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 June 30, 2023 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 o ...

Urogen Pharma Ltd (NASDAQ:URGN) Q1 2023 Earnings Conference Call May 11, 2023 10:00 AM ET Company Participants Vincent Perrone - Senior Director, IR Elizabeth Barrett - President, CEO & Director Mark Schoenberg - Chief Medical Officer Jeffrey Bova - Chief Commercial Officer Dong Kim - CFO Conference Call Participants Raghuram Selvaraju - H.C. Wainwright & Co. Roderick Ma - Goldman Sachs Group Matthew Kaplan - Ladenburg Thalmann & Co. Rohan Mathur - Oppenheimer Boris Peaker - TD Cowen Operator Good morning, ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) For the quarter ended March 31, 2023, UroGen Pharma Ltd. reported total revenues of $17.2 million, a net loss of $30.2 million, and held cash, cash equivalents, and marketable securities of $75.2 million [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) For the quarter ended March 31, 2023, UroGen Pharma Ltd. reported total revenues of $17.2 million, a net loss of $30.2 million, and held cash, cash equivalents, and marketable securities of $75.2 million - The company has experienced net losses since inception, with an accumulated deficit of **$607.3 million** as of March 31, 2023, raising substantial doubt about its ability to continue as a going concern without raising additional capital[24](index=24&type=chunk)[25](index=25&type=chunk)[26](index=26&type=chunk) [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2023, total assets were $113.0 million, down from $135.6 million at year-end 2022, primarily due to a decrease in cash and marketable securities, leading to a total shareholders' deficit of $116.6 million Condensed Consolidated Balance Sheet Data (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $36,540 | $55,408 | | Total current assets | $95,973 | $128,907 | | **Total Assets** | **$112,954** | **$135,619** | | Total current liabilities | $25,234 | $23,916 | | Prepaid forward obligation | $101,912 | $98,923 | | Long-term debt | $97,941 | $97,537 | | **Total Liabilities** | **$229,508** | **$224,980** | | Accumulated deficit | ($607,317) | ($577,104) | | **Total Shareholders' Deficit** | **($116,554)** | **($89,361)** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended March 31, 2023, revenue increased to $17.2 million from $13.6 million in the prior-year period, resulting in a net loss of $30.2 million, or ($1.30) per share, compared to a net loss of $28.4 million, or ($1.25) per share, for the same period in 2022 Statement of Operations Highlights (in thousands, except per share data) | Metric | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Revenue | $17,192 | $13,564 | | Gross Profit | $14,927 | $12,039 | | Research and development expenses | $12,498 | $12,696 | | Selling, general and administrative expenses | $24,474 | $21,300 | | Operating loss | ($22,045) | ($21,957) | | **Net Loss** | **($30,213)** | **($28,392)** | | **Net loss per ordinary share** | **($1.30)** | **($1.25)** | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) In the first quarter of 2023, net cash used in operating activities was $25.8 million, net cash provided by investing activities was $6.3 million, and net cash provided by financing activities was $0.7 million, resulting in a net decrease in cash and cash equivalents of $18.9 million Cash Flow Summary (in thousands) | Activity | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($25,807) | ($23,996) | | Net cash provided by investing activities | $6,270 | $13,596 | | Net cash provided by financing activities | $671 | $70,742 | | **Increase (Decrease) in Cash** | **($18,866)** | **$60,342** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on developing and commercializing treatments for urothelial cancers using its proprietary RTGel technology, with revenue from Jelmyto increasing to $17.2 million in Q1 2023, but continues to incur significant losses, raising substantial doubt about its ability to continue as a going concern without securing additional financing - The company is developing innovative solutions for urothelial cancers using its proprietary RTGel reverse-thermal hydrogel technology, including the FDA-approved Jelmyto, UGN-102, and UGN-301[111](index=111&type=chunk) - The Phase 3 ENVISION trial for UGN-102 completed its target enrollment of **220 patients** in December 2022, with an anticipated NDA submission in 2024 assuming positive findings[132](index=132&type=chunk) - The company believes its existing cash and projected revenues will only fund operations until **mid-way through the first quarter of 2024**, necessitating significant additional financing and raising substantial doubt about its ability to continue as a going concern[176](index=176&type=chunk)[177](index=177&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) Comparing Q1 2023 to Q1 2022, revenue increased by $3.6 million due to higher Jelmyto sales volume, while operating expenses and interest expense also rose, contributing to an increased net loss Comparison of Operations for the three months ended March 31 (in thousands) | Account | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Revenue | $17,192 | $13,564 | $3,628 | | Cost of revenue | $2,265 | $1,525 | $740 | | Research and development | $12,498 | $12,696 | ($198) | | Selling and marketing | $14,143 | $13,351 | $792 | | General and administrative | $10,331 | $7,949 | $2,382 | | **Net loss** | **($30,213)** | **($28,392)** | **($1,821)** | [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2023, the company had $75.2 million in cash, cash equivalents, and marketable securities, but with an accumulated deficit of $607.3 million and anticipated continued losses, management concluded there is substantial doubt about the company's ability to continue as a going concern without securing additional financing - The company has an at-the-market (ATM) sales agreement with Cowen with approximately **$83.4 million** remaining capacity as of March 31, 2023[172](index=172&type=chunk) - The company entered into a loan agreement with Pharmakon for a senior secured term loan of up to **$100 million**, fully funded as of December 2022, requiring interest-only payments for the first 48 months[174](index=174&type=chunk)[81](index=81&type=chunk) - Net cash used in operating activities increased to **$25.8 million** in Q1 2023 from **$24.0 million** in Q1 2022, primarily due to financing costs and timing of accruals, partially offset by increased Jelmyto sales[190](index=190&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risks, including interest rate fluctuations on its investment portfolio, inflation affecting labor and clinical trial costs, and foreign currency exchange risk, particularly with New Israeli Shekels (NIS) operating expenses - The company's primary market risks are interest rate fluctuations on its **$75.2 million** in cash and marketable securities, and foreign currency exchange risk[193](index=193&type=chunk) - A significant portion of operating expenses are in New Israeli Shekels (NIS), creating exposure to adverse movements in the NIS/USD exchange rate, though a **10% change** in Q1 2023 would not have had a material effect on operating expenses[196](index=196&type=chunk) [Controls and Procedures](index=42&type=section&id=Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures as of March 31, 2023, concluding they were effective at a reasonable assurance level, with no material changes in internal control over financial reporting during the quarter - The principal executive officer and principal financial officer concluded that as of March 31, 2023, the company's disclosure controls and procedures were effective at a reasonable assurance level[199](index=199&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2023, that have materially affected, or are reasonably likely to materially affect, internal controls[200](index=200&type=chunk) [PART II. OTHER INFORMATION](index=43&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that management believes are likely to have a material adverse effect on its business - UroGen is not currently a party to any legal proceedings that, in the opinion of management, are likely to have a material adverse effect on the business[202](index=202&type=chunk) [Item 1A. Risk Factors](index=43&type=page&id=Item%201A.%20Risk%20Factors) The company outlines numerous risks to its business, including substantial doubt about its ability to continue as a going concern due to the need for significant additional financing, high dependence on Jelmyto's commercial success, and risks in clinical development, manufacturing, competition, intellectual property, regulatory landscapes, and operations in Israel - **Financial Risk:** The company will require additional financing to fund operations and achieve its goals, as existing resources are only expected to be sufficient until **mid-way through Q1 2024**, raising substantial doubt about its ability to continue as a going concern[204](index=204&type=chunk)[213](index=213&type=chunk)[214](index=214&type=chunk) - **Commercial Risk:** The company is highly dependent on the successful commercialization of Jelmyto and faces significant competition, with market opportunities potentially smaller than anticipated and achieving broad physician adoption as a key challenge[204](index=204&type=chunk)[229](index=229&type=chunk)[244](index=244&type=chunk) - **Development and Regulatory Risk:** The company is dependent on the success of its pipeline, particularly UGN-102, as clinical drug development is a lengthy, expensive, and uncertain process, and earlier trial results may not predict future success[204](index=204&type=chunk)[252](index=252&type=chunk)[273](index=273&type=chunk) - **Operational and Supply Chain Risk:** The company relies on third-party, single-source suppliers for key raw materials and components, increasing the risk of supply disruptions that could impair development and commercialization[206](index=206&type=chunk)[297](index=297&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=118&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[503](index=503&type=chunk) [Item 3. Defaults Upon Senior Securities](index=118&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - None[503](index=503&type=chunk) [Item 4. Mine Safety Disclosures](index=118&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - None[504](index=504&type=chunk) [Item 5. Other Information](index=118&type=section&id=Item%205.%20Other%20Information) There was no other information to report for the period - None[505](index=505&type=chunk) [Item 6. Exhibits](index=119&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the quarterly report, including the Articles of Association, certifications by the CEO and CFO pursuant to the Sarbanes-Oxley Act, and Inline XBRL data files

Patient Population and Treatment Efficacy - The annual treatable patient population for low-grade UTUC in the United States is estimated to be approximately 6,000 to 7,000, while the annual treatable population for low-grade intermediate risk NMIBC is around 80,000[490]. - Jelmyto achieved a complete response (CR) rate of 58% (41 out of 71 patients) in the intent-to-treat population during the Phase 3 OLYMPUS trial, with a durability of response estimated at 81.8% at 12 months[496]. - The median duration of response for Jelmyto was reported to be 28.9 months based on long-term follow-up data from the OLYMPUS trial[497]. - UGN-102 demonstrated a complete response rate of 65% (41 out of 63 patients) in the Phase 2b OPTIMA II trial, with a durable response probability of 72.5% at nine months after CR[503]. - The Phase 3 ENVISION trial for UGN-102 has completed enrollment of 220 patients across 90 sites, with an NDA submission anticipated in 2024 assuming positive findings[508]. Financial Performance - Revenue for the year ended December 31, 2022, was $64.4 million, an increase of $16.4 million from $48.0 million in 2021, reflecting higher sales volume of the product Jelmyto[520][541]. - The company's consolidated net revenue for the year ended December 31, 2022, was $64.4 million, with gross revenue from product sales representing a majority[598]. - Total revenue for 2022 was $64.36 million, a 34% increase from $48.04 million in 2021[606]. - Gross profit for 2022 reached $56.70 million, compared to $42.89 million in 2021, reflecting a gross margin improvement[606]. - The net loss for the year ended December 31, 2022, was $109.8 million, a slight improvement from a net loss of $110.8 million in 2021[540]. - The operating loss narrowed to $79.0 million in 2022 from $92.3 million in 2021, indicating improved operational efficiency[540]. - The accumulated deficit as of December 31, 2022, was $577.1 million, with expectations of continued losses for the foreseeable future[554]. Expenses and Cost Management - Cost of revenue increased to $7.7 million in 2022 from $5.2 million in 2021, resulting in a gross margin of approximately 87.5% for 2022[522][542]. - Research and development expenses rose to $52.9 million in 2022, up from $47.6 million in 2021, indicating continued investment in product development[540]. - Selling and marketing expenses increased to $51.9 million in 2022 compared to $47.6 million in 2021, reflecting efforts to promote Jelmyto[540]. - General and administrative expenses decreased to $30.9 million in 2022 from $39.9 million in 2021, showing cost management in administrative functions[540]. - Interest expense on long-term debt was $8.4 million in 2022, compared to zero in 2021, related to the Pharmakon loan initiated in March 2022[547]. Cash Flow and Financing - As of December 31, 2022, the company had $100.0 million in cash and cash equivalents and marketable securities, with cash in excess of immediate requirements invested primarily in U.S. dollars[549]. - Net cash used in operating activities was $87.6 million in 2022, compared to $84.9 million in 2021, reflecting an increase of $2.7 million due to financing costs and timing of accruals[559]. - Net cash provided by financing activities was $97.1 million in 2022, up from $72.3 million in 2021, primarily due to net proceeds from the Pharmakon loan[561]. - The company anticipates needing significant additional financing within the next twelve months to continue operations, as existing resources are projected to be insufficient beyond mid-way through the first quarter of 2024[555]. Inventory and Assets - As of December 31, 2022, total inventories increased to $6.695 million from $5.852 million in 2021, representing a growth of approximately 14.4%[662]. - Total assets increased to $135.62 million in 2022, up from $119.75 million in 2021, indicating growth in the company's asset base[604]. - Cash and cash equivalents at the end of 2022 were $55.41 million, an increase from $44.36 million at the end of 2021[604]. Market and Regulatory Environment - Jelmyto's new product exclusivity lasts until April 15, 2023, and orphan drug exclusivity extends to April 15, 2027, with key patents expiring in January 2031[493]. - All Medicare patients are covered for Jelmyto, with over 150 million lives covered by commercial plans[499]. - The company has initiated a registry to capture data and evaluate real-world outcomes for patients treated with Jelmyto[500]. Debt and Obligations - The Company entered into a loan agreement with Pharmakon for a senior secured term loan of up to $100 million, funded in two tranches: $75 million in March 2022 and $25 million in December 2022[685]. - The loan requires interest-only payments for the first 48 months, followed by principal and interest payments, with an interest rate of 3-month LIBOR plus 8.25%[685]. - The carrying value of the Pharmakon loan as of December 31, 2022, was $97.537 million after accounting for capitalized costs and discounts[687]. Tax and Regulatory Compliance - The company provides for income taxes based on pretax income and applicable tax rates in various jurisdictions, including Israel and the U.S.[581]. - The Company has incurred tax losses totaling approximately $419.1 million as of December 31, 2022, which can be carried forward indefinitely[538].

Financial Data and Key Metrics Changes - UroGen Pharma reported net product revenues of $64.4 million for the full year 2022, representing a 34% increase from 2021 [4][21] - For Q4 2022, JELMYTO net revenues were over $18.1 million, compared to $16.1 million for the same period in 2021 [21] - The company ended the year with $100 million in cash, expected to finance operations into the first half of 2024 [24] Business Line Data and Key Metrics Changes - JELMYTO's adoption metrics showed a 21% increase in repeat accounts, rising from 177 to 214 [16] - The number of activated sites increased from 930 to 983 [16] - Research and development expenses for Q4 2022 were $14.4 million, up from $13.1 million in the prior year [21] Market Data and Key Metrics Changes - UroGen anticipates JELMYTO net revenues for 2023 to be in the range of $76 million to $86 million, reflecting a growth of 20% to 30% over 2022 [7][23] - The company expects to report top-line data from both Phase 3 studies of UGN-102 by mid-year 2023 [6][13] Company Strategy and Development Direction - UroGen views JELMYTO as a proof of concept for the larger bladder cancer market, with UGN-102 expected to be a main growth driver if approved [5][8] - The company is focused on solid execution to turn the combined revenue opportunity of JELMYTO and UGN-102 into a reality, estimated at $1 billion [8] - UroGen is exploring multiple avenues to strengthen its balance sheet, including potential strategic partnerships [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data from clinical trials and the potential for UGN-102 to transform treatment paradigms [6][14] - The company is committed to managing expenses diligently while prioritizing cash preservation [24] - Management highlighted the importance of durability data for UGN-102 as a key factor for FDA submission in 2024 [60] Other Important Information - The company has completed enrollment for the ENVISION study in less than a year, indicating strong interest from urologists [5][9] - UroGen's Phase 1 trial with UGN-301 continues to enroll, aimed at identifying suitable doses for future combination therapies [14] Q&A Session Summary Question: What are the expectations for durability data from ENVISION? - Management expects similar results to OPTIMA II, as ENVISION will only include patients with recurrent disease, which was not a differentiating factor in previous studies [27] Question: Are there plans for strategic partnerships related to UGN-102? - Management is always looking for opportunities for strategic partnerships but emphasizes the importance of maintaining cash flow and reducing expenses [28] Question: What drives JELMYTO uptake and how will the company optimize value outside the U.S.? - The main driver is patient identification and physician experience, with plans for additional clinical work to support reimbursement in international markets [31][34] Question: Will additional infrastructure be needed for UGN-102's commercial strategy? - Due to a 95% overlap in prescriber base, significant resource expansion is not anticipated [36] Question: What factors could drive further adoption of JELMYTO in 2023? - Key factors include operational data from the FDA's stability period extension, long-term follow-up data, and real-world evidence supporting JELMYTO's efficacy [39][40] Question: What is the regulatory timeline for UGN-102? - The key rate-limiting step is obtaining durability data, with an expected FDA submission in 2024 [60][61] Question: Will there be additional trials for at-home administration of UGN-102? - No additional large studies are planned, but the company is open to supporting investigator-initiated studies if demand arises [51]

UroGen Pharma Ltd. (NASDAQ:URGN) Q3 2022 Earnings Conference Call November 10, 2022 10:00 AM ET Company Participants Vincent Perrone - Senior Director-Investor Relations Liz Barrett - President & Chief Executive Officer Mark Schoenberg - Chief Medical Officer Jeff Bova - Chief Commercial Officer Don Kim - Chief Financial Officer Conference Call Participants Dipesh Patel - H.C. Wainwright Boris Peaker - Cowen Matt Kaplan - Ladenburg Chris Howerton - Jefferies Paul Choi - Goldman Sachs Leland Gershell - Oppe ...

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 September 30, 2022 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 ...

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 June 30, 2022 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 o ...

Urogen Pharma Ltd (NASDAQ:URGN) Q2 2022 Earnings Conference Call August 11, 2022 10:00 AM ET Company Participants Vincent Perrone - Senior Director, IR Elizabeth Barrett - President, CEO & Director Mark Schoenberg - Chief Medical Officer Jeffrey Bova - Chief Commercial Officer Dong Kim - CFO Conference Call Participants Christopher Howerton - Jefferies Raghuram Selvaraju - H.C. Wainwright & Co. Boris Peaker - Cowen and Company Matthew Kaplan - Ladenburg Thalmann & Co. Leland Gershell - Oppenheimer Operator ...

UroGen Pharma Ltd. (NASDAQ:URGN) Q1 2022 Earnings Conference Call May 10, 2022 10:00 AM ET Company Participants Vincent Perrone - Senior Director of IR Liz Barrett - President and CEO Mark Schoenberg - Chief Medical Officer Jeff Bova - Chief Commercial Officer Don Kim - CFO Conference Call Participants Ram Selvaraju - H.C. Wainwright Boris Peaker - Cowen Chris Howerton - Jefferies Matt Kaplan - Ladenburg Thalmann Leland Gershell - Oppenheimer Anita Dushyanth - Berenberg Capital Operator Good morning, ladies ...