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Akebia Therapeutics Inc. (AKBA-6.38%) has submitted its Annual Report on Form 10-K filing for the fiscal year ended December 31, 2024. The report provides an overview of the company's business activities, financial condition, and potential risks associated with its operations.
Akebia Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutics for kidney disease. The company's current portfolio includes two commercial products: Vafseo and Auryxia, which target anemia due to chronic kidney disease (CKD) in adult patients on dialysis. Vafseo, an oral HIF prolyl hydroxylase inhibitor, was approved by the U.S. Food and Drug Administration (FDA) in March 2024, and its shipment commenced in January 2025. Auryxia is an orally administered medicine approved for the control of serum phosphorus levels in adult patients with dialysis-dependent CKD and the treatment of iron deficiency anemia (IDA) in adult patients with non-dialysis-dependent CKD.
The company has established commercial supply agreements for Vafseo with dialysis organizations covering nearly 100% of dialysis patients in the U.S. The current U.S. market opportunity for treating anemia due to CKD in patients on dialysis is approximately $1 billion, with Vafseo being the only oral HIF-based treatment available. In the European Union, United Kingdom, Switzerland, and Australia, Vafseo is approved for treating symptomatic anemia associated with CKD in adults on chronic maintenance dialysis. In Japan, Vafseo is approved for both dialysis dependent and non-dialysis dependent CKD patients and is marketed by Mitsubishi Tanabe Pharma Corporation (MTPC).
Akebia's strategy focuses on three main areas: driving Vafseo to become the standard of care for anemia due to CKD, leveraging HIF-based technology to address unmet medical needs within and beyond kidney disease, and exploring strategic growth opportunities. The company is also investing in research and development to expand its pipeline, including the development of AKB-9090 and AKB-10108 for potential use in cardiac surgery-related acute kidney injury (CS-AKI), acute respiratory distress syndrome (ARDS), and retinopathy of prematurity (ROP) in neonates.
Akebia's commercial success depends on its ability to maintain contracts with dialysis organizations for the sale of Auryxia and Vafseo in the U.S., secure adequate pricing and reimbursement, and achieve market acceptance. The company has faced challenges, including competition from other pharmaceutical companies, potential side effects of its products, and evolving regulatory requirements. The company is also subject to various federal and state laws governing its international business practices, including the Foreign Corrupt Practices Act and the European Union General Data Protection Regulation, which impose compliance obligations and potential penalties for violations.
Akebia has conducted several clinical trials for its products, including the global Phase 3 INNO2VATE and PRO2TECT programs for vadadustat. While vadadustat met the primary and key secondary efficacy endpoints in the INNO2VATE program, it did not meet the primary safety endpoint of non-inferiority for MACE in the PRO2TECT program. Despite these challenges, Akebia is committed to pursuing label expansion for Vafseo for the treatment of anemia in non-dialysis dependent CKD patients and is planning a Phase 3 trial to evaluate Vafseo for this indication in the U.S.
Akebia's business strategy also includes exploring strategic transactions to acquire assets, businesses, or rights to products, product candidates, or technologies that could enhance its competitive position. The company has entered into several license and collaboration agreements, including with MEDICE Arzneimittel Pütter GmbH & Co. KG for the development and commercialization of Vafseo in the European Economic Area, the United Kingdom, Switzerland, and Australia, and with Mitsubishi Tanabe Pharma Corporation for the commercialization of Vafseo in Japan and certain other Asian countries.
The company has also entered into a royalty interest acquisition agreement with HealthCare Royalty Partners IV, L.P., selling its right to receive royalties and sales milestones for Vafseo in Japan and certain other Asian countries. Akebia is also exploring additional commercial and development opportunities to expand its pipeline and portfolio of novel therapeutics through both internal research and external innovation.
Akebia's proprietary position is protected through a series of patents and patent applications related to its products, product candidates, and discovery programs. The company also relies on know-how, technological innovation, and potential in-licensing opportunities to maintain its competitive position.
The company is subject to extensive regulation by government authorities in the U.S., European Union, Japan, and other jurisdictions. This includes regulations governing clinical trials, marketing authorization, commercial sales, distribution of drug products, and compliance with privacy and data security laws. Changes in these regulations or failure to comply with them could adversely impact Akebia's business.
Akebia's financial position and ability to generate revenue depend on the successful commercialization of Auryxia and Vafseo, as well as on the company's ability to manage expenses and obtain additional financing if needed. The company has incurred significant losses since its inception and anticipates that it will continue to incur losses for the foreseeable future. The loss of exclusivity for Auryxia in March 2025 and the competitive landscape for its products may impact future revenue and profitability.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Akebia Therapeutics Inc. annual 10-K report dated March 13, 2025. To report an error, please email earnings@qz.com.