UroGen Pharma Ltd. Files 2023 Annual Report on Form 10-K

TL;DR

<b>UroGen Pharma Ltd. filed its 2023 10-K, detailing financial performance and adjustments to net operating loss carryforwards.</b>

AI Summary

UroGen Pharma Ltd. (URGN) filed a Annual Report (10-K) with the SEC on March 14, 2024. UroGen Pharma Ltd. filed its 2023 Form 10-K on March 14, 2024. The company reported financial results for the fiscal year ending December 31, 2023. Adjustments for nondeductible amounts in tax returns reduced net operating loss carryforward by approximately $8.9 million. Prepaid forward obligation amounts of $3.0 million and $2.3 million were included in current liabilities for 2023 and 2022, respectively. Raw materials totaling $1.7 million and $2.4 million were held as non-current assets in 2023 and 2022, respectively.

Why It Matters

For investors and stakeholders tracking UroGen Pharma Ltd., this filing contains several important signals. The filing provides a comprehensive overview of UroGen Pharma's financial health and operational status for the fiscal year 2023, crucial for investors assessing the company's trajectory. Specific details on tax adjustments and asset valuations offer insights into the company's financial management and potential future tax liabilities or benefits.

Risk Assessment

Risk Level: medium — UroGen Pharma Ltd. shows moderate risk based on this filing. The company's financial disclosures, including adjustments to net operating loss carryforwards and significant prepaid obligations, indicate potential complexities in financial reporting and tax management that warrant careful investor scrutiny.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand the impact of tax adjustments and asset valuations on UroGen Pharma's financial position.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period for the 10-K.)
• 2024-03-14 — Filing Date (Date the 10-K was filed.)
• 8.9 — NOL Reduction (Approximate million dollar reduction in net operating loss carryforward.)
• 3.0 — Prepaid Obligation (2023) (Million dollar prepaid forward obligation as of Dec 31, 2023.)
• 2.3 — Prepaid Obligation (2022) (Million dollar prepaid forward obligation as of Dec 31, 2022.)
• 1.7 — Raw Materials (2023) (Million dollar raw materials as non-current assets as of Dec 31, 2023.)
• 2.4 — Raw Materials (2022) (Million dollar raw materials as non-current assets as of Dec 31, 2022.)

Key Players & Entities

• UroGen Pharma Ltd. (company) — Filer of the 10-K report.
• Mark Schoenberg (person) — Chief Medical Officer.
• $8.9 million (dollar_amount) — Reduction in net operating loss carryforward due to tax adjustments.
• $3.0 million (dollar_amount) — Prepaid forward obligation included in current liabilities as of December 31, 2023.
• $2.3 million (dollar_amount) — Prepaid forward obligation included in current liabilities as of December 31, 2022.
• $1.7 million (dollar_amount) — Raw materials included within other non-current assets as of December 31, 2023.
• $2.4 million (dollar_amount) — Raw materials included within other non-current assets as of December 31, 2022.

FAQ

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.

Filing Documents

• urgn20231231_10k.htm (10-K) — 2049KB
• ex_636699.htm (EX-10.7) — 11KB
• ex_636700.htm (EX-10.12) — 11KB
• ex_637873.htm (EX-10.18) — 24KB
• ex_636478.htm (EX-10.31) — 30KB
• ex_636479.htm (EX-10.32) — 281KB
• ex_638794.htm (EX-10.35) — 1258KB
• ex_599309.htm (EX-23.1) — 2KB
• ex_599310.htm (EX-31.1) — 14KB
• ex_599311.htm (EX-31.2) — 14KB
• ex_599312.htm (EX-32.1) — 7KB
• ex_636467.htm (EX-97) — 28KB
• pipeline03112024.jpg (GRAPHIC) — 40KB
• 0001437749-24-007753.txt (&nbsp;) — 10610KB
• urgn-20231231.xsd (EX-101.SCH) — 84KB
• urgn-20231231_cal.xml (EX-101.CAL) — 58KB
• urgn-20231231_def.xml (EX-101.DEF) — 503KB
• urgn-20231231_lab.xml (EX-101.LAB) — 451KB
• urgn-20231231_pre.xml (EX-101.PRE) — 551KB
• urgn20231231_10k_htm.xml (XML) — 1187KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 23 Item 1B. Unresolved Staff Comments 61 Item 1C. Cybersecurity 61 Item 2.

Properties

Properties 61 Item 3.

Legal Proceedings

Legal Proceedings 61 Item 4. Mine Safety Disclosures 61 PART II. 62 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 62 Item 6. [Reserved] 62 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 63 Item 7A.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 73 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 74 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 95 Item 9A.

Controls and Procedures

Controls and Procedures 95 Item 9B. Other Information 95 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 95 PART III. 96 Item 10. Directors, Executive Officers and Corporate Governance 96 Item 11.

Executive Compensation

Executive Compensation 96 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 96 Item 13. Certain Relationships and Related Transactions and Director Independence 96 Item 14. Principal Accountant Fees and Services 96 PART IV. 97 Item 15. Exhibits, Financial Statement Schedules 97 Item 16. Form 10-K Summary 98 Table of Contents PART I INTRODUCTION Unless otherwise indicated, "UroGen Pharma," "UroGen," "the Company," "our Company," "we," "us" and "our" refer to UroGen Pharma Ltd. and its subsidiary, UroGen Pharma, Inc. UroGen RTGel and Jelmyto are trademarks of ours that we use in this Annual Report on Form 10-K (this "Annual Report"). This Annual Report also includes trademarks, tradenames, and service marks that are the property of other organizations. Solely for convenience, our trademarks and tradenames referred to in this Annual Report appear without the or symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or the right of the applicable licensor to our trademark and tradenames. We do not intend our use or display of other companies' trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies. We maintain our books and records in U.S. dollars, and prepare our financial statements in accordance with accounting principles generally accepted in the United States ("GAAP"), as issued by the Financial Accounting Standards Board. The terms "shekel," "Israeli shekel" and "NIS" refer to New Israeli Shekels, the lawful currency of the State of Israel, and the terms "dollar," "U.S. dollar" or "$" refer to United States dollars, the lawful currency of the United States. All references to "shares" in this Annual Report refer to ordinary shares of UroGen Pharma Ltd., par value NIS 0.01 per share. We have made rounding adjustments to some of the figures included in thi

Business

Item 1. Business Overview We are a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers. We have developed RTGel reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based technology that has the potential to improve therapeutic profiles of existing drugs. Our technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our approved product Jelmyto (mitomycin) for pyelocalyceal solution, and our investigational candidate, UGN-102 (mitomycin) for intravesical solution, are designed to ablate tumors by non-surgical means and to treat several forms of non-muscle invasive urothelial cancer, including low-grade upper tract urothelial cancer ("low-grade UTUC") and low-grade intermediate risk non-muscle invasive bladder cancer ("low-grade intermediate risk NMIBC"), respectively. In addition, our immuno-uro-oncology pipeline includes UGN-301 (zalifrelimab), an anti-CTLA-4 antibody, which we intend to study as both monotherapy and combination therapy. RTGel : Our Reverse Thermal Hydrogel Technology RTGel is a novel proprietary polymeric biocompatible, reverse thermal gelation hydrogel technology, which, unlike the general characteristics of most forms of matter, is liquid at lower temperatures and converts into gel form when warmed to body temperature. We believe that these characteristics promote ease of delivery into and retention of drugs in body cavities, including the bladder and the upper urinary tract, forming a transient reservoir of drug that dissolves over time while preventing rapid excretion, providing for increased dwell time. RTGel leverages the physiologic flow of urine to provide a natural exit from the body. RTGel 's components are polymer-based and are inactive ingredients that are used in U.S. Food and Drug Administration ("FDA") approved Jelmyto . We formula