UroGen’s reformulated chemo drug Jelmyto faces a make-or-break year in 2022 as analysts mull its “considerable uncertainty.”
The drug, approved in April 2020 and launched that June, ran straight into a tough COVID environment. But, as the U.S. moves out of the pandemic phase onto a more even keel, things should be looking up for the therapy.
Analysts at Jefferies, however, say the overall picture for the drug is mixed, and its future hangs in the balance. This week, UroGen reported $16.2 million in sales for the drug for the fourth quarter, 42% quarter-on-quarter growth for Jelmyto, which looks on paper like a healthy rise.
But Jefferies says this growth looks less healthy when you compare it to previous earnings, which “were lower than expected partially due to COVID-linked restrictions.”
The firm said the company, helmed by Big Pharma veteran Liz Barrett, has made “continued efforts on improving enrollments and sites activation resulting in 18% increase since last [quarter].”
But overall revenues in 2021 “were mixed,” and this year “remains critical for Jelmyto’s success.” It reported $48 million for the full year, which UroGen said was in line with its guidance. The drug made $11.8 million in 2020 though it was only launched in the summer.
“While we are optimistic on recent trend, there is considerable uncertainty,” the analysts wrote in a note to clients this week. As we near the post-pandemic environment, we should get "a clear picture on [the company’s] path to meet revenue expectations.”
As such, Jefferies said it has lowered U.S. market penetration for Jelmyto “from 25% to 15% along with lower ramp, peak sales now around $165 million.”
The company scored approval for the drug in April 2020, the first-ever green light for the biopharma. The approval was in upper tract urothelial cancer (UTUC)—the first nonsurgical option approved to treat the disease.
At launch, UroGen built out a team of 48 sales staff and embraced digital communication to chat virtually with physicians who treat UTUC.