CAMBRIDGE, Mass. - Akebia Therapeutics, Inc. (NASDAQ: NASDAQ:AKBA) announced today that it has regained full rights to sell Vafseo® (vadadustat) Tablets in the United States after terminating its license agreement with CSL (OTC:CSLLY) Vifor.
This move is intended to streamline operational management and improve the drug's commercial prospects. Akebia, a biopharmaceutical firm focused on kidney disease treatments, also disclosed the wholesale acquisition cost (WAC) for Vafseo, which is $1,278 for a 30-day supply.
The termination agreement with CSL Vifor includes a royalty structure, where Akebia will make quarterly payments based on Vafseo's net sales, with the option to reduce the royalty rate starting July 1, 2027. This strategic decision allows Akebia to directly engage with dialysis centers and other third-party organizations for contracting purposes.
In preparation for the commercial launch, Akebia submitted a Transitional Drug Add-on Payment Adjustment (TDAPA) application in June 2024. The company anticipates the assignment of Healthcare Common Procedure Coding System (HCPCS) codes by October 2024 and full TDAPA designation by January 1, 2025. The pricing strategy for Vafseo reflects its potential use in both dialysis and non-dialysis patient populations, should it receive approval for the latter.
Akebia's CEO, John P. Butler, expressed optimism about the progress in contract discussions with dialysis organizations. These organizations are expected to cover the majority of eligible Vafseo patients before 2025. The company's established renal sales and medical affairs teams are poised to drive prescriber demand and facilitate these crucial contracts.
Akebia will conduct an investor conference call today at 8:00 a.m. Eastern Time to discuss these commercial updates. Interested parties can register for the call online, and the webcast will be available shortly after the live event on Akebia's website.
The information provided in this article is based on a press release statement from Akebia Therapeutics.
In other recent news, Akebia Therapeutics has seen notable developments. The company recently appointed Erik Ostrowski as Senior Vice President, Chief Financial Officer, Chief Business Officer, Treasurer, and Principal Financial (NASDAQ:PFG) Officer. Ostrowski brings a wealth of experience from his previous roles at AVROBIO, Inc., Summit Therapeutics (NASDAQ:SMMT) plc, and Organogenesis Inc.
In addition, Akebia reported Q1 2024 financial results, with revenues totaling $32.6 million, an improvement from the previous year. Despite a net loss of $18 million, the company remains well-capitalized with $42 million in cash and equivalents. The firm expects to maintain stable spending throughout the year.
Akebia is also making strategic moves with its anemia treatment product, Vafseo. The company's initiatives include driving demand and securing contracts with dialysis providers.
Furthermore, Akebia is exploring the potential of expanding Vafseo's label to non-dialysis chronic kidney disease patients, a move that could significantly drive value post-launch. These are the recent developments regarding Akebia Therapeutics.
InvestingPro Insights
As Akebia Therapeutics (NASDAQ: AKBA) embarks on a new chapter with the full rights to sell Vafseo® in the U.S., the company's financial health and stock performance are critical for investors monitoring its commercial strategy. According to recent data from InvestingPro, Akebia has a market capitalization of $226.36 million, reflecting its size and potential in the biopharmaceutical space. Despite the company's focus on operational efficiency and market prospects, analysts have raised concerns, as indicated by a significant 30.88% decline in revenue over the last twelve months as of Q1 2024.
Investors should note that Akebia has experienced a 14.1% return over the last week, signaling potential investor optimism or market reactions to recent developments. This is coupled with the fact that the company does not pay dividends, which may affect the investment strategy for those seeking regular income from their holdings. The InvestingPro Tips also reveal that Akebia is not expected to be profitable this year, and it has been trading at a high EBITDA valuation multiple, which could be a point of consideration for evaluating the company's current valuation.
For those interested in a deeper analysis, there are additional InvestingPro Tips available, providing a comprehensive outlook on Akebia's financials and market performance. Subscribers can access these tips by visiting the InvestingPro platform for Akebia at https://www.investing.com/pro/AKBA. Moreover, by using the coupon code PRONEWS24, readers can get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, further enriching their investment research with valuable insights.
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