UroGen Pharma(URGN)
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Urogen Pharma (URGN) Presents At 39th Annual J.P. Morgan Healthcare Conference - Slideshow
2021-01-21 01:33
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(URGN) - 2020 Q3 - Earnings Call Transcript
2020-11-09 20:02
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 ...
UroGen Pharma(URGN) - 2020 Q3 - Quarterly Report
2020-11-09 12:40
[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(URGN) - 2020 Q2 - Earnings Call Transcript
2020-08-10 17:24
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 ...
UroGen Pharma(URGN) - 2020 Q2 - Quarterly Report
2020-08-10 11:35
For the quarterly period ended June 30, 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 WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION UROGEN PHARMA LTD. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or o ...
UroGen Pharma (URGN) Presents At Jefferies Healthcare Conference - Slideshow
2020-06-03 22:13
UROGEN CORPORATE PRESENTATION JEFFERIES HEALTHCARE CONFERENCE June 2, 2020 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 physician uptake following the Jelmyto launch; plans for the successful launch of Jelmyto; the timing for completion of commerci ...
UroGen Pharma(URGN) - 2020 Q1 - Earnings Call Transcript
2020-05-10 13:38
UroGen Pharma Ltd. (NASDAQ:URGN) Q1 2020 Earnings Conference Call May 7, 2020 8:30 AM ET Company Participants Kate Bechtold - Senior Director, Investor Relations Liz Barrett - President & Chief Executive Officer Mark Schoenberg - Chief Medical Officer Jeff Bova - Senior Vice President, Commercial Peter Pfreundschuh - Chief Financial Officer Conference Call Participants Derek Archila - Stifel Nicolaus Paul Choi - Goldman Sachs Matthew Kaplan - Ladenburg Thalmann Boris Peaker - Cowen Leland Gershell - Oppenhe ...
UroGen Pharma(URGN) - 2020 Q1 - Quarterly Report
2020-05-07 11:03
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, 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 jurisdiction of incorporation or ...
UroGen Pharma(URGN) - 2019 Q4 - Earnings Call Transcript
2020-03-02 19:23
UroGen Pharma Ltd. (NASDAQ:URGN) Q4 2019 Earnings Conference Call March 2, 2020 8:30 AM ET Company Participants Kate Bechtold - Senior Director, Investor Relations Liz Barrett - President and Chief Executive Officer Mark Schoenberg - Chief Medical Officer Peter Pfreundschuh - Chief Financial Officer Jeff Bova - Senior Vice President, Commercial Conference Call Participants Derek Archila - Stifel Nicolaus Chris Howerton - Jefferies Paul Choi - Goldman Sachs Ram Selvaraju - H.C. Wainwright & Co. Matthew Kapla ...
UroGen Pharma(URGN) - 2019 Q4 - Annual Report
2020-03-02 12:33
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, 2019 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) Israel 98-1460746 (Sta ...