Celgene Corporation
Oct 27, 2011
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Celgene Reports Record Third Quarter 2011 Operating and Financial Results

-Total Revenue of $1.25 Billion Increased 37 Percent Y/Y
-Non-GAAP Diluted Earnings Per Share of $1.02 Increased 36 Percent Y/Y
-REVLIMID® Global Net Product Sales of $820 Million Increased 28 Percent Y/Y
-RaisingNon-GAAP EPS Range to $3.78 - $3.80 from $3.45 - $3.55

SUMMIT, N.J., Oct 27, 2011 (BUSINESS WIRE) --

Celgene Corporation (NASDAQ: CELG) reported Non-GAAP net product sales of $1,218 million for the third quarter of 2011, a 38 percent increase from the same period in 2010. Non-GAAP net income for the third quarter of 2011 increased 34 percent to $469 million compared to $350 million in the third quarter of 2010. For the same periods, Non-GAAP diluted earnings per share increased 36 percent to $1.02 from $0.75.

Based on U.S. GAAP (Generally Accepted Accounting Principles), Celgene reported third quarter 2011 net product sales of $1,219 million and net income of $373 million or $0.81 per diluted share. For the third quarter of 2010, net product sales were $886 million and net income was $281 million or $0.60 per diluted share.

"The third quarter results demonstrate continued strong operational momentum throughout our global businesses. Our revenue is diversifying as we expand our global reach," said Bob Hugin, Chief Executive Officer of Celgene Corporation. "Our investments in over 25 late-stage clinical trials are designed to support multiple regulatory submissions over the next 18 months to sustain long-term growth."

Updated 2011 Financial Outlook

Celgene raised its full year 2011 financial guidance. This guidance consists of the following:

Q3 Financial Highlights

Unless otherwise stated, all comparisons are for the third quarter of 2011 compared to the third quarter of 2010. The non-GAAP operating expenses presented below exclude share-based employee compensation expense, non-core operations acquired from Abraxis, acquisition-related milestone payments, and upfront payments for R&D collaborations.

Net Product Sales Performance

Research and Development (R&D)

Non-GAAP R&D expenses were $307 million compared to $232 million for the third quarter of 2010. The third quarter 2011 included R&D expense associated with Abraxis activities, which were acquired in October 2010. In addition, Celgene recorded a $7.5 million milestone payment to Acceleron Pharma, Inc., associated with the advancement of ACE-536 into phase I development. ACE-536 is being evaluated for a number of serious conditions that are associated with anemia. The Company is conducting over 25 late-stage trials evaluating new products or new indications for existing products. Several of the larger trials are approaching peak accrual and are expected to complete enrollment by year-end. On a GAAP basis, R&D expenses were $357 million for the third quarter of 2011 and $254 million for the same period in 2010.

Selling, General, and Administrative (SG&A)

Non-GAAP SG&A expenses were $276 million for the third quarter of 2011 compared to $204 million for the third quarter of 2010. The increase was primarily due to higher marketing and sales related expenses resulting from product launches for REVLIMID in Japan, ISTODAX® in the United States, and ABRAXANE in the United States and Europe, in addition to expenses and integration costs related to the Abraxis business. On a GAAP basis, SG&A expenses were $303 million for the third quarter of 2011 and $228 million for the same period in 2010.

Cash, Cash Equivalents, and Marketable Securities

Operating cash flow for the first nine months of 2011 increased 37 percent to $1,338 million. Under its authorized stock repurchase program, Celgene purchased approximately 15.5 million shares during the third quarter at a total cost of approximately $885 million. As of September 30, 2011, the Company had $2,034 million remaining under the existing program. The Company ended the third quarter with $2,579 million in cash and marketable securities.

Product & Pipeline Updates

Hematology

REVLIMID: With resolution of the Article 20 review by the Committee for Medicinal Products (CHMP), Celgene is proceeding with its application in Europe for the treatment of newly diagnosed multiple myeloma (NDMM) and maintenance therapy. The Company believes a decision on the application could be reached by the European Medicines Agency (EMA) during the first half of 2012. Celgene plans to submit regulatory applications for NDMM in additional markets, including the U.S., in 2012.

The Company expects to file for approval of relapsed and refractory multiple myeloma with the State Food and Drug Administration (SFDA) in China by year-end 2011. During the first quarter of 2012, Celgene anticipates a regulatory filing for deletion 5q transfusion dependent low-risk myelodysplastic syndromes with the EMA.

Pomalidomide: Presentation of the final phase II data from POM-002 in relapsed and refractory multiple myeloma is expected at the American Society of Hematology meeting in December. In this trial, pomalidomide demonstrated consistent clinical activity in patients who were relapsed and refractory after receiving prior therapies, including REVLIMID, THALOMID, and bortezomib. The Company is conducting a broad clinical program to support global registrations for pomalidomide in relapsed and refractory multiple myeloma and myelofibrosis.

Oncology

ABRAXANE: Celgene plans to submit a supplemental new drug application (sNDA) to the FDA for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) by year-end. The Company is evaluating regulatory strategies to obtain NSCLC approvals in international markets.

Phase I/II data in metastatic pancreatic cancer were recently published in the Journal of Clinical Oncology. The study reported ABRAXANE in combination with gemcitabine demonstrated clinical activity. Gemcitabine is currently the standard of care for patients in this setting. These data are being confirmed in an ongoing phase III trial that is expected to complete patient accrual in the first quarter of 2012.

A phase III trial comparing ABRAXANE to decarbazine in over 500 treatment-naïve metastatic melanoma patients is underway. Progression-free survival is the primary endpoint, with overall survival as a key secondary endpoint. Data on the primary efficacy endpoint is expected in the middle of 2012.

REVLIMID: During October, a phase III trial completed accruing over 1,000 patients with castrate-resistant prostate cancer. Patients are receiving the combination of docetaxel and prednisone with or without REVLIMID. Data on overall survival, the trial's primary endpoint, are expected during 2013. REVLIMID is not approved as a treatment for metastatic castrate-resistant prostate cancer.

Inflammation & Immunology

Apremilast: Enrollment of 1,325 patients in two phase III trials (one in psoriatic arthritis and one in psoriasis) is completed. Three additional phase III trials (two in psoriatic arthritis and one in psoriasis) are expected to complete enrollment by year-end. Data from these pivotal studies are expected beginning in the middle of 2012 and positive data would support the initial registrations. An additional phase III trial in treatment-naïve psoriatic arthritis patients is expected to complete enrollment in the first half of 2012 and could support future indications.

Data from a phase II trial in ankylosing spondylitis will be presented at the American College of Rheumatology in November 2011. A phase III trial in ankylosing spondylitis is planned to begin in the first quarter of 2012. Enrollment in a phase IIb trial for rheumatoid arthritis is complete, with data expected during the first half of 2012.

Conference Call and Webcast Information

Celgene will host a conference call to discuss the results and achievements of its third quarter 2011 and its operating and financial performance on October 27, 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 October 27, 2011, until midnight ET November 3, 2011. To access the replay, in the U.S. dial 855-859-2056; international dial 404-537-3406; and Participant Passcode 14291156. The Company's fourth quarter financial and operational results are expected to be reported in late January.

About REVLIMID

In the U.S., REVLIMID (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma (MM) patients who have received at least one prior therapy. REVLIMID is indicated for patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

About ABRAXANE

In the U.S., ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six month of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

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.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.

In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains non-GAAP financial measures that we believe provide investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information. These non-GAAP measures should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. We typically exclude certain GAAP items that management does not believe affect our basic operations and that do not meet the GAAP definition of unusual or non-recurring items.Other companies may define these measures in different ways. See the attached Reconciliations of GAAP to non-GAAP Net Income for explanations of the amounts excluded and included to arrive at non-GAAP net income and non-GAAP earnings per share amounts for the three-month and nine-month periods ended September 30, 2011 and 2010 and for the projected amounts for the year ending December 31, 2011.

                                                       
Celgene Corporation and Subsidiaries
Condensed Consolidated Statements of Income
(Unaudited)
(In thousands, except per share data)
                                                         
                                                         
              Three-Month Periods Ended         Nine-Month Periods Ended
              September 30,         September 30,
              2011         2010         2011         2010
                                                         
Net product sales           $ 1,219,118           $ 885,656         $ 3,457,055           $ 2,468,164
Collaborative agreements and other revenue             3,766             2,241           16,468             7,165
Royalty revenue             26,853             22,214           84,650             78,728
  Total revenue             1,249,737             910,111           3,558,173             2,554,057
                                                         
Cost of goods sold (excluding amortization of                                                      
  acquired intangible assets)             94,645             63,542           348,356             193,450
Research and development             356,839             253,547           1,163,837             800,965
Selling, general and administrative             303,303             228,281           911,207             655,522
Amortization of acquired intangible assets             75,044             46,540           214,181             135,201
Acquisition related (gains) charges and restructuring, net           (11,209)             7,495           (117,430)             20,193
  Total costs and expenses             818,622             599,405           2,520,151             1,805,331
                                                         
Operating income             431,115             310,706           1,038,022             748,726
                                                         
Equity in (gains) losses of affiliated companies             1,661             1,384           966             746
Interest and other income (expense), net             (16,813)             20,840           (19,196)             42,819
                                                         
Income before income taxes             412,641             330,162           1,017,860             790,799
                                                         
Income tax provision             39,657             49,011           110,582             119,854
                                                         
Net income             372,984             281,151           907,278             670,945
                                                         
Non-controlling interest             -             -           694             -
                                                         
Net income attributable to Celgene           $ 372,984           $ 281,151         $ 907,972           $ 670,945
                                                         
                                                         
Net income per common share attributable to Celgene:                                                      
  Basic           $ 0.83           $ 0.61         $ 1.97           $ 1.46
  Diluted           $ 0.81           $ 0.60         $ 1.94           $ 1.44
                                                         
Weighted average shares - basic             452,019             459,653           460,161             459,957
                                                         
Weighted average shares - diluted             459,530             466,332           467,052             467,137
                                                         
                                                         
              September 30,         December 31,                          
              2011         2010                          
Balance sheet items:                                                      
  Cash, cash equivalents & marketable securities           $ 2,579,087           $ 2,601,301                          
  Total assets             9,763,107             10,177,162                          
  Short-term borrowings             269,125             -                          
  Long-term debt             1,277,316             1,247,584                          
  Total equity            

5,605,090

            5,995,472                          
Celgene Corporation and Subsidiaries
Reconciliation of GAAP to Non-GAAP Net Income
(In thousands, except per share data)
                                                                   
                    Three-Month Periods Ended         Nine-Month Periods Ended
                    September 30,         September 30,
                    2011         2010         2011         2010
                                                                   
Net income attributable to Celgene - GAAP                 $ 372,984           $ 281,151           $ 907,972           $ 670,945  
                                                                   
  Before tax adjustments:                                                                
  Net product sales:                                                                
  Sales of products to be divested:                                                                
  Pharmion         (1)         (1,468)             (2,049)             (3,671)             (6,723)  
  Abraxis         (1)         -             -             (21,265)             -  
                                                                   
  Collaborative agreements and other revenue:                                                                
  Abraxis non-core revenues         (2)         -             -             (1,714)             -  
                                                                   
  Cost of goods sold (excluding amortization                                                                
  of acquired intangible assets):                                                                
  Share-based compensation expense         (3)         2,627             1,787             7,054             4,909  
  Abraxis inventory step-up         (4)         6,945             -             90,278             -  
  Cost of products to be divested:                                                                
  Pharmion         (2)         4,008             (468)             6,137             8,214  
  Abraxis         (2)         -             -             13,151             -  
  EntreMed intercompany royalty         (5)         -             (81)             -             (81)  
                                                                   
  Research and development:                                                                
  Share-based compensation expense         (3)         24,527             21,220             79,999             60,372  
  Abraxis non-core activities         (2)         -             -             8,728             -  
  IPR&D impairment         (6)         -             -             118,000             -  
  Upfront collaboration payments         (7)         25,000             -             65,982             121,176  
                                                                   
  Selling, general and administrative:                                                                
  Share-based compensation expense         (3)         27,198             24,161             75,905             66,277  
  Abraxis non-core activities         (2)         -             -             15,065             -  
                                                                   
  Amortization of acquired intangible assets:                                                                
  Pharmion         (8)         39,937             39,990             119,812             119,918  
  Gloucester         (8)         12,875             6,550             27,342             15,283  
  Abraxis         (8)         22,232             -             67,027             -  
                                                                   
  Acquisition related (gains) charges and restructuring, net:                                                      
  Gloucester contingent liability accretion         (9)         2,037             5,943             14,198             16,697  
  Abraxis acquisition costs         (9)         (31)             1,552             (357)             3,496  
  Abraxis restructuring costs         (9)         199             -             5,474             -  
  Change in fair value of contingent value                                                                
  rights issued as part of Abraxis acquisition         (9)         (13,414)             -             (136,745)             -  
                                                                   
  Equity in (gains) losses of affiliated companies:                                                                
  EntreMed, Inc.         (10)         53             501             542             943  
  Abraxis non-core activities         (2)         -             -             1,932             -  
                                                                   
  Interest and other income (expense), net:                                                                
  Abraxis non-core activities         (2)         -             -             104             -  
  Gain on divestment of non-core activities         (11)         -             -             (2,931)             -  
                                                                   
  Non-controlling interest:                                                                
  Abraxis non-core activities         (2)         -             -             (694)             -  
                                                                   
  Net income tax adjustments         (12)         (56,455)             (30,379)             (177,475)             (113,723)  
Net income - non-GAAP                 $ 469,254           $ 349,878           $ 1,279,850           $ 967,703  
                                                                   
Net income per common share - non-GAAP:                                                                
  Basic                 $ 1.04           $ 0.76           $ 2.78           $ 2.10  
  Diluted                 $ 1.02           $ 0.75           $ 2.74           $ 2.07  
         
Celgene Corporation and Subsidiaries
Reconciliation 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 totaling $54,352 for the three-month period ended September 30, 2011 and $47,168 for the three-month
      period ended September 30, 2010. The after tax net impact reduced GAAP net income for the three-month period ended September 30, 2011 by
      $40,624, or $0.09 per diluted share and for the three-month period ended September 30, 2010 by $36,428, or $0.08 per diluted share. Exclude share-
      based compensation expense totaling $162,958 for the nine-month period ended September 30, 2011 and $131,558 for the nine-month period ended
      September 30, 2010. The after tax net impact reduced GAAP net income for the nine-month period ended September 30, 2011 by $121,360, or
      $0.26 per diluted share and for the nine-month period ended September 30, 2010 by $101,650, or $0.22 per diluted share.
(4)     Exclude acquisition-related inventory step-up adjustments to fair value which were expensed for Abraxis in 2011.
(5)     Exclude the Company's share of THALOMID royalties payable to EntreMed, Inc. for the three- and nine-month periods ended September 30, 2010.
(6)     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.
(7)     Exclude upfront payments for research and development collaboration arrangements with Acceleron Pharma for the three-month period in 2011,
      the Institute for Advanced Health for the nine-month period in 2011 and Agios Pharmaceuticals, Inc. for the nine-month period in 2010.
(8)     Exclude amortization of acquired intangible assets from the acquisitions of Pharmion, Gloucester Pharmaceuticals, Inc., or Gloucester, and Abraxis.
(9)     Exclude acquisition related (gains) charges and restructuring for Gloucester and Abraxis.
(10)     Exclude the Company's share of EntreMed, Inc. equity losses.
(11)     Exclude gain recognized on divestment of non-core activities obtained in the acquisition of Abraxis.
(12)     Net income tax adjustments reflects the estimated tax effect of the above adjustments.
Celgene Corporation and Subsidiaries
Reconciliation of Full-Year 2011 Projected GAAP to Non-GAAP Net Income
(In thousands, except per share data)
                           
                           
              Range
              Low   High
                           
Projected net income - GAAP           $ 1,334,000     $ 1,360,000  
                           
  Before tax adjustments:                        
  Total Revenue:                        
  Revenue from products to be divested             (29,000)       (26,000)  
                           
  Cost of goods sold (excluding amortization                        
  of acquired intangible assets):                        
  Share-based compensation expense             9,000       8,000  
  Abraxis inventory step-up             90,000       90,000  
  Cost of products to be divested             21,000       20,000  
                           
  Research and development:                        
  Share-based compensation expense             112,000       102,000  
  Abraxis non-core activities             9,000       9,000  
  IPR&D impairment             118,000       118,000  
  Upfront collaboration payments             66,000       66,000  
                           
  Selling, general and administrative:                        
  Share-based compensation expense             99,000       89,000  
  Abraxis non-core activities             15,000       15,000  
                           
  Amortization of acquired intangible assets             288,000       288,000  
                           
  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             (137,000)       (137,000)  
                           
  Other non-operating items             (2,000)       (2,000)  
                           
  Net income tax adjustments             (265,000)       (262,000)  
                           
Projected net income - non-GAAP           $ 1,750,000     $ 1,759,000  
                           
Projected net income per diluted common share - GAAP           $ 2.88     $ 2.94  
                           
Projected net income per diluted common share - non-GAAP           $ 3.78     $ 3.80  
                           
Projected weighted average diluted shares             463,000       463,000  

SOURCE: Celgene Corporation

Celgene Corporation
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or
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