What changed in this filing

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Item 8. Financial Statements and Supplementary Data

2025-03-10 compared with 2024-03-14 · 379 added, 179 removed, 701 unchanged (44% of the section changed)

14 unchanged sentences

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.

Substantial Doubt About the Company ’ s Ability to Continue as a Going Concern

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern.

As discussed in Note 2 to the consolidated financial statements, the Company has incurred losses and experienced negative operating cash flows since its inception that raise substantial doubt about its ability to continue as a going concern.

Management's plans in regard to these matters are also described in Note 2.

The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

12 unchanged sentences

We believe that our audits provide a reasonable basis for our opinion.

Emphasis of Matter

As discussed in Note 2 to the 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 may need to raise additional capital in the future or reduce operating expenditures.

Management’s evaluation of the events and conditions and management’s plans to mitigate these matters are also described in Note 2.

Critical Audit Matters

2 unchanged sentences

Revenue Recognition - Gross Revenue from Product Sales

As described in Notes 1, 3 and 12 to the consolidated financial statements, product sales from the Company’s commercial product, Jelmyto, are recognized as revenue 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 includes gross revenue and management’s estimate of returns, consideration paid to the customer, chargebacks relating to differences between the wholesale acquisition cost and the contracted price offered to the end consumer, chargebacks relating to 340B drug pricing programs and other government sponsored programs, Medicaid drug rebate programs, the Company’s copay assistance program, and Medicare refunds for discarded drug.

As described in Notes 1, 3 and 12 to the consolidated financial statements, product sales from the Company’s commercial product, Jelmyto, are recognized as revenue 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 of Jelmyto are recognized through the Company's arrangements with two customers as defined by ASC 606, both of which are third-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 to 340B 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’s consolidated net revenue was $90.4 million for the year ended December 31, 2024, of which gross revenue from product sales represented a majority.

1 unchanged sentence

Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements.

These procedures included, among others (i) testing the Company’s reconciliation of gross revenue recognized from product sales to third-party information, (ii) evaluating reconciling items, as applicable, (iii) confirming sales terms with the Company’s single customer, (iv) confirming accounts receivable from product sales of Jelmyto with the Company’s single customer, and (v) evaluating a sample of gross revenue transactions by obtaining and inspecting source documents, including the customer contract, purchase orders, invoices, proof of delivery, cash remittances, and bank statements, as applicable.

These procedures included, among others (i) testing the Company’s reconciliation of gross revenue recognized from product sales to third-party information, (ii) evaluating reconciling items, as applicable, (iii) confirming sales terms with the Company’s customers, (iv) confirming a sample of outstanding customer invoice balances as of December 31, 2024, and (v) evaluating a sample of gross revenue transactions by obtaining and inspecting source documents, including the customer contract, purchase orders, invoices, proof of delivery, cash remittances, and bank statements, as applicable.

/s/ PricewaterhouseCoopers LLP

11 unchanged sentences

Restricted cash

Accounts receivable

Accounts receivable, net

20,302 15,443

Prepaid expenses and other current assets

10,281 11,101

Total current assets

12 unchanged sentences

Employee related accrued expenses

10,570 10,814

Other current liabilities

19 unchanged sentences

( 806,222 ) ( 679,348 )

Accumulated other comprehensive income (loss)

Accumulated other comprehensive income

Total Shareholders' Deficit

7 unchanged sentences

Year Ended December 31,

$ 90,398 $ 82,713

Cost of revenue

81,517 73,352

Operating expenses:

Research and development expenses

57,145 45,614

Selling, general and administrative expenses

121,154 93,274

Operating loss

( 96,782 ) ( 65,536 )

Financing on prepaid forward obligation

( 23,411 ) ( 21,552 )

Interest expense on long-term debt

( 12,521 ) ( 14,715 )

Interest and other income, net

Loss before income taxes

( 124,042 ) ( 98,324 )

Income tax expense

( 2,832 ) ( 3,920 )

$ ( 126,874 ) $ ( 102,244 )

Statements of Comprehensive Loss

$ ( 126,874 ) $ ( 102,244 )

Other comprehensive income (loss)

Unrealized gain (loss) on investments

Unrealized gain on investments

Comprehensive Loss

$ ( 126,830 ) $ ( 102,125 )

Net loss per ordinary share - basic and diluted

$ ( 2.96 ) $ ( 3.55 )

Weighted average number of shares outstanding used in computation of basic and diluted loss per ordinary share

42,876,737 28,834,303

The accompanying notes are an integral part of these consolidated financial statements.

8 unchanged sentences

Balance as of December 31, 2022

23,129,953 $ 63 $ 487,787 $ (577,104 ) $ (107 ) $ (89,361 )

Changes during 2023

Exercise of options into ordinary shares

460,053 1 872 873

Share-based compensation

Other comprehensive loss

Issuance of pre-funded warrants, net of issuance costs

48,700 48,700

Conversion of pre-funded warrants into ordinary shares

1,599,733 5 ( 5 ) —

Issuance of ordinary shares, net of issuance costs

7,300,380 20 67,338 67,358

Other comprehensive income

(102,244 ) (102,244 )

Balance as of December 31, 2023

32,490,119 $ 89 $ 614,035 $ ( 679,348 ) $ 12 $ ( 65,212 )

Changes during 2024

Exercise of options into ordinary shares

419,731 1 320 321

Share-based compensation

13,108 13,108

Issuance of pre-funded warrants, net of issuance costs

Conversion of pre-funded warrants into ordinary shares

18,641 18,641

Issuance of ordinary shares, net of issuance costs

9,321,896 25 151,144 151,169

Other comprehensive income

( 126,874 ) ( 126,874 )

Balance as of December 31, 2024

42,231,746 $ 115 $ 797,248 $ (806,222 ) $ 56 $ (8,803 )

The accompanying notes are an integral part of these consolidated financial statements.

7 unchanged sentences

Depreciation and amortization

Inventory Obsolescence

Accrued financing on prepaid forward obligation

4 unchanged sentences

Amortization (accretion) of discount on long-term debt

( 1,305 ) 1,014

Amortization of right-of-use assets

1 unchanged sentence

( 3,554 ) ( 1,348 )

Accounts receivable

Accounts receivable, net

( 4,859 ) ( 2,739 )

Prepaid expenses and other current assets

820 ( 3,626 )

Other non-current assets

702 ( 1,269 )

Accounts payable and accrued expenses

Employee related accrued expenses

( 244 ) 2,557

Other current liabilities

1 unchanged sentence

( 1,034 ) ( 987 )

Restricted deposit

Uncertain tax positions

8 unchanged sentences

( 295 ) ( 194 )

Net cash (used in) provided by investing activities

Net cash used in investing activities

( 20,613 ) ( 953 )

1 unchanged sentence

Proceeds from exercise of options into ordinary shares

Proceeds from issuance of long-term debt

Proceeds from pre-funded warrant issuance, net of $ 1,654 of issuance costs

Proceeds from ordinary share issuance, net of $ 2,288 of issuance costs

Issuance cost related to at-the-market issuances

Proceeds from issuance of long-term debt, net of issuance costs

Proceeds from pre-funded warrant issuance, net of issuance costs

18,641 48,700

Proceeds from ordinary shares issuance, net of issuance costs

151,169 67,358

Net cash provided by financing activities

18 unchanged sentences

UPL and UPI (together the “Company”) is a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers.

Since commencing operations, the Company has devoted substantially all of its efforts to securing intellectual property rights, performing research and development activities, including conducting clinical trials and manufacturing activities, hiring personnel, launching the Company’s first commercial product, Jelmyto (mitomycin) for pyelocalyceal solution, formerly known as UGN- 101, clinical development of UGN- 102, and raising capital to support and expand these activities.

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, 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 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.

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.

Jelmyto consists of mitomycin, an established chemotherapy, and sterile hydrogel, using the Company's proprietary sustained release RTGel 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

5 unchanged sentences

All material intercompany balances and transactions have been eliminated during consolidation.

In accordance with the accounting guidance related to the presentation of financial statements, management evaluates whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern for the next twelve months from the date the financial statements are issued.

In accordance with the accounting guidance related to the presentation of financial statements, management evaluates whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern for the next 12 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 do not 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 its ability to raise additional capital to fund its operations, produce cash inflows from Jelmyto product sales and develop UGN- 102.

The Company believes that absent sufficient proceeds received from equity, financing, or business development transactions, the Company will not have sufficient cash and cash equivalents to fund its operations beyond one year from the issuance of these financial statements.

Accordingly, the Company will, over the next twelve months, require significant additional financing to continue its operations.

In addition, there can be no assurances that the Company will be able to secure such additional financing if at all, on terms that are satisfactory to the Company, and in amounts sufficient to meet its needs.

These factors raise substantial doubt about the ability of the Company to continue as a going concern.

Failure to successfully receive additional financing will require the Company to delay, limit or reduce product development and commercialization efforts.

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 beyond one 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 may need to raise additional capital in the future or reduce operating expenditures.

There can be no 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 is not 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

4 unchanged sentences

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.

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.

13 unchanged sentences

Cash and cash equivalents and marketable securities totaled $ 241.7 million as of December 31, 2024.

Available-for-sale debt securities are carried at fair value with unrealized gains and losses reported in other comprehensive income/loss within shareholders’ equity.

The Company accounts for its investments, which include cash equivalents and marketable securities, as available-for-sale in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 320, “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.

17 unchanged sentences

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’s accounts receivables are composed of net sales of Jelmyto arising from the Company's arrangements with two 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 has not experienced any credit losses related to this customer and has not currently recognized any allowance for doubtful accounts.

The Company has not experienced any credit losses related to arrangements with customers and has not currently recognized any allowance for doubtful accounts.

UROGEN PHARMA LTD.

11 unchanged sentences

For Jelmyto , the Company commenced capitalization of inventory at the receipt of FDA approval.

Costs related to inventories that are not expected to be manufactured and sold within the next 12 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.

11 unchanged sentences

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 Company is party to a transaction with RTW Investments (the “RTW Transaction”) in which the Company received funds to support the launch of Jelmyto and the development of UGN- 102 in return for tiered, future cash payments based on net sales of Jelmyto 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 Topic 835 - 30, “Imputation of Interest”.

See Note 9 for further discussion related to the prepaid forward obligation.

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.

Long-Term Debt

4 unchanged sentences

See Note 10 for further discussion related to long-term debt.

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 right-of-use assets on the 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 long-term lease liabilities on the consolidated balance sheets.

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 Topic 842, “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.

UROGEN PHARMA LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

Lease expense is recognized on a straight-line basis for operating leases.

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 operating expense on the consolidated statements of operations in the same line item as expense arising from fixed lease payments.

Variable lease payments are presented as selling, general and administrative expenses in the consolidated statements of operations.

The Company has elected the practical expedient to not separate between lease and non-lease components.

The Company’s lease terms may include options to extend the lease.

2 unchanged sentences

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.

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.

ROU assets 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.

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 of Jelmyto are recognized through the Company's arrangements with two customers as defined by ASC 606, both of which are third -party national specialty distributors.

Research and Development Expenses

16 unchanged sentences

Pre-funded Warrants

The Company issued pre-funded warrants in connection with a private placement transaction that are accounted for as a freestanding equity-linked financial instrument that meets the criteria for equity classification under ASC 480, “Distinguishing Liabilities from Equity,” and ASC 815, “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 issuance date using a relative fair value allocation method.

The Company valued the pre-funded warrants at issuance, concluding that their sales price approximated their fair value, and allocated the net sales proceeds from the private placement transaction proportionately to the ordinary shares and pre-funded warrants.

See Note 15 for further discussion related to the private placement transaction.

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 ASC 480, “Distinguishing Liabilities from Equity,” and ASC 815, “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

2 unchanged sentences

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

The Company’s pre-funded warrants requires the holder to pay nominal consideration to receive the Company’s ordinary shares and are therefore considered outstanding shares in determining basic and diluted earnings per share in accordance with ASC Topic 260, “Earnings per Share”.

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 Topic 260, “Earnings per Share.”

UROGEN PHARMA LTD.

15 unchanged sentences

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 is currently evaluating the potential impact of the adoption of ASU 2023 - 07 on the Company’s financial disclosures.

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 Update No.

4 unchanged sentences

ASU 2023 - 09 allows for adoption using either a prospective or retrospective transition method.

In November 2024, the FASB issued Accounting Standards Update No.

2024 - 03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220 - 40 ) ("ASU 2024 - 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 ASU 2024 - 03 on the Company’s financial disclosures.

The Company has reviewed other Accounting Standards Updates recently issued by the FASB, and determined that none of these pronouncements will have a significant impact on the Company's consolidated financial statements and related disclosures.

5 unchanged sentences

Accounts payable

$ 10,931 $ 6,514

Accrued sales reserves

4 unchanged sentences

Total accounts payable and accrued expenses

$ 27,431 $ 16,538

Interest and Other Income, Net

2 unchanged sentences

Interest income

Other income, net

$ 8,901 $ 2,641

Other income (loss), net

Total interest and other income, net

$ 8,672 $ 3,479

N OTE 5 – I NVENTORIES

3 unchanged sentences

Raw materials (1)

$ 4,924 $ 4,464

Finished goods

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, 2024 and December 31, 2023, respectively.

Changes in non-current assets are reflected on the consolidated statements of cash flows within the caption of other non-current assets.

These raw materials are not expected to be manufactured and sold within the next 12 months.

Changes in non-current inventories are reflected on the consolidated statements of cash flows within the caption of other non-current assets.

N OTE 6 – F AIR V ALUE M EASUREMENTS

23 unchanged sentences

Money market funds

$ 41,008 $ 41,008 $ —

Marketable securities

$ 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 Level 1 and Level 2 fair value measurement criteria as of December 31, 2023 are as follows (in thousands):

3 unchanged sentences

Identical Assets

Cash equivalents

Money market funds

$ 9,704 $ 9,704 $ —

Marketable securities

$ 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.

8 unchanged sentences

Money market funds

$ 41,008 $ — $ — $ 41,008

Marketable securities

$ 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

UROGEN PHARMA LTD.

4 unchanged sentences

Unrealized Losses

Cash equivalents

Money market funds

$ 9,704 $ — $ — $ 9,704

Marketable securities

$ 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.

3 unchanged sentences

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 rising interest rates.

The unrealized loss was primarily driven by fluctuations in interest rates.

The Company does not expect to settle the debentures at a price less than the amortized cost basis of the investment;

2 unchanged sentences

As of December 31, 2024 , the Company believes the cost basis for its marketable securities were recoverable in all material aspects and no allowance for credit losses were recognized in the period.

The Company’s investments as of December 31, 2023 mature at various dates through January 2026.

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):

2 unchanged sentences

Maturities within one year

$ 105,706 $ 51,670

Maturities after one year through three years

Total investments

$ 110,728 $ 56,172

N OTE 8 – P ROPERTY AND E QUIPMENT

5 unchanged sentences

accumulated depreciation and amortization

( 4,281 ) ( 3,952 )

Property and equipment, net

1 unchanged sentence

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:

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 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 and, 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.

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.

The rate in effect for the year ended December 31, 2023 for annual net sales up to $ 200 million was 13.0 %.

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:

Pursuant to the agreement, the initial cash payment rate of 9.5% on Jelmyto 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 were not 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 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 %.

If the Company does not receive FDA approval for UGN- 102 by June 30, 2025, 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.

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 a first 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.

18 unchanged sentences

The second tranche of $ 25 million was funded in December 2022.

The facility will mature five years from initial funding and can be prepaid in whole at the Company's discretion, at any time, subject to prepayment premiums and make-whole amounts.

The loan will require interest-only payments for the first 48 months followed by principal and interest payments with interest accruing using 3 -month London Inter-Bank Offered Rate (“LIBOR”) (with a 1.25 % floor) plus 8.25 %.

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 will accrues interest using a benchmark rate of 3 -month SOFR plus a 0.26161 % adjustment.

Effective July 2023, the loan accrued interest using a benchmark rate of 3 -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 additional third and fourth tranche of senior secured loan.

The third tranche of $ 25.0 million was funded in September 2024.

The fourth tranche of $ 75.0 million will become available at the Company's option no 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, 2025 and (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 of 3 -month SOFR plus 7.25 % plus an additional adjustment of 0.26161 %.

All outstanding principal will be required to be repaid in four equal quarterly installments commencing in the second quarter of 2026, with a one -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 is not required to maintain any financial covenants.

The Company incurred financing expenses of $ 4.2 million which are recognized as a direct offset to the long-term debt on the Company's consolidated balance sheets.

The Company incurred financing expenses of $ 4.2 million related to the first and second tranches funded in 2022, and $ 0.5 million related to the third tranche funded in 2024, which are recognized as a direct offset to the long-term debt on the Company's consolidated balance sheets.

These debt issuance costs are amortized over the term of the debt using the effective interest method, and are recorded in the consolidated statements of operations as "Interest expense."

The following table shows the activity with respect to the carrying value of the long-term debt, in thousands:

Long-term debt at closing of Pharmakon loan

Capitalized costs and discounts

Carrying value of Pharmakon loan as of December 31, 2022

Interest expense

Carrying value of Pharmakon loan as of December 31, 2023

Third tranche of Pharmakon loan

Capitalized costs and discounts

Interest expense

2 unchanged sentences

Operating Leases

The Company had the following office and laboratory facility leases as of December 31, 2023 :

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.

4 unchanged sentences

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 $ 0.1 million as of December 31, 2023 .

In November 2019, UPI entered into a sublease for this office space, with a lease commencement date of January 1, 2020 and terminating at the end of the lease term in March 2024.

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 remaining rental payments to be received over the lease term is approximately $ 0.1 million as of December 31, 2023 .

The Company accounts for the sublease as on operating lease in accordance with ASC 842.

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.

2 unchanged sentences

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.

1 unchanged sentence

The Company’s leases do not contain any residual value guarantees or material restrictive covenants.

The Company’s leases expire at various dates from 2024 through 2026, with varying renewal and termination options.

The Company’s active leases expire at various dates from 2025 through 2028, with varying renewal and termination options.

The components of lease cost for the year ended December 31, 2024 and 2023 were as follows (in thousands):

1 unchanged sentence

Year Ended December 31, 2023

Finance lease cost:

Amortization of right-of-use assets

Interest on lease liabilities

Operating lease cost

Sublease income

( 42 ) ( 224 )

Variable lease cost

2 unchanged sentences

Year Ended December 31, 2023

Right-of-use assets

Long-term lease liabilities

Other current liabilities

Finance lease right-of-use assets

$ 2,285 $ 1,671

Operating lease right-of-use assets

Finance long-term lease liabilities

Operating long-term lease liabilities

Other current liabilities related to finance leases

Other current liabilities related to operating leases

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 term and discount rate amounts):

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

2 unchanged sentences

Operating cash flows from operating leases

$ 933 $ 1,169

Right-of-use assets obtained in exchange for new finance lease liabilities

Right-of-use assets obtained in exchange for new operating lease liabilities

Weighted-average remaining lease term of finance leases (in years)

Weighted-average remaining lease term of operating leases (in years)

Weighted-average discount rate of finance leases

Weighted-average discount rate of operating leases

10.24 % 10.21 %

UROGEN PHARMA LTD.

1 unchanged sentence

As of December 31, 2024 , maturities of lease liabilities were as follows (in thousands):

Operating Leases

Finance Leases

Years ending December 31,

1 unchanged sentence

Present value of lease liabilities

As of December 31, 2022 , maturities of lease liabilities were as follows (in thousands):

Operating Leases

2 unchanged sentences

Present value of lease liabilities

As of December 31, 2023 , 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,

Total future minimum sublease payments

As of December 31, 2022 , undiscounted cash flows to be received under the Company’s operating sublease on an annual basis was as follows (in thousands):

Operating Leases

Years ending December 31,

Total future minimum sublease payments

N OTE 12 – R EVENUE F ROM P RODUCT S ALES

2 unchanged sentences

Year Ended December 31, 2023

Reserves related to items that are contractually able to be net settled are recognized as contra accounts receivable while other remaining reserves are recognized within other current liabilities on the consolidated balance sheets.

$ 90,398 $ 82,713

All product sales of Jelmyto are recognized through the Company's arrangements with two customers as defined by ASC 606, both of which are third -party national specialty distributors.

The Company's largest customer comprises over 90 % of product sales throughout the full year 2024, and approximately 80 % of accounts receivables at December 31, 2024.

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 is not 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 and 2023 , in thousands:

Reserves related to government sponsored programs

Medicare refunds for discarded drug reserve

Other reserves

1 unchanged sentence

Balance as of December 31, 2022

$ 590 $ — $ 847 $ 1,437

Changes during 2023

11,110 3,451 8,807 23,368

( 10,638 ) — ( 8,196 ) ( 18,834 )

Balance as of December 31, 2023

$ 1,062 $ 3,451 $ 1,458 $ 5,971

Changes during 2024

13,870 3,920 11,273 29,063

( 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

UROGEN PHARMA LTD.

4 unchanged sentences

("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 as AGEN1884 (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 using RTGel technology that is in Phase 1 clinical development for high-grade NMIBC.

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 the sequential use of UGN- 201 and UGN- 301 as an investigational treatment for high-grade NMIBC.

Pursuant to the agreement, the Company has made bi-annual payments totaling $ 2.0 million to MD Anderson to fund the collaboration, recognized evenly over the associated period through research and development expenses.

In July 2022, the Company determined that it had achieved the objectives that it established when the agreement was initiated, and notified MD Anderson that it was exercising its right to conclude the collaboration in 2022 as the Company did not foresee initiating further development activities as part of the collaboration, although the Company will continue to collaborate on existing joint projects.

As a result of this notification, the Company is not responsible for any further fixed bi-annual funding payments in 2023, although the Company will be responsible for costs related to existing joint projects to the extent they exceed the payments already made to MD Anderson.

UGN- 301 is a formulation of zalifrelimab administered using RTGel technology that is in Phase 1 clinical development for high-grade non-muscle invasive bladder cancer.

N OTE 14 – E MPLOYEE R IGHTS U PON R ETIREMENT

13 unchanged sentences

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.

Since the Company's inception, the Board has not 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 the first quarter of 2024, 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 July 26, 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, 2023 and 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 will not expire until exercised in full.

The pre-funded warrants may not 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.

The pre-funded warrants may not 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 (File No.

333 - 274423 ) filed with the U.S.

Securities and Exchange Commission (“SEC”) on September 8, 2023, which was declared effective on September 15, 2023.

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, purchased 1,572,327 of the Shares in the Private Placement, for an aggregate purchase price of $ 15.0 million.

Cohen is the Chair and Chief Investment Officer of Monograph.

(“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.

Cohen was the Chair and Chief Investment Officer of Monograph at the time of purchase.

Underwritten Public Offering

On June 17, 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 will not expire until exercised in full.

In addition, the Underwriters were granted an option exercisable for 30 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.

N OTE 16 – S HARE- B ASED C OMPENSATION

7 unchanged sentences

For non-employees and for non-Israeli employees, the Plans 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.

Employees are typically granted stock options and/or RSUs, upon commencement of employment.

Also, eligible employees may receive 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.

5 unchanged sentences

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.

On January 31, 2023, the Board approved a performance stock unit ("PSU") award of 100,000 shares under the 2017 Plan to the Company's Chief Executive Officer, subject to shareholder approval.

Vesting of these PSUs will depend upon obtaining regulatory approval for the Company’s lead product candidate UGN- 102 in the three years following the grant.

The PSU award was approved by the Company’s shareholders at the 2023 Annual Shareholders’ Meeting on September 7, 2023.

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 the first 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 of 2025.

The Company accounted for the modification as a Type I probable-to-probable modification under ASC 718.

As the modification did not 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 the 2017 Plan was 1,400,000 .

On January 1, 2018, the share reserve increased by 250,167 to 1,650,167 shares.

On October 12, 2018, the Company increased the number of ordinary shares authorized for issuance under the 2017 Plan by 1,900,000 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 the 2017 Plan by 400,000 to 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 the 2017 Plan by 400,000 to 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 the 2017 Plan by 400,000 to 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 the 2017 Plan by 450,000 to 5,200,167 shares.

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 the 2017 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 the 2017 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 the 2017 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 the 2017 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 the 2017 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 the 2017 Plan by 800,000 shares to a total of 6,000,167 shares.

In May 2019, the Company adopted the UroGen Pharma Ltd.

2 unchanged sentences

The only persons eligible to receive grants under the Inducement Plan are individuals who satisfy the standards for inducement grants under Nasdaq Marketplace Rule 5635 (c)( 4 ) 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.

In December 2021, the Board approved a 300,000 increase in the share reserve of the Inducement Plan to 1,200,000 shares.

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.

5 unchanged sentences

During 2024, the Company granted 238,614 options with exercise prices ranging from $ 13.11 to $ 15.16 per share.

During 2022 , the Company granted 410,064 options with exercise prices ranging from $ 5.19 to $ 11.88 per share.

The fair value of options granted during 2023 and 2022 was $ 4.3 million and $ 2.2 million, respectively.

The weighted average fair value of options granted during 2024 and 2023 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.

3 unchanged sentences

13.11 - 15.16

5.19 9 11.88 8

Dividend yield

1 unchanged sentence

81.00 %- 89.12 % 67.21 %- 81.00 %

72.35 %- 81.00 %

Risk-free interest rate

3.61 %- 4.42 % 3.47 %- 4.42 %

1.69 %- 4.14 %

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.

1 unchanged sentence

The following table summarizes the number of employee and non-employee options outstanding under the Plan for the years ended December 31, 2023 and 2022 , and related information:

Number of options

Weighted Average price per share

Outstanding as of December 31, 2021

The following table summarizes the number of employee and non-employee options outstanding under the Plans for the years ended December 31, 2024 and 2023 , and related information:

average exercise price

average remaining

contractual life

Outstanding as of December 31, 2023

2,685,796 $ 25.35 7.37 $ 5,131

238,614 13.80

( 277,901 ) 24.05

( 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

UROGEN PHARMA LTD.

1 unchanged sentence

The intrinsic value of stock options exercised was $ 0.2 million and $ 0.7 million for the years ended December 31, 2024 and 2023 , respectively.

The following table summarizes the outstanding and exercisable options as of December 31, 2023 :

Options outstanding

Options exercisable

Exercise price per share

Number of options outstanding at end of year

Weighted average remaining contractual life

Number of options exercisable at end of year

Weighted average remaining contractual life

10.01 - 20.00

20.01 - 30.00

30.01 - 40.00

40.01 - 50.00

50.01 - 59.23

The aggregate intrinsic value of the total vested and exercisable options as of December 31, 2023 is $ 1.6 million.

The following table summarizes information about RSU activity as of December 31, 2024 :

3 unchanged sentences

Outstanding as of December 31, 2024

Vested and released

Outstanding as of December 31, 2023

The fair value of RSUs granted during 2024 and 2023 was $ 14.5 million and $ 10.4 million, respectively.

3 unchanged sentences

Research and development expenses

$ 2,235 $ 1,905

Selling, general and administrative expenses

Total share-based compensation expense

$ 13,108 $ 9,344

UROGEN PHARMA LTD.

19 unchanged sentences

12,441 11,953

Accrued expenses

Interest expense

In-process research and development

Lease Liabilities

Issuance costs

Total deferred tax assets

169,324 143,887

Less—valuation allowance

( 168,555 ) ( 143,566 )

Deferred tax assets, net of valuation allowance

Right-of-use asset

( 725 ) ( 276 )

Lease Liabilities

Accrued expenses

Depreciation of fixed assets

( 44 ) ( 45 )

Less—valuation allowance

Total deferred tax liabilities

( 769 ) ( 321 )

24 unchanged sentences

$ 2,832 $ 3,920

(1) In the course of preparing the 2022 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 in the current year.

( 1 ) In the course of preparing the 2022 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 in 2023.

UROGEN PHARMA LTD.

1 unchanged sentence

Pretax loss for December 31, 2024 and 2023 includes pretax loss from foreign (United States) jurisdictions of $ 11.0 million and $ 17.9 million, respectively.

The Internal Revenue Code contains provisions that may limit our use of federal net operating loss carryforwards if significant changes occur in the constructive stock ownership of UroGen Pharma Inc.

The Internal Revenue Code of 1986, as amended (the “Code”), contains provisions that may limit 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 Section 382 of the Code, utilization of its net operating loss carryforwards could be restricted under Section 382 of the Code and similar state provisions.

2 unchanged sentences

As of December 31, 2024 and 2023 , 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 uncertain tax positions is as follows (in thousands):

Uncertain tax positions at the beginning of the year

A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands):

Unrecognized tax benefits at the beginning of the year

$ 1,974 $ 1,974

1 unchanged sentence

Gross increases — tax positions in prior period

Uncertain tax positions at the end of the year

Unrecognized tax benefits at the end of the year

$ 1,974 $ 1,974

The balances of uncertain tax positions as of December 31, 2023 would affect the Company’s effective tax rate if recognized.

The Company has recorded a liability for uncertain tax positions of $ 3.2 million as of December 31, 2023 for tax positions relating to transfer pricing between affiliated entities.

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, 2024 and December 31, 2023, respectively.

The Company recognizes interest accrued and penalties related to uncertain tax positions as a component of income tax expense.

As of December 31, 2023 , the Company's liability for uncertain tax positions includes $ 1.2 million of accrued interest and penalties.

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 will not 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.

1 unchanged sentence

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 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.

The Company has received final tax assessments up to and including its 2017 tax year.

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 next 12 months.

Based upon the information currently available, the Company does not reasonably expect any other changes in its existing uncertain tax positions in the next 12 months.

The Company has received final tax assessments up to and including its 2017 tax year in Israel and 2020 in the US.

N OTE 18 – R ELATED P ARTIES

See Note 15 for discussion regarding an affiliated investor in the Private Placement for the year ended December 31, 2023.

There were no related party transactions for the year ended December 31, 2024.

See Note 15 for discussion regarding an affiliated investor in the private placement transaction for the year ended December 31, 2023 .

See Note 21 for discussion related to a subsequent event in February 2025 which involved a related party.

N OTE 19 – C OMMITMENTS AND C ONTINGENCIES

3 unchanged sentences

The Company does not anticipate recognizing any significant losses relating to these arrangements.

On February 25, 2024, we received a Paragraph IV Certification Notice Letter from Teva, providing notification that Teva has submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of Jelmyto .

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 of Jelmyto .

In the Notice Letter, Teva alleges that two of the patents listed in the FDA Orange Book for Jelmyto , U.S.

Patent Numbers 9,040,074 and 9,950,069, each of which expires in January 2031, are invalid, unenforceable, or will not be infringed by Teva’s manufacture, use, or sale of the generic product described in its ANDA submission.

If we are unable to maintain patent protection for Jelmyto , Jelmyto will be subject to immediate competition from generic entrants after regulatory exclusivity expires in April 2027.

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 Numbers 9,040,074 and 9,950,069 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 other two Teva entities.

If the Company is unsuccessful in securing the requested court relief, Jelmyto may be subject to immediate competition from an FDA approved generic product after regulatory exclusivity for Jelmyto expires in April 2027.

UROGEN PHARMA LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

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 year 2024, 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 year 2024, 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.

See Note 11 for further discussion regarding lease commitments.

N OTE 20 – S UBSEQUENT E VENTS

In February 2024, the Company sold 1,400,468 ordinary shares under the ATM Sales Agreement, for gross proceeds of approximately $ 26.6 million.

The net proceeds to the Company after deducting sales commissions to Cowen were approximately $ 25.9 million.

Following such sale, the remaining capacity under the ATM Sales Agreement is approximately $ 56.8 million.

On March 13, 2024, we entered into an amended and restated loan agreement with Pharmakon for an additional third and fourth tranche of senior secured loan.

The third tranche of $25.0 million is mandatory and required to be drawn by September 30, 2024, subject to satisfaction of customary conditions.

The fourth tranche of $ 75.0 million may be drawn at our option no later than August 29, 2025, subject to (i) having successfully drawn the immediately preceding $25.0M tranche, (ii) receiving FDA approval of an NDA for UGN- 102 no later than June 30, 2025 and (iii) satisfaction of customary conditions.

All outstanding loans with Pharmakon accrue interest using a benchmark rate of 3 -month SOFR plus 7.25 % plus an additional adjustment of 0.26161%.

All outstanding principal will be required to be repaid in four equal quarterly installments commencing in the second quarter of 2026, with a one -year extension upon FDA approval of an NDA for UGN- 102.

All outstanding loans with Pharmakon can be prepaid in whole at the Company's discretion, at any time, subject to prepayment premiums, make-whole amounts and fees.

N OTE 20 – 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 a single 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,

Research and development expenses

R&D project materials & services

$ 38,556 $ 26,928

Employee compensation

14,882 14,796

Rent, office, utilities & technology

Other expenses

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

Rent, office, utilities & technology

Other expenses (1)

Total selling, general and administrative expenses

$ 121,154 $ 93,274

( 1 ) Other expenses primarily consist of insurance, sponsorship, grants, other fees and taxes.

N OTE 21 – 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 Note 15 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 the 30 consecutive trading days ending on (and including) the trading day immediately prior to the Closing Date, (ii) agreed to pay IconOVir a one -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.

UROGEN PHARMA LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

NOTE 22 - SELECTED UNAUDITED QUARTERLY FINANCIAL DATA

Certain unaudited selected quarterly financial results for the quarters within 2024 and 2023 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

$ 18,781 $ 21,848 $ 40,629 $ 25,204 $ 65,833 $ 24,565 $ 90,398

$ 17,053 $ 19,619 $ 36,672 $ 22,751 $ 59,423 $ 22,094 $ 81,517

$ ( 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, and third quarters of 2024 was revised to record an immaterial correction to the amounts originally reported in the March 31, 2024 Form 10 -Q filed on May 13, 2024, June 30, 2024 Form 10 -Q filed on August 13, 2024, and September 30, 2024 Form 10 -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 were not 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

$ 17,192 $ 21,139 $ 38,331 $ 20,852 $ 59,183 $ 23,530 $ 82,713

$ 14,927 $ 18,696 $ 33,623 $ 18,485 $ 52,108 $ 21,244 $ 73,352

$ ( 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 )

UROGEN PHARMA LTD.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 8. Financial Statements and Supplementary Data