Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Feb. 26, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Fiscal Year Focus | 2020 | ||
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 | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Shell Company | false | ||
Entity Emerging Growth Company | false | ||
Entity Common Stock, Shares Outstanding | 22,272,848 | ||
Entity Public Float | $ 525.4 | ||
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 | ||
ICFR Auditor Attestation Flag | false | ||
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, 2020 are incorporated by reference into Part III of this report. III |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 52,864 | $ 49,688 |
Marketable securities | 49,154 | 97,389 |
Restricted cash | 1,226 | 523 |
Accounts receivable | 7,047 | |
Inventory | 1,964 | |
Prepaid expenses and other current assets | 3,364 | 1,034 |
Total current assets | 115,619 | 148,634 |
Non-current assets: | ||
Property and equipment, net | 2,046 | 977 |
Restricted deposit | 223 | 223 |
Right of use asset | 2,158 | 3,735 |
Marketable securities | 1,893 | 48,555 |
Other non-current assets | 66 | 264 |
Total Assets | 122,005 | 202,388 |
Current liabilities: | ||
Accounts payable and accrued expenses | 10,023 | 11,186 |
Employee related accrued expenses | 9,554 | 6,711 |
Other current liabilities | 1,859 | 1,585 |
Total current liabilities: | 21,436 | 19,482 |
Non-current liabilities: | ||
Long-term lease liability | 1,497 | 2,604 |
Uncertain tax positions liability | 2,717 | |
Total Liabilities | 25,650 | 22,086 |
Commitments and contingencies (Note 17) | ||
Shareholders' equity: | ||
Ordinary shares, NIS 0.01 par value; 100,000,000 shares authorized at December 31, 2020 and 2019; 22,167,791 and 21,026,184 shares issued and outstanding as of December 31, 2020 and 2019, respectively | 60 | 57 |
Additional paid-in capital | 452,525 | 407,986 |
Accumulated deficit | (356,501) | (228,017) |
Accumulated other comprehensive income | 271 | 276 |
Total Shareholders' Equity | 96,355 | 180,302 |
Total Liabilities and Shareholders' Equity | $ 122,005 | $ 202,388 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - ₪ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
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 | 22,167,791 | 21,026,184 |
Ordinary shares, outstanding | 22,167,791 | 21,026,184 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Statement [Abstract] | ||
Revenues, net | $ 11,799,000 | $ 18,000 |
Cost of revenues | 1,009,000 | |
Gross profit | 10,790,000 | 18,000 |
Operating expenses: | ||
Research and development expenses | 47,310,000 | 49,297,000 |
Selling, general and administrative expenses | 90,219,000 | 60,199,000 |
Operating loss | (126,739,000) | (109,478,000) |
Interest and other income, net | 1,629,000 | 4,332,000 |
Loss before income taxes | (125,110,000) | (105,146,000) |
Income tax expense | 3,374,000 | |
Net Loss | (128,484,000) | (105,146,000) |
Statements of Comprehensive Loss | ||
Net loss | (128,484,000) | (105,146,000) |
Other comprehensive income | ||
Unrealized (loss) gain on marketable securities | (5,000) | 276,000 |
Comprehensive Loss | $ (128,489,000) | $ (104,870,000) |
Loss per ordinary share basic and diluted | $ (5.90) | $ (5.12) |
Weighted average number of shares outstanding used in computation of basic and diluted loss per ordinary share | 21,780,826 | 20,528,727 |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Ordinary Shares | Additional Paid-In Capital | Accumulated Deficit | Other Comprehensive Income |
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 (loss) | 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 | ||||
Exercise of options into ordinary shares | 740 | $ 1 | 739 | ||
Exercise of options into ordinary shares, shares | 441,607 | ||||
Share-based compensation | 28,025 | 28,025 | |||
Issuance of ordinary shares in public offering, net of issuance expenses | 15,777 | $ 2 | 15,775 | ||
Issuance of ordinary shares in public offering, net of issuance expenses, shares | 700,000 | ||||
Other comprehensive income (loss) | (5) | (5) | |||
Net loss | (128,484) | (128,484) | |||
Balance at Dec. 31, 2020 | $ 96,355 | $ 60 | $ 452,525 | $ (356,501) | $ 271 |
Balance,Share at Dec. 31, 2020 | 22,167,791 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash Flows From Operating Activities | ||
Net loss | $ (128,484) | $ (105,146) |
Adjustment to reconcile net loss to net cash from operating activities: | ||
Depreciation and amortization | 416 | 296 |
Amortization (accretion) on marketable securities | 439 | (572) |
Stock-based compensation | 28,025 | 29,967 |
Amortization of right of use asset | 1,628 | 1,028 |
Lease liability | (1,541) | (910) |
Changes in operating assets and liabilities: | ||
Inventory | (1,964) | |
Accounts receivable | (7,047) | |
Prepaid expenses and other current assets | (2,330) | (394) |
Accounts payable and accrued expenses | (1,245) | 2,928 |
Employee related accrued expenses | 2,843 | 1,786 |
Current tax payable | 657 | |
Uncertain tax positions | 2,717 | |
Net cash used in operating activities | (105,886) | (71,017) |
Cash Flows From Investing Activities | ||
Change in restricted deposit | (172) | |
Purchase of marketable securities | (29,688) | (197,686) |
Maturities of marketable securities | 124,141 | 52,590 |
Purchase of property and equipment | (1,215) | (325) |
Net cash provided by (used in) investing activities | 93,238 | (145,593) |
Cash Flows From Financing Activities | ||
Proceeds from exercise of options into ordinary shares | 740 | 3,664 |
Issuance of ordinary shares, net of issuance expenses | 15,853 | 161,662 |
Issuance cost related to at-the-market issuances | (66) | (76) |
Net cash provided by financing activities | 16,527 | 165,250 |
Decrease in Cash and Cash Equivalents | 3,879 | (51,360) |
Cash, Cash Equivalents and Restricted Cash at Beginning of Year | 50,211 | 101,571 |
Cash, Cash Equivalents and Restricted Cash at End of Year | 54,090 | 50,211 |
Supplemental Disclosures of Non-Cash Activities | ||
Purchase of property and equipment | 270 | |
Issuance cost | 188 | |
New lease liabilities | $ 51 | $ 1,741 |
Business and Nature of Operatio
Business and Nature of Operations | 12 Months Ended |
Dec. 31, 2020 | |
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 wholly owned a n UPL o l g Jelmyto On April 15, 2020, the U.S. Food and Drug Administration (“FDA”) granted expedited approval for Jelmyto Jelmyto RTGel . |
Basis of Presentation
Basis of Presentation | 12 Months Ended |
Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Basis of Presentation | NOTE 2-BASIS OF PRESENTATION The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States. The consolidated financial statements include the accounts of UPL and its wholly owned subsidiary UPI. All material intercompany balances and transactions have been eliminated during consolidation. The Company has experienced net losses since its inception and has an accumulated deficit of $356.5 million and $228.0 million as of December 31, 2020 and 2019, 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 non-clinical studies and clinical trials. The success of the Company depends on the ability to successfully commercialize its technologies to support its operations and strategic plan. Based on management’s cash flow projections the Company believes that its cash and cash equivalents and marketable securities are sufficient to fund the Company’s planned operations for at least the next 12 months. The Company will need to raise additional capital to finance the continued launch of Jelmyto and support its Phase 3 ATLAS trial. There can be no assurances that the Company will be able to secure such additional financing if at all, or at terms that are satisfactory to the Company, and that it will be sufficient to meet its needs. In the event the Company is not successful in obtaining sufficient funding, this could force us to delay, limit, or reduce our product development, commercialization efforts or other operations. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
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 critical estimates relate i Functional Currency The U.S. dollar (“Dollar”) is the currency of the primary economic environment in which the operations of the Company are conducted. Therefore, the functional currency of the Company is the Dollar. Accordingly, transactions in currencies other than the Dollar are measured and recorded in the functional currency using the exchange rate in effect at the date of the transaction. At the balance sheet date, monetary assets and liabilities that are denominated in currencies other than the Dollar are measured using the official exchange rate at the balance sheet date. The effects of foreign currency re-measurements are recorded in the consolidated statements of operations as “Interest and other income, net” Cash and Cash Equivalents; Marketable Securities 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. 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 and Equity 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 are recorded as a component of interest and other income (expense), net. The cost of securities sold is based on the specific-identification method. Short-term investments are valued using models or other valuation methodologies that use Level 2 inputs. These models are primarily industry-standard models that consider various assumptions, including time value, yield curve, volatility factors, default rates, current market and contractual prices for the underlying financial instruments, as well as other relevant economic measures. The majority of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. For individual debt securities classified as available-for-sale securities where there has been a decline in fair value below amortized cost, the Company determines whether the decline resulted from a credit loss or other factors. The Company records impairment relating to credit losses through an allowance for credit losses, limited by the amount that the fair value is less than the amortized cost basis. Impairment that has not been recorded through an allowance for credit losses is recorded through other comprehensive income, net of applicable taxes. 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 ’ The Company’s product sales are recognized through the Company's arrangement with a single customer, a third-party national specialty distributor. The Company assesses the need for an allowance for doubtful accounts primarily based on creditworthiness, historical payment experience and general economic conditions. The Company has not experienced any credit losses related to this customer and has not currently recognized any allowance for doubtful accounts. 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 it operates, including Israel and the U.S. Deferred l e n s a a The n Inventory The Company capitalizes inventory costs related to products to be sold in the ordinary course of business. The Company makes a determination of capitalizing inventory costs for a product based on, among other factors, status of regulatory approval, information regarding safety, efficacy and expectations relating to commercial sales and recoverability of costs. For Jelmyto The Company values its inventory at the lower of cost or net realizable value. The Company measures inventory approximating actual cost under a first-in, first-out basis. The Company assesses recoverability of inventory each reporting period to determine any write down to net realizable value resulting from excess or obsolete inventories. Property and Equipment Property and equipment are recorded at historical cost, net of accumulated depreciation, amortization and, if applicable, impairment charges. The Company reviews its property and equipment assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Property and equipment are depreciated over the following useful lives (in years): Useful Lives Computers and software 3 Laboratory equipment 3-6.5 Furniture 5-16.5 Manufacturing equipment 2 Leasehold improvements are amortized on a straight-line basis over the shorter of their estimated useful lives or lease terms. See Note 8 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. 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 to extend the lease. The lease extensions are included in the measurement of the right of use asset and lease liability when it is reasonably certain that it will exercise that option. Because most of 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. 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 (“Transition Date”). ROU assets for operating leases are periodically reviewed for impairment losses under ASC 360-10, “Property, Plant, and Equipment”, to determine whether an ROU asset is impaired, and if so, the amount of the impairment loss to recognize. Revenues Product sales from Jelmyto Jelmyto The Company also derived revenues from its license and supply agreement with Allergan Pharmaceuticals International Limited (“Allergan”), a wholly owned subsidiary of Allergan plc which is now a part of AbbVie Inc. (the “Allergan/AbbVie Agreement”). Under the Allergan/AbbVie Agreement, the Company granted Allergan an exclusive license to develop, commercialize, and otherwise exploit products that contain reverse thermal hydrogel (“ RTGel RTGel RTGel . Research and Development Expenses Research s i d a l l Selling, General and Administrative Expenses Selling, general and administrative expenses consist primarily of personnel costs (including share-based compensation related to directors, employees and consultants). Other significant costs include commercial, medical affairs, external professional service costs, facility costs, accounting and audit services, legal services and other consulting fees. Selling, general and administrative costs are expensed as incurred. 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. 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 options is determined using the Black-Scholes option-pricing model. The fair value of a restricted stock unit (“RSU”) equaled the closing price of the Company’s ordinary shares on the grant date. The The s n g Net Loss per Ordinary Share Basic net loss per share is computed by dividing the net loss attributable to ordinary shareholders by the weighted-average number of ordinary 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 ordinary shares that would have been outstanding if the potential ordinary shares had been issued and if the additional ordinary shares were dilutive. 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, 2020 2019 Basic and diluted: Loss attributable to equity holders of the Company $ 128,484 $ 105,146 Loss attributable to equity holders of the Company, after deducting dividend accumulated for preferred shares $ 128,484 $ 105,146 Weighted-average number of ordinary shares 21,780,826 20,528,727 Loss per ordinary share $ 5.90 $ 5.12 Recently Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments, or ASU 2016-13. ASU 2016-13 requires the Company to measure and recognize expected credit losses for certain financial instruments, including trade receivables, as an allowance that reflects the Company’s current estimate of credit losses expected to be incurred. For available-for-sale debt securities with unrealized losses, the standard requires allowances to be recorded through net income instead of directly reducing the amortized cost of the investment under the prior other-than-temporary impairment model. The Company applied the modified retrospective transition method as of the date of initial application, January 1, 2020. As of December 31, 2020, the Company believes the cost basis for its marketable securities were recoverable in all material aspects and no credit impairments were recognized in the period. Similarly, the Company estimates minimal current expected credit losses on trade receivables and has not recognized any allowance for doubtful accounts in the period. |
Other Financial Information
Other Financial Information | 12 Months Ended |
Dec. 31, 2020 | |
Other Financial Information [Abstract] | |
Other Financial Information | NOTE 4-OTHER FINANCIAL INFORMATION Accounts Payable and Accrued Expenses Accounts payable and accrued expenses consist of the following as of December 31, 2020 and 2019 (in thousands): December 31, 2020 December 31, 2019 Accounts payable $ 3,271 $ 4,694 Accrued sales reserves 382 — Accrued clinical expenses 1,359 399 Accrued research and development costs 1,356 2,644 Accrued general and administrative expenses 2,440 2,767 Accrued other expense 1,215 682 Total accrued expenses and other current liabilities $ 10,023 $ 11,186 Interest and Other Income (Expenses), Net Interest and other income (expenses) consisted of the following as of December 31, 2020 and 2019 (in thousands): Year Ended December 31, 2020 2019 Interest income 1,986 4,616 Other finance expenses (357 ) (284 ) Total interest and other income $ 1,629 $ 4,332 |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Inventories | NOTE 5-INVENTORIES Inventories consist of the following as of December 31, 2020 and December 31, 2019 (in thousands): December 31, 2020 December 31, 2019 Raw materials $ 1,051 — Finished goods 913 — Total inventories $ 1,964 $ — |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | NOTE 6-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 ’ s own assumptions. The carrying amounts of the Company ’ Assets and liabilities measured at fair value on a recurring basis based on Level 1 and Level 2 fair value measurement criteria as of December 31, 2020 are as follows (in thousands): Fair Value Measurements Using Quoted Prices Significant in Active Other Balance as of Markets for Observable December 31, Identical Assets Inputs 2020 (Level 1) (Level 2) Marketable securities: US government $ 29,186 $ 29,186 $ — Corporate bonds 21,861 — 21,861 Money market funds (1) 39,744 39,744 — Total marketable securities $ 90,791 $ 68,930 $ 21,861 (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 and Level 2 fair value measurement criteria as of December 31, 2019 are as follows (in thousands): Fair Value Measurements Using Quoted Prices Significant in Active Other Balance as of Markets for Observable December 31, Identical Assets Inputs 2019 (Level 1) (Level 2) 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 — Certificates of deposit 4,108 — 4,108 Total marketable securities $ 162,942 $ 83,092 $ 79,850 (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, 2020 | |
Investments Debt And Equity Securities [Abstract] | |
Marketable Securities | NOTE 7-MARKETABLE SECURITIES The following table summarizes the Company’s marketable securities as of December 31, 2020 (in thousands): Amortized Cost Basis Unrealized Gains Fair Value Marketable securities: US government $ 28,970 $ 216 $ 29,186 Corporate bonds 21,806 55 21,861 Money market funds (1) 39,744 — 39,744 Total marketable securities $ 90,520 $ 271 $ 90,791 (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, 2020, 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, 2020, the Company did not hold any marketable securities in an unrealized loss position. In accordance with the Company’s general investment strategy, the Company does not intend to sell the investments before maturity. As of December 31, 2020, the Company believes the cost basis for its marketable securities were recoverable in all material aspects and no credit impairments were recognized in the period. The Company’s marketable securities as of December 31, 2020 mature at various dates through February 2022. The fair values of marketable securities by contractual maturity consist of the following (in thousands): December 31, 2020 December 31, 2019 Maturities within one year $ 88,898 $ 114,386 Maturities after one year through three years 1,893 48,556 Total marketable securities $ 90,791 $ 162,942 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2020 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | NOTE 8-PROPERTY AND EQUIPMENT Property and equipment, consists of the following as of December 31, 2020 and 2019 (in thousands): December 31, 2020 2019 Laboratory equipment $ 333 $ 259 Computer equipment and software 1,676 416 Furniture 597 544 Leasehold improvements 609 530 Manufacturing equipment 226 226 3,441 1,975 Less: accumulated depreciation and amortization (1,395 ) (998 ) Property and equipment, net $ 2,046 $ 977 Depreciation and amortization expense was $0.4 million and $0.3 million for the years ended December 31, 2020 and 2019, respectively. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Leases | NOTE 9-LEASES Operating Leases The Company has the following office and laboratory facility leases: • In April 2016, UPL signed an addendum to its November 2014 lease agreement for the Company’s executive offices located in Israel, in order to increase the office space rented and to extend the rent period until 2019. In March 2019, UPL exercised the agreement extension option and extended the rental period for an additional three years until August 2022. • In September 2017, UPI entered into a new lease agreement for its office space in New York, which the Company previously used as its headquarters. The lease agreement commenced in October 2017 and terminates in February 2021. In October 2020, the Company committed to and announced a plan to close the New York office and fully impaired the associated right of use asset. • In April 2018, UPI entered into a new lease agreement for an office in Los Angeles, California. The lease commencement date was July 10, 2018 and terminates in March 2024. The landlord provided a tenant allowance for leasehold improvements of $0.2 million that was accounted for as a lease incentive. The Company’s remaining contractual obligation under this lease is approximately $0.9 million as of December 31, 2020. In November 2019, UPI entered into a sublease for this office space, with a lease commencement date of January 1, 2020 and continuing until the end of the lease term in March 2024. The subtenants exercised their early access clause and moved into the premises the end of November 2019. The remaining rental payments to be received over the lease term is approximately $0.7 million as of December 31, 2020 . 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. • In November 2019, UPI entered into a new lease agreement for an office in Princeton, New Jersey, which the Company now uses as its headquarters. The lease commencement date was November 29, 2019 and the lease term is 38 months. The Company’s remaining contractual obligation under this lease is approximately $1.2 million as of December 31, 2020. In addition, the Company leases operating office equipment and vehicles. 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 2023, with varying renewal and termination options. The components of lease cost for the year ended December 31, 2020 were as follows (in thousands) Year Ended December 31, 2020 Operating lease cost $ 1,812 Sublease income (224 ) Variable lease cost 129 $ 1,717 The amounts recognized as of December 31, 2020 were as follows (in thousands): December 31, 2020 Right of use asset $ 2,158 Long-term lease liability 1,497 Other current liabilities 1,202 In October 2020, the Company committed to and announced a plan to close the New York office and recognized impairment losses of approximately $0.2 million in relation to the associated right of use asset. Supplemental information related to leases for the periods reported is as follows (in thousands): Year Ended December 31, 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases 1,726 Right-of-use assets obtained in exchange for new operating lease liabilities 135 Weighted-average remaining lease term of operating leases 2.26 years Weighted-average discount rate of operating leases 5.38% As of December 31, 2020, maturities of lease liabilities were as follows (in thousands): Operating Leases Years ending December 31, 2021 $ 1,307 2022 1,150 2023 357 2024 58 2025 and thereafter — Total future minimum lease payments $ 2,872 Less: Interest (173 ) Present value of lease liabilities $ 2,699 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 Subleases As of December 31, 2020, undiscounted cash flows to be received under the Company’s operating sublease on an annual basis was as follows (in thousands): Operating Leases Years ending December 31, 2021 $ 235 2022 243 2023 251 2024 49 2025 and thereafter — Total future minimum sublease payments $ 778 Sublease income is recognized net within operating expenses. Sublease income for the year ended December 31, 2020 was as follows (in thousands): Year Ended December 31, 2020 Sublease income from fixed lease payments $ 224 |
Revenue from Product Sales
Revenue from Product Sales | 12 Months Ended |
Dec. 31, 2020 | |
Revenue From Contract With Customer [Abstract] | |
Revenue from Product Sales | NOTE 10-REVENUE FROM PRODUCT SALES Net product sales consist of the following for the year ended December 31, 2020 and 2019 (in thousands): Year Ended December 31, 2020 December 31, 2019 Jelmyto $ 11,799 $ — |
License and Collaboration Agree
License and Collaboration Agreements | 12 Months Ended |
Dec. 31, 2020 | |
Liscense Agreement [Abstract] | |
License and Collaboration Agreements | NOTE 11- LICENSE AND COLLABORATION AGREEMENTS Allergan/AbbVie Agreement In October 2016, the Company entered into the Allergan/AbbVie Agreement and granted Allergan (now part of AbbVie) an exclusive worldwide license to research, develop, manufacture and commercialize pharmaceutical products that contain RTGel ® Under the Allergan/AbbVie Agreement, Allergan is solely responsible for costs and development of the Licensed Products and obtaining all regulatory approvals for Licensed Products worldwide, as well as worldwide commercialization of the Licensed Products 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. 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. As of December 31, 2020, since inception of the Allergan/AbbVie Agreement the Company has received a total of $25.0 million in milestone payments from Allergan. 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 the Company’s patent coverage of Licensed Products. The Company is responsible for payments to any third party for certain RTGel Under the Allergan/AbbVie 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 RTGel In August 2020, the Company announced that the Phase 2 APOLLO trial did not meet the primary endpoint, it is believed to be the result of BOTOX not effectively permeating the urothelium. The Company and AbbVie are continuing to explore the potential use of RTGel Agenus Agreement In November 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 NMIBC 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. |
Employee Rights Upon Retirement
Employee Rights Upon Retirement | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 | |
Equity [Abstract] | |
Shareholders' Equity | NOTE 13-SHAREHOLDERS’ EQUITY Ordinary Shares The Company had 100.0 million ordinary shares authorized for issuance as of December d w a 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 (the “ATM Sales Agreement”) w ith Cowen and Company, LLC (“Cowen”), to or through Cowen, acting as sales agent or principal |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-Based Compensation | NOTE 14-SHARE-BASED COMPENSATION In a The b the “capital gains” track, as set out in Section 102. The Company registered the Plan un d er the capital gains track, which offers more favorable tax rates to the employees. As a result, and pursuant to the terms of Section 102, the Company is not allowed to claim as an ex p ense for tax purposes the amounts credited to the employees in respect of options granted to them under the P l an, including amounts recorded as salary be n efits in the Company’s accounts, with the exception of the work-income b e nefit component, if any, determined on grant date. For non-employees and for non-Israeli employees, the Plan is subject to Section 3(i) of the Israeli Income Tax Ordinance. Employees are typically granted stock options and/or restricted stock units, or RSUs, upon commencement of employment. Also, eligible employees may receive an annual grant of options or RSU’s. Non-employee members of the Board typically receive a grant of RSUs and/or stock options annually. The term of any 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 equity of the Company, the exercise price shall not be less than 110% of the fair market value of an ordinary share of stock on the date of grant. The Company’s RSU and 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 either equal quarterly or annual amounts for the two years following the one-year anniversary of the grant date. Options generally vest in a 33% increment upon the first anniversary of the grant date, and in either equal quarterly or annual amounts for the two years following the one-year anniversary of the grant date. In March 2017, the Board adopted the 2017 Equity Incentive Plan (the "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, RSU awards, performance share awards, performance cash awards, and other forms of share 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 the Board. The maximum number of ordinary shares that may be issued upon the exercise of 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 increased the amount of registered ordinary shares of the Company’s 2017 Plan by 1,900,000 to 3,550,167. On June 8, 2020 the Company increased the amount of registered ordinary of the Company’s 2017 plan by 400,000 to 3,950,167. 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 grant-date 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, the Board 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 Board 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 In June 2020, the Board approved grants of an aggregate of 70,000 options to its non-employee directors. Each 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 $28.24 per share. The options vest quarterly over one year and expire 10 years from the grant date. The grant date fair value of these options was approximately $1.5 million. Options : Set a) During 2020, the Company granted 400,600 options with exercise prices ranging from $16.50 to $29.41 per share. b) During n The fair value of options granted during 2020 and 2019 was $6.7 and $27.6 million, respectively. The o c The e 2020 2019 Value of ordinary shares $16.50-29.41 $33.21-47.57 Dividend yield 0% 0% Expected volatility 71.43%-79.80% 74.09%-80.52% Risk-free interest rate 0.37%-1.35% 1.36%-2.62% Expected term 5.9-10 years 5.8-10 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, 2019 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 Granted 400,600 24.33 Canceled/Forfeited (408,534 ) 44.68 Exercised (137,070 ) 5.40 Outstanding as of December 31, 2020 2,726,331 $ 31.29 The intrinsic value of stock options exercised was $2.3 million and $14.2 million for the years ended December 31, 2020 and 2019, respectively. The i 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 - 10.00 588,324 1.99 588,324 1.99 $10.01 - 20.00 268,000 8.77 75,000 6.39 $20.01 - 30.00 272,800 8.19 139,999 7.24 $30.01 - 40.00 413,500 6.72 340,833 6.36 $40.01 - 50.00 1,063,041 7.17 771,250 6.93 $50.01 - 59.23 120,666 7.00 115,332 6.98 2,726,331 2,030,738 The x The following table summarizes information about RSU activity as of December 31, 2020: Outstanding Restricted Stock Units Outstanding as of January 1, 2019 263,699 Granted 455,465 Vested and released (183,975 ) Forfeited (15,762 ) Outstanding as of December 31, 2019 519,427 Granted 591,480 Vested and released (304,537 ) Forfeited (85,954 ) Outstanding as of December 31, 2020 720,416 The fair value of RSUs granted during 2020 and 2019 was $15.6 and $19.9 million, respectively. The total unrecognized compensation cost of RSUs as of December 31, 2020 is $17.6 million with a weighted average recognition period of 1.84 years. The p Year ended December 31, 2020 2019 Research and development expenses $ 6,432 $ 8,291 Selling, general and administrative expenses 21,593 21,676 Total share-based compensation expense $ 28,025 $ 29,967 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | NOTE 15-INCOME TAXES The Corporate tax rate The applicable Israeli tax rate relevant to the Company for 2018 and thereafter is 23%. For financial reporting purposes, the expense for current income taxes consists of the following: 2020 2019 Current taxes: U.S. Federal $ 3,218 - U.S. State 156 - Total current taxes $ 3,374 - Deferred 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, 2020 2019 In respect of: Net operating loss carryforward $ 57,607 $ 33,817 Research and development expenses 5,362 4,591 Stock-based compensation 9,278 6,543 Issuance costs 978 2,063 In-process research and development 2,329 2,749 Right of use asset (372 ) (800 ) Lease Liability 473 896 Accrued expenses 1,589 762 Depreciation of fixed assets (299 ) (90 ) Other 18 62 Less—valuation allowance (76,963 ) (50,593 ) Net deferred tax assets $ — $ — The change in valuation allowance for the years ended December 31, 2020 and 2019 were as follows: 2020 2019 Balance at the beginning of the year $ (50,593 ) $ (28,249 ) Changes during the year (26,370 ) (22,344 ) Balance at the end of the year $ (76,963 ) $ (50,593 ) The main reconciling item between the statutory tax rates of the Company and the effective rate is the share-based compensation , the provision for a full valuation allowance in respect of tax benefits from carryforward tax losses due to the uncertainty of the realization of such tax benefits , and expense related to uncertain tax positions . A reconciliation of the Company’s statutory tax rate to effective tax is as follows: December 31, 2020 2019 Pretax income $ (125,110 ) $ (105,146 ) Statutory rate 23% 23% Income tax expense/(benefit) at statutory rate (28,775 ) (24,184 ) Additional tax (tax saving) in respect of: Non-deductible expenses 1,439 2,076 Different tax rate of foreign subsidiaries 17 20 Uncertain tax positions 2,717 - Change in valuation allowance 26,370 22,344 Other 1,607 (257 ) Income tax expense $ 3,374 $ - 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, 2020, and December 31, 2019, the Company had approximately $250.2 and $151.9 million of net carryforward tax losses, respectively, available to reduce future taxable income without limitation of use. Uncertain tax positions A reconciliation of the beginning and ending amount of uncertain tax positions is as follows: 2020 2019 Uncertain tax positions at the beginning of the year - - Gross increases — tax positions in current period 2,717 - Gross increases — tax positions in prior period - - Uncertain tax positions at the end of the year 2,717 - The balances of uncertain tax positions as of December 31, 2020 would affect the Company’s effective tax rate if recognized. The Company has recorded liabilities for uncertain tax positions of $2.7 million as of December 31, 2020 for tax positions relating to transfer pricing between affiliated entities. The Company recognizes interest accrued and penalties related to uncertain tax positions as a component of income tax expense. As of December 31, 2020, the Company has accrued $0.7 million of interest and penalties related to uncertain tax positions. The Company operates on a global basis and is subject to tax laws and regulations in the US and Israel. The estimate of the Company’s tax liabilities relating to uncertain tax positions requires management to assess uncertainties and to make judgments about the application of complex tax laws and regulations, expectations regarding the outcome of tax authority examinations, as well as the ultimate measurement of potential liabilities. The uncertain tax positions are reviewed quarterly and adjusted as events occur that could affect potential liabilities for additional taxes, including lapsing of applicable statutes of limitations, correspondence with tax authorities, proposed assessments by tax authorities, identification of new issues, and issuance of new legislation or regulations. The Company believes that adequate amounts of tax have been provided in income tax expense for any adjustments that may result from its uncertain tax positions. Based upon the information currently available, the Company does not reasonably expect changes in its existing uncertain tax positions in the next 12 months and have recorded the gross uncertain tax positions as a long-term liability. The Company has received final tax assessments up to and including its 2014 tax year. |
Related Parties
Related Parties | 12 Months Ended |
Dec. 31, 2020 | |
Related Party Transactions [Abstract] | |
Related Parties | NOTE 16-RELATED PARTIES There were no related party transactions for the year ended December 31, 2020 or 2019. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | NOTE 17-COMMITMENTS AND CONTINGENCIES In the normal course of business, the Company enters into contracts that contain a variety of indemnifications with its employees, licensors, suppliers and service providers. Further, the Company indemnifies its directors and officers who are, or were, serving at the Company ’ ’ Grants (“ The n d Israeli Ministry of Industry and Commerce 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 total payment under the IIA approval, net of the royalties already paid, $6.6 million, was fully paid during the first quarter of 2020 and recognized as research and development expense. Based on this payment, 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 at least 75% of its based R&D jobs in Israel (at the time of settlement) for a period of at least three years, all other obligations with the IIA ceased to exist as per the agreement. Separation Agreement On September 7, 2020, the Company entered into a Separation Agreement with Peter Pfreundschuh, the Company’s Chief Financial Officer, which sets forth the terms of Mr. Pfreundschuh’s termination of employment with the Company, effective as of October 15, 2020. The arrangement includes cash severance, a pro rata portion of the target annual bonus for calendar year 2020 contingent on certain performance conditions, and partial acceleration of share-based compensation. The Company recognized $0.7 million during the year ended December 31, 2020 in relation to this arrangement. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | NOTE 18-SUBSEQUENT EVENTS In January 2021, the Company announced that it entered into a three-year strategic research collaboration agreement with MD Anderson focusing on UGN-302 as an investigational treatment for high-grade NMIBC. Under the agreement, MD Anderson and the Company will collaborate on the design and conduct of non-clinical and clinical studies with oversight from a joint steering committee. The Company will provide funding, developmental candidates, and other support. Pursuant to the agreement, the Company made an upfront payment to MD Anderson of $500,000. In March 2021, the Company announced a transaction with RTW Investments (“RTW”) totaling $75.0 million in funding for the Company to support the launch of Jelmyto and the development of UGN-102. RTW will provide the Company with an upfront cash payment of $75.0 million and will receive tiered future payments based on global annual net product sales of Jelmyto and UGN-102, if approved. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The Company ’ |
Use of Estimates | Use of Estimates The a i i n a critical estimates relate 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 are conducted. Therefore, the functional currency of the Company is the Dollar. Accordingly, transactions in currencies other than the Dollar are measured and recorded in the functional currency using the exchange rate in effect at the date of the transaction. At the balance sheet date, monetary assets and liabilities that are denominated in currencies other than the Dollar are measured using the official exchange rate at the balance sheet date. The effects of foreign currency re-measurements are recorded in the consolidated statements of operations as “Interest and other income, net” |
Cash and Cash Equivalents; Marketable Securities | Cash and Cash Equivalents; Marketable Securities 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. 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 and Equity 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 are recorded as a component of interest and other income (expense), net. The cost of securities sold is based on the specific-identification method. Short-term investments are valued using models or other valuation methodologies that use Level 2 inputs. These models are primarily industry-standard models that consider various assumptions, including time value, yield curve, volatility factors, default rates, current market and contractual prices for the underlying financial instruments, as well as other relevant economic measures. The majority of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. For individual debt securities classified as available-for-sale securities where there has been a decline in fair value below amortized cost, the Company determines whether the decline resulted from a credit loss or other factors. The Company records impairment relating to credit losses through an allowance for credit losses, limited by the amount that the fair value is less than the amortized cost basis. Impairment that has not been recorded through an allowance for credit losses is recorded through other comprehensive income, net of applicable taxes. |
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 ’ The Company’s product sales are recognized through the Company's arrangement with a single customer, a third-party national specialty distributor. The Company assesses the need for an allowance for doubtful accounts primarily based on creditworthiness, historical payment experience and general economic conditions. The Company has not experienced any credit losses related to this customer and has not currently recognized any allowance for doubtful accounts. |
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 it operates, including Israel and the U.S. Deferred l e n s a a The n |
Inventory | Inventory The Company capitalizes inventory costs related to products to be sold in the ordinary course of business. The Company makes a determination of capitalizing inventory costs for a product based on, among other factors, status of regulatory approval, information regarding safety, efficacy and expectations relating to commercial sales and recoverability of costs. For Jelmyto The Company values its inventory at the lower of cost or net realizable value. The Company measures inventory approximating actual cost under a first-in, first-out basis. The Company assesses recoverability of inventory each reporting period to determine any write down to net realizable value resulting from excess or obsolete inventories. |
Property and Equipment | Property and Equipment Property and equipment are recorded at historical cost, net of accumulated depreciation, amortization and, if applicable, impairment charges. The Company reviews its property and equipment assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Property and equipment are depreciated over the following useful lives (in years): Useful Lives Computers and software 3 Laboratory equipment 3-6.5 Furniture 5-16.5 Manufacturing equipment 2 Leasehold improvements are amortized on a straight-line basis over the shorter of their estimated useful lives or lease terms. See Note 8 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. 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 to extend the lease. The lease extensions are included in the measurement of the right of use asset and lease liability when it is reasonably certain that it will exercise that option. Because most of 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. 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 (“Transition Date”). ROU assets for operating leases are periodically reviewed for impairment losses under ASC 360-10, “Property, Plant, and Equipment”, to determine whether an ROU asset is impaired, and if so, the amount of the impairment loss to recognize. |
Revenues | Revenues Product sales from Jelmyto Jelmyto The Company also derived revenues from its license and supply agreement with Allergan Pharmaceuticals International Limited (“Allergan”), a wholly owned subsidiary of Allergan plc which is now a part of AbbVie Inc. (the “Allergan/AbbVie Agreement”). Under the Allergan/AbbVie Agreement, the Company granted Allergan an exclusive license to develop, commercialize, and otherwise exploit products that contain reverse thermal hydrogel (“ RTGel RTGel RTGel . |
Research and Development Expenses | Research and Development Expenses Research s i d a l l |
Selling General and Administrative Expenses | Selling, General and Administrative Expenses Selling, general and administrative expenses consist primarily of personnel costs (including share-based compensation related to directors, employees and consultants). Other significant costs include commercial, medical affairs, external professional service costs, facility costs, accounting and audit services, legal services and other consulting fees. Selling, general and administrative costs are expensed as incurred. 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. |
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 options is determined using the Black-Scholes option-pricing model. The fair value of a restricted stock unit (“RSU”) equaled the closing price of the Company’s ordinary shares on the grant date. The The s n g |
Net Loss per Ordinary Share | Net Loss per Ordinary Share Basic net loss per share is computed by dividing the net loss attributable to ordinary shareholders by the weighted-average number of ordinary 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 ordinary shares that would have been outstanding if the potential ordinary shares had been issued and if the additional ordinary shares were dilutive. 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, 2020 2019 Basic and diluted: Loss attributable to equity holders of the Company $ 128,484 $ 105,146 Loss attributable to equity holders of the Company, after deducting dividend accumulated for preferred shares $ 128,484 $ 105,146 Weighted-average number of ordinary shares 21,780,826 20,528,727 Loss per ordinary share $ 5.90 $ 5.12 |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments, or ASU 2016-13. ASU 2016-13 requires the Company to measure and recognize expected credit losses for certain financial instruments, including trade receivables, as an allowance that reflects the Company’s current estimate of credit losses expected to be incurred. For available-for-sale debt securities with unrealized losses, the standard requires allowances to be recorded through net income instead of directly reducing the amortized cost of the investment under the prior other-than-temporary impairment model. The Company applied the modified retrospective transition method as of the date of initial application, January 1, 2020. As of December 31, 2020, the Company believes the cost basis for its marketable securities were recoverable in all material aspects and no credit impairments were recognized in the period. Similarly, the Company estimates minimal current expected credit losses on trade receivables and has not recognized any allowance for doubtful accounts in the period. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Property and Equipment Useful Lives | Property and equipment are depreciated over the following useful lives (in years): Useful Lives Computers and software 3 Laboratory equipment 3-6.5 Furniture 5-16.5 Manufacturing equipment 2 |
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, 2020 2019 Basic and diluted: Loss attributable to equity holders of the Company $ 128,484 $ 105,146 Loss attributable to equity holders of the Company, after deducting dividend accumulated for preferred shares $ 128,484 $ 105,146 Weighted-average number of ordinary shares 21,780,826 20,528,727 Loss per ordinary share $ 5.90 $ 5.12 |
Other Financial Information (Ta
Other Financial Information (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Other Financial Information [Abstract] | |
Schedule of Accounts Payable and Accrued Expenses | Accounts payable and accrued expenses consist of the following as of December 31, 2020 and 2019 (in thousands): December 31, 2020 December 31, 2019 Accounts payable $ 3,271 $ 4,694 Accrued sales reserves 382 — Accrued clinical expenses 1,359 399 Accrued research and development costs 1,356 2,644 Accrued general and administrative expenses 2,440 2,767 Accrued other expense 1,215 682 Total accrued expenses and other current liabilities $ 10,023 $ 11,186 |
Schedule of Interest and Other Income (Expenses) | Interest and other income (expenses) consisted of the following as of December 31, 2020 and 2019 (in thousands): Year Ended December 31, 2020 2019 Interest income 1,986 4,616 Other finance expenses (357 ) (284 ) Total interest and other income $ 1,629 $ 4,332 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Summary of Inventories | Inventories consist of the following as of December 31, 2020 and December 31, 2019 (in thousands): December 31, 2020 December 31, 2019 Raw materials $ 1,051 — Finished goods 913 — Total inventories $ 1,964 $ — |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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 and Level 2 fair value measurement criteria as of December 31, 2020 are as follows (in thousands): Fair Value Measurements Using Quoted Prices Significant in Active Other Balance as of Markets for Observable December 31, Identical Assets Inputs 2020 (Level 1) (Level 2) Marketable securities: US government $ 29,186 $ 29,186 $ — Corporate bonds 21,861 — 21,861 Money market funds (1) 39,744 39,744 — Total marketable securities $ 90,791 $ 68,930 $ 21,861 (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 and Level 2 fair value measurement criteria as of December 31, 2019 are as follows (in thousands): Fair Value Measurements Using Quoted Prices Significant in Active Other Balance as of Markets for Observable December 31, Identical Assets Inputs 2019 (Level 1) (Level 2) 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 — Certificates of deposit 4,108 — 4,108 Total marketable securities $ 162,942 $ 83,092 $ 79,850 (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, 2020 | |
Investments Debt And Equity Securities [Abstract] | |
Summary of Marketable Securities | The following table summarizes the Company’s marketable securities as of December 31, 2020 (in thousands): Amortized Cost Basis Unrealized Gains Fair Value Marketable securities: US government $ 28,970 $ 216 $ 29,186 Corporate bonds 21,806 55 21,861 Money market funds (1) 39,744 — 39,744 Total marketable securities $ 90,520 $ 271 $ 90,791 (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, 2020 December 31, 2019 Maturities within one year $ 88,898 $ 114,386 Maturities after one year through three years 1,893 48,556 Total marketable securities $ 90,791 $ 162,942 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment, consists of the following as of December 31, 2020 and 2019 (in thousands): December 31, 2020 2019 Laboratory equipment $ 333 $ 259 Computer equipment and software 1,676 416 Furniture 597 544 Leasehold improvements 609 530 Manufacturing equipment 226 226 3,441 1,975 Less: accumulated depreciation and amortization (1,395 ) (998 ) Property and equipment, net $ 2,046 $ 977 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Components of Lease Cost | The components of lease cost for the year ended December 31, 2020 were as follows (in thousands) Year Ended December 31, 2020 Operating lease cost $ 1,812 Sublease income (224 ) Variable lease cost 129 $ 1,717 |
Schedule of Amounts Recognized | The amounts recognized as of December 31, 2020 were as follows (in thousands): December 31, 2020 Right of use asset $ 2,158 Long-term lease liability 1,497 Other current liabilities 1,202 |
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, 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases 1,726 Right-of-use assets obtained in exchange for new operating lease liabilities 135 Weighted-average remaining lease term of operating leases 2.26 years Weighted-average discount rate of operating leases 5.38% |
Schedule of Maturities of Lease Liabilities | As of December 31, 2020, maturities of lease liabilities were as follows (in thousands): Operating Leases Years ending December 31, 2021 $ 1,307 2022 1,150 2023 357 2024 58 2025 and thereafter — Total future minimum lease payments $ 2,872 Less: Interest (173 ) Present value of lease liabilities $ 2,699 |
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 |
Schedule of Undiscounted Cash Flows to be Received Under Operating Sublease on an Annual Basis | As of December 31, 2020, undiscounted cash flows to be received under the Company’s operating sublease on an annual basis was as follows (in thousands): Operating Leases Years ending December 31, 2021 $ 235 2022 243 2023 251 2024 49 2025 and thereafter — Total future minimum sublease payments $ 778 |
Schedule of Sublease Income Recognized Net within Operating Expenses | Sublease income is recognized net within operating expenses. Sublease income for the year ended December 31, 2020 was as follows (in thousands): Year Ended December 31, 2020 Sublease income from fixed lease payments $ 224 |
Revenue from Product Sales (Tab
Revenue from Product Sales (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Revenue From Contract With Customer [Abstract] | |
Schedule of Net Product Sales | Net product sales consist of the following for the year ended December 31, 2020 and 2019 (in thousands): Year Ended December 31, 2020 December 31, 2019 Jelmyto $ 11,799 $ — |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Schedule of Fair Value of Options Granted | The e 2020 2019 Value of ordinary shares $16.50-29.41 $33.21-47.57 Dividend yield 0% 0% Expected volatility 71.43%-79.80% 74.09%-80.52% Risk-free interest rate 0.37%-1.35% 1.36%-2.62% Expected term 5.9-10 years 5.8-10 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, 2019 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 Granted 400,600 24.33 Canceled/Forfeited (408,534 ) 44.68 Exercised (137,070 ) 5.40 Outstanding as of December 31, 2020 2,726,331 $ 31.29 |
Summary of Number of Options Outstanding and Exercisable | The i 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 - 10.00 588,324 1.99 588,324 1.99 $10.01 - 20.00 268,000 8.77 75,000 6.39 $20.01 - 30.00 272,800 8.19 139,999 7.24 $30.01 - 40.00 413,500 6.72 340,833 6.36 $40.01 - 50.00 1,063,041 7.17 771,250 6.93 $50.01 - 59.23 120,666 7.00 115,332 6.98 2,726,331 2,030,738 |
Summary of Information about RSU Activity | The following table summarizes information about RSU activity as of December 31, 2020: Outstanding Restricted Stock Units Outstanding as of January 1, 2019 263,699 Granted 455,465 Vested and released (183,975 ) Forfeited (15,762 ) Outstanding as of December 31, 2019 519,427 Granted 591,480 Vested and released (304,537 ) Forfeited (85,954 ) Outstanding as of December 31, 2020 720,416 |
Schedule of Effect of Share-Based Compensation on Statements of Operations | The p Year ended December 31, 2020 2019 Research and development expenses $ 6,432 $ 8,291 Selling, general and administrative expenses 21,593 21,676 Total share-based compensation expense $ 28,025 $ 29,967 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Schedule of Expense for Current Income Taxes | For financial reporting purposes, the expense for current income taxes consists of the following: 2020 2019 Current taxes: U.S. Federal $ 3,218 - U.S. State 156 - Total current taxes $ 3,374 - |
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, 2020 2019 In respect of: Net operating loss carryforward $ 57,607 $ 33,817 Research and development expenses 5,362 4,591 Stock-based compensation 9,278 6,543 Issuance costs 978 2,063 In-process research and development 2,329 2,749 Right of use asset (372 ) (800 ) Lease Liability 473 896 Accrued expenses 1,589 762 Depreciation of fixed assets (299 ) (90 ) Other 18 62 Less—valuation allowance (76,963 ) (50,593 ) Net deferred tax assets $ — $ — |
Schedule of Change in Valuation Allowance | The change in valuation allowance for the years ended December 31, 2020 and 2019 were as follows: 2020 2019 Balance at the beginning of the year $ (50,593 ) $ (28,249 ) Changes during the year (26,370 ) (22,344 ) Balance at the end of the year $ (76,963 ) $ (50,593 ) |
Reconciliation of Statutory Tax Rate to Effective Tax | A reconciliation of the Company’s statutory tax rate to effective tax is as follows: December 31, 2020 2019 Pretax income $ (125,110 ) $ (105,146 ) Statutory rate 23% 23% Income tax expense/(benefit) at statutory rate (28,775 ) (24,184 ) Additional tax (tax saving) in respect of: Non-deductible expenses 1,439 2,076 Different tax rate of foreign subsidiaries 17 20 Uncertain tax positions 2,717 - Change in valuation allowance 26,370 22,344 Other 1,607 (257 ) Income tax expense $ 3,374 $ - |
Reconciliation of Uncertain Tax Positions | A reconciliation of the beginning and ending amount of uncertain tax positions is as follows: 2020 2019 Uncertain tax positions at the beginning of the year - - Gross increases — tax positions in current period 2,717 - Gross increases — tax positions in prior period - - Uncertain tax positions at the end of the year 2,717 - |
Business and Nature of Operat_2
Business and Nature of Operations - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Date of incorporation | 2004-04 |
Date of operating commencement | 2016-02 |
Basis of Presentation - Additit
Basis of Presentation - Addititonal Information (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ||
Accumulated deficit | $ 356,501 | $ 228,017 |
Significant Accounting Polici_4
Significant Accounting Policies - Property and Equipment Useful Lives (Details) | 12 Months Ended |
Dec. 31, 2020 | |
Computers and Software | |
Property Plant And Equipment [Line Items] | |
Property and Equipment, Useful Lives | 3 years |
Laboratory Equipment | Minimum | |
Property Plant And Equipment [Line Items] | |
Property and Equipment, Useful Lives | 3 years |
Laboratory Equipment | Maximum | |
Property Plant And Equipment [Line Items] | |
Property and Equipment, Useful Lives | 6 years 6 months |
Furniture | Minimum | |
Property Plant And Equipment [Line Items] | |
Property and Equipment, Useful Lives | 5 years |
Furniture | Maximum | |
Property Plant And Equipment [Line Items] | |
Property and Equipment, Useful Lives | 16 years 6 months |
Manufacturing Equipment | |
Property Plant And Equipment [Line Items] | |
Property and Equipment, Useful Lives | 2 years |
Significant Accounting Polici_5
Significant Accounting Policies - Schedule of Calculation of Basic and Diluted Loss per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Basic and diluted: | ||
Loss attributable to equity holders of the Company | $ 128,484 | $ 105,146 |
Loss attributable to equity holders of the Company, after deducting dividend accumulated for preferred shares | $ 128,484 | $ 105,146 |
Weighted-average number of ordinary shares | 21,780,826 | 20,528,727 |
Loss per ordinary share | $ 5.90 | $ 5.12 |
Significant Accounting Polici_6
Significant Accounting Policies - Additional Information (Details) - ASU 2016-13 | Dec. 31, 2020 |
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | |
Change in Accounting Principle, Accounting Standards Update, Adopted [true false] | true |
Change in Accounting Principle, Accounting Standards Update, Adoption Date | Jan. 1, 2020 |
Change in Accounting Principle, Accounting Standards Update, Immaterial Effect [true false] | false |
Other Financial Information - S
Other Financial Information - Schedule of Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Other Financial Information [Abstract] | ||
Accounts payable | $ 3,271 | $ 4,694 |
Accrued sales reserves | 382 | |
Accrued clinical expenses | 1,359 | 399 |
Accrued research and development costs | 1,356 | 2,644 |
Accrued general and administrative expenses | 2,440 | 2,767 |
Accrued other expense | 1,215 | 682 |
Total accrued expenses and other current liabilities | $ 10,023 | $ 11,186 |
Other Financial Information -_2
Other Financial Information - Schedule of Interest and Other Income (Expenses) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Other Financial Information [Abstract] | ||
Interest income | $ 1,986 | $ 4,616 |
Other finance expenses | (357) | (284) |
Total interest and other income | $ 1,629 | $ 4,332 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Inventory Disclosure [Abstract] | |
Raw materials | $ 1,051 |
Finished goods | 913 |
Total inventories | $ 1,964 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2020USD ($) | |
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, 2020 | Dec. 31, 2019 |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | $ 90,791 | $ 162,942 |
Fair Value, Measurements, Recurring | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 90,791 | 162,942 |
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: | 68,930 | 83,092 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 21,861 | 79,850 |
Fair Value, Measurements, Recurring | US Government | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 29,186 | 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: | 29,186 | 66,094 |
Fair Value, Measurements, Recurring | Corporate Bonds | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 21,861 | 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: | 21,861 | 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: | 39,744 | 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: | $ 39,744 | 16,998 |
Fair Value, Measurements, Recurring | Certificates of Deposit | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 4,108 | |
Fair Value, Measurements, Recurring | Certificates 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, 2020 | Dec. 31, 2019 |
Marketable securities: | ||
Amortized Cost Basis | $ 90,520 | |
Unrealized Gains | 271 | |
Fair Value | 90,791 | $ 162,942 |
US Government | ||
Marketable securities: | ||
Amortized Cost Basis | 28,970 | |
Unrealized Gains | 216 | |
Fair Value | 29,186 | |
Corporate Bonds | ||
Marketable securities: | ||
Amortized Cost Basis | 21,806 | |
Unrealized Gains | 55 | |
Fair Value | 21,861 | |
Money Market Funds | ||
Marketable securities: | ||
Amortized Cost Basis | 39,744 | |
Fair Value | $ 39,744 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Investments Debt And Equity Securities [Abstract] | |
Available-for-sale debt securities, unrealized gain position | $ 300,000 |
Available-for-sale debt securities, unrealized loss position | 0 |
Other-than-temporary impairment Loss, debt securities, portion recognized in earnings | $ 0 |
Marketable Securities - Summa_2
Marketable Securities - Summary of Fair Values of Marketable Securities by Contractual Maturity (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Available For Sale Securities Debt Maturities Fair Value [Abstract] | ||
Maturities within one year | $ 88,898 | $ 114,386 |
Maturities after one year through three years | 1,893 | 48,556 |
Total marketable securities | $ 90,791 | $ 162,942 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property Plant And Equipment [Line Items] | ||
Property and equipment | $ 3,441 | $ 1,975 |
Less: accumulated depreciation and amortization | (1,395) | (998) |
Property and equipment, net | 2,046 | 977 |
Laboratory Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 333 | 259 |
Computers and Software | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 1,676 | 416 |
Furniture | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 597 | 544 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 609 | 530 |
Manufacturing Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | $ 226 | $ 226 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Property Plant And Equipment [Abstract] | ||
Depreciation and amortization expense | $ 0.4 | $ 0.3 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Nov. 30, 2019 | Apr. 30, 2018 | Dec. 31, 2020 | |
Lessee Lease Description [Line Items] | |||
Operating leases, existence of option to extend | true | ||
Operating leases, options to extend lease term, description | UPL signed an addendum to its November 2014 lease agreement for the Company’s executive offices located in Israel, in order to increase the office space rented and to extend the rent period until 2019. In March 2019, UPL exercised the agreement extension option and extended the rental period for an additional three years until August 2022. | ||
Operating leases, options to extend lease term | 3 years | ||
Operating lease extended lease expiration, month and year | 2022-08 | ||
Remaining rental payments to be received over the lease term | $ 224 | ||
Minimum | |||
Lessee Lease Description [Line Items] | |||
Lease expiration year | 2021 | ||
Maximum | |||
Lessee Lease Description [Line Items] | |||
Lease expiration year | 2023 | ||
New York | |||
Lessee Lease Description [Line Items] | |||
Impairment losses on operating leases | $ 200 | ||
New York | UroGen Pharma Inc. | |||
Lessee Lease Description [Line Items] | |||
Lease commencement period, month and year | 2017-10 | ||
Lease termination period, month and year | 2021-02 | ||
Los Angeles, California | UroGen Pharma Inc. | |||
Lessee Lease Description [Line Items] | |||
Lease termination period, month and year | 2024-03 | ||
Lease commencement date | Jul. 10, 2018 | ||
Proceeds from tenant allowance | $ 200 | ||
Remaining contractual obligation | $ 900 | ||
Lessee operating sublease commencement date | Jan. 1, 2020 | ||
Lessee operating sublease termination period, month and year | 2024-03 | ||
Remaining rental payments to be received over the lease term | 700 | ||
Princeton, NJ | UroGen Pharma Inc. | Lease Agreement | |||
Lessee Lease Description [Line Items] | |||
Lease commencement date | Nov. 29, 2019 | ||
Remaining contractual obligation | $ 1,200 | ||
Lease term | 38 months |
Leases - Components of Lease Co
Leases - Components of Lease Cost (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Leases [Abstract] | |
Operating lease cost | $ 1,812 |
Sublease income | (224) |
Variable lease cost | 129 |
Lease, Cost | $ 1,717 |
Leases - Schedule of Amounts Re
Leases - Schedule of Amounts Recognized (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Leases [Abstract] | ||
Right of use asset | $ 2,158 | $ 3,735 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:OtherAssetsNoncurrent | |
Long-term lease liability | $ 1,497 | $ 2,604 |
Other current liabilities | $ 1,202 | |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent |
Leases - Schedule of Supplement
Leases - Schedule of Supplemental Information Related to Leases (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Cash paid for amounts included in the measurement of lease liabilities: | |
Operating cash flows from operating leases | $ 1,726 |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 135 |
Weighted-average remaining lease term of operating leases | 2 years 3 months 3 days |
Weighted-average discount rate of operating leases | 5.38% |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Leases [Abstract] | ||
2021 | $ 1,307 | |
2022 | 1,150 | |
2023 | 357 | |
2024 | 58 | |
Total future minimum lease payments | 2,872 | |
Less: Interest | (173) | |
Present value of lease liabilities | $ 2,699 | |
2020 | $ 1,758 | |
2021 | 1,269 | |
2022 | 1,101 | |
2023 | 348 | |
2024 and thereafter | 58 | |
Total future minimum lease payments | $ 4,534 |
Leases - Schedule of Undiscount
Leases - Schedule of Undiscounted Cash Flows to be Received Under Operating Sublease on an Annual Basis (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Leases [Abstract] | |
2021 | $ 235 |
2022 | 243 |
2023 | 251 |
2024 | 49 |
Total future minimum sublease payments | $ 778 |
Leases - Schedule of Sublease I
Leases - Schedule of Sublease Income Recognized Net within Operating Expenses (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Leases [Abstract] | |
Sublease income from fixed lease payments | $ 224 |
Revenue from Product Sales - Sc
Revenue from Product Sales - Schedule of Net Product Sales (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue From Contract With Customer [Abstract] | ||
Revenue From Contract With Customer Product And Service [Extensible List] | urgn:Jelmyto1Member | urgn:Jelmyto1Member |
Revenues, net | $ 11,799 | $ 18 |
License and Collaboration Agr_2
License and Collaboration Agreements - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Nov. 30, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | |
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 | ||
Maximum | Agenus Agreement | |||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||
Royalty ranging on net sales of licensed products | 20.00% | ||
Minimum | Agenus Agreement | |||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||
Royalty ranging on net sales of licensed products | 14.00% | ||
Allergan/AbbVie | License Agreement | |||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||
Milestone payments received for licensing agreement | $ 25,000,000 | ||
Allergan/AbbVie | 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 |
Shareholders' Equity - Addition
Shareholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2019 | Jan. 31, 2019 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Class Of Stock [Line Items] | |||||
Ordinary shares, shares authorized | 100,000,000 | 100,000,000 | 100,000,000 | ||
Ordinary shares, issued | 21,026,184 | 22,167,791 | 21,026,184 | ||
Ordinary shares, outstanding | 21,026,184 | 22,167,791 | 21,026,184 | ||
Issuance of ordinary shares, consideration received net of underwriting discounts and commissions and issuance costs | $ 15,777 | $ 161,447 | |||
Issuance of ordinary shares, net of issuance expenses | $ 15,853 | $ 161,662 | |||
Cowen and Company Limited Liability Company | ATM Sales Agreement | |||||
Class Of Stock [Line Items] | |||||
Issuance of ordinary shares, shares | 700,000 | ||||
Issuance of ordinary shares, net of issuance expenses | $ 16,600 | ||||
Net proceeds from issuance ordinary shares after deducting sales commissions | 15,800 | ||||
Issuance of ordinary shares, value, remaining capacity | $ 83,400 | ||||
Cowen and Company Limited Liability Company | ATM Sales Agreement | Maximum | |||||
Class Of Stock [Line Items] | |||||
Issuance of ordinary shares, consideration received net of underwriting discounts and commissions and issuance costs | $ 100,000 | ||||
Underwritten Public Offering | |||||
Class Of Stock [Line Items] | |||||
Issuance of ordinary shares, shares | 4,207,317 | ||||
Additional ordinary shares exercised under underwriters option to purchase at the public offering price | 548,780 | ||||
Issuance of ordinary shares, price per share | $ 41 | ||||
Issuance of ordinary shares, consideration received net of underwriting discounts and commissions and issuance costs | $ 161,400 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) | Jun. 08, 2020shares | Jan. 03, 2019USD ($)$ / sharesshares | Oct. 12, 2018shares | Jan. 01, 2018shares | Jun. 30, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($) | Jun. 30, 2019USD ($)$ / sharesshares | Mar. 31, 2017shares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | May 31, 2019shares |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Stock options granted | shares | 400,600 | 955,732 | |||||||||
Share-based compensation | $ 28,025,000 | $ 29,967,000 | |||||||||
Stock option exercise prices ranging lower limit | $ / shares | $ 16.50 | $ 33.21 | |||||||||
Stock option exercise prices ranging upper limit | $ / shares | $ 29.41 | $ 47.57 | |||||||||
Fair value of option granted | $ 6,700,000 | $ 27,600,000 | |||||||||
Unrecognized compensation cost of employee options | $ 13,500,000 | ||||||||||
Expected to be recognized over a weighted average period | 1 year 4 months 13 days | ||||||||||
Intrinsic value of stock options exercised | $ 2,300,000 | 14,200,000 | |||||||||
Aggregate intrinsic value of the total vested and exercisable options | $ 7,700,000 | ||||||||||
Options | General and Administrative Expenses | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share-based compensation | $ 900,000 | ||||||||||
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 | 10 years | |||||||||
Awards vesting period | 1 year | 1 year | |||||||||
Number of stock options approved for grants | shares | 70,000 | 70,000 | |||||||||
Stock options granted | shares | 10,000 | 10,000 | |||||||||
Exercise of option to ordinary shares conversion ratio | 1 | 1 | |||||||||
Stock option exercise | $ / shares | $ 28.24 | $ 34.83 | |||||||||
Estimated fair value of options granted | $ 1,500,000 | $ 1,900,000 | |||||||||
Options | Chairman of Board of Directors | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Stock options granted | shares | 10,000 | 10,000 | |||||||||
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 | ||||||||||
Share-based compensation | $ 0 | ||||||||||
Expected to be recognized over a weighted average period | 1 year 10 months 2 days | ||||||||||
Fair value of RSUs granted | $ 15,600,000 | $ 19,900,000 | |||||||||
Unrecognized compensation cost of RSUs | $ 17,600,000 | ||||||||||
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) | 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 | 400,000 | 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 | 3,950,167 | 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, 2020 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Dividend yield | 0.00% | 0.00% |
Expected volatility, Minimum | 71.43% | 74.09% |
Expected volatility, Maximum | 79.80% | 80.52% |
Risk-free interest rate, Minimum | 0.37% | 1.36% |
Risk-free interest rate, Maximum | 1.35% | 2.62% |
Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Value of ordinary shares | $ 16.5 | $ 33.21 |
Expected term | 5 years 10 months 24 days | 5 years 9 months 18 days |
Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Value of ordinary shares | $ 29.41 | $ 47.57 |
Expected term | 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, 2020 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Options, Granted | 400,600 | 955,732 |
Employees and Non-employees | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Options, Outstanding beginning balance | 2,871,335 | 2,522,981 |
Number of Options, Granted | 400,600 | 955,732 |
Number of Options, Canceled/Forfeited | (408,534) | (183,725) |
Number of Options, Exercised | (137,070) | (423,653) |
Number of Options, Outstanding ending balance | 2,726,331 | 2,871,335 |
Weighted Average Price Per Share, Outstanding beginning balance | $ 32.93 | $ 26.16 |
Weighted Average Price Per Share, Granted | 24.33 | 41.96 |
Weighted Average Price Per Share, Canceled/Forfeited | 44.68 | 41.85 |
Weighted Average Price Per Share, Exercised | 5.40 | 9.10 |
Weighted Average Price Per Share, Outstanding ending balance | $ 31.29 | $ 32.93 |
Share Based Compensation - Su_2
Share Based Compensation - Summary of Number of Options Outstanding and Exercisable (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Options outstanding, exercise price per share | $ 16.50 | $ 33.21 |
Options outstanding, exercise price per share | $ 29.41 | $ 47.57 |
Options outstanding, number of options outstanding at end of year | 2,726,331 | |
Options exercisable, number of options outstanding at end of year | 2,030,738 | |
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 | 588,324 | |
Options outstanding, weighted average remaining contractual life | 1 year 11 months 26 days | |
Options exercisable, number of options outstanding at end of year | 588,324 | |
Options exercisable, weighted average remaining contractual life | 1 year 11 months 26 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 | 268,000 | |
Options outstanding, weighted average remaining contractual life | 8 years 9 months 7 days | |
Options exercisable, number of options outstanding at end of year | 75,000 | |
Options exercisable, weighted average remaining contractual life | 6 years 4 months 20 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 | 272,800 | |
Options outstanding, weighted average remaining contractual life | 8 years 2 months 8 days | |
Options exercisable, number of options outstanding at end of year | 139,999 | |
Options exercisable, weighted average remaining contractual life | 7 years 2 months 26 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 | 413,500 | |
Options outstanding, weighted average remaining contractual life | 6 years 8 months 19 days | |
Options exercisable, number of options outstanding at end of year | 340,833 | |
Options exercisable, weighted average remaining contractual life | 6 years 4 months 9 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 | 1,063,041 | |
Options outstanding, weighted average remaining contractual life | 7 years 2 months 1 day | |
Options exercisable, number of options outstanding at end of year | 771,250 | |
Options exercisable, weighted average remaining contractual life | 6 years 11 months 4 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 | 120,666 | |
Options outstanding, weighted average remaining contractual life | 7 years | |
Options exercisable, number of options outstanding at end of year | 115,332 | |
Options exercisable, weighted average remaining contractual life | 6 years 11 months 23 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, 2020 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Options, Outstanding beginning balance | 519,427 | 263,699 |
Granted | 591,480 | 455,465 |
Vested and released | (304,537) | (183,975) |
Forfeited | (85,954) | (15,762) |
Number of Options, Outstanding ending balance | 720,416 | 519,427 |
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, 2020 | Dec. 31, 2019 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation | $ 28,025 | $ 29,967 |
Research and Development Expenses | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation | 6,432 | 8,291 |
Selling, General and Administrative Expenses | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation | $ 21,593 | $ 21,676 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Corporate tax rate | 23.00% | 23.00% | 23.00% |
Net carryforward tax losses | $ 250,200 | $ 151,900 | |
Liabilities for uncertain tax positions | 2,717 | ||
Accrued interest and penalties related to uncertain tax positions | $ 700 |
Income Taxes - Schedule of Expe
Income Taxes - Schedule of Expense for Current Income Taxes (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Current taxes: | |
U.S. Federal | $ 3,218 |
U.S. State | 156 |
Total current taxes | $ 3,374 |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Income Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
In respect of: | |||
Net operating loss carryforward | $ 57,607 | $ 33,817 | |
Research and development expenses | 5,362 | 4,591 | |
Stock-based compensation | 9,278 | 6,543 | |
Issuance costs | 978 | 2,063 | |
In-process research and development | 2,329 | 2,749 | |
Right of use asset | (372) | (800) | |
Lease Liability | 473 | 896 | |
Accrued expenses | 1,589 | 762 | |
Depreciation of fixed assets | (299) | (90) | |
Other | 18 | 62 | |
Less—valuation allowance | $ (76,963) | $ (50,593) | $ (28,249) |
Income Taxes - Schedule of Chan
Income Taxes - Schedule of Change in Valuation Allowance (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Valuation Allowance [Abstract] | ||
Balance at the beginning of the year | $ (50,593) | $ (28,249) |
Changes during the year | (26,370) | (22,344) |
Balance at the end of the year | $ (76,963) | $ (50,593) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Statutory Tax Rate to Effective Tax (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Expense Benefit Continuing Operations Income Tax Reconciliation [Abstract] | |||
Pretax income | $ (125,110) | $ (105,146) | |
Statutory rate | 23.00% | 23.00% | 23.00% |
Income tax expense/(benefit) at statutory rate | $ (28,775) | $ (24,184) | |
Non-deductible expenses | 1,439 | 2,076 | |
Different tax rate of foreign subsidiaries | 17 | 20 | |
Uncertain tax positions | 2,717 | ||
Change in valuation allowance | 26,370 | 22,344 | |
Other | 1,607 | $ (257) | |
Income tax expense | $ 3,374 |
Income Taxes - Reconciliation_2
Income Taxes - Reconciliation of Uncertain Tax Positions (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Income Tax Disclosure [Abstract] | |
Gross increases — tax positions in current period | $ 2,717 |
Uncertain tax positions at the end of the year | $ 2,717 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2020 | Mar. 31, 2020 | |
Pfreundschuh | ||
Commitments And Contingent Liabilities [Line Items] | ||
Employee termination cost | $ 0.7 | |
IIA | ||
Commitments And Contingent Liabilities [Line Items] | ||
Royalty amount payable | $ 6.6 | |
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 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - USD ($) | 1 Months Ended | |
Mar. 31, 2021 | Jan. 31, 2021 | |
MD Anderson | Subsequent Events | ||
Subsequent Event [Line Items] | ||
Upfront cash payments made | $ 500,000 | |
RTW Investments | Scenario Forecast | ||
Subsequent Event [Line Items] | ||
Upfront fee | $ 75,000,000 |