-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, KlD3p50W0lFpIm+/ko7llmVlSID7vhYXL+ST1/OYJ5lHHivLalYvWyVcg68JZAeP SPkDPa3m/ZPvPWoCyxQQuw== 0000835887-06-000046.txt : 20061109 0000835887-06-000046.hdr.sgml : 20061109 20061109095044 ACCESSION NUMBER: 0000835887-06-000046 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20061109 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20061109 DATE AS OF CHANGE: 20061109 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PROGENICS PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000835887 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 133379479 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23143 FILM NUMBER: 061199783 BUSINESS ADDRESS: STREET 1: 777 OLD SAW MILL RIVER ROAD CITY: TARRYTOWN STATE: NY ZIP: 10591 BUSINESS PHONE: 9147892800 MAIL ADDRESS: STREET 1: 777 OLD SAW MILL RIVER ROAD CITY: TARRYTOWN STATE: NY ZIP: 10591 8-K 1 form8k11092006.htm FORM 8-K EARNINGS PRESS RELEASE Q3 2006 Form 8-K Earnings press release Q3 2006
 
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
CURRENT REPORT
 
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported) November 9, 2006
 
             Progenics Pharmaceuticals, Inc.             
(Exact name of registrant as specified in its charter)
 
Delaware
 
000-23143
 
13-3379479
(State or other jurisdiction
of incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)
 
 
 
 
 
777 Old Saw Mill River Road, Tarrytown, New York
 
10591
(Address of principal executive offices)
 
(Zip Code)
Registrant's telephone number, including area code (914) 789-2800
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
         o  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
   o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
   o  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
   o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 

 
 

 

 
Item 2.02   Results of Operations and Financial Condition.
 
     On November 9, 2006, the Company announced its operational results for the quarter ended September 30, 2006. A copy of the press release is attached hereto as Exhibit 99.1.
 
     The information furnished pursuant to Item 2.02 in this Form 8-K shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section, unless we specifically incorporate it by reference in a document filed under the Securities Act of 1933 or the Securities Exchange Act of 1934. We undertake no duty or obligation to publicly update or revise the information furnished pursuant to Item 2.02 in this Form 8-K.
 
Item 9.01   Financial Statements and Exhibits.
 
(c) Exhibits
 
Exhibit No.     Description
 
99.1                   Press Release dated November 9, 2006
 

 
 

 

 
 
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
PROGENICS PHARMACEUTICALS, INC.
 
By:  /s/ ROBERT A. MCKINNEY                            
    Robert A. McKinney
    Chief Financial Officer, Senior Vice President,
    Finance & Operations and Treasurer
 
Date: November 9, 2006
 
 
 
 



EX-99.1 2 ex99_111092006.htm EXHIBIT 99.1 EARNINGS PRESS RELEASE Q3 2006 Exhibit 99.1 Earnings press release Q3 2006



For Immediate Release

Contact:
Progenics Pharmaceuticals, Inc.
Richard W. Krawiec, Ph.D.
VP, Investor Relations and Corporate Communications
(914) 789-2800
rkrawiec@progenics.com
 
PROGENICS PHARMACEUTICALS REPORTS
THIRD QUARTER 2006 RESULTS
 
Tarrytown, NY, November 9, 2006 - Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) today announced its results of operations for the third quarter, and the first nine months, ended September 30, 2006.

Revenues for the third quarter ended September 30, 2006 totaled $17.8 million compared to $2.8 million for the same quarter in 2005. For the first nine months of 2006, Progenics reported revenues of $48.0 million compared to $7.4 million for the comparable period in 2005. Revenues primarily reflect reimbursement received by the Company for its research and development activities under its collaboration with Wyeth (NYSE: WYE) relating to methylnaltrexone, recognition of revenue relating to Wyeth’s upfront payment to Progenics in the methylnaltrexone collaboration, and government grants and contracts.

The Company’s expenses for the third quarter of 2006 were $22.7 million compared to $14.1 million for the third quarter of 2005. For the nine months ended September 30, 2006, expenses totaled $73.7 million compared to $45.2 million for the nine months ended September 30, 2005. The increase in expenses for the three and nine months ended September 30, 2006 is principally due to increased research and development activity related to Progenics’ collaboration with Wyeth and an increase in headcount. In addition, the increase in expenses for the nine months ended September 30, 2006 was due to the one-time $13.2 million expense related to the acquisition of PSMA Development Company LLC in the second quarter of 2006.

The net loss for the third quarter of 2006 was $2.9 million compared to a net loss of $10.7 million for the same period in 2005. The net loss per share for the third quarter of 2006 was $(0.11) basic and diluted, compared to a net loss per share of $(0.49), basic and diluted, for the same period of 2005. The net loss for the first nine months of 2006 was $19.9 million, compared to a net loss of $36.7 million for the same period in 2005. The net loss per share for the first nine months of 2006 was $(0.78), basic and diluted, compared to a net loss per share of $(1.87), basic and diluted, for the same period of 2005. The Company ended the third quarter of 2006 with cash, cash equivalents and marketable securities of $148.5 million.

In connection with its collaboration with Wyeth, Progenics recognized revenues of $14.5 million for the third quarter of 2006; $5.1 million of which related to the $60 million upfront payment received by Progenics upon commencement of the collaboration and $9.4 million for reimbursement of Progenics’ development expenses for the third quarter of 2006. For the first nine months of 2006, Progenics recognized $40.1 million of revenue from the Wyeth collaboration: $14.5 million from the upfront payment and $25.6 million as reimbursement of its development expenses.

 
 

 


During the third quarter of 2006, Progenics Pharmaceuticals and Wyeth announced the initiation of a phase 2 clinical trial to evaluate once-daily dosing of oral methylnaltrexone. This trial is designed to identify the dose(s) of methylnaltrexone to be taken forward into the phase 3 clinical studies that will evaluate the efficacy, safety and tolerability of oral methylnaltrexone for opioid-induced constipation (OIC) in patients treated with opioids for chronic pain. The companies also announced the initiation of the first of two global, pivotal, phase 3 clinical trials to evaluate the safety and efficacy of intravenous methylnaltrexone for the treatment of post-operative ileus (POI), a debilitating impairment of the gastrointestinal tract that occurs after surgery. There are no medicines currently approved to treat POI.

Progenics Pharmaceuticals, Inc., of Tarrytown, NY is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. Principal programs are directed toward symptom management and supportive care and the treatment of HIV infection and cancer. The Company has four product candidates in clinical development and several others in preclinical development. The Company, in collaboration with Wyeth, is developing methylnaltrexone for the treatment of opioid-induced side effects, including constipation and post-operative ileus. In the area of HIV infection, the Company is developing the viral-entry inhibitor PRO 140, a humanized monoclonal antibody targeting the HIV coreceptor CCR5 (in phase 1b studies). In addition, the Company is conducting research on ProVax, a novel prophylactic HIV vaccine. The Company is developing in vivo immuno-therapies for prostate cancer, including a human monoclonal antibody-drug conjugate directed against prostate-specific membrane antigen (PSMA), a protein found on the surface of prostate cancer cells. Progenics is also developing vaccines designed to stimulate an immune response to PSMA. A recombinant PSMA vaccine is in phase 1 clinical testing. The Company is also developing a cancer vaccine, GMK, in phase 3 clinical trials for the treatment of malignant melanoma.

 
(Financial Tables Follow)

 
 

 


PROGENICS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except net loss per share)
 
   
Three Months Ended
 
Nine Months Ended
 
   
9/30/2006
 
9/30/2005
 
9/30/2006
 
9/30/2005
 
Revenues:
                 
     Contract research and development from collaborator
 
$
14,527
       
$
40,060
       
     Contract research and development from JV
       
$
211
       
$
781
 
     Research grants and contracts
   
3,316
   
2,548
   
7,842
   
6,618
 
     Product sales
   
5
   
15
   
70
   
39
 
         Total revenues
   
17,848
   
2,774
   
47,972
   
7,438
 
                           
Expenses:
                         
     Research and development
   
15,751
   
9,952
   
56,288
   
32,517
 
     General and administrative
   
6,610
   
3,344
   
16,138
   
9,386
 
     Loss in JV
         
384
   
121
   
1,928
 
     Depreciation and amortization
   
381
   
417
   
1,106
   
1,369
 
        Total expenses
   
22,742
   
14,097
   
73,653
   
45,200
 
                           
Operating loss
   
(4,894
)
 
(11,323
)
 
(25,681
)
 
(37,762
)
                           
Other income:
                         
     Interest income
   
1,959
   
580
   
5,775
   
1,030
 
                           
Net loss
 
$
(2,935
)
$
(10,743
)
$
(19,906
)
$
(36,732
)
                           
     Net loss per share; basic and diluted
 
$
(0.11
)
$
(0.49
)
$
(0.78
)
$
(1.87
)
                           

CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
 
   
September 30, 2006
 
December 31, 2005
 
           
Cash, cash equivalents and marketable securities
 
$
148,513
 
$
173,090
 
Accounts receivable
   
2,986
   
3,287
 
Fixed assets, net
   
9,559
   
4,156
 
Other assets
   
3,112
   
3,470
 
        Total assets
 
$
164,170
 
$
184,003
 
               
Liabilities
 
$
57,026
 
$
71,271
 
Stockholders’ equity
   
107,144
   
112,732
 
               
   Total liabilities and stockholders’ equity
 
$
164,170
 
$
184,003
 
               


 
 

 


DISCLOSURE NOTICE: The information contained in this document is current as of November 9, 2006. This press release contains forward-looking statements. Any statements contained herein that are not statements of historical fact may be forward-looking statements. When the Company uses the words ‘anticipates,’ ‘plans,’ ‘expects’ and similar expressions, it is identifying forward-looking statements. Such forward-looking statements involve risks and uncertainties which may cause the Company’s actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. Such factors include, among others, the uncertainties associated with product development, the risk that clinical trials will not commence or proceed as planned, the risks and uncertainties associated with dependence upon the actions of our corporate, academic and other collaborators and of government regulatory agencies, the risk that our licenses to intellectual property may be terminated because of our failure to have satisfied performance milestones, the risk that products that appear promising in early clinical trials do not demonstrate efficacy in larger-scale clinical trials, the risk that we may not be able to manufacture commercial quantities of our products, the uncertainty of future profitability and other factors set forth more fully in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and other reports filed with the Securities and Exchange Commission, to which investors are referred for further information. In particular, the Company cannot assure you that any of its programs will result in a commercial product.

Progenics does not have a policy of updating or revising forward-looking statements and assumes no obligation to update any forward-looking statements contained in this document as a result of new information or future events or developments. Thus, it should not be assumed that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements.

 
Editor’s Note:
Additional information on Progenics is available at http://www.progenics.com

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-----END PRIVACY-ENHANCED MESSAGE-----