Akebia Therapeutics, Inc. (NASDAQ:AKBA) is a fully integrated commercial-stage biopharmaceutical company focused on addressing patients' unmet needs in the kidney disease community. The company's portfolio includes two approved products, Auryxia® and Vafseo®, and a robust pipeline of novel therapeutics targeting areas of unmet needs in acute care settings.
Business Overview
Akebia Therapeutics aims to improve the lives of people impacted by kidney disease. The company's two approved products, Auryxia and Vafseo, play a crucial role in managing the complications associated with chronic kidney disease (CKD).
Auryxia is an orally administered medicine approved and marketed in the U.S. for two indications: (1) the control of serum phosphorus levels in adult patients with dialysis-dependent CKD, and (2) the treatment of iron deficiency anemia in adult patients with non-dialysis-dependent CKD. Auryxia generated net product revenue of $134.6 million in 2023.
Vafseo (vadadustat) is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor approved in the U.S. on March 27, 2024, for the treatment of anemia due to CKD in adults who have been receiving dialysis for at least three months. Akebia plans to commercialize Vafseo in the U.S. in partnership with Vifor (International) Ltd. (now a part of CSL Limited), or CSL Vifor.
Akebia has also granted exclusive licenses to commercialize Vafseo in Japan to Mitsubishi Tanabe Pharma Corporation (MTPC) and in the European Economic Area, United Kingdom, Switzerland, and Australia to MEDICE Arzneimittel Pütter GmbH & Co. KG (Medice).
Financials
For the full year 2023, Akebia reported total revenues of $194.6 million, consisting of $134.6 million in net product revenue from Auryxia and $60.0 million in license, collaboration, and other revenue. The company's net loss for the year was $51.9 million, with an operating cash outflow of $23.4 million and free cash outflow of $23.4 million.
In the first quarter of 2024, Akebia generated total revenues of $32.6 million, including $31.0 million in net product revenue and $1.6 million in license, collaboration, and other revenue. The company reported a net loss of $18.0 million for the quarter, with an operating cash outflow of $19.4 million and free cash outflow of $19.4 million.
Akebia's cash and cash equivalents stood at $42.0 million as of March 31, 2024. The company also has access to additional financing through its $55.0 million term loan facility with Kreos Capital, of which $45.0 million was drawn as of the end of the first quarter.
Vafseo Approval and Launch Execution
The approval of Vafseo in the U.S. in March 2024 represents a significant milestone for Akebia. The company is now focused on executing a successful commercial launch of the product, which it believes has the potential to become a new oral standard of care for dialysis patients with anemia due to CKD.
Akebia has taken several key steps to prepare for the Vafseo launch, including:
Expanding its field-based medical and commercial teams by 55% to engage with prescribers and build demand for the product.
Initiating contract discussions with large dialysis organizations to secure access and favorable pricing for Vafseo.
Submitting an application for Transitional Drug Add-on Payment Adjustment (TDAPA) reimbursement, which is expected to facilitate rapid adoption of Vafseo upon its availability in January 2025.
Collaborating with key investigators and dialysis providers on a study to generate additional data to support further physician education and utilization of Vafseo.
Exploring potential label expansion opportunities for Vafseo, including in non-dialysis CKD patients, to maximize the product's long-term growth potential.
Akebia's management is confident in the company's ability to execute a successful Vafseo launch, citing the strong unmet medical need, high awareness and positive perception of the HIF class among nephrologists, and the product's differentiated profile compared to the other approved HIF-PH inhibitor.
Auryxia Outlook and Expansion Opportunities
While Vafseo represents Akebia's primary commercial opportunity, the company continues to focus on maximizing the value of its established product, Auryxia. The company believes Auryxia's position in the dialysis market will be enhanced by the inclusion of oral phosphate binders in the ESRD bundled payment system starting in January 2025.
Akebia is working to secure favorable contracts with dialysis organizations to maintain Auryxia's access and utilization, even in the face of potential generic competition following the loss of exclusivity in March 2025. The company also sees opportunities to expand Auryxia's reach, particularly in the non-dialysis CKD population, where it believes the product can play a role in managing hyperphosphatemia and iron deficiency anemia.
Furthermore, Akebia's partner, Averoa SAS, has submitted a marketing authorization application for ferric citrate (the active ingredient in Auryxia) in Europe. If approved, Averoa plans to make the product available to patients throughout the European Union, potentially providing an additional revenue stream for Akebia.
Pipeline and Future Growth Opportunities
Beyond its two commercial products, Akebia maintains a robust pipeline of novel therapeutic candidates targeting areas of unmet need in acute care settings. The company's pipeline includes AKB-9090, which is being evaluated for potential use in acute kidney injury or acute respiratory distress syndrome, and AKB-10108 for the treatment of retinopathy of prematurity in neonates.
Akebia is also exploring opportunities to in-license or acquire additional product candidates or technologies to further diversify its portfolio and drive long-term growth. The company's strong cash position and access to financing provide it with the resources to pursue strategic transactions that could complement its existing business.
Risks and Challenges
While Akebia's outlook appears promising, the company faces several risks and challenges that investors should consider:
Successful commercialization of Vafseo: Akebia's ability to execute a successful launch of Vafseo and achieve widespread adoption in the dialysis market will be critical to the company's future success.
Competitive landscape: Akebia faces competition from other HIF-PH inhibitors, as well as established erythropoiesis-stimulating agents, in the anemia treatment market.
Regulatory and reimbursement hurdles: Akebia's ability to obtain favorable pricing and reimbursement for its products, both in the U.S. and internationally, will be a key determinant of their commercial success.
Patent expiration and generic competition: The loss of exclusivity for Auryxia in March 2025 could lead to increased competition and pressure on the product's pricing and market share.
Pipeline development and execution: Akebia's ability to advance its pipeline candidates through clinical development and regulatory approval will be crucial for driving long-term growth.
Conclusion
Akebia Therapeutics is well-positioned for growth following the approval of Vafseo and the continued focus on maximizing the value of Auryxia. The company's successful execution of the Vafseo launch, combined with its efforts to expand Auryxia's reach and develop its pipeline, could drive significant value for shareholders in the years to come. However, investors should closely monitor the company's ability to navigate the competitive landscape, regulatory environment, and patent expiration challenges to ensure Akebia's long-term success.