Akebia, CSL Vifor enter termination agreement of the Vafseo license agreement

Akebia Therapeutics announced key updates pertaining to the commercial launch of VafseoTablets. Akebia will host an investor conference call at 8:00 a.m. ET on Thursday, July 11. 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 percentage on annual net sales up to $450M to a mid-single digit percentage on annual net sales above $450M. 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 percentage of Akebia’s annual net sales of Vafseo up to $450M and eliminate the royalty payment on annual net sales above $450M. In June, Akebia submitted its TDAPA application. Akebia expects to have Healthcare Common Procedure Coding System, or HCPCS, codes assigned in October and full TDAPA designation by January 1, 2025. 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.