Full Press Release Details
UroGen Pharma Delivers Double Digit JELMYTO Growth and Prepares for the Next Phase of the Company
with on Track Rolling Submission of UGN-102
PRINCETON, N.J. March 14, 2024 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, 2023, and provided an overview of recent developments.
In 2023, UroGen achieved important operational and clinical milestones, setting us up for further success in the coming years, said Liz Barrett,
President, and Chief Executive Officer of UroGen. The Phase 3 ATLAS and ENVISION trials both produced meaningful and unprecedented results underscoring the potential of UGN-102 to fundamentally change
the way patients with low-grade intermediate-risk non-muscle invasive bladder cancer are treated. We look forward to reporting the
12-month duration of response data from ENVISION in the second quarter of 2024 and to completing submission of an NDA in September of this year. UGN-102 has the
potential to address a more than $3 billion market opportunity and, if approved, has the potential to be transformative for our company. JELMYTO continues to show double digit growth with patient and physician adoption expected to continue to
2023 and Recent Business Highlights:
UGN-102 (mitomycin) for intravesical solution:
JELMYTO (mitomycin) for pyelocalyceal solution in low-grade upper tract
urothelial cancer (LG-UTUC):
Next-generation novel mitomycin-based formulation for urothelial cancers
Up to $100 Million Letter of Credit Facility with Funds Managed by Pharmakon
Fourth Quarter and Full Year 2023 Financial Results
JELMYTO Revenue: UroGen reported JELMYTO net product revenues of $23.5 million in the fourth quarter of 2023, compared to $18.1
million for the same period in 2023. Net JELMYTO product revenue for the full year 2023 was $82.7 million, compared to $64.4 million in 2022. Despite strong unit growth, full year 2023 net revenues were impacted by higher than
forecast 340B chargebacks and first time estimated Medicare refunds for discarded drug, offset by non-patient purchases.
R&D Expense: Research and development expenses for the fourth quarter of 2023 were $11.3 million, including non-cash share-based compensation expense of $0.5 million as compared to $14.5 million, including non-cash share-based compensation expense
of $0.6 million, for the same period in 2022. Research and development expenses for the full year 2023 were $45.6 million, including non-cash share-based compensation expense of
$1.9 million as compared to $52.9 million, including non-cash share-based compensation expense of $2.6 million, in 2022.
SG&A Expense: Selling, general and administrative expenses for the fourth quarter of 2023 were $24.6 million, including non-cash share-based compensation expense of $2.1 million. This compares to $21.6 million, including non-cash share-based compensation expense
of $1.8 million, for the same period in 2022. Selling, general and administrative expenses for the full year 2023 were $93.3 million, including non-cash share-based compensation expense of
$7.4 million. This compares to $82.8 million, including non-cash share-based compensation expense of $8.0 million, in 2022.
Financing on Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid
forward obligation to RTW Investments of $5.5 million in the fourth quarter of 2023, compared to $5.1 million in the same period in 2022. Non-cash financing expense related to the RTW Investments
obligation was $21.6 million for the full year 2023, compared to $21.6 million in 2022. The rate applied to cash payments incurred in 2023 is 13% based on global JELMTYO net product sales of $82.7 million in 2023.
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 and $14.7 million, respectively for the fourth quarter and full year 2023, compared to $3.2 million and $8.4 million in the same periods in 2022. The higher amount in 2023 was a result of interest expense for four
full quarters in 2023, whereas the first and second tranches of the loan were funded in March 2022 and December 2022, respectively.
UroGen reported a net loss of $26.0 million or ($0.72) per basic and diluted share in the fourth quarter of 2023 compared with a net loss of $28.9 million or ($1.25) per basic and diluted share in the same period in 2022. Net
loss was $102.2 million or ($3.55) per basic and diluted share in the full year 2023 compared with a net loss of $109.8 million or ($4.81) per basic and diluted share in 2022.
Cash & Cash Equivalents: As of December 31, 2023, cash, cash equivalents and marketable securities totaled
2024 Revenue, Operating Expense and RTW Expense Guidance: The Company anticipates full year 2024 net product revenues from
JELMYTO to be in the range of $95 to $102 million. Increased discounts related to Medicare refunds for discarded drugs and 340B purchases will further impact net revenues in 2024. The Company also expects full year 2024 operating
expenses in the range of $175 to $185 million, including non-cash share-based compensation expense of $6 to $11 million, subject to market
conditions. The Company also reiterates anticipated full year 2024 non-cash financing expense related to the prepaid obligation to RTW Investments in the range of $21 to $26 million. Of this amount
approximately $12.4 to $13.3 million is expected to 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 UroGen 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.
SELECTED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
| December 31, 2023 | December 31, 2022 | |||||||
| Cash and cash equivalents and marketable securities | $ | 141,469 | $ | 99,963 | ||||
| Total assets | $ | 178,311 | $ | 135,619 | ||||
| Total liabilities | $ | 243,523 | $ | 224,980 | ||||
| Total shareholders deficit | $ | (65,212 | ) | $ | (89,361 | ) |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(U.S. dollars in thousands, except share and per share data)
| Three months ended December 31, (Unaudited) | Year ended December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue 1 | $ | 23,530 | $ | 18,092 | $ | 82,713 | $ | 64,357 | ||||||||
| Cost of revenue | 2,286 | 2,263 | 9,361 | 7,654 | ||||||||||||
| Gross profit | 21,244 | 15,829 | 73,352 | 56,703 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 11,302 | 14,477 | 45,614 | 52,906 | ||||||||||||
| Selling, general and administrative expenses | 24,551 | 21,634 | 93,274 | 82,838 | ||||||||||||
| Total operating expenses | 35,853 | 36,111 | 138,888 | 135,744 | ||||||||||||
| Operating loss | (14,609 | ) | (20,282 | ) | (65,536 | ) | (79,041 | ) | ||||||||
| Financing on prepaid forward obligation | (5,505 | ) | (5,081 | ) | (21,552 | ) | (21,559 | ) | ||||||||
| Interest expense on long-term debt | (3,586 | ) | (3,223 | ) | (14,715 | ) | (8,438 | ) | ||||||||
| Interest and other income, net | 1,538 | 406 | 3,479 | 1,010 | ||||||||||||
| Loss before income taxes | $ | (22,162 | ) | $ | (28,180 | ) | $ | (98,324 | ) | $ | (108,028 | ) | ||||
| Income tax expense | (3,854 | ) | (689 | ) | (3,920 | ) | (1,775 | ) | ||||||||
| Net loss | $ | (26,016 | ) | $ | (28,869 | ) | $ | (102,244 | ) | $ | (109,783 | ) | ||||
| Net loss per ordinary share basic and diluted | $ | (0.72 | ) | $ | (1.25 | ) | $ | (3.55 | ) | $ | (4.81 | ) | ||||
| Weighted average shares outstanding, basic and diluted | 36,153,634 | 23,088,891 | 28,834,303 | 22,806,812 |
JELMYTO (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel
containing 4 mg mitomycin per mL gel indicated for the treatment of adult patients with LG-UTUC. 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.
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:
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)
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 innovative drug formulation of mitomycin, currently in Phase 3
development for the treatment of low-grade, intermediate-risk, non-muscle invasive bladder cancer
(LG-IR-NMIBC). Utilizing UroGen s proprietary RTGel technology, a 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 in an outpatient setting. Assuming positive findings from the durability of response endpoint from the ENVISION Phase 3 study, UroGen
anticipates completing its NDA submission for UGN-102 in September with a potential FDA decision as early as the first quarter of 2025.
About UroGen Pharma Ltd.
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 the 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. Our first product to treat low-grade upper tract urothelial cancer and investigational treatment
UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer are designed to
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: operational and clinical milestones achieved in 2023 will set the Company up for further success in the coming years; the potential of UGN-102 to fundamentally change the way
patients with LG-IR-NMIBC are treated; the expected timing for the release of 12-month duration of response data from ENVISION in
the second quarter of 2024 and that such data will be sufficient to support the submission of an NDA for UGN-102; the expected timing for completing a submission of an NDA to the FDA for UGN-102 and the potential FDA decision; the potential of UGN-102 to address more than $3 billion in market opportunity and to be transformative to the Company;
expectations that JELMYTO patient and physician adoption is expected to continue to increase; the potential of the license and supply agreement with medac GmbH to allow UroGen to extend patent protection on its urothelial cancer franchise;
UroGen s pending U.S. patent applications potentially providing protection for UGN-103 and UGN-104 until December 2041; UroGen s plans to initiate Phase 3
studies to explore the safety and efficacy of UGN-103 and UGN-104 in 2024; UroGen s ability to access an additional $75 million under the amended credit
facility with Pharmakon Advisors, in addition to the required $25 million draw; UroGen s 2024 financial guidance; 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. Words and phrases such as anticipate, assume, believe, expected,
if, indicate, look forward to, potential, will, or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. 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 findings from the durability of
response endpoint from the ENVISION Phase 3 study may not be positive, and in such event, UroGen s NDA pathway could be negatively impacted; even if the durability of response endpoint data from the ENVISION Phase 3 study are positive there is
no guarantee that the current clinical development plan for UGN-102 will ultimately support submission of an NDA, notwithstanding the current agreement with the FDA; even if an NDA for UGN-102 is accepted by the FDA, there is no guarantee that such NDA will be sufficient to support approval of UGN-102 on the timeframe expected, or at all; UroGen s
ability to access the additional $75 million under the amended credit facility with Pharmakon Advisers (in addition to the required $25 million draw) is subject to certain drawdown conditions; the ability to maintain regulatory approval;