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–(BUSINESS WIRE)–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.”

Recent Highlights

  • 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.
    • In 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.
  • 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 Barrett as 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.

Upcoming Milestones

  • 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
    2019.

    • 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 FDA as 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.
  • BotuGel: Allergan continues
    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

  • As of December 31, 2018, cash, cash equivalents, and short-term
    investments totaled $101.3 million. In addition, the Company raised
    net proceeds of approximately $162 million from 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, 2018
    were $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, 2018 were $11.5 million, including
    non-cash share-based compensation expense of $3.0 million.
  • General and administrative expenses for the year ended December 31,
    2018 were $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, 2018 were $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
    million for 2019, which is expected to include non-cash stock-based
    compensation expense in the range of $24 to $27 million subject 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 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.

       
UROGEN PHARMA LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
 
December 31, 2018 December 31, 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
 
           
UROGEN PHARMA LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
 
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.

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 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.

 
1 BOTOX® is a proprietary trademark of Allergan Pharmaceuticals

Contacts

UROGEN:
Kate Bechtold
Director, Corporate
Communications & Investor Relations
Kate.Bechtold@urogen.com
914-552-0456

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