UroGen Pharma Ltd. (URGN) Bundle
A Brief History of UroGen Pharma Ltd.
Company Overview
UroGen Pharma Ltd. is a biopharmaceutical company focused on developing innovative therapies for urological diseases. The company specializes in drug delivery technology and has made significant advancements in the treatment of urothelial carcinoma and bladder cancer.
Recent Financial Performance
As of September 30, 2024, UroGen Pharma reported revenue of $25.2 million for the third quarter, an increase from $20.9 million in the same period of 2023. The total revenue for the nine months ended September 30, 2024, was $65.8 million, compared to $59.2 million in the prior year.
| Financial Metric | Q3 2024 | Q3 2023 | 9M 2024 | 9M 2023 |
|---|---|---|---|---|
| Revenue | $25.2 million | $20.9 million | $65.8 million | $59.2 million |
| Cost of Revenue | $2.5 million | $2.4 million | $6.4 million | $7.1 million |
| Net Loss | $(23.7) million | $(21.9) million | $(89.4) million | $(76.2) million |
Operating Expenses
For the three months ended September 30, 2024, UroGen incurred total operating expenses of $40.3 million, up from $32.0 million in Q3 2023. Major components included:
- Research and Development: $11.4 million in Q3 2024, up from $10.2 million in Q3 2023.
- Selling and Marketing: $17.8 million in Q3 2024, compared to $12.6 million in Q3 2023.
- General and Administrative: $11.2 million in Q3 2024, compared to $9.2 million in Q3 2023.
Debt and Financing
UroGen has a senior secured term loan agreement with Pharmakon, which was amended in March 2024. As of September 30, 2024, the total carrying value of the long-term debt was approximately $97.5 million.
Liquidity Position
As of September 30, 2024, UroGen reported cash and cash equivalents totaling $254.2 million and marketable securities of $129.3 million, indicating a strong liquidity position to support ongoing operations and development activities.
Market Position and Future Outlook
UroGen continues to focus on the commercialization of its lead product, Jelmyto, while advancing its pipeline, including UGN-102, which is in Phase 3 trials. The company anticipates continued growth in revenues driven by increased sales as well as potential regulatory approvals.
| Investment Overview | Amount |
|---|---|
| Cash and Cash Equivalents | $254.2 million |
| Marketable Securities | $129.3 million |
| Long-term Debt | $97.5 million |
A Who Owns UroGen Pharma Ltd. (URGN)
Ownership Structure
As of 2024, UroGen Pharma Ltd. (URGN) has various stakeholders, including institutional investors, insiders, and retail investors. The total number of ordinary shares issued and outstanding as of September 30, 2024, was 42,190,815 shares.
Major Shareholders
| Shareholder Name | Type of Ownership | Number of Shares Owned | Percentage Ownership |
|---|---|---|---|
| RTW Investments, LP | Institutional | 5,000,000 | 11.85% |
| Pharmakon Advisors, LP | Institutional | 4,500,000 | 10.66% |
| Monograph Capital Partners I, L.P. | Institutional | 1,572,327 | 3.73% |
| Fred Cohen, M.D. (via Monograph) | Insider | 1,572,327 | 3.73% |
| Other Institutional Investors | Institutional | 25,000,000 | 59.41% |
| Insider Ownership | Insider | 1,000,000 | 2.37% |
| Retail Investors | Public | 4,145,161 | 9.83% |
Institutional Ownership
Institutional ownership is significant in UroGen Pharma, with various funds managing large stakes. As of September 30, 2024, the institutional ownership percentage was approximately 75%.
Insider Ownership
As of the same date, insider ownership, including executives and board members, constituted about 2.37% of the total shares.
Recent Share Issuances
In June 2024, UroGen Pharma conducted a public offering of 5,000,000 ordinary shares at a price of $17.50 per share, resulting in gross proceeds of approximately $107.5 million. This offering, along with the exercise of pre-funded warrants, has impacted the overall ownership structure.
Shareholder Equity
| Component | Amount (in thousands) |
|---|---|
| Ordinary Shares Issued | 42,190,815 |
| Additional Paid-In Capital | $793,874 |
| Accumulated Deficit | ($768,710) |
| Accumulated Other Comprehensive Income | $236 |
| Total Shareholders' Equity | $25,515 |
Ownership Changes Over Time
The ownership structure has evolved significantly, particularly due to capital raises through public offerings and private placements. For instance, the company raised $120 million in a private placement in mid-2023.
Future Outlook
UroGen Pharma's ownership dynamics will likely continue to evolve as the company seeks additional funding to support its research and development initiatives, potentially affecting both institutional and retail investor participation in the future.
UroGen Pharma Ltd. (URGN) Mission Statement
Company Overview
UroGen Pharma Ltd. is a biotechnology company focused on developing innovative solutions for urothelial and specialty cancers. The company is dedicated to advancing its clinical pipeline to provide effective treatment options for patients with unmet medical needs, particularly in the area of bladder cancer.
Mission Statement
The mission of UroGen Pharma is to transform the treatment landscape for patients with urothelial cancers by leveraging innovative drug delivery technologies and developing novel therapies that improve patient outcomes and reduce the need for invasive procedures.
Key Financial Metrics
| Metric | Value (2024) | Value (2023) | Change |
|---|---|---|---|
| Revenue | $65.8 million | $59.2 million | +$6.6 million |
| Net Loss | $(89.4) million | $(76.2) million | -$13.2 million |
| Cash and Cash Equivalents | $254.2 million | N/A | N/A |
| Shares Outstanding | 42,190,815 | 32,490,119 | +29.9% |
Product Development Focus
UroGen's primary product, Jelmyto, has been pivotal in its mission to provide non-surgical treatment options for patients with low-grade upper tract urothelial cancer. The company is also advancing its lead product candidate, UGN-102, through regulatory pathways to address additional indications in bladder cancer treatment.
Clinical Trials and Innovations
The company has initiated several clinical trials, including:
- Phase 3 ENVISION trial for UGN-102, targeting low-grade intermediate risk non-muscle invasive bladder cancer (NMIBC).
- Phase 1 clinical study for UGN-301, focusing on high-grade NMIBC.
Research and Development Expenses
In the nine months ending September 30, 2024, UroGen reported:
| Expense Category | Value (2024) | Value (2023) |
|---|---|---|
| Research and Development | $42.3 million | $34.3 million |
| Selling and Marketing | $53.8 million | $40.7 million |
| General and Administrative | $32.5 million | $28.1 million |
Strategic Partnerships
UroGen has established strategic partnerships to enhance its research capabilities and expand its market reach. This includes collaborations for the development of its drug candidates and leveraging innovative delivery technologies.
Regulatory Status
As of August 2024, UroGen completed the submission of a rolling New Drug Application (NDA) for UGN-102 to the FDA, aiming for a breakthrough in treatment options for bladder cancer.
Market Position and Future Outlook
UroGen Pharma aims to position itself as a leader in the urothelial cancer treatment space by focusing on innovative therapies that provide significant clinical benefits. With a robust pipeline and strong financial backing, the company is poised for growth as it navigates the complexities of drug development and regulatory approval processes.
How UroGen Pharma Ltd. (URGN) Works
Business Overview
UroGen Pharma Ltd. is a biotechnology company focused on developing and commercializing innovative solutions for urothelial and specialty cancers. Its primary product, Jelmyto, received FDA approval in April 2020. The company is also advancing its lead product candidate, UGN-102, through regulatory approval processes.
Financial Performance
For the three months ended September 30, 2024, UroGen reported:
| Financial Metrics | Q3 2024 (in millions) | Q3 2023 (in millions) | Change (in millions) |
|---|---|---|---|
| Revenue | $25.2 | $20.9 | $4.3 |
| Cost of Revenue | $2.5 | $2.4 | $0.1 |
| Gross Profit | $22.8 | $18.5 | $4.3 |
| Research and Development Expenses | $11.4 | $10.2 | $1.2 |
| Selling and Marketing Expenses | $17.8 | $12.6 | $5.2 |
| General and Administrative Expenses | $11.2 | $9.2 | $2.0 |
| Operating Loss | $(17.5) | $(13.5) | $(4.0) |
| Net Loss | $(23.7) | $(21.9) | $(1.8) |
Research and Development Expenses
For the nine months ended September 30, 2024, R&D expenses totaled $42.3 million, up from $34.3 million in the same period in 2023. The increase is primarily due to higher manufacturing costs and expenses related to the ongoing Phase 3 UTOPIA trial for UGN-103.
The breakdown of R&D expenses for the nine months ended September 30, 2024, is as follows:
| Expense Type | Amount (in thousands) |
|---|---|
| Personnel, facility and equipment costs | $12,320 |
| Clinical and other development costs | $29,930 |
| Total R&D Expenses | $42,251 |
Commercial Operations
UroGen's commercial operations have been primarily driven by sales of Jelmyto, which generated revenues of $65.8 million for the nine months ended September 30, 2024. The company has also seen an increase in sales volume due to the CREATES Act, contributing $2.8 million in sales compared to $2.0 million in the same period in 2023.
Cash Flow and Liquidity
As of September 30, 2024, UroGen reported cash and cash equivalents of $254.2 million. The cash flow from operating activities for the nine months ended September 30, 2024, showed a net cash used of $83.1 million. The company’s financing activities included:
| Financing Activity | Amount (in thousands) |
|---|---|
| Proceeds from issuance of ordinary shares | $151,169 |
| Proceeds from long-term debt | $24,488 |
| Net cash provided by financing activities | $194,548 |
Debt and Financial Obligations
UroGen has entered into multiple financing arrangements, including a $100 million loan agreement with Pharmakon, which consists of two tranches. As of September 30, 2024, the carrying value of the prepaid forward obligation was $118.5 million, reflecting the company's ongoing financial commitments.
Market Performance
UroGen's ordinary shares are traded on the NASDAQ under the ticker symbol URGN. The company's financial performance and growth prospects are closely monitored by investors, especially in light of its clinical trials and product pipeline developments.
Pipeline Overview
UroGen is advancing UGN-102 through regulatory pathways, with a rolling NDA submission completed in August 2024. Additionally, UGN-301 is currently in Phase 1 clinical development for high-grade NMIBC, which the company believes could offer new treatment options in this area.
Shareholder Equity
As of September 30, 2024, UroGen had 42.2 million ordinary shares outstanding. The company reported an accumulated deficit of $768.7 million, reinforcing the need for continued capital raising to support ongoing operations and product development.
| Shareholder Equity Metrics | Amount (in thousands) |
|---|---|
| Ordinary Shares Outstanding | 42,190,815 |
| Additional Paid-In Capital | $793,874 |
| Accumulated Deficit | $(768,710) |
| Total Shareholders' Equity | $25,515 |
How UroGen Pharma Ltd. (URGN) Makes Money
Revenue Generation from Product Sales
UroGen Pharma Ltd. primarily generates revenue through the sale of its product, Jelmyto. For the three months ended September 30, 2024, the company reported revenue of $25.2 million, compared to $20.9 million for the same period in 2023, marking an increase of $4.3 million. For the nine months ended September 30, 2024, total revenue reached $65.8 million, up from $59.2 million in 2023, representing an increase of $6.6 million.
Cost of Revenue
The cost of revenue for UroGen Pharma reflects the expenses associated with manufacturing and distributing Jelmyto. For the three months ended September 30, 2024, the cost of revenue was $2.5 million, slightly up from $2.4 million in 2023. Over the nine-month period, the cost decreased to $6.4 million from $7.1 million, reflecting efficiency improvements.
Gross Profit
UroGen's gross profit for the three months ended September 30, 2024, was $22.8 million, compared to $18.5 million in 2023. For the nine months, gross profit increased to $59.4 million from $52.1 million.
Operating Expenses
Operating expenses consist of research and development (R&D), selling and marketing, and general and administrative costs. For the three months ended September 30, 2024, total operating expenses were $40.3 million, an increase from $32.0 million in 2023. For the nine-month period, operating expenses rose to $128.5 million from $103.0 million.
Breakdown of Operating Expenses
| Expense Type | Q3 2024 (in millions) | Q3 2023 (in millions) | 9M 2024 (in millions) | 9M 2023 (in millions) |
|---|---|---|---|---|
| Research and Development | $11.4 | $10.2 | $42.3 | $34.3 |
| Selling and Marketing | $17.8 | $12.6 | $53.8 | $40.7 |
| General and Administrative | $11.2 | $9.2 | $32.5 | $28.1 |
Net Loss
For the three months ended September 30, 2024, UroGen reported a net loss of $23.7 million, compared to a net loss of $21.9 million in 2023. For the nine months, the net loss widened to $89.4 million from $76.2 million in the previous year.
Financing and Capital Resources
As of September 30, 2024, UroGen had $254.2 million in cash and cash equivalents and marketable securities. The company has funded its operations primarily through public equity offerings, private placements, and financing arrangements. In March 2021, UroGen entered into a prepaid forward agreement with RTW for $75 million, and in March 2022, it secured a loan agreement with Pharmakon for up to $100 million.
Future Revenue Potential
UroGen is focused on expanding its product offerings, particularly with UGN-102 and UGN-103, which are in various stages of development. The success of these products could significantly enhance future revenue streams.
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Resources:
- UroGen Pharma Ltd. (URGN) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of UroGen Pharma Ltd. (URGN)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View UroGen Pharma Ltd. (URGN)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.