CAMBRIDGE, Mass. – Akebia Therapeutics Inc. (NASDAQ:AKBA), a biopharmaceutical company, and U.S. Renal Care, a dialysis service provider, today announced a multi-year commercial supply contract for Vafseo®, a treatment for anemia due to chronic kidney disease (CKD) in dialysis patients. The agreement, which covers all U.S. Renal Care centers, will make Vafseo available to physicians and patients starting January 2025.
Vafseo, approved by the U.S. Food and Drug Administration in March 2024, is a once-daily oral medication that stimulates red blood cell production. Akebia anticipates Vafseo will receive Transitional Drug Add-on Payment Adjustment designation in January 2025, which could impact Medicare reimbursement for the drug.
John P. Butler, CEO of Akebia, expressed enthusiasm for the partnership, emphasizing the potential benefit to nearly 2000 nephrologists who will be able to prescribe Vafseo. Mark Caputo, CEO of U.S. Renal Care, also conveyed optimism about the collaboration and the development of treatment protocols for Vafseo.
The deal is expected to provide a new option for managing anemia in the CKD patient population undergoing dialysis. Vafseo works by activating the body's response to hypoxia, which naturally increases the production of erythropoietin, hemoglobin, and red blood cells.
However, it is important to note that Vafseo comes with a boxed warning regarding increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access. The drug is contraindicated in patients with uncontrolled hypertension and known hypersensitivity to its components. Other warnings and precautions include the potential for hepatotoxicity, worsening hypertension, seizures, gastrointestinal erosion, and the lack of established safety for CKD patients not on dialysis.
The safety and efficacy of Vafseo have been established for the indicated patient group, and it is approved for use in 37 countries. The most common adverse reactions reported were hypertension and diarrhea.
This announcement is based on a press release statement from Akebia Therapeutics.
In other recent news, Akebia Therapeutics initiated a clinical trial for Vafseo in collaboration with U.S. Renal Care, aiming to evaluate the drug's effects on dialysis patients. The company also ended its collaboration with CSL (OTC:CSLLY) Vifor and amended loan terms with Kreos Capital VII, managed by BlackRock Inc (NYSE:BLK). This resulted in Akebia regaining full sales rights to Vafseo in the United States, with a disclosed wholesale acquisition cost of $1,278 for a 30-day supply.
In addition, Akebia appointed Erik Ostrowski as Senior Vice President, Chief Financial Officer, Chief Business Officer, Treasurer, and Principal Financial (NASDAQ:PFG) Officer, bringing diverse biotechnology finance experience to the company. On the financial front, Akebia reported an improvement in Q1 2024 revenues, totaling $32.6 million, despite a net loss of $18 million. The company remains well-capitalized with $42 million in cash and equivalents. These are some of the recent developments at Akebia Therapeutics.
InvestingPro Insights
As Akebia Therapeutics (NASDAQ:AKBA) secures this significant multi-year contract with U.S. Renal Care for Vafseo, investors may be interested in the company's financial health and market performance. According to InvestingPro data, Akebia's market capitalization stands at $279.68 million, reflecting its position in the biopharmaceutical industry.
The company's revenue for the last twelve months as of Q2 2024 was $174.5 million, with a gross profit margin of 82.29%. This high margin suggests that Akebia has been efficient in managing its production costs, which could be beneficial as it scales up production of Vafseo for the U.S. Renal Care contract.
Interestingly, Akebia has shown a strong return over the last three months, with a price total return of 42.14%. This recent performance may be indicative of market optimism surrounding the FDA approval of Vafseo in March 2024 and the subsequent commercial agreements like the one announced with U.S. Renal Care.
However, it's important to note that Akebia is not currently profitable, as highlighted by one of the InvestingPro Tips. This is not uncommon for biopharmaceutical companies in the growth phase, especially those launching new products. The success of Vafseo could be crucial for Akebia's path to profitability.
Another InvestingPro Tip reveals that two analysts have revised their earnings upwards for the upcoming period. This could suggest growing confidence in Akebia's financial prospects, possibly influenced by the potential revenue from the Vafseo contract.
For investors seeking more comprehensive analysis, InvestingPro offers additional tips and insights that could provide a deeper understanding of Akebia's financial position and growth potential.
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