CAMBRIDGE, Mass. - Akebia Therapeutics, Inc. (NASDAQ: NASDAQ:AKBA), a biopharmaceutical company focused on kidney disease treatments, has announced a multi-year commercial contract with a top kidney care service provider in the United States. This agreement, set to expand patient access to its anemia drug Vafseo® (vadadustat), is expected to impact over 200,000 dialysis patients nationwide.
Vafseo, designed to treat anemia associated with chronic kidney disease (CKD) in adults on dialysis, received FDA approval in March 2024. It works by activating the body's response to low oxygen levels, thereby stimulating the production of erythropoietin to increase hemoglobin and red blood cell counts.
The Center for Medicare & Medicaid Services has approved Vafseo for Transitional Drug Add-On Payment Adjustment reimbursement, effective January 1, 2025, and assigned a Level II Healthcare Common Procedure Coding System code for billing purposes.
Nik Grund, Akebia's Chief Commercial Officer, emphasized the company's commitment to broadening Vafseo access as a key element of their commercial launch strategy. He expressed confidence that the supply agreement with a major dialysis organization will significantly enhance the drug's availability among physicians and patients.
It's important to note that while Vafseo has been approved for use in 37 countries, it comes with a boxed warning regarding increased risks of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access when targeting hemoglobin levels above 11 g/dL.
Akebia anticipates that Vafseo will become available in the U.S. in January 2025. This news is based on a press release statement from Akebia Therapeutics.
In other recent news, Akebia Therapeutics has extended its supply agreement with STA Pharmaceutical, securing the long-term supply of vadadustat, an investigational treatment for anemia due to chronic kidney disease. The company has also made significant strides in the commercialization of its anemia drug, Vafseo. The Center for Medicare & Medicaid Services has approved additional reimbursement for Vafseo to dialysis organizations, a move expected to support the drug's adoption.
Akebia has signed a substantial commercial supply agreement with U.S. Renal Care for Vafseo, set to be available in January 2025. Additionally, the company has initiated a clinical trial, known as the VOICE trial, in collaboration with U.S. Renal Care to evaluate Vafseo's effects on dialysis patients.
H.C. Wainwright has reiterated a Buy rating for Akebia, reflecting confidence in the company's commercial strategy and the potential market penetration of Vafseo. 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. Erik Ostrowski has been appointed as Senior Vice President, Chief Financial Officer, Chief Business Officer, Treasurer, and Principal Financial (NASDAQ:PFG) Officer.
InvestingPro Insights
Akebia Therapeutics' recent commercial contract for Vafseo® marks a significant milestone for the company, potentially impacting its financial outlook. According to InvestingPro data, Akebia's market capitalization stands at $288.09 million, reflecting investor interest in the company's growth prospects.
Despite the promising news, it's worth noting that Akebia is not currently profitable, with a negative P/E ratio of -7.49 over the last twelve months as of Q2 2024. This aligns with an InvestingPro Tip indicating that analysts do not anticipate the company will be profitable this year. However, the company's gross profit margin of 82.29% suggests strong potential for profitability once revenue scales up with Vafseo's launch.
Interestingly, Akebia has seen a substantial 65.08% price total return over the past year, which corresponds to another InvestingPro Tip highlighting the company's high return over the last year. This positive market sentiment may be attributed to investor optimism surrounding Vafseo's approval and commercial prospects.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights. Currently, there are 6 more InvestingPro Tips available for Akebia Therapeutics, providing a deeper understanding of the company's financial health and market position.
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