UroGen Pharma Enters Material Definitive Agreement on Dec 28

TL;DR

**UroGen Pharma just signed a big deal; details pending but it's a material agreement.**

AI Summary

UroGen Pharma Ltd. filed an 8-K on January 2, 2024, to report a material definitive agreement entered into on December 28, 2023. This filing indicates a significant corporate action, likely a new contract or partnership, that could impact the company's future operations and financial performance. For investors, this matters because such agreements can signal new revenue streams, expanded market reach, or increased operational costs, directly influencing the stock's valuation and future prospects.

Why It Matters

This filing signals a new, important business arrangement for UroGen Pharma, which could significantly affect its financial health and growth trajectory. Investors should monitor for details of this agreement to assess its potential impact on revenue and profitability.

Risk Assessment

Risk Level: medium — The risk is medium because while a material agreement is reported, the specific terms and financial implications are not disclosed in this filing, creating uncertainty.

Analyst Insight

A smart investor would await further disclosures from UroGen Pharma regarding the specifics of this material definitive agreement to understand its financial implications before making any investment decisions.

Key Numbers

• 001-38079 — Commission File Number (identifies UroGen Pharma's registration with the SEC)
• 2023-12-28 — Date of Earliest Event Reported (indicates when the material definitive agreement was entered into)
• NIS0.01 — Par Value per Share (the nominal value of UroGen Pharma's Ordinary Shares)

Key Players & Entities

• UroGen Pharma Ltd. (company) — the registrant filing the 8-K
• December 28, 2023 (date) — date of the earliest event reported (entry into material definitive agreement)
• January 2, 2024 (date) — date the 8-K was filed
• NIS0.01 (dollar_amount) — par value per Ordinary Share
• Nasdaq Stock Market LLC (company) — exchange where UroGen Pharma's shares are registered

Forward-Looking Statements

• UroGen Pharma will release further details about the material definitive agreement. (UroGen Pharma Ltd.) — high confidence, target: Q1 2024
• The agreement will involve a partnership or licensing deal for a pharmaceutical product. (UroGen Pharma Ltd.) — medium confidence, target: Q1 2024

FAQ

Filing Documents

• d231255d8k.htm (8-K) — 24KB
• 0001193125-24-000244.txt ( ) — 143KB
• urgn-20231228.xsd (EX-101.SCH) — 3KB
• urgn-20231228_lab.xml (EX-101.LAB) — 18KB
• urgn-20231228_pre.xml (EX-101.PRE) — 11KB
• d231255d8k_htm.xml (XML) — 3KB

01

Item 1.01 Entry into a Material Definitive Agreement. On December 28, 2023, UroGen Pharma Ltd. (the "Company") entered into Amendment No. 2 (the "Amendment") to its Manufacturing & Supply Agreement with Cenexi-Laboratoires Thissen S.A. ("Cenexi"), dated as of April 24, 2020 and amended as of March 2, 2022 (as amended by the Amendment, the "Agreement"). Pursuant to the Amendment, and in anticipation of the potential approval and subsequent launch of UGN-102, (i) the parties extended the initial term of the Agreement through April 1, 2027, (ii) the Company revised its minimum annual quantity (MAQ) forecast of bulk product (mitomycin) purchases under the Agreement, (iii) the parties agreed to certain terms, and agreed to a schedule to negotiate other terms of conditions, related to Cenexi's purchase, installation, validation and qualification of certain capital equipment for use exclusively in the manufacture of mitomycin product to be supplied to the Company under the Agreement (the "Dedicated Equipment"), and the performance of refurbishment activities, and (iv) the Company agreed to reimburse Cenexi for up to approximately 4.4 million in connection with the purchase and other activities described in the foregoing clause (iii), to be expensed in accordance with a budget and payment timeline to be negotiated by the parties.

Forward-Looking Statements

Forward-Looking Statements This report contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the potential approval and subsequent launch of UGN-102; the future negotiation of the terms and conditions of the purchase, installation, validation and qualification of the Dedicated Equipment and the performance of refurbishment activities. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: preliminary results may not be indicative of results that may be observed in the future; the timing and success of clinical trials and potential safety and other complications thereof; unforeseen delays that may impact the timing of progressing clinical trials, reporting data and initiating product launches; the findings from the durability of response endpoint from the ENVISION Phase 3 study may not be positive, and in such event, the Company's NDA pathway for UGN-102 could be negatively impacted; even if the durability of response endpoint data from the ENVISION Phase 3 study are positive, there is no guarantee that the NDA for UGN-102 will be sufficient to support approval of UGN-102 on the timeframe expected, or at all; the Company and Cenexi may not be able to successfully agree upon the terms and conditions related to the Dedicated Equipment; and third-party performance. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, filed with the SEC on November 14, 2023, the events and circumstances discussed in such forward-looking statements may not occur, and the Company's actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this report and are based

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Date: January 2, 2024 UROGEN PHARMA LTD. By: /s/ Don Kim Don Kim Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR