UROGEN PHARMA LADENBURG THALMANN HEALTHCARE CONFERENCE JULY 14, 2021 2 Forward Looking Statements This investor presentation contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation: the potential market opportunity of Jelmyto in LG-UTUC; commercial plans for favorable market access and both patient and physician uptake; expected interest in prescribing Jelmyto; the continued successful launch of Jelmyto; the potential ...

UroGen Pharma Ltd. (NASDAQ:URGN) Q1 2021 Earnings Conference Call May 13, 2021 8:30 AM ET Company Participants Lee Roth - Burns McClellan Liz Barrett - President and CEO Jeff Bova - Chief Commercial Officer Mark Schoenberg - Chief Medical Officer Molly Henderson - CFO Conference Call Participants Hannah Adeoye - JPMorgan Chris Howerton - Jefferies Ram Selvaraju - H.C. Wainwright Matt Kaplan - Ladenburg Thalmann Paul Choi - Goldman Sachs Leland Gershell - Oppenheimer Operator Good morning, ladies and gentlem ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38079 UROGEN PHARMA LTD. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or ...

UroGen Pharma Ltd. (NASDAQ:URGN) Q4 2020 Results Earnings Conference Call March 18, 2021 8:30 AM ET Company Participants Sara Sherman - Head, Investor Relations Liz Barrett - President and CEO Dr. Mark Schoenberg - Chief Medical Officer Jeff Bova - Chief Commercial Officer Molly Henderson - Chief Financial Officer Conference Call Participants Chris Howerton - Jefferies Derek Archila - Stifel Hannah Adeoye - J.P. Morgan Matt Kaplan - Ladenburg Thalmann Paul Choi - Goldman Sachs Operator Good morning, ladies ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_____________ to ________________ Commission file number: 001-38079 UROGEN PHARMA LTD. (Exact name of registrant as specified in its charter) (State or other jurisd ...

UROGEN PHARMA OPPENHEIMER 31ST ANNUAL HEALTHCARE CONFERENCE MARCH 16, 2021 2 Forward Looking Statements This investor presentation contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation: the potential market opportunity of Jelmyto in LG-UTUC; commercial plans for favorable market access and both patient and physician uptake; expected interest in prescribing Jelmyto; the continued successful launch of Jelmyto; the pot ...

UROGEN PHARMA J.P. MORGAN 2021 HEALTHCARE CONFERENCE JANUARY 13, 2021 2 Forward Looking Statements This investor presentation contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation: the potential market opportunity of Jelmyto in LG-UTUC; commercial plans for favorable market access and both patient and physician uptake; expected interest in prescribing Jelmyto; the continued successful launch of Jelmyto; the potentia ...

UroGen Pharma Ltd (NASDAQ:URGN) Q3 2020 Earnings Conference Call November 9, 2020 8:30 AM ET Company Participants Sara Sherman – Head of Investor Relations Liz Barrett – President and Chief Executive Officer Mark Schoenberg – Chief Medical Officer Jeff Bova – Chief Commercial Officer Molly Henderson – Chief Financial Officer Conference Call Participants Ram Selvaraju – H. C. Wainwright Derek Archila – Stifel Leland Gershell – Oppenheimer Eric Joseph – J.P. Morgan Matt Kaplan – Ladenburg Thalmann Operator Go ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This part details the company's unaudited financial statements, management's analysis, and market risk disclosures [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Presents unaudited financial statements reflecting the initial commercialization of Jelmyto [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $139.9 million due to lower cash, while liabilities and equity also declined Condensed Consolidated Balance Sheets (in thousands) | | September 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $24,565 | $49,688 | | Marketable securities | $100,958 | $145,944 | | Accounts receivable | $2,810 | $— | | Inventory | $1,346 | $— | | Total current assets | $129,338 | $148,634 | | TOTAL ASSETS | $139,893 | $202,388 | | **Liabilities and Shareholders' Equity** | | | | Total current liabilities | $17,618 | $19,482 | | TOTAL LIABILITIES | $19,366 | $22,086 | | TOTAL SHAREHOLDERS' EQUITY | $120,527 | $180,302 | | TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $139,893 | $202,388 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company generated initial revenue of $3.5 million in Q3 but saw an increased net loss of $28.8 million Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended Sep 30, | Nine Months Ended Sep 30, | | :--- | :--- | :--- | | | **2020** | **2019** | **2020** | **2019** | | Revenues | $3,461 | $— | $3,833 | $18 | | Gross profit | $3,152 | $— | $3,476 | $18 | | Research and development expenses | $10,211 | $9,481 | $34,905 | $29,203 | | Selling, general and administrative expenses | $22,065 | $13,972 | $68,056 | $40,454 | | Operating loss | ($29,124) | ($23,453) | ($99,485) | ($69,639) | | NET LOSS | ($28,816) | ($22,252) | ($97,958) | ($66,173) | | Net loss per ordinary share basic and diluted | ($1.31) | ($1.06) | ($4.52) | ($3.25) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations increased to $84.6 million, offset by cash from investing and financing activities Condensed Consolidated Statements of Cash Flow (in thousands) | | Nine Months Ended September 30, | | :--- | :--- | | | **2020** | **2019** | | Net cash used in operating activities | $(84,644) | $(45,017) | | Net cash provided by (used in) investing activities | $43,773 | $(154,889) | | Net cash provided by financing activities | $16,449 | $165,005 | | DECREASE IN CASH AND CASH EQUIVALENTS | $(24,422) | $(34,901) | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Details key events including Jelmyto's FDA approval, an accumulated deficit, and financing activities - The FDA granted **expedited approval for Jelmyto** on April 15, 2020, for the treatment of adults with low-grade upper tract urothelial cancer (LG-UTUC)[22](index=22&type=chunk) - The company has experienced net losses since inception, with an **accumulated deficit of $326.0 million** as of September 30, 2020[25](index=25&type=chunk) - In January 2020, the company paid **$6.6 million to the Israeli Innovation Authority (IIA)** to unwind its obligations regarding past R&D grants[112](index=112&type=chunk) - In the second quarter of 2020, the company sold 700,000 ordinary shares under its ATM Sales Agreement, raising **net proceeds of approximately $15.8 million**[94](index=94&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Discusses the commercial launch of Jelmyto, pipeline progress, financial results, and liquidity position - On April 15, 2020, the **FDA approved Jelmyto** for adult patients with LG-UTUC, granting it new product exclusivity through April 2023 and **Orphan Drug exclusivity through April 2027**[121](index=121&type=chunk) - The **commercial launch of Jelmyto** in the U.S. began in June 2020, supported by a commercial team of 48 representatives[124](index=124&type=chunk) - Interim data from the Phase 2b OPTIMA II trial for UGN-102 showed a **65% complete response rate**, and a **Phase 3 study is expected to start by the end of 2020**[128](index=128&type=chunk)[129](index=129&type=chunk) Comparison of Results of Operations (in thousands) | | Three Months Ended Sep 30, | Nine Months Ended Sep 30, | | :--- | :--- | :--- | | | **2020** | **2019** | **2020** | **2019** | | Revenues | $3,461 | $— | $3,833 | $18 | | R&D Expenses | $10,211 | $9,481 | $34,905 | $29,203 | | Selling & Marketing Expenses | $10,992 | $3,926 | $34,398 | $9,701 | | General & Admin Expenses | $11,073 | $10,046 | $33,658 | $30,753 | | Net Loss | $(28,816) | $(22,252) | $(97,958) | $(66,173) | - As of September 30, 2020, the company had **$125.5 million in cash, cash equivalents, and marketable securities**, which is deemed **sufficient to fund operations for at least the next 12 months**[178](index=178&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Outlines primary market risks from interest rate fluctuations and foreign currency exchange - The company is exposed to **interest rate risk** on its portfolio of cash equivalents and marketable securities, which totaled **$125.5 million** as of September 30, 2020[189](index=189&type=chunk) - **Significant foreign currency exchange risk** exists due to operating expenses incurred in New Israeli Shekels (NIS), and the company **does not currently engage in currency hedging**[191](index=191&type=chunk)[192](index=192&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2020 - The company's management concluded that **disclosure controls and procedures were effective** as of September 30, 2020[195](index=195&type=chunk) - There were **no changes in internal control over financial reporting** during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[196](index=196&type=chunk) [PART II. OTHER INFORMATION](index=33&type=section&id=PART%20II.%20OTHER%20INFORMATION) Covers legal proceedings, risk factors, and other required corporate disclosures [Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently party to any material legal proceedings - The company is **not currently a party to any legal proceedings** expected to have a material adverse effect on its business[199](index=199&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) Outlines significant risks including dependence on Jelmyto, competition, and supply chain vulnerabilities - The company is **highly dependent on the successful commercialization of its only approved product, Jelmyto**, and has limited experience in marketing[201](index=201&type=chunk)[204](index=204&type=chunk) - The business could be **adversely affected by health pandemics, including the COVID-19 pandemic**, which could disrupt trials, commercial launch, and the supply chain[201](index=201&type=chunk)[297](index=297&type=chunk) - The company **relies on third-party subcontractors and single-source suppliers** for raw materials and manufacturing, posing supply chain risks[201](index=201&type=chunk)[265](index=265&type=chunk) - The company has a limited operating history, a **history of significant losses ($326.0 million accumulated deficit)**, and will require substantial additional financing[201](index=201&type=chunk)[303](index=303&type=chunk) - Significant operations in Israel expose the company to **risks from political, economic, and military instability** in the region[201](index=201&type=chunk)[427](index=427&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=77&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities for the period - None[446](index=446&type=chunk) [Defaults Upon Senior Securities](index=77&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[446](index=446&type=chunk) [Mine Safety Disclosures](index=77&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's business - None[447](index=447&type=chunk) [Other Information](index=77&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this item - None[448](index=448&type=chunk) [Exhibits](index=78&type=section&id=Item%206.%20Exhibits) Lists filed exhibits, including executive agreements and Sarbanes-Oxley certifications - Filed exhibits include a **separation agreement with the former CFO** and **employment agreements with new executives**[449](index=449&type=chunk) - **Certifications from the Principal Executive Officer and Principal Financial Officer** pursuant to the Sarbanes-Oxley Act are included as exhibits[449](index=449&type=chunk)

UroGen Pharma Ltd. (NASDAQ:URGN) Q2 2020 Earnings Conference Call August 10, 2020 8:30 AM ET Company Participants Kate Bechtold - Senior Director, IR Liz Barrett - President & CEO Mark Schoenberg - Chief Medical Officer Jeff Bova - SVP, Commercial Peter Pfreundschuh - CFO Conference Call Participants Boris Peaker - Cowen Leland Gershell - Oppenheimer Paul Choi - Goldman Sachs Matt Kaplan - Ladenburg Thalmann Operator Thank you for standing by and welcome to the UroGen Pharma Second Quarter 2020 Financial Re ...