Full Press Release Details
UroGen Pharma Reports Third Quarter 2019 Financial Results and Recent
Corporate Developments
Completed Submission of New Drug Application (NDA) to U.S. FDA for UGN-101 in Patients with Low-Grade Upper Tract Urothelial Cancer (LG UTUC)
Exclusive Worldwide License Agreement with
Agenus to Advance Treatment of High-Grade Urinary Tract Cancers in Combination with UGN-201
Conference Call and Webcast to be Held Today at 8:30 AM ET
NEW YORK, November 12, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address
unmet needs in uro-oncology, today announced financial results for the third quarter ended September 30, 2019 and provided an overview of the Company s recent developments.
On behalf of the UroGen team, we are very pleased to announce that we have completed the New Drug Application (NDA) submission for UGN-101 to the FDA. This is a very important milestone for UroGen and for patients with low-grade UTUC as UGN-101has the potential to
bring the first primary chemoablation drug to these patients. I am proud of the UroGen team and investigators who have helped to make this key milestone a reality, said Liz Barrett, President and Chief Executive Officer of UroGen. Beyond
UGN-101, we have taken important steps to build a company that can deliver long-term sustainable growth through our focus on high unmet need areas utilizing both local delivery and novel medicines. We ve
demonstrated that relentless commitment with our recently announced positive complete response data for investigational agent UGN-102 in patients with intermediate risk LG NMIBC, and our exclusive
collaboration with Agenus to advance therapies for high-grade urinary tract cancers. We look forward to a strong future for UroGen.
Highlights and Upcoming Milestones
Third Quarter 2019 Financial Results; 2019 Guidance
Conference Call & Webcast Information
Members of UroGen s management team will host a live conference call and webcast today at 8:30 am Eastern Time to review the Company s financial
results and provide a general business update.
The live webcast can be accessed by visiting the Investors section of the Company s website at
http://investors.urogen.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (888) 771-4371 (U.S.) or (847) 585-4405 (International) to listen to the live conference call. The conference ID number for the live call will be 49159339. An archive of the webcast
will be available for two weeks on the Company s website.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per share data)
| September 30, 2019 | December 31, 2018 | |||||||
| Assets | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 66,147 | $ | 101,318 | ||||
| Marketable Securities | 92,046 | |||||||
| Restricted deposit | 523 | 253 | ||||||
| Prepaid expenses and other current assets | 1,160 | 672 | ||||||
| TOTAL CURRENT ASSETS | 159,876 | 102,243 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Property and equipment, net | 893 | 948 | ||||||
| Restricted deposit | 55 | 51 | ||||||
| Marketable Securities | 63,506 | |||||||
| Other non-current assets | 2,423 | 317 | ||||||
| TOTAL ASSETS | $ | 226,753 | $ | 103,559 | ||||
| Liabilities and Shareholders equity | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accrued expenses | $ | 7,880 | $ | 8,540 | ||||
| Employee related accrued expenses | 5,082 | 4,925 | ||||||
| Other current liabilities | 1,126 | |||||||
| TOTAL CURRENT LIABILITIES | 14,088 | 13,465 | ||||||
| NON-CURRENT LIABILITIES: | ||||||||
| Long-term lease liability | 1,749 | |||||||
| TOTAL NON-CURRENT LIABILITIES | 1,749 | |||||||
| TOTAL LIABILITIES | 15,837 | 13,465 | ||||||
| TOTAL SHAREHOLDERS EQUITY | 210,916 | 90,094 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS EQUITY | $ | 226,753 | $ | 103,559 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(U.S. dollars in thousands, except share and per share data)
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| REVENUES | $ | $ | 283 | 18 | $ | 1,128 | ||||||||||
| COST OF REVENUES | 1,055 | 1,803 | ||||||||||||||
| GROSS (LOSS) PROFIT | (772 | ) | 18 | (675 | ) | |||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Research and development expenses | 9,481 | 9,574 | 29,203 | 25,469 | ||||||||||||
| General and administrative expenses | 13,972 | 10,743 | 40,454 | 27,019 | ||||||||||||
| OPERATING LOSS | (23,453 | ) | (21,089 | ) | (69,639 | ) | (53,163 | ) | ||||||||
| FINANCE INCOME, NET | 1,201 | 556 | 3,466 | 1,323 | ||||||||||||
| REALIZED LOSS ON SALE OF SHORT-TERM INVESTMENT | (100 | ) | ||||||||||||||
| NET LOSS | $ | (22,252 | ) | $ | (20,533 | ) | $ | (66,173 | ) | $ | (51,940 | ) | ||||
| NET LOSS PER ORDINARY SHARE, BASIC AND DILUTED | $ | (1.06 | ) | $ | (1.28 | ) | $ | (3.25 | ) | $ | (3.30 | ) | ||||
| WEIGHTED AVERAGE SHARES OUTSTANDING, BASIC AND | ||||||||||||||||
| DILUTED | 20,916,780 | 16,092,583 | 20,373,070 | 15,721,445 | ||||||||||||
| STATEMENT OF COMPREHENSIVE LOSS | ||||||||||||||||
| NET LOSS | $ | (22,252 | ) | $ | (20,533 | ) | $ | (66,173 | ) | $ | (51,940 | ) | ||||
| OTHER COMPREHENSIVE INCOME: | ||||||||||||||||
| UNREALIZED GAIN ON MARKETABLE SECURITIES | 22 | 303 | ||||||||||||||
| COMPREHENSIVE LOSS | $ | (22,230 | ) | $ | (20,533 | ) | $ | (65,870 | ) | $ | (51,940 | ) |
About UroGen Pharma Ltd.
UroGen Pharma Ltd. (Nasdaq:URGN) is a clinical-stage biopharmaceutical company developing advanced non-surgical
treatments to address unmet needs in the field of urology, with a focus on uro-oncology. UroGen has developed RTGel reverse-thermal hydrogel, a
proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs. UroGen s sustained release technology is designed to enable longer exposure of the urinary tract tissue
to medications, making local therapy a potentially more effective treatment option. UroGen s lead investigational candidates, UGN-101 (mitomycin gel) for instillation, and
UGN-102 (mitomycin gel) for intravesical instillation, are designed to ablate tumors by non-surgical means and to treat several forms of
non-muscle invasive urothelial cancer, including low-grade upper tract urothelial cancer and low-grade non-muscle invasive bladder cancer, respectively. UroGen is headquartered in New York, NY with operations in Los Angeles, CA and Israel.
Forward Looking Statements
This press release contains
forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation: the potential of UGN-101 for LG UTUC; the potential approval of UGN-101 and the timing thereof; the expectation that UGN-101, if approved, will be the first drug approved for the non-surgical
treatment of LG UTUC; the expected readiness of UroGen for a potential commercial launch of UGN-101 in 1H 2020; the potential of UroGen s proprietary
RTGel technology platform to improve therapeutic profiles of existing drugs; the opportunity and potential of UGN-102 for LG NMIBC; the planned
initiation of a Phase 3 pivotal study of UGN-102 in LG NMIBC following discussions with FDA; plans for clinical development of UGN-201 and initiation of human studies;
and plans to develop and commercialize zalifrelimab (AGEN1884, anti-CTLA-4 antibody) in combination with UGN-201 for the treatment of urinary tract cancers via
intravesical delivery, including plans for initial development in high-grade NMIBC. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the design, timing and success of clinical trials,
including the OLYMPUS Phase 3 trial, the OPTIMA II Phase 2b trial, Phase 3 studies for UGN-102, anticipated studies for UGN-201, and anticipated studies of zalifrelimab
(AGEN1884, anti-CTLA-4 antibody) in combination with UGN-201 for the treatment of urinary tract cancers via intravesical delivery, and potential safety and other
complications thereof; the ability to obtain regulatory approval within the timeframe expected, or at all; the ability to maintain regulatory approval; complications associated with achieving
commercial readiness for the launch of a new product; the labeling for any approved product; the scope, progress and expansion of developing and commercializing UroGen s product candidates; the size and growth of the market(s) therefor and the
rate and degree of market acceptance thereof vis- -vis alternative therapies; and UroGen s ability to attract or retain key management, members of the board
of directors and personnel. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen s Form 10-Q filed with the SEC on
November 12, 2019, and other filings that UroGen makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and UroGen 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 press release and are based on information available to UroGen as of the date of this release.
Senior Director, Investor Relations