0000835887-12-000025.txt : 20120508 0000835887-12-000025.hdr.sgml : 20120508 20120508120042 ACCESSION NUMBER: 0000835887-12-000025 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20120331 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20120508 DATE AS OF CHANGE: 20120508 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: 12820391 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 form8_k1q2012results.htm PROGENICS FORM 8-K 1Q 2012 OPERATING RESULTS form8_k1q2012results.htm

UNITED STATES
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 4, 2012
 
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.
 
Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced its operational results for the quarter and three months ended March 31, 2012.  A copy of its press release is included in this Report as Exhibit 99.1.
 
The information furnished pursuant to this Item 2.02 shall not be deemed to be “filed” for purposes of Section 18 of the U.S. 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 Exchange Act or the U.S. Securities Act of 1933. We undertake no duty or obligation to publicly update or revise the information so furnished.
 
Item 5.02.                       Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(b)           On May 4, 2012, Mark F. Dalton notified the Board of Directors of the Company of his intention not to stand for re-election to the Board at the Company’s 2012 Annual Meeting of Stockholders, scheduled to be held on June 13, at which time he will cease to be a director. Mr. Dalton’s decision not to stand for re-election is not the result of any disagreement with the Company relating to its operations, policies or practices or any other matter.

 Item 9.01.                      Financial Statements and Exhibits.
 
(d) Exhibits
  
Exhibit No.                     Description
 
99.1                                  Press Release dated May 8, 2012.
 

 
 

 

SIGNATURES
 
 
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
 
 
 
Date: May 8, 2012 




EX-99.1 2 ex99_11q2012results.htm PROGENICS EXHIBIT 99.1 1Q 2012 OPERATING RESULTS ex99_11q2012results.htm

Progenics Logo
 
 
 

Contact:
 
Amy Martini
Corporate Affairs
(914) 789-2816
amartini@progenics.com
 

PROGENICS PHARMACEUTICALS ANNOUNCES
FIRST QUARTER 2012 FINANCIAL RESULTS

Tarrytown, NY, May 8, 2012 – Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced its results of operations for the quarter ended March 31.

Net loss for the quarter was $13.1 million, or $0.39 basic and diluted per share, compared to a net loss of $22.9 million ($0.69 per share) in 2011, primarily due to a $10.0 million decrease in total expenses from the prior-year quarter. Progenics ended the quarter with cash, cash equivalents and securities of $59.3 million, using $12.1 million for operations in the quarter.

First quarter revenue totaled $2.2 million, down $0.2 million from the 2011 period, reflecting decreases in collaboration revenue and research grants, and $1.8 million in royalty revenue. (No royalty income was recorded in the first quarter of 2011 during the Relistor® collaboration transition.) Current first quarter royalty revenue increased $0.6 million from the fourth quarter of 2011. Net sales reported by Progenics’ Relistor collaborators were:

   
Relistor® Net Sales Reported by Collaborators
(millions)
 
   
Three Months Ended
 
   
March 31,
   
December 31,
 
   
2012
   
2011
   
2011
 
U.S.
  $ 11.3     $ 1.8     $ 8.0  
Ex-U.S.
    1.0       1.5       0.8  
   Global
  $ 12.3     $ 3.3     $ 8.8  

First quarter research and development expenses decreased by $8.5 million, primarily from lower phase 3 oral methylnaltrexone clinical trial expenses and Relistor contract manufacturing expenses. First quarter general and administrative expenses were $1.5 million below the first quarter in 2011. These decreases were partially offset by $3.5 million of cash and non-cash equity vesting expenses recognized on Vice Chairman Paul Maddon’s retirement, which also increased total cash used in the quarter by $2.0 million, to $14.1 million.

First Quarter and Recent Events
 
·  
Relistor global net sales increased 40% over the previous quarter.
 
·  
The pending supplemental New Drug Application (sNDA) for Relistor to treat opioid-induced constipation in adult patients with chronic, non-cancer pain is now July 27 of this year.

 
 

 
Progenics Announces First Quarter Financial Results

 

 
·  
Progenics’ longest serving outside director, Mark Dalton, announced his retirement from the Board as of the upcoming Annual Meeting.
 
Peter Crowley, Progenics’ Chairman, said, “On behalf of the entire Board of Directors, I express our deep gratitude for Mark Dalton’s many contributions to the company over the last 22 years. It has been our great pleasure to work with him through times of challenge and accomplishment. Mark’s leadership and strategic perspective have been highly valued by us and will be greatly missed.”

Conference Call and Webcast

Progenics will review first quarter financial results in a conference call today at 8:30 a.m. EDT. To participate, please dial (877) 250-8889 (domestic) or (720) 545-0001 (international) and reference conference ID 78324492. A live webcast will be available on the Events section of the Progenics website, www.progenics.com, and a replay will be available on the website for two weeks.

- Financial Tables follow -

 
 

 
Progenics Announces First Quarter Financial Results 


PROGENICS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except net loss per share)
 
   
For the Three Months Ended
March 31,
 
   
2012
   
2011
 
Revenues:
           
  Royalty income
  $ 1,834     $ -  
  Collaboration revenue
    291       1,083  
  Research grants
    86       1,264  
  Other revenues
    15       41  
     Total revenues
    2,226       2,388  
                 
Expenses:
               
   Research and development
    10,909       19,179  
   License fees – research and development
    40       364  
   Royalty expense
    185       57  
   General and administrative
    3,721       5,197  
   Depreciation and amortization
    472       536  
      Total expenses
    15,327       25,333  
                 
Operating loss
    (13,101 )     (22,945 )
                 
Other income:
               
   Interest income
    15       18  
      Total other income
    15       18  
                 
Net loss
  $ (13,086 )   $ (22,927 )
                 
Net loss per share; basic and diluted
  $ (0.39 )   $ (0.69 )
Weighted average shares outstanding; basic and diluted
    33,761       33,273  

CONDENSED CONSOLIDATED BALANCE SHEETS
 (in thousands)
 
   
March 31,
 2012
   
December 31,
 2011
 
   
(unaudited)
       
             
Cash and cash equivalents
  $ 56,099     $ 70,105  
Accounts receivable
    2,403       1,516  
Auction rate securities
    3,240       3,332  
Fixed assets, net
    4,004       4,038  
Other assets
    1,160       1,119  
   Total assets
  $ 66,906     $ 80,110  
                 
Liabilities
  $ 5,177     $ 7,943  
Deferred revenue
    315       366  
    Total liabilities
    5,492       8,309  
    Stockholders’ equity
    61,414       71,801  
Total liabilities and stockholders’ equity
  $ 66,906     $ 80,110  


 
 

 
Progenics Announces First Quarter Financial Results

About Relistor

Progenics has exclusively licensed development and commercialization rights for its first commercial product, Relistor®, to Salix Pharmaceuticals, Ltd. for markets worldwide other than Japan, where Ono Pharmaceutical Co., Ltd. holds an exclusive license for the subcutaneous formulation. Relistor (methylnaltrexone bromide) subcutaneous injection is a first-in-class treatment for opioid-induced constipation approved in more than 50 countries for patients with advanced illness. Regulatory approval is pending for use of Relistor by patients with chronic, non-cancer pain.
 
Important Safety Information for subcutaneous Relistor

Relistor is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of Relistor beyond four months has not been studied.

Relistor is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with Relistor and consult their physician. Use of Relistor has not been studied in patients with peritoneal catheters.

Safety and efficacy of Relistor have not been established in pediatric patients.

Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvie’s syndrome). Perforations have involved varying regions of the GI tract (e.g., stomach, duodenum, colon).

Use Relistor with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with Relistor and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms.

The most common adverse reactions reported with Relistor compared with placebo in clinical trials were abdominal pain (28.5% vs. 9.8%), flatulence (13.3% vs. 5.7%), nausea (11.5% vs. 4.9%), dizziness (7.3% vs. 2.4%), diarrhea (5.5% vs. 2.4%), and hyperhidrosis (6.7% vs. 6.5%).

Relistor full Prescribing Information for the U.S. is available at www.relistor.com.

 
 

 
Progenics Announces First Quarter Financial Results


About Progenics

Progenics Pharmaceuticals, Inc., of Tarrytown, N.Y., is a biopharmaceutical company dedicated to developing innovative medicines to treat disease, with a focus on cancer and related conditions. Progenics’ pipeline candidates include PSMA ADC, a human monoclonal antibody-drug conjugate in phase 1 testing for treatment of prostate cancer, and preclinical stage novel multiplex phosphoinositide 3-kinase (PI3K) inhibitors for the treatment of cancer. Progenics has exclusively licensed development and commercialization rights for its first commercial product, Relistor®, to Salix Pharmaceuticals, Ltd. for markets worldwide other than Japan, where Ono Pharmaceutical Co., Ltd. holds an exclusive license for the subcutaneous formulation. Relistor (methylnaltrexone bromide) subcutaneous injection is a first-in-class treatment for opioid-induced constipation approved in more than 50 countries for patients with advanced illness. Regulatory approval is pending for use of Relistor by patients with chronic, non-cancer pain.

This press release may contain projections and other forward-looking statements regarding future events. Such statements are predictions only, and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties include, among others, the cost, timing and results of clinical trials and other development activities; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; market acceptance for approved products; generic and other competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; and possible safety or efficacy concerns, general business, financial and accounting risks and litigation. More information concerning Progenics and such risks and uncertainties is available on its website, and in its press releases and reports it files with the U.S. Securities and Exchange Commission. Progenics is providing the information in this press release as of its date and does not undertake any obligation to update or revise it, whether as a result of new information, future events or circumstances or otherwise.

Additional information concerning Progenics and its business may be available in press releases or other public announcements and public filings made after this release.
 
(PGNX-F)
 
Editors Note:
 
For more information, please visit www.progenics.com.
 
For more information about Relistor, please visit www.relistor.com.
 



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