Akebia Therapeutics, Inc. (AKBA) Bundle
A Brief History of Akebia Therapeutics, Inc. (AKBA)
Company Formation and Initial Developments
Akebia Therapeutics, Inc. was founded in 2010 and is based in Cambridge, Massachusetts. The company focuses on developing therapies for patients with kidney disease. The initial public offering (IPO) took place on May 1, 2015, raising approximately $79 million at a price of $15 per share.
Key Product Developments
The company’s lead product, vadadustat, is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor aimed at treating anemia associated with chronic kidney disease (CKD). In December 2020, Akebia submitted a New Drug Application (NDA) for vadadustat to the U.S. Food and Drug Administration (FDA).
Regulatory Milestones
In March 2021, the FDA accepted the NDA for vadadustat, giving it Priority Review status. The Prescription Drug User Fee Act (PDUFA) date was set for August 2021. The product was subsequently approved by the FDA in February 2022.
Financial Performance
As of Q2 2023, Akebia reported revenue of $22.4 million, primarily from product sales of vadadustat. The total revenue for the fiscal year 2022 was reported at $84 million.
| Year | Total Revenue ($ million) | Research and Development Expenses ($ million) | Net Income ($ million) |
|---|---|---|---|
| 2020 | 20.3 | 30.1 | -36.0 |
| 2021 | 45.8 | 60.3 | -57.0 |
| 2022 | 84.0 | 65.4 | -50.0 |
| 2023 (Q2) | 22.4 | 15.2 | -12.0 |
Market Capitalization and Stock Performance
As of October 2023, Akebia Therapeutics had a market capitalization of approximately $200 million. The share price fluctuated between $2 and $10 throughout the year, reflecting the volatility typical within the biotechnology sector.
Strategic Collaborations
In 2016, Akebia entered into a collaboration agreement with Otsuka Pharmaceutical for the development and commercialization of vadadustat in Japan. The deal included upfront payments and potential milestone payments that could total up to $239 million.
Challenges and Market Competition
The company faces competition from other anemia treatments, including those developed by companies such as Amgen and Roche. The competitive landscape continues to pressure Akebia's market share and pricing strategies.
Recent Developments
In July 2023, Akebia announced a restructuring plan aimed at optimizing its resources and extending its cash runway. This included a projected reduction in workforce by approximately 30% to streamline operations.
A Who Owns Akebia Therapeutics, Inc. (AKBA)
Shareholder Composition
The ownership structure of Akebia Therapeutics, Inc. (AKBA) consists of institutional investors, retail investors, and company insiders. As of the most recent data:
| Type of Owner | Percentage Owned | Number of Shares Owned |
|---|---|---|
| Institutional Investors | 63.1% | 27,300,000 |
| Insiders | 5.4% | 2,300,000 |
| Retail Investors | 31.5% | 13,600,000 |
Major Institutional Shareholders
The major institutional shareholders of Akebia Therapeutics include the following:
| Institution Name | Shares Owned | Percentage of Total Shares |
|---|---|---|
| Vanguard Group, Inc. | 5,700,000 | 13.2% |
| BlackRock, Inc. | 5,200,000 | 12.0% |
| State Street Corporation | 3,900,000 | 9.0% |
| Geode Capital Management, LLC | 2,100,000 | 4.8% |
| Invesco Ltd. | 1,500,000 | 3.4% |
Insider Ownership
Insider ownership is an important factor in understanding the alignment of interests between management and shareholders. As of the latest SEC filings:
| Insider Name | Position | Shares Owned |
|---|---|---|
| John P. Butler | CEO | 800,000 |
| Sharon M. Atkinson | CFO | 500,000 |
| Edward F. Gallagher | CMO | 400,000 |
| John E. Dineen | Board Member | 300,000 |
| Mary L. F. Calkins | Board Member | 200,000 |
Recent Financial Performance
In the most recent fiscal year, Akebia Therapeutics reported:
- Revenue: $45 million
- Net Loss: $35 million
- Cash and Cash Equivalents: $50 million
- Market Capitalization: Approximately $212 million
Stock Performance
The stock performance of Akebia Therapeutics (AKBA) has varied significantly. Recent trading data shows:
- 52-Week Low: $1.30
- 52-Week High: $7.50
- Current Share Price: $2.90
- Daily Trading Volume: 1,000,000 shares
Summary of Ownership Structure
To summarize the ownership structure:
- Strong institutional interest, comprising over 63% of the total shares.
- Insider ownership reflects a vested interest in the success of the company.
- Retail investors hold a significant portion of shares, indicative of public interest.
Akebia Therapeutics, Inc. (AKBA) Mission Statement
Company Overview
Akebia Therapeutics, Inc., traded under the ticker symbol AKBA, is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapies for patients with kidney disease. The company's mission is centered around delivering innovative medicines that address significant unmet medical needs in this patient population.
Mission Statement
Akebia Therapeutics aims to provide transformative therapies to patients with kidney disease, enhancing their quality of life through effective management of their conditions. The company is committed to pursuing scientific excellence, fostering innovation, and prioritizing the needs of patients in every decision they make.
Core Values
- Patient-Centricity: The company prioritizes patient needs in its drug development efforts.
- Innovation: Continuous investment in research and technology to develop new therapies.
- Collaboration: Working with healthcare professionals and partners to achieve common goals.
- Integrity: Upholding the highest ethical standards in all operations.
- Excellence: Striving for the highest quality in research, development, and products.
Financial Performance
As of the end of 2022, Akebia Therapeutics reported total revenues of approximately $68.3 million, primarily derived from product sales and collaborations. The company has experienced fluctuations in its stock price, with a 52-week range from $0.90 to $4.50. The market capitalization stood at approximately $330 million as of October 2023.
| Financial Metric | 2022 Amount | 2023 (estimate) |
|---|---|---|
| Total Revenues | $68.3 million | $72 million |
| Net Income (Loss) | ($45.2 million) | ($40 million) |
| Cash and Cash Equivalents | $100 million | $90 million |
| Market Capitalization | $330 million | $350 million |
| Stock Price (as of October 2023) | $2.20 | N/A |
Research and Development Focus
Akebia Therapeutics’ pipeline includes several investigational products, such as:
- Vadadustat: An oral medication designed for the treatment of anemia due to chronic kidney disease.
- Other Investigational Therapies: Targeting various aspects of kidney disease management.
Strategic Collaborations
The company engages in strategic partnerships to bolster its mission. Key collaborations include:
- Collaboration with Otsuka Pharmaceutical: Focused on the development of vadadustat.
- Partnerships for Global Market Expansion: Aimed at enhancing product availability worldwide.
Future Outlook
Akebia Therapeutics plans to strengthen its research capabilities and expand its portfolio of kidney disease therapies. The company aims to achieve regulatory approvals for its key products, with several expected milestones in the coming years.
How Akebia Therapeutics, Inc. (AKBA) Works
Company Overview
Akebia Therapeutics, Inc. (NASDAQ: AKBA) is a biotechnology company that focuses on developing innovative therapies to treat kidney disease. The company primarily aims to address the unmet needs of patients with chronic kidney disease (CKD) and its associated complications.
Key Products
Akebia's lead product candidate is Vadadustat, a HIF (hypoxia-inducible factor) prolyl hydroxylase inhibitor designed to treat anemia in CKD patients. Vadadustat received FDA approval in March 2021.
Financial Overview
As of Q2 2023, Akebia Therapeutics reported the following key financial statistics:
| Financial Metric | Q2 2023 Amount | Q2 2022 Amount |
|---|---|---|
| Revenue | $13.2 million | $10.8 million |
| Net Loss | ($29.5 million) | ($31.2 million) |
| Cash and Cash Equivalents | $87 million | $95 million |
| Outstanding Shares | 65 million | 62 million |
Research and Development
Akebia invests heavily in R&D to enhance its pipeline. For the fiscal year 2022, the R&D expenses amounted to $55 million.
As of 2023, Akebia is involved in several ongoing clinical trials, including:
- Phase 3 trial for Vadadustat in dialysis patients
- Phase 2 trial evaluating the combination therapy of Vadadustat and other agents
Market Performance
As of October 2023, the stock price of Akebia Therapeutics (AKBA) is approximately $1.34 per share, down from approximately $3.71 a year before.
The market capitalization of Akebia Therapeutics stands at $87 million as of October 2023.
Partnerships and Collaborations
Akebia Therapeutics has established collaborations with various pharmaceutical companies, including:
- Otsuka Pharmaceutical for co-development and commercialization of Vadadustat
- Collaboration agreements with other biotech firms for research initiatives
Future Outlook
Analyst projections for Akebia's revenue growth suggest potential increases as new therapies are developed and approved. The expected revenue for the fiscal year 2023 is $65 million, reflecting a growth trajectory driven by expanding product lines and market penetration.
Current estimates indicate a potential increase in Vadadustat sales, projecting approximately $35 million in sales for the year ahead.
How Akebia Therapeutics, Inc. (AKBA) Makes Money
Product Revenue
Akebia Therapeutics primarily generates revenue through the sale of its pharmaceutical products. The company focuses on treating kidney diseases, specifically anemia related to chronic kidney disease (CKD).
As of the latest financial report for the year 2022, Akebia's product sales amounted to approximately $69.3 million. The main product contributing to this revenue is **vadadustat**, a drug developed for the treatment of anemia due to CKD, which is marketed under the brand name **Vadadustat**.
Collaborations and Licensing Agreements
In addition to direct product sales, Akebia Therapeutics has entered into various collaborations and licensing agreements that also contribute to its revenue.
- In 2022, Akebia recorded approximately $37 million from collaboration agreements.
- Revenue from collaborations includes milestone payments and royalties from partner companies.
- Akebia's collaboration with **Otsuka Pharmaceutical** for vadadustat in the U.S. and Canada is a significant source of income.
| Year | Product Revenue | Collaboration Revenue |
|---|---|---|
| 2020 | $54.2 million | $35.0 million |
| 2021 | $64.2 million | $28.0 million |
| 2022 | $69.3 million | $37.0 million |
Research and Development (R&D) Funding
Akebia Therapeutics also secures funding through government grants and private investment aimed at advancing its research and development initiatives.
- In 2021, Akebia received a grant of $5 million from the **National Institute of Health** (NIH) aimed at supporting ongoing research.
- The company has consistently invested a significant portion of its revenue back into R&D, with a reported expenditure of approximately $120 million for 2022.
Financial Performance Metrics
The financial health of Akebia Therapeutics can be assessed through key performance metrics, which provide insight into its revenue-generating capabilities.
- Net revenue for 2022: $106.3 million
- Gross profit margin: approximately 25%
- Operating expenses for 2022: $165.3 million
- Net loss for 2022: $62.8 million
| Metric | 2020 | 2021 | 2022 |
|---|---|---|---|
| Net Revenue | $89.2 million | $92.2 million | $106.3 million |
| Gross Profit Margin | 21% | 22% | 25% |
| Operating Expenses | $150.0 million | $160.0 million | $165.3 million |
| Net Loss | $50.0 million | $67.5 million | $62.8 million |
Market Opportunities
The burgeoning market for CKD and related treatments presents significant opportunities for Akebia Therapeutics to expand its revenue streams.
- The global CKD market is projected to reach $20 billion by 2025.
- Increasing prevalence of CKD worldwide creates a growing customer base for Akebia's products.
- Potential international expansion and new drug approvals could further enhance revenue potential.
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