Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | May 07, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | URGN | |
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, Shares Outstanding | 20,791,445 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 246,692 | $ 101,318 |
Restricted deposit | 407 | 253 |
Prepaid expenses and other current assets | 1,196 | 672 |
TOTAL CURRENT ASSETS | 248,295 | 102,243 |
NON-CURRENT ASSETS | ||
Property and equipment, net | 929 | 948 |
Restricted deposit | 51 | 51 |
Other non-current assets | 2,777 | 317 |
TOTAL ASSETS | 252,052 | 103,559 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued expenses | 5,942 | 8,540 |
Employee related accrued expenses | 3,334 | 4,925 |
Other current liabilities | 1,001 | |
TOTAL CURRENT LIABILITIES | 10,277 | 13,465 |
NON-CURRENT LIABILITIES: | ||
Long-term lease liability | 2,184 | |
TOTAL NON-CURRENT LIABILITIES | 2,184 | |
TOTAL LIABILITIES | 12,461 | 13,465 |
COMMITMENTS AND CONTINGENCIES (Note 13) | ||
SHAREHOLDERS’ EQUITY: | ||
Ordinary shares, NIS 0.01 par value; 100,000,000 shares authorized at March 31, 2019 and December 31, 2018; 20,758,348 and 16,214,883 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively | 56 | 44 |
Additional paid-in capital | 383,850 | 212,921 |
Accumulated deficit | (144,315) | (122,871) |
TOTAL SHAREHOLDERS’ EQUITY | 239,591 | 90,094 |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 252,052 | $ 103,559 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) (unaudited) - ₪ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Ordinary shares, par value | ₪ 0.01 | ₪ 0.01 |
Ordinary shares, shares authorized | 100,000,000 | 100,000,000 |
Ordinary shares, issued | 20,758,348 | 16,214,883 |
Ordinary shares, outstanding | 20,758,348 | 16,214,883 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Income Statement [Abstract] | ||
REVENUES | $ 481 | |
COST OF REVENUES | 430 | |
GROSS PROFIT | 51 | |
OPERATING EXPENSES: | ||
RESEARCH AND DEVELOPMENT EXPENSES, NET | $ 9,726 | 7,622 |
GENERAL AND ADMINISTRATIVE EXPENSES | 12,707 | 6,069 |
OPERATING LOSS | (22,433) | (13,640) |
FINANCE INCOME, NET | (989) | (258) |
NET LOSS | $ (21,444) | $ (13,382) |
LOSS PER ORDINARY SHARE BASIC AND DILUTED | $ 1.11 | $ 0.88 |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER ORDINARY SHARE | 19,340,082 | 15,267,939 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (unaudited) - USD ($) $ in Thousands | Total | Ordinary Shares | Additional Paid-In Capital | Accumulated Deficit |
Balance at Dec. 31, 2017 | $ 68,515 | $ 37 | $ 115,692 | $ (47,214) |
Balance,Share at Dec. 31, 2017 | 13,751,390 | |||
Exercise of options into ordinary shares, shares | 39,665 | |||
Share-based compensation | 4,541 | 4,541 | ||
Issuance of ordinary shares in public offering, net of issuance expenses | 64,193 | $ 5 | 64,188 | |
Issuance of ordinary shares in public offering, net of issuance expenses, shares | 1,682,926 | |||
Net loss | (13,382) | (13,382) | ||
Balance at Mar. 31, 2018 | 123,867 | $ 42 | 184,421 | (60,596) |
Balance,Share at Mar. 31, 2018 | 15,473,981 | |||
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 | 2,047 | $ 1 | 2,046 | |
Exercise of options into ordinary shares, shares | 336,148 | |||
Share-based compensation | 7,447 | 7,447 | ||
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 | |||
Net loss | (21,444) | (21,444) | ||
Balance at Mar. 31, 2019 | $ 239,591 | $ 56 | $ 383,850 | $ (144,315) |
Balance,Share at Mar. 31, 2019 | 20,758,348 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (21,444) | $ (13,382) |
Adjustment to reconcile net loss to net cash from operating activities: | ||
Depreciation and amortization | 63 | 240 |
Stock-based compensation | 7,447 | 4,541 |
Exchange rate differences | 1 | |
Realized loss on sale of short-term investment | 100 | |
Right of use asset | 245 | |
Lease liability | (173) | |
Changes in operating assets and liabilities: | ||
Increase in inventory | (33) | |
Increase in accounts receivable | (4) | |
(Increase) decrease in prepaid expenses and other current assets | (41) | 232 |
Decrease in accounts payable and accrued expenses | (2,440) | (206) |
Decrease in deferred revenues | (454) | |
Decrease in employee related accrued expenses | (1,591) | (659) |
Net cash used in operating activities | (17,934) | (9,624) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Short-term investments | 35,901 | |
Purchase of property and equipment | (44) | (72) |
Net cash (used in) provided by investing activities | (44) | 35,829 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from exercise of options into ordinary shares | 1,532 | |
Issuance of ordinary shares, net of issurance expenses | 161,974 | 64,256 |
Net cash provided by financing activities | 163,506 | 64,256 |
INCREASE IN CASH AND CASH EQUIVALENTS | 145,528 | 90,461 |
CASH, CASH EQUIVALENTS AND RESTRICED CASH AT BEGINNING OF THE YEAR | 101,571 | 36,999 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF THE YEAR | 247,099 | 127,460 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Non-cash issuance cost | 312 | $ 21 |
Exercise of options | $ 515 |
Business and Nature of Operatio
Business and Nature of Operations | 3 Months Ended |
Mar. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Business and Nature of Operations | Nature of Operations UroGen 0 UroGen a n UPL o l g |
Basis of Presentation
Basis of Presentation | 3 Months Ended |
Mar. 31, 2019 | |
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 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 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 of 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 to present fairly the 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, 2018. 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 not generated any revenue from the sale of products since its inception. The Company has experienced net losses since its inception and has an accumulated deficit of $144.3 million and $122.9 million as of March 31, 2019 and December 31, 2018, respectively. The Company expects to incur losses and have negative net cash flows from operating activities as it expands its portfolio and engages in further research and development activities, particularly conducting preclinical studies and clinical trials. The success of the Company depends on its ability to develop its technologies to the point of U.S. Food and Drug Administration ( “ ” |
Significant Accounting Policies
Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 3-SIGNIFICANT ACCOUNTING POLICIES Principles of Consolidation The Company ’ Use of Estimates The a i i n a i Functional The p l Accordingly, l n i a condensed a ( Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents consist primarily of money market funds and bank money market accounts and are stated at cost, which approximates fair value. Short-Term Investments The Company from time to time invests in short-term investments that consist of mutual and bond funds. While these investments are considered highly liquid and available to fund current operations, there is more than an insignificant risk of change in value due to interest rate, quoted price, or penalty on withdrawal and are therefore classified as short-term investments. The Company classifies its short-term investments 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. 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 ’ Financial instruments that potentially subject the Company to concentration of credit risk consist principally of cash and cash equivalents and short-term investments. The Company deposits cash and cash equivalents with highly rated financial institutions, has not experienced any credit losses in these accounts and does not believe it is exposed to significant credit risk on these instruments. Income Taxes The Company provides for income taxes based on pretax income, if any, and applicable tax rates available in the various jurisdictions in which we operate. Deferred l e n s a a The n l w a Property and Equipment Property and equipment is recorded at historical cost, net of accumulated depreciation, amortization and, if applicable, impairment charges. 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 6 for further discussion regarding property and equipment. Leases The Company is a lessee in several noncancelable operating leases, primarily for office space, office equipment and vehicles. The Company currently has no finance leases. 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. We applied the modified retrospective transition method and elected the transition option to use the effective date of January 1, 2019 as the date of initial application (“Transition Date”). Consequently, the disclosures required under Topic 842 are not provided for dates and periods before January 1, 2019. Topic 842 provides a number of optional practical expedients in transition. The Company elected the ‘package of practical expedients’, which permits not to reassess under Topic 842 its prior conclusions about lease identification, lease classification, and initial direct costs. The Company did not elect the use-of-hindsight or the practical expedient pertaining to land easements; the latter not being applicable to the Company. Topic 842 had a material impact on our condensed consolidated balance sheets, but did not have an impact on our condensed consolidated statements of operations. The most significant impact was the recognition of ROU assets and lease liabilities for operating leases. ROU assets for operating leases are periodically reviewed for impairment losses under ASC 360-10, “Property, Plant, and Equipment”, to determine whether a ROU asset is impaired, and if so, the amount of the impairment loss to recognize. Revenues The Company derives virtually all of its revenues from its license and supply agreement (the “Allergan Agreement”) with Allergan Pharmaceuticals International Limited (“Allergan”), a wholly owned subsidiary of Allergan plc. Under the Allergan Agreement, the Company grants Allergan an exclusive license to develop, commercialize, and otherwise exploit products that contain reverse thermally triggered hydrogel (“RTGel”) and agrees to supply Allergan with pre-clinical and clinical quantities of the RTGel product, also referred to as the RTGel The Company determined that Allergan is its customer and the Allergan Agreement is in scope of ASC 606, which was adopted as of January 1, 2018. The Company adopted ASC 606 under the modified retrospective method, which did not have a material impact on the condensed consolidated statements of operations. Supply of RTGel to Allergan The Company recognizes revenue related to supply of RTGel at a point in time, upon delivery to Allergan. During the three months ended March 31, 2019 and 2018, the Company recognized $0 and $0.5 million of revenue related to RTGel supplied to Allergan, respectively. Shipping and handling costs associated with supply of RTGel are accounted for as a fulfillment cost and are in included in cost of revenues. General and Administrative Expenses General and administrative expenses consist primarily of salaries and other related costs, including share-based compensation, for personnel in executive, finance, accounting, legal, investor relations, facilities, business development and human resources functions. Other significant costs include facility costs not otherwise included in research and development expenses, legal fees relating to corporate matters, insurance, public company expenses relating to maintaining compliance with listing rules of the Nasdaq Stock Market and requirements of the U.S. Securities and Exchange Commission (“SEC”), insurance and investor relations costs, and fees for accounting and consulting services. General and administrative costs are expensed as incurred, and the Company accrues for services provided by third parties related to the above expenses by monitoring the status of services provided and receiving estimates from its service providers and adjusting its accruals as actual costs become known. Research and Development Expenses Research s i d a l l The l e l 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 our ordinary shares on the grant date. As o The s n g As of December 31, 2018, the Company adopted ASU 2018-07, Compensation-Stock Compensation, which establishes that the measurement of equity-classified nonemployee awards will be fixed at the grant date. The adoption of ASU 2018-07 did not have an impact on the condensed consolidated statements of operations. Net Loss per Common Share Basic net loss per share is computed by dividing the net loss attributable to common shareholders by the weighted-average number of common shares outstanding. Diluted net loss per share is computed similarly to basic net loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted loss per share as their effect is anti-dilutive. Recent Accounting Pronouncements In June 2018, the FASB issued ASU No. In February 2016, the FASB issued ASU No. 2016-02, “Leases” (“Topic 842”). Topic 842 supersedes existing guidance in Leases (“Topic 840”). Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU 2018-10, Codification Improvements to Topic 842, Leases; ASU No. 2018-11, Targeted Improvements; ASU 2018-20, Narrow-Scope Improvements for Lessors; and ASU 2019-01 – Leases. Topic 842 requires lessees to recognize ROU assets and lease liabilities on the balance sheet for leases with lease terms greater than twelve months, including those classified as operating leases. The Company adopted Topic 842 and related interpretations effective January 1, 2019 and recognized ROU assets and operating lease liabilities of $3.4 million. |
Other Financial Information
Other Financial Information | 3 Months Ended |
Mar. 31, 2019 | |
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 March 31, 2019 and December 31, 2018, respectively (in thousands): March 31, 2019 December 31, 2018 Accounts payable $ 1,700 $ 4,272 Accrued clinical expenses 839 673 Accrued research and development costs 1,396 780 Accrued general and administrative expenses 1,298 1,029 Accrued other expense 709 1,786 Total accounts payable and accrued expenses $ 5,942 $ 8,540 Finance (Income) Expense Finance (income) expense consisted of the following as of March 31, 2019 and 2018, respectively (in thousands): Three Months Ended March 31, 2019 2018 Interest income on cash and cash equivalents $ (1,010 ) $ (422 ) Realized loss on sale of short-term investment — 100 Other finance expenses 21 64 Total finance income $ (989 ) $ (258 ) |
Fair Value Measurements and Inv
Fair Value Measurements and Investments in Marketable Securities | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements and Investments in Marketable Securities | NOTE 5-FAIR VALUE MEASUREMENTS AND INVESTMENTS IN MARKETABLE SECURITIES The Company follows authoritative accounting guidance, which among other things, defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities; Level 2: Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. Level 3: Unobservable inputs that reflect the reporting entity ’ The carrying amounts of the Company ’ Assets and liabilities measured at fair value on a recurring basis based on Level 1, Level 2, and Level 3 fair value measurement criteria as of March 31, 2019 are as follows (in thousands): Fair Value Measurements Using Quoted Prices Significant in Active Other Significant Balance as of Markets for Observable Unobservable March 31, Identical Assets Inputs Inputs 2019 (Level 1) (Level 2) (Level 3) Assets: Money market funds (1) $ 40,026 $ 40,026 $ — $ — (1) Included within cash and equivalents on the condensed consolidated balance sheets. Assets and liabilities measured at fair value on a recurring basis based on Level 1, Level 2, and Level 3 fair value measurement criteria as of December 31, 2018 are as follows (in thousands): Fair Value Measurements Using Quoted Prices Significant in Active Other Significant Balance as of Markets for Observable Unobservable December 31, Identical Assets Inputs Inputs 2018 (Level 1) (Level 2) (Level 3) Assets: Money market funds (1) $ 89,965 $ 89,965 $ — $ — (1) Included within cash and equivalents on the condensed consolidated balance sheets. The Company ’ |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | NOTE 6-PROPERTY AND EQUIPMENT Property and equipment, consists of the following as of March 31, 2019 and December 31, 2018 (in thousands): March 31, 2019 December 31, 2018 Laboratory equipment $ 241 $ 241 Computer equipment and software 309 271 Furniture 394 395 Leasehold improvements 561 561 Manufacturing equipment 228 227 1,733 1,695 Less: accumulated depreciation and amortization (804 ) (747 ) Property and equipment, net $ 929 $ 948 Depreciation and amortization expenses were $0.1 million and $0.2 million for the three months ended March 31, 2019 and 2018, respectively. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Leases | NOTE 7-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 principal 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 New York headquarters. The lease agreement commenced in October 2017 and terminates in February 2021. • 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. 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 2019 through 2022, with varying renewal and termination options. The components of lease cost for the three months ended March 31, 2019 were as follows (in thousands) Three Months Ended March 31, 2019 Operating lease cost $ 302 Variable lease cost 30 $ 332 The amounts recognized upon adoption and as of March 31, 2019 were as follows (in thousands): January 1, 2019 March 31, 2019 Other non-current assets $ 3,022 $ 2,777 Long-term lease liability 2,429 2,184 Other current liabilities 929 1,001 As of March 31, 2019, no impairment losses have been recognized to date. Supplemental information related to leases for the periods reported is as follows (in thousands): Three Months Ended March 31, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operation leases 256 Right-of-use assets obtained in exchange for new operating lease liabilities 3,022 Weighted-average remaining lease term of operating leases 3.33 years Weighted-average discount rate of operating leases 7.24% As of March 31, 2019, maturities of lease liabilities were as follows (in thousands): Operating Leases Years ending December 31, 2019 (excluding the three months ended March 31, 2019) $ 886 2020 1,220 2021 649 2022 492 2023 301 2024 and thereafter 58 Total future minimum lease payments $ 3,606 Less: Interest 421 Present value of lease liabilities $ 3,185 As of December 31, 2018, maturities of lease liabilities were as follows (in thousands): Operating Leases Years ending December 31, 2019 $ 1,136 2020 1,251 2021 676 2022 567 2023 301 2024 and thereafter 58 Total future minimum lease payments $ 3,989 Rent expense charged to operations was $1.2 million for the year ended December 31, 2018. |
License and Collaboration Agree
License and Collaboration Agreements | 3 Months Ended |
Mar. 31, 2019 | |
Liscense Agreement [Abstract] | |
License and Collaboration Agreements | NOTE 8-LICENSE AND COLLABORATION AGREEMENTS Allergan Agreement In October 2016, the Company entered into the Allergan Agreement with Allergan and granted Allergan an exclusive worldwide license to research, develop, manufacture and commercialize pharmaceutical products that contain RTGel and clostridial toxins (including BOTOX), alone or in combination with certain other active ingredients, referred to as the Licensed Products, which are approved for the treatment of adults with overactive bladder who cannot use or do not adequately respond to anticholinergics. Additionally, the Company granted Allergan a non-exclusive, worldwide license to use certain of the Company’s trademarks as required for Allergan to practice its exclusive license with respect to the Licensed Products. Under the Allergan 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 has previously supplied 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. 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. During the three months ended March 31, 2019 and 2018 the Company recognized revenue of $0 and $0.5 million related to RTGel that was supplied to Allergan, respectively. Further, the Company is eligible to receive additional material milestone payments of up to an aggregate of $200.0 million upon the successful completion of certain development, regulatory and commercial milestones. As of March 31, 2019, since inception of the Allergan 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 our patent coverage of Licensed Products. The Company is responsible for payments to any third party for certain RTGel-related third-party intellectual properties. Under the Allergan Agreement, Allergan granted the Company a non-exclusive, sublicensable, fully paid-up, perpetual, worldwide license under any improvements Allergan makes to the composition, formulation, or manufacture of RTGel for the research, development, manufacture and commercialization of any product containing RTGel and any active ingredient (other than a clostridial toxin) for all indications other than indications covered by the agreement and an exclusive, sublicensable, royalty-bearing (in low single digits), perpetual worldwide license under such improvements for use in the prevention or treatment of oncology indications. The Company plans to continue to research, develop and commercialize other products combining RTGel with other active ingredients, except that there are certain restrictions with respect to the overactive bladder and neurogenic detrusor overactivity indications. Subject to provisions called out in the Allergan Agreement, Allergan may unilaterally terminate the Allergan Agreement for any reason upon advance notice. In addition, either party may terminate the Allergan Agreement for various reasons, as previously disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018 filed with the SEC on February 28, 2019. Early-Stage Feasibility Evaluation with Janssen Research & Development, LLC (“Janssen”) See Note 14 for further discussion regarding an early-stage feasibility evaluation with Janssen. |
Shareholders_ Equity
Shareholders’ Equity | 3 Months Ended |
Mar. 31, 2019 | |
Equity [Abstract] | |
Shareholders' Equity | NOTE 9-SHAREHOLDERS’ EQUITY The Company had 100.0 million ordinary shares authorized for issuance as of March 31, 2019 and December d w (the “Board”) In January 2018, the Company completed an underwritten public offering of 1,682,926 of its ordinary shares, including 219,512 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $41.00 per share. The net proceeds to the Company from the public offering were approximately $64.2 million, after deducting the underwriting discounts and commissions and payment of other offering expenses. In January 2019, the Company completed an underwritten public offering of 4,207,317 of its ordinary shares, including 548,780 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $41.00 per share. The net proceeds to the Company from the offering were approximately $161.4 million, after deducting the underwriting discounts and commissions and payment of other offering expenses. |
Share-Based Compensation
Share-Based Compensation | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-Based Compensation | NOTE 10-SHARE-BASED COMPENSATION In a The b d p l n e Certain management and professional level employees typically receive options and RSU grants upon commencement of employment. Eligible employees may also receive a grant of options or RSUs annually and vest over one year. 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 equal quarterly 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 equal quarterly amounts for the three years following the one-year anniversary of the grant date. The 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 January 2, 2019, the Company announced the resignation of its former CEO, and the Board approved a severance package, which included a combination of cash and modifications to grants of his related option awards in the amount of $3.4 million. The cash element followed the termination section in the CEO employment agreement, and the options element included acceleration to certain grants of his related option awards. The fair value of the modifications to these option awards was estimated at $2.8 million. The entire severance package was recorded in general and administrative and research and development expenses, based on salary allocations respectively, in the condensed consolidated statements of operations for the year ended December 31, 2018. On January 3, 2019, the Company appointed Elizabeth Barrett as its President and Chief Executive Officer. In connection with Ms. Barrett’s employment, she was granted 277,432 options to purchase the Company’s ordinary shares, at an exercise price of $47.57, as well as 317,065 RSUs, with a combined fair value of $24.1 million. The p condensed consolidated Three Months Ended March 31, 2019 2018 Research and development expenses $ 2,338 $ 2,473 General and administrative expenses 5,109 2,068 $ 7,447 $ 4,541 The total unrecognized compensation cost of options and RSUs at March 31, 2019 is $63.2 million with a weighted average recognition period of 2.4 years. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | NOTE 11-INCOME TAXES The |
Related Parties
Related Parties | 3 Months Ended |
Mar. 31, 2019 | |
Related Party Transactions [Abstract] | |
Related Parties | NOTE 12-RELATED PARTIES UPI 1 h d In April 2018, UPI terminated its lease for offices at 689 Fifth Avenue in New York, and on December 1, 2018, UPI and Kite Pharma, Inc., completed a full assignment and assumption of the lease to Allogene Therapeutics, Inc. of which Arie Belldegrun, M.D., serves as the Chairman of the Board of Directors. UPI recorded a loss on disposal of fixed assets of $0.2 million for the year ended December 31, 2018, regarding accelerated depreciation on the leasehold improvements associated with the lease, and there is no further liability as of December 31, 2018. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | NOTE 13-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 ’ ’ Leases Grants Israeli Innovation Authority in Israel (“ The n d The Company is committed to pay royalties to the Government of Israel on proceeds from sales of products in the research and development of which the IIA participates by way of grants. At the time the grants were received, successful development of the related projects was not assured. In the case of failure of a project that was partly financed as above, the Company is not obligated to pay any such royalties. Under the terms of the funding from the IIA, royalties of 3% to 5% are payable on sales of products developed from a project so funded, up to 100% of the amount of the grant received by the Company (dollar linked); with the addition of annual interest at a rate based on 12-month LIBOR. The Company is subject to several conditions, including restrictions on its intellectual property. As March 31, 2019 n i Leases See Note 7 for further discussion regarding lease commitments. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | NOTE 14-SUBSEQUENT EVENTS On April 22, 2019, the Company entered into an agreement with Janssen to conduct an early-stage feasibility evaluation in a therapeutic area of mutual interest. The Company and Janssen will each conduct certain activities under the terms of the agreement, and the Company will incur the costs of its own efforts related to the feasibility evaluation. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The Company ’ |
Use of Estimates | Use of Estimates The a i i n a i |
Foreign Currency | Functional The p l Accordingly, l n i a condensed a ( |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents consist primarily of money market funds and bank money market accounts and are stated at cost, which approximates fair value. |
Short-Term Investments | Short-Term Investments The Company from time to time invests in short-term investments that consist of mutual and bond funds. While these investments are considered highly liquid and available to fund current operations, there is more than an insignificant risk of change in value due to interest rate, quoted price, or penalty on withdrawal and are therefore classified as short-term investments. The Company classifies its short-term investments 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. |
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 ’ Financial instruments that potentially subject the Company to concentration of credit risk consist principally of cash and cash equivalents and short-term investments. The Company deposits cash and cash equivalents with highly rated financial institutions, has not experienced any credit losses in these accounts and does not believe it is exposed to significant credit risk on these instruments. |
Income Taxes | Income Taxes The Company provides for income taxes based on pretax income, if any, and applicable tax rates available in the various jurisdictions in which we operate. Deferred l e n s a a The n l w a |
Property and Equipment | Property and Equipment Property and equipment is recorded at historical cost, net of accumulated depreciation, amortization and, if applicable, impairment charges. 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 6 for further discussion regarding property and equipment. |
Leases | Leases The Company is a lessee in several noncancelable operating leases, primarily for office space, office equipment and vehicles. The Company currently has no finance leases. 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. We applied the modified retrospective transition method and elected the transition option to use the effective date of January 1, 2019 as the date of initial application (“Transition Date”). Consequently, the disclosures required under Topic 842 are not provided for dates and periods before January 1, 2019. Topic 842 provides a number of optional practical expedients in transition. The Company elected the ‘package of practical expedients’, which permits not to reassess under Topic 842 its prior conclusions about lease identification, lease classification, and initial direct costs. The Company did not elect the use-of-hindsight or the practical expedient pertaining to land easements; the latter not being applicable to the Company. Topic 842 had a material impact on our condensed consolidated balance sheets, but did not have an impact on our condensed consolidated statements of operations. The most significant impact was the recognition of ROU assets and lease liabilities for operating leases. ROU assets for operating leases are periodically reviewed for impairment losses under ASC 360-10, “Property, Plant, and Equipment”, to determine whether a ROU asset is impaired, and if so, the amount of the impairment loss to recognize. |
Revenues | Revenues The Company derives virtually all of its revenues from its license and supply agreement (the “Allergan Agreement”) with Allergan Pharmaceuticals International Limited (“Allergan”), a wholly owned subsidiary of Allergan plc. Under the Allergan Agreement, the Company grants Allergan an exclusive license to develop, commercialize, and otherwise exploit products that contain reverse thermally triggered hydrogel (“RTGel”) and agrees to supply Allergan with pre-clinical and clinical quantities of the RTGel product, also referred to as the RTGel The Company determined that Allergan is its customer and the Allergan Agreement is in scope of ASC 606, which was adopted as of January 1, 2018. The Company adopted ASC 606 under the modified retrospective method, which did not have a material impact on the condensed consolidated statements of operations. Supply of RTGel to Allergan The Company recognizes revenue related to supply of RTGel at a point in time, upon delivery to Allergan. During the three months ended March 31, 2019 and 2018, the Company recognized $0 and $0.5 million of revenue related to RTGel supplied to Allergan, respectively. Shipping and handling costs associated with supply of RTGel are accounted for as a fulfillment cost and are in included in cost of revenues. |
General and Administrative Expenses | General and Administrative Expenses General and administrative expenses consist primarily of salaries and other related costs, including share-based compensation, for personnel in executive, finance, accounting, legal, investor relations, facilities, business development and human resources functions. Other significant costs include facility costs not otherwise included in research and development expenses, legal fees relating to corporate matters, insurance, public company expenses relating to maintaining compliance with listing rules of the Nasdaq Stock Market and requirements of the U.S. Securities and Exchange Commission (“SEC”), insurance and investor relations costs, and fees for accounting and consulting services. General and administrative costs are expensed as incurred, and the Company accrues for services provided by third parties related to the above expenses by monitoring the status of services provided and receiving estimates from its service providers and adjusting its accruals as actual costs become known. |
Research and Development Expenses | Research and Development Expenses Research s i d a l l The l e l |
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 our ordinary shares on the grant date. As o The s n g As of December 31, 2018, the Company adopted ASU 2018-07, Compensation-Stock Compensation, which establishes that the measurement of equity-classified nonemployee awards will be fixed at the grant date. The adoption of ASU 2018-07 did not have an impact on the condensed consolidated statements of operations. |
Net Loss per Common Share | Net Loss per Common Share Basic net loss per share is computed by dividing the net loss attributable to common shareholders by the weighted-average number of common shares outstanding. Diluted net loss per share is computed similarly to basic net loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted loss per share as their effect is anti-dilutive. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2018, the FASB issued ASU No. In February 2016, the FASB issued ASU No. 2016-02, “Leases” (“Topic 842”). Topic 842 supersedes existing guidance in Leases (“Topic 840”). Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU 2018-10, Codification Improvements to Topic 842, Leases; ASU No. 2018-11, Targeted Improvements; ASU 2018-20, Narrow-Scope Improvements for Lessors; and ASU 2019-01 – Leases. Topic 842 requires lessees to recognize ROU assets and lease liabilities on the balance sheet for leases with lease terms greater than twelve months, including those classified as operating leases. The Company adopted Topic 842 and related interpretations effective January 1, 2019 and recognized ROU assets and operating lease liabilities of $3.4 million. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
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) | 3 Months Ended |
Mar. 31, 2019 | |
Other Financial Information [Abstract] | |
Schedule of Accounts Payable and Accrued Expenses | Accounts payable and accrued expenses consist of the following as of March 31, 2019 and December 31, 2018, respectively (in thousands): March 31, 2019 December 31, 2018 Accounts payable $ 1,700 $ 4,272 Accrued clinical expenses 839 673 Accrued research and development costs 1,396 780 Accrued general and administrative expenses 1,298 1,029 Accrued other expense 709 1,786 Total accounts payable and accrued expenses $ 5,942 $ 8,540 |
Schedule of Finance (Income) Expense | Finance (income) expense consisted of the following as of March 31, 2019 and 2018, respectively (in thousands): Three Months Ended March 31, 2019 2018 Interest income on cash and cash equivalents $ (1,010 ) $ (422 ) Realized loss on sale of short-term investment — 100 Other finance expenses 21 64 Total finance income $ (989 ) $ (258 ) |
Fair Value Measurements and I_2
Fair Value Measurements and Investments in Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis | Assets and liabilities measured at fair value on a recurring basis based on Level 1, Level 2, and Level 3 fair value measurement criteria as of March 31, 2019 are as follows (in thousands): Fair Value Measurements Using Quoted Prices Significant in Active Other Significant Balance as of Markets for Observable Unobservable March 31, Identical Assets Inputs Inputs 2019 (Level 1) (Level 2) (Level 3) Assets: Money market funds (1) $ 40,026 $ 40,026 $ — $ — (1) Included within cash and equivalents on the condensed consolidated balance sheets. Assets and liabilities measured at fair value on a recurring basis based on Level 1, Level 2, and Level 3 fair value measurement criteria as of December 31, 2018 are as follows (in thousands): Fair Value Measurements Using Quoted Prices Significant in Active Other Significant Balance as of Markets for Observable Unobservable December 31, Identical Assets Inputs Inputs 2018 (Level 1) (Level 2) (Level 3) Assets: Money market funds (1) $ 89,965 $ 89,965 $ — $ — (1) Included within cash and equivalents on the condensed consolidated balance sheets. |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment, consists of the following as of March 31, 2019 and December 31, 2018 (in thousands): March 31, 2019 December 31, 2018 Laboratory equipment $ 241 $ 241 Computer equipment and software 309 271 Furniture 394 395 Leasehold improvements 561 561 Manufacturing equipment 228 227 1,733 1,695 Less: accumulated depreciation and amortization (804 ) (747 ) Property and equipment, net $ 929 $ 948 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Components of Lease Cost | The components of lease cost for the three months ended March 31, 2019 were as follows (in thousands) Three Months Ended March 31, 2019 Operating lease cost $ 302 Variable lease cost 30 $ 332 |
Schedule of Amounts Recognized Upon Adoption | The amounts recognized upon adoption and as of March 31, 2019 were as follows (in thousands): January 1, 2019 March 31, 2019 Other non-current assets $ 3,022 $ 2,777 Long-term lease liability 2,429 2,184 Other current liabilities 929 1,001 |
Schedule of Supplemental Information Related to Leases | Supplemental information related to leases for the periods reported is as follows (in thousands): Three Months Ended March 31, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operation leases 256 Right-of-use assets obtained in exchange for new operating lease liabilities 3,022 Weighted-average remaining lease term of operating leases 3.33 years Weighted-average discount rate of operating leases 7.24% |
Schedule of Maturities of Lease Liabilities | As of March 31, 2019, maturities of lease liabilities were as follows (in thousands): Operating Leases Years ending December 31, 2019 (excluding the three months ended March 31, 2019) $ 886 2020 1,220 2021 649 2022 492 2023 301 2024 and thereafter 58 Total future minimum lease payments $ 3,606 Less: Interest 421 Present value of lease liabilities $ 3,185 |
Schedule of Maturities of Lease Liabilities | As of December 31, 2018, maturities of lease liabilities were as follows (in thousands): Operating Leases Years ending December 31, 2019 $ 1,136 2020 1,251 2021 676 2022 567 2023 301 2024 and thereafter 58 Total future minimum lease payments $ 3,989 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
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 Three Months Ended March 31, 2019 2018 Research and development expenses $ 2,338 $ 2,473 General and administrative expenses 5,109 2,068 $ 7,447 $ 4,541 |
Business and Nature of Operat_2
Business and Nature of Operations - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Date of incorporation | Apr. 30, 2004 |
Date of operating commencement | Feb. 29, 2016 |
Basis of Presentation - Additit
Basis of Presentation - Addititonal Information (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ||
Accumulated deficit | $ 144,315 | $ 122,871 |
Significant Accounting Polici_4
Significant Accounting Policies - Property and Equipment Useful Lives (Details) | 3 Months Ended |
Mar. 31, 2019 | |
Computers and Software | |
Property Plant And Equipment [Line Items] | |
Property and Equipment, Useful Lives | 3 years |
Laboratory Equipment | Minimum | |
Property Plant And Equipment [Line Items] | |
Property and Equipment, Useful Lives | 3 years |
Laboratory Equipment | Maximum | |
Property Plant And Equipment [Line Items] | |
Property and Equipment, Useful Lives | 6 years 6 months |
Furniture | Minimum | |
Property Plant And Equipment [Line Items] | |
Property and Equipment, Useful Lives | 5 years |
Furniture | Maximum | |
Property Plant And Equipment [Line Items] | |
Property and Equipment, Useful Lives | 16 years 6 months |
Manufacturing Equipment | |
Property Plant And Equipment [Line Items] | |
Property and Equipment, Useful Lives | 2 years |
Significant Accounting Polici_5
Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Jan. 01, 2019 | |
Summary Of Significant Accounting Policy [Line Items] | |||
REVENUES | $ 481 | ||
Operating lease liabilities | $ 3,185 | ||
Operating lease Right-of-Use assets | 2,777 | $ 3,022 | |
Accounting Standards Update 2016-02 | |||
Summary Of Significant Accounting Policy [Line Items] | |||
Operating lease liabilities | 3,400 | ||
Operating lease Right-of-Use assets | $ 3,400 | ||
Allergan | |||
Summary Of Significant Accounting Policy [Line Items] | |||
REVENUES | $ 0 | $ 500 | |
Type of Revenue [Extensible List] | urgn:RTGelMember | urgn:RTGelMember |
Other Financial Information - S
Other Financial Information - Schedule of Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Other Financial Information [Abstract] | ||
Accounts payable | $ 1,700 | $ 4,272 |
Accrued clinical expenses | 839 | 673 |
Accrued research and development costs | 1,396 | 780 |
Accrued general and administrative expenses | 1,298 | 1,029 |
Accrued other expense | 709 | 1,786 |
Total accounts payable and accrued expenses | $ 5,942 | $ 8,540 |
Other Financial Information -_2
Other Financial Information - Schedule of Finance (Income) Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Other Financial Information [Abstract] | ||
Interest income on cash and cash equivalents | $ (1,010) | $ (422) |
Realized loss on sale of short-term investment | 100 | |
Other finance expenses | 21 | 64 |
Total finance income | $ (989) | $ (258) |
Fair Value Measurements and I_3
Fair Value Measurements and Investments in Marketable Securities - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Fair Value Disclosures [Abstract] | |
Fair value assets, transfers between level 1 to level 2 | $ 0 |
Fair value assets, transfers between level 2 to level 1 | 0 |
Fair value liabilities, transfers between level 1 to level 2 | 0 |
Fair value liabilities, transfers between level 2 to level 1 | 0 |
Fair value assets, transfers into level 3 | 0 |
Fair value assets, transfers out of level 3 | 0 |
Fair value liabilities, transfers into level 3 | 0 |
Fair value liabilities, transfers out of level 3 | $ 0 |
Fair Value Measurements and I_4
Fair Value Measurements and Investments in Marketable Securities - Summary of Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - Fair Value, Measurements, Recurring - Money Market Funds - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Assets: | ||
Assets measured at fair value | $ 40,026 | $ 89,965 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Assets: | ||
Assets measured at fair value | $ 40,026 | $ 89,965 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Property Plant And Equipment [Line Items] | ||
Property and equipment | $ 1,733 | $ 1,695 |
Less: accumulated depreciation and amortization | (804) | (747) |
Property and equipment, net | 929 | 948 |
Laboratory Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 241 | 241 |
Computers and Software | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 309 | 271 |
Furniture | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 394 | 395 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 561 | 561 |
Manufacturing Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | $ 228 | $ 227 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Property Plant And Equipment [Abstract] | ||
Depreciation and amortization expense | $ 0.1 | $ 0.2 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Apr. 30, 2018 | Sep. 30, 2017 | Mar. 31, 2019 | Dec. 31, 2018 | |
Lessee Lease Description [Line Items] | ||||
Operating leases, existence of option to extend | true | |||
Operating leases, options to extend lease term, description | 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 | |||
Operating lease extended lease expiration, month and year | 2022-08 | |||
Impairment losses on operating leases | $ 0 | |||
Rent expense | $ 1,200,000 | |||
Minimum | ||||
Lessee Lease Description [Line Items] | ||||
Lease expiration year | 2019 | |||
Maximum | ||||
Lessee Lease Description [Line Items] | ||||
Lease expiration year | 2022 | |||
UroGen Pharma Inc. | ||||
Lessee Lease Description [Line Items] | ||||
Lease commencement date | Jul. 10, 2018 | Oct. 31, 2017 | May 31, 2016 | |
Lease termination date | Mar. 31, 2024 | Feb. 28, 2021 | ||
Proceeds from tenant allowance | $ 200,000 |
Leases - Components of Lease Co
Leases - Components of Lease Cost (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Leases [Abstract] | |
Operating lease cost | $ 302 |
Variable lease cost | 30 |
Lease, Cost | $ 332 |
Leases - Schedule of Amounts Re
Leases - Schedule of Amounts Recognized Upon Adoption (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Jan. 01, 2019 |
Leases [Abstract] | ||
Operating lease Right-of-Use assets | $ 2,777 | $ 3,022 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:OtherAssetsNoncurrent | us-gaap:OtherAssetsNoncurrent |
Long-term lease liability | $ 2,184 | $ 2,429 |
Other current liabilities | $ 1,001 | $ 929 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent | us-gaap:OtherLiabilitiesCurrent |
Leases - Schedule of Supplement
Leases - Schedule of Supplemental Information Related to Leases (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Cash paid for amounts included in the measurement of lease liabilities: | |
Operating cash flows from operation leases | $ 256 |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 3,022 |
Weighted-average remaining lease term of operating leases | 3 years 3 months 29 days |
Weighted-average discount rate of operating leases | 7.24% |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Leases [Abstract] | ||
2019 (excluding the three months ended March 31, 2019) | $ 886 | |
2020 | 1,220 | |
2021 | 649 | |
2022 | 492 | |
2023 | 301 | |
2024 and thereafter | 58 | |
Total future minimum lease payments | 3,606 | |
Less: Interest | 421 | |
Operating lease liabilities | $ 3,185 | |
2019 | $ 1,136 | |
2020 | 1,251 | |
2021 | 676 | |
2022 | 567 | |
2023 | 301 | |
2024 and thereafter | 58 | |
Total future minimum lease payments | $ 3,989 |
License and Collaboration Agr_2
License and Collaboration Agreements - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||
Revenues | $ 481 | |
Allergan | ||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||
Revenues | $ 0 | $ 500 |
Type of Revenue [Extensible List] | urgn:RTGelMember | urgn:RTGelMember |
Allergan | License Agreement | ||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||
Milestone payments received for licensing agreement | $ 25,000 | |
Allergan | License Agreement | Maximum | ||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||
License agreement additional milestone payments eligible to receive | $ 200,000 |
Shareholders' Equity - Addition
Shareholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | |||
Jan. 31, 2019 | Jan. 31, 2018 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Class Of Stock [Line Items] | |||||
Ordinary shares, shares authorized | 100,000,000 | 100,000,000 | |||
Ordinary shares, issued | 20,758,348 | 16,214,883 | |||
Ordinary shares, outstanding | 20,758,348 | 16,214,883 | |||
Issuance of ordinary shares, consideration received net of underwriting discounts and commissions and issuance costs | $ 161,447 | $ 64,193 | |||
Underwritten Public Offering | |||||
Class Of Stock [Line Items] | |||||
Issuance of ordinary shares, shares | 4,207,317 | 1,682,926 | |||
Additional ordinary shares exercised under underwriters option to purchase at the public offering price | 548,780 | 219,512 | |||
Issuance of ordinary shares, price per share | $ 41 | $ 41 | |||
Issuance of ordinary shares, consideration received net of underwriting discounts and commissions and issuance costs | $ 161,400 | $ 64,200 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | Jan. 03, 2019 | Jan. 02, 2019 | Oct. 12, 2018 | Jan. 01, 2018 | Mar. 31, 2017 | Mar. 31, 2019 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Awards vesting period | 1 year | |||||
Unrecognized compensation cost of options and RSUs | $ 63.2 | |||||
Expected to be recognized over a weighted average period | 2 years 4 months 24 days | |||||
Options | Board Of Directors | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Grants related option awards | $ 3.4 | |||||
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 | $ 47.57 | |||||
Options | General and Administrative and Research and Development Expenses | Board Of Directors | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Estimated fair value of options granted | $ 2.8 | |||||
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 | |||||
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 | 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 | $ 24.1 | |||||
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 | 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 | 3,550,167 | 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 | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation | $ 7,447 | $ 4,541 |
Research and Development Expenses | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation | 2,338 | 2,473 |
General and Administrative Expenses | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation | $ 5,109 | $ 2,068 |
Related Parties - Additional In
Related Parties - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Apr. 30, 2018 | Sep. 30, 2017 | Mar. 31, 2019 | Dec. 31, 2018 | |
Related Party Transaction [Line Items] | ||||
Operating lease liabilities | $ 3,185,000 | |||
UroGen Pharma Inc. | ||||
Related Party Transaction [Line Items] | ||||
Lease agreement date | Nov. 30, 2015 | |||
Lease commencement date | Jul. 10, 2018 | Oct. 31, 2017 | May 31, 2016 | |
Gain (loss) on disposal of fixed assets | $ 200,000 | |||
Operating lease liabilities | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - IIA $ in Millions | 1 Months Ended | 3 Months Ended |
Mar. 31, 2019USD ($) | Mar. 31, 2019USD ($) | |
Commitments And Contingent Liabilities [Line Items] | ||
Royalty paid | $ 0.8 | |
Minimum | ||
Commitments And Contingent Liabilities [Line Items] | ||
Royalty fees payable on product sales, percentage | 3.00% | |
Maximum | ||
Commitments And Contingent Liabilities [Line Items] | ||
Royalty fees payable on product sales, percentage | 5.00% | |
Maximum percentage of royalty payable on grant received | 300.00% | 100.00% |
Royalty amount payable | $ 2.1 | $ 2.1 |