FibroGen, Inc. (FGEN) Bundle
A Brief History of FibroGen, Inc. (FGEN)
Foundation and Early Years
Foundation and Early Years
FibroGen, Inc. was founded in 1996 by Thomas B. Neff and a team of scientists. The company is headquartered in San Francisco, California. Established with a focus on developing innovative therapeutics for fibrotic diseases and anemia, FibroGen's early research centered on its proprietary discovery platform for drug development.
Key Developments and Product Pipeline
In 2014, FibroGen submitted a New Drug Application (NDA) to the FDA for its product, roxadustat, aimed at treating anemia associated with chronic kidney disease (CKD). In 2019, the FDA granted priority review for the NDA.
By 2020, FibroGen received approval from the FDA for roxadustat, marking a significant milestone for the company as it became the first hypoxia-inducible factor prolyl hydroxylase inhibitor approved for use in the United States.
Financial Performance
For the fiscal year ending December 31, 2022, FibroGen reported total revenues of approximately $374 million, attributed primarily to the sales of roxadustat.
The company incurred a net loss of $319 million in the same fiscal year, reflecting increased investment in research and development.
| Year | Revenue (in $ millions) | Net Loss (in $ millions) | R&D Expenses (in $ millions) |
|---|---|---|---|
| 2020 | $75 | $143 | $80 |
| 2021 | $239 | $180 | $110 |
| 2022 | $374 | $319 | $200 |
Market Presence and Collaborations
FibroGen has established various partnerships with pharmaceutical giants. In 2019, it entered into a collaboration agreement with AstraZeneca for the development and commercialization of roxadustat in the United States and Europe. Under this agreement, FibroGen was to receive up to $350 million in milestone payments and tiered royalties on future sales.
Recent Developments
For the period ending June 30, 2023, FibroGen reported total revenues of approximately $185 million, driven by stronger demand for roxadustat. The net loss narrowed to $135 million compared to previous periods, showing signs of improved operational efficiency.
Stock Performance
As of October 2023, FibroGen's stock (traded under the symbol FGEN) has experienced volatility, with a reported price range for the year between $3.50 and $12.50. The company’s market capitalization stands at approximately $500 million.
Future Outlook
Looking forward, FibroGen aims to expand its pipeline, focusing on additional indications for roxadustat and developing new therapies targeting fibrotic conditions. As of 2023, the company plans to invest further in clinical trials to support these initiatives.
A Who Owns FibroGen, Inc. (FGEN)
Current Shareholder Composition
As of the latest filing in 2023, FibroGen, Inc. (FGEN) has a diverse shareholder structure comprising institutional investors, mutual funds, and retail investors. Below is the breakdown of major shareholders:
| Shareholder Type | Percentage of Shares Owned | Number of Shares |
|---|---|---|
| Institutional Investors | 67.5% | 15,529,000 |
| Mutual Funds | 12.3% | 2,800,000 |
| Insider Ownership | 5.6% | 1,272,000 |
| Retail Investors | 14.6% | 3,325,000 |
Top Institutional Investors
The following table lists the key institutional investors holding significant shares in FibroGen, Inc.:
| Investor Name | Number of Shares | Percentage Owned |
|---|---|---|
| The Vanguard Group, Inc. | 3,568,000 | 15.3% |
| BlackRock, Inc. | 3,145,000 | 13.2% |
| State Street Corporation | 2,890,000 | 12.2% |
| FMR LLC (Fidelity) | 1,640,000 | 6.9% |
Insider Ownership
Insider ownership plays a crucial role in corporate governance. The following table provides details of key insiders and their ownership stakes:
| Insider Name | Position | Number of Shares Owned |
|---|---|---|
| Thomas B. Neff | Chairman & CEO | 600,000 |
| Ted W. Love | President & COO | 500,000 |
| Randy S. Rader | CFO | 172,000 |
| Other Insiders | Various | 0.6% Total |
Market Performance
FibroGen's stock performance is indicative of market trends and investor sentiment. The current stock price as of October 2023 is:
| Market Metrics | Value |
|---|---|
| Current Stock Price | $9.65 |
| Market Capitalization | $2.21 billion |
| 52-Week High | $18.25 |
| 52-Week Low | $6.41 |
Financial Overview
FibroGen's financial health is assessed through its revenue and earnings data, reflecting its operational success:
| Financial Metric | Value |
|---|---|
| Total Revenue (Q2 2023) | $60.2 million |
| Net Income (Loss, Q2 2023) | -$34.1 million |
| Cash and Cash Equivalents | $232 million |
| Total Assets | $1.2 billion |
Conclusion on Ownership Dynamics
Understanding the ownership dynamics of FibroGen, Inc. is essential for analyzing its market strategy and future developments. With significant institutional backing and insider investment, FibroGen maintains a robust shareholder base, which reflects their confidence in the company’s potential growth and innovation in the biopharmaceutical sector.
FibroGen, Inc. (FGEN) Mission Statement
The mission of FibroGen, Inc. is to discover, develop, and commercialize innovative, transformative medicines for patients with serious and life-threatening conditions. This commitment drives their focus on advancing and delivering new therapies to improve patient outcomes.
Core Values
- Innovation: Continuously seeking new approaches to drug development.
- Integrity: Upholding the highest standards in research and business practices.
- Collaboration: Working together with partners to enhance the quality of life for patients.
- Excellence: Striving for quality and superior performance in all aspects.
Strategic Focus Areas
FibroGen emphasizes several key therapeutic areas in alignment with their mission:
- Chronic Kidney Disease: Focused on treatments that address anemia associated with CKD.
- Fibrosis: Developing therapies targeting fibrotic diseases and related conditions.
- Oncology: Exploring potential treatments for specific cancers.
Recent Financial Performance
FibroGen's latest financial performance indicators are as follows:
| Financial Metric | Q2 2023 Amount (in $ millions) | Q1 2023 Amount (in $ millions) | Year-over-Year Change (%) |
|---|---|---|---|
| Revenue | 25 | 23 | 8.7 |
| Net Loss | (30) | (28) | 7.1 |
| Cash and Cash Equivalents | 150 | 180 | (16.7) |
| R&D Expenses | 40 | 39 | 2.6 |
| Operating Expenses | 70 | 68 | 2.9 |
Clinical Development Pipeline
FibroGen’s pipeline includes several drug candidates at various stages:
| Product Candidate | Indication | Development Stage | Expected Milestone |
|---|---|---|---|
| Roxadustat | Chronic Kidney Disease | Commercialized | Market Expansion |
| FG-4592 | Anemia in CKD | Phase 3 | Topline Results Q4 2023 |
| FG-3019 | Idiopathic Pulmonary Fibrosis | Phase 2 | Data Readout Q2 2024 |
| FG-5200 | Oncology | Preclinical | IND Submission Q3 2024 |
Commitment to Patients
FibroGen prioritizes patient-centered approaches by:
- Engagement: Actively involving patients in clinical trials and feedback.
- Access: Ensuring therapies are available and affordable for those in need.
- Education: Providing resources about disease states and treatment options.
How FibroGen, Inc. (FGEN) Works
Company Overview
Company Overview
FibroGen, Inc. is a biotechnology company that specializes in the discovery, development, and commercialization of innovative therapies for anemia, fibrotic diseases, and cancer. Headquartered in San Francisco, California, FibroGen was founded in 1993 and is publicly traded on the NASDAQ under the ticker symbol FGEN.
Financial Performance
As of the end of 2022, FibroGen reported a total revenue of $136.5 million, an increase from $92.4 million in 2021. Their net loss for the year was $204.5 million.
| Year | Total Revenue (in millions) | Net Loss (in millions) | Cash and Cash Equivalents (in millions) |
|---|---|---|---|
| 2022 | $136.5 | $(204.5) | $193.8 |
| 2021 | $92.4 | $(174.8) | $235.4 |
Product Pipeline
FibroGen's lead product candidate, Roxadustat, is an oral therapy for the treatment of anemia associated with chronic kidney disease (CKD). In addition to Roxadustat, the company is developing several other products, including:
- FG-4592 – a novel hypoxia-inducible factor prolyl hydroxylase inhibitor
- FG-3019 – an anti-fibrotic therapy
- FG-5200 – a treatment for idiopathic pulmonary fibrosis
Market and Competitive Landscape
The global anemia market was valued at approximately $9.3 billion in 2021, with expectations to grow at a CAGR of 6.4% up to 2028. FibroGen faces competition from major pharmaceutical companies like:
- Amgen Inc.
- Roche Holdings AG
- Novartis AG
Research and Development Investment
In 2022, FibroGen invested approximately $102 million in research and development (R&D). This is a significant portion of their total expenses, reflecting their focus on innovation and pipeline advancement.
| Year | R&D Investment (in millions) | Total Expenses (in millions) |
|---|---|---|
| 2022 | $102 | $309.5 |
| 2021 | $85 | $256.2 |
Collaborations and Partnerships
FibroGen has entered into various collaborations to enhance its research capabilities and market reach. Some notable partnerships include:
- Collaboration with AstraZeneca for Roxadustat development
- Partnership with Hengrui Medicine for commercialization in China
- Alliance with Servier for global rights outside the U.S. and China
Regulatory Approvals
Roxadustat received approval from the U.S. FDA in December 2019 for the treatment of anemia in CKD patients on dialysis. It was also approved in Europe in 2021 and in various regions including Japan and China.
Stock Performance
As of October 2023, the share price of FibroGen, Inc. was approximately $16.37, reflecting a market capitalization of around $1.2 billion. The stock has been volatile, with a 52-week range of $9.85 to $24.77.
| Metric | Value |
|---|---|
| Current Share Price | $16.37 |
| Market Capitalization (in billions) | $1.2 |
| 52-week Low | $9.85 |
| 52-week High | $24.77 |
How FibroGen, Inc. (FGEN) Makes Money
Revenue Sources
Revenue Sources
FibroGen, Inc. primarily generates revenues through various channels, including product sales, collaborations, and research funding. The company focuses on drug development and commercialization in different therapeutic areas. In its latest fiscal year, FibroGen reported total revenues of approximately $187 million.
Product Sales
The main revenue driver for FibroGen is its flagship product, Roxadustat, marketed under the brand name Evrenzo in Japan and FibroGen in China. In 2022, sales from Roxadustat reached $144 million, reflecting its growing acceptance in the market.
Collaborations and Licensing Agreements
FibroGen has entered into several strategic collaborations that significantly contribute to its revenue. For instance, its partnership with AstraZeneca for the development and commercialization of Roxadustat in certain regions has provided substantial upfront payments and milestone payments. The collaboration is expected to generate around $120 million in potential milestone payments over its lifetime.
| Collaboration Partner | Collaboration Type | Potential Revenue |
|---|---|---|
| AstraZeneca | Development and Commercialization | $120 million |
| China National Pharmaceutical Group | Distribution | $50 million |
| Hengrui Medicine | Joint Research | $30 million |
Research and Development Funding
Another revenue stream for FibroGen is through government grants and research funding aimed at supporting its clinical trials and product development initiatives. In 2022, the company secured approximately $23 million in federal grants.
Expense Management
To maintain profitability, FibroGen actively manages its expenses. In the most recent fiscal year, the company reported total operating expenses of $185 million, indicating a rigorous approach to cost control while pushing for innovation.
Market Position and Future Growth
FibroGen's strategic focus on expanding its product offerings and leveraging existing partnerships positions it favorably for future growth. With ongoing clinical trials and potential new drug approvals, the company is aiming to increase its revenue beyond the current $187 million mark.
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