Attached files

file filename
8-K - FORM 8-K - CELGENE CORP /DE/c91328e8vk.htm
Exhibit 99.1
         
Contact:
       
 
  David W. Gryska   Brian P. Gill
 
  Sr. Vice President and   Vice President,
 
  Chief Financial Officer   Corporate Communications
 
  Celgene Corporation   Celgene Corporation
 
  (908) 673-9059   (908) 673-9530 
 
CELGENE REPORTS RECORD THIRD QUARTER 2009 OPERATING AND FINANCIAL RESULTS
Record Third Quarter Results Driven By Gains in Global Market Share, Duration of Therapy and Reimbursement Approvals
REVLIMID® Third Quarter Global Sales Increased 31% Y/Y and 13% Q/Q
REVLIMID U.S. Total Share Increased to Approximately 34%; Strong Share Gains in Second and Third Lines of Therapy in Europe
VIDAZA® Third Quarter Global Sales Increased 62% Y/Y and 12% Q/Q
First Interim Analysis of MM-015 Phase III Study To Be Presented at American Society of Hematology Annual Meeting
2009 Third Quarter Financial Results Year-Over-Year:
    Non-GAAP Total Revenue Increased 18 Percent to $692 Million; GAAP Total Revenue $695 Million
 
    REVLIMID Net Product Sales Increased 31 Percent to $450 Million
 
    VIDAZA Net Product Sales Increased 62 Percent to $103 Million
 
    THALOMID® Net Product Sales Totaled $110 Million
 
    Non-GAAP Operating Income Increased 30 Percent to $292 Million; GAAP Operating Income $236 Million
 
    Non-GAAP Net Income Increased 40 Percent to $260 Million; GAAP Net Income $217 Million
 
    Non-GAAP Earnings Per Share Increased 40 Percent to $0.56 Per Diluted Share; GAAP Earnings $0.46 Per Diluted Share

 

 


 

Recent Developments And Highlights:
    REVLIMID® Reimbursement Approvals In United Kingdom And Canada
 
    Additional REVLIMID Regulatory Approvals in the Middle East and Latin America
 
    Lancet Oncology Published Results From ECOG EA403 Phase III Trial, Demonstrating REVLIMID Plus Low-Dose Dexamethasone Is An Active Regimen For Patients With Newly Diagnosed Multiple Myeloma (MM)
 
    NHL-001 Study Published In Journal Of Clinical Oncology Reported REVLIMID Demonstrated Single Agent Activity With Durable Responses In A Heavily Pretreated Patient Population
 
    Advancing REVLIMID Solid Tumor Program In Prostate Cancer, Renal Cell Carcinoma, Pancreatic Cancer, and Colorectal Cancer
 
    Journal Of Clinical Oncology Published Two Articles Highlighting Clinical Potential Of Pomalidomide As Treatment For MM and Myelofibrosis
 
    VIDAZA® Upgraded By National Comprehensive Cancer Network (NCCN) To Preferred Therapy Based On Unprecedented Survival For Intermediate-2 And High-Risk Myelodysplastic Syndromes (MDS)
 
    VIDAZA Now Listed By NCCN As Low Intensity Treatment Option For Patients With Acute Myeloid Leukemia
 
    Initiated Phase II Trial Of ACE-011 For Treatment Of Chemotherapy Induced Anemia In Metastatic Breast Cancer
 
    Completed Enrollment Of Phase I Proof-Of-Principle Study For Proprietary PDA-001 Placenta-Derived Stem Cells In Crohn’s Disease
 
    Celgene Cellular Therapeutics Patent Estate Highlighted In Nature Biotechnology
2009 Selected Corporate Objectives:
    Maximize Global Clinical, Regulatory And Commercial Potential Of REVLIMID, VIDAZA, Pomalidomide, Apremilast, Amrubicin, ACE-011, PDA-001 And THALOMID®
 
    Meet With EMEA, FDA and International Regulatory Agencies Regarding MM-015 Filing Strategy
 
    Commercial Launch of REVLIMID In Australia
 
    Gain Health Canada Regulatory Approval For VIDAZA In High-Risk MDS
 
    Submit REVLIMID Regulatory Filing For Del 5q MDS In Japan
 
    Advance REVLIMID Lymphoma Initiative Through More Than 60 Clinical Trials Worldwide, Including Novel Combinations In Multiple Patient Segments
 
    Advance REVLIMID Chronic Lymphocytic Leukemia (CLL) Initiative Through More Than 40 Clinical Trials Worldwide
 
    Complete Apremilast Phase II Study In Recalcitrant Psoriasis And Phase IIb Study In Moderate-To-Severe Psoriasis
 
    Complete Enrollment of Amrubicin Phase III Trial In Patients With Small Cell Lung Cancer

 

 


 

SUMMIT, NJ — (October 22, 2009) — Celgene Corporation (NASDAQ: CELG) announced non-GAAP (Generally Accepted Accounting Principles) net income of $259.8 million, or non-GAAP earnings per diluted share of $0.56 for the quarter ended September 30, 2009. Non-GAAP net income for the third quarter of 2008 was $185.9 million, or non-GAAP earnings per diluted share of $0.40. Based on U.S. GAAP, Celgene reported net income of $216.8 million, or earnings per diluted share of $0.46 for the quarter ended September 30, 2009. GAAP net income for the third quarter of 2008 was $136.8 million, or earnings per diluted share of $0.29.
Celgene posted non-GAAP net income of $681.0 million or non-GAAP earnings per diluted share of $1.46 during the first nine months of 2009 as compared to non-GAAP net income of $517.9 million and non-GAAP earnings per diluted share of $1.13 in 2008. On a GAAP basis, Celgene reported net income of $522.5 million or earnings per diluted share of $1.12 for the first nine months of 2009, compared to GAAP net loss of $1.384 billion or a loss per diluted share of $3.17 in 2008, which was primarily due to an in-process research and development charge associated with the acquisition of Pharmion Corporation in March 2008.
“All key functional areas — commercial, clinical, regulatory, and operations — executed as planned globally and delivered an exceptional quarter,” said Chairman and Chief Executive Officer Sol J. Barer, Ph.D., “We are looking forward to sharing significant clinical data with you across a broad range of Celgene compounds in the fourth quarter that will demonstrate the extraordinary global potential of our deep and diverse clinical pipeline.”
Product Sales Performance
Non-GAAP total revenue was a record $692.2 million for the quarter ended September 30, 2009, an increase of 18 percent from 2008. GAAP total revenue was $695.1 million for the quarter ended September 30, 2009. The increase in total revenue was driven by global market share gains, reimbursement approvals, increased duration of therapy of REVLIMID® and the global growth of VIDAZA®. REVLIMID net sales were $449.6 million, an increase of 31 percent over the same period in 2008. THALOMID® net sales (inclusive of Thalidomide Pharmion™ and Thalidomide Celgene™) were $110.0 million. VIDAZA net sales were $103.1 million, an increase of 62 percent over sales in the third quarter of 2008. Revenue from Focalin® and the Ritalin® family of drugs totaled $25.8 million for the third quarter of 2009 compared to $23.8 million over the same period last year.
For the first nine months of 2009, non-GAAP total revenue was a record $1.919 billion, an increase of 19 percent year-over-year. GAAP total revenue was $1.929 billion for the nine months ended September 30, 2009. REVLIMID net sales for the first nine months of 2009 reached $1.209 billion, an increase of 27 percent over $955.2 million for the same period in 2008. THALOMID net sales for the first nine months of 2009 were $329.2 million. Vidaza net sales for the first nine months of 2009 reached $270.5 million, an increase of 97 percent over the same period in 2008, which excludes 2008 Vidaza sales prior to the March 7 acquisition of Pharmion.

 

 


 

Research and Development
To support clinical development and to advance global regulatory filings, the company increased R&D investments in multiple international clinical programs. For the third quarter of 2009, non-GAAP R&D expenses, which exclude share-based employee compensation expense, were $178.2 million compared to $149.9 million for the third quarter of 2008. These R&D expenditures continue to support ongoing clinical progress in multiple proprietary development programs for REVLIMID®, pomalidomide and other IMiDs® compounds; VIDAZA®; amrubicin, our lead compound for small cell lung cancer; apremilast and our other oral anti-inflammatory compounds; our kinase inhibitor programs; our Activin inhibitor program with ACE-011 and placenta-derived stem cell programs. On a GAAP basis, R&D expenses were $193.4 million for the third quarter of 2009 and $160.9 million for the same period in 2008.
Selling, General, and Administrative
Non-GAAP selling, general and administrative expenses, which exclude share-based employee compensation expense, were $172.3 million for the third quarter of 2009 compared to $152.0 million for the third quarter of 2008. The increase in expenses was due primarily to unrestricted donations to non-profit organizations for co-pay assistance. On a GAAP basis, selling, general and administrative expenses were $192.5 million for the third quarter of 2009 compared to $168.6 million for the third quarter of 2008.
Interest and Other Income, Net
For the quarter ended September 30, 2009, interest and other income, net, was $34.9 million compared to $21.6 million in the same period in 2008.
Cash, Cash Equivalents, and Marketable Securities
Celgene reported $2.764 billion in cash, cash equivalents, and marketable securities as of September 30, 2009.
Non-GAAP Financial Information
See the attached Reconciliation of GAAP to Non-GAAP Net Income (Loss) 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- and nine-month periods ended September 30, 2009 and 2008. 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 third quarter 2009 and its operating and financial performance on October 22, 2009, at 9 a.m. EDT. The conference call will be available by webcast at www.celgene.com. An audio replay of the call will be available from noon October 22, 2009, until midnight EDT October 29, 2009. To access the replay, in the U.S. dial 888-203-1112; outside the U.S. dial 719-457-0820; and enter reservation number 9504107. The Company’s fourth quarter 2009 financial and operational results will be reported on January 28, 2010.
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, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company’s filings with the Securities and Exchange Commission such as Form 10-K, 10-Q and 8-K reports.
# # #

 

 


 

Celgene Corporation and Subsidiaries
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share data)
                                 
    Three Months Ended     Nine Months Ended  
    September 30,     September 30,  
    2009     2008     2009     2008  
 
                               
Net product sales
  $ 667,967     $ 567,017     $ 1,842,353     $ 1,541,556  
Collaborative agreements and other revenue
    2,381       2,402       6,979       9,960  
Royalty revenue
    24,789       23,046       79,524       75,011  
 
                       
Total revenue
    695,137       592,465       1,928,856       1,626,527  
 
                       
 
                               
Cost of goods sold (excluding amortization of acquired intangible assets)
    52,058       70,534       167,259       190,452  
Research and development
    193,362       160,911       593,109       462,650  
Selling, general and administrative
    192,512       168,607       542,264       485,345  
Amortization of acquired intangible assets
    21,111       32,833       67,403       77,842  
Acquired in-process research and development
                      1,740,000  
 
                       
Total costs and expenses
    459,043       432,885       1,370,035       2,956,289  
 
                       
Operating income (loss)
    236,094       159,580       558,821       (1,329,762 )
 
                               
Equity in losses of affiliated companies
    329       2,338       944       8,761  
Interest and other income, net
    34,937       21,630       113,257       70,270  
 
                       
 
                               
Income (loss) before income taxes
    270,702       178,872       671,134       (1,268,253 )
 
                               
Income tax provision
    53,887       42,058       148,602       116,138  
 
                       
 
                               
Net income (loss)
  $ 216,815     $ 136,814     $ 522,532     $ (1,384,391 )
 
                       
 
                               
Per common share:
                               
Net income (loss) — basic
  $ 0.47     $ 0.30     $ 1.14     $ (3.17 )
Net income (loss) — diluted
  $ 0.46     $ 0.29     $ 1.12     $ (3.17 )
 
                               
Weighted average shares — basic
    458,834       456,509       459,332       437,206  
 
                       
 
                               
Weighted average shares — diluted
    467,057       468,891       467,469       437,206  
 
                       
                 
    September 30,     December 31,  
    2009     2008  
Balance sheet items:
               
Cash, cash equivalents & marketable securities
  $ 2,764,448     $ 2,222,091  
Total assets
    5,082,286       4,445,270  
Stockholders’ equity
    4,109,099       3,491,328  

 

 


 

Celgene Corporation and Subsidiaries
Reconciliation of GAAP to Non-GAAP Net Income (Loss)
(In thousands, except per share data)
                                         
            Three Months Ended     Nine Months Ended  
            September 30,     September 30,  
            2009     2008     2009     2008  
 
                                       
Net income (loss) — GAAP
          $ 216,815     $ 136,814     $ 522,532     $ (1,384,391 )
 
                                       
Before tax adjustments:
                                       
Net product sales:
                                       
Pharmion products to be divested
    (1 )     (2,902 )     (5,725 )     (9,367 )     (12,153 )
 
                                       
Cost of goods sold (excluding amortization of acquired intangible assets):
                                       
Share-based compensation expense
    (2 )     1,331       668       3,304       1,829  
Pharmion inventory step-up
    (3 )           7,545       354       18,668  
Pharmion products to be divested
    (1 )     1,127       2,450       5,395       5,014  
EntreMed intercompany royalty
    (4 )     (197 )     (398 )     (197 )     (398 )
 
                                       
Research and development:
                                       
Share-based compensation expense
    (2 )     15,178       10,964       44,841       32,264  
Upfront collaboration payments
    (5 )                 34,500       45,000  
 
                                       
Selling, general and administrative:
                                       
Share-based compensation expense
    (2 )     20,167       16,596       56,384       41,557  
 
                                       
Amortization of acquired intangible assets
    (6 )     21,111       32,833       67,403       77,842  
Acquired in-process research and development
    (7 )                       1,740,000  
 
                                       
Equity in losses of affiliated companies:
                                       
Equity in losses of EntreMed
    (8 )     321       763       980       2,821  
 
                                       
Net income tax adjustments
    (9 )     (13,115 )     (16,638 )     (45,119 )     (50,191 )
 
                             
Net income — non-GAAP
          $ 259,836     $ 185,872     $ 681,010     $ 517,862  
 
                               
 
                                       
Per common share -non-GAAP:
                                       
Net income — basic
          $ 0.57     $ 0.41     $ 1.48     $ 1.18  
Net income — diluted
    (10 )   $ 0.56     $ 0.40     $ 1.46     $ 1.13  
Explanation of adjustments:
     
(1)   Exclude sales and costs related to former non-core Pharmion Corp. products to be divested.
 
(2)   Exclude SFAS 123R share-based compensation expense for the third quarter totaling $36,676 in 2009 and $28,228 in 2008. The after tax net impact reduced GAAP net income for the third quarter by $28,585, or $0.06 per diluted share in 2009 and $22,253, or $0.05 per diluted share in 2008. Exclude SFAS 123R share-based compensation expense for the nine-month periods totaling $104,529 in 2009 and $75,650 in 2008. The after tax net impact reduced GAAP net income for the nine-month periods by $81,048, or $0.17 per diluted share in 2009 and $60,800, or $0.14 per diluted share in 2008.
 
(3)   Exclude acquisition-related Pharmion Corp. inventory step-up adjustment to fair value expensed during the period.
 
(4)   Exclude the Company’s share of THALOMID royalties payable to EntreMed, Inc.
 
(5)   Exclude upfront payments for research and development collaboration arrangements with GlobeImmune, Inc. and Array BioPharma Inc. of $30,000 and $4,500, respectively, for the nine-month period in 2009 and Acceleron Pharma, Inc. of $45,000 for the nine-month period in 2008.
 
(6)   Exclude amortization of acquired intangible assets for the third quarter of 2009 and 2008 resulting from the acquisition of Pharmion Corp. of $21,111 and $32,833, respectively. Exclude amortization of acquired intangible assets for the nine-month periods from the acquisition of Pharmion Corp. of $67,403 in 2009 and from the acquisitions of Pharmion Corp. and Penn T of $76,205 and $1,637, respectively, in 2008.
 
(7)   Exclude the in-process research and development write-off related to the acquisition of Pharmion Corp. in the nine-month period in 2008.
 
(8)   Exclude the Company’s share of equity losses in EntreMed, Inc.
 
(9)   Net income tax adjustments reflects the tax effect of the above adjustments.
 
(10)   Diluted net income per share for the nine-month period of 2008 was determined using diluted weighted average shares of 459,304.