0001437749-21-026620 | 10-Q | XBRL Viewer

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Document And Entity Information - shares	9 Months Ended
Document And Entity Information - shares	Sep. 30, 2021	Nov. 03, 2021
Document Information [Line Items]
Entity Central Index Key	0001668243
Entity Registrant Name	UroGen Pharma Ltd.
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2021
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2021
Document Transition Report	false
Entity File Number	001-38079
Entity Incorporation, State or Country Code	L3
Entity Tax Identification Number	98-1460746
Entity Address, Address Line One	400 Alexander Park Drive
Entity Address, City or Town	Princeton
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	08540
City Area Code	646
Local Phone Number	768-9780
Title of 12(b) Security	Ordinary Shares, par value NIS 0.01 per share
Trading Symbol	URGN
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		22,420,325

Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands	Sep. 30, 2021	Dec. 31, 2020
Current assets:
Cash and cash equivalents	$ 55,337	$ 52,864
Marketable securities	50,872	49,154
Restricted cash	1,226	1,226
Accounts receivable	7,784	7,047
Inventories	3,808	1,964
Prepaid expense and other current assets	6,113	3,364
Total current assets	125,140	115,619
Non-current assets:
Property and equipment, net	1,978	2,046
Restricted deposit	223	223
Right of use asset	1,418	2,158
Marketable securities	4,071	1,893
Other non-current assets	1,773	66
Total Assets	134,603	122,005
Current liabilities:
Accounts payable and accrued expense	11,062	10,023
Employee related accrued expense	6,476	9,554
Other current liabilities	2,268	1,859
Total current liabilities:	19,806	21,436
Non-current liabilities:
Prepaid forward obligation	79,927	0
Long-term lease liability	616	1,497
Uncertain tax positions liability	2,717	2,717
Total Liabilities	103,066	25,650
Commitments and contingencies (Note 14)
Shareholders' equity:
Ordinary shares, NIS 0.01 par value; 100,000,000 shares authorized at September 30, 2021 and December 31, 2020; 22,404,845 and 22,167,791 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively	61	60
Additional paid-in capital	470,341	452,525
Accumulated deficit	(438,869)	(356,501)
Accumulated other comprehensive income	4	271
Total Shareholders' Equity	31,537	96,355
Total Liabilities and Shareholders' Equity	$ 134,603	$ 122,005

Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - ₪ / shares	Sep. 30, 2021	Dec. 31, 2020
Ordinary shares, par value (in ILS per share)	₪ 0.01	₪ 0.01
Ordinary shares, authorized (in shares)	100,000,000	100,000,000
Ordinary shares, issued (in shares)	22,404,845	22,167,791
Ordinary shares, outstanding (in shares)	22,404,845	22,167,791

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Revenue	$ 11,351	$ 3,461	$ 31,868	$ 3,833
Cost of revenue	1,244	309	3,568	357
Gross profit	10,107	3,152	28,300	3,476
Operating expense:
Research and development expense	11,923	10,211	34,560	34,905
Selling, general and administrative expense	21,624	22,065	66,117	68,056
Operating loss	(23,440)	(29,124)	(72,377)	(99,485)
Financing on prepaid forward obligation	(6,828)	0	(9,948)	0
Interest and other income, net	57	308	269	1,527
Loss before income taxes	(30,211)	(28,816)	(82,056)	(97,958)
Income tax expense	0	0	312	0
Net Loss	(30,211)	(28,816)	(82,368)	(97,958)
Statements of Comprehensive Loss
Net loss	(30,211)	(28,816)	(82,368)	(97,958)
Other comprehensive income
Unrealized (loss) gain on marketable securities	(41)	(268)	(267)	216
Comprehensive Loss	$ (30,252)	$ (29,084)	$ (82,635)	$ (97,742)
Net loss per ordinary share basic and diluted (in dollars per share)	$ (1.35)	$ (1.31)	$ (3.69)	$ (4.52)
Weighted average number of shares outstanding used in computation of basic and diluted loss per ordinary share (in shares)	22,380,598	22,058,343	22,318,589	21,657,712

Condensed Consolidated Statements of Shareholders' Equity (Unaudited) - USD ($) $ in Thousands	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	AOCI Attributable to Parent [Member]	Total
Balance (in shares) at Dec. 31, 2019	21,026,184
Balance at Dec. 31, 2019	$ 57	$ 407,986	$ (228,017)	$ 276	$ 180,302
Exercise of options into ordinary shares (in shares)	345,248
Exercise of options into ordinary shares	$ 1	690			691
Share-based compensation		21,499			21,499
Other comprehensive income (loss)				216	216
Net loss			(97,958)		(97,958)
Issuance of ordinary shares in public offering, net of issuance expense (in shares)	700,000
Issuance of ordinary shares in public offering, net of issuance expense	$ 2	15,775			15,777
Balance (in shares) at Sep. 30, 2020	22,071,432
Balance at Sep. 30, 2020	$ 60	445,950	(325,975)	492	120,527
Balance (in shares) at Jun. 30, 2020	22,001,296
Balance at Jun. 30, 2020	$ 60	438,999	(297,159)	760	142,660
Exercise of options into ordinary shares (in shares)	70,136
Exercise of options into ordinary shares	$ 0	188			188
Share-based compensation		6,763			6,763
Other comprehensive income (loss)				(268)	(268)
Net loss			(28,816)		(28,816)
Balance (in shares) at Sep. 30, 2020	22,071,432
Balance at Sep. 30, 2020	$ 60	445,950	(325,975)	492	120,527
Balance (in shares) at Dec. 31, 2020	22,167,791
Balance at Dec. 31, 2020	$ 60	452,525	(356,501)	271	96,355
Exercise of options into ordinary shares (in shares)	237,054
Exercise of options into ordinary shares	$ 1	60			61
Share-based compensation		17,756			17,756
Other comprehensive income (loss)				(267)	(267)
Net loss			(82,368)		(82,368)
Balance (in shares) at Sep. 30, 2021	22,404,845
Balance at Sep. 30, 2021	$ 61	470,341	(438,869)	4	31,537
Balance (in shares) at Jun. 30, 2021	22,354,533
Balance at Jun. 30, 2021	$ 61	464,823	(408,658)	45	56,271
Exercise of options into ordinary shares (in shares)	50,312
Exercise of options into ordinary shares	$ 0	3			3
Share-based compensation		5,515			5,515
Other comprehensive income (loss)				(41)	(41)
Net loss			(30,211)		(30,211)
Balance (in shares) at Sep. 30, 2021	22,404,845
Balance at Sep. 30, 2021	$ 61	$ 470,341	$ (438,869)	$ 4	$ 31,537

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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- Definition

Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity.

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+ Details

Condensed Consolidated Statements of Cash Flow (Unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Cash Flows From Operating Activities
Net loss	$ (82,368)	$ (97,958)
Adjustment to reconcile net loss to net cash from operating activities:
Depreciation and amortization	618	295
Accrued financing on prepaid forward obligation	8,583	0
Amortization on marketable securities	343	386
Share-based compensation	17,756	21,499
Amortization of right of use asset	704	1,134
Lease liability	(914)	(1,157)
Changes in operating assets and liabilities:
Inventory	(1,844)	(1,346)
Accounts receivable	(737)	(2,810)
Prepaid expense and other current assets	(2,749)	(3,261)
Other non-current assets	(1,573)	0
Accounts payable and accrued expense	1,032	(2,506)
Employee related accrued expense	(3,078)	1,080
Other current liabilities	(595)	0
Net cash used in operating activities	(64,822)	(84,644)
Cash Flows From Investing Activities
Purchases of marketable securities	(51,594)	(29,687)
Sales of marketable securities	2,463
Maturities of marketable securities	44,625	74,503
Purchases of property and equipment	(550)	(1,043)
Net cash (used in) provided by investing activities	(5,056)	43,773
Cash Flows From Financing Activities
Proceeds from prepaid forward arrangement	72,417	0
Proceeds from exercise of options into ordinary shares	61	651
Issuances of ordinary shares, net of issuance expense	0	15,853
Issuance cost related to at-the-market issuances	(127)	(55)
Net cash provided by financing activities	72,351	16,449
Increase (Decrease) in Cash and Cash Equivalents	2,473	(24,422)
Cash, Cash Equivalents and Restricted Cash at Beginning of Period	54,090	50,211
Cash, Cash Equivalents and Restricted Cash at End of Period	56,563	25,789
Supplemental Disclosures of Non-Cash Activities
Non-cash new lease liabilities	(36)	51
Non-cash issuance cost	7	0
Exercise of options	$ 0	$ 40

Note 1 - Business and Nature of Operations

9 Months Ended

Sep. 30, 2021

Notes to Financial Statements

Nature of Operations [Text Block]

Note 1 – Business and Nature of Operations

Nature of Operations

UroGen Pharma Ltd. is an Israeli company incorporated in April 2004 (“UPL”).

UroGen Pharma Inc., a wholly owned subsidiary of UPL, was incorporated in Delaware in October 2015 and began operating in February 2016 (“UPI”).

UPL and UPI (together the “Company”) is a biopharmaceutical company focused on building and commercializing novel solutions that treat specialty cancers and urologic diseases. Since commencing operations, the Company has devoted substantially all of its efforts to securing intellectual property rights, performing research and development activities, including conducting clinical trials and manufacturing activities, hiring personnel, launching the Company’s first commercial product, Jelmyto (mitomycin) for pyelocalyceal solution, formerly known as UGN-101 and raising capital to support and expand these activities.

On April 15, 2020, the U.S. Food and Drug Administration (“FDA”) granted expedited approval for Jelmyto, a first-in-class treatment indicated for adults with low-grade upper tract urothelial cancer (“low grade-UTUC”). Jelmyto consists of mitomycin, an established chemotherapy, and sterile hydrogel, using our proprietary sustained release RTGel technology. It has been designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means.

Note 2 - Basis of Presentation

9 Months Ended

Sep. 30, 2021

Notes to Financial Statements

Basis of Accounting [Text Block]

Note 2 – Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements. In the opinion of the Company’s management, the accompanying condensed consolidated financial statements contain all adjustments (consisting of normal recurring accruals and adjustments) necessary for fair statement of its financial position, results of operations and cash flows of the Company at the dates and for the periods indicated. Interim results are not necessarily indicative of results for the full fiscal year. The year-end condensed consolidated balance sheet data was derived from audited financial statements but does not include all disclosures required by accounting principles generally accepted in the United States. The unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (“SEC”) on March 18, 2021.

The consolidated financial statements include the accounts of UPL and its wholly owned subsidiary UPI. Intercompany balances and transactions have been eliminated during consolidation.

The Company has experienced net losses since its inception and has an accumulated deficit of $438.9 million and $356.5 million as of September 30, 2021 and December 31, 2020, respectively. The Company expects to incur losses and have negative net cash flows from operating activities as it executes on its strategy including engaging in further research and development activities, particularly conducting non-clinical studies and clinical trials.

The success of the Company depends on the ability to successfully commercialize its technologies to support its operations and strategic plan. Based on management’s cash flow projections the Company believes that its cash and cash equivalents and marketable securities are sufficient to fund the Company’s planned operations for at least the next 12 months. The Company anticipates that it will need to raise additional capital in the future. There can be no assurances that the Company will be able to secure such additional financing if at all, or on terms that are satisfactory to the Company, and that it will be sufficient to meet its needs. In the event the Company is not successful in obtaining sufficient funding, this could force us to delay, limit, or reduce our product development, commercialization efforts or other operations.

Note 3 - Significant Accounting Policies

9 Months Ended

Sep. 30, 2021

Notes to Financial Statements

Significant Accounting Policies [Text Block]

Note 3 – Significant Accounting Policies

Principles of Consolidation

The condensed consolidated financial statements include the accounts of UPL and its subsidiary, UPI. Intercompany balances and transactions have been eliminated during consolidation.

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expense during the reporting period. Actual results may differ from those estimates. As applicable to the unaudited condensed consolidated financial statements, the critical accounting estimates relate to the fair value of share-based compensation, measurement of revenue, estimate of uncertain tax positions, and measurement of liabilities accounted for under the interest method.

Functional Currency

The U.S. dollar (“Dollar”) is the currency of the primary economic environment in which the operations of the Company are conducted. Therefore, the functional currency of the Company is the Dollar.

Accordingly, transactions in currencies other than the Dollar are measured and recorded in the functional currency using the exchange rate in effect at the date of the transaction. At the balance sheet date, monetary assets and liabilities that are denominated in currencies other than the Dollar are measured using the official exchange rate at the balance sheet date. The effects of foreign currency re-measurements are recorded in the condensed consolidated statements of operations as “Interest and other income, net.”

Cash and Cash Equivalents; Marketable Securities

The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents consist primarily of money market funds and bank money market accounts and are stated at cost, which approximates fair value.

Cash and cash equivalents and marketable securities totaled $110.3 million as of September 30, 2021. The Company classifies its marketable securities as available-for-sale in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 320, “Investments — Debt and Equity Securities”. Available-for-sale debt securities are carried at fair value with unrealized gains and losses reported in other comprehensive income/loss within shareholders’ equity. Realized gains and losses are recorded as a component of interest and other income (expense), net. The cost of securities sold is based on the specific-identification method.

Short-term investments are valued using models or other valuation methodologies that use Level 2 inputs. These models are primarily industry-standard models that consider various assumptions, including time value, yield curve, volatility factors, default rates, current market and contractual prices for the underlying financial instruments, as well as other relevant economic measures. The majority of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace.

For individual debt securities classified as available-for-sale securities where there has been a decline in fair value below amortized cost, the Company determines whether the decline resulted from a credit loss or other factors. The Company records impairment relating to credit losses through an allowance for credit losses, limited by the amount that the fair value is less than the amortized cost basis. Impairment that has not been recorded through an allowance for credit losses is recorded through other comprehensive income, net of applicable taxes.

Concentration of Credit Risk

Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist primarily of cash and cash equivalents and marketable securities. The primary objectives for the Company’s investment portfolio are the preservation of capital and the maintenance of liquidity. The Company does not enter into any investment transaction for trading or speculative purposes.

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-party national specialty distributor. The Company assesses the need for an allowance for doubtful accounts primarily based on creditworthiness, historical payment experience and general economic conditions. The Company has not experienced any credit losses related to this customer and has not currently recognized any allowance for doubtful accounts.

Income Taxes

The Company provides for income taxes based on pretax income, if any, and applicable tax rates available in the various jurisdictions in which it operates, including Israel and the U.S. deferred 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 that the deferred taxes will not be realized in the foreseeable future.

The Company follows a two-step approach in recognizing and measuring uncertain tax positions. After concluding that a particular filing position can be recognized (i.e., has a more-likely-than-not chance of being sustained), ASC 740-10-30-7 requires that the amount of benefit recognized be measured using a methodology based on the concept of cumulative probability. Under this methodology, the amount of benefit recorded represents the largest amount of tax benefit that is greater than 50% likely to be realized upon settlement with a taxing authority that has full knowledge of all relevant information. See Note 15 for further discussion related to income taxes.

Inventory

The Company capitalizes inventory costs related to products to be sold in the ordinary course of business. The Company makes a determination of capitalizing inventory costs for a product based on, among other factors, status of regulatory approval, information regarding safety, efficacy and expectations relating to commercial sales and recoverability of costs. For Jelmyto, the Company commenced capitalization of inventory at the receipt of FDA approval.

The Company values its inventory at the lower of cost or net realizable value. The Company measures inventory approximating actual cost under a first-in, first-out basis. The Company assesses recoverability of inventory each reporting period to determine any write down to net realizable value resulting from excess or obsolete inventories.

Property and Equipment

Property and equipment are recorded at historical cost, net of accumulated depreciation, amortization and, if applicable, impairment charges. The Company reviews its property and equipment assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.

Property and equipment are depreciated over the following useful lives (in years):

Useful Lives

Computers and software
3

Laboratory equipment
3 - 6.5

Furniture
5 - 16.5

Manufacturing equipment
2

Leasehold improvements are amortized on a straight-line basis over the shorter of their estimated useful lives or lease terms. See Note 8 for further discussion regarding property and equipment.

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 and the development of UGN-102 in return for tiered, future cash payments based on net sales of Jelmyto and UGN-102, if approved by the FDA. The net proceeds received under the RTW Transaction were recognized as a long-term liability. The subsequent measurement for the liability follows the accounting principles defined in ASC Topic 835-30, “Imputation of Interest”. See Note 9 for further discussion related to the prepaid forward obligation.

Leases

The Company is a lessee in several noncancelable operating leases, primarily for office space, office equipment and vehicles. The Company currently has no finance leases.

The Company accounts for leases in accordance with ASC Topic 842, “Leases”. The Company determines if an arrangement is a lease at inception. Right-of-use (“ROU”) assets and operating lease liabilities are recognized based on the present value of lease payments over the lease term as of the commencement date. Operating lease ROU assets are presented as operating lease right of use assets on the condensed consolidated balance sheets. The current portion of operating lease liabilities is included in other current liabilities and the long-term portion is presented separately as operating lease liabilities on the condensed consolidated balance sheets.

Lease expense is recognized on a straight-line basis for operating leases. Variable lease payments associated with the Company’s leases are recognized when the event, activity, or circumstance in the lease agreement on which those payments are assessed occurs. Variable lease payments are presented as operating expense on the condensed consolidated statements of operations in the same line item as expense arising from fixed lease payments.

The Company’s lease terms may include options to extend the lease. The lease extensions are included in the measurement of the right of use asset and lease liability when it is reasonably certain that it will exercise that option.

Because most of the Company’s leases do not provide an implicit rate of return, an incremental borrowing rate is used based on the information available at the commencement date in determining the present value of lease payments on an individual lease basis. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms.

ROU assets for operating leases are periodically reviewed for impairment losses under ASC 360-10, “Property, Plant, and Equipment”, to determine whether an ROU asset is impaired, and if so, the amount of the impairment loss to recognize.

Revenue

Product sales from Jelmyto are recognized as revenue under ASC 606 at the point in time that control of the product has been transferred to the customer, generally at the point the product has been delivered to the treating physician. All product sales of Jelmyto are recognized through the Company's arrangement with a single customer, a third-party national specialty distributor. Net revenue recognized include management’s estimate of returns, consideration paid to the customer, chargebacks relating to differences between the wholesale acquisition cost and the contracted price offered to the end consumer, chargebacks relating to 340b drug pricing programs, Medicaid drug rebate programs, and the Company’s copay assistance program, which are estimated based on industry benchmarking studies as well as the Company’s historical experience.

Research and Development Expense

Research and development costs are expensed as incurred and consist primarily of the cost of salaries, share-based compensation expense, payroll taxes and other employee benefits, subcontractors and materials used for research and development activities, including nonclinical studies, clinical trials, manufacturing costs and professional services. The costs of services performed by others in connection with the research and development activities of the Company, including research and development conducted by others on behalf of the Company, shall be included in research and development costs and expensed as the contracted work is performed. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial or project and the invoices received from its external service providers. The Company adjusts its accrual as actual costs become known. Where contingent milestone payments are due to third parties under research and development arrangements or license agreements, the milestone payment obligations are expensed when the milestone results are achieved.

Selling General and Administrative Expense

Selling, general and administrative expense consists primarily of personnel costs (including share-based compensation related to directors, employees and consultants). Other significant costs include commercial, medical affairs, external professional service costs, facility costs, accounting and audit services, legal services, and other consulting fees. Selling, general and administrative costs are expensed as incurred, and the Company accrues for services provided by third parties related to the above expenses by monitoring the status of services provided and receiving estimates from its service providers and adjusting its accruals as actual costs become known.

Share-Based Compensation

Share-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as expense over the required service period, which is equal to the vesting period. The fair value of options is determined using the Black-Scholes option-pricing model. The fair value of a restricted stock unit (“RSU”) equaled the closing price of the Company’s ordinary shares on the grant date. The Company accounts for forfeitures as they occur in accordance with ASC Topic 718, “Compensation—Stock Compensation”.

The Company elected to recognize compensation costs for awards conditioned only on continued service that have a graded vesting schedule using the straight-line method and to value the awards based on the single-option award approach.

Net Loss per Ordinary Share

Basic net loss per share is computed by dividing the net loss attributable to ordinary shareholders by the weighted-average number of ordinary shares outstanding. Diluted net loss per share is computed similarly to basic net loss per share except that the denominator is increased to include the number of additional ordinary shares that would have been outstanding if the potential ordinary shares had been issued and if the additional ordinary shares were dilutive.

For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted loss per share as their effect is anti-dilutive.

Recently Issued Accounting Pronouncements

The Company has reviewed the Accounting Standards Updates recently issued by the Financial Accounting Standards Board, and determined that they are not applicable to the Company.

Note 4 - Other Financial Information

9 Months Ended

Sep. 30, 2021

Notes to Financial Statements

Other Financial Information [Text Block]

Note 4 – Other Financial Information

Accounts Payable and Accrued Expense

Accounts payable and accrued expense consists of the following as of September 30, 2021 and December 31, 2020 (in thousands):

	*September 30,*		*December 31,*
	*2021*		*2020*
Accounts payable	$	4,060	$	3,271
Accrued sales reserves		847		382
Accrued clinical expense		2,504		1,359
Accrued research and development expense		1,406		1,356
Accrued selling, general and administrative expense		1,638		2,440
Accrued other expense		607		1,215
Total accounts payable and accrued expense	$	11,062	$	10,023

Interest and Other Income (Expense), Net

Interest and other income (expense) consisted of the following as of September 30, 2021 and 2020 (in thousands):

	*Nine Months Ended September 30,*
	*2021*			*2020*
Interest income	$	345		$	1,719
Other finance (expense), net		(76	)		(192	)
Total interest and other income, net	$	269		$	1,527

Note 5 - Inventories

9 Months Ended

Sep. 30, 2021

Notes to Financial Statements

Inventory Disclosure [Text Block]

Note 5 – Inventories

Inventories consist of the following as of September 30, 2021 and December 31, 2020 (in thousands):

	*September 30,*		*December 31,*
	*2021*		*2020*
Raw materials⁽¹⁾	$	4,106	$	1,051
Finished goods		1,275		913
Total inventories	$	5,381	$	1,964

⁽¹⁾	$1.6 million of raw materials at September 30, 2021 are included within other non-current assets on the condensed consolidated balance sheets.

Note 6 - Fair Value Measurements

9 Months Ended

Sep. 30, 2021

Notes to Financial Statements

Fair Value Disclosures [Text Block]

Note 6 – Fair Value Measurements

The Company follows authoritative accounting guidance, which among other things, defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability.

As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:

Level 1:

Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities.

Level 2:

Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.

Level 3:

Unobservable inputs that reflect the reporting entity’s own assumptions.

The carrying amounts of the Company’s other current assets, accounts payable and accrued liabilities are generally considered to be representative of their fair value because of the short-term nature of these instruments. No transfers between levels have occurred during the periods presented.

Assets and liabilities measured at fair value on a recurring basis based on Level 1 and Level 2 fair value measurement criteria as of September 30, 2021 are as follows (in thousands):

			*Fair Value Measurements Using*
			*Quoted Prices*		*Significant*
			*in Active*		*Other*
	*Balance as of*		*Markets for*		*Observable*
	*September 30,*		*Identical Assets*		*Inputs*
	*2021*		*(Level 1)*		*(Level 2)*
Marketable securities:
US government	$	19,401	$	19,401	$	—
Corporate bonds		12,349		—		12,349
Commercial paper		15,989		—		15,989
Money market funds⁽¹⁾		35,924		35,924		—
Certificates of deposit		7,204		—		7,204
Total marketable securities	$	90,867	$	55,325	$	35,542

⁽¹⁾	Included within cash and cash equivalents on the condensed consolidated balance sheets.

Assets and liabilities measured at fair value on a recurring basis based on Level 1 and Level 2 fair value measurement criteria as of December 31, 2020 are as follows (in thousands):

			Fair Value Measurements Using
			Quoted Prices		Significant
			in Active		Other
	*Balance as of*		*Markets for*		*Observable*
	*December 31,*		*Identical Assets*		*Inputs*
	*2020*		*(Level 1)*		*(Level 2)*
Marketable securities:
US government	$	29,186	$	29,186	$	—
Corporate bonds		21,861		—		21,861
Money market funds⁽¹⁾		39,744		39,744		—
Total marketable securities	$	90,791	$	68,930	$	21,861

⁽¹⁾	Included within cash and cash equivalents on the condensed consolidated balance sheets.

The Company’s in money market funds are valued based on publicly available quoted market prices for identical securities as of September 30, 2021 and December 31, 2020.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Note 7 - Marketable Securities

9 Months Ended

Sep. 30, 2021

Notes to Financial Statements

Investments in Debt and Marketable Equity Securities (and Certain Trading Assets) Disclosure [Text Block]

Note 7 – Marketable Securities

The following table summarizes the Company’s marketable securities as of September 30, 2021 (in thousands):

	*Amortized*		*Unrealized*		*Unrealized*
	*Cost Basis*		*Gains*		*Losses*		*Fair Value*
Marketable securities:
US government	$	19,399	$	2	$	—	$	19,401
Corporate bonds		12,348		1		—		12,349
Commercial paper		15,988		1		—		15,989
Money market funds⁽¹⁾		35,924		—		—		35,924
Certificates of deposit		7,204		—		—		7,204
Total marketable securities	$	90,863	$	4	$	—	$	90,867

⁽¹⁾	Included within cash and cash equivalents on the condensed consolidated balance sheets

The Company classifies its marketable securities as available-for-sale and they consist of all debt securities. The amortized cost basis as of September 30, 2021 includes $0.1 million of accrued interest receivable. As of September 30, 2021 marketable securities were in a net unrealized gain position. Unrealized gains and losses on available-for-sale debt securities are included as a component of comprehensive loss.

As of September 30, 2021, the aggregate fair value of marketable securities held by the Company in an unrealized loss position was $11.9 million which consisted of 13 securities. The unrealized loss was primarily driven by minor fluctuations in the fair value of corporate bonds. The Company does not expect to settle the debentures at a price less than the amortized cost basis of the investment; the Company expects to recover the entire amortized cost basis of the security. In accordance with the Company’s general investment strategy, the Company does not intend to sell the investments before maturity. As of September 30, 2021, the Company believes the cost basis for its marketable securities were recoverable in all material aspects and no credit impairments were recognized in the period.

The Company’s marketable securities as of September 30, 2021 mature at various dates through February 2022. The fair values of marketable securities by contractual maturity consist of the following (in thousands):

	September 30,		December 31,
	2021		2020
Maturities within one year	$	86,797	$	88,898
Maturities after one year through three years		4,070		1,893
Total marketable securities	$	90,867	$	90,791

Note 8 - Property and Equipment

9 Months Ended

Sep. 30, 2021

Notes to Financial Statements

Property, Plant and Equipment Disclosure [Text Block]

Note 8 – Property and Equipment

Property and equipment, consists of the following as of September 30, 2021 and December 31, 2020 (in thousands):

	*September 30,*			*December 31,*
	*2021*			*2020*
Laboratory equipment	$	355		$	333
Computer equipment and software		2,024			1,676
Furniture		597			597
Leasehold improvements		617			609
Manufacturing equipment		398			226
		3,991			3,441
Less: accumulated depreciation and amortization		(2,013	)		(1,395	)
Property and equipment, net	$	1,978		$	2,046

Depreciation and amortization expense was $0.2 million and $0.6 million for the three and nine months ended September 30, 2021 and $0.1 million and $0.3 million for the three and nine months ended September 30, 2020.

Note 9 - Prepaid Forward Obligation

9 Months Ended

Sep. 30, 2021

Notes to Financial Statements

Prepaid Forward Obligation Disclosure [Text Block]

Note 9 – Prepaid Forward Obligation

In March 2021, the Company entered into a prepaid forward agreement with RTW Investments (“RTW”). Under the terms of the RTW Transaction, the Company received $75.0 million ($72.4 million net of transaction costs) to support the continued launch of Jelmyto and the development of UGN-102. In return for the transferred funds, RTW is entitled to receive tiered, future cash payments based on aggregate worldwide annual net product sales of Jelmyto in an amount equal to: (i) 9.5% of annual net sales up to $200 million, (ii) 3.0% of annual net sales for annual net sales between $200 million and $300 million, and (iii) 1.0% of annual net sales for annual net sales above $300 million. If certain revenue thresholds for Jelmyto aggregate worldwide annual net sales are not met, the future cash payments to RTW with respect to Jelmyto annual net sales up to $200 million will increase by 3.5%, and may decrease back to 9.5% dependent on the Company meeting certain subsequent Jelmyto aggregate worldwide annual net sales thresholds.

In addition, subject to FDA approval of UGN-102, RTW is entitled to receive tiered, future cash payments based on aggregate worldwide annual net product sales of UGN-102 in an amount equal to: (i) 2.5% of annual net sales up to $200 million, (ii) 1.0% of annual net sales for annual net sales between $200 million and $300 million, and (iii) 0.5% of annual net sales for annual net sales above $300 million. If the Company does not receive FDA approval for UGN-102 by a specified date, the future cash payments to RTW with respect to aggregate worldwide annual net sales of Jelmyto across all Jelmyto annual net sales tiers will increase by 1.5%.

In accordance with the prepaid forward agreement, the Company will be required to make payments of amounts owed to RTW each calendar quarter, through and until the quarter in which the aggregate cash payments received by RTW are equal to or greater than $300 million. As security for the payment and fulfilment of these amounts throughout the arrangement, the Company has granted RTW a first priority security interest in Jelmyto and UGN-102, including the regulatory approvals, intellectual property, material agreements, proceeds and accounts receivable related to these products.

In May 2021, following the receipt of necessary regulatory approvals, the Company received the $75.0 million prepaid forward payment ($72.4 million net of transaction costs) from RTW and recognized an associated prepaid forward obligation liability. The subsequent measurement for the liability follows the accounting principles as defined in ASC 835-30, “Imputation of Interest”; each period the Company makes a payment to RTW, and recognizes expense related to financing on the prepaid forward obligation based on an imputed rate derived from the expected future payments. The Company uses a prospective approach for reassessing the effective rate in which a new rate is computed each period based on the current carrying value of the obligation and the revised estimated future payments. Changes in future payments from previous estimates are included in the future financing expense on a prospective basis. The Company does not expect to make any principal payments in the next 12 months.

The following table shows the activity with respect to the carrying value of the prepaid forward liability, in thousands:

Prepaid forward obligation at closing of RTW Transaction	$	75,000
Capitalized closing costs		(2,583	)
Financing on prepaid forward obligation		9,948
Amounts paid and payable		(2,438	)
Carrying value of prepaid forward obligation as of September 30, 2021	$	79,927

Note 10 - Leases

9 Months Ended

Sep. 30, 2021

Notes to Financial Statements

Lessee, Operating Leases [Text Block]

Note 10 – Leases

Operating Leases

The Company has the following office and laboratory facility leases:

•

In April 2016, UPL signed an addendum to its November 2014 lease agreement for the Company’s offices located in Israel, in order to increase the office space rented and to extend the rent period until 2019. In March 2019, UPL utilized the agreement extension option and extended the rent period for additional three years until August 2022.

•

In September 2017, UPI entered into a new lease agreement for its office space in New York, which the Company previously used as its headquarters. The lease agreement commenced in October 2017 and terminated in February 2021.

•

In April 2018, UPI entered into a new lease agreement for an office in Los Angeles, California. The lease commencement date was July 10, 2018 and terminates in March 2024. The landlord provided a tenant allowance for leasehold improvements of $0.2 million that was accounted for as a lease incentive. The Company’s remaining contractual obligation under this lease is approximately $0.7 million as of September 30, 2021. In November 2019, UPI entered into a sublease for this office space, with a lease commencement date of January 1, 2020 and continuing until the end of the lease term in March 2024. The subtenants exercised their early access clause and moved into the premises at the end of November 2019. The remaining rental payments to be received over the lease term is approximately $0.5 million as of September 30, 2021. The Company accounts for the sublease as on operating lease in accordance with ASC 842-10-25-2 and ASC 842-10-25-3. The main lease was considered for impairment and the amount was determined to be immaterial.

•

In November 2019, UPI entered into a new lease agreement for an office in Princeton, New Jersey, which the Company now uses as its headquarters. The lease commencement date was November 29, 2019 and the lease term is 38 months. The Company’s remaining contractual obligation under this lease is approximately $0.7 million as of September 30, 2021.

In addition, the Company has other operating office equipment and vehicle leases. The Company’s operating leases may require minimum rent payments, contingent rent payments adjusted periodically for inflation, or rent payments equal to the greater of a minimum rent or contingent rent. The Company’s leases do not contain any residual value guarantees or material restrictive covenants. The Company’s leases expire at various dates from 2021 through 2023, with varying renewal and termination options.

The components of lease cost for the three and nine months ended September 30, 2021 were as follows (in thousands):

	*Three Months Ended*						*Nine Months Ended*
	*September 30,*						*September 30,*
	*2021*			*2020*			*2021*			*2020*
Operating lease cost	$	259		$	424		$	786		$	1,282
Sublease income		(56	)		(56	)		(168	)		(168	)
Variable lease cost		15			28			51			114
	$	218		$	396		$	669		$	1,228

The amounts recognized as of September 30, 2021 and December 31, 2020 were as follows (in thousands):

	*September 30,*		*December 31,*
	*2021*		*2020*
Right of use asset	$	1,418	$	2,158
Long-term lease liabilities		616		1,497
Other current liabilities		1,133		1,202

As of September 30, 2021, no impairment losses have been recognized to date.

Supplemental information related to leases for the nine months ended September 30, 2021 is as follows (in thousands):



Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases	2,734
Right-of-use assets obtained in exchange for new operating lease liabilities	135
Weighted-average remaining lease term of operating leases (in years)	1.68
Weighted-average discount rate of operating leases	5.51	%

Subleases

As of September 30, 2021, undiscounted cash flows to be received under the Company’s operating sublease on an annual basis were as follows (in thousands):

	*Operating Leases*
Years ending December 31,
Remainder of 2021	$	59
2022		243
2023		251
2024		49
2025 and thereafter		—
	$	602

Sublease income is recognized net within operating expense. Sublease income for the three and nine months ended September 30, 2021 was as follows (in thousands):

	*Three Months Ended*				*Nine Months Ended*
	*September 30,*				*September 30,*
	*2021*		*2020*		*2021*		*2020*

Sublease income from fixed lease payments	$	56	$	56	$	168	$	168

Note 11 - Revenue from Product Sales

9 Months Ended

Sep. 30, 2021

Notes to Financial Statements

Revenue from Contract with Customer [Text Block]

Note 11 – Revenue From Product Sales

Net product sales consist of the following for the three and nine months ended September 30, 2021 (in thousands):

	*Three Months Ended*				*Nine Months Ended*
	*September 30,*				*September 30,*
	*2021*		*2020*		*2021*		*2020*
Jelmyto	$	11,351	$	3,461	$	31,868	$	3,833

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

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+ Details

Note 12 - License and Collaboration Agreements

9 Months Ended

Sep. 30, 2021

Notes to Financial Statements

Collaborative Arrangement Disclosure [Text Block]

Note 12 – License and Collaboration Agreements

Allergan/AbbVie Agreement

In October 2016, the Company entered into a license agreement with Allergan (the "Allergan/AbbVie Agreement") and granted Allergan (now part of AbbVie) an exclusive worldwide license to research, develop, manufacture and commercialize pharmaceutical products that contain RTGel and clostridial toxins (including BOTOX®), alone or in combination with certain other active ingredients, referred to as the Licensed Products, which are approved for the treatment of adults with overactive bladder who cannot use or do not adequately respond to anticholinergics.

In October 2017, Allergan commenced a Phase 2 clinical trial of BOTOX/RTGel for the treatment of OAB, with the potential to evolve from multiple injections of BOTOX into the bladder to a single instillation of the novel formulation. In August 2020, the Company announced that the Phase 2 APOLLO trial did not meet the primary endpoint. The data suggested that this result may have been due to BOTOX not effectively permeating the urothelium. Over the past year, the Company has been in discussions with AbbVie to determine whether other products in their portfolio would be complementary with RTGel. Based on this review, the Company determined that there was limited interest to pursue combinatorial products, and therefore, have terminated the relationship in order to allow for maximum flexibility for the RTGel intellectual property.

Agenus Agreement

In November 2019, the Company entered into a license agreement with Agenus Inc., pursuant to which Agenus granted to the Company an exclusive, worldwide (not including Argentina, Brazil, Chile, Colombia, Peru, Venezuela and their respective territories and possessions), royalty-bearing, sublicensable license under Agenus’s intellectual property rights to develop, make, use, sell, import, and otherwise commercialize products incorporating a proprietary antibody of Agenus known as AGEN1884 for the treatment of cancers of the urinary tract via intravesical delivery. AGEN1884 is an anti-CTLA-4 antagonist that is currently being evaluated by Agenus as a monotherapy in PD-1 refractory patients and in combination with Agenus’ anti-PD-1 antibody in solid tumors. Initially, the Company plans to develop AGEN1884 in combination with UGN-201 for the treatment of high-grade NMIBC.

Pursuant to the license agreement, the Company paid Agenus an upfront fee of $10.0 million and has agreed to pay Agenus up to $115.0 million upon achieving certain clinical development and regulatory milestones, up to $85.0 million upon achieving certain commercial milestones, and royalties on net sales of licensed products in the 14%-20% range. The Company will be responsible for all development and commercialization activities. Under the terms of the license agreement, Agenus has agreed to use commercially reasonable efforts to supply AGEN1884 to the Company for use in preclinical studies or clinical trials.

Unless earlier terminated in accordance with the terms of the license agreement, the license agreement will expire on a product-by-product and country-by-country basis at the later of (a) the expiration of the last to expire valid claim of a licensed patent right that covers the licensed product in such country or (b) 15 years after the first commercial sale of the licensed product in such country. The Company may terminate the license agreement for convenience upon 180 days’ written notice to Agenus. Either party may terminate the license agreement upon 60 days’ notice to the other party if, prior to the first commercial sale of a licensed product, the Company substantially ceases to conduct development activities of the licensed products for nine consecutive months (and during such period, Agenus has complied with its obligations under the license agreement) other than in response to a requirement of an applicable regulatory authority or an event outside of the Company’s control. In addition, either party may terminate the license agreement in the event of an uncured material breach of the other party.

MD Anderson Agreement

In January 2021, the Company announced that it entered into a three-year strategic research collaboration agreement with MD Anderson focusing on UGN-302 as an investigational treatment for high-grade NMIBC. Under the agreement, MD Anderson and the Company will collaborate on the design and conduct of non-clinical and clinical studies with oversight from a joint steering committee. The Company will provide funding, developmental candidates, and other support. Pursuant to the agreement, the Company makes bi-annual payments to MD Anderson to fund the collaboration. As of September 30, 2021, the Company has made payments to MD Anderson of $500,000 recognized evenly over the associated period through research and development expense.

Note 13 - Shareholders' Equity

9 Months Ended

Sep. 30, 2021

Notes to Financial Statements

Stockholders' Equity Note Disclosure [Text Block]

Note 13 – Shareholders’ Equity

The Company had 100.0 million ordinary shares authorized for issuance as of September 30, 2021 and December 31, 2020. The Company had 22.4 million and 22.2 million ordinary shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively. Each ordinary share is entitled to one vote. The holders of ordinary shares are also entitled to receive dividends whenever funds are legally available, when and if declared by the Board of Directors (the “Board”). Since its inception, the Board has not declared any dividends.

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

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+ Details

Note 14 - Share-based Compensation

9 Months Ended

Sep. 30, 2021

Notes to Financial Statements

Share-based Payment Arrangement [Text Block]

Note 14 – Share-Based Compensation

In October 2010, the Board approved a share option plan (the “Plan”) for grants to Company employees, consultants, directors, and other service providers.

The grant of options to Israeli employees under the Plan is subject to the terms stipulated by Section 102 of the Israeli Income Tax Ordinance (“Section 102”). The option grants are subject to the track chosen by the Company, either the “regular income” track or the “capital gains” track, as set out in Section 102. The Company registered the Plan under the capital gains track, which offers more favorable tax rates to the employees. As a result, and pursuant to the terms of Section 102, the Company is not allowed to claim as an expense for tax purposes the amounts credited to the employees in respect of options granted to them under the Plan, including amounts recorded as salary benefits in the Company’s accounts, with the exception of the work-income benefit component, if any, determined on grant date. For non-employees and for non-Israeli employees, the Plan is subject to Section 3(i) of the Israeli Income Tax Ordinance.

Employees are typically granted stock options and/or restricted stock units ("RSUs"), upon commencement of employment. Also, eligible employees may receive an annual grant of options or RSUs. Non-employee members of the Board typically receive a grant of stock options and/or RSUs annually. The term of any option granted under the Plan cannot exceed 10 years. Options shall not have an exercise price less than 100% of the fair market value of the Company’s ordinary shares on the grant date, and generally vest over a period of three years. If the individual possesses more than 10% of the combined voting power of all classes of equity of the Company, the exercise price shall not be less than 110% of the fair market value of an ordinary share on the date of grant.

The Company’s RSU and option grants provide for accelerated or continued vesting in certain circumstances as defined in the plans and related grant agreements, including a termination in connection with a change in control. RSUs generally vest in a 33% increment upon the first anniversary of grant, and in either equal quarterly or annual amounts for the two years following the one-year anniversary of the grant date. Options generally vest in a 33% increment upon the first anniversary of the grant date, and in either equal quarterly or annual amounts for the two years following the one-year anniversary of the grant date.

The expected volatility is based on a mix of the Company’s historical volatility, and the historical volatility of comparable companies with similar attributes to the Company, including industry, stage of life cycle, size and financial leverage. The risk-free interest rate assumption is based on observed interest rates appropriate for the expected term of the options granted. The expected term is the length of time until the expected dates of exercising the options and is estimated for employees using the simplified method due to insufficient specific historical information of employees’ exercise behavior, and for non-employees, and directors using the contractual term.

In March 2017, the Board adopted the 2017 Equity Incentive Plan (the "2017 Plan"), which was approved by the shareholders in April 2017. The 2017 Plan provides for the grant of stock options, stock appreciation rights, restricted stock awards, RSU awards, performance share awards, performance cash awards, and other forms of share awards to the Company's employees, directors and consultants.

The maximum number of ordinary shares that was initially authorized for issuance under the 2017 Plan is 1,400,000. On January 1, 2018, the share reserve increased by 250,167 to 1,650,167. On October 12, 2018, the Company increased the amount of registered ordinary shares of the Company’s 2017 Plan by 1,900,000 to 3,550,167. On June 8, 2020 the Company’s shareholders approved an increase to the amount of registered ordinary shares of the Company’s 2017 Plan by 400,000 to 3,950,167. On June 7, 2021, the Company’s shareholders approved an increase of the amount of registered ordinary shares of the Company’s 2017 Plan by 400,000 to 4,350,167.

In May 2019, the Company adopted the UroGen Pharma Ltd. 2019 Inducement Plan (the “Inducement Plan”). Under the Inducement Plan, the Company is authorized to issue up to 900,000 ordinary shares pursuant to awards issued under the Inducement Plan. The only persons eligible to receive grants of Awards (as defined below) under the Inducement Plan are individuals who satisfy the standards for inducement grants under Nasdaq Marketplace Rule 5635(c)(4) or 5635(c)(3) and the related guidance under Nasdaq IM 5635-1, including individuals who were not previously an employee or director of the Company or are following a bona fide period of non-employment, in each case as an inducement material to such individual’s agreement to enter into employment with the Company. Under the Inducement Plan, an “Award” is a nonstatutory stock option, RSU or other right to receive ordinary shares pursuant to the Inducement Plan.

As of September 30, 2021, 3,587,774 ordinary shares are subject to outstanding awards under the Company's share-based compensation plans and 1,362,156 ordinary shares remain available for future awards.

The following table illustrates the effect of share-based compensation on the condensed consolidated statements of operations (in thousands):

	*Three Months Ended*				*Nine Months Ended*
	*September 30,*				*September 30,*
	*2021*		*2020*		*2021*		*2020*
Research and development expense	$	971	$	1,519	$	3,119	$	5,032
Selling, general and administrative expense		4,544		5,244		14,637		16,467
	$	5,515	$	6,763	$	17,756	$	21,499

The total unrecognized compensation cost of options and RSUs at September 30, 2021 is $22.9 million with a weighted average recognition period of 1.76 years.

Note 15 - Income Taxes

9 Months Ended

Sep. 30, 2021

Notes to Financial Statements

Income Tax Disclosure [Text Block]

Note 15 – Income Taxes

UroGen Pharma Ltd. is taxed under Israeli tax laws. As of September 30, 2021, the Company continues to maintain a full valuation allowance against deferred tax assets for all jurisdictions. In evaluating the need for a valuation allowance, the Company considers all sources of taxable income available to realize the deferred tax asset, including the future reversal of existing temporary differences, forecasts of future taxable income, and tax planning strategies. The Company has cumulative global pretax losses for the years ended 2020, 2019 and 2018, and for the nine months ended September 30, 2021. The Company will continue to assess the extent to which its deferred tax assets may be realized in the future and will adjust the valuation allowance as needed.

The Company has a liability for uncertain tax positions of $2.7 million as of September 30, 2021, for tax positions relating to transfer pricing between affiliated entities. The Company recognizes interest accrued and penalties related to uncertain tax positions as a component of income tax expense. As of September 30, 2021, the Company’s liability for uncertain tax positions includes $0.7 million of interest and penalties accrued during 2020.

The Company operates on a global basis and is subject to tax laws and regulations in the U.S. and Israel. The estimate of the Company’s tax liabilities relating to uncertain tax positions requires management to assess uncertainties and to make judgments about the application of complex tax laws and regulations, expectations regarding the outcome of tax authority examinations, as well as the ultimate measurement of potential liabilities.

The uncertain tax positions are reviewed quarterly and adjusted as events occur that could affect potential liabilities for additional taxes, including lapsing of applicable statutes of limitations, correspondence with tax authorities, proposed assessments by tax authorities, identification of new issues, and issuance of new legislation or regulations. The Company believes that adequate amounts of tax have been provided in income tax expense for any adjustments that may result from its uncertain tax positions. Based upon the information currently available, the Company does not reasonably expect changes in its existing uncertain tax positions in the next 12 months and has recorded the gross uncertain tax positions as a long-term liability.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

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+ Details

Note 16 - Related Parties

9 Months Ended

Sep. 30, 2021

Notes to Financial Statements

Note 16 – Related Parties

There were no related party transactions for the nine months ended September 30, 2021 or 2020.

Note 17 - Commitments and Contingencies

9 Months Ended

Sep. 30, 2021

Notes to Financial Statements

Commitments and Contingencies Disclosure [Text Block]

Note 17 – Commitments and Contingencies

In the normal course of business, the Company enters into contracts that contain a variety of indemnifications with its employees, licensors, suppliers and service providers. Further, the Company indemnifies its directors and officers who are, or were, serving at the Company’s request in such capacities. The Company’s maximum exposure under these arrangements is unknown as of September 30, 2021 and December 31, 2020. The Company does not anticipate recognizing any significant losses relating to these arrangements.

Grants from the Israeli Innovation Authority in Israel (“IIA”)

The Company has received grants from the IIA for research and development funding. Up until 2007, the IIA participation in the funding of the Company’s operations was by grants provided to Granot Ventures, a government supported technology incubator, as part of the Israeli Ministry of Industry and Commerce Director General Directive 8.2. Since 2008, the funding was provided directly to the Company.

On January 12, 2020, the IIA approved the Company's request to unwind its obligation to the IIA regarding grants that were loaned to the Company between January 2004 and September 2016. The total payment under the IIA approval, net of the royalties already paid, $6.6 million, was fully paid during the first quarter of 2020 and recognized as research and development expense. Based on this payment, the Company will have full freedom to transfer IIA-funded technology or manufacture products developed with IIA-funded technology outside of the State of Israel. Other than the commitment to continue at least 75% of its based R&D jobs in Israel (at the time of settlement) for a period of at least three years, all other obligations with the IIA ceased to exist as per the agreement.

Leases

See Note 10 for further discussion regarding lease commitments.

Note 18 - Subsequent Events

9 Months Ended

Sep. 30, 2021

Notes to Financial Statements

Subsequent Events [Text Block]

Note 18 – Subsequent Events

See Note 12 for discussion related to the Allergan/AbbVie Agreement.

Significant Accounting Policies (Policies)

9 Months Ended

Sep. 30, 2021

Accounting Policies [Abstract]

Consolidation, Policy [Policy Text Block]

Principles of Consolidation

The condensed consolidated financial statements include the accounts of UPL and its subsidiary, UPI. Intercompany balances and transactions have been eliminated during consolidation.

Use of Estimates, Policy [Policy Text Block]

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expense during the reporting period. Actual results may differ from those estimates. As applicable to the unaudited condensed consolidated financial statements, the critical accounting estimates relate to the fair value of share-based compensation, measurement of revenue, estimate of uncertain tax positions, and measurement of liabilities accounted for under the interest method.

Foreign Currency Transactions and Translations Policy [Policy Text Block]

Functional Currency

The U.S. dollar (“Dollar”) is the currency of the primary economic environment in which the operations of the Company are conducted. Therefore, the functional currency of the Company is the Dollar.

Accordingly, transactions in currencies other than the Dollar are measured and recorded in the functional currency using the exchange rate in effect at the date of the transaction. At the balance sheet date, monetary assets and liabilities that are denominated in currencies other than the Dollar are measured using the official exchange rate at the balance sheet date. The effects of foreign currency re-measurements are recorded in the condensed consolidated statements of operations as “Interest and other income, net.”

Cash, Cash Equivalents and Marketable Securities Policy [Policy Text Block]

Cash and Cash Equivalents; Marketable Securities

The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents consist primarily of money market funds and bank money market accounts and are stated at cost, which approximates fair value.

Cash and cash equivalents and marketable securities totaled $110.3 million as of September 30, 2021. The Company classifies its marketable securities as available-for-sale in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 320, “Investments — Debt and Equity Securities”. Available-for-sale debt securities are carried at fair value with unrealized gains and losses reported in other comprehensive income/loss within shareholders’ equity. Realized gains and losses are recorded as a component of interest and other income (expense), net. The cost of securities sold is based on the specific-identification method.

Short-term investments are valued using models or other valuation methodologies that use Level 2 inputs. These models are primarily industry-standard models that consider various assumptions, including time value, yield curve, volatility factors, default rates, current market and contractual prices for the underlying financial instruments, as well as other relevant economic measures. The majority of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace.

For individual debt securities classified as available-for-sale securities where there has been a decline in fair value below amortized cost, the Company determines whether the decline resulted from a credit loss or other factors. The Company records impairment relating to credit losses through an allowance for credit losses, limited by the amount that the fair value is less than the amortized cost basis. Impairment that has not been recorded through an allowance for credit losses is recorded through other comprehensive income, net of applicable taxes.

Concentration 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 enter into any investment transaction for trading or speculative purposes.

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-party national specialty distributor. The Company assesses the need for an allowance for doubtful accounts primarily based on creditworthiness, historical payment experience and general economic conditions. The Company has not experienced any credit losses related to this customer and has not currently recognized any allowance for doubtful accounts.

Income Tax, Policy [Policy Text Block]

Income Taxes

The Company provides for income taxes based on pretax income, if any, and applicable tax rates available in the various jurisdictions in which it operates, including Israel and the U.S. deferred taxes are computed using the asset and liability method. Under the asset and liability method, deferred income tax assets and liabilities are determined based on the differences between the financial reporting and tax bases of assets and liabilities and are measured using the currently enacted tax rates and laws. A valuation allowance is recognized to the extent that it is more likely than not that the deferred taxes will not be realized in the foreseeable future.

The Company follows a two-step approach in recognizing and measuring uncertain tax positions. After concluding that a particular filing position can be recognized (i.e., has a more-likely-than-not chance of being sustained), ASC 740-10-30-7 requires that the amount of benefit recognized be measured using a methodology based on the concept of cumulative probability. Under this methodology, the amount of benefit recorded represents the largest amount of tax benefit that is greater than 50% likely to be realized upon settlement with a taxing authority that has full knowledge of all relevant information. See Note 15 for further discussion related to income taxes.

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 commenced capitalization of inventory at the receipt of FDA approval.

The Company values its inventory at the lower of cost or net realizable value. The Company measures inventory approximating actual cost under a first-in, first-out basis. The Company assesses recoverability of inventory each reporting period to determine any write down to net realizable value resulting from excess or obsolete inventories.

Property, 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 be recoverable.

Property and equipment are depreciated over the following useful lives (in years):

		Useful Lives
Computers and software		3
Laboratory equipment		3 - 6.5
Furniture		5 - 16.5
Manufacturing equipment		2

Leasehold improvements are amortized on a straight-line basis over the shorter of their estimated useful lives or lease terms. See Note 8 for further discussion regarding property and equipment.

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 and the development of UGN-102 in return for tiered, future cash payments based on net sales of Jelmyto and UGN-102, if approved by the FDA. The net proceeds received under the RTW Transaction were recognized as a long-term liability. The subsequent measurement for the liability follows the accounting principles defined in ASC Topic 835-30, “Imputation of Interest”. See Note 9 for further discussion related to the prepaid forward obligation.

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 finance leases.

The Company accounts for leases in accordance with ASC Topic 842, “Leases”. The Company determines if an arrangement is a lease at inception. Right-of-use (“ROU”) assets and operating lease liabilities are recognized based on the present value of lease payments over the lease term as of the commencement date. Operating lease ROU assets are presented as operating lease right of use assets on the condensed consolidated balance sheets. The current portion of operating lease liabilities is included in other current liabilities and the long-term portion is presented separately as operating lease liabilities on the condensed consolidated balance sheets.

Lease expense is recognized on a straight-line basis for operating leases. Variable lease payments associated with the Company’s leases are recognized when the event, activity, or circumstance in the lease agreement on which those payments are assessed occurs. Variable lease payments are presented as operating expense on the condensed consolidated statements of operations in the same line item as expense arising from fixed lease payments.

The Company’s lease terms may include options to extend the lease. The lease extensions are included in the measurement of the right of use asset and lease liability when it is reasonably certain that it will exercise that option.

Because most of the Company’s leases do not provide an implicit rate of return, an incremental borrowing rate is used based on the information available at the commencement date in determining the present value of lease payments on an individual lease basis. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms.

ROU assets for operating leases are periodically reviewed for impairment losses under ASC 360-10, “Property, Plant, and Equipment”, to determine whether an ROU asset is impaired, and if so, the amount of the impairment loss to recognize.

Revenue [Policy Text Block]

Revenue

Product sales from Jelmyto are recognized as revenue under ASC 606 at the point in time that control of the product has been transferred to the customer, generally at the point the product has been delivered to the treating physician. All product sales of Jelmyto are recognized through the Company's arrangement with a single customer, a third-party national specialty distributor. Net revenue recognized include management’s estimate of returns, consideration paid to the customer, chargebacks relating to differences between the wholesale acquisition cost and the contracted price offered to the end consumer, chargebacks relating to 340b drug pricing programs, Medicaid drug rebate programs, and the Company’s copay assistance program, which are estimated based on industry benchmarking studies as well as the Company’s historical experience.

Research and Development Expense, Policy [Policy Text Block]

Research and Development Expense

Research and development costs are expensed as incurred and consist primarily of the cost of salaries, share-based compensation expense, payroll taxes and other employee benefits, subcontractors and materials used for research and development activities, including nonclinical studies, clinical trials, manufacturing costs and professional services. The costs of services performed by others in connection with the research and development activities of the Company, including research and development conducted by others on behalf of the Company, shall be included in research and development costs and expensed as the contracted work is performed. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial or project and the invoices received from its external service providers. The Company adjusts its accrual as actual costs become known. Where contingent milestone payments are due to third parties under research and development arrangements or license agreements, the milestone payment obligations are expensed when the milestone results are achieved.

Selling, General and Administrative Expenses, Policy [Policy Text Block]

Selling General and Administrative Expense

Selling, general and administrative expense consists primarily of personnel costs (including share-based compensation related to directors, employees and consultants). Other significant costs include commercial, medical affairs, external professional service costs, facility costs, accounting and audit services, legal services, and other consulting fees. Selling, general and administrative costs are expensed as incurred, and the Company accrues for services provided by third parties related to the above expenses by monitoring the status of services provided and receiving estimates from its service providers and adjusting its accruals as actual costs become known.

Share-based 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, “Compensation—Stock Compensation”.

The Company elected to recognize compensation costs for awards conditioned only on continued service that have a graded vesting schedule using the straight-line method and to value the awards based on the single-option award approach.

Earnings Per Share, Policy [Policy Text Block]

Net Loss per Ordinary Share

Basic net loss per share is computed by dividing the net loss attributable to ordinary shareholders by the weighted-average number of ordinary shares outstanding. Diluted net loss per share is computed similarly to basic net loss per share except that the denominator is increased to include the number of additional ordinary shares that would have been outstanding if the potential ordinary shares had been issued and if the additional ordinary shares were dilutive.

For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted loss per share as their effect is anti-dilutive.

New Accounting Pronouncements, Policy [Policy Text Block]

Recently Issued Accounting Pronouncements

The Company has reviewed the Accounting Standards Updates recently issued by the Financial Accounting Standards Board, and determined that they are not applicable to the Company.

Note 3 - Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2021

Notes Tables

Property, Plant and Equipment, Useful Life [Table Text Block]

		Useful Lives
Computers and software		3
Laboratory equipment		3 - 6.5
Furniture		5 - 16.5
Manufacturing equipment		2

Note 4 - Other Financial Information (Tables)

9 Months Ended

Sep. 30, 2021

Notes Tables

Schedule of Accounts Payable and Accrued Liabilities [Table Text Block]

	*September 30,*		*December 31,*
	*2021*		*2020*
Accounts payable	$	4,060	$	3,271
Accrued sales reserves		847		382
Accrued clinical expense		2,504		1,359
Accrued research and development expense		1,406		1,356
Accrued selling, general and administrative expense		1,638		2,440
Accrued other expense		607		1,215
Total accounts payable and accrued expense	$	11,062	$	10,023

Interest Income and Interest Expense Disclosure [Table Text Block]

	*Nine Months Ended September 30,*
	*2021*			*2020*
Interest income	$	345		$	1,719
Other finance (expense), net		(76	)		(192	)
Total interest and other income, net	$	269		$	1,527

Note 5 - Inventories (Tables)

9 Months Ended

Sep. 30, 2021

Notes Tables

Schedule of Inventory, Current [Table Text Block]

	*September 30,*		*December 31,*
	*2021*		*2020*
Raw materials⁽¹⁾	$	4,106	$	1,051
Finished goods		1,275		913
Total inventories	$	5,381	$	1,964

Note 6 - Fair Value Measurements (Tables)

9 Months Ended

Sep. 30, 2021

Notes Tables

Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block]

			*Fair Value Measurements Using*
			*Quoted Prices*		*Significant*
			*in Active*		*Other*
	*Balance as of*		*Markets for*		*Observable*
	*September 30,*		*Identical Assets*		*Inputs*
	*2021*		*(Level 1)*		*(Level 2)*
Marketable securities:
US government	$	19,401	$	19,401	$	—
Corporate bonds		12,349		—		12,349
Commercial paper		15,989		—		15,989
Money market funds⁽¹⁾		35,924		35,924		—
Certificates of deposit		7,204		—		7,204
Total marketable securities	$	90,867	$	55,325	$	35,542

			Fair Value Measurements Using
			Quoted Prices		Significant
			in Active		Other
	*Balance as of*		*Markets for*		*Observable*
	*December 31,*		*Identical Assets*		*Inputs*
	*2020*		*(Level 1)*		*(Level 2)*
Marketable securities:
US government	$	29,186	$	29,186	$	—
Corporate bonds		21,861		—		21,861
Money market funds⁽¹⁾		39,744		39,744		—
Total marketable securities	$	90,791	$	68,930	$	21,861

Note 7 - Marketable Securities (Tables)

9 Months Ended

Sep. 30, 2021

Notes Tables

Marketable Securities [Table Text Block]

	*Amortized*		*Unrealized*		*Unrealized*
	*Cost Basis*		*Gains*		*Losses*		*Fair Value*
Marketable securities:
US government	$	19,399	$	2	$	—	$	19,401
Corporate bonds		12,348		1		—		12,349
Commercial paper		15,988		1		—		15,989
Money market funds⁽¹⁾		35,924		—		—		35,924
Certificates of deposit		7,204		—		—		7,204
Total marketable securities	$	90,863	$	4	$	—	$	90,867

Investments Classified by Contractual Maturity Date [Table Text Block]

	September 30,		December 31,
	2021		2020
Maturities within one year	$	86,797	$	88,898
Maturities after one year through three years		4,070		1,893
Total marketable securities	$	90,867	$	90,791

Note 8 - Property and Equipment (Tables)

9 Months Ended

Sep. 30, 2021

Notes Tables

Property, Plant and Equipment [Table Text Block]

	*September 30,*			*December 31,*
	*2021*			*2020*
Laboratory equipment	$	355		$	333
Computer equipment and software		2,024			1,676
Furniture		597			597
Leasehold improvements		617			609
Manufacturing equipment		398			226
		3,991			3,441
Less: accumulated depreciation and amortization		(2,013	)		(1,395	)
Property and equipment, net	$	1,978		$	2,046

Note 9 - Prepaid Forward Obligation (Tables)

9 Months Ended

Sep. 30, 2021

Notes Tables

Schedule of Activity in the Carrying Value of the Prepaid Forward Liability [Table Text Block]

Prepaid forward obligation at closing of RTW Transaction	$	75,000
Capitalized closing costs		(2,583	)
Financing on prepaid forward obligation		9,948
Amounts paid and payable		(2,438	)
Carrying value of prepaid forward obligation as of September 30, 2021	$	79,927

Note 10 - Leases (Tables)

9 Months Ended

Sep. 30, 2021

Notes Tables

Lease, Cost [Table Text Block]

	*Three Months Ended*						*Nine Months Ended*
	*September 30,*						*September 30,*
	*2021*			*2020*			*2021*			*2020*
Operating lease cost	$	259		$	424		$	786		$	1,282
Sublease income		(56	)		(56	)		(168	)		(168	)
Variable lease cost		15			28			51			114
	$	218		$	396		$	669		$	1,228

Assets and Liabilities, Lessee [Table Text Block]

	*September 30,*		*December 31,*
	*2021*		*2020*
Right of use asset	$	1,418	$	2,158
Long-term lease liabilities		616		1,497
Other current liabilities		1,133		1,202

Schedule of Supplemental Information Related to Leases [Table Text Block]



Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases	2,734
Right-of-use assets obtained in exchange for new operating lease liabilities	135
Weighted-average remaining lease term of operating leases (in years)	1.68
Weighted-average discount rate of operating leases	5.51	%

Lessor, Operating Lease, Payment to be Received, Fiscal Year Maturity [Table Text Block]

	*Operating Leases*
Years ending December 31,
Remainder of 2021	$	59
2022		243
2023		251
2024		49
2025 and thereafter		—
	$	602

Lessee, Operating Lease, Sublease Income Recognized Net in Operating Expenses [Table Text Block]

	*Three Months Ended*				*Nine Months Ended*
	*September 30,*				*September 30,*
	*2021*		*2020*		*2021*		*2020*

Sublease income from fixed lease payments	$	56	$	56	$	168	$	168

Note 11 - Revenue from Product Sales (Tables)

9 Months Ended

Sep. 30, 2021

Notes Tables

Disaggregation of Revenue [Table Text Block]

	*Three Months Ended*				*Nine Months Ended*
	*September 30,*				*September 30,*
	*2021*		*2020*		*2021*		*2020*
Jelmyto	$	11,351	$	3,461	$	31,868	$	3,833

Note 14 - Share-based Compensation (Tables)

9 Months Ended

Sep. 30, 2021

Notes Tables

Share-based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block]

	*Three Months Ended*				*Nine Months Ended*
	*September 30,*				*September 30,*
	*2021*		*2020*		*2021*		*2020*
Research and development expense	$	971	$	1,519	$	3,119	$	5,032
Selling, general and administrative expense		4,544		5,244		14,637		16,467
	$	5,515	$	6,763	$	17,756	$	21,499

Note 2 - Basis of Presentation (Details Textual) - USD ($) $ in Thousands	Sep. 30, 2021	Dec. 31, 2020
Retained Earnings (Accumulated Deficit), Ending Balance	$ (438,869)	$ (356,501)

- Definition

The cumulative amount of the reporting entity's undistributed earnings or deficit.

+ References + Details

Note 3 - Significant Accounting Policies (Details Textual) $ in Millions	Sep. 30, 2021 USD ($)
Cash, Cash Equivalents, and Short-term Investments, Total	$ 110.3

Note 3 - Significant Accounting Policies - Useful Lives of Property and Equipment (Details)	9 Months Ended
	Sep. 30, 2021
Computers and Software [Member]
Useful life (Year)	3 years
Laboratory Equipment [Member] \| Minimum [Member]
Useful life (Year)	3 years
Laboratory Equipment [Member] \| Maximum [Member]
Useful life (Year)	6 years 6 months
Furniture [Member[ \| Minimum [Member]
Useful life (Year)	5 years
Furniture [Member[ \| Maximum [Member]
Useful life (Year)	16 years 6 months
Manufacturing Equipment [Member]
Useful life (Year)	2 years

Note 4 - Other Financial Information - Accounts Payable and Accrued Expense (Details) - USD ($) $ in Thousands	Sep. 30, 2021	Dec. 31, 2020
Accounts payable	$ 4,060	$ 3,271
Accrued sales reserves	847	382
Accrued clinical expense	2,504	1,359
Accrued research and development expense	1,406	1,356
Accrued selling, general and administrative expense	1,638	2,440
Accrued other expense	607	1,215
Total accounts payable and accrued expense	$ 11,062	$ 10,023

Note 4 - Other Financial Information - Interest and Other Income (Expense), Net (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Interest income			$ 345	$ 1,719
Other finance (expense), net			(76)	(192)
Total interest and other income, net	$ 57	$ 308	$ 269	$ 1,527

Note 5 - Inventories (Details Textual) - USD ($)
$ in Thousands

Sep. 30, 2021

Dec. 31, 2020

Inventory, Raw Materials, Net of Reserves

^[1]

$ 4,106

$ 1,051

Other Noncurrent Assets [Member]

Inventory, Raw Materials, Net of Reserves

$ 1,600

[1]	$1.0 million of raw materials at September 30, 2021 are included within other non-current assets on the condensed consolidated balance sheets.

Note 5 - Inventories - Inventories (Details) - USD ($)
$ in Thousands

Sep. 30, 2021

Dec. 31, 2020

Raw materials(1)

^[1]

$ 4,106

$ 1,051

Finished goods

1,275

913

Total inventories

$ 5,381

$ 1,964

[1]	$1.0 million of raw materials at September 30, 2021 are included within other non-current assets on the condensed consolidated balance sheets.

Note 6 - Fair Value Measurements - Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($)
$ in Thousands

Sep. 30, 2021

Dec. 31, 2020

Fair value

$ 90,867

$ 90,791

US Treasury and Government [Member]

Fair value

19,401

Corporate Debt Securities [Member]

Fair value

12,349

Money Market Funds [Member]

Fair value

^[1]

35,924

Commercial Paper [Member]

Fair value

15,989

Certificates of Deposit [Member]

Fair value

7,204

Fair Value, Recurring [Member]

Fair value

90,867

90,791

Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member]

Fair value

55,325

68,930

Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member]

Fair value

35,542

21,861

Fair Value, Recurring [Member] | US Treasury and Government [Member]

Fair value

19,401

29,186

Fair Value, Recurring [Member] | US Treasury and Government [Member] | Fair Value, Inputs, Level 1 [Member]

Fair value

19,401

29,186

Fair Value, Recurring [Member] | US Treasury and Government [Member] | Fair Value, Inputs, Level 2 [Member]

Fair value

Fair Value, Recurring [Member] | Corporate Debt Securities [Member]

Fair value

12,349

21,861

Fair Value, Recurring [Member] | Corporate Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member]

Fair value

Fair Value, Recurring [Member] | Corporate Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member]

Fair value

12,349

21,861

Fair Value, Recurring [Member] | Money Market Funds [Member]

Fair value

^[2]

35,924

39,744

Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member]

Fair value

^[2]

35,924

39,744

Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member]

Fair value

^[2]

$ 0

Fair Value, Recurring [Member] | Commercial Paper [Member]

Fair value

15,989

Fair Value, Recurring [Member] | Commercial Paper [Member] | Fair Value, Inputs, Level 1 [Member]

Fair value

Fair Value, Recurring [Member] | Commercial Paper [Member] | Fair Value, Inputs, Level 2 [Member]

Fair value

15,989

Fair Value, Recurring [Member] | Certificates of Deposit [Member]

Fair value

7,204

Fair Value, Recurring [Member] | Certificates of Deposit [Member] | Fair Value, Inputs, Level 1 [Member]

Fair value

Fair Value, Recurring [Member] | Certificates of Deposit [Member] | Fair Value, Inputs, Level 2 [Member]

Fair value

$ 7,204

[1]	Included within cash and cash equivalents on the condensed consolidated balance sheets
[2]	Included within cash and cash equivalents on the condensed consolidated balance sheets.

Note 7 - Marketable Securities (Details Textual) $ in Millions	Sep. 30, 2021 USD ($)
Debt Securities, Available-for-Sale, Accrued Interest, after Allowance for Credit Loss, Total	$ 0.1
Debt Securities, Available-for-sale, Unrealized Loss Position, Total	$ 11.9
Debt Securities, Available-for-sale, Unrealized Loss Position, Number of Positions	13

Note 7 - Marketable Securities - Summary of Marketable Securities (Details) - USD ($)
$ in Thousands

Sep. 30, 2021

Dec. 31, 2020

$ 90,863

90,867

$ 90,791

US Treasury and Government [Member]

19,399

19,401

Corporate Debt Securities [Member]

12,348

12,349

Commercial Paper [Member]

15,988

15,989

Money Market Funds [Member]

Amortized cost basis

^[1]

35,924

Unrealized gains

^[1]

Unrealized losses

^[1]

Fair value

^[1]

35,924

Certificates of Deposit [Member]

7,204

$ 7,204

[1]	Included within cash and cash equivalents on the condensed consolidated balance sheets

Note 7 - Marketable Securities - Fair Values of Marketable Securities by Contractual Maturity (Details) - USD ($) $ in Thousands	Sep. 30, 2021	Dec. 31, 2020
Maturities within one year	$ 86,797	$ 88,898
Maturities after one year through three years	4,070	1,893
Total marketable securities	$ 90,867	$ 90,791

Note 8 - Property and Equipment (Details Textual) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Depreciation, Depletion and Amortization, Total	$ 200	$ 100	$ 618	$ 295

Note 8 - Property and Equipment - Property and Equipment (Details) - USD ($) $ in Thousands	Sep. 30, 2021	Dec. 31, 2020
Property and equipment, gross	$ 3,991	$ 3,441
Less: accumulated depreciation and amortization	(2,013)	(1,395)
Property and equipment, net	1,978	2,046
Laboratory Equipment [Member]
Property and equipment, gross	355	333
Computers and Software [Member]
Property and equipment, gross	2,024	1,676
Furniture [Member[
Property and equipment, gross	597	597
Leasehold Improvements [Member]
Property and equipment, gross	617	609
Manufacturing Equipment [Member]
Property and equipment, gross	$ 398	$ 226

Note 9 - Prepaid Forward Obligation (Details Textual) - USD ($) $ in Thousands	1 Months Ended		9 Months Ended
	May 31, 2021	Mar. 31, 2021	Sep. 30, 2021	Sep. 30, 2020
Proceeds from Prepaid Forward Arrangement, Net			$ 72,417	$ 0
RTW Investments [Member]
Proceeds from Prepaid Forward Obligation	$ 75,000	$ 75,000
Proceeds from Prepaid Forward Arrangement, Net	$ 72,400	72,400
Prepaid Forward Agreement, Minimum Future Cash Flows		$ 300,000
Prepaid Forward Obligation, Expected Cash Flows in Next Twelve Months			$ 0
RTW Investments [Member] \| Sales of Up to $200 Million [Member] \| Jelmyto [Member]
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales		9.50%
Prepaid Forward Agreement, Future Cash Flows, Increase in Percentage of Net Sales		3.50%
RTW Investments [Member] \| Sales Between $200 Million and $300 Million [Member] \| Jelmyto [Member]
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales		3.00%
RTW Investments [Member] \| Sales Over $300 Million [Member] \| Jelmyto [Member]
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales		1.00%
RTW Investments [Member] \| Sales Up to $200 Million with FDA Approval [Member] \| UGN-102 [Member]
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales		2.50%
RTW Investments [Member] \| Sales Between $200 Million and $300 Million with FDA Approval [Member]
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales		1.00%
RTW Investments [Member] \| Sales Over $300 Million with FDA Approval [Member]
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales		0.50%
Prepaid Forward Agreement, Future Cash Flows, Increase in Percentage of Net Sales		1.50%

Note 9 - Prepaid Forward Obligation - Activity in the Carrying Value of the Prepaid Forward Liability (Details) - USD ($) $ in Thousands	3 Months Ended		5 Months Ended	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2021	Sep. 30, 2020
Prepaid forward obligation at closing of RTW Transaction			$ 75,000	$ 0
Capitalized closing costs			(2,583)
Financing on prepaid forward obligation	$ 6,828	$ (0)	9,948	9,948	$ (0)
Amounts paid and payable			(2,438)
Carrying value of prepaid forward obligation as of September 30, 2021	$ 79,927		$ 79,927	$ 79,927

Note 10 - Leases (Details Textual) - USD ($) $ in Thousands	9 Months Ended
Note 10 - Leases (Details Textual) - USD ($) $ in Thousands	Sep. 30, 2021	Nov. 29, 2019	Jul. 10, 2018
Lessor, Operating Lease, Payments to be Received, Total	$ 602
Operating Lease, Impairment Loss	0
Lease Agreement for Office in Los Angeles, California [Member] \| UroGen Pharma Inc. [Member]
Incentive from Lessor			$ 200
Operating Lease, Liability, Total	700
Lessor, Operating Lease, Payments to be Received, Total	500
Lease Agreement for Office in Princeton, New Jersey [Member] \| UroGen Pharma Inc. [Member]
Operating Lease, Liability, Total	$ 700
Lessee, Operating Lease, Term of Contract (Month)		38 months

Note 10 - Leases - Components of Lease Cost (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Operating lease cost	$ 259	$ 424	$ 786	$ 1,282
Sublease income	(56)	(56)	(168)	(168)
Variable lease cost	15	28	51	114
Lease, Cost, Total	$ 218	$ 396	$ 669	$ 1,228

Note 10 - Leases - Amounts of Assets and Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2021	Dec. 31, 2020
Right of use asset	$ 1,418	$ 2,158
Long-term lease liabilities	616	1,497
Other current liabilities	$ 1,133	$ 1,202

Note 10 - Leases - Supplemental Information Related to Leases (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2021 USD ($)
Operating cash flows from operating leases	$ 2,734
Right-of-use assets obtained in exchange for new operating lease liabilities	$ 135
Weighted-average remaining lease term of operating leases (Year)	1 year 8 months 4 days
Weighted-average discount rate of operating leases	5.51%

Note 10 - Leases - Undiscounted Cash Flows to be Received Under Sublease (Details) $ in Thousands	Sep. 30, 2021 USD ($)
Remainder of 2021	$ 59
2022	243
2023	251
2024	49
2025 and thereafter	0
Lessor, Operating Lease, Payments to be Received, Total	$ 602

Note 10 - Leases - Sublease Income Recognized (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Sublease income from fixed lease payments	$ 56	$ 56	$ 168	$ 168

Note 11 - Revenue from Product Sales - Net Product Sales (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Revenue	$ 11,351	$ 3,461	$ 31,868	$ 3,833
Jelmyto [Member]
Revenue	$ 11,351	$ 3,461	$ 31,868	$ 3,833

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8906-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 40
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e9031-108599

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 41
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e9038-108599

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8933-108599

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8933-108599

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 4
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130543-203045

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8736-108599

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8736-108599

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 42
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e9054-108599

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 5
-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130545-203045

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 924
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 11.L)
-URI http://asc.fasb.org/extlink&oid=6472922&loc=d3e499488-122856

+ Details

Note 12 - License and Collaboration Agreements (Details Textual) - USD ($)	1 Months Ended		9 Months Ended
	Jan. 31, 2021	Nov. 30, 2019	Sep. 30, 2021
Agenus Inc. [Member]
Payments for License Agreement		$ 10,000,000.0
License Agreement, Maximum Payable for Certain Clinical Development and Regulatory Milestones		115,000,000.0
License Agreement, Maximum Payable for Certain Commercial Milestones		$ 85,000,000.0
License Agreement, Expiration Term (Year)		15 years
Agenus Inc. [Member] \| Minimum [Member]
License Agreement, Royalty, Percentage of Net Sales of Licensed Products		14.00%
Agenus Inc. [Member] \| Maximum [Member]
License Agreement, Royalty, Percentage of Net Sales of Licensed Products		20.00%
MD Anderson [Member]
Collaboration Agreement, Term (Year)	3 years
Research and Development Arrangement, Contract to Perform for Others, Costs Incurred, Gross			$ 500,000

Note 13 - Shareholders' Equity (Details Textual) - shares	Sep. 30, 2021	Dec. 31, 2020
Common Stock, Shares Authorized (in shares)	100,000,000	100,000,000
Common Stock, Shares, Issued, Total (in shares)	22,404,845	22,167,791

Note 14 - Share-based Compensation (Details Textual) - USD ($) $ in Millions					9 Months Ended
	Jun. 07, 2021	Jun. 08, 2020	Oct. 12, 2018	Jan. 01, 2018	Sep. 30, 2021	Mar. 31, 2017
Common Stock, Capital Shares Reserved for Future Issuance (in shares)					3,587,774
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares)					1,362,156
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total					$ 22.9
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year)					1 year 9 months 3 days
Share-based Payment Arrangement, Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period (Year)					2 years
Share-based Payment Arrangement, Option [Member] \| Share-based Payment Arrangement, Tranche One [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage					33.00%
Restricted Stock Units (RSUs) [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period (Year)					2 years
Restricted Stock Units (RSUs) [Member] \| Share-based Payment Arrangement, Tranche One [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage					33.00%
Share Option Plan [Member] \| Share-based Payment Arrangement, Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period (Year)					3 years
Share-based Compensation Arrangement By Share-based Payment Award, Individual Voting Powers, Percentage					10.00%
Two Thousand Seventeen Equity Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares)	4,350,167	3,950,167	3,550,167	1,650,167		1,400,000
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in shares)	400,000	400,000	1,900,000	250,167
The 2019 Inducement Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares)					900,000
Maximum [Member] \| Share Option Plan [Member] \| Share-based Payment Arrangement, Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period (Year)					10 years
Minimum [Member] \| Share Option Plan [Member] \| Share-based Payment Arrangement, Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Purchase Price of Common Stock, Percent					100.00%
Share-based Compensation Arrangement By Share-based Payment Award, Percentage of Purchase Price for Individuals Having More than Ten Percent of Combined Voting Power					110.00%

Note 14 - Share-based Compensation - Effect of Share-based Compensation On the Condensed Consolidated Statements of Operations (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Share-based compensation	$ 5,515	$ 6,763	$ 17,756	$ 21,499
Research and Development Expense [Member]
Share-based compensation	971	1,519	3,119	5,032
Selling, General and Administrative Expenses [Member]
Share-based compensation	$ 4,544	$ 5,244	$ 14,637	$ 16,467

Note 15 - Income Taxes (Details Textual) $ in Millions	Sep. 30, 2021 USD ($)
Unrecognized Tax Benefits, Ending Balance	$ 2.7
Unrecognized Tax Benefits, Income Tax Penalties and Interest Accrued, Total	$ 0.7

Note 17 - Commitments and Contingencies (Details Textual) - USD ($) $ in Millions	9 Months Ended
	Sep. 30, 2021	Mar. 31, 2020
Accrued Royalties		$ 6.6
Maximum Percentage of Commitment to Continue Employment of Research and Development Jobs	75.00%
Maximum Term for Commitment to Continue Employment of Research and Development Jobs (Year)	3 years