Celgene second-quarter non-GAAP total revenue increases 36% to $850 million

Celgene Corporation (NASDAQ: CELG):

“Our portfolio of products and promising hematology and immune-inflammatory pipeline position us to make an increasingly meaningful impact on the lives of patients suffering from serious unmet medical conditions. By combining operational excellence with innovative science, we are strategically positioned to produce sustained long-term growth.”

2010 Second Quarter Financial Results Year-Over-Year

  • Non-GAAP Total Revenue Increased 36 Percent to $850 Million; GAAP Total Revenue $853 Million
  • Global REVLIMID Net Product Sales Increased 48 Percent to $587 Million
  • Global VIDAZA Net Product Sales Increased 43 Percent to $132 Million
  • Global THALOMID® Net Product Sales of $98 Million
  • Non-GAAP Operating Income Increased 55 Percent to $390 Million; GAAP Operating Income $168 Million
  • Non-GAAP Net Income Increased 50 Percent to $323 Million; GAAP Net Income $155 Million
  • Non-GAAP Diluted Earnings Per Share Increased 50 Percent to $0.69; GAAP Diluted Earnings Per Share $0.33

2010 Financial Outlook Update (excluding effects of the proposed acquisition of Abraxis BioScience, unless noted)

  • Total Revenue Expected to Increase Approximately 28 Percent Year-Over-Year to a Range of $3.40 to $3.45 Billion, Up From a Previous Range of $3.3 to $3.4 Billion
  • REVLIMID Net Product Sales Anticipated to Increase Approximately 37 Percent Year-Over-Year to a Range of $2.30 to $2.35 Billion, Up From a Previous Range of $2.2 to $2.3 Billion
  • Non-GAAP Diluted Earnings Per Share Expected to Increase Approximately 30 Percent Year-Over-Year to a Range of $2.65 to $2.70 (Includes Approximate $0.05 Dilution From Proposed Acquisition of Abraxis BioScience), Up From a Previous Range of $2.60 to $2.65

Recent Developments and Highlights

  • Signed Definitive Merger Agreement to Acquire Abraxis BioScience
  • Successfully Implemented Senior Management Succession Plan: Dr. Sol J. Barer Appointed Executive Chairman of the Board of Directors and Robert J. Hugin Appointed Chief Executive Officer
  • REVLIMID® Granted Regulatory and Reimbursement Approval in Japan for Use in Combination With Dexamethasone For Patients With Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Standard Therapy
  • More Than 100 Presentations and Posters Evaluating Celgene Products Highlighted at American Society of Clinical Oncology (ASCO) Annual Meeting, International Myeloma Working Group Summit, and European Hematology Association Annual Meeting
  • Initiated PSA-002, a Phase III Trial Evaluating Apremilast in Psoriatic Arthritis
  • Initiated DLC-001, a Phase II/III Study of REVLIMID in Patients With Diffuse Large B-Cell Lymphoma
  • Completed U.S. Pivotal Study of ISTODAX® in Peripheral T-Cell Lymphoma
  • Initiated Phase I Trial of TORKi (mTOR Kinase Inhibitor) CC-223
  • Initiated REN-001, a Phase II Trial Evaluating ACE-011 in Patients With Renal Anemia

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
  • Launch REVLIMID in Japan for Multiple Myeloma
  • Complete Enrollment of MM-020, a Phase III Trial>
  • Submit ISTODAX Peripheral T-cell Lymphoma Regulatory Filing with Food and Drug Administration
  • 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 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 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

Celgene Corporation (NASDAQ: CELG) announced non-GAAP (Generally Accepted Accounting Principles) net income of $323.3 million, or non-GAAP diluted earnings per share of $0.69 for the quarter ended June 30, 2010. Non-GAAP net income for the second quarter of 2009 was $216.0 million or non-GAAP diluted earnings per share of $0.46. Based on U.S. GAAP, Celgene reported net income of $155.4 million, or diluted earnings per share of $0.33 for the quarter ended June 30, 2010. GAAP net income for the second quarter of 2009 was $142.8 million, or diluted earnings per share of $0.31.

Celgene posted non-GAAP net income of $617.8 million or non-GAAP diluted earnings per share of $1.32 during the first six months of 2010 as compared to non-GAAP net income of $421.2 million and non-GAAP diluted earnings per share of $0.90 in 2009. On a GAAP basis, Celgene reported net income of $389.8 million, or diluted earnings per share of $0.83 for the first six months of 2010, compared to GAAP net income of $305.7 million, or diluted earnings per share of $0.65 in 2009.

"These outstanding results reflect the effectiveness of our operating strategies and the exceptional execution of our global team," said Robert J. Hugin, Chief Executive Officer of Celgene Corporation. "Our portfolio of products and promising hematology and immune-inflammatory pipeline position us to make an increasingly meaningful impact on the lives of patients suffering from serious unmet medical conditions. By combining operational excellence with innovative science, we are strategically positioned to produce sustained long-term growth."

Product Sales Performance

Non-GAAP total revenue was a record $850.4 million for the quarter ended June 30, 2010, an increase of 36 percent from 2009. GAAP total revenue was $852.7 million for the quarter ended June 30, 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 $587.1 million, an increase of 48 percent over the same period in 2009. Global THALOMID® (inclusive of Thalidomide Celgene® and Thalidomide Pharmion®) and VIDAZA® net sales were $97.8 million and $131.8 million, respectively. Revenue from Focalin® and the Ritalin® family of drugs totaled $27.0 million for the second quarter of 2010 compared to $24.2 million over the same period in 2009.

For the first six months of 2010, non-GAAP total revenue was a record $ 1.639 billion, an increase of 34 percent year-over-year. GAAP total revenue was $1.644 billion for the six months ended June 30, 2010. REVLIMID net sales for the first six months of 2010 reached $1.118 billion, an increase of 47 percent over $759.8 million for the same period in 2009. THALOMID net sales for the first six months of 2010 were $201.8 million. Vidaza net sales for the first six months of 2010 reached $252.1 million, an increase of 51 percent over the same period in 2009.

Research and Development

For the second quarter of 2010, non-GAAP R&D expenses, which exclude upfront collaboration payments and share-based employee compensation expense, were $201.6 million compared to $169.0 million for the second 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; 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 $342.8 million for the second quarter of 2010 and $218.5 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 $197.1 million for the second quarter of 2010 compared to $156.9 million for the second quarter of 2009. The increase was primarily due to an increase in donations to non-profit foundations, in addition to marketing and sales expenses related to the continued expansion of our international commercial activities. On a GAAP basis, selling, general and administrative expenses were $219.3 million for the second quarter of 2010 and $176.3 million in the same period in 2009.

Interest and Other Income, Net

For the quarter ended June 30, 2010, interest and other income, net, decreased to $4.6 million compared to $28.7 million in the same period in 2009. The decrease was primarily due to a reduction in interest and investment income as well as a loss on net hedging and foreign currency revaluation in the quarter ended June 30, 2010, compared to a gain in the same period in 2009.

Cash, Cash Equivalents, and Marketable Securities

Celgene reported $3.145 billion in cash, cash equivalents, and marketable securities as of June 30, 2010.

Source:

Celgene Corporation

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post
You might also like...
Study of condensates offers new hope for the treatment of neurodegenerative diseases