Akebia Therapeutics, Inc. announced key updates pertaining to the commercial launch of Vafseo (vadadustat) Tablets. The company will host an investor conference call at 8:00 a.m. ET on July 11, 2024. 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, the company has 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 U.S. In addition, the company has have made significant progress in contract discussions with dialysis organizations for both Auryxia and Vafseo. Having now executed this agreement with CSL Vifor, the company can accelerate contracting discussions and expect to have contracts in place with dialysis providers treating the vast majority of eligible Vafseo patients before January 2025. 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 U.S. net product sales.

As a result, Akebia regained full rights to sell Vafseo in the U.S. and is able to contract directly with all dialysis organizations effective immediately. Akebia believes its existing and well-established renal sales and medical affairs teams are equipped to drive prescriber demand and enable dialysis organization contracting. Under the terms of the agreement, CSL Vifor is entitled to quarterly tiered royalty payments ranging from a high single-digit%age on annual net sales up to $450 million to a mid-single digit%age on annual net sales above $450 million.

Akebia has the opportunity to buy down the royalty agreement beginning on July 1, 2027 with a one-time payment to CSL Vifor, which would decrease the royalty payments to a mid-single digit%age of Akebia's annual net sales of Vafseo up to $450 million and eliminate the royalty payment on annual net sales above $450 million. 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 $1,278 for a 30-day supply at the minimum starting dose, or approximately $15,500 per year. The entire dialysis business will be a contracted business, offering an off-invoice discount as well as volume tier discounts off this WAC price. The potential label expansion into non-dialysis patients was an important factor in determining the WAC pricing for Vafseo.