Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 03, 2021 | |
Document Information [Line Items] | ||
Entity Central Index Key | 0001668243 | |
Entity Registrant Name | UroGen Pharma Ltd. | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2021 | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2021 | |
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 | |
Title of 12(b) Security | Ordinary Shares, par value NIS 0.01 per share | |
Trading Symbol | URGN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 22,420,325 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 55,337 | $ 52,864 |
Marketable securities | 50,872 | 49,154 |
Restricted cash | 1,226 | 1,226 |
Accounts receivable | 7,784 | 7,047 |
Inventories | 3,808 | 1,964 |
Prepaid expense and other current assets | 6,113 | 3,364 |
Total current assets | 125,140 | 115,619 |
Non-current assets: | ||
Property and equipment, net | 1,978 | 2,046 |
Restricted deposit | 223 | 223 |
Right of use asset | 1,418 | 2,158 |
Marketable securities | 4,071 | 1,893 |
Other non-current assets | 1,773 | 66 |
Total Assets | 134,603 | 122,005 |
Current liabilities: | ||
Accounts payable and accrued expense | 11,062 | 10,023 |
Employee related accrued expense | 6,476 | 9,554 |
Other current liabilities | 2,268 | 1,859 |
Total current liabilities: | 19,806 | 21,436 |
Non-current liabilities: | ||
Prepaid forward obligation | 79,927 | 0 |
Long-term lease liability | 616 | 1,497 |
Uncertain tax positions liability | 2,717 | 2,717 |
Total Liabilities | 103,066 | 25,650 |
Commitments and contingencies (Note 14) | ||
Shareholders' equity: | ||
Ordinary shares, NIS 0.01 par value; 100,000,000 shares authorized at September 30, 2021 and December 31, 2020; 22,404,845 and 22,167,791 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively | 61 | 60 |
Additional paid-in capital | 470,341 | 452,525 |
Accumulated deficit | (438,869) | (356,501) |
Accumulated other comprehensive income | 4 | 271 |
Total Shareholders' Equity | 31,537 | 96,355 |
Total Liabilities and Shareholders' Equity | $ 134,603 | $ 122,005 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - ₪ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Ordinary shares, par value (in ILS per share) | ₪ 0.01 | ₪ 0.01 |
Ordinary shares, authorized (in shares) | 100,000,000 | 100,000,000 |
Ordinary shares, issued (in shares) | 22,404,845 | 22,167,791 |
Ordinary shares, outstanding (in shares) | 22,404,845 | 22,167,791 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenue | $ 11,351 | $ 3,461 | $ 31,868 | $ 3,833 |
Cost of revenue | 1,244 | 309 | 3,568 | 357 |
Gross profit | 10,107 | 3,152 | 28,300 | 3,476 |
Operating expense: | ||||
Research and development expense | 11,923 | 10,211 | 34,560 | 34,905 |
Selling, general and administrative expense | 21,624 | 22,065 | 66,117 | 68,056 |
Operating loss | (23,440) | (29,124) | (72,377) | (99,485) |
Financing on prepaid forward obligation | (6,828) | 0 | (9,948) | 0 |
Interest and other income, net | 57 | 308 | 269 | 1,527 |
Loss before income taxes | (30,211) | (28,816) | (82,056) | (97,958) |
Income tax expense | 0 | 0 | 312 | 0 |
Net Loss | (30,211) | (28,816) | (82,368) | (97,958) |
Statements of Comprehensive Loss | ||||
Net loss | (30,211) | (28,816) | (82,368) | (97,958) |
Other comprehensive income | ||||
Unrealized (loss) gain on marketable securities | (41) | (268) | (267) | 216 |
Comprehensive Loss | $ (30,252) | $ (29,084) | $ (82,635) | $ (97,742) |
Net loss per ordinary share basic and diluted (in dollars per share) | $ (1.35) | $ (1.31) | $ (3.69) | $ (4.52) |
Weighted average number of shares outstanding used in computation of basic and diluted loss per ordinary share (in shares) | 22,380,598 | 22,058,343 | 22,318,589 | 21,657,712 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Shareholders' Equity (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Total |
Balance (in shares) at Dec. 31, 2019 | 21,026,184 | ||||
Balance at Dec. 31, 2019 | $ 57 | $ 407,986 | $ (228,017) | $ 276 | $ 180,302 |
Exercise of options into ordinary shares (in shares) | 345,248 | ||||
Exercise of options into ordinary shares | $ 1 | 690 | 691 | ||
Share-based compensation | 21,499 | 21,499 | |||
Other comprehensive income (loss) | 216 | 216 | |||
Net loss | (97,958) | (97,958) | |||
Issuance of ordinary shares in public offering, net of issuance expense (in shares) | 700,000 | ||||
Issuance of ordinary shares in public offering, net of issuance expense | $ 2 | 15,775 | 15,777 | ||
Balance (in shares) at Sep. 30, 2020 | 22,071,432 | ||||
Balance at Sep. 30, 2020 | $ 60 | 445,950 | (325,975) | 492 | 120,527 |
Balance (in shares) at Jun. 30, 2020 | 22,001,296 | ||||
Balance at Jun. 30, 2020 | $ 60 | 438,999 | (297,159) | 760 | 142,660 |
Exercise of options into ordinary shares (in shares) | 70,136 | ||||
Exercise of options into ordinary shares | $ 0 | 188 | 188 | ||
Share-based compensation | 6,763 | 6,763 | |||
Other comprehensive income (loss) | (268) | (268) | |||
Net loss | (28,816) | (28,816) | |||
Balance (in shares) at Sep. 30, 2020 | 22,071,432 | ||||
Balance at Sep. 30, 2020 | $ 60 | 445,950 | (325,975) | 492 | 120,527 |
Balance (in shares) at Dec. 31, 2020 | 22,167,791 | ||||
Balance at Dec. 31, 2020 | $ 60 | 452,525 | (356,501) | 271 | 96,355 |
Exercise of options into ordinary shares (in shares) | 237,054 | ||||
Exercise of options into ordinary shares | $ 1 | 60 | 61 | ||
Share-based compensation | 17,756 | 17,756 | |||
Other comprehensive income (loss) | (267) | (267) | |||
Net loss | (82,368) | (82,368) | |||
Balance (in shares) at Sep. 30, 2021 | 22,404,845 | ||||
Balance at Sep. 30, 2021 | $ 61 | 470,341 | (438,869) | 4 | 31,537 |
Balance (in shares) at Jun. 30, 2021 | 22,354,533 | ||||
Balance at Jun. 30, 2021 | $ 61 | 464,823 | (408,658) | 45 | 56,271 |
Exercise of options into ordinary shares (in shares) | 50,312 | ||||
Exercise of options into ordinary shares | $ 0 | 3 | 3 | ||
Share-based compensation | 5,515 | 5,515 | |||
Other comprehensive income (loss) | (41) | (41) | |||
Net loss | (30,211) | (30,211) | |||
Balance (in shares) at Sep. 30, 2021 | 22,404,845 | ||||
Balance at Sep. 30, 2021 | $ 61 | $ 470,341 | $ (438,869) | $ 4 | $ 31,537 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flow (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash Flows From Operating Activities | ||
Net loss | $ (82,368) | $ (97,958) |
Adjustment to reconcile net loss to net cash from operating activities: | ||
Depreciation and amortization | 618 | 295 |
Accrued financing on prepaid forward obligation | 8,583 | 0 |
Amortization on marketable securities | 343 | 386 |
Share-based compensation | 17,756 | 21,499 |
Amortization of right of use asset | 704 | 1,134 |
Lease liability | (914) | (1,157) |
Changes in operating assets and liabilities: | ||
Inventory | (1,844) | (1,346) |
Accounts receivable | (737) | (2,810) |
Prepaid expense and other current assets | (2,749) | (3,261) |
Other non-current assets | (1,573) | 0 |
Accounts payable and accrued expense | 1,032 | (2,506) |
Employee related accrued expense | (3,078) | 1,080 |
Other current liabilities | (595) | 0 |
Net cash used in operating activities | (64,822) | (84,644) |
Cash Flows From Investing Activities | ||
Purchases of marketable securities | (51,594) | (29,687) |
Sales of marketable securities | 2,463 | |
Maturities of marketable securities | 44,625 | 74,503 |
Purchases of property and equipment | (550) | (1,043) |
Net cash (used in) provided by investing activities | (5,056) | 43,773 |
Cash Flows From Financing Activities | ||
Proceeds from prepaid forward arrangement | 72,417 | 0 |
Proceeds from exercise of options into ordinary shares | 61 | 651 |
Issuances of ordinary shares, net of issuance expense | 0 | 15,853 |
Issuance cost related to at-the-market issuances | (127) | (55) |
Net cash provided by financing activities | 72,351 | 16,449 |
Increase (Decrease) in Cash and Cash Equivalents | 2,473 | (24,422) |
Cash, Cash Equivalents and Restricted Cash at Beginning of Period | 54,090 | 50,211 |
Cash, Cash Equivalents and Restricted Cash at End of Period | 56,563 | 25,789 |
Supplemental Disclosures of Non-Cash Activities | ||
Non-cash new lease liabilities | (36) | 51 |
Non-cash issuance cost | 7 | 0 |
Exercise of options | $ 0 | $ 40 |
Note 1 - Business and Nature of
Note 1 - Business and Nature of Operations | 9 Months Ended |
Sep. 30, 2021 | |
Notes to Financial Statements | |
Nature of Operations [Text Block] | Note 1 Business and Nature of Operations Nature of Operations UroGen Pharma Ltd. is an Israeli company incorporated in April 2004 ( UroGen Pharma Inc., a wholly owned subsidiary of UPL, was incorporated in Delaware in October 2015 February 2016 ( UPL and UPI (together the “Company”) is a biopharmaceutical company focused on building and commercializing novel solutions that treat specialty cancers and urologic diseases. Since commencing operations, the Company has devoted substantially all of its efforts to securing intellectual property rights, performing research and development activities, including conducting clinical trials and manufacturing activities, hiring personnel, launching the Company’s first Jelmyto 101 On April 15, 2020, Jelmyto first Jelmyto RTGel |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation | 9 Months Ended |
Sep. 30, 2021 | |
Notes to Financial Statements | |
Basis of Accounting [Text Block] | 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 10 X. not not not 10 December 31, 2020, March 18, 2021. The consolidated financial statements include the accounts of UPL and its wholly owned subsidiary UPI. Intercompany balances and transactions have been eliminated during consolidation. The Company has experienced net losses since its inception and has an accumulated deficit o f $ September 30, 2021 December 31, 2020, The success of the Company depends on the ability to successfully commercialize its technologies to support its operations and strategic plan. Based on management’s cash flow projections the Company believes that its cash and cash equivalents and marketable securities are sufficient to fund the Company’s planned operations for at least the next 12 no not |
Note 3 - Significant Accounting
Note 3 - Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | 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 preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expense during the reporting period. Actual results may Functional Currency The U.S. dollar (“Dollar”) is the currency of the primary economic environment in which the operations of the Company are conducted. Therefore, the functional currency of the Company is the Dollar. Accordingly, transactions in currencies other than the Dollar are measured and recorded in the functional currency using the exchange rate in effect at the date of the transaction. At the balance sheet date, monetary assets and liabilities that are denominated in currencies other than the Dollar are measured using the official exchange rate at the balance sheet date. The effects of foreign currency re-measurements are recorded in the condensed consolidated statements of operations as “Interest and other income, net.” Cash and Cash Equivalents; Marketable Securities The Company considers all highly liquid investments with an original maturity of three Cash and cash equivalents and marketable securities totaled $110.3 million as of September 30, 2021 320, Short-term investments are valued using models or other valuation methodologies that use Level 2 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 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’s investment portfolio are the preservation of capital and the maintenance of liquidity. The Company does not The Company’s investment policy limits investments to certain types of instruments such as certificates of deposit, money market instruments, obligations issued by the U.S. government and U.S. government agencies as well as corporate debt securities, and places restrictions on maturities and concentration by type and issuer. The Company maintains cash balances in excess of amounts insured by the Federal Deposit Insurance Corporation and concentrated within a limited number of financial institutions. The accounts are monitored by management to mitigate the risk. The Company’s product sales are recognized through the Company's arrangement with a single customer, a third not not 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 taxes are computed using the asset and liability method. Under the asset and liability method, deferred income tax assets and liabilities are determined based on the differences between the financial reporting and tax bases of assets and liabilities and are measured using the currently enacted tax rates and laws. A valuation allowance is recognized to the extent that it is more likely than not not The Company follows a two not 740 10 30 7 50% 15 Inventory The Company capitalizes inventory costs related to products to be sold in the ordinary course of business. The Company makes a determination of capitalizing inventory costs for a product based on, among other factors, status of regulatory approval, information regarding safety, efficacy and expectations relating to commercial sales and recoverability of costs. For Jelmyto The Company values its inventory at the lower of cost or net realizable value. The Company measures inventory approximating actual cost under a first first . 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 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 Prepaid Forward Obligation The Company is party to a transaction with RTW Investments (the “RTW Transaction”) in which the Company received funds to support the continued launch of Jelmyto 102 Jelmyto 102, 835 30, 9 Leases The Company is a lessee in several noncancelable operating leases, primarily for office space, office equipment and vehicles. The Company currently has no The Company accounts for leases in accordance with ASC Topic 842, . 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 Because most of the Company’s leases do not ROU assets for operating leases are periodically reviewed for impairment losses under ASC 360 10, Revenue Product sales from Jelmyto 606 Jelmyto third 340b Research and Development Expense Research and development costs are expensed as incurred and consist primarily of the cost of salaries, share-based compensation expense, 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 Selling General and Administrative Expense Selling, general and administrative expense consists primarily of personnel costs (including share-based compensation related to directors, employees and consultants). Other significant costs include commercial, medical affairs, external professional service costs, facility costs, accounting and audit services, legal services, and other consulting fees. Selling, general and administrative costs are expensed as incurred, and the Company accrues for services provided by third 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, The Company elected to recognize compensation costs for awards conditioned only on continued service that have a graded vesting schedule using the straight-line method and to value the awards based on the single-option award approach. 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 Issued Accounting Pronouncements The Company has reviewed the Accounting Standards Updates recently issued by the Financial Accounting Standards Board, and determined that they are not |
Note 4 - Other Financial Inform
Note 4 - Other Financial Information | 9 Months Ended |
Sep. 30, 2021 | |
Notes to Financial Statements | |
Other Financial Information [Text Block] | Note 4 Other Financial Information Accounts Payable and Accrued Expense Accounts payable and accrued expense consists of the following as of September 30, 2021 December 31, 2020 September 30, December 31, 2021 2020 Accounts payable $ 4,060 $ 3,271 Accrued sales reserves 847 382 Accrued clinical expense 2,504 1,359 Accrued research and development expense 1,406 1,356 Accrued selling, general and administrative expense 1,638 2,440 Accrued other expense 607 1,215 Total accounts payable and accrued expense $ 11,062 $ 10,023 Interest and Other Income (Expense), Net Interest and other income (expense) consisted of the following as of September 30, 2021 2020 Nine Months Ended September 30, 2021 2020 Interest income $ 345 $ 1,719 Other finance (expense), net (76 ) (192 ) Total interest and other income, net $ 269 $ 1,527 |
Note 5 - Inventories
Note 5 - Inventories | 9 Months Ended |
Sep. 30, 2021 | |
Notes to Financial Statements | |
Inventory Disclosure [Text Block] | Note 5 Inventories Inventories consist of the following as of September 30, 2021 December 31, 2020 September 30, December 31, 2021 2020 Raw materials (1) $ 4,106 $ 1,051 Finished goods 1,275 913 Total inventories $ 5,381 $ 1,964 ( 1 $1.6 million of raw materials at September 30, 2021 |
Note 6 - Fair Value Measurement
Note 6 - Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | 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 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 Level 3: Unobservable inputs that reflect the reporting entity’s own assumptions. The carrying amounts of the Company’s other current assets, accounts payable and accrued liabilities are generally considered to be representative of their fair value because of the short-term nature of these instruments. No Assets and liabilities measured at fair value on a recurring basis based on Level 1 2 September 30, 2021 Fair Value Measurements Using Quoted Prices Significant in Active Other Balance as of Markets for Observable September 30, Identical Assets Inputs 2021 (Level 1) (Level 2) Marketable securities: US government $ 19,401 $ 19,401 $ — Corporate bonds 12,349 — 12,349 Commercial paper 15,989 — 15,989 Money market funds (1) 35,924 35,924 — Certificates of deposit 7,204 — 7,204 Total marketable securities $ 90,867 $ 55,325 $ 35,542 ( 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 2 December 31, 2020 Fair Value Measurements Using Quoted Prices Significant in Active Other Balance as of Markets for Observable December 31, Identical Assets Inputs 2020 (Level 1) (Level 2) Marketable securities: US government $ 29,186 $ 29,186 $ — Corporate bonds 21,861 — 21,861 Money market funds (1) 39,744 39,744 — Total marketable securities $ 90,791 $ 68,930 $ 21,861 ( 1 Included within cash and cash equivalents on the condensed consolidated balance sheets. The Company’s in money market funds are valued based on publicly available quoted market prices for identical securities as of September 30, 2021 December 31, 2020. |
Note 7 - Marketable Securities
Note 7 - Marketable Securities | 9 Months Ended |
Sep. 30, 2021 | |
Notes to Financial Statements | |
Investments in Debt and Marketable Equity Securities (and Certain Trading Assets) Disclosure [Text Block] | Note 7 Marketable Securities The following table summarizes the Company’s marketable securities as of September 30, 2021 Amortized Unrealized Unrealized Cost Basis Gains Losses Fair Value Marketable securities: US government $ 19,399 $ 2 $ — $ 19,401 Corporate bonds 12,348 1 — 12,349 Commercial paper 15,988 1 — 15,989 Money market funds (1) 35,924 — — 35,924 Certificates of deposit 7,204 — — 7,204 Total marketable securities $ 90,863 $ 4 $ — $ 90,867 ( 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, 2021 September 30, 2021 As of September 30, 2021 not not September 30, 2021 no The Company’s marketable securities as of September 30, 2021 February 2022. September 30, December 31, 2021 2020 Maturities within one year $ 86,797 $ 88,898 Maturities after one year through three years 4,070 1,893 Total marketable securities $ 90,867 $ 90,791 |
Note 8 - Property and Equipment
Note 8 - Property and Equipment | 9 Months Ended |
Sep. 30, 2021 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | Note 8 Property and Equipment Property and equipment, consists of the following as of September 30, 2021 December 31, 2020 September 30, December 31, 2021 2020 Laboratory equipment $ 355 $ 333 Computer equipment and software 2,024 1,676 Furniture 597 597 Leasehold improvements 617 609 Manufacturing equipment 398 226 3,991 3,441 Less: accumulated depreciation and amortization (2,013 ) (1,395 ) Property and equipment, net $ 1,978 $ 2,046 Depreciation and amortization expense was $0.2 million and $0.6 three nine September 30, 2021 three nine September 30, 2020 |
Note 9 - Prepaid Forward Obliga
Note 9 - Prepaid Forward Obligation | 9 Months Ended |
Sep. 30, 2021 | |
Notes to Financial Statements | |
Prepaid Forward Obligation Disclosure [Text Block] | Note 9 Prepaid Forward Obligation In March 2021, $72.4 Jelmyto 102. Jelmyto $200 $200 $300 $300 Jelmyto not Jelmyto $200 may 9.5% Jelmyto In addition, subject to FDA approval of UGN- 102, 102 $200 $200 $300 $300 not 102 Jelmyto Jelmyto In accordance with the prepaid forward agreement, the Company will be required to make payments of amounts owed to RTW each calendar quarter, through and until the quarter in which the aggregate cash payments received by RTW are equal to or greater than $300 million. As security for the payment and fulfilment of these amounts throughout the arrangement, the Company has granted RTW a first Jelmyto 102, In May 2021, 72.4 835 30, not 12 The following table shows the activity with respect to the carrying value of the prepaid forward liability, in thousands: Prepaid forward obligation at closing of RTW Transaction $ 75,000 Capitalized closing costs (2,583 ) Financing on prepaid forward obligation 9,948 Amounts paid and payable (2,438 ) Carrying value of prepaid forward obligation as of September 30, 2021 $ 79,927 |
Note 10 - Leases
Note 10 - Leases | 9 Months Ended |
Sep. 30, 2021 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | Note 10 Leases Operating Leases The Company has the following office and laboratory facility leases: • In April 2016, November 2014 2019. March 2019, three August 2022. • In September 2017, October 2017 February 2021. • In April 2018, July 10, 2018 March 2024. September 30, 2021 November 2019, January 1, 2020 March 2024. November 2019. September 30, 2021 842 10 25 2 842 10 25 3. • In November 2019, November 29, 2019 September 30, 2021 In addition, the Company has other operating office equipment and vehicle leases. The Company’s operating leases may not 2021 2023, The components of lease cost for the three nine September 30, 2021 Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Operating lease cost $ 259 $ 424 $ 786 $ 1,282 Sublease income (56 ) (56 ) (168 ) (168 ) Variable lease cost 15 28 51 114 $ 218 $ 396 $ 669 $ 1,228 The amounts recognized as of September 30, 2021 December 31, 2020 September 30, December 31, 2021 2020 Right of use asset $ 1,418 $ 2,158 Long-term lease liabilities 616 1,497 Other current liabilities 1,133 1,202 As of September 30, 2021 Supplemental information related to leases for the nine September 30, 2021 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases 2,734 Right-of-use assets obtained in exchange for new operating lease liabilities 135 Weighted-average remaining lease term of operating leases (in years) 1.68 Weighted-average discount rate of operating leases 5.51 % Subleases As of September 30, 2021 Operating Leases Years ending December 31, Remainder of 2021 $ 59 2022 243 2023 251 2024 49 2025 and thereafter — $ 602 Sublease income is recognized net within operating expense. Sublease income for the three nine September 30, 2021 Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Sublease income from fixed lease payments $ 56 $ 56 $ 168 $ 168 |
Note 11 - Revenue from Product
Note 11 - Revenue from Product Sales | 9 Months Ended |
Sep. 30, 2021 | |
Notes to Financial Statements | |
Revenue from Contract with Customer [Text Block] | Note 11 Revenue From Product Sales Net product sales consist of the following for the three nine September 30, 2021 Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Jelmyto $ 11,351 $ 3,461 $ 31,868 $ 3,833 |
Note 12 - License and Collabora
Note 12 - License and Collaboration Agreements | 9 Months Ended |
Sep. 30, 2021 | |
Notes to Financial Statements | |
Collaborative Arrangement Disclosure [Text Block] | Note 12 License and Collaboration Agreements Allergan/AbbVie Agreement In October 2016, RTGel not In October 2017, 2 RTGel August 2020, 2 not may not Agenus Agreement In November 2019, not AGEN1884 AGEN1884 4 1 1 AGEN1884 201 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 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 may 180 may 60 first nine may MD Anderson Agreement In January 2021, three 302 September 30, 2021 |
Note 13 - Shareholders' Equity
Note 13 - Shareholders' Equity | 9 Months Ended |
Sep. 30, 2021 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | Note 13 Shareholders Equity The Company had 100.0 million ordinary shares authorized for issuance as of September 30, 2021 December 31, 2020. September 30, 2021 December 31, 2020, one not |
Note 14 - Share-based Compensat
Note 14 - Share-based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
Notes to Financial Statements | |
Share-based Payment Arrangement [Text Block] | Note 14 Share-Based Compensation In October 2010, The grant of options to Israeli employees under the Plan is subject to the terms stipulated by Section 102 102” 102. 102, not 3 Employees are typically granted stock options and/or restricted stock units ("RSUs"), upon commencement of employment. Also, eligible employees may not three not 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 two one first two one The expected volatility is based on a mix of the Company’s historical volatility, and the historical volatility of comparable companies with similar attributes to the Company, including industry, stage of life cycle, size and financial leverage. The risk-free interest rate assumption is based on observed interest rates appropriate for the expected term of the options granted. The expected term is the length of time until the expected dates of exercising the options and is estimated for employees using the simplified method due to insufficient specific historical information of employees’ exercise behavior, and for non-employees, and directors using the contractual term. In March 2017, 2017 "2017 April 2017. 2017 The maximum number of ordinary shares that was initially authorized for issuance under the 2017 January 1, 2018, October 12, 2018, 2017 June 8, 2020 2017 June 7, 2021, 2017 In May 2019, 2019 5635 4 5635 3 5635 1, not As of September 30, 2021 , 3,587,774 ordinary shares are subject to outstanding awards under the Company's share-based compensation plans and 1,362,156 ordinary shares remain available for future awards. The following table illustrates the effect of share-based compensation on the condensed consolidated statements of operations (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Research and development expense $ 971 $ 1,519 $ 3,119 $ 5,032 Selling, general and administrative expense 4,544 5,244 14,637 16,467 $ 5,515 $ 6,763 $ 17,756 $ 21,499 The total unrecognized compensation cost of options and RSUs at September 30, 2021 |
Note 15 - Income Taxes
Note 15 - Income Taxes | 9 Months Ended |
Sep. 30, 2021 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | Note 15 Income Taxes UroGen Pharma Ltd. is taxed under Israeli tax laws. As of September 30, 2021 2020, 2019 2018, nine September 30, 2021 may The Company has a liability for uncertain tax positions of $2.7 million as of September 30, 2021 September 30, 2021 2020. The Company operates on a global basis and is subject to tax laws and regulations in the U.S. and Israel. The estimate of the Company’s tax liabilities relating to uncertain tax positions requires management to assess uncertainties and to make judgments about the application of complex tax laws and regulations, expectations regarding the outcome of tax authority examinations, as well as the ultimate measurement of potential liabilities. The uncertain tax positions are reviewed quarterly and adjusted as events occur that could affect potential liabilities for additional taxes, including lapsing of applicable statutes of limitations, correspondence with tax authorities, proposed assessments by tax authorities, identification of new issues, and issuance of new legislation or regulations. The Company believes that adequate amounts of tax have been provided in income tax expense for any adjustments that may not 12 |
Note 16 - Related Parties
Note 16 - Related Parties | 9 Months Ended |
Sep. 30, 2021 | |
Notes to Financial Statements | |
Related Party Transactions Disclosure [Text Block] | Note 16 Related Parties There were no nine September 30, 2021 2020. |
Note 17 - Commitments and Conti
Note 17 - Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | Note 17 Commitments and Contingencies In the normal course of business, the Company enters into contracts that contain a variety of indemnifications with its employees, licensors, suppliers and service providers. Further, the Company indemnifies its directors and officers who are, or were, serving at the Company’s request in such capacities. The Company’s maximum exposure under these arrangements is unknown as of September 30, 2021 December 31, 2020. not Grants from the Israeli Innovation Authority in Israel ( IIA ) The Company has received grants from the IIA for research and development funding. Up until 2007, 8.2. 2008, On January 12, 2020, January 2004 September 2016. first 2020 three Leases See Note 10 |
Note 18 - Subsequent Events
Note 18 - Subsequent Events | 9 Months Ended |
Sep. 30, 2021 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | Note 18 Subsequent Events See Note 12 |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Consolidation, Policy [Policy Text Block] | 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, Policy [Policy Text Block] | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expense during the reporting period. Actual results may |
Foreign Currency Transactions and Translations Policy [Policy Text Block] | Functional Currency The U.S. dollar (“Dollar”) is the currency of the primary economic environment in which the operations of the Company are conducted. Therefore, the functional currency of the Company is the Dollar. Accordingly, transactions in currencies other than the Dollar are measured and recorded in the functional currency using the exchange rate in effect at the date of the transaction. At the balance sheet date, monetary assets and liabilities that are denominated in currencies other than the Dollar are measured using the official exchange rate at the balance sheet date. The effects of foreign currency re-measurements are recorded in the condensed consolidated statements of operations as “Interest and other income, net.” |
Cash, Cash Equivalents and Marketable Securities Policy [Policy Text Block] | Cash and Cash Equivalents; Marketable Securities The Company considers all highly liquid investments with an original maturity of three Cash and cash equivalents and marketable securities totaled $110.3 million as of September 30, 2021 320, Short-term investments are valued using models or other valuation methodologies that use Level 2 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 |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | 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’s investment portfolio are the preservation of capital and the maintenance of liquidity. The Company does not The Company’s investment policy limits investments to certain types of instruments such as certificates of deposit, money market instruments, obligations issued by the U.S. government and U.S. government agencies as well as corporate debt securities, and places restrictions on maturities and concentration by type and issuer. The Company maintains cash balances in excess of amounts insured by the Federal Deposit Insurance Corporation and concentrated within a limited number of financial institutions. The accounts are monitored by management to mitigate the risk. The Company’s product sales are recognized through the Company's arrangement with a single customer, a third not not |
Income Tax, Policy [Policy Text Block] | 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 taxes are computed using the asset and liability method. Under the asset and liability method, deferred income tax assets and liabilities are determined based on the differences between the financial reporting and tax bases of assets and liabilities and are measured using the currently enacted tax rates and laws. A valuation allowance is recognized to the extent that it is more likely than not not The Company follows a two not 740 10 30 7 50% 15 |
Inventory, Policy [Policy Text Block] | Inventory The Company capitalizes inventory costs related to products to be sold in the ordinary course of business. The Company makes a determination of capitalizing inventory costs for a product based on, among other factors, status of regulatory approval, information regarding safety, efficacy and expectations relating to commercial sales and recoverability of costs. For Jelmyto The Company values its inventory at the lower of cost or net realizable value. The Company measures inventory approximating actual cost under a first first . |
Property, Plant and Equipment, Policy [Policy Text Block] | 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 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 |
Prepaid Forward Obligation Policy [Policy Text Block] | Prepaid Forward Obligation The Company is party to a transaction with RTW Investments (the “RTW Transaction”) in which the Company received funds to support the continued launch of Jelmyto 102 Jelmyto 102, 835 30, 9 |
Lessee, Leases [Policy Text Block] | Leases The Company is a lessee in several noncancelable operating leases, primarily for office space, office equipment and vehicles. The Company currently has no The Company accounts for leases in accordance with ASC Topic 842, . 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 Because most of the Company’s leases do not ROU assets for operating leases are periodically reviewed for impairment losses under ASC 360 10, |
Revenue [Policy Text Block] | Revenue Product sales from Jelmyto 606 Jelmyto third 340b |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Expense Research and development costs are expensed as incurred and consist primarily of the cost of salaries, share-based compensation expense, 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 |
Selling, General and Administrative Expenses, Policy [Policy Text Block] | Selling General and Administrative Expense Selling, general and administrative expense consists primarily of personnel costs (including share-based compensation related to directors, employees and consultants). Other significant costs include commercial, medical affairs, external professional service costs, facility costs, accounting and audit services, legal services, and other consulting fees. Selling, general and administrative costs are expensed as incurred, and the Company accrues for services provided by third |
Share-based Payment Arrangement, Director [Policy Text Block] | 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, The Company elected to recognize compensation costs for awards conditioned only on continued service that have a graded vesting schedule using the straight-line method and to value the awards based on the single-option award approach. |
Earnings Per Share, Policy [Policy Text Block] | 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. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Issued Accounting Pronouncements The Company has reviewed the Accounting Standards Updates recently issued by the Financial Accounting Standards Board, and determined that they are not |
Note 3 - Significant Accounti_2
Note 3 - Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Notes Tables | |
Property, Plant and Equipment, Useful Life [Table Text Block] | Useful Lives Computers and software 3 Laboratory equipment 3 - 6.5 Furniture 5 - 16.5 Manufacturing equipment 2 |
Note 4 - Other Financial Info_2
Note 4 - Other Financial Information (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Notes Tables | |
Schedule of Accounts Payable and Accrued Liabilities [Table Text Block] | September 30, December 31, 2021 2020 Accounts payable $ 4,060 $ 3,271 Accrued sales reserves 847 382 Accrued clinical expense 2,504 1,359 Accrued research and development expense 1,406 1,356 Accrued selling, general and administrative expense 1,638 2,440 Accrued other expense 607 1,215 Total accounts payable and accrued expense $ 11,062 $ 10,023 |
Interest Income and Interest Expense Disclosure [Table Text Block] | Nine Months Ended September 30, 2021 2020 Interest income $ 345 $ 1,719 Other finance (expense), net (76 ) (192 ) Total interest and other income, net $ 269 $ 1,527 |
Note 5 - Inventories (Tables)
Note 5 - Inventories (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | September 30, December 31, 2021 2020 Raw materials (1) $ 4,106 $ 1,051 Finished goods 1,275 913 Total inventories $ 5,381 $ 1,964 |
Note 6 - Fair Value Measureme_2
Note 6 - Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Notes Tables | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | Fair Value Measurements Using Quoted Prices Significant in Active Other Balance as of Markets for Observable September 30, Identical Assets Inputs 2021 (Level 1) (Level 2) Marketable securities: US government $ 19,401 $ 19,401 $ — Corporate bonds 12,349 — 12,349 Commercial paper 15,989 — 15,989 Money market funds (1) 35,924 35,924 — Certificates of deposit 7,204 — 7,204 Total marketable securities $ 90,867 $ 55,325 $ 35,542 Fair Value Measurements Using Quoted Prices Significant in Active Other Balance as of Markets for Observable December 31, Identical Assets Inputs 2020 (Level 1) (Level 2) Marketable securities: US government $ 29,186 $ 29,186 $ — Corporate bonds 21,861 — 21,861 Money market funds (1) 39,744 39,744 — Total marketable securities $ 90,791 $ 68,930 $ 21,861 |
Note 7 - Marketable Securities
Note 7 - Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Notes Tables | |
Marketable Securities [Table Text Block] | Amortized Unrealized Unrealized Cost Basis Gains Losses Fair Value Marketable securities: US government $ 19,399 $ 2 $ — $ 19,401 Corporate bonds 12,348 1 — 12,349 Commercial paper 15,988 1 — 15,989 Money market funds (1) 35,924 — — 35,924 Certificates of deposit 7,204 — — 7,204 Total marketable securities $ 90,863 $ 4 $ — $ 90,867 |
Investments Classified by Contractual Maturity Date [Table Text Block] | September 30, December 31, 2021 2020 Maturities within one year $ 86,797 $ 88,898 Maturities after one year through three years 4,070 1,893 Total marketable securities $ 90,867 $ 90,791 |
Note 8 - Property and Equipme_2
Note 8 - Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | September 30, December 31, 2021 2020 Laboratory equipment $ 355 $ 333 Computer equipment and software 2,024 1,676 Furniture 597 597 Leasehold improvements 617 609 Manufacturing equipment 398 226 3,991 3,441 Less: accumulated depreciation and amortization (2,013 ) (1,395 ) Property and equipment, net $ 1,978 $ 2,046 |
Note 9 - Prepaid Forward Obli_2
Note 9 - Prepaid Forward Obligation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Notes Tables | |
Schedule of Activity in the Carrying Value of the Prepaid Forward Liability [Table Text Block] | Prepaid forward obligation at closing of RTW Transaction $ 75,000 Capitalized closing costs (2,583 ) Financing on prepaid forward obligation 9,948 Amounts paid and payable (2,438 ) Carrying value of prepaid forward obligation as of September 30, 2021 $ 79,927 |
Note 10 - Leases (Tables)
Note 10 - Leases (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Notes Tables | |
Lease, Cost [Table Text Block] | Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Operating lease cost $ 259 $ 424 $ 786 $ 1,282 Sublease income (56 ) (56 ) (168 ) (168 ) Variable lease cost 15 28 51 114 $ 218 $ 396 $ 669 $ 1,228 |
Assets and Liabilities, Lessee [Table Text Block] | September 30, December 31, 2021 2020 Right of use asset $ 1,418 $ 2,158 Long-term lease liabilities 616 1,497 Other current liabilities 1,133 1,202 |
Schedule of Supplemental Information Related to Leases [Table Text Block] | Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases 2,734 Right-of-use assets obtained in exchange for new operating lease liabilities 135 Weighted-average remaining lease term of operating leases (in years) 1.68 Weighted-average discount rate of operating leases 5.51 % |
Lessor, Operating Lease, Payment to be Received, Fiscal Year Maturity [Table Text Block] | Operating Leases Years ending December 31, Remainder of 2021 $ 59 2022 243 2023 251 2024 49 2025 and thereafter — $ 602 |
Lessee, Operating Lease, Sublease Income Recognized Net in Operating Expenses [Table Text Block] | Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Sublease income from fixed lease payments $ 56 $ 56 $ 168 $ 168 |
Note 11 - Revenue from Produc_2
Note 11 - Revenue from Product Sales (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Notes Tables | |
Disaggregation of Revenue [Table Text Block] | Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Jelmyto $ 11,351 $ 3,461 $ 31,868 $ 3,833 |
Note 14 - Share-based Compens_2
Note 14 - Share-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Notes Tables | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Research and development expense $ 971 $ 1,519 $ 3,119 $ 5,032 Selling, general and administrative expense 4,544 5,244 14,637 16,467 $ 5,515 $ 6,763 $ 17,756 $ 21,499 |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation (Details Textual) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Retained Earnings (Accumulated Deficit), Ending Balance | $ (438,869) | $ (356,501) |
Note 3 - Significant Accounti_3
Note 3 - Significant Accounting Policies (Details Textual) $ in Millions | Sep. 30, 2021USD ($) |
Cash, Cash Equivalents, and Short-term Investments, Total | $ 110.3 |
Note 3 - Significant Accounti_4
Note 3 - Significant Accounting Policies - Useful Lives of Property and Equipment (Details) | 9 Months Ended |
Sep. 30, 2021 | |
Computers and Software [Member] | |
Useful life (Year) | 3 years |
Laboratory Equipment [Member] | Minimum [Member] | |
Useful life (Year) | 3 years |
Laboratory Equipment [Member] | Maximum [Member] | |
Useful life (Year) | 6 years 6 months |
Furniture [Member[ | Minimum [Member] | |
Useful life (Year) | 5 years |
Furniture [Member[ | Maximum [Member] | |
Useful life (Year) | 16 years 6 months |
Manufacturing Equipment [Member] | |
Useful life (Year) | 2 years |
Note 4 - Other Financial Info_3
Note 4 - Other Financial Information - Accounts Payable and Accrued Expense (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Accounts payable | $ 4,060 | $ 3,271 |
Accrued sales reserves | 847 | 382 |
Accrued clinical expense | 2,504 | 1,359 |
Accrued research and development expense | 1,406 | 1,356 |
Accrued selling, general and administrative expense | 1,638 | 2,440 |
Accrued other expense | 607 | 1,215 |
Total accounts payable and accrued expense | $ 11,062 | $ 10,023 |
Note 4 - Other Financial Info_4
Note 4 - Other Financial Information - Interest and Other Income (Expense), Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Interest income | $ 345 | $ 1,719 | ||
Other finance (expense), net | (76) | (192) | ||
Total interest and other income, net | $ 57 | $ 308 | $ 269 | $ 1,527 |
Note 5 - Inventories (Details T
Note 5 - Inventories (Details Textual) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | |
Inventory, Raw Materials, Net of Reserves | [1] | $ 4,106 | $ 1,051 |
Other Noncurrent Assets [Member] | |||
Inventory, Raw Materials, Net of Reserves | $ 1,600 | ||
[1] | $1.0 million of raw materials at September 30, 2021 are included within other non-current assets on the condensed consolidated balance sheets. |
Note 5 - Inventories - Inventor
Note 5 - Inventories - Inventories (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | |
Raw materials(1) | [1] | $ 4,106 | $ 1,051 |
Finished goods | 1,275 | 913 | |
Total inventories | $ 5,381 | $ 1,964 | |
[1] | $1.0 million of raw materials at September 30, 2021 are included within other non-current assets on the condensed consolidated balance sheets. |
Note 6 - Fair Value Measureme_3
Note 6 - Fair Value Measurements - Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | |
Fair value | $ 90,867 | $ 90,791 | |
US Treasury and Government [Member] | |||
Fair value | 19,401 | ||
Corporate Debt Securities [Member] | |||
Fair value | 12,349 | ||
Money Market Funds [Member] | |||
Fair value | [1] | 35,924 | |
Commercial Paper [Member] | |||
Fair value | 15,989 | ||
Certificates of Deposit [Member] | |||
Fair value | 7,204 | ||
Fair Value, Recurring [Member] | |||
Fair value | 90,867 | 90,791 | |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Fair value | 55,325 | 68,930 | |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Fair value | 35,542 | 21,861 | |
Fair Value, Recurring [Member] | US Treasury and Government [Member] | |||
Fair value | 19,401 | 29,186 | |
Fair Value, Recurring [Member] | US Treasury and Government [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Fair value | 19,401 | 29,186 | |
Fair Value, Recurring [Member] | US Treasury and Government [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Fair value | 0 | 0 | |
Fair Value, Recurring [Member] | Corporate Debt Securities [Member] | |||
Fair value | 12,349 | 21,861 | |
Fair Value, Recurring [Member] | Corporate Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Fair value | 0 | 0 | |
Fair Value, Recurring [Member] | Corporate Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Fair value | 12,349 | 21,861 | |
Fair Value, Recurring [Member] | Money Market Funds [Member] | |||
Fair value | [2] | 35,924 | 39,744 |
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Fair value | [2] | 35,924 | 39,744 |
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Fair value | [2] | 0 | $ 0 |
Fair Value, Recurring [Member] | Commercial Paper [Member] | |||
Fair value | 15,989 | ||
Fair Value, Recurring [Member] | Commercial Paper [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Fair value | 0 | ||
Fair Value, Recurring [Member] | Commercial Paper [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Fair value | 15,989 | ||
Fair Value, Recurring [Member] | Certificates of Deposit [Member] | |||
Fair value | 7,204 | ||
Fair Value, Recurring [Member] | Certificates of Deposit [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Fair value | 0 | ||
Fair Value, Recurring [Member] | Certificates of Deposit [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Fair value | $ 7,204 | ||
[1] | Included within cash and cash equivalents on the condensed consolidated balance sheets | ||
[2] | Included within cash and cash equivalents on the condensed consolidated balance sheets. |
Note 7 - Marketable Securitie_2
Note 7 - Marketable Securities (Details Textual) $ in Millions | Sep. 30, 2021USD ($) |
Debt Securities, Available-for-Sale, Accrued Interest, after Allowance for Credit Loss, Total | $ 0.1 |
Debt Securities, Available-for-sale, Unrealized Loss Position, Total | $ 11.9 |
Debt Securities, Available-for-sale, Unrealized Loss Position, Number of Positions | 13 |
Note 7 - Marketable Securitie_3
Note 7 - Marketable Securities - Summary of Marketable Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | |
Amortized cost basis | $ 90,863 | ||
Unrealized gains | 4 | ||
Unrealized losses | 0 | ||
Fair value | 90,867 | $ 90,791 | |
US Treasury and Government [Member] | |||
Amortized cost basis | 19,399 | ||
Unrealized gains | 2 | ||
Unrealized losses | 0 | ||
Fair value | 19,401 | ||
Corporate Debt Securities [Member] | |||
Amortized cost basis | 12,348 | ||
Unrealized gains | 1 | ||
Unrealized losses | 0 | ||
Fair value | 12,349 | ||
Commercial Paper [Member] | |||
Amortized cost basis | 15,988 | ||
Unrealized gains | 1 | ||
Unrealized losses | 0 | ||
Fair value | 15,989 | ||
Money Market Funds [Member] | |||
Amortized cost basis | [1] | 35,924 | |
Unrealized gains | [1] | 0 | |
Unrealized losses | [1] | 0 | |
Fair value | [1] | 35,924 | |
Certificates of Deposit [Member] | |||
Amortized cost basis | 7,204 | ||
Unrealized gains | 0 | ||
Unrealized losses | 0 | ||
Fair value | $ 7,204 | ||
[1] | Included within cash and cash equivalents on the condensed consolidated balance sheets |
Note 7 - Marketable Securitie_4
Note 7 - Marketable Securities - Fair Values of Marketable Securities by Contractual Maturity (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Maturities within one year | $ 86,797 | $ 88,898 |
Maturities after one year through three years | 4,070 | 1,893 |
Total marketable securities | $ 90,867 | $ 90,791 |
Note 8 - Property and Equipme_3
Note 8 - Property and Equipment (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Depreciation, Depletion and Amortization, Total | $ 200 | $ 100 | $ 618 | $ 295 |
Note 8 - Property and Equipme_4
Note 8 - Property and Equipment - Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Property and equipment, gross | $ 3,991 | $ 3,441 |
Less: accumulated depreciation and amortization | (2,013) | (1,395) |
Property and equipment, net | 1,978 | 2,046 |
Laboratory Equipment [Member] | ||
Property and equipment, gross | 355 | 333 |
Computers and Software [Member] | ||
Property and equipment, gross | 2,024 | 1,676 |
Furniture [Member[ | ||
Property and equipment, gross | 597 | 597 |
Leasehold Improvements [Member] | ||
Property and equipment, gross | 617 | 609 |
Manufacturing Equipment [Member] | ||
Property and equipment, gross | $ 398 | $ 226 |
Note 9 - Prepaid Forward Obli_3
Note 9 - Prepaid Forward Obligation (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended | ||
May 31, 2021 | Mar. 31, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | |
Proceeds from Prepaid Forward Arrangement, Net | $ 72,417 | $ 0 | ||
RTW Investments [Member] | ||||
Proceeds from Prepaid Forward Obligation | $ 75,000 | $ 75,000 | ||
Proceeds from Prepaid Forward Arrangement, Net | $ 72,400 | 72,400 | ||
Prepaid Forward Agreement, Minimum Future Cash Flows | $ 300,000 | |||
Prepaid Forward Obligation, Expected Cash Flows in Next Twelve Months | $ 0 | |||
RTW Investments [Member] | Sales of Up to $200 Million [Member] | Jelmyto [Member] | ||||
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales | 9.50% | |||
Prepaid Forward Agreement, Future Cash Flows, Increase in Percentage of Net Sales | 3.50% | |||
RTW Investments [Member] | Sales Between $200 Million and $300 Million [Member] | Jelmyto [Member] | ||||
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales | 3.00% | |||
RTW Investments [Member] | Sales Over $300 Million [Member] | Jelmyto [Member] | ||||
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales | 1.00% | |||
RTW Investments [Member] | Sales Up to $200 Million with FDA Approval [Member] | UGN-102 [Member] | ||||
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales | 2.50% | |||
RTW Investments [Member] | Sales Between $200 Million and $300 Million with FDA Approval [Member] | ||||
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales | 1.00% | |||
RTW Investments [Member] | Sales Over $300 Million with FDA Approval [Member] | ||||
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales | 0.50% | |||
Prepaid Forward Agreement, Future Cash Flows, Increase in Percentage of Net Sales | 1.50% |
Note 9 - Prepaid Forward Obli_4
Note 9 - Prepaid Forward Obligation - Activity in the Carrying Value of the Prepaid Forward Liability (Details) - USD ($) $ in Thousands | 3 Months Ended | 5 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | |
Prepaid forward obligation at closing of RTW Transaction | $ 75,000 | $ 0 | |||
Capitalized closing costs | (2,583) | ||||
Financing on prepaid forward obligation | $ 6,828 | $ 0 | 9,948 | 9,948 | $ 0 |
Amounts paid and payable | (2,438) | ||||
Carrying value of prepaid forward obligation as of September 30, 2021 | $ 79,927 | $ 79,927 | $ 79,927 |
Note 10 - Leases (Details Textu
Note 10 - Leases (Details Textual) - USD ($) $ in Thousands | 9 Months Ended | ||
Sep. 30, 2021 | Nov. 29, 2019 | Jul. 10, 2018 | |
Lessor, Operating Lease, Payments to be Received, Total | $ 602 | ||
Operating Lease, Impairment Loss | 0 | ||
Lease Agreement for Office in Los Angeles, California [Member] | UroGen Pharma Inc. [Member] | |||
Incentive from Lessor | $ 200 | ||
Operating Lease, Liability, Total | 700 | ||
Lessor, Operating Lease, Payments to be Received, Total | 500 | ||
Lease Agreement for Office in Princeton, New Jersey [Member] | UroGen Pharma Inc. [Member] | |||
Operating Lease, Liability, Total | $ 700 | ||
Lessee, Operating Lease, Term of Contract (Month) | 38 months |
Note 10 - Leases - Components o
Note 10 - Leases - Components of Lease Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Operating lease cost | $ 259 | $ 424 | $ 786 | $ 1,282 |
Sublease income | (56) | (56) | (168) | (168) |
Variable lease cost | 15 | 28 | 51 | 114 |
Lease, Cost, Total | $ 218 | $ 396 | $ 669 | $ 1,228 |
Note 10 - Leases - Amounts of A
Note 10 - Leases - Amounts of Assets and Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Right of use asset | $ 1,418 | $ 2,158 |
Long-term lease liabilities | 616 | 1,497 |
Other current liabilities | $ 1,133 | $ 1,202 |
Note 10 - Leases - Supplemental
Note 10 - Leases - Supplemental Information Related to Leases (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Operating cash flows from operating leases | $ 2,734 |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 135 |
Weighted-average remaining lease term of operating leases (Year) | 1 year 8 months 4 days |
Weighted-average discount rate of operating leases | 5.51% |
Note 10 - Leases - Undiscounted
Note 10 - Leases - Undiscounted Cash Flows to be Received Under Sublease (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Remainder of 2021 | $ 59 |
2022 | 243 |
2023 | 251 |
2024 | 49 |
2025 and thereafter | 0 |
Lessor, Operating Lease, Payments to be Received, Total | $ 602 |
Note 10 - Leases - Sublease Inc
Note 10 - Leases - Sublease Income Recognized (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Sublease income from fixed lease payments | $ 56 | $ 56 | $ 168 | $ 168 |
Note 11 - Revenue from Produc_3
Note 11 - Revenue from Product Sales - Net Product Sales (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenue | $ 11,351 | $ 3,461 | $ 31,868 | $ 3,833 |
Jelmyto [Member] | ||||
Revenue | $ 11,351 | $ 3,461 | $ 31,868 | $ 3,833 |
Note 12 - License and Collabo_2
Note 12 - License and Collaboration Agreements (Details Textual) - USD ($) | 1 Months Ended | 9 Months Ended | |
Jan. 31, 2021 | Nov. 30, 2019 | Sep. 30, 2021 | |
Agenus Inc. [Member] | |||
Payments for License Agreement | $ 10,000,000 | ||
License Agreement, Maximum Payable for Certain Clinical Development and Regulatory Milestones | 115,000,000 | ||
License Agreement, Maximum Payable for Certain Commercial Milestones | $ 85,000,000 | ||
License Agreement, Expiration Term (Year) | 15 years | ||
Agenus Inc. [Member] | Minimum [Member] | |||
License Agreement, Royalty, Percentage of Net Sales of Licensed Products | 14.00% | ||
Agenus Inc. [Member] | Maximum [Member] | |||
License Agreement, Royalty, Percentage of Net Sales of Licensed Products | 20.00% | ||
MD Anderson [Member] | |||
Collaboration Agreement, Term (Year) | 3 years | ||
Research and Development Arrangement, Contract to Perform for Others, Costs Incurred, Gross | $ 500,000 |
Note 13 - Shareholders' Equity
Note 13 - Shareholders' Equity (Details Textual) - shares | Sep. 30, 2021 | Dec. 31, 2020 |
Common Stock, Shares Authorized (in shares) | 100,000,000 | 100,000,000 |
Common Stock, Shares, Issued, Total (in shares) | 22,404,845 | 22,167,791 |
Note 14 - Share-based Compens_3
Note 14 - Share-based Compensation (Details Textual) - USD ($) $ in Millions | Jun. 07, 2021 | Jun. 08, 2020 | Oct. 12, 2018 | Jan. 01, 2018 | Sep. 30, 2021 | Mar. 31, 2017 |
Common Stock, Capital Shares Reserved for Future Issuance (in shares) | 3,587,774 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares) | 1,362,156 | |||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | $ 22.9 | |||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 1 year 9 months 3 days | |||||
Share-based Payment Arrangement, Option [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period (Year) | 2 years | |||||
Share-based Payment Arrangement, Option [Member] | Share-based Payment Arrangement, Tranche One [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 33.00% | |||||
Restricted Stock Units (RSUs) [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period (Year) | 2 years | |||||
Restricted Stock Units (RSUs) [Member] | Share-based Payment Arrangement, Tranche One [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 33.00% | |||||
Share Option Plan [Member] | Share-based Payment Arrangement, Option [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period (Year) | 3 years | |||||
Share-based Compensation Arrangement By Share-based Payment Award, Individual Voting Powers, Percentage | 10.00% | |||||
Two Thousand Seventeen Equity Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares) | 4,350,167 | 3,950,167 | 3,550,167 | 1,650,167 | 1,400,000 | |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in shares) | 400,000 | 400,000 | 1,900,000 | 250,167 | ||
The 2019 Inducement Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares) | 900,000 | |||||
Maximum [Member] | Share Option Plan [Member] | Share-based Payment Arrangement, Option [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period (Year) | 10 years | |||||
Minimum [Member] | Share Option Plan [Member] | Share-based Payment Arrangement, Option [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Purchase Price of Common Stock, Percent | 100.00% | |||||
Share-based Compensation Arrangement By Share-based Payment Award, Percentage of Purchase Price for Individuals Having More than Ten Percent of Combined Voting Power | 110.00% |
Note 14 - Share-based Compens_4
Note 14 - Share-based Compensation - Effect of Share-based Compensation On the Condensed Consolidated Statements of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based compensation | $ 5,515 | $ 6,763 | $ 17,756 | $ 21,499 |
Research and Development Expense [Member] | ||||
Share-based compensation | 971 | 1,519 | 3,119 | 5,032 |
Selling, General and Administrative Expenses [Member] | ||||
Share-based compensation | $ 4,544 | $ 5,244 | $ 14,637 | $ 16,467 |
Note 15 - Income Taxes (Details
Note 15 - Income Taxes (Details Textual) $ in Millions | Sep. 30, 2021USD ($) |
Unrecognized Tax Benefits, Ending Balance | $ 2.7 |
Unrecognized Tax Benefits, Income Tax Penalties and Interest Accrued, Total | $ 0.7 |
Note 17 - Commitments and Con_2
Note 17 - Commitments and Contingencies (Details Textual) - USD ($) $ in Millions | 9 Months Ended | |
Sep. 30, 2021 | Mar. 31, 2020 | |
Accrued Royalties | $ 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 (Year) | 3 years |