UroGen Pharma(URGN)

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Urogen Pharma (URGN) Surges 9.7%: Is This an Indication of Further Gains?
ZACKS· 2024-06-17 10:01
Urogen Pharma (URGN) shares soared 9.7% in the last trading session to close at $19.20. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 32.5% gain over the past four weeks. This company is expected to post quarterly loss of $0.88 per share in its upcoming report, which represents a year-over-year change of +14.6%. Revenues are expected to be $23.69 million, up 12% from the year-ago quarter. For Urogen Pharma, the consensus EPS es ...
UroGen Pharma(URGN) - 2024 Q1 - Earnings Call Transcript
2024-05-13 22:30
UroGen Pharma Ltd. (NASDAQ:URGN) Q1 2024 Earnings Conference Call May 13, 2024 10:00 AM ET Company Participants Vincent Perrone - Head of IR Elizabeth Barrett - President & CEO Mark Schoenberg - Chief Medical Officer Don Kim - CFO Jeff Bova - Chief Commercial Officer Conference Call Participants Tara Bancroft - TD Cowen Raghuram Selvaraju - H.C. Wainwright & Co Matt Kaplan - Ladenburg Thalmann Leland Gershell - Oppenheimer Operator Good morning ladies and gentlemen. Thank you for standing by. Welcome to the ...
UroGen Pharma(URGN) - 2024 Q1 - Quarterly Report
2024-05-13 12:05
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, 2024 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(URGN) - 2024 Q1 - Quarterly Results
2024-05-13 12:01
Exhibit 99.1 UroGen Pharma Announces Date for ENVISION Data, New Long-Term Jelmyto Durability Data, and Reports 2024 First Quarter Financial Results and Business Highlights "In 2024 to date, UroGen has made excellent progress in both our commercial business and pipeline of innovative products designed to treat urothelial and specialty cancers," said Liz Barrett, President, and Chief Executive Officer of UroGen. "The upcoming announcement of 12-month duration of response results from ENVISION will be a key c ...
UroGen Pharma(URGN) - 2023 Q4 - Earnings Call Transcript
2024-03-15 00:13
UroGen Pharma Ltd. (NASDAQ:URGN) Q4 2023 Earnings Conference Call March 14, 2024 10:00 AM ET Company Participants Vincent Perrone - Head of IR Elizabeth Barrett - President and CEO Mark Schoenberg - Chief Medical Officer Dong Kim - CFO Jeffrey Bova - Chief Commercial Officer Silvio Pacheco - VP of Market Access Conference Call Participants Tara Bancroft - TD Cowen Leland Gershell - Oppenheimer Paul Choi - Goldman Sachs Matt Kaplan - Ladenburg Thalmann Operator Good morning, ladies and gentlemen. Thank you f ...
UroGen Pharma(URGN) - 2023 Q4 - Annual Report
2024-03-14 12:17
PART I [Business](index=7&type=section&id=Item%201.%20Business) UroGen Pharma develops and commercializes urothelial and specialty cancer treatments using its proprietary RTGel® reverse-thermal hydrogel technology, with Jelmyto® as its primary approved product [Overview and Technology](index=7&type=section&id=Overview%20and%20Technology) The company's core is the RTGel® reverse-thermal hydrogel, a proprietary technology that is liquid at cool temperatures and becomes a gel at body temperature, allowing sustained drug release - UroGen's proprietary RTGel® is a reverse thermal hydrogel that is liquid when cool and gels at body temperature, designed to enable longer exposure of urinary tract tissue to medications[24](index=24&type=chunk)[25](index=25&type=chunk) - RTGel technology increases the dwell time of mitomycin in the upper urinary tract from approximately five minutes (standard aqueous formulation) to about **six hours**, enhancing drug-tissue coverage[29](index=29&type=chunk) [Product Pipeline](index=8&type=section&id=Product%20Pipeline) UroGen's pipeline is led by Jelmyto®, approved for low-grade UTUC, with lead candidate UGN-102 targeting low-grade intermediate-risk NMIBC, and other next-generation formulations and an immuno-oncology program in development UroGen Pharma Product Pipeline Status | Product Candidate | Indication | Development Stage | | :--- | :--- | :--- | | **Jelmyto® (UGN-101)** | Low-Grade UTUC | Approved & Commercialized | | **UGN-102** | Low-Grade Intermediate Risk NMIBC | Phase 3 (NDA Submission Planned) | | **UGN-103** | Low-Grade Intermediate Risk NMIBC | Phase 3 (Planned 2024) | | **UGN-104** | Low-Grade UTUC | Phase 3 (Planned 2024) | | **UGN-301 (Zalifrelimab)** | High-Grade NMIBC | Phase 1 | - Jelmyto® (mitomycin) for pyelocalyceal solution was approved by the FDA on April 15, 2020, for the treatment of adult patients with low-grade UTUC, holding Orphan Drug exclusivity until April 15, 2027[33](index=33&type=chunk) - The Phase 3 ENVISION trial for UGN-102 met its primary endpoint, showing a **79.2% rate of complete response (CR)** at three months, with a rolling NDA submission planned for September 2024[56](index=56&type=chunk)[58](index=58&type=chunk) - The company is developing UGN-103 and UGN-104, next-generation formulations of UGN-102 and Jelmyto, respectively, in partnership with medac, with Phase 3 studies planned for 2024[59](index=59&type=chunk)[60](index=60&type=chunk) [Strategy, Competition, and Intellectual Property](index=15&type=section&id=Strategy%2C%20Competition%2C%20and%20Intellectual%20Property) UroGen's strategy focuses on establishing Jelmyto as the standard of care, advancing UGN-102, and expanding its uro-oncology pipeline, while facing competition from surgical procedures and other pharmaceutical companies, supported by a robust intellectual property portfolio - Key growth strategies include establishing Jelmyto as the standard of care, advancing UGN-102 towards regulatory approval, expanding the uro-oncology pipeline with candidates like UGN-301, UGN-103, and UGN-104, and exploring collaborations[80](index=80&type=chunk)[81](index=81&type=chunk)[82](index=82&type=chunk) - The company holds a strong intellectual property position with **43 granted patents worldwide** and over **45 pending applications**, with U.S. patents protecting Jelmyto, UGN-102, and RTGel technology expiring between 2024 and 2037[78](index=78&type=chunk)[86](index=86&type=chunk) - Competition arises from the current standard of care (surgical tumor resection) and other pharmaceutical companies such as Janssen, Lipac, Bristol Myers Squibb, Merck, and Ferring Pharmaceuticals, developing drugs for NMIBC and other uro-oncology indications[93](index=93&type=chunk)[94](index=94&type=chunk)[96](index=96&type=chunk) [Government Regulation](index=19&type=section&id=Government%20Regulation) The company is subject to extensive FDA and global regulations covering product development, manufacturing, and marketing, utilizing the 505(b)(2) pathway for its mitomycin-based products, with ongoing post-approval oversight and compliance with healthcare laws - The FDA approval process is extensive, requiring nonclinical studies, an effective IND, and adequate and well-controlled human clinical trials (Phase 1-3) to establish safety and efficacy before an NDA submission[100](index=100&type=chunk)[101](index=101&type=chunk)[103](index=103&type=chunk) - The company utilizes the **505(b)(2) regulatory pathway**, which allows an NDA to rely on FDA's prior findings of safety and efficacy for a previously approved drug, potentially streamlining development[108](index=108&type=chunk) - Jelmyto received **Orphan Drug Designation**, providing **seven years of marketing exclusivity** in the U.S. for its approved indication, ending in April 2027[33](index=33&type=chunk)[115](index=115&type=chunk) - The business is subject to numerous healthcare laws, including the federal Anti-Kickback Statute, False Claims Act, HIPAA, and the Sunshine Act, which regulate relationships with healthcare professionals and government reimbursement programs[135](index=135&type=chunk)[136](index=136&type=chunk)[140](index=140&type=chunk)[141](index=141&type=chunk) [Manufacturing, Commercial Operations, and Corporate Information](index=28&type=section&id=Manufacturing%2C%20Commercial%20Operations%2C%20and%20Corporate%20Information) UroGen relies on third-party contract manufacturers for all raw materials and finished products, has established a U.S. commercial team of approximately 80 representatives for Jelmyto, and as of January 31, 2024, had 201 employees worldwide, with principal executive offices in Princeton, NJ - The company does not own manufacturing facilities and relies on third-party contract manufacturers for all raw materials, active ingredients, and finished products for both clinical trials and commercial supply[159](index=159&type=chunk) - A customer-facing team of approximately **80 representatives**, including territory business managers, clinical nurse educators, and medical science liaisons, has been established to support the commercialization of Jelmyto in the U.S[162](index=162&type=chunk) - As of January 31, 2024, the company had **201 employees**, with **161 located in the United States** and **40 in Israel**[165](index=165&type=chunk) [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including historical losses, financing needs, high dependency on Jelmyto and UGN-102, competition, supply chain issues, IP challenges, and regulatory and geopolitical instability - The company has a history of significant losses (**$102.2 million in 2023**) and an accumulated deficit of **$679.3 million**, raising substantial doubt about its ability to continue as a going concern without additional financing[170](index=170&type=chunk)[180](index=180&type=chunk) - High dependency on the successful commercialization of Jelmyto and the regulatory approval and success of UGN-102 are primary business risks[194](index=194&type=chunk)[215](index=215&type=chunk) - Reliance on third-party, single-source suppliers for key components like mitomycin API and RTGel hydrogel presents significant supply chain risks[257](index=257&type=chunk)[258](index=258&type=chunk) - The company faces intellectual property risks, highlighted by a Paragraph IV Certification Notice from Teva Pharmaceuticals seeking to market a generic version of Jelmyto by challenging its patents[209](index=209&type=chunk)[321](index=321&type=chunk) - Operations in Israel expose the company to political, economic, and military instability, which could disrupt research and development activities[425](index=425&type=chunk) [Unresolved Staff Comments](index=75&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - None[450](index=450&type=chunk) [Cybersecurity](index=75&type=section&id=Item%201C.%20Cybersecurity) The company has implemented an information security program supervised by the Chief Financial Officer and IT Department to manage cybersecurity risks, with Audit Committee oversight, utilizing third-party service providers, and maintaining an incident response policy - The company's cybersecurity risk management is supervised by the Chief Financial Officer and the IT Department, with oversight from the Audit Committee of the Board of Directors[452](index=452&type=chunk)[458](index=458&type=chunk) - The company's strategy includes using third-party service providers for security management roles to identify, assess, and manage cybersecurity threats through various methods like monitoring, threat assessments, and vulnerability scans[452](index=452&type=chunk)[455](index=455&type=chunk) - A cybersecurity incident response policy is in place, designed to escalate significant incidents to management and the Audit Committee to ensure proper mitigation and remediation[461](index=461&type=chunk) [Properties](index=76&type=section&id=Item%202.%20Properties) The company leases approximately 20,913 square feet in Princeton, NJ for its principal executive offices and an 11,495 square foot facility in Israel for research and development, which management deems adequate for current needs - The company's principal executive offices are leased in Princeton, NJ (**~20,913 sq. ft.**), and its primary R&D laboratories are in a leased facility in Israel (**~11,495 sq. ft.**)[463](index=463&type=chunk) [Legal Proceedings](index=76&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that are expected to have a material adverse effect on its business - The company is not currently party to any material legal proceedings[464](index=464&type=chunk) [Mine Safety Disclosures](index=76&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[465](index=465&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=77&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) UroGen's ordinary shares trade on the Nasdaq Global Market under the symbol 'URGN', with 16 registered holders as of March 7, 2024, and the company has never paid dividends, intending to retain earnings for business development, also restricted by its loan agreement - The company's ordinary shares trade on the Nasdaq Global Market under the symbol **URGN**[468](index=468&type=chunk) - The company has never paid dividends and does not expect to in the foreseeable future, due to its policy of retaining earnings for growth and restrictions under its loan agreement[470](index=470&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=78&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) UroGen's 2023 revenue increased, net loss improved, and liquidity was bolstered by financing, though current resources are projected to fund operations only until Q1 2025, raising going concern doubts [Results of Operations](index=85&type=section&id=Results%20of%20Operations) For 2023, revenue increased by 28.5% to $82.7 million, gross profit grew, operating loss narrowed to $65.5 million due to lower R&D expenses, partially offset by increased SG&A and interest expenses, resulting in a net loss of $102.2 million Results of Operations (2023 vs. 2022) | Metric | 2023 (in thousands) | 2022 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | **Revenue** | $82,713 | $64,357 | $18,356 | | Gross Profit | $73,352 | $56,703 | $16,649 | | Research and development | $45,614 | $52,906 | ($7,292) | | Selling and marketing | $54,703 | $51,920 | $2,783 | | General and administrative | $38,571 | $30,918 | $7,653 | | **Operating loss** | ($65,536) | ($79,041) | $13,505 | | **Net loss** | ($102,244) | ($109,783) | $7,539 | - Revenue increased by **$18.3 million (28.5%)** in 2023 compared to 2022, primarily due to increased sales volume of Jelmyto[529](index=529&type=chunk) - Research and development expenses decreased by **$7.3 million**, mainly due to the conclusion of the ATLAS trial and lower costs for the Phase 3 ENVISION trial for UGN-102[531](index=531&type=chunk) [Liquidity and Capital Resources](index=86&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2023, the company had $141.5 million in cash and equivalents, funded by equity offerings, debt, and product sales, including a $120.0 million private placement in 2023 and an amended loan agreement with Pharmakon, though current resources are projected to fund operations only until Q1 2025, raising substantial doubt about its going concern ability - The company had **$141.5 million** in cash, cash equivalents, and marketable securities as of December 31, 2023[538](index=538&type=chunk) - In July 2023, the company raised aggregate gross proceeds of **$120.0 million** through a private placement of ordinary shares and pre-funded warrants[544](index=544&type=chunk) - The company's existing resources are estimated to be sufficient to fund operations only until the **first quarter of 2025**, which raises substantial doubt about its ability to continue as a going concern[546](index=546&type=chunk) - In March 2024, the company amended its loan agreement with Pharmakon, securing access to an additional **$25.0 million tranche** (mandatory draw by Sept 2024) and an optional **$75.0 million tranche** contingent on UGN-102 FDA approval[543](index=543&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=91&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company is exposed to interest rate risk on its investment portfolio and significant foreign currency exchange risk due to New Israeli Shekel operating expenses, but does not currently use hedging instruments - The company's primary market risks are interest rate fluctuations on its marketable securities and foreign currency exchange risk[574](index=574&type=chunk)[576](index=576&type=chunk) - A significant portion of operating expenses are incurred in New Israeli Shekels (NIS), exposing the company to fluctuations between the NIS and the U.S. dollar, its reporting currency[576](index=576&type=chunk) - The company does not currently engage in currency hedging activities to reduce its foreign currency exposure[577](index=577&type=chunk) [Financial Statements and Supplementary Data](index=92&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section contains the company's audited consolidated financial statements for 2023 and 2022, including the Independent Registered Public Accounting Firm's report highlighting going concern doubt, and various financial statements with accompanying notes - The Report of Independent Registered Public Accounting Firm expresses substantial doubt about the Company's ability to continue as a going concern due to its history of losses and negative operating cash flows[583](index=583&type=chunk) Key Financial Statement Data (as of Dec 31, 2023) | Metric | Amount (in thousands) | | :--- | :--- | | **Assets** | | | Cash and cash equivalents | $95,002 | | Total Current Assets | $169,186 | | Total Assets | $178,311 | | **Liabilities & Equity** | | | Total Current Liabilities | $31,212 | | Long-term debt | $98,551 | | Total Liabilities | $243,523 | | Total Shareholders' Deficit | ($65,212) | Key Financial Statement Data (Year ended Dec 31, 2023) | Metric | Amount (in thousands) | | :--- | :--- | | Revenue | $82,713 | | Gross Profit | $73,352 | | Operating Loss | ($65,536) | | Net Loss | ($102,244) | | Net cash used in operating activities | ($76,376) | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=122&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[746](index=746&type=chunk) [Controls and Procedures](index=122&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2023, with no material changes identified - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2023[748](index=748&type=chunk) - Based on the COSO framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2023[750](index=750&type=chunk) [Other Information](index=122&type=section&id=Item%209B.%20Other%20Information) This section discloses the Chief Medical Officer's Rule 10b5-1 trading plan, the March 2024 amended loan agreement with Pharmakon providing up to $100 million in additional financing, and notice for the 2024 Annual Meeting of Shareholders - On March 13, 2024, the company entered into an amended and restated loan agreement with Pharmakon for up to **$100 million** in additional financing, structured in two tranches[753](index=753&type=chunk) - The Chief Medical Officer, Mark Schoenberg, entered into a Rule 10b5-1 trading plan on December 26, 2023, to sell up to **30,000 ordinary shares**[752](index=752&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=123&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[761](index=761&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=124&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) The information required for this item, including details on directors, executive officers, and corporate governance, will be provided in an amendment to the Form 10-K, to be filed by April 29, 2024 - Information will be provided in a future amendment to the Form 10-K[763](index=763&type=chunk) [Executive Compensation](index=124&type=section&id=Item%2011.%20Executive%20Compensation) The information required for this item regarding executive compensation will be provided in an amendment to the Form 10-K, to be filed by April 29, 2024 - Information will be provided in a future amendment to the Form 10-K[765](index=765&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=124&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) The information required for this item concerning security ownership will be provided in an amendment to the Form 10-K, to be filed by April 29, 2024 - Information will be provided in a future amendment to the Form 10-K[766](index=766&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=124&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The information required for this item regarding related party transactions and director independence will be provided in an amendment to the Form 10-K, to be filed by April 29, 2024 - Information will be provided in a future amendment to the Form 10-K[767](index=767&type=chunk) [Principal Accountant Fees and Services](index=124&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) The information required for this item regarding principal accountant fees and services will be provided in an amendment to the Form 10-K, to be filed by April 29, 2024 - Information will be provided in a future amendment to the Form 10-K[768](index=768&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=125&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the financial statements, included in Item 8, and provides a comprehensive list of all exhibits filed with the Form 10-K, including corporate governance documents, material contracts, and officer certifications - This item contains a list of all exhibits filed with the annual report, including corporate governance documents, material contracts, and required certifications[772](index=772&type=chunk)[773](index=773&type=chunk) [Form 10-K Summary](index=127&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company indicates that there is no Form 10-K summary - None[775](index=775&type=chunk)
UroGen Pharma(URGN) - 2023 Q4 - Annual Results
2024-03-14 12:16
Financial Performance - UroGen reported net product revenues of $82.7 million for 2023, representing an increase of approximately 28% compared to $64.4 million in 2022[5][11][10]. - UroGen's cash, cash equivalents, and marketable securities totaled $141.5 million as of December 31, 2023, up from $99.9 million in 2022[21]. - UroGen reported a net loss of $102.2 million for the full year 2023, compared to a net loss of $109.8 million in 2022[16]. - Selling, general and administrative expenses for 2023 were $93.3 million, compared to $82.8 million in 2022[13]. - Research and development expenses for 2023 were $45.6 million, a decrease from $52.9 million in 2022[12]. Product Development and Pipeline - The company initiated a rolling New Drug Application (NDA) for UGN-102 in January 2024, with plans to complete the submission by September 2024 and a potential FDA decision as early as Q1 2025[4][3]. - UroGen anticipates completing its NDA submission for UGN-102 in September 2024, with a potential FDA decision as early as Q1 2025[32]. - UroGen plans to initiate Phase 3 studies for UGN-103 and UGN-104 in 2024, targeting low-grade intermediate-risk non-muscle invasive bladder cancer and low-grade upper tract urothelial cancer, respectively[10]. - UroGen plans to initiate Phase 3 studies for UGN-103 and UGN-104 in 2024, expanding its product pipeline[34]. - UroGen's NDA submission for UGN-102 is contingent on positive findings from the ENVISION Phase 3 study, with data expected in Q2 2024[34]. Market Opportunity and Growth - UroGen's UGN-102 has a market opportunity exceeding $3 billion, aiming to transform treatment for low-grade, intermediate-risk, non-muscle invasive bladder cancer[34]. - The company anticipates full year 2024 net product revenues from JELMYTO to be in the range of $95 to $102 million[17]. - JELMYTO patient and physician adoption is expected to continue increasing, contributing to UroGen's growth[34]. - Patient enrollment, new patient starts, and total doses for JELMYTO grew approximately 25% year-over-year[10]. Financial Flexibility - The company signed a restructured agreement with Pharmakon Advisors, providing up to an additional $100 million credit facility[5][9]. - The company has access to an additional $75 million under an amended credit facility with Pharmakon Advisors, enhancing its financial flexibility[34]. Technology and Patient Considerations - UroGen's proprietary RTGel technology aims to improve therapeutic profiles of existing drugs, potentially making local delivery more effective[34]. - The most common side effects of JELMYTO include urinary tract infection and nausea, highlighting the need for patient monitoring[30]. - Approximately 6,000 - 7,000 new or recurrent low-grade upper tract urothelial cancer patients are diagnosed annually in the U.S.[31]. Intellectual Property - UroGen's pending U.S. patent applications could provide protection for UGN-103 and UGN-104 until December 2041, securing its competitive position[34].
UroGen Pharma(URGN) - 2023 Q3 - Earnings Call Transcript
2023-11-14 19:59
Urogen Pharma Ltd (NASDAQ:URGN) Q3 2023 Earnings Conference Call November 14, 2023 10:00 AM ET Company Participants Vincent Perrone - Senior Director, IR Elizabeth Barrett - President, CEO & Director Mark Schoenberg - Chief Medical Officer Dong Kim - CFO Jeffrey Bova - Chief Commercial Officer Conference Call Participants Leland Gershell - Oppenheimer Raghuram Selvaraju - H.C. Wainwright & Co. Boris Peaker - TD Cowen Paul Choi - Goldman Sachs Group Operator Good morning, ladies and gentlemen, and thank you ...
UroGen Pharma(URGN) - 2023 Q3 - Quarterly Report
2023-11-14 13:24
UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the quarterly period ended September 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 WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UROGEN PHARMA LTD. N/A (Former name, former address and former fiscal year, if changed since last report) Securities re ...
UroGen Pharma(URGN) - 2023 Q2 - Earnings Call Transcript
2023-08-10 17:57
UroGen Pharma Ltd. (NASDAQ:URGN) Q2 2023 Results Conference Call August 10, 2023 10:00 AM ET Company Participants Vincent Perrone - Head Investor Relations Liz Barrett - President and Chief Executive Officer Mark Schoenberg - Chief Medical Officer Jeff Bova - Chief Commercial Officer Don Kim - Chief Financial Officer Conference Call Participants Raghuram Selvaraju - H.C. Wainwright Boris Peaker - TD Cowen Leland Gershell - Oppenheimer Matt Kaplan - Ladenburg Thalmann Operator Good morning, ladies and gentle ...