Perhaps it’s because this company isn’t focused on the latest gene therapy treatment, or maybe it’s because it’s headquartered in Israel, but UroGen Pharma (NASDAQ: URGN) is one biotech that’s flying under-the-radar of most investors.
However, continuing to overlook this stock could be a mistake as the company nears the launch of its first commercial product, UGN-101, which analyst Leland Gershell at Oppenheimer estimated could generate annual sales of more than $500 million.
That’s a massive number when you consider that UroGen is currently valued at around $525 million.
UGN-101 is a first-line treatment for low-grade upper tract urothelial cancer (LG UTUC). The FDA has already granted it Orphan Drug, Fast Track, and Breakthrough Therapy Designations, all of which will help to prioritize the regulatory review process.
The company began its rolling submission process back in December, and it is expected the New Drug Application (NDA) will be completed in the second half of this year with possible marketing approval and product launch at the beginning of 2020.
UGN-101 is a non-invasive mitomycin gel treatment for LG UTUC. In the pivotal stage 3 OLYMPUS clinical trial for UGN-101, 57% of patients achieved a complete response (CR) rate four to six weeks after completion of the treatment, and all of those patients remained disease free after six months.
This is huge because right now, there are no approved drugs for the cancer and the standard of care is surgery, though there is a high rate of recurrence. Thus, if approved, UGN-101 would become the first drug available for the non-surgical treatment of LG UTUC.
“We are pleased to report that the CR and durability data remain consistent with the Interim Analysis presented in May 2018. These results continue to validate the potential of UGN-101 to shift the surgical treatment paradigm and benefit patients whose only alternative would be repetitive endoscopic surgical intervention or complete loss of a kidney,” Mark P. Schoenberg, M.D., Chief Medical Officer at UroGen, said in a press release. “The durability observed in the OLYMPUS study provides further evidence that the non-surgical treatment of LG UTUC with UGN-101 may result in clinically-meaningful, recurrence free survival.”
UGN-101 isn’t the only promising candidate in UroGen’s pipeline. Its UGN-102 hydrogel, which uses the same active drug as UGN-101, has competed a phase 2 trial for the treatment of low-grade non-muscle invasive bladder cancer (LG NMIBC). As with LG UTUC, there are no approved drugs for first-line treatment for LG NMIBC currently on the market. There are over 80,000 new cases of bladder cancer in the U.S. annually.
Phase 2 data are also expected later this year for BotuGel, which is a combination of UroGen’s RTGel technology and Allergan’s (NYSE: AGN) botox being evaluated for the treatment of overactive bladder. Allergan holds the exclusive rights to the treatment, however, UroGen is eligible to earn milestone payments and royalties and BotuGel could be an important proving ground for the RTGel technology platform which could help the company attract other big partners.
The business is also flush with cash, ending 2018 with $101 million in cash and cash equivalents to which it raised an additional $162 million in net proceeds from a share offering back in January. Management believes that sum is enough to fund operations for “anticipated activities,” including the launch of UGN-101, for 36 months.
There are currently six Buy ratings for the stock and analysts’ average price target for URGN is $68.40, suggesting possible upside of 87% over the next twelve months.