UroGen Pharma Ltd. 10-K

Item 9A. Controls and Procedures   Evaluation of Disclosure Controls and Procedures   Our management, with the participation of our chief executive and financial officers (our principal executive officer and principal financial officer, respectively), evaluated the effectiveness of our disclosures controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of December 31, 2022. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate, to allow timely decisions regarding required disclosure.   Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of December 31, 2022, our principal executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were effective at a reasonable assurance level.   Management ’ s Annual Report on Internal Control Over Financial Reporting   Management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule 13a-15(f). Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.   Management has assessed the effectiveness of our internal control over financial reporting based on the framework set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework (2013 framework). Based on our evaluation, management has concluded that our internal control over financial reporting was effective as of December 31, 2022.   Changes in Internal Control over Financial Reporting   We regularly review our system of internal control over financial reporting and make changes to our processes and systems to improve controls and increase efficiency, while ensuring that we maintain an effective internal control environment. Changes may include such activities as implementing new, more efficient systems, consolidating activities, and migrating processes. There were no changes in our internal control over financial reporting during the quarter ended December 31, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.   Item 9B. Other Information   None.   Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections   Not applicable.   92 Table of Contents   PART III   Item 10. Directors, Executive Officers and Corporate Governance   The information required by this Item and not set forth below will be set forth in the section headed “—Election of Directors” and “Information Regarding the Board of Directors and Corporate Governance” in our definitive Proxy Statement for our 2023 Annual Meeting of Shareholders to be filed with the SEC by May 1, 2023 ("Proxy Statement"), and is incorporated in this Annual Report by reference.   We have adopted a code of ethics for directors, officers (including our principal executive officer, principal financial officer and principal accounting officer) and employees, known as the Corporate Code of Ethics and Conduct. The Corporate Code of Ethics and Conduct is available on our website at  http://www.urogen.com  under the Corporate Governance section of our Investors page. We will promptly disclose on our website (i) the nature of any amendment to the policy that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions and (ii) the nature of any waiver, including an implicit waiver, from a provision of the policy that is granted to one of these specified individuals, the name of such person who is granted the waiver and the date of the waiver. Shareholders may request a free copy of the Corporate Code of Ethics and Conduct from c/o UroGen Pharma Ltd., 400 Alexander Park Dr., Princeton, NJ 08540.   Item 11. Executive Compensation   The information required by this Item will be set forth in the section headed “Executive Compensation” in the Proxy Statement and is incorporated in this Annual Report by reference.   Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters   The information required by this Item will be set forth in the section headed “Security Ownership of Certain Beneficial Owners and Management” in the Proxy Statement and is incorporated in this Annual Report by reference.   Information regarding our equity compensation plans will be set forth in the section headed “Executive Compensation” in the Proxy Statement and is incorporated in this Annual Report by reference.   Item 13. Certain Relationships and Related Transactions, and Director Independence   The information required by this Item will be set forth in the sections headed “Transactions With Related Persons” and “Information Regarding the Board of Directors and Corporate Governance” in the Proxy Statement and is incorporated in this Annual Report by reference.   Item 14. Principal Accountant Fees and Services   The information required by this Item will be set forth in the section headed “—Ratification of Selection of Independent Registered Public Accounting Firm” in the Proxy Statement and is incorporated in this Annual Report by reference.   93 Table of Contents   PART IV   Item 15. Exhibits, Financial Statement Schedules   (a)(1) Financial Statements.   The response to this portion of Item 15 is set forth under Part II, Item 8 above.   (a)(2) Financial Statement Schedules.   All schedules have been omitted because they are not required or because the required information is given in the Financial Statements or Notes thereto set forth under Item 8 above.   (a)(3) Exhibits.     Exhibit Number   Exhibit Description       2.1   Asset Purchase Agreement, dated October 1, 2015, between the Registrant and Telormedix SA (incorporated by reference to Exhibit 10.4 to the Registrant’s Registration Statement on Form F-1 (File No. 333-217201), filed with the SEC on April 7, 2017).       3.1   Articles of Association of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Report on Form 6-K (File No. 001-38079), filed with the SEC on May 18, 2017).       4.1   Reference is made to Exhibit 3.1 .       4.2   Description of the Registrant’s Ordinary Shares (incorporated by reference to Exhibit 4.2 to the Registrant’s Annual Report on Form 10-K (File No. 001-38079), filed with the SEC on March 2, 2020).       10.1*   Form of Officer Indemnity and Exculpation Agreement (incorporated by reference to Exhibit 99.2 to the Registrant’s Report Form 6-K (File No. 001-38079), filed with the SEC on July 13, 2018).       10.2*   Amended and Restated 2010 Israeli Share Option Plan (incorporated by reference to Exhibit 4.2 to the Registrant’s Annual Report on Form 20-F (File No. 001-38079), filed with the SEC on March 15, 2018).       10.3*   2017 Equity Incentive Plan, as amended.       10.4*   2017 Israeli Equity Incentive Sub Plan to the 2017 Equity Incentive Plan (incorporated by reference to Exhibit 10.7 to the Registrant’s Registration Statement on Form F-1 (File No. 333-217201), filed with the SEC on April 7, 2017).       10.5   UroGen Pharma Ltd. 2019 Inducement Plan, as amended (incorporated by reference to Exhibit 10.5 to the Registrant's Annual Report on Form 10-K (File No. 001-38079), filed with the SEC on March 21, 2022).       10.6   Form of Stock Option Grant Notice and Stock Option Agreement under the UroGen Pharma Ltd. 2019 Inducement Plan (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No. 001-38079), filed with the SEC on May 28, 2019).       10.7   Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement under the UroGen Pharma Ltd. 2019 Inducement Plan (incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K (File No. 001-38079), filed with the SEC on May 28, 2019).       10.8*   Amended and Restated Compensation Policy for Officer Holders.       10.9*   Employment Agreement by and between the Registrant and Elizabeth Barrett, dated as of January 3, 2019 (incorporated by reference to Exhibit 10.9 to the Registrant’s Annual Report on Form 10-K (File No. 001-38079), filed with the SEC on February 28, 2019).   94 Table of Contents   10.10*   Amendment 1 to Employment Agreement by and between the Registrant and Elizabeth Barrett, dated as of January 26, 2021 (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-38079), filed with the SEC on May 13, 2021).       10.11*   Omnibus Amendment to Equity Awards by and between the Registrant and Elizabeth Barrett, dated as of January 19, 2021 (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-38079), filed with the SEC on May 13, 2021).       10.12*   Employment Agreement by and between the Registrant and Mark Schoenberg, dated as of December 5, 2017 (incorporated by reference to Exhibit 10.12 to the Registrant’s Annual Report on Form 10-K (File No. 001-38079), filed with the SEC on February 28, 2019).       10.13*   Amendment 1 to Employment Agreement by and between the Registrant and Mark Schoenberg, dated as of January 26, 2021 (incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-8079), filed with the SEC on May 13, 2021).       10.14*   Amendment 2 to Employment Agreement by and between the Registrant and Mark Schoenberg, dated as of March 15, 2021 (incorporated by reference to Exhibit 10.5 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-38079), filed with the SEC on May 13, 2021).       10.15*   Employment Agreement between the Registrant and Jason Smith, dated August 12, 2020 (incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-38079), filed with the SEC on November 9, 2020).       10.16*   Amendment 1 to Employment Agreement between the Registrant and Jason Smith, dated January 26, 2021 (incorporated by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-38079), filed with the SEC on May 13, 2021).       10.17   Employment Agreement between the Company and Dong Kim, dated March 20, 2022 (incorporated by reference to Exhibit 10.1 to the Registrant ’ s Current Report on Form 8-K (File No. 001-38079), filed with the SEC on March 21, 2022).       10.18 †   License Agreement, dated November 8, 2019, by and between the Registrant and Agenus Inc. (incorporated by reference to Exhibit 10.14 to the Registrant’s Annual Report on Form 10-K (File No. 001-38079), filed with the SEC on March 2, 2020).       10.19   Lease Agreement, dated November 4, 2019, by and between the Registrant and Witman Properties, L.L.C. and Alexander Road at Davanne, L.L.C. (incorporated by reference to Exhibit 10.15 to the Registrant’s Annual Report on Form 10-K (File No. 001-38079), filed with the SEC on March 2, 2020).       10.20   Amendment to Lease Agreement, dated June 8, 2022, by and between the Registrant and Witman Properties, L.L.C. and Alexander Road at Davanne, L.L.C. (incorporated by reference to Exhibit 10.2 to the Registrant ’ s Quarterly Report on Form 10-Q (File No. 001-38079), filed with the SEC on August 11, 2022).       10.21 †   Manufacturing and Supply Agreement, dated May 30, 2020, by and between the Registrant and Isotopia Molecular Imaging Ltd. (the “ Isotopia Agreement ” ) and the extension to the Isotopia Agreement, dated August 25, 2022, by and between the Registrant and Isotopia Molecular Imaging Ltd. (incorporated by reference to Exhibit 10.1 to the Registrant ’ s Quarterly Report on Form 10-Q (File No. 001-38079), filed with the SEC on November 10, 2022).       10.22 †   Manufacturing & Supply Agreement, dated as of April 24, 2020 and amended as of March 2, 2022, by and between UroGen Pharma Ltd. and Cenexi-Laboratoires Thissen s.a. (incorporated by reference to Exhibit 10.2 to the Registrant ’ s Quarterly Report on Form 10-Q (File No. 001-38079), filed with the SEC on May 10, 2022).       10.23   Loan Agreement, dated as of March 7, 2022, by and among UroGen Pharma Ltd. (the “ Company ” ), UroGen Pharma, Inc., as the borrower, and certain direct and indirect subsidiaries of the Company party thereto from time to time, as guarantors, BPCR Limited Partnership, as a lender, BioPharma Credit Investments V (Master) LP, as a lender, and BioPharma Credit PLC, as collateral agent for the lenders (incorporated by reference to Exhibit 10.1 to the Registrant ’ s Quarterly Report on Form 10-Q (File No. 001-38079), filed with the SEC on May 10, 2022).       21.1   Subsidiary of the Registrant.       23.1   Consent of PricewaterhouseCoopers LLP, an independent registered public accounting firm.       23.2††   Consent of Independent Registered Public Accounting Firm       24.1   Power of Attorney (see signature page hereto).       31.1   Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.       31.2   Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.       32.1   Certification of Principal Executive and Financial Officers Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.       101   The following financial information from the Annual Report on Form 10-K of UroGen Pharma Ltd. for the year ended December 31, 2022, formatted in Inline XBRL (extensible Business Reporting Language): (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Operations, (iii) Consolidated Statements of Changes in Shareholders Equity, (iv) Consolidated Statements of Cash Flows, and (v) the Notes to Consolidated Financial Statements.       104   The cover page to this Annual Report on Form 10-K has been formatted in Inline XBRL   * Management contract or compensatory plan. † Certain portions of this exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K. †† Correction of the hyperlink for Exhibit 23.1 to the Form S-3 (File Number 333-268398), filed with the SEC on November 15, 2022.   Item 16. Form 10-K Summary   None.   95 Table of Contents   SIGNATURES   Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.     UROGEN PHARMA LTD.     March 24, 2023   By: /s/ Elizabeth Barrett     Elizabeth Barrett     Chief Executive Officer   SIGNATURES AND POWER OF ATTORNEY   We, the undersigned directors and officers of UroGen Pharma Ltd. (the “Company”), hereby severally constitute and appoint Elizabeth Barrett and Don Kim, and each of them singly, our true and lawful attorneys, with full power to them, and to each of them singly, to sign for us and in our names in the capacities indicated below, any and all amendments to this Annual Report on Form 10-K, and to file or cause to be filed the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as each of us might or could do in person, and hereby ratifying and confirming all that said attorneys, and each of them, or their substitute or substitutes, shall do or cause to be done by virtue of this Power of Attorney.   Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.   Name   Title   Date           /s/ Elizabeth Barrett   Chief Executive Officer, Director   March 24, 2023 Elizabeth Barrett   (Principal Executive Officer)               /s/ Don Kim   Chief Financial Officer   March 24, 2023 Don Kim   (Principal Financial and Accounting Officer)               /s/ Arie Belldegrun   Chair   March 24, 2023 Arie Belldegrun, M.D.                   /s/ Cynthia Butitta   Director   March 24, 2023 Cynthia Butitta                   /s/ Fred E. Cohen   Director   March 24, 2023 Fred E. Cohen                   /s/ Leana S. Wen   Director   March 24, 2023 Leana S. Wen                   /s/ Stuart Holden   Director   March 24, 2023 Stuart Holden, M.D.                   /s/ Ran Nussbaum   Director   March 24, 2023 Ran Nussbaum                   /s/ Dan Wildman   Director   March 24, 2023 Dan Wildman           96