Delaware
|
000-23143
|
13-3379479
|
||
(State or other jurisdiction
of incorporation)
|
(Commission
File Number)
|
(IRS Employer
Identification No.)
|
||
|
One World Trade Center, 47th Floor, New York, New York |
10007
|
||
|
(Address of principal executive offices) |
(Zip Code)
|
||
Registrant's telephone number, including area code (646) 975-2500
|
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.
|
Item 9.01.
|
Financial Statements and Exhibits.
|
(d)
|
Exhibits
|
Exhibit No.
|
Description
|
|
PROGENICS PHARMACEUTICALS, INC.
|
|
|
By:
|
/s/ Patrick Fabbio
|
|
|
Patrick Fabbio
|
|
|
Senior Vice President and Chief Financial Officer
|
|
|
(Principal Financial and Accounting Officer)
|
![]() |
Progenics Pharmaceuticals, Inc.
One World Trade Center
47th Floor, Suite J
New York, New York 10007
(646) 975-2500
www.progenics.com
|
·
|
On July 19, the Company Announced FDA Approval of RELISTOR® Tablets, Triggering a $50 Million Milestone
|
·
|
Ultra-Orphan Radiotherapeutic Candidate AZEDRA® Registrational Trial Topline Results Expected Between December 2016 and March 2017
|
·
|
Licensed PSMA Antibody Technology to Bayer and Recognition of $5 Million in Upfront and Milestone Revenue
|
·
|
Phase 3 Study Enrollment of PSMA-Targeted SPECT/CT Imaging Agent 1404 Ongoing
|
·
|
Second Quarter 2016 RELISTOR Subcutaneous (SC) Net Sales of $15.9 Million
|
·
|
On Track to Initiate Phase 2/3 Trial for PyLTM Imaging Agent and Phase 1 Trial For 1095 This Year
|
·
|
On July 19, the Company Announced that the FDA has approved RELISTOR tablets for the treatment of opioid induced constipation in adults with chronic non-cancer pain. The approval triggered a $50 million milestone payment on July 25 from Progenics' partner, Valeant, as well as subsequent royalties and up to $200 million in sales milestones.
|
·
|
RELISTOR SC Net Sales for the Second Quarter 2016 Total $15.9 Million. The second quarter 2016 sales, as reported to the Company by Valeant, translated to $2.4 million in royalty revenue for the second quarter of 2016.
|
·
|
AZEDRA Topline Results Expected Between December 2016 and March 2017. In late 2016 or early 2017, Progenics expects to report topline results from its ongoing registrational trial of AZEDRA. If the AZEDRA trial meets the endpoints of the SPA, the Company expects to submit an NDA to the FDA during the first half of 2017.
|
·
|
Granted an Exclusive License to Bayer for the Development and Commercialization of Therapeutic Antibodies Combining Progenics' PSMA Antibody Technology with Bayer's Targeted Thorium Conjugate Technology. Progenics recognized revenue of $5 million in the second quarter of 2016, constituting the $4 million upfront payment and the first pre-clinical development milestone of $1 million. Under terms of the agreement, the Company is entitled to up to an additional $48 million in potential clinical and regulatory development milestones, single digit royalties on net sales, and potential sales milestone payments up to an aggregate of $130 million.
|
·
|
Enrollment in Pivotal Phase 3 Study of 1404 is Ongoing. The study will enroll up to 450 patients with newly-diagnosed or low-grade prostate cancer who are candidates for active surveillance. The Company's plans for an interim analysis during the fourth quarter of 2016 to assess futility and evaluate the need for a sample size re-estimation remain unchanged.
|
·
|
Presented Data from its PSMA-Targeted Prostate Cancer Imaging Programs at the Society of Nuclear Medicine and Molecular Imaging 2016 Annual Meeting in San Diego. The data highlighted the potential of the Company's SPEC/CT imaging agent 1404 and PET/CT imaging agent PyL to detect prostate cancer.
|
·
|
On-Track to Initiate Phase 2/3 Trial of PyL by Year-End. The study is designed to assess the diagnostic accuracy of PyL PET/CT imaging in patients with high risk and/or metastatic prostate cancer.
|
·
|
Company Remains On-Track to Initiate a Phase 1 Trial of 1095 in the Fourth Quarter of 2016. The Phase 1 Study of 1095, a PSMA-Targeted Therapeutic for Metastatic Prostate Cancer, will be conducted at Memorial Sloan Kettering Cancer Center.
|
PROGENICS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
|
||||||||||||||||
For the Three Months Ended
June 30,
|
For the Six Months Ended
June 30,
|
|||||||||||||||
2016
|
2015
|
2016
|
2015
|
|||||||||||||
Revenues:
|
(Unaudited) | |||||||||||||||
Royalty income
|
$
|
2,380
|
$
|
1,773
|
$
|
4,569
|
$
|
1,947
|
||||||||
Collaboration revenue
|
6,073
|
145
|
6,315
|
210
|
||||||||||||
Other revenues
|
23
|
19
|
42
|
28
|
||||||||||||
Total revenues
|
8,476
|
1,937
|
10,926
|
2,185
|
||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
7,988
|
6,718
|
17,137
|
13,207
|
||||||||||||
General and administrative
|
5,599
|
6,127
|
11,416
|
9,852
|
||||||||||||
Change in contingent consideration liability
|
600
|
800
|
800
|
1,100
|
||||||||||||
Total operating expenses
|
14,187
|
13,645
|
29,353
|
24,159
|
||||||||||||
Operating loss
|
(5,711
|
)
|
(11,708
|
)
|
(18,427
|
)
|
(21,974
|
)
|
||||||||
Other income:
|
||||||||||||||||
Interest income
|
54
|
11
|
97
|
23
|
||||||||||||
Total other income
|
54
|
11
|
97
|
23
|
||||||||||||
Net loss
|
(5,657
|
)
|
(11,697
|
)
|
(18,330
|
)
|
(21,951
|
)
|
||||||||
Net loss attributable to noncontrolling interests
|
(19
|
)
|
-
|
(37
|
)
|
-
|
||||||||||
Net loss attributable to Progenics
|
$
|
(5,638
|
)
|
$
|
(11,697
|
)
|
$
|
(18,293
|
)
|
$
|
(21,951
|
)
|
||||
Net loss per share attributable to Progenics - basic and diluted
|
$
|
(0.08
|
)
|
$
|
(0.17
|
)
|
$
|
(0.26
|
)
|
$
|
(0.32
|
)
|
||||
Weighted average shares outstanding – basic and diluted
|
69,947
|
69,647
|
69,947
|
69,642
|
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
|
||||||||
June 30, 2016
|
December 31, 2015
|
|||||||
(unaudited)
|
(audited)
|
|||||||
Cash and cash equivalents
|
$
|
60,146
|
$
|
74,103
|
||||
Accounts receivable, net
|
3,563
|
3,543
|
||||||
Property and equipment, net
|
3,702
|
2,407
|
||||||
Intangible assets, net and goodwill
|
43,761
|
43,867
|
||||||
Other assets
|
7,032
|
7,331
|
||||||
Total assets
|
$
|
118,204
|
$
|
131,251
|
||||
Current liabilities
|
$
|
13,429
|
$
|
9,729
|
||||
Acquisition-related contingent consideration liability
|
19,600
|
18,800
|
||||||
Deferred tax and other liabilities
|
11,337
|
12,061
|
||||||
Total liabilities
|
44,366
|
40,590
|
||||||
Total Progenics stockholders' equity
|
73,672
|
90,456
|
||||||
Noncontrolling interests
|
166
|
205
|
||||||
Total stockholders' equity
|
73,838
|
90,661
|
||||||
Total liabilities and stockholders' equity
|
$
|
118,204
|
$
|
131,251
|
Contact:
|
Melissa Downs
Investor Relations
(646) 975-2533
mdowns@progenics.com
|