-----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, GJqUe+4FMSTIFh4qpDIW1+jk9Nuw2jNBtQx6tRkYslyemXOIWhfX2Yh+x3ovlRDm h6dMQAOSmfIRPU/6S70ooA== 0000835887-07-000013.txt : 20070509 0000835887-07-000013.hdr.sgml : 20070509 20070509103253 ACCESSION NUMBER: 0000835887-07-000013 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070509 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070509 DATE AS OF CHANGE: 20070509 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: 07830759 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 form8k592007.htm FORM 8-K MAY 9, 2007 Form 8-K May 9, 2007
 
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) May 9, 2007
 
             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 May 9, 2006, the Company announced its operational results for the quarter ended March 31, 2007. 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.
 
(d) Exhibits
 
Exhibit No.     Description
 
99.1                   Press Release dated May 9, 2007
 

 
 

 

 

 
 
 
 
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: May 9, 2007
 
 
 
 



EX-99.1 2 ex99_1592007.htm EXHIBIT 99.1 EARNINGS PRESS RELEASE MARCH 31, 2007 Exhibit 99.1 Earnings Press Release March 31, 2007

 

For Immediate Release

Contact:
Investors:
Progenics Pharmaceuticals, Inc.
Richard W. Krawiec, Ph.D.
Vice President
Corporate Affairs
(914) 789-2814
rkrawiec@progenics.com
Media:
Barri Winiarski
WeissComm Partners
(914) 584-7468
       

PROGENICS PHARMACEUTICALS REPORTS
FIRST QUARTER 2007 RESULTS

Tarrytown, NY, May 9, 2007 - Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced its results of operations for the quarter ended March 31, 2007.

Revenues for the quarter ended March 31, 2007 totaled $17.6 million compared to revenues of $11.0 million for the same period in 2006. Revenues for the quarter primarily reflect reimbursement by Wyeth for development work performed by the Company under our methylnaltrexone collaboration ($10.5 million in 2007 and $4.1 million in 2006), recognition of a portion of the $60 million upfront payment received from Wyeth in December 2005 ($5.0 million in 2007 and $4.4 million in 2006) and funding from government grants and contracts ($2.1 million in 2007 and $2.5 million in 2006).

The Company’s expenses for the first quarter of 2007 were $29.9 million, compared to $15.6 million for the first quarter of 2006, including $2.9 million of non-cash expense for share-based compensation in 2007, compared to $2.2 million for the same period in 2006. The increase in expenses was primarily due to a $12.6 million increase in research and development expenses related to our collaboration with Wyeth, preparation for clinical trials for our other product candidates and an increase in headcount. General and administrative expenses also increased $1.7 million, primarily due to an increase in headcount.

The Company reported a net loss of ($10.4 million) or ($0.40) per share (basic and diluted) for the first quarter of 2007, compared to a net loss of ($2.6 million) or ($0.10) per share (basic and diluted) for the first quarter of 2006. At the end of the first quarter of 2007, Progenics had $140.1 million in cash, cash equivalents and marketable securities compared to $149.1 million at December 31, 2006.

Developments in early 2007

·  
Progenics submitted a New Drug Application for marketing approval to the U.S. Food and Drug Administration for the subcutaneous formulation of methylnaltrexone for the treatment of opioid-induced constipation in patients receiving palliative care.

 
 

 


·  
Wyeth Pharmaceuticals and Progenics announced that Wyeth had begun clinical testing of a new formulation of oral methylnaltrexone for the treatment of opioid-induced constipation. Preliminary results from a phase 2 trial conducted by Wyeth showed that the initial formulation of oral methylnaltrexone tested was generally well tolerated, but did not exhibit sufficient clinical activity to advance into phase 3 testing.

·  
Progenics announced positive results from a phase 1b trial of PRO 140, a humanized monoclonal antibody designed to inhibit entry of HIV (human immunodeficiency virus) into healthy cells. Results showed that patients receiving a single 5.0 mg/kg dose, the highest dose tested, achieved an average maximum decrease of viral concentrations in the blood of 98.5%. In these patients, reductions in viral load of greater than 90%, on average, persisted for two-to-three weeks after receiving a single dose of the drug. PRO 140 was generally well tolerated in this phase 1b proof-of-concept study.

“Progenics plans to be very busy in 2007,” said Paul J. Maddon, Progenics’ Founder, Chief Executive Officer and Chief Science Officer. “We experienced our most significant milestone in the Company’s history during the first quarter, the filing of our first New Drug Application for the subcutaneous formulation of methylnaltrexone in patients receiving palliative care. In May, our progress continued as we reported positive data in our phase 1b clinical trial of PRO 140, with results representing the largest reported single-dose mean reduction in viral load for any HIV agent. We expect the balance of 2007 to remain active, including the planned submission of the subcutaneous form of methylnaltrexone for regulatory marketing approval in Europe, completion of pivotal phase 3 studies of methylnaltrexone in post-operative ileus, the initiation of clinical trials for PRO 140, and the filing of an Investigational New Drug application for our antibody-drug conjugate for metastatic prostate cancer.”

Company profile

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 gastroenterology, virology and oncology. 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 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 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 STATEMENTS OF OPERATIONS
(in thousands, except net loss per share)

  
   
Three Months Ended
March 31,
 
   
2007
 
2006
 
           
Revenues:
             
               
   Contract research and development from collaborator
 
$
15,499
 
$
8,488
 
   Research grants and contracts
   
2,119
   
2,462
 
   Product sales
   
19
   
51
 
      Total revenues
   
17,637
   
11,001
 
               
Expenses:
             
   Research and development
   
22,421
   
10,283
 
   License fees - research and development
   
750
   
275
 
   General and administrative
   
6,276
   
4,512
 
Loss in joint venture
         
121
 
   Depreciation and amortization
   
492
   
363
 
      Total expenses
   
29,939
   
15,554
 
               
      Operating loss
   
(12,302
)
 
(4,553
)
               
   Interest income
   
1,869
   
1,910
 
      Net loss
 
$
(10,433
)
$
(2,643
)
               
   Net loss per share; basic and diluted
 
$
(0.40
)
$
(0.10
)
               

 
CONDENSED BALANCE SHEETS
(in thousands)
 
   
March 31, 2007
 
December 31, 2006
 
           
Cash, cash equivalents and marketable securities
 
$
140,129
 
$
149,100
 
Accounts receivable
   
1,699
   
1,699
 
Fixed assets, net
   
11,962
   
11,387
 
Other assets
   
3,381
   
3,725
 
      Total assets
 
$
157,171
 
$
165,911
 
               
Liabilities
 
$
50,927
 
$
55,065
 
Stockholders’ equity
   
106,244
   
110,846
 
               
      Total liabilities and stockholders’ equity
 
$
157,171
 
$
165,911
 
               


 
 

 


DISCLOSURE NOTICE: The information contained in this document is current as of May 9, 2007. 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, 2006 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 available at http://www.progenics.com.


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