal Clinical Trials and 16 Preclinical Programs Addressing More Than 25 Serious and Debilitating Diseases
• Initiate Apremilast Phase III Studies in Moderate-To-Severe Psoriasis and Psoriatic Arthritis, and Phase II Study in Rheumatoid Arthritis
• Initiate Pomalidomide Phase III Studies in Multiple Myeloma and Myelofibrosis
• Complete Amrubicin Phase III Trial in Patients With Small Cell Lung Cancer
• Initiate DLC-001, A Phase II/III Study of REVLIMID in Patients With Diffuse Large B-Cell Lymphoma
• Initiate Multiple Phase II Trials for PDA-001 Cellular Therapy
• Initiate Phase II Trial for JNK CC-930 in Idiopathic Pulmonary Fibrosis and Discoid Lupus Erythematosus
• Initiate Phase I Trial of TORKi (mTOR Kinase Inhibitor) CC-223

Celgene Corporation (NASDAQ: CELG) announced non-GAAP (Generally Accepted Accounting Principles) net income of $294.6 million, or non-GAAP diluted earnings per share of $0.63 for the quarter ended March 31, 2010. Non-GAAP net income for the first quarter of 2009 was $205.1 million or non-GAAP diluted earnings per share of $0.44. Based on U.S. GAAP, Celgene reported net income of $234.4 million, or diluted earnings per share of $0.50 for the quarter ended March 31, 2010. GAAP net income for the first quarter of 2009 was $162.9 million, or diluted earnings per share of $0.35.

"Our exceptional first quarter operating results represent the collective efforts of our Celgene team worldwide as we not only continue our global expansion, but also continue our efforts to discover and deliver new therapies," said Chairman and Chief Executive Officer Sol J. Barer, Ph.D. "To this end we highlighted the next generations of Celgene therapies at our recent R&D day and we are aggressively investing in this pipeline to ensure sustainable growth."

Product Sales Performance

Non-GAAP total revenue was a record $788.9 million for the quarter ended March 31, 2010, an increase of 31 percent from 2009. GAAP total revenue was $791.3 million for the quarter ended March 31, 2010. The increase in total revenue was driven by global market share gains and increased duration of therapy of REVLIMID^®. Net sales of REVLIMID were $530.5 million, an increase of 46 percent over the same period in 2009. Global THALOMID^® (inclusive of Thalidomide Celgene™ and Thalidomide Pharmion™) and VIDAZA^® net sales were $104.0 million and $120.3 million, respectively. Revenue from Focalin^® and the Ritalin^® family of drugs totaled $29.7 million for the first quarter of 2010 compared to $27.0 million over the same period in 2009.

Healthcare Reform Legislation

Recently passed U.S. healthcare reform legislation negatively impacted first quarter 2010 revenues by approximately $4 million. The full year 2010 revenue impact is expected to be approximately $35-$40 million. The primary components of the legislation that are expected to impact the Company's business during 2010 include an increase in the Medicaid rebate from 15.1% to 23.1% and an extension of that rebate to Medicaid Managed Care Organizations.

Research and Development

For the first quarter of 2010, non-GAAP R&D expenses, which exclude share-based employee compensation expense, were $185.5 million compared to $166.5 million for the first quarter of 2009. These R&D expenditures continue to support ongoing clinical progress in multiple proprietary development programs for REVLIMID, pomalidomide and other IMiDs^® compounds; VIDAZA; ISTODAX^®; 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 $204.7 million for the first quarter of 2010 and $181.2 million in the same period in 2009.

Selling, General, and Administrative

Non-GAAP selling, general and administrative expenses, which exclude share-based employee compensation expense, were $188.0 million for the first quarter of 2010 compared to $156.6 million for the first quarter of 2009. The increase was primarily due to marketing and sales expenses related to product launch activities of VIDAZA^® in Europe and the continued expansion of our international commercial activities. On a GAAP basis, selling, general and administrative expenses were $208.0 million for the first quarter of 2010 and $173.4 million in the same period in 2009.

Interest and Other Income, Net

For the quarter ended March 31, 2010, interest and other income, net, decreased to $17.4 million compared to $49.6 million in the same period in 2009. The decrease was primarily due to reduced net hedging and foreign currency revaluation gains.

Cash, Cash Equivalents, and Marketable Securities

Celgene reported $2.954 billion in cash, cash equivalents, and marketable securities as of March 31, 2010.

SOURCE Celgene Corporation