Delaware
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000-23143
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13-3379479
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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777 Old Saw Mill River Road, Tarrytown, New York
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10591
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(Address of principal executive offices)
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(Zip Code)
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Registrant's telephone number, including area code (914) 789-2800
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o
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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o
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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o
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 2.02.
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Results of Operations and Financial Condition.
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Item 9.01.
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Financial Statements and Exhibits.
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(d)
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Exhibits
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Exhibit No.
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Description
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PROGENICS PHARMACEUTICALS, INC.
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By:
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/s/ ANGELO W. LOVALLO, JR.
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Angelo W. Lovallo, Jr.
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Vice President, Finance & Treasurer
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(Principal Financial and Accounting Officer)
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![]() |
Progenics Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591
Fax: (914) 789-2817
(914) 789-2800
www.progenics.com
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·
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In August, Progenics entered into an exclusive worldwide licensing agreement for [18F]DCFPyL ("PyL"), a clinical-stage prostate specific membrane antigen (PSMA)-targeted imaging agent for prostate cancer, with Johns Hopkins University.
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·
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In July, Progenics announced that the FDA designated Azedra as a Breakthrough Therapy for the treatment of patients with malignant pheochromocytoma and paraganglioma. Azedra is currently being evaluated in a pivotal Phase 2b trial, which is being conducted under a Special Protocol Assessment Agreement (SPA), and has received Orphan Drug and Fast Track designations from the FDA.
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·
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In July, the Company also announced details of its planned Phase 3 clinical trial for 1404, a developmental stage small molecule designed to help visualize prostate cancer by targeting prostate specific membrane antigen (PSMA). The Phase 3 clinical trial is expected to enroll approximately 450 patients with biopsy-proven low-grade prostate cancer who are candidates for active surveillance but have planned to undergo radical prostatectomy, and will evaluate the specificity and sensitivity of 1404 to identify clinically significant prostate cancer. Progenics expects to commence the Phase 3 trial by the end of this year.
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·
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In July, Sheldon Hirt joined Progenics as Executive Vice President and General Counsel. Mr. Hirt previously served as Senior Vice President, Legal Affairs and Assistant General Counsel at Actavis plc.
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·
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In June, Progenics and Valeant announced that Valeant had submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for RELISTOR® Tablets for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
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·
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Also in June, Progenics and Valeant announced that the European Commission had approved RELISTOR® Subcutaneous Injection for the treatment of OIC when response to laxative therapy has not been sufficient in adult patients. The decision is applicable to all 28 European Union member states plus Iceland and Norway and includes an additional one year of marketing protection.
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PROGENICS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except net loss per share)
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||||||||||||||||
For the Three Months Ended
June 30,
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For the Six Months Ended
June 30,
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|||||||||||||||
2015
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2014
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2015
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2014
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|||||||||||||
Revenues:
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||||||||||||||||
Royalty income
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$
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1,773
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$
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1,367
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$
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1,947
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$
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2,102
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||||||||
Collaboration revenue
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145
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72
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210
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1,121
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||||||||||||
Other revenues
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19
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38
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28
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69
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||||||||||||
Total revenues
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1,937
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1,477
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2,185
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3,292
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Expenses:
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||||||||||||||||
Research and development
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6,362
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7,848
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12,825
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14,767
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License fees – research and development
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178
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180
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162
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270
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Royalty expense
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178
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147
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220
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229
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General and administrative
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5,998
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3,856
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9,591
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7,261
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Depreciation and amortization
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129
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133
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261
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277
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||||||||||||
Change in contingent consideration liability
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800
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400
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1,100
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900
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||||||||||||
Total expenses
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13,645
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12,564
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24,159
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23,704
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||||||||||||
Operating loss
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(11,708
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)
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(11,087
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)
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(21,974
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)
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(20,412
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)
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||||||||
Other income:
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Interest income
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11
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13
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23
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25
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||||||||||||
Total other income
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11
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13
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23
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25
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||||||||||||
Net loss before income tax benefit
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(11,697
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)
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(11,074
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)
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(21,951
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)
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(20,387
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)
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Income tax benefit
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-
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1
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-
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1
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Net loss
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$
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(11,697
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)
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$
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(11,073
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)
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$
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(21,951
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)
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$
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(20,386
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)
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Net loss per share; basic and diluted
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$
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(0.17
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)
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$
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(0.16
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)
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$
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(0.32
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)
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$
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(0.31
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)
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Weighted average shares outstanding; basic and diluted
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69,647
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69,561
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69,642
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66,775
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CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
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||||||||
June 30,
2015
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December 31,
2014
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|||||||
(unaudited)
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||||||||
Cash and cash equivalents
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$
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99,309
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$
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119,302
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Accounts receivable, net
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1,409
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109
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||||||
Fixed assets, net
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2,524
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2,552
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Intangible assets, net and goodwill
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36,402
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36,402
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||||||
Other assets
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2,790
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2,672
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||||||
Total assets
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$
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142,434
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$
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161,037
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Current liabilities
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$
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6,631
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$
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6,685
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Contingent consideration liability
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18,300
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17,200
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Deferred tax and other liabilities
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12,218
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12,243
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Total liabilities
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37,149
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36,128
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Stockholders' equity
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105,285
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124,909
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||||||
Total liabilities and stockholders' equity
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$
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142,434
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$
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161,037
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Contact:
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Melissa Downs
Investor Relations
(914) 789-2801
mdowns@progenics.com
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