• Vertex Pharmaceuticals for kidney disease.
• A specialized biotech company developing and commercializing drugs for kidney conditions, akin to a focused, smaller version of Amgen.

• Auryxia (ferric citrate): A prescription medication used to manage elevated phosphorus levels in adults with chronic kidney disease (CKD) on dialysis, and to treat iron deficiency anemia in adults with CKD not on dialysis.
• Vadadustat: An oral medication developed to treat anemia caused by chronic kidney disease (CKD) by stimulating the production of red blood cells.

Major Customers of Akebia Therapeutics (AKBA)

Akebia Therapeutics primarily sells its pharmaceutical products to other companies, specifically large pharmaceutical wholesale distributors. These distributors then supply pharmacies, hospitals, and other healthcare providers.

Based on Akebia Therapeutics' public filings, a substantial portion of their revenue from product sales is generated from the following three major wholesale drug distributors:

• Cencora (formerly AmerisourceBergen Corporation) (Symbol: COR)
• Cardinal Health, Inc. (Symbol: CAH)
• McKesson Corporation (Symbol: MCK)

• F. Hoffmann-La Roche Ltd. (Symbol: ROG)
• Norwich Pharmaceuticals, Inc.

Mr. Butler joined Akebia as a director in July 2013 and was appointed President and Chief Executive Officer in September 2013. Prior to Akebia, he served as Chief Executive Officer of Inspiration Biopharmaceuticals, Inc. from 2011 to 2013, where he led transactions that resulted in the sale of its hemophilia assets to Cangene Corporation and Baxter International for total aggregate consideration that could exceed $1 billion. From 1997 to 2011, Mr. Butler held various positions at Genzyme Corporation, including President of the rare genetic diseases business and leading the renal division, growing it to $1 billion in revenue. He also held sales and marketing positions at Amgen and Hoffmann-La Roche. Mr. Butler led Akebia's Initial Public Offering in 2014 and the 2018 merger with Keryx Biopharmaceuticals. He has also served on the boards of Zynerba Pharmaceuticals, Inc., Relypsa, Inc., and was Chairman of Keryx Biopharmaceuticals.

Mr. Ostrowski was appointed Senior Vice President, Chief Financial Officer, and Chief Business Officer in June 2024. Before joining Akebia, he served as President, Interim Chief Executive Officer, and Chief Financial Officer at Avrobio, where he led the execution of its merger with Tectonic Therapeutic. Prior to Avrobio, Mr. Ostrowski was Chief Financial Officer of Summit Therapeutics, where he led its initial public offering on Nasdaq. He also has over ten years of experience in investment banking, including at Leerink Partners and Robertson Stephens.

Dr. Burke serves as Senior Vice President, Chief Research & Development Officer. His background includes significant experience in research and development within the biopharmaceutical industry.

Ms. Garko is the Senior Vice President, Chief Technical Officer. She is responsible for the technical operations of Akebia Therapeutics.

Mr. Grund holds the position of Senior Vice President, Chief Commercial Officer. He is responsible for Akebia's commercial strategy and operations.

1. Regulatory and Commercial Limitations of Vafseo (Vadadustat)

   Akebia Therapeutics' lead product, Vafseo (vadadustat), received a limited approval from the U.S. Food and Drug Administration (FDA) in March 2024 for the treatment of anemia due to chronic kidney disease (CKD) exclusively in adult patients on dialysis. This approval came with a boxed warning highlighting an increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access. Furthermore, in November 2025, Akebia announced a strategic decision to discontinue its efforts to gain a broader label for Vafseo for non-dialysis CKD patients, citing a misalignment with the FDA regarding the VALOR trial. This decision significantly constrains the drug's market potential to the dialysis setting, limiting its overall revenue-generating capacity and future growth opportunities.

2. Intense Competition and Limited Market Expansion

   Even within its approved indication for dialysis patients, Vafseo faces substantial competition from existing and new therapies in the hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor class, including daprodustat (Jesduvroq), which was approved by the FDA prior to Vafseo. The decision to cease pursuit of the non-dialysis CKD market for Vafseo further restricts Akebia's ability to expand its market share and diversify its revenue streams, leaving it highly dependent on a competitive and segment-limited market.

3. Ongoing Financial Losses and Need for Additional Capital

   Akebia Therapeutics has a history of accumulating significant operating losses, and its path to sustained profitability remains challenging. Financial reports indicate negative pre-tax and total profit margins as of November 2025. The company also carries a high total debt-to-equity ratio and significant leverage. There is an ongoing risk that Akebia may need to raise additional capital to fund its operations and pipeline development, which could lead to further dilution for existing shareholders or require the company to enter into unfavorable financing agreements.

The clear emerging threat for Akebia Therapeutics (AKBA) is the U.S. market dominance established by **GSK's Jesduvroq (daprodustat)**. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, the same novel class of drugs as Akebia's Vafseo (vadadustat). Jesduvroq received FDA approval in February 2023 for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis in the United States. In contrast, Akebia's vadadustat received a Complete Response Letter from the FDA in March 2022, effectively denying its approval in the U.S. due to safety concerns. This means GSK has secured a significant first-mover advantage and is the only approved HIF-PH inhibitor available in the crucial U.S. market, thereby directly competing with and largely precluding Akebia's core product (vadadustat) from its largest potential market.

Akebia Therapeutics (AKBA) is poised for future revenue growth over the next 2-3 years, driven by several key factors related to its primary products, Vafseo and Auryxia, as well as pipeline expansion.

1. Accelerated U.S. Adoption and Market Penetration of Vafseo (vadadustat)
   Vafseo, launched in the U.S. in the first quarter of 2025, has shown strong initial performance, exceeding revenue guidance with $12.0 million in net product revenue in Q1 2025 and $13.3 million in Q2 2025, representing a 55% sequential increase in demand sales. Akebia has secured commercial supply contracts with dialysis organizations covering nearly 100% of dialysis patients in the U.S. The company anticipates a significant expansion of Vafseo prescribing access, projecting an increase from approximately 40,000 patients at the end of Q2 2025 to over 75,000 by the end of Q3 2025, and further to over 275,000 patients by Q4 2025, bolstered by an operational pilot with major dialysis providers like DaVita.

2. Vafseo Label Expansion to Non-Dialysis Chronic Kidney Disease (CKD) Patients
   A significant future revenue driver is the potential expansion of Vafseo's label to include late-stage CKD patients who are not on dialysis. Akebia plans to initiate the Phase 3 VALOR clinical trial in the second half of 2025 to study vadadustat in this larger market segment. This expansion could unlock a substantial new patient population and drive considerable revenue growth beyond the current dialysis-dependent indication.

3. Resilience and Continued Performance of Auryxia (ferric citrate)
   Despite losing IP exclusivity in March 2025, Auryxia has demonstrated unexpected resilience, with net product revenues increasing to $43.8 million in Q1 2025 (from $31.0 million in Q1 2024) and $47.2 million in Q2 2025 (from $41.2 million in Q2 2024). This sustained performance is attributed to the absence of significant generic approvals (only one authorized generic) and Auryxia qualifying for Transitional Drug Add-on Payment Adjustment (TDAPA) reimbursement. While future sales could be impacted by additional generic competition, Auryxia's strong current performance continues to contribute to Akebia's revenue stream.

4. International Expansion of Vafseo and XOANACYL
   Vafseo's international presence is growing, with its recommendation by the United Kingdom's National Institute for Health and Care Excellence (NICE) in January 2025 for symptomatic anemia in adults undergoing dialysis for CKD. Akebia's partner, Medice, has subsequently launched Vafseo in the U.K. Additionally, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion in April 2025, recommending the approval of XOANACYL (Ferric Citrate as Coordination Complex) for treating elevated serum phosphorous and iron deficiency in adult CKD patients. These international approvals and launches represent opportunities for revenue growth outside the U.S.

Share Issuance

• In March 2025, Akebia Therapeutics priced an underwritten public offering of 25,000,000 shares of common stock at $2.00 per share, expecting to raise $50.0 million in gross proceeds.
• In May 2020, the company announced an upsized underwritten public offering of 11,000,000 shares of common stock at a price of $12.00 per share, with expected gross proceeds of $132,000,000.
• Akebia granted stock options to newly hired employees as inducement awards, including 51,825 options in October 2025 and 47,000 options in July 2024.

Capital Expenditures

• Akebia Therapeutics reported capital expenditures of $0.32 million in 2020, $0.06 million in 2021, and $0.11 million in 2022.
• The company's capital expenditures were $0.00 million in 2023 and $0.03 million in 2024.
• As of June 30, 2025, capital expenditures amounted to $0.15 million.