Celgene Corporation (NASDAQ: CELG):
“The results for the quarter were outstanding and they reflect the ongoing momentum that Celgene is creating as we leverage our business model and position our Company for long-term success”
2011 First Quarter Financial Results Year-Over-Year
- Non-GAAP Total Revenue Increased 40 Percent to $1.11 Billion; GAAP Total Revenue $1.13 Billion
- Global REVLIMID Net Product Sales Increased 39 Percent to $738 Million
- Global VIDAZA® Net Product Sales Increased 36 Percent to $163 Million
- Global THALOMID® Net Product Sales of $85 Million
- Global ABRAXANE® Net Product Sales of $74 Million
- Non-GAAP Operating Income Increased 35 Percent to $486 Million; GAAP Operating Income $288 Million
- Non-GAAP Net Income Increased 34 Percent to $393 Million; GAAP Net Income $256 Million
- Non-GAAP Diluted Earnings Per Share Increased 32 Percent to $0.83; GAAP Diluted Earnings Per Share $0.54
2011 Financial Outlook Update
- Non-GAAP Total Revenue Expected to Increase Approximately 25 Percent Year-Over-Year to a Range of $4.45 to $4.55 Billion, Up From a Previous Range of $4.4 to $4.5 Billion
- REVLIMID Net Product Sales Anticipated to Increase Approximately 26 Percent Year-Over-Year to a Range of $3.05 to $3.15 Billion, Up From a Previous Range of $3.0 to $3.1 Billion
- Non-GAAP Diluted Earnings Per Share Expected to Increase Approximately 21 Percent Year-Over-Year to a Range of $3.35 to $3.40, Up From a Previous Range of $3.30 to $3.35
Recent Developments and Highlights
- VIDAZA® Received Positive Final Appraisal Determination from National Institute for Health and Clinical Excellence for Use in the National Health Service in England and Wales
- Initiated International Phase III Trial of Pomalidomide in Relapsed/Refractory Multiple Myeloma Patients
- REVLIMID® IP Estate Increased With Orange Book Listing of Additional Granted US Patent and Allowance of Two Applications
- ISTODAX® Supplemental New Drug Application (sNDA) Granted FDA Priority Review For Treatment of Progressive or Relapsed Peripheral T-Cell Lymphoma (PTCL)
- ABRAXANE® Plus Gemcitabine Added to National Comprehensive Cancer Network (NCCN) Guidelines as Therapy for Pancreatic Cancer
- ISTODAX Added to NCCN Guidelines as Therapy for Relapsed/Refractory PTCL in Both Transplant and Non-Transplant Patients
- ISTODAX Marketing Authorization Application Submitted to European Medicines Agency (EMA) For Relapsed or Refractory PTCL
- ABRAXANE in an Independent Phase II Clinical Study Demonstrated a Response Rate of 32% in Metastatic Platinum-refractory Urothelial Cancer
- Approximately 300 Abstracts Evaluating Celgene Products to be Presented at Major Medical Meetings in Q2 2011
- Elected to Board of Directors Michael A. Friedman, MD, President and Chief Executive Officer, City of Hope Cancer Center
- Announced $1.5 Billion Share Repurchase Program During Q1 2011
2011 Selected Clinical/Regulatory Objectives
- Submit REVLIMID Newly Diagnosed Multiple Myeloma Regulatory Filing with FDA
- Submit REVLIMID del 5q Myelodysplastic Syndromes Regulatory Filing With EMA
- Launch ISTODAX in PTCL in the United States
- Complete Enrollment of Pomalidomide Phase III Trial in Myelofibrosis
- Complete Enrollment of Pivotal Phase II Trials Evaluating REVLIMID in Mantle Cell Lymphoma
- Initiate Phase III Study of REVLIMID in Patients with Follicular Lymphoma
- Launch ABRAXANE for Metastatic Breast Cancer in the European Union
- Submit ABRAXANE Non-Small Cell Lung Cancer sNDA to FDA
- Complete Enrollment of ABRAXANE Phase III Trial in Pancreatic Cancer
- Complete Enrollment of ABRAXANE Phase II Trials in Melanoma, Bladder and Ovarian Cancer
- Complete Enrollment of REVLIMID Phase III Trial in Castrate Resistant Prostate Cancer
- Advance Development Program of TORKi (mTOR Kinase Inhibitor) CC-223
Inflammation and Immunology
- Present Phase II Data with Apremilast in Ankylosing Spondylitis
- Complete Enrollment of Six Phase III Trials Evaluating Apremilast in Psoriatic Arthritis (n = 2,000), and in Moderate-to-Severe Psoriasis (n = 1,200)
- Advance Phase II Apremilast Trial in Rheumatoid Arthritis
- Advance Development Program of Cellular Therapy PDA-001 in Crohn's Disease, Multiple Sclerosis, Rheumatoid Arthritis, and Other Diseases
Celgene Corporation (NASDAQ: CELG) announced non-GAAP (Generally Accepted Accounting Principles) net income of $393 million, or non-GAAP diluted earnings per share of $0.83 for the quarter ended March 31, 2011. Non-GAAP net income for the first quarter of 2010 was $295 million or non-GAAP diluted earnings per share of $0.63. Based on U.S. GAAP, Celgene reported net income of $256 million, or GAAP diluted earnings per share of $0.54 for the quarter ended March 31, 2011. GAAP net income for the first quarter of 2010 was $234 million, or GAAP diluted earnings per share of $0.50.
"The results for the quarter were outstanding and they reflect the ongoing momentum that Celgene is creating as we leverage our business model and position our Company for long-term success," said Bob Hugin, Chief Executive Officer of Celgene Corporation.
Product Sales Performance
Non-GAAP total revenue was a record $1.11 billion for the quarter ended March 31, 2011, an increase of 40 percent over 2010. GAAP total revenue was $1.13 billion for the quarter ended March 31, 2011. The increase in total revenue was driven by global market share gains, geographic expansion and increased duration of therapy of REVLIMID® and VIDAZA®. Net sales of REVLIMID were $738 million, an increase of 39 percent over the same period in 2010. VIDAZA® net sales were $163 million, an increase of 36 percent from 2010. Global THALOMID® (inclusive of Thalidomide Celgene® and Thalidomide Pharmion®) net sales were $85 million, an 18 percent decrease from 2010. ABRAXANE® net sales were $74 million.
Research and Development
For the first quarter of 2011, non-GAAP R&D expenses, which exclude share-based employee compensation expense, non-core R&D operations acquired from Abraxis and an impairment of acquired IPR&D, were $278 million compared to $186 million for the first quarter of 2010. These R&D expenditures continue to support ongoing clinical progress in multiple proprietary development programs for REVLIMID, VIDAZA, ABRAXANE, ISTODAX®, pomalidomide, apremilast and our oral anti-inflammatory compounds; our kinase inhibitor program; our activin inhibitor program with ACE-011; and our cellular therapy programs. On a GAAP basis, R&D expenses were $435 million for the first quarter of 2011 and $205 million in the same period in 2010.
Selling, General, and Administrative
Non-GAAP selling, general and administrative expenses, which exclude share-based employee compensation expense, and expenses from non-core selling, general, and administrative activities acquired from Abraxis, were $270 million for the first quarter of 2011 compared to $188 million for the first quarter of 2010. The increase was primarily due to higher marketing and sales related expenses resulting from ongoing product launch activities, including REVLIMID in Japan, VIDAZA in Europe and ISTODAX in the United States, launch of ABRAXANE, as well as Abraxis integration and higher facilities costs. On a GAAP basis, selling, general and administrative expenses were $302 million for the first quarter of 2011 and $208 million in the same period in 2010.
Interest and Other Income, Net
For the quarter ended March 31, 2011, non-GAAP interest and other income, net, decreased to a slight loss compared to a $17 million gain in the same period in 2010. The decrease was primarily due to interest expense associated with the $1.25 billion in senior notes issued in October 2010, as well as a decrease in interest income earned in the quarter ended March 31, 2011, compared to the same period in 2010.
Cash, Cash Equivalents, and Marketable Securities
Celgene reported $2.43 billion in cash, cash equivalents, and marketable securities as of March 31, 2011. Celgene repurchased 8.5 million shares during the first quarter for approximately $450 million.