Full Press Release Details
UroGen Pharma Reports Second Quarter 2021 Financial Results and Recent Corporate
PRINCETON, N.J., August 4, 2021 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing
novel solutions that treat specialty cancers and urologic diseases, today announced financial results for the second quarter ended June 30, 2021, and provided an overview of the Company s recent developments.
At UroGen, every day we are working towards our goal of fundamentally changing the way urologic cancers are treated because we believe patients deserve
better options than invasive or repetitive surgeries to treat chronic recurrences, said Liz Barrett, President and Chief Executive Officer of UroGen. Jelmyto was the first of our product candidates to demonstrate this paradigm-shift
towards more innovative therapies. Our strong revenue in the second quarter reinforces our belief in the value of this novel treatment for adult patients suffering from low-grade upper tract urothelial cancer.
This provides a strong foundation and clear proof of concept of the power of our platform and reinforces our commitment to revolutionizing the treatment of urologic cancers globally while we advance our pipeline in critical areas of uro-oncology and
Business Highlights:
Jelmyto (mitomycin) for pyelocalyceal solution:
UGN-102 (mitomycin) for intravesical
Second Quarter 2021 Financial Results:
Jelmyto Revenue: UroGen reported net product sales of Jelmyto for the second quarter ended June 30, 2021 of $13.0 million.
R&D Expense: Research and development expenses for the second quarter ended June 30, 2021 were $12.1 million, including non-cash share-based compensation expense of $1.0 million. This compares to $8.1 million, including non-cash share-based compensation expense of $1.6 million,
for the same period in 2020.
SG&A Expense: Selling, general and administrative expenses for the second quarter ended June 30, 2021 were
$22.3 million, including non-cash share-based compensation expense of $5.0 million. This compares to $24.0 million, including non-cash share-based
compensation expense of $5.5 million, for the same period in 2020.
Financing on Prepaid Forward Obligation: UroGen reported financing expense
related to the prepaid forward obligation to RTW Investments of $3.1 million for the second quarter ended June 30, 2021.
reported, and in accordance with U.S. generally accepted accounting principles, the Company anticipates accruing approximately $12 to $15 million in non-operating financing expense relating to the RTW
transaction, of which cash payments for 2021 will equal 9.5% of net Jelmyto sales recognized subsequent to the May 2021 closing.
reported a net loss of $26.2 million, or basic and diluted net loss per ordinary share of $1.17, for the second quarter ended June 30, 2021. This compares to $31.3 million, or basic and diluted net loss per ordinary share of $1.44,
for the same period in 2020.
Cash & Cash Equivalents: As of June 30, 2021, cash, cash equivalents and marketable
securities totaled $129.3 million.
2021 Operating Expense Guidance: The Company continues to anticipate operating expenses in the range
of $155 to $165 million, including non-cash share-based compensation expense of $24 to $28 million, subject to market conditions.
Conference Call & Webcast Information:
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 (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 1539383. An archive of the webcast will be available for two weeks on the Company s website.
SELECTED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
| June 30, 2021 | December 31, 2020 | |||||||
| Cash and cash equivalents and marketable securities | $ | 129,322 | $ | 103,911 | ||||
| Total assets | $ | 153,768 | $ | 122,005 | ||||
| Total liabilities | $ | 97,497 | $ | 25,650 | ||||
| Total shareholders equity | $ | 56,271 | $ | 96,355 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(U.S. dollars in thousands, except share and per share data)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue | $ | 13,032 | $ | 372 | $ | 20,517 | $ | 372 | ||||||||
| Cost of revenue | 1,427 | 48 | 2,324 | 48 | ||||||||||||
| Gross profit | 11,605 | 324 | 18,193 | 324 | ||||||||||||
| Operating expense: | ||||||||||||||||
| Research and development expense | 12,124 | 8,106 | 22,637 | 24,694 | ||||||||||||
| Selling, general and administrative expense | 22,304 | 24,018 | 44,493 | 45,991 | ||||||||||||
| Total operating expense | 34,428 | 32,124 | 67,130 | 70,685 | ||||||||||||
| Operating loss | (22,823 | ) | (31,800 | ) | (48,937 | ) | (70,361 | ) | ||||||||
| Financing on prepaid forward obligation | (3,120 | ) | (3,120 | ) | ||||||||||||
| Interest and other income, net | 33 | 451 | 212 | 1,219 | ||||||||||||
| Loss before income taxes | $ | (25,910 | ) | $ | (31,349 | ) | $ | (51,845 | ) | $ | (69,142 | ) | ||||
| Income tax expense | 312 | 312 | ||||||||||||||
| Net loss | $ | (26,222 | ) | $ | (31,349 | ) | $ | (52,157 | ) | $ | (69,142 | ) | ||||
| Net loss per ordinary share basic and diluted | $ | (1.17 | ) | $ | (1.44 | ) | $ | (2.34 | ) | $ | (3.22 | ) | ||||
| Weighted average shares outstanding, basic and diluted | 22,331,119 | 21,753,001 | 22,287,037 | 21,454,341 |
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.
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 non-muscle invasive bladder cancer. 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 reported topline interim results from the Phase 2b OPTIMA II trial in May 2020 and initiated a Phase 3 study to further
investigate UGN-102 in the treatment of this condition in December 2020.
About the Phase 3 ATLAS Trial
ATLAS is a global, open-label, randomized controlled Phase 3 trial designed to assess the efficacy and safety of
UGN-102, with or without transurethral resection of bladder tumor (TURBT), versus TURBT alone in patients diagnosed with low-grade intermediate risk non-muscle invasive
bladder cancer (LG-IR-NMIBC), defined as 1 or 2 of the following: new or recurrent multifocal bladder tumors, a solitary new or recurrent tumor >3 cm, or LG-IR-NMIBC recurrence in less than 12 months following a prior tumor diagnosis requiring endoscopic surgical resection or ablation. The trial is anticipated to enroll
approximately 630 patients in over 100 clinical sites in the U.S., Europe and Israel.
Patients will be randomized 1:1 to either UGN-102 or TURBT. Patients in the UGN-102 arm will be treated with six weekly intravesical instillations of UGN-102. At the 3-month time point, patients will be assessed for response. Patients who have demonstrated a complete response to either UGN-102 or TURBT, will continue for long-term follow-up for evidence of recurrence. Patients who demonstrate presence of persistent disease at 3-months, in either arm, will undergo a TURBT and then will also continue for
long-term follow up for evidence of recurrence. The primary endpoint of the study is disease free survival.
Learn more about the ATLAS trial at
www.clinicaltrials.gov (NCT04688931)
About UroGen Pharma Ltd.
UroGen is a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases 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
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 goal of fundamentally changing the way urologic cancers are treated; our belief that
our sales of Jelmyto during the second quarter of 2021 provides a strong foundation and clear proof of concept of the power of our platform; expected enrollment with respect to the Phase 3 ATLAS trial for
UGN-102; the intended advancement of the UGN-302 program; UroGen s plan to extend Jelmyto access in Japan and Europe and the expected timing for updates on this
plan; the potential of UroGen s proprietary RTGel technology platform to improve therapeutic profiles of existing drugs; and financial guidance for 2021. These 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 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; 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. 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-Q filed with the SEC on August 4, 2021, and other
filings that UroGen 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 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.
Head of Investor Relations
JELMYTO and UroGen are registered trademarks of UroGen Pharma, Ltd.