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”
“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:
- A topline data readout of the primary endpoint from the ENVISION Phase 3 pivotal study of UGN-102 evaluating the complete response (CR) rate of ~240 patients at 3-months after first instillation is expected this summer.
- Topline data from the ATLAS clinical trial, the predecessor to ENVISION, is expected summer 2023 and will evaluate complete response, duration of response and safety from ~280 patients that completed the trial.
- Announced preliminary results of a study to assess the feasibility of home instillation of UGN-102. In this study, UGN-102 was suitable to administer at home by a visiting nurse under the supervision of a treating physician and resulted in 75% (n=8) of patients achieving a complete response, defined as no detectable disease 3 months after starting treatment.
JELMYTO (mitomycin) for pyelocalyceal solution in low-grade upper tract urothelial cancer (LG-UTUC):
- Generated net product revenue of $17.2 million for the first quarter of 2023, representing ~27% growth over the first quarter of 2022.
- Activated sites on May 1, 2023 were 1,009, compared to 983 on March 1, 2023, while repeat accounts on May 1, 2023 were 235, compared to 214 on March 1, 2023.
- A positive American Urologic Association (AUA) meeting was headlined by the first ever AUA and Society of Urologic Oncology (SUO) treatment guideline for LG-UTUC, recommending use of JELMYTO in certain clinical scenarios. The guideline states that tumor ablation should be the initial management option for patients with low-risk favorable UTUC, for which JELMYTO can be a treatment option as part of a kidney sparing approach intended to prevent radical nephroureterectomies (RNU) in low-risk UTUC patients.
- New retrospective study presented at AUA 2023 reported on the use of JELMYTO in treating patients with UTUC after complete endoscopic ablation. Patients in this retrospective study who underwent complete endoscopic ablation followed by JELMYTO were more likely to be disease-free at first endoscopic evaluation than those who underwent chemoablation alone (69% vs. 40%). In the Phase 3 OLYMPUS study of JELMYTO, LG-UTUC patients in the primary chemoablation setting achieved a 58% complete response rate at first endoscopic evaluation.
- New retrospective study presented at AUA 2023 reported similar outcomes when utilizing Jelmyto in treating LG-UTUC of the ureter compared to renal pelvic cancers. In this analysis, 47 patients had UTUC tumors involving the ureter, with 12 cases of ureteral tumor only (8.8%) and 35 cases of ureteral plus renal pelvic tumors (25.7%). The investigators reported no difference in outcomes at first endoscopic evaluation based on tumor location (p=0.644). JELMYTO is approved for the chemoablation of low-grade upper tract urothelial cancer (LG-UTUC) involving the renal pelvis and calyces.
First Quarter 2022 Financial Results:
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.
Financing on 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.
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.
| UROGEN PHARMA LTD. | ||||||||
| SELECTED CONSOLIDATED BALANCE SHEETS | ||||||||
| (U.S. dollars in thousands) | ||||||||
| (Unaudited) | ||||||||
| 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 | ) | ||
| UROGEN PHARMA LTD. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
| (U.S. dollars in thousands, except share and per share data) | ||||||||
| (Unaudited) | ||||||||
| 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 | ||||||
Source: https://www.businesswire.com/
