Document And Entity Information
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 |
Condensed Consolidated Balance
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 |
Condensed Consolidated Balanc_2
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 |
Condensed Consolidated Statemen
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 |
Condensed Consolidated Statem_2
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) |
Condensed Consolidated Statem_3
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 |
Condensed Consolidated Statem_4
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 |
Note 1 - Summary of Significant
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. 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 ® TM 3 first 1095 2 1095 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 first ● 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. 65 65 $98,150. ● Patient enrollment for the Phase 3 18 five 3 208 14 ● The first 2 1095 Progenics’1095 ● 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 ● 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. 2 5 No. 8,524,276, ● 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 1404 99m 1404 ● 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, 510 ● 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 ® $4.0 three 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 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 Strategic partnerships : ● RELISTOR ® ● 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 1 May 2019, first 1 $2.0 ● CytoDyn Inc. (“CytoDyn”) acquired leronlimab (PRO 140 CCR5 March 2019 first three ● Curium has exclusive rights to develop, manufacture and commercialize PyL ( 18 ● ROTOP has exclusive rights to develop, manufacture and commercialize 1404 1404 1404 2020. 1404 ● 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 three 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, 1997, Liquidity At June 30, 2019, $84.8 $52.9 $137.7 December 31, 2018. one 10 may may 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 |
Note 2 - New Accounting Pronoun
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. Recently Adopted In February 2016, 2016 02 2016 02” Leases (Topic 842 12 The FASB has subsequently issued the following amendments to ASU 2016 02, January 1, 2019, ● ASU No. 2018 01, Leases (Topic 842 842, not 842 842 not 840, Leases ● ASU No. 2018 10, Codification Improvements to Topic 842, 2016 02. ● ASU No. 2018 11, Leases (Topic 842 2016 02 not ● ASU No. 2018 20, Narrow-Scope Improvements for Lessors 2016 02. ● ASU No. 2019 01, Leases (Topic 842 We adopted the new leasing standards on January 1, 2019, January 1, 2019 not The adoption of this standard impacted our 2019 $15.3 $13.5 not Recently Issued In August 2018, 2018 13 2018 13” Fair Value Measurement - Disclosure Framework (Topic 820 2018 13 December 15, 2019. In June 2016, 2016 13, Financial Instruments - Credit Losses (Topic 326 November 2018, 2018 19, Codification Improvements to Topic 326, April 2019, 2019 04, Codification Improvements to Topic 326, Financial Instruments—Credit Losses, Topic 815, Topic 825, Instruments 2016 13. May 2019, 2019 05, Financial Instruments—Credit Losses ( Topic 326 ): Targeted Transition Relief . may 2016 13 December 15, 2019. |
Note 3 - Net Loss Per Share
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 six June 30, 2019 2018, not 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 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 |
Note 4 - Fair Value Measurement
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 ● Level 1 ● Level 2 1 ● Level 3 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 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 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”) 820 820, 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 June 30, 2019 Milestone payments due upon first 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 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 one 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 June 30, 2019 December 31, 2018 ( $6.2 six June 30, 2019 $8.0 first 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 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 |
Note 5 - Accounts Receivable
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 December 31, 2018 ( 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, Go
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, $8.0 1095. ® Purchase Price Allocation 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 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 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 may one No June 30, 2019 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 ( 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
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 June 30, 2019 December 31, 2018 ( 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 |
Note 8 - Commitments and Contin
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 not one Abbreviated New Drug Application Litigations RELISTOR Subcutaneous Injection Paragraph IV Certifications - Mylan On or about October 6, 2015, November 20, 2015, December 22, 2015, December 23, 2015, four 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 8180 8,247,425, 8,420,663, 8,552,025, 8,822,490 February 4, 2016, No. 9,180,125. January 4, 2016 ( 2:16 00035 8,247,425, 8,420,663, 8,552,025, 8,822,490 January 25, 2016, No. 9,180,125. September 1, 2017 ( 2:17 06714 No. 9,669,096 September 18, 2017, No. 9,492,445. The 2:15 8180 2:16 00035 2:15 08353 2:16 00889 2:15 08180 May 1, 2018, 8 No. 8,552,025. May 23, 2018, 54 8 ’025 Litigation in the 2:17 06714 not 2:15 8180 Federal Circuit Appeal On May 25, 2018, On July 9, 2018, July 17, 2018, September 12, 2018. February 8, 2019, April 9, 2019. July 2, 2019. August 6, 2019. Paragraph IV Certification – Actavis On or about October 27, 2015, January 5, 2016, January 8, 2016, three Settlement Agreement - Actavis On May 25, 2018, No. 2:15 08180 No. 2:17 06714. 30 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; ( 21. 355 5 not 180 180 not not 180 181 third ® third not 180 first third ® 505 2 first No. 021964 ® ® first third Paragraph IV Certification - Par On or about July 15, 2017, 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 06449 8,247,425, 8,420,663, 8,552,025, 8,822,490, 9,180,125, 9,669,096 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 06557 8,247,425, 8,420,663, 8,552,025, 8,822,490, 9,180,125, 9,669,096 November 30, 2017. Settlement Agreement - Par On May 10, 2018, No. 17 06449 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 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; ( one hundred eighty-one 181 third 21. 355 5 ® third ® ® third not 180 first not one hundred fifty 150 RELISTOR Tablets - Actavis Paragraph IV Certifications On or about October 24, 2016 October 24, 2017, two 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 09038 8,420,663, 8,524,276, 8,956,651, 9,180,125, 9,314,461 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 12857 9,724,343 9,492,445 The 2:16 09038 2:17 12857 2:16 09038 four May 6, 2019 May 9, 2019. July 17, 2019, No. 8,524,276 No. 209615 may not 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 13722 No. 10,307,417 2:19 13722 not European Opposition Proceedings In addition to the above described ANDA notifications, in October 2015, three EP1615646 September 24, 2015 EP2368553 September 29, 2015 September 30, 2015 EP2368554 September 24, 2015 May 11, 2017, EP2368553 June 28, 2017, EP1615646 July 4, 2017, EP2368554 EP1615646 September 22, 2020. not EP2368553 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 We are or may 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, On November 8, 2018, 617 617, February 27, 2019, On November 27, 2018, 3 038 996 A1 14 799 340.6 18 172 716.5, EP18 184 296.4, 18 203 547.7 December 10, 2018, November 27, 2018. December 20, 2018, 15/131,118; 16/038,729 16/114988 On February 27, 2019, two €416, 000 August 6, 2019 August 6, first |
Note 9 - Operating Leases
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 not 9.5% three six June 30, 2019, $0.6 $1.1 one 11.3 one five three six June 30, 2019, $0.5 $1.0 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, 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 |
Note 10 - Non-recourse Long-ter
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, $50.0 no 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, March 31, 2018, 50% September 30, 2021, June 30, 2025. 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, no |
Note 11 - Stockholders' Equity
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 $0.0013, 20.0 $0.001. Shelf Registration During the first 2017, $250.0 $250.0 $75.0 one “2017 In October 2018, no $250.0 $250.0 $75.0 one In addition, in October 2018 2017 “2018 2018 may $75.0 2018 may ten |
Note 12 - Stock-based Compensat
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 “2005 11,450,000 2005 June 2018 2018 2005 2018 2005 ● The 2018 “2018 4,800,000 2018 March 27, 2028. The stock option plans provide that options may 100% may ten three five Stock Options The following table summarizes stock options activity for the six June 30, 2019 ( 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 six June 30, 2019 $2.37 $2.86 three six June 30, 2018 $6.12 $4.58 The total intrinsic value (the excess of the market price over the exercise price) was approximately $5.1 $2.7 $4.4 June 30, 2019. No six June 30, 2018. Stock-Based Compensation Expense We account for stock-based awards issued to employees in accordance with the provisions of ASC 718 718, Compensation – Stock Compensation three five 718 505 50 50 505, Equity 718, 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 zero not not 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 six June 30, 2019 2018 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, $5.9 2.2 |
Significant Accounting Policies
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 not 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 December 31, 2018. not |
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 |
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 For contracts determined to be within the scope of ASU 2014 09, Revenue from Contracts with Customers (Topic 606 2014 09” 606” not 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 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 not not 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 six June 30, 2019 2018 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 60 Royalty income License and o ther revenue not We had receivable contract balances of $10.6 $3.8 June 30, 2019 December 31, 2018, 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 $1.5 June 30, 2019 December 31, 2018, 617 2019 |
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 three six June 30, 2019 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 not may 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 twelve |
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 $2.7 June 30, 2019 December 31, 2018, 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 1 - Summary of Significa_2
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 |
Note 3 - Net Loss Per Share (Ta
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 |
Note 4 - Fair Value Measureme_2
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 |
Note 5 - Accounts Receivable (T
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 |
Note 6 - Recent Acquisition, _2
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 |
Note 7 - Accrued Expenses (Tabl
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 |
Note 9 - Operating Leases (Tabl
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 |
Note 10 - Non-recourse Long-t_2
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 |
Note 12 - Stock-based Compens_2
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 |
Note 1 - Summary of Significa_3
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 |
Note 1 - Summary of Significa_4
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 |
Note 1 - Summary of Significa_5
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 |
Note 2 - New Accounting Prono_2
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 |
Note 3 - Net Loss Per Share - C
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) |
Note 3 - Net Loss Per Share -_2
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. |
Note 4 - Fair Value Measureme_3
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 |
Note 4 - Fair Value Measureme_4
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 |
Note 4 - Fair Value Measureme_5
Note 4 - Fair Value Measurements - Contingent Consideration Liabilities (Details) $ in Thousands | Jun. 30, 2019USD ($) |
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 |
Note 4 - Fair Value Measureme_6
Note 4 - Fair Value Measurements - Quantitative Information for Fair Value Measurement of Level 3 (Details) $ in Thousands | Jun. 30, 2019USD ($) | Dec. 31, 2018USD ($) |
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 |
Note 4 - Fair Value Measureme_7
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 |
Note 5 - Accounts Receivable -
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 |
Note 6 - Recent Acquisition, _3
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, 2019USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | |
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 |
Note 6 - Recent Acquisition, _4
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 |
Note 6 - Recent Acquisition, _5
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 |
Note 6 - Recent Acquisition, _6
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, 2019USD ($) |
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 |
Note 7 - Accrued Expenses - Sum
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 |
Note 8 - Commitments and Cont_2
Note 8 - Commitments and Contingencies (Details Textual) | Feb. 27, 2019EUR (€) |
Deposit With Court as Security [Member] | Pending Litigation [Member] | |
Estimated Litigation Liability | € 416,000 |
Note 9 - Operating Leases (Deta
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 | |
Minimum [Member] | |||
Lessee, Operating Lease, Remaining Lease Term | 1 year | ||
Maximum [Member] | |||
Lessee, Operating Lease, Remaining Lease Term | 11 years 109 days |
Note 9 - Operating Leases - Lea
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 |
Note 9 - Operating Leases - Fut
Note 9 - Operating Leases - Future Lease Payments (Details) $ in Thousands | Jun. 30, 2019USD ($) |
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 |
Note 10 - Non-recourse Long-t_3
Note 10 - Non-recourse Long-term Debt, Net (Details Textual) - Royalty-backed Loan [Member] - USD ($) $ in Millions | 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% |
Note 10 - Non-recourse Long-t_4
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 |
Note 11 - Stockholders' Equity
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 |
Note 12 - Stock-based Compens_3
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 |
Note 12 - Stock-based Compens_4
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$ / sharesshares | Dec. 31, 2018$ / sharesshares | |
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 |
Note 12 - Stock-based Compens_5
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% |
Note 12 - Stock-based Compens_6
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 |