Full Press Release Details
UroGen Pharma Reports Fourth Quarter and Full-year 2021 Financial Results
and Recent Corporate Developments
PRINCETON, N.J., March 21, 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 fourth quarter and full year ended December 31, 2021, and overview of recent developments.
I am proud of the progress we made in 2021 on behalf of patients as we ve expanded access to Jelmyto and set the stage for important commercial and clinical
milestones in the year ahead, said Liz Barrett, President and Chief Executive Officer of UroGen. Our vision is to completely transform uro-oncology. With our enhanced capital position, solid adoption of Jelmyto in urothelial cancer,
clinical progress in bladder cancer dosing patients in the single-arm pivotal Phase 3 ENVISION trial with UGN-102 and IND submission for
UGN-301, our anti-CTLA4 antibody, we expect to deliver on that vision.
Business Highlights:
Jelmyto (mitomycin) for pyelocalyceal solution in low-grade Upper Tract Urothelial Cancer
UGN-102 (mitomycin) for intravesical solution:
UGN-301 (zalifrelimab) for intravesical solution:
Up to $100 Million Senior Secured Term Loan Facility with Funds Managed by Pharmakon Advisors
Fourth Quarter 2021 Financial Results:
Jelmyto Revenue: UroGen reported net product revenue of Jelmyto for the fourth quarter 2021 of $16.2 million. Net product revenue was $48.0 million for
the full year 2021, compared to $11.8 million in 2020 with the launch of Jelmyto in June 2020.
R&D Expense: Research and development expenses for
the fourth quarter 2021 were $13.1 million, including non-cash share-based compensation expense of $0.9 million as compared to $12.4 million, including
non-cash share-based compensation expense of $1.4 million, for the same period in 2020. Research and development expenses for the full year 2021 were $47.6 million, including non-cash share-based compensation expense of $4.0 million. This compares to $47.3 million, including non-cash share-based compensation expense of $6.4 million,
for the full year 2020.
SG&A Expense: Selling, general and administrative expenses for the fourth quarter 2021 were $21.4 million, including non-cash share-based compensation expense of $4.5 million. This compares to $22.2 million, including non-cash share-based compensation expense of $5.1 million,
for the same period in 2020. Selling, general and administrative expenses for the full year 2021 were $87.5 million, including non-cash share-based compensation expense of $19.1 million. This
compares to $90.2 million, including non-cash share-based compensation expense of $21.6 million for the full year 2020.
Financing on Prepaid Forward Obligation: UroGen reported financing expense related to the prepaid forward
obligation to RTW Investments of $7.3 million for the fourth quarter 2021. Financing expense related to the prepaid forward obligation to RTW Investments totaled $17.3 million for the full year 2021. The rate for 2022 will be 13% based on
$48 million of global net product sales of Jelmyto in 2021.
Net Loss: UroGen reported a net loss of $28.5 million, or basic and diluted net loss
per ordinary share of $1.27, for the fourth quarter 2021 as compared to $30.5 million, or basic and diluted net loss per ordinary share of $1.38, for the same period in 2020. UroGen reported a net loss of $110.8 million, or basic and
diluted net loss per ordinary share of $4.96, for the full year 2021 versus $128.5 million, or basic and diluted net loss per ordinary share of $5.90, for the full year 2020.
Cash & Cash Equivalents: As of December 31, 2021, cash, cash equivalents and marketable securities totaled $89.8 million, and
does not include the first tranche of the term loan facility.
2022 Revenue, Operating Expense and RTW Expense Guidance: The Company anticipates full year
2022 net product revenues from Jelmyto to be in the range of $70 to $80 million. The Company anticipates 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 anticipates full year 2022 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 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 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 7897224. An archive of the webcast
will be available for two weeks on the Company s website.
SELECTED CONSOLIDATED BALANCE SHEETS
| As of December 31, 2021 | As of December 31, 2020 | |||||||
| Cash and cash equivalents and marketable securities | $ | 89,814 | $ | 103,911 | ||||
| Total assets | $ | 119,746 | $ | 122,005 | ||||
| Total liabilities | $ | 111,333 | $ | 25,650 | ||||
| Total shareholders equity | $ | 8,413 | $ | 96,355 |
CONDENSED CONSOLIDATED INCOME STATEMENT
dollars in thousands, except share and per share data)
| Three months ended December 31, | Year ended December 31, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenues, net | $ | 16,174 | $ | 7,966 | $ | 48,042 | $ | 11,799 | ||||||||
| Cost of revenues | 1,589 | 652 | 5,157 | 1,009 | ||||||||||||
| Gross profit | 14,585 | 7,314 | 42,885 | 10,790 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 13,082 | 12,405 | 47,642 | 47,310 | ||||||||||||
| Selling, general and administrative expenses | 21,418 | 22,163 | 87,535 | 90,219 | ||||||||||||
| Total operating expenses | 34,500 | 34,568 | 135,177 | 137,529 | ||||||||||||
| Operating loss | (19,915 | ) | (27,254 | ) | (92,292 | ) | (126,739 | ) | ||||||||
| Financing on prepaid forward obligation | (7,343 | ) | (17,291 | ) | ||||||||||||
| Interest and other income, net | (57 | ) | 102 | 212 | 1,629 | |||||||||||
| Loss before income taxes | (27,315 | ) | (27,152 | ) | (109,371 | ) | (125,110 | ) | ||||||||
| Income tax expense | 1,137 | 3,374 | 1,449 | 3,374 | ||||||||||||
| Net loss | $ | (28,452 | ) | $ | (30,526 | ) | $ | (110,820 | ) | $ | (128,484 | ) | ||||
| Net loss per ordinary share basic and diluted | $ | (1.27 | ) | $ | (1.38 | ) | $ | (4.96 | ) | $ | (5.90 | ) | ||||
| Weighted average shares outstanding, basic and diluted | 22,433,206 | 22,146,581 | 22,347,481 | 21,780,826 |
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
You should not 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
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 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 the Phase 3 ATLAS Trial
The Phase 3 ATLAS trial was a global,
open-label, randomized controlled study 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 NMIBC, defined as 1 or 2 of the following: new or recurrent multifocal bladder tumors, a solitary new or recurrent tumor >3 cm, or low-grade
intermediate risk NMIBC recurrence in less than 12 months following a prior tumor diagnosis requiring endoscopic surgical resection or ablation.
randomized 1:1 to either UGN-102 or TURBT. Patients in the UGN-102 arm were treated with six weekly intravesical instillations of
UGN-102. At the three-month time point, patients were 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 three-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 was disease free survival. On November 10, 2021, the Company announced that, following discussions with the FDA, it has ceased enrollment in the
Phase 3 ATLAS trial and plans to initiate a new, single-arm Phase 3 study of UGN-102 in early 2022. All patients enrolled in the treatment arm of the Phase 3 ATLAS trial
will continue to receive treatment and undergo follow up.
Learn more about the Phase 3 ATLAS trial at www.clinicaltrials.gov (NCT04688931)
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 designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit
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 design, objectives and timing of the Phase 3 ENVISION trial; the expected benefits that may be demonstrated by the Phase 3 ENVISION trial; plans with respect to the treatment and follow up of patients previously enrolled in