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Press release from Business Wire

Celgene Reports Record First Quarter 2011 Operating and Financial Results

<p> - <i>Non-GAAP</i> <i>Total Revenue of $1.11 Billion Increased 40 Percent Y/Y</i> </p> <p> - <i>Non-GAAP First Quarter Diluted Earnings Per Share of $0.83 Increased 32 Percent Y/Y</i> </p> <p> - <i>REVLIMID</i><sup><i>®</i></sup><i> First Quarter Global Net Product Sales of $738 Million Increased 39 Percent Y/Y</i> </p>

Thursday, April 28, 2011

Celgene Reports Record First Quarter 2011 Operating and Financial Results07:30 EDT Thursday, April 28, 2011 SUMMIT, N.J. (Business Wire) -- Celgene Corporation (NASDAQ: CELG): 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 ISTODAXAdded 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 ObjectivesHematology 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 Oncology 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. Non-GAAP Financial Information See the attached Reconciliation of GAAP to non-GAAP Net Income 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-month periods ended March 31, 2011 and 2010. See the attached Reconciliation of Full-Year 2011 Projected GAAP to Non-GAAP Net Income for an explanation of the amounts excluded and included to arrive at projected non-GAAP net income and non-GAAP earnings per share amounts for the year ending December 31, 2011. 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. We exclude certain items that management does not believe affect our basic operations and 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 first quarter 2011 and its operating and financial performance on April 28, 2011, at 9 a.m. ET. The conference call will be available by webcast at www.celgene.com. An audio replay of the call will be available from noon April 28, 2011, until midnight ET May 5, 2011. To access the replay, in the U.S. dial 800-642-1687; outside the U.S. dial 706-645-9291; and enter reservation number 58936690. The Company's second quarter financial and operational results are expected to be reported in late July. 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. The Company's actual results, performance, or achievements could be materially different from those projected by these forward-looking statements. The factors that could cause actual results, performance, or achievements to differ from the forward-looking statements are discussed in the Company's filings with the Securities and Exchange Commission, such as the Company's Form 10-K, 10-Q and 8-K reports. Given these risks and uncertainties, you are cautioned not to place undue reliance on the forward-looking statements.     Celgene Corporation and SubsidiariesCondensed Consolidated Statements of Income(Unaudited)(In thousands, except per share data)     Three Months Ended March 31,   2011     2010     Net product sales $ 1,083,609 $ 759,411 Collaborative agreements and other revenue 9,303 2,380 Royalty revenue   32,369     29,463   Total revenue   1,125,281     791,254     Cost of goods sold (excluding amortization of acquired intangible assets) 127,268 61,915 Research and development 435,478 204,657 Selling, general and administrative 302,261 207,978 Amortization of acquired intangible assets 69,050 41,593 Acquisition related (gains) charges and restructuring, net   (96,744 )   4,862   Total costs and expenses   837,313     521,005     Operating income 287,968 270,249   Equity in (gains) losses of affiliated companies 556 (741 ) Interest and other income (expense), net   (604 )   17,369     Income before income taxes 286,808 288,359   Income tax provision   31,722     53,917     Net income 255,086 234,442   Non-controlling interest   504     -     Net income attributable to Celgene $ 255,590   $ 234,442       Net income per common share attributable to Celgene: Basic $ 0.55 $ 0.51 Diluted $ 0.54 $ 0.50   Weighted average shares - basic   465,993     459,914     Weighted average shares - diluted   472,235     467,655       March 31, December 31,   2011     2010   Balance sheet items: Cash, cash equivalents & marketable securities $ 2,430,619 $ 2,601,301 Total assets 9,844,353 10,177,162 Long-term debt 1,247,420 1,247,584 Total equity 5,878,837 5,995,472           Celgene Corporation and SubsidiariesReconciliation of GAAP to Non-GAAP Net Income(In thousands, except per share data)   Three Months Ended March 31,   2011     2010     Net income attributable to Celgene - GAAP $ 255,590 $ 234,442   Before tax adjustments: Net product sales: Sales of products to be divested: Pharmion (1 ) (1,072 ) (2,374 ) Abraxis (1 ) (15,831 ) -   Collaborative agreements and other revenue: Abraxis non-core revenues (2 ) (905 ) -   Cost of goods sold (excluding amortization of acquired intangible assets): Share-based compensation expense (3 ) 2,007 1,520 Abraxis inventory step-up (4 ) 41,667 - Cost of products to be divested: Pharmion (2 ) 1,001 4,286 Abraxis (2 ) 9,549 -   Research and development: Share-based compensation expense (3 ) 32,592 19,129 Abraxis non-core activities (2 ) 6,849 - IPR&D impairment (5 ) 118,000 -   Selling, general and administrative: Share-based compensation expense (3 ) 23,094 19,931 Abraxis non-core activities (2 ) 9,208 -   Amortization of acquired intangible assets: Pharmion (6 ) 39,937 39,937 Gloucester (6 ) 6,550 1,656 Abraxis (6 ) 22,563 -   Acquisition related (gains) charges and restructuring, net: Gloucester contingent liability accretion (7 ) 6,053 4,862 Abraxis acquisition costs (7 ) 49 - Abraxis restructuring costs (7 ) 2,742 - Change in fair value of contingent value rights issued as part of Abraxis acquisition (7 ) (105,588 ) -   Equity in (gains) losses of affiliated companies: EntreMed, Inc. (8 ) 255 385 Abraxis non-core activities (2 ) 1,845 -   Interest and other income (expense), net: Abraxis non-core activities (2 ) 98 -   Non-controlling interest: Abraxis non-core activities (2 ) (504 ) -   Net income tax adjustments (9 )   (62,360 )   (29,213 ) Net income attributable to Celgene - non-GAAP $ 393,389   $ 294,561     Net income per common share attributable to Celgene -non-GAAP: Basic $ 0.84 $ 0.64 Diluted $ 0.83 $ 0.63   Celgene Corporation and SubsidiariesReconciliation of GAAP to Non-GAAP Net Income     Explanation of adjustments: (1) Exclude sales related to non-core former Pharmion Corp., or Pharmion, and Abraxis BioScience Inc., or Abraxis, products to be divested. (2) Exclude the estimated impact of activities arising from the acquisitions of Abraxis that are not related to core nab technology and of Pharmion that are planned to be divested, including other miscellaneous revenues, the cost of goods sold for products to be divested as well as operating expenses and other costs related to such activities. (3) Exclude share-based compensation expense for the first quarter totaling $57,693 in 2011 and $40,580 in 2010. The after tax net impact reduced GAAP net income for the first quarter by $42,241, or $0.09 per diluted share in 2011 and $31,373, or $0.07 per diluted share in 2010. (4) Exclude acquisition-related inventory step-up adjustments to fair value which were expensed for Abraxis in 2011. (5) IPR&D impairment related to a reduction in the probability of obtaining progression free survival labeling for the treatment of non-small cell lung cancer for ABRAXANE in the United States. (6) Exclude amortization of acquired intangible assets from the acquisitions of Pharmion, Gloucester Pharmaceuticals, Inc., or Gloucester and Abraxis. (7) Exclude acquisition related (gains) charges and restructuring for Gloucester and Abraxis. (8) Exclude the Company's share of EntreMed, Inc. equity losses. (9) Net income tax adjustments reflects the estimated tax effect of the above adjustments.     Celgene Corporation and SubsidiariesReconciliation of Full-Year 2011 Projected GAAP to Non-GAAP Net Income(In thousands, except per share data)     Range Low High   Projected net income - GAAP $ 1,160,000 $ 1,208,000   Before tax adjustments: Total Revenue: Revenue from products to be divested (26,000 ) (24,000 )   Cost of goods sold (excluding amortization of acquired intangible assets): Share-based compensation expense 7,000 6,000 Abraxis inventory step-up 90,000 90,000 Cost of products to be divested 16,000 14,000   Research and development: Share-based compensation expense 128,000 116,000 Abraxis non-core activities 10,000 9,000 IPR&D impairment 118,000 118,000   Selling, general and administrative: Share-based compensation expense 91,000 83,000 Abraxis non-core activities 13,000 12,000   Amortization of acquired intangible assets 285,000 285,000   Acquisition related (gains) charges and restructuring, net: Gloucester contingent liability accretion 16,000 16,000 Abraxis restructuring costs 6,000 5,000 Change in fair value of contingent value rights issued as part of Abraxis acquisition (106,000 ) (106,000 )   Equity in (gains) losses of affiliated companies: Abraxis non-core activities 3,000 2,000   Non-controlling interest: Abraxis non-core activities (1,000 ) (1,000 )   Net income tax adjustments (230,000 ) (230,000 )     Projected net income - non-GAAP $ 1,580,000   $ 1,603,000     Projected net income per diluted common share - GAAP $ 2.46 $ 2.56   Projected net income per diluted common share - non-GAAP $ 3.35 $ 3.40   Projected weighted average diluted shares   471,500     471,500   Celgene CorporationJacqualyn A. Fouse, 908-673-9956Sr. Vice President and Chief Financial OfficerorTim Smith, 908-673-9951DirectorInvestor Relations