Wed, Apr 30, 8:02 PM (12 days ago)
**UroGen Pharma Ltd. (URGN) 10-K/A Summary** **Financial Performance:** - Revenue: $90.4 million for JELMYTO® in 2024, up 12% from 2023. - Strategic collaborations and partnerships were entered to explore the potential of proprietary RTGel technology. - Completed an underwritten public offering of ordinary shares for $123.6 million. - Restructured loan agreement with Pharmakon Advisors, providing additional funding of up to $100 million. **Executive Compensation:** - CEO Elizabeth Barrett's total direct compensation was positioned at approximately the 20th percentile of the compensation peer group. - Non-CEO executives' total direct compensation was positioned at approximately the 15th percentile of the compensation peer group. - 2024 Say-on-Pay vote resulted in over 87% approval, indicating shareholder support for executive compensation practices. **Strategic Overview:** - UGN-102 Pivotal ENVISION trial demonstrated a 12-month duration of response of 82.3%. - New drug application (NDA) for UGN-102 was accepted by the FDA, with a PDUFA target action date set for June 13, 2025. - Secured an exclusive license from medac GmbH for a next-generation novel mitomycin-based formulation for urothelial cancers. - Received a new U.S. patent covering the use of UGN-103 and UGN-104 development programs. **Future Outlook:** - Focus on advancing development programs, clinical activities, and commercialization. - Strategic partnerships and collaborations to enhance long-term growth. - Continued focus on regulatory approvals and market expansion. **Risk Factors:** - Dependence on the success of key product candidates. - Regulatory approval risks. - Competitive landscape and market dynamics. - Financial condition and liquidity risks. **Market Position:** - Strong market position with JELMYTO® achieving significant revenue growth. - Strategic initiatives to enhance market presence and product portfolio. - Continued investment in research and development to drive innovation. **Changes in the 10-K/A:** - The amendment includes updated certifications from the Company’s principal executive officer and principal financial officer. - No other changes were made to the Form 10-K other than those described above. - The amendment does not reflect subsequent events occurring after the original filing date of the Form 10-K or modify or update the financial statements, consents, or any other items or disclosures made in the Form 10-K.