UroGen Pharma Secures $25M Loan as UGN-102 Awaits Potential FDA Approval

Key Insights

• UroGen Pharma obtained a $25 million loan to support its corporate and working capital needs, with the loan's terms tied to FDA approval of UGN-102.
• The loan's interest rate is based on the three-month Secured Overnight Financing Rate (SOFR) plus 7.25%, with potential for term extension upon FDA approval.
• UroGen Pharma has completed its New Drug Application (NDA) to the FDA for UGN-102, a treatment for non-muscle invasive bladder cancer, after positive Phase 3 trial results.

UroGen Pharma Ltd. (NASDAQ:URGN) has secured a $25 million loan to bolster its financial resources as it awaits potential FDA approval for UGN-102 (mitomycin), a therapy targeting non-muscle invasive bladder cancer. The loan agreement, detailed in a recent SEC filing, could extend to March 2028 if the FDA approves UGN-102 by June 30, 2025, marking a critical juncture for the company's growth trajectory.

The Tranche C Loan, advanced on Monday, is part of an amended agreement with lenders BPCR Limited Partnership and BioPharma Credit Investments V (Master) LP. The interest rate is pegged to the three-month Secured Overnight Financing Rate (SOFR) plus 7.25%, with an additional 0.26% adjustment and a 2.50% minimum floor. Interest payments are due quarterly, with principal repayment scheduled to begin on June 30, 2026, or June 30, 2027, contingent on FDA approval.

UGN-102's Path to Potential Approval

UroGen Pharma recently completed its New Drug Application (NDA) to the FDA for UGN-102 following promising results from the Phase 3 ENVISION trial. The trial demonstrated a 12-month complete response rate of 82.3% in patients who achieved a complete response at three months, underscoring the drug's potential efficacy in treating non-muscle invasive bladder cancer.

Financial Health and Analyst Outlook

In Q2 2024, UroGen Pharma reported a 16% sequential increase and a 3% year-over-year growth in net product revenue for JELMYTO, reaching $21.8 million. The company also raised approximately $116.2 million in a public offering to support the launch of UGN-102, should it receive FDA approval.

Analysts have expressed confidence in UroGen's future, with Oppenheimer reiterating an Outperform rating and a $40.00 price target, and H.C. Wainwright reaffirming a Buy rating with a $60 price target. These ratings are based on the anticipated approval and subsequent launch of UGN-102, which is projected to generate over $1 billion in sales over time.

Additional Developments

UroGen Pharma also secured a U.S. patent for its RTGel® technology combined with a mitomycin formulation, aimed at treating specific low-grade urothelial cancers. This patent is expected to remain in effect until December 2041.