10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 10-Q 

(Mark One)

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
	For the quarterly period ended June 30, 2019
	Or
☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
	For the transition period from ___________ to ___________

Commission File No. 000-23143

PROGENICS PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)

Delaware	13-3379479
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification Number)

One World Trade Center, 47^th Floor
New York, NY 10007
(Address of principal executive offices, including zip code)

Registrant’s telephone number, including area code: (646) 975-2500

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common stock, par value $0.0013	PGNX	The Nasdaq Global Select Market

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

Large accelerated filer  ☐	Accelerated filer   ☒
Non-accelerated filer    ☐	Smaller reporting company ☒
	Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes ☐ No ☒

As of August 5, 2019, a total of 86,421,634 shares of common stock, par value $0.0013 per share, were outstanding.

1

PROGENICS PHARMACEUTICALS, INC.

INDEX

		Page No.
Part I	FINANCIAL INFORMATION
Item 1.	Financial Statements (unaudited)
	Condensed Consolidated Balance Sheets	3
	Condensed Consolidated Statements of Operations	4
	Condensed Consolidated Statements of Comprehensive Loss	5
	Condensed Consolidated Statements of Stockholders’ Equity	6
	Condensed Consolidated Statements of Cash Flows	7
	Notes to Condensed Consolidated Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	27
Item 3.	Quantitative and Qualitative Disclosures about Market Risk	35
Item 4.	Controls and Procedures	35
PART II	OTHER INFORMATION
Item 1.	Legal Proceedings	35
Item 1A.	Risk Factors	36
Item 6.	Exhibits	37
	Signatures	38

2

PART I — FINANCIAL INFORMATION

Item 1. Financial Statements

PROGENICS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except per share data)

	June 30,			December 31,
	2019			2018
ASSETS	(unaudited)			(audited)
Current assets:
Cash and cash equivalents	$	84,823		$	137,686
Accounts receivable, net		10,569			3,803
Other current assets		4,806			2,640
Total current assets		100,198			144,129
Property and equipment, net		7,008			3,944
Intangible assets, net		7,375			6,666
Goodwill		17,847			13,074
Operating right-of-use lease assets		13,889			-
Other assets		6,464			1,684
Total assets	$	152,781		$	169,497
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	272		$	444
Accrued expenses		16,938			10,533
Contingent consideration liability		-			7,050
Current portion of debt, net		5,806			5,419
Operating lease liabilities		555			-
Total current liabilities		23,571			23,446
Long-term debt, net		36,342			39,180
Operating lease liabilities		15,312			-
Contingent consideration liability		4,800			3,950
Deferred tax liability		28			28
Other liabilities		-			1,818
Total liabilities		80,053			68,422
Commitments and Contingencies
Stockholders’ equity:
Preferred stock, $0.001 par value Authorized - 20,000 shares; issued and outstanding - none		-			-
Common stock, $0.0013 par value Authorized - 160,000 shares; issued - 86,599 shares in 2019 and 84,742 shares in 2018		112			110
Additional paid-in capital		724,027			713,019
Treasury stock at cost, 200 shares of common stock		(2,741	)		(2,741	)
Subscription receivable		(933	)		-
Accumulated other comprehensive loss		(94	)		(105	)
Accumulated deficit		(647,643	)		(609,208	)
Total stockholders’ equity		72,728			101,075
Total liabilities and stockholders’ equity	$	152,781		$	169,497

The accompanying notes are an integral part of these condensed consolidated financial statements.

3

PROGENICS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS 

(In thousands, except per share data)

(Unaudited)

	Three Months Ended						Six Months Ended
	June 30,						June 30,
	2019			2018			2019			2018
Revenues:
Product sales	$	270		$	-		$	270		$	-
Royalty income		3,593			3,530			7,754			6,588
License and other revenue		6,103			348			6,223			479
Total revenue		9,966			3,878			14,247			7,067
Operating expenses:
Cost of goods sold		493			-			493			-
Research and development		13,080			9,347			25,472			17,457
Selling, general and administrative		14,570			7,569			23,794			14,266
Change in contingent consideration liability		916			1,300			1,816			2,100
Total operating expenses		29,059			18,216			51,575			33,823
Operating loss		(19,093	)		(14,338	)		(37,328	)		(26,756	)
Other (expense) income:
Interest (expense) income and other income, net		(607	)		(930	)		(1,107	)		(1,936	)
Total other (expense) income		(607	)		(930	)		(1,107	)		(1,936	)
Loss before income tax benefit		(19,700	)		(15,268	)		(38,435	)		(28,692	)
Income tax benefit		-			96			-			96
Net loss	$	(19,700	)	$	(15,172	)	$	(38,435	)	$	(28,596	)
Net loss per share - basic and diluted	$	(0.23	)	$	(0.20	)	$	(0.45	)	$	(0.39	)
Weighted-average shares - basic and diluted		85,000			74,017			84,772			73,271

The accompanying notes are an integral part of these condensed consolidated financial statements.

4

PROGENICS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(In thousands)

(Unaudited)

	Three Months Ended						Six Months Ended
	June 30,						June 30,
	2019			2018			2019			2018
Net loss	$	(19,700	)	$	(15,172	)	$	(38,435	)	$	(28,596	)
Other comprehensive loss:
Foreign currency translation adjustments		53			(38	)		11			(56	)
Comprehensive loss	$	(19,647	)	$	(15,210	)	$	(38,424	)	$	(28,652	)

The accompanying notes are an integral part of these condensed consolidated financial statements.

5

PROGENICS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY 

(In thousands)

(Unaudited)

	Common Stock				Common Stock Subscribed				Additional					Accumulated  Other						Treasury Stock						Total
	Number				Number				Paid-in		Accumulated			Comprehensive			Subscription			Number						Stockholders’
	of Shares		Par Value		of Shares		Par Value		Capital		Deficit			Loss			Receivable			of Shares			Cost			Equity
Balance at December 31, 2018		84,742	$	110		-	$	-	$	713,019	$	(609,208	)	$	(105	)	$	-			(200	)	$	(2,741	)	$	101,075
Net loss		-		-		-		-		-		(18,735	)		-			-			-			-			(18,735	)
Foreign currency translation adjustments		-		-		-		-		-		-			(42	)		-			-			-			(42	)
Stock-based compensation expense		-		-		-		-		1,077		-			-			-			-			-			1,077
Balance at March 31, 2019		84,742	$	110		-	$	-	$	714,096	$	(627,943	)	$	(147	)	$	-			(200	)	$	(2,741	)	$	83,375
Net loss		-		-		-		-		-		(19,700	)		-			-			-			-			(19,700	)
Foreign currency translation adjustments		-		-		-		-		-		-			53			-			-			-			53
Stock-based compensation expense		-		-		-		-		994		-			-			-			-			-			994
Issuance of common stock to former shareholders of MIP, net of payments to advisors		1,632		2		-		-		7,737		-			-			-			-			-			7,739
Exercise of stock options		50		-		-		-		267		-			-			-			-			-			267
Subscription receivable in connection with exercise of stock options		-		-		175		-		933		-			-			(933	)		-			-			-
Balance at June 30, 2019		86,424	$	112		175	$	-	$	724,027	$	(647,643	)	$	(94	)	$	(933	)		(200	)	$	(2,741	)	$	72,728

	Common Stock				Common Stock Subscribed					Additional						Accumulated  Other						Treasury Stock						Total
	Number				Number					Paid-in			Accumulated			Comprehensive			Subscription			Number						Stockholders’
	of Shares		Par Value		of Shares			Par Value		Capital			Deficit			Loss			Receivable			of Shares			Cost			Equity
Balance at December 31, 2017		71,325	$	93		320		$	-	$	609,829		$	(541,586	)	$	(33	)	$	(2,109	)		(200	)	$	(2,741	)	$	63,453
Net loss		-		-		-			-		-			(13,424	)		-			-			-			-			(13,424	)
Foreign currency translation adjustments		-		-		-			-		-			-			(18	)		-			-			-			(18	)
Stock-based compensation expense		-		-		-			-		1,048			-			-			-			-			-			1,048
Cumulative effect of ASU 2014-09 adoption		-		-		-			-		-			35			-			-			-			-			35
Issuance of common stock in connection with at-the-market offering, net of commissions and issuance costs		1,537		2		(320	)		-		7,414			-			-			2,109			-			-			9,525
Subscription of common stock in connection with at-the-market offering, net of commissions		-		-		103			-		750			-			-			(750	)		-			-			-
Balance at March 31, 2018		72,862	$	95		103		$	-	$	619,041		$	(554,975	)	$	(51	)	$	(750	)		(200	)	$	(2,741	)	$	60,619
Net loss		-		-		-			-		-			(15,172	)		-			-			-			-			(15,172	)
Foreign currency translation adjustments		-		-		-			-		-			-			(38	)		-			-			-			(38	)
Stock-based compensation expense		-		-		-			-		2,130			-			-			-			-			-			2,130
Cumulative effect of ASU 2014-09 adoption		-		-		-			-		-			-			-			-			-			-			-
Issuance of common stock in connection with at-the-market offering, net of commissions and issuance costs		2,097		2		-			-		15,288			-			-			-			-			-			15,290
Subscription of common stock in connection with at-the-market offering, net of commissions		-		-		(103	)		-		(750	)		-			-			750			-			-			-
Balance at June 30, 2018		74,959	$	97		-		$	-	$	635,709		$	(570,147	)	$	(89	)	$	-			(200	)	$	(2,741	)	$	62,829

The accompanying notes are an integral part of these condensed consolidated financial statements.

6

PROGENICS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS 

(In thousands)

(Unaudited)

	Six Months Ended
	June 30,
	2019			2018
Cash flows from operating activities:
Net loss	$	(38,435	)	$	(28,596	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense		2,071			3,178
Depreciation and amortization		1,166			590
Non-cash interest expense		139			137
Other		11			(96	)
Change in fair value of contingent consideration liability		1,816			2,100
Changes in assets and liabilities:
Accounts receivable		(6,764	)		164
Other current assets		(2,073	)		63
Other assets		(2,705	)		-
Accounts payable		(169	)		(2,797	)
Accrued expenses		6,446			(77	)
Other current liabilities		39			-
Other liabilities		(242	)		145
Net cash used in operating activities		(38,700	)		(25,189	)
Cash flows from investing activities:
Acquisition of AZEDRA manufacturing assets		(8,000	)		-
Purchases of property and equipment		(1,827	)		(502	)
Portion of MIP milestones paid to former advisor		(277	)		-
Net cash used in investing activities		(10,104	)		(502	)
Cash flows from financing activities:
Net proceeds from issuance of common stock in connection with at-the-market offering		-			24,815
Repayment of debt		(2,590	)		(2,179	)
Proceeds from exercise of stock options		267			-
Net cash (used in) provided by financing activities		(2,323	)		22,636
Effect of currency rate changes on cash, cash equivalents and restricted cash		2			(93	)
Net decrease in cash, cash equivalents, and restricted cash		(51,125	)		(3,148	)
Cash, cash equivalents, and restricted cash at beginning of period		139,220			92,164
Cash, cash equivalents, and restricted cash at end of period	$	88,095		$	89,016
Supplemental disclosure of cash flow information
Cash paid for interest	$	2,131		$	2,381
Non-cash financing activity
Subscription receivable	$	933		$	-

The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets to the total of the same such amounts shown above for the six months ended June 30, 2019 and 2018:

Cash, cash equivalents and restricted cash information
Cash and cash equivalents at beginning of period		137,686		90,642
Restricted cash included in long-term assets at the beginning of period		1,534		1,522
Cash, cash equivalents and restricted cash at beginning of period	$	139,220	$	92,164
Cash and cash equivalents at end of period		84,823		87,490
Restricted cash included in long-term assets at the end of period		3,272		1,526
Cash, cash equivalents, and restricted cash at end of period	$	88,095	$	89,016

The accompanying notes are an integral part of these condensed consolidated financial statements.

7

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

Note 1. Summary of Significant Accounting Policies

Business

Progenics Pharmaceuticals, Inc. (and its subsidiaries collectively the “Company,” “Progenics”, “we”, or “us”) is an oncology company focused on the development and commercialization of innovative targeted medicines and artificial intelligence to find, fight and follow cancer. Highlights of our recent progress include the first commercial revenue for AZEDRA^®, completion of enrollment of the PyL^TM pivotal Phase 3 trial, and dosing of the first patient in the 1095 open label Phase 2 trial. Our pipeline includes therapeutic agents designed to precisely target cancer (AZEDRA, 1095 and PSMA TTC), as well as prostate-specific membrane antigen (“PSMA”) targeted imaging agents for prostate cancer (PyL and 1404).

Recent and Continued Progress:

● AZEDRA Launch – A team of Nuclear Medicine Technologists, Sales Representatives, Medical Science Liaisons and Access Specialists are in the field assisting centers of excellence and payers with utilizing and reimbursing AZEDRA. This quarter we completed the first administrations of commercial AZEDRA and recorded our first commercial sales.

● Centers for Medicare & Medicaid Services ("CMS") approved a new technology add-on payment ("NTAP") for AZEDRA when administered in the hospital inpatient setting for Medicare beneficiaries in FY 2020. The NTAP will cover the lesser of 65 percent of the average cost of AZEDRA, or 65 percent of the costs in excess of the Medicare Severity Diagnosis Related Groups ("MS–DRG") payment for the case. As a result, the maximum NTAP for a case involving a therapeutic dose of AZEDRA is $98,150.

● Patient enrollment for the Phase 3 CONDOR trial evaluating the diagnostic performance and clinical impact of PyL (¹⁸F-DCFPyL) was completed five months ahead of schedule. The Phase 3 CONDOR trial is a multi-center, open label trial that dosed 208 patients with biochemical recurrence of prostate cancer at 14 sites in the U.S. and Canada. Top-line data is expected by year end.

● The first patient was dosed in the ongoing Phase 2 trial of 1095 in combination with enzalutamide in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). Progenics’1095 is a small molecule radiotherapeutic designed to selectively bind to the extracellular domain of prostate specific membrane antigen (“PSMA”), a protein that is highly expressed on prostate cancer cells.

● We reached alignment with the U.S. Food and Drug Administration (“FDA”) on a clinical development plan to support an expanded label for AZEDRA for the treatment of patients with unresectable or metastatic neuroendocrine tumors (“NETs”) who are MIBG-avid. Progenics plans to conduct a basket study that will evaluate AZEDRA in patients with NETs that are MIBG-avid, including gastroenteropancreatic neuroendocrine tumors as well as other NETs and utilize a dosing regimen that enables outpatient administration. The basket study is expected to begin by the end of the year and enroll approximately 150 patients at sites in the U.S. and Canada.

● The U.S. District Court of New Jersey upheld the validity and determined the infringement by Actavis Laboratories FL, Inc. (“Actavis”) of a patent protecting RELISTOR Tablets, which expires in March 2031. Defendant, Actavis, a subsidiary of Teva Pharmaceutical Industries Ltd., had challenged the validity of and had alleged non-infringement of Claims 2 and 5 of U.S. Patent No. 8,524,276, which protects the formulation of RELISTOR Tablets.

● We entered into an exclusive license agreement with ROTOP Pharmaka GmbH (“ROTOP”), a Germany-based developer of radiopharmaceuticals for nuclear medicine diagnostics, to develop and commercialize 1404 in Europe. 1404 is a technetium-99m labeled small molecule which binds to PSMA and is used as an imaging agent to diagnose and detect localized prostate cancer as well as soft tissue and bone metastases. Under the terms of the collaboration, ROTOP will be responsible for the development, regulatory approvals and commercialization of 1404 in Europe while Progenics is entitled to double-digit, tiered royalties on net sales in the territory.

● The automated Bone Scan Index (“aBSI”) automatically segments the anatomical regions of the skeleton and detects and classifies lesions in the bone scans of prostate cancer patients. The aBSI has been shown to be an objective measure of the quantitative change in disease burden and is a prognostic biomarker in patients with metastatic prostate cancer. In August 2019, the Company received 510(k) clearance from the FDA to market its cloud-based version of aBSI product in the U.S. This clearance of our cloud-based software as a medical device is an essential step towards the further development of PSMA AI.

● We entered into a transfer agreement with FUJIFILM Toyama Chemical Co, Ltd. (“FUJIFILM”) for the rights to the Company’s aBSI product in Japan for use under the name BONENAVI^®. Under the terms of the agreement, FUJIFILM acquired, by a combination of purchase and license, the Japanese software, source code, supporting data and all Japanese patents associated with the aBSI product from Progenics for use in Japan. In exchange, Progenics received $4.0 million in an upfront payment and will receive service fees for aBSI and other AI products over three years in Japan. BONENAVI has been licensed to FUJIFILM for use in Japan since 2011.

● We initiated a collaboration that provides the VA Greater Los Angeles Healthcare System (“VAGLAHS”) with access to the Company’s AI platform for investigational use. In the project, the VAGLAHS network will gain access to Progenics’ machine learning platforms, which includes the aBSI and the PSMA AI platforms. The collaboration will explore novel predictive machine learning algorithms from the digital medical images and its associated clinical outcomes. These novel algorithms will be prospectively validated at VAGLAHS for effective healthcare management of veterans with prostate cancer. This project is the nation’s first collaborative effort to validate cutting-edge machine learning tools for improving treatment management of veterans with prostate cancer and provides additional validation to Progenics’ AI platform.

8

Corporate:

● Progenics appointed Huw Jones to the newly created role of Vice President, Commercial. Mr. Jones joins Progenics following several years on the commercial strategy and operations team at Novartis Pharmaceuticals, as well as its subsidiaries, Advanced Accelerator Applications SA and Novartis Oncology. In his two decades at Novartis and its subsidiaries, Mr. Jones held various global leadership roles, including Executive Director and Global Brand Leader, Head of Global Commercial Excellence, as well as positions of increasing responsibility in general management, sales, marketing, training and commercial operations.

Strategic partnerships:

● RELISTOR^® (methylnaltrexone bromide) is licensed to Salix Pharmaceuticals, Inc., a wholly-owned subsidiary of Bausch Health Companies Inc. (“Bausch”, which is the predecessor of Valeant Pharmaceuticals International, Inc.). RELISTOR subcutaneous injection and RELISTOR Tablets are approved by the FDA for the treatment of opioid-induced constipation in adults with chronic non-cancer pain.

● Bayer AG (“Bayer”) has exclusive worldwide rights to develop and commercialize products using our PSMA antibody technology, in combination with Bayer’s alpha-emitting radionuclides. Bayer is developing PSMA TTC, a thorium-227 labeled PSMA-targeted antibody therapeutic. Bayer initiated a Phase 1 trial of PSMA TTC in patients with metastatic castration-resistant prostate cancer. In May 2019, Bayer dosed the first patient in the Phase 1 trial which triggered a $2.0 million milestone payment, recorded as part of the license and other revenue.

● CytoDyn Inc. (“CytoDyn”) acquired leronlimab (PRO 140), which acquisition included a milestone and royalty payment obligations to us. Leronlimab is a fully humanized monoclonal antibody which is a cellular targeting CCR5 entry antagonist and is currently in development for the treatment of HIV. CytoDyn announced in March 2019 that it filed its first of three sections of its Biologics License Application (“BLA”) to the FDA for leronlimab for the treatment of HIV under the Rolling Review process.

● Curium has exclusive rights to develop, manufacture and commercialize PyL (¹⁸F-DCFPyL) in Europe. Under the terms of the collaboration, Curium is responsible for the development, regulatory approvals and commercialization of PyL in Europe, and Progenics is entitled to royalties on net sales of PyL.

● ROTOP has exclusive rights to develop, manufacture and commercialize 1404 in Europe. Under the terms of the collaboration, ROTOP is responsible for the development, regulatory approvals and commercialization of 1404 in Europe. We understand from ROTOP that it plans to hold an expert panel meeting with Key Opinion Leaders (“KOLs”) in the PSMA imaging field, as well as regulatory experts, to review existing data on 1404 and obtain guidance on the clinical development. Upon agreement on a path forward, ROTOP will request a meeting with European regulators and start a clinical trial in early 2020. Under this agreement, Progenics is entitled to double-digit, tiered royalties on future net sales of 1404 in Europe.

● FUJIFILM has rights to the Company’s aBSI product in Japan for use under the name BONENAVI. Under the terms of the agreement, FUJIFILM acquired, by a combination of purchase and license, the Japanese software, source code, supporting data and all Japanese patents associated with the aBSI product from us for use in Japan. In exchange, Progenics received a $4.0 million upfront payment and is entitled to service fees for the next three years.

Our current principal sources of revenue from operations are royalty and development and commercial milestones from Bausch and Bayer. Royalty and further milestone payments from Bausch or Bayer depend on success in development and commercialization of RELISTOR and our PSMA antibody technology, respectively, which is dependent on many factors, such as Bausch or Bayer’s respective efforts, decisions by the FDA and other regulatory bodies, competition from drugs for the same or similar indications, and the outcome of clinical and other testing of the licensed products.

We commenced principal operations in 1988, became publicly traded in 1997, and throughout have been engaged primarily in research and development efforts, establishing corporate collaborations, launching AZEDRA and other related business activities. Certain of our intellectual property rights are held by wholly-owned subsidiaries. Our U.S. operations are presently conducted at our headquarters in New York and our manufacturing facility in Somerset, New Jersey. The operations of our wholly-owned foreign subsidiary, EXINI Diagnostics A.B. (“EXINI”), are conducted at our facility in Lund, Sweden. We operate under a single operating segment, which includes development, manufacturing and commercialization of pharmaceutical products and other technologies to target, diagnose and treat cancer. Our operating segment is regularly evaluated for financial performance by our chief operating decision maker, who is our Chief Executive Officer.

9

Liquidity

At June 30, 2019, we had $84.8 million of cash and cash equivalents, a decrease of $52.9 million from $137.7 million at December 31, 2018. We expect that this amount will be sufficient to fund operations as currently anticipated beyond one year from the filing date of this Quarterly Report on Form 10-Q. We have historically funded our operations to a significant extent from capital-raising and we expect to require additional funding in the future, the availability of which is never guaranteed and may be uncertain. We expect that we may continue to incur operating losses.

Basis of Presentation

Our unaudited condensed consolidated financial statements have been prepared in accordance with applicable presentation requirements, and accordingly, do not include all information and disclosures necessary for a presentation of our financial position, results of operations, and cash flows in conformity with accounting principles generally accepted in the U.S. (“GAAP”). In the opinion of management, these financial statements reflect all adjustments, consisting primarily of normal recurring accruals necessary for a fair statement of results for the periods presented. The results of operations for interim periods are not necessarily indicative of the results for the full year.

Our unaudited condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2018. The year-end consolidated balance sheet data in these financial statements were derived from audited financial statements but do not include all disclosures required by GAAP.

Principles of Consolidation

The condensed consolidated financial statements include the accounts of Progenics as well as its wholly-owned subsidiaries. All material intercompany transactions and balances have been eliminated in consolidation.

Use of Estimates

The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results may differ from those estimates.

Revenue Recognition

We recognize revenue when our customers obtain control of the promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To account for our revenue arrangements, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy our performance obligations.

For contracts determined to be within the scope of ASU 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09” or the “Topic 606”), we assess the goods or services promised within each contract for the purpose of identifying them as performance obligations. We must apply judgement in assessing whether each promised good or service is distinct. If a promised good or service is not distinct, we will combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct.

The transaction price is then determined and allocated to the identified performance obligations in proportion to their estimated fair value, which requires significant judgment. Variable consideration, which is estimated using the expected value method or the most likely amount method, is included in the transaction price only if, in our judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur.

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For arrangements that include development, regulatory or sales milestone payments, we evaluate whether the milestones are probable of being reached and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within our control or the licensee’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received.

We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

The following table summarizes our revenue streams from contracts with customers for the three and six months ended June 30, 2019 and 2018 (in thousands):

	Three months ended June 30,				Six months ended June 30,
	2019		2018		2019		2018
Product sales	$	270	$	-	$	270	$	-
Royalty income		3,593		3,530		7,754		6,588
License and other revenue		6,103		348		6,223		479
Total revenue	$	9,966	$	3,878	$	14,247	$	7,067

Product sales – represent revenue from sales of AZEDRA directly to hospitals. Our performance obligations are to provide AZEDRA based on sales orders from hospitals, which have been verified by our commercial team as properly credentialed to receive, handle, administer and dispose of radioactive materials. We recognize revenue after the customer takes title and has obtained control of the product. Our contracts with hospitals stipulate that product is shipped free on board destination. We invoice hospitals after the products have been delivered and invoice payments are generally due within 60 days of invoice date. We record sales to hospitals based on AZEDRA’s list price per mCi and the amount prescribed based upon a dosimetric assessment of each patient. We record product sales net of any variable consideration due to rebates and discounts provided under governmental and other programs, and other sales-related deductions, such as product returns and copay assistance programs. Shipping and handling costs associated with finished goods delivered to customers are recorded as a selling expense.

Royalty income – represents revenue from the sales-based royalties under our intellectual property licensing arrangements and is recognized upon net sales of the licensed products.

License and other revenue – represents revenue from upfront payments (fixed consideration) and development and sales milestones, sublicense payments, support and service payments and sales-based bonus payments (variable consideration) under our licensing or software arrangements. The fixed consideration will be recognized as revenue at the time when the transfer of know-how is completed. The variable consideration will be estimated using the most likely amount method and recognized only when we have “a high degree of confidence” that revenue will not be reversed in a subsequent reporting period. The other revenue also includes revenue from product sales of research reagents, that is recognized upon shipment to the end customer (i.e. control of the product is deemed to be transferred).

We had receivable contract balances of $10.6 million and $3.8 million as of June 30, 2019 and December 31, 2018, respectively, primarily related to the royalty revenue and upfront and milestone payments under our partnerships, which are included in license and other revenue (see Note 5. Accounts Receivable).

Restricted Cash

Restricted cash included in long-term assets of $3.3 million and $1.5 million at June 30, 2019 and December 31, 2018, respectively, represents collateral for a letter of credit securing a lease obligation (for both periods), collateral for a letter of credit related to equipment purchases and a security deposit with the German District Court related to the PSMA-617 litigation (for the 2019 period). We believe the carrying value of this asset approximates fair value.

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Foreign Currency Translation

Our international subsidiaries generally consider their respective local currency to be their functional currency. Assets and liabilities of these international subsidiaries are translated into U.S. dollars at quarter-end exchange rates and revenues and expenses are translated at average exchange rates during the quarter and year-to-date period. Foreign currency translation adjustments for the reported periods are included in accumulated other comprehensive loss in our condensed consolidated statements of comprehensive loss, and the cumulative effect is included in the stockholders’ equity section of our condensed consolidated balance sheets. Realized gains and losses denominated in foreign currencies are recorded in operating expenses in our condensed consolidated statements of operations and were not material to our consolidated results of operations for the three and six months ended June 30, 2019 or 2018.

Leases

We determine whether an arrangement is or contains a lease at its inception. We recognize lease liabilities based on the present value of the minimum lease payments not yet paid by using the lease term and discount rate determined at lease commencement. As most of our leases do not provide an implicit rate, we use our incremental borrowing rate to determine the present value of our lease payments. Our leases may include options to extend or terminate a lease when it is reasonably certain that we will exercise that option. We recognize the operating right-of-use (“ROU”) lease assets at amounts equal to the lease liability adjusted for prepaid or accrued rent, remaining balance of any lease incentives and unamortized initial direct costs.

The operating lease liabilities are reported in other current liabilities and other noncurrent liabilities and the related ROU lease assets are reported in other noncurrent assets on our condensed consolidated balance sheets. Lease expense for our operating leases is calculated on a straight-line basis over the lease term and is reported in research and development and selling, general and administrative expenses on our condensed consolidated statements of operations. We do not recognize a lease liability or ROU lease assets for leases whose lease terms, at commencement, are twelve months or less, or for leases which are below the established capitalization threshold.

Property and Equipment

Property and equipment is recorded at historical cost, net of accumulated depreciation and amortization of $3.1 million and $2.7 million as of June 30, 2019 and December 31, 2018, respectively. The following table summarizes our property and equipment (in thousands):

	June 30,			December 31,
	2019			2018
Machinery and equipment	$	3,949		$	2,992
Leasehold improvements		3,052			1,734
Computer equipment		632			721
Furniture and fixtures		909			878
Construction in progress		1,612			317
Property and equipment, gross		10,154			6,642
Less - accumulated depreciation		(3,146	)		(2,698	)
Property and equipment, net	$	7,008		$	3,944

Note 2. New Accounting Pronouncements 

Recently Adopted

In February 2016, the FASB issued ASU 2016-02 (“ASU 2016-02”), Leases (Topic 842). This standard established a right-of-use model that requires all lessees to recognize right-of-use assets and liabilities on their balance sheet that arise from leases with terms longer than 12 months as well as provide disclosures with respect to certain qualitative and quantitative information related to their leasing arrangements.

The FASB has subsequently issued the following amendments to ASU 2016-02, which have the same effective date and transition date of January 1, 2019, and which we collectively refer to as the new leasing standards:

● ASU No. 2018-01, Leases (Topic 842): Land Easement Practical Expedient for Transition to Topic 842, which permits an entity to elect an optional transition practical expedient to not evaluate under Topic 842 land easements that exist or expired prior to adoption of Topic 842 and that were not previously accounted for as leases under the prior standard, ASC 840, Leases.

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● ASU No. 2018-10, Codification Improvements to Topic 842, Leases, which amends certain narrow aspects of the guidance issued in ASU 2016-02.

● ASU No. 2018-11, Leases (Topic 842): Targeted Improvements, which allows for a transition approach to initially apply ASU 2016-02 at the adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption as well as an additional practical expedient for lessors to not separate non-lease components from the associated lease component.

● ASU No. 2018-20, Narrow-Scope Improvements for Lessors, which contains certain narrow scope improvements to the guidance issued in ASU 2016-02.

● ASU No. 2019-01, Leases (Topic 842): Codification Improvements.

We adopted the new leasing standards on January 1, 2019, using a modified retrospective transition approach to be applied to leases existing as of, or entered into after, January 1, 2019 and did not adjust comparative periods. We also elected the package of practical expedients permitted under this standard, which among other things, allowed us to carry forward the lease classification for our existing leases. In preparation for the adoption of this standard and to enable preparation of the required financial information, we implemented new internal controls and processes.

The adoption of this standard impacted our 2019 opening consolidated balance sheet as we recorded operating lease liabilities of $15.3 million and ROU lease assets of $13.5 million, which equals the lease liabilities net of deferred rent and lease incentives previously recorded on our balance sheet under the old guidance. The adoption of this standard did not have an impact on our consolidated statements of operations or cash flows.

Recently Issued 

In August 2018, the FASB issued ASU 2018-13 (“ASU 2018-13”), Fair Value Measurement - Disclosure Framework (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement. The updated guidance improves the disclosure requirements on fair value measurements. ASU 2018-13 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Early adoption is permitted for any removed or modified disclosures. We are currently assessing the timing of adopting the updated provisions and the impact of the updated provisions on our consolidated financial statements.

In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. In November 2018, the FASB issued ASU 2018-19, Codification Improvements to Topic 326, Financial Instruments-Credit Losses and in April 2019, the FASB issued ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments—Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, which amend the scope and transition requirements of ASU 2016-13. The standard requires a financial asset (or a group of financial assets) measured at amortized cost basis to be presented at the net amount expected to be collected. The measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions and reasonable and supportable forecasts that affect the collectability of the reported amount. In May 2019, the FASB issued ASU 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief. This ASU addresses certain stakeholders’ concerns by providing an option to irrevocably elect the fair value option for certain financial assets previously measured at amortized cost basis. For those entities, the targeted transition relief will increase comparability of financial statement information by providing an option to align measurement methodologies for similar financial assets. Furthermore, the targeted transition relief also may reduce the costs for some entities to comply with the amendments in Update 2016-13 while still providing financial statement users with decision-useful information. The standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. We are currently evaluating the impact this guidance will have on our consolidated financial statements.

Note 3. Net Loss Per Share

Our basic net loss per share amounts have been computed by dividing net loss by the weighted-average number of common shares outstanding during the period. For the three and six months ended June 30, 2019 and 2018, we reported net losses and, accordingly, potential common shares were not included since such inclusion would have been anti-dilutive.

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The calculations of net loss per share, basic and diluted, are as follows (amounts in thousands, except per share data):

				Weighted-Average
				Shares
	Net Loss			Outstanding		Per Share
	(Numerator)			(Denominator)		Amount
Three months ended June 30, 2019
Basic and diluted	$	(19,700	)		85,000	$	(0.23	)
Six months ended June 30, 2019
Basic and diluted	$	(38,435	)		84,772	$	(0.45	)
Three months ended June 30, 2018
Basic and diluted	$	(15,172	)		74,017	$	(0.20	)
Six months ended June 30, 2018
Basic and diluted	$	(28,596	)		73,271	$	(0.39	)

The following table summarizes anti-dilutive common shares or common shares where performance conditions have not been met, that were excluded from the calculation of diluted net loss per share (in thousands):

	Three Months Ended June 30,				Six Months Ended June 30,
	2019		2018		2019		2018
Stock options		6,298		3,237		6,382		3,236
Contingent consideration liability (1)		778		2,351		778		2,351
Total securities excluded		7,076		5,588		7,160		5,587

⁽¹⁾ Calculated as follows: (a) the contingent consideration liability balance divided by (b) the closing stock price of our common stock.

Note 4. Fair Value Measurements

To estimate the fair values of our financial assets and liabilities, we use valuation approaches within a hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of us. Unobservable inputs are inputs that reflect our assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy is divided into three levels based on the source of inputs as follows:

● Level 1 – Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that we have the ability to access

● Level 2 – Valuations for which all significant inputs are observable, either directly or indirectly, other than Level 1 inputs

● Level 3 – Valuations based on inputs that are unobservable and significant to the overall fair value measurement

The availability of observable inputs can vary among the various types of financial assets and liabilities. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, the inputs used for measuring fair value may fall into different levels of the fair value hierarchy. In such cases, for financial statement disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is categorized is based on the lowest level of input used that is significant to the overall fair value measurement.

We believe the carrying amounts of our cash equivalents, restricted cash, accounts receivable, other current assets, other assets, accounts payable and accrued expenses approximated their fair values as of June 30, 2019 and December 31, 2018.

We record the contingent consideration liability resulting from our acquisition of Molecular Insight Pharmaceuticals, Inc. (“MIP”) at fair value in accordance with Accounting Standards Codification (“ASC”) 820 (Topic 820, Fair Value Measurement).

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The following tables summarize each major class of our financial assets and liabilities measured at fair value on a recurring basis as of the dates indicated, classified by valuation hierarchy (in thousands):

			Fair Value Measurements at June 30, 2019
			Quoted Prices in Active		Significant Other		Significant
	Balance at		Markets for		Observable		Unobservable
	June 30,		Identical Assets		Inputs		Inputs
	2019		(Level 1)		(Level 2)		(Level 3)
Assets:
Money market funds	$	82,737	$	82,737	$	-	$	-
Total assets	$	82,737	$	82,737	$	-	$	-
Liabilities:
Contingent consideration liability	$	4,800	$	-	$	-	$	4,800
Total liabilities	$	4,800	$	-	$	-	$	4,800

			Fair Value Measurements at December 31, 2018
			Quoted Prices in Active		Significant Other		Significant
	Balance at		Markets for		Observable		Unobservable
	December 31,		Identical Assets		Inputs		Inputs
	2018		(Level 1)		(Level 2)		(Level 3)
Assets:
Money market funds	$	136,052	$	136,052	$	-	$	-
Total assets	$	136,052	$	136,052	$	-	$	-
Liabilities:
Contingent consideration liability	$	11,000	$	-	$	-	$	11,000
Total liabilities	$	11,000	$	-	$	-	$	11,000

The contingent consideration liability of $4.8 million as of June 30, 2019 represents the estimated fair value of the future potential milestone payments to former MIP stockholders (shown in the tables below).

Milestone payments due upon first commercial sale and/or from proceeds received from license revenue (in thousands):

Program	Consideration		Form of Payment
1095		5,000	Cash or Progenics common stock
1404		9,984	Cash or Progenics common stock or cash in the case of license revenue
	$	14,984

Net sales milestone payments due upon first achievement of specified net sales target in any single calendar year across all MIP-related programs (in thousands):

	Consideration		Form of Payment at Progenics' Option
$30 million	$	5,000	Cash or Progenics common stock
$60 million		5,000	Cash or Progenics common stock
$100 million		10,000	Cash or Progenics common stock
$250 million		20,000	Cash or Progenics common stock
$500 million		30,000	Cash or Progenics common stock
	$	70,000

We consider this liability a Level 3 instrument (one with significant unobservable inputs) in the fair value hierarchy. The estimated fair value was determined based on probability adjusted discounted cash flow and Monte Carlo simulation models that included significant estimates and assumptions pertaining to commercialization events and sales targets. The most significant unobservable inputs are the probabilities of achieving regulatory approval of the development projects and subsequent commercial success.

Significant changes in any of the probabilities of success or the probabilities as to the periods in which milestones will be achieved would result in a significantly higher or lower fair value measurement. We record the contingent consideration liability at fair value with changes in estimated fair values recorded in change in contingent consideration liability in our condensed consolidated statements of operations.

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The following table summarizes quantitative information and assumptions pertaining to the fair value measurement of the Level 3 inputs at June 30, 2019 and December 31, 2018 (in thousands). The decrease in the contingent consideration liability of $6.2 million during the six months ended June 30, 2019 was primarily due to an $8.0 million payment for the AZEDRA first commercial sale milestone, which was partially offset by an increase in the AZEDRA sales forecasts associated with the planned initiation of a basket study to expand the label for AZEDRA and a decrease in the discount period used to calculate the present value of the contingent consideration liability.

	Fair Value at
	June 30,
	2019		Valuation Technique	Unobservable Input	Assumption
Contingent Consideration Liability:
1095 commercialization	$	450	Probability adjusted discounted	Probability of success		18%
			cash flow model	Period of expected milestone achievement		2026
				Discount rate		10%
1404 commercialization		250	Probability adjusted discounted	Probability of success		43%
			cash flow model	Period of expected milestone achievement	2022	-	2035
				Discount rate		10%
Net sales targets		4,100	Monte-Carlo simulation	Probability of success	18%	-	90%
				Discount rate		10%
Total	$	4,800

	Fair Value at
	December 31,
	2018		Valuation Technique	Unobservable Input	Assumption
Contingent Consideration Liability:
AZEDRA commercialization	$	7,050	Probability adjusted discounted	Probability of success		90%
			cash flow model	Period of expected milestone achievement		2019
				Discount rate		10%
1095 commercialization		450	Probability adjusted discounted	Probability of success		18%
			cash flow model	Period of expected milestone achievement		2026
				Discount rate		10%
Net sales targets		3,500	Monte-Carlo simulation	Probability of success	18%	-	90%
				Discount rate		10%
Total	$	11,000

For those financial instruments with significant Level 3 inputs, the following table summarizes the activities for the periods indicated (in thousands):

	Liability - Contingent Consideration
	Fair Value Measurements Using
	Significant Unobservable Inputs
	(Level 3)
	Three Months Ended June 30,					Six Months Ended June 30,
	2019			2018		2019			2018
Balance at beginning of period	$	11,900		$	17,600	$	11,000		$	16,800
Fair value change included in net loss		916			1,300		1,816			2,100
Payments		(8,016	)		-		(8,016	)		-
Balance at end of period	$	4,800		$	18,900	$	4,800		$	18,900
Changes in unrealized gains or losses for the period included in earnings (or changes in net assets) for liabilities held at the end of the reporting period	$	916		$	1,300	$	1,816		$	2,100

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Note 5. Accounts Receivable

Our accounts receivable represent amounts due to us from royalties, collaborators, product sales and, to a small extent, sales of research reagents, and consisted of the following at June 30, 2019 and December 31, 2018 (in thousands):

	June 30,		December 31,
	2019		2018
Royalties	$	3,593	$	3,151
Bayer milestone		2,000		-
FUJIFILM transfer		4,000		-
Other		976		652
Accounts receivable, net	$	10,569	$	3,803

Note 6. Recent Acquisition, Goodwill, In-Process Research and Development and Other Intangible Assets

Recent Acquisition

In February 2019, we acquired the AZEDRA manufacturing assets for $8.0 million cash consideration and entered into a sublease agreement for the radiopharmaceutical manufacturing facility located in Somerset, New Jersey. The Somerset site serves as the launch facility for AZEDRA and will also provide manufacturing support for the Company’s development stage radiopharmaceuticals, including 1095. The production of AZEDRA uses a proprietary Ultratrace^® process which concentrates the MIBG targeted radiolytic activity by eliminating non-therapeutic “cold” MIBG molecules, giving AZEDRA a uniquely high specific activity.

Purchase Price Allocation: We accounted for this acquisition as a business combination by allocating the consideration we paid to the fair values of the assets acquired at the effective date of the acquisition, as summarized below. The difference between the fair value of the acquisition consideration and the estimated fair value of the identifiable assets represents potential future economic benefits arising from the acquisition, and has been recorded as goodwill.

The following table summarizes the allocation of the consideration paid to the estimated fair values of the assets acquired as of the acquisition date (in thousands):

	Amount
Cash consideration	$	8,000
Tangible assets acquired:
Machinery and equipment		682
Leasehold improvements		1,300
Total tangible assets acquired		1,982
Intangible assets - Somerset		1,245
Total tangible and intangible assets acquired		3,227
Goodwill	$	4,773

The replacement cost method, a variation of the cost approach, was applied to assess the value of the assets acquired by Progenics. The principle behind this method is that the value represents the current cost of a similar new asset having the nearest equivalent utility as the asset being valued. It generally represents the maximum amount that a prudent investor will pay for a comparable asset. The cost approach provides a systematic framework for estimating the value of tangible or intangible assets based on the economic principle of substitution, and that no prudent investor will purchase an existing asset for more than it will cost to create a comparable asset. Under this approach, value is estimated by developing the cost to either replace or reproduce (replicate) the asset of similar utility.

The acquired Somerset intangible assets represent manufacturing know-how, which is comprised of documented technical data and information, formulae, standards, specifications, processes, methods, code books, as well as all information, knowledge, trade practices and secrets utilized by the Somerset facility in manufacturing of the AZEDRA. We estimate the remaining useful life of the Somerset intangible to be approximately six years.

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Goodwill, In-Process Research and Development and Other Intangible Assets

The fair values of in-process research and development (“IPR&D”) and other identified intangible assets acquired in business combinations are capitalized. We utilize the “income method,” which applies a probability weighting that considers the risk of development and commercialization to the estimated future net cash flows that are derived from projected sales revenues and estimated costs or “replacement costs”, whichever is greater. These projections are based on factors such as relevant market size, patent protection, historical pricing of similar products and expected industry trends. The estimated future net cash flows are then discounted to the present value using an appropriate discount rate. This analysis is performed for each IPR&D project and other identified intangible assets, independently. IPR&D assets are treated as indefinite-lived intangible assets until completion or abandonment of the projects, at which time the assets are amortized over the remaining useful life or written off, as appropriate. Other identified intangible assets, which include the technology asset acquired as part of the EXINI business combination, AZEDRA product rights intangible and Somerset intangible, are amortized over the relevant estimated useful lives. The IPR&D assets are tested for impairment at least annually or when a triggering event occurs that could indicate a potential impairment and any impairment loss is recognized in our condensed consolidated statements of operations.

Goodwill represents excess consideration in a business combination over the fair value of identifiable net assets acquired. Goodwill is not amortized but is subject to impairment testing at least annually or when a triggering event occurs that could indicate a potential impairment. We determine whether goodwill may be impaired by comparing the fair value of the reporting unit (we have determined that we have only one reporting unit for this purpose), calculated as the product of shares outstanding and the share price as of the end of a period, to its carrying value (for this purpose, our total stockholders’ equity). No goodwill impairment has been recognized as of June 30, 2019 or 2018.

The following tables summarize the activity related to our goodwill and intangible assets (in thousands):

					Other
					Intangible
	Goodwill		IPR&D		Assets
Balance at January 1, 2019	$	13,074	$	600	$	6,066
Increase related to Somerset acquisition		4,773		-		1,245
Amortization expense		-		-		(536	)
Balance at June 30, 2019	$	17,847	$	600	$	6,775

					Other
					Intangible
	Goodwill		IPR&D		Assets
Balance at January 1, 2018	$	13,074	$	28,700	$	1,669
Amortization expense		-		-		(106	)
Balance at June 30, 2018	$	13,074	$	28,700	$	1,563

The following table reflects the components of the finite-lived intangible assets as of June 30, 2019 (in thousands):

	Gross Amount		Accumulated Amortization		Net Carrying Value
Intangible assets - AZEDRA product rights	$	4,900	$	642	$	4,258
Intangible assets - Somerset		1,245		80		1,165
Intangible assets - EXINI technology		2,120		768		1,352
Total	$	8,265	$	1,490	$	6,775

Note 7. Accrued Expenses

The carrying value of our accrued expenses approximates fair value, as it represents amounts that will be satisfied within one year. Accrued expenses consisted of the following at June 30, 2019 and December 31, 2018 (in thousands):

	June 30,		December 31,
	2019		2018
Accrued legal and professional fees	$	6,763	$	1,305
Accrued clinical trial costs		4,514		2,318
Accrued payroll and related costs		2,254		2,871
Accrued contract manufacturing costs		1,753		2,516
Accrued consulting costs		734		862
Other		920		661
Accrued expenses	$	16,938	$	10,533

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Note 8. Commitments and Contingencies

We are or may be involved in disputes, governmental and/or regulatory inspections, inquiries, investigations, and proceedings that could result in litigation, and other litigation matters that arise from time to time. The process of resolving matters through litigation or other means is inherently uncertain and it is possible that an unfavorable resolution of these matters will adversely affect us, our results of operations, financial condition, and cash flows. While it is not possible to accurately predict or determine the eventual outcomes of these items, an adverse determination in one or more of these items currently pending could have a material adverse effect on our consolidated results of operations, financial position, or cash flows.

Abbreviated New Drug Application Litigations

RELISTOR Subcutaneous Injection

Paragraph IV Certifications - Mylan

On or about October 6, 2015, November 20, 2015, December 22, 2015, and December 23, 2015, Progenics, Salix Pharmaceuticals, Inc. (“Salix”) and Wyeth LLC (“Wyeth”) received four separate notifications of a Paragraph IV certification for RELISTOR (methylnaltrexone bromide) subcutaneous injection, for certain patents that are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, also known as “the Orange Book.” The certifications resulted from the filing by Mylan Pharmaceuticals Inc. of an Abbreviated New Drug Application (“ANDA”) with the FDA, challenging such patents for RELISTOR subcutaneous injection and seeking to obtain approval to market a generic version of RELISTOR subcutaneous injection before some or all of these patents expire.

District Court Actions

Progenics, Salix, Valeant (now Bausch Health Companies Inc., “Bausch”), and Wyeth filed suit against Mylan Pharmaceuticals, Inc. and Mylan Inc. in the District of New Jersey on November 19, 2015 (2:15-cv-8180-SRC-CLW) seeking declaratory judgment of infringement of U.S. Patent Nos. 8,247,425, 8,420,663, 8,552,025, and 8,822,490 based upon Mylan Pharmaceutical Inc.’s filing of its ANDA seeking to obtain approval to market a generic version of RELISTOR vials before some or all of these patents expire. On February 4, 2016, Progenics, Salix, Bausch, and Wyeth filed an amended complaint, identifying Mylan Laboratories Ltd. as an additional Defendant, and further seeking declaratory judgment of infringement of U.S. Patent No. 9,180,125. Progenics, Salix, Bausch, and Wyeth filed suit against Mylan Pharmaceuticals, Inc., Mylan Laboratories Ltd., and Mylan Inc. in the District of New Jersey on January 4, 2016 (2:16-cv-00035-SRC-CLW) seeking declaratory judgment of infringement of U.S. Patent Nos. 8,247,425, 8,420,663, 8,552,025, and 8,822,490 based upon Mylan Pharmaceutical Inc.’s filing of its ANDA seeking to obtain approval to market a generic version of RELISTOR prefilled syringes before some or all of these patents expire. On January 25, 2016, Progenics, Salix, Bausch, and Wyeth filed an amended complaint, further seeking declaratory judgment of infringement of U.S. Patent No. 9,180,125. Progenics, Salix, Bausch, and Wyeth filed suit against Mylan Pharmaceuticals, Inc., Mylan Laboratories Ltd., and Mylan Inc. in the District of New Jersey on September 1, 2017 (2:17-cv-06714-SRC-CLW) seeking declaratory judgment of infringement of U.S. Patent No. 9,669,096 based upon Mylan Pharmaceutical Inc.’s filing of ANDAs seeking to obtain approval to market generic versions of RELISTOR vials and prefilled syringes before the patents expires. On September 18, 2017, Progenics, Salix, Bausch, and Wyeth filed an amended complaint, further seeking declaratory judgment of infringement of U.S. Patent No. 9,492,445.

The 2:15-cv-8180-SRC-CLW, 2:16-cv-00035-SRC-CLW, 2:15-cv-08353-SRC-CLW, and 2:16-cv-00889-SRC-CLW actions were consolidated into a single action in the District of New Jersey (2:15-cv-08180-SRC-CLW). On May 1, 2018, the Court granted Plaintiffs’ motion for partial summary judgment as to the validity of claim 8 of U.S. Patent No. 8,552,025. On May 23, 2018, the Court entered an order for final judgment under Fed. R. Civ. P. 54(b) in favor of Plaintiffs and against Mylan as to claim 8 of the ’025 patent.

Litigation in the 2:17-cv-06714-SRC-CLW action is underway. Fact discovery in this action has closed and expert discovery deadlines have not yet been set. This action has been consolidated for purposes of trial only with the 2:15-cv-8180 action.

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Federal Circuit Appeal

On May 25, 2018, Mylan filed a Notice of Appeal to the United States Court of Appeals for the Federal Circuit. The matter is currently pending on appeal at the Federal Circuit.

On July 9, 2018, Bausch and Salix filed a motion to disqualify Katten Muchin Rosenman LLP as counsel for Mylan. On July 17, 2018, an order was issued stating the briefing on the merits of Mylan’s appeal pending the disposition of the motion to disqualify. Oral argument was held on September 12, 2018. A decision disqualifying Katten Muchin Rosenman LLP as counsel for Mylan was issued on February 8, 2019, by the Federal Circuit. Merits briefing is currently underway. Mylan submitted its opening brief on April 9, 2019. Plaintiffs filed their responsive brief on July 2, 2019. Mylan filed its reply brief on August 6, 2019.

Paragraph IV Certification – Actavis

On or about October 27, 2015, January 5, 2016, and January 8, 2016, Progenics, Salix and Wyeth received three separate notifications of a Paragraph IV certification for certain patents for RELISTOR (methylnaltrexone bromide) subcutaneous injection, for certain patents that are listed in the FDA’s Orange Book. The certifications resulted from the filing by Actavis LLC of an ANDA with the FDA, challenging such patents for RELISTOR subcutaneous injection and seeking to obtain approval to market a generic version of RELISTOR subcutaneous injection before some or all of these patents expire.

Settlement Agreement - Actavis

On May 25, 2018, Progenics, Bausch, Salix, Wyeth (Progenics, Bausch and Salix, each “Plaintiff” and collectively “Plaintiffs”) and Actavis LLC (“Actavis”) entered into a Settlement and License Agreement (the “Actavis Agreement”) relating to Civil Action No. 2:15-cv-08180 and Civil Action No. 2:17-cv-06714. The following is a summary of the material terms of the Actavis Agreement. The Actavis Agreement provides for a full settlement and release by both Plaintiffs and Actavis of all claims that were or could have been asserted in the District Court Cases and all resulting damages or other remedies. Plaintiffs and Actavis have agreed to and, in fact, filed a Stipulated Consent Judgment and Injunction after the execution of the Actavis Agreement. Plaintiffs and Actavis have further acknowledged and agreed that the 30-month stay imposed by the FDA in relation to the approval of Actavis’ ANDAs for the Actavis Products (the “Actavis ANDAs”) should be terminated.

Under the Actavis Agreement, Plaintiffs grant Actavis a non-exclusive, royalty-free, non-transferable, non-sublicensable, limited license under the Patents-In-Suit to make, import, and sell each of the Actavis Products in the U.S. beginning on the earliest of (a) January 1, 2028; (b) for each of the Actavis Products, if Actavis is a “First Applicant” (as defined in 21. U.S.C. § 355(j)(5)(B)(iv)(II)) and has not forfeited, relinquished or otherwise waived its 180-day exclusivity, 180 days prior to the date on which an entity not a First Applicant is permitted to commercially sell such Actavis Product in the U.S. under authorization from Plaintiffs; (c) for each of the Actavis Products, if Actavis either is not a First Applicant or otherwise has forfeited, relinquished or otherwise waived its 180-day exclusivity, the earlier of (i) 181 days after any third party that is a First Applicant markets a corresponding single-dose vial or pre-filled syringe that has been FDA approved or submitted for approval under an ANDA as a generic version of RELISTOR^® Injection for subcutaneous use (the “Generic Products”) in the U.S., or (ii) the date on which a third party that is either not a First Applicant or otherwise has waived its 180-day exclusivity markets, or is first authorized by Plaintiffs to begin marketing, such Generic Product; (d) for each of the Actavis Products, the date on which a third party that has sought or received approval from the FDA under a “New Drug Application” (as defined in the US Federal Drug and Cosmetic Act and regulations promulgated thereunder) (“NDA”) for a corresponding single-dose vial or pre-filled syringe of methylnaltrexone bromide for subcutaneous use for which RELISTOR^® Injection is the listed drug (a “Section 505(b)(2) Applicant”) markets or is first authorized by Plaintiffs to begin marketing such corresponding product; (e) for each of the Actavis Products, the date on which a corresponding generic version of the single-dose vial or pre-filled syringe of methylnaltrexone bromide for subcutaneous use approved under NDA No. 021964 for RELISTOR^® Injection that is marketed or intended for marketing in the U.S. without the RELISTOR^® trademark (an “Authorized Generic Product”) is first marketed in the U.S. by a third party; or (f) the earlier of (i) the date on which a final court decision is entered holding that each of the unexpired claims of the Patents-In-Suit are invalid and/or unenforceable, or (ii) the date on which the Patents-In-Suit have expired, been permanently abandoned, or delisted from the Orange Book. The Actavis Agreement also gives Actavis a limited right to grant sublicenses to its affiliates for certain pre-marketing activities.

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Paragraph IV Certification - Par

On or about July 15, 2017, Progenics, Salix and Wyeth received notification of a Paragraph IV certification for RELISTOR (methylnaltrexone bromide) subcutaneous injection, for certain patents that are listed in the FDA’s Orange Book. The certification resulted from the filing by Par Sterile Products, LLC (“Par Sterile”) of an ANDA with the FDA, challenging such patents for RELISTOR subcutaneous injection and seeking to obtain approval to market a generic version of RELISTOR subcutaneous injection before some or all of these patents expire.

District Court Actions

Progenics, Salix, Bausch, and Wyeth filed suit against Par Sterile Products, Par Pharmaceutical, Inc. (“Par Pharmaceutical” and, together with Par Sterile, “Par”), and Endo International plc in the District of New Jersey on August 25, 2017 (2:17-cv-06449-SRC-CLW) seeking declaratory judgment of infringement of U.S. Patent Nos. 8,247,425, 8,420,663, 8,552,025, 8,822,490, 9,180,125, and 9,669,096 based upon Par Sterile Product’s filing of an ANDA seeking to obtain approval to market a generic version of RELISTOR vials before some or all of these patents expire.

Progenics, Salix, Bausch, and Wyeth filed suit against Par Sterile Products, Par Pharmaceutical, and Endo International plc in the Southern District of New York on August 25, 2017 (1:17-cv-06557-PAE) seeking declaratory judgment of infringement of U.S. Patent Nos. 8,247,425, 8,420,663, 8,552,025, 8,822,490, 9,180,125, and 9,669,096 based upon Par Sterile Product’s filing of an ANDA seeking to obtain approval to market a generic version of RELISTOR vials before some or all of these patents expire. This action was voluntarily dismissed on November 30, 2017.

Settlement Agreement - Par

On May 10, 2018, Progenics, Bausch, Salix, Wyeth and Par entered into a Settlement and License Agreement (the “Par Agreement”) relating to Civil Action No. 17-06449-SRC-CLW (the “District Court Case”). The following is a summary of the material terms of the Par Agreement.

The Par Agreement provides for a full settlement and release by both Plaintiffs and Par of all claims that were or could have been asserted in the District Court Case and all resulting damages or other remedies. Plaintiffs and Par have agreed to and, in fact, filed a Stipulated Consent Judgment and Injunction after the execution of the Par Agreement. Plaintiffs and Par have further acknowledged and agreed that the 30-month stay imposed by the FDA in relation to the approval of Par’s ANDA for the Par Products (the “Par ANDA”) should be terminated.

Under the Par Agreement, Plaintiffs grant Par a non-exclusive, royalty-free, non-transferable, non-sublicensable, limited license under the Patents-In-Suit to make, import, and sell the Par Products in the U.S., or make outside the U.S. solely for importation into the U.S. (the “Par License”) beginning on the earliest of (i) September 30, 2030; (ii) for either of the Par Products, one hundred eighty-one (181) days after any third party who is the “First Applicant” (as defined in 21. U.S.C. § 355(j)(5)(B)(iv)(II)) markets a single-dose vial or pre-filled syringe that has been FDA approved or submitted for approval under an ANDA as a generic version of RELISTOR^® Injection for subcutaneous use (the “Generic Products”); (iii) for either of the Par Products, the date on which a non-First Applicant third party markets an authorized generic (under the RELISTOR^® New Drug Application (“NDA”) but without the RELISTOR^® trademark) single-dose vial or pre-filled syringe of methylnaltrexone bromide for subcutaneous use in the U.S.; (iv) for either of the Par Products, the date on which a third party who is not a First Applicant (or who is a First Applicant who has forfeited or otherwise waived its 180-day exclusivity) markets or is first authorized by Plaintiffs to market the Generic Products in the U.S.; (v) the date on which a final court decision is entered holding that each of the asserted claims against Par in the District Court Case from the Patents-In-Suit are invalid and/or unenforceable, or not infringed by the single-dose vial Par Product; or (vi) the date on which the Patents-In-Suit have expired, been permanently abandoned or delisted from the FDA’s Orange Book. Plaintiffs have also granted to Par a limited pre-commercialization license to manufacture and/or import the Par Products into the U.S. starting one hundred fifty (150) days prior to the effective date of the Par License solely to the extent reasonably necessary to enable Par to market the Par Products in the U.S. on or after the effective date of the Par License.

RELISTOR Tablets - Actavis

Paragraph IV Certifications

On or about October 24, 2016 and October 24, 2017, Progenics, Salix, Bausch and Wyeth received two separate notifications of a Paragraph IV certification for RELISTOR (methylnaltrexone bromide) tablets, for certain patents that are listed in the FDA’s Orange Book. The certification resulted from the filing by Actavis Laboratories Fl., Inc. (“Actavis”) of an ANDA with the FDA, challenging such patents for RELISTOR tablets and seeking to obtain approval to market a generic version of RELISTOR tablets before some or all of these patents expire.

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District Court Actions

Progenics, Salix, Bausch, and Wyeth filed suit against Actavis, Actavis LLC, Teva Pharmaceuticals USA, Inc., and Teva Pharmaceuticals Industries Ltd. in the District of New Jersey on December 6, 2016 (2:16-cv-09038-SRC-CLW) seeking declaratory judgment of infringement of U.S. Patent Nos. 8,420,663, 8,524,276, 8,956,651, 9,180,125, and 9,314,461 based upon Actavis’s filing of an ANDA seeking to obtain approval to market a generic version of RELISTOR tablets before some or all of these patents expire.

Progenics, Salix, Bausch, and Wyeth filed suit against Actavis, Actavis LLC, Teva Pharmaceuticals USA, Inc., and Teva Pharmaceuticals Industries Ltd. in the District of New Jersey on December 8, 2017 (2:17-cv-12857-SRC-CLW) seeking declaratory judgment of infringement of U.S. Patent Nos. 9,724,343 and 9,492,445 based upon Actavis’s filing of an ANDA seeking to obtain approval to market a generic version of RELISTOR tablets before some or all of these patents expire.

The 2:16-cv-09038-SRC-CLW and 2:17-cv-12857-SRC-CLW actions were consolidated into a single action in the District of New Jersey (2:16-cv-09038-SRC-CLW). A four day bench trial was held from May 6, 2019 through May 9, 2019. On July 17, 2019, the Court issued an Order finding the asserted claims of U.S. Patent No. 8,524,276 valid and infringed. The Court additionally ordered that the effective date of any approval of Actavis’s ANDA No. 209615 may not be earlier than the expiration date of U.S. Patent No. 8,524,276.

Progenics, Salix, Bausch, and Wyeth filed suit against Actavis, Actavis LLC, Teva Pharmaceuticals USA, Inc., and Teva Pharmaceuticals Industries Ltd. in the District of New Jersey on June 13, 2019 (2:19-cv-13722-SRC-CLW) seeking declaratory judgment of infringement of U.S. Patent No. 10,307,417 based upon Actavis’s filing of an ANDA seeking to obtain approval to market a generic version of RELISTOR tablets before this patent expires. Litigation in the 2:19-cv-13722-SRC-CLW action is not yet underway.

European Opposition Proceedings

In addition to the above described ANDA notifications, in October 2015, Progenics received notices of opposition to three European patents relating to methylnaltrexone. Notices of opposition against EP1615646 were filed on September 24, 2015 separately by each of Actavis Group PTC ehf and Fresenius Kabi Deutschland GmbH. Notices of opposition against EP2368553 were filed on September 29, 2015 and September 30, 2015 by Fresenius Kabi Deutschland GmbH and Actavis Group PTC ehf, respectively. Notices of opposition against EP2368554 were filed on September 24, 2015 separately by each of Actavis Group PTC ehf and Fresenius Kabi Deutschland GmbH. On May 11, 2017, the opposition division provided notice that EP2368553 will be revoked. On June 28, 2017, the opposition division provided notice that EP1615646 will be revoked. On July 4, 2017, the opposition division provided notice that EP2368554 will be revoked. Each of these matters are on appeal with the European Patent Office. Oral proceedings for EP1615646 are set to occur on September 22, 2020. A date for oral proceedings has not yet been set in the appeals concerning EP2368553 and EP2368554.

For each of the above-described proceedings, we and Bausch continue to cooperate closely to vigorously defend and enforce RELISTOR intellectual property rights. Pursuant to the RELISTOR license agreement between Progenics and Bausch, Bausch has the first right to enforce the intellectual property rights at issue and is responsible for the costs of such enforcement.

We are or may be from time to time involved in various other disputes, governmental and/or regulatory inspections, inquires, investigations and proceedings that could result in litigation, and other litigation matters that arise from time to time. The process of resolving matters through litigation or other means is inherently uncertain and it is possible that an unfavorable resolution of these matters will adversely affect us, our results of operations, financial condition, and cash flows.

PSMA-617

German District Court Litigation

We announced a lawsuit and associated worldwide patent ownership dispute based on our claims to certain inventions related to PSMA-617, a PSMA-targeted radiopharmaceutical compound under development for the treatment of prostate cancer that is the subject of certain European and U.S. Patent Applications filed by the University of Heidelberg (“the University”).

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On November 8, 2018, MIP filed a complaint against the University in the District Court of Mannheim in Germany. In this Complaint, the Company claims that the discovery and development of PSMA-617 was related to work performed under a research collaboration sponsored by MIP. MIP alleged that the University breached certain contracts with MIP and that MIP is the co-owner of inventions embodied in certain worldwide patent filings related to PSMA-617, currently pending in Europe and the United States that were filed by the University in its own name. On February 27, 2019, Endocyte, Inc., a wholly owned subsidiary of Novartis AG, filed a motion to intervene in the German litigation. Endocyte is the exclusive licensee of the patent rights that are the subject of the German proceedings.

On November 27, 2018, MIP requested that the European Patent Office (“EPO”) stay the examination of European Patent (EP) 3 038 996 A1 (EP 14 799 340.6) and of the Divisional Applications EP 18 172 716.5, EP18 184 296.4, and EP 18 203 547.7 pending a decision from the German District Court on MIP’s Complaint. On December 10, 2018, the EPO granted MIP’s request and stayed the examination of the patent and patent applications effective November 27, 2018. Likewise, on December 20, 2018, MIP filed a Confirmation of Ownership with the United States Patent and Trademark Office (“USPTO”) in the corresponding US patent applications (US Serial Nos. 15/131,118; 16/038,729 and 16/114988). MIP’s filing with the USPTO takes the position that, in light of the collaboration and contracts between MIP and the University, MIP is the co-owner of these pending U.S. patent applications.

On February 27, 2019, the German District Court entered two orders in the litigation. First, the Court set €416, 000 as the amount MIP must deposit with the Court as security in the event of an unfavorable final decision on the merits of the dispute. Second, the Court set a hearing date of August 6, 2019 during which it will consider the various arguments of the parties and determine the next steps of the litigation. On August 6, the District Court of Mannheim in Germany held the first oral hearing in the case. The Court considered procedural matters and granted the parties the right to make further submissions.

Note 9. Operating Leases

We lease office and manufacturing space and certain office equipment under noncancelable operating leases. We determine whether an arrangement is or contains a lease at its inception. We recognize lease liabilities based on the present value of the minimum lease payments not yet paid, by using the lease term and discount rate determined at lease commencement. As our leases do not provide an implicit rate, we use our incremental borrowing rate of 9.5% commensurate with the underlying lease terms to determine the present value of our lease payments. Rental payments are recognized as rent expense on a straight-line basis over the term of the lease and for the three and six months ended June 30, 2019, we recognized rent expense in the amount of $0.6 million and $1.1 million, respectively. Our leases have remaining lease terms of one year to 11.3 years, one of which includes an option to extend the lease for five years. For the three and six months ended June 30, 2019, cash payments against operating lease liabilities totaled $0.5 million and $1.0 million, respectively.

The information related to our leases is as follows (in thousands):

	June 30,
Operating leases	2019
Operating ROU lease assets, noncurrent	$	13,889
Operating lease liabilities, current		555
Operating lease liabilities, noncurrent		15,312

At June 30, 2019, future lease payments for noncancelable operating leases are as follows (in thousands):

2019 (excluding the six months ending June 30, 2019)	$	1,002
2020		2,040
2021		2,077
2022		2,213
2023		2,255
Thereafter		16,807
Total future minimum lease payments		26,394
Less imputed interest		(10,527	)
Total lease liabilities	$	15,867

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Note 10. Non-Recourse Long-Term Debt, Net

On November 4, 2016, through a new wholly-owned subsidiary MNTX Royalties Sub LLC (“MNTX Royalties”), we entered into a $50.0 million loan agreement (the “Royalty-Backed Loan”) with a fund managed by HealthCare Royalty Partners III, L.P. (“HCRP”). Under the terms of the Royalty-Backed Loan, the lenders have no recourse to us or to any of our assets other than the right to receive royalty payments from the commercial sales of RELISTOR products owed under our agreement with Bausch. The RELISTOR royalty payments will be used to repay the principal and interest on the loan. The Royalty-Backed Loan bears interest at a per annum rate of 9.5%.

Under the terms of the loan agreement, payments of interest and principal, if any, are made on the last day of each calendar quarter out of RELISTOR royalty payments received since the immediately-preceding payment date. On each payment date prior to March 31, 2018, RELISTOR royalty payments received since the immediately preceding payment date were applied solely to the payment of interest on the loan, with any royalties in excess of the interest amount retained by us. Beginning on March 31, 2018, 50% of RELISTOR royalty payments received since the immediately-preceding payment date in excess of accrued interest on the loan are used to repay the principal of the loan, with the balance retained by us. Starting on September 30, 2021, all of the RELISTOR royalties received since the immediately-preceding payment date will be used to repay the interest and outstanding principal balance until the balance is fully repaid. The loan has a maturity date of June 30, 2025. Upon the occurrence of certain triggers in the loan agreement and if HCRP so elects, all of the RELISTOR royalty payments received after the immediately-preceding payment date shall be applied to the payment of interest and repayment of principal until the principal of the loan is fully repaid. In the event of such an election by HCRP, we have the right to repay the loan without any prepayment penalty.

In connection with the Royalty-Backed Loan, the debt issuance costs have been recorded as a debt discount in our consolidated balance sheets and are being amortized and recorded as interest expense throughout the life of the loan using the effective interest method.

The following tables summarize the components of the Royalty-Backed Loan in our condensed consolidated financial statements for the periods presented (in thousands):

	June 30,			December 31,
Condensed Consolidated Balance Sheets	2019			2018
Outstanding principal balance, current portion	$	6,057		$	5,688
Unamortized debt discount, current portion		(251	)		(269	)
Current portion of debt, net	$	5,806		$	5,419
Outstanding principal balance, long-term portion	$	36,715		$	39,674
Unamortized debt discount, long-term portion		(373	)		(494	)
Long-term debt, net	$	36,342		$	39,180

	Three Months Ended				Six Months Ended
	June 30,				June 30,
Condensed Consolidated Statements of Operations	2019		2018		2019		2018
Interest expense	$	1,053	$	1,176	$	2,130	$	2,381
Non-cash interest expense		69		74		140		137
Total interest expense included in interest (expense) income, net	$	1,122	$	1,250	$	2,270	$	2,518

As of June 30, 2019, we were in compliance with all material covenants under the Royalty-Backed Loan and there was no material adverse change in our business, operations, or financial conditions, as defined in the loan agreement.

Note 11. Stockholders’ Equity

Common Stock and Preferred Stock

We are authorized to issue 160.0 million shares of our common stock, par value $0.0013, and 20.0 million shares of preferred stock, par value $0.001. The Board of Directors (the “Board”) has the authority to issue common and preferred shares, in series, with rights and privileges as determined by the Board.

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Shelf Registration 

During the first quarter of 2017, we filed a shelf registration statement that permitted: (a) the offering, issuance and sale of up to a maximum aggregate offering price of $250.0 million of our common stock, preferred stock, debt securities, warrants, rights and/or units; and (b) as part of the $250.0 million, the offering, issuance and sale by us of up to a maximum aggregate offering price of $75.0 million of our common stock under our sales agreement with Cantor Fitzgerald & Co. (“Cantor”) in one or more at-the-market (“ATM”) offerings (the “2017 Sales Agreement”).

In October 2018, we filed a new shelf registration statement. The new shelf registration replaced our prior shelf registration statement, pursuant to which no additional securities will be offered or sold. The new shelf registration statement permits: (a) the offering, issuance and sale of up to a maximum aggregate offering price of $250.0 million of our common stock, preferred stock, debt securities, warrants, rights and/or units; and (b) as part of the $250.0 million, the offering, issuance and sale by us of up to a maximum aggregate offering price of $75.0 million of our common stock under our sales agreement with Cantor in one or more ATM offerings.

In addition, in October 2018 we entered into a new sales agreement with Cantor, as sales agent, which replaced the 2017 Sales Agreement (the “2018 Sales Agreement”). Pursuant to the 2018 Sales Agreement, we may offer and sell through Cantor, from time to time, shares of our common stock up to an aggregate offering price of $75.0 million. The 2018 Sales Agreement may be terminated by Cantor or us at any time upon ten days’ notice, or by Cantor at any time in certain circumstances, including the occurrence of a material adverse change in our business or financial condition.

Note 12. Stock-Based Compensation

Equity Incentive Plans

We adopted the following stockholder-approved equity incentive plans:

●     The 2005 Stock Incentive Plan (the “2005 Plan”), which authorized the issuance of up to 11,450,000 shares of common stock covering several different types of awards, including stock options, restricted shares, stock appreciation rights, performance shares, and phantom stock. The 2005 Plan was terminated in June 2018 at the time the 2018 Stock Incentive Plan was approved. Shares available for new awards under the 2005 Plan at the time of termination became available for awards under the 2018 Stock Incentive Plan. Options granted before termination of the 2005 Plan will continue to remain outstanding until exercised, cancelled or expired.

●     The 2018 Stock Incentive Plan (the “2018 Plan”), pursuant to which we are authorized to issue up to 4,800,000 shares of common stock covering several different types of awards, including stock options, restricted shares, stock appreciation rights, performance shares, and phantom stock. The 2018 Plan will terminate on March 27, 2028.

The stock option plans provide that options may be granted at an exercise price of 100% of fair market value of our common stock on the date of grant, may be exercised in full or in installments, at the discretion of the Board or its Compensation Committee, and must be exercised within ten years from date of grant. Stock options generally vest pro rata over three to five years. We recognize stock-based compensation expense on a straight-line basis over the requisite service (vesting) period based on fair values. We use historical data to estimate expected employee behaviors related to option exercises and forfeitures and included these expected forfeitures as a part of the estimate of stock-based compensation expense as of the grant date. We adjust the total amount of stock-based compensation expense recognized for each award, in the period in which each award vests, to reflect the actual forfeitures related to that award. Changes in our estimated forfeiture rate will result in changes in the rate at which compensation cost for an award is recognized over its vesting period.

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Stock Options

The following table summarizes stock options activity for the six months ended June 30, 2019 (in thousands, except per share data or as otherwise noted):

						Weighted
				Weighted		Average
	Number			Average		Remaining
	of Shares			Exercise Price		Contractual Life
Outstanding at January 1, 2019		6,264		$	6.79		6.02
Granted		1,392		$	4.52
Cancelled		(230	)	$	7.17
Exercised		(225	)	$	5.33
Expired		(27	)	$	7.79
Outstanding at June 30, 2019		7,174		$	6.38		6.44
Exercisable at June 30, 2019		4,647		$	6.63		5.03
Vested and expected to vest at June 30, 2019		6,519		$	6.46		6.17

The weighted-average fair value of options granted during the three and six months ended June 30, 2019 was $2.37 and $2.86 per share, respectively and during the three and six months ended June 30, 2018 was $6.12 and $4.58 per share, respectively.

The total intrinsic value (the excess of the market price over the exercise price) was approximately $5.1 million for stock options outstanding, $2.7 million for stock options exercisable, and $4.4 million for stock options vested and expected to vest as of June 30, 2019. No stock options were exercised during the six months ended June 30, 2018.

Stock-Based Compensation Expense

We account for stock-based awards issued to employees in accordance with the provisions of ASC 718 (Topic 718, Compensation – Stock Compensation). We recognize stock-based compensation expense on a straight-line basis over the service period of the award, which is generally three to five years. Stock-based awards issued to consultants are accounted for in accordance with the provisions of ASC 718 and ASC 505-50 (Subtopic 50 “Equity-Based Payments to Non-Employees” of Topic 505, Equity). Options granted to consultants are periodically revalued as the options vest and are recognized as an expense over the related period of service or the vesting period, whichever is longer. Under the provisions of ASC 718, members of the Board are considered employees for calculation of stock-based compensation expense.

We estimated the fair value of the stock options granted on the date of grant using a Black-Scholes valuation model that used the weighted-average assumptions noted in the following table. The risk-free interest rate assumption we use is based upon United States Treasury interest rates appropriate for the expected life of the awards. The expected life (estimated period of time that we expect employees, directors, and consultants to hold their stock options) was estimated based on historical rates for three group classifications, (i) employees, (ii) outside directors and officers, and (iii) consultants. Expected volatility was based on historical volatility of our stock price for a period equal to the stock option’s expected life and calculated on a daily basis. The expected dividend rate is zero since we do not currently pay cash dividends on our common stock and do not anticipate doing so in the foreseeable future.

	Three Months Ended						Six Months Ended
	June 30,						June 30,
	2019			2018			2019			2018
Risk-free interest rate		2.04	%		2.91	%		2.61	%		2.71	%
Expected life (in years)		5.27			7.15			6.52			6.72
Expected volatility		60	%		70	%		66	%		69	%
Expected dividend yield		--			--			--			--

Stock-based compensation expense for the three and six months ended June 30, 2019 and 2018 was recorded in our condensed consolidated statement of operations as follows (in thousands):

	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2019		2018		2019		2018
Research and development expenses	$	387	$	452	$	837	$	977
Selling, general and administrative expenses		607		1,678		1,234		2,201
Total stock-based compensation expense	$	994	$	2,130	$	2,071	$	3,178

At June 30, 2019, unrecognized stock-based compensation expense related to stock options was approximately $5.9 million and is expected to be recognized over a weighted-average period of approximately 2.2 years.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) is intended to assist the reader in understanding the business of Progenics Pharmaceuticals, Inc. and its subsidiaries (the “Company”, “Progenics”, “we”, or “us”). MD&A is provided as a supplement to, and should be read in conjunction with, our Annual Report on Form 10-K for the year ended December 31, 2018. Our results of operations discussed in MD&A are presented in conformity with accounting principles generally accepted in the U.S. (“GAAP”). We operate under a single research and development business segment. Therefore, our results of operations are discussed on a consolidated basis.

Note Regarding Forward-Looking Statements

This document and other public statements we make may contain statements that do not relate strictly to historical fact, any of which may be forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements contained in this communication that refer to our estimated or anticipated future results or other non-historical facts are forward-looking statements that reflect our current perception of existing trends and information as of the date of this communication. Forward looking statements generally will be accompanied by words such as “anticipate”, “believe”, “plan”, “could”, “should”, “estimate”, “expect”, “forecast”, “outlook”, “guidance”, “intend”, “may”, “might”, “will”, “possible”, “potential”, “predict”, “project”, or other similar words, phrases or expressions. In evaluating such statements, we urge you to specifically consider the various risk factors identified under Part I, Item 1A. “Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2018, as updated by our subsequent Quarterly Reports on Form 10-Q, which could cause actual events or results to differ materially from those indicated by forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties which may cause our actual results, performance or achievements to be materially different from those expressed or implied by such statements. While it is impossible to identify or predict all such matters, these differences between forward-looking statements and our actual results, performance or achievement may result from, among other things; the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and product candidates, including the risks that clinical trials will not commence or proceed as planned; products which appear to be promising in early trials will not demonstrate efficacy or safety in larger-scale trials; clinical trial data on our products and product candidates will be unfavorable; our products will not receive marketing approval from regulators or, if approved, do not gain sufficient market acceptance to justify development and commercialization costs; the sales of RELISTOR^® and other products by our partners and the revenue and income generated for us thereby may not meet expectations; our commercial launch of AZEDRA^® may not meet revenue and income expectations; competing products currently on the market or in development might reduce the commercial potential of our products; we, our collaborators or others might identify side effects after the product is on the market; efficacy or safety concerns regarding marketed products, whether or not originating from subsequent testing or other activities by us, governmental regulators, other entities or organizations or otherwise, and whether or not scientifically justified, may lead to product recalls, withdrawals of marketing approval, reformulation of the product, additional pre-clinical testing or clinical trials, changes in labeling of the product, the need for additional marketing applications, declining sales, or other adverse events; the inherent uncertainty of outcomes in intellectual property disputes such as the dispute with University of Heidelberg regarding PSMA-617; the costs and management distraction attendant to activist stockholder campaigns; and risks related to changes in the composition of our Board of Directors following our most recent annual meeting of stockholders.

We are also subject to risks and uncertainties associated with the actions of our corporate, academic and other collaborators and government regulatory agencies, including risks from market forces and trends; potential product liability; intellectual property, litigation and other dispute resolution, environmental and other risks; a potential inability to obtain sufficient capital, recruit and retain employees, enter into favorable collaborations, transactions, or other relationships, or the risk that existing or future relationships or transactions may not proceed as planned; the potential for cybersecurity breaches of our systems and information technology; the risk that current and pending patent protection for our products may be invalid, unenforceable or challenged, or fail to provide adequate market exclusivity, or that our rights to in-licensed intellectual property may be terminated for our failure to satisfy performance milestones; the risk of difficulties in, and regulatory compliance relating to, manufacturing products; and the uncertainty of our future profitability.

Risks and uncertainties to which we are subject also include general economic conditions, including interest and currency exchange-rate fluctuations and the availability of capital; changes in generally accepted accounting principles; the impact of legislation and regulatory compliance; the highly regulated nature of our business, including government cost-containment initiatives and restrictions on third-party payments for our products; trade buying patterns; the competitive climate of our industry; and other factors set forth in this document and other reports filed with the U.S. Securities and Exchange Commission (“SEC”). In particular, we cannot assure you that AZEDRA^® or RELISTOR^® will be commercially successful or be approved in the future in other indications or jurisdictions, or that any of our other programs will result in a commercial product.

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We do not have a policy of updating or revising forward-looking statements and, except as expressly required by law, we disclaim any intent or obligation to update or revise any statements as a result of new information or future events or developments. It should not be assumed that our silence over time means that actual events are bearing out as expressed or implied in forward-looking statements.

Overview

Business

We are an oncology company focused on the development and commercialization of innovative targeted medicines and artificial intelligence to find, fight and follow cancer. Highlights of our recent progress include the first commercial revenue for AZEDRA, completion of enrollment of the PyL pivotal Phase 3 trial, and dosing of the first patient in the 1095 open label Phase 2 trial. Our pipeline includes therapeutic agents designed to precisely target cancer (AZEDRA, 1095 and PSMA TTC), as well as a prostate-specific membrane antigen (“PSMA”) targeted imaging agents for prostate cancer (PyL and 1404).

Our business strategy requires us to manage our business to provide for the continued development, manufacturing and potential commercialization of our proprietary and partnered product candidates. This includes identifying and advancing a pipeline of product candidates by identifying product candidates, technologies and businesses for acquisition and in-licensing that we believe are a strategic fit with our existing business.

Our strategy also calls for us to undertake increased research and development activities and to manage an increasing number of relationships with partners and other third parties, while simultaneously managing the capital necessary to support this strategy. An element of our research and development strategy has been to in-license technology and product candidates.

We may consider opportunities to out-license our development and clinical programs or to in-license or acquire additional oncology compounds and/or programs. We may also consider other strategic transactions from time to time that are consistent with our business strategy and objectives.

Product / Candidate	Description	Status	Market	Rights
Ultra-Orphan Theranostic
AZEDRA (iobenguane I 131)  555 MBq/mL injection	Unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma	Approved	U.S	Progenics
Prostate Cancer Theranostics
PyL (18F-DCFPyL)	PSMA-targeted PET/CT imaging agent for prostate cancer	Enrollment Completed in Phase 3	Worldwide (ex. EU, AU, & NZ)	Progenics
PyL (18F-DCFPyL)	PSMA-targeted PET/CT imaging agent for prostate cancer	Meeting with EMA	Europe	Curium
1095 (I 131 1095)	PSMA-targeted small molecule therapeutic for treatment of metastatic prostate cancer	Phase 2	Worldwide	Progenics
PSMA TTC (BAY 2315497)	PSMA-targeted antibody conjugate therapeutic for treatment of metastatic prostate cancer	Phase 1	Worldwide	Bayer
1404	Technetium-99m PSMA-targeted SPECT/CT imaging agent for prostate cancer	Meeting with EMA	Europe	ROTOP
Digital Technology
PSMA AI	Imaging analysis technology that uses artificial intelligence and machine learning to quantify and automate the reading of PSMA targeted imaging	Investigational Use Only	Worldwide	Progenics
Automated Bone Scan Index (aBSI)	Automated reading and quantification of bone scans of prostate cancer patients using artificial intelligence and deep learning	CE marked (EU countries) 510(k) cleared in the U.S.	Worldwide (ex. Japan)	Progenics
Automated Bone Scan Index (BONENAVI)	Automated reading and quantification of bone scans of prostate cancer patients using artificial intelligence and deep learning	Approved	Japan	FUJIFILM
Other Programs
RELISTOR Subcutaneous Injection (methylnaltrexone bromide)	OIC in adults with chronic non-cancer pain or advanced-illness adult patients	Approved	Worldwide	Bausch
RELISTOR Tablets    (methylnaltrexone bromide)	OIC in adults with chronic non-cancer pain	Approved	U.S.	Bausch
Leronlimab (PRO 140)	HIV Infection	Rolling BLA Submission to FDA	U.S.	CytoDyn

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Ultra-Orphan Theranostic: 

● AZEDRA^® (iobenguane I 131) is a radiotherapeutic, approved for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. AZEDRA is the first and only FDA-approved therapy for this indication. We anticipate opportunities for growth of AZEDRA beyond its existing label through the development of new indications.

Prostate Cancer Theranostics:

● PyL (also known as ¹⁸F-DCFPyL) is a fluorinated PSMA-targeted PET imaging agent that enables visualization of both bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. In the U.S. and Canada, we completed enrollment of the pivotal Phase 3 trial evaluating the diagnostic performance and clinical impact of PyL in men with biochemical recurrence of prostate cancer. Curium has licensed exclusive rights to develop and commercialize PyL in Europe.

● 1095 (also known as I-131-1095) is a PSMA-targeted Iodine-131 labeled small molecule that is designed to deliver a dose of beta radiation directly to prostate cancer cells with minimal impact on the surrounding healthy tissues. We are conducting a Phase 2 clinical trial in combination with enzalutamide in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC).

● PSMA TTC is a thorium-227 labeled PSMA-targeted antibody therapeutic. PSMA TTC is designed to deliver a dose of alpha radiation directly to prostate cancer cells with minimal impact on the surrounding healthy tissues. Bayer AG (“Bayer”) has exclusive worldwide rights to develop and commercialize products using our PSMA antibody technology in combination with Bayer’s alpha-emitting radionuclides. Bayer is developing PSMA TTC, a thorium-227 labeled PSMA-targeted antibody therapeutic. Bayer is conducting a Phase 1 trial of PSMA TTC in patients with metastatic castration-resistant prostate cancer.

● 1404 is a technetium-99m labeled small molecule which binds to PSMA and is used as an imaging agent to diagnose and detect localized prostate cancer as well as soft tissue and bone metastases. ROTOP Pharmaka GmbH (“ROTOP”), a Germany-based developer of radiopharmaceuticals for nuclear medicine diagnostics, has exclusive rights to develop and commercialize 1404 in Europe.

Digital Technology:

● PSMA AI is an imaging analysis technology that uses artificial intelligence and machine learning to quantify and automate the reading of PSMA-targeted imaging. We recently completed a performance study of our automated segmentation algorithms with PyL/CT images from our PyL research access initiative. The results from this analysis will be presented at an upcoming scientific conference.

● Automated Bone Scan Index (aBSI) calculates the disease burden of prostate cancer by quantifying the hotspots on bone scans and automatically calculating the bone scan index value, representing the disease burden of prostate cancer shown on the bone scan. This quantifiable and reproducible calculation of the bone scan index value is intended to aid in the diagnosis and treatment of men with prostate cancer and may have utility in monitoring the course of the disease. The Japanese rights to aBSI have been transferred and sold to FUJIFILM Toyama Chemical Co, Ltd. (“FUJIFILM”) under the name BONENAVI^®. The cloud based aBSI 510(k) was cleared by the FDA for clinical use in the U.S. on August 5, 2019.

Other Programs: 

● RELISTOR^® is a treatment for opioid-induced constipation (“OIC”) that addresses its underlying mechanism of OIC and decreases the constipating side effects induced by opioid pain medications such as morphine and codeine without diminishing their ability to relieve pain. RELISTOR is approved in two forms: a subcutaneous injection (12 mg and 8 mg) and an oral tablet (450 mg once daily). Any references herein to RELISTOR do not imply that any other form or possible use of the drug has received approval. RELISTOR subcutaneous injection is being sold in the U.S., European Union (“E.U.”), and Canada, and RELISTOR tablets are being sold in the U.S. RELISTOR’s approved U.S. label and full U.S. prescribing information is available at www.RELISTOR.com. Other approved labels for RELISTOR apply in ex-U.S. markets.

● Leronlimab (PRO 140) is a fully humanized monoclonal antibody which is a cellular targeting CCR5 entry antagonist and is currently in Phase 3 development for the treatment of HIV infection. It is owned by CytoDyn and, pursuant to our agreement with CytoDyn, we have the right to receive certain milestone and royalty payments. CytoDyn announced in March 2019 that it filed its first of three sections of its Biologics License Application (“BLA”) to the FDA for leronlimab for the treatment of HIV under the Rolling Review process.

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Bausch Agreement

Under our agreement with Salix Pharmaceuticals, Inc., a wholly-owned subsidiary of Bausch Health Companies Inc. (“Bausch”, which is the predecessor of Valeant Pharmaceuticals International, Inc.), we received a development milestone of $40.0 million upon U.S. marketing approval for subcutaneous RELISTOR in non-cancer pain patients in 2014, and a development milestone of $50.0 million for the U.S. marketing approval of an oral formulation of RELISTOR in 2016. We are also eligible to receive up to $200.0 million of commercialization milestone payments upon first achievement of specified U.S. net sales targets in any single calendar year. The following table summarizes the commercialization milestones:

U.S. Net Sales Levels in any Single Calendar Year	Payment
	(In thousands)
In excess of $100 million	$	10,000
In excess of $150 million		15,000
In excess of $200 million		20,000
In excess of $300 million		30,000
In excess of $750 million		50,000
In excess of $1 billion		75,000
	$	200,000

Each commercialization milestone payment is payable one time only, regardless of the number of times the condition is satisfied, and all six payments could be made within the same calendar year. We are also eligible to receive royalties from Bausch and its affiliates based on the following royalty scale: 15% on worldwide net sales up to $100 million, 17% on the next $400 million in worldwide net sales, and 19% on worldwide net sales over $500 million each calendar year, and 60% of any upfront, milestone, reimbursement or other revenue (net of costs of goods sold, as defined, and territory-specific research and development expense reimbursement) Bausch receives from sublicensees outside the U.S.

Bayer Agreement 

Under our April 2016 agreement with a subsidiary of Bayer granting Bayer exclusive worldwide rights to develop and commercialize products using our PSMA antibody technology, we received an upfront payment of $4.0 million and milestone payments totaling $5.0 million and could receive up to an additional $44.0 million in potential clinical and regulatory development milestones. We are also entitled to single-digit royalties on net sales, and potential net sales milestone payments up to an aggregate total of $130.0 million.

CytoDyn Agreement

We sold Leronlimab (PRO 140) to CytoDyn Inc. (“CytoDyn”) in 2012, which sale included milestone and royalty payment obligations to us. Leronlimab is a fully humanized monoclonal antibody which is a cellular targeting CCR5 entry antagonist and is currently in development for the treatment of HIV.

Under our 2012 agreement with CytoDyn, CytoDyn is responsible for all development, manufacturing and commercialization efforts. Pursuant to such agreement, we have received $5.0 million in upfront and milestone payments, together with rights to receive an additional $5.0 million upon the first U.S. or E.U. approval for the sale of the drug, and a 5% royalty on the net sales of approved product(s).

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ROTOP Agreement

We entered into an exclusive license agreement with ROTOP, a Germany-based developer of radiopharmaceuticals for nuclear medicine diagnostics, to develop and commercialize 1404 in Europe.

Under the terms of the collaboration, ROTOP will be responsible for the development, regulatory approvals and commercialization of 1404 in Europe while Progenics is entitled to double-digit, tiered royalties on net sales in the territory.

FUJIFILM Agreement

We entered into a transfer agreement with FUJIFILM for the rights to the Company’s aBSI product in Japan for use under the name BONENAVI.

Under the terms of the agreement, FUJIFILM acquired, by a combination of purchase and license, the Japanese software, source code, supporting data and all Japanese patents associated with the aBSI product from Progenics for use in Japan. In exchange, Progenics received $4.0 million in an upfront payment and FUJIFILM agreed to pay Progenics support and service fees for aBSI and other AI products over three years in Japan. BONENAVI has been licensed to FUJIFILM for use in Japan since 2011.

Results of Operations

The following table is an overview of our results of operations (in thousands, except percentages):

	Three Months Ended									Six Months Ended
	June 30,									June 30,
	2019			2018			Change			2019			2018			Change
Total revenue	$	9,966		$	3,878			157	%	$	14,247		$	7,067			102	%
Operating expenses	$	29,059		$	18,216			(60%	)	$	51,575		$	33,823			(52%	)
Operating loss	$	(19,093	)	$	(14,338	)		(33%	)	$	(37,328	)	$	(26,756	)		(40%	)
Net loss	$	(19,700	)	$	(15,172	)		(30%	)	$	(38,435	)	$	(28,596	)		(34%	)

Revenue 

Our sources of revenue include AZEDRA product sales, royalties and license fees from Bausch and other collaborators. The following table is a summary of our worldwide revenue (in thousands, except percentages):

	Three Months Ended							Six Months Ended
	June 30,							June 30,
Source	2019		2018		Change			2019		2018		Change
AZEDRA product sales	$	270	$	-		N/A		$	270	$	-		N/A
Royalty income		3,593		3,530		2	%		7,754		6,588		18	%
License and other revenue		6,103		348		1654	%		6,223		479		1199	%
Total revenue	$	9,966	$	3,878		157	%	$	14,247	$	7,067		102	%

AZEDRA product sales. In June 2019 we recorded our first commercial product sales of AZEDRA in the U.S. (no sales-related deductions or discounts were applicable to the June 2019 sales). There were no sales of AZEDRA for the three and six months ended June 30, 2018, as AZEDRA was not approved until July 2018.

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Royalty income. We recognized royalty income primarily based on the below net sales of RELISTOR, as reported to us by Bausch (in thousands, except percentages).

	Three Months Ended							Six Months Ended
	June 30,							June 30,
	2019		2018		Change			2019		2018		Change
U.S.	$	23,800	$	23,500		1	%	$	50,200	$	43,800		15	%
Outside U.S.		200		-		N/A			1,500		100		1400	%
Worldwide net sales of RELISTOR	$	24,000	$	23,500		2	%	$	51,700	$	43,900		18	%

Royalty income increased by $0.1 million, or 2%, during the three months ended June 30, 2019, compared to the same period in 2018, and by $1.2 million, or 18% during the six months ended June 30, 2019, compared to the same period in 2018, due primarily to higher net sales.

License and other revenue. The license and other revenue increased by $5.8 million and $5.7 million for the three and six months ended June 30, 2019, respectively, compared to the same periods in 2018. These increases were primarily due to the achievement of a $2.0 million milestone under the Bayer agreement for initiation of a Phase 1 trial of PSMA TTC and a $4.0 million upfront payment from FUJIFILM under the aBSI agreement.

Operating Expenses

The following table is a summary of our operating expenses (in thousands, except percentages):

	Three Months Ended							Six Months Ended
	June 30,							June 30,
Operating Expenses	2019		2018		Change			2019		2018		Change
Cost of goods sold	$	493	$	-		N/A		$	493	$	-		N/A
Research and development		13,080		9,347		(40%	)		25,472		17,457		(46%	)
Selling, general and administrative		14,570		7,569		(92%	)		23,794		14,266		(67%	)
Change in contingent consideration liability		916		1,300		30	%		1,816		2,100		14	%
Total operating expenses	$	29,059	$	18,216		(60%	)	$	51,575	$	33,823		(52%	)

Cost of Goods Sold (“COGS”)

COGS includes cost of direct materials and labor and indirect expenses used in the manufacturing of AZEDRA beginning with the first commercial sale in June 2019.

Research and Development (“R&D”)

We do not track fully burdened R&D costs separately for each of our product candidates. We review our R&D expenses by focusing on external and internal development costs. External development costs consist of costs associated with our clinical trials, including pharmaceutical development and manufacturing of clinical trial materials. Included in other costs are external corporate overhead costs that are not specific or allocated to any one program. Internal costs consist of salaries and wages, share-based compensation and benefits, which are not tracked by program as several of our departments support multiple development programs. The following table summarizes the external costs attributable to each program and internal costs (in thousands):

	Three Months Ended June 30,				Six Months Ended June 30,
	2019		2018		2019		2018
External Costs
PyL	$	3,996	$	2,578	$	7,148	$	4,168
AZEDRA		1,758		1,203		5,469		2,373
1404		89		679		216		1,964
1095		2,085		187		2,963		570
PSMA AI		291		428		598		598
Other		1,551		1,212		2,196		1,374
Total External Costs	$	9,770	$	6,287	$	18,590	$	11,047
Internal Costs		3,310		3,060		6,882		6,410
Total R&D Costs	$	13,080	$	9,347	$	25,472	$	17,457

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R&D expenses increased by $3.7 million, or 40%, during the three months ended June 30, 2019, compared to the same period in 2018, primarily resulting from higher clinical trial and contract manufacturing costs for clinical trial materials for 1095 and PyL, as well as higher costs associated with the transition for the AZEDRA manufacturing site and additional production capacity for iodine-based products. R&D expenses increased by $8.0 million, or 46%, during the six months ended June 30, 2019, compared to the same period in 2018, primarily due to higher costs associated with the transition for the AZEDRA manufacturing site and additional production capacity for iodine-based products, higher clinical trial and contract manufacturing costs for clinical trial materials for 1095 and PyL, partially offset by lower clinical trial costs for 1404.

Selling, General and Administrative (“SG&A”)

SG&A expenses increased by $7.0 million, or 92% and $9.5 million, or 67%, during the three and six months ended June 30, 2019, respectively, compared to the same periods in 2018. The three and six months increases were primarily due to higher legal and advisory fees of $5.5 million and $5.9 million, respectively, associated with the contested election at our 2019 Annual Meeting of Shareholders, higher PSMA-617 litigation costs of $1.0 million and $1.8 million, respectively, and higher costs associated with the buildout of commercial infrastructure to support the launch and distribution of AZEDRA.

Change in Contingent Consideration Liability

The change in the contingent consideration liability of $0.9 million during the three months ended June 30, 2019 was primarily attributable to an increase in the AZEDRA sales forecasts associated with the planned initiation of a basket study to expand the label for AZEDRA, which is used to calculate the potential milestone payments to former MIP stockholders, compared to a change of $1.3 million in the same period in 2018, resulting primarily from higher estimated probability of success of AZEDRA. The contingent consideration liability increased by $1.8 million during the six months ended June 30, 2019, primarily due to an increase in the AZEDRA sales forecasts associated with the planned initiation of a basket study to expand the label for AZEDRA and first quarter increase in the probability of success for the AZEDRA commercialization milestone. The contingent consideration liability increased by $2.1 million during the six months ended June 30, 2018, primarily due to a higher estimated probability of success of AZEDRA.

Other (Expense) Income

The following table is a summary of our other (expense) income (in thousands, except percentages):

	Three Months Ended									Six Months Ended
	June 30,									June 30,
	2019			2018			Change			2019			2018			Change
Interest (expense) income, net	$	(538	)	$	(856	)		37	%	$	(967	)	$	(1,799	)		46	%
Other (expense) income, net		(69	)		(74	)		7	%		(140	)		(137	)		(2	%)
Other (expense) income	$	(607	)	$	(930	)		35	%	$	(1,107	)	$	(1,936	)		43	%

Total other (expense) income, net decreased by $0.3 million, or 35%, and $0.8 million, or 43%, during the three and six months ended June 30, 2019, respectively, compared to the same periods in 2018.

Liquidity and Capital Resources

The following table is a summary of selected financial data (in thousands):

	June 30,		December 31,
	2019		2018
Cash and cash equivalents	$	84,823	$	137,686
Accounts receivable, net	$	10,569	$	3,803
Total assets	$	152,781	$	169,497
Working capital	$	76,627	$	120,683

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Our current principal sources of revenue from operations are royalties and development and commercial milestones. Our principal sources of liquidity are our existing cash and cash equivalents. As of June 30, 2019, we had cash and cash equivalents of approximately $84.8 million, a decrease of $52.9 million from $137.7 million at December 31, 2018, reflecting primarily cash used for operating expenses and for the acquisition, transition and start-up costs of the Somerset manufacturing site for the AZEDRA launch. We expect to continue to have significant cash requirements to support product development activities and the commercial launch of AZEDRA. The amount and timing of our cash requirements will depend on the progress and success of our clinical development programs, regulatory and market acceptance, and the resources we devote to research and commercialization activities. The amount of cash on-hand will depend on the progress of various clinical programs, potential sales from the launch of AZEDRA, and the achievement of various milestones and royalties under our existing license agreements.

We believe that our current cash and cash equivalents will be sufficient to fund our operations for at least the next twelve months. We expect to fund our operations going forward with existing cash resources, anticipated revenues from our existing license agreements, sales of AZEDRA, and cash that we may raise through future capital raising and other financing transactions.

If we do not realize sufficient royalty or milestone revenue from our license agreements, sales of AZEDRA, or are unable to enter into favorable collaboration, license, asset sale, additional capital raising, or other financing transactions, we will have to reduce, delay, or eliminate spending on certain programs, and/or take other economic measures.

Cash Flows

The following table is a summary of our cash flow activities (in thousands):

	Six Months Ended
	June 30,
	2019			2018
Net cash used in operating activities	$	(38,700	)	$	(25,189	)
Net cash used in investing activities	$	(10,104	)	$	(502	)
Net cash (used in) provided by financing activities	$	(2,323	)	$	22,636

Operating Activities

 Net cash used in operating activities during the six months ended June 30, 2019 was primarily attributable to operating expenses, net of non-cash items including the change in fair value of contingent consideration liability.

Investing Activities

Net cash used in investing activities during the six months ended June 30, 2019 was primarily related to the acquisition of AZEDRA manufacturing assets in Somerset, New Jersey and capital expenditures at contract manufacturing organizations related to additional iodine manufacturing capacity.

Financing Activities

Net cash used in financing activities during the six months ended June 30, 2019 was primarily attributable to repayment of debt under the Royalty-Backed Loan with HealthCare Royalty Partners III, L.P.

Off-Balance Sheet Arrangements and Guarantees

We have no obligations under off-balance sheet arrangements and do not guarantee the obligations of any other unconsolidated entity.

Critical Accounting Policies

We prepare our financial statements in conformity with accounting principles generally accepted in the U.S. Our significant accounting policies are disclosed in Note 2. Summary of Significant Accounting Policies to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2018. The selection and application of these accounting principles and methods requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, as well as certain financial statement disclosures. We evaluate these estimates on an ongoing basis. We base these estimates on historical experience and on various other assumptions that we believe reasonable under the circumstances. The results of these evaluations form the basis for making judgments about the carrying values of assets and liabilities that are not otherwise readily apparent. While we believe that the estimates and assumptions we use in preparing the financial statements are appropriate, they are subject to a number of factors and uncertainties regarding their ultimate outcome and, therefore, actual results could differ from these estimates.

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There have been no changes to our critical accounting policies and estimates as of and for the six months ended June 30, 2019 as noted in Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2018.

Recent Accounting Developments

Refer to our discussion of recently adopted accounting pronouncements and other recent accounting pronouncements in Note 2. New Accounting Pronouncements to the accompanying unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

Our primary investment objective is to preserve principal. Our money market funds have variable interest rates and totaled $82.7 million at June 30, 2019. As a result, we do not believe that these investment balances have a material exposure to interest-rate risk.

The majority of our business is conducted in U.S. dollars. However, we do conduct certain transactions in other currencies, including Euros, British Pounds, Swiss Francs, and Swedish Krona. Historically, fluctuations in foreign currency exchange rates have not materially affected our condensed consolidated results of operations, and during the three and six months ended June 30, 2019 and 2018, our consolidated results of operations were not materially affected by fluctuations in foreign currency exchange rates.

Item 4. Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports, is recorded, processed, summarized and reported within the timelines specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), as appropriate, to allow timely decisions regarding required disclosures. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving the desired control objectives, and in reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. We have a Disclosure Committee consisting of certain members of our senior management which monitors and implements our policy of disclosing material information concerning the Company in accordance with applicable law.

As required by SEC Rule 13a-15(e), we carried out an evaluation, under the supervision and with the participation of senior management, including our CEO and CFO, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this report. Based upon the foregoing, our CEO and CFO concluded that our current disclosure controls and procedures, as designed and implemented, were effective at the reasonable assurance level.

There have been no changes in our internal control over financial reporting, as such term is defined in the Exchange Act Rules 13a-15(f) and 15d-15(f), during our last fiscal quarter that have materially affected, or are reasonably likely to materially affect our internal control over financial reporting.

PART II - OTHER INFORMATION

Item 1. Legal Proceedings

There have been no material changes from the information discussed in Part I, Item 3. Legal Proceedings of our Annual Report on Form 10-K for the year ended December 31, 2018. We are or may be from time to time involved in various other disputes, governmental, and/or regulatory inspections, inquiries, investigations, and proceedings that could result in litigation, and other litigation matters that arise from time to time. The process of resolving matters through litigation or other means is inherently uncertain and it is possible that an unfavorable resolution of these matters will adversely affect us, our results of operations, financial condition, and cash flows. Refer to our discussion in Note 8. Commitments and Contingencies to the accompanying unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

35

Item 1A. Risk Factors

The following risk factor and other information included in this Quarterly Report on Form 10-Q should be carefully considered. Other than the risk factor below, there have been no material changes from the information discussed in Part I, Item 1A. Risk Factors of our Annual Report on Form 10-K for the year ended December 31, 2018. You should carefully consider the risks and uncertainties we discussed below and in our Form 10-K before deciding to invest in, or retain, shares of our common stock. These are not the only risks and uncertainties that we face. Additional risks and uncertainties that we do not currently know about or that we currently believe are immaterial, or that we have not predicted, may also harm our business operations or adversely affect us. If any of these risks or uncertainties actually occur, our business, financial condition, operating results, or liquidity could be materially harmed.

Our business could be negatively affected as a result of actions of activist stockholders, which could cause uncertainty about the strategic direction of our business and negatively impact the trading value of our securities.

Activist stockholders may, from time to time, attempt to effect changes in our strategic direction and how our company is governed or may seek to acquire control over our company. Activist stockholders may seek to increase short-term stockholder value by advocating corporate actions such as financial restructuring, increased borrowing, special dividends, stock repurchases, or even sales of assets or the entire company. Activist campaigns can also seek to change the composition of our board of directors, and campaigns that contest or conflict with our strategic direction could have an adverse effect on our results of operations and financial condition. We may not be able to successfully defend against activist stockholders, which could be disruptive to our business. Even if we were to successfully defend against any future proxy contest or future or ongoing activist campaign, responding to activist stockholders can be costly and time-consuming, and can divert significant time and attention of our board of directors and management from pursuing our business strategies.

In May 2019, Velan Capital, L.P., Altiva Management Inc., Balaji Venkataraman, Virinder Nohria, LTE Partners, LLC, LTE Management, LLC, Melkonian Capital Management, LLC, Ryan Melkonian, Terence Cooke and Deepak Sarpangal initiated a withhold campaign, seeking stockholder support to vote against or abstain from voting on the re-election of certain directors of the Company at the 2019 annual meeting of stockholders. Based on final voting results, two directors did not receive a majority of votes cast. In accordance with the Company’s By-Laws, each of our directors submitted a contingent resignation to the Board, which becomes effective only if a director does not receive sufficient votes for re-election at an annual meeting and the Board accepts the resignation. On August 7, 2019, in accordance with the Company’s By-Laws and the recommendation of the Nominating and Corporate Governance Committee, the Board accepted the contingent resignations of Peter J. Crowley and Michael D. Kishbauch, with an effective date of October 17, 2019, 90 days following the certification of the election results from the 2019 annual meeting of stockholders, or such earlier time as the Board determines the responsibilities of the resigning directors have been sufficiently transitioned to the remaining Board members.

We may choose to initiate, or may become subject to, litigation as a result of continued or further stockholder activist campaigns, which would serve as a further distraction to our board of directors and management and could require us to incur significant additional costs.

Actions such as those described above could cause significant fluctuations in our stock price based upon temporary or speculative market perceptions or other factors that do not necessarily reflect the underlying fundamentals and prospects of our business. Such actions may also result in unanticipated perceived uncertainties as to our future direction, control, and ability to execute on our strategy, which could lead to the perception of instability or a change in the direction of our business, as well as a belief that the board of directors might decide to implement changes to its composition or management. Such perceptions and beliefs may result in the loss of potential business opportunities, make it more difficult to pursue our strategic initiatives, or limit our ability to attract and retain qualified personnel and business partners, any of which could adversely affect our business and operating results.

36

Item 6. Exhibits 

(a)  Exhibits

Exhibit Number *	Description
3.1(1)	Amended and Restated Certificate of Incorporation of the Registrant.
3.2(2)	Amended and Restated By-laws of the Registrant.
4.1(3)	Specimen Certificate for Common Stock, $0.0013 par value per share, of the Registrant.
10.1(4)	Progenics Pharmaceuticals, Inc. 2018 Performance Incentive Plan.
10.2(5)	Settlement and License Agreement by and among Progenics Pharmaceuticals, Inc., Valeant Pharmaceuticals International, Inc., Salix Pharmaceuticals, Inc., Wyeth LLC, and Actavis LLC., entered into as of May 25, 2018.
10.3(6)	Settlement and License Agreement by and among Progenics Pharmaceuticals, Inc., Valeant Pharmaceuticals International, Inc., Salix Pharmaceuticals, Inc., Wyeth LLC, and Par Sterile Products, LLC and Par Pharmaceutical, Inc., dated May 10, 2018.
10.4(7)	Amendment to the Stock Purchase and Sale Agreement, dated May 9, 2019, by and between Progenics Pharmaceuticals, Inc., Molecular Insight Pharmaceuticals, Inc., and Highland Capital Management, L.P., as stockholders’ representative.
31.1	Certification of Mark R. Baker, Chief Executive Officer of the Registrant, pursuant to Rule 13a-14(a) and Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.
31.2	Certification of Patrick Fabbio, Executive Vice President and Chief Financial Officer (Principal Financial and Accounting Officer) of the Registrant, pursuant to Rule 13a-14(a) and Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.
32	Certification of the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101	Interactive Data Files:
101.INS	XBRL Instance Document
101.SCH	XBRL Taxonomy Extension Schema
101.CAL	XBRL Taxonomy Extension Calculation Linkbase
101.LAB	XBRL Taxonomy Extension Label Linkbase
101.PRE	XBRL Taxonomy Extension Presentation Linkbase
101.DEF	XBRL Taxonomy Extension Definition Document

*     Exhibits footnoted as previously filed have been filed as an exhibit to the document of the Registrant or other registrant referenced in the footnote below, and are incorporated by reference herein.

⁽¹⁾ Previously filed in Current Report on Form 8-K filed on June 13, 2013.

⁽²⁾ Previously filed in Current Report on Form 8-K filed on April 1, 2019.

⁽³⁾ Previously filed in Registration Statement on Form S-1, Commission File No. 333-13627.

⁽⁴⁾ Previously filed in Current Report on Form 8-K filed on June 14, 2018.

⁽⁵⁾ Previously filed in Current Report on Form 8-K filed on May 31, 2018.

⁽⁶⁾ Previously filed in Current Report on Form 8-K filed on May 11, 2018.

⁽⁷⁾ Previously filed in Current Report on Form 8-K filed on May 14, 2019.

37

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 thereunto duly authorized.

	PROGENICS PHARMACEUTICALS, INC.
Date: August 9, 2019	By:	/s/ Patrick Fabbio
		Patrick Fabbio Executive Vice President and Chief Financial Officer (Principal Financial and Accounting Officer)

38

EX-31.1

Exhibit 31.1

CERTIFICATION

PURSUANT TO RULE 13a-14(a) AND RULE 15d-14(a) UNDER THE

SECURITIES EXCHANGE ACT OF 1934, AS AMENDED

I, Mark R. Baker, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Progenics Pharmaceuticals, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

	/s/ Mark R. Baker
Date: August 9, 2019	Mark R. Baker Chief Executive Officer (Principal Executive Officer)

EX-31.2

Exhibit 31.2

CERTIFICATION

PURSUANT TO RULE 13a-14(a) AND RULE 15d-14(a) UNDER THE

SECURITIES EXCHANGE ACT OF 1934, AS AMENDED

I, Patrick Fabbio, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Progenics Pharmaceuticals, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

	/s/ Patrick Fabbio
Date: August 9, 2019	Patrick Fabbio Executive Vice President and Chief Financial Officer (Principal Financial and Accounting Officer)

EX-32

Exhibit 32

CERTIFICATION PURSUANT 

TO 18 U.S.C. SECTION 1350, 

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Each of the undersigned hereby certifies, in his capacity as an officer of Progenics Pharmaceuticals, Inc. (the “Company”), for the purposes of 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:

(1) The Quarterly Report of the Company on Form 10-Q for the period ended June 30, 2019 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: August 9, 2019	/s/ Mark R. Baker
	Mark R. Baker Chief Executive Officer (Principal Executive Officer)
	/s/ Patrick Fabbio
	Patrick Fabbio Executive Vice President and Chief Financial Officer (Principal Financial and Accounting Officer)

A signed original of this written statement required by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to Progenics Pharmaceuticals, Inc. and will be retained by Progenics Pharmaceuticals, Inc. and furnished to the Securities and Exchange Commission or its staff upon request. 

XML

Document And Entity Information - shares	6 Months Ended
	Jun. 30, 2019	Aug. 05, 2019
Document Information [Line Items]
Entity Registrant Name	Progenics Pharmaceuticals Inc
Entity Central Index Key	0000835887
Trading Symbol	pgnx
Current Fiscal Year End Date	--12-31
Entity Filer Category	Accelerated Filer
Entity Current Reporting Status	Yes
Entity Emerging Growth Company	false
Entity Small Business	true
Entity Common Stock, Shares Outstanding (in shares)		86,421,634
Entity Shell Company	false
Document Type	10-Q
Document Period End Date	Jun. 30, 2019
Document Fiscal Year Focus	2019
Document Fiscal Period Focus	Q2
Amendment Flag	false
Title of 12(b) Security	Common Stock

XML

Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands	Jun. 30, 2019	Dec. 31, 2018
ASSETS
Cash and cash equivalents	$ 84,823	$ 137,686
Accounts receivable, net	10,569	3,803
Other current assets	4,806	2,640
Total current assets	100,198	144,129
Property and equipment, net	7,008	3,944
Intangible assets, net	7,375	6,666
Goodwill	17,847	13,074
Operating right-of-use lease assets	13,889
Other assets	6,464	1,684
Total assets	152,781	169,497
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable	272	444
Accrued expenses	16,938	10,533
Contingent consideration liability		7,050
Current portion of debt, net	5,806	5,419
Operating lease liabilities	555
Total current liabilities	23,571	23,446
Long-term debt, net	36,342	39,180
Operating lease liabilities	15,312
Contingent consideration liability	4,800	3,950
Deferred tax liability	28	28
Other liabilities		1,818
Total liabilities	80,053	68,422
Commitments and Contingencies
Stockholders’ equity:
Preferred stock, $0.001 par value Authorized - 20,000 shares; issued and outstanding - none	0	0
Common stock, $0.0013 par value Authorized - 160,000 shares; issued - 86,599 shares in 2019 and 84,742 shares in 2018	112	110
Additional paid-in capital	724,027	713,019
Treasury stock at cost, 200 shares of common stock	(2,741)	(2,741)
Subscription receivable	(933)
Accumulated other comprehensive loss	(94)	(105)
Accumulated deficit	(647,643)	(609,208)
Total stockholders’ equity	72,728	101,075
Total liabilities and stockholders’ equity	$ 152,781	$ 169,497

XML

Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares shares in Thousands	Jun. 30, 2019	Dec. 31, 2018
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized (in shares)	20,000	20,000
Preferred stock, shares issued (in shares)	0	0
Preferred stock, shares outstanding (in shares)	0	0
Common stock, par value (in dollars per share)	$ 0.0013	$ 0.0013
Common stock, shares authorized (in shares)	160,000	160,000
Common stock, shares issued (in shares)	86,599	84,742
Treasury stock at cost, shares (in shares)	200	200

XML

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
Revenues:
Product sales	$ 9,966	$ 3,878	$ 14,247	$ 7,067
Operating expenses:
Cost of goods sold	493		493
Research and development	13,080	9,347	25,472	17,457
Selling, general and administrative	14,570	7,569	23,794	14,266
Change in contingent consideration liability	916	1,300	1,816	2,100
Total operating expenses	29,059	18,216	51,575	33,823
Operating loss	(19,093)	(14,338)	(37,328)	(26,756)
Other (expense) income:
Interest (expense) income and other income, net	(607)	(930)	(1,107)	(1,936)
Total other (expense) income	(607)	(930)	(1,107)	(1,936)
Loss before income tax benefit	(19,700)	(15,268)	(38,435)	(28,692)
Income tax benefit		96		96
Net loss	$ (19,700)	$ (15,172)	$ (38,435)	$ (28,596)
Net loss per share - basic and diluted (in dollars per share)	$ (0.23)	$ (0.20)	$ (0.45)	$ (0.39)
Weighted-average shares - basic and diluted (in shares)	85,000	74,017	84,772	73,271
Product [Member]
Revenues:
Product sales	$ 270		$ 270
Royalty [Member]
Revenues:
Product sales	3,593	3,530	7,754	6,588
License and Other [Member]
Revenues:
Product sales	$ 6,103	$ 348	$ 6,223	$ 479

XML

Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
Net loss	$ (19,700)	$ (15,172)	$ (38,435)	$ (28,596)
Other comprehensive loss:
Foreign currency translation adjustments	53	(38)	11	(56)
Comprehensive loss	$ (19,647)	$ (15,210)	$ (38,424)	$ (28,652)

XML

Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) shares in Thousands, $ in Thousands	Common Stock [Member]	Common Stock Subscribed [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	AOCI Attributable to Parent [Member]	Subscription Receivable [Member]	Treasury Stock [Member]	Total
Balance (in shares) at Dec. 31, 2017	71,325	320					(200)
Balance at Dec. 31, 2017	$ 93		$ 609,829	$ (541,586)	$ (33)	$ (2,109)	$ (2,741)	$ 63,453
Net loss				(13,424)				(13,424)
Foreign currency translation adjustments					(18)			(18)
Stock-based compensation expense			1,048					1,048
Issuance of common stock to former shareholders of MIP, net of payments to advisors (in shares)	1,537	(320)
Issuance of common stock to former shareholders of MIP, net of payments to advisors	$ 2		7,414			2,109		9,525
Cumulative effect of ASU 2014-09 adoption				35				35
Subscription of common stock in connection with at-the-market offering, net of commissions (in shares)		103
Subscription of common stock in connection with at-the-market offering, net of commissions			750			(750)
Balance (in shares) at Mar. 31, 2018	72,862	103					(200)
Balance at Mar. 31, 2018	$ 95		619,041	(554,975)	(51)	(750)	$ (2,741)	60,619
Balance (in shares) at Dec. 31, 2017	71,325	320					(200)
Balance at Dec. 31, 2017	$ 93		609,829	(541,586)	(33)	(2,109)	$ (2,741)	63,453
Net loss								(28,596)
Foreign currency translation adjustments								(56)
Balance (in shares) at Jun. 30, 2018	74,959						(200)
Balance at Jun. 30, 2018	$ 97		635,709	(570,147)	(89)		$ (2,741)	62,829
Balance (in shares) at Mar. 31, 2018	72,862	103					(200)
Balance at Mar. 31, 2018	$ 95		619,041	(554,975)	(51)	(750)	$ (2,741)	60,619
Net loss				(15,172)				(15,172)
Foreign currency translation adjustments					(38)			(38)
Stock-based compensation expense			2,130					2,130
Issuance of common stock to former shareholders of MIP, net of payments to advisors (in shares)	2,097
Issuance of common stock to former shareholders of MIP, net of payments to advisors	$ 2		15,288					15,290
Cumulative effect of ASU 2014-09 adoption
Subscription of common stock in connection with at-the-market offering, net of commissions (in shares)		(103)
Subscription of common stock in connection with at-the-market offering, net of commissions			(750)			750
Balance (in shares) at Jun. 30, 2018	74,959						(200)
Balance at Jun. 30, 2018	$ 97		635,709	(570,147)	(89)		$ (2,741)	62,829
Balance (in shares) at Dec. 31, 2018	84,742						(200)
Balance at Dec. 31, 2018	$ 110		713,019	(609,208)	(105)		$ (2,741)	101,075
Net loss				(18,735)				(18,735)
Foreign currency translation adjustments					(42)			(42)
Stock-based compensation expense			1,077					1,077
Balance (in shares) at Mar. 31, 2019	84,742						(200)
Balance at Mar. 31, 2019	$ 110		714,096	(627,943)	(147)		$ (2,741)	83,375
Balance (in shares) at Dec. 31, 2018	84,742						(200)
Balance at Dec. 31, 2018	$ 110		713,019	(609,208)	(105)		$ (2,741)	101,075
Net loss								(38,435)
Foreign currency translation adjustments								$ 11
Exercise of stock options (in shares)								225
Balance (in shares) at Jun. 30, 2019	86,424	175					(200)
Balance at Jun. 30, 2019	$ 112		724,027	(647,643)	(94)	(933)	$ (2,741)	$ 72,728
Balance (in shares) at Mar. 31, 2019	84,742						(200)
Balance at Mar. 31, 2019	$ 110		714,096	(627,943)	(147)		$ (2,741)	83,375
Net loss				(19,700)				(19,700)
Foreign currency translation adjustments					53			53
Stock-based compensation expense			994					994
Issuance of common stock to former shareholders of MIP, net of payments to advisors (in shares)	1,632
Issuance of common stock to former shareholders of MIP, net of payments to advisors	$ 2		7,737					7,739
Exercise of stock options (in shares)	50
Exercise of stock options			267					267
Subscription receivable in connection with exercise of stock options (in shares)		175
Subscription receivable in connection with exercise of stock options			933			(933)
Balance (in shares) at Jun. 30, 2019	86,424	175					(200)
Balance at Jun. 30, 2019	$ 112		$ 724,027	$ (647,643)	$ (94)	$ (933)	$ (2,741)	$ 72,728

XML

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018
Cash flows from operating activities:
Net loss	$ (38,435,000)	$ (28,596,000)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	2,071,000	3,178,000
Depreciation and amortization	1,166,000	590,000
Non-cash interest expense	139,000	137,000
Other	11,000	(96,000)
Change in fair value of contingent consideration liability	1,816,000	2,100,000
Changes in assets and liabilities:
Accounts receivable	(6,764,000)	164,000
Other current assets	(2,073,000)	63,000
Other assets	(2,705,000)
Accounts payable	(169,000)	(2,797,000)
Accrued expenses	6,446,000	(77,000)
Other current liabilities	39,000
Other liabilities	(242,000)	145,000
Net cash used in operating activities	(38,700,000)	(25,189,000)
Cash flows from investing activities:
Acquisition of AZEDRA manufacturing assets	(8,000,000)
Purchases of property and equipment	(1,827,000)	(502,000)
Portion of MIP milestones paid to former advisor	(277,000)
Net cash used in investing activities	(10,104,000)	(502,000)
Cash flows from financing activities:
Net proceeds from issuance of common stock in connection with at-the-market offering		24,815,000
Repayment of debt	(2,590,000)	(2,179,000)
Proceeds from exercise of stock options	267,000
Net cash (used in) provided by financing activities	(2,323,000)	22,636,000
Effect of currency rate changes on cash, cash equivalents and restricted cash	2,000	(93,000)
Net decrease in cash, cash equivalents, and restricted cash	(51,125,000)	(3,148,000)
Cash, cash equivalents, and restricted cash at beginning of period	139,220,000	92,164,000
Cash, cash equivalents, and restricted cash at end of period	88,095,000	89,016,000
Supplemental disclosure of cash flow information
Cash paid for interest	2,131,000	2,381,000
Non-cash financing activity
Subscription receivable	933,000
Cash, cash equivalents and restricted cash information
Cash and cash equivalents at beginning of period	137,686,000	90,642,000
Restricted cash included in long-term assets at the beginning of period	1,534,000	1,522,000
Cash, cash equivalents, and restricted cash at beginning of period	139,220,000	92,164,000
Cash and cash equivalents at end of period	84,823,000	87,490,000
Restricted cash included in long-term assets at the end of period	3,272,000	1,526,000
Cash, cash equivalents, and restricted cash at end of period	$ 88,095,000	$ 89,016,000

XML

Note 1 - Summary of Significant Accounting Policies

6 Months Ended

Jun. 30, 2019

Notes to Financial Statements

Business Description and Accounting Policies [Text Block]

Note

1.

Summary of Significant Accounting Policies

Business

Progenics Pharmaceuticals, Inc. (and its subsidiaries collectively the “Company,” “Progenics”, “we”, or “us”) is an oncology company focused on the development and commercialization of innovative targeted medicines and artificial intelligence to find, fight and follow cancer. Highlights of our recent progress include the

first

commercial revenue for AZEDRA

®

, completion of enrollment of the PyL

TM

pivotal Phase

3

trial, and dosing of the

first

patient in the

1095

open label Phase

2

trial. Our pipeline includes therapeutic agents designed to precisely target cancer (AZEDRA,

1095

and PSMA TTC), as well as prostate-specific membrane antigen (“PSMA”) targeted imaging agents for prostate cancer (PyL and

1404

).

Recent

and Continued

Progress

:

● AZEDRA Launch – A team of Nuclear Medicine Technologists, Sales Representatives, Medical Science Liaisons and Access Specialists are in the field assisting centers of excellence and payers with utilizing and reimbursing AZEDRA. This quarter we completed the first administrations of commercial AZEDRA and recorded our first commercial sales.

● Centers for Medicare & Medicaid Services ("CMS") approved a new technology add-on payment ("NTAP") for AZEDRA when administered in the hospital inpatient setting for Medicare beneficiaries in FY 2020. The NTAP will cover the lesser of 65 percent of the average cost of AZEDRA, or 65 percent of the costs in excess of the Medicare Severity Diagnosis Related Groups ("MS–DRG") payment for the case. As a result, the maximum NTAP for a case involving a therapeutic dose of AZEDRA is $98,150.

● Patient enrollment for the Phase 3 CONDOR trial evaluating the diagnostic performance and clinical impact of PyL ( 18 F-DCFPyL) was completed five months ahead of schedule. The Phase 3 CONDOR trial is a multi-center, open label trial that dosed 208 patients with biochemical recurrence of prostate cancer at 14 sites in the U.S. and Canada. Top-line data is expected by year end.

● The first patient was dosed in the ongoing Phase 2 trial of 1095 in combination with enzalutamide in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). Progenics’1095 is a small molecule radiotherapeutic designed to selectively bind to the extracellular domain of prostate specific membrane antigen (“PSMA”), a protein that is highly expressed on prostate cancer cells.

● We reached alignment with the U.S. Food and Drug Administration (“FDA”) on a clinical development plan to support an expanded label for AZEDRA for the treatment of patients with unresectable or metastatic neuroendocrine tumors (“NETs”) who are MIBG-avid. Progenics plans to conduct a basket study that will evaluate AZEDRA in patients with NETs that are MIBG-avid, including gastroenteropancreatic neuroendocrine tumors as well as other NETs and utilize a dosing regimen that enables outpatient administration. The basket study is expected to begin by the end of the year and enroll approximately 150 patients at sites in the U.S. and Canada.

● The U.S. District Court of New Jersey upheld the validity and determined the infringement by Actavis Laboratories FL, Inc. (“Actavis”) of a patent protecting RELISTOR Tablets, which expires in March 2031. Defendant, Actavis, a subsidiary of Teva Pharmaceutical Industries Ltd., had challenged the validity of and had alleged non-infringement of Claims 2 and 5 of U.S. Patent No. 8,524,276, which protects the formulation of RELISTOR Tablets.

● We entered into an exclusive license agreement with ROTOP Pharmaka GmbH (“ROTOP”), a Germany-based developer of radiopharmaceuticals for nuclear medicine diagnostics, to develop and commercialize 1404 in Europe. 1404 is a technetium- 99m labeled small molecule which binds to PSMA and is used as an imaging agent to diagnose and detect localized prostate cancer as well as soft tissue and bone metastases. Under the terms of the collaboration, ROTOP will be responsible for the development, regulatory approvals and commercialization of 1404 in Europe while Progenics is entitled to double-digit, tiered royalties on net sales in the territory.

● The automated Bone Scan Index (“aBSI”) automatically segments the anatomical regions of the skeleton and detects and classifies lesions in the bone scans of prostate cancer patients. The aBSI has been shown to be an objective measure of the quantitative change in disease burden and is a prognostic biomarker in patients with metastatic prostate cancer. In August 2019, the Company received 510 (k) clearance from the FDA to market its cloud-based version of aBSI product in the U.S. This clearance of our cloud-based software as a medical device is an essential step towards the further development of PSMA AI.

● We entered into a transfer agreement with FUJIFILM Toyama Chemical Co, Ltd. (“FUJIFILM”) for the rights to the Company’s aBSI product in Japan for use under the name BONENAVI ® . Under the terms of the agreement, FUJIFILM acquired, by a combination of purchase and license, the Japanese software, source code, supporting data and all Japanese patents associated with the aBSI product from Progenics for use in Japan. In exchange, Progenics received $4.0 million in an upfront payment and will receive service fees for aBSI and other AI products over three years in Japan. BONENAVI has been licensed to FUJIFILM for use in Japan since 2011.

● We initiated a collaboration that provides the VA Greater Los Angeles Healthcare System (“VAGLAHS”) with access to the Company’s AI platform for investigational use. In the project, the VAGLAHS network will gain access to Progenics’ machine learning platforms, which includes the aBSI and the PSMA AI platforms. The collaboration will explore novel predictive machine learning algorithms from the digital medical images and its associated clinical outcomes. These novel algorithms will be prospectively validated at VAGLAHS for effective healthcare management of veterans with prostate cancer. This project is the nation’s first collaborative effort to validate cutting-edge machine learning tools for improving treatment management of veterans with prostate cancer and provides additional validation to Progenics’ AI platform.

Corporate:

● Progenics appointed Huw Jones to the newly created role of Vice President, Commercial. Mr. Jones joins Progenics following several years on the commercial strategy and operations team at Novartis Pharmaceuticals, as well as its subsidiaries, Advanced Accelerator Applications SA and Novartis Oncology. In his two decades at Novartis and its subsidiaries, Mr. Jones held various global leadership roles, including Executive Director and Global Brand Leader, Head of Global Commercial Excellence, as well as positions of increasing responsibility in general management, sales, marketing, training and commercial operations.

Strategic partnerships

:

● RELISTOR ® (methylnaltrexone bromide) is licensed to Salix Pharmaceuticals, Inc., a wholly-owned subsidiary of Bausch Health Companies Inc. (“Bausch”, which is the predecessor of Valeant Pharmaceuticals International, Inc.). RELISTOR subcutaneous injection and RELISTOR Tablets are approved by the FDA for the treatment of opioid-induced constipation in adults with chronic non-cancer pain.

● Bayer AG (“Bayer”) has exclusive worldwide rights to develop and commercialize products using our PSMA antibody technology, in combination with Bayer’s alpha-emitting radionuclides. Bayer is developing PSMA TTC, a thorium- 227 labeled PSMA-targeted antibody therapeutic. Bayer initiated a Phase 1 trial of PSMA TTC in patients with metastatic castration-resistant prostate cancer. In May 2019, Bayer dosed the first patient in the Phase 1 trial which triggered a $2.0 million milestone payment, recorded as part of the license and other revenue.

● CytoDyn Inc. (“CytoDyn”) acquired leronlimab (PRO 140 ), which acquisition included a milestone and royalty payment obligations to us. Leronlimab is a fully humanized monoclonal antibody which is a cellular targeting CCR5 entry antagonist and is currently in development for the treatment of HIV. CytoDyn announced in March 2019 that it filed its first of three sections of its Biologics License Application (“BLA”) to the FDA for leronlimab for the treatment of HIV under the Rolling Review process.

● Curium has exclusive rights to develop, manufacture and commercialize PyL ( 18 F-DCFPyL) in Europe. Under the terms of the collaboration, Curium is responsible for the development, regulatory approvals and commercialization of PyL in Europe, and Progenics is entitled to royalties on net sales of PyL.

● ROTOP has exclusive rights to develop, manufacture and commercialize 1404 in Europe. Under the terms of the collaboration, ROTOP is responsible for the development, regulatory approvals and commercialization of 1404 in Europe. We understand from ROTOP that it plans to hold an expert panel meeting with Key Opinion Leaders (“KOLs”) in the PSMA imaging field, as well as regulatory experts, to review existing data on 1404 and obtain guidance on the clinical development. Upon agreement on a path forward, ROTOP will request a meeting with European regulators and start a clinical trial in early 2020. Under this agreement, Progenics is entitled to double-digit, tiered royalties on future net sales of 1404 in Europe.

● FUJIFILM has rights to the Company’s aBSI product in Japan for use under the name BONENAVI. Under the terms of the agreement, FUJIFILM acquired, by a combination of purchase and license, the Japanese software, source code, supporting data and all Japanese patents associated with the aBSI product from us for use in Japan. In exchange, Progenics received a $4.0 million upfront payment and is entitled to service fees for the next three years.

Our current principal sources of revenue from operations are royalty and development and commercial milestones from Bausch and Bayer. Royalty and further milestone payments from Bausch or Bayer depend on success in development and commercialization of RELISTOR and our PSMA antibody technology, respectively, which is dependent on many factors, such as Bausch or Bayer’s respective efforts, decisions by the FDA and other regulatory bodies, competition from drugs for the same or similar indications, and the outcome of clinical and other testing of the licensed products.

We commenced principal operations in

1988,

became publicly traded in

1997,

and throughout have been engaged primarily in research and development efforts, establishing corporate collaborations, launching AZEDRA and other related business activities. Certain of our intellectual property rights are held by wholly-owned subsidiaries. Our U.S. operations are presently conducted at our headquarters in New York and our manufacturing facility in Somerset, New Jersey. The operations of our wholly-owned foreign subsidiary, EXINI Diagnostics A.B. (“EXINI”), are conducted at our facility in Lund, Sweden. We operate under a single operating segment, which includes development, manufacturing and commercialization of pharmaceutical products and other technologies to target, diagnose and treat cancer. Our operating segment is regularly evaluated for financial performance by our chief operating decision maker, who is our Chief Executive Officer.

Liquidity

At

June 30, 2019,

we had

$84.8

million of cash and cash equivalents, a decrease of

$52.9

million from

$137.7

million at

December 31, 2018.

We expect that this amount will be sufficient to fund operations as currently anticipated beyond

one

year from the filing date of this Quarterly Report on Form

10

-Q. We have historically funded our operations to a significant extent from capital-raising and we expect to require additional funding in the future, the availability of which is never guaranteed and

may

be uncertain. We expect that we

may

continue to incur operating losses.

Basis of Presentation

Our unaudited condensed consolidated financial statements have been prepared in accordance with applicable presentation requirements, and accordingly, do

not

include all information and disclosures necessary for a presentation of our financial position, results of operations, and cash flows in conformity with accounting principles generally accepted in the U.S. (“GAAP”). In the opinion of management, these financial statements reflect all adjustments, consisting primarily of normal recurring accruals necessary for a fair statement of results for the periods presented. The results of operations for interim periods are

not

necessarily indicative of the results for the full year.

Our unaudited condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto contained in our Annual Report on Form

10

-K for the year ended

December 31, 2018.

The year-end consolidated balance sheet data in these financial statements were derived from audited financial statements but do

not

include all disclosures required by GAAP.

Principles of Consolidation

The condensed consolidated financial statements include the accounts of Progenics as well as its wholly-owned subsidiaries. All material intercompany transactions and balances have been eliminated in consolidation.

Use of Estimates

The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results

may

differ from those estimates.

Revenue Recognition

We recognize revenue when our customers obtain control of the promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To account for our revenue arrangements, we perform the following

five

steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy our performance obligations.

For contracts determined to be within the scope of ASU

2014

-

09,

Revenue from Contracts with Customers (Topic

606

)

(“ASU

2014

-

09”

or the “Topic

606”

), we assess the goods or services promised within each contract for the purpose of identifying them as performance obligations. We must apply judgement in assessing whether each promised good or service is distinct. If a promised good or service is

not

distinct, we will combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct.

The transaction price is then determined and allocated to the identified performance obligations in proportion to their estimated fair value, which requires significant judgment. Variable consideration, which is estimated using the expected value method or the most likely amount method, is included in the transaction price only if, in our judgment, it is probable that a significant future reversal of cumulative revenue under the contract will

not

occur.

For arrangements that include development, regulatory or sales milestone payments, we evaluate whether the milestones are probable of being reached and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would

not

occur, the associated milestone value is included in the transaction price. Milestone payments that are

not

within our control or the licensee’s control, such as regulatory approvals, are generally

not

considered probable of being achieved until those approvals are received.

We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

The following table summarizes our revenue streams from contracts with customers for the

three

and

six

months ended

June 30, 2019

and

2018

(in thousands):

	Three months ended June 30,				Six months ended June 30,
	2019		2018		2019		2018
Product sales	$	270	$	-	$	270	$	-
Royalty income		3,593		3,530		7,754		6,588
License and other revenue		6,103		348		6,223		479
Total revenue	$	9,966	$	3,878	$	14,247	$	7,067

Product sales

– represent revenue from sales of AZEDRA directly to hospitals. Our performance obligations are to provide AZEDRA based on sales orders from hospitals, which have been verified by our commercial team as properly credentialed to receive, handle, administer and dispose of radioactive materials. We recognize revenue after the customer takes title and has obtained control of the product. Our contracts with hospitals stipulate that product is shipped free on board destination. We invoice hospitals after the products have been delivered and invoice payments are generally due within

60

days of invoice date. We record sales to hospitals based on AZEDRA’s list price per mCi and the amount prescribed based upon a dosimetric assessment of each patient. We record product sales net of any variable consideration due to rebates and discounts provided under governmental and other programs, and other sales-related deductions, such as product returns and copay assistance programs. Shipping and handling costs associated with finished goods delivered to customers are recorded as a selling expense.

Royalty income

– represents revenue from the sales-based royalties under our intellectual property licensing arrangements and is recognized upon net sales of the licensed products.

License and o

ther revenue

– represents revenue from upfront payments (fixed consideration) and development and sales milestones, sublicense payments, support and service payments and sales-based bonus payments (variable consideration) under our licensing or software arrangements. The fixed consideration will be recognized as revenue at the time when the transfer of know-how is completed. The variable consideration will be estimated using the most likely amount method and recognized only when we have “a high degree of confidence” that revenue will

not

be reversed in a subsequent reporting period. The other revenue also includes revenue from product sales of research reagents, that is recognized upon shipment to the end customer (i.e. control of the product is deemed to be transferred).

We had receivable contract balances of

$10.6

million and

$3.8

million as of

June 30, 2019

and

December 31, 2018,

respectively, primarily related to the royalty revenue and upfront and milestone payments under our partnerships, which are included in license and other revenue (see

Note

5

.

Accounts Receivable

).

Restricted Cash

Restricted cash included in long-term assets of

$3.3

million and

$1.5

million at

June 30, 2019

and

December 31, 2018,

respectively, represents collateral for a letter of credit securing a lease obligation (for both periods), collateral for a letter of credit related to equipment purchases and a security deposit with the German District Court related to the PSMA-

617

litigation (for the

2019

period). We believe the carrying value of this asset approximates fair value.

Foreign Currency Translation

Our international subsidiaries generally consider their respective local currency to be their functional currency. Assets and liabilities of these international subsidiaries are translated into U.S. dollars at quarter-end exchange rates and revenues and expenses are translated at average exchange rates during the quarter and year-to-date period. Foreign currency translation adjustments for the reported periods are included in accumulated other comprehensive loss in our condensed consolidated statements of comprehensive loss, and the cumulative effect is included in the stockholders’ equity section of our condensed consolidated balance sheets. Realized gains and losses denominated in foreign currencies are recorded in operating expenses in our condensed consolidated statements of operations and were

not

material to our consolidated results of operations for the

three

and

six

months ended

June 30, 2019

or

2018.

Leases

We determine whether an arrangement is or contains a lease at its inception. We recognize lease liabilities based on the present value of the minimum lease payments

not

yet paid by using the lease term and discount rate determined at lease commencement. As most of our leases do

not

provide an implicit rate, we use our incremental borrowing rate to determine the present value of our lease payments. Our leases

may

include options to extend or terminate a lease when it is reasonably certain that we will exercise that option. We recognize the operating right-of-use (“ROU”) lease assets at amounts equal to the lease liability adjusted for prepaid or accrued rent, remaining balance of any lease incentives and unamortized initial direct costs.

The operating lease liabilities are reported in other current liabilities and other noncurrent liabilities and the related ROU lease assets are reported in other noncurrent assets on our condensed consolidated balance sheets. Lease expense for our operating leases is calculated on a straight-line basis over the lease term and is reported in research and development and selling, general and administrative expenses on our condensed consolidated statements of operations. We do

not

recognize a lease liability or ROU lease assets for leases whose lease terms, at commencement, are

twelve

months or less, or for leases which are below the established capitalization threshold.

Property and Equipment

Property and equipment is recorded at historical cost, net of accumulated depreciation and amortization of

$3.1

million and

$2.7

million as of

June 30, 2019

and

December 31, 2018,

respectively. The following table summarizes our property and equipment (in thousands):

	June 30,			December 31,
	2019			2018
Machinery and equipment	$	3,949		$	2,992
Leasehold improvements		3,052			1,734
Computer equipment		632			721
Furniture and fixtures		909			878
Construction in progress		1,612			317
Property and equipment, gross		10,154			6,642
Less - accumulated depreciation		(3,146	)		(2,698	)
Property and equipment, net	$	7,008		$	3,944

XML

Note 2 - New Accounting Pronouncements

6 Months Ended

Jun. 30, 2019

Notes to Financial Statements

Description of New Accounting Pronouncements Not yet Adopted [Text Block]

Note

2.

New Accounting Pronouncements

Recently Adopted

In

February 2016,

the FASB issued ASU

2016

-

02

(“ASU

2016

-

02”

),

Leases (Topic

842

)

. This standard established a right-of-use model that requires all lessees to recognize right-of-use assets and liabilities on their balance sheet that arise from leases with terms longer than

12

months as well as provide disclosures with respect to certain qualitative and quantitative information related to their leasing arrangements.

The FASB has subsequently issued the following amendments to ASU

2016

-

02,

which have the same effective date and transition date of

January 1, 2019,

and which we collectively refer to as the new leasing standards:

● ASU No. 2018 - 01, Leases (Topic 842 ): Land Easement Practical Expedient for Transition to Topic 842, which permits an entity to elect an optional transition practical expedient to not evaluate under Topic 842 land easements that exist or expired prior to adoption of Topic 842 and that were not previously accounted for as leases under the prior standard, ASC 840, Leases .

● ASU No. 2018 - 10, Codification Improvements to Topic 842, Leases , which amends certain narrow aspects of the guidance issued in ASU 2016 - 02.

● ASU No. 2018 - 11, Leases (Topic 842 ): Targeted Improvements , which allows for a transition approach to initially apply ASU 2016 - 02 at the adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption as well as an additional practical expedient for lessors to not separate non-lease components from the associated lease component.

● ASU No. 2018 - 20, Narrow-Scope Improvements for Lessors , which contains certain narrow scope improvements to the guidance issued in ASU 2016 - 02.

● ASU No. 2019 - 01, Leases (Topic 842 ): Codification Improvements .

We adopted the new leasing standards on

January 1, 2019,

using a modified retrospective transition approach to be applied to leases existing as of, or entered into after,

January 1, 2019

and did

not

adjust comparative periods. We also elected the package of practical expedients permitted under this standard, which among other things, allowed us to carry forward the lease classification for our existing leases. In preparation for the adoption of this standard and to enable preparation of the required financial information, we implemented new internal controls and processes.

The adoption of this standard impacted our

2019

opening consolidated balance sheet as we recorded operating lease liabilities of

$15.3

million and ROU lease assets of

$13.5

million, which equals the lease liabilities net of deferred rent and lease incentives previously recorded on our balance sheet under the old guidance. The adoption of this standard did

not

have an impact on our consolidated statements of operations or cash flows.

Recently Issued

In

August 2018,

the FASB issued ASU

2018

-

13

(“ASU

2018

-

13”

),

Fair Value Measurement - Disclosure Framework (Topic

820

): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement

. The updated guidance improves the disclosure requirements on fair value measurements. ASU

2018

-

13

is effective for fiscal years, and interim periods within those fiscal years, beginning after

December 15, 2019.

Early adoption is permitted for any removed or modified disclosures. We are currently assessing the timing of adopting the updated provisions and the impact of the updated provisions on our consolidated financial statements.

In

June 2016,

the FASB issued ASU

2016

-

13,

Financial Instruments - Credit Losses (Topic

326

): Measurement of Credit Losses on Financial Instruments

. In

November 2018,

the FASB issued ASU

2018

-

19,

Codification Improvements to Topic

326,

Financial Instruments-Credit Losses

and in

April 2019,

the FASB issued ASU

2019

-

04,

Codification Improvements to Topic

326,

Financial Instruments—Credit Losses,

Topic

815,

Derivatives and Hedging, and

Topic

825,

Financial

Instruments

, which amend the scope and transition requirements of ASU

2016

-

13.

The standard requires a financial asset (or a group of financial assets) measured at amortized cost basis to be presented at the net amount expected to be collected. The measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions and reasonable and supportable forecasts that affect the collectability of the reported amount. In

May 2019,

the FASB issued ASU

2019

-

05,

Financial Instruments—Credit Losses

(

Topic

326

): Targeted Transition Relief

.

This ASU addresses certain stakeholders’ concerns by providing an option to irrevocably elect the fair value option for certain financial assets previously measured at amortized cost basis. For those entities, the targeted transition relief will increase comparability of financial statement information by providing an option to align measurement methodologies for similar financial assets. Furthermore, the targeted transition relief also

may

reduce the costs for some entities to comply with the amendments in Update

2016

-

13

while still providing financial statement users with decision-useful information. The standard is effective for fiscal years, and interim periods within those fiscal years, beginning after

December 15, 2019.

We are currently evaluating the impact this guidance will have on our consolidated financial statements.

XML

Note 3 - Net Loss Per Share

6 Months Ended

Jun. 30, 2019

Notes to Financial Statements

Earnings Per Share [Text Block]

Note

3

. Net

Loss

Per Share

Our basic net loss per share amounts have been computed by dividing net loss by the weighted-average number of common shares outstanding during the period. For the

three

and

six

months ended

June 30, 2019

and

2018,

we reported net losses and, accordingly, potential common shares were

not

included since such inclusion would have been anti-dilutive.

The calculations of net loss per share, basic and diluted, are as follows (amounts in thousands, except per share data):

				Weighted-Average
				Shares
	Net Loss			Outstanding		Per Share
	(Numerator)			(Denominator)		Amount
Three months ended June 30, 2019
Basic and diluted	$	(19,700	)		85,000	$	(0.23	)
Six months ended June 30, 2019
Basic and diluted	$	(38,435	)		84,772	$	(0.45	)
Three months ended June 30, 2018
Basic and diluted	$	(15,172	)		74,017	$	(0.20	)
Six months ended June 30, 2018
Basic and diluted	$	(28,596	)		73,271	$	(0.39	)

The following table summarizes anti-dilutive common shares or common shares where performance conditions have

not

been met, that were excluded from the calculation of diluted net loss per share (in thousands):

	Three Months Ended June 30,				Six Months Ended June 30,
	2019		2018		2019		2018
Stock options		6,298		3,237		6,382		3,236
Contingent consideration liability (1)		778		2,351		778		2,351
Total securities excluded		7,076		5,588		7,160		5,587

(

1

)

Calculated as follows: (a) the contingent consideration liability balance divided by (b) the closing stock price of our common stock.

XML

Note 4 - Fair Value Measurements

6 Months Ended

Jun. 30, 2019

Notes to Financial Statements

Fair Value Disclosures [Text Block]

Note

4

. Fair Value Measurements

To estimate the fair values of our financial assets and liabilities, we use valuation approaches within a hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of us. Unobservable inputs are inputs that reflect our assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy is divided into

three

levels based on the source of inputs as follows:

● Level 1 – Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that we have the ability to access

● Level 2 – Valuations for which all significant inputs are observable, either directly or indirectly, other than Level 1 inputs

● Level 3 – Valuations based on inputs that are unobservable and significant to the overall fair value measurement

The availability of observable inputs can vary among the various types of financial assets and liabilities. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, the inputs used for measuring fair value

may

fall into different levels of the fair value hierarchy. In such cases, for financial statement disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is categorized is based on the lowest level of input used that is significant to the overall fair value measurement.

We believe the carrying amounts of our cash equivalents, restricted cash, accounts receivable, other current assets, other assets, accounts payable and accrued expenses approximated their fair values as of

June 30, 2019

and

December 31, 2018.

We record the contingent consideration liability resulting from our acquisition of Molecular Insight Pharmaceuticals, Inc. (“MIP”) at fair value in accordance with Accounting Standards Codification (“ASC”)

820

(Topic

820,

Fair Value Measurement

).

The following tables summarize each major class of our financial assets and liabilities measured at fair value on a recurring basis as of the dates indicated, classified by valuation hierarchy (in thousands):

			Fair Value Measurements at June 30, 2019
			Quoted Prices in Active		Significant Other		Significant
	Balance at		Markets for		Observable		Unobservable
	June 30,		Identical Assets		Inputs		Inputs
	2019		(Level 1)		(Level 2)		(Level 3)
Assets:
Money market funds	$	82,737	$	82,737	$	-	$	-
Total assets	$	82,737	$	82,737	$	-	$	-
Liabilities:
Contingent consideration liability	$	4,800	$	-	$	-	$	4,800
Total liabilities	$	4,800	$	-	$	-	$	4,800

			Fair Value Measurements at December 31, 2018
			Quoted Prices in Active		Significant Other		Significant
	Balance at		Markets for		Observable		Unobservable
	December 31,		Identical Assets		Inputs		Inputs
	2018		(Level 1)		(Level 2)		(Level 3)
Assets:
Money market funds	$	136,052	$	136,052	$	-	$	-
Total assets	$	136,052	$	136,052	$	-	$	-
Liabilities:
Contingent consideration liability	$	11,000	$	-	$	-	$	11,000
Total liabilities	$	11,000	$	-	$	-	$	11,000

The contingent consideration liability of

$4.8

million as of

June 30, 2019

represents the estimated fair value of the future potential milestone payments to former MIP stockholders (shown in the tables below).

Milestone payments due upon

first

commercial sale and/or from proceeds received from license revenue (in thousands):

Program	Consideration		Form of Payment
1095		5,000	Cash or Progenics common stock
1404		9,984	Cash or Progenics common stock or cash in the case of license revenue
	$	14,984

Net sales milestone payments due upon

first

achievement of specified net sales target in any single calendar year across all MIP-related programs (in thousands):

	Consideration		Form of Payment at Progenics' Option
$30 million	$	5,000	Cash or Progenics common stock
$60 million		5,000	Cash or Progenics common stock
$100 million		10,000	Cash or Progenics common stock
$250 million		20,000	Cash or Progenics common stock
$500 million		30,000	Cash or Progenics common stock
	$	70,000

We consider this liability a Level

3

instrument (

one

with significant unobservable inputs) in the fair value hierarchy. The estimated fair value was determined based on probability adjusted discounted cash flow and Monte Carlo simulation models that included significant estimates and assumptions pertaining to commercialization events and sales targets. The most significant unobservable inputs are the probabilities of achieving regulatory approval of the development projects and subsequent commercial success.

Significant changes in any of the probabilities of success or the probabilities as to the periods in which milestones will be achieved would result in a significantly higher or lower fair value measurement. We record the contingent consideration liability at fair value with changes in estimated fair values recorded in change in contingent consideration liability in our condensed consolidated statements of operations.

The following table summarizes quantitative information and assumptions pertaining to the fair value measurement of the Level

3

inputs at

June 30, 2019

and

December 31, 2018 (

in thousands). The decrease in the contingent consideration liability of

$6.2

million during the

six

months ended

June 30, 2019

was primarily due to an

$8.0

million payment for the AZEDRA

first

commercial sale milestone, which was partially offset by an increase in the AZEDRA sales forecasts associated with the planned initiation of a basket study to expand the label for AZEDRA and a decrease in the discount period used to calculate the present value of the contingent consideration liability.

	Fair Value at
	June 30,
	2019		Valuation Technique	Unobservable Input	Assumption
Contingent Consideration Liability:
1095 commercialization	$	450	Probability adjusted discounted	Probability of success		18%
			cash flow model	Period of expected milestone achievement		2026
				Discount rate		10%
1404 commercialization		250	Probability adjusted discounted	Probability of success		43%
			cash flow model	Period of expected milestone achievement	2022	-	2035
				Discount rate		10%
Net sales targets		4,100	Monte-Carlo simulation	Probability of success	18%	-	90%
				Discount rate		10%
Total	$	4,800

	Fair Value at
	December 31,
	2018		Valuation Technique	Unobservable Input	Assumption
Contingent Consideration Liability:
AZEDRA commercialization	$	7,050	Probability adjusted discounted	Probability of success		90%
			cash flow model	Period of expected milestone achievement		2019
				Discount rate		10%
1095 commercialization		450	Probability adjusted discounted	Probability of success		18%
			cash flow model	Period of expected milestone achievement		2026
				Discount rate		10%
Net sales targets		3,500	Monte-Carlo simulation	Probability of success	18%	-	90%
				Discount rate		10%
Total	$	11,000

For those financial instruments with significant Level

3

inputs, the following table summarizes the activities for the periods indicated (in thousands):

	Liability - Contingent Consideration
	Fair Value Measurements Using
	Significant Unobservable Inputs
	(Level 3)
	Three Months Ended June 30,					Six Months Ended June 30,
	2019			2018		2019			2018
Balance at beginning of period	$	11,900		$	17,600	$	11,000		$	16,800
Fair value change included in net loss		916			1,300		1,816			2,100
Payments		(8,016	)		-		(8,016	)		-
Balance at end of period	$	4,800		$	18,900	$	4,800		$	18,900
Changes in unrealized gains or losses for the period included in earnings (or changes in net assets) for liabilities held at the end of the reporting period	$	916		$	1,300	$	1,816		$	2,100

XML

Note 5 - Accounts Receivable

6 Months Ended

Jun. 30, 2019

Notes to Financial Statements

Loans, Notes, Trade and Other Receivables Disclosure [Text Block]

Note

5

. Accounts Receivable

Our accounts receivable represent amounts due to us from royalties, collaborators, product sales and, to a small extent, sales of research reagents, and consisted of the following at

June 30, 2019

and

December 31, 2018 (

in thousands):

	June 30,		December 31,
	2019		2018
Royalties	$	3,593	$	3,151
Bayer milestone		2,000		-
FUJIFILM transfer		4,000		-
Other		976		652
Accounts receivable, net	$	10,569	$	3,803

XML

Note 6 - Recent Acquisition, Goodwill, In-process Research and Development and Other Intangible Assets

6 Months Ended

Jun. 30, 2019

Notes to Financial Statements

Intangible Assets Disclosure [Text Block]

Note

6

.

Recent Acquisition,

Goodwill, In-Process Research and Development and Other Intangible Assets

Recent

Acquisition

In

February 2019,

we acquired the AZEDRA manufacturing assets for

$8.0

million cash consideration and entered into a sublease agreement for the radiopharmaceutical manufacturing facility located in Somerset, New Jersey. The Somerset site serves as the launch facility for AZEDRA and will also provide manufacturing support for the Company’s development stage radiopharmaceuticals, including

1095.

The production of AZEDRA uses a proprietary Ultratrace

®

process which concentrates the MIBG targeted radiolytic activity by eliminating non-therapeutic “cold” MIBG molecules, giving AZEDRA a uniquely high specific activity.

Purchase Price Allocation

: We accounted for this acquisition as a business combination by allocating the consideration we paid to the fair values of the assets acquired at the effective date of the acquisition, as summarized below. The difference between the fair value of the acquisition consideration and the estimated fair value of the identifiable assets represents potential future economic benefits arising from the acquisition, and has been recorded as goodwill.

The following table summarizes the allocation of the consideration paid to the estimated fair values of the assets acquired as of the acquisition date (in thousands):

	Amount
Cash consideration	$	8,000
Tangible assets acquired:
Machinery and equipment		682
Leasehold improvements		1,300
Total tangible assets acquired		1,982
Intangible assets - Somerset		1,245
Total tangible and intangible assets acquired		3,227
Goodwill	$	4,773

The replacement cost method, a variation of the cost approach, was applied to assess the value of the assets acquired by Progenics. The principle behind this method is that the value represents the current cost of a similar new asset having the nearest equivalent utility as the asset being valued. It generally represents the maximum amount that a prudent investor will pay for a comparable asset. The cost approach provides a systematic framework for estimating the value of tangible or intangible assets based on the economic principle of substitution, and that

no

prudent investor will purchase an existing asset for more than it will cost to create a comparable asset. Under this approach, value is estimated by developing the cost to either replace or reproduce (replicate) the asset of similar utility.

The acquired Somerset intangible assets represent manufacturing know-how, which is comprised of documented technical data and information, formulae, standards, specifications, processes, methods, code books, as well as all information, knowledge, trade practices and secrets utilized by the Somerset facility in manufacturing of the AZEDRA. We estimate the remaining useful life of the Somerset intangible to be approximately

six

years.

Goodwill, In-Process Research and Development and Other Intangible Assets

The fair values of in-process research and development (“IPR&D”) and other identified intangible assets acquired in business combinations are capitalized. We utilize the “income method,” which applies a probability weighting that considers the risk of development and commercialization to the estimated future net cash flows that are derived from projected sales revenues and estimated costs or “replacement costs”, whichever is greater. These projections are based on factors such as relevant market size, patent protection, historical pricing of similar products and expected industry trends. The estimated future net cash flows are then discounted to the present value using an appropriate discount rate. This analysis is performed for each IPR&D project and other identified intangible assets, independently. IPR&D assets are treated as indefinite-lived intangible assets until completion or abandonment of the projects, at which time the assets are amortized over the remaining useful life or written off, as appropriate. Other identified intangible assets, which include the technology asset acquired as part of the EXINI business combination, AZEDRA product rights intangible and Somerset intangible, are amortized over the relevant estimated useful lives. The IPR&D assets are tested for impairment at least annually or when a triggering event occurs that could indicate a potential impairment and any impairment loss is recognized in our condensed consolidated statements of operations.

Goodwill represents excess consideration in a business combination over the fair value of identifiable net assets acquired. Goodwill is

not

amortized but is subject to impairment testing at least annually or when a triggering event occurs that could indicate a potential impairment. We determine whether goodwill

may

be impaired by comparing the fair value of the reporting unit (we have determined that we have only

one

reporting unit for this purpose), calculated as the product of shares outstanding and the share price as of the end of a period, to its carrying value (for this purpose, our total stockholders’ equity).

No

goodwill impairment has been recognized as of

June 30, 2019

or

2018.

The following tables summarize the activity related to our goodwill and intangible assets (in thousands):

					Other
					Intangible
	Goodwill		IPR&D		Assets
Balance at January 1, 2019	$	13,074	$	600	$	6,066
Increase related to Somerset acquisition		4,773		-		1,245
Amortization expense		-		-		(536	)
Balance at June 30, 2019	$	17,847	$	600	$	6,775

					Other
					Intangible
	Goodwill		IPR&D		Assets
Balance at January 1, 2018	$	13,074	$	28,700	$	1,669
Amortization expense		-		-		(106	)
Balance at June 30, 2018	$	13,074	$	28,700	$	1,563

The following table reflects the components of the finite-lived intangible assets as of

June 30, 2019 (

in thousands):

	Gross Amount		Accumulated Amortization		Net Carrying Value
Intangible assets - AZEDRA product rights	$	4,900	$	642	$	4,258
Intangible assets - Somerset		1,245		80		1,165
Intangible assets - EXINI technology		2,120		768		1,352
Total	$	8,265	$	1,490	$	6,775

XML

Note 7 - Accrued Expenses

6 Months Ended

Jun. 30, 2019

Notes to Financial Statements

Accounts Payable and Accrued Liabilities Disclosure [Text Block]

Note

7

. Accrued Expenses

The carrying value of our accrued expenses approximates fair value, as it represents amounts that will be satisfied within

one

year. Accrued expenses consisted of the following at

June 30, 2019

and

December 31, 2018 (

in thousands):

	June 30,		December 31,
	2019		2018
Accrued legal and professional fees	$	6,763	$	1,305
Accrued clinical trial costs		4,514		2,318
Accrued payroll and related costs		2,254		2,871
Accrued contract manufacturing costs		1,753		2,516
Accrued consulting costs		734		862
Other		920		661
Accrued expenses	$	16,938	$	10,533

XML

Note 8 - Commitments and Contingencies

6 Months Ended

Jun. 30, 2019

Notes to Financial Statements

Commitments and Contingencies Disclosure [Text Block]

Note

8

. Commitments and Contingencies

We are or

may

be involved in disputes, governmental and/or regulatory inspections, inquiries, investigations, and proceedings that could result in litigation, and other litigation matters that arise from time to time. The process of resolving matters through litigation or other means is inherently uncertain and it is possible that an unfavorable resolution of these matters will adversely affect us, our results of operations, financial condition, and cash flows. While it is

not

possible to accurately predict or determine the eventual outcomes of these items, an adverse determination in

one

or more of these items currently pending could have a material adverse effect on our consolidated results of operations, financial position, or cash flows.

Abbreviated New Drug Application Litigations

RELISTOR Subcutaneous Injection

Paragraph IV Certifications

- Mylan

On or about

October 6, 2015,

November 20, 2015,

December 22, 2015,

and

December 23, 2015,

Progenics, Salix Pharmaceuticals, Inc. (“Salix”) and Wyeth LLC (“Wyeth”) received

four

separate notifications of a Paragraph IV certification for RELISTOR (methylnaltrexone bromide) subcutaneous injection, for certain patents that are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, also known as “the Orange Book.” The certifications resulted from the filing by Mylan Pharmaceuticals Inc. of an Abbreviated New Drug Application (“ANDA”) with the FDA, challenging such patents for RELISTOR subcutaneous injection and seeking to obtain approval to market a generic version of RELISTOR subcutaneous injection before some or all of these patents expire.

District Court Actions

Progenics, Salix, Valeant (now Bausch Health Companies Inc., “Bausch”), and Wyeth filed suit against Mylan Pharmaceuticals, Inc. and Mylan Inc. in the District of New Jersey on

November 19, 2015 (

2:15

-cv-

8180

-SRC-CLW) seeking declaratory judgment of infringement of U.S. Patent Nos.

8,247,425,

8,420,663,

8,552,025,

and

8,822,490

based upon Mylan Pharmaceutical Inc.’s filing of its ANDA seeking to obtain approval to market a generic version of RELISTOR vials before some or all of these patents expire. On

February 4, 2016,

Progenics, Salix, Bausch, and Wyeth filed an amended complaint, identifying Mylan Laboratories Ltd. as an additional Defendant, and further seeking declaratory judgment of infringement of U.S. Patent

No.

9,180,125.

Progenics, Salix, Bausch, and Wyeth filed suit against Mylan Pharmaceuticals, Inc., Mylan Laboratories Ltd., and Mylan Inc. in the District of New Jersey on

January 4, 2016 (

2:16

-cv-

00035

-SRC-CLW) seeking declaratory judgment of infringement of U.S. Patent Nos.

8,247,425,

8,420,663,

8,552,025,

and

8,822,490

based upon Mylan Pharmaceutical Inc.’s filing of its ANDA seeking to obtain approval to market a generic version of RELISTOR prefilled syringes before some or all of these patents expire. On

January 25, 2016,

Progenics, Salix, Bausch, and Wyeth filed an amended complaint, further seeking declaratory judgment of infringement of U.S. Patent

No.

9,180,125.

Progenics, Salix, Bausch, and Wyeth filed suit against Mylan Pharmaceuticals, Inc., Mylan Laboratories Ltd., and Mylan Inc. in the District of New Jersey on

September 1, 2017 (

2:17

-cv-

06714

-SRC-CLW) seeking declaratory judgment of infringement of U.S. Patent

No.

9,669,096

based upon Mylan Pharmaceutical Inc.’s filing of ANDAs seeking to obtain approval to market generic versions of RELISTOR vials and prefilled syringes before the patents expires. On

September 18, 2017,

Progenics, Salix, Bausch, and Wyeth filed an amended complaint, further seeking declaratory judgment of infringement of U.S. Patent

No.

9,492,445.

The

2:15

-cv-

8180

-SRC-CLW,

2:16

-cv-

00035

-SRC-CLW,

2:15

-cv-

08353

-SRC-CLW, and

2:16

-cv-

00889

-SRC-CLW actions were consolidated into a single action in the District of New Jersey (

2:15

-cv-

08180

-SRC-CLW). On

May 1, 2018,

the Court granted Plaintiffs’ motion for partial summary judgment as to the validity of claim

8

of U.S. Patent

No.

8,552,025.

On

May 23, 2018,

the Court entered an order for final judgment under Fed. R. Civ. P.

54

(b) in favor of Plaintiffs and against Mylan as to claim

8

of the

’025

patent.

Litigation in the

2:17

-cv-

06714

-SRC-CLW action is underway. Fact discovery in this action has closed and expert discovery deadlines have

not

yet been set. This action has been consolidated for purposes of trial only with the

2:15

-cv-

8180

action.

Federal Circuit Appeal

On

May 25, 2018,

Mylan filed a Notice of Appeal to the United States Court of Appeals for the Federal Circuit. The matter is currently pending on appeal at the Federal Circuit.

On

July 9, 2018,

Bausch and Salix filed a motion to disqualify Katten Muchin Rosenman LLP as counsel for Mylan. On

July 17, 2018,

an order was issued stating the briefing on the merits of Mylan’s appeal pending the disposition of the motion to disqualify. Oral argument was held on

September 12, 2018.

A decision disqualifying Katten Muchin Rosenman LLP as counsel for Mylan was issued on

February 8, 2019,

by the Federal Circuit. Merits briefing is currently underway. Mylan submitted its opening brief on

April 9, 2019.

Plaintiffs filed their responsive brief on

July 2, 2019.

Mylan filed its reply brief on

August 6, 2019.

Paragraph IV Certification – Actavis

On or about

October 27, 2015,

January 5, 2016,

and

January 8, 2016,

Progenics, Salix and Wyeth received

three

separate notifications of a Paragraph IV certification for certain patents for RELISTOR (methylnaltrexone bromide) subcutaneous injection, for certain patents that are listed in the FDA’s Orange Book. The certifications resulted from the filing by Actavis LLC of an ANDA with the FDA, challenging such patents for RELISTOR subcutaneous injection and seeking to obtain approval to market a generic version of RELISTOR subcutaneous injection before some or all of these patents expire.

Settlement Agreement

-

Actavis

On

May 25, 2018,

Progenics, Bausch, Salix, Wyeth (Progenics, Bausch and Salix, each “Plaintiff” and collectively “Plaintiffs”) and Actavis LLC (“Actavis”) entered into a Settlement and License Agreement (the “Actavis Agreement”) relating to Civil Action

No.

2:15

-cv-

08180

and Civil Action

No.

2:17

-cv-

06714.

The following is a summary of the material terms of the Actavis Agreement. The Actavis Agreement provides for a full settlement and release by both Plaintiffs and Actavis of all claims that were or could have been asserted in the District Court Cases and all resulting damages or other remedies. Plaintiffs and Actavis have agreed to and, in fact, filed a Stipulated Consent Judgment and Injunction after the execution of the Actavis Agreement. Plaintiffs and Actavis have further acknowledged and agreed that the

30

-month stay imposed by the FDA in relation to the approval of Actavis’ ANDAs for the Actavis Products (the “Actavis ANDAs”) should be terminated.

Under the Actavis Agreement, Plaintiffs grant Actavis a non-exclusive, royalty-free, non-transferable, non-sublicensable, limited license under the Patents-In-Suit to make, import, and sell each of the Actavis Products in the U.S. beginning on the earliest of (a)

January 1, 2028; (

b) for each of the Actavis Products, if Actavis is a “First Applicant” (as defined in

21.

U.S.C. §

355

(j)(

5

)(B)(iv)(II)) and has

not

forfeited, relinquished or otherwise waived its

180

-day exclusivity,

180

days prior to the date on which an entity

not

a First Applicant is permitted to commercially sell such Actavis Product in the U.S. under authorization from Plaintiffs; (c) for each of the Actavis Products, if Actavis either is

not

a First Applicant or otherwise has forfeited, relinquished or otherwise waived its

180

-day exclusivity, the earlier of (i)

181

days after any

third

party that is a First Applicant markets a corresponding single-dose vial or pre-filled syringe that has been FDA approved or submitted for approval under an ANDA as a generic version of RELISTOR

®

Injection for subcutaneous use (the “Generic Products”) in the U.S., or (ii) the date on which a

third

party that is either

not

a First Applicant or otherwise has waived its

180

-day exclusivity markets, or is

first

authorized by Plaintiffs to begin marketing, such Generic Product; (d) for each of the Actavis Products, the date on which a

third

party that has sought or received approval from the FDA under a “New Drug Application” (as defined in the US Federal Drug and Cosmetic Act and regulations promulgated thereunder) (“NDA”) for a corresponding single-dose vial or pre-filled syringe of methylnaltrexone bromide for subcutaneous use for which RELISTOR

®

Injection is the listed drug (a “Section

505

(b)(

2

) Applicant”) markets or is

first

authorized by Plaintiffs to begin marketing such corresponding product; (e) for each of the Actavis Products, the date on which a corresponding generic version of the single-dose vial or pre-filled syringe of methylnaltrexone bromide for subcutaneous use approved under NDA

No.

021964

for RELISTOR

®

Injection that is marketed or intended for marketing in the U.S. without the RELISTOR

®

trademark (an “Authorized Generic Product”) is

first

marketed in the U.S. by a

third

party; or (f) the earlier of (i) the date on which a final court decision is entered holding that each of the unexpired claims of the Patents-In-Suit are invalid and/or unenforceable, or (ii) the date on which the Patents-In-Suit have expired, been permanently abandoned, or delisted from the Orange Book. The Actavis Agreement also gives Actavis a limited right to grant sublicenses to its affiliates for certain pre-marketing activities.

Paragraph IV Certification - Par

On or about

July 15, 2017,

Progenics, Salix and Wyeth received notification of a Paragraph IV certification for RELISTOR (methylnaltrexone bromide) subcutaneous injection, for certain patents that are listed in the FDA’s Orange Book. The certification resulted from the filing by Par Sterile Products, LLC (“Par Sterile”) of an ANDA with the FDA, challenging such patents for RELISTOR subcutaneous injection and seeking to obtain approval to market a generic version of RELISTOR subcutaneous injection before some or all of these patents expire.

District Court Actions

Progenics, Salix, Bausch, and Wyeth filed suit against Par Sterile Products, Par Pharmaceutical, Inc. (“Par Pharmaceutical” and, together with Par Sterile, “Par”), and Endo International plc in the District of New Jersey on

August 25, 2017 (

2:17

-cv-

06449

-SRC-CLW) seeking declaratory judgment of infringement of U.S. Patent Nos.

8,247,425,

8,420,663,

8,552,025,

8,822,490,

9,180,125,

and

9,669,096

based upon Par Sterile Product’s filing of an ANDA seeking to obtain approval to market a generic version of RELISTOR vials before some or all of these patents expire.

Progenics, Salix, Bausch, and Wyeth filed suit against Par Sterile Products, Par Pharmaceutical, and Endo International plc in the Southern District of New York on

August 25, 2017 (

1:17

-cv-

06557

-PAE) seeking declaratory judgment of infringement of U.S. Patent Nos.

8,247,425,

8,420,663,

8,552,025,

8,822,490,

9,180,125,

and

9,669,096

based upon Par Sterile Product’s filing of an ANDA seeking to obtain approval to market a generic version of RELISTOR vials before some or all of these patents expire. This action was voluntarily dismissed on

November 30, 2017.

Settlement Agreement - Par

On

May 10, 2018,

Progenics, Bausch, Salix, Wyeth and Par entered into a Settlement and License Agreement (the “Par Agreement”) relating to Civil Action

No.

17

-

06449

-SRC-CLW (the “District Court Case”). The following is a summary of the material terms of the Par Agreement.

The Par Agreement provides for a full settlement and release by both Plaintiffs and Par of all claims that were or could have been asserted in the District Court Case and all resulting damages or other remedies. Plaintiffs and Par have agreed to and, in fact, filed a Stipulated Consent Judgment and Injunction after the execution of the Par Agreement. Plaintiffs and Par have further acknowledged and agreed that the

30

-month stay imposed by the FDA in relation to the approval of Par’s ANDA for the Par Products (the “Par ANDA”) should be terminated.

Under the Par Agreement, Plaintiffs grant Par a non-exclusive, royalty-free, non-transferable, non-sublicensable, limited license under the Patents-In-Suit to make, import, and sell the Par Products in the U.S., or make outside the U.S. solely for importation into the U.S. (the “Par License”) beginning on the earliest of (i)

September 30, 2030; (

ii) for either of the Par Products,

one hundred eighty-one

(

181

) days after any

third

party who is the “First Applicant” (as defined in

21.

U.S.C. §

355

(j)(

5

)(B)(iv)(II)) markets a single-dose vial or pre-filled syringe that has been FDA approved or submitted for approval under an ANDA as a generic version of RELISTOR

®

Injection for subcutaneous use (the “Generic Products”); (iii) for either of the Par Products, the date on which a non-First Applicant

third

party markets an authorized generic (under the RELISTOR

®

New Drug Application (“NDA”) but without the RELISTOR

®

trademark) single-dose vial or pre-filled syringe of methylnaltrexone bromide for subcutaneous use in the U.S.; (iv) for either of the Par Products, the date on which a

third

party who is

not

a First Applicant (or who is a First Applicant who has forfeited or otherwise waived its

180

-day exclusivity) markets or is

first

authorized by Plaintiffs to market the Generic Products in the U.S.; (v) the date on which a final court decision is entered holding that each of the asserted claims against Par in the District Court Case from the Patents-In-Suit are invalid and/or unenforceable, or

not

infringed by the single-dose vial Par Product; or (vi) the date on which the Patents-In-Suit have expired, been permanently abandoned or delisted from the FDA’s Orange Book. Plaintiffs have also granted to Par a limited pre-commercialization license to manufacture and/or import the Par Products into the U.S. starting

one hundred fifty

(

150

) days prior to the effective date of the Par License solely to the extent reasonably necessary to enable Par to market the Par Products in the U.S. on or after the effective date of the Par License.

RELISTOR Tablets - Actavis

Paragraph IV Certifications

On or about

October 24, 2016

and

October 24, 2017,

Progenics, Salix, Bausch and Wyeth received

two

separate notifications of a Paragraph IV certification for RELISTOR (methylnaltrexone bromide) tablets, for certain patents that are listed in the FDA’s Orange Book. The certification resulted from the filing by Actavis Laboratories Fl., Inc. (“Actavis”) of an ANDA with the FDA, challenging such patents for RELISTOR tablets and seeking to obtain approval to market a generic version of RELISTOR tablets before some or all of these patents expire.

District Court Actions

Progenics, Salix, Bausch, and Wyeth filed suit against Actavis, Actavis LLC, Teva Pharmaceuticals USA, Inc., and Teva Pharmaceuticals Industries Ltd. in the District of New Jersey on

December 6, 2016 (

2:16

-cv-

09038

-SRC-CLW) seeking declaratory judgment of infringement of U.S. Patent Nos.

8,420,663,

8,524,276,

8,956,651,

9,180,125,

and

9,314,461

based upon Actavis’s filing of an ANDA seeking to obtain approval to market a generic version of RELISTOR tablets before some or all of these patents expire.

Progenics, Salix, Bausch, and Wyeth filed suit against Actavis, Actavis LLC, Teva Pharmaceuticals USA, Inc., and Teva Pharmaceuticals Industries Ltd. in the District of New Jersey on

December 8, 2017 (

2:17

-cv-

12857

-SRC-CLW) seeking declaratory judgment of infringement of U.S. Patent Nos.

9,724,343

and

9,492,445

based upon Actavis’s filing of an ANDA seeking to obtain approval to market a generic version of RELISTOR tablets before some or all of these patents expire.

The

2:16

-cv-

09038

-SRC-CLW and

2:17

-cv-

12857

-SRC-CLW actions were consolidated into a single action in the District of New Jersey (

2:16

-cv-

09038

-SRC-CLW). A

four

day bench trial was held from

May 6, 2019

through

May 9, 2019.

On

July 17, 2019,

the Court issued an Order finding the asserted claims of U.S. Patent

No.

8,524,276

valid and infringed. The Court additionally ordered that the effective date of any approval of Actavis’s ANDA

No.

209615

may

not

be earlier than the expiration date of U.S. Patent

No.

8,524,276.

Progenics, Salix, Bausch, and Wyeth filed suit against Actavis, Actavis LLC, Teva Pharmaceuticals USA, Inc., and Teva Pharmaceuticals Industries Ltd. in the District of New Jersey on

June 13, 2019 (

2:19

-cv-

13722

-SRC-CLW) seeking declaratory judgment of infringement of U.S. Patent

No.

10,307,417

based upon Actavis’s filing of an ANDA seeking to obtain approval to market a generic version of RELISTOR tablets before this patent expires. Litigation in the

2:19

-cv-

13722

-SRC-CLW action is

not

yet underway.

European Opposition Proceedings

In addition to the above described ANDA notifications, in

October 2015,

Progenics received notices of opposition to

three

European patents relating to methylnaltrexone. Notices of opposition against

EP1615646

were filed on

September 24, 2015

separately by each of Actavis Group PTC ehf and Fresenius Kabi Deutschland GmbH. Notices of opposition against

EP2368553

were filed on

September 29, 2015

and

September 30, 2015

by Fresenius Kabi Deutschland GmbH and Actavis Group PTC ehf, respectively. Notices of opposition against

EP2368554

were filed on

September 24, 2015

separately by each of Actavis Group PTC ehf and Fresenius Kabi Deutschland GmbH. On

May 11, 2017,

the opposition division provided notice that

EP2368553

will be revoked. On

June 28, 2017,

the opposition division provided notice that

EP1615646

will be revoked. On

July 4, 2017,

the opposition division provided notice that

EP2368554

will be revoked. Each of these matters are on appeal with the European Patent Office. Oral proceedings for

EP1615646

are set to occur on

September 22, 2020.

A date for oral proceedings has

not

yet been set in the appeals concerning

EP2368553

and

EP2368554.

For each of the above-described proceedings, we and Bausch continue to cooperate closely to vigorously defend and enforce RELISTOR intellectual property rights. Pursuant to the RELISTOR license agreement between Progenics and Bausch, Bausch has the

first

right to enforce the intellectual property rights at issue and is responsible for the costs of such enforcement.

We are or

may

be from time to time involved in various other disputes, governmental and/or regulatory inspections, inquires, investigations and proceedings that could result in litigation, and other litigation matters that arise from time to time. The process of resolving matters through litigation or other means is inherently uncertain and it is possible that an unfavorable resolution of these matters will adversely affect us, our results of operations, financial condition, and cash flows.

PSMA-

617

German District Court Litigation

We announced a lawsuit and associated worldwide patent ownership dispute based on our claims to certain inventions related to PSMA-

617,

a PSMA-targeted radiopharmaceutical compound under development for the treatment of prostate cancer that is the subject of certain European and U.S. Patent Applications filed by the University of Heidelberg (“the University”).

On

November 8, 2018,

MIP filed a complaint against the University in the District Court of Mannheim in Germany. In this Complaint, the Company claims that the discovery and development of PSMA-

617

was related to work performed under a research collaboration sponsored by MIP. MIP alleged that the University breached certain contracts with MIP and that MIP is the co-owner of inventions embodied in certain worldwide patent filings related to PSMA-

617,

currently pending in Europe and the United States that were filed by the University in its own name. On

February 27, 2019,

Endocyte, Inc., a wholly owned subsidiary of Novartis AG, filed a motion to intervene in the German litigation. Endocyte is the exclusive licensee of the patent rights that are the subject of the German proceedings.

On

November 27, 2018,

MIP requested that the European Patent Office (“EPO”) stay the examination of European Patent (EP)

3

038

996

A1

(EP

14

799

340.6

) and of the Divisional Applications EP

18

172

716.5,

EP18

184

296.4,

and EP

18

203

547.7

pending a decision from the German District Court on MIP’s Complaint. On

December 10, 2018,

the EPO granted MIP’s request and stayed the examination of the patent and patent applications effective

November 27, 2018.

Likewise, on

December 20, 2018,

MIP filed a Confirmation of Ownership with the United States Patent and Trademark Office (“USPTO”) in the corresponding US patent applications (US Serial Nos.

15/131,118;

16/038,729

and

16/114988

). MIP’s filing with the USPTO takes the position that, in light of the collaboration and contracts between MIP and the University, MIP is the co-owner of these pending U.S. patent applications.

On

February 27, 2019,

the German District Court entered

two

orders in the litigation. First, the Court set

€416,

000

as the amount MIP must deposit with the Court as security in the event of an unfavorable final decision on the merits of the dispute. Second, the Court set a hearing date of

August 6, 2019

during which it will consider the various arguments of the parties and determine the next steps of the litigation. On

August 6,

the District Court of Mannheim in Germany held the

first

oral hearing in the case. The Court considered procedural matters and granted the parties the right to make further submissions.

XML

Note 9 - Operating Leases

6 Months Ended

Jun. 30, 2019

Notes to Financial Statements

Lessee, Operating Leases [Text Block]

Note

9.

Operating

Leases

We lease office and manufacturing space and certain office equipment under noncancelable operating leases. We determine whether an arrangement is or contains a lease at its inception. We recognize lease liabilities based on the present value of the minimum lease payments

not

yet paid, by using the lease term and discount rate determined at lease commencement. As our leases do

not

provide an implicit rate, we use our incremental borrowing rate of

9.5%

commensurate with the underlying lease terms to determine the present value of our lease payments. Rental payments are recognized as rent expense on a straight-line basis over the term of the lease and for the

three

and

six

months ended

June 30, 2019,

we recognized rent expense in the amount of

$0.6

million and

$1.1

million, respectively. Our leases have remaining lease terms of

one

year to

11.3

years,

one

of which includes an option to extend the lease for

five

years. For the

three

and

six

months ended

June 30, 2019,

cash payments against operating lease liabilities totaled

$0.5

million and

$1.0

million, respectively.

The information related to our leases is as follows (in thousands):

	June 30,
Operating leases	2019
Operating ROU lease assets, noncurrent	$	13,889
Operating lease liabilities, current		555
Operating lease liabilities, noncurrent		15,312

At

June 30, 2019,

future lease payments for noncancelable operating leases are as follows (in thousands):

2019 (excluding the six months ending June 30, 2019)	$	1,002
2020		2,040
2021		2,077
2022		2,213
2023		2,255
Thereafter		16,807
Total future minimum lease payments		26,394
Less imputed interest		(10,527	)
Total lease liabilities	$	15,867

XML

Note 10 - Non-recourse Long-term Debt, Net

6 Months Ended

Jun. 30, 2019

Notes to Financial Statements

Debt Disclosure [Text Block]

Note

10

. Non-Recourse Long-Term Debt, Net

On

November 4, 2016,

through a new wholly-owned subsidiary MNTX Royalties Sub LLC (“MNTX Royalties”), we entered into a

$50.0

million loan agreement (the “Royalty-Backed Loan”) with a fund managed by HealthCare Royalty Partners III, L.P. (“HCRP”). Under the terms of the Royalty-Backed Loan, the lenders have

no

recourse to us or to any of our assets other than the right to receive royalty payments from the commercial sales of RELISTOR products owed under our agreement with Bausch. The RELISTOR royalty payments will be used to repay the principal and interest on the loan. The Royalty-Backed Loan bears interest at a per annum rate of

9.5%.

Under the terms of the loan agreement, payments of interest and principal, if any, are made on the last day of each calendar quarter out of RELISTOR royalty payments received since the immediately-preceding payment date. On each payment date prior to

March 31, 2018,

RELISTOR royalty payments received since the immediately preceding payment date were applied solely to the payment of interest on the loan, with any royalties in excess of the interest amount retained by us. Beginning on

March 31, 2018,

50%

of RELISTOR royalty payments received since the immediately-preceding payment date in excess of accrued interest on the loan are used to repay the principal of the loan, with the balance retained by us. Starting on

September 30, 2021,

all of the RELISTOR royalties received since the immediately-preceding payment date will be used to repay the interest and outstanding principal balance until the balance is fully repaid. The loan has a maturity date of

June 30, 2025.

Upon the occurrence of certain triggers in the loan agreement and if HCRP so elects, all of the RELISTOR royalty payments received after the immediately-preceding payment date shall be applied to the payment of interest and repayment of principal until the principal of the loan is fully repaid. In the event of such an election by HCRP, we have the right to repay the loan without any prepayment penalty.

In connection with the Royalty-Backed Loan, the debt issuance costs have been recorded as a debt discount in our consolidated balance sheets and are being amortized and recorded as interest expense throughout the life of the loan using the effective interest method.

The following tables summarize the components of the Royalty-Backed Loan in our condensed consolidated financial statements for the periods presented (in thousands):

	June 30,			December 31,
Condensed Consolidated Balance Sheets	2019			2018
Outstanding principal balance, current portion	$	6,057		$	5,688
Unamortized debt discount, current portion		(251	)		(269	)
Current portion of debt, net	$	5,806		$	5,419
Outstanding principal balance, long-term portion	$	36,715		$	39,674
Unamortized debt discount, long-term portion		(373	)		(494	)
Long-term debt, net	$	36,342		$	39,180

	Three Months Ended				Six Months Ended
	June 30,				June 30,
Condensed Consolidated Statements of Operations	2019		2018		2019		2018
Interest expense	$	1,053	$	1,176	$	2,130	$	2,381
Non-cash interest expense		69		74		140		137
Total interest expense included in interest (expense) income, net	$	1,122	$	1,250	$	2,270	$	2,518

As of

June 30, 2019,

we were in compliance with all material covenants under the Royalty-Backed Loan and there was

no

material adverse change in our business, operations, or financial conditions, as defined in the loan agreement.

XML

Note 11 - Stockholders' Equity

6 Months Ended

Jun. 30, 2019

Notes to Financial Statements

Stockholders' Equity Note Disclosure [Text Block]

Note

1

1

. Stockholders

’

Equity

Common Stock and Preferred Stock

We are authorized to issue

160.0

million shares of our common stock, par value

$0.0013,

and

20.0

million shares of preferred stock, par value

$0.001.

The Board of Directors (the “Board”) has the authority to issue common and preferred shares, in series, with rights and privileges as determined by the Board.

Shelf Registration

During the

first

quarter of

2017,

we filed a shelf registration statement that permitted: (a) the offering, issuance and sale of up to a maximum aggregate offering price of

$250.0

million of our common stock, preferred stock, debt securities, warrants, rights and/or units; and (b) as part of the

$250.0

million, the offering, issuance and sale by us of up to a maximum aggregate offering price of

$75.0

million of our common stock under our sales agreement with Cantor Fitzgerald & Co. (“Cantor”) in

one

or more at-the-market (“ATM”) offerings (the

“2017

Sales Agreement”).

In

October 2018,

we filed a new shelf registration statement. The new shelf registration replaced our prior shelf registration statement, pursuant to which

no

additional securities will be offered or sold. The new shelf registration statement permits: (a) the offering, issuance and sale of up to a maximum aggregate offering price of

$250.0

million of our common stock, preferred stock, debt securities, warrants, rights and/or units; and (b) as part of the

$250.0

million, the offering, issuance and sale by us of up to a maximum aggregate offering price of

$75.0

million of our common stock under our sales agreement with Cantor in

one

or more ATM offerings.

In addition, in

October 2018

we entered into a new sales agreement with Cantor, as sales agent, which replaced the

2017

Sales Agreement (the

“2018

Sales Agreement”). Pursuant to the

2018

Sales Agreement, we

may

offer and sell through Cantor, from time to time, shares of our common stock up to an aggregate offering price of

$75.0

million. The

2018

Sales Agreement

may

be terminated by Cantor or us at any time upon

ten

days’ notice, or by Cantor at any time in certain circumstances, including the occurrence of a material adverse change in our business or financial condition.

XML

Note 12 - Stock-based Compensation

6 Months Ended

Jun. 30, 2019

Notes to Financial Statements

Share-based Payment Arrangement [Text Block]

Note

1

2

. Stock-Based Compensation

Equity Incentive Plans

We adopted the following stockholder-approved equity incentive plans:

●     The

2005

Stock Incentive Plan (the

“2005

Plan”), which authorized the issuance of up to

11,450,000

shares of common stock covering several different types of awards, including stock options, restricted shares, stock appreciation rights, performance shares, and phantom stock. The

2005

Plan was terminated in

June 2018

at the time the

2018

Stock Incentive Plan was approved. Shares available for new awards under the

2005

Plan at the time of termination became available for awards under the

2018

Stock Incentive Plan. Options granted before termination of the

2005

Plan will continue to remain outstanding until exercised, cancelled or expired.

●     The

2018

Stock Incentive Plan (the

“2018

Plan”), pursuant to which we are authorized to issue up to

4,800,000

shares of common stock covering several different types of awards, including stock options, restricted shares, stock appreciation rights, performance shares, and phantom stock. The

2018

Plan will terminate on

March 27, 2028.

The stock option plans provide that options

may

be granted at an exercise price of

100%

of fair market value of our common stock on the date of grant,

may

be exercised in full or in installments, at the discretion of the Board or its Compensation Committee, and must be exercised within

ten

years from date of grant. Stock options generally vest pro rata over

three

to

five

years. We recognize stock-based compensation expense on a straight-line basis over the requisite service (vesting) period based on fair values. We use historical data to estimate expected employee behaviors related to option exercises and forfeitures and included these expected forfeitures as a part of the estimate of stock-based compensation expense as of the grant date. We adjust the total amount of stock-based compensation expense recognized for each award, in the period in which each award vests, to reflect the actual forfeitures related to that award. Changes in our estimated forfeiture rate will result in changes in the rate at which compensation cost for an award is recognized over its vesting period.

Stock Options

The following table summarizes stock options activity for the

six

months ended

June 30, 2019 (

in thousands, except per share data or as otherwise noted):

						Weighted
				Weighted		Average
	Number			Average		Remaining
	of Shares			Exercise Price		Contractual Life
Outstanding at January 1, 2019		6,264		$	6.79		6.02
Granted		1,392		$	4.52
Cancelled		(230	)	$	7.17
Exercised		(225	)	$	5.33
Expired		(27	)	$	7.79
Outstanding at June 30, 2019		7,174		$	6.38		6.44
Exercisable at June 30, 2019		4,647		$	6.63		5.03
Vested and expected to vest at June 30, 2019		6,519		$	6.46		6.17

The weighted-average fair value of options granted during the

three

and

six

months ended

June 30, 2019

was

$2.37

and

$2.86

per share, respectively and during the

three

and

six

months ended

June 30, 2018

was

$6.12

and

$4.58

per share, respectively.

The total intrinsic value (the excess of the market price over the exercise price) was approximately

$5.1

million for stock options outstanding,

$2.7

million for stock options exercisable, and

$4.4

million for stock options vested and expected to vest as of

June 30, 2019.

No

stock options were exercised during the

six

months ended

June 30, 2018.

Stock-Based Compensation Expense

We account for stock-based awards issued to employees in accordance with the provisions of ASC

718

(Topic

718,

Compensation – Stock Compensation

). We recognize stock-based compensation expense on a straight-line basis over the service period of the award, which is generally

three

to

five

years. Stock-based awards issued to consultants are accounted for in accordance with the provisions of ASC

718

and ASC

505

-

50

(Subtopic

50

“Equity-Based Payments to Non-Employees” of Topic

505,

Equity

). Options granted to consultants are periodically revalued as the options vest and are recognized as an expense over the related period of service or the vesting period, whichever is longer. Under the provisions of ASC

718,

members of the Board are considered employees for calculation of stock-based compensation expense.

We estimated the fair value of the stock options granted on the date of grant using a Black-Scholes valuation model that used the weighted-average assumptions noted in the following table. The risk-free interest rate assumption we use is based upon United States Treasury interest rates appropriate for the expected life of the awards. The expected life (estimated period of time that we expect employees, directors, and consultants to hold their stock options) was estimated based on historical rates for

three

group classifications, (i) employees, (ii) outside directors and officers, and (iii) consultants. Expected volatility was based on historical volatility of our stock price for a period equal to the stock option’s expected life and calculated on a daily basis. The expected dividend rate is

zero

since we do

not

currently pay cash dividends on our common stock and do

not

anticipate doing so in the foreseeable future.

	Three Months Ended						Six Months Ended
	June 30,						June 30,
	2019			2018			2019			2018
Risk-free interest rate		2.04	%		2.91	%		2.61	%		2.71	%
Expected life (in years)		5.27			7.15			6.52			6.72
Expected volatility		60	%		70	%		66	%		69	%
Expected dividend yield		--			--			--			--

Stock-based compensation expense for the

three

and

six

months ended

June 30, 2019

and

2018

was recorded in our condensed consolidated statement of operations as follows (in thousands):

	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2019		2018		2019		2018
Research and development expenses	$	387	$	452	$	837	$	977
Selling, general and administrative expenses		607		1,678		1,234		2,201
Total stock-based compensation expense	$	994	$	2,130	$	2,071	$	3,178

At

June 30, 2019,

unrecognized stock-based compensation expense related to stock options was approximately

$5.9

million and is expected to be recognized over a weighted-average period of approximately

2.2

years.

XML

Significant Accounting Policies (Policies)

6 Months Ended

Jun. 30, 2019

Accounting Policies [Abstract]

Basis of Accounting, Policy [Policy Text Block]

Basis of Presentation

Our unaudited condensed consolidated financial statements have been prepared in accordance with applicable presentation requirements, and accordingly, do

not

include all information and disclosures necessary for a presentation of our financial position, results of operations, and cash flows in conformity with accounting principles generally accepted in the U.S. (“GAAP”). In the opinion of management, these financial statements reflect all adjustments, consisting primarily of normal recurring accruals necessary for a fair statement of results for the periods presented. The results of operations for interim periods are

not

necessarily indicative of the results for the full year.

Our unaudited condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto contained in our Annual Report on Form

10

-K for the year ended

December 31, 2018.

The year-end consolidated balance sheet data in these financial statements were derived from audited financial statements but do

not

include all disclosures required by GAAP.

Consolidation, Policy [Policy Text Block]

Principles of Consolidation

The condensed consolidated financial statements include the accounts of Progenics as well as its wholly-owned subsidiaries. All material intercompany transactions and balances have been eliminated in consolidation.

Use of Estimates, Policy [Policy Text Block]

Use of Estimates

The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results

may

differ from those estimates.

Revenue [Policy Text Block]

Revenue Recognition

We recognize revenue when our customers obtain control of the promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To account for our revenue arrangements, we perform the following

five

steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy our performance obligations.

For contracts determined to be within the scope of ASU

2014

-

09,

Revenue from Contracts with Customers (Topic

606

)

(“ASU

2014

-

09”

or the “Topic

606”

), we assess the goods or services promised within each contract for the purpose of identifying them as performance obligations. We must apply judgement in assessing whether each promised good or service is distinct. If a promised good or service is

not

distinct, we will combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct.

The transaction price is then determined and allocated to the identified performance obligations in proportion to their estimated fair value, which requires significant judgment. Variable consideration, which is estimated using the expected value method or the most likely amount method, is included in the transaction price only if, in our judgment, it is probable that a significant future reversal of cumulative revenue under the contract will

not

occur.

For arrangements that include development, regulatory or sales milestone payments, we evaluate whether the milestones are probable of being reached and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would

not

occur, the associated milestone value is included in the transaction price. Milestone payments that are

not

within our control or the licensee’s control, such as regulatory approvals, are generally

not

considered probable of being achieved until those approvals are received.

We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

The following table summarizes our revenue streams from contracts with customers for the

three

and

six

months ended

June 30, 2019

and

2018

(in thousands):

	Three months ended June 30,				Six months ended June 30,
	2019		2018		2019		2018
Product sales	$	270	$	-	$	270	$	-
Royalty income		3,593		3,530		7,754		6,588
License and other revenue		6,103		348		6,223		479
Total revenue	$	9,966	$	3,878	$	14,247	$	7,067

Product sales

– represent revenue from sales of AZEDRA directly to hospitals. Our performance obligations are to provide AZEDRA based on sales orders from hospitals, which have been verified by our commercial team as properly credentialed to receive, handle, administer and dispose of radioactive materials. We recognize revenue after the customer takes title and has obtained control of the product. Our contracts with hospitals stipulate that product is shipped free on board destination. We invoice hospitals after the products have been delivered and invoice payments are generally due within

60

days of invoice date. We record sales to hospitals based on AZEDRA’s list price per mCi and the amount prescribed based upon a dosimetric assessment of each patient. We record product sales net of any variable consideration due to rebates and discounts provided under governmental and other programs, and other sales-related deductions, such as product returns and copay assistance programs. Shipping and handling costs associated with finished goods delivered to customers are recorded as a selling expense.

Royalty income

– represents revenue from the sales-based royalties under our intellectual property licensing arrangements and is recognized upon net sales of the licensed products.

License and o

ther revenue

– represents revenue from upfront payments (fixed consideration) and development and sales milestones, sublicense payments, support and service payments and sales-based bonus payments (variable consideration) under our licensing or software arrangements. The fixed consideration will be recognized as revenue at the time when the transfer of know-how is completed. The variable consideration will be estimated using the most likely amount method and recognized only when we have “a high degree of confidence” that revenue will

not

be reversed in a subsequent reporting period. The other revenue also includes revenue from product sales of research reagents, that is recognized upon shipment to the end customer (i.e. control of the product is deemed to be transferred).

We had receivable contract balances of

$10.6

million and

$3.8

million as of

June 30, 2019

and

December 31, 2018,

respectively, primarily related to the royalty revenue and upfront and milestone payments under our partnerships, which are included in license and other revenue (see

Note

5

.

Accounts Receivable

).

Cash and Cash Equivalents, Restricted Cash and Cash Equivalents, Policy [Policy Text Block]

Restricted Cash

Restricted cash included in long-term assets of

$3.3

million and

$1.5

million at

June 30, 2019

and

December 31, 2018,

respectively, represents collateral for a letter of credit securing a lease obligation (for both periods), collateral for a letter of credit related to equipment purchases and a security deposit with the German District Court related to the PSMA-

617

litigation (for the

2019

period). We believe the carrying value of this asset approximates fair value.

Foreign Currency Transactions and Translations Policy [Policy Text Block]

Foreign Currency Translation

Our international subsidiaries generally consider their respective local currency to be their functional currency. Assets and liabilities of these international subsidiaries are translated into U.S. dollars at quarter-end exchange rates and revenues and expenses are translated at average exchange rates during the quarter and year-to-date period. Foreign currency translation adjustments for the reported periods are included in accumulated other comprehensive loss in our condensed consolidated statements of comprehensive loss, and the cumulative effect is included in the stockholders’ equity section of our condensed consolidated balance sheets. Realized gains and losses denominated in foreign currencies are recorded in operating expenses in our condensed consolidated statements of operations and were

not

material to our consolidated results of operations for the

three

and

six

months ended

June 30, 2019

or

2018.

Lessee, Leases [Policy Text Block]

Leases

We determine whether an arrangement is or contains a lease at its inception. We recognize lease liabilities based on the present value of the minimum lease payments

not

yet paid by using the lease term and discount rate determined at lease commencement. As most of our leases do

not

provide an implicit rate, we use our incremental borrowing rate to determine the present value of our lease payments. Our leases

may

include options to extend or terminate a lease when it is reasonably certain that we will exercise that option. We recognize the operating right-of-use (“ROU”) lease assets at amounts equal to the lease liability adjusted for prepaid or accrued rent, remaining balance of any lease incentives and unamortized initial direct costs.

The operating lease liabilities are reported in other current liabilities and other noncurrent liabilities and the related ROU lease assets are reported in other noncurrent assets on our condensed consolidated balance sheets. Lease expense for our operating leases is calculated on a straight-line basis over the lease term and is reported in research and development and selling, general and administrative expenses on our condensed consolidated statements of operations. We do

not

recognize a lease liability or ROU lease assets for leases whose lease terms, at commencement, are

twelve

months or less, or for leases which are below the established capitalization threshold.

Property, Plant and Equipment, Policy [Policy Text Block]

Property and Equipment

Property and equipment is recorded at historical cost, net of accumulated depreciation and amortization of

$3.1

million and

$2.7

million as of

June 30, 2019

and

December 31, 2018,

respectively. The following table summarizes our property and equipment (in thousands):

	June 30,			December 31,
	2019			2018
Machinery and equipment	$	3,949		$	2,992
Leasehold improvements		3,052			1,734
Computer equipment		632			721
Furniture and fixtures		909			878
Construction in progress		1,612			317
Property and equipment, gross		10,154			6,642
Less - accumulated depreciation		(3,146	)		(2,698	)
Property and equipment, net	$	7,008		$	3,944

XML

Note 1 - Summary of Significant Accounting Policies (Tables)

6 Months Ended

Jun. 30, 2019

Notes Tables

Disaggregation of Revenue [Table Text Block]

	Three months ended June 30,				Six months ended June 30,
	2019		2018		2019		2018
Product sales	$	270	$	-	$	270	$	-
Royalty income		3,593		3,530		7,754		6,588
License and other revenue		6,103		348		6,223		479
Total revenue	$	9,966	$	3,878	$	14,247	$	7,067

Property, Plant and Equipment [Table Text Block]

	June 30,			December 31,
	2019			2018
Machinery and equipment	$	3,949		$	2,992
Leasehold improvements		3,052			1,734
Computer equipment		632			721
Furniture and fixtures		909			878
Construction in progress		1,612			317
Property and equipment, gross		10,154			6,642
Less - accumulated depreciation		(3,146	)		(2,698	)
Property and equipment, net	$	7,008		$	3,944

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Note 3 - Net Loss Per Share (Tables)

6 Months Ended

Jun. 30, 2019

Notes Tables

Schedule of Earnings Per Share, Basic and Diluted [Table Text Block]

				Weighted-Average
				Shares
	Net Loss			Outstanding		Per Share
	(Numerator)			(Denominator)		Amount
Three months ended June 30, 2019
Basic and diluted	$	(19,700	)		85,000	$	(0.23	)
Six months ended June 30, 2019
Basic and diluted	$	(38,435	)		84,772	$	(0.45	)
Three months ended June 30, 2018
Basic and diluted	$	(15,172	)		74,017	$	(0.20	)
Six months ended June 30, 2018
Basic and diluted	$	(28,596	)		73,271	$	(0.39	)

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]

	Three Months Ended June 30,				Six Months Ended June 30,
	2019		2018		2019		2018
Stock options		6,298		3,237		6,382		3,236
Contingent consideration liability (1)		778		2,351		778		2,351
Total securities excluded		7,076		5,588		7,160		5,587

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Note 4 - Fair Value Measurements (Tables)

6 Months Ended

Jun. 30, 2019

Notes Tables

Fair Value, Assets Measured on Recurring Basis [Table Text Block]

			Fair Value Measurements at June 30, 2019
			Quoted Prices in Active		Significant Other		Significant
	Balance at		Markets for		Observable		Unobservable
	June 30,		Identical Assets		Inputs		Inputs
	2019		(Level 1)		(Level 2)		(Level 3)
Assets:
Money market funds	$	82,737	$	82,737	$	-	$	-
Total assets	$	82,737	$	82,737	$	-	$	-
Liabilities:
Contingent consideration liability	$	4,800	$	-	$	-	$	4,800
Total liabilities	$	4,800	$	-	$	-	$	4,800

			Fair Value Measurements at December 31, 2018
			Quoted Prices in Active		Significant Other		Significant
	Balance at		Markets for		Observable		Unobservable
	December 31,		Identical Assets		Inputs		Inputs
	2018		(Level 1)		(Level 2)		(Level 3)
Assets:
Money market funds	$	136,052	$	136,052	$	-	$	-
Total assets	$	136,052	$	136,052	$	-	$	-
Liabilities:
Contingent consideration liability	$	11,000	$	-	$	-	$	11,000
Total liabilities	$	11,000	$	-	$	-	$	11,000

Schedule of Business Acquisitions by Acquisition, Contingent Consideration [Table Text Block]

Program	Consideration		Form of Payment
1095		5,000	Cash or Progenics common stock
1404		9,984	Cash or Progenics common stock or cash in the case of license revenue
	$	14,984

	Consideration		Form of Payment at Progenics' Option
$30 million	$	5,000	Cash or Progenics common stock
$60 million		5,000	Cash or Progenics common stock
$100 million		10,000	Cash or Progenics common stock
$250 million		20,000	Cash or Progenics common stock
$500 million		30,000	Cash or Progenics common stock
	$	70,000

Fair Value Inputs, Assets and Liabilities, Quantitative Information [Table Text Block]

	Fair Value at
	June 30,
	2019		Valuation Technique	Unobservable Input	Assumption
Contingent Consideration Liability:
1095 commercialization	$	450	Probability adjusted discounted	Probability of success		18%
			cash flow model	Period of expected milestone achievement		2026
				Discount rate		10%
1404 commercialization		250	Probability adjusted discounted	Probability of success		43%
			cash flow model	Period of expected milestone achievement	2022	-	2035
				Discount rate		10%
Net sales targets		4,100	Monte-Carlo simulation	Probability of success	18%	-	90%
				Discount rate		10%
Total	$	4,800

	Fair Value at
	December 31,
	2018		Valuation Technique	Unobservable Input	Assumption
Contingent Consideration Liability:
AZEDRA commercialization	$	7,050	Probability adjusted discounted	Probability of success		90%
			cash flow model	Period of expected milestone achievement		2019
				Discount rate		10%
1095 commercialization		450	Probability adjusted discounted	Probability of success		18%
			cash flow model	Period of expected milestone achievement		2026
				Discount rate		10%
Net sales targets		3,500	Monte-Carlo simulation	Probability of success	18%	-	90%
				Discount rate		10%
Total	$	11,000

Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block]

	Liability - Contingent Consideration
	Fair Value Measurements Using
	Significant Unobservable Inputs
	(Level 3)
	Three Months Ended June 30,					Six Months Ended June 30,
	2019			2018		2019			2018
Balance at beginning of period	$	11,900		$	17,600	$	11,000		$	16,800
Fair value change included in net loss		916			1,300		1,816			2,100
Payments		(8,016	)		-		(8,016	)		-
Balance at end of period	$	4,800		$	18,900	$	4,800		$	18,900
Changes in unrealized gains or losses for the period included in earnings (or changes in net assets) for liabilities held at the end of the reporting period	$	916		$	1,300	$	1,816		$	2,100

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Note 5 - Accounts Receivable (Tables)

6 Months Ended

Jun. 30, 2019

Notes Tables

Schedule of Accounts, Notes, Loans and Financing Receivable [Table Text Block]

	June 30,		December 31,
	2019		2018
Royalties	$	3,593	$	3,151
Bayer milestone		2,000		-
FUJIFILM transfer		4,000		-
Other		976		652
Accounts receivable, net	$	10,569	$	3,803

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Note 6 - Recent Acquisition, Goodwill, In-process Research and Development and Other Intangible Assets (Tables)

6 Months Ended

Jun. 30, 2019

Notes Tables

Schedule of Business Acquisitions, by Acquisition [Table Text Block]

	Amount
Cash consideration	$	8,000
Tangible assets acquired:
Machinery and equipment		682
Leasehold improvements		1,300
Total tangible assets acquired		1,982
Intangible assets - Somerset		1,245
Total tangible and intangible assets acquired		3,227
Goodwill	$	4,773

Schedule of Intangible Assets and Goodwill [Table Text Block]

					Other
					Intangible
	Goodwill		IPR&D		Assets
Balance at January 1, 2019	$	13,074	$	600	$	6,066
Increase related to Somerset acquisition		4,773		-		1,245
Amortization expense		-		-		(536	)
Balance at June 30, 2019	$	17,847	$	600	$	6,775

					Other
					Intangible
	Goodwill		IPR&D		Assets
Balance at January 1, 2018	$	13,074	$	28,700	$	1,669
Amortization expense		-		-		(106	)
Balance at June 30, 2018	$	13,074	$	28,700	$	1,563

Components of Finite Lived Intangible Assets [Table Text Block]

	Gross Amount		Accumulated Amortization		Net Carrying Value
Intangible assets - AZEDRA product rights	$	4,900	$	642	$	4,258
Intangible assets - Somerset		1,245		80		1,165
Intangible assets - EXINI technology		2,120		768		1,352
Total	$	8,265	$	1,490	$	6,775

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Note 7 - Accrued Expenses (Tables)

6 Months Ended

Jun. 30, 2019

Notes Tables

Schedule of Accounts Payable and Accrued Liabilities [Table Text Block]

	June 30,		December 31,
	2019		2018
Accrued legal and professional fees	$	6,763	$	1,305
Accrued clinical trial costs		4,514		2,318
Accrued payroll and related costs		2,254		2,871
Accrued contract manufacturing costs		1,753		2,516
Accrued consulting costs		734		862
Other		920		661
Accrued expenses	$	16,938	$	10,533

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Note 9 - Operating Leases (Tables)

6 Months Ended

Jun. 30, 2019

Notes Tables

Lease, Cost [Table Text Block]

	June 30,
Operating leases	2019
Operating ROU lease assets, noncurrent	$	13,889
Operating lease liabilities, current		555
Operating lease liabilities, noncurrent		15,312

Lessee, Operating Lease, Liability, Maturity [Table Text Block]

2019 (excluding the six months ending June 30, 2019)	$	1,002
2020		2,040
2021		2,077
2022		2,213
2023		2,255
Thereafter		16,807
Total future minimum lease payments		26,394
Less imputed interest		(10,527	)
Total lease liabilities	$	15,867

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Note 10 - Non-recourse Long-term Debt, Net (Tables)

6 Months Ended

Jun. 30, 2019

Notes Tables

Schedule of Long-term Debt Instruments [Table Text Block]

	June 30,			December 31,
Condensed Consolidated Balance Sheets	2019			2018
Outstanding principal balance, current portion	$	6,057		$	5,688
Unamortized debt discount, current portion		(251	)		(269	)
Current portion of debt, net	$	5,806		$	5,419
Outstanding principal balance, long-term portion	$	36,715		$	39,674
Unamortized debt discount, long-term portion		(373	)		(494	)
Long-term debt, net	$	36,342		$	39,180

	Three Months Ended				Six Months Ended
	June 30,				June 30,
Condensed Consolidated Statements of Operations	2019		2018		2019		2018
Interest expense	$	1,053	$	1,176	$	2,130	$	2,381
Non-cash interest expense		69		74		140		137
Total interest expense included in interest (expense) income, net	$	1,122	$	1,250	$	2,270	$	2,518

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Note 12 - Stock-based Compensation (Tables)

6 Months Ended

Jun. 30, 2019

Notes Tables

Share-based Payment Arrangement, Option, Activity [Table Text Block]

						Weighted
				Weighted		Average
	Number			Average		Remaining
	of Shares			Exercise Price		Contractual Life
Outstanding at January 1, 2019		6,264		$	6.79		6.02
Granted		1,392		$	4.52
Cancelled		(230	)	$	7.17
Exercised		(225	)	$	5.33
Expired		(27	)	$	7.79
Outstanding at June 30, 2019		7,174		$	6.38		6.44
Exercisable at June 30, 2019		4,647		$	6.63		5.03
Vested and expected to vest at June 30, 2019		6,519		$	6.46		6.17

Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block]

	Three Months Ended						Six Months Ended
	June 30,						June 30,
	2019			2018			2019			2018
Risk-free interest rate		2.04	%		2.91	%		2.61	%		2.71	%
Expected life (in years)		5.27			7.15			6.52			6.72
Expected volatility		60	%		70	%		66	%		69	%
Expected dividend yield		--			--			--			--

Share-based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block]

	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2019		2018		2019		2018
Research and development expenses	$	387	$	452	$	837	$	977
Selling, general and administrative expenses		607		1,678		1,234		2,201
Total stock-based compensation expense	$	994	$	2,130	$	2,071	$	3,178

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Note 1 - Summary of Significant Accounting Policies (Details Textual) - USD ($)	1 Months Ended	3 Months Ended		6 Months Ended
	May 31, 2019	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018	Oct. 01, 2019	Mar. 31, 2019	Dec. 31, 2018	Dec. 31, 2017
Revenue from Contract with Customer, Including Assessed Tax		$ 9,966,000	$ 3,878,000	$ 14,247,000	$ 7,067,000
Cash and Cash Equivalents, at Carrying Value, Ending Balance		84,823,000	87,490,000	84,823,000	87,490,000			$ 137,686,000	$ 90,642,000
Cash and Cash Equivalents, Period Increase (Decrease), Total				(52,900,000)
Accounts Receivable, after Allowance for Credit Loss, Current, Total		10,569,000		10,569,000				3,803,000
Restricted Cash and Cash Equivalents, Noncurrent, Total		3,272,000	1,526,000	3,272,000	1,526,000		$ 1,500,000	1,534,000	$ 1,522,000
Foreign Currency Transaction Gain (Loss), Realized		0	0	0	0
Accumulated Depreciation, Depletion and Amortization, Property, Plant, and Equipment, Ending Balance		3,146,000		3,146,000				$ 2,698,000
License and Other [Member]
Revenue from Contract with Customer, Including Assessed Tax		$ 6,103,000	$ 348,000	6,223,000	$ 479,000
Technology Add-on Payment for AZEDRA [Member] | Forecast [Member]
Program Agreement, Percent of Reimbursement, Maximum						65.00%
Program Agreement, Maximum Payment						$ 98,150
Transfer Agreement of Bone Scan Index Product Rights for Use in Japan [Member] | FUJIFILM [Member]
Proceeds From Sale of License				$ 4,000,000
Milestone Payment for Bayer Phase 1 Trial [Member] | License and Other [Member]
Revenue from Contract with Customer, Including Assessed Tax	$ 2,000,000

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Note 1 - Summary of Significant Accounting Policies - Disaggregation of Revenue (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
Product sales	$ 9,966	$ 3,878	$ 14,247	$ 7,067
AZEDRA Product Sales [Member
Product sales	270		270
Royalty [Member]
Product sales	3,593	3,530	7,754	6,588
License and Other [Member]
Product sales	$ 6,103	$ 348	$ 6,223	$ 479

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Note 1 - Summary of Significant Accounting Policies - Property and Equipment (Details) - USD ($) $ in Thousands	Jun. 30, 2019	Dec. 31, 2018
Property and equipment, gross	$ 10,154	$ 6,642
Less - accumulated depreciation	(3,146)	(2,698)
Property and equipment, net	7,008	3,944
Machinery and Equipment [Member]
Property and equipment, gross	3,949	2,992
Leasehold Improvements [Member]
Property and equipment, gross	3,052	1,734
Computer Equipment [Member]
Property and equipment, gross	632	721
Furniture and Fixtures [Member]
Property and equipment, gross	909	878
Construction in Progress [Member]
Property and equipment, gross	$ 1,612	$ 317

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Note 2 - New Accounting Pronouncements (Details Textual) - USD ($) $ in Thousands	Jun. 30, 2019	Jan. 01, 2019	Dec. 31, 2018
Operating Lease, Liability, Total	$ 15,867
Operating Lease, Right-of-Use Asset	$ 13,889
Accounting Standards Update 2016-02 [Member]
Operating Lease, Liability, Total		$ 15,300
Operating Lease, Right-of-Use Asset		$ 13,500

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Note 3 - Net Loss Per Share - Calculations of Net (Loss) Income Per Share, Basic and Diluted (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands	3 Months Ended				6 Months Ended
	Jun. 30, 2019	Mar. 31, 2019	Jun. 30, 2018	Mar. 31, 2018	Jun. 30, 2019	Jun. 30, 2018
Basic and diluted, net loss attributable to Progenics	$ (19,700)	$ (18,735)	$ (15,172)	$ (13,424)	$ (38,435)	$ (28,596)
Basic and diluted, weighted average shares outstanding (in shares)	85,000		74,017		84,772	73,271
Basic and diluted, per share amount (in dollars per share)	$ (0.23)		$ (0.20)		$ (0.45)	$ (0.39)

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Note 3 - Net Loss Per Share - Common Shares Excluded from Calculation of Diluted Net (Loss) Income Per Share (Details) - shares shares in Thousands		3 Months Ended		6 Months Ended
		Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
Antidilutive securities (in shares)		7,076	5,588	7,160	5,587
Share-based Payment Arrangement, Option [Member]
Antidilutive securities (in shares)		6,298	3,237	6,382	3,236
Contingent Consideration Liability [Member]
Antidilutive securities (in shares)	[1]	778	2,351	778	2,351

[1] Calculated as follows: (a) the contingent consideration liability balance divided by (b) the closing stock price of our common stock.

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Note 4 - Fair Value Measurements (Details Textual) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018	Dec. 31, 2018
Business Combination, Contingent Consideration, Liability, Total	$ 4,800		$ 4,800		$ 11,000
Business Combination, Contingent Consideration Arrangements, Change in Amount of Contingent Consideration, Liability	$ 916	$ 1,300	1,816	$ 2,100
AZERDA Commercial Sale Milestone [Member]
Business Combination, Contingent Consideration Arrangements, Change in Amount of Contingent Consideration, Liability			(6,200)
Payments for Milestones in Business Combination			$ 8,000

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Note 4 - Fair Value Measurements - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands	Jun. 30, 2019	Dec. 31, 2018
Money market funds	$ 82,737	$ 136,052
Total assets	82,737	136,052
Fair value	4,800	11,000
Total liabilities	4,800	11,000
Fair Value, Inputs, Level 1 [Member]
Money market funds	82,737	136,052
Total assets	82,737	136,052
Fair value
Total liabilities
Fair Value, Inputs, Level 2 [Member]
Money market funds
Total assets
Fair value
Total liabilities
Fair Value, Inputs, Level 3 [Member]
Money market funds
Total assets
Fair value	4,800	11,000
Total liabilities	$ 4,800	$ 11,000

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Note 4 - Fair Value Measurements - Contingent Consideration Liabilities (Details) $ in Thousands	Jun. 30, 2019 USD ($)
Molecular Insight Pharmaceuticals, Inc. [Member] | Milestone Payment upon First Commercial Sale [Member]
Contingent Consideration	$ 14,984
Molecular Insight Pharmaceuticals, Inc. [Member] | Milestone Payment upon Achievement of All Levels of Net Sales [Member]
Contingent Consideration	70,000
Molecular Insight Pharmaceuticals, Inc. [Member] | Milestone Payment upon Achievement of Net Sales Level 2 [Member]
Contingent Consideration	5,000
Molecular Insight Pharmaceuticals, Inc. [Member] | Milestone Payment upon Achievement of Net Sales Level 3 [Member]
Contingent Consideration	10,000
Molecular Insight Pharmaceuticals, Inc. [Member] | Milestone Payment upon Achievement of Net Sales Level 4 [Member]
Contingent Consideration	20,000
Molecular Insight Pharmaceuticals, Inc. [Member] | Milestone Payment upon Achievement of Net Sales Level 5 [Member]
Contingent Consideration	30,000
Milestone Payment upon Achievement of Net Sales Level 1 [Member] | Milestone Payment upon Achievement of All Levels of Net Sales [Member]
Contingent Consideration	5,000
The 1095 Program[Member] | Molecular Insight Pharmaceuticals, Inc. [Member] | Milestone Payment upon First Commercial Sale [Member]
Contingent Consideration	5,000
The 1404 Program [Member] | Molecular Insight Pharmaceuticals, Inc. [Member] | Milestone Payment upon First Commercial Sale [Member]
Contingent Consideration	$ 9,984

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Note 4 - Fair Value Measurements - Quantitative Information for Fair Value Measurement of Level 3 (Details) $ in Thousands	Jun. 30, 2019 USD ($)	Dec. 31, 2018 USD ($)
Fair value	$ 4,800	$ 11,000
MIP-1095 Commercialization [Member]
Fair value	$ 450	$ 450
MIP-1095 Commercialization [Member] | Measurement Input, Probability of Success [Member]
Measurement input	0.18	0.18
MIP-1095 Commercialization [Member] | Measurement Input, Period of Expected Milestone Achievement [Member]
Measurement input	2,026	2,026
MIP-1095 Commercialization [Member] | Measurement Input, Discount Rate [Member]
Measurement input	0.1	0.1
AZEDRA Commercialization [Member]
Fair value		$ 7,050
AZEDRA Commercialization [Member] | Measurement Input, Probability of Success [Member]
Measurement input		0.9
AZEDRA Commercialization [Member] | Measurement Input, Period of Expected Milestone Achievement [Member]
Measurement input		2,019
AZEDRA Commercialization [Member] | Measurement Input, Discount Rate [Member]
Measurement input		0.1
The 1404 Commercialization [Member]
Fair value	$ 250
The 1404 Commercialization [Member] | Measurement Input, Probability of Success [Member]
Measurement input	0.43
The 1404 Commercialization [Member] | Measurement Input, Period of Expected Milestone Achievement [Member] | Minimum [Member]
Measurement input	2,022
The 1404 Commercialization [Member] | Measurement Input, Period of Expected Milestone Achievement [Member] | Maximum [Member]
Measurement input	2,035
The 1404 Commercialization [Member] | Measurement Input, Discount Rate [Member]
Measurement input	0.1
Net sales targets [Member]
Fair value	$ 4,100	$ 3,500
Net sales targets [Member] | Measurement Input, Probability of Success [Member] | Minimum [Member]
Measurement input	0.18	0.18
Net sales targets [Member] | Measurement Input, Probability of Success [Member] | Maximum [Member]
Measurement input	0.9	0.9
Net sales targets [Member] | Measurement Input, Discount Rate [Member]
Measurement input	0.1	0.1

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Note 4 - Fair Value Measurements - Summary of Activities in Financial Instruments With Level 3 Inputs (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
Balance	$ 11,900	$ 17,600	$ 11,000	$ 16,800
Fair value change included in net loss	916	1,300	1,816	2,100
Payments	(8,016)		(8,016)
Balance	4,800	18,900	4,800	18,900
Changes in unrealized gains or losses for the period included in earnings (or changes in net assets) for liabilities held at the end of the reporting period	$ 916	$ 1,300	$ 1,816	$ 2,100

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Note 5 - Accounts Receivable - Summary of Accounts Receivable (Details) - USD ($) $ in Thousands	Jun. 30, 2019	Dec. 31, 2018
Accounts receivable, net	$ 10,569	$ 3,803
Royalties [Member]
Accounts receivable, net	3,593	3,151
Bayer Milestone [Member]
Accounts receivable, net	2,000
FUJIFILM Transfer [Member]
Accounts receivable, net	4,000
Other [Member]
Accounts receivable, net	$ 976	$ 652

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Note 6 - Recent Acquisition, Goodwill, In-process Research and Development and Other Intangible Assets (Details Textual) $ in Thousands	1 Months Ended	6 Months Ended
	Feb. 28, 2019 USD ($)	Jun. 30, 2019 USD ($)	Jun. 30, 2018 USD ($)
Payments to Acquire Businesses, Gross		$ 8,000
Finite-Lived Intangible Asset, Useful Life		6 years
Number of Reporting Units		1
Goodwill, Impairment Loss		$ 0	$ 0
AZEDRA [Member]
Payments to Acquire Businesses, Gross	$ 8,000

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Note 6 - Recent Acquisition, Goodwill, In-process Research and Development and Other Intangible Assets - Consideration and Assets Acquired (Details) - USD ($) $ in Thousands	1 Months Ended	6 Months Ended
	Feb. 28, 2019	Jun. 30, 2019	Jun. 30, 2018	Dec. 31, 2018	Dec. 31, 2017
Cash consideration		$ 8,000
Goodwill		$ 17,847	$ 13,074	$ 13,074	$ 13,074
AZEDRA [Member]
Cash consideration	$ 8,000
Machinery and equipment	682
Leasehold improvements	1,300
Total tangible assets acquired	1,982
Intangible assets - Somerset	1,245
Total tangible and intangible assets acquired	3,227
Goodwill	$ 4,773

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Note 6 - Recent Acquisition, Goodwill, In-process Research and Development and Other Intangible Assets - Summary of Goodwill and Intangible Assets (Details) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018
Balance, Goodwill	$ 13,074	$ 13,074
Increase related to Somerset acquisition	4,773
Amortization expense
Balance, Goodwill	17,847	13,074
Balance, Finite-lived Intangible Assets	6,775
In Process Research and Development [Member]
Balance, Finite-lived Intangible Assets	600	28,700
Increase related to Somerset acquisition
Amortization expense, Finite-lived Intangible Assets
Balance, Finite-lived Intangible Assets	600	28,700
Other Intangible Assets [Member]
Balance, Finite-lived Intangible Assets	6,066	1,669
Increase related to Somerset acquisition	1,245
Amortization expense, Finite-lived Intangible Assets	(536)	(106)
Balance, Finite-lived Intangible Assets	$ 6,775	$ 1,563

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Note 6 - Recent Acquisition, Goodwill, In-process Research and Development and Other Intangible Assets - Components of Finite-lived Intangible Assets (Details) $ in Thousands	Jun. 30, 2019 USD ($)
Gross amount	$ 8,265
Accumulated amortization	1,490
Net carrying value	6,775
AZEDRA Product Rights [Member]
Gross amount	4,900
Accumulated amortization	642
Net carrying value	4,258
Somerset [Member]
Gross amount	1,245
Accumulated amortization	80
Net carrying value	1,165
EXINI Technology [Member]
Gross amount	2,120
Accumulated amortization	768
Net carrying value	$ 1,352

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Note 7 - Accrued Expenses - Summary of Accrued Expenses (Details) - USD ($) $ in Thousands	Jun. 30, 2019	Dec. 31, 2018
Accrued legal and professional fees	$ 6,763	$ 1,305
Accrued clinical trial costs	4,514	2,318
Accrued payroll and related costs	2,254	2,871
Accrued contract manufacturing costs	1,753	2,516
Accrued consulting costs	734	862
Other	920	661
Accrued expenses	$ 16,938	$ 10,533

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Note 8 - Commitments and Contingencies (Details Textual)	Feb. 27, 2019 EUR (€)
Deposit With Court as Security [Member] | Pending Litigation [Member]
Estimated Litigation Liability	€ 416,000

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Note 9 - Operating Leases (Details Textual) - USD ($) $ in Millions	3 Months Ended	6 Months Ended
	Jun. 30, 2019	Jun. 30, 2019	Mar. 31, 2019
Operating Lease, Weighted Average Discount Rate, Percent	9.50%	9.50%
Operating Lease, Expense	$ 0.6	$ 1.1
Lessee, Operating Lease, Renewal Term			5 years
Operating Lease, Payments	$ 0.5	$ 1.0
Minimum [Member]
Lessee, Operating Lease, Remaining Lease Term		1 year
Maximum [Member]
Lessee, Operating Lease, Remaining Lease Term		11 years 109 days

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Note 9 - Operating Leases - Lease Information (Details) - USD ($) $ in Thousands	Jun. 30, 2019	Dec. 31, 2018
Operating ROU lease assets, noncurrent	$ 13,889
Operating lease liabilities, current	555
Operating lease liabilities, noncurrent	$ 15,312

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Note 9 - Operating Leases - Future Lease Payments (Details) $ in Thousands	Jun. 30, 2019 USD ($)
2019 (excluding the six months ending June 30, 2019)	$ 1,002
2020	2,040
2021	2,077
2022	2,213
2023	2,255
Thereafter	16,807
Total future minimum lease payments	26,394
Less imputed interest	(10,527)
Total lease liabilities	$ 15,867

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Note 10 - Non-recourse Long-term Debt, Net (Details Textual) - Royalty-backed Loan [Member] - USD ($) $ in Millions		15 Months Ended
	Nov. 04, 2016	Jun. 30, 2019
Proceeds from Issuance of Long-term Debt, Total	$ 50
Debt Instrument, Interest Rate, Stated Percentage	9.50%
Percentage of Royalty Payments in Excess of Accrued Loan Interest to be Applied to Principal		50.00%

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Note 10 - Non-recourse Long-term Debt, Net - Summary of Royalty-backed Loan (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018	Dec. 31, 2018
Current portion of debt, net	$ 5,806		$ 5,806		$ 5,419
Long-term debt, net	36,342		36,342		39,180
Royalty-backed Loan [Member]
Outstanding principal balance, current portion	6,057		6,057		5,688
Unamortized debt discount, current portion	(251)		(251)		(269)
Current portion of debt, net	5,806		5,806		5,419
Outstanding principal balance, long-term portion	36,715		36,715		39,674
Unamortized debt discount, long-term portion	(373)		(373)		(494)
Long-term debt, net	36,342		36,342		$ 39,180
Interest expense	1,053	$ 1,176	2,130	$ 2,381
Non-cash interest expense	69	74	140	137
Total interest expense included in interest (expense) income, net	$ 1,122	$ 1,250	$ 2,270	$ 2,518

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Note 11 - Stockholders' Equity (Details Textual) - USD ($) $ / shares in Units, shares in Thousands, $ in Millions	1 Months Ended	3 Months Ended
	Oct. 31, 2018	Mar. 31, 2017	Jun. 30, 2019	Dec. 31, 2018
Common Stock, Shares Authorized			160,000	160,000
Common Stock, Par or Stated Value Per Share			$ 0.0013	$ 0.0013
Preferred Stock, Shares Authorized			20,000	20,000
Preferred Stock, Par or Stated Value Per Share			$ 0.001	$ 0.001
Replacement Shelf Registration	$ 250	$ 250
Common Stock Sales Agreement with Agent, Maximum Aggregate Offering Price	$ 75	$ 75

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Note 12 - Stock-based Compensation (Details Textual) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value	$ 2.37	$ 6.12	$ 2.86	$ 4.58
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value	$ 5,100		$ 5,100
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Intrinsic Value	2,700		2,700
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Aggregate Intrinsic Value	$ 4,400		$ 4,400
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value				$ 0
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate	0.00%	0.00%	0.00%	0.00%
Share-based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount	$ 5,900		$ 5,900
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition			2 years 73 days
Share-based Payment Arrangement, Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period			10 years
Share-based Payment Arrangement, Option [Member] | Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period			3 years
Share-based Payment Arrangement, Option [Member] | Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period			5 years
The 2005 Stock Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized	11,450,000		11,450,000
The 2018 Stock Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized	4,800,000		4,800,000

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Note 12 - Stock-based Compensation - Summary of Option Activity Under the Plans (Details) shares in Thousands	6 Months Ended	12 Months Ended
	Jun. 30, 2019 $ / shares shares	Dec. 31, 2018 $ / shares shares
Outstanding, shares (in shares) | shares	6,264
Outstanding, Weighted Average Exercise Price (in dollars per share) | $ / shares	$ 6.79
Outstanding, Weighted Average Remaining Contractual Life (Year)	6 years 160 days	6 years 7 days
Granted, shares (in shares) | shares	1,392
Granted, Weighted Average Exercise Price (in dollars per share) | $ / shares	$ 4.52
Cancelled, shares (in shares) | shares	(230)
Cancelled, Weighted Average Exercise Price (in dollars per share) | $ / shares	$ 7.17
Exercised, shares (in shares) | shares	(225)
Exercised, Weighted Average Exercise Price (in dollars per share) | $ / shares	$ 5.33
Expired, shares (in shares) | shares	(27)
Expired, Weighted Average Exercise Price (in dollars per share) | $ / shares	$ 7.79
Outstanding, shares (in shares) | shares	7,174	6,264
Outstanding, Weighted Average Exercise Price (in dollars per share) | $ / shares	$ 6.38	$ 6.79
Exercisable, shares (in shares) | shares	4,647
Exercisable, Weighted Average Exercise Price (in dollars per share) | $ / shares	$ 6.63
Exercisable, Weighted Average Remaining Contractual Life (Year)	5 years 10 days
Vested and expected to vest, shares (in shares) | shares	6,519
Vested and expected to vest, Weighted Average Exercise Price (in dollars per share) | $ / shares	$ 6.46
Vested and expected to vest, Weighted Average Remaining Contractual Life (Year)	6 years 62 days

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Note 12 - Stock-based Compensation - Assumptions Used in Computing the Fair Value of Option Grants (Details)	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
Risk-free interest rate	2.04%	2.91%	2.61%	2.71%
Expected life (in years) (Year)	5 years 98 days	7 years 54 days	6 years 189 days	6 years 262 days
Expected volatility	60.00%	70.00%	66.00%	69.00%
Expected dividend yield	0.00%	0.00%	0.00%	0.00%

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Note 12 - Stock-based Compensation - Allocation of Recognized Period Costs (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
Total compensation expense recognized	$ 994	$ 2,130	$ 2,071	$ 3,178
Research and Development Expense [Member]
Total compensation expense recognized	387	452	837	977
Selling, General and Administrative Expenses [Member]
Total compensation expense recognized	$ 607	$ 1,678	$ 1,234	$ 2,201