Full Press Release Details
UroGen Pharma to Report Fourth Quarter and Full Year 2018 Financial Results
On Track to Complete UGN-101 Rolling NDA Submission to the FDA in 2H 2019
Acceleration of Pre-Commercial Activities and Infrastructure Buildout Underway to Support the
Potential U.S. Approval and Launch of UGN-101 in 1H 2020
Initial Data from UGN-102 Trial Anticipated in 2019
Conference Call and Webcast to be Held Today at 8:30 AM ET
NEW YORK, February 28, 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 fourth quarter and full year ended December 31, 2018 and provided an overview of the Company s recent developments.
Our clinical and corporate execution in 2018 places UroGen in a position of strength as we prepare to potentially deliver
UGN-101 as the first approved therapy for patients with low-grade upper tract urothelial cancer (LG UTUC), said Liz Barrett, President and Chief Executive Officer
of UroGen. With this solid foundation, we remain intensely focused on finalizing our rolling New Drug Application (NDA) and accelerating commercial preparation to ensure a successful launch upon approval with seamless adoption of UGN-101. We believe UGN-101 is just the beginning of what may be possible with our proprietary RTGel technology platform.
LG UTUC represents a clinical challenge as the current treatment of surgical intervention can put patients at risk for the well-known complications
associated with repetitive surgical procedures and potential kidney removal, said Mark P. Schoenberg, M.D., Chief Medical Officer of UroGen. If approved, UGN-101 could be a true breakthrough for
patients by providing an option to avoid the risks and downstream consequences associated with surgery while arming urologists in general practice with a simple-to-use,
kidney sparing approach to the management of their patient s disease.
Upcoming Milestones:
Fourth Quarter and Full Year 2018 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 48205742. 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)
| December 31, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Assets | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 101,318 | $ | 36,999 | ||||
| Short-term investments | 36,001 | |||||||
| Restricted deposit | 253 | 198 | ||||||
| Inventory | 316 | |||||||
| Prepaid expenses and other current assets | 672 | 958 | ||||||
| TOTAL CURRENT ASSETS | 102,243 | 74,472 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Property and equipment, net | 948 | 805 | ||||||
| Restricted deposit | 51 | 29 | ||||||
| Other non-current assets | 317 | 244 | ||||||
| TOTAL ASSETS | $ | 103,559 | $ | 75,550 | ||||
| Liabilities and Shareholders equity | ||||||||
| LIABILITIES: | ||||||||
| Accounts payable and accrued expenses | $ | 8,540 | $ | 4,435 | ||||
| Employee related accrued expenses | 4,925 | 1,950 | ||||||
| Deferred revenues | 650 | |||||||
| TOTAL LIABILITIES | 13,465 | 7,035 | ||||||
| TOTAL SHAREHOLDERS EQUITY | 90,094 | 68,515 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS EQUITY | $ | 103,559 | $ | 75,550 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
| Year ended December 31, | Three months ended December 31, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| REVENUES | $ | 1,128 | $ | 8,158 | $ | $ | 327 | |||||||||
| COST OF REVENUES | 1,803 | 600 | 287 | |||||||||||||
| GROSS PROFIT | (675 | ) | 7,558 | 40 | ||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Research and development expenses | 36,934 | 18,697 | 11,465 | 6,761 | ||||||||||||
| General and administrative expenses | 39,571 | 8,811 | 12,552 | 3,437 | ||||||||||||
| OPERATING LOSS | 77,180 | 19,950 | 24,017 | 10,158 | ||||||||||||
| FINANCE (INCOME) EXPENSES, NET | (1,648 | ) | 31 | (425 | ) | (91 | ) | |||||||||
| LOSS BEFORE INCOME TAXES | 75,532 | 19,981 | 23,592 | 10,067 | ||||||||||||
| INCOME TAX EXPENSE | 125 | 19 | 125 | |||||||||||||
| NET LOSS | $ | 75,657 | $ | 20,000 | $ | 23,717 | $ | 10,067 | ||||||||
| NET LOSS PER ORDINARY SHARE, BASIC AND DILUTED | $ | 4.80 | $ | 2.14 | $ | 1.46 | $ | 0.74 | ||||||||
| WEIGHTED AVERAGE SHARES OUTSTANDING, BASIC AND DILUTED | 15,754,193 | 9,716,790 | 16,212,274 | 13,612,814 |
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 , 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 potentially 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 bladder cancer, respectively. UroGen is headquartered in New York, NY with operations in Los Angeles, CA and Israel.
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995,
including with respect to the completion of the rolling NDA for UGN-101, approval, launch and adoption of UGN-101, the potential of UroGen s proprietary RTGel
technology platform, timing with respect to data for UGN-102 and BotuGel, and the potential of UGN-102 and BotuGel, which statements are subject to a number of risks,
uncertainties and assumptions, including, but not limited to: the timing and success of clinical trials and potential complications thereof; the ability to obtain and maintain regulatory approval; the labeling for any approved product; the scope,
progress and expansion of developing and commercializing UroGen Pharma 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 Pharma 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 Pharma s Form 10-K to be filed with the SEC on February 28, 2019 and other filings that UroGen Pharma 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 Pharma 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 Pharma as of the date of this release.
Director, Corporate Communications & Investor Relations