Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 19, 2020 | Jun. 28, 2019 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Title of 12(b) Security | Ordinary Shares, par value NIS 0.01 per share | ||
Trading Symbol | URGN | ||
Security Exchange Name | NASDAQ | ||
Entity Registrant Name | UROGEN PHARMA LTD. | ||
Entity Central Index Key | 0001668243 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Shell Company | false | ||
Entity Emerging Growth Company | false | ||
Entity Common Stock, Shares Outstanding | 21,154,965 | ||
Entity Public Float | $ 695.3 | ||
Entity Interactive Data Current | Yes | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity File Number | 001-38079 | ||
Entity Incorporation, State or Country Code | L3 | ||
Entity Tax Identification Number | 98-1460746 | ||
Entity Address, Address Line One | 400 Alexander Park | ||
Entity Address, City or Town | Princeton | ||
Entity Address, State or Province | NJ | ||
Entity Address, Postal Zip Code | 08540 | ||
City Area Code | 646 | ||
Local Phone Number | 768-9780 | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE Document Description 10-K Part Portions of the registrant’s definitive proxy statement to be filed with the Securities and Exchange Commission pursuant to Regulation 14A within 120 days after the registrant’s fiscal year ended December 31, 2019 are incorporated by reference into Part III of this report. III |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 49,688 | $ 101,318 |
Marketable securities | 97,389 | |
Restricted cash | 523 | 253 |
Prepaid expenses and other current assets | 1,034 | 672 |
TOTAL CURRENT ASSETS | 148,634 | 102,243 |
NON-CURRENT ASSETS | ||
Property and equipment, net | 977 | 948 |
Restricted deposit | 223 | 51 |
Right of use asset | 3,735 | |
Marketable securities | 48,555 | |
Other non-current assets | 264 | 317 |
TOTAL ASSETS | 202,388 | 103,559 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued expenses | 11,186 | 8,540 |
Employee related accrued expenses | 6,711 | 4,925 |
Other current liabilities | 1,585 | |
TOTAL CURRENT LIABILITIES | 19,482 | 13,465 |
NON-CURRENT LIABILITY: | ||
Long-term lease liability | 2,604 | |
TOTAL LIABILITIES | 22,086 | 13,465 |
COMMITMENTS AND CONTINGENCIES (Note 14) | ||
SHAREHOLDERS’ EQUITY: | ||
Ordinary shares, NIS 0.01 par value; 100,000,000 shares authorized at December 31, 2019 and 2018; 21,026,184 and 16,214,883 shares issued and outstanding as of December 31, 2019 and 2018, respectively | 57 | 44 |
Additional paid-in capital | 407,986 | 212,921 |
Accumulated deficit | (228,017) | (122,871) |
Accumulated other comprehensive income | 276 | |
TOTAL SHAREHOLDERS’ EQUITY | 180,302 | 90,094 |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 202,388 | $ 103,559 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - ₪ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Ordinary shares, par value | ₪ 0.01 | ₪ 0.01 |
Ordinary shares, shares authorized | 100,000,000 | 100,000,000 |
Ordinary shares, issued | 21,026,184 | 16,214,883 |
Ordinary shares, outstanding | 21,026,184 | 16,214,883 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Statement [Abstract] | |||
REVENUES | $ 18 | $ 1,128 | $ 8,158 |
COST OF REVENUES | 1,803 | 600 | |
GROSS PROFIT (LOSS) | 18 | (675) | 7,558 |
OPERATING EXPENSES: | |||
RESEARCH AND DEVELOPMENT EXPENSES | 49,297 | 36,934 | 18,697 |
GENERAL AND ADMINISTRATIVE EXPENSES | 60,199 | 39,571 | 8,811 |
OPERATING LOSS | (109,478) | (77,180) | (19,950) |
INTEREST AND OTHER (INCOME) EXPENSES, NET | (4,332) | (1,648) | 31 |
LOSS BEFORE INCOME TAXES | (105,146) | (75,532) | (19,981) |
INCOME TAX EXPENSE | 125 | 19 | |
NET LOSS | (105,146) | (75,657) | (20,000) |
STATEMENTS OF COMPREHENSIVE LOSS | |||
NET LOSS | (105,146) | (75,657) | (20,000) |
OTHER COMPREHENSIVE INCOME: | |||
UNREALIZED GAIN ON MARKETABLE SECURITIES | 276 | ||
COMPREHENSIVE LOSS | $ (104,870) | $ (75,657) | $ (20,000) |
LOSS PER ORDINARY SHARE BASIC AND DILUTED | $ (5.12) | $ (4.80) | $ (2.14) |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER ORDINARY SHARE | 20,528,727 | 15,754,193 | 9,716,790 |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) $ in Thousands | Total | IPO | Ordinary Shares | Ordinary SharesIPO | Preferred Shares | Additional Paid-In Capital | Additional Paid-In CapitalIPO | Accumulated Deficit | Other Comprehensive Income |
Balance at Dec. 31, 2016 | $ 16,307 | $ 6 | $ 13 | $ 43,502 | $ (27,214) | ||||
Balance,Share at Dec. 31, 2016 | 2,305,743 | 5,193,427 | |||||||
Exercise of options into ordinary shares | 404 | $ 2 | 402 | ||||||
Exercise of options into ordinary shares, shares | 743,806 | ||||||||
Share-based compensation | 6,300 | 6,300 | |||||||
Exercise of warrants into preferred shares | 4,732 | $ 1 | 4,731 | ||||||
Exercise of warrants into preferred shares, shares | 364,036 | ||||||||
Exercise of preferred shares into ordinary shares | $ 14 | $ (14) | |||||||
Exercise of preferred shares into ordinary shares, shares | 5,557,463 | (5,557,463) | |||||||
Issuance of ordinary shares in public offering, net of issuance expenses | $ 60,772 | $ 15 | $ 60,757 | ||||||
Issuance of ordinary shares in public offering, net of issuance expenses, shares | 5,144,378 | ||||||||
Net loss | (20,000) | (20,000) | |||||||
Balance at Dec. 31, 2017 | 68,515 | $ 37 | 115,692 | (47,214) | |||||
Balance,Share at Dec. 31, 2017 | 13,751,390 | ||||||||
Exercise of options into ordinary shares | 2,401 | $ 2 | 2,399 | ||||||
Exercise of options into ordinary shares, shares | 780,567 | ||||||||
Share-based compensation | 30,642 | 30,642 | |||||||
Issuance of ordinary shares in public offering, net of issuance expenses | 64,193 | $ 5 | 64,188 | ||||||
Issuance of ordinary shares in public offering, net of issuance expenses, shares | 1,682,926 | ||||||||
Net loss | (75,657) | (75,657) | |||||||
Balance at Dec. 31, 2018 | 90,094 | $ 44 | 212,921 | (122,871) | |||||
Balance,Share at Dec. 31, 2018 | 16,214,883 | ||||||||
Exercise of options into ordinary shares | 3,664 | $ 2 | 3,662 | ||||||
Exercise of options into ordinary shares, shares | 603,984 | ||||||||
Share-based compensation | 29,967 | 29,967 | |||||||
Issuance of ordinary shares in public offering, net of issuance expenses | $ 161,447 | $ 11 | $ 161,436 | ||||||
Issuance of ordinary shares in public offering, net of issuance expenses, shares | 4,207,317 | ||||||||
Other comprehensive income | 276 | $ 276 | |||||||
Net loss | (105,146) | (105,146) | |||||||
Balance at Dec. 31, 2019 | $ 180,302 | $ 57 | $ 407,986 | $ (228,017) | $ 276 | ||||
Balance,Share at Dec. 31, 2019 | 21,026,184 |
CONSOLIDATED STATEMENTS OF SH_2
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (Parenthetical) $ in Thousands | 12 Months Ended |
Dec. 31, 2017USD ($) | |
IPO | |
Shares issuance expense and underwriters discounts | $ 6,105 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ (105,146) | $ (75,657) | $ (20,000) |
Adjustment to reconcile net loss to net cash from operating activities: | |||
Depreciation and amortization | 296 | 417 | 207 |
Amortization/Accretion on marketable securities | (572) | ||
Stock-based compensation | 29,967 | 30,642 | 6,300 |
Fair value adjustment of warrants for preferred shares | 168 | ||
Realized loss on sale of short-term investment | 100 | ||
Amortization of right of use asset | 1,028 | ||
Change in lease liability | (910) | ||
Changes in operating assets and liabilities: | |||
Decrease (increase) in inventory | 316 | (211) | |
Decrease in accounts receivable | 83 | ||
(Increase) decrease in prepaid expenses and other current assets | (394) | 318 | (562) |
Increase in accounts payable and accrued expenses | 2,928 | 4,205 | 2,534 |
(Decrease) increase in deferred revenues | (650) | 650 | |
Increase in employee related accrued expenses | 1,786 | 2,975 | 1,263 |
Net cash used in operating activities | (71,017) | (37,334) | (9,568) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Sale of short-term investments | 35,901 | ||
Purchase of marketable securities | (197,686) | (36,001) | |
Maturities of marketable securities | 52,590 | ||
Change in restricted deposit | (172) | (54) | (5) |
Purchase of property and equipment | (325) | (560) | (271) |
Net cash (used in) provided by investing activities | (145,593) | 35,287 | (36,277) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from exercise of options into ordinary shares | 3,664 | 2,401 | 404 |
Proceeds from exercise of warrants for preferred shares | 382 | ||
Issuance cost for shelf filing | (76) | ||
Issuance of ordinary shares, net of issuance expenses | 161,662 | 64,235 | 60,841 |
Issuance cost for secondary offering | (215) | (42) | |
Net cash provided by financing activities | 165,250 | 66,421 | 61,585 |
INCREASE IN CASH AND CASH EQUIVALENTS | (51,360) | 64,374 | 15,740 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF THE YEAR | 101,571 | 37,197 | 21,457 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF THE YEAR | 50,211 | 101,571 | 37,197 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | |||
Non-cash issuance cost | 188 | $ 102 | 202 |
Non-cash new lease liabilities | $ 1,741 | ||
Exercise of warrants to preferred shares | $ 4,732 |
Business and Nature of Operatio
Business and Nature of Operations | 12 Months Ended |
Dec. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Business and Nature of Operations | NOTE 1-BUSINESS AND NATURE OF OPERATIONS Nature of Operations UroGen 0 UroGen a n UroGen and UroGen Pharma Inc. biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases. As of the date of issuance of the consolidated financial statements, the Company has the ability to fund its planned operations for at least the next 12 months. However, the Company’s product candidates may never achieve commercialization and it will continue to incur losses for the foreseeable future. Therefore, in order to fund the Company’s research and development expenses, general and administrative expenses and capital expenditures until such time that the Company can generate substantial revenues, the Company may need to raise additional funds. |
Basis of Presentation and Manag
Basis of Presentation and Management Plans | 12 Months Ended |
Dec. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Basis of Presentation and Management Plans | NOTE 2-BASIS OF PRESENTATION AND MANAGEMENT PLANS The Company has not generated any revenue from the sale of products since its inception. The Company has experienced net losses since its inception and has an accumulated deficit of $228.0 million and $122.9 million as of December 31, 2019 and 2018, respectively. The Company expects to incur losses and have negative net cash flows from operating activities as it expands its portfolio and engages in further research and development activities, particularly conducting nonclinical studies and clinical trials. The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States. The success of the Company depends on its ability to develop its technologies to the point of U.S. Food and Drug Administration ( “ ” ’ ’ |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | NOTE 3-SIGNIFICANT ACCOUNTING POLICIES Principles of Consolidation The Company ’ Use of Estimates The a i i n a i Functional Currency The U.S. dollar (“Dollar”) is the currency of the primary economic environment in which the operations of the Company and subsidiary are conducted. Therefore, the functional currency of the Company is the Dollar. Accordingly, transactions in currencies other than the Do l lar are measured and recorded in the functional currency usi n g the exchange rate in effect at the date of the transaction. At the balance sheet date, monetary assets and liab i lities that are denominated in currencies other than the Dollar are measured using the official exch a nge rate at the balance sheet date. The effects of foreign currency re-measurements are recorded in the consolidated statements of operations as “ I nterest and other ( income ) expenses , net .” Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents consist primarily of money market funds and bank money market accounts and are stated at cost, which approximates fair value. Marketable Securities The Company classifies its marketable securities as available-for-sale in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 320, “Investments — Debt Securities”. Available-for-sale debt securities are carried at fair value with unrealized gains and losses reported in other comprehensive income/loss within shareholders’ equity. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in interest and other income (expense), net. The cost of securities sold is based on the specific-identification method. The Company reviews its available-for-sale securities for other-than-temporary declines in fair value below its cost basis each quarter and whenever events or changes in circumstances indicate that the cost basis of an asset may not be recoverable. This evaluation is based on a number Concentration of Credit Risk Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist primarily of cash and cash equivalents and marketable securities. The primary objectives for the Company ’ The Company ’ Income Taxes The Company provides for income taxes based on pretax income, if any, and applicable tax rates available in the various jurisdictions in which we operate. Deferred l e n s a a The n l w a Property and Equipment Property and equipment is recorded at historical cost, net of accumulated depreciation, amortization and, if applicable, impairment charges. We review our property and equipment assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Annual % Computers and software 33 Laboratory equipment 15-30 Furniture 6-15 Manufacturing equipment 50 Leasehold improvements are amortized on a straight-line basis over the shorter of their estimated useful lives or lease terms. See Note 6 for further discussion regarding property and equipment. Leases The Company is a lessee in several noncancelable operating leases, primarily for office space, office equipment and vehicles. The Company currently has no finance leases. Commencing January 1, 2019, the Company accounts for leases in accordance with ASC Topic 842, “Leases” . Lease expense is recognized on a straight-line basis for operating leases. Variable lease payments associated with the Company’s leases are recognized when the event, activity, or circumstance in the lease agreement on which those payments are assessed occurs. Variable lease payments are presented as operating expense on the consolidated statements of operations in the same line item as expense arising from fixed lease payments. The Company’s lease terms may include options of the Company as the lessee to extend the lease. The lease extensions are included in the measurement of the right of use asset and lease liability if it is reasonably certain that it will exercise that option. Because the Company’s leases do not provide an implicit rate of return, an incremental borrowing rate is used based on the information available at the commencement date in determining the present value of lease payments on an individual lease basis. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. The Company has lease agreements with lease and non-lease components and has elected the practical expedient to combine lease and non-lease components for all underlying classes of assets. We applied the modified retrospective transition method and elected the transition option to use the effective date of January 1, 2019 as the date of initial application (“Transition Date”). Consequently, the disclosures required under Topic 842 are not provided for dates and periods before January 1, 2019. Topic 842 provides for a number of optional practical expedients in transition. The Company elected the ‘package of practical expedients’, which permits not to reassess under Topic 842 its prior conclusions about lease identification, lease classification, and initial direct costs. The Company did not elect the use-of-hindsight or the practical expedient pertaining to land easements; the latter not being applicable to the Company. Topic 842 had a material impact on our consolidated balance sheets but did not have an impact on our consolidated statements of operations. The most significant impact was the recognition of $3.7 million in ROU assets and $4.2 million in lease liabilities. ROU assets for operating leases are periodically reviewed for impairment losses under ASC 360-10, “Property, Plant, and Equipment”, to determine whether a ROU asset is impaired, and if so, the amount of the impairment loss to recognize. Accounts Payable and Accrued Expenses Accrued expenses and other current liabilities consist of the following as of December 31, 2019 and 2018, respectively (in thousands): December 31, 2019 December 31, 2018 Accounts payable $ 4,694 $ 4,272 Accrued clinical expenses 399 673 Accrued research and development costs 2,644 780 Accrued general and administrative expenses 2,767 1,029 Accrued other expense 682 1,786 Total accrued expenses and other current liabilities $ 11,186 $ 8,540 Revenues The Company derives virtually all of its revenues from its license and supply agreement with Allergan. Under the agreement, the Company grants Allergan an exclusive license to develop, commercialize, and otherwise exploit products that contain RTGel and agrees to supply Allergan with pre-clinical and clinical quantities of the RTGel product, also referred to as the RTGel The Company determined that Allergan is its customer and the license and supply agreements are in scope of ASC 606, which was adopted as of January 1, 2018. The Company adopted ASC 606 under the modified retrospective method, which did not have a material impact on the Consolidated Statements of Operations. Previously, the Company analyzed revenues under ASC 605, which states that revenue w o i Under ASC 606, in determining the appropriate amount of revenue to be recognized as it fulfills its obligations under the agreements with Allergan, the Company performs the following steps: 1) Identification of the contract; 2) Determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; 3) Measurement of the transaction price, including the constraint on variable consideration; 4) Allocation of the transaction price to the performance obligations; 5) Recognition of revenue when or as the Company satisfies each performance obligation. In 1) The customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (that is, the good or service is capable of being distinct); and 2) The entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the contract). The license agreement contains two performance obligations: (a) the license component and (b) Allergan’s right to require supply services of RTGel vials from the Company. The l p Allocating the C onsideration in the A rrangement Since the license to the Company’s intellectual property was determined to be functional and distinct from the other performance obligations identified in the arrangement, the Company recognized revenues from non-refundable, up-front fees allocated to the license when the license was transferred to Allergan and Allergan was able to use and benefit from the license. During the year ended December 31, 2016, the Company received A b e l c Development and Regulatory Milestone Payments At the inception of an arrangement that includes development milestone payments, the Company evaluates whether the development milestones are considered probable of being reached and estimates 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 development milestone value is included in the transaction price. Development milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The milestones are allocated entirely to the license performance obligation, as (1) the terms of milestone and royalty payments relate specifically to the license and (2) allocating milestones and royalties to the license performance obligation is consistent with the overall allocation objective, because management’s estimate of the supply fee approximates the standalone selling price for RTGel vials and management’s estimate of milestones and royalties approximates the standalone selling price of the license. During the year ended December 31, 2017, the Company recognized revenue of $7.5 million related to a development milestone payment resulting from Allergan’s submission of an IND application for the Company’s RTGel in combination with Allergan’s BOTOX for the treatment of overactive bladder to the U.S. FDA. Royalties Based on Allergan’s Revenue The Company is also n Supply of RTGel to Allergan The Company recognizes revenue related to supply of RTGel at a point in time, upon delivery to Allergan. During the years ended December 31, 2019, 2018 and 2017, the Company recognized $18,000, $1.1 million and $0.7 million of revenue related to RTGel vials supplied to Allergan, respectively. Shipping and handling costs associated with supply of RTGel vials are accounted for as a fulfillment cost and are in included in cost of revenues. General and Administrative Expenses General and administrative expenses consist primarily of personnel costs (including share-based compensation related to directors, executives, finance, commercial, medical affairs, business development, investor relations and human resources functions). Other significant costs include commercial, medical affairs, external professional service costs, facility costs, accounting and audit services, legal services and other consulting fees. General and administrative costs are expensed as incurred, and the Company accrues for services provided by third parties related to the above expenses by monitoring the status of services provided and receiving estimates from its service providers and adjusting its accruals as actual costs become known. Research and Development Research s i d a l l License fees and development milestone payments related to in-licensed products and technology are expensed as in-process research and development if it is determined at that point that they have no established alternative future use. On November 8, 2019, the Company entered into a license agreement with Agenus Inc. pursuant to which Agenus granted to the Company an exclusive, worldwide (not including Argentina, Brazil, Chile, Colombia, Peru, Venezuela and their respective territories and possessions), royalty-bearing, sublicensable license under Agenus’s intellectual property rights to develop, make, use, sell, import, and otherwise commercialize products incorporating a proprietary antibody of Agenus known as AGEN1884 for the treatment of cancers of the urinary tract via intravesical delivery. AGEN1884 is an anti-CTLA-4 antagonist that is currently being evaluated by Agenus as a monotherapy in PD-1 refractory patients and in combination with Agenus’ anti-PD-1 antibody in solid tumors. Initially, the Company plans to develop AGEN1884 in combination with UGN-201 for the treatment of high-grade non-muscle invasive bladder cancer. Pursuant to the license agreement, the Company paid Agenus an upfront fee of $10.0 million and has agreed to pay Agenus up to $115.0 million upon achieving certain clinical development and regulatory milestones, up to $85.0 million upon achieving certain commercial milestones, and royalties on net sales of licensed products in the 14% to 20% range. The Company will be responsible for all development and commercialization activities. Under the terms of the license agreement, Agenus has agreed to use commercially reasonable efforts to supply AGEN1884 to the Company for use in preclinical studies or clinical trials. No inventory was purchased on the effective date and subsequent purchases of pre-clinical and clinical supplies are at arm’s length and are priced at cost plus mark-up. The Company’s acquired right to Agenus’s intellectual property represents a single identifiable asset sourced from the license agreement. Therefore, all the fair value associated with the license agreement is concentrated in one identifiable asset and is not considered a business in accordance with ASC 805-10-55-5A. Therefore, the Company has accounted for the right to Agenus’s intellectual property acquired under the license agreement as an acquisition of an asset. Share-Based Compensation Share-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as expense over the required service period, which is equal to the vesting period. The fair value of stock options is determined using the Black-Scholes option-pricing model. The fair value of a restricted stock unit equaled the closing price of our ordinary shares on the grant date.The The s n g As of December 31, 2018, the Company adopted ASU 2018-07, Compensation-Stock Compensation, which establishes that the measurement of equity-classified nonemployee awards will be fixed at the grant date. The adoption of ASU 2018-07 did not have an impact on the condensed consolidated statements of operations. Interest and Other (Income) Expense, net Interest and Other (Income) Expense, net, consisted of the following as of December 31, 2019 and 2018 (in thousands): Year Ended December 31, 2019 2018 2017 Changes in fair value of warrants for preferred shares $ — $ — $ 168 Interest income on cash, cash equivalents and marketable securities (4,616 ) (1,872 ) (125 ) Realized loss on sale of short-term investment — 100 — Other expense (income) 284 124 (12 ) Total interest and other (income) expenses $ (4,332 ) $ (1,648 ) $ 31 Net Loss per Common Share Basic net loss per share is computed by dividing the net loss attributable to common shareholders by the weighted-average number of common shares outstanding. Diluted net loss per share is computed similarly to basic net loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. In addition, the net loss attributable to common shareholders is adjusted for Series A and A-1 Preferred Stock dividends for the periods in which Series A and A-1 Preferred Stock is outstanding. For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted loss per share as their effect is anti-dilutive. The following table summarizes the calculation of basic and diluted loss per common share for the periods presented (in thousands, except share and per share amounts): Year Ended December 31, 2019 2018 2017 Basic and diluted: Loss attributable to equity holders of the Company $ 105,146 $ 75,657 $ 20,000 Dividend accumulated for preferred shares during the period $ — $ — $ 825 Loss attributable to equity holders of the Company, after deducting dividend accumulated for preferred shares $ 105,146 $ 75,657 $ 20,825 Weighted-average number of ordinary shares 20,528,727 15,754,193 9,716,790 Loss per ordinary share $ 5.12 $ 4.80 $ 2.14 Recently Issued Accounting Pronouncements In June 2016, the Financial Accounting Standards Board, or Accounting Standards Update, or Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments, Recently Adopted Accounting Pronouncements In February 2016, FASB issued ASU No. 2016-02, “Leases”, or Topic 842. Topic 842 supersedes existing guidance in Leases (“Topic 840”). Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; and ASU No. 2018-11, Targeted Improvements. Topic 842 requires lessees to recognize right-of-use, or ROU, assets and lease liabilities on the balance sheet for leases with lease terms greater than twelve months, including those classified as operating leases. Leases are classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the income statement. The lease liability is measured at the present value of the unpaid lease payments and the ROU assets are derived from the calculation of the lease liability. Lease payments will include fixed and in-substance fixed payments, variable payments based on an index or rate, exercise price of purchase options that are reasonably certain to be exercised, termination penalties, and probable amounts the lessee will owe under a residual value guarantee. Topic 842 also requires lessees to disclose key information about leasing arrangements. Lessor accounting will remain largely unchanged. The Company applied the modified retrospective transition method and elected the transition option to use the effective date of January 1, 2019 as the date of initial application, or Transition Date. Consequently, financial information was not updated, and the disclosures required under the Topic 842 were not provided for dates and periods before January 1, 2019. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | NOTE 4-FAIR VALUE MEASUREMENTS The Company follows authoritative accounting guidance, which among other things, defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2: Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. Level 3: Unobservable inputs that reflect the reporting entity ’ The carrying amounts of the Company ’ Assets and liabilities measured at fair value on a recurring basis based on Level 1, Level 2, and Level 3 fair value measurement criteria as of December 31, 2019 are as follows (in thousands): Fair Value Measurements Using Quoted Prices Significant in Active Other Significant Balance as of Markets for Observable Unobservable December 31, Identical Assets Inputs Inputs 2019 (Level 1) (Level 2) (Level 3) Marketable securities: US government $ 66,094 $ 66,094 $ — $ — Corporate bonds 68,084 — 68,084 — Commercial paper 7,658 — 7,658 — Money market funds (1) 16,998 16,998 — — Certification of deposit 4,108 — 4,108 — $ 162,942 $ 83,092 $ 79,850 $ — (1) Included within cash and cash equivalents on the Company s consolidated balance sheets. Assets and liabilities measured at fair value on a recurring basis based on Level 1, Level 2, and Level 3 fair value measurement criteria as of December 31, 2018 are as follows (in thousands): Fair Value Measurements Using Quoted Prices Significant in Active Other Significant Balance as of Markets for Observable Unobservable December 31, Identical Assets Inputs Inputs 2018 (Level 1) (Level 2) (Level 3) Assets: Money market funds (1) $ 89,965 $ 89,965 $ — $ — (1) Included within cash and cash equivalents on the Company s consolidated balance sheets. The Company ’ |
Marketable Securities
Marketable Securities | 12 Months Ended |
Dec. 31, 2019 | |
Investments Debt And Equity Securities [Abstract] | |
Marketable Securities | NOTE 5-MARKETABLE SECURITIES The following table summarizes the Company’s marketable securities as of December 31, 2019 (in thousands): Amortized Cost Basis Unrealized Gains Unrealized Losses Fair Value Marketable securities: US government $ 65,947 $ 147 $ — $ 66,094 Corporate bonds 67,957 131 (4 ) 68,084 Commercial paper 7,658 — — 7,658 Money market funds (1) 16,998 — — 16,998 Certificates of deposit 4,106 2 — 4,108 $ 162,666 $ 280 $ (4 ) $ 162,942 (1) Included within cash and cash equivalents on the Company s consolidated balance sheets. The Company classifies its marketable securities as available-for-sale, and they consist of all debt securities. As of December 31, 2019, they were in a net unrealized gain position of $0.3 million. Unrealized gains and losses on available-for-sale debt securities are included as a component of comprehensive loss. As of December 31, 2019, the aggregate fair value of marketable securities held by the Company in an unrealized loss position was $17.9 million, which consisted of 17 securities. No securities have been in an unrealized loss position for more than 12 months. As of December 31, 2019 and 2018, the Company considered the decreases in market value on its marketable securities to be temporary in nature and did not consider any of the Company’s investments to be other-than-temporarily impaired. The Company’s marketable securities as of December 31, 2019 mature at various dates through November 2021. The fair values of marketable securities by contractual maturity consist of the following (in thousands): December 31, 2019 December 31, 2018 Maturities within one year $ 114,386 $ 89,965 Maturities after one year through three years 48,556 — $ 162,942 $ 89,965 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | NOTE 6-PROPERTY AND EQUIPMENT Property and equipment, consists of the following as of December 31, 2019 and 2018 (in thousands): December 31, 2019 2018 Laboratory equipment $ 259 $ 241 Computer equipment and software 416 271 Furniture 544 395 Leasehold improvements 530 561 Manufacturing equipment 226 227 1,975 1,695 Less: accumulated depreciation and amortization (998 ) (747 ) Property and equipment, net $ 977 $ 948 Depreciation and amortization expense was $0.3 million $0.4 million and $0.2 million for the years ended December 31, 2019, 2018 and 2017, respectively. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Leases | NOTE 7-LEASES In April 2016, UroGen Pharma Ltd. signed an addendum to its November 2014 lease agreement for the Company’s principal executive offices located in Israel, in order to increase the office space rented and to extend the rent period until September 2019, with an option to extend the lease for an additional period of three years. In 2019, the option was exercised, and the lease period was extended until September 2022. UroGen Pharma Inc. entered into a lease agreement for its office for a period of seven years commencing on May 1, 2016. As part of the agreement it provided the lessor with a letter of credit which renews on an annual basis. On December 1, 2018 it completed a full assignment and assumption of the lease to Allogene Therapeutics, Inc. The letter of credit was returned and there is no further liability to the Company as of December 31, 2018. In September 2017, UroGen Pharma Inc. entered into a new lease agreement for its New York headquarters. The lease agreement commenced in October 2017 and shall terminate in February 2021. The remaining contractual obligation is approximately $0.8 million. In April 2018, UroGen Pharma Inc. entered into a new lease agreement for an office in Los Angeles, CA. The lease commencement date was July 10, 2018 and terminates in March 2024. The contractual obligation for the remainder of the lease is $1.2 million. In November 2019, UroGen Pharma Inc. subleased its offices in Los Angeles, CA. The lease commencement date was January 1, 2020 and terminates in March 2024. The subtenants exercised their early access clause and moved into the premises the end of November 2019. The expected rental income over the lease term is approximately $1.2 million. The Company accounts for the sublease as on operating lease in accordance with ASC 842-10-25-2 and ASC 842-10-25-3. The main lease was considered for impairment and the amount was determined to be immaterial. Also, in November 2019, UroGen Pharma Inc. In addition, the Company has other operating office equipment and vehicle leases. The Company’s operating leases may require minimum rent payments, contingent rent payments adjusted periodically for inflation, or rent payments equal to the greater of a minimum rent or contingent rent. The Company’s leases do not contain any residual value guarantees or material restrictive covenants. The Company’s leases expire at various dates from 2021 through 2024, with varying renewal and termination options. The components of lease cost for the year ended December 31, 2019 were as follows (in thousands) Year Ended December 31, 2019 Operating lease cost $ 1,243 Sublease income (19 ) Variable lease cost 105 $ 1,329 The amounts recognized upon adoption and as of December 31, 2019 were as follows (in thousands): January 1, 2019 December 31, 2019 Right of use asset $ 3,022 $ 3,735 Long-term lease liability 2,429 2,604 Other current liabilities 929 1,585 As of December 31, 2019, no impairment losses have been recognized to date. Supplemental information related to leases for the periods reported is as follows (in thousands): Year Ended December 31, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases 1,192 Right-of-use assets obtained in exchange for new operating lease liabilities 1,741 Weighted-average remaining lease term of operating leases 2.91 years Weighted-average discount rate of operating leases 5.54% As of December 31, 2019, maturities of lease liabilities were as follows (in thousands): Operating Leases Years ending December 31, 2020 $ 1,758 2021 1,269 2022 1,101 2023 348 2024 and thereafter 58 Total future minimum lease payments $ 4,534 Less: Interest 345 Present value of lease liabilities $ 4,189 As of December 31, 2018, maturities of lease liabilities were as follows (in thousands): Operating Leases Years ending December 31, 2019 $ 1,136 2020 1,251 2021 676 2022 567 2023 301 2024 and thereafter 58 Total future minimum lease payments $ 3,989 Rent expense charged to operations was $1.2 million, $1.2 million, and $0.6 million for the years ended December 31, 2019, 2018 and 2017, respectively. |
License and Collaboration Agree
License and Collaboration Agreements | 12 Months Ended |
Dec. 31, 2019 | |
Liscense Agreement [Abstract] | |
License and Collaboration Agreements | NOTE 8- LICENSE AND COLLABORATION AGREEMENTS Allergan Agreement In October 2016, the Company entered into the Allergan Agreement with Allergan and granted Allergan an exclusive worldwide license to research, develop, manufacture and commercialize pharmaceutical products that contain RTGel and clostridial toxins (including BOTOX), alone or in combination with certain other active ingredients, referred to as the Licensed Products, which are approved for the treatment of adults with overactive bladder who cannot use or do not adequately respond to anticholinergics. Additionally, the Company granted Allergan a non-exclusive, worldwide license to use certain of our trademarks as required for Allergan to practice its exclusive license with respect to the Licensed Products. Under the Allergan Agreement, Allergan is solely responsible, at its expense, for developing the Licensed Products and obtaining all regulatory approvals for Licensed Products worldwide. Allergan is also solely responsible, at its expense, for commercializing the Licensed Products worldwide after receiving the regulatory approval to do so. Allergan is required to use commercially reasonable efforts to develop and commercialize the Licensed Products for overactive bladder in certain major market countries. The Company will supply Allergan with certain quantities of RTGel for development of Licensed Products through Phase 2 clinical trials using BOTOX together with RTGel in patients with overactive bladder, at Allergan’s request and expense. Allergan has the right to reduce the next milestone payment if there is a material supply failure from the Company . Prior to completion of the first Phase 2 clinical trial, Allergan has the right to request that the Company transfer s to Allergan our manufacturing process for RTGel and Allergan will assume the responsibility to manufacture RTGel and Licensed Product for its own development and commercialization activities. Allergan paid the Company a nonrefundable upfront license fee of $17.5 million upon signing the agreement, and, in the third quarter of 2017, the Company received an additional $7.5 million milestone payment upon the submission by Allergan of an IND to the FDA for a Licensed Product. In October 2017, Allergan began a Phase 2 study of RTGel in combination with BOTOX for the treatment of overactive bladder. Additionally, during the years ended December 31, 2018 and 2017 the Company recognized revenue of $1.1 million and $0.7 million related to RTGel that was supplied to Allergan, respectively. Further, the Company is eligible to receive additional material milestone payments of up to an aggregate of $200.0 million upon the successful completion of certain development, regulatory and commercial milestones, including $20.0 million upon initiation of a Phase 3 clinical trial for a Licensed Product for overactive bladder; $15.0 million upon initiation of a Phase 3 clinical trial for a Licensed Product for a specified second indication; $50.0 million and $25.0 million upon the first commercial sale of a Licensed Product for overactive bladder in the United States and the European Union, respectively; $25.0 million and $15.0 million upon the first commercial sale of a Licensed Product for a specified second indication in the United States and the European Union, respectively; and $50.0 million upon net sales of all Licensed Products of $500.0 million. Allergan will pay the Company a tiered royalty in the low single digits based on worldwide annual net sales of Licensed Products, subject to certain reductions for the market entry of competing products and/or loss of our patent coverage of Licensed Products. The Company is responsible for payments to any third party for certain RTGel-related third party intellectual properties. Under the Allergan Agreement, Allergan granted the Company a non-exclusive, sublicensable, fully paid-up, perpetual, worldwide license under any improvements Allergan makes to the composition, formulation, or manufacture of RTGel for the research, development, manufacture and commercialization of any product containing RTGel and any active ingredient (other than a clostridial toxin) for all indications other than indications covered by the agreement and an exclusive, sublicensable, royalty-bearing (in low single digits), perpetual worldwide license under such improvements for use in the prevention or treatment of oncology indications. Either party may terminate the Allergan Agreement for uncured material breach by the other party and for the insolvency of the other party. The Company may terminate the Allergan Agreement if Allergan or its affiliates challenges any of our patents licensed to Allergan and such patent challenge is not required under a court order or subpoena and is not a defense against a claim, action or proceeding asserted by the Company, its affiliates or licensees against Allergan, its affiliates or sublicensees. In addition, Allergan may unilaterally terminate the Allergan Agreement for any reason upon advance notice. If Allergan has the right to terminate the Allergan Agreement due to an uncured material breach by the Company, Allergan may elect to continue the agreement and reduce all future milestone and royalty payment obligations to the Company by a specified percentage. In the event of any termination of the Allergan Agreement, Allergan will assign or grant a right of reference to any regulatory documentation related to RTGel to the Company, all rights and licenses to Allergan will terminate, and the license Allergan granted to us under their improvements to RTGel will continue. Agenus Agreement On November 8, 2019, the Company entered into a license agreement with Agenus Inc, pursuant to which Agenus granted to the Company an exclusive, worldwide (not including Argentina, Brazil, Chile, Colombia, Peru, Venezuela and their respective territories and possessions), royalty-bearing, sublicensable license under Agenus’s intellectual property rights to develop, make, use, sell, import, and otherwise commercialize products incorporating a proprietary antibody of Agenus known as AGEN1884 for the treatment of cancers of the urinary tract via intravesical delivery. AGEN1884 is an anti-CTLA-4 antagonist that is currently being evaluated by Agenus as a monotherapy in PD-1 refractory patients and in combination with Agenus’ anti-PD-1 antibody in solid tumors. Initially, the Company plans to develop AGEN1884 in combination with UGN-201 for the treatment of high-grade non-muscle invasive bladder cancer. Pursuant to the license Agreement, the Company paid Agenus an upfront fee of $10.0 million and has agreed to pay Agenus up to $115.0 million upon achieving certain clinical development and regulatory milestones, up to $85.0 million upon achieving certain commercial milestones, and royalties on net sales of licensed products in the 14%-20% range. The Company will be responsible for all development and commercialization activities. Under the terms of the license agreement, Agenus has agreed to use commercially reasonable efforts to supply AGEN1884 to the Company for use in preclinical studies or clinical trials. Unless earlier terminated in accordance with the terms of the license agreement, the license agreement will expire on a product-by-product and country-by-country basis at the later of (a) the expiration of the last to expire valid claim of a licensed patent right that covers the licensed product in such country or (b) 15 years after the first commercial sale of the licensed product in such country. The Company may terminate the license agreement for convenience upon 180 days’ written notice to Agenus. Either party may terminate the license agreement upon 60 days’ notice to the other party if, prior to the first commercial sale of a licensed product, the Company substantially ceases to conduct development activities of the licensed products for nine consecutive months (and during such period, Agenus has complied with its obligations under the license agreement) other than in response to a requirement of an applicable regulatory authority or an event outside of the Company’s control. In addition, either party may terminate the license agreement in the event of an uncured material breach of the other party. The Company recorded the $10.0 million milestone in acquired in-process research and development expenses for the year ended December 31, 2019. Early-Stage Feasibility Evaluation with Janssen Research & Development, LLC On April 22, 2019, the Company entered into an agreement with Janssen to conduct an early-stage feasibility evaluation in a therapeutic area of mutual interest. The Company and Janssen will each conduct certain activities under the terms of the agreement, and the Company will incur the costs of its own efforts related to the feasibility evaluation. |
Employee Rights Upon Retirement
Employee Rights Upon Retirement | 12 Months Ended |
Dec. 31, 2019 | |
Employee Rights Upon Retirement [Abstract] | |
Employee Rights Upon Retirement | NOTE In Israel, the e The a g n i o c The n j i p |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Shareholders' Equity | NOTE 10-SHAREHOLDERS’ EQUITY Ordinary Shares The Company had 100.0 million ordinary shares authorized for issuance as of December d w a On April 19, 2017, the Company’s board of directors and shareholders approved an aggregate 3.2 for-1 share split of the Company’s ordinary, Preferred A and Preferred A-1 shares. The share split was effected on April 19, 2017 by the issuance of 2.2 ordinary shares for each outstanding ordinary, Preferred A and Preferred A-1 share held immediately prior to the share split. In May 2017, the Company completed an IPO on the Nasdaq Global Market, in which it issued 5,144,378 ordinary shares, at a public offering price of $13.00 per share, in consideration for $60.8 million, net of underwriting discounts and commissions and issuance costs, including exercise of the underwriters’ option to purchase additional 671,005 ordinary shares at the IPO price. Upon completion of the IPO, the Company converted all outstanding warrants for Preferred A-1 shares into 364,036 Preferred A-1 shares of the Company (see below). Subsequently, the Company converted all outstanding Preferred A and Preferred A-1 shares into ordinary shares at a ratio of 1:1. As of December 31, 2017, the Company’s share capital was composed entirely of ordinary shares. In January 2018, the Company completed an underwritten public offering of 1,682,926 of its ordinary shares, including 219,512 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $41.00 per share. The net proceeds to the Company from the public offering were approximately $64.2 million, after deducting the underwriting discounts and commissions and payment of other offering expenses. In January 2019, the Company completed an underwritten public offering of 4,207,317 of its ordinary shares, including 548,780 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $41.00 per share. The net proceeds to the Company from the offering were approximately $161.4 million, after deducting the underwriting discounts and commissions and payment of other offering expenses. In December 2019, the Company entered into a sales agreement pursuant to which the Company may from time to time offer and sell the Company’s ordinary shares having an aggregate offering price of up to $100.0 million. The shares are offered and will be sold pursuant to the Company’s shelf registration statement on Form S-3 which was declared effective by the SEC on January 2, 2020. No sales have occurred under this agreement as of the date of this filing. Warrants for Preferred A-1 Shares In 2014, as part of a share purchase agreement, the Company issued warrants (the “A-1 warrants”) for preferred shares. The warrants were exercisable for Series A-1 preferred shares, in consideration for cash representing the exercise price. The A-1 warrants were measured at fair value in every reporting period, and changes in their fair value were recognized in earnings within finance expenses, net. In connection with the completion of the IPO, the Company converted all outstanding warrants into 364,036 Preferred A-1 shares of the Company and subsequently converted all of its preferred shares, including the Preferred A-1 shares, into ordinary shares. The Company’s warrants outstanding prior to the IPO were exercisable for Series A-1 preferred shares at an exercise price of $7.81 per share. Prior to the IPO, such warrants were exercisable for 728,312 Preferred A-1 shares. Series A Preferred Shares In October 2015 the Company entered into an asset purchase agreement with Telormedix SA (“TMX”) pursuant to which the Company purchased all of the intellectual property assets of TMX (in process R&D) in consideration for 691,200 Series A preferred shares of the Company at a price per share of $5.94, which were subsequently converted into ordinary shares on the date of the IPO. The Company will issue additional shares upon the occurrence of each of three milestones as set in the agreement. The Company has deemed the probability of achieving these milestones to be remote. The acquired intellectual property costs totaling $4.1 million were expensed as incurred to research and development costs in accordance with ASC 730, as the intellectual property is purchased from others for a particular research and development project and has no alternative future uses and therefore no separate economic value. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-Based Compensation | NOTE 11-SHARE-BASED COMPENSATION In a The b d p l n e Certain management and professional level employees typically receive stock options and RSU grants upon commencement of employment. Eligible employees may also receive a grant of stock options or RSUs annually. Non-employee members of our Board of Directors and any new, future directors may receive a grant of RSUs and/or stock options annually. The term of any stock option granted under the Plan cannot exceed 10 years. Options shall not have an exercise price less than 100% of the fair market value of the Company’s ordinary shares on the grant date, and generally vest over a period of three years. If the individual possesses more than 10% of the combined voting power of all classes of stock of the Company, the exercise price shall not be less than 110% of the fair market value of a common share of stock on the date of grant. The Company’s RSU and stock option grants provide for accelerated or continued vesting in certain circumstances as defined in the plans and related grant agreements, including a termination in connection with a change in control. RSUs generally vest in a 33% increment upon the first anniversary of grant, and in equal quarterly amounts for the two years following the one-year anniversary of the grant date. Stock options generally vest in a 33% increment upon the first anniversary of the grant date, and in equal quarterly amounts for the three years following the one-year anniversary of the grant date. In March 2017, the Company’s Board of Directors adopted the 2017 Equity Incentive Plan ("2017 Plan"), which was approved by the shareholders in April 2017. The 2017 Plan provides for the grant of incentive stock options to the Company's employees and for the grant of nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance stock awards, performance cash awards, and other forms of stock awards to the Company's employees, directors and consultants. The maximum number of ordinary shares that may initially be issued under the 2017 Plan is 1,400,000. In addition, the number of ordinary shares reserved for issuance under the 2017 Plan will automatically increase on January 1st of each calendar year, from January 1, 2018 through January 1, 2026, so that the number of such shares reserved for issuance will equal 12% of the total number of ordinary shares outstanding on the last day of the calendar month prior to the date of each automatic increase, or a lesser number of shares determined by our board of directors. The maximum number of ordinary shares that may be issued upon the exercise of incentive stock options under the 2017 Plan is 5,600,000. On January 1, 2018, the share reserve increased by 250,167 to 1,650,167. On October 12, 2018, the Company filed a registration statement on Form S-8 increasing the amount of registered ordinary shares of the Company’s 2017 Plan by 1,900,000 to 3,550,167. In April 2017, the Company’s board of directors approved modifications of performance conditions for 67,200 restricted stock units and contingent options for executive management. The Company recorded an expense of $0.5 million under general and administrative expenses with respect to these modifications. In August 2018, in addition to the modifications, one senior executive was granted 10,466 RSUs in which no compensation expense was taken because the award vests upon a future performance condition that is not currently probable of occurring. During the year ended December 31, 2018, the Company recorded $7.2 million in general and administrative and research and development expenses in the Company’s Statements of Operations for the year ended December 31, 2018 related to the stock option modifications related to the termination of certain senior executives, based on the executive’s respective allocations. On January 2, 2019, the Company announced the resignation of its CEO, and the Company's board of directors approved a severance package, which included a combination of cash and modifications to grants of his related option awards in the amount of $3.4 million. The cash element followed the termination section in the CEO employment agreement, and the options element included acceleration to certain grants of his related option awards. The fair value of the modifications to these option awards was estimated at $2.8 million. The entire severance package was recorded in general and administrative and research and development expenses, based on salary allocations respectively, in the Company’s Statements of Operations for the year ended December 31, 2018. On January 3, 2019, the Company appointed Elizabeth Barrett as its President and Chief Executive Officer. In connection with Ms. Barrett’s employment, she was granted 277,432 options to purchase the Company’s ordinary shares, at an exercise price of $47.57, as well as 317,065 RSUs, with a combined fair value of $24.1 million. In May 2019, the Company adopted the UroGen Pharma Ltd. 2019 Inducement Plan (the “Inducement Plan”). Under the Inducement Plan, the Company is authorized to issue up to 900,000 ordinary shares pursuant to awards issued under the Inducement Plan. The only persons eligible to receive grants of Awards (as defined below) under the Inducement Plan are individuals who satisfy the standards for inducement grants under Nasdaq Marketplace Rule 5635(c)(4) or 5635(c)(3) and the related guidance under Nasdaq IM 5635-1, including individuals who were not previously an employee or director of the Company or are following a bona fide period of non-employment, in each case as an inducement material to such individual’s agreement to enter into employment with the Company. Under the Inducement Plan, an “Award” is a nonstatutory stock option, restricted stock unit or other right to receive ordinary shares pursuant to the Inducement Plan. In June 2019, as part of the Company’s Annual Meeting of Shareholders, the Company’s Board of Directors approved grants of 70,000 options to its non-employee directors. Each then current non-employee director, including the Chairman of the Board, received a grant of 10,000 options. Each option is exercisable into one ordinary share of the Company’s stock at an exercise price of $34.83 per share. The options vest quarterly over one year and expire 10 years from grant date. The grant date fair value of these options was approximately $1.9 million. In December 2019, the Company’s board of directors approved a modification of options and RSU's for a consultant. The Company recorded an expense of $0.9 million under general and administrative expenses with respect to options' modification. No Options : Set 19 a) During n b) During n c) During n The fair value of options granted during 2019, 2018 and 2017 was $27.6 million, $40.3 million and $10.9 million, respectively. The o c The e 2019 2018 2017 Value of ordinary shares $33.21-47.57 $38.64-59.23 $1.58-39.26 Dividend yield 0% 0% 0% Expected volatility 74.09%-80.52% 72.00%-82.04% 68.45%-76.32% Risk-free interest rate 1.36%-2.62% 1.72%-3.07% 1.38%-2.47% Expected term 5.8-10 years 0.2-10 years 3.9-10 years The on a mix of the Company's historical volatility and c e The employee and non-employee o b a Number of options Weighted Average price per share Outstanding as of January 1, 2017 2,389,899 $ 4.69 Granted 589,600 * $ 23.95 Canceled/Forfeited (45,186 ) $ 5.41 Exercised (690,281 ) $ 4.12 Outstanding as of December 31, 2017 2,244,032 $ 9.91 Granted 1,195,000 $ 47.19 Canceled/Forfeited (167,149 ) $ 35.37 Exercised (748,902 ) $ 8.99 Outstanding as of December 31, 2018 2,522,981 $ 26.16 Granted 955,732 $ 41.96 Canceled/Forfeited (183,725 ) $ 41.85 Exercised (423,653 ) $ 9.10 Outstanding as of December 31, 2019 2,871,335 $ 32.93 * Includes 9,600 ordinary shares issuable upon the vesting of options granted in 2016, which were contingent upon the closing of the IPO The intrinsic value of stock options exercised was $14.2 million, $31.6 million, and $21.4 for the years ended December 31, 2019, 2018, and 2017, respectively. The i 0 Options outstanding Options exercisable Exercise price per share Number of options outstanding at end of year Weighted average remaining contractual life Number of options exercisable at end of year Weighted average remaining contractual life $0.00 - 10.00 725,394 2.80 725,394 2.80 $10.01 - 20.00 75,000 7.39 63,333 7.40 $20.01 - 30.00 100,000 7.82 66,668 7.82 $30.01 - 40.00 433,500 7.78 208,331 6.33 $40.01 - 50.00 1,340,441 8.49 366,273 7.44 $50.01 - 59.23 197,000 7.94 145,000 7.80 2,871,335 1,574,999 The x The following table summarizes information about RSU activity as of December 31, 2019: Outstanding Restricted Stock Units Outstanding as of January 1, 2017 275,200 Granted 123,300 * Vested and released (121,940 ) Forfeited — Outstanding as of December 31, 2017 276,560 Granted 116,493 Vested and released (118,447 ) Forfeited (10,907 ) Outstanding as of December 31, 2018 263,699 Granted 455,465 Vested and released (183,975 ) Forfeited (15,762 ) Outstanding as of December 31, 2019 519,427 * Including 28,800 ordinary shares issuable upon the vesting of options granted in 2016, which were contingent upon the closing of the IPO The fair value of RSUs granted during 2019, 2018 and 2017 was $19.9 million, $5.7 million, and $3.3, respectively. The total unrecognized compensation cost of RSUs as of December 31, 2019 is $16.1 million with a weighted average recognition period of 2.04 years. The p Year ended December 31, 2019 2018 2017 Research and development expenses $ 8,291 $ 12,038 $ 3,923 General and administrative expenses 21,676 18,604 2,377 $ 29,967 $ 30,642 $ 6,300 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | NOTE 12-INCOME TAXES The Corporate tax rate Presented hereunder are the Israeli tax rates relevant to the Company: 2017 – 24% 2018 and thereafter– 23% Current taxes for the reported periods are calculated according to the tax rates presented above. Income Tax Regulations (Rules on Bookkeeping by Foreign Invested Companies and Certain Partnerships and Determination of their Taxable Income), 1986: As a "Controller Foreign Cooperation" (as defined in the Israeli Law for the Encouragement of Capital Investments-1959), the Company's management has elected to apply Income Tax Regulations (Rules for Maintaining Accounting Records of Foreign Invested Companies and Certain Partnerships and Determining Their Taxable Income) – 1986, from January 2018. Accordingly, its taxable income or loss is calculated in US Dollars. Law for the Encouragement of Industry (Taxation), 1969: The Company is an “Industrial Company” under the Law for the Encouragement of Industry (Taxation), 1969 and, therefore, is entitled to certain tax benefits, mainly as follows: • Amortization in three equal annual portions of issuance expenses when registering shares for trading as from the date the shares of the company were registered. • An 8-year period of amortization for acquired patents and know-how used in the process of development performed by the enterprise. Deferred income taxes: Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company and its subsidiary deferred tax assets are as follows: December 31, 2019 2018 2017 In respect of: Net operating loss carryforward $ 33,817 $ 16,943 $ 5,844 Deferred rent — 61 46 Research and development expenses 4,591 3,891 2,887 Stock-based compensation 6,543 4,769 897 Issuance costs 2,063 1,367 1,261 In-process research and development 2,749 629 761 Right of use asset (800 ) — — Lease Liability 896 — — Accrued expenses 762 598 5 Depreciation of fixed assets (90 ) (93 ) — Other 62 84 24 Less—valuation allowance (50,593 ) (28,249 ) (11,725 ) Net deferred tax assets $ — $ — $ — The change in valuation allowance for the years ended December 31, 2019, 2018 and 2017 were as follows: 2019 2018 2017 Balance at the beginning of the year $ (28,249 ) $ (11,725 ) $ (4,158 ) Changes during the year (22,344 ) (16,524 ) (7,567 ) Balance at the end of the year $ (50,593 ) $ (28,249 ) $ (11,725 ) The main reconciling item between the statutory tax rates of the Company and the effective rate is the share-based compensation and provision for full valuation allowance in respect of tax benefits from carryforward tax losses due to the uncertainty of the realization of such tax benefits. Regarding the Company’s U.S. operations, as of December 31, 2019, UroGen Pharma Inc. The Internal Revenue Code contains provisions that may limit our use of federal net operating loss carryforwards if significant changes occur in the constructive stock ownership of UroGen Pharma Inc Losses for tax purposes carried forward to future years As of December 31, 2019, and December 31, 2018, the Company had approximately $151.9 million and $72.1 million of net carryforward tax losses, respectively, available to reduce future taxable income without limitation of use. Tax assessments UroGen Pharma Ltd, has received final tax assessments up to and including its 2013 tax year. |
Related Parties
Related Parties | 12 Months Ended |
Dec. 31, 2019 | |
Related Party Transactions [Abstract] | |
Related Parties | NOTE 13-RELATED PARTIES UroGen Pharma Inc. 1 h d In April 2018, it terminated its lease for offices at 689 Fifth Avenue in New York, and on December 1, 2018, UroGen Pharma Inc. and Kite Pharma, Inc., completed a full assignment and assumption of the lease to Allogene Therapeutics, Inc. of which Arie Belldegrun, M.D., serves as the Chairman of the Board of Directors. UroGen Pharma Inc. There were no related party transactions for the year ended December 31, 2019. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | NOTE 14-COMMITMENTS AND CONTINGENCIES Grants (“ The n d The Company is committed to pay royalties to the Government of Israel on proceeds from sales of products in the research and development of which the IIA participates by way of grants. At the time the grants were received, successful development of the related projects was not assured. In the case of failure of a project that was partly financed as above, the Company is not obligated to pay any such royalties. Under the terms of the funding from the IIA, royalties of 3% to 5% are payable on sales of products developed from a project so funded, up to 100% of the amount of the grant received by the Company (dollar linked); with the addition of annual interest at a rate based on 12-month LIBOR. The Company is subject to several conditions, including restrictions on its intellectual property. As n i |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | NOTE 15-SUBSEQUENT EVENTS On January 2, 2020, the Company’s shelf registration statement on Form S-3 was declared effective by the SEC. As a result, the Company is permitted pursuant to its December 2019 sales agreement with Cowen and Company, LLC to offer and sell ordinary shares of stock having an aggregate offering price of up to $100.0 million pursuant to such agreement. On January 12, 2020, the IIA Office of Chief Scientist approved the company's request to unwind its obligation to the IIA regarding grants that were loaned to the company between January 2004 and September 2016. The Company has previously reported that the repayment of these grants could be up to three-times of the original grants and other amounts. Under the approval from the IIA, the Company will be required to: 1. Make a one-time payment in 2020, for up to three-times the grants provided (linked to Plan No. 33889) plus annual interest, net of a deduction for the royalties already paid in accordance with Appendix B of the Section 18(F) to Instructions for Benefit Track No. 1 - R&D Fund ("Benefit Track"). 2. Make a commitment to continue employment of at least 75% of its base R&D jobs in Israel (at the time of settlement) for a period of at least 3 years, in accordance with Appendix B of the Benefit Track. The total payment under the IIA approval, net of the royalties already paid, amounts to $6.6 million plus any additional accrued interest since January 2020. The Company will pay this amount in the first quarter of 2020. Subject to payment to the IIA to unwind the Company’s obligation, the company will have full freedom to transfer IIA-funded technology or manufacture products developed with IIA-funded technology outside of the State of Israel. Other than the commitment to continue employment, all other obligations with the IIA will also cease to exist as per the current agreement. |
Selected Quarterly Financial Da
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data (Unaudited) | NOTE 16-SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) The following financial information reflects all normal recurring adjustments, which are, in the opinion of management, necessary for a fair statement of the results of the interim periods. Summarized quarterly data for 2019 and 2018 are as follows (in thousands, except per share data): 2019 First Quarter Second Quarter Third Quarter Fourth Quarter Total Total revenues $ — $ 18 $ — $ — $ 18 Total operating expenses $ 22,433 $ 23,771 $ 23,453 $ 39,839 $ 109,496 Loss from operations $ (22,433 ) $ (23,753 ) $ (23,453 ) $ (39,839 ) $ (109,478 ) Net loss attributable to common shareholders $ (21,444 ) $ (22,477 ) $ (22,252 ) $ (38,973 ) $ (105,146 ) Net loss per share attributable to common shareholders - basic and diluted $ (1.11 ) $ (1.08 ) $ (1.06 ) $ (1.86 ) $ (5.12 ) 2018 First Quarter Second Quarter Third Quarter Fourth Quarter Total Total revenues $ 481 $ 364 $ 283 $ — $ 1,128 Total operating expenses $ 13,691 $ 18,480 $ 20,317 $ 24,017 $ 76,505 Loss from operations $ (13,640 ) $ (18,434 ) $ (21,089 ) $ (24,017 ) $ (77,180 ) Net loss attributable to common shareholders $ (13,382 ) $ (18,026 ) $ (20,533 ) $ (23,716 ) $ (75,657 ) Net loss per share attributable to common shareholders - basic and diluted $ (0.88 ) $ (1.14 ) $ (1.28 ) $ (1.46 ) $ (4.80 ) Net loss per share is computed independently for each of the quarters presented in the tables above. Therefore, the sum of the quarterly per-share calculations will not equal the annual per share calculation. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The Company ’ |
Use of Estimates | Use of Estimates The a i i n a i |
Functional Currency | Functional Currency The U.S. dollar (“Dollar”) is the currency of the primary economic environment in which the operations of the Company and subsidiary are conducted. Therefore, the functional currency of the Company is the Dollar. Accordingly, transactions in currencies other than the Do l lar are measured and recorded in the functional currency usi n g the exchange rate in effect at the date of the transaction. At the balance sheet date, monetary assets and liab i lities that are denominated in currencies other than the Dollar are measured using the official exch a nge rate at the balance sheet date. The effects of foreign currency re-measurements are recorded in the consolidated statements of operations as “ I nterest and other ( income ) expenses , net .” |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents consist primarily of money market funds and bank money market accounts and are stated at cost, which approximates fair value. |
Marketable Securities | Marketable Securities The Company classifies its marketable securities as available-for-sale in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 320, “Investments — Debt Securities”. Available-for-sale debt securities are carried at fair value with unrealized gains and losses reported in other comprehensive income/loss within shareholders’ equity. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in interest and other income (expense), net. The cost of securities sold is based on the specific-identification method. The Company reviews its available-for-sale securities for other-than-temporary declines in fair value below its cost basis each quarter and whenever events or changes in circumstances indicate that the cost basis of an asset may not be recoverable. This evaluation is based on a number |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist primarily of cash and cash equivalents and marketable securities. The primary objectives for the Company ’ The Company ’ |
Income Taxes | Income Taxes The Company provides for income taxes based on pretax income, if any, and applicable tax rates available in the various jurisdictions in which we operate. Deferred l e n s a a The n l w a |
Property and Equipment | Property and Equipment Property and equipment is recorded at historical cost, net of accumulated depreciation, amortization and, if applicable, impairment charges. We review our property and equipment assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Annual % Computers and software 33 Laboratory equipment 15-30 Furniture 6-15 Manufacturing equipment 50 Leasehold improvements are amortized on a straight-line basis over the shorter of their estimated useful lives or lease terms. See Note 6 for further discussion regarding property and equipment. |
Leases | Leases The Company is a lessee in several noncancelable operating leases, primarily for office space, office equipment and vehicles. The Company currently has no finance leases. Commencing January 1, 2019, the Company accounts for leases in accordance with ASC Topic 842, “Leases” . Lease expense is recognized on a straight-line basis for operating leases. Variable lease payments associated with the Company’s leases are recognized when the event, activity, or circumstance in the lease agreement on which those payments are assessed occurs. Variable lease payments are presented as operating expense on the consolidated statements of operations in the same line item as expense arising from fixed lease payments. The Company’s lease terms may include options of the Company as the lessee to extend the lease. The lease extensions are included in the measurement of the right of use asset and lease liability if it is reasonably certain that it will exercise that option. Because the Company’s leases do not provide an implicit rate of return, an incremental borrowing rate is used based on the information available at the commencement date in determining the present value of lease payments on an individual lease basis. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. The Company has lease agreements with lease and non-lease components and has elected the practical expedient to combine lease and non-lease components for all underlying classes of assets. We applied the modified retrospective transition method and elected the transition option to use the effective date of January 1, 2019 as the date of initial application (“Transition Date”). Consequently, the disclosures required under Topic 842 are not provided for dates and periods before January 1, 2019. Topic 842 provides for a number of optional practical expedients in transition. The Company elected the ‘package of practical expedients’, which permits not to reassess under Topic 842 its prior conclusions about lease identification, lease classification, and initial direct costs. The Company did not elect the use-of-hindsight or the practical expedient pertaining to land easements; the latter not being applicable to the Company. Topic 842 had a material impact on our consolidated balance sheets but did not have an impact on our consolidated statements of operations. The most significant impact was the recognition of $3.7 million in ROU assets and $4.2 million in lease liabilities. ROU assets for operating leases are periodically reviewed for impairment losses under ASC 360-10, “Property, Plant, and Equipment”, to determine whether a ROU asset is impaired, and if so, the amount of the impairment loss to recognize. |
Accounts Payable and Accrued Expenses | Accounts Payable and Accrued Expenses Accrued expenses and other current liabilities consist of the following as of December 31, 2019 and 2018, respectively (in thousands): December 31, 2019 December 31, 2018 Accounts payable $ 4,694 $ 4,272 Accrued clinical expenses 399 673 Accrued research and development costs 2,644 780 Accrued general and administrative expenses 2,767 1,029 Accrued other expense 682 1,786 Total accrued expenses and other current liabilities $ 11,186 $ 8,540 |
Revenues | Revenues The Company derives virtually all of its revenues from its license and supply agreement with Allergan. Under the agreement, the Company grants Allergan an exclusive license to develop, commercialize, and otherwise exploit products that contain RTGel and agrees to supply Allergan with pre-clinical and clinical quantities of the RTGel product, also referred to as the RTGel The Company determined that Allergan is its customer and the license and supply agreements are in scope of ASC 606, which was adopted as of January 1, 2018. The Company adopted ASC 606 under the modified retrospective method, which did not have a material impact on the Consolidated Statements of Operations. Previously, the Company analyzed revenues under ASC 605, which states that revenue w o i Under ASC 606, in determining the appropriate amount of revenue to be recognized as it fulfills its obligations under the agreements with Allergan, the Company performs the following steps: 1) Identification of the contract; 2) Determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; 3) Measurement of the transaction price, including the constraint on variable consideration; 4) Allocation of the transaction price to the performance obligations; 5) Recognition of revenue when or as the Company satisfies each performance obligation. In 1) The customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (that is, the good or service is capable of being distinct); and 2) The entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the contract). The license agreement contains two performance obligations: (a) the license component and (b) Allergan’s right to require supply services of RTGel vials from the Company. The l p Allocating the C onsideration in the A rrangement Since the license to the Company’s intellectual property was determined to be functional and distinct from the other performance obligations identified in the arrangement, the Company recognized revenues from non-refundable, up-front fees allocated to the license when the license was transferred to Allergan and Allergan was able to use and benefit from the license. During the year ended December 31, 2016, the Company received A b e l c Development and Regulatory Milestone Payments At the inception of an arrangement that includes development milestone payments, the Company evaluates whether the development milestones are considered probable of being reached and estimates 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 development milestone value is included in the transaction price. Development milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The milestones are allocated entirely to the license performance obligation, as (1) the terms of milestone and royalty payments relate specifically to the license and (2) allocating milestones and royalties to the license performance obligation is consistent with the overall allocation objective, because management’s estimate of the supply fee approximates the standalone selling price for RTGel vials and management’s estimate of milestones and royalties approximates the standalone selling price of the license. During the year ended December 31, 2017, the Company recognized revenue of $7.5 million related to a development milestone payment resulting from Allergan’s submission of an IND application for the Company’s RTGel in combination with Allergan’s BOTOX for the treatment of overactive bladder to the U.S. FDA. Royalties Based on Allergan’s Revenue The Company is also n Supply of RTGel to Allergan The Company recognizes revenue related to supply of RTGel at a point in time, upon delivery to Allergan. During the years ended December 31, 2019, 2018 and 2017, the Company recognized $18,000, $1.1 million and $0.7 million of revenue related to RTGel vials supplied to Allergan, respectively. Shipping and handling costs associated with supply of RTGel vials are accounted for as a fulfillment cost and are in included in cost of revenues. |
General and Administrative Expenses | General and Administrative Expenses General and administrative expenses consist primarily of personnel costs (including share-based compensation related to directors, executives, finance, commercial, medical affairs, business development, investor relations and human resources functions). Other significant costs include commercial, medical affairs, external professional service costs, facility costs, accounting and audit services, legal services and other consulting fees. General and administrative costs are expensed as incurred, and the Company accrues for services provided by third parties related to the above expenses by monitoring the status of services provided and receiving estimates from its service providers and adjusting its accruals as actual costs become known. |
Research and Development | Research and Development Research s i d a l l License fees and development milestone payments related to in-licensed products and technology are expensed as in-process research and development if it is determined at that point that they have no established alternative future use. On November 8, 2019, the Company entered into a license agreement with Agenus Inc. pursuant to which Agenus granted to the Company an exclusive, worldwide (not including Argentina, Brazil, Chile, Colombia, Peru, Venezuela and their respective territories and possessions), royalty-bearing, sublicensable license under Agenus’s intellectual property rights to develop, make, use, sell, import, and otherwise commercialize products incorporating a proprietary antibody of Agenus known as AGEN1884 for the treatment of cancers of the urinary tract via intravesical delivery. AGEN1884 is an anti-CTLA-4 antagonist that is currently being evaluated by Agenus as a monotherapy in PD-1 refractory patients and in combination with Agenus’ anti-PD-1 antibody in solid tumors. Initially, the Company plans to develop AGEN1884 in combination with UGN-201 for the treatment of high-grade non-muscle invasive bladder cancer. Pursuant to the license agreement, the Company paid Agenus an upfront fee of $10.0 million and has agreed to pay Agenus up to $115.0 million upon achieving certain clinical development and regulatory milestones, up to $85.0 million upon achieving certain commercial milestones, and royalties on net sales of licensed products in the 14% to 20% range. The Company will be responsible for all development and commercialization activities. Under the terms of the license agreement, Agenus has agreed to use commercially reasonable efforts to supply AGEN1884 to the Company for use in preclinical studies or clinical trials. No inventory was purchased on the effective date and subsequent purchases of pre-clinical and clinical supplies are at arm’s length and are priced at cost plus mark-up. The Company’s acquired right to Agenus’s intellectual property represents a single identifiable asset sourced from the license agreement. Therefore, all the fair value associated with the license agreement is concentrated in one identifiable asset and is not considered a business in accordance with ASC 805-10-55-5A. Therefore, the Company has accounted for the right to Agenus’s intellectual property acquired under the license agreement as an acquisition of an asset. |
Share-Based Compensation | Share-Based Compensation Share-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as expense over the required service period, which is equal to the vesting period. The fair value of stock options is determined using the Black-Scholes option-pricing model. The fair value of a restricted stock unit equaled the closing price of our ordinary shares on the grant date.The The s n g As of December 31, 2018, the Company adopted ASU 2018-07, Compensation-Stock Compensation, which establishes that the measurement of equity-classified nonemployee awards will be fixed at the grant date. The adoption of ASU 2018-07 did not have an impact on the condensed consolidated statements of operations. |
Interest and Other (Income) Expense, net | Interest and Other (Income) Expense, net Interest and Other (Income) Expense, net, consisted of the following as of December 31, 2019 and 2018 (in thousands): Year Ended December 31, 2019 2018 2017 Changes in fair value of warrants for preferred shares $ — $ — $ 168 Interest income on cash, cash equivalents and marketable securities (4,616 ) (1,872 ) (125 ) Realized loss on sale of short-term investment — 100 — Other expense (income) 284 124 (12 ) Total interest and other (income) expenses $ (4,332 ) $ (1,648 ) $ 31 |
Net Loss per Common Share | Net Loss per Common Share Basic net loss per share is computed by dividing the net loss attributable to common shareholders by the weighted-average number of common shares outstanding. Diluted net loss per share is computed similarly to basic net loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. In addition, the net loss attributable to common shareholders is adjusted for Series A and A-1 Preferred Stock dividends for the periods in which Series A and A-1 Preferred Stock is outstanding. For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted loss per share as their effect is anti-dilutive. The following table summarizes the calculation of basic and diluted loss per common share for the periods presented (in thousands, except share and per share amounts): Year Ended December 31, 2019 2018 2017 Basic and diluted: Loss attributable to equity holders of the Company $ 105,146 $ 75,657 $ 20,000 Dividend accumulated for preferred shares during the period $ — $ — $ 825 Loss attributable to equity holders of the Company, after deducting dividend accumulated for preferred shares $ 105,146 $ 75,657 $ 20,825 Weighted-average number of ordinary shares 20,528,727 15,754,193 9,716,790 Loss per ordinary share $ 5.12 $ 4.80 $ 2.14 |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In June 2016, the Financial Accounting Standards Board, or Accounting Standards Update, or Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments, Recently Adopted Accounting Pronouncements In February 2016, FASB issued ASU No. 2016-02, “Leases”, or Topic 842. Topic 842 supersedes existing guidance in Leases (“Topic 840”). Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; and ASU No. 2018-11, Targeted Improvements. Topic 842 requires lessees to recognize right-of-use, or ROU, assets and lease liabilities on the balance sheet for leases with lease terms greater than twelve months, including those classified as operating leases. Leases are classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the income statement. The lease liability is measured at the present value of the unpaid lease payments and the ROU assets are derived from the calculation of the lease liability. Lease payments will include fixed and in-substance fixed payments, variable payments based on an index or rate, exercise price of purchase options that are reasonably certain to be exercised, termination penalties, and probable amounts the lessee will owe under a residual value guarantee. Topic 842 also requires lessees to disclose key information about leasing arrangements. Lessor accounting will remain largely unchanged. The Company applied the modified retrospective transition method and elected the transition option to use the effective date of January 1, 2019 as the date of initial application, or Transition Date. Consequently, financial information was not updated, and the disclosures required under the Topic 842 were not provided for dates and periods before January 1, 2019. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Annual Rates of Depreciation | Annual % Computers and software 33 Laboratory equipment 15-30 Furniture 6-15 Manufacturing equipment 50 |
Schedule of Accrued Expenses And Other Current Liabilities | Accrued expenses and other current liabilities consist of the following as of December 31, 2019 and 2018, respectively (in thousands): December 31, 2019 December 31, 2018 Accounts payable $ 4,694 $ 4,272 Accrued clinical expenses 399 673 Accrued research and development costs 2,644 780 Accrued general and administrative expenses 2,767 1,029 Accrued other expense 682 1,786 Total accrued expenses and other current liabilities $ 11,186 $ 8,540 |
Schedule of Interest and Other (Income) Expense, net | Interest and Other (Income) Expense, net, consisted of the following as of December 31, 2019 and 2018 (in thousands): Year Ended December 31, 2019 2018 2017 Changes in fair value of warrants for preferred shares $ — $ — $ 168 Interest income on cash, cash equivalents and marketable securities (4,616 ) (1,872 ) (125 ) Realized loss on sale of short-term investment — 100 — Other expense (income) 284 124 (12 ) Total interest and other (income) expenses $ (4,332 ) $ (1,648 ) $ 31 |
Schedule of Calculation of Basic and Diluted Loss Per Share | The following table summarizes the calculation of basic and diluted loss per common share for the periods presented (in thousands, except share and per share amounts): Year Ended December 31, 2019 2018 2017 Basic and diluted: Loss attributable to equity holders of the Company $ 105,146 $ 75,657 $ 20,000 Dividend accumulated for preferred shares during the period $ — $ — $ 825 Loss attributable to equity holders of the Company, after deducting dividend accumulated for preferred shares $ 105,146 $ 75,657 $ 20,825 Weighted-average number of ordinary shares 20,528,727 15,754,193 9,716,790 Loss per ordinary share $ 5.12 $ 4.80 $ 2.14 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis | Assets and liabilities measured at fair value on a recurring basis based on Level 1, Level 2, and Level 3 fair value measurement criteria as of December 31, 2019 are as follows (in thousands): Fair Value Measurements Using Quoted Prices Significant in Active Other Significant Balance as of Markets for Observable Unobservable December 31, Identical Assets Inputs Inputs 2019 (Level 1) (Level 2) (Level 3) Marketable securities: US government $ 66,094 $ 66,094 $ — $ — Corporate bonds 68,084 — 68,084 — Commercial paper 7,658 — 7,658 — Money market funds (1) 16,998 16,998 — — Certification of deposit 4,108 — 4,108 — $ 162,942 $ 83,092 $ 79,850 $ — (1) Included within cash and cash equivalents on the Company s consolidated balance sheets. Assets and liabilities measured at fair value on a recurring basis based on Level 1, Level 2, and Level 3 fair value measurement criteria as of December 31, 2018 are as follows (in thousands): Fair Value Measurements Using Quoted Prices Significant in Active Other Significant Balance as of Markets for Observable Unobservable December 31, Identical Assets Inputs Inputs 2018 (Level 1) (Level 2) (Level 3) Assets: Money market funds (1) $ 89,965 $ 89,965 $ — $ — (1) Included within cash and cash equivalents on the Company s consolidated balance sheets. |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Investments Debt And Equity Securities [Abstract] | |
Summary of Marketable Securities | The following table summarizes the Company’s marketable securities as of December 31, 2019 (in thousands): Amortized Cost Basis Unrealized Gains Unrealized Losses Fair Value Marketable securities: US government $ 65,947 $ 147 $ — $ 66,094 Corporate bonds 67,957 131 (4 ) 68,084 Commercial paper 7,658 — — 7,658 Money market funds (1) 16,998 — — 16,998 Certificates of deposit 4,106 2 — 4,108 $ 162,666 $ 280 $ (4 ) $ 162,942 (1) Included within cash and cash equivalents on the Company s consolidated balance sheets. |
Summary of Fair Values of Marketable Securities by Contractual Maturity | The fair values of marketable securities by contractual maturity consist of the following (in thousands): December 31, 2019 December 31, 2018 Maturities within one year $ 114,386 $ 89,965 Maturities after one year through three years 48,556 — $ 162,942 $ 89,965 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment, consists of the following as of December 31, 2019 and 2018 (in thousands): December 31, 2019 2018 Laboratory equipment $ 259 $ 241 Computer equipment and software 416 271 Furniture 544 395 Leasehold improvements 530 561 Manufacturing equipment 226 227 1,975 1,695 Less: accumulated depreciation and amortization (998 ) (747 ) Property and equipment, net $ 977 $ 948 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Components of Lease Cost | The components of lease cost for the year ended December 31, 2019 were as follows (in thousands) Year Ended December 31, 2019 Operating lease cost $ 1,243 Sublease income (19 ) Variable lease cost 105 $ 1,329 |
Schedule of Amounts Recognized Upon Adoption | The amounts recognized upon adoption and as of December 31, 2019 were as follows (in thousands): January 1, 2019 December 31, 2019 Right of use asset $ 3,022 $ 3,735 Long-term lease liability 2,429 2,604 Other current liabilities 929 1,585 |
Schedule of Supplemental Information Related to Leases | Supplemental information related to leases for the periods reported is as follows (in thousands): Year Ended December 31, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases 1,192 Right-of-use assets obtained in exchange for new operating lease liabilities 1,741 Weighted-average remaining lease term of operating leases 2.91 years Weighted-average discount rate of operating leases 5.54% |
Schedule of Maturities of Lease Liabilities | As of December 31, 2019, maturities of lease liabilities were as follows (in thousands): Operating Leases Years ending December 31, 2020 $ 1,758 2021 1,269 2022 1,101 2023 348 2024 and thereafter 58 Total future minimum lease payments $ 4,534 Less: Interest 345 Present value of lease liabilities $ 4,189 |
Schedule of Maturities of Lease Liabilities | As of December 31, 2018, maturities of lease liabilities were as follows (in thousands): Operating Leases Years ending December 31, 2019 $ 1,136 2020 1,251 2021 676 2022 567 2023 301 2024 and thereafter 58 Total future minimum lease payments $ 3,989 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Schedule of Fair Value of Options Granted | The e 2019 2018 2017 Value of ordinary shares $33.21-47.57 $38.64-59.23 $1.58-39.26 Dividend yield 0% 0% 0% Expected volatility 74.09%-80.52% 72.00%-82.04% 68.45%-76.32% Risk-free interest rate 1.36%-2.62% 1.72%-3.07% 1.38%-2.47% Expected term 5.8-10 years 0.2-10 years 3.9-10 years |
Summary of Number of Employee and Non-employee Options Outstanding Under the Plan | The employee and non-employee o b a Number of options Weighted Average price per share Outstanding as of January 1, 2017 2,389,899 $ 4.69 Granted 589,600 * $ 23.95 Canceled/Forfeited (45,186 ) $ 5.41 Exercised (690,281 ) $ 4.12 Outstanding as of December 31, 2017 2,244,032 $ 9.91 Granted 1,195,000 $ 47.19 Canceled/Forfeited (167,149 ) $ 35.37 Exercised (748,902 ) $ 8.99 Outstanding as of December 31, 2018 2,522,981 $ 26.16 Granted 955,732 $ 41.96 Canceled/Forfeited (183,725 ) $ 41.85 Exercised (423,653 ) $ 9.10 Outstanding as of December 31, 2019 2,871,335 $ 32.93 * Includes 9,600 ordinary shares issuable upon the vesting of options granted in 2016, which were contingent upon the closing of the IPO |
Summary of Number of Options Outstanding and Exercisable | The i 0 Options outstanding Options exercisable Exercise price per share Number of options outstanding at end of year Weighted average remaining contractual life Number of options exercisable at end of year Weighted average remaining contractual life $0.00 - 10.00 725,394 2.80 725,394 2.80 $10.01 - 20.00 75,000 7.39 63,333 7.40 $20.01 - 30.00 100,000 7.82 66,668 7.82 $30.01 - 40.00 433,500 7.78 208,331 6.33 $40.01 - 50.00 1,340,441 8.49 366,273 7.44 $50.01 - 59.23 197,000 7.94 145,000 7.80 2,871,335 1,574,999 |
Summary of Information about RSU Activity | The following table summarizes information about RSU activity as of December 31, 2019: Outstanding Restricted Stock Units Outstanding as of January 1, 2017 275,200 Granted 123,300 * Vested and released (121,940 ) Forfeited — Outstanding as of December 31, 2017 276,560 Granted 116,493 Vested and released (118,447 ) Forfeited (10,907 ) Outstanding as of December 31, 2018 263,699 Granted 455,465 Vested and released (183,975 ) Forfeited (15,762 ) Outstanding as of December 31, 2019 519,427 * Including 28,800 ordinary shares issuable upon the vesting of options granted in 2016, which were contingent upon the closing of the IPO |
Schedule of Effect of Share-Based Compensation on Statements of Operations | The p Year ended December 31, 2019 2018 2017 Research and development expenses $ 8,291 $ 12,038 $ 3,923 General and administrative expenses 21,676 18,604 2,377 $ 29,967 $ 30,642 $ 6,300 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Schedule of Deferred Income Taxes | Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company and its subsidiary deferred tax assets are as follows: December 31, 2019 2018 2017 In respect of: Net operating loss carryforward $ 33,817 $ 16,943 $ 5,844 Deferred rent — 61 46 Research and development expenses 4,591 3,891 2,887 Stock-based compensation 6,543 4,769 897 Issuance costs 2,063 1,367 1,261 In-process research and development 2,749 629 761 Right of use asset (800 ) — — Lease Liability 896 — — Accrued expenses 762 598 5 Depreciation of fixed assets (90 ) (93 ) — Other 62 84 24 Less—valuation allowance (50,593 ) (28,249 ) (11,725 ) Net deferred tax assets $ — $ — $ — |
Schedule of Change in Valuation Allowance | The change in valuation allowance for the years ended December 31, 2019, 2018 and 2017 were as follows: 2019 2018 2017 Balance at the beginning of the year $ (28,249 ) $ (11,725 ) $ (4,158 ) Changes during the year (22,344 ) (16,524 ) (7,567 ) Balance at the end of the year $ (50,593 ) $ (28,249 ) $ (11,725 ) |
Selected Quarterly Financial _2
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summarized Quarterly Data | The following financial information reflects all normal recurring adjustments, which are, in the opinion of management, necessary for a fair statement of the results of the interim periods. Summarized quarterly data for 2019 and 2018 are as follows (in thousands, except per share data): 2019 First Quarter Second Quarter Third Quarter Fourth Quarter Total Total revenues $ — $ 18 $ — $ — $ 18 Total operating expenses $ 22,433 $ 23,771 $ 23,453 $ 39,839 $ 109,496 Loss from operations $ (22,433 ) $ (23,753 ) $ (23,453 ) $ (39,839 ) $ (109,478 ) Net loss attributable to common shareholders $ (21,444 ) $ (22,477 ) $ (22,252 ) $ (38,973 ) $ (105,146 ) Net loss per share attributable to common shareholders - basic and diluted $ (1.11 ) $ (1.08 ) $ (1.06 ) $ (1.86 ) $ (5.12 ) 2018 First Quarter Second Quarter Third Quarter Fourth Quarter Total Total revenues $ 481 $ 364 $ 283 $ — $ 1,128 Total operating expenses $ 13,691 $ 18,480 $ 20,317 $ 24,017 $ 76,505 Loss from operations $ (13,640 ) $ (18,434 ) $ (21,089 ) $ (24,017 ) $ (77,180 ) Net loss attributable to common shareholders $ (13,382 ) $ (18,026 ) $ (20,533 ) $ (23,716 ) $ (75,657 ) Net loss per share attributable to common shareholders - basic and diluted $ (0.88 ) $ (1.14 ) $ (1.28 ) $ (1.46 ) $ (4.80 ) |
Business and Nature of Operat_2
Business and Nature of Operations - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Date of incorporation | 2004-04 |
Date of operating commencement | 2016-02 |
Basis of Presentation and Man_2
Basis of Presentation and Management Plans - Addititonal Information (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ||
Accumulated deficit | $ 228,017 | $ 122,871 |
Significant Accounting Polici_4
Significant Accounting Policies - Schedule of Annual Rates of Depreciation (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Computers and Software | |
Property Plant And Equipment [Line Items] | |
Property and equipment, annual rates of depreciation | 33.00% |
Laboratory Equipment | Minimum | |
Property Plant And Equipment [Line Items] | |
Property and equipment, annual rates of depreciation | 15.00% |
Laboratory Equipment | Maximum | |
Property Plant And Equipment [Line Items] | |
Property and equipment, annual rates of depreciation | 30.00% |
Furniture | Minimum | |
Property Plant And Equipment [Line Items] | |
Property and equipment, annual rates of depreciation | 6.00% |
Furniture | Maximum | |
Property Plant And Equipment [Line Items] | |
Property and equipment, annual rates of depreciation | 15.00% |
Manufacturing Equipment | |
Property Plant And Equipment [Line Items] | |
Property and equipment, annual rates of depreciation | 50.00% |
Significant Accounting Polici_5
Significant Accounting Policies - Additional Information (Details) | Nov. 08, 2019USD ($) | Oct. 07, 2016USD ($) | Jun. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Sep. 30, 2017USD ($) | Dec. 31, 2019USD ($)Obligation | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Jan. 01, 2019USD ($) |
Summary Of Significant Accounting Policy [Line Items] | ||||||||||||
Operating lease Right-of-Use assets | $ 3,735,000 | $ 3,022,000 | ||||||||||
Operating lease liabilities | $ 4,189,000 | |||||||||||
Number of performance obligation | Obligation | 2 | |||||||||||
Upfront fee allocated to license component | $ 17,500,000 | |||||||||||
Revenues | $ 18,000 | $ 283,000 | $ 364,000 | $ 481,000 | 18,000 | $ 1,128,000 | $ 8,158,000 | |||||
Agenus Agreement | ||||||||||||
Summary Of Significant Accounting Policy [Line Items] | ||||||||||||
Upfront fee | $ 10,000,000 | |||||||||||
Maximum amount payable upon achieving certain clinical development and regulatory milestones | 115,000,000 | |||||||||||
Maximum amount payable upon achieving certain commercial milestones | $ 85,000,000 | |||||||||||
Agenus Agreement | Minimum | ||||||||||||
Summary Of Significant Accounting Policy [Line Items] | ||||||||||||
Royalty ranging on net sales of licensed products | 14.00% | |||||||||||
Agenus Agreement | Maximum | ||||||||||||
Summary Of Significant Accounting Policy [Line Items] | ||||||||||||
Royalty ranging on net sales of licensed products | 20.00% | |||||||||||
Allergan | ||||||||||||
Summary Of Significant Accounting Policy [Line Items] | ||||||||||||
Consideration received for license and future supply services | $ 17,500,000 | $ 17,500,000 | ||||||||||
Milestone payment for licensing agreement | $ 7,500,000 | 7,500,000 | ||||||||||
Revenues | $ 18,000 | $ 1,100,000 | $ 700,000 | |||||||||
Type Of Revenue Extensible List | urgn:RTGelMember | urgn:RTGelMember | urgn:RTGelMember | |||||||||
Accounting Standards Update 2016-02 | ||||||||||||
Summary Of Significant Accounting Policy [Line Items] | ||||||||||||
Operating lease Right-of-Use assets | 3,700,000 | |||||||||||
Operating lease liabilities | $ 4,200,000 |
Significant Accounting Polici_6
Significant Accounting Policies - Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | ||
Accounts payable | $ 4,694 | $ 4,272 |
Accrued clinical expenses | 399 | 673 |
Accrued research and development costs | 2,644 | 780 |
Accrued general and administrative expenses | 2,767 | 1,029 |
Accrued other expense | 682 | 1,786 |
Total accrued expenses and other current liabilities | $ 11,186 | $ 8,540 |
Significant Accounting Polici_7
Significant Accounting Policies - Schedule of Interest and Other (Income) Expense, net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Accounting Policies [Abstract] | |||
Changes in fair value of warrants for preferred shares | $ 168 | ||
Interest income on cash, cash equivalents and marketable securities | $ (4,616) | $ (1,872) | (125) |
Realized loss on sale of short-term investment | 100 | ||
Other expense (income) | 284 | 124 | (12) |
Total interest and other (income) expenses | $ (4,332) | $ (1,648) | $ 31 |
Significant Accounting Polici_8
Significant Accounting Policies - Schedule of Calculation of Basic and Diluted Loss per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Basic and diluted: | |||||||||||
Loss attributable to equity holders of the Company | $ 38,973 | $ 22,252 | $ 22,477 | $ 21,444 | $ 23,716 | $ 20,533 | $ 18,026 | $ 13,382 | $ 105,146 | $ 75,657 | $ 20,000 |
Dividend accumulated for preferred shares during the period | 825 | ||||||||||
Loss attributable to equity holders of the Company, after deducting dividend accumulated for preferred shares | $ 105,146 | $ 75,657 | $ 20,825 | ||||||||
Weighted-average number of ordinary shares | 20,528,727 | 15,754,193 | 9,716,790 | ||||||||
Loss per ordinary share | $ 1.86 | $ 1.06 | $ 1.08 | $ 1.11 | $ 1.46 | $ 1.28 | $ 1.14 | $ 0.88 | $ 5.12 | $ 4.80 | $ 2.14 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Fair Value Disclosures [Abstract] | |
Fair value assets, transfers between level 1 to level 2 | $ 0 |
Fair value assets, transfers between level 2 to level 1 | 0 |
Fair value liabilities, transfers between level 1 to level 2 | 0 |
Fair value liabilities, transfers between level 2 to level 1 | 0 |
Fair value assets, transfers into level 3 | 0 |
Fair value assets, transfers out of level 3 | 0 |
Fair value liabilities, transfers into level 3 | 0 |
Fair value liabilities, transfers out of level 3 | $ 0 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | $ 162,942 | $ 89,965 |
Fair Value, Measurements, Recurring | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 162,942 | |
Fair Value, Measurements, Recurring | Money Market Funds | ||
Assets: | ||
Assets measured at fair value | 89,965 | |
Fair Value, Measurements, Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 83,092 | |
Fair Value, Measurements, Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | Money Market Funds | ||
Assets: | ||
Assets measured at fair value | $ 89,965 | |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 79,850 | |
Fair Value, Measurements, Recurring | US Government | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 66,094 | |
Fair Value, Measurements, Recurring | US Government | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 66,094 | |
Fair Value, Measurements, Recurring | Corporate Bonds | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 68,084 | |
Fair Value, Measurements, Recurring | Corporate Bonds | Significant Other Observable Inputs (Level 2) | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 68,084 | |
Fair Value, Measurements, Recurring | Commercial Paper | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 7,658 | |
Fair Value, Measurements, Recurring | Commercial Paper | Significant Other Observable Inputs (Level 2) | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 7,658 | |
Fair Value, Measurements, Recurring | Money Market Funds | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 16,998 | |
Fair Value, Measurements, Recurring | Money Market Funds | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 16,998 | |
Fair Value, Measurements, Recurring | Certification Of Deposit | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 4,108 | |
Fair Value, Measurements, Recurring | Certification Of Deposit | Significant Other Observable Inputs (Level 2) | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | $ 4,108 |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Marketable securities: | ||
Amortized Cost Basis | $ 162,666 | |
Unrealized Gains | 280 | |
Unrealized Losses | (4) | |
Fair Value | 162,942 | $ 89,965 |
US Government | ||
Marketable securities: | ||
Amortized Cost Basis | 65,947 | |
Unrealized Gains | 147 | |
Fair Value | 66,094 | |
Corporate Bonds | ||
Marketable securities: | ||
Amortized Cost Basis | 67,957 | |
Unrealized Gains | 131 | |
Unrealized Losses | (4) | |
Fair Value | 68,084 | |
Commercial Paper | ||
Marketable securities: | ||
Amortized Cost Basis | 7,658 | |
Fair Value | 7,658 | |
Money Market Funds | ||
Marketable securities: | ||
Amortized Cost Basis | 16,998 | |
Fair Value | 16,998 | |
Certificates of Deposit | ||
Marketable securities: | ||
Amortized Cost Basis | 4,106 | |
Unrealized Gains | 2 | |
Fair Value | $ 4,108 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Details) $ in Millions | Dec. 31, 2019USD ($)Security |
Investments Debt And Equity Securities [Abstract] | |
Available-for-sale debt securities, unrealized gain position | $ | $ 0.3 |
Available-for-sale debt securities, unrealized loss position | $ | $ 17.9 |
Available-for-sale debt securities, number of securities in unrealized loss position | Security | 17 |
Available-for-sale debt securities, number of securities in unrealized loss position for more than 12 months | Security | 0 |
Marketable Securities - Summa_2
Marketable Securities - Summary of Fair Values of Marketable Securities by Contractual Maturity (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Available For Sale Securities Debt Maturities Fair Value [Abstract] | ||
Maturities within one year | $ 114,386 | $ 89,965 |
Maturities after one year through three years | 48,556 | |
Debt securities, Available-for-sale | $ 162,942 | $ 89,965 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Property Plant And Equipment [Line Items] | ||
Property and equipment | $ 1,975 | $ 1,695 |
Less: accumulated depreciation and amortization | (998) | (747) |
Property and equipment, net | 977 | 948 |
Laboratory Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 259 | 241 |
Computers and Software | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 416 | 271 |
Furniture | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 544 | 395 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 530 | 561 |
Manufacturing Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | $ 226 | $ 227 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Property Plant And Equipment [Abstract] | |||
Depreciation and amortization expense | $ 0.3 | $ 0.4 | $ 0.2 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||||
Nov. 30, 2019 | Oct. 31, 2019 | Apr. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Lessee Lease Description [Line Items] | |||||||
Operating leases, existence of option to extend | true | ||||||
Operating leases, options to extend lease term, description | UroGen Pharma Ltd. signed an addendum to its November 2014 lease agreement for the Company’s principal executive offices located in Israel, in order to increase the office space rented and to extend the rent period until September 2019, with an option to extend the lease for an additional period of three years. In 2019, the option was exercised, and the lease period was extended until September 2022. | ||||||
Operating leases, options to extend lease term | 3 years | ||||||
Operating lease extended lease expiration, month and year | 2022-09 | ||||||
Impairment losses on operating leases | $ 0 | ||||||
Rent expense | $ 1,200,000 | $ 1,200,000 | $ 600,000 | ||||
Minimum | |||||||
Lessee Lease Description [Line Items] | |||||||
Lease expiration year | 2021 | ||||||
Maximum | |||||||
Lessee Lease Description [Line Items] | |||||||
Lease expiration year | 2024 | ||||||
UroGen Pharma Inc. | |||||||
Lessee Lease Description [Line Items] | |||||||
Lease commencement period, month and year | 2017-10 | 2016-05 | |||||
Lease termination period, month and year | 2024-03 | 2024-03 | 2021-02 | ||||
Remaining contractual obligation | $ 1,200 | $ 800,000 | |||||
Lease commencement date | Jan. 1, 2020 | Nov. 29, 2019 | Jul. 10, 2018 | ||||
Rent income | $ 1,200 | ||||||
UroGen Pharma Inc. | Lease Agreement | |||||||
Lessee Lease Description [Line Items] | |||||||
Lease term | 38 months |
Leases - Components of Lease Co
Leases - Components of Lease Cost (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Leases [Abstract] | |
Operating lease cost | $ 1,243 |
Sublease income | (19) |
Variable lease cost | 105 |
Lease, Cost | $ 1,329 |
Leases - Schedule of Amounts Re
Leases - Schedule of Amounts Recognized Upon Adoption (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Jan. 01, 2019 |
Leases [Abstract] | ||
Right of use asset | $ 3,735 | $ 3,022 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:OtherAssetsNoncurrent | us-gaap:OtherAssetsNoncurrent |
Long-term lease liability | $ 2,604 | $ 2,429 |
Other current liabilities | $ 1,585 | $ 929 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent | us-gaap:OtherLiabilitiesCurrent |
Leases - Schedule of Supplement
Leases - Schedule of Supplemental Information Related to Leases (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Cash paid for amounts included in the measurement of lease liabilities: | |
Operating cash flows from operating leases | $ 1,192 |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 1,741 |
Weighted-average remaining lease term of operating leases | 2 years 10 months 28 days |
Weighted-average discount rate of operating leases | 5.54% |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Leases [Abstract] | ||
2020 | $ 1,758 | |
2021 | 1,269 | |
2022 | 1,101 | |
2023 | 348 | |
2024 and thereafter | 58 | |
Total future minimum lease payments | 4,534 | |
Less: Interest | 345 | |
Operating lease liabilities | $ 4,189 | |
2019 | $ 1,136 | |
2020 | 1,251 | |
2021 | 676 | |
2022 | 567 | |
2023 | 301 | |
2024 and thereafter | 58 | |
Total future minimum lease payments | $ 3,989 |
License and Collaboration Agr_2
License and Collaboration Agreements - Additional Information (Details) - USD ($) | Nov. 08, 2019 | Oct. 07, 2016 | Jun. 30, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
Revenues | $ 18,000 | $ 283,000 | $ 364,000 | $ 481,000 | $ 18,000 | $ 1,128,000 | $ 8,158,000 | ||||
Agenus Agreement | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
Upfront fee | $ 10,000,000 | ||||||||||
Maximum amount payable upon achieving certain clinical development and regulatory milestones | 115,000,000 | ||||||||||
Maximum amount payable upon achieving certain commercial milestones | $ 85,000,000 | ||||||||||
License agreement milestone in acquired in-process research and development expenses | 10,000,000 | ||||||||||
Agenus Agreement | After First Commercial Sale of Licensed Product | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
License agreement expiration term | 15 years | ||||||||||
Agenus Agreement | Maximum | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
Royalty ranging on net sales of licensed products | 20.00% | ||||||||||
Agenus Agreement | Minimum | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
Royalty ranging on net sales of licensed products | 14.00% | ||||||||||
Allergan | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
Consideration received for license and future supply services | $ 17,500,000 | $ 17,500,000 | |||||||||
Milestone payment for licensing agreement | $ 7,500,000 | 7,500,000 | |||||||||
Revenues | $ 18,000 | $ 1,100,000 | $ 700,000 | ||||||||
Type Of Revenue Extensible List | urgn:RTGelMember | urgn:RTGelMember | urgn:RTGelMember | ||||||||
Allergan | License Agreement | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
Net sales of licensed products | $ 500,000,000 | ||||||||||
Allergan | License Agreement | Maximum | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
License agreement additional milestone payments eligible to receive | 200,000,000 | ||||||||||
Allergan | License Agreement | Upon Initiation of Phase 3 Clinical Trial for a Licensed Product for Overactive Bladder | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
License agreement additional milestone payments eligible to receive | 20,000,000 | ||||||||||
Allergan | License Agreement | Upon Initiation of Phase 3 Clinical Trial for a Licensed Product for a Specified Second Indication | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
License agreement additional milestone payments eligible to receive | 15,000,000 | ||||||||||
Allergan | License Agreement | Upon Net Sales of All Licensed Products of $500.0 Million | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
License agreement additional milestone payments eligible to receive | 50,000,000 | ||||||||||
Allergan | United States | License Agreement | Upon First Commercial Sale of a Licensed Product for Overactive Bladder | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
License agreement additional milestone payments eligible to receive | 50,000,000 | ||||||||||
Allergan | United States | License Agreement | Upon First Commercial Sale of a Licensed Product for a Specified Second Indication | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
License agreement additional milestone payments eligible to receive | 25,000,000 | ||||||||||
Allergan | European Union | License Agreement | Upon First Commercial Sale of a Licensed Product for Overactive Bladder | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
License agreement additional milestone payments eligible to receive | 25,000,000 | ||||||||||
Allergan | European Union | License Agreement | Upon First Commercial Sale of a Licensed Product for a Specified Second Indication | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
License agreement additional milestone payments eligible to receive | $ 15,000,000 |
Shareholders' Equity - Addition
Shareholders' Equity - Additional Information (Details) | Mar. 02, 2020USD ($) | Jan. 02, 2020USD ($) | Apr. 19, 2017shares | Jan. 31, 2019USD ($)$ / sharesshares | Jan. 31, 2018USD ($)$ / sharesshares | May 31, 2017USD ($)$ / sharesshares | Oct. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2019USD ($)shares | Dec. 31, 2018USD ($)shares | Dec. 31, 2017USD ($) | Dec. 31, 2014$ / sharesshares |
Class Of Stock [Line Items] | |||||||||||
Ordinary shares, shares authorized | 100,000,000 | 100,000,000 | |||||||||
Ordinary shares, issued | 21,026,184 | 16,214,883 | |||||||||
Ordinary shares, outstanding | 21,026,184 | 16,214,883 | |||||||||
Proceeds from sales | $ | $ 161,662,000 | $ 64,235,000 | $ 60,841,000 | ||||||||
Research and development expenses incurred | $ | 49,297,000 | 36,934,000 | 18,697,000 | ||||||||
Cowen and Company Limited Liability Company | Subsequent Event | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Proceeds from sales | $ | $ 0 | ||||||||||
Cowen and Company Limited Liability Company | Maximum | Subsequent Event | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Issuance of ordinary shares, consideration received net of underwriting discounts and commissions and issuance costs | $ | $ 100,000,000 | ||||||||||
IPO | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Issuance of ordinary shares, consideration received net of underwriting discounts and commissions and issuance costs | $ | $ 161,447,000 | $ 64,193,000 | $ 60,772,000 | ||||||||
Preferred A and Preferred A-1 shares into ordinary shares conversion ratio | 100.00% | ||||||||||
IPO | NASDAQ CAPITAL MARKET | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Issuance of ordinary shares, shares | 5,144,378 | ||||||||||
Issuance of ordinary shares, price per share | $ / shares | $ 13 | ||||||||||
Issuance of ordinary shares, consideration received net of underwriting discounts and commissions and issuance costs | $ | $ 60,800,000 | ||||||||||
Additional ordinary shares exercised under underwriters option to purchase at the public offering price | 671,005 | ||||||||||
Underwritten Public Offering | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Issuance of ordinary shares, shares | 4,207,317 | 1,682,926 | |||||||||
Issuance of ordinary shares, price per share | $ / shares | $ 41 | $ 41 | |||||||||
Issuance of ordinary shares, consideration received net of underwriting discounts and commissions and issuance costs | $ | $ 161,400,000 | $ 64,200,000 | |||||||||
Additional ordinary shares exercised under underwriters option to purchase at the public offering price | 548,780 | 219,512 | |||||||||
Preferred A-1 Shares | IPO | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Stock issued during period upon conversion of warrants, shares | 364,036 | ||||||||||
Warrant exercise price per share | $ / shares | $ 7.81 | ||||||||||
Exercisable number of warrants for preferred shares | 728,312 | ||||||||||
TMX | Intellectual Property Costs | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Stock split description | On April 19, 2017, the Company’s board of directors and shareholders approved an aggregate 3.2 for-1 share split of the Company’s ordinary, Preferred A and Preferred A-1 shares. The share split was effected on April 19, 2017 by the issuance of 2.2 ordinary shares for each outstanding ordinary, Preferred A and Preferred A-1 share held immediately prior to the share split | ||||||||||
Research and development expenses incurred | $ | $ 4,100,000 | ||||||||||
TMX | Series A Preferred Shares | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Share split conversion ratio | 3.2 | ||||||||||
Issuance of ordinary shares for each outstanding ordinary, Preferred A and Preferred A-1 shares held immediately prior to share split | 2.2 | ||||||||||
Purchase of IP R&D in consideration, shares | 691,200 | ||||||||||
Preferred stock price per share | $ / shares | $ 5.94 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) | Jan. 03, 2019USD ($)$ / sharesshares | Jan. 02, 2019USD ($) | Oct. 12, 2018shares | Jan. 01, 2018shares | Dec. 31, 2019USD ($) | Jun. 30, 2019USD ($)$ / sharesshares | Aug. 31, 2018USD ($)shares | Apr. 30, 2017USD ($)shares | Mar. 31, 2017shares | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | May 31, 2019shares | Dec. 31, 2016shares |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Share-based compensation | $ 29,967,000 | $ 30,642,000 | $ 6,300,000 | |||||||||||
Stock options granted | shares | 955,732 | 1,195,000 | 589,600 | |||||||||||
Stock option exercise prices ranging lower limit | $ / shares | $ 33.21 | $ 38.64 | $ 1.78 | |||||||||||
Stock option exercise prices ranging upper limit | $ / shares | $ 47.57 | $ 59.23 | $ 39.26 | |||||||||||
Fair value of option granted | $ 27,600,000 | $ 40,300,000 | $ 10,900,000 | |||||||||||
Unrecognized compensation cost of employee options | $ 30,800,000 | $ 30,800,000 | ||||||||||||
Expected to be recognized over a weighted average period | 1 year 8 months 19 days | |||||||||||||
Number of ordinary shares issuable upon vesting of options granted | shares | 9,600 | |||||||||||||
Intrinsic value of stock options exercised | $ 14,200,000 | 31,600,000 | 21,400,000 | |||||||||||
Aggregate intrinsic value of the total vested and exercisable options | 22,000,000 | 22,000,000 | ||||||||||||
General and Administrative Expenses | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Share-based compensation | 21,676,000 | 18,604,000 | 2,377,000 | |||||||||||
Research and Development Expenses | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Share-based compensation | $ 8,291,000 | 12,038,000 | $ 3,923,000 | |||||||||||
Options | Board Of Directors | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Grants related option awards | $ 3,400,000 | |||||||||||||
Options | Elizabeth Barrett | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Option to purchase of ordinary shares | shares | 277,432 | |||||||||||||
Exercise price of option to purchase of ordinary shares | $ / shares | $ 47.57 | |||||||||||||
Options | Non-employee Directors | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Stock options granted, expected term | 10 years | |||||||||||||
Awards vesting period | 1 year | |||||||||||||
Estimated fair value of options granted | $ 1,900,000 | |||||||||||||
Number of stock options approved for grants | shares | 70,000 | |||||||||||||
Stock options granted | shares | 10,000 | |||||||||||||
Exercise of option to ordinary shares conversion ratio | 1 | |||||||||||||
Stock option exercise | $ / shares | $ 34.83 | |||||||||||||
Options | Chairman of Board of Directors | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Stock options granted | shares | 10,000 | |||||||||||||
Options | General and Administrative Expenses | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Share-based compensation | 900,000 | 7,200,000 | ||||||||||||
Options | Research and Development Expenses | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Share-based compensation | $ 7,200,000 | |||||||||||||
Options | General and Administrative and Research and Development Expenses | Board Of Directors | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Estimated fair value of options granted | $ 2,800,000 | |||||||||||||
Options | Tranche One | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Vesting percentage | 33.00% | |||||||||||||
Restricted Stock Units (RSUs) | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Awards vesting period | 2 years | |||||||||||||
Modifications of performance conditions in shares | shares | 67,200 | |||||||||||||
Share-based compensation | 0 | |||||||||||||
Share-based compensation arrangement by share-based payment award, granted | shares | 455,465 | 116,493 | 123,300 | |||||||||||
Expected to be recognized over a weighted average period | 2 years 14 days | |||||||||||||
Number of ordinary shares issuable upon vesting of options granted | shares | 28,800 | |||||||||||||
Fair value of RSUs granted | $ 19,900,000 | $ 5,700,000 | $ 3,300,000 | |||||||||||
Unrecognized compensation cost of RSUs | $ 16,100,000 | $ 16,100,000 | ||||||||||||
Restricted Stock Units (RSUs) | Senior Executive | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Share-based compensation | $ 0 | |||||||||||||
Share-based compensation arrangement by share-based payment award, granted | shares | 10,466 | |||||||||||||
Restricted Stock Units (RSUs) | Elizabeth Barrett | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Option to purchase of ordinary shares | shares | 317,065 | |||||||||||||
Restricted Stock Units (RSUs) | General and Administrative Expenses | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Share-based compensation | $ 500,000 | |||||||||||||
Restricted Stock Units (RSUs) | Tranche One | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Vesting percentage | 33.00% | |||||||||||||
2017 Equity Incentive Plan | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Maximum number of ordinary share issuable under the 2017 incentive plan | shares | 1,400,000 | 5,600,000 | ||||||||||||
Number of ordinary shares reserved for issuance, percentage | 12.00% | |||||||||||||
Increase in number of ordinary share issuable under the 2017 incentive plan | shares | 1,900,000 | 250,167 | ||||||||||||
Stock Options and Restricted Stock Units (RSUs) | Elizabeth Barrett | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Fair value | $ 24,100,000 | |||||||||||||
Plan | Options | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Awards vesting period | 3 years | |||||||||||||
Combined voting power percentage | 10.00% | |||||||||||||
Ordinary Shares | 2019 Inducement Plan | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Number of stock options approved for grants | shares | 900,000 | |||||||||||||
Ordinary Shares | 2017 Equity Incentive Plan | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Maximum number of ordinary share issuable under the 2017 incentive plan | shares | 3,550,167 | 1,650,167 | ||||||||||||
Maximum | Plan | Options | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Stock options granted, expected term | 10 years | |||||||||||||
Minimum | Plan | Options | ||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||||
Exercise price of stock options as percentage of fair market value of shares on grant date | 100.00% | |||||||||||||
Stock options exercise price percentage for individuals possesses more than 10% of the combined voter power | 110.00% |
Share Based Compensation - Sche
Share Based Compensation - Schedule of Fair Value of Options Granted (Details) - Options - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Dividend yield | 0.00% | 0.00% | 0.00% |
Expected volatility, Minimum | 74.09% | 72.00% | 68.45% |
Expected volatility, Maximum | 80.52% | 82.04% | 76.32% |
Risk-free interest rate, Minimum | 1.36% | 1.72% | 1.38% |
Risk-free interest rate, Maximum | 2.62% | 3.07% | 2.47% |
Minimum | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Value of ordinary shares | $ 33.21 | $ 38.64 | $ 1.58 |
Expected term | 5 years 9 months 18 days | 2 months 12 days | 3 years 10 months 24 days |
Maximum | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Value of ordinary shares | $ 47.57 | $ 59.23 | $ 39.26 |
Expected term | 10 years | 10 years | 10 years |
Share Based Compensation - Summ
Share Based Compensation - Summary of Number of Employee and Non-employee Options Outstanding Under the Plan (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Number of Options, Granted | 955,732 | 1,195,000 | 589,600 |
Employees and Non-employees | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Number of Options, Outstanding beginning balance | 2,522,981 | 2,244,032 | 2,389,899 |
Number of Options, Granted | 955,732 | 1,195,000 | 589,600 |
Number of Options, Canceled/Forfeited | (183,725) | (167,149) | (45,186) |
Number of Options, Exercised | (423,653) | (748,902) | (690,281) |
Number of Options, Outstanding ending balance | 2,871,335 | 2,522,981 | 2,244,032 |
Weighted Average Price Per Share, Outstanding beginning balance | $ 26.16 | $ 9.91 | $ 4.69 |
Weighted Average Price Per Share, Granted | 41.96 | 47.19 | 23.95 |
Weighted Average Price Per Share, Canceled/Forfeited | 41.85 | 35.37 | 5.41 |
Weighted Average Price Per Share, Exercised | 9.10 | 8.99 | 4.12 |
Weighted Average Price Per Share, Outstanding ending balance | $ 32.93 | $ 26.16 | $ 9.91 |
Share Based Compensation - Su_2
Share Based Compensation - Summary of Number of Options Outstanding and Exercisable (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Options outstanding, exercise price per share | $ 33.21 | $ 38.64 | $ 1.78 |
Options outstanding, exercise price per share | $ 47.57 | $ 59.23 | $ 39.26 |
Options outstanding, number of options outstanding at end of year | 2,871,335 | ||
Options exercisable, number of options outstanding at end of year | 1,574,999 | ||
0.00 - 10.00 | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Options outstanding, exercise price per share | $ 0 | ||
Options outstanding, exercise price per share | $ 10 | ||
Options outstanding, number of options outstanding at end of year | 725,394 | ||
Options outstanding, weighted average remaining contractual life | 2 years 9 months 18 days | ||
Options exercisable, number of options outstanding at end of year | 725,394 | ||
Options exercisable, weighted average remaining contractual life | 2 years 9 months 18 days | ||
10.01 - 20.00 | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Options outstanding, exercise price per share | $ 10.01 | ||
Options outstanding, exercise price per share | $ 20 | ||
Options outstanding, number of options outstanding at end of year | 75,000 | ||
Options outstanding, weighted average remaining contractual life | 7 years 4 months 20 days | ||
Options exercisable, number of options outstanding at end of year | 63,333 | ||
Options exercisable, weighted average remaining contractual life | 7 years 4 months 24 days | ||
20.01 - 30.00 | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Options outstanding, exercise price per share | $ 20.01 | ||
Options outstanding, exercise price per share | $ 30 | ||
Options outstanding, number of options outstanding at end of year | 100,000 | ||
Options outstanding, weighted average remaining contractual life | 7 years 9 months 25 days | ||
Options exercisable, number of options outstanding at end of year | 66,668 | ||
Options exercisable, weighted average remaining contractual life | 7 years 9 months 25 days | ||
30.01 - 40.00 | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Options outstanding, exercise price per share | $ 30.01 | ||
Options outstanding, exercise price per share | $ 40 | ||
Options outstanding, number of options outstanding at end of year | 433,500 | ||
Options outstanding, weighted average remaining contractual life | 7 years 9 months 10 days | ||
Options exercisable, number of options outstanding at end of year | 208,331 | ||
Options exercisable, weighted average remaining contractual life | 6 years 3 months 29 days | ||
40.01 - 50.00 | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Options outstanding, exercise price per share | $ 40.01 | ||
Options outstanding, exercise price per share | $ 50 | ||
Options outstanding, number of options outstanding at end of year | 1,340,441 | ||
Options outstanding, weighted average remaining contractual life | 8 years 5 months 26 days | ||
Options exercisable, number of options outstanding at end of year | 366,273 | ||
Options exercisable, weighted average remaining contractual life | 7 years 5 months 8 days | ||
50.01 - 59.23 | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Options outstanding, exercise price per share | $ 50.01 | ||
Options outstanding, exercise price per share | $ 59.23 | ||
Options outstanding, number of options outstanding at end of year | 197,000 | ||
Options outstanding, weighted average remaining contractual life | 7 years 11 months 8 days | ||
Options exercisable, number of options outstanding at end of year | 145,000 | ||
Options exercisable, weighted average remaining contractual life | 7 years 9 months 18 days |
Share Based Compensation - Su_3
Share Based Compensation - Summary of Information about RSU Activity (Details) - Restricted Stock Units (RSUs) - shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Number of Options, Outstanding beginning balance | 263,699 | 276,560 | 275,200 |
Granted | 455,465 | 116,493 | 123,300 |
Vested and released | (183,975) | (118,447) | (121,940) |
Forfeited | (15,762) | (10,907) | |
Number of Options, Outstanding ending balance | 519,427 | 263,699 | 276,560 |
Share Based Compensation - Sc_2
Share Based Compensation - Schedule of Effect of Share-Based Compensation on Statements of Operations (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation | $ 29,967 | $ 30,642 | $ 6,300 |
Research and Development Expenses | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation | 8,291 | 12,038 | 3,923 |
General and Administrative Expenses | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation | $ 21,676 | $ 18,604 | $ 2,377 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax [Line Items] | |||
Corporate tax rate | 23.00% | 23.00% | 24.00% |
Federal tax net operating losses carryforward | $ 2.6 | ||
State tax net operating losses carryforward | $ 0.6 | ||
Federal and state net operating losses expiration year | 2036 | ||
Net carryforward tax losses | $ 151.9 | $ 72.1 | |
Patents | |||
Income Tax [Line Items] | |||
Acquired intangible asset amortization period | 8 years |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Income Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
In respect of: | ||||
Net operating loss carryforward | $ 33,817 | $ 16,943 | $ 5,844 | |
Deferred rent | 61 | 46 | ||
Research and development expenses | 4,591 | 3,891 | 2,887 | |
Stock-based compensation | 6,543 | 4,769 | 897 | |
Issuance costs | 2,063 | 1,367 | 1,261 | |
In-process research and development | 2,749 | 629 | 761 | |
Right of use asset | (800) | |||
Lease Liability | 896 | |||
Accrued expenses | 762 | 598 | 5 | |
Depreciation of fixed assets | (90) | (93) | ||
Other | 62 | 84 | 24 | |
Less—valuation allowance | $ (50,593) | $ (28,249) | $ (11,725) | $ (4,158) |
Income Taxes - Schedule of Chan
Income Taxes - Schedule of Change in Valuation Allowance (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Valuation Allowance [Abstract] | |||
Balance at the beginning of the year | $ (28,249) | $ (11,725) | $ (4,158) |
Changes during the year | (22,344) | (16,524) | (7,567) |
Balance at the end of the year | $ (50,593) | $ (28,249) | $ (11,725) |
Related Parties - Additional In
Related Parties - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Sep. 30, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | |
Related Party Transaction [Line Items] | |||
Operating lease liabilities | $ 4,189,000 | ||
UroGen Pharma Inc. | |||
Related Party Transaction [Line Items] | |||
Lease agreement period, month and year | 2015-11 | ||
Lease commencement period, month and year | 2017-10 | 2016-05 | |
Gain (loss) on disposal of fixed assets | $ 200,000 | ||
Operating lease liabilities | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - IIA - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Commitments And Contingent Liabilities [Line Items] | ||
Royalty amount payable | $ 0.8 | $ 0.8 |
Minimum | ||
Commitments And Contingent Liabilities [Line Items] | ||
Royalty fees payable on product sales, percentage | 3.00% | |
Maximum | ||
Commitments And Contingent Liabilities [Line Items] | ||
Royalty fees payable on product sales, percentage | 5.00% | |
Maximum percentage of royalty payable on grant received | 100.00% | |
Royalty amount payable | $ 2.1 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - USD ($) | Jan. 12, 2020 | Jan. 02, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
IIA | ||||
Subsequent Event [Line Items] | ||||
Maximum percentage of commitment to continue employment of research and development jobs | 75.00% | |||
Maximum term for commitment to continue employment of research and development jobs | 3 years | |||
Royalty amount payable | $ 800,000 | $ 800,000 | ||
Subsequent Event | IIA | ||||
Subsequent Event [Line Items] | ||||
Royalty amount payable | $ 6,600,000 | |||
Maximum | IIA | ||||
Subsequent Event [Line Items] | ||||
Royalty amount payable | $ 2,100,000 | |||
Cowen and Company Limited Liability Company | Maximum | Subsequent Event | ||||
Subsequent Event [Line Items] | ||||
Aggregate offering price of ordinary shares | $ 100,000,000 |
Selected Quarterly Financial _3
Selected Quarterly Financial Data (Unaudited) - Summarized Quarterly Data (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Total revenues | $ 18 | $ 283 | $ 364 | $ 481 | $ 18 | $ 1,128 | $ 8,158 | ||||
Total operating expenses | $ 39,839 | $ 23,453 | 23,771 | $ 22,433 | $ 24,017 | 20,317 | 18,480 | 13,691 | 109,496 | 76,505 | |
Loss from operations | (39,839) | (23,453) | (23,753) | (22,433) | (24,017) | (21,089) | (18,434) | (13,640) | (109,478) | (77,180) | (19,950) |
Net loss attributable to common shareholders | $ (38,973) | $ (22,252) | $ (22,477) | $ (21,444) | $ (23,716) | $ (20,533) | $ (18,026) | $ (13,382) | $ (105,146) | $ (75,657) | $ (20,000) |
Net loss per share attributable to common shareholders - basic and diluted | $ (1.86) | $ (1.06) | $ (1.08) | $ (1.11) | $ (1.46) | $ (1.28) | $ (1.14) | $ (0.88) | $ (5.12) | $ (4.80) | $ (2.14) |