UroGen Pharma Ltd. is a biopharmaceutical company focused on developing and commercializing innovative bladder cancer treatments.

# Company Summary: UroGen Pharma Ltd.

## Business Overview
UroGen Pharma Ltd. is a biopharmaceutical company focused on developing and commercializing innovative bladder cancer treatments. The company's primary goal is to create therapies that improve patient care and generate long-term shareholder value.

## Key Products and Technologies
- **JELMYTO®**: A marketed product with gross revenue of $90.4 million in 2024, representing a 12% increase from 2023’s $82.7 million. Its revenue is driven primarily by demand growth.
- **UGN-102**: A lead product candidate that has received FDA acceptance of its New Drug Application (NDA) in October 2024, with a PDUFA review target date of June 13, 2025. The product is under regulatory review for bladder cancer treatment.
- **RTGel Technology**: Proprietary delivery technology that enhances the clinical effectiveness of therapeutics, including immunotherapies. The company has licensed a next-generation mitomycin-based formulation from medac GmbH for further development.
- **Additional Candidates**: UGN-103 and UGN-104 are in development for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) and low-grade upper tract urothelial cancer (LG-UTUC), respectively. They are protected by US patents expiring in December 2041.

## Research and Collaborations
- The company has entered into multiple strategic research collaborations to explore the potential of its RTGel technology to boost the efficacy of various immunotherapies, supporting long-term growth.

## Financials
- **Number of Customers**: The document does not specify the number of customers.
- **Employees**: Number of employees is not explicitly stated in the provided text.
- **Revenue**: 
  - **JELMYTO®** revenue for 2024 was **$90.4 million**, compared to **$82.7 million** in 2023.
- **Income**: Income figures are not provided in the excerpt; only revenue details for the primary product are included.

## Other Strategic Moves
- Restructured a loan agreement with Pharmakon Advisors, providing up to **$100 million in additional funding**.
- Completed an underwritten public offering raising **$123.6 million gross proceeds**.
- Secured a US patent protecting key developmental programs in bladder cancer treatments through December 2041.

## Corporate Focus
The company's strategic initiatives include advancing its lead product through regulatory review, expanding its pipeline with innovative formulations and collaborations, and increasing revenue from existing marketed products.

UroGen Pharma Ltd. is a biopharmaceutical company focused on developing innovative treatments for urological cancers and complex conditions of the urinary tract.

# UroGen Pharma Ltd. Overview

UroGen Pharma Ltd. is a biopharmaceutical company focused on developing innovative treatments for urological cancers and complex conditions of the urinary tract. The company operates primarily in the field of uro-oncology, aiming to address unmet medical needs in bladder cancer and related disorders.

## Key Areas of Focus
- **Research and Development:** UroGen Pharma is dedicated to the development of novel therapies to optimize outcomes in patients with uro-oncological diseases. Their lead product candidate is UGN-102, a mitomycin for intravesical treatment of low-grade intermediate risk non-muscle invasive bladder cancer.
- **Regulatory Approvals:** The company has successfully achieved year-over-year revenue increases and obtained various regulatory approvals, exemplified by Jelmyto, which received New Technology Ambulatory Payment Classification from the Centers for Medicare & Medicaid Services effective October 1, 2023.
- **Product Pipeline:** UroGen is advancing multiple clinical programs that are pivotal to its growth and strategic objectives, including drugs for bladder cancer and other urological conditions.

## Company Statistics
- **Headquarters:** 400 Alexander Park, Princeton, NJ, USA
- **Number of Employees:** Approximately 100
- **Customers:** The company does not have a specific number of "customers" as it primarily engages healthcare providers, hospitals, and healthcare systems.
- **Revenue:** For the fiscal year ending December 31, 2023, UroGen Pharma reported an annual revenue of approximately $80 million, with a year-over-year increase of 28%.
- **Net Income:** UroGen reported a net income for FY 2023, reflecting their progress in revenue generation through established and emerging products, though specific figures on net income were not disclosed in the amendment.

## Business Model
UroGen Pharma's business model revolves around:
- **Clinical Trials:** Conducting comprehensive clinical trials to establish the safety and efficacy of their drug candidates to obtain FDA approvals.
- **Commercialization:** Preparing and executing strategies to market their approved therapies effectively.
- **Strategic Partnerships:** Collaborating with other biopharmaceutical companies to enhance their distribution and research efforts and to secure licensing agreements, thereby increasing their operational footprint.

## Conclusion
UroGen Pharma Ltd. is strategically positioned in the biopharmaceutical industry, focusing on innovative therapies for urological conditions with a robust pipeline and growing revenue base. The company aims to improve patient outcomes through its research initiatives and commitment to addressing unmet needs in the field of uro-oncology.

UroGen Pharma Ltd.

10-K / April 30, 2025

10-K / April 29, 2024

10-K / April 30, 2025

Company Summary: UroGen Pharma Ltd.

Business Overview

Key Products and Technologies

Research and Collaborations

Financials

Other Strategic Moves

Corporate Focus