UroGen Pharma to Report Fourth Quarter and Full Year 2018 Financial Results
On Track to Complete UGN-101 Rolling NDA Submission to the
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
“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
“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
UGN-101 Clinical Development:
In the fourth quarter, the
U.S. Food and Drug Administration( FDA) granted Breakthrough Therapy Designation (BTD) for UGN-101 (mitomycin gel) for instillation, an investigational mitomycin formulation for the non-surgical treatment of patients with LG UTUC.
January 2019, the Company announced positive topline results from the pivotal Phase 3 OLYMPUS clinical trial of UGN-101, in which 57 percent of patients achieved a complete response (CR) rate at their primary disease evaluation (PDE, or the primary endpoint) which was conducted four to six weeks after completion of UGN-101 treatment.
- In the fourth quarter, the
- Pipeline Advancement:
- The Company continues to enroll patients as part of its Phase 2b OPTIMA II clinical trial of UGN-102 (mitomycin gel) for intravesical instillation as a potential first-line chemoablation agent in the treatment of intermediate risk patients with low-grade non-muscle invasive bladder cancer (LG NMIBC) at risk for recurrence.
- Corporate Developments:
UroGen strengthened its leadership team with the appointment of
Liz Barrettas President and Chief Executive Officer. Ms. Barrett has over 30 years of industry experience spanning multiple areas including oncology, specialty care, surgical franchises, and consumer marketing in multiple geographic regions, most recently serving as CEO of Novartis Oncology and as a member of the Executive Committee of Novartis.
The Company enhanced its financial position with the completion of
a successful public offering of ordinary shares in
January 2019, resulting in net proceeds of approximately $162 million. These proceeds leave the company well-capitalized to execute on upcoming milestones, including preparation for potential commercialization of UGN-101, continued clinical development of our second product candidate (UGN-102), and advancement of our pipeline.
- UroGen strengthened its leadership team with the appointment of
- UGN-101: UroGen remains on
track to complete its rolling NDA for UGN-101 in 2H 2019 and is
planning for potential approval in 1H 2020. If approved, UGN-101 would
be the first drug approved for the non-surgical treatment of LG UTUC.
- The company continues to build out its commercial infrastructure and focus on scientific awareness to support adoption and seamless integration of UGN-101 into the urologist practice following potential regulatory approval.
- UGN-102: The Company
intends to report initial data from the OPTIMA II trial of UGN-102 in
Similar to UGN-101, UGN-102 has the potential to transform the
treatment paradigm for patients with LG NMIBC, as there are
currently no drugs approved by the
FDAas first-line treatment for LG NMIBC.
- UGN-102 represents a substantial opportunity in UroGen’s pipeline with the potential to initially address up to approximately 80,000 patients for whom repetitive surgical resection via Transurethral Resection of Bladder Tumor (TURBT) remains the standard of care.
- Similar to UGN-101, UGN-102 has the potential to transform the treatment paradigm for patients with LG NMIBC, as there are currently no drugs approved by the
Allergancontinues to enroll patients in its Phase 2 trial of BotuGel, UroGen’s RTGel in combination with BOTOX®1, for the treatment of overactive bladder. Phase 2 data is expected in 2019.
Fourth Quarter and Full Year 2018 Financial Results; 2019 Guidance
December 31, 2018, cash, cash equivalents, and short-term investments totaled $101.3 million. In addition, the Company raised net proceeds of approximately $162 millionfrom an underwritten public offering in January 2019. Based on anticipated activities, the current cash balance is projected to carry the company for the next 24-36 months.
Research and development expenses for the year ended
December 31, 2018were $36.9 million, including non-cash share-based compensation expense of $12.0 million. Research and development expenses for the three months ended December 31, 2018were $11.5 million, including non-cash share-based compensation expense of $3.0 million.
General and administrative expenses for the year ended
December 31, 2018were $39.6 million, including non-cash share-based compensation expense of $18.6 million. General and administrative expenses for the three months ended December 31, 2018were $12.6 million, including non-cash share-based compensation expense of $5.9 million.
The Company reported a net loss of
$75.7 million, or basic and diluted net loss per ordinary share of $4.80, for the year ended December 31, 2018. The Company reported a net loss of $23.7 million, or basic and diluted net loss per ordinary share of $1.46, for the three months ended December 31, 2018.
The Company anticipates a net loss in the range of
$100 to $115 millionfor 2019, which is expected to include non-cash stock-based compensation expense in the range of $24 to $27 millionsubject to market conditions. The projected change in net loss for 2019 versus 2018 is expected to be largely attributable to the buildout of commercial infrastructure in anticipation of the potential launch of UGN-101. The Company has 20.4 million ordinary shares outstanding post the closing of our most recent financing in January.
Conference Call & Webcast Information
Members of UroGen’s management team will host a live conference call and
webcast today at
The live webcast can be accessed by visiting the Investors section of the Company’s website at http://investors.urogen.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (888) 771-4371 (U.S.) or (847) 585-4405 (International) to listen to the live conference call. The conference ID number for the live call will be 48205742. An archive of the webcast will be available for two weeks on the Company’s website.
|UROGEN PHARMA LTD.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|(U.S. dollars in thousands, except share and per share data)|
|December 31, 2018||December 31, 2017|
|Cash and cash equivalents||$||101,318||$||36,999|
|Prepaid expenses and other current assets||672||958|
|TOTAL CURRENT ASSETS||102,243||74,472|
|Property and equipment, net||948||805|
|Other non-current assets||317||244|
|Liabilities and Shareholders' equity|
|Accounts payable and accrued expenses||$||8,540||$||4,435|
|Employee related accrued expenses||4,925||1,950|
|TOTAL SHAREHOLDERS’ EQUITY||90,094||68,515|
|TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY||$||103,559||$||75,550|
|UROGEN PHARMA LTD.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(U.S. dollars in thousands, except share and per share data)|
|Year ended December 31,||Three months ended December 31,|
|COST OF REVENUES||1,803||600||-||287|
|Research and development expenses||36,934||18,697||11,465||6,761|
|General and administrative expenses||39,571||8,811||12,552||3,437|
|FINANCE (INCOME) EXPENSES, NET||(1,648||)||31||(425||)||(91||)|
|LOSS BEFORE INCOME TAXES||75,532||19,981||23,592||10,067|
|INCOME TAX EXPENSE||125||19||125||—|
|NET LOSS PER ORDINARY SHARE, BASIC AND DILUTED||$||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|
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 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-à-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
|1||BOTOX® is a proprietary trademark of Allergan Pharmaceuticals|
Director, Corporate Communications & Investor Relations