Benzinga | Jul 14, 2021 08:03AM EDT

UroGen Pharma Affirms Previous FY21 Guidance; Sees Operating Expenses $155M-$165M; Sees Q2 2021 Operating Expenses $33M-$38M

UroGen Pharma Ltd. (NASDAQ:URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that it expects net product revenue from Jelmyto sales for the second quarter ended June 30, 2021, to be approximately $13.0 million, representing an increase of over 70% compared to the first quarter of 2021 and the highest quarterly sales since Jelmyto was launched in June 2020. Additionally, operating expenses in the second quarter of 2021 are anticipated to be in the range of $33 to $38 million. Cash, cash equivalents and marketable securities as of June 30, 2021, are expected to be approximately $129.0 million.

"Our strong, preliminary top line results for the second quarter of 2021 have validated our belief that increased vaccination rates and the general re-opening of activities throughout the United States would correlate to increased adoption of Jelmyto as an innovative treatment for patients with low-grade upper tract urothelial cancer," said Liz Barrett, President and Chief Executive Officer of UroGen. "The momentum in Jelmyto sales gives us increased confidence in physician adoption of this paradigm shifting therapy. We are optimistic that this trend will continue as our commercial team actively engages in-person with healthcare providers to activate new sites and increase usage at existing sites. We look forward to reporting our full results for the second quarter of 2021 in early August."

The Company expects to report full financial results for the second quarter ended June 30, 2021, and host a conference call on Wednesday, August 4, 2021. A press release with the details for the conference call will be issued approximately one week prior to the planned reporting date.

Preliminary Financial Results

The preliminary financial results set forth above are based on management's initial review of the Company's results as of and for the quarter ended June 30, 2021, and are subject to revision based upon the Company's quarter-end closing procedures and the completion of the review by the Company's external auditors of the Company's quarter-end financial statements. Actual results may differ materially from these preliminary results as a result of the completion of quarter-end closing procedures, final adjustments, and other developments arising between now and the time that the Company's financial results are finalized. In addition, these preliminary results are not a comprehensive statement of the Company's financial results for the quarter ended June 30, 2021, should not be viewed as a substitute for complete financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the Company's results for any future period.

2021 Operating Expense Guidance

The Company affirms its previously announced guidance for full-year operating expenses in the range of $155 to $165 million, including non-cash share-based compensation expense of $24 to $28 million, subject to market conditions.

About Jelmyto(r)

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(tm) 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.