Akebia Therapeutics Provides Update on Continued Momentum of Commercial Launch of Vafseo® (vadadustat) Tablets
Akebia Therapeutics has announced significant updates for the commercial launch of Vafseo® (vadadustat) Tablets. Following a termination agreement with CSL Vifor, Akebia now holds full rights to sell Vafseo in the U.S. The Wholesale Acquisition Cost (WAC) has been set at $1,278 for a 30-day supply. Akebia has submitted a TDAPA application for Vafseo, anticipating designation by January 1, 2025. The company aims to finalize contracts with dialysis providers covering the majority of eligible patients by the end of 2024. Additionally, Akebia will host a conference call on July 11, 2024, at 8:00 a.m. ET to discuss these updates.
- Akebia regained full rights to sell Vafseo in the U.S., enhancing control over sales and distribution.
- Vafseo's Wholesale Acquisition Cost (WAC) set at $1,278 for a 30-day supply provides a clear pricing structure.
- Akebia expects to gain TDAPA designation by January 1, 2025, potentially boosting reimbursements.
- Finalizing contracts with dialysis providers by the end of 2024 could secure substantial market share.
- Obligation for Akebia to make quarterly tiered royalty payments to CSL Vifor, ranging from high single-digit to mid-single digits, which may impact profitability.
- Potential financial burden of the one-time payment to CSL Vifor starting July 1, 2027, to reduce royalty payments.
Insights
Akebia's termination agreement with CSL Vifor simplifies operational execution and improves economics. This move allows Akebia to regain full rights to sell Vafseo in the U.S., enabling them to contract directly with dialysis organizations. The royalty structure, which includes tiered royalties and the option to buy down from 2027, is critical to understand. This structure will influence Akebia's profitability based on sales performance. For retail investors, the immediate control over sales and the subsequent potential reduction in royalty percentages could mean a more streamlined and potentially profitable operation in the long term. However, the initial royalty payments, even at single-digit percentages, could impact near-term profitability.
The Wholesale Acquisition Cost (WAC) pricing of $1,278 for a 30-day supply reflects both the dialysis and potential non-dialysis markets. This pricing strategy indicates that Akebia is positioning Vafseo to compete effectively in both segments. The planned discounts and volume tier discounts further suggest aggressive market penetration strategies aimed at driving adoption. Investors should note that while the high WAC pricing sets a strong revenue potential, it needs to be balanced against the competitive landscape and insurance reimbursement scenarios.
Finally, the TDAPA application submission is a critical milestone. If approved, the TDAPA period starting January 2025 would provide additional financial flexibility by adjusting payment structures, potentially aiding in the drug's adoption and revenue generation during this two-year period. Investors need to keep an eye on this development as it can significantly impact short-term revenue dynamics.
Akebia's move to regain U.S. sales rights for Vafseo marks a significant strategic shift. By bringing sales operations in-house, Akebia is set to streamline its revenue channels and potentially enhance market responsiveness. This strategic shift is likely aimed at reducing operational complexities and improving market penetration efficiency. The key aspect for investors here is the ability of Akebia's established renal sales and medical teams to drive prescriber demand. This internal control could lead to better-targeted marketing and sales strategies, enhancing overall market share in the competitive renal medication market.
Vafseo's pricing strategy at $1,278 for a 30-day supply is noteworthy. This pricing not only reflects its value proposition but also hints at its target market and competitive positioning. For investors, it's critical to consider how this pricing aligns with market expectations, competitive pricing and payer coverage dynamics. The planned off-invoice and volume tier discounts suggest a well-thought-out approach to gain market traction and foster long-term customer relationships.
Another focal point is the potential impact of the TDAPA designation. If approved, the TDAPA period starting in 2025 could significantly enhance Vafseo's market adoption, offering temporary financial relief to dialysis centers adopting the drug. This could accelerate Vafseo's uptake and establish a strong market base, which is important for sustaining long-term revenue growth.
- Akebia regains full rights to sell Vafseo® (vadadustat) Tablets in the
U.S. following the execution of a royalty-based termination agreement with CSL Vifor to simplify operational execution and improve economics - Announced Vafseo WAC pricing of
for a 30-day supply$1,278 - Submitted TDAPA application for Vafseo in June 2024 and expects designation on January 1, 2025
Akebia to host investor conference call at 8:00 a.m. ET on July 11, 2024
"Since Vafseo approval in late March, our team has worked diligently on commercial launch activities to drive prescriber demand with the goal to optimize Vafseo's revenue ramp during the two-year Transitional Drug Add-on Payment Adjustment (TDAPA) period expected to begin in January 2025 and beyond," said John P. Butler, Chief Executive Officer of Akebia. "This is a multi-faceted endeavor, and today I am excited to share progress made on multiple fronts. First, we have established a wholesale acquisition cost (WAC) that reflects the value of Vafseo in both the dialysis and, if approved, non-dialysis populations. Additionally, contracting effectively with dialysis organizations is critical to a successful launch. To help facilitate the contracting process, as well as simplify the operational management of the product, we have agreed with CSL Vifor to terminate the existing license, resulting in Akebia regaining rights to sell Vafseo to Fresenius Kidney Care dialysis centers and specific other third-party dialysis organizations in the
Vafseo Commercial Launch Updates:
CSL Vifor Agreement: Akebia and CSL Vifor have entered into a termination agreement of the license agreement providing for the payment of royalties by Akebia to CSL Vifor on Vafseo
TDAPA Submission: In June, Akebia submitted its TDAPA application. Akebia expects to have Healthcare Common Procedure Coding System (HCPCS) codes assigned in October 2024 and full TDAPA designation by January 1, 2025.
Vafseo Pricing: Vafseo WAC has been set at
Conference Call Information
Akebia will host a conference call on Thursday, July 11, 2024 at 8:00 a.m. Eastern Time to discuss Vafseo commercial updates. To access the call, please register by clicking on this Registration Link, and you will be provided with dial in details. To avoid delays and ensure timely connection, we encourage dialing into the conference call 15 minutes ahead of the scheduled start time.
A live webcast of the conference call will be available via the "Investors" section of Akebia's website at: https://ir.akebia.com/. An online archive of the webcast can be accessed via the Investors section of Akebia's website at https://ir.akebia.com approximately two hours after the event.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in
Forward-Looking Statements
Statements in this press release regarding Akebia Therapeutics, Inc.'s ("Akebia's") strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the
Akebia Therapeutics®, Auryxia® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc. and its affiliates.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
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SOURCE Akebia Therapeutics, Inc.
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