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8-K - FORM 8-K - CELGENE CORP /DE/c03950e8vk.htm
Exhibit 99.1
         
Contact:
       
 
  David Gryska   Tim Smith
 
  Sr. Vice President and   Director
 
  Chief Financial Officer   Investor Relations
 
  Celgene Corporation   Celgene Corporation
 
  (908) 673-9059   (908) 673-9951 
CELGENE REPORTS RECORD SECOND QUARTER 2010 OPERATING AND FINANCIAL RESULTS
Record Second Quarter Results Driven By Market Share Gains Across Major Markets
REVLIMID® Second Quarter Global Net Product Sales Increased 48% Y/Y
VIDAZA® Second Quarter Global Net Product Sales Increased 43% Y/Y
Non-GAAP Second Quarter Diluted Earnings Per Share Increased 50% Y/Y
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

 

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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 (n=1590) Evaluating REVLIMID and Low-Dose Dexamethasone Versus Melphalan, Prednisone and Thalidomide in NDMM
 
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
SUMMIT, NJ — (July 29, 2010) — 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.

 

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“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.

 

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Cash, Cash Equivalents, and Marketable Securities
Celgene reported $3.145 billion in cash, cash equivalents, and marketable securities as of June 30, 2010.
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 and six-month periods ended June 30, 2010 and 2009. See the attached Reconciliation of Full-Year 2010 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, 2010. 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. Certain unusual or non-recurring items that management does not believe affect the company’s basic operations 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 second quarter 2010 and its operating and financial performance on July 29, 2010, 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 July 29, 2010, until midnight ET August 5, 2010. To access the replay, in the U.S. dial 800-642-1687; outside the U.S. dial 706-645-9291; and enter reservation number 83920237. The Company’s third quarter 2010 financial and operational results are expected to be reported in late October.
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 Operations
(Unaudited)
(In thousands, except per share data)
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2010     2009     2010     2009  
 
                               
Net product sales
  $ 823,097     $ 598,154     $ 1,582,508     $ 1,174,386  
Collaborative agreements and other revenue
    2,544       2,354       4,924       4,598  
Royalty revenue
    27,051       28,158       56,514       54,735  
 
                       
Total revenue
    852,692       628,666       1,643,946       1,233,719  
 
                       
 
                               
Cost of goods sold (excluding amortization of acquired intangible assets)
    67,993       50,902       129,908       115,201  
Research and development
    342,761       218,500       547,418       399,747  
Selling, general and administrative
    219,262       176,311       427,241       349,752  
Amortization of acquired intangible assets
    47,068       22,667       88,661       46,292  
Acquisition related charges
    7,836             12,698        
 
                       
Total costs and expenses
    684,920       468,380       1,205,926       910,992  
 
                       
 
                               
Operating income
    167,772       160,286       438,020       322,727  
 
                               
Equity in (gains) losses of affiliated companies
    103       (157 )     (638 )     615  
Interest and other income, net
    4,610       28,721       21,979       78,320  
 
                       
Income before income taxes
    172,279       189,164       460,637       400,432  
Income tax provision
    16,927       46,329       70,843       94,715  
 
                       
Net income
  $ 155,352     $ 142,835     $ 389,794     $ 305,717  
 
                       
 
                               
Net income per common share:
                               
Basic
  $ 0.34     $ 0.31     $ 0.85     $ 0.67  
Diluted
  $ 0.33     $ 0.31     $ 0.83     $ 0.65  
 
                               
Weighted average shares — basic
    460,309       459,586       460,112       459,584  
 
                       
Weighted average shares — diluted
    467,425       467,082       467,557       467,759  
 
                       
                 
    June 30,     December 31,  
    2010     2009  
Balance sheet items:
               
Cash, cash equivalents & marketable securities
  $ 3,144,617     $ 2,996,752  
Total assets
    6,178,238       5,389,311  
Stockholders’ equity
    4,927,810       4,394,606  

 

 


 

Celgene Corporation and Subsidiaries
Reconciliation of GAAP to Non-GAAP Net Income
(In thousands, except per share data)
                                         
            Three Months Ended     Six Months Ended  
            June 30,     June 30,  
            2010     2009     2010     2009  
 
                                       
Net income — GAAP
          $ 155,352     $ 142,835     $ 389,794     $ 305,717  
 
                                       
Before tax adjustments:
                                       
Net product sales:
                                       
Pharmion products to be divested
    (1 )     (2,301 )     (2,515 )     (4,675 )     (6,466 )
 
                                       
Cost of goods sold (excluding amortization of acquired intangible assets):
                                       
Share-based compensation expense
    (2 )     1,602       1,001       3,121       1,973  
Pharmion inventory step-up
    (3 )                       354  
Pharmion products to be divested
    (1 )     4,397       2,000       8,683       4,268  
 
                                       
Research and development:
                                       
Share-based compensation expense
    (2 )     20,023       14,965       39,153       29,663  
Upfront collaboration payments
    (4 )     121,176       34,500       121,176       34,500  
 
                                       
Selling, general and administrative:
                                       
Share-based compensation expense
    (2 )     22,185       19,363       42,116       36,217  
 
                                       
Amortization of acquired intangible assets:
                                       
Pharmion
    (5 )     39,991       22,667       79,928       46,292  
Gloucester
    (5 )     7,077             8,733        
 
                                       
Acquisition related charges Gloucester contingent liability accretion
    (6 )     5,892             10,754        
Abraxis acquisition costs
    (6 )     1,944             1,944        
 
                                       
Equity in losses of affiliated companies - EntreMed
    (7 )     56       321       442       659  
 
                                       
Net income tax adjustments
    (8 )     (54,130 )     (19,112 )     (83,344 )     (32,004 )
 
                             
Net income — non-GAAP
          $ 323,264     $ 216,025     $ 617,825     $ 421,173  
 
                             
 
                                       
Net income per common share -non-GAAP:
                                       
Basic
          $ 0.70     $ 0.47     $ 1.34     $ 0.92  
Diluted
          $ 0.69     $ 0.46     $ 1.32     $ 0.90  
     
Explanation of adjustments:
 
(1)   Exclude sales and costs related to former non-core Pharmion Corp., or Pharmion, products to be divested.
 
(2)   Exclude share-based compensation expense for the second quarter totaling $43,810 in 2010 and $35,329 in 2009. The after tax net impact reduced GAAP net income for the second quarter by $33,850, or $0.07 per diluted share in 2010 and $27,315, or $0.06 per diluted share in 2009. Exclude share-based compensation expense for the six-month perod totaling $84,390 in 2010 and $67,853 in 2009. The after tax net impact reduced GAAP net income for the six-month period by $65,223, or $0.14 per diluted share in 2010 and $52,462, or $0.11 per diluted share in 2009.
 
(3)   Exclude acquisition-related Pharmion inventory step-up adjustment to fair value expensed during the period.
 
(4)   Exclude upfront payments for research and development collaboration arrangements with Agios Pharmaceuticals, Inc. for both the three-month and six-month periods in 2010 and GlobeImmune, Inc. and Array BioPharma Inc. of $30,000 and $4,500, respectively for both the three-month and six-month periods in 2009.
 
(5)   Exclude amortization of acquired intangible assets from the acquisitions of Pharmion and Gloucester Pharmaceuticals, Inc., or Gloucester.
 
(6)   Exclude acquisition related charges for Gloucester and the proposed acquisition of Abraxis BioScience, Inc.
 
(7)   Exclude the Company’s share of equity losses in EntreMed, Inc.
 
(8)   Net income tax adjustments reflects the estimated tax effect of the above adjustments.

 

 


 

Celgene Corporation and Subsidiaries
Reconciliation of Full-Year 2010 Projected GAAP to Non-GAAP Net Income
(In thousands, except per share data)
                 
    Range  
    Low     High  
 
               
Projected net income — GAAP
  $ 805,000     $ 859,000  
 
               
Before tax adjustments:
               
 
               
Share-based compensation expense
    180,000       175,000  
 
               
Amortization of acquired intangible assets:
               
Pharmion
    160,000       160,000  
Gloucester
    22,000       22,000  
Abraxis
    30,000       20,000  
 
               
Upfront collaboration payments
    121,000       121,000  
 
               
Acquisition related charges
               
Gloucester
    23,000       23,000  
Abraxis
    50,000       30,000  
 
Pharmion products to be divested
    4,000       4,000  
 
               
Net income tax adjustments
    (147,000 )     (142,000 )
 
           
Projected net income — non-GAAP
  $ 1,248,000     $ 1,272,000  
 
           
 
               
Projected net income per diluted common share — GAAP
  $ 1.71     $ 1.82  
 
               
Projected net income per diluted common share — non-GAAP
  $ 2.65     $ 2.70  
 
               
Projected weighted average diluted shares
    471,000       471,000