Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 07, 2023 | |
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 | 2023 | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
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 | 30,866,320 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 119,305 | $ 55,408 |
Marketable securities | 28,114 | 44,556 |
Restricted cash | 817 | 813 |
Accounts receivable | 12,847 | 12,704 |
Inventories | 5,002 | 4,325 |
Prepaid expenses and other current assets | 16,038 | 11,101 |
Total current assets | 182,123 | 128,907 |
Non-current assets: | ||
Property and equipment, net | 823 | 1,297 |
Restricted deposit | 225 | 223 |
Right of use assets | 1,905 | 2,452 |
Marketable securities | 6,507 | 0 |
Other non-current assets | 2,050 | 2,740 |
Total Assets | 193,633 | 135,619 |
Current liabilities: | ||
Accounts payable and accrued expenses | 14,083 | 12,383 |
Employee related accrued expenses | 8,152 | 8,257 |
Other current liabilities | 3,553 | 3,276 |
Total current liabilities: | 25,788 | 23,916 |
Non-current liabilities: | ||
Prepaid forward obligation | 107,276 | 98,923 |
Long-term debt | 98,518 | 97,537 |
Long-term lease liabilities | 1,026 | 1,586 |
Uncertain tax positions liability | 3,018 | 3,018 |
Total Liabilities | 235,626 | 224,980 |
Commitments and Contingencies (Note 18) | ||
Shareholders' Deficit: | ||
Ordinary shares, NIS 0.01 par value, 100,000,000 shares authorized at September 30, 2023 and December 31, 2022; 30,854,778 and 23,129,953 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 84 | 63 |
Additional paid-in capital | 611,389 | 487,787 |
Accumulated deficit | (653,332) | (577,104) |
Accumulated other comprehensive loss | (134) | (107) |
Total Shareholders' Deficit | (41,993) | (89,361) |
Total Liabilities and Shareholders' Deficit | $ 193,633 | $ 135,619 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - ₪ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
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) | 30,854,778 | 23,129,953 |
Ordinary shares, outstanding (in shares) | 30,854,778 | 23,129,953 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue | $ 20,852 | $ 16,097 | $ 59,183 | $ 46,265 |
Cost of revenue | 2,367 | 2,020 | 7,075 | 5,391 |
Gross profit | 18,485 | 14,077 | 52,108 | 40,874 |
Operating expenses: | ||||
Research and development expenses | 10,230 | 13,093 | 34,312 | 38,429 |
Selling, general and administrative expenses | 21,755 | 19,071 | 68,723 | 61,204 |
Operating loss | (13,500) | (18,087) | (50,927) | (58,759) |
Financing on prepaid forward obligation | (5,479) | (4,819) | (16,047) | (16,478) |
Interest expense on long-term debt | (3,815) | (2,694) | (11,129) | (5,215) |
Interest and other income, net | 906 | 478 | 1,941 | 604 |
Loss before income taxes | (21,888) | (25,122) | (76,162) | (79,848) |
Income tax expense | 9 | (709) | (66) | (1,066) |
Net Loss | (21,879) | (25,831) | (76,228) | (80,914) |
Statements of Comprehensive Loss | ||||
Net loss | (21,879) | (25,831) | (76,228) | (80,914) |
Other comprehensive income (loss) | ||||
Unrealized gain (loss) on investments | 20 | (99) | (27) | (130) |
Comprehensive Loss | $ (21,859) | $ (25,930) | $ (76,255) | $ (81,044) |
Net loss per ordinary share - basic and diluted (in dollars per share) | $ (0.68) | $ (1.13) | $ (2.89) | $ (3.56) |
Weighted average number of shares outstanding used in computation of basic and diluted loss per ordinary share (in shares) | 32,298,182 | 22,798,263 | 26,358,719 | 22,711,686 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Shareholders' Deficit (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings, Appropriated [Member] | AOCI Attributable to Parent [Member] | Total |
Balance (in shares) at Dec. 31, 2021 | 22,462,995 | ||||
Balance at Dec. 31, 2021 | $ 61 | $ 475,698 | $ (467,321) | $ (25) | $ 8,413 |
Exercise of options into ordinary shares (in shares) | 548,329 | ||||
Exercise of options into ordinary shares | $ 2 | 1,131 | 1,133 | ||
Share-based compensation | 8,212 | 8,212 | |||
Other comprehensive income (loss) | (130) | (130) | |||
Net loss | (80,914) | (80,914) | |||
Balance (in shares) at Sep. 30, 2022 | 23,011,324 | ||||
Balance at Sep. 30, 2022 | $ 63 | 485,041 | (548,235) | (155) | (63,286) |
Balance (in shares) at Jun. 30, 2022 | 22,727,891 | ||||
Balance at Jun. 30, 2022 | $ 62 | 481,485 | (522,404) | (56) | (40,913) |
Exercise of options into ordinary shares (in shares) | 283,433 | ||||
Exercise of options into ordinary shares | $ 1 | 1,116 | 1,117 | ||
Share-based compensation | 2,440 | 2,440 | |||
Other comprehensive income (loss) | (99) | (99) | |||
Net loss | (25,831) | (25,831) | |||
Balance (in shares) at Sep. 30, 2022 | 23,011,324 | ||||
Balance at Sep. 30, 2022 | $ 63 | 485,041 | (548,235) | (155) | (63,286) |
Balance (in shares) at Dec. 31, 2022 | 23,129,953 | ||||
Balance at Dec. 31, 2022 | $ 63 | 487,787 | (577,104) | (107) | (89,361) |
Exercise of options into ordinary shares (in shares) | 424,445 | ||||
Exercise of options into ordinary shares | $ 1 | 832 | 833 | ||
Share-based compensation | 6,732 | 6,732 | |||
Issuance of pre-funded warrant, net of issuance costs | 48,700 | 48,700 | |||
Issuance of ordinary share, net of issuance costs (in shares) | 7,300,380 | ||||
Issuance of ordinary share, net of issuance costs | $ 20 | 67,338 | 67,358 | ||
Other comprehensive income (loss) | (27) | (27) | |||
Net loss | (76,228) | (76,228) | |||
Balance (in shares) at Sep. 30, 2023 | 30,854,778 | ||||
Balance at Sep. 30, 2023 | $ 84 | 611,389 | (653,332) | (134) | (41,993) |
Balance (in shares) at Jun. 30, 2023 | 23,498,617 | ||||
Balance at Jun. 30, 2023 | $ 64 | 493,109 | (631,453) | (154) | (138,434) |
Exercise of options into ordinary shares (in shares) | 55,781 | ||||
Exercise of options into ordinary shares | $ 0 | 18 | 18 | ||
Share-based compensation | 2,224 | 2,224 | |||
Issuance of pre-funded warrant, net of issuance costs | 48,700 | 48,700 | |||
Issuance of ordinary share, net of issuance costs (in shares) | 7,300,380 | ||||
Issuance of ordinary share, net of issuance costs | $ 20 | 67,338 | 67,358 | ||
Other comprehensive income (loss) | 20 | 20 | |||
Net loss | (21,879) | (21,879) | |||
Balance (in shares) at Sep. 30, 2023 | 30,854,778 | ||||
Balance at Sep. 30, 2023 | $ 84 | $ 611,389 | $ (653,332) | $ (134) | $ (41,993) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flow (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash Flows From Operating Activities | ||
Net loss | $ (76,228) | $ (80,914) |
Adjustment to reconcile net loss to net cash from operating activities: | ||
Depreciation and amortization | 612 | 688 |
Inventory Obsolescence | 0 | 615 |
Accrued financing on prepaid forward obligation | 8,714 | 11,019 |
(Accretion) on marketable securities | (622) | (93) |
Share-based compensation | 6,732 | 8,212 |
Amortization of discount on long-term debt | 981 | 1,077 |
Amortization of right of use assets | 669 | 679 |
Changes in operating assets and liabilities: | ||
Inventory | (677) | (645) |
Accounts receivable | (143) | 2,288 |
Prepaid expenses and other current assets | (4,937) | (3,104) |
Other non-current assets | 690 | (1,000) |
Accounts payable and accrued expenses | 1,700 | (2,746) |
Employee related accrued expenses | (105) | (323) |
Other current liabilities | 0 | (704) |
Lease liabilities | (766) | (856) |
Net cash used in operating activities | (63,380) | (65,807) |
Cash Flows From Investing Activities | ||
Purchases of marketable securities | (35,009) | (63,009) |
Maturities of marketable securities | 45,538 | 41,202 |
Purchases of property and equipment | (138) | (241) |
Net cash (used in) provided by investing activities | 10,391 | (22,048) |
Cash Flows From Financing Activities | ||
Proceeds from exercise of options into ordinary shares | 833 | 1,133 |
Proceeds from issuance of long-term debt | 0 | 70,793 |
Proceeds from pre-funded warrant issuance, net | 48,700 | 0 |
Proceeds from ordinary share issuance, net | 67,358 | 0 |
Issuance cost related to at-the-market issuances | 0 | (160) |
Net cash provided by financing activities | 116,891 | 71,766 |
Increase (Decrease) in Cash and Cash Equivalents | 63,902 | (16,089) |
Cash, Cash Equivalents and Restricted Cash at Beginning of Period | 56,220 | 45,587 |
Cash, Cash Equivalents and Restricted Cash at End of Period | 120,122 | 29,498 |
Supplemental Disclosures of Non-Cash Activities | ||
Right of use assets obtained in exchange for new operating lease liabilities | $ 122 | $ 2,165 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flow (Unaudited) (Parentheticals) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Issuance costs | $ 0 |
Private Placement [Member] | |
Issuance costs | 2,288 |
Private Placement [Member] | Pre-funded Warrant [Member] | |
Issuance costs | $ 1,654 |
Note 1 - Business and Nature of
Note 1 - Business and Nature of Operations | 9 Months Ended |
Sep. 30, 2023 | |
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 biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers. 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, 102, On April 15, 2020, Jelmyto first Jelmyto RTGel |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation | 9 Months Ended |
Sep. 30, 2023 | |
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, 2022, March 24, 2023. The Company has experienced net losses since its inception and has an accumulated deficit o f $653.3 September 30, 2023 December 31, 2022, In accordance with the accounting guidance related to the presentation of financial statements, management evaluates whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern for the next 12 not may Jelmyto 102. On July 26, 2023, 14 Based on the Company's cash, cash equivalents and marketable securities as of September 30, 2023, one no not |
Note 3 - Significant Accounting
Note 3 - Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | Note 3 Significant Accounting Policies Principles of Consolidation The Company's 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 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 presents all highly liquid investments with an original maturity of three Cash and cash equivalents and marketable securities totaled $153.9 million as of September 30, 2023 320, Certain 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 Restricted cash is related primarily to cash held to secure corporate credit cards; restricted deposits are related to cash held to secure leases. 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 United States. 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% 16 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 - 10 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 Long-Term Debt The Company is party to a loan agreement with funds managed by Pharmakon Advisors, L.P. (“Pharmakon”). The Company recognizes interest expense in current earnings, and accrued interest within other current liabilities on the condensed consolidated balance sheets. The Company recognizes capitalized financing expenses as a direct offset to the long-term debt on the Company's condensed consolidated balance sheets, and amortizes them over the term of the debt using the effective interest method. See Note 10 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 Expenses Research and development costs are expensed as incurred and consist primarily of the cost of salaries, share-based compensation expenses, payroll taxes and other employee benefits, subcontractors and materials used for research and development activities, including nonclinical studies, clinical trials, manufacturing costs and professional services. The costs of services performed by others in connection with the research and development activities of the Company, including research and development conducted by others on behalf of the Company, shall be included in research and development costs and expensed as the contracted work is performed. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial or project and the invoices received from its external service providers. The Company adjusts its accrual as actual costs become known. Where contingent milestone payments are due to third Selling, General and Administrative Expenses Selling, general and administrative expenses consist primarily of personnel costs (including share-based compensation related to directors, employees and consultants). Other significant costs include commercial, medical affairs, external professional service costs, facility costs, accounting and audit services, legal services and other consulting fees. Selling, general and administrative costs are expensed as incurred, 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. For performance stock units (“PSUs”), cost is measured at the grant date based on the fair value of the award and is recognized over any relevant service period as expense when the achievement of the performance condition is probable. The fair value of options is determined using the Black-Scholes option-pricing model. The fair value of a restricted stock unit (“RSU”) or a PSU equals 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. Pre-funded Warrants The Company issued pre-funded warrants in connection with a private placement transaction that are accounted for as a freestanding equity-linked financial instrument that meets the criteria for equity classification under ASC 480, 815, 14 Net Loss per Ordinary Share Basic net loss per share is computed by dividing the net loss attributable to ordinary shareholders by the weighted-average number of ordinary shares outstanding. Diluted net loss per share is computed similarly to basic net loss per share except that the denominator is increased to include the number of additional ordinary shares that would have been outstanding if the potential ordinary shares had been issued and if the additional ordinary shares were dilutive. For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted loss per share as their effect is anti-dilutive. The Company’s pre-funded warrants requires the holder to pay nominal consideration to receive the Company’s ordinary shares and are therefore considered outstanding shares in determining basic and diluted earnings per share in accordance with ASC Topic 260, Recently Adopted Issued 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, 2023 | |
Notes to Financial Statements | |
Other Financial Information [Text Block] | Note 4 Other Financial Information Accounts Payable and Accrued Expenses Accounts payable and accrued expenses consisted of the following as of September 30, 2023 December 31, 2022 September 30, December 31, 2023 2022 Accounts payable $ 4,041 $ 5,527 Accrued sales reserves 2,710 618 Accrued clinical expenses 1,566 2,853 Accrued research and development expenses 1,349 1,285 Accrued selling, general and administrative expenses 2,601 1,609 Accrued other expenses 1,816 491 Total accounts payable and accrued expenses $ 14,083 $ 12,383 Interest and Other Income, Net Interest and other income, net consisted of the following for the nine September 30, 2023 2022 Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Interest income $ 835 $ 441 $ 1,915 $ 469 Other income, net 71 37 26 135 Total interest and other income, net $ 906 $ 478 $ 1,941 $ 604 |
Note 5 - Inventories
Note 5 - Inventories | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Inventory Disclosure [Text Block] | Note 5 Inventories Inventories consisted of the following as of September 30, 2023 December 31, 2022 September 30, December 31, 2023 2022 Raw materials (1) $ 4,948 $ 4,676 Finished goods 1,735 2,019 Total inventories $ 6,683 $ 6,695 ( 1 September 30, 2023 December 31, 2022, |
Note 6 - Fair Value Measurement
Note 6 - Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
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 cash, restricted cash, 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 assets and liabilities. The carrying value of the prepaid forward obligation (See Note 9 3 The Company estimated the fair value of long-term debt (see Note 10 3 three No Assets measured at fair value on a recurring basis based on Level 1 2 September 30, 2023 Fair Value Measurements Using Quoted Prices Significant in Active Other Balance as of Markets for Observable September 30, Identical Assets Inputs 2023 (Level 1) (Level 2) Assets: Cash equivalents Money market funds $ 15,591 $ 15,591 $ — US government 1,976 1,976 — Commercial paper 2,976 — 2,976 Total cash equivalents 20,543 17,567 2,976 Marketable securities U.S. government 17,022 17,022 — Corporate bonds 5,524 — 5,524 Commercial paper 7,025 — 7,026 Certificates of deposit 5,050 — 5,049 Total marketable securities 34,621 17,022 17,599 Total assets at fair value $ 55,164 $ 34,589 $ 20,575 Assets measured at fair value on a recurring basis based on Level 1 2 December 31, 2022 Fair Value Measurements Using Quoted Prices Significant in Active Other Balance as of Markets for Observable December 31, Identical Assets Inputs 2022 (Level 1) (Level 2) Marketable securities U.S. government $ 28,693 $ 28,693 $ — Corporate bonds 2,387 — 2,387 Commercial paper 9,392 — 9,392 Certificates of deposit 4,084 — 4,084 Total marketable securities $ 44,556 $ 28,693 $ 15,863 The Company’s investments in U.S. government bonds and money market funds are measured based on publicly available quoted market prices for identical securities as of September 30, 2023 December 31, 2022. |
Note 7 - Investments
Note 7 - Investments | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Investments in Debt and Marketable Equity Securities (and Certain Trading Assets) Disclosure [Text Block] | Note 7 Investments The following table summarizes the Company’s investments as of September 30, 2023 Amortized Unrealized Unrealized Cost Basis Gains Losses Fair Value Assets: Cash equivalents Money market funds $ 15,591 $ — $ — $ 15,591 US government 1,976 — — 1,976 Commercial paper 2,977 — (1 ) 2,976 Total cash equivalents 20,544 — (1 ) 20,544 Marketable securities: U.S. government 17,089 — (67 ) 17,022 Corporate bonds 5,586 — (62 ) 5,524 Commercial paper 7,028 — (3 ) 7,025 Certificates of deposit 5,051 1 (2 ) 5,050 Total marketable securities 34,754 1 (134 ) 34,621 Total assets at fair value $ 55,299 $ 1 $ (135 ) $ 55,165 The Company classifies its investments as available-for-sale, and they consist entirely of debt securities. As of September 30, 2023 September 30, 2023 As of September 30, 2023 not not September 30, 2023 no The Company’s investments as of September 30, 2023 January 2026. September 30, December 31, 2023 2022 Maturities within one year $ 49,635 $ 44,556 Maturities after one year through three years 5,529 — Total investments $ 55,164 $ 44,556 |
Note 8 - Property and Equipment
Note 8 - Property and Equipment | 9 Months Ended |
Sep. 30, 2023 | |
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, 2023 December 31, 2022 September 30, December 31, 2023 2022 Laboratory equipment $ 459 $ 452 Computer equipment and software 2,235 2,168 Furniture 612 602 Leasehold improvements 617 617 Manufacturing equipment 662 608 4,585 4,447 Less: accumulated depreciation and amortization (3,762 ) (3,150 ) Property and equipment, net $ 823 $ 1,297 Depreciation and amortization expense was $0.2 million and $0.6 million for the three nine September 30, 2023 three nine September 30, 2022 |
Note 9 - Prepaid Forward Obliga
Note 9 - Prepaid Forward Obligation | 9 Months Ended |
Sep. 30, 2023 | |
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 nine September 30, 2023 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 first Jelmyto 102, In May 2021 , not 12 The following table shows the activity with respect to the carrying value of the prepaid forward liability for the year ended December 31, 2022 nine September 30, 2023, Carrying value of prepaid forward obligation as of December 31, 2021 $ 85,713 Financing on prepaid forward obligation 21,559 Amounts paid and payable (1) (8,349 ) Carrying value of prepaid forward obligation as of December 31, 2022 98,923 Financing on prepaid forward obligation 16,047 Amounts paid and payable (1) (7,694 ) Carrying value of prepaid forward obligation as of September 30, 2023 $ 107,276 ( 1 September 30, 2023 December 31, 2022, |
Note 10 - Long-term Debt
Note 10 - Long-term Debt | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | Note 10 On March 7, 2022, two first March 2022. second December 2022. five first 48 3 June 29, 2023, July 2023, 3 not The Company incurred financing expenses of $4.2 million which are recognized as a direct offset to the long-term debt on the Company's condensed consolidated balance sheets. These debt issuance costs are amortized over the term of the debt using the effective interest method, and are recorded in the condensed consolidated statements of operations as "Interest expense". The following table shows the activity with respect to the carrying value of the long-term debt, in thousands: Long-term debt at closing of Pharmakon loan $ 100,000 Capitalized costs and discounts (4,217 ) Interest expense 8,438 Amounts paid (6,685 ) Carrying value of Pharmakon loan as of December 31, 2022 97,537 Interest expense 11,129 Amounts paid (10,147 ) Carrying value of Pharmakon loan as of September 30, 2023 $ 98,518 |
Note 11 - Leases
Note 11 - Leases | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | Note 11 Leases Operating Leases The Company had the following office and laboratory facility leases as of September 30, 2023 • In April 2016, November 2014 three August 2022. July 2022, September 2025. September 30, 2023. • In April 2018, July 10, 2018 March 2024. September 30, 2023 November 2019, January 1, 2020 March 2024. November 2019. September 30, 2023 842. • In November 2019, November 29, 2019 January 31, 2023. June 2022, January 31, 2026. September 30, 2023 In addition, the Company has other operating office equipment and vehicle leases. The Company’s operating leases may not 2023 2026, The components of lease cost for the three nine September 30, 2023 2022 Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Operating lease cost $ 225 $ 219 $ 710 $ 735 Sublease income (56 ) (56 ) (168 ) (168 ) Variable lease cost 13 16 51 52 $ 182 $ 179 $ 593 $ 619 The amounts recognized as of September 30, 2023 December 31, 2022 September 30, December 31, 2023 2022 Right-of-use assets $ 1,905 $ 2,452 Long-term lease liabilities 1,026 1,586 Other current liabilities 858 941 As of September 30, 2023 no Supplemental information related to leases for the nine September 30, 2023 2022 Nine Months Ended September 30, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases 878 901 Right-of-use assets obtained in exchange for new operating lease liabilities 122 2,165 Weighted-average remaining lease term of operating leases (in years) 2.11 2.95 Weighted-average discount rate of operating leases 10.16 % 10.21 % As of September 30, 2023 Operating Leases Years ending December 31, Remainder of 2023 $ 291 2024 923 2025 813 2026 57 2027 and thereafter — Total future minimum lease payments $ 2,084 Less: Interest (200 ) Present value of lease liabilities $ 1,884 Subleases As of September 30, 2023 Operating Leases Years ending December 31, Remainder of 2023 $ 63 2024 49 2025 and thereafter — $ 112 |
Note 12 - Revenue From Product
Note 12 - Revenue From Product Sales | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Revenue from Contract with Customer [Text Block] | Note 12 Revenue From Product Sales Net product sales consist of the following for the three nine September 30, 2023 2022 Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Jelmyto $ 20,852 $ 16,097 $ 59,183 $ 46,265 Net revenue recognized includes gross revenue and management’s estimate of returns, consideration paid to the customer, chargebacks relating to differences between the wholesale acquisition cost and the contracted price offered to the end consumer, chargebacks relating to 340b September 30, 2023 Reserves related to government sponsored programs Other reserves Total accrued sales reserves Balance as of December 31, 2022 $ 590 $ 847 $ 1,437 Accruals 8,224 8,276 16,500 Utilizations (7,418 ) (5,979 ) (13,397 ) Balance as of September 30, 2023 $ 1,396 $ 3,144 $ 4,540 |
Note 13 - License and Collabora
Note 13 - License and Collaboration Agreements | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Collaborative Arrangement Disclosure [Text Block] | Note 13 License and Collaboration Agreements Agenus Agreement In November 2019, not AGEN1884 4 301 RTGel 1 MD Anderson Agreement In January 2021, three 201 301 July 2022, 2022 not not 2023, |
Note 14 - Shareholders' Equity
Note 14 - Shareholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Equity [Text Block] | Note 14 Shareholders Equity The Company had 100.0 million ordinary shares authorized for issuance as of September 30, 2023 December 31, 2022 September 30, 2023 December 31, 2022 one not On July 26, 2023, July 28, 2023 August 9, 2023 ( not may not The Shares and the ordinary shares issuable upon exercise of the pre-funded warrants were registered pursuant to the Company’s registration statement on Form S- 3 No. 333 274423 September 8, 2023, September 15, 2023. Monograph Capital Partners I, L.P. (“Monograph”), a life sciences venture firm that is affiliated with Fred Cohen, M.D., a director of the Company, purchased 1,572,327 of the Shares in the Private Placement, for an aggregate purchase price of $15.0 million. Dr. Cohen is the Chair and Chief Investment Officer of Monograph. |
Note 15 - Share-based Compensat
Note 15 - Share-based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | Note 15 Share-Based Compensation In October 2010, "2010 March 2017, 2017 "2017 2010 April 2017. 2017 The grant of options to Israeli employees under the Plans 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. On January 31, 2023, 2017 102 three 2023 September 7, 2023. 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 June 8, 2022, 2017 September 7, 2023, 2017 In May 2019, 2019 5635 4 5635 1, not December 2021, As of September 30, 2023 , ordinary shares are subject to outstanding awards under the Company's share-based compensation plans and 1,498,367 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, 2023 2022 2023 2022 Research and development expenses $ 415 $ 642 $ 1,436 $ 2,040 Selling, general and administrative expenses 1,809 1,798 5,296 6,172 Total share-based compensation expense $ 2,224 $ 2,440 $ 6,732 $ 8,212 The total unrecognized compensation cost of options and RSUs at September 30, 2023 |
Note 16 - Income Taxes
Note 16 - Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | Note 16 Income Taxes UroGen Pharma Ltd. is taxed under Israeli tax laws. As of September 30, 2023 2022, 2021 2020, nine September 30, 2023 may The Company has a liability for uncertain tax positions of $3.0 million as of September 30, 2023 September 30, 2023 The Company operates on a global basis and is subject to tax laws and regulations in the United States 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 17 - Related Parties
Note 17 - Related Parties | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Related Party Transactions Disclosure [Text Block] | Note 17 Related Parties See Note 14 nine September 30, 2023. nine September 30, 2022. |
Note 18 - Commitments and Conti
Note 18 - Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | Note 18 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, 2023 December 31, 2022 not Leases See Note 11 |
Note 19 - Subsequent Events
Note 19 - Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | Note 19 Subsequent Events The Company has evaluated and determined there were no |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Consolidation, Policy [Policy Text Block] | Principles of Consolidation The Company's 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 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 presents all highly liquid investments with an original maturity of three Cash and cash equivalents and marketable securities totaled $153.9 million as of September 30, 2023 320, Certain 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 Restricted cash is related primarily to cash held to secure corporate credit cards; restricted deposits are related to cash held to secure leases. |
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 United States. 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% 16 |
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 - 10 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 |
Debt, Policy [Policy Text Block] | Long-Term Debt The Company is party to a loan agreement with funds managed by Pharmakon Advisors, L.P. (“Pharmakon”). The Company recognizes interest expense in current earnings, and accrued interest within other current liabilities on the condensed consolidated balance sheets. The Company recognizes capitalized financing expenses as a direct offset to the long-term debt on the Company's condensed consolidated balance sheets, and amortizes them over the term of the debt using the effective interest method. See Note 10 |
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 Expenses Research and development costs are expensed as incurred and consist primarily of the cost of salaries, share-based compensation expenses, payroll taxes and other employee benefits, subcontractors and materials used for research and development activities, including nonclinical studies, clinical trials, manufacturing costs and professional services. The costs of services performed by others in connection with the research and development activities of the Company, including research and development conducted by others on behalf of the Company, shall be included in research and development costs and expensed as the contracted work is performed. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial or project and the invoices received from its external service providers. The Company adjusts its accrual as actual costs become known. Where contingent milestone payments are due to third |
Selling, General and Administrative Expenses, Policy [Policy Text Block] | Selling, General and Administrative Expenses Selling, general and administrative expenses consist primarily of personnel costs (including share-based compensation related to directors, employees and consultants). Other significant costs include commercial, medical affairs, external professional service costs, facility costs, accounting and audit services, legal services and other consulting fees. Selling, general and administrative costs are expensed as incurred, 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. For performance stock units (“PSUs”), cost is measured at the grant date based on the fair value of the award and is recognized over any relevant service period as expense when the achievement of the performance condition is probable. The fair value of options is determined using the Black-Scholes option-pricing model. The fair value of a restricted stock unit (“RSU”) or a PSU equals 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. |
Stockholders' Equity, Policy [Policy Text Block] | Pre-funded Warrants The Company issued pre-funded warrants in connection with a private placement transaction that are accounted for as a freestanding equity-linked financial instrument that meets the criteria for equity classification under ASC 480, 815, 14 |
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. The Company’s pre-funded warrants requires the holder to pay nominal consideration to receive the Company’s ordinary shares and are therefore considered outstanding shares in determining basic and diluted earnings per share in accordance with ASC Topic 260, |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Adopted Issued 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, 2023 | |
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 - 10 |
Note 4 - Other Financial Info_2
Note 4 - Other Financial Information (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Schedule of Accounts Payable and Accrued Liabilities [Table Text Block] | September 30, December 31, 2023 2022 Accounts payable $ 4,041 $ 5,527 Accrued sales reserves 2,710 618 Accrued clinical expenses 1,566 2,853 Accrued research and development expenses 1,349 1,285 Accrued selling, general and administrative expenses 2,601 1,609 Accrued other expenses 1,816 491 Total accounts payable and accrued expenses $ 14,083 $ 12,383 |
Interest Income and Interest Expense Disclosure [Table Text Block] | Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Interest income $ 835 $ 441 $ 1,915 $ 469 Other income, net 71 37 26 135 Total interest and other income, net $ 906 $ 478 $ 1,941 $ 604 |
Note 5 - Inventories (Tables)
Note 5 - Inventories (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | September 30, December 31, 2023 2022 Raw materials (1) $ 4,948 $ 4,676 Finished goods 1,735 2,019 Total inventories $ 6,683 $ 6,695 |
Note 6 - Fair Value Measureme_2
Note 6 - Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 2023 (Level 1) (Level 2) Assets: Cash equivalents Money market funds $ 15,591 $ 15,591 $ — US government 1,976 1,976 — Commercial paper 2,976 — 2,976 Total cash equivalents 20,543 17,567 2,976 Marketable securities U.S. government 17,022 17,022 — Corporate bonds 5,524 — 5,524 Commercial paper 7,025 — 7,026 Certificates of deposit 5,050 — 5,049 Total marketable securities 34,621 17,022 17,599 Total assets at fair value $ 55,164 $ 34,589 $ 20,575 Fair Value Measurements Using Quoted Prices Significant in Active Other Balance as of Markets for Observable December 31, Identical Assets Inputs 2022 (Level 1) (Level 2) Marketable securities U.S. government $ 28,693 $ 28,693 $ — Corporate bonds 2,387 — 2,387 Commercial paper 9,392 — 9,392 Certificates of deposit 4,084 — 4,084 Total marketable securities $ 44,556 $ 28,693 $ 15,863 |
Note 7 - Investments (Tables)
Note 7 - Investments (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Marketable Securities [Table Text Block] | Amortized Unrealized Unrealized Cost Basis Gains Losses Fair Value Assets: Cash equivalents Money market funds $ 15,591 $ — $ — $ 15,591 US government 1,976 — — 1,976 Commercial paper 2,977 — (1 ) 2,976 Total cash equivalents 20,544 — (1 ) 20,544 Marketable securities: U.S. government 17,089 — (67 ) 17,022 Corporate bonds 5,586 — (62 ) 5,524 Commercial paper 7,028 — (3 ) 7,025 Certificates of deposit 5,051 1 (2 ) 5,050 Total marketable securities 34,754 1 (134 ) 34,621 Total assets at fair value $ 55,299 $ 1 $ (135 ) $ 55,165 |
Investments Classified by Contractual Maturity Date [Table Text Block] | September 30, December 31, 2023 2022 Maturities within one year $ 49,635 $ 44,556 Maturities after one year through three years 5,529 — Total investments $ 55,164 $ 44,556 |
Note 8 - Property and Equipme_2
Note 8 - Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | September 30, December 31, 2023 2022 Laboratory equipment $ 459 $ 452 Computer equipment and software 2,235 2,168 Furniture 612 602 Leasehold improvements 617 617 Manufacturing equipment 662 608 4,585 4,447 Less: accumulated depreciation and amortization (3,762 ) (3,150 ) Property and equipment, net $ 823 $ 1,297 |
Note 9 - Prepaid Forward Obli_2
Note 9 - Prepaid Forward Obligation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Schedule of Activity in the Carrying Value of the Prepaid Forward Liability [Table Text Block] | Carrying value of prepaid forward obligation as of December 31, 2021 $ 85,713 Financing on prepaid forward obligation 21,559 Amounts paid and payable (1) (8,349 ) Carrying value of prepaid forward obligation as of December 31, 2022 98,923 Financing on prepaid forward obligation 16,047 Amounts paid and payable (1) (7,694 ) Carrying value of prepaid forward obligation as of September 30, 2023 $ 107,276 |
Note 10 - Long-term Debt (Table
Note 10 - Long-term Debt (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Schedule of Long-Term Debt Instruments [Table Text Block] | Long-term debt at closing of Pharmakon loan $ 100,000 Capitalized costs and discounts (4,217 ) Interest expense 8,438 Amounts paid (6,685 ) Carrying value of Pharmakon loan as of December 31, 2022 97,537 Interest expense 11,129 Amounts paid (10,147 ) Carrying value of Pharmakon loan as of September 30, 2023 $ 98,518 |
Note 11 - Leases (Tables)
Note 11 - Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Lease, Cost [Table Text Block] | Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Operating lease cost $ 225 $ 219 $ 710 $ 735 Sublease income (56 ) (56 ) (168 ) (168 ) Variable lease cost 13 16 51 52 $ 182 $ 179 $ 593 $ 619 |
Assets and Liabilities, Lessee [Table Text Block] | September 30, December 31, 2023 2022 Right-of-use assets $ 1,905 $ 2,452 Long-term lease liabilities 1,026 1,586 Other current liabilities 858 941 |
Schedule of Supplemental Information Related to Leases [Table Text Block] | Nine Months Ended September 30, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases 878 901 Right-of-use assets obtained in exchange for new operating lease liabilities 122 2,165 Weighted-average remaining lease term of operating leases (in years) 2.11 2.95 Weighted-average discount rate of operating leases 10.16 % 10.21 % |
Lessee, Operating Lease, Liability, to be Paid, Maturity [Table Text Block] | Operating Leases Years ending December 31, Remainder of 2023 $ 291 2024 923 2025 813 2026 57 2027 and thereafter — Total future minimum lease payments $ 2,084 Less: Interest (200 ) Present value of lease liabilities $ 1,884 |
Lessor, Operating Lease, Payment to be Received, Maturity [Table Text Block] | Operating Leases Years ending December 31, Remainder of 2023 $ 63 2024 49 2025 and thereafter — $ 112 |
Note 12 - Revenue From Produc_2
Note 12 - Revenue From Product Sales (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Disaggregation of Revenue [Table Text Block] | Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Jelmyto $ 20,852 $ 16,097 $ 59,183 $ 46,265 |
Schedule of Sales Reserves [Table Text Block] | Reserves related to government sponsored programs Other reserves Total accrued sales reserves Balance as of December 31, 2022 $ 590 $ 847 $ 1,437 Accruals 8,224 8,276 16,500 Utilizations (7,418 ) (5,979 ) (13,397 ) Balance as of September 30, 2023 $ 1,396 $ 3,144 $ 4,540 |
Note 15 - Share-based Compens_2
Note 15 - Share-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Research and development expenses $ 415 $ 642 $ 1,436 $ 2,040 Selling, general and administrative expenses 1,809 1,798 5,296 6,172 Total share-based compensation expense $ 2,224 $ 2,440 $ 6,732 $ 8,212 |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation (Details Textual) - USD ($) $ in Thousands | Jul. 26, 2023 | Sep. 30, 2023 | Dec. 31, 2022 |
Retained Earnings (Accumulated Deficit) | $ (653,332) | $ (577,104) | |
Proceeds from Issuance of Private Placement | $ 120,000 |
Note 3 - Significant Accounti_3
Note 3 - Significant Accounting Policies (Details Textual) $ in Millions | Sep. 30, 2023 USD ($) |
Cash, Cash Equivalents, and Short-Term Investments | $ 153.9 |
Note 3 - Significant Accounti_4
Note 3 - Significant Accounting Policies - Useful Lives of Property and Equipment (Details) | Sep. 30, 2023 |
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] | Minimum [Member] | |
Useful life (Year) | 2 years |
Manufacturing Equipment [Member] | Maximum [Member] | |
Useful life (Year) | 10 years |
Note 4 - Other Financial Info_3
Note 4 - Other Financial Information - Accounts Payable and Accrued Expense (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accounts payable | $ 4,041 | $ 5,527 |
Accrued sales reserves | 2,710 | 618 |
Accrued clinical expenses | 1,566 | 2,853 |
Accrued research and development expenses | 1,349 | 1,285 |
Accrued selling, general and administrative expenses | 2,601 | 1,609 |
Accrued other expenses | 1,816 | 491 |
Total accounts payable and accrued expenses | $ 14,083 | $ 12,383 |
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, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Interest income | $ 835 | $ 441 | $ 1,915 | $ 469 |
Other income, net | 71 | 37 | 26 | 135 |
Total interest and other income, net | $ 906 | $ 478 | $ 1,941 | $ 604 |
Note 5 - Inventories (Details T
Note 5 - Inventories (Details Textual) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | |
Inventory, Raw Materials, Net of Reserves | [1] | $ 4,948 | $ 4,676 |
Other Noncurrent Assets [Member] | |||
Inventory, Raw Materials, Net of Reserves | $ 1,700 | $ 2,400 | |
[1]$1.7 million and $2.4 million of raw materials are included within other non-current assets on the condensed consolidated balance sheets at September 30, 2023 and December 31, 2022, respectively. Changes in non-current assets are reflected on the condensed consolidated statements of cash flows within the caption of other non-current assets. |
Note 5 - Inventories - Inventor
Note 5 - Inventories - Inventories (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | |
Raw materials | [1] | $ 4,948 | $ 4,676 |
Finished goods | 1,735 | 2,019 | |
Total inventories | $ 6,683 | $ 6,695 | |
[1]$1.7 million and $2.4 million of raw materials are included within other non-current assets on the condensed consolidated balance sheets at September 30, 2023 and December 31, 2022, respectively. Changes in non-current assets are reflected on the condensed consolidated statements of cash flows within the caption of other non-current assets. |
Note 6 - Fair Value Measureme_3
Note 6 - Fair Value Measurements - Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Fair value | $ 34,621 | |
Marketable securities | 34,621 | |
Money Market Funds [Member] | ||
Cash equivalents, fair value | 15,591 | |
US Treasury and Government [Member] | ||
Cash equivalents, fair value | 1,976 | |
Commercial Paper [Member] | ||
Cash equivalents, fair value | 2,976 | |
US Treasury Securities [Member] | ||
Fair value | 17,022 | |
Marketable securities | 17,022 | |
Corporate Debt Securities [Member] | ||
Fair value | 5,524 | |
Marketable securities | 5,524 | |
Commercial Paper, Not Included with Cash and Cash Equivalents [Member] | ||
Fair value | 7,025 | |
Marketable securities | 7,025 | |
Certificates of Deposit [Member] | ||
Fair value | 5,050 | |
Marketable securities | 5,050 | |
Fair Value, Recurring [Member] | ||
Cash equivalents, fair value | 20,543 | |
Fair value | 34,621 | $ 44,556 |
Marketable securities | 34,621 | 44,556 |
Total assets at fair value | 55,164 | |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash equivalents, fair value | 17,567 | |
Fair value | 17,022 | 28,693 |
Marketable securities | 17,022 | 28,693 |
Total assets at fair value | 34,589 | |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Cash equivalents, fair value | 2,976 | |
Fair value | 17,599 | 15,863 |
Marketable securities | 17,599 | 15,863 |
Total assets at fair value | 20,575 | |
Fair Value, Recurring [Member] | Money Market Funds [Member] | ||
Cash equivalents, fair value | 15,591 | |
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash equivalents, fair value | 15,591 | |
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Cash equivalents, fair value | 0 | |
Fair Value, Recurring [Member] | US Treasury and Government [Member] | ||
Cash equivalents, fair value | 1,976 | |
Fair Value, Recurring [Member] | US Treasury and Government [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash equivalents, fair value | 1,976 | |
Fair Value, Recurring [Member] | US Treasury and Government [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Cash equivalents, fair value | 0 | |
Fair Value, Recurring [Member] | Commercial Paper [Member] | ||
Cash equivalents, fair value | 2,976 | |
Fair Value, Recurring [Member] | Commercial Paper [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash equivalents, fair value | 0 | |
Fair Value, Recurring [Member] | Commercial Paper [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Cash equivalents, fair value | 2,976 | |
Fair Value, Recurring [Member] | US Treasury Securities [Member] | ||
Fair value | 17,022 | 28,693 |
Marketable securities | 17,022 | 28,693 |
Fair Value, Recurring [Member] | US Treasury Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair value | 17,022 | 28,693 |
Marketable securities | 17,022 | 28,693 |
Fair Value, Recurring [Member] | US Treasury Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair value | 0 | 0 |
Marketable securities | 0 | 0 |
Fair Value, Recurring [Member] | Corporate Debt Securities [Member] | ||
Fair value | 5,524 | 2,387 |
Marketable securities | 5,524 | 2,387 |
Fair Value, Recurring [Member] | Corporate Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair value | 0 | 0 |
Marketable securities | 0 | 0 |
Fair Value, Recurring [Member] | Corporate Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair value | 5,524 | 2,387 |
Marketable securities | 5,524 | 2,387 |
Fair Value, Recurring [Member] | Commercial Paper, Not Included with Cash and Cash Equivalents [Member] | ||
Fair value | 7,025 | 9,392 |
Marketable securities | 7,025 | 9,392 |
Fair Value, Recurring [Member] | Commercial Paper, Not Included with Cash and Cash Equivalents [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair value | 0 | 0 |
Marketable securities | 0 | 0 |
Fair Value, Recurring [Member] | Commercial Paper, Not Included with Cash and Cash Equivalents [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair value | 7,026 | 9,392 |
Marketable securities | 7,026 | 9,392 |
Fair Value, Recurring [Member] | Certificates of Deposit [Member] | ||
Fair value | 5,050 | 4,084 |
Marketable securities | 5,050 | 4,084 |
Fair Value, Recurring [Member] | Certificates of Deposit [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair value | 0 | 0 |
Marketable securities | 0 | 0 |
Fair Value, Recurring [Member] | Certificates of Deposit [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair value | 5,049 | 4,084 |
Marketable securities | $ 5,049 | $ 4,084 |
Note 7 - Investments (Details T
Note 7 - Investments (Details Textual) $ in Millions | Sep. 30, 2023 USD ($) |
Debt Securities, Available-for-Sale, Unrealized Loss Position | $ 32.7 |
Debt Securities, Available-for-Sale, Unrealized Loss Position, Number of Positions | 40 |
Note 7 - Investments - Summary
Note 7 - Investments - Summary of Marketable Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Cash equivalents | $ 119,305 | $ 55,408 |
Amortized cost basis | 34,754 | |
Unrealized gains | 1 | |
Unrealized losses | (134) | |
Fair value | 34,621 | |
Total assets at fair value | 55,299 | |
Total assets at fair value, unrealized gains | 1 | |
Total assets at fair value, unrealized losses | (135) | |
Total assets at fair value, fair value | 55,165 | |
US Treasury Securities [Member] | ||
Amortized cost basis | 17,089 | |
Unrealized gains | 0 | |
Unrealized losses | (67) | |
Fair value | 17,022 | |
Corporate Debt Securities [Member] | ||
Amortized cost basis | 5,586 | |
Unrealized gains | 0 | |
Unrealized losses | (62) | |
Fair value | 5,524 | |
Commercial Paper, Not Included with Cash and Cash Equivalents [Member] | ||
Amortized cost basis | 7,028 | |
Unrealized gains | 0 | |
Unrealized losses | (3) | |
Fair value | 7,025 | |
Certificates of Deposit [Member] | ||
Amortized cost basis | 5,051 | |
Unrealized gains | 1 | |
Unrealized losses | (2) | |
Fair value | 5,050 | |
Money Market Funds [Member] | ||
Cash equivalents | 15,591 | |
Cash equivalents, unrealized gains | 0 | |
Cash equivalents, unrealized loss | 0 | |
Cash equivalents, fair value | 15,591 | |
US Treasury and Government [Member] | ||
Cash equivalents | 1,976 | |
Cash equivalents, unrealized gains | 0 | |
Cash equivalents, unrealized loss | 0 | |
Cash equivalents, fair value | 1,976 | |
Commercial Paper [Member] | ||
Cash equivalents | 2,977 | |
Cash equivalents, unrealized gains | 0 | |
Cash equivalents, unrealized loss | (1) | |
Cash equivalents, fair value | 2,976 | |
Cash Equivalents [Member] | ||
Cash equivalents | 20,544 | |
Cash equivalents, unrealized gains | 0 | |
Cash equivalents, unrealized loss | (1) | |
Cash equivalents, fair value | $ 20,544 |
Note 7 - Marketable Securities
Note 7 - Marketable Securities - Fair Values of Marketable Securities by Contractual Maturity (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Maturities within one year | $ 49,635 | $ 44,556 |
Maturities after one year through three years | 5,529 | 0 |
Total investments | $ 55,164 | $ 44,556 |
Note 8 - Property and Equipme_3
Note 8 - Property and Equipment (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Depreciation, Depletion and Amortization | $ 200 | $ 200 | $ 612 | $ 688 |
Note 8 - Property and Equipme_4
Note 8 - Property and Equipment - Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Property and equipment, gross | $ 4,585 | $ 4,447 |
Less: accumulated depreciation and amortization | (3,762) | (3,150) |
Property and equipment, net | 823 | 1,297 |
Laboratory Equipment [Member] | ||
Property and equipment, gross | 459 | 452 |
Computers and Software [Member] | ||
Property and equipment, gross | 2,235 | 2,168 |
Furniture [Member[ | ||
Property and equipment, gross | 612 | 602 |
Leasehold Improvements [Member] | ||
Property and equipment, gross | 617 | 617 |
Manufacturing Equipment [Member] | ||
Property and equipment, gross | $ 662 | $ 608 |
Note 9 - Prepaid Forward Obli_3
Note 9 - Prepaid Forward Obligation (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | ||||
May 31, 2021 | Mar. 31, 2021 | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Prepaid Forward Obligation | $ 107,276 | $ 98,923 | $ 85,713 | ||
Other Current Liabilities [Member] | |||||
Prepaid Forward Obligation | 2,700 | $ 2,300 | |||
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 | $ 200,000 | ||||
Prepaid Forward Agreement, Minimum Future Cash Flows, Rate (Rate) | 13% | ||||
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% | ||||
RTW Investments [Member] | Sales Over $300 Million [Member] | Jelmyto [Member] | |||||
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales | 1% | ||||
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% | ||||
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 | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | ||
Carrying value of prepaid forward obligation | $ 98,923 | $ 85,713 | $ 85,713 | |||
Financing on prepaid forward obligation | $ 5,479 | $ 4,819 | 16,047 | $ 16,478 | 21,559 | |
Amounts paid and payable (1) | [1] | (7,694) | (8,349) | |||
Carrying value of prepaid forward obligation | $ 107,276 | $ 107,276 | $ 98,923 | |||
[1]$2.7 million and $2.3 million of the Amounts paid and payable are included as current portion of the prepaid forward obligation within other current liabilities on the condensed consolidated balance sheets as of September 30, 2023 and December 31, 2022, respectively. |
Note 10 - Long-term Debt (Detai
Note 10 - Long-term Debt (Details Textual) - Secured Debt [Member] - USD ($) $ in Millions | 1 Months Ended | |
Mar. 07, 2022 | Jul. 31, 2023 | |
Secured Long-Term Debt, Noncurrent | $ 100 | |
Secured Long Term Debt, First Tranche | 75 | |
Secured Long Term Debt, Additional Draw | $ 25 | |
Long-Term Debt, Term (Year) | 5 years | |
Debt Instrument, LIBOR Floor | 1.25% | |
Debt Issuance Costs, Gross | $ 4.2 | |
London Interbank Offered Rate (LIBOR) 1 [Member] | ||
Debt Instrument, Basis Spread on Variable Rate | 8.25% | |
Secured Overnight Financing Rate (SOFR) [Member] | ||
Debt Instrument, Basis Spread on Variable Rate | 0.26161% |
Note 10 - Long-term Debt - Long
Note 10 - Long-term Debt - Long Term Debt (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Jan. 01, 2022 | |
Interest expense | $ 3,815 | $ 2,694 | $ 11,129 | $ 5,215 | ||
Interest expense | 3,815 | $ 2,694 | 11,129 | $ 5,215 | ||
Pharmakon Loan [Member] | ||||||
Long-term debt at closing of Pharmakon loan | $ 100,000 | |||||
Capitalized costs and discounts | $ (4,217) | |||||
Interest expense | 11,129 | $ 8,438 | ||||
Amounts paid | (10,147) | (10,147) | (6,685) | |||
Carrying value of Pharmakon loan as of December 31, 2022 | $ 98,518 | 98,518 | 97,537 | |||
Interest expense | $ 11,129 | $ 8,438 |
Note 11 - Leases (Details Textu
Note 11 - Leases (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Apr. 30, 2018 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Nov. 29, 2019 | |
Lessee, Operating Lease, Liability, to be Paid | $ 2,084 | $ 2,084 | ||||
Operating Lease, Liability | 1,884 | 1,884 | ||||
Sublease Income | 56 | $ 56 | 168 | $ 168 | ||
Company Offices in Israel [Member] | ||||||
Lessee, Operating Lease, Liability, to be Paid | 500 | 500 | ||||
Lease Agreement for Office in Los Angeles, California [Member] | UroGen Pharma Inc. [Member] | ||||||
Operating Lease, Impairment Loss | $ 200 | |||||
Operating Lease, Liability | 100 | 100 | ||||
Sublease Income | 100 | |||||
Lease Agreement for Office in Princeton, New Jersey [Member] | UroGen Pharma Inc. [Member] | ||||||
Operating Lease, Liability | $ 1,300 | $ 1,300 | ||||
Lessee, Operating Lease, Term of Contract (Month) | 38 months |
Note 11 - Leases - Components o
Note 11 - Leases - Components of Lease Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Operating lease cost | $ 225 | $ 219 | $ 710 | $ 735 |
Sublease income | (56) | (56) | (168) | (168) |
Variable lease cost | 13 | 16 | 51 | 52 |
Lease, Cost | $ 182 | $ 179 | $ 593 | $ 619 |
Note 11 - Leases - Amounts of A
Note 11 - Leases - Amounts of Assets and Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Right-of-use assets | $ 1,905 | $ 2,452 |
Long-term lease liabilities | 1,026 | 1,586 |
Other Current Liabilities [Member] | ||
Other current liabilities | $ 858 | $ 941 |
Note 11 - Leases - Supplemental
Note 11 - Leases - Supplemental Information Related to Leases (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Operating cash flows from operating leases | $ 878 | $ 901 |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 122 | $ 2,165 |
Weighted-average remaining lease term of operating leases (Year) | 2 years 1 month 9 days | 2 years 11 months 12 days |
Weighted-average discount rate of operating leases | 10.16% | 10.21% |
Note 11 - Leases - Maturities o
Note 11 - Leases - Maturities of Lease Liabilities (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Remainder of 2023 | $ 291 |
2024 | 923 |
2025 | 813 |
2026 | 57 |
2027 and thereafter | 0 |
Total future minimum lease payments | 2,084 |
Less: Interest | (200) |
Present value of lease liabilities | $ 1,884 |
Note 11 - Leases - Undiscounted
Note 11 - Leases - Undiscounted Cash Flows to be Received Under Sublease (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Remainder of 2023 | $ 63 |
2024 | 49 |
2025 and thereafter | 0 |
Lessor, Operating Lease, Payment to be Received | $ 112 |
Note 12 - Revenue From Produc_3
Note 12 - Revenue From Product Sales - Net Product Sales (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue | $ 20,852 | $ 16,097 | $ 59,183 | $ 46,265 |
Jelmyto [Member] | ||||
Revenue | $ 20,852 | $ 16,097 | $ 59,183 | $ 46,265 |
Note 12 - Revenue From Produc_4
Note 12 - Revenue From Product Sales - Sales Reserves Activity (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Balance | $ 1,437 |
Accruals | 16,500 |
Utilizations | (13,397) |
Balance | 4,540 |
Government Sponsored Programs Reserves [Member] | |
Balance | 590 |
Accruals | 8,224 |
Utilizations | (7,418) |
Balance | 1,396 |
Other Reserves [Member] | |
Balance | 847 |
Accruals | 8,276 |
Utilizations | (5,979) |
Balance | $ 3,144 |
Note 13 - License and Collabo_2
Note 13 - License and Collaboration Agreements (Details Textual) - MD Anderson [Member] - USD ($) $ in Millions | 1 Months Ended | 9 Months Ended |
Jan. 31, 2021 | Sep. 30, 2023 | |
Collaboration Agreement, Term (Year) | 3 years | |
Research and Development Arrangement, Contract to Perform for Others, Costs Incurred, Gross | $ 2 |
Note 14 - Shareholders' Equity
Note 14 - Shareholders' Equity (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 234 Months Ended | ||
Jul. 26, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | |
Common Stock, Shares Authorized (in shares) | 100,000,000 | 100,000,000 | |
Common Stock, Shares, Issued (in shares) | 30,854,778 | 23,129,953 | |
Common Stock, Shares, Outstanding (in shares) | 30,854,778 | 23,129,953 | |
Dividends, Common Stock | $ 0 | ||
Proceeds from Issuance of Private Placement | $ 120,000 | ||
Pre-funded Warrant [Member] | |||
Class of Warrant or Right, Outstanding (in shares) | 5,278,776 | ||
Class of Warrants or Rights, Issuance Price Per Share (in dollars per share) | $ 9.539 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.001 | ||
Private Placement [Member] | |||
Stock Issued During Period, Shares, New Issues (in shares) | 7,300,380 | ||
Shares Issued, Price Per Share (in dollars per share) | $ 9.54 | ||
Placement Agents and Financial Advisors Fees | $ 3,600 | ||
Private Placement [Member] | Monograph Capital Partners [Member] | |||
Stock Issued During Period, Shares, New Issues (in shares) | 1,572,327 | ||
Proceeds from Issuance of Private Placement | $ 15,000 |
Note 15 - Share-based Compens_3
Note 15 - Share-based Compensation (Details Textual) - USD ($) $ in Millions | 1 Months Ended | 9 Months Ended | |||||||||
Sep. 07, 2023 | Jun. 08, 2022 | Jun. 07, 2021 | Jun. 08, 2020 | Oct. 12, 2018 | Jan. 01, 2018 | Dec. 31, 2021 | Sep. 30, 2023 | Jan. 31, 2023 | May 31, 2019 | Mar. 31, 2017 | |
Common Stock, Capital Shares Reserved for Future Issuance (in shares) | 3,781,335 | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 1,498,367 | ||||||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 15.6 | ||||||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 2 years | ||||||||||
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% | ||||||||||
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% | ||||||||||
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% | ||||||||||
Two Thousand Seventeen Equity Incentive Plan [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 5,200,167 | 4,750,167 | 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) | 450,000 | 400,000 | 400,000 | 400,000 | 1,900,000 | 250,167 | |||||
Two Thousand Seventeen Equity Incentive Plan [Member] | Performance Shares [Member] | Chief Executive Officer [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 100,000 | ||||||||||
The 2019 Inducement Plan [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 900,000 | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in shares) | 300,000 | ||||||||||
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% | ||||||||||
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% |
Note 15 - Share-based Compens_4
Note 15 - 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, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based compensation | $ 2,224 | $ 2,440 | $ 6,732 | $ 8,212 |
Research and Development Expense [Member] | ||||
Share-based compensation | 415 | 642 | 1,436 | 2,040 |
Selling, General and Administrative Expenses [Member] | ||||
Share-based compensation | $ 1,809 | $ 1,798 | $ 5,296 | $ 6,172 |
Note 16 - Income Taxes (Details
Note 16 - Income Taxes (Details Textual) $ in Millions | Sep. 30, 2023 USD ($) |
Unrecognized Tax Benefits | $ 3 |
Unrecognized Tax Benefits, Income Tax Penalties and Interest Accrued | $ 1.1 |
Note 17 - Related Parties (Deta
Note 17 - Related Parties (Details Textual) $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Related Party Transaction, Amounts of Transaction | $ 0 |