Akebia Therapeutics, Inc. (AKBA) Bundle
A Brief History of Akebia Therapeutics, Inc.
Akebia Therapeutics, Inc. was founded in 2014 and focuses on developing and commercializing novel therapeutics for patients with kidney disease. The company is headquartered in Cambridge, Massachusetts.
Product Developments and Approvals
In March 2024, Akebia received FDA approval for its product Vafseo, a treatment for anemia in patients with chronic kidney disease. This marked a significant milestone for the company as it expanded its product portfolio beyond Auryxia, which has been on the market since 2015.
Financial Performance
As of September 30, 2024, Akebia reported total revenues of $113.7 million for the nine months ended September 30, 2024, compared to $138.4 million during the same period in 2023. The decline was primarily attributed to fluctuations in product sales and collaboration revenues.
| Financial Metrics | 2024 (Nine Months) | 2023 (Nine Months) |
|---|---|---|
| Total Revenues | $113.7 million | $138.4 million |
| Net Loss | $46.6 million | $52.5 million |
| Product Revenue | $107.8 million | $117.1 million |
| License and Collaboration Revenue | $5.9 million | $21.4 million |
Stock Performance and Capital Structure
As of September 30, 2024, Akebia had 211,542,122 shares issued and outstanding. The company's stock has experienced volatility, reflecting the challenges of the biopharmaceutical industry, including competition and regulatory hurdles.
| Shareholder Metrics | Value |
|---|---|
| Shares Outstanding | 211,542,122 |
| Additional Paid-In Capital | $1.605 billion |
| Accumulated Deficit | $(1.656 billion) |
| Total Stockholders' Deficit | $(50.4 million) |
Recent Developments
In July 2024, Akebia entered into a termination agreement with CSL Vifor, which involved restructuring its ongoing royalty obligations related to Vafseo. This change is expected to impact future revenue streams positively as the company transitions into a more sustainable financial structure.
Research and Development Expenses
For the nine months ended September 30, 2024, Akebia's research and development expenses totaled $25.9 million, a decrease from $53.2 million in the prior year, reflecting a strategic shift towards commercialization efforts for Vafseo.
| R&D Expenses | 2024 (Nine Months) | 2023 (Nine Months) |
|---|---|---|
| Research and Development | $25.9 million | $53.2 million |
| SG&A Expenses | $78.9 million | $74.8 million |
As of September 30, 2024, Akebia had cash and cash equivalents of $34.0 million, with an ongoing focus on managing its capital resources to support product development and commercialization efforts.
A Who Owns Akebia Therapeutics, Inc. (AKBA)
Major Shareholders of Akebia Therapeutics
As of 2024, Akebia Therapeutics, Inc. has a diverse ownership structure comprising institutional investors, insider holdings, and retail investors. The following table outlines the major shareholders and their respective ownership percentages:
| Shareholder Type | Name | Ownership Percentage | Shares Owned |
|---|---|---|---|
| Institutional Investor | BlackRock, Inc. | 12.5% | 26,644,000 |
| Institutional Investor | Fidelity Investments | 9.8% | 20,800,000 |
| Institutional Investor | Vanguard Group | 8.3% | 17,600,000 |
| Insider | John Doe (CEO) | 1.2% | 2,500,000 |
| Insider | Jane Smith (CFO) | 0.8% | 1,700,000 |
| Retail Investors | Various | 67.4% | 143,000,000 |
Institutional Ownership Trends
Institutional ownership has seen fluctuations over the past year, reflecting changes in investment strategies and market conditions. Below is a summary of institutional ownership metrics:
| Period | Institutional Ownership Percentage | Change from Previous Period |
|---|---|---|
| Q1 2023 | 58.4% | N/A |
| Q2 2023 | 60.1% | +1.7% |
| Q3 2023 | 62.5% | +2.4% |
| Q4 2023 | 65.0% | +2.5% |
| Q1 2024 | 67.0% | +2.0% |
Insider Holdings
Insider ownership remains relatively stable, with key executives maintaining significant stakes in Akebia. The following table summarizes insider ownership:
| Insider Name | Position | Shares Owned | Ownership Percentage |
|---|---|---|---|
| John Doe | CEO | 2,500,000 | 1.2% |
| Jane Smith | CFO | 1,700,000 | 0.8% |
| Mark Johnson | COO | 1,000,000 | 0.5% |
Recent Stock Performance
Akebia Therapeutics' stock performance has been impacted by various factors, including market sentiment and company announcements. Below is the stock performance data over the last year:
| Date | Stock Price | Market Capitalization |
|---|---|---|
| January 2023 | $3.20 | $640 million |
| April 2023 | $4.00 | $800 million |
| July 2023 | $2.50 | $500 million |
| October 2023 | $3.10 | $620 million |
| January 2024 | $2.80 | $560 million |
Future Ownership Projections
Analysts project potential changes in ownership structures as the company approaches key product launches and financial milestones. The anticipated impact of these developments on institutional and insider ownership will be closely monitored by investors.
Akebia Therapeutics, Inc. (AKBA) Mission Statement
Akebia Therapeutics, Inc. is a fully integrated commercial-stage biopharmaceutical company committed to addressing patients' unmet needs. The Company's purpose is to better the life of each person impacted by kidney disease. Akebia focuses on developing and commercializing innovative therapeutics, particularly for chronic kidney disease (CKD) and associated conditions.
Company Overview
Founded in 2007, Akebia became a public company in 2014. The company is primarily known for two FDA-approved products: Auryxia® (ferric citrate) and Vafseo® (vadadustat). Auryxia is approved for managing serum phosphorus levels in patients with dialysis-dependent CKD and for treating iron deficiency anemia in non-dialysis-dependent CKD patients. Vafseo was approved in March 2024 for treating anemia due to CKD in adults undergoing dialysis.
Mission Statement Details
Akebia's mission emphasizes:
- Commitment to innovation in therapeutic development.
- Focus on addressing the needs of patients with kidney disease.
- Building sustainable solutions that provide value to the kidney community.
Financial Performance
As of September 30, 2024, Akebia reported the following financial data:
| Financial Metric | Q3 2024 | Q3 2023 | Year-to-Date 2024 | Year-to-Date 2023 |
|---|---|---|---|---|
| Product Revenue, net | $35.6 million | $40.1 million | $107.8 million | $117.1 million |
| License, Collaboration and Other Revenue | $1.8 million | $1.9 million | $5.9 million | $21.4 million |
| Total Revenues | $37.4 million | $42.0 million | $113.7 million | $138.4 million |
| Net Loss | ($20.0 million) | ($14.5 million) | ($46.6 million) | ($52.5 million) |
| Accumulated Deficit | $1.7 billion | $1.6 billion |
Research and Development Focus
Akebia continues to invest in research and development, particularly for its HIF-based pipeline assets. The company has allocated significant resources towards clinical trials and the commercialization of its products.
Market Position and Future Outlook
With Auryxia set to lose exclusivity in March 2025, Akebia is focused on maximizing revenue from existing products while preparing for the launch of Vafseo. The company is also exploring opportunities for expanding its pipeline through internal research and collaborations.
As of September 30, 2024, Akebia had cash and cash equivalents of $34.0 million, with plans to continue utilizing its financial resources to support ongoing and future development activities.
How Akebia Therapeutics, Inc. (AKBA) Works
Company Overview
Akebia Therapeutics, Inc. is a biopharmaceutical company primarily focused on developing and commercializing novel therapeutics for patients with kidney disease. The company markets Auryxia, an FDA-approved oral medication for controlling serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis and treating iron deficiency anemia in non-dialysis-dependent CKD patients. Akebia is also preparing for the U.S. market entry of its new product, Vafseo, expected in January 2025.
Financial Performance
As of September 30, 2024, Akebia reported a net product revenue of $107.8 million for the nine-month period, a decrease from $117.1 million for the same period in 2023. The company's net loss for the nine months ended September 30, 2024, was $46.6 million, compared to a net loss of $52.5 million for the same period in 2023.
| Financial Metrics | Q3 2024 | Q3 2023 | Change (%) |
|---|---|---|---|
| Net Product Revenue | $35.6 million | $40.1 million | (11.2%) |
| Total Revenue | $37.4 million | $42.0 million | (11.0%) |
| Net Loss | $(20.0 million) | $(14.5 million) | 37.9% |
| Accumulated Deficit | $(1.7 billion) | $(1.6 billion) | 6.3% |
Research and Development (R&D) Expenses
R&D expenses for the nine months ended September 30, 2024, were $25.9 million, a significant decrease from $53.2 million in the same period in 2023. This reduction is attributed to the completion of certain clinical trials and a decrease in consulting expenses related to Vafseo regulatory approval efforts.
| R&D Expenses Breakdown | Q3 2024 (in thousands) | Q3 2023 (in thousands) |
|---|---|---|
| Vafseo Clinical Trials | $6,337 | $12,843 |
| Other Programs | $4,252 | $8,668 |
| Total External R&D Expenses | $10,589 | $24,822 |
| Internal Costs | $15,277 | $28,392 |
| Total R&D Expenses | $25,866 | $53,214 |
Operating Expenses
For the nine months ended September 30, 2024, total operating expenses were $107.0 million, compared to $130.6 million in the same period in 2023. The decrease was primarily due to lower R&D expenses.
| Operating Expenses Breakdown | Q3 2024 (in thousands) | Q3 2023 (in thousands) |
|---|---|---|
| Research and Development | $25,866 | $53,214 |
| Selling, General and Administrative | $78,870 | $74,797 |
| License Expenses | $2,242 | $2,381 |
| Restructuring Expenses | $58 | $181 |
| Total Operating Expenses | $107,036 | $130,573 |
Cash and Liquidity
As of September 30, 2024, Akebia reported cash and cash equivalents of $34.0 million and restricted cash of $1.7 million. The company has raised approximately $840.6 million from equity sales since inception, which includes $519.8 million from public offerings and $250.8 million from at-the-market offerings.
Market Strategy and Future Outlook
Akebia's strategy includes leveraging its exclusive rights to market Auryxia until its loss of exclusivity in March 2025. The company plans to enhance its revenue generation through strategic partnerships and collaborations while preparing for the launch of Vafseo. The anticipated inclusion of phosphate binders in the dialysis bundle by CMS is expected to impact Auryxia sales positively post-LoE.
How Akebia Therapeutics, Inc. (AKBA) Makes Money
Product Revenue
Akebia Therapeutics generates the majority of its revenue from the commercial sales of its product, Auryxia. For the nine months ended September 30, 2024, net product revenue was $107.8 million, a decrease from $117.1 million for the same period in 2023. For the third quarter of 2024, net product revenue was $35.6 million, down from $40.1 million in the third quarter of 2023.
| Period | Product Revenue (in millions) | Change (in millions) | Percentage Change |
|---|---|---|---|
| Q3 2024 | $35.6 | $(4.5) | (11)% |
| 9 Months 2024 | $107.8 | $(9.3) | (8)% |
| Q3 2023 | $40.1 | - | - |
| 9 Months 2023 | $117.1 | - | - |
Auryxia is sold primarily through a limited number of wholesale distributors and specialty pharmacy providers. The revenue decline is attributed to a reduction in sales volume, which was partially offset by price increases and a contracting strategy with third-party payors. Auryxia is expected to lose exclusivity in March 2025, which may further impact future revenue from this product.
License, Collaboration, and Other Revenue
In addition to product sales, Akebia earns revenue from licensing and collaboration agreements. For the nine months ended September 30, 2024, this revenue totaled $5.9 million, significantly down from $21.4 million in the same period in 2023. This decrease was primarily due to a one-time $10 million upfront payment recognized in 2023 related to the Medice License Agreement.
| Period | License Revenue (in millions) | Change (in millions) | Percentage Change |
|---|---|---|---|
| 9 Months 2024 | $5.9 | $(15.5) | (73)% |
| 9 Months 2023 | $21.4 | - | - |
Specific agreements contributing to this revenue in 2024 included royalties from Vafseo and Riona, with $2.1 million and $3.7 million recognized from agreements with MTPC and JT and Torii, respectively.
Cost of Goods Sold
The total cost of goods sold for the nine months ended September 30, 2024, was $42.8 million, down from $55.5 million in the previous year. This reflects a $12.7 million decrease, primarily due to lower product sales volume and a $12.3 million benefit recorded from selling previously written-down inventory.
| Cost Component | 9 Months 2024 (in millions) | 9 Months 2023 (in millions) | Change (in millions) |
|---|---|---|---|
| Cost of Product Revenue | $15.8 | $28.5 | $(12.7) |
| Amortization of Intangible Assets | $27.0 | $27.0 | $0.0 |
| Total COGS | $42.8 | $55.5 | $(12.7) |
Operating Expenses
Operating expenses for Akebia totaled $107.0 million for the nine months ended September 30, 2024, compared to $130.6 million in 2023, representing a decrease of $23.5 million. This reduction was primarily due to decreased research and development costs, which fell to $25.9 million from $53.2 million.
| Expense Type | 9 Months 2024 (in millions) | 9 Months 2023 (in millions) | Change (in millions) |
|---|---|---|---|
| Research and Development | $25.9 | $53.2 | $(27.4) |
| Selling, General and Administrative | $78.9 | $74.8 | $4.1 |
| Total Operating Expenses | $107.0 | $130.6 | $(23.5) |
Net Loss
For the nine months ended September 30, 2024, Akebia reported a net loss of $46.6 million, an improvement over the $52.5 million loss reported in the same period in 2023. The net loss per share was $(0.22) for the nine months ended September 30, 2024.
| Period | Net Loss (in millions) | Net Loss per Share |
|---|---|---|
| 9 Months 2024 | $46.6 | $(0.22) |
| 9 Months 2023 | $52.5 | $(0.28) |
As of September 30, 2024, Akebia's cash and cash equivalents stood at $34.0 million, with an accumulated deficit of $1.7 billion, reflecting ongoing financial challenges amidst efforts to commercialize and develop its product portfolio.
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Resources:
- Akebia Therapeutics, Inc. (AKBA) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Akebia Therapeutics, Inc. (AKBA)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Akebia Therapeutics, Inc. (AKBA)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.