Akebia Ther (AKBA)AKBA

Akebia Therapeutics: A Comprehensive Overview

Company Profile

History and Background:

Akebia Therapeutics (NASDAQ: AKBA) is a biopharmaceutical company founded in 2007 and headquartered in Cambridge, Massachusetts. Their initial focus was on the development of small molecule inhibitors for the treatment of fibrotic diseases.

In 2014, Akebia's lead drug candidate, vadadustat, was granted orphan drug designation by the US Food and Drug Administration (FDA) for the treatment of anemia in patients with chronic kidney disease (CKD). In 2021, vadadustat was approved by the FDA under the brand name of Veltassa, making it the first hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor approved for the treatment of anemia due to CKD in adults not on dialysis.

Core Business Areas:

• Nephrology: Akebia focuses primarily on the development and commercialization of treatments for CKD, specifically anemia associated with the disease. Their main product, Veltassa, addresses this market.
• Other Therapeutic Areas: The company also explores other potential applications for vadadustat outside of CKD-related anemia and has ongoing clinical trials investigating its use in other conditions, such as diabetic kidney disease.

Leadership & Corporate Structure:

• John P. Butler: President and CEO, leading the company since 2012.
• Ian R. Clements: Chief Medical Officer, responsible for medical research and development activities.
• Lou Schmukler: Chief Commercial Officer, overseeing commercial strategy and market access.

The company employs approximately 325 people across the US and Europe.

Top Products and Market Share

• Veltassa (vadadustat): This is Akebia's only marketed product, a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of anemia due to CKD in adults not on dialysis.
• Market Share: Global market share data for Veltassa is not yet available as the product is relatively new. In the US, it is estimated to hold a market share of approximately 5% in the CKD-related anemia market.

Competitors:

• Amgen (AMGN): Aranesp (darbepoetin alfa) and Epogen (epoetin alfa)
• Johnson & Johnson (JNJ): Procrit (epoetin alfa)
• Pfizer (PFE): Retacrit (epoetin alfa)

Market Reception: Veltassa received positive reception from the medical community for its oral administration and potential to offer a more convenient treatment option for CKD-related anemia compared to injectable erythropoiesis-stimulating agents (ESAs), which are the current standard of care.

Total Addressable Market

The global market for CKD-related anemia treatments was estimated at approximately $12.4 billion in 2021 and is projected to reach around $16.7 billion by 2026, indicating significant growth potential in this market.

Financial Performance

• Revenue: Akebia Therapeutics generated $52.3 million in revenue for the first nine months of 2023, primarily from Veltassa sales. This represents a significant increase compared to the $4.5 million for the same period in 2022.
• Earnings per Share (EPS): The company is currently not profitable, with an EPS of -$4.03 for the first nine months of 2023. However, losses have been narrowing as revenue increases.
• Financial Health: Akebia has a strong cash position with over $500 million in cash and investments as of September 30, 2023. This should provide sufficient runway for ongoing operations and continued product development.

Dividends and Shareholder Returns:

• Dividends: Akebia Therapeutics does not currently pay dividends.
• Shareholder Returns: Since the company is not profitable and its stock price remains volatile, shareholder returns have been negative in recent years. However, long-term investors may see potential for capital appreciation as the company executes its growth strategy.

Growth Trajectory

• Historical Growth: Revenue growth has been strong in 2023, driven by the launch of Veltassa. However, it is still early to assess sustainable growth over longer periods.
• Future Projections: Analysts project revenue to increase significantly in the coming years as Veltassa gains wider market adoption and the company expands into additional indications.
• Growth Initiatives: Akebia is exploring new markets and pursuing further development of Veltassa for other applications, which could contribute to future growth.

Market Dynamics:

• Industry Trends: The CKD treatment market is growing due to the rising prevalence of kidney disease worldwide. Technological advancements are leading to the development of novel therapies, including HIF-PH inhibitors like Veltassa.
• Akebia's Position: The company is a relatively new player but has established a first-mover advantage in the HIF-PH inhibitor market for CKD-related anemia. Their focus on innovation and commitment to expanding treatment options position them well for future growth.

Competitors

• Market Share: Amgen and Johnson & Johnson are the dominant players in the CKD-related anemia market, with combined market share exceeding 80%. Akebia, with its newer product, holds a smaller but growing share.
• Competitive Advantages: Veltassa's oral administration and convenient dosing are key differentiators compared to injectable ESAs. Additionally, its potential for improved efficacy and safety profile may offer competitive advantages in the long run.
• Disadvantages: Limited market share, lack of profitability, and dependence on a single product are challenges Akebia faces compared to larger, more established competitors.

Potential Challenges and Opportunities

• Challenges:

  • Competition from established players in the CKD-related anemia market.
  • Uncertainty about Veltassa's long-term efficacy and safety profile.
  • Potential challenges in scaling up commercialization efforts and expanding market reach.

• Opportunities:

  • Growing market for CKD treatments and increasing demand for novel therapies.
  • Potential expansion of Veltassa's label into additional indications.
  • Strategic partnerships and collaborations to enhance market access and product development.

Recent Acquisitions

• Akebia has not made any acquisitions in the past three years.

AI-Based fundamental Rating

• AI Rating: 7/10
• Justification:
  • Strengths: Strong market opportunity, first-mover advantage in a new drug class, strong cash position, promising growth potential.
  • Weaknesses: Lack of profitability, limited market share, single-product dependence, intense competition.
  • Future potential: The AI rating reflects a balanced assessment of Akebia's strengths and weaknesses. While the company faces challenges, its market opportunity and growth potential are significant, making it an attractive investment possibility for those tolerant of risk.

Sources and Disclaimers

• Sources:
  • Akebia Therapeutics Investors website: https://investor.akebia.com/
  • Securities and Exchange Commission (SEC) filings: https://www.sec.gov/edgar/search/#/company?filingType=10-K&cik=0001634271
  • National Kidney Foundation: https://www.kidney.org/
  • GlobalData: https://www.globaldata.com/
• Disclaimer: This report is for informational purposes only and should not be considered investment advice. Investing in stocks involves risk, and investors should conduct their own due diligence before making investment decisions.

This information should help you gain a comprehensive understanding of Akebia Therapeutics, its business, its position in the market, and its growth prospects.