CAMBRIDGE, Mass. - Akebia Therapeutics, Inc. (NASDAQ: NASDAQ:AKBA), a biopharmaceutical firm focused on kidney disease treatments, has announced that its anemia drug Vafseo (vadadustat) has been approved for the Transitional Drug Add-On Payment Adjustment (TDAPA) by the Center for Medicare & Medicaid Services (CMS). Starting January 1, 2025, the program will provide additional reimbursement for Vafseo to dialysis organizations on top of the end-stage renal disease (ESRD) bundled rate for a period of two years.
Vafseo, approved by the U.S. Food and Drug Administration in March 2024, is set to be available in the market in January 2025 for the treatment of anemia due to chronic kidney disease in adults on dialysis for at least three months. The TDAPA status is meant to support the adoption of innovative treatments within dialysis practices.
In addition, Akebia has been assigned a Level II Healthcare Common Procedure Coding System (HCPCS) code for Vafseo, which will streamline the billing process for Medicare enrollees at dialysis organizations. CMS is expected to issue further billing guidance to these organizations in the coming weeks, facilitating the separate TDAPA payment.
Nicholas Grund, Chief Commercial Officer of Akebia, emphasized the importance of TDAPA in encouraging dialysis organizations to integrate new treatments. He noted that the reimbursement status and the HCPCS code are significant milestones in the commercial launch of Vafseo. The company plans to continue engaging with dialysis organizations and healthcare providers, including at the upcoming American Society of Nephrology conference, to foster interest and drive demand for Vafseo.
Vafseo is a once-daily oral medication that stimulates the body's response to hypoxia, thereby increasing the production of erythropoietin, hemoglobin, and red blood cells to manage anemia in adults with chronic kidney disease on dialysis. It has been approved for use in 37 countries but comes with a warning of increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access when targeting hemoglobin levels above 11 g/dL.
This news is based on a press release statement from Akebia Therapeutics, Inc.
In other recent news, Akebia Therapeutics has entered into a significant commercial supply agreement with U.S. Renal Care for its FDA-approved drug Vafseo, which is expected to be available in January 2025. Vafseo is designed to treat anemia caused by chronic kidney disease in adults on dialysis. The agreement includes all dialysis centers operated by U.S. Renal Care, the fastest-growing dialysis provider in the nation.
Akebia has also initiated a clinical trial, known as the VOICE trial, in collaboration with U.S. Renal Care to evaluate Vafseo's effects on dialysis patients. Furthermore, Akebia has ended its collaboration with CSL (OTC:CSLLY) Vifor and amended loan terms with Kreos Capital VII, managed by BlackRock Inc (NYSE:BLK), which resulted in regaining full sales rights to Vafseo in the United States.
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. Akebia also appointed Erik Ostrowski as Senior Vice President, Chief Financial Officer, Chief Business Officer, Treasurer, and Principal Financial (NASDAQ:PFG) Officer. These are the recent developments at Akebia Therapeutics.
InvestingPro Insights
As Akebia Therapeutics (NASDAQ: AKBA) prepares for the commercial launch of Vafseo, investors should consider some key financial metrics and insights from InvestingPro. Despite the positive news about TDAPA approval, which could boost revenue starting in 2025, the company faces some financial challenges.
According to InvestingPro data, Akebia's revenue for the last twelve months as of Q2 2024 stood at $174.5 million, with a concerning revenue decline of 13.13% over the same period. This decline is even more pronounced in the quarterly figures, with a 22.58% drop in Q2 2024 compared to the previous year. These figures underscore the importance of Vafseo's successful launch for the company's future growth.
On a more positive note, Akebia has shown a strong return of 18.52% over the last three months, indicating growing investor optimism, possibly in anticipation of Vafseo's launch. This aligns with the company's efforts to engage with dialysis organizations and healthcare providers to drive demand for the new drug.
InvestingPro Tips highlight that analysts do not anticipate the company to be profitable this year, which is consistent with the reported operating loss of $33.52 million for the last twelve months. However, it's worth noting that two analysts have revised their earnings upwards for the upcoming period, suggesting some optimism about the company's near-term prospects.
For investors considering Akebia's potential, it's important to note that InvestingPro offers additional tips and insights that could provide a more comprehensive view of the company's financial health and prospects. There are 6 additional tips available on InvestingPro, which could be valuable for making informed investment decisions.
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