Full Press Release Details
UroGen Pharma Meets Revenue Goal, Reports First Quarter 2023 Financial Results and Recent Corporate Developments
PRINCETON, N.J. May 11, 2023 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, 2023, and provided an overview of recent developments.
2023 is off to a promising start as we reported double-digit year-over-year growth in worldwide JELMYTO net sales during the first quarter, said
Liz Barrett, President, and Chief Executive Officer of UroGen. Jelmyto adoption continues to grow, attributable to the growing body of evidence supporting its benefits in a real-world setting, combined with key initiatives that have expanded
access and improved logistical efficiencies for physicians and patients. As we look ahead to summer 2023, we have several key events to prepare for, primarily topline results from both the ENVISION and ATLAS clinical trials investigating the
potential of UGN-102 for the treatment of LG-IR-NMIBC. With prospective favorable results, we will look to submit a New Drug
Application (NDA) for UGN-102 in 2024 to the U.S. Food & Drug Administration (FDA), for which we are already actively preparing.
Business Highlights:
UGN-102 (mitomycin) for intravesical solution:
JELMYTO (mitomycin) for
pyelocalyceal solution in low-grade upper tract urothelial cancer (LG-UTUC):
Jelmyto Revenue: UroGen reported net product revenue of Jelmyto for the first quarter 2023 of $17.2 million, compared
to $13.6 million in the first quarter of 2022.
R&D Expense: Research and development expenses for the first quarter 2023 were
$12.5 million, including non-cash share-based compensation expense of $0.5 million as compared to $12.7 million, including non-cash share-based
compensation expense of $0.7 million, for the same period in 2022.
SG&A Expense: Selling, general and administrative expenses for the
first quarter 2023 were $24.5 million, including non-cash share-based compensation expense of $1.8 million. This compares to $21.3 million, including
non-cash share-based compensation expense of $2.2 million, for the same period in 2022.
Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $5.2 million for the first quarter 2023. The rate applied to cash
payments incurred in 2023 is 13% based on global net product sales of JELMTYO in 2022.
Interest Expense on Long-Term Debt: Interest expense related to the $100 million term loan
facility with funds managed by Pharmakon Advisors was $3.6 million for the first quarter of 2023, compared to $0.3 million for the same period last year due to the transaction closing in March 2022 and the final $25 million draw down
under the term loan facility in December 2022.
Net Loss: UroGen reported a net loss of $30.2 million, or basic and diluted net loss per
ordinary share of $1.30, for the first quarter 2023 as compared to $28.4 million, or basic and diluted net loss per ordinary share of $1.25, for the same period in 2022.
Cash & Cash Equivalents: As of March 31, 2023, cash, cash equivalents and marketable securities totaled $75.2 million.
2023 Revenue, Operating Expense and RTW Expense Guidance: The Company reiterates anticipated full year 2023 net product revenues from JELMYTO to
be in the range of $76 to $86 million. The Company reiterates anticipated full year 2023 operating expenses in the range of $135 to $145 million, including non-cash share-based compensation expense
of $6.0 to $11.0 million, subject to market conditions. The Company reiterates anticipated full year 2023 non-cash financing expense related to the prepaid obligation to RTW Investments in the range of
$21.0 to $26.0 million. Of this amount approximately $9.9 to $11.2 million is expected to be in cash.
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 UroGen s financial results and provide a general business
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.
SELECTED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
| March 31, 2023 | December 31, 2022 | |||||||
| Cash and cash equivalents and marketable securities | $ | 75,218 | $ | 99,963 | ||||
| Total assets | $ | 112,954 | $ | 135,619 | ||||
| Total liabilities | $ | 229,508 | $ | 224,980 | ||||
| Total shareholders deficit | $ | (116,554 | ) | $ | (89,361 | ) |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(U.S. dollars in thousands, except share and per share data)
| Three months ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Revenue | $ | 17,192 | $ | 13,564 | ||||
| Cost of revenue | 2,265 | 1,525 | ||||||
| Gross profit | 14,927 | 12,039 | ||||||
| Operating expenses: | ||||||||
| Research and development expenses | 12,498 | 12,696 | ||||||
| Selling, general and administrative expenses | 24,474 | 21,300 | ||||||
| Total operating expenses | 36,972 | 33,996 | ||||||
| Operating loss | (22,045 | ) | (21,957 | ) | ||||
| Financing on prepaid forward obligation | (5,224 | ) | (5,826 | ) | ||||
| Interest expense on long-term debt | (3,553 | ) | (282 | ) | ||||
| Interest and other income (expense), net | 630 | (2 | ) | |||||
| Loss before income taxes | $ | (30,192 | ) | $ | (28,067 | ) | ||
| Income tax expense | (21 | ) | (325 | ) | ||||
| Net loss | $ | (30,213 | ) | $ | (28,392 | ) | ||
| Statements of Comprehensive Loss | ||||||||
| Net Loss | $ | (30,213 | ) | $ | (28,392 | ) | ||
| Other Comprehensive loss | ||||||||
| Unrealized gain (loss) on investments | 62 | (44 | ) | |||||
| Comprehensive Loss | $ | (30,151 | ) | $ | (28,436 | ) | ||
| Net loss per ordinary share, basic and diluted | $ | (1.30 | ) | $ | (1.25 | ) | ||
| Weighted average shares outstanding, basic and diluted | 23,279,951 | 22,631,509 |
JELMYTO (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for primary chemoablative treatment of LG-UTUC in adults. It is recommended for primary treatment of biopsy-proven LG-UTUC in patients deemed appropriate candidates for renal-sparing therapy. JELMYTO is a viscous
liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a
retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to
remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.
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:
How will I receive JELMYTO?
After receiving JELMYTO:
JELMYTO may cause serious side effects, including:
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
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 RTGel 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
About the Phase 3 ENVISION Trial
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 completed target enrollment with approximately 240 patients across 90 sites. 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 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 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. JELMYTO (mitomycin) for pyelocalyceal solution and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer are designed to ablate tumors by non-surgical means. UroGen is headquartered in
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: 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 plans for reporting complete response data from ENVISION and topline data from ATLAS and the timing thereof; plans with respect to a regulatory submission for UGN-102 and the timing thereof; financial guidance for 2023; the potential of UroGen s proprietary RTGel technology to improve therapeutic profiles of existing drugs and UroGen s sustained release
technology making local delivery potentially more effective as compared to other treatment options. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: preliminary results may not be
indicative of results that may be observed in the future; the timing and success of clinical trials and potential safety and other complications thereof; unforeseen delays that may impact the timing of progressing clinical trials and reporting data;
the ability to obtain regulatory approval within the timeframe expected, or at all; the ability to maintain regulatory approval; complications associated with commercialization activities; the labeling for any approved product;
competition in UroGen s industry; 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; UroGen s ability to attract or retain key management, members of the board of
directors and personnel; UroGen s RTGel technology may not perform as expected; UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology; UroGen s financial condition and
need for additional capital in the future. 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 24, 2023, 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.
JELMYTO , RTGel and UroGen are registered trademarks of UroGen Pharma Ltd.
Senior Director, Investor Relations
609-460-3588 ext. 1093
Director, Corporate Communications
609-460-3583 ext. 1083
Source: UroGen Pharma Ltd.