Full Press Release Details
UroGen Pharma Reports Third Quarter 2022 Financial Results and Recent Corporate Developments
PRINCETON, N.J. November 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 third quarter ended September 30, 2022, and provided an overview of recent developments.
From a consistent vision to pipeline advancement and product commercialization, we remain highly encouraged by the inroads we have made creating a new
market in how urologic cancers are treated. Despite slightly lower revenue compared to the previous quarter, JELMYTO s favorable growth trends, which include a substantial increase of year-over-year net product revenues, new site activations,
and recent real-world outcomes data, continues to give us confidence in the LG-UTUC opportunity as we work to replicate the success we ve had in certain key markets, said Liz Barrett, President and
Chief Executive Officer of UroGen. We anticipate that the FDA authorization this quarter to extend JELMYTO s in-use period for the admixture from 8 hours to 96 hours following reconstitution will
provide yet another significant opportunity towards driving market adoption and expansion.
In parallel, we are rapidly advancing perhaps the most exciting investigational product in our
pipeline, UGN-102, which has the potential to transform the treatment of bladder cancer and significantly broaden the utilization of our RTGel
reverse-thermal hydrogel technology, continued Ms. Barrett. ENVISION, our Phase 3 pivotal trial of UGN-102 in
LG-IR-NMIBC, is on pace to complete enrollment as soon as the end of the month, bringing us one step closer to realizing
UGN-102 s potential as the first non-surgical primary therapeutic to treat this important subset of bladder cancer patients. As we advance each of these programs,
as well as our broader portfolio, we continue a disciplined and balanced approach to capital preservation in support of growing our business and maintaining a strong balance sheet.
Business Highlights:
(mitomycin) for pyelocalyceal solution in low-grade Upper Tract Urothelial Cancer (LG-UTUC):
for intravesical solution:
UGN-301 (zalifrelimab) for intravesical solution:
Board of Directors Appointments
2022 Financial Results:
Jelmyto Revenue: UroGen reported net product revenue of JELMYTO for the third quarter 2022
of $16.1 million, compared to $11.4 million in the third quarter of 2021, representing an increase of 41% from the same period last year.
R&D Expense: Research and development expenses for the third quarter 2022 were $13.1 million, including
non-cash share-based compensation expense of $0.6 million as compared to $11.9 million, including non-cash share-based compensation expense of
$1.0 million, for the same period in 2021.
SG&A Expense: Selling, general and administrative expenses for the third quarter 2022 were
$19.1 million, including non-cash share-based compensation expense of $1.8 million. This compares to $21.6 million, including non-cash share-based
compensation expense of $4.5 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 $4.8 million for the third quarter 2022.
Interest Expense on Long-Term Debt: Interest expense related to the up to $100 million term loan facility with funds managed by Pharmakon Advisors
was $2.7 million for the third quarter of 2022. As the transaction closed in March 2022, there was no such expense in the third quarter of 2021.
Net Loss: UroGen reported a net loss of $25.8 million, or basic and diluted net loss per ordinary share of $1.13, for the third quarter 2022 as
compared to $30.2 million, or basic and diluted net loss per ordinary share of $1.35, for the same period in 2021.
Cash & Cash Equivalents: As of September 30, 2022, cash, cash equivalents
and marketable securities totaled $95.9 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.
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
SELECTED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
| September 30, 2022 (Unaudited) | December 31, 2021 | |||||||
| Cash and cash equivalents and marketable securities | $ | 95,911 | $ | 89,814 | ||||
| Total assets | $ | 128,473 | $ | 119,746 | ||||
| Total liabilities | $ | 191,759 | $ | 111,333 | ||||
| Total shareholders equity (deficit) | $ | (63,286 | ) | $ | 8,413 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(U.S. dollars in thousands, except share and per share data)
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue | $ | 16,097 | $ | 11,351 | $ | 46,265 | $ | 31,868 | ||||||||
| Cost of revenue | 2,020 | 1,244 | 5,391 | 3,568 | ||||||||||||
| Gross profit | 14,077 | 10,107 | 40,874 | 28,300 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 13,093 | 11,923 | 38,429 | 34,560 | ||||||||||||
| Selling, general and administrative expenses | 19,071 | 21,624 | 61,204 | 66,117 | ||||||||||||
| Total operating expenses | 32,164 | 33,527 | 99,633 | 100,677 | ||||||||||||
| Operating loss | (18,087 | ) | (23,440 | ) | (58,759 | ) | (72,377 | ) | ||||||||
| Financing on prepaid forward obligation | (4,819 | ) | (6,828 | ) | (16,478 | ) | (9,948 | ) | ||||||||
| Interest expense on long-term debt | (2,694 | ) | (5,215 | ) | ||||||||||||
| Interest and other income | 478 | 57 | 604 | 269 | ||||||||||||
| Loss before income taxes | $ | (25,122 | ) | $ | (30,211 | ) | $ | (79,848 | ) | $ | (82,056 | ) | ||||
| Income tax expense | (709 | ) | (1,066 | ) | (312 | ) | ||||||||||
| Net loss | $ | (25,831 | ) | $ | (30,211 | ) | $ | (80,914 | ) | $ | (82,368 | ) | ||||
| Net loss per ordinary share basic and diluted | $ | (1.13 | ) | $ | (1.35 | ) | $ | (3.56 | ) | $ | (3.69 | ) | ||||
| Weighted average shares outstanding, basic and diluted | 22,798,263 | 22,380,598 | 22,711,686 | 22,318,589 |
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:
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.
Please see JELMYTO 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 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 are
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 implications of the extension of the in-use period for JELMYTO for all stakeholders, including greater flexibility for customers in choosing when to mix and schedule
instillations; RTGel s potential to improve the therapeutic profiles of existing drugs; UroGen s sustained release technology making local delivery potentially more effective as compared to other treatment options; the ongoing Phase 3
ENVISION trial for UGN-102, the design and objectives thereof, the number of patients to be enrolled and the timing for completion of enrollment; the design, potential benefits and commercial potential for UGN-102, if approved; plans with respect to a regulatory submission for UGN-102 and the timing thereof; the potential of UGN-102 to
significantly broaden the utility of UroGen s RTGel technology; and the ongoing Phase 1 clinical study for UGN-301 and the design, enrollment, and timing thereof, including the evaluation of the safety
and tolerability of UGN-301 as monotherapy and in combination with other immunomodulators, including UGN-201. 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 availability of the second tranche term loan under the term loan facility with Pharmakon and the ability to satisfy required
customary bring-down conditions and deliverables for the second tranche; 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 Quarterly Report on Form 10-Q filed with the SEC on August 11, 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
JELMYTO and UroGen are
registered trademarks of UroGen Pharma Ltd.
Senior Director, Investor Relations