Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 20, 2023 | Jun. 30, 2022 | |
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 | FY | ||
Document Fiscal Year Focus | 2022 | ||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Transition Report | false | ||
Entity File Number | 001-38079 | ||
Entity Incorporation, State or Country Code | L3 | ||
Entity Tax Identification Number | 98-1460746 | ||
Entity Address, Address Line One | 400 Alexander Park | ||
Entity Address, City or Town | Princeton | ||
Entity Address, State or Province | NJ | ||
Entity Address, Postal Zip Code | 08540 | ||
City Area Code | 646 | ||
Local Phone Number | 768-9780 | ||
Title of 12(b) Security | Ordinary Shares, par value NIS 0.01 per share | ||
Trading Symbol | URGN | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 145,100,000 | ||
Entity Common Stock, Shares Outstanding | 23,440,521 | ||
Auditor Firm ID | 238 | ||
Auditor Name | PricewaterhouseCoopers LLP | ||
Auditor Location | Florham Park, New Jersey |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Money market funds | $ 55,408 | $ 44,360 |
Marketable securities | 44,556 | 44,779 |
Restricted cash | 813 | 1,226 |
Accounts receivable | 12,704 | 11,717 |
Inventories | 4,325 | 4,832 |
Prepaid expenses and other current assets | 11,101 | 7,476 |
Total current assets | 128,907 | 114,390 |
Non-current assets: | ||
Property and equipment, net | 1,297 | 1,967 |
Restricted deposit | 223 | 223 |
Right of use assets | 2,452 | 1,180 |
Marketable securities | 0 | 675 |
Other non-current assets | 2,740 | 1,311 |
Total Assets | 135,619 | 119,746 |
Current liabilities: | ||
Accounts payable and accrued expenses | 12,383 | 12,102 |
Employee related accrued expenses | 8,257 | 6,948 |
Other current liabilities | 3,276 | 3,330 |
Total current liabilities: | 23,916 | 22,380 |
Non-current liabilities: | ||
Prepaid forward obligation | 98,923 | 85,713 |
Long-term debt | 97,537 | 0 |
Long-term lease liabilities | 1,586 | 398 |
Uncertain tax positions liability | 3,018 | 2,842 |
Total Liabilities | 224,980 | 111,333 |
Commitments and Contingencies (Note 19) | ||
Shareholders' Equity (Deficit): | ||
Ordinary shares, NIS 0.01 par value; 100,000,000 shares authorized at December 31, 2022 and 2021; 23,129,953 and 22,462,995 shares issued and outstanding as of December 31, 2022 and 2021, respectively | 63 | 61 |
Additional paid-in capital | 487,787 | 475,698 |
Accumulated deficit | (577,104) | (467,321) |
Accumulated other comprehensive loss | (107) | (25) |
Total Shareholders' (Deficit) Equity | (89,361) | 8,413 |
Total Liabilities and Shareholders' (Deficit) Equity | $ 135,619 | $ 119,746 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - ₪ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
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) | 23,129,953 | 22,462,995 |
Ordinary shares, outstanding (in shares) | 23,129,953 | 22,462,995 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue | $ 64,357 | $ 48,042 |
Cost of revenue | 7,654 | 5,157 |
Gross profit | 56,703 | 42,885 |
Operating expenses: | ||
Research and development expenses | 52,906 | 47,642 |
Selling, general and administrative expenses | 82,838 | 87,535 |
Operating loss | (79,041) | (92,292) |
Financing on prepaid forward obligation | (21,559) | (17,291) |
Interest expense on long-term debt | (8,438) | 0 |
Interest and other income, net | 1,010 | 212 |
Loss before income taxes | (108,028) | (109,371) |
Income tax expense | (1,755) | (1,449) |
Net Loss | (109,783) | (110,820) |
Statements of Comprehensive Loss | ||
Net loss | (109,783) | (110,820) |
Other comprehensive (loss) | ||
Unrealized (loss) on investments | (82) | (296) |
Comprehensive Loss | $ (109,865) | $ (111,116) |
Net loss per ordinary share - basic and diluted (in dollars per share) | $ (4.81) | $ (4.96) |
Weighted average number of shares outstanding used in computation of basic and diluted loss per ordinary share (in shares) | 22,806,812 | 22,347,481 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity (Deficit) - 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, 2020 | 22,167,791 | ||||
Balance at Dec. 31, 2020 | $ 452,525 | $ (356,501) | $ 271 | $ 96,355 | |
Exercise of options into ordinary shares (in shares) | 295,204 | ||||
Exercise of options into ordinary shares | $ 1 | 60 | |||
Share-based compensation | 23,113 | 23,113 | |||
Other comprehensive income (loss) | (296) | (296) | |||
Net loss | (110,820) | (110,820) | |||
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) | 666,958 | ||||
Exercise of options into ordinary shares | $ 2 | 1,509 | 1,511 | ||
Share-based compensation | 10,580 | 10,580 | |||
Other comprehensive income (loss) | (82) | (82) | |||
Net loss | (109,783) | (109,783) | |||
Balance (in shares) at Dec. 31, 2022 | 23,129,953 | ||||
Balance at Dec. 31, 2022 | $ 63 | $ 487,787 | $ (577,104) | $ (107) | $ (89,361) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash Flows From Operating Activities | ||
Net loss | $ (109,783) | $ (110,820) |
Adjustment to reconcile net loss to net cash from operating activities: | ||
Depreciation and amortization | 924 | 831 |
Inventory Obsolescence | 870 | 0 |
Accrued financing on prepaid forward obligation | 14,007 | 14,848 |
Amortization (accretion) on marketable securities | (498) | 476 |
Share-based compensation | 10,580 | 23,113 |
Amortization of discount on long-term debt | 1,754 | 0 |
Amortization of right of use assets | 893 | 942 |
Changes in operating assets and liabilities: | ||
Inventory | (362) | (2,868) |
Accounts receivable | (987) | (4,671) |
Prepaid expenses and other current assets | (3,626) | (4,111) |
Other non-current assets | (1,269) | (1,020) |
Accounts payable and accrued expenses | 281 | 1,998 |
Employee related accrued expenses | 1,309 | (2,606) |
Other current liabilities | (703) | 47 |
Lease liabilities | (1,125) | (1,176) |
Uncertain tax positions | 176 | 125 |
Net cash used in operating activities | (87,559) | (84,892) |
Cash Flows From Investing Activities | ||
Purchases of marketable securities | (63,009) | (51,898) |
Sales of marketable securities | 0 | 2,463 |
Maturities of marketable securities | 64,323 | 54,256 |
Purchases of property and equipment | (254) | (752) |
Net cash provided by investing activities | 1,060 | 4,069 |
Cash Flows From Financing Activities | ||
Proceeds from prepaid forward arrangement | 0 | 72,402 |
Proceeds from exercise of options into ordinary shares | 1,511 | 61 |
Proceeds from issuance of long-term debt | 95,783 | 0 |
Issuance cost related to at-the-market issuances | (160) | (144) |
Net cash provided by financing activities | 97,134 | 72,319 |
Increase (Decrease) in Cash and Cash Equivalents | 10,635 | (8,504) |
Cash, Cash Equivalents and Restricted Cash at Beginning of Year | 45,586 | 54,090 |
Cash, Cash Equivalents and Restricted Cash at End of Year | 56,221 | 45,586 |
Supplemental Disclosures of Non-Cash Activities | ||
Non-cash issuance cost | 0 | 81 |
Right of use assets obtained in exchange for new operating lease liabilities | $ 2,165 | $ (36) |
Note 1 - Business and Nature of
Note 1 - Business and Nature of Operations | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Nature of Operations [Text Block] | Note 1 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 | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Basis of Accounting [Text Block] | Note 2 The Company has experienced net losses since its inception and has an accumulated deficit of $577.1 million and $467.3 million as of December 31, 2022 2021 The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States. The consolidated financial statements include the accounts of UPL and its wholly owned subsidiary UPI. All material intercompany balances and transactions have been eliminated during consolidation. 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 twelve not may 102. The Company believes that absent sufficient proceeds received from equity, financing, or business development transactions, the Company will not one twelve no |
Note 3 - Significant Accounting
Note 3 - Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | Note 3 Significant Accounting Policies Principles of Consolidation The Company’s 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 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 The Company accounts for its investments, which include cash equivalents and marketable securities, as available-for-sale in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 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 consolidated balance sheets. The Company recognizes capitalized financing expenses as a direct offset to the long-term debt on the Company's 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 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. 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. The following table summarizes the calculation of basic and diluted loss per common share for the periods presented (in thousands, except share and per share amounts): Year Ended December 31, 2022 2021 Basic and diluted: Loss attributable to equity holders of the Company $ 109,783 $ 110,820 Weighted-average number of ordinary shares 22,806,812 22,347,481 Loss per ordinary share $ 4.81 $ 4.96 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 | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Other Financial Information [Text Block] | N OTE 4 o f I Accounts Payable and Accrued Expenses Accounts payable and accrued expenses consisted of the following as of December 31, 2022 2021 December 31, 2022 December 31, 2021 Accounts payable $ 5,527 $ 5,786 Accrued sales reserves 618 497 Accrued clinical expenses 2,853 1,377 Accrued research and development expenses 1,285 1,748 Accrued selling, general and administrative expenses 1,609 1,965 Accrued other expenses 491 729 Total accounts payable and accrued expenses $ 12,383 $ 12,102 Interest and Other Income, Net Interest and other income, net consisted of the following as of December 31, 2022 2021 Year Ended December 31, 2022 2021 Interest income $ 938 $ 365 Other income (expense), net 72 (153 ) Total interest and other income, net $ 1,010 $ 212 |
Note 5 - Inventories
Note 5 - Inventories | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Inventory Disclosure [Text Block] | N OTE 5 I Inventories consist of the following as of December 31, 2022 December 31, 2021 December 31, 2022 December 31, 2021 Raw materials (1) $ 4,676 $ 3,894 Finished goods 2,019 1,958 Total inventories $ 6,695 $ 5,852 ( 1 December 31, 2022 December 31, 2021, |
Note 6 - Fair Value Measurement
Note 6 - Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | N OTE 6 F V M 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: Level 2: not Level 3: 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 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 US 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 Assets measured at fair value on a recurring basis based on Level 1 2 December 31, 2021 Fair Value Measurements Using Quoted Prices Significant in Active Other Balance as of Markets for Observable December 31, Identical Assets Inputs 2021 (Level 1) (Level 2) Assets: Cash equivalents Money market funds $ 21,402 $ 21,402 $ — Marketable securities US government $ 19,307 $ 19,307 $ — Corporate bonds 8,652 — 8,652 Commercial paper 14,492 — 14,492 Certificates of deposit 3,003 — 3,003 Total marketable securities $ 45,454 $ 19,307 $ 26,147 Total assets at fair value $ 66,856 $ 40,709 $ 26,147 The Company’s investments in US government bonds and money market funds are measured based on publicly available quoted market prices for identical securities as of December 31, 2022 2021 |
Note 7 - Investments
Note 7 - Investments | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Investments in Debt and Marketable Equity Securities (and Certain Trading Assets) Disclosure [Text Block] | NOTE 7 I The following table summarizes the Company’s investments as of December 31, 2022 Amortized Cost Basis Unrealized Gains Unrealized Losses Fair Value Marketable securities US government $ 28,742 $ — $ (49 ) $ 28,693 Corporate bonds 2,392 — (5 ) 2,387 Commercial paper 9,417 — (25 ) 9,392 Certificates of deposit 4,112 — (28 ) 4,084 Total marketable securities $ 44,663 $ — $ (107 ) $ 44,556 The following table summarizes the Company’s investments as of December 31, 2021 ( Amortized Cost Basis Unrealized Gains Unrealized Losses Fair Value Assets: Cash equivalents Money market funds $ 21,402 $ — $ — $ 21,402 Marketable securities US government $ 19,325 $ — $ (18 ) $ 19,307 Corporate bonds 8,657 — (5 ) 8,652 Commercial paper 14,494 — (2 ) 14,492 Certificates of deposit 3,004 — (1 ) 3,003 Total marketable securities $ 45,480 $ — $ (26 ) $ 45,454 Total assets at fair value $ 66,882 $ — $ (26 ) $ 66,856 The Company classifies its investments as available-for-sale, and they consist entirely of debt securities. As of December 31, 2022 December 31, 2022 As of December 31, 2022 20 not not December 31, 2022 no The Company’s investments as of December 31, 2022 August 2023. December 31, 2022 December 31, 2021 Maturities within one year $ 44,556 $ 66,181 Maturities after one year through three years — 675 Total investments $ 44,556 $ 66,856 |
Note 8 - Property and Equipment
Note 8 - Property and Equipment | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | N OTE 8 P E Property and equipment, consists of the following as of December 31, 2022 2021 December 31, 2022 2021 Laboratory equipment $ 452 $ 360 Computer equipment and software 2,168 2,064 Furniture 602 597 Leasehold improvements 617 617 Manufacturing equipment 608 555 4,447 4,193 Less: accumulated depreciation and amortization (3,150 ) (2,226 ) Property and equipment, net $ 1,297 $ 1,967 Depreciation and amortization expense was $0.9 million and $0.8 million for the years ended December 31, 2022 2021 |
Note 9 - Prepaid Forward Obliga
Note 9 - Prepaid Forward Obligation | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Prepaid Forward Obligation Disclosure [Text Block] | NOTE 9 Prepaid Forward Obligation In March 2021 , 102. Jelmyto $200 $200 $300 $300 Jelmyto not Jelmyto $200 may 9.5 % Jelmyto December 31, 2022 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 (in thousands): Prepaid forward obligation at closing of RTW Transaction $ 75,000 Capitalized closing costs (2,599 ) Financing on prepaid forward obligation 17,291 Amounts paid and payable (1) (3,979 ) 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) (8,348 ) Carrying value of prepaid forward obligation as of December 31, 2022 $ 98,923 ( 1 December 31, 2022 December 31, 2021, |
Note 10 - Long-term Debt
Note 10 - Long-term Debt | 12 Months Ended |
Dec. 31, 2022 | |
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 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 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 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 |
Note 11 - Leases
Note 11 - Leases | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | N OTE 11 L eases Operating Leases The Company had the following office and laboratory facility leases as of December 31, 2022 • In April 2016, November 2014 three August 2022. July 2022, September 2025. December 31, 2022. • In September 2017, October 2017 February 2021. • In April 2018, July 10, 2018 March 2024. December 31, 2022 November 2019, January 1, 2020 March 2024. November 2019. December 31, 2022 842. • In November 2019, November 29, 2019 January 31, 2023. June 2022, January 31, 2026. December 31, 2022 In addition, the Company has other operating office equipment and vehicle leases. The Company’s operating leases may not 2022 2026, The components of lease cost for the year ended December 31, 2022 2021 Year Ended December 31, 2022 Year Ended December 31, 2021 Operating lease cost $ 975 $ 1,045 Sublease income (224 ) (224 ) Variable lease cost 65 66 $ 816 $ 887 The amounts recognized as of December 31, 2022 2021 Year Ended December 31, 2022 Year Ended December 31, 2021 Right-of-use assets $ 2,452 $ 1,180 Long-term lease liabilities 1,586 398 Other current liabilities 941 1,089 As of December 31, 2022, Supplemental information related to leases for the periods reported is as follows (in thousands, except for lease term and discount rate amounts): Year Ended December 31, 2022 Year Ended December 31, 2021 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases 1,195 1,300 Right-of-use assets obtained in exchange for new operating lease liabilities 2,165 — Weighted-average remaining lease term of operating leases (in years) 2.73 1.46 Weighted-average discount rate of operating leases 10.25 % 5.62 % As of December 31, 2022 Operating Leases Years ending December 31, 2023 $ 1,146 2024 904 2025 788 2026 49 Total future minimum lease payments $ 2,887 Less: Interest (360 ) Present value of lease liabilities $ 2,527 As of December 31, 2021 Operating Leases Years ending December 31, 2022 $ 1,141 2023 357 2024 58 Total future minimum lease payments $ 1,556 Subleases As of December 31, 2022 Operating Leases Years ending December 31, 2023 $ 251 2024 49 Total future minimum sublease payments $ 300 As of December 31, 2021, Operating Leases Years ending December 31, 2022 $ 243 2023 251 2024 49 Total future minimum sublease payments $ 543 Sublease income is recognized net within operating expenses. Sublease income for the year ended December 31, 2022 2021 Year Ended December 31, 2022 Year Ended December 31, 2021 Sublease income from fixed lease payments $ 224 $ 224 |
Note 12 - Revenue From Product
Note 12 - Revenue From Product Sales | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Revenue from Contract with Customer [Text Block] | N OTE 12 R F P S ALES Net product sales consist of the following for the year ended December 31, 2022 2021 Year Ended Year Ended December 31, 2022 Year Ended December 31, 2021 Jelmyto $ 64,357 $ 48,042 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 December 31, 2022 2021 Reserves related to government sponsored programs Other reserves Total accrued sales reserves Balance as of January 1, 2021 $ 323 $ 519 $ 842 Changes during 2021 Accruals 3,824 4,415 8,239 Utilizations (3,774 ) (3,993 ) (7,767 ) Balance as of December 31, 2021 $ 373 $ 941 $ 1,314 Changes during 2022 Accruals 6,967 6,463 13,430 Utilizations (6,750 ) (6,557 ) (13,307 ) Balance as of December 31, 2022 $ 590 $ 847 $ 1,437 |
Note 13 - License and Collabora
Note 13 - License and Collaboration Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Collaborative Arrangement Disclosure [Text Block] | N OTE 13 L C A Agenus Agreement In November 2019, not AGEN1884 4 301 RTGel 1 MD Anderson Agreement In January 2021, three 201 301 December 31, 2022 July 2022, 2022 not not |
Note 14 - Employee Rights Upon
Note 14 - Employee Rights Upon Retirement | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Employee Rights Upon Retirement [Text Block] | N OTE 14 E R U R In Israel, the Company is required by law to make severance payments upon dismissal of an employee or upon termination of employment in certain other circumstances. The Company operates a number of post-employment defined contribution plans. A defined contribution plan is a program that benefits an employee after termination of employment, under which the Company regularly makes fixed payments to a separate and independent entity so that the Company has no not not The Company operates pension and severance compensation plans subject to Section 14 5723 1963. |
Note 15 - Shareholders' Equity
Note 15 - Shareholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | N OTE 15 S ’ E Ordinary Shares The Company had 100.0 million ordinary shares authorized for issuance as of December 31, 2022 2021 December 31, 2022 2021 one not |
Note 16 - Share-based Compensat
Note 16 - Share-based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | N OTE 16 S B C 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. 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 In May 2019, 2019 5635 4 5635 1, not December 2021, As of December 31, 2022, Options granted: Set forth below are grants made by the Company as of December 31, 2022 three tenth a) During 2022 b) During 2021 The fair value of options granted during 2022 2021 The total unrecognized compensation cost of options as of December 31, 2022 The fair value of options granted was computed using the Black-Scholes model. The underlying data used for computing the fair value of the options are as follows: 2022 2021 Value of ordinary shares 5.19911.888 11.92222.077 Dividend yield 0% 0% Expected volatility 72.35%-81.00% 73.76%-79.16% Risk-free interest rate 1.69%-4.14% 0.60%-1.62% Expected term (in years) 6.0-10 years 6.0-10 years 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. The following table summarizes the number of employee and non-employee options outstanding under the Plan for the years ended December 31, 2022 2021 Number of options Weighted Average price per share Outstanding as of January 1, 2021 2,726,331 $ 31.29 Granted 593,000 17.29 Forfeited (337,717 ) 39.18 Exercised (12,057 ) 5.00 Outstanding as of December 31, 2021 2,969,557 $ 27.70 Granted 410,064 7.82 Forfeited (496,417 ) 27.97 Exercised (292,665 ) 5.16 Outstanding as of December 31, 2022 2,590,539 $ 27.05 Vested and expected to vest, December 31, 2022 2,590,539 $ 27.05 Exercisable, December 31, 2022 1,910,065 $ 32.03 The intrinsic value of stock options exercised was $0.8 million and $0.2 million for the years ended December 31, 2022 2021 The following table summarizes the outstanding and exercisable options as of December 31, 2022 Options outstanding Options exercisable Exercise price per share Number of options outstanding at end of year Weighted average remaining contractual life Number of options exercisable at end of year Weighted average remaining contractual life $ 0.00 - 10.00 585,166 8.61 265,767 1.16 $ 10.01 - 20.00 451,166 7.94 253,660 7.31 $ 20.01 - 30.00 470,675 6.88 307,106 6.30 $ 30.01 - 40.00 331,000 3.57 331,000 3.57 $ 40.01 - 50.00 666,532 5.57 666,532 5.57 $ 50.01 - 59.23 86,000 5.43 86,000 5.43 2,590,539 1,910,065 The aggregate intrinsic value of the total vested and exercisable options as of December 31, 2022 The following table summarizes information about RSU activity as of December 31, 2022 Outstanding Restricted Stock Units Outstanding as of January 1, 2021 720,416 Granted 501,125 Vested and released (283,147 ) Forfeited (185,120 ) Outstanding as of December 31, 2021 753,274 Granted 445,980 Vested and released (374,293 ) Forfeited (134,006 ) Outstanding as of December 31, 2022 690,955 The fair value of RSUs granted during 2022 2021 December 31, 2022 The following table illustrates the effect of share-based compensation on the Statements of Operations: Year ended December 31, 2022 2021 Research and development expenses $ 2,626 $ 4,009 Selling, general and administrative expenses 7,954 19,104 Total share-based compensation expense $ 10,580 $ 23,113 |
Note 17 - Income Taxes
Note 17 - Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | N OTE 17 I NCOME T AXES The Company is taxed under Israeli tax laws: Corporate tax rate The applicable Israeli tax rate relevant to the Company for 2021 For financial reporting purposes, the expense for current income taxes consists of the following (in thousands): 2022 2021 Current taxes: U.S. Federal $ 584 $ 1,454 U.S. State 1,171 (5 ) Total current taxes $ 1,755 $ 1,449 Deferred income taxes: Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company and its subsidiary deferred tax assets are as follows (in thousands): December 31, 2022 2021 In respect of: Net operating loss carryforward $ 96,434 $ 77,277 Research and development expenses 17,949 8,988 Stock-based compensation 11,485 10,958 Issuance costs - 65 In-process research and development 1,489 1,909 Right of use asset (434 ) (228 ) Lease Liabilities 461 282 Accrued expenses 1,769 1,207 Depreciation of fixed assets (113 ) (158 ) Other 561 319 Less—valuation allowance (129,601 ) (100,619 ) Net deferred tax assets $ — $ — The change in valuation allowance for the years ended December 31, 2022 2021 2022 2021 Balance at the beginning of the year $ (100,619 ) $ (76,963 ) Changes during the year (28,982 ) (23,656 ) Balance at the end of the year $ (129,601 ) $ (100,619 ) The main reconciling item between the statutory tax rates of the Company and the effective rate is the share-based compensation, the provision for a full valuation allowance in respect of tax benefits from carryforward tax losses due to the uncertainty of the realization of such tax benefits, utilization of tax credits and expense related to uncertain tax positions. A reconciliation of the Company’s statutory tax rate to effective tax is as follows (in thousands, except statutory rate): December 31, 2022 2021 Pretax loss $ (108,028 ) $ (109,371 ) Statutory rate 23 % 23 % Income tax expense/(benefit) at statutory rate (24,847 ) (25,155 ) Additional tax (tax saving) in respect of: Non-deductible compensation expense 1,052 2,264 R&D and orphan drug credits (3,586 ) - Different tax rate of foreign subsidiaries (263 ) (58 ) Uncertain tax positions 176 125 Change in valuation allowance 28,982 23,656 Other 241 617 Income tax expense $ 1,755 $ 1,449 Pretax loss for December 31, 2022 2021 The Internal Revenue Code contains provisions that may 382 382 2018 Losses for tax purposes carried forward to future years As of December 31, 2022 2021 Uncertain tax positions A reconciliation of the beginning and ending amount of uncertain tax positions is as follows (in thousands): 2022 2021 Uncertain tax positions at the beginning of the year $ 2,842 $ 2,717 Gross increases — tax positions in current period — — Gross increases — tax positions in prior period 176 125 Uncertain tax positions at the end of the year $ 3,018 $ 2,842 The balances of uncertain tax positions as of December 31, 2022 The Company has recorded a liability for uncertain tax positions of $3.0 million as of December 31, 2022 December 31, 2022 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 The Company has received final tax assessments up to and including its 2015 |
Note 18 - Related Parties
Note 18 - Related Parties | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Related Party Transactions Disclosure [Text Block] | N OTE 18 R P There were no December 31, 2022 2021 |
Note 19 - Commitments and Conti
Note 19 - Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | N OTE 19 C C 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 December 31, 2022 2021 not Leases See Note 11 |
Note 20 - Subsequent Events
Note 20 - Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | N OTE 20 S E The Company has evaluated and determined there were no |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Consolidation, Policy [Policy Text Block] | Principles of Consolidation The Company’s 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 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 The Company accounts for its investments, which include cash equivalents and marketable securities, as available-for-sale in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 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 consolidated balance sheets. The Company recognizes capitalized financing expenses as a direct offset to the long-term debt on the Company's 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 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. 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. The following table summarizes the calculation of basic and diluted loss per common share for the periods presented (in thousands, except share and per share amounts): Year Ended December 31, 2022 2021 Basic and diluted: Loss attributable to equity holders of the Company $ 109,783 $ 110,820 Weighted-average number of ordinary shares 22,806,812 22,347,481 Loss per ordinary share $ 4.81 $ 4.96 |
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) | 12 Months Ended |
Dec. 31, 2022 | |
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 |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | Year Ended December 31, 2022 2021 Basic and diluted: Loss attributable to equity holders of the Company $ 109,783 $ 110,820 Weighted-average number of ordinary shares 22,806,812 22,347,481 Loss per ordinary share $ 4.81 $ 4.96 |
Note 4 - Other Financial Info_2
Note 4 - Other Financial Information (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Accounts Payable and Accrued Liabilities [Table Text Block] | December 31, 2022 December 31, 2021 Accounts payable $ 5,527 $ 5,786 Accrued sales reserves 618 497 Accrued clinical expenses 2,853 1,377 Accrued research and development expenses 1,285 1,748 Accrued selling, general and administrative expenses 1,609 1,965 Accrued other expenses 491 729 Total accounts payable and accrued expenses $ 12,383 $ 12,102 |
Interest Income and Interest Expense Disclosure [Table Text Block] | Year Ended December 31, 2022 2021 Interest income $ 938 $ 365 Other income (expense), net 72 (153 ) Total interest and other income, net $ 1,010 $ 212 |
Note 5 - Inventories (Tables)
Note 5 - Inventories (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | December 31, 2022 December 31, 2021 Raw materials (1) $ 4,676 $ 3,894 Finished goods 2,019 1,958 Total inventories $ 6,695 $ 5,852 |
Note 6 - Fair Value Measureme_2
Note 6 - Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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 December 31, Identical Assets Inputs 2022 (Level 1) (Level 2) Marketable securities US 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 Fair Value Measurements Using Quoted Prices Significant in Active Other Balance as of Markets for Observable December 31, Identical Assets Inputs 2021 (Level 1) (Level 2) Assets: Cash equivalents Money market funds $ 21,402 $ 21,402 $ — Marketable securities US government $ 19,307 $ 19,307 $ — Corporate bonds 8,652 — 8,652 Commercial paper 14,492 — 14,492 Certificates of deposit 3,003 — 3,003 Total marketable securities $ 45,454 $ 19,307 $ 26,147 Total assets at fair value $ 66,856 $ 40,709 $ 26,147 |
Note 7 - Investments (Tables)
Note 7 - Investments (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Marketable Securities [Table Text Block] | Amortized Cost Basis Unrealized Gains Unrealized Losses Fair Value Marketable securities US government $ 28,742 $ — $ (49 ) $ 28,693 Corporate bonds 2,392 — (5 ) 2,387 Commercial paper 9,417 — (25 ) 9,392 Certificates of deposit 4,112 — (28 ) 4,084 Total marketable securities $ 44,663 $ — $ (107 ) $ 44,556 Amortized Cost Basis Unrealized Gains Unrealized Losses Fair Value Assets: Cash equivalents Money market funds $ 21,402 $ — $ — $ 21,402 Marketable securities US government $ 19,325 $ — $ (18 ) $ 19,307 Corporate bonds 8,657 — (5 ) 8,652 Commercial paper 14,494 — (2 ) 14,492 Certificates of deposit 3,004 — (1 ) 3,003 Total marketable securities $ 45,480 $ — $ (26 ) $ 45,454 Total assets at fair value $ 66,882 $ — $ (26 ) $ 66,856 |
Investments Classified by Contractual Maturity Date [Table Text Block] | December 31, 2022 December 31, 2021 Maturities within one year $ 44,556 $ 66,181 Maturities after one year through three years — 675 Total investments $ 44,556 $ 66,856 |
Note 8 - Property and Equipme_2
Note 8 - Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | December 31, 2022 2021 Laboratory equipment $ 452 $ 360 Computer equipment and software 2,168 2,064 Furniture 602 597 Leasehold improvements 617 617 Manufacturing equipment 608 555 4,447 4,193 Less: accumulated depreciation and amortization (3,150 ) (2,226 ) Property and equipment, net $ 1,297 $ 1,967 |
Note 9 - Prepaid Forward Obli_2
Note 9 - Prepaid Forward Obligation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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 (2,599 ) Financing on prepaid forward obligation 17,291 Amounts paid and payable (1) (3,979 ) 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) (8,348 ) Carrying value of prepaid forward obligation as of December 31, 2022 $ 98,923 |
Note 10 - Long-term Debt (Table
Note 10 - Long-term Debt (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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 |
Note 11 - Leases (Tables)
Note 11 - Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Lease, Cost [Table Text Block] | Year Ended December 31, 2022 Year Ended December 31, 2021 Operating lease cost $ 975 $ 1,045 Sublease income (224 ) (224 ) Variable lease cost 65 66 $ 816 $ 887 |
Assets and Liabilities, Lessee [Table Text Block] | Year Ended December 31, 2022 Year Ended December 31, 2021 Right-of-use assets $ 2,452 $ 1,180 Long-term lease liabilities 1,586 398 Other current liabilities 941 1,089 |
Schedule of Supplemental Information Related to Leases [Table Text Block] | Year Ended December 31, 2022 Year Ended December 31, 2021 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases 1,195 1,300 Right-of-use assets obtained in exchange for new operating lease liabilities 2,165 — Weighted-average remaining lease term of operating leases (in years) 2.73 1.46 Weighted-average discount rate of operating leases 10.25 % 5.62 % |
Lessee, Operating Lease, Liability, Maturity [Table Text Block] | Operating Leases Years ending December 31, 2023 $ 1,146 2024 904 2025 788 2026 49 Total future minimum lease payments $ 2,887 Less: Interest (360 ) Present value of lease liabilities $ 2,527 Operating Leases Years ending December 31, 2022 $ 1,141 2023 357 2024 58 Total future minimum lease payments $ 1,556 |
Lessor, Operating Lease, Payment to be Received, Fiscal Year Maturity [Table Text Block] | Operating Leases Years ending December 31, 2023 $ 251 2024 49 Total future minimum sublease payments $ 300 Operating Leases Years ending December 31, 2022 $ 243 2023 251 2024 49 Total future minimum sublease payments $ 543 |
Lessee, Operating Lease, Sublease Income Recognized Net in Operating Expenses [Table Text Block] | Year Ended December 31, 2022 Year Ended December 31, 2021 Sublease income from fixed lease payments $ 224 $ 224 |
Note 12 - Revenue From Produc_2
Note 12 - Revenue From Product Sales (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Disaggregation of Revenue [Table Text Block] | Year Ended Year Ended December 31, 2022 Year Ended December 31, 2021 Jelmyto $ 64,357 $ 48,042 |
Schedule of Sales Reserves [Table Text Block] | Reserves related to government sponsored programs Other reserves Total accrued sales reserves Balance as of January 1, 2021 $ 323 $ 519 $ 842 Changes during 2021 Accruals 3,824 4,415 8,239 Utilizations (3,774 ) (3,993 ) (7,767 ) Balance as of December 31, 2021 $ 373 $ 941 $ 1,314 Changes during 2022 Accruals 6,967 6,463 13,430 Utilizations (6,750 ) (6,557 ) (13,307 ) Balance as of December 31, 2022 $ 590 $ 847 $ 1,437 |
Note 16 - Share-based Compens_2
Note 16 - Share-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | 2022 2021 Value of ordinary shares 5.19911.888 11.92222.077 Dividend yield 0% 0% Expected volatility 72.35%-81.00% 73.76%-79.16% Risk-free interest rate 1.69%-4.14% 0.60%-1.62% Expected term (in years) 6.0-10 years 6.0-10 years |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Number of options Weighted Average price per share Outstanding as of January 1, 2021 2,726,331 $ 31.29 Granted 593,000 17.29 Forfeited (337,717 ) 39.18 Exercised (12,057 ) 5.00 Outstanding as of December 31, 2021 2,969,557 $ 27.70 Granted 410,064 7.82 Forfeited (496,417 ) 27.97 Exercised (292,665 ) 5.16 Outstanding as of December 31, 2022 2,590,539 $ 27.05 Vested and expected to vest, December 31, 2022 2,590,539 $ 27.05 Exercisable, December 31, 2022 1,910,065 $ 32.03 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding and Exercisable [Table Text Block] | Options outstanding Options exercisable Exercise price per share Number of options outstanding at end of year Weighted average remaining contractual life Number of options exercisable at end of year Weighted average remaining contractual life $ 0.00 - 10.00 585,166 8.61 265,767 1.16 $ 10.01 - 20.00 451,166 7.94 253,660 7.31 $ 20.01 - 30.00 470,675 6.88 307,106 6.30 $ 30.01 - 40.00 331,000 3.57 331,000 3.57 $ 40.01 - 50.00 666,532 5.57 666,532 5.57 $ 50.01 - 59.23 86,000 5.43 86,000 5.43 2,590,539 1,910,065 |
Share-Based Payment Arrangement, Restricted Stock Unit, Activity [Table Text Block] | Outstanding Restricted Stock Units Outstanding as of January 1, 2021 720,416 Granted 501,125 Vested and released (283,147 ) Forfeited (185,120 ) Outstanding as of December 31, 2021 753,274 Granted 445,980 Vested and released (374,293 ) Forfeited (134,006 ) Outstanding as of December 31, 2022 690,955 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Year ended December 31, 2022 2021 Research and development expenses $ 2,626 $ 4,009 Selling, general and administrative expenses 7,954 19,104 Total share-based compensation expense $ 10,580 $ 23,113 |
Note 17 - Income Taxes (Tables)
Note 17 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Components of Income Tax Expense (Benefit) [Table Text Block] | 2022 2021 Current taxes: U.S. Federal $ 584 $ 1,454 U.S. State 1,171 (5 ) Total current taxes $ 1,755 $ 1,449 |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | December 31, 2022 2021 In respect of: Net operating loss carryforward $ 96,434 $ 77,277 Research and development expenses 17,949 8,988 Stock-based compensation 11,485 10,958 Issuance costs - 65 In-process research and development 1,489 1,909 Right of use asset (434 ) (228 ) Lease Liabilities 461 282 Accrued expenses 1,769 1,207 Depreciation of fixed assets (113 ) (158 ) Other 561 319 Less—valuation allowance (129,601 ) (100,619 ) Net deferred tax assets $ — $ — |
Summary of Valuation Allowance [Table Text Block] | 2022 2021 Balance at the beginning of the year $ (100,619 ) $ (76,963 ) Changes during the year (28,982 ) (23,656 ) Balance at the end of the year $ (129,601 ) $ (100,619 ) |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | December 31, 2022 2021 Pretax loss $ (108,028 ) $ (109,371 ) Statutory rate 23 % 23 % Income tax expense/(benefit) at statutory rate (24,847 ) (25,155 ) Additional tax (tax saving) in respect of: Non-deductible compensation expense 1,052 2,264 R&D and orphan drug credits (3,586 ) - Different tax rate of foreign subsidiaries (263 ) (58 ) Uncertain tax positions 176 125 Change in valuation allowance 28,982 23,656 Other 241 617 Income tax expense $ 1,755 $ 1,449 |
Schedule of Unrecognized Tax Benefits Roll Forward [Table Text Block] | 2022 2021 Uncertain tax positions at the beginning of the year $ 2,842 $ 2,717 Gross increases — tax positions in current period — — Gross increases — tax positions in prior period 176 125 Uncertain tax positions at the end of the year $ 3,018 $ 2,842 |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation (Details Textual) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Retained Earnings (Accumulated Deficit), Total | $ (577,104) | $ (467,321) |
Note 3 - Significant Accounti_3
Note 3 - Significant Accounting Policies - Useful Lives of Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2022 | |
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 3 - Significant Accounti_4
Note 3 - Significant Accounting Policies - Schedule of Calculation of Basic and Diluted Loss Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Loss attributable to equity holders of the Company | $ 109,783 | $ 110,820 |
Weighted-average number of ordinary shares (in shares) | 22,806,812 | 22,347,481 |
Loss per ordinary share (in dollars per share) | $ 4.81 | $ 4.96 |
Note 4 - Other Financial Info_3
Note 4 - Other Financial Information - Accounts Payable and Accrued Expense (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Accounts payable | $ 5,527 | $ 5,786 |
Accrued sales reserves | 618 | 497 |
Accrued clinical expenses | 2,853 | 1,377 |
Accrued research and development expenses | 1,285 | 1,748 |
Accrued selling, general and administrative expenses | 1,609 | 1,965 |
Accrued other expenses | 491 | 729 |
Total accounts payable and accrued expenses | $ 12,383 | $ 12,102 |
Note 4 - Other Financial Info_4
Note 4 - Other Financial Information - Interest and Other Income (Expense), Net (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Interest income | $ 938 | $ 365 |
Other income (expense), net | 72 | (153) |
Total interest and other income, net | $ 1,010 | $ 212 |
Note 5 - Inventories (Details T
Note 5 - Inventories (Details Textual) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | |
Inventory, Raw Materials, Net of Reserves | [1] | $ 4,676 | $ 3,894 |
Other Noncurrent Assets [Member] | |||
Inventory, Raw Materials, Net of Reserves | $ 2,400 | $ 1,000 | |
[1]$2.4 million and $1.0 million of raw materials are included within other non-current assets on the consolidated balance sheets at December 31, 2022 and December 31, 2021, respectively. |
Note 5 - Inventories - Inventor
Note 5 - Inventories - Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | |
Raw materials | [1] | $ 4,676 | $ 3,894 |
Finished goods | 2,019 | 1,958 | |
Total inventories | $ 6,695 | $ 5,852 | |
[1]$2.4 million and $1.0 million of raw materials are included within other non-current assets on the consolidated balance sheets at December 31, 2022 and December 31, 2021, respectively. |
Note 6 - Fair Value Measureme_3
Note 6 - Fair Value Measurements - Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | |
Fair value | $ 44,556 | $ 45,454 | |
Corporate Debt Securities [Member] | |||
Fair value | 2,387 | 8,652 | |
US Treasury and Government [Member] | |||
Fair value | 28,693 | 19,307 | |
Certificates of Deposit [Member] | |||
Fair value | 4,084 | 3,003 | |
Fair Value, Recurring [Member] | |||
Fair value | 44,556 | 45,454 | |
Total assets at fair value | 66,856 | ||
Fair Value, Recurring [Member] | Corporate Debt Securities [Member] | |||
Fair value | 2,387 | 8,652 | |
Fair Value, Recurring [Member] | US Treasury and Government [Member] | |||
Fair value | 19,307 | ||
Fair Value, Recurring [Member] | Certificates of Deposit [Member] | |||
Fair value | 4,084 | 3,003 | |
Fair Value, Recurring [Member] | Commercial Paper, Not Included with Cash and Cash Equivalents [Member] | |||
Fair value | 14,492 | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Fair value | 28,693 | 19,307 | |
Total assets at fair value | 40,709 | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | Corporate Debt Securities [Member] | |||
Fair value | 0 | 0 | |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | US Treasury and Government [Member] | |||
Fair value | 19,307 | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | Certificates of Deposit [Member] | |||
Fair value | 0 | 0 | |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | Commercial Paper, Not Included with Cash and Cash Equivalents [Member] | |||
Fair value | 0 | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Fair value | 15,863 | 26,147 | |
Total assets at fair value | 26,147 | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | Corporate Debt Securities [Member] | |||
Fair value | 2,387 | 8,652 | |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | US Treasury and Government [Member] | |||
Fair value | 0 | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | Certificates of Deposit [Member] | |||
Fair value | 4,084 | 3,003 | |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | Commercial Paper, Not Included with Cash and Cash Equivalents [Member] | |||
Fair value | 14,492 | ||
US Government Corporations and Agencies Securities [Member] | Fair Value, Recurring [Member] | |||
Cash equivalents, fair value | 28,693 | ||
US Government Corporations and Agencies Securities [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Cash equivalents, fair value | 28,693 | ||
US Government Corporations and Agencies Securities [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Cash equivalents, fair value | 0 | ||
Money Market Funds [Member] | |||
Cash equivalents, fair value | [1] | 21,402 | |
Money Market Funds [Member] | Fair Value, Recurring [Member] | |||
Cash equivalents, fair value | 21,402 | ||
Money Market Funds [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Cash equivalents, fair value | 21,402 | ||
Money Market Funds [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Cash equivalents, fair value | $ 0 | ||
Commercial Paper [Member] | Fair Value, Recurring [Member] | |||
Cash equivalents, fair value | 9,392 | ||
Commercial Paper [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Cash equivalents, fair value | 0 | ||
Commercial Paper [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Cash equivalents, fair value | $ 9,392 | ||
[1]Included within cash and cash equivalents on the Company’s consolidated balance sheets. |
Note 7 - Investments (Details T
Note 7 - Investments (Details Textual) $ in Millions | Dec. 31, 2022 USD ($) |
Debt Securities, Available-for-Sale, Unrealized Loss Position, Total | $ 42.2 |
Note 7 - Marketable Securities
Note 7 - Marketable Securities - Summary of Marketable Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | |
Amortized cost basis | $ 44,663 | $ 45,480 | |
Unrealized gains | 0 | 0 | |
Unrealized losses | (107) | (26) | |
Fair value | 44,556 | 45,454 | |
Money market funds | 55,408 | 44,360 | |
Total assets at fair value | 66,882 | ||
Total assets at fair value, unrealized gains | 0 | ||
Total assets at fair value, unrealized losses | (26) | ||
Total assets at fair value, fair value | 66,856 | ||
Money Market Funds [Member] | |||
Money market funds | [1] | 21,402 | |
Money market funds, unrealized gains | [1] | 0 | |
Money market funds, unrealized loss | [1] | 0 | |
Money market funds, fair value | [1] | 21,402 | |
US Treasury and Government [Member] | |||
Amortized cost basis | 28,742 | 19,325 | |
Unrealized gains | 0 | 0 | |
Unrealized losses | (49) | (18) | |
Fair value | 28,693 | 19,307 | |
Corporate Debt Securities [Member] | |||
Amortized cost basis | 2,392 | 8,657 | |
Unrealized gains | 0 | 0 | |
Unrealized losses | (5) | (5) | |
Fair value | 2,387 | 8,652 | |
Commercial Paper [Member] | |||
Amortized cost basis | 9,417 | 14,494 | |
Unrealized gains | 0 | 0 | |
Unrealized losses | (25) | (2) | |
Fair value | 9,392 | 14,492 | |
Certificates of Deposit [Member] | |||
Amortized cost basis | 4,112 | 3,004 | |
Unrealized gains | 0 | 0 | |
Unrealized losses | (28) | (1) | |
Fair value | $ 4,084 | $ 3,003 | |
[1]Included within cash and cash equivalents on the Company’s consolidated balance sheets. |
Note 7 - Marketable Securitie_2
Note 7 - Marketable Securities - Fair Values of Marketable Securities by Contractual Maturity (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Maturities within one year | $ 44,556 | $ 66,181 |
Maturities after one year through three years | 0 | 675 |
Total investments | $ 44,556 | $ 66,856 |
Note 8 - Property and Equipme_3
Note 8 - Property and Equipment (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Depreciation, Depletion and Amortization, Total | $ 924 | $ 831 |
Note 8 - Property and Equipme_4
Note 8 - Property and Equipment - Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property and equipment, gross | $ 4,447 | $ 4,193 |
Less: accumulated depreciation and amortization | (3,150) | (2,226) |
Property and equipment, net | 1,297 | 1,967 |
Laboratory Equipment [Member] | ||
Property and equipment, gross | 452 | 360 |
Computers and Software [Member] | ||
Property and equipment, gross | 2,168 | 2,064 |
Furniture [Member[ | ||
Property and equipment, gross | 602 | 597 |
Leasehold Improvements [Member] | ||
Property and equipment, gross | 617 | 617 |
Manufacturing Equipment [Member] | ||
Property and equipment, gross | $ 608 | $ 555 |
Note 9 - Prepaid Forward Obli_3
Note 9 - Prepaid Forward Obligation (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
May 31, 2021 | Mar. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Proceeds from Prepaid Forward Arrangement, Net | $ 0 | $ 72,402 | |||
Prepaid Forward Obligation | 98,923 | 85,713 | $ 75,000 | ||
Other Current Liabilities [Member] | |||||
Prepaid Forward Obligation | 2,300 | $ 1,500 | |||
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 | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | ||
Prepaid forward obligation at closing of RTW Transaction | $ 85,713 | $ 75,000 | |
Capitalized closing costs | (2,599) | ||
Financing on prepaid forward obligation | 21,559 | 17,291 | |
Amounts paid and payable (1) | (8,348) | (3,979) | [1] |
Carrying value of prepaid forward obligation as of December 31, 2021 | $ 98,923 | $ 85,713 | |
[1]$2.3 million and $1.5 million of the Amounts paid and payable are included as current portion of the prepaid forward obligation within other current liabilities on the consolidated balance sheets as of December 31, 2022 and December 31, 2021, respectively. |
Note 10 - Long-term Debt (Detai
Note 10 - Long-term Debt (Details Textual) - Secured Debt [Member] $ in Millions | Mar. 07, 2022 USD ($) |
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) [Member] | |
Debt Instrument, Basis Spread on Variable Rate | 8.25% |
Note 10 - Long-term Debt - Long
Note 10 - Long-term Debt - Long Term Debt (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Interest expense | $ 8,438 | $ 0 |
Pharmakon Loan [Member] | ||
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 |
Note 11 - Leases (Details Textu
Note 11 - Leases (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Oct. 31, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Nov. 29, 2019 | |
Operating Lease, Liability, Total | $ 2,527 | |||
Operating Lease, Impairment Loss | 0 | |||
Sublease Income | 224 | $ 224 | ||
Lease Agreement for Office in Israel [Member] | UroGen Pharma Inc. [Member] | ||||
Operating Lease, Liability, Total | 700 | |||
Lease Agreement for Office in Los Angeles, California [Member] | UroGen Pharma Inc. [Member] | ||||
Operating Lease, Liability, Total | 400 | |||
Operating Lease, Impairment Loss | $ 200 | |||
Sublease Income | 300 | |||
Lease Agreement for Office in Princeton, New Jersey [Member] | UroGen Pharma Inc. [Member] | ||||
Operating Lease, Liability, Total | $ 1,800 | |||
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 | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating lease cost | $ 975 | $ 1,045 |
Sublease income | (224) | (224) |
Variable lease cost | 65 | 66 |
Lease, Cost, Total | $ 816 | $ 887 |
Note 11 - Leases - Amounts of A
Note 11 - Leases - Amounts of Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Right-of-use assets | $ 2,452 | $ 1,180 |
Long-term lease liabilities | 1,586 | 398 |
Other Current Liabilities [Member] | ||
Other current liabilities | $ 941 | $ 1,089 |
Note 11 - Leases - Supplemental
Note 11 - Leases - Supplemental Information Related to Leases (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating cash flows from operating leases | $ 1,195 | $ 1,300 |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 2,165 | $ 0 |
Weighted-average remaining lease term of operating leases (Year) | 2 years 8 months 23 days | 1 year 5 months 15 days |
Weighted-average discount rate of operating leases | 10.25% | 5.62% |
Note 11 - Leases - Maturities o
Note 11 - Leases - Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Year one | $ 1,146 | $ 1,141 |
Year two | 904 | 357 |
Year three | 788 | 58 |
Year four | 49 | |
Total future minimum lease payments | 2,887 | $ 1,556 |
Less: Interest | (360) | |
Present value of lease liabilities | $ 2,527 |
Note 11 - Leases - Undiscounted
Note 11 - Leases - Undiscounted Cash Flows to be Received Under Sublease (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
2023, received | $ 251 | $ 243 |
2024, received | 49 | 251 |
Total future minimum sublease payments | 300 | 543 |
2022, received | 251 | 243 |
2023, received | $ 49 | 251 |
2024, received | $ 49 |
Note 11 - Leases - Sublease Inc
Note 11 - Leases - Sublease Income Recognized (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Sublease income from fixed lease payments | $ 224 | $ 224 |
Note 12 - Revenue From Produc_3
Note 12 - Revenue From Product Sales - Net Product Sales (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue | $ 64,357 | $ 48,042 |
Jelmyto [Member] | ||
Revenue | $ 64,357 | $ 48,042 |
Note 12 - Revenue From Produc_4
Note 12 - Revenue From Product Sales - Sales Reserves Activity (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Balance | $ 1,314 | $ 842 |
Accruals | 13,430 | 8,239 |
Utilizations | (13,307) | (7,767) |
Balance | 1,437 | 1,314 |
Government Sponsored Programs Reserves [Member] | ||
Balance | 373 | 323 |
Accruals | 6,967 | 3,824 |
Utilizations | (6,750) | (3,774) |
Balance | 590 | 373 |
Other Reserves [Member] | ||
Balance | 941 | 519 |
Accruals | 6,463 | 4,415 |
Utilizations | (6,557) | (3,993) |
Balance | $ 847 | $ 941 |
Note 13 - License and Collabo_2
Note 13 - License and Collaboration Agreements (Details Textual) - MD Anderson [Member] - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended |
Jan. 31, 2021 | Dec. 31, 2022 | |
Collaboration Agreement, Term (Year) | 3 years | |
Research and Development Arrangement, Contract to Perform for Others, Costs Incurred, Gross | $ 2 |
Note 15 - Shareholders' Equity
Note 15 - Shareholders' Equity (Details Textual) - shares | Dec. 31, 2022 | Dec. 31, 2021 |
Common Stock, Shares Authorized (in shares) | 100,000,000 | 100,000,000 |
Common Stock, Shares, Outstanding, Ending Balance (in shares) | 23,129,953 | 22,462,995 |
Note 16 - Share-based Compens_3
Note 16 - Share-based Compensation (Details Textual) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2022 | Jun. 08, 2022 | Jun. 07, 2021 | Jun. 08, 2020 | Oct. 12, 2018 | Jan. 01, 2018 | Dec. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | May 31, 2019 | Mar. 31, 2017 | |
Common Stock, Capital Shares Reserved for Future Issuance (in shares) | 3,281,494 | 3,281,494 | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 1,595,328 | 1,595,328 | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross (in shares) | 410,064 | 593,000 | |||||||||
Share-Based Payment Arrangement, Option, Exercise Price Range, Lower Range Limit (in dollars per share) | $ 5.19 | $ 11.92 | |||||||||
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit (in dollars per share) | $ 11.88 | $ 22.07 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Granted, Fair Value | $ 2.2 | $ 7 | |||||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | $ 4 | $ 4 | |||||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 1 year 7 months 6 days | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period, Intrinsic Value | $ 0.8 | 0.2 | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Exercisable, Aggregate Intrinsic Value | $ 0.9 | $ 0.9 | |||||||||
Share-Based Payment Arrangement, Option [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period (Year) | 10 years | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period (Year) | 3 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 | ||||||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 1 year 7 months 2 days | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other Than Options, Granted, Fair Value | $ 3.2 | $ 9.9 | |||||||||
Share-Based Payment Arrangement, Nonvested Award, Excluding Option, Cost Not yet Recognized, Amount | $ 5.8 | $ 5.8 | |||||||||
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) | 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) | 400,000 | 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 | ||||||||||
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 16 - Share-based Compens_4
Note 16 - Share-based Compensation - Fair Value of Options Granted Valuation Assumption (Details) - Share-Based Payment Arrangement, Option [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Dividend yield | 0% | 0% |
Expected volatility, minimum | 72.35% | 73.76% |
Expected volatility, maximum | 81% | 79.16% |
Risk-free interest rate, minimum | 1.69% | 0.60% |
Risk-free interest rate, maximum | 4.14% | 1.62% |
Minimum [Member] | ||
Value of ordinary shares (in dollars per share) | $ 5.19 | $ 11.92 |
Maximum [Member] | ||
Value of ordinary shares (in dollars per share) | $ 11.88 | $ 22.07 |
Note 16 - Share-based Compens_5
Note 16 - Share-based Compensation - Number of Employee and Non-employee Options Outstanding (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Granted, number of options (in shares) | 410,064 | 593,000 |
Forfeited, number of options (in shares) | (496,417) | (337,717) |
Forfeited, weighted average price per share (in dollars per share) | $ 27.97 | $ 39.18 |
Employees and Non-employees [Member] | ||
Outstanding, number of options (in shares) | 2,969,557 | 2,726,331 |
Outstanding, weighted average price per share (in dollars per share) | $ 27.70 | $ 31.29 |
Granted, number of options (in shares) | 410,064 | 593,000 |
Granted, weighted average price per share (in dollars per share) | $ 7.82 | $ 17.29 |
Exercised, number of options (in shares) | (292,665) | (12,057) |
Exercised, weighted average price per share (in dollars per share) | $ 5.16 | $ 5 |
Outstanding, number of options (in shares) | 2,590,539 | 2,969,557 |
Outstanding, weighted average price per share (in dollars per share) | $ 27.05 | $ 27.70 |
Vested and expected to vest (in shares) | 2,590,539 | |
Vested and expected to vest, weighted average price per share (in dollars per share) | $ 27.05 | |
Exercisable (in shares) | 1,910,065 | |
Exercisable, weighted average price per share (in dollars per share) | $ 32.03 |
Note 16 - Share-based Compens_6
Note 16 - Share-based Compensation - Outstanding and Exercisable Options (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Exercise price per share, lower limit (in dollars per share) | $ 5.19 | $ 11.92 |
Exercise price per share, upper limit (in dollars per share) | $ 11.88 | $ 22.07 |
Number of options outstanding (in shares) | 2,590,539 | |
Number of options exercisable (in shares) | 1,910,065 | |
Exercise Price Per Share Range One [Member] | ||
Exercise price per share, lower limit (in dollars per share) | $ 0 | |
Exercise price per share, upper limit (in dollars per share) | $ 10 | |
Number of options outstanding (in shares) | 585,166 | |
Options outstanding, Weighted average remaining contractual life (Year) | 8 years 7 months 9 days | |
Number of options exercisable (in shares) | 265,767 | |
Options exercisable, Weighted average remaining contractual life (Year) | 1 year 1 month 28 days | |
Exercise Price Per Share Range Two [Member] | ||
Exercise price per share, lower limit (in dollars per share) | $ 10.01 | |
Exercise price per share, upper limit (in dollars per share) | $ 20 | |
Number of options outstanding (in shares) | 451,166 | |
Options outstanding, Weighted average remaining contractual life (Year) | 7 years 11 months 8 days | |
Number of options exercisable (in shares) | 253,660 | |
Options exercisable, Weighted average remaining contractual life (Year) | 7 years 3 months 21 days | |
Exercise Price Per Share Range Three [Member] | ||
Exercise price per share, lower limit (in dollars per share) | $ 20.01 | |
Exercise price per share, upper limit (in dollars per share) | $ 30 | |
Number of options outstanding (in shares) | 470,675 | |
Options outstanding, Weighted average remaining contractual life (Year) | 6 years 10 months 17 days | |
Number of options exercisable (in shares) | 307,106 | |
Options exercisable, Weighted average remaining contractual life (Year) | 6 years 3 months 18 days | |
Exercise Price Per Share Range Four [Member] | ||
Exercise price per share, lower limit (in dollars per share) | $ 30.01 | |
Exercise price per share, upper limit (in dollars per share) | $ 40 | |
Number of options outstanding (in shares) | 331,000 | |
Options outstanding, Weighted average remaining contractual life (Year) | 3 years 6 months 25 days | |
Number of options exercisable (in shares) | 331,000 | |
Options exercisable, Weighted average remaining contractual life (Year) | 3 years 6 months 25 days | |
Exercise Price Per Share Range Five [Member] | ||
Exercise price per share, lower limit (in dollars per share) | $ 40.01 | |
Exercise price per share, upper limit (in dollars per share) | $ 50 | |
Number of options outstanding (in shares) | 666,532 | |
Options outstanding, Weighted average remaining contractual life (Year) | 5 years 6 months 25 days | |
Number of options exercisable (in shares) | 666,532 | |
Options exercisable, Weighted average remaining contractual life (Year) | 5 years 6 months 25 days | |
Exercise Price Per Share Range Six [Member] | ||
Exercise price per share, lower limit (in dollars per share) | $ 50.01 | |
Exercise price per share, upper limit (in dollars per share) | $ 59.23 | |
Number of options outstanding (in shares) | 86,000 | |
Options outstanding, Weighted average remaining contractual life (Year) | 5 years 5 months 4 days | |
Number of options exercisable (in shares) | 86,000 | |
Options exercisable, Weighted average remaining contractual life (Year) | 5 years 5 months 4 days |
Note 16 - Share-based Compens_7
Note 16 - Share-based Compensation - Summary of RSU Activity (Details) - Restricted Stock Units (RSUs) [Member] - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Outstanding, RSU (in shares) | 753,274 | 720,416 |
Granted, RSU (in shares) | 445,980 | 501,125 |
Vested and released, RSU (in shares) | (374,293) | (283,147) |
Forfeited, RSU (in shares) | (134,006) | (185,120) |
Outstanding, RSU (in shares) | 690,955 | 753,274 |
Note 16 - Share-based Compens_8
Note 16 - Share-based Compensation - Effect of Share-based Compensation on the Condensed Consolidated Statements of Operations (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based compensation | $ 10,580 | $ 23,113 |
Research and Development Expense [Member] | ||
Share-based compensation | 2,626 | 4,009 |
Selling, General and Administrative Expenses [Member] | ||
Share-based compensation | $ 7,954 | $ 19,104 |
Note 17 - Income Taxes (Details
Note 17 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 23% | 23% | |
Income (Loss) from Continuing Operations before Income Taxes, Foreign | $ (13,300) | $ (10,100) | |
Operating Loss Carryforwards | 419,100 | 335,800 | |
Unrecognized Tax Benefits, Ending Balance | 3,018 | $ 2,842 | $ 2,717 |
Unrecognized Tax Benefits, Income Tax Penalties and Interest Accrued, Total | $ 1,100 |
Note 17 - Income Taxes - Summar
Note 17 - Income Taxes - Summary of Current Income Taxes Expenses (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
U.S. Federal | $ 584 | $ 1,454 |
U.S. State | 1,171 | (5) |
Total current taxes | $ 1,755 | $ 1,449 |
Note 17 - Income Taxes - Compon
Note 17 - Income Taxes - Components of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Net operating loss carryforward | $ 96,434 | $ 77,277 | |
Stock-based compensation | 11,485 | 10,958 | |
Issuance costs | 0 | 65 | |
In-process research and development | 1,489 | 1,909 | |
Right of use asset, deferred tax assets | (434) | (228) | |
Lease Liabilities | 461 | 282 | |
Accrued expenses | 1,769 | 1,207 | |
Depreciation of fixed assets | (113) | (158) | |
Other | 561 | 319 | |
Less—valuation allowance | (129,601) | (100,619) | $ (76,963) |
Net deferred tax assets | $ 0 | $ 0 |
Note 17 - Income Taxes - Change
Note 17 - Income Taxes - Changes in Valuation Allowance (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Balance | $ (100,619) | $ (76,963) |
Changes during the year | (28,982) | (23,656) |
Balance | $ (129,601) | $ (100,619) |
Note 17 - Income Taxes - Reconc
Note 17 - Income Taxes - Reconciliation of Statutory Tax Rate to Effective Tax (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | ||
Pretax loss | $ (108,028) | $ (109,371) | |
Statutory rate | 23% | 23% | |
Income tax expense/(benefit) at statutory rate | $ (24,847) | $ (25,155) | |
Non-deductible compensation expense | [1] | 1,052 | 2,264 |
R&D and orphan drug credits | (3,586) | 0 | |
Different tax rate of foreign subsidiaries | (263) | (58) | |
Uncertain tax positions | 176 | 125 | |
Change in valuation allowance | 28,982 | 23,656 | |
Other | [1] | 241 | 617 |
Income tax expense | $ 1,755 | $ 1,449 | |
[1]Certain prior period amounts have been reclassified to conform with the current period presentation |
Note 17 - Income Taxes - Reco_2
Note 17 - Income Taxes - Reconciliation of Uncertain Tax Positions (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Uncertain tax positions at the beginning of the year | $ 2,842 | $ 2,717 |
Gross increases — tax positions in current period | 0 | 0 |
Gross increases — tax positions in prior period | 176 | 125 |
Uncertain tax positions at the end of the year | $ 3,018 | $ 2,842 |