Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2020 | Nov. 04, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | URGN | |
Title of 12(b) Security | Ordinary Shares, par value NIS 0.01 per share | |
Security Exchange Name | NASDAQ | |
Entity Registrant Name | UROGEN PHARMA LTD. | |
Entity Central Index Key | 0001668243 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Ordinary Shares Outstanding | 22,093,054 | |
Entity Shell Company | false | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Document Quarterly 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 Drive | |
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 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 24,565 | $ 49,688 |
Marketable securities | 95,058 | 97,389 |
Restricted cash | 1,224 | 523 |
Accounts receivable | 2,810 | |
Inventory | 1,346 | |
Prepaid expenses and other current assets | 4,335 | 1,034 |
Total current assets | 129,338 | 148,634 |
Non-current assets: | ||
Property and equipment, net | 1,725 | 977 |
Restricted deposit | 223 | 223 |
Right of use asset | 2,652 | 3,735 |
Marketable securities | 5,900 | 48,555 |
Other non-current assets | 55 | 264 |
TOTAL ASSETS | 139,893 | 202,388 |
Current liabilities: | ||
Accounts payable and accrued expenses | 8,492 | 11,186 |
Employee related accrued expenses | 7,791 | 6,711 |
Other current liabilities | 1,335 | 1,585 |
Total current liabilities: | 17,618 | 19,482 |
Non-current liabilities: | ||
Long-term lease liability | 1,748 | 2,604 |
TOTAL LIABILITIES | 19,366 | 22,086 |
Commitments and contingencies (Note 14) | ||
Shareholders' equity: | ||
Ordinary shares, NIS 0.01 par value; 100,000,000 shares authorized at September 30, 2020 and December 31, 2019; 22,071,432 and 21,026,184 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively | 60 | 57 |
Additional paid-in capital | 445,950 | 407,986 |
Accumulated deficit | (325,975) | (228,017) |
Accumulated other comprehensive income | 492 | 276 |
TOTAL SHAREHOLDERS’ EQUITY | 120,527 | 180,302 |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 139,893 | $ 202,388 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) (unaudited) - ₪ / shares | Sep. 30, 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 | 22,071,432 | 21,026,184 |
Ordinary shares, outstanding | 22,071,432 | 21,026,184 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Income Statement [Abstract] | ||||
Revenues | $ 3,461 | $ 3,833 | $ 18 | |
Cost of revenues | 309 | 357 | ||
Gross profit | 3,152 | 3,476 | 18 | |
Operating expenses: | ||||
Research and development expenses | 10,211 | $ 9,481 | 34,905 | 29,203 |
Selling, general and administrative expenses | 22,065 | 13,972 | 68,056 | 40,454 |
Operating loss | (29,124) | (23,453) | (99,485) | (69,639) |
Interest and other income, net | 308 | 1,201 | 1,527 | 3,466 |
NET LOSS | (28,816) | (22,252) | (97,958) | (66,173) |
STATEMENTS OF COMPREHENSIVE LOSS | ||||
Net loss | (28,816) | (22,252) | (97,958) | (66,173) |
Other comprehensive income | ||||
Unrealized (loss) gain on marketable securities | (268) | 22 | 216 | 303 |
COMPREHENSIVE LOSS | $ (29,084) | $ (22,230) | $ (97,742) | $ (65,870) |
Net loss per ordinary share basic and diluted | $ (1.31) | $ (1.06) | $ (4.52) | $ (3.25) |
Weighted average number of shares outstanding used in computation of basic and diluted loss per ordinary share | 22,058,343 | 20,916,780 | 21,657,712 | 20,373,070 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (unaudited) - 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 | 3,343 | $ 2 | 3,341 | ||
Exercise of options into ordinary shares, shares | 522,050 | ||||
Share-based compensation | 21,902 | 21,902 | |||
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 | 303 | $ 303 | |||
Net loss | (66,173) | (66,173) | |||
Balance at Sep. 30, 2019 | 210,916 | $ 57 | 399,600 | (189,044) | 303 |
Balance,Share at Sep. 30, 2019 | 20,944,250 | ||||
Balance at Jun. 30, 2019 | 224,779 | $ 57 | 391,233 | (166,792) | 281 |
Balance,Share at Jun. 30, 2019 | 20,849,515 | ||||
Exercise of options into ordinary shares | 1,124 | 1,124 | |||
Exercise of options into ordinary shares, shares | 94,735 | ||||
Share-based compensation | 7,243 | 7,243 | |||
Other comprehensive income | 22 | 22 | |||
Net loss | (22,252) | (22,252) | |||
Balance at Sep. 30, 2019 | 210,916 | $ 57 | 399,600 | (189,044) | 303 |
Balance,Share at Sep. 30, 2019 | 20,944,250 | ||||
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 | 691 | $ 1 | 690 | ||
Exercise of options into ordinary shares, shares | 345,248 | ||||
Share-based compensation | 21,499 | 21,499 | |||
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 | 216 | 216 | |||
Net loss | (97,958) | (97,958) | |||
Balance at Sep. 30, 2020 | 120,527 | $ 60 | 445,950 | (325,975) | 492 |
Balance,Share at Sep. 30, 2020 | 22,071,432 | ||||
Balance at Jun. 30, 2020 | 142,660 | $ 60 | 438,999 | (297,159) | 760 |
Balance,Share at Jun. 30, 2020 | 22,001,296 | ||||
Exercise of options into ordinary shares | 188 | 188 | |||
Exercise of options into ordinary shares, shares | 70,136 | ||||
Share-based compensation | 6,763 | 6,763 | |||
Other comprehensive income | (268) | (268) | |||
Net loss | (28,816) | (28,816) | |||
Balance at Sep. 30, 2020 | $ 120,527 | $ 60 | $ 445,950 | $ (325,975) | $ 492 |
Balance,Share at Sep. 30, 2020 | 22,071,432 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (97,958) | $ (66,173) |
Adjustment to reconcile net loss to net cash from operating activities: | ||
Depreciation and amortization | 295 | 188 |
Amortization/Accretion on marketable securities | 386 | (497) |
Stock-based compensation | 21,499 | 21,902 |
Amortization of right of use asset | 1,134 | 736 |
Lease liability | (1,157) | (620) |
Changes in operating assets and liabilities: | ||
Inventory | (1,346) | |
Accounts receivable | (2,810) | |
Prepaid expenses and other current assets | (3,261) | (520) |
Accounts payable and accrued expenses | (2,506) | (190) |
Employee related accrued expenses | 1,080 | 157 |
Net cash used in operating activities | (84,644) | (45,017) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Change in restricted deposit | (4) | |
Purchase of marketable securities | (29,687) | (168,852) |
Maturities of marketable securities | 74,503 | 14,100 |
Purchases of property and equipment | (1,043) | (133) |
Net cash provided by (used in) investing activities | 43,773 | (154,889) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from exercise of options into ordinary shares | 651 | 3,343 |
Issuance of ordinary shares, net of issuance expenses | 15,853 | 161,662 |
Issuance cost related to at-the-market issuances | (55) | |
Net cash provided by financing activities | 16,449 | 165,005 |
DECREASE IN CASH AND CASH EQUIVALENTS | (24,422) | (34,901) |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF THE PERIOD | 50,211 | 101,571 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF THE PERIOD | 25,789 | $ 66,670 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH ACTIVITIES: | ||
Non-cash new lease liabilities | 51 | |
Exercise of options | $ 40 |
Business and Nature of Operatio
Business and Nature of Operations | 9 Months Ended |
Sep. 30, 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 On April 15, 2020, the U.S. Food and Drug Administration (“FDA”) granted expedited approval for Jelmyto, a first-in-class treatment indicated for adults with low-grade upper tract urothelial cancer (“LG-UTUC”). Jelmyto consists of mitomycin, an established chemotherapy, and sterile hydrogel, using our proprietary sustained release RTGel technology. It has been designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Sep. 30, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Basis of Presentation | NOTE 2-BASIS OF PRESENTATION The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements. In the opinion of the Company’s management, the accompanying condensed consolidated financial statements contain all adjustments (consisting of normal recurring accruals and adjustments) necessary for fair statement of its financial position, results of operations and cash flows of the Company at the dates and for the periods indicated. Interim results are not necessarily indicative of results for the full fiscal year. The year-end condensed consolidated balance sheet data was derived from audited financial statements but does not include all disclosures required by accounting principles generally accepted in the United States. The unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (“SEC”) on March 2, 2020. 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 $326.0 million and $228.0 million as of September 30, 2020 and December 31, 2019, respectively. The Company expects to incur losses and have negative net cash flows from operating activities as it continues its commercial launch of Jelmyto, and 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 its ability to develop its technologies to the point of FDA approval and subsequent revenue generation and, the Company must raise enough capital to finance these efforts. 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. However, in the future, the Company may need to raise additional capital to finance the continued operating and capital requirements of the Company. There can be no assurances that the Company will be able to secure such additional financing, or if available, that it will be sufficient to meet its needs. If the Company cannot obtain adequate working capital, it may be forced to reevaluate its planned business operations. |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | NOTE 3-SIGNIFICANT ACCOUNTING POLICIES Principles of Consolidation The condensed consolidated financial statements include the accounts of UPL and its subsidiary, UPI. Intercompany balances and transactions have been eliminated during consolidation. Use of Estimates The a i i n a i Functional The p l Accordingly, l n i a condensed a ( 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. Cash and cash equivalents and marketable securities totaled $125.5 million as of September 30, 2020. The Company classifies its marketable securities as available-for-sale in accordance with the Financial Accounting Standards Board (“ 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 commenced capitalization of inventory at the receipt of FDA approval. 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 condensed 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 are recognized as revenue under ASC 606 at the point in time that control of the product has been transferred to the customer, generally at the point the product has been delivered to the treating physician. All product sales of Jelmyto are recognized through the Company's arrangement with a single customer, a third-party national specialty distributor. Net revenues recognized include management’s estimate of returns, consideration paid to the customer, chargebacks relating to differences between the wholesale acquisition cost and the contracted price offered to the end consumer, chargebacks relating to 340b drug pricing programs, Medicaid drug rebate programs, and the Company’s copay assistance program, which are estimated based on industry benchmarking studies as well as the Company’s historical experience. The Company also derives revenues from its license and supply agreement (the “Allergan/AbbVie Agreement”) with Allergan Pharmaceuticals International Limited (“Allergan”), a wholly owned subsidiary of Allergan plc which is now a part of AbbVie Inc. 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”) and agreed to supply Allergan with pre-clinical and clinical quantities of the RTGel product, also referred to as the RTGel Research and Development Expenses Research and development costs are expensed as incurred and consist primarily of the cost of salaries, share-based compensation expenses, payroll taxes and other employee benefits, subcontractors and materials used for research and development activities, including nonclinical studies, clinical trials, manufacturing costs and professional services. The costs of services performed by others in connection with the research and development activities of the Company, including research and development conducted by others on behalf of the Company, shall be included in research and development costs and expensed as the contracted work is performed. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial or project and the invoices received from its external service providers. The Company adjusts its accrual as actual costs become known. Where contingent milestone payments are due to third parties under research and development arrangements or license agreements, the milestone payment obligations are expensed when the milestone results are achieved. Selling General and Administrative Expenses Selling, general and administrative expenses consist primarily of personnel costs (including share-based compensation related to directors, executives, finance, commercial, medical affairs, business development, investor relations and human resources functions). Other significant costs include commercial, medical affairs, external professional service costs, facility costs, accounting and audit services, legal services, and other consulting fees. Selling, general and administrative costs are expensed as incurred, and the Company accrues for services provided by third parties related to the above expenses by monitoring the status of services provided and receiving estimates from its service providers and adjusting its accruals as actual costs become known. 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 Company accounts for forfeitures as they occur in accordance with ASC Topic 718, “Compensation—Stock Compensation”. 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. 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, or the Transition Date. As of September 30, 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 | 9 Months Ended |
Sep. 30, 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 September 30, 2020 and December 31, 2019 (in thousands): September 30, 2020 December 31, 2019 Accounts payable $ 4,134 $ 4,694 Accrued clinical expenses 756 399 Accrued research and development costs 1,190 2,644 Accrued selling, general and administrative expenses 1,982 2,767 Accrued other expense 430 682 Total accounts payable and accrued expenses $ 8,492 $ 11,186 Interest and Other Income (Expenses), Net Interest and other income (expenses) consisted of the following as of September 30, 2020 and 2019 (in thousands): Nine Months Ended September 30, 2020 2019 Interest income $ 1,719 $ 3,610 Other finance expenses (192 ) (144 ) Total finance income $ 1,527 $ 3,466 |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2020 | |
Inventory Disclosure [Abstract] | |
Inventories | NOTE 5-INVENTORIES Inventories consist of the following as of September 30, 2020 and December 31, 2019 (in thousands): September 30, 2020 December 31, 2019 Raw materials $ 927 — Finished goods 419 — $ 1,346 $ — |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 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 ’ 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 September 30, 2020 are as follows (in thousands): Fair Value Measurements Using Quoted Prices Significant in Active Other Balance as of Markets for Observable September 30, Identical Assets Inputs 2020 (Level 1) (Level 2) Marketable securities: US government $ 42,551 $ 42,551 $ — Corporate bonds 37,080 — 37,080 Commercial paper 19,696 — 19,696 Money market funds (1) 3,288 3,288 — Certificates of deposit 1,631 — 1,631 $ 104,246 $ 45,839 $ 58,407 (1) Included within cash and cash equivalents on the condensed 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 $ 162,942 $ 83,092 $ 79,850 (1) Included within cash and cash equivalents on the condensed consolidated balance sheets. The Company ’ |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2020 | |
Investments Debt And Equity Securities [Abstract] | |
Marketable Securities | NOTE 7-MARKETABLE SECURITIES The following table summarizes the Company’s marketable securities as of September 30, 2020 (in thousands): Amortized Cost Basis Unrealized Gains Unrealized Losses Fair Value Marketable securities: US government $ 42,204 $ 347 $ — $ 42,551 Corporate bonds 36,939 141 — 37,080 Commercial paper 19,692 4 — 19,696 Money market funds (1) 3,288 — — 3,288 Certificates of deposit 1,631 — — 1,631 $ 103,754 $ 492 $ — $ 104,246 (1) Included within cash and cash equivalents on the condensed consolidated balance sheets. The Company classifies its marketable securities as available-for-sale and they consist of all debt securities. The amortized cost basis as of September 30, 2020 includes $0.3 million of accrued interest receivable . Unrealized gains and losses on available-for-sale debt securities are included as a component of comprehensive loss. As of September 30, 2020 As of September 30, 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 September 30, 2020 mature at various dates through February 2022. The fair values of marketable securities by contractual maturity consist of the following (in thousands): September 30, 2020 December 31, 2019 Maturities within one year $ 98,346 $ 114,386 Maturities after one year through three years 5,900 48,556 $ 104,246 $ 162,942 |
Property and Equipment
Property and Equipment | 9 Months Ended |
Sep. 30, 2020 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | NOTE 8-PROPERTY AND EQUIPMENT Property and equipment, consists of the following as of September 30, 2020 and December 31, 2019 (in thousands): September 30, 2020 December 31, 2019 Laboratory equipment $ 331 $ 259 Computer equipment and software 1,256 416 Furniture 597 544 Leasehold improvements 606 530 Manufacturing equipment 226 226 3,016 1,975 Less: accumulated depreciation and amortization (1,291 ) (998 ) Property and equipment, net $ 1,725 $ 977 Depreciation and amortization expenses were $0.1 million and $0.3 million and $0.1 million and $0.2 million, for the three and nine months ended September 30, 2020 and 2019, respectively. |
Leases
Leases | 9 Months Ended |
Sep. 30, 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 utilized the agreement extension option and extended the rent period for 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. The Company’s remaining contractual obligation under this lease is approximately $0.3 million as of September 30, 2020. • 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 $1.0 million as of September 30, 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 $0.8 million as of September 30, 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, NJ, 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 $1.3 million as of September 30, 2020. In addition, the Company has other operating office equipment and vehicle leases. The Company’s operating leases may require minimum rent payments, contingent rent payments adjusted periodically for inflation, or rent payments equal to the greater of a minimum rent or contingent rent. The Company’s leases do not contain any residual value guarantees or material restrictive covenants. The Company’s leases expire at various dates from 2021 through 2023, with varying renewal and termination options. The components of lease cost for the three and nine months ended September 30, 2020 were as follows (in thousands) Three Months Ended September 30, 2020 Nine Months Ended September 30, 2020 Operating lease cost $ 424 $ 1,282 Sublease income $ (56 ) $ (168 ) Variable lease cost 28 114 $ 396 $ 1,228 The amounts recognized as of September 30, 2020 were as follows (in thousands): September 30, 2020 Right of use asset $ 2,652 Long-term lease liability 1,748 Other current liabilities 1,335 As of September 30, 2020, no impairment losses have been recognized to date. Supplemental information related to leases for the periods reported is as follows (in thousands): Nine Months Ended September 30, 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases 1,306 Right-of-use assets obtained in exchange for new operating lease liabilities 135 Weighted-average remaining lease term of operating leases 2.40 years Weighted-average discount rate of operating leases 5.42% Subleases As of September 30, 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, Remainder of 2020 $ 57 2021 235 2022 243 2023 251 2024 49 2025 and thereafter — $ 835 Sublease income is recognized net within operating expenses. Sublease income for the three and nine months ended September 30, 2020 was as follows (in thousands): Three Months Ended September 30, 2020 Nine Months Ended September 30, 2020 Sublease income from fixed lease payments $ 56 $ 168 |
Revenue from Product Sales
Revenue from Product Sales | 9 Months Ended |
Sep. 30, 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 three and nine months ended September 30, 2020 (in thousands): Three Months Ended September 30, 2020 Nine Months Ended September 30, 2020 Jelmyto $ 3,461 $ 3,833 |
License and Collaboration Agree
License and Collaboration Agreements | 9 Months Ended |
Sep. 30, 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 and clostridial toxins (including BOTOX ® 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. The Company will supply Allergan with certain quantities of RTGel for development of Licensed Products through Phase 2 clinical trials using BOTOX together with RTGel in patients with overactive bladder, at Allergan’s request and expense. Allergan has the right to reduce the next milestone payment if there is a material supply failure from the Company. Prior to completion of the first Phase 2 clinical trial, Allergan has the right to request that the Company transfers to Allergan the Company’s manufacturing process for RTGel and Allergan will assume the responsibility to manufacture RTGel and Licensed Product for its own development and commercialization activities. 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 September 30, 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-related third-party intellectual properties. 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 for the research, development, manufacture and commercialization of any product containing RTGel and any active ingredient (other than a clostridial toxin) for all indications other than indications covered by the agreement and an exclusive, sublicensable, royalty-bearing (in low single digits), perpetual worldwide license under such improvements for use in the prevention or treatment of oncology indications. In August 2020, the Company announced that the Phase 2 APOLLO trial did not meet the primary endpoint, believed to be the result of BOTOX not effectively permeating the urothelium. UroGen and AbbVie will continue to explore the use of RTGel with AbbVie’s portfolio of toxin proteins. 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 non-muscle invasive bladder cancer. Pursuant to the license Agreement, the Company paid Agenus an upfront fee of $10.0 million and has agreed to pay Agenus up to $115.0 million upon achieving certain clinical development and regulatory milestones, up to $85.0 million upon achieving certain commercial milestones, and royalties on net sales of licensed products in the 14%-20% range. The Company will be responsible for all development and commercialization activities. Under the terms of the license agreement, Agenus has agreed to use commercially reasonable efforts to supply AGEN1884 to the Company for use in preclinical studies or clinical trials. Unless earlier terminated in accordance with the terms of the license agreement, the license agreement will expire on a product-by-product and country-by-country basis at the later of (a) the expiration of the last to expire valid claim of a licensed patent right that covers the licensed product in such country or (b) 15 years after the first commercial sale of the licensed product in such country. The Company may terminate the license agreement for convenience upon 180 days’ written notice to Agenus. Either party may terminate the license agreement upon 60 days’ notice to the other party if, prior to the first commercial sale of a licensed product, the Company substantially ceases to conduct development activities of the licensed products for nine consecutive months (and during such period, Agenus has complied with its obligations under the license agreement) other than in response to a requirement of an applicable regulatory authority or an event outside of the Company’s control. In addition, either party may terminate the license agreement in the event of an uncured material breach of the other party. As of September 30, 2020, since inception of the Agenus Agreement, the Company has paid a total of $10.0 |
Shareholders' Equity
Shareholders' Equity | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
Shareholders' Equity | NOTE 12-SHAREHOLDERS’ EQUITY The Company had 100.0 million ordinary shares authorized for issuance as of September 30, 2020 and December 31, 2019, respectively. The Company had 22.1 million and 21.0 million ordinary shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively. Each d w (the “Board”) 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 $ 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 | 9 Months Ended |
Sep. 30, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-Based Compensation | NOTE 13-SHARE-BASED COMPENSATION In a The b d p l n e Certain management and professional level employees typically receive options and restricted stock units, or RSU, grants upon commencement of employment. Also, eligible employees may receive an annual grant of options or RSUs. Non-employee members of the Board and any new, future directors may 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 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. The a mix of the Company’s historical volatility, and c e 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 shares 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, as part of the Company’s Annual Meeting of Shareholders, 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 compensation expense was taken in relation to the RSUs modification because the award vests upon a future performance condition that is not currently probable of occurring. In June 2020, the Board granted 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. The p condensed consolidated For the Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Research and development expenses $ 1,519 $ 2,069 5,032 6,379 Selling, general and administrative expenses 5,244 5,174 16,467 15,523 $ 6,763 $ 7,243 $ 21,499 $ 21,902 The total unrecognized compensation cost of options and RSUs at September 30, 2020 is $34.3 million with a weighted average recognition period of 1.67 years. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | NOTE 14-INCOME TAXES UroGen Pharma Ltd. |
Related Parties
Related Parties | 9 Months Ended |
Sep. 30, 2020 | |
Related Party Transactions [Abstract] | |
Related Parties | NOTE 15-RELATED PARTIES There were no related party transactions for the nine months ended September 30, 2020 or the nine months ended September 30, 2019. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | NOTE 16-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 Israeli Innovation Authority in Israel (“ The n Israeli d 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 quarter ended September 30, 2020 in relation to this arrangement. Leases See Note 9 for further discussion regarding lease commitments. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | NOTE 17-SUBSEQUENT EVENTS In October 2020, the Company appointed a new Chief Financial Officer and General Counsel. In connection with their employment, they were granted options to purchase the Company’s ordinary shares as well as RSUs under the Inducement Plan with a combined grant-date fair value of $2.4 million. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The condensed consolidated financial statements include the accounts of UPL and its subsidiary, UPI. Intercompany balances and transactions have been eliminated during consolidation. |
Use of Estimates | Use of Estimates The a i i n a i |
Functional Currency | Functional The p l Accordingly, l n i a condensed a ( |
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. Cash and cash equivalents and marketable securities totaled $125.5 million as of September 30, 2020. The Company classifies its marketable securities as available-for-sale in accordance with the Financial Accounting Standards Board (“ 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 commenced capitalization of inventory at the receipt of FDA approval. 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 condensed 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 are recognized as revenue under ASC 606 at the point in time that control of the product has been transferred to the customer, generally at the point the product has been delivered to the treating physician. All product sales of Jelmyto are recognized through the Company's arrangement with a single customer, a third-party national specialty distributor. Net revenues recognized include management’s estimate of returns, consideration paid to the customer, chargebacks relating to differences between the wholesale acquisition cost and the contracted price offered to the end consumer, chargebacks relating to 340b drug pricing programs, Medicaid drug rebate programs, and the Company’s copay assistance program, which are estimated based on industry benchmarking studies as well as the Company’s historical experience. The Company also derives revenues from its license and supply agreement (the “Allergan/AbbVie Agreement”) with Allergan Pharmaceuticals International Limited (“Allergan”), a wholly owned subsidiary of Allergan plc which is now a part of AbbVie Inc. 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”) and agreed to supply Allergan with pre-clinical and clinical quantities of the RTGel product, also referred to as the RTGel |
Research and Development Expenses | Research and Development Expenses Research and development costs are expensed as incurred and consist primarily of the cost of salaries, share-based compensation expenses, payroll taxes and other employee benefits, subcontractors and materials used for research and development activities, including nonclinical studies, clinical trials, manufacturing costs and professional services. The costs of services performed by others in connection with the research and development activities of the Company, including research and development conducted by others on behalf of the Company, shall be included in research and development costs and expensed as the contracted work is performed. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial or project and the invoices received from its external service providers. The Company adjusts its accrual as actual costs become known. Where contingent milestone payments are due to third parties under research and development arrangements or license agreements, the milestone payment obligations are expensed when the milestone results are achieved. |
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, executives, finance, commercial, medical affairs, business development, investor relations and human resources functions). Other significant costs include commercial, medical affairs, external professional service costs, facility costs, accounting and audit services, legal services, and other consulting fees. Selling, general and administrative costs are expensed as incurred, and the Company accrues for services provided by third parties related to the above expenses by monitoring the status of services provided and receiving estimates from its service providers and adjusting its accruals as actual costs become known. |
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 Company accounts for forfeitures as they occur in accordance with ASC Topic 718, “Compensation—Stock Compensation”. 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. |
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, or the Transition Date. As of September 30, 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) | 9 Months Ended |
Sep. 30, 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 |
Other Financial Information (Ta
Other Financial Information (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Other Financial Information [Abstract] | |
Schedule of Accounts Payable and Accrued Expenses | Accounts payable and accrued expenses consist of the following as of September 30, 2020 and December 31, 2019 (in thousands): September 30, 2020 December 31, 2019 Accounts payable $ 4,134 $ 4,694 Accrued clinical expenses 756 399 Accrued research and development costs 1,190 2,644 Accrued selling, general and administrative expenses 1,982 2,767 Accrued other expense 430 682 Total accounts payable and accrued expenses $ 8,492 $ 11,186 |
Schedule of Interest and Other Income (Expenses) | Interest and other income (expenses) consisted of the following as of September 30, 2020 and 2019 (in thousands): Nine Months Ended September 30, 2020 2019 Interest income $ 1,719 $ 3,610 Other finance expenses (192 ) (144 ) Total finance income $ 1,527 $ 3,466 |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Inventory Disclosure [Abstract] | |
Summary of Inventories | Inventories consist of the following as of September 30, 2020 and December 31, 2019 (in thousands): September 30, 2020 December 31, 2019 Raw materials $ 927 — Finished goods 419 — $ 1,346 $ — |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 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 September 30, 2020 are as follows (in thousands): Fair Value Measurements Using Quoted Prices Significant in Active Other Balance as of Markets for Observable September 30, Identical Assets Inputs 2020 (Level 1) (Level 2) Marketable securities: US government $ 42,551 $ 42,551 $ — Corporate bonds 37,080 — 37,080 Commercial paper 19,696 — 19,696 Money market funds (1) 3,288 3,288 — Certificates of deposit 1,631 — 1,631 $ 104,246 $ 45,839 $ 58,407 (1) Included within cash and cash equivalents on the condensed 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 $ 162,942 $ 83,092 $ 79,850 (1) Included within cash and cash equivalents on the condensed consolidated balance sheets. |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Investments Debt And Equity Securities [Abstract] | |
Summary of Marketable Securities | The following table summarizes the Company’s marketable securities as of September 30, 2020 (in thousands): Amortized Cost Basis Unrealized Gains Unrealized Losses Fair Value Marketable securities: US government $ 42,204 $ 347 $ — $ 42,551 Corporate bonds 36,939 141 — 37,080 Commercial paper 19,692 4 — 19,696 Money market funds (1) 3,288 — — 3,288 Certificates of deposit 1,631 — — 1,631 $ 103,754 $ 492 $ — $ 104,246 (1) Included within cash and cash equivalents on the condensed 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) September 30, 2020 December 31, 2019 Maturities within one year $ 98,346 $ 114,386 Maturities after one year through three years 5,900 48,556 $ 104,246 $ 162,942 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment, consists of the following as of September 30, 2020 and December 31, 2019 (in thousands): September 30, 2020 December 31, 2019 Laboratory equipment $ 331 $ 259 Computer equipment and software 1,256 416 Furniture 597 544 Leasehold improvements 606 530 Manufacturing equipment 226 226 3,016 1,975 Less: accumulated depreciation and amortization (1,291 ) (998 ) Property and equipment, net $ 1,725 $ 977 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Leases [Abstract] | |
Components of Lease Cost | The components of lease cost for the three and nine months ended September 30, 2020 were as follows (in thousands) Three Months Ended September 30, 2020 Nine Months Ended September 30, 2020 Operating lease cost $ 424 $ 1,282 Sublease income $ (56 ) $ (168 ) Variable lease cost 28 114 $ 396 $ 1,228 |
Schedule of Amounts Recognized | The amounts recognized as of September 30, 2020 were as follows (in thousands): September 30, 2020 Right of use asset $ 2,652 Long-term lease liability 1,748 Other current liabilities 1,335 |
Schedule of Supplemental Information Related to Leases | Supplemental information related to leases for the periods reported is as follows (in thousands): Nine Months Ended September 30, 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases 1,306 Right-of-use assets obtained in exchange for new operating lease liabilities 135 Weighted-average remaining lease term of operating leases 2.40 years Weighted-average discount rate of operating leases 5.42% |
Schedule of Undiscounted Cash Flows to be Received Under Operating Sublease on an Annual Basis | As of September 30, 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, Remainder of 2020 $ 57 2021 235 2022 243 2023 251 2024 49 2025 and thereafter — $ 835 |
Schedule of Sublease Income Recognized Net within Operating Expenses | Sublease income is recognized net within operating expenses. Sublease income for the three and nine months ended September 30, 2020 was as follows (in thousands): Three Months Ended September 30, 2020 Nine Months Ended September 30, 2020 Sublease income from fixed lease payments $ 56 $ 168 |
Revenue from Product Sales (Tab
Revenue from Product Sales (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Revenue From Contract With Customer [Abstract] | |
Schedule of Net Product Sales | Net product sales consist of the following for the three and nine months ended September 30, 2020 (in thousands): Three Months Ended September 30, 2020 Nine Months Ended September 30, 2020 Jelmyto $ 3,461 $ 3,833 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Schedule of Effect of Share-Based Compensation on Condensed Consolidated Statements of Operations | The p condensed consolidated For the Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Research and development expenses $ 1,519 $ 2,069 5,032 6,379 Selling, general and administrative expenses 5,244 5,174 16,467 15,523 $ 6,763 $ 7,243 $ 21,499 $ 21,902 |
Business and Nature of Operat_2
Business and Nature of Operations - Additional Information (Details) | 9 Months Ended |
Sep. 30, 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 | Sep. 30, 2020 | Dec. 31, 2019 |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ||
Accumulated deficit | $ 325,975 | $ 228,017 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional Information (Details) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Accounting Policies [Abstract] | ||
Total cash and cash equivalents and marketable securities | $ 125,500,000 | |
Provision for uncertain tax positions | $ 0 | $ 0 |
Significant Accounting Polici_5
Significant Accounting Policies - Property and Equipment Useful Lives (Details) | 9 Months Ended |
Sep. 30, 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 |
Other Financial Information - S
Other Financial Information - Schedule of Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Other Financial Information [Abstract] | ||
Accounts payable | $ 4,134 | $ 4,694 |
Accrued clinical expenses | 756 | 399 |
Accrued research and development costs | 1,190 | 2,644 |
Accrued selling, general and administrative expenses | 1,982 | 2,767 |
Accrued other expense | 430 | 682 |
Total accounts payable and accrued expenses | $ 8,492 | $ 11,186 |
Other Financial Information -_2
Other Financial Information - Schedule of Interest and Other Income (Expenses) (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Other Financial Information [Abstract] | ||
Interest income | $ 1,719 | $ 3,610 |
Other finance expenses | (192) | (144) |
Total finance income | $ 1,527 | $ 3,466 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Details) $ in Thousands | Sep. 30, 2020USD ($) |
Inventory Disclosure [Abstract] | |
Raw materials | $ 927 |
Finished goods | 419 |
Inventory | $ 1,346 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | 9 Months Ended |
Sep. 30, 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 | Sep. 30, 2020 | Dec. 31, 2019 |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | $ 104,246 | $ 162,942 |
Fair Value, Measurements, Recurring | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 104,246 | 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: | 45,839 | 83,092 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 58,407 | 79,850 |
Fair Value, Measurements, Recurring | US Government | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 42,551 | 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: | 42,551 | 66,094 |
Fair Value, Measurements, Recurring | Corporate Bonds | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 37,080 | 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: | 37,080 | 68,084 |
Fair Value, Measurements, Recurring | Commercial Paper | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 19,696 | 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: | 19,696 | 7,658 |
Fair Value, Measurements, Recurring | Money Market Funds | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 3,288 | 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: | 3,288 | 16,998 |
Fair Value, Measurements, Recurring | Certificates of Deposit | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Marketable securities: | 1,631 | 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: | $ 1,631 | $ 4,108 |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Marketable securities: | ||
Amortized Cost Basis | $ 103,754 | |
Unrealized Gains | 492 | |
Fair Value | 104,246 | $ 162,942 |
US Government | ||
Marketable securities: | ||
Amortized Cost Basis | 42,204 | |
Unrealized Gains | 347 | |
Fair Value | 42,551 | |
Corporate Bonds | ||
Marketable securities: | ||
Amortized Cost Basis | 36,939 | |
Unrealized Gains | 141 | |
Fair Value | 37,080 | |
Commercial Paper | ||
Marketable securities: | ||
Amortized Cost Basis | 19,692 | |
Unrealized Gains | 4 | |
Fair Value | 19,696 | |
Money Market Funds | ||
Marketable securities: | ||
Amortized Cost Basis | 3,288 | |
Fair Value | 3,288 | |
Certificates of Deposit | ||
Marketable securities: | ||
Amortized Cost Basis | 1,631 | |
Fair Value | $ 1,631 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Details) | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Investments Debt And Equity Securities [Abstract] | |
Accrued interest receivable | $ 300,000 |
Available-for-sale debt securities, unrealized gain position | 500,000 |
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 | Sep. 30, 2020 | Dec. 31, 2019 |
Available For Sale Securities Debt Maturities Fair Value [Abstract] | ||
Maturities within one year | $ 98,346 | $ 114,386 |
Maturities after one year through three years | 5,900 | 48,556 |
Debt securities, Available-for-sale | $ 104,246 | $ 162,942 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Property Plant And Equipment [Line Items] | ||
Property and equipment | $ 3,016 | $ 1,975 |
Less: accumulated depreciation and amortization | (1,291) | (998) |
Property and equipment, net | 1,725 | 977 |
Laboratory Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 331 | 259 |
Computers and Software | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 1,256 | 416 |
Furniture | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 597 | 544 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 606 | 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 | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Property Plant And Equipment [Abstract] | ||||
Depreciation and amortization expense | $ 0.1 | $ 0.1 | $ 0.3 | $ 0.2 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Nov. 30, 2019 | Apr. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2020 | Sep. 30, 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 utilized the agreement extension option and extended the rent period for additional three years until August 2022. | ||||
Operating leases, options to extend lease term | 3 years | 3 years | |||
Operating lease extended lease expiration, month and year | 2022-08 | ||||
Remaining rental payments to be received over the lease term | $ 56,000 | $ 168,000 | |||
Impairment losses on operating leases | $ 0 | ||||
Minimum | |||||
Lessee Lease Description [Line Items] | |||||
Lease expiration year | 2021 | ||||
Maximum | |||||
Lessee Lease Description [Line Items] | |||||
Lease expiration year | 2023 | ||||
UroGen Pharma Inc. | New York | |||||
Lessee Lease Description [Line Items] | |||||
Lease commencement period, month and year | 2017-10 | ||||
Lease termination period, month and year | 2021-02 | ||||
Remaining contractual obligation | 300,000 | $ 300,000 | |||
UroGen Pharma Inc. | Los Angeles, California | |||||
Lessee Lease Description [Line Items] | |||||
Lease termination period, month and year | 2024-03 | ||||
Remaining contractual obligation | 1,000,000 | 1,000,000 | |||
Lease commencement date | Jul. 10, 2018 | ||||
Proceeds from tenant allowance | $ 200,000 | ||||
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 | 800,000 | ||||
UroGen Pharma Inc. | Princeton, NJ | Lease Agreement | |||||
Lessee Lease Description [Line Items] | |||||
Remaining contractual obligation | $ 1,300,000 | $ 1,300,000 | |||
Lease commencement date | Nov. 29, 2019 | ||||
Lease term | 38 months |
Leases - Components of Lease Co
Leases - Components of Lease Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2020 | Sep. 30, 2020 | |
Leases [Abstract] | ||
Operating lease cost | $ 424 | $ 1,282 |
Sublease income | (56) | (168) |
Variable lease cost | 28 | 114 |
Lease, Cost | $ 396 | $ 1,228 |
Leases - Schedule of Amounts Re
Leases - Schedule of Amounts Recognized (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Leases [Abstract] | ||
Right of use asset | $ 2,652 | $ 3,735 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:OtherAssetsNoncurrent | |
Long-term lease liability | $ 1,748 | $ 2,604 |
Other current liabilities | $ 1,335 | |
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 | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Cash paid for amounts included in the measurement of lease liabilities: | |
Operating cash flows from operating leases | $ 1,306 |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 135 |
Weighted-average remaining lease term of operating leases | 2 years 4 months 24 days |
Weighted-average discount rate of operating leases | 5.42% |
Leases - Schedule of Undiscount
Leases - Schedule of Undiscounted Cash Flows to be Received Under Operating Sublease on an Annual Basis (Details) $ in Thousands | Sep. 30, 2020USD ($) |
Leases [Abstract] | |
Remainder of 2020 | $ 57 |
2021 | 235 |
2022 | 243 |
2023 | 251 |
2024 | 49 |
Lessee operating sublease payments to be received | $ 835 |
Leases - Schedule of Sublease I
Leases - Schedule of Sublease Income Recognized Net within Operating Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2020 | Sep. 30, 2020 | |
Leases [Abstract] | ||
Sublease income from fixed lease payments | $ 56 | $ 168 |
Revenue from Product Sales - Sc
Revenue from Product Sales - Schedule of Net Product Sales (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2020 | Sep. 30, 2019 | |
Revenue From Contract With Customer [Abstract] | |||
Revenue from Contract with Customer, Product and Service [Extensible List] | urgn:JelmytoMember | urgn:JelmytoMember | |
Revenues | $ 3,461 | $ 3,833 | $ 18 |
License and Collaboration Agr_2
License and Collaboration Agreements - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended |
Nov. 30, 2019 | Dec. 31, 2019 | Sep. 30, 2020 | |
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||
Payments on license agreement milestone in acquired in process research and development expenses | $ 10,000,000 | ||
Agenus Agreement | |||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||
Upfront fee | $ 10,000,000 | ||
Maximum amount payable upon achieving certain clinical development and regulatory milestones | 115,000,000 | ||
Maximum amount payable upon achieving certain commercial milestones | $ 85,000,000 | ||
License agreement milestone in acquired in-process research and development expenses | $ 10,000,000 | ||
Agenus Agreement | After First Commercial Sale of Licensed Product | |||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||
License agreement expiration term | 15 years | ||
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 | 9 Months Ended | ||
Dec. 31, 2019 | Jan. 31, 2019 | Jun. 30, 2020 | Sep. 30, 2020 | Sep. 30, 2019 | |
Class Of Stock [Line Items] | |||||
Ordinary shares, shares authorized | 100,000,000 | 100,000,000 | |||
Ordinary shares, issued | 21,026,184 | 22,071,432 | |||
Ordinary shares, outstanding | 21,026,184 | 22,071,432 | |||
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 | Maximum | ATM Sales Agreement | |||||
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 | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($)shares | Sep. 30, 2019USD ($) | May 31, 2019shares |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||||
Share-based compensation expense | $ | $ 6,763,000 | $ 7,243,000 | $ 21,499,000 | $ 21,902,000 | |||||||||
Unrecognized compensation cost of options and RSUs | $ | $ 34,300,000 | $ 34,300,000 | |||||||||||
Expected to be recognized over a weighted average period | 1 year 8 months 1 day | ||||||||||||
Options | General and Administrative Expenses | |||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||||
Share-based compensation expense | $ | $ 900,000 | ||||||||||||
Options | Elizabeth Barrett | |||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||||
Option to purchase of ordinary 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] | |||||||||||||
Options granted, expected term | 10 years | 10 years | |||||||||||
Awards vesting period | 1 year | 1 year | |||||||||||
Number of stock options approved for grants | 70,000 | 70,000 | |||||||||||
Stock options granted | 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 | 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 expense | $ | $ 0 | ||||||||||||
Restricted Stock Units (RSUs) | Elizabeth Barrett | |||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||||
Option to purchase of ordinary 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 | 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 | 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 | 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 | 3,950,167 | 3,550,167 | 1,650,167 | ||||||||||
Maximum | Plan | Options | |||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||||
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 Effect of Share-Based Compensation on Condensed Consolidated Statements of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation | $ 6,763 | $ 7,243 | $ 21,499 | $ 21,902 |
Research and Development Expenses | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation | 1,519 | 2,069 | 5,032 | 6,379 |
Selling, General and Administrative Expenses | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation | $ 5,244 | $ 5,174 | $ 16,467 | $ 15,523 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 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) $ in Millions | 1 Months Ended |
Oct. 31, 2020USD ($) | |
Subsequent Events | Stock Options and Restricted Stock Units (RSUs) | New Chief Financial Officer and General Counsel | |
Subsequent Event [Line Items] | |
Fair value | $ 2.4 |