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8-K - FORM 8-K - CELGENE CORP /DE/c16146e8vk.htm
Exhibit 99.1
Contact:
     
Jacqualyn A. Fouse
  Tim Smith
Sr. Vice President and
  Director
Chief Financial Officer
  Investor Relations
Celgene Corporation
  Celgene Corporation
(908) 673-9956
  (908) 673-9951
CELGENE REPORTS RECORD FIRST QUARTER 2011 OPERATING
AND FINANCIAL RESULTS
Non-GAAP Total Revenue of $1.11 Billion Increased 40 Percent Y/Y
Non-GAAP First Quarter Diluted Earnings Per Share of $0.83 Increased 32 Percent Y/Y
REVLIMID® First Quarter Global Net Product Sales of $738 Million Increased 39 Percent Y/Y
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

 

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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
Hematology
 
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
SUMMIT, NJ — (April 28, 2011) — 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.

 

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“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.

 

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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.
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Celgene Corporation and Subsidiaries
Condensed 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 Subsidiaries
Reconciliation 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 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 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 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
  $ 1,160,000     $ 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