UroGen Pharma Ltd
For the period ended Dec 31, 2024. Filed Mar 10, 2025.
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FY2024 · Filed Mar 10, 2025
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Notes to Consolidated Financial Statements
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 2015and began operating in February 2016 (*“UPI”).
UPL and UPI (together the “Company”) is a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers. Since commencing operations, the Company has devoted substantially all of its efforts to securing intellectual property rights, performing research and development activities, including conducting clinical trials and manufacturing activities, hiring personnel, launching the Company’sfirst commercial product,Jelmyto (mitomycin) for pyelocalyceal solution, formerly known as UGN-101, advancing UGN-102 through regulatory approval, and raising capital to support and expand these activities.
On* April 15, 2020,the U.S. Food and Drug Administration (“FDA”) granted expedited approval forJelmyto*, afirst-in-class treatment indicated for adults with low-grade upper tract urothelial cancer.Jelmyto consists of mitomycin, an established chemotherapy, and sterile hydrogel, using the Company's proprietary sustained releaseRTGel technology. It has been designed to prolong exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means.
In* August 2024,the Company completed the submission of the rolling NDA for UGN-102. In October 2024,the FDA accepted the Company's NDA for UGN-102 (mitomycin) for intravesical solution and assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of June 13, 2025.*
Note 2 – Basis of Presentation
The Company has experienced net losses since its inception and has an accumulated deficit of $806.2 million and $679.3 million as of* December 31, 2024* and2023, 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.
The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States. The consolidated financial statements include the accounts of UPL and its wholly owned subsidiary UPI. All material intercompany balances and transactions have been eliminated during consolidation.
In accordance with the accounting guidance related to the presentation of financial statements, management evaluates whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern for the next12 months from the date the financial statements are issued. The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern, and donot include any adjustments relating to the carrying amounts and classification of assets and liabilities that* may*be necessary should the Company be unable to continue as a going concern. The Company’s ability to continue as a going concern is expected to be impacted by the advancement of UGN-102 through regulatory approval, its ability to raise additional capital to fund its operations, and produce cash inflows from Jelmyto product sales.
Based on the Company's cash, cash equivalents and marketable securities as of* December**31,* 2024, together with management’s cash flow projections, the Company believes that it has sufficient cash and cash equivalents to fund its operations beyondone year from the issuance of these consolidated financial statements. If the Company is unable to obtain approval for UGN-102 and generate sufficient cash inflows from the sale and distribution of UGN-102, the Company* mayneed to raise additional capital in the future or reduce operating expenditures. There can beno* assurances that the Company will be able to secure such additional financing on terms that are satisfactory to the Company, in an amount sufficient to meet the Company's needs, or at all. In the event the Company isnot successful in obtaining sufficient funding, this could force the Company to delay, limit, reduce or terminate the Company's product development, commercialization efforts or other operations.
Note 3 –Significant Accounting Policies
Principles of Consolidation
The Company’s consolidated financial statements include the accounts of UPL and its subsidiary, UPI. Intercompany balances and transactions have been eliminated during consolidation.
Use of Estimates
The preparation of financial statements in conformity with U.S. Generally Accepted Accounting Principles 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 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.
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Functional Currency
The U.S. dollar (“Dollar”) is the currency of the primary economic environment in which the operations of the Company are conducted. Therefore, the functional currency of the Company is the Dollar.
Accordingly, transactions in currencies other than the Dollar are measured and recorded in the functional currency using the exchange rate in effect at the date of the transaction. At the balance sheet date, monetary assets and liabilities that are denominated in currencies other than the Dollar are measured using the official exchange rate at the balance sheet date. The effects of foreign currency re-measurements are recorded in the consolidated statements of operations as “Interest and other income, net.”
Cash and Cash Equivalents; Marketable Securities
The Company presents all highly liquid investments with an original maturity ofthree months or less when purchased as cash equivalents. Cash and cash equivalents generally consist 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 $241.7 million as of* December**31,* 2024. The Company accounts for its investments, which include cash equivalents and marketable securities, as available-for-sale in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic320, “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, net. The cost of securities sold is based on the specific-identification method.
Certain short-term investments are valued using models or other valuation methodologies that use Level2 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 hasnot been recorded through an allowance for credit losses is recorded through other comprehensive income, net of applicable taxes.
Restricted cash is related primarily to cash held to secure corporate credit cards; restricted deposits are related to cash held to secure leases.
Concentration of Credit Risk
Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist primarily of cash and cash equivalents and marketable securities. The primary objectives for the Company’s investment portfolio are the preservation of capital and the maintenance of liquidity. The Company doesnot 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 accounts receivables are composed of net sales ofJelmyto arising from the Company's arrangements withtwo third-party national specialty distributors. The Company assesses the need for an allowance for doubtful accounts primarily based on creditworthiness, historical payment experience and general economic conditions. The Company hasnot experienced any credit losses related to arrangements with customers and hasnot currently recognized any allowance for doubtful accounts.
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The Company provides for income taxes based on pretax income, if any, and applicable tax rates available in the various jurisdictions in which it operates, including Israel and the United States. Deferred taxes are computed using the asset and liability method. Under the asset and liability method, deferred income tax assets and liabilities are determined based on the differences between the financial reporting and tax bases of assets and liabilities and are measured using the currently enacted tax rates and laws. A valuation allowance is recognized to the extent that it is more likely thannot that the deferred taxes willnot be realized in the foreseeable future.
The Company follows atwo-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), ASC740-10-30-7 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 than50% likely to be realized upon settlement with a taxing authority that has full knowledge of all relevant information. See Note17 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. ForJelmyto, the Company commenced capitalization of inventory at the receipt of FDA approval. Costs related to inventories that arenot expected to be manufactured and sold within the next12 months are classified as long-term assets and presented within Other non-current assets on the consolidated balance sheets.
The Company values its inventory at the lower of cost or net realizable value. The Company measures inventory approximating actual cost under afirst-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 - 10 |
Leasehold improvements are amortized on a straight-line basis over the shorter of their estimated useful lives or lease terms. See Note8 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 launch ofJelmyto and the development of UGN-102 in return for tiered, future cash payments based on net sales ofJelmyto and, subject to FDA approval, UGN-102, UGN-103 and UGN-104. The net proceeds received under the RTW Transaction were recognized as a long-term liability. The Company recognizes the current cash payable amounts under the arrangement within other current liabilities on the consolidated balance sheets. The subsequent measurement for the liability follows the accounting principles defined in ASC Topic835-30, “Imputation of Interest.” See Note9 for further discussion related to the prepaid forward obligation.
Long-Term Debt
The Company is party to a loan agreement with funds managed by Pharmakon Advisors, L.P. (“Pharmakon”). The Company recognizes interest expense in current earnings, and accrued interest within other current liabilities on the consolidated balance sheets. The Company recognizes capitalized financing expenses as a direct offset to the long-term debt on the Company's consolidated balance sheets, and amortizes them over the term of the debt using the effective interest method. See Note10 for further discussion related to long-term debt.
Leases
The Company is a lessee in several noncancelable operating and finance leases, primarily for office space, office equipment and vehicles.
The Company accounts for leases in accordance with ASC Topic842, “Leases.” The Company determines if an arrangement is a lease at inception. The Company additionally evaluates leases at their inception to determine if they are to be accounted for as an operating lease or a finance lease. Right-of-use (“ROU”) assets and lease liabilities are recognized based on the present value of lease payments over the lease term as of the commencement date. Certain adjustments to the ROU asset* may*be required for items such as initial direct costs paid or incentives received. Operating and finance lease ROU assets are presented as right-of-use assets on the consolidated balance sheets. The current portion of lease liabilities is included in other current liabilities and the long-term portion is presented separately as long-term lease liabilities on the consolidated balance sheets.
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Lease expense for operating leases is recognized on a straight-line basis over the lease term. For finance leases, the expense consists of interest on the lease liability and amortization of the right-of-use asset. 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 selling, general and administrative expenses in the consolidated statements of operations. The Company has elected the practical expedient tonot separate between lease and non-lease components.
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 donot 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 are periodically reviewed for impairment losses under ASC360-10, “Property, Plant, and Equipment,” to determine whether an ROU asset is impaired, and if so, the amount of the impairment loss to recognize.
Net revenue from product sales is recognized at the transaction price when the specialty distributors obtain control of the Company’s products, which occurs at a point in time, typically upon delivery of the product to the treating physician. All product sales ofJelmyto are recognized through the Company's arrangements withtwo customers as defined by ASC606, both of which arethird-party national specialty distributors. Net revenue recognized includes gross revenue and management’s estimate of returns, consideration paid to the customers, chargebacks relating to differences between the wholesale acquisition cost and the contracted price offered to the end consumer, chargebacks relating to340B drug pricing programs and other government sponsored programs, Medicaid drug rebate programs, the Company’s copay assistance program, and Medicare refunds for discarded drug, which are estimated based on the Company’s historical experience.
Research and Development Expenses
Research and development costs are expensed as incurred and consist primarily of the cost of salaries, share-based compensation expenses, payroll taxes and other employee benefits, subcontractors and materials used for research and development activities, including nonclinical studies, clinical trials, manufacturing costs and professional services. The costs of services performed by others in connection with the research and development activities of the Company, including research and development conducted by others on behalf of the Company, shall be included in research and development costs and expensed as the contracted work is performed. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial or project and the invoices received from its external service providers. The Company adjusts its accrual as actual costs become known. Where contingent milestone payments are due tothird parties under research and development arrangements or license agreements, the milestone payment obligations are expensed when such development milestone results are achieved.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist primarily of personnel costs (including share-based compensation related to directors, employees and consultants). Other significant costs include commercial, medical affairs, external professional service costs, facility costs, accounting and audit services, legal services and other consulting fees. Selling, general and administrative costs are expensed as incurred, and the Company accrues for services provided bythird 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. For performance stock units (“PSUs”), cost is measured at the grant date based on the fair value of the award and is recognized over any relevant service period as expense when the achievement of the performance condition is probable. The fair value of options is determined using the Black-Scholes option-pricing model. The fair value of a restricted stock unit ("RSU") or a PSU equals the closing price of the Company’s ordinary shares on the grant date. The Company accounts for forfeitures as they occur in accordance with ASC Topic718, “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.
Pre-funded Warrants
The Company's outstanding pre-funded warrants are accounted for as a freestanding equity-linked financial instrument that meets the criteria for equity classification under ASC480, “Distinguishing Liabilities from Equity,” and ASC815, “Derivatives and Hedging.” Accordingly, the Company classifies the pre-funded warrants as a component of permanent shareholders’ equity within additional paid-in capital and records them at the applicable issuance date using a relative fair value allocation method. The Company valued the pre-funded warrants at the applicable issuance date, concluding that their sales price approximated their fair value, and allocated the net sales proceeds from the applicable equity transaction proportionately to the ordinary shares and pre-funded warrants.
Net Loss per Ordinary Share
Basic net loss per share is computed by dividing the net loss attributable to ordinary shareholders by the weighted-average number of ordinary shares outstanding. Diluted net loss per share is computed similarly to basic net loss per share except that the denominator is increased to include the number of additional ordinary shares that would have been outstanding if the potential ordinary shares had been issued and if the additional ordinary shares were dilutive.
For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted loss per share as their effect is anti-dilutive.
The Company’s pre-funded warrants require the holder to pay nominal consideration to receive the Company’s ordinary shares and are therefore considered outstanding shares in determining basic and diluted earnings per share in accordance with ASC Topic260, “Earnings per Share.”
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The following table summarizes the calculation of basic and diluted loss per ordinary share for the periods presented (in thousands, except share and per share amounts):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Basic and diluted: | ||
| Loss attributable to equity holders of the Company | $(126,874) | $(102,244) |
| Weighted-average number of ordinary shares | 42,876,737 | 28,834,303 |
| Loss per ordinary share | $(2.96) | $(3.55) |
Recently Adopted or Issued Accounting Pronouncements
In* November 2023,the FASB issued Accounting Standards UpdateNo.* 2023-07, Segment Reporting (Topic280): Improvements to Reportable Segment Disclosures ("ASU2023-07"), which provides guidance to improve the disclosures about a public entity’s reportable segments and address requests from investors for additional, more detailed information about a reportable segment’s expenses. Public entities must adopt the new guidance for fiscal years beginning after* December 15, 2023,and interim periods within fiscal years beginning after December 15, 2024.*The amendments in this ASU must be applied on a retrospective basis to all prior periods presented in the financial statements and early adoption is permitted. The Company has adopted the new guidance, which applies to all public entities, including those with a single reportable segment. The amendments primarily enhance segment expense disclosures.
In* December 2023,the FASB issued Accounting Standards UpdateNo.* 2023-09, Income Taxes (Topic740): Improvements to Income Tax Disclosures (“ASU2023-09”), which will require the Company to disclose specified additional information in its income tax rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. ASU2023-09 will also require the Company to disaggregate its income taxes paid disclosure by federal, state and foreign taxes, with further disaggregation required for significant individual jurisdictions. The Company will adopt ASU2023-09 for the2025 year-end and is currently evaluating the potential impact of the adoption on the Company’s financial disclosures. ASU2023-09 allows for adoption using either a prospective or retrospective transition method.
In* November 2024,the FASB issued Accounting Standards UpdateNo.* 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic220-40) ("ASU2024-03"), which provides guidance to improve the disclosures about a public business entity’s expenses. Public entities must adopt the new guidance for fiscal years beginning after* December 15, 2026,and interim reporting periods beginning after December 15, 2027.The Company is currently evaluating the potential impact of the adoption of ASU2024*-03 on the Company’s financial disclosures.
The Company has reviewed other Accounting Standards Updates recently issued by the FASB, and determined thatnone of these pronouncements will have a significant impact on the Company's consolidated financial statements and related disclosures.
NOTE4 –o THERf INANCIALI NFORMATION
Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses consisted of the following as of* December 31, 2024* and2023 (in thousands):
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| Accounts payable | $10,931 | $6,514 |
| Accrued sales reserves | 5,151 | 4,391 |
| Accrued clinical expenses | 2,027 | 1,246 |
| Accrued research and development expenses | 2,173 | 1,049 |
| Accrued selling, general and administrative expenses | 6,000 | 2,752 |
| Accrued other expenses | 1,149 | 586 |
| Total accounts payable and accrued expenses | $27,431 | $16,538 |
Interest and Other Income, Net
Interest and other income, net consisted of the following for the year ended* December 31, 2024* and2023 (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Interest income | $8,901 | $2,641 |
| Other income (loss), net | (229) | 838 |
| Total interest and other income, net | $8,672 | $3,479 |
NOTE5 –INVENTORIES
Inventories consisted of the following as of* December 31, 2024* and* December 31, 2023* (in thousands):
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| Raw materials (1) | $4,924 | $4,464 |
| Finished goods | 4,522 | 2,877 |
| Total inventories | $9,446 | $7,341 |
(1) $0.2 million and $1.7 million of raw materials are included within other non-current assets on the consolidated balance sheets at* December 31, 2024and December 31, 2023,respectively. These raw materials arenot* expected to be manufactured and sold within the next12 months. Changes in non-current inventories are reflected on the consolidated statements of cash flows within the caption of other non-current assets.
NOTE6 –FAIRV ALUEM EASUREMENTS
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.
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As a basis for considering such assumptions, athree-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:
Level1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities.
Level2: 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 arenot active.
Level3: Unobservable inputs that reflect the reporting entity’s own assumptions.
The carrying amounts of the Company’s cash, restricted cash, other current assets, accounts payable and accrued liabilities are generally considered to be representative of their fair value because of the short-term nature of these assets and liabilities.
The carrying value of the prepaid forward obligation (See Note9 - Prepaid Forward Obligation) approximates its fair value. The Company estimated the fair value of the prepaid forward obligation using Level3 inputs, including internally developed financial forecasts and management's estimate of probability of success related to product candidates, and determined that the effective interest rate in the obligation approximates market rates for loans with similar terms and risk characteristics.
The Company estimated the fair value of long-term debt (see Note10 - Long-Term Debt) using the income approach with Level3 inputs. The Company estimated future floating rate interest payments using a forward curve of athree-month benchmark rate, and estimated fair value based on publicly available data reported in the financial statements of publicly traded venture lending companies. Based on a reasonable range of yields for debt instruments of similar tenor in a similar industry, the Company determined that the carrying value of the long-term debt on the Company's balance sheet approximates its fair value.
No transfers between levels have occurred during the periods presented.
Assets measured at fair value on a recurring basis based on Level1 and Level2 fair value measurement criteria as of* December 31, 2024* 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 | |
| 2024 | (Level 1) | (Level 2) | |
| Assets: | |||
| Cash equivalents | |||
| Money market funds | $41,008 | $41,008 | $— |
| Marketable securities | |||
| U.S. government | $26,053 | $26,053 | $— |
| Corporate bonds | 14,980 | — | 14,980 |
| Commercial paper | 26,622 | — | 26,622 |
| Certificates of deposit | 2,065 | — | 2,065 |
| Total marketable securities | $69,720 | $26,053 | $43,667 |
| Total assets at fair value | $110,728 | $67,061 | $43,667 |
Assets measured at fair value on a recurring basis based on Level1 and Level2 fair value measurement criteria as of* December 31, 2023* 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 | |
| 2023 | (Level 1) | (Level 2) | |
| Assets: | |||
| Cash equivalents | |||
| Money market funds | $9,704 | $9,704 | $— |
| Marketable securities | |||
| U.S. government | $28,634 | $28,634 | $— |
| Corporate bonds | 6,738 | — | 6,738 |
| Commercial paper | 7,101 | — | 7,101 |
| Certificates of deposit | 3,995 | — | 3,995 |
| Total marketable securities | $46,468 | $28,634 | $17,834 |
| Total assets at fair value | $56,172 | $38,338 | $17,834 |
The Company’s investments in U.S. government bonds and money market funds are measured based on publicly available quoted market prices for identical securities as of* December 31, 2024* and2023. The Company's investments in corporate bonds, commercial paper and certificates of deposits are measured based on quotes from market makers for similar items in active markets.
NOTE7 –Investments
The following table summarizes the Company’s investments as of* December 31, 2024* (in thousands):
| Amortized Cost Basis | Unrealized Gains | Unrealized Losses | Fair Value | |
|---|---|---|---|---|
| Assets: | ||||
| Cash equivalents | ||||
| Money market funds | $41,008 | $— | $— | $41,008 |
| Marketable securities | ||||
| U.S. government | $26,019 | $34 | $— | $26,053 |
| Corporate bonds | 14,966 | 15 | (1) | 14,980 |
| Commercial paper | 26,608 | 15 | (1) | 26,622 |
| Certificates of deposit | 2,071 | — | (6) | 2,065 |
| Total marketable securities | $69,664 | $64 | $(8) | $69,720 |
| Total assets at fair value | $110,672 | $64 | $(8) | $110,728 |
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The following table summarizes the Company’s investments as of* December 31, 2023 (*in thousands):
| Amortized Cost Basis | Unrealized Gains | Unrealized Losses | Fair Value | |
|---|---|---|---|---|
| Assets: | ||||
| Cash equivalents | ||||
| Money market funds | $9,704 | $— | $— | $9,704 |
| Marketable securities | ||||
| U.S. government | $28,618 | $36 | $(20) | $28,634 |
| Corporate bonds | 6,756 | 2 | (20) | 6,738 |
| Commercial paper | 7,094 | 8 | (1) | 7,101 |
| Certificates of deposit | 3,988 | 7 | — | 3,995 |
| Total marketable securities | $46,456 | $53 | $(41) | $46,468 |
| Total assets at fair value | $56,160 | $53 | $(41) | $56,172 |
The Company classifies its investments as available-for-sale, and they consist entirely of debt securities. As of* December 31, 2024*, the amortized cost of investments included an immaterial amount of accrued interest. As of* December 31, 2024*, 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* December 31, 2024*, the aggregate fair value of investments held by the Company in an unrealized loss position was $14.4 million which consisted of 12 securities. The unrealized loss was primarily driven by fluctuations in interest rates. The Company doesnot 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 doesnot intend to sell the investments before maturity. As of* December 31, 2024*, the Company believes the cost basis for its marketable securities were recoverable in all material aspects andno allowance for credit losses were recognized in the period.
The Company’s investments as of* December 31, 2024* mature at various dates through* November**2026.* The fair values of investments by contractual maturity consist of the following (in thousands):
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| Maturities within one year | $105,706 | $51,670 |
| Maturities after one year through three years | 5,022 | 4,502 |
| Total investments | $110,728 | $56,172 |
NOTE8 –PROPERTY ANDE QUIPMENT
Property and equipment, consists of the following as of* December 31, 2024* and2023 (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Laboratory equipment | $473 | $464 |
| Computer equipment and software | 2,542 | 2,293 |
| Furniture | 612 | 612 |
| Leasehold improvements | 626 | 617 |
| Manufacturing equipment | 683 | 655 |
| 4,936 | 4,641 | |
| Less: accumulated depreciation and amortization | (4,281) | (3,952) |
| Property and equipment, net | $655 | $689 |
Depreciation and amortization expense was $0.3 million and $0.8 million for the years ended* December 31, 2024* and2023, respectively.
NOTE 9 –Prepaid Forward Obligation
In* March 2021,the Company entered into a prepaid forward agreement with RTW. Under the terms of the RTW Transaction, the Company received $75.0 million ($72.4 million net of transaction costs) to support the launch ofJelmyto* 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 ofJelmytoand, subject to FDA approval, UGN-102, UGN-103 and UGN-104, 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. Pursuant to the agreement, the initial cash payment rate of9.5% onJelmyto aggregate worldwide annual net sales of up to $200 million was increased to 13.0% and remained at that rate during the year ended* December**31,* 2024 because certain revenue thresholds werenot met.
In addition, subject to FDA approval of UGN-102 and UGN-103, RTW is entitled to receive tiered, future cash payments based on aggregate worldwide annual net product sales of UGN-102 and UGN-103 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 doesnot receive FDA approval for UGN-102 by* June 30, 2025,the future cash payments to RTW with respect to aggregate worldwide annual net sales ofJelmyto* across allJelmyto 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 of* December 31, 2024,the cumulative amounts paid and payable by the Company were $34.8 million. As security for the payment and fulfilment of these amounts throughout the arrangement, the Company has granted RTW afirst* priority security interest in*Jelmyto,*UGN-102, UGN-103 and UGN-104, 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. Each period the Company makes a payment to RTW, an expense is recognized related to financing on the prepaid forward obligation based on an imputed rate derived from the expected future payments. Management reassesses the effective rate 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 future financing expense. The Company doesnot expect to make any principal payments in the next12* months.
The following table shows the activity with respect to the carrying value of the prepaid forward liability for the year ended* December 31, 2024and2023* (in thousands):
| Carrying value of prepaid forward obligation as of December 31, 2022 | $98,923 |
|---|---|
| Financing on prepaid forward obligation | 21,552 |
| Amounts paid and payable (1) | (10,753) |
| Carrying value of prepaid forward obligation as of December 31, 2023 | 109,722 |
| Financing on prepaid forward obligation | 23,411 |
| Amounts paid and payable (1) | (11,746) |
| Carrying value of prepaid forward obligation as of December 31, 2024 | $121,387 |
(1)$6.5 million and $3.0 million of the Amounts paid and payable are included as current portion of the prepaid forward obligation within other current liabilities on the consolidated balance sheets as of* December 31, 2024* and* December 31,*2023, respectively.
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NOTE10 –Long-Term Debt
On* March 7,2022, the Company entered into a loan agreement with Pharmakon for a senior secured term loan of up to $100 million intwo tranches. Thefirst tranche of $75 million was funded in March 2022.Thesecond* tranche of $25 million was funded in* December 2022.*
On* June 29, 2023,the loan agreement with Pharmakon was amended to replace the benchmark governing the interest rate with a rate based on the secured overnight financing rate ("SOFR") published by the Federal Reserve Bank of New York. Effective July 2023,the loan accrued interest using a benchmark rate of3*-month SOFR plus 8.25% plus an additional adjustment of 0.26161%.
On* March 13, 2024,the Company entered into an amended and restated loan agreement with Pharmakon for an additionalthird* andfourth tranche of senior secured loan. Thethird tranche of $25.0 million was funded in* September 2024.Thefourth* tranche of $75.0 million will become available at the Company's optionno later than* August 29, 2025,subject to (i) receiving FDA approval of a new drug application (“NDA”) for UGN-102 no later than June 30, 2025and (ii) the satisfaction of customary bring down conditions and deliverables. Under the amended and restated loan agreement, all outstanding loans with Pharmakon accrue interest using a benchmark rate of3*-month SOFR plus 7.25% plus an additional adjustment of 0.26161%. All outstanding principal will be required to be repaid infour equal quarterly installments commencing in thesecond quarter of2026, with aone-year extension possible upon FDA approval of an NDA for UGN-102 by* June 30, 2025.All outstanding loans with Pharmakon can be prepaid in whole at the Company's discretion, at any time, subject to prepayment premiums and make-whole amounts. The Company isnot* required to maintain any financial covenants.
The Company incurred financing expenses of $4.2 million related to thefirst andsecond tranches funded in2022, and $0.5 million related to thethird tranche funded in2024, which are recognized as a direct offset to the long-term debt on the Company's consolidated balance sheets. These debt issuance costs are amortized over the term of the debt using the effective interest method, and are recorded in the consolidated statements of operations as "Interest expense."
The following table shows the activity with respect to the carrying value of the long-term debt, in thousands:
| Carrying value of Pharmakon loan as of December 31, 2022 | $97,537 |
|---|---|
| Interest expense | 14,715 |
| Amounts paid | (13,701) |
| Carrying value of Pharmakon loan as of December 31, 2023 | 98,551 |
| Third tranche of Pharmakon loan | 25,000 |
| Capitalized costs and discounts | (512) |
| Interest expense | 12,521 |
| Amounts paid | (13,826) |
| Carrying value of Pharmakon loan as of December 31, 2024 | $121,734 |
NOTE11 –Leases
Operating Leases
The Company had the following office and laboratory facility leases during the period covered by this report:
| • | 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 for an additional three years until August 2022. In July 2022, the Company signed a lease extension agreement for the Company’s offices located in Israel, extending the term of the lease through September 2025. The Company's remaining contractual obligation under this lease is approximately $0.2 million as of December 31, 2024. |
| • | 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 terminated in March 2024. The landlord provided a tenant allowance for leasehold improvements of $0.2 million that was accounted for as a lease incentive. In November 2019, UPI entered into a sublease for this office space, with a lease commencement date of January 1, 2020, which continued 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 Company accounted for the sublease as an operating lease in accordance with ASC 842. |
| • | 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 with an original lease term of 38 months, expiring January 31, 2023. In June 2022, the Company signed a lease extension for the Princeton office, extending the term of the lease through January 31, 2026. The Company’s remaining contractual obligation under this lease is approximately $0.6 million as of December 31, 2024. |
Finance Leases
| • | In July 2024, UPI entered into a new master lease agreement for vehicles, primarily for use by employees in sales, field services, and roles that require regular travel. Under the terms of the master lease agreement, the Company will lease various vehicles from time to time with an initial lease term of 48 months commencing on the delivery date of the vehicle with an option to continue month-to-month for an unlimited period of time. Lease payments are fixed, with payments due monthly in advance, and include charges for depreciation, maintenance, and other related services. At the end of each lease term, the Company is required to make a terminal rental adjustment based on the difference between the vehicle’s contractual book value and its estimated wholesale value, which may result in additional payments or refunds. The Company may also be required to pay additional rent if the vehicle exceeds certain mileage limits or shows abnormal wear and tear during the lease term. The Company’s remaining contractual obligation under this lease is approximately $3.0 million as of December 31, 2024. |
In addition, the Company has other operating office equipment and vehicle leases. The Company’s operating leases* mayrequire 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 donot* contain any residual value guarantees or material restrictive covenants. The Company’s active leases expire at various dates from2025 through2028, with varying renewal and termination options.
The components of lease cost for the year ended* December 31, 2024* and2023 were as follows (in thousands):
| Year Ended December 31, 2024 | Year Ended December 31, 2023 | |
|---|---|---|
| Finance lease cost: | ||
| Amortization of right-of-use assets | $36 | $— |
| Interest on lease liabilities | 20 | — |
| Operating lease cost | 900 | 934 |
| Sublease income | (42) | (224) |
| Variable lease cost | 70 | 73 |
| $984 | $783 | |
The amounts recognized as of* December 31, 2024* and2023 were as follows (in thousands):
| Year Ended December 31, 2024 | Year Ended December 31, 2023 | |
|---|---|---|
| Finance lease right-of-use assets | $2,285 | $1,671 |
| Operating lease right-of-use assets | 849 | — |
| Finance long-term lease liabilities | 1,595 | 844 |
| Operating long-term lease liabilities | 58 | — |
| Other current liabilities related to finance leases | 745 | — |
| Other current liabilities related to operating leases | 785 | 819 |
As of* December 31, 2024*, no impairment losses have been recognized.
Supplemental information related to leases for the periods reported is as follows (in thousands, except for lease terms and discount rate amounts):
| Year Ended December 31, 2024 | Year Ended December 31, 2023 | |
|---|---|---|
| Cash paid for amounts included in the measurement of lease liabilities: | ||
| Operating cash flows from operating leases | $933 | $1,169 |
| Right-of-use assets obtained in exchange for new finance lease liabilities | $2,321 | $— |
| Right-of-use assets obtained in exchange for new operating lease liabilities | $— | $122 |
| Weighted-average remaining lease term of finance leases (in years) | 3.94 | — |
| Weighted-average remaining lease term of operating leases (in years) | 1.02 | 1.92 |
| Weighted-average discount rate of finance leases | 13.82% | — |
| Weighted-average discount rate of operating leases | 10.24% | 10.21% |
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As of* December 31, 2024*, maturities of lease liabilities were as follows (in thousands):
| Finance Leases | |
|---|---|
| Years ending December 31, | |
| 2025 | $998 |
| 2026 | 657 |
| 2027 | 657 |
| 2028 | 642 |
| Total future minimum lease payments | $2,954 |
| Less: Interest | (614) |
| Present value of lease liabilities | $2,340 |
| Operating Leases | |
|---|---|
| Years ending December 31, | |
| 2025 | $824 |
| 2026 | 58 |
| Total future minimum lease payments | $882 |
| Less: Interest | (39) |
| Present value of lease liabilities | $843 |
NOTE12 –REVENUEFROMP RODUCTS ALES
Net product sales consist of the following for the year ended* December 31, 2024* and2023 (in thousands):
| Year Ended December 31, 2024 | Year Ended December 31, 2023 | |
|---|---|---|
| Jelmyto | $90,398 | $82,713 |
All product sales ofJelmyto are recognized through the Company's arrangements withtwo customers as defined by ASC606, both of which arethird-party national specialty distributors. The Company's largest customer comprises over 90% of product sales throughout the full year2024, and approximately 80% of accounts receivables at* December 31, 2024.Net revenue recognized includes gross revenue and management’s estimate of returns, consideration paid to the customers, chargebacks relating to differences between the wholesale acquisition cost and the contracted price offered to the end consumer, chargebacks relating to340B* drug pricing programs and other government sponsored programs, Medicaid drug rebate programs, the Company’s copay assistance program, and Medicare refunds for discarded drug. The Company estimates these elements of variable consideration based on the contractual or statutory terms governing the arrangements and the Company’s historical experience, and constrains the net revenue recognized for product sales to the value that isnot probable to be reversed when the uncertainty associated with the variable consideration is subsequently resolved. Reserves for chargebacks and returns are net settled and recognized as contra accounts receivable while the remaining reserves are recognized within other current liabilities on the consolidated balance sheets. The following table shows the activity with respect to sales reserves for the year ended* December 31, 2024* and2023, in thousands:
| Reserves related to government sponsored programs | Medicare refunds for discarded drug reserve | Other reserves | Total accrued sales reserves | |
|---|---|---|---|---|
| Balance as of December 31, 2022 | $590 | $— | $847 | $1,437 |
| Accruals | 11,110 | 3,451 | 8,807 | 23,368 |
| Utilizations | (10,638) | — | (8,196) | (18,834) |
| Balance as of December 31, 2023 | $1,062 | $3,451 | $1,458 | $5,971 |
| Accruals | 13,870 | 3,920 | 11,273 | 29,063 |
| Utilizations | (13,822) | — | (10,785) | (24,607) |
| Changes to prior period estimates | (223) | 358 | — | 135 |
| Balance as of December 31, 2024 | $887 | $7,729 | $1,946 | $10,562 |
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NOTE13 –LICENSE ANDC OLLABORATIONA GREEMENTS
In* November 2019,the Company entered into a license agreement with Agenus Inc. ("Agenus"), 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 monoclonal antibody of Agenus known asAGEN1884* (zalifrelimab), an anti-CTLA-4 antagonist, for the treatment of cancers of the urinary tract via intravesical delivery. UGN-301 is a formulation of zalifrelimab administered usingRTGeltechnology that is in Phase1 clinical development for high-grade non-muscle invasive bladder cancer.
NOTE14 –EMPLOYEER IGHTSUPONR ETIREMENT
In Israel, the Company is required by law to make severance payments upon dismissal of an employee or upon termination of employment in certain other circumstances.
The Company operates a number of post-employment defined contribution plans. A defined contribution plan is a program that benefits an employee after termination of employment, under which the Company regularly makes fixed payments to a separate and independent entity so that the Company hasno legal or constructive obligation to pay additional contributions if the fund doesnot hold sufficient assets to pay all employees the benefits relating to employee service in the current and prior periods. The fund assets arenot included in the Company’s financial position.
The Company operates pension and severance compensation plans subject to Section14 of the Israeli Severance Pay Law,5723-1963. The plans are funded through payments to insurance companies or pension funds administered by trustees. In accordance with its terms, the plans meet the definition of a defined contribution plan, as defined above.
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NOTE15 –SHAREHOLDERS’** EQUITY**
The Company had 100.0 million ordinary shares authorized for issuance as of* December 31, 2024* and2023. The Company had42.2 million and32.5 million ordinary shares issued and outstanding as of* December 31, 2024* and2023, respectively. Each ordinary share is entitled toone 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 the Company's inception, the Board hasnot declared any dividends.
ATM Sales Agreement
In* December 2019,*the Company entered into a sales agreement (the “ATM Sales Agreement”) with TD Securities (USA) LLC (f/k/a Cowen and Company, LLC) (“TD Cowen”)
pursuant to which the Company* may*from time to time offer and sell the Company's ordinary shares having an aggregate offering price of up to $100.0 million.
During thefirst quarter of2024, the Company sold 3,400,468 ordinary shares under the ATM Sales Agreement, for gross proceeds of approximately $56.1 million. The net proceeds to the Company after deducting sales commissions to TD Cowen were approximately $54.7 million. The remaining capacity under the ATM Sales Agreement was approximately $27.3 million as of* December 31, 2024.The shares will be offered and sold, if any, pursuant to the Company's shelf registration statement on Form S-3 filed with the SEC on November 15, 2022,which was declared effective on November 29, 2022,*or a subsequent shelf registration statement.
Securities Purchase Agreement
On* July26,* 2023, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional and other accredited investors (the “Purchasers”), pursuant to which the Company agreed to sell and issue to the Purchasers 7,300,380 ordinary shares of the Company (“Shares”) and 5,278,776 of pre-funded warrants to purchase ordinary shares of the Company at a purchase price of $9.54 per Share or $9.539 for each ordinary share underlying a pre-funded warrant, in a private placement transaction that closed on* July 28, 2023and August 9, 2023 (the “Private Placement”) for aggregate gross proceeds of $120.0 million, before deducting fees to placement agents and financial advisors and before other expenses paid by the Company. Each pre-funded warrant has an exercise price of $0.001 per ordinary share, subject to customary adjustments, became exercisable upon original issuance and willnot* expire until exercised in full. The pre-funded warrants* maynot* be exercised to the extent that the aggregate number of ordinary shares beneficially owned by the holder thereof immediately following such exercise would exceed a specified beneficial ownership limitation. The aggregate fee paid by the Company to placement agents and financial advisors was $3.6 million, plus the reimbursement of certain expenses.
Resales of the Shares and the ordinary shares issuable upon exercise of the pre-funded warrants were registered pursuant to the Company’s registration statement on Form S-3 (FileNo. 333-274423) filed with the SEC on* September 8, 2023,which was declared effective on September 15, 2023.*
On* December 20, 2023,the Company issued 1,599,733 ordinary shares through a cashless conversion of 1,599,840 pre-funded warrants for the purchase of ordinary shares of the Company. On January**24,* 2025, the Company issued 3,206,271 ordinary shares through a conversion of 3,206,271 pre-funded warrants for the purchase of ordinary shares of the Company.
Monograph Capital Partners I, L.P. (“Monograph”), a life sciences venture firm that is affiliated with Fred Cohen, M.D., a director of the Company at the time, purchased 1,572,327 of the Shares in the Private Placement, for an aggregate purchase price of $15.0 million. Dr. Cohen was the Chair and Chief Investment Officer of Monograph at the time of purchase.
Underwritten Public Offering
On* June17,* 2024, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with TD Securities (USA) LLC and Guggenheim Securities, LLC, as representatives of the several underwriters named therein (collectively, the “Underwriters”), relating to the issuance and sale in a public offering of 5,000,000 ordinary shares of the Company for $17.50 per share and pre-funded warrants to purchase 1,142,857 ordinary shares of the Company for $17.499 per pre-funded warrant. The offering closed on* June 20, 2024.The gross proceeds to the Company from the closing of the offering were $107.5 million, before deducting underwriting discounts and commissions and offering expenses of $7.3 million. Each pre-funded warrant has an exercise price of $0.001 per ordinary share, subject to customary adjustments, is exercisable at any time and willnot* expire until exercised in full. The pre-funded warrants* maynot* be exercised if the aggregate number of ordinary shares beneficially owned by the holder thereof immediately following such exercise would exceed a specified beneficial ownership limitation. In addition, the Underwriters were granted an option exercisable for30 days, to purchase up to 921,428 additional shares at the public offering price, less the underwriting discounts and commissions. On* July 18, 2024,*the Company completed the closing of the sale of 921,428 additional shares in the offering following the exercise in full of the Underwriters’ option to purchase additional shares, which resulted in additional gross proceeds to the Company of $16.1 million before deducting underwriting discounts and commissions and offering expenses paid by the Company of $1.0 million.
NOTE16 –SHARE-BASEDC OMPENSATION
In* October 2010,the Board approved a share option plan (the“2010* Plan”) for grants to Company employees, consultants, directors, and other service providers. Subsequently, in* March 2017,the Board adopted the2017* Equity Incentive Plan (the*"2017* Plan" and, together with the2010 Plan, the "Plans"), which was approved by the shareholders in* April 2017.The2017* 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 grant of options to Israeli employees under the Plans is subject to the terms stipulated by Section102 of the Israeli Income Tax Ordinance (“Section102”). 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 Section102. The Company registered the Plans under the capital gains track, which offers more favorable tax rates to the employees. As a result, and pursuant to the terms of Section102, the Company isnot allowed to claim as an expense for tax purposes the amounts credited to the employees in respect of options granted to them under the Plans, 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 Plans is subject to Section3(i) of the Israeli Income Tax Ordinance.
Employees are typically granted stock options and/or RSUs, upon commencement of employment. Also, eligible employees* mayreceive an annual grant of options, RSUs and/or PSUs. Non-employee members of the Board typically receive a grant of stock options upon initial appointment to the Board, and/or stock options annually. The term of any option granted under the Plans cannot exceed 10 years. Options shallnot* 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 ofthree years. If the individual possesses more than 10% of the combined voting power of all classes of equity of the Company, the exercise price shallnot 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 thefirst anniversary of grant, and in either equal quarterly or annual amounts for thetwo years following theone-year anniversary of the grant date. Options generally vest in a 33% increment upon thefirst anniversary of the grant date, and in either equal quarterly or annual amounts for thetwo years following theone-year anniversary of the grant date. The Company also grants PSUs to certain employees. The PSU’s currently outstanding vest based on either the earlier of obtaining regulatory approval for the Company’s lead product candidate UGN-102 or the occurrence of a change in control, or for certain other awards, the achievement of thefirst commercial sale of UGN-102 in the United States following UGN-102's receipt of regulatory approval. In* June 2024,the Company amended certain RSU and PSU awards granted to the chief executive officer to defer vesting until the end of2025.* The Company accounted for the modification as a Type I probable-to-probable modification under ASC718. As the modification didnot result in any incremental fair value at the modification date, the Company continues to recognize the original grant-date fair value ratably over the original service period or expected performance period.
The maximum number of ordinary shares that was initially authorized for issuance under the2017 Plan was 1,400,000. On* January 1, 2018,the share reserve increased by 250,167 shares to 1,650,167 shares. On October 12, 2018,the Company increased the number of ordinary shares authorized for issuance under the2017* Plan by 1,900,000 shares to 3,550,167 shares. On* June 8, 2020,the Company’s shareholders approved an increase to the number of ordinary shares authorized for issuance under the2017* Plan by 400,000 shares to a total share reserve of 3,950,167 shares. On* June 7, 2021,the Company’s shareholders approved an increase to the number of ordinary shares authorized for issuance under the2017* Plan by 400,000 shares to a total share reserve of 4,350,167 shares. On* June 8, 2022,the Company's shareholders approved an increase to the number of ordinary shares authorized for issuance under the2017* Plan by 400,000 shares to a total share reserve of 4,750,167 shares. On* September 7, 2023,the Company's shareholders approved an increase to the number of ordinary shares authorized for issuance under the2017* Plan by 450,000 shares to a total share reserve of 5,200,167 shares. On* August 6, 2024,the Company's shareholders approved an increase to the number of ordinary shares authorized for issuance under the2017* Plan by 800,000 shares to a total of 6,000,167 shares.
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 inducement awards. The only persons eligible to receive grants under the Inducement Plan are individuals who satisfy the standards for inducement grants under Nasdaq Marketplace Rule5635*(c)(4) and the related guidance under Nasdaq IM5635-1, including individuals who werenot 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. In* December 2021,the Board approved an increase to the number of shares authorized for issuance under the Inducement Plan of 300,000 shares. In June 2024,*the Board approved an increase to the number of shares authorized for issuance under the Inducement Plan of 600,000 shares to a total of 1,800,000 shares.
As of* December 31, 2024,*4,119,671 ordinary shares are subject to outstanding awards under the Company's share-based compensation plans and 1,654,692 ordinary shares remain available for future awards.
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Options granted:
Set forth below are grants made by the Company as of* December 31, 2024*. The majority of options vest over three years and expire on thetenth anniversary of the date of grant. During2024, the Company granted 238,614 options with exercise prices ranging from $13.11 to $15.16 per share.
The weighted average fair value of options granted during2024 and2023 was $2.5 million and $4.3 million, respectively.
The total unrecognized compensation cost of options as of* December 31, 2024* was $3.1 million, which is expected to be recognized over a weighted average period of 1.75 years.
The fair value of options granted was computed using the Black-Scholes model. The underlying data used for computing the fair value of the options are as follows:
| 2024 | 2023 | |
|---|---|---|
| Value of ordinary shares | 13.11-15.16 | 8.84-17.94 |
| Dividend yield | 0% | 0% |
| Expected volatility | 81.00%-89.12% | 67.21%-81.00% |
| Risk-free interest rate | 3.61%-4.42% | 3.47%-4.42% |
| Expected term (in years) | 6.0-10 years | 6.0-10 years |
The expected volatility is based on a mix of the Company's historical volatility and the historical volatility of comparable companies with similar attributes to the Company, including industry, stage of life cycle, size and financial leverage. The risk-free interest rate assumption is based on observed interest rates appropriate for the expected term of the options granted. The expected term is the length of time until the expected dates of exercising the options and is estimated for employees using the simplified method due to insufficient specific historical information of employees’ exercise behavior, and for non-employees, and directors using the contractual term.
The following table summarizes the number of employee and non-employee options outstanding under the Plans for the years ended* December 31, 2024* and2023, and related information:
| Number of options | Weighted average exercise price per share | Weighted average remaining contractual life | Aggregate intrinsic value | |
|---|---|---|---|---|
| Outstanding as of December 31, 2023 | 2,685,796 | $25.35 | 7.37 | $5,131 |
| Granted | 238,614 | 13.80 | ||
| Forfeited | (277,901) | 24.05 | ||
| Exercised | (34,666) | 9.25 | ||
| Outstanding as of December 31, 2024 | 2,611,843 | $24.65 | 5.80 | $1,092 |
| Vested and expected to vest, December 31, 2024 | 2,611,843 | $24.65 | 5.80 | $1,092 |
| Exercisable, December 31, 2024 | 2,051,867 | $28.24 | 5.04 | $743 |
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The intrinsic value of stock options exercised was $0.2 million and $0.7 million for the years ended* December 31, 2024* and2023, respectively.
The following table summarizes information about RSU activity as of* December 31, 2024*:
| Outstanding Restricted Stock Units | |
|---|---|
| Outstanding as of December 31, 2023 | 1,098,684 |
| Granted | 964,369 |
| Vested and released | (385,065) |
| Forfeited | (170,160) |
| Outstanding as of December 31, 2024 | 1,507,828 |
The fair value of RSUs granted during2024 and2023 was $14.5 million and $10.4 million, respectively. The total unrecognized compensation cost of RSUs as of* December 31, 2024* is $12.1 million with a weighted average recognition period of 2.00 years.
The following table illustrates the effect of share-based compensation on the Statements of Operations:
| Year ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Research and development expenses | $2,235 | $1,905 |
| Selling, general and administrative expenses | 10,873 | 7,439 |
| Total share-based compensation expense | $13,108 | $9,344 |
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NOTE17 –INCOMET AXES
The Company is taxed under Israeli tax laws:
Corporate tax rate
The applicable Israeli tax rate relevant to the Company for2023 and thereafter is 23%.
For financial reporting purposes, the expense for current income taxes consists of the following (in thousands):
| 2024 | 2023 | |
|---|---|---|
| Current taxes: | ||
| U.S. Federal | $2,206 | $2,937 |
| U.S. State | 626 | 983 |
| Total current taxes | $2,832 | $3,920 |
Deferred income taxes:
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company and its subsidiary deferred tax assets are as follows (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| In respect of: | ||
| Net operating loss carryforward | $122,944 | $103,566 |
| Research and development expenses | 26,231 | 22,451 |
| Stock-based compensation | 12,441 | 11,953 |
| Accrued expenses | 2,371 | 2,310 |
| Interest expense | 2,630 | 1,345 |
| In-process research and development | 815 | 1,102 |
| Lease Liabilities | 683 | 283 |
| Issuance costs | 221 | — |
| Other | 988 | 877 |
| Total deferred tax assets | 169,324 | 143,887 |
| Less—valuation allowance | (168,555) | (143,566) |
| Deferred tax assets, net of valuation allowance | 769 | 321 |
| Right-of-use asset | (725) | (276) |
| Depreciation of fixed assets | (44) | (45) |
| Total deferred tax liabilities | (769) | (321) |
| Net deferred tax assets | $— | $— |
The change in valuation allowance for the years ended* December 31, 2024* and2023 were as follows (in thousands):
| 2024 | 2023 | |
|---|---|---|
| Balance at the beginning of the year | $(143,566) | $(129,601) |
| Changes during the year | (24,989) | (13,965) |
| Balance at the end of the year | $(168,555) | $(143,566) |
The main reconciling items between the statutory tax rates of the Company and the effective rate are nondeductible expenses related to financing on the prepaid forward obligation and share-based compensation, the provision for a full valuation allowance in respect of tax benefits from carryforward tax losses due to the uncertainty of the realization of such tax benefits, utilization of tax credits and expense related to uncertain tax positions. A reconciliation of the Company’s statutory tax rate to effective tax is as follows (in thousands, except statutory rate):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Pretax loss | $(124,042) | $(98,324) |
| Statutory rate | 23% | 23% |
| Income tax expense/(benefit) at statutory rate | (28,530) | (22,615) |
| Additional tax (tax saving) in respect of: | ||
| Non-deductible expenses | 6,929 | 5,704 |
| R&D and orphan drug credits | (510) | (1,197) |
| Different tax rate of foreign subsidiaries | (669) | (689) |
| Uncertain tax positions | 597 | 176 |
| Change in valuation allowance(1) | 24,989 | 22,898 |
| Other | 26 | (358) |
| Income tax expense | $2,832 | $3,920 |
(1) In the course of preparing the2022 tax returns, adjustments were made for certain nondeductible amounts, reducing net operating loss carryforward and reflected as a change in valuation allowance of approximately $8.9 million in2023.
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Pretax loss for* December 31, 2024* and2023 includes pretax loss from foreign (United States) jurisdictions of $11.0 million and $17.9 million, respectively.
The Internal Revenue Code of1986, as amended (the “Code”), contains provisions that* maylimit our use of federal net operating loss carryforwards if significant changes occur in the constructive stock ownership of UroGen Pharma, Inc. In the event it has had an “ownership change” within the meaning of Section382* of the Code, utilization of its net operating loss carryforwards could be restricted under Section382 of the Code and similar state provisions. Such limitations could result in the expiration of the net operating carryforwards incurred before2018 before their utilization.
Losses for tax purposes carried forward to future years
As of* December 31, 2024* and2023, the Company had approximately $533.9 million and $452.0 million of carryforward tax losses, prior to tax effecting, respectively, available to reduce future taxable income without limitation of use. The Company's carryforward tax losses relate to losses generated in Israel and can be carried forward indefinitely.
Uncertain tax positions
A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands):
| 2024 | 2023 | |
|---|---|---|
| Unrecognized tax benefits at the beginning of the year | $1,974 | $1,974 |
| Gross increases — tax positions in current period | — | — |
| Gross increases — tax positions in prior period | — | — |
| Unrecognized tax benefits at the end of the year | $1,974 | $1,974 |
The liability for uncertain tax positions of $3.8 million as of* December 31, 2024* is related to transfer pricing between affiliated entities. The uncertain tax positions liability on the consolidated balance sheets includes $1.8 million and $1.2 million of accrued interest and penalties related to unrecognized tax benefits at* December 31, 2024and December 31, 2023,respectively. The Company recognizes interest accrued and penalties related to uncertain tax positions as a component of income tax expense. If recognized, balances of uncertain tax positions as of December 31, 2024* would result in incremental net operating loss carryforwards, which would be expected to require a full valuation allowance based on present circumstances, therefore, the uncertain tax positions willnot impact the effective tax rate.
The Company operates on a global basis and is subject to tax laws and regulations in the United States and Israel. The estimate of the Company’s tax liabilities relating to uncertain tax positions requires management to assess uncertainties and to make judgments about the application of complex tax laws and regulations, expectations regarding the outcome of tax authority examinations, as well as the ultimate measurement of potential liabilities.
The uncertain tax positions are reviewed quarterly and adjusted as events occur that could affect potential liabilities for additional taxes, including lapsing of applicable statutes of limitations, correspondence with tax authorities, proposed assessments by tax authorities, identification of new issues, and issuance of new legislation or regulations. The Company recognizes its gross uncertain tax positions as a long-term liabilities. The Company believes that adequate amounts of tax have been provided in income tax expense for any adjustments that* mayresult from its uncertain tax positions. Approximately $1.4 million of the liability for uncertain tax positions relate to tax years for which the statute of limitations will expire within the next12* months. Based upon the information currently available, the Company doesnot reasonably expect any other changes in its existing uncertain tax positions in the next12 months.
The Company has received final tax assessments up to and including its2017 tax year in Israel and2020 in the US.
NOTE18 –RELATEDP ARTIES
There wereno related party transactions for the year ended* December31,* 2024. See Note15 for discussion regarding an affiliated investor in the private placement transaction for the year ended* December31,* 2023*.* See Note21 for discussion related to a subsequent event in* February 2025*which involved a related party.
NOTE19 –COMMITMENTS ANDC ONTINGENCIES
In the normal course of business, the Company enters into contracts that contain a variety of indemnifications with its employees, licensors, suppliers and service providers. Further, the Company indemnifies its directors and officers who are, or were, serving at the Company’s request in such capacities. The Company’s maximum exposure under these arrangements is unknown as of* December 31, 2024* and2023. The Company doesnot anticipate recognizing any significant losses relating to these arrangements.
On* February 25, 2024,the Company received from Teva, a Paragraph IV Certification Notice Letter dated February 20, 2024,providing notification that Teva submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version ofJelmyto*. In the Notice Letter, Teva alleges thattwo of the patents listed in the FDA Orange Book forJelmyto, U.S. Patent Numbers9,040,074 and9,950,069, each of which expires in* January 2031,are invalid, unenforceable, or willnot* be infringed by Teva’s manufacture, use, or sale of the generic product described in its ANDA submission. On* April 2, 2024,the Company filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S. Patent Numbers9,040,074* and9,950,069 and seeking a permanent injunction preventing U.S. market entry of Teva’s generic product prior to the expiry of such patents. The Company stipulated to the dismissal of Teva Pharmaceutical Industries, Ltd. without prejudice and the action continues against the othertwo Teva entities. If the Company is unsuccessful in securing the requested court relief,Jelmyto * maybe subject to immediate competition from an FDA approved generic product after regulatory exclusivity forJelmyto* expires in* April 2027.*
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Separation Agreements
On* June 26, 2024,the Company entered into a separation agreement with Jeff Bova, the Company’s former Chief Commercial Officer, which sets forth the terms of Mr. Bova's termination of employment with the Company, effective as of September 30, 2024.The arrangement includes cash severance, a pro rata portion of the target annual bonus for calendar year2024,* and partial acceleration of share-based compensation. The Company recognized $1.1 million within selling, general and administrative expenses during the year ended* December**31,* 2024 in relation to this arrangement.
On* October 7, 2024,the Company entered into a separation and consulting agreement with Don Kim, pursuant to which Mr. Kim resigned from his positions as the Company’s Chief Financial Officer, principal financial officer and principal accounting officer, effective October 8, 2024.The arrangement includes cash severance, target annual bonus for calendar year2024,* a post-separation consulting arrangement, and partial acceleration of share-based compensation. The Company recognized $0.8 million within selling, general and administrative expenses during the year ended* December**31,* 2024 in relation to this arrangement.
Leases
See Note11 for further discussion regarding lease commitments.
NOTE20 –Segment Reporting
The Company is engaged in the development and commercialization of innovative solutions for the treatment of urothelial and specialty cancers. The Company has asingle operating segment and reportable segment focused on these business activities, and its operations are managed on a consolidated basis. The primary revenue source for the segment comes from sales of the Company’s approved product, Jelmyto, primarily conducted in the United States.
The Company’s Chief Operating Decision Maker (“CODM”) is the Chief Executive Officer (“CEO”). The CODM assesses performance and allocates resources based on net income or loss, which is the primary measure of performance, as reported in the Consolidated Statements of Operations and Comprehensive Loss. Additionally, net income or loss is used to monitor performance relative to budgeted targets and to evaluate financial performance in relation to the Company’s strategic goals. For additional information, refer to the Consolidated Statements of Operations and Comprehensive Loss for detailed measures of segment revenues, expenses, and profit or loss.
Information about significant segment expenses regularly provided to the CODM is as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Research and development expenses | ||
| R&D project materials & services | $38,556 | $26,928 |
| Employee compensation | 14,882 | 14,796 |
| Rent, office, utilities & technology | 2,972 | 3,569 |
| Other expenses | 735 | 321 |
| Total research and development expenses | $57,145 | $45,614 |
| Selling, general and administrative expenses | ||
| Employee compensation | $59,709 | $52,605 |
| Commercial & medical affairs services | 27,205 | 14,210 |
| Professional services | 14,031 | 11,650 |
| Travel, meetings & conferences | 12,962 | 8,796 |
| Rent, office, utilities & technology | 3,283 | 2,790 |
| Other expenses (1) | 3,964 | 3,223 |
| Total selling, general and administrative expenses | $121,154 | $93,274 |
(1) Other expenses primarily consist of insurance, sponsorship, grants, other fees and taxes.
NOTE21 –Subsequent events
On* January**24,* 2025, the Company issued 3,206,271 ordinary shares through a conversion of 3,206,271 pre-funded warrants for the purchase of ordinary shares of the Company. See Note15 for further discussion related to shareholders' equity.
On* February 14, 2025 (*the “Closing Date”), the Company entered into an Asset Purchase Agreement (the “Agreement”) with IconOVir Bio, Inc. (“IconOVir”), pursuant to which the Company purchased and acquired certain assets of IconOVir (the “Transferred Assets”), including the product candidate ICVB-1042 and certain contracts, intellectual property rights, regulatory applications, submissions and registrations, and data and other rights related thereto, and assumed certain liabilities and obligations of IconOVir arising under certain contracts of IconOVir acquired by the Company.
As consideration for the Transferred Assets and subject to the terms and conditions of the Agreement, on the Closing Date the Company (i) issued 374,843 ordinary shares of the Company (the “Company Shares”) to IconOVir, which represents a purchase price of $4.0 million divided by the volume-weighted average closing price of the Company Shares on The Nasdaq Stock Market over the30 consecutive trading days ending on (and including) the trading day immediately prior to the Closing Date, (ii) agreed to pay IconOVir aone-time payment of $15.0 million in cash upon the achievement of a cumulative aggregate worldwide net sales milestone for all products, including combination products, that incorporate or comprise ICVB-1042 (“ICVB Products”), (iii) agreed to pay IconOVir a low, single-digit percentage royalty, on an ICVB Product-by-ICVB Product basis, on the annual, worldwide net sales of such ICVB Product during the royalty term, subject to certain reductions as set forth in the Agreement, and (iv) agreed to assume certain immaterial liabilities arising under certain acquired contracts ((i), (ii), (iii), and (iv) collectively, the “Purchase Price”).
The Company also granted IconOVir certain piggyback registration rights with respect to the Company Shares issued to IconOVir, subject to customary exceptions and cutback rights.
Entities affiliated with Arie Belldegrun, M.D., the Chair of the Board of Directors of the Company, hold certain promissory notes of IconOVir that* may*entitle such entities to receive, in the aggregate, approximately 28.3% of the Purchase Price paid to IconOVir pursuant to the Agreement.
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NOTE22 - SELECTED UNAUDITED QUARTERLY FINANCIAL DATA
Certain unaudited selected quarterly financial results for the quarters within2024 and2023 are presented as follows:
| For the Three Months Ended March 31 | For the Three Months Ended June 30 | For the Six Months Ended June 30 | For the Three Months Ended September 30 | For the Nine Months Ended September 30 | For the Three Months December 31 | For the Year Ended December 31 | |
|---|---|---|---|---|---|---|---|
| Revenue | $18,781 | $21,848 | $40,629 | $25,204 | $65,833 | $24,565 | $90,398 |
| Gross profit | $17,053 | $19,619 | $36,672 | $22,751 | $59,423 | $22,094 | $81,517 |
| Net loss | $(32,286) | $(33,403) | $(65,689) | $(23,673) | $(89,362) | $(37,512) | $(126,874) |
| Weighted-average number of ordinary shares (1) | 37,059,186 | 40,501,315 | 38,785,924 | 46,779,637 | 41,476,892 | 47,030,820 | 42,876,737 |
| Basic and diluted loss per ordinary share (1) | $(0.87) | $(0.82) | $(1.69) | $(0.51) | $(2.15) | $(0.80) | $(2.96) |
(1) The loss per share, both basic and diluted, for the first, second, andthird quarters of2024 was revised to record an immaterial correction to the amounts originally reported in the* March 31, 2024Form10*-Q filed on* May 13, 2024,** June 30, 2024Form10*-Q filed on* August 13, 2024,and September 30, 2024Form10*-Q filed on* November 6, 2024,by incorporating the 3,679,400 shares of pre-funded warrants outstanding as of each respective reporting period, which werenot* included in the previous calculations and are now reflected in the weighted average shares outstanding.
| For the Three Months Ended March 31 | For the Three Months Ended June 30 | For the Six Months Ended June 30 | For the Three Months Ended September 30 | For the Nine Months Ended September 30 | For the Three Months December 31 | For the Year Ended December 31 | |
|---|---|---|---|---|---|---|---|
| Revenue | $17,192 | $21,139 | $38,331 | $20,852 | $59,183 | $23,530 | $82,713 |
| Gross profit | $14,927 | $18,696 | $33,623 | $18,485 | $52,108 | $21,244 | $73,352 |
| Net loss | $(30,213) | $(24,136) | $(54,349) | $(21,879) | $(76,228) | $(26,016) | $(102,244) |
| Weighted-average number of ordinary shares | 23,279,951 | 23,462,016 | 23,371,878 | 32,298,182 | 26,358,719 | 36,153,634 | 28,834,303 |
| Basic and diluted loss per ordinary share | $(1.30) | $(1.03) | $(2.33) | $(0.68) | $(2.89) | $(0.72) | $(3.55) |
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The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.