1. Think of them like Vertex Pharmaceuticals, but instead of cystic fibrosis, they focus on developing and commercializing therapies for kidney diseases.

2. They're similar to a specialized version of Amgen, concentrating their efforts primarily on kidney disease treatments.

• Vadadustat: An investigational oral therapy in Phase III development for the treatment of anemia due to chronic kidney disease (CKD).
• Auryxia: A ferric citrate used to control serum phosphorus levels in adult patients with DD-CKD on dialysis and treat iron deficiency anemia in adult patients with CKD not on dialysis.

Akebia Therapeutics (AKBA) sells primarily to other companies. Based on the provided background information, its major customers are its collaboration partners for the development and commercialization of vadadustat:

• Otsuka Pharmaceutical Co. Ltd. (TYO: 4578)
• Mitsubishi Tanabe Pharma Corporation (TYO: 4508)

These companies have agreements with Akebia for the development and commercialization of vadadustat in specific territories worldwide.

• Cambrex Corporation
• Hovione PharmaScience, SA
• Thermo Fisher Scientific Inc. (TMO)
• WuXi AppTec Co., Ltd. (HKEX: 2359, SSE: 603259)
• Fareva Holdings S.A.S.
• Catalent, Inc. (CTLT)

John P. Butler, President and Chief Executive Officer

John P. Butler joined Akebia as a director in July 2013 and was appointed President and Chief Executive Officer in September 2013. He has over 35 years of experience leading the development, launch, and commercialization of innovative therapies. Prior to Akebia, Mr. Butler served as the Chief Executive Officer of Inspiration Biopharmaceuticals, Inc. from 2011 until 2013, where he led transactions that resulted in the sale of its hemophilia assets to Cangene Corporation and Baxter International for aggregate consideration that could exceed $1 billion. From 1997 to 2011, he held various positions at Genzyme Corporation, including President of the rare genetic diseases business and leading the renal division, which grew to $1 billion in annual revenue. Earlier in his career, he held sales and marketing positions at Amgen and Hoffmann-La Roche. He also led Akebia's Initial Public Offering in 2014 and the 2018 merger with Keryx Biopharmaceuticals.

Erik Ostrowski, Senior Vice President, Chief Financial Officer and Chief Business Officer

Erik Ostrowski was appointed Senior Vice President, Chief Financial Officer, and Chief Business Officer of Akebia in June 2024. Before joining Akebia, Mr. Ostrowski served as President, Interim Chief Executive Officer, and Chief Financial Officer at Avrobio, where he led the company through its merger with Tectonic Therapeutic. His previous roles include Chief Financial Officer of Summit Therapeutics, where he led its initial public offering (IPO) on Nasdaq. Mr. Ostrowski also has over ten years of experience in investment banking, with tenures at Leerink Partners and Robertson Stephens.

Steven K. Burke, M.D., Senior Vice President, Research & Development and Chief Medical Officer

Steven K. Burke, M.D., serves as Akebia's Senior Vice President, Research & Development and Chief Medical Officer.

Nicholas Grund, Senior Vice President, Chief Commercial Officer

Nicholas Grund is the Senior Vice President, Chief Commercial Officer at Akebia Therapeutics.

Carolyn Rucci, Senior Vice President, Chief Legal Officer, General Counsel, Secretary

Carolyn Rucci holds the position of Senior Vice President, Chief Legal Officer, General Counsel, and Secretary at Akebia Therapeutics.

The key risks to Akebia Therapeutics (AKBA) are primarily centered on the commercialization and market access of its lead product, Vafseo (vadadustat), and the declining revenue from its older product, Auryxia.

1. Limited U.S. Label for Vafseo (vadadustat) and Inability to Expand to Non-Dialysis Patients: While Vafseo received U.S. FDA approval in March 2024 for the treatment of anemia due to chronic kidney disease (CKD) in adults on dialysis, this approval is significantly restricted. The FDA had previously issued a Complete Response Letter in March 2022, citing safety concerns including major adverse cardiovascular events (MACE), increased risk of thromboembolic events, and drug-induced liver injury. As a result, Vafseo's U.S. label is limited to dialysis-dependent patients and carries a boxed warning for increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access. Akebia has since halted plans to pursue a broad label for Vafseo in non-dialysis CKD patients after failing to reach consensus with the FDA on a trial design, thereby limiting access to a larger potential market segment.
2. Generic Competition for Auryxia: Akebia's other commercial product, Auryxia (ferric citrate), which is used to control serum phosphorus levels and treat iron deficiency anemia in CKD patients, faces increasing generic competition. Its patent exclusivity ended in March 2025, and generic alternatives are expected to significantly impact Auryxia's sales and revenues, leading to a projected decrease in 2026.
3. Intense Competition and Pricing Pressure in the Anemia Due to CKD Market: The market for treating anemia due to CKD is highly competitive, with established injectable erythropoiesis-stimulating agents (ESAs) like Epogen and Aranesp, as well as other oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitors such as GSK's daprodustat. Additionally, changes in dialysis anemia reimbursement, such as the transition from TDAPA to a bundled payment system in 2027, may lead to pricing pressure and reduced revenue for Vafseo. This competitive landscape, combined with the safety profile and restricted label for Vafseo, could hinder its market penetration and commercial success.

Akebia Therapeutics (AKBA) develops and commercializes therapeutics for patients with kidney diseases, with its main products being vadadustat (Vafseo) and Auryxia (ferric citrate).

Vadadustat (Vafseo)

Vadadustat is approved for the treatment of anemia due to chronic kidney disease (CKD) in adult patients who are on dialysis.

• For the U.S. market addressing anemia in dialysis patients, the estimated addressable market opportunity is approximately $1 billion per year.
• Across the seven major markets (7MM), which include the U.S., France, Germany, Italy, Spain, the UK, and Japan, the chronic kidney disease anemia market is projected to grow from $4.4 billion in 2024 to $5.3 billion in 2034. The U.S. market alone is expected to represent $2.7 billion in 2034, increasing from $2.1 billion in 2024.

Auryxia (ferric citrate)

Auryxia is used to control serum phosphorus levels in adult patients with dialysis-dependent chronic kidney disease (DD-CKD) on dialysis (hyperphosphatemia) and for the treatment of iron deficiency anemia in adult patients with CKD not on dialysis.

Hyperphosphatemia in DD-CKD:

• The global hyperphosphatemia treatment market was valued at $2.6 billion in 2024 and is projected to reach $5.6 billion by 2034.
• The U.S. hyperphosphatemia treatment market was valued at $1,052.6 million in 2024. Another estimate for the U.S. market size was approximately $2.4 billion in 2023.

Iron Deficiency Anemia in CKD Not on Dialysis:

• In the U.S., an estimated 650,000 people with chronic kidney disease not on dialysis are currently treated for iron deficiency anemia.
• The broader global iron-deficiency anemia therapy market was valued at $5.35 billion in 2024 and is projected to reach $11.46 billion by 2032.

Akebia Therapeutics, Inc. (AKBA) is expected to drive future revenue growth over the next 2-3 years primarily through the commercialization of its recently approved product, Vafseo (vadadustat), and advancements in its pipeline.

Here are 3-5 expected drivers of future revenue growth:

1. U.S. Commercial Launch and Uptake of Vafseo: Vafseo (vadadustat), approved by the FDA on March 27, 2024, for the treatment of anemia due to chronic kidney disease (CKD) in adults on dialysis, became available in January 2025. Akebia anticipates significant revenue growth from Vafseo in 2026 and beyond. This growth is expected to be fueled by expanded patient access across dialysis organizations, an increase in new patient starts, and improved patient adherence rates, particularly as dialysis providers implement observed dosing protocols. The company is actively working to establish Vafseo as the standard of care.
2. Vafseo Label Expansion into Non-Dialysis Dependent (NDD) CKD Patients: Akebia plans to pursue label expansion opportunities for Vafseo. This includes engaging with the FDA on potential new indications and aiming to initiate a Phase 3 clinical trial (VALOR) by the end of 2025 to study vadadustat for treating anemia in late-stage CKD patients not on dialysis. Expanding into the NDD CKD market represents a substantial opportunity to reach a broader patient population.
3. International Commercialization of Vafseo: Vadadustat (Vafseo) has already received marketing authorization in Europe (April 2023) and Japan, with approvals in a total of 32 countries globally. Akebia regained full rights to vadadustat in key territories including the U.S., Europe, and China in June 2022. While the company is actively seeking a partner for European commercialization, revenue generated from these international markets, either through direct sales or collaboration agreements and royalties, is expected to contribute to future growth.
4. Advancement of Rare Kidney Disease Pipeline: Akebia is strategically investing revenue generated from Vafseo to advance its mid-stage pipeline in rare kidney diseases. This includes the ongoing enrollment in a Phase 2 clinical trial of praliciguat for focal segmental glomerulosclerosis (FSGS) and plans to initiate a Phase 2 basket study for AKB-097 in complement-mediated kidney diseases in the second half of 2026. Additionally, a Phase 1 study for AKB-9090 targeting acute kidney injury is planned for the first half of the current year. Successful progression and potential commercialization of these pipeline assets could serve as significant long-term revenue drivers.

Share Issuance

• Akebia Therapeutics raised $66.4 million in 2025 through the sale of common stock via an underwritten public offering and an At-The-Market (ATM) facility.
• The number of outstanding shares for Akebia Therapeutics increased by 21.91% in one year, reaching 267.88 million shares outstanding.
• The quarterly shares outstanding increased from 0.166 billion at the end of 2021 to 0.211 billion at the end of 2024, and further to 0.274 billion by September 2025.

Outbound Investments

• In November 2025, Akebia entered into an asset purchase agreement with Q32 Bio Inc. to acquire AKB-097, a clinical-stage development candidate, for an upfront payment of $7 million, with potential for additional milestone payments.

Capital Expenditures

• Akebia Therapeutics reported capital expenditures of -$291,000 in the last 12 months.
• Over the past five years, the average capital expenditure (CapEx) for Akebia Therapeutics has been $1.01 million.
• The company's highest CapEx over the past five years was $2.81 million.