Full Press Release Details
UroGen Pharma Reports First Quarter 2022 Financial Results
and Recent Corporate Developments
PRINCETON, N.J., May 10, 2022 - UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative
solutions that treat urothelial and specialty cancers, today announced financial results for the first quarter ended March 31, 2022, and provided an overview of recent developments.
The first quarter of 2022 saw further commercial, clinical and operational progress as we continued to grow patient access to Jelmyto, advance
our clinical-stage candidates and significantly strengthened our financial position in support of our business, said Liz Barrett, President, and Chief Executive Officer of UroGen. Thus far in 2022, we have begun enrolling patients in the
Phase 3 ENVISION pivotal trial of UGN-102 in low-grade, intermediate-risk NMIBC and initiated a
first-in-human, multi-arm Phase 1 clinical study of UGN-301 in high-grade NMIBC. Our
accomplishments throughout 2021 and early 2022, coupled with our strengthened balance sheet, position us well to continue to execute on our strategic initiatives as we look to accelerate growth and advance our mission of transforming the treatment
paradigm for patients with urothelial cancers.
Business Highlights:
Jelmyto (mitomycin) for pyelocalyceal solution in low-grade Upper Tract Urothelial Cancer (LG-UTUC):
UGN-102 (mitomycin) for intravesical solution:
UGN-301 (zalifrelimab) for intravesical solution:
First Quarter 2022 Financial Results:
Revenue: UroGen reported net product revenue of Jelmyto for the first quarter 2022 of $13.6 million, compared to $7.5 million in the first quarter of 2021.
R&D Expense: Research and development expenses for the first quarter 2022 were $12.7 million, including
non-cash share-based compensation expense of $0.7 million as compared to $10.5 million, including non-cash share-based compensation expense of
$1.1 million, for the same period in 2021.
SG&A Expense: Selling, general and administrative expenses for the first quarter 2022 were
$21.3 million, including non-cash share-based compensation expense of $2.2 million. This compares to $22.2 million, including non-cash share-based
compensation expense of $5.1 million, for the same period in 2021.
Financing on Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $5.8 million for the first quarter 2022. The rate applied to cash payments incurred in 2022 is 13% based on
$48 million of global net product sales of Jelmyto in 2021.
Net Loss: UroGen reported a net loss of $28.4 million, or basic and diluted
net loss per ordinary share of $1.25, for the first quarter 2022 as compared to $25.9 million, or basic and diluted net loss per ordinary share of $1.17, for the same period in 2021.
Cash & Cash Equivalents: As of March 31, 2022, cash, cash equivalents and marketable securities totaled
$137.1 million. This includes the first $75 million tranche of the up to $100 million term loan facility with funds managed by Pharmakon Advisors, which closed in March 2022.
2022 Revenue, Operating Expense and RTW Expense Guidance: The Company reiterates anticipated full year 2022 net product revenues from Jelmyto to
be in the range of $70 to $80 million. The Company reiterates anticipated full year 2022 operating expenses in the range of $140 to $160 million, including non-cash share-based compensation expense
of $10 to $16 million, subject to market conditions. The Company reiterates anticipated full year 2022 non-cash financing expense related to the prepaid obligation to RTW Investments in the range of $22
to $26 million, of which approximately $9.1 to $10.4 million will be paid in cash.
Conference Call & Webcast Information: Members of UroGen s management
team will host a live conference call and webcast today at 10:00 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 commencement of the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (855) 765-5685 (U.S.) or
(615) 247-5916 (International) to listen to the live conference call. The conference ID number for the live call will be 6687048. An archive of the webcast will be available for two weeks on the Company s
SELECTED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
| March 31, 2022 | December 31, 2021 | |||||||
| Cash and cash equivalents and marketable securities | $ | 137,118 | $ | 89,814 | ||||
| Total assets | $ | 165,715 | $ | 119,746 | ||||
| Total liabilities | $ | 182,789 | $ | 111,333 | ||||
| Total shareholders equity | $ | (17,074 | ) | $ | 8,413 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(U.S. dollars in thousands, except share and per share data)
| Three months ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| Revenue | $ | 13,564 | $ | 7,485 | ||||
| Cost of revenue | 1,525 | 897 | ||||||
| Gross profit | 12,039 | 6,588 | ||||||
| Operating expense: | ||||||||
| Research and development expenses | 12,696 | 10,513 | ||||||
| Selling, general and administrative expenses | 21,300 | 22,189 | ||||||
| Total operating expense | 33,996 | 32,702 | ||||||
| Operating loss | (21,957 | ) | (26,114 | ) | ||||
| Financing on prepaid forward obligation | (5,826 | ) | ||||||
| Interest expense on long-term debt | (282 | ) | ||||||
| Other income (expense) | (2 | ) | 179 | |||||
| Loss before income taxes | $ | (28,067 | ) | $ | (25,935 | ) | ||
| Income tax expense | (325 | ) | ||||||
| Net loss | $ | (28,392 | ) | $ | (25,935 | ) | ||
| Net loss per ordinary share basic and diluted | $ | (1.25 | ) | $ | (1.17 | ) | ||
| Weighted average shares outstanding, basic and diluted | 22,631,509 | 22,242,375 |
Jelmyto (mitomycin) for
pyelocalyceal solution, is a drug formulation of mitomycin indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC).
Utilizing the RTGel technology platform, UroGen s proprietary sustained release, hydrogel-based formulation, Jelmyto is designed to enable longer exposure of urinary tract tissue to
mitomycin, thereby enabling the treatment of tumors by non-surgical means. Jelmyto is delivered to patients using standard ureteral catheters or nephrostomy tube. The U.S. FDA previously granted Orphan Drug,
Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC. On April 15, 2020, the FDA approved Jelmyto, making it the first drug approved for the treatment of LG-UTUC in adult patients.
APPROVED USE FOR JELMYTO
JELMYTO is a prescription medicine used to treat adults with a type of cancer of the lining of the
upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).
IMPORTANT SAFETY INFORMATION
receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
Before receiving JELMYTO, tell your healthcare
provider about all your medical conditions, including if you:
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6
months after the last dose.
Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you
should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.
How will I receive JELMYTO?
After receiving JELMYTO:
JELMYTO may cause serious side effects, including:
The most common side effects of JELMYTO include:
urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain. You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda/gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.
Full Prescribing Information, including the Patient Information, for additional information.
About Upper Tract Urothelial Cancer (UTUC)
Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S. Between five percent and ten percent of
primary urothelial cancers originate in the ureter or renal pelvis and are collectively referred to as upper tract urothelial cancers (UTUC). In the U.S., there are approximately 6,000 - 7,000 new or recurrent
low-grade UTUC patients annually. Most cases are diagnosed in patients over 70 years old, and these older patients often face comorbidities. There are limited treatment options for UTUC, with the most common
being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). These treatments can lead to a high rate of recurrence and relapse.
UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of low-grade intermediate risk
NMIBC. Utilizing the RTGelTM Technology Platform, UroGen s proprietary sustained release, hydrogel-based formulation, UGN-102 is designed to enable
longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary
catheter. The Company presented results from the Phase 2b OPTIMA II trial in September 2021.
About the Phase 3 ENVISION Trial
The Phase 3 ENVISION trial is a single-arm, multinational, multicenter study evaluating the efficacy and safety of UGN-102 (mitomycin) as primary chemoablative therapy in patients with low-grade, intermediate-risk NMIBC. The Phase 3 ENVISION trial is expected to enroll approximately 220
patients across 90 sites and study participants will receive six once-weekly intravesical instillations of UGN-102. The planned primary endpoint will evaluate the complete response rate at three months after
the first installation, and the key secondary endpoint will evaluate durability over time in patients who achieve complete response at the three-month assessment. Based on discussions with the FDA, and enrollment expected by the end of 2022,
assuming positive findings, UroGen anticipates submitting an NDA for UGN-102 in 2024.
Learn more about the Phase
3 ENVISION trial at www.clinicaltrials.gov (NCT05243550)
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients
deserve better options. UroGen has developed RTGelTM reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic
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, statements regarding: our ability to execute on our strategic initiatives and continue to execute on our
strategic initiatives as we look to accelerate growth and advance our mission of transforming the treatment paradigm for uro-oncology patients; the number of patients expected to be enrolled and the timing for
completion of enrollment with respect to our ongoing Phase 3 ENVISION trial; our belief that the design of the Phase 3 ENVISION trial increases our probability of regulatory success; plans with respect to a regulatory submission for UGN-102 and the
timing thereof; the ongoing Phase 1 clinical study for UGN-301 and the design, objectives and timing thereof; the availability of the second tranche term
loan under the term loan facility; and financial guidance for 2022. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: clinical trial enrollment challenges that may impact the expected
timing of our planned clinical trials, including challenges related to the ongoing COVID-19 pandemic and the Russia-Ukraine conflict; the timing and success of clinical trials 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 commercialization activities, including complications resulting
from the ongoing COVID-19 pandemic; 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; the ability to satisfy required customary bring down
conditions and deliverables for the second tranche of the term loan facility with Pharmakon; UroGen s ability to attract or retain key management, members of the board of directors and personnel; and any negative effects on UroGen s
business, commercialization and product development plans caused by or associated with COVID-19 or geopolitical events. 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-K filed with the SEC on March 21, 2022, as well as in the Risk Factors section of UroGen s Quarterly Report on Form 10-Q being filed with the SEC later today (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.